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WO2024261699A1 - Système respiratoire pour faciliter la physiothérapie respiratoire - Google Patents

Système respiratoire pour faciliter la physiothérapie respiratoire Download PDF

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Publication number
WO2024261699A1
WO2024261699A1 PCT/IB2024/056054 IB2024056054W WO2024261699A1 WO 2024261699 A1 WO2024261699 A1 WO 2024261699A1 IB 2024056054 W IB2024056054 W IB 2024056054W WO 2024261699 A1 WO2024261699 A1 WO 2024261699A1
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WO
WIPO (PCT)
Prior art keywords
breathing
flow
user
assistance apparatus
gases
Prior art date
Application number
PCT/IB2024/056054
Other languages
English (en)
Inventor
Madeleine Rose CLEMENTS
Anton Kim GULLEY
Alberto Antonio ZAFFARONI
Original Assignee
Fisher & Paykel Healthcare Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fisher & Paykel Healthcare Limited filed Critical Fisher & Paykel Healthcare Limited
Publication of WO2024261699A1 publication Critical patent/WO2024261699A1/fr

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    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
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Definitions

  • 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.
  • 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.
  • the present disclosure relates to a mouthpiece attachment and system for use with a breathing assistance apparatus to facilitate breathing exercises as part of a therapy programme and measuring performance and/or compliance.
  • the mouthpiece attachment may be used to perform breathing exercises or may be used to obtain measurements that are indicative of, related to, or analogous to breathing exercises.
  • the breathing exercises relate to spirometry
  • the mouthpiece attachment may be considered to be a surrogate spirometer attachment.
  • 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.
  • 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.
  • the present disclosure provides a mouthpiece attachment and system for facilitating breathing exercises as part of a therapy programme and measuring performance and/or compliance.
  • this disclosure broadly comprises a breathing assistance apparatus that is configured to provide a flow of gases, comprising: a flow generator that is operable to generate a flow of gases along a flow path of the breathing assistance apparatus; a breathing conduit for delivery of the flow of gases; a mouthpiece attachment that is fluidly connected or connectable to a patient-end of the breathing conduit to receive the flow of gases; and a controller that is operable to control the breathing assistance apparatus, the controller being configured to control the flow of gases delivered to the mouthpiece attachment to control a pneumatic resistance provided at the mouthpiece attachment while a user performs one or more steps of a breathing exercise with the mouthpiece attachment, the steps of the breathing exercise comprising any one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing.
  • a flow generator that is operable to generate a flow of gases along a flow path of the
  • the breathing assistance apparatus further comprises a humidifier, optionally situated along the flow path of the apparatus between the flow generator and mouthpiece attachment.
  • the flow generator comprises a blower and/or turbine.
  • controlling the pneumatic resistance comprises providing a positive flow of gases at a constant pressure or a constant flow rate.
  • 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.
  • 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.
  • the one or more sensors are provided in a housing of the breathing assistance apparatus along with the flow generator and controller.
  • the flow rate sensor is provided in the form of an ultrasonic-type sensor and/or a heated bead flow sensor.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • controlling the pneumatic resistance at the mouthpiece attachment as the user breathes against a fixed positive expiratory pressure comprises providing a flow rate of the flow of gases sufficient to induce a pre-defined constant PEP at the mouthpiece attachment.
  • controlling the pneumatic resistance at the mouthpiece attachment as the user breathes against an oscillating positive expiratory pressure comprises providing a flow rate of the flow of gases sufficient to induce an oscillating PEP at the mouthpiece attachment.
  • 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.
  • the breathing assistance apparatus further comprises a flutter valve.
  • the controller is in communication with a display screen.
  • 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.
  • the controller is further configured to cause the display screen to display a flow and/or breath profile for user to follow in their performance of the one or more steps of the breathing exercise.
  • 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.
  • 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. 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.
  • the display screen is touch-sensitive and configured to receive inputs from the user.
  • 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.
  • the adjustments are confined to boundaries configured by a medical professional managing the patient.
  • 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.
  • the breathing assistance apparatus further comprises a wireless communications module that is in electrical communication with the controller.
  • the controller is further configured to communicate data via the wireless communications module to a remote device or server for storage and/or processing.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the data communicated comprises compliance data relating to the user’s compliance to a breathing exercise programme.
  • the data communicated comprises subjective feedback data generated by the user.
  • the subjective feedback data comprises at least one response to at least one questionnaire.
  • the data is transmitted to the remote device or server is in the form of a report or report data.
  • the controller is further configured to prompt a user to perform the one or more steps of the breathing exercise.
  • prompting a user to perform the one or more steps of the breathing exercise comprises providing the prompt via the breathing assistance apparatus.
  • prompting a user to perform the one or more steps of the breathing exercise comprises generating an audio prompt by the breathing assistance apparatus.
  • 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.
  • 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.
  • 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.
  • 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 is configurable.
  • the periodic interval is 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 is remotely configurable by a medical professional using an external device that is in data communication with the breathing assistance apparatus.
  • the controller is configured to customize one or more of the timing, form and/or content of a prompt depending on the user.
  • the steps of the breathing exercise may further comprise any one or more of: breathing against intrapulmonary percussive ventilation (IPV), and/or breathing against continuous positive airway pressure (CPAP) with oscillations.
  • IPV intrapulmonary percussive ventilation
  • CPAP continuous positive airway pressure
  • the mouthpiece attachment comprises one or more exhaust openings
  • the controller is configured to detect or decode a user-generated pneumatic signal that is generated by user manipulation of the one or more exhaust openings of the mouthpiece attachment.
  • the controller is configured to detect or decode the user-generated pneumatic signal based at least partly on analysing one or more sensed characteristics of the flow of gases.
  • the one or more sensed characteristics of the flow of gases varies or changes based on user manipulation of the one or more exhaust openings of the mouthpiece attachment.
  • the controller is configured to detect or decode the user-generated pneumatic signal by analysing the one or more sensed characteristics of the flow of gases for variations or changes that correspond to user manipulation of the one or more exhaust openings of the mouthpiece attachment.
  • the controller is configured to control or operate one or more functions of the apparatus in response to detecting or decoding the user-generated pneumatic signal.
  • the one or more functions of the apparatus include any one or more of the following: initiating an exercise mode of the apparatus for the breathing exercises, ceasing an exercise mode of the apparatus, and/or synchronising a characteristic of the flow of gases to the user’s breathing cycle.
  • the controller is configured to detect or decode a plurality different user-generated pneumatic signals, each being generated by a different respective user manipulation of the one or more exhaust openings of the mouthpiece attachment.
  • this disclosure broadly comprises a system for providing respiratory therapy and breathing exercises, comprising: a breathing assistance apparatus that is configured to provide a flow of gases, the breathing assistance apparatus comprising: a flow generator that is operable to generate the flow of gases along a flow path of the apparatus; a controller that is operable to control the breathing assistance apparatus, the controller being configured to control the flow of gases provided to a mouthpiece attachment while the user performs one or more steps of a breathing exercise with the mouthpiece attachment; and a wireless communications module in electrical communication with the controller; a remote computing device, the remote computing device being configured to: receive data from the controller of the breathing assistance apparatus via the wireless communications module; wherein the data comprises at least data indicative of the breathing of the user during performance of one or more steps of the breathing exercise.
  • the remote device is one or more of a remote data processing server, smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device or other suitable peripheral with the prerequisite communication and processing capabilities.
  • this disclosure broadly comprises a method of monitoring compliance to a breathing exercise programme, comprising: providing a breathing assistance apparatus comprising: a flow generator for generating a flow of gases; one or more sensors for sensing or determining one or more characteristics of the flow of gases and generating representative sensor data; and a controller in electrical communication with: the flow generator, the one or more sensors, and a display screen; providing a breathing conduit comprising a proximal end for connection to an outlet of the breathing assistance apparatus, and a distal end; providing a mouthpiece attachment for connection to the distal end of the breathing conduit; providing a user with instructions to perform one or more breathing exercises or breathing exercise steps via the display screen of the breathing assistance apparatus; detecting whether or not a user has performed the one or more breathing exercises or breathing exercise steps by identifying a patient-associated feature in the sensor data representative of one or more characteristics of the flow of gases.
  • the breathing assistance apparatus may further comprise a wireless communications module that is in electrical communication with the controller.
  • the method may further comprise communicating data via the wireless communications module to a remote device or server for storage and/or processing.
  • the data communicated may comprise data relating to one or more characteristics of the flow of gases as detected by one or more sensors of the apparatus.
  • the data communicated may comprise 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.
  • the data communicated may comprise determined user breathing parameter data including one or more of the user’s respiratory rate, minute ventilation, and/or tidal volume.
  • the data communicated may comprise performance data relating to the user's performance of a breathing exercise programme, the breathing exercise and/or specific steps of the breathing exercise.
  • the data communicated may comprise compliance data relating to the user's compliance to a breathing exercise programme.
  • the method may comprise transmitting the data to the remote device or server in the form of a report or report data.
  • This third aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to the first and/or second aspects of the disclosure.
  • this disclosure broadly comprises a method of treating a respiratory disorder using a breathing assistance apparatus, the method comprising: providing a breathing assistance apparatus comprising: a flow generator that is operable to generate a flow of gases along a flow path of the apparatus; a breathing conduit for delivery of the flow of gases; a mouthpiece attachment for breathing exercises that is fluidly connected or connectable to a patient-end of the breathing conduit to receive the flow of gases; controlling the flow of gases through the mouthpiece attachment to control a pneumatic resistance provided at the mouthpiece attachment while a user performs one or more steps of a breathing exercise, the steps comprising one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing.
  • a breathing assistance apparatus comprising: a flow generator that is operable to generate a flow of gases along a flow path of the apparatus; a breathing conduit for delivery of the flow
  • providing the breathing assistance apparatus may comprise providing a breathing assistance apparatus according to the first aspect of the disclosure and any of its associated features or configurations.
  • This fourth aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to any of the first-third aspects of the disclosure.
  • this disclosure broadly comprises a method of diagnosing a respiratory disorder using a breathing assistance apparatus, the method comprising: providing a breathing assistance apparatus comprising: a flow generator that is operable to generate a flow of gases along a flow path of the apparatus; one or more sensors for sensing or determining one or more characteristics of the flow of gases and generating representative sensor data; a breathing conduit for delivery of the flow of breathable gases; a mouthpiece attachment for breathing exercises that is fluidly connected or connectable to a patientend of the breathing conduit to receive the flow of gases; and controlling the flow of gases through the mouthpiece attachment to control a pneumatic resistance provided at the mouthpiece attachment while a user performs one or more steps of a breathing exercise, the steps comprising one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing; identifying a patient-associated feature in
  • This fifth aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to any of the first-fourth aspects of the disclosure.
  • this disclosure broadly comprises a breathing exercise apparatus that is configured to provide a flow of breathable gases, comprising: a flow generator that is operable to generate a flow of breathable gases along a flow path of the apparatus; a breathing conduit for delivery of the flow of breathable gases; a mouthpiece attachment for breathing exercises that is fluidly connected or connectable to a patient-side end of the breathing conduit to receive the flow of breathable gases; and a controller that is operable to control the breathing exercise apparatus, the controller being configured to control the flow of gases into the mouthpiece attachment to control a pneumatic resistance provided at the mouthpiece attachment while a user performs one or more steps of a breathing exercise with the mouthpiece attachment, the steps comprising one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing.
  • a flow generator that is operable to generate a flow of breathable gases along
  • This sixth aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to any of the first-fifth aspects of the disclosure.
  • this disclosure broadly comprises a respiratory therapy device configured to provide respiratory therapy, the respiratory therapy device comprising: a flow generator that is operable to generate a flow of breathable gases along a flow path of the device; a breathing conduit for delivery of the flow of breathable gases; a mouthpiece attachment for breathing exercises that is fluidly connected or connectable to a patient-side end of the breathing conduit to receive the flow of breathable gases; and a controller that is operable to control the respiratory therapy device, the controller being configured to control the flow of gases into the mouthpiece attachment to control a pneumatic resistance provided at the mouthpiece attachment while a user performs one or more steps of a breathing exercise with the mouthpiece attachment, the steps comprising one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing.
  • This seventh aspect of the disclosure may further comprise any one or more of the features or configuration
  • this disclosure broadly comprises a breathing assistance apparatus that is configured to provide a flow of breathable gases to a user, comprising: a flow generator that is operable to generate a flow of breathable gases along a flow path of the apparatus; and a controller that is operable to control the breathing assistance apparatus, the controller being configured to control the flow of gases to control a pneumatic resistance provided to the user while the user performs one or more steps of a breathing exercise, the steps comprising one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing.
  • PEP positive expiratory pressure
  • OPEP oscillating positive expiratory pressure
  • This eighth aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to any of the first-seventh aspects of the disclosure.
  • this disclosure broadly comprises a breathing assistance apparatus that is configured to provide a flow of breathable gases to a user, comprising: a flow generator that is operable to generate a flow of breathable gases along a flow path of the apparatus; and a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus in either a therapy mode in which the controller controls the flow of gases to provide respiratory therapy to a user, or an exercise mode in which the controller controls the flow of gases to control a pneumatic resistance provided to the user while the user performs one or more steps of a breathing exercise, the steps comprising one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing; wherein the breathing assistance apparatus is configured to connect with a mouthpiece attachment for delivery of the flow of breathable gases to the user when operating in the exercise mode
  • This nineth aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to any of the first-eighth aspects of the disclosure.
  • this disclosure broadly comprises an apparatus comprising: a flow generator operable to generate a flow of breathable gases along a flow path of the apparatus; one or more sensors for sensing or determining one or more characteristics of the flow of gases and generating representative sensor data; a breathing conduit for delivery of the flow of breathable gases; a mouthpiece attachment for breathing exercises that is fluidly connected or connectable to a patient-side end of the breathing conduit to receive the flow of breathable gases; and a controller being configured to control the flow of gases through the mouthpiece attachment to control a pneumatic resistance provided at the mouthpiece attachment while the user performs one or more steps of a breathing exercise, the steps comprising one or more of: normal breathing; tidal breathing; maximal breathing; huffing; breathing against a fixed positive expiratory pressure (PEP); breathing against an oscillating positive expiratory pressure (OPEP); slow and deep inhalation; and/or pursed lip breathing; wherein the controller is further configured to identify a patient-associated feature in the sensor data representative of one or more characteristics of
  • This tenth aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to any of the first-nineth aspects of the disclosure.
  • this disclosure broadly comprises a system for providing respiratory therapy and breathing exercises, the system comprising: a breathing assistance apparatus that is configured to provide a flow of breathable gases, the breathing assistance apparatus comprising: a flow generator that is operable to generate a flow of breathable gases along a flow path of the apparatus; a controller that is operable to control the breathing assistance apparatus, the controller being configured to control the flow of gases provided to a user performing one or more steps of a breathing exercise; wherein the system further comprises a mouthpiece attachment for delivery of the flow of breathable gases to the user, said mouthpiece attachment being fluidly connectable to the flow path of the breathing assistance apparatus.
  • This eleventh aspect of the disclosure may further comprise any one or more of the features or configurations discussed above in relation to any of the first-tenth aspects of the disclosure.
  • 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 method of any one or more aspects above.
  • 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.
  • API application program interface
  • 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.
  • Figure 1 shows schematically a breathing assistance apparatus configured to provide a respiratory therapy to a patient.
  • 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.
  • Figure 2B illustrates a block diagram of an example controller.
  • 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.
  • 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.
  • Figure 6 shows a perspective view from a connector end of a mouthpiece attachment in an example embodiment.
  • Figure 7 shows a perspective view from a mouthpiece end of the mouthpiece attachment of Figure 6.
  • Figure 8 shows a first side elevation view of the mouthpiece attachment of Figure 6.
  • Figure 9 shows a second side elevation view of the mouthpiece attachment of Figure 6.
  • Figure 10 shows a plan view of the mouthpiece attachment of Figure 6.
  • Figure 11 shows an underside view of the mouthpiece attachment of Figure 6.
  • Figure 12 shows a first end view of the mouthpiece attachment of Figure 6 from a mouthpiece end.
  • Figure 13 shows a second end view of the mouthpiece attachment of Figure 6 from a connector end.
  • Figure 14 shows a cross-sectional view of the mouthpiece attachment through lines AA of Figures 12 and 13.
  • Figure 15 shows a close-up perspective view of a connector end of the mouthpiece attachment of Figure 6.
  • Figure 16 shows a first end perspective view of an example embodiment of a removable mouthpiece for the mouthpiece attachment.
  • Figure 17 shows a second end perspective view of the removable mouthpiece of Figure 16.
  • Figure 18 shows a plan view of the removable mouthpiece of Figure 16.
  • Figure 19 shows a cross-sectional view of the removable mouthpiece through line BB of Figure 18.
  • Figure 20 shows a side elevation view of the removable mouthpiece of Figure 16.
  • 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.
  • Figure 23 shows an exploded perspective view of the mouthpiece attachment and removable mouthpiece of Figure 22.
  • Figure 24 shows a side view of the mouthpiece attachment with assembled mouthpiece of Figure 22.
  • Figure 25 shows a cross-sectional view of the mouthpiece attachment with assembled mouthpiece through line DD of Figure 24.
  • Figure 26 shows a plan view of the mouthpiece attachment with assembled mouthpiece of Figure 22.
  • Figure 27 shows a cross-sectional view of the mouthpiece attachment with assembled mouthpiece through line EE of Figure 26.
  • Figure 28 shows a first perspective view of the mouthpiece attachment with assembled mouthpiece of Figure 22 including clip formations.
  • Figure 29 shows a second perspective view of the mouthpiece attachment with assembled mouthpiece and clip formations of Figure 28.
  • Figure 30 shows a side elevation view of the mouthpiece attachment with assembled mouthpiece and clip formations of Figure 28.
  • 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.
  • 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.
  • 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.
  • Figures 34A-34C show example schematic GUI display screen prompts instructing the user to disconnect the patient interface in accordance with an example configuration.
  • Figures 35A-35C show example schematic GUI display screen prompts instructing the user to connect the mouthpiece attachment to the flow path of the breathing assistance apparatus.
  • Figures 36A-36F show example schematic GUI display screen prompts instructing the user to perform forced exhalation manoeuvres in accordance with an example configuration.
  • Figures 37A and 37B show example schematic GUI display screen prompts instructing the user to breathe normally following the forced exhalation manoeuvres in accordance with an example configuration.
  • Figure 38 shows an example schematic GUI display screen prompt instructing the user about a non-therapy mode.
  • Figure 39 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 40 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.
  • Figure 41 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.
  • Figures 42A and 42B are graphs of example user-generated flow rate data for healthy and sick persons performing breathing exercises with the mouthpiece attachment and breathing assistance apparatus.
  • the mouthpiece attachment is an attachment or auxiliary component for use with a breathing assistance apparatus or respiratory system or exercise system or exercise apparatus.
  • 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.
  • 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.
  • the mouthpiece attachment is configured to fluidly couple to the flow of gases generated by a breathing assistance apparatus or an apparatus with a flow generator generally, or is otherwise in fluid communication with the flow of gases.
  • the mouthpiece attachment is configured to fluidly couple or connect to the end of, or partway along, the flow path of a breathing assistance apparatus such that it receives a flow of gases generated by the breathing assistance apparatus.
  • the mouthpiece attachment is removably connectable to the breathing assistance apparatus.
  • the mouthpiece attachment is removably connectable to the breathing assistance apparatus or flow path of an apparatus via one or more intermediate flow-path components such as, but not limited to, humidifiers, connectors, ports, bypass circuits or ports, couplers, breathing conduits, or the like.
  • the mouthpiece attachment may connect to the end of a patient breathing conduit, such as a flexible breathing conduit connected to the gases outlet of an apparatus.
  • the mouthpiece attachment may instead be permanently attached to (or formed integrally as a part of) a flexible breathing conduit.
  • the mouthpiece attachment may connect directly to the gases outlet or any other accessible outlet or port along the flow path of the breathing assistance apparatus.
  • the mouthpiece attachment may attach to the gases outlet of the apparatus that typically connects to a patient breathing conduit.
  • the breathing assistance apparatus may comprise a removable humidification chamber that is in fluid communication with the flow generator such that it receives the flow of gases generated by the flow generator.
  • the removable humidification chamber may be connected or fluidly coupled to the flow generator by a gases outlet port of the apparatus.
  • the gases outlet port may be the outlet of the flow generator or may be in fluid communication with the flow generator outlet.
  • the humidifier or humidifier chamber may be bypassed via a bypass conduit or other bypass configuration.
  • 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.
  • the mouthpiece attachment connects to the flow path such that it is in fluid communication with the flow of gases generated by the flow generator and/or breathing assistance apparatus.
  • the mouthpiece attachment comprises a main body extending between a connector end and a mouthpiece end.
  • the connector and mouthpiece ends are fluidly connected by a main lumen or lumens (e.g., a channel or passage) extending between the ends of the main body.
  • the main body may be a tubular component extending between the connector end and mouthpiece end.
  • the main body may be substantially hollow.
  • the connector end comprises one or more openings or ports for fluidly connecting to an end of a flexible breathing conduit connected to the breathing assistance apparatus.
  • the mouthpiece end provides or can receive a mouthpiece that comprises one or more openings or ports to provide fluid communication with the user’s airway, when in use.
  • One or more exhaust openings e.g., vents
  • the vent or vents may be in fluid communication with the main lumen.
  • a controller of the breathing assistance apparatus may, manually or automatically, initiate an exercise mode.
  • the controller may prompt the user (e.g., via visual and/or audible prompts or notifications) to undertake or follow one or more steps to perform a breathing exercise or series of breathing exercises.
  • 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).
  • gases e.g., air or air supplemented with one or more other gases such as oxygen
  • 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.
  • the phrase ‘pneumatic resistance’ as used in this disclosure 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).
  • the controlled flow rate and/or pressure of the flow of gases may define the nature of the pneumatic resistance.
  • 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.
  • 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.
  • the controller of the breathing assistance apparatus may also be configured to capture measurement data during a measurement process.
  • the measurement data may comprise or represent one or more characteristics of the flow of gases (e.g., airflow measurements) and/or user breathing information or measurements.
  • the measurement data may be captured during the performance of the breathing exercises.
  • the controller may operate the measurement process concurrently while the user is performing the breathing exercises in the exercise mode of the apparatus.
  • the breathing assistance apparatus can capture the measurement data via sensing one or more characteristics of the flow of gases in the flow path via one or more sensors.
  • the sensor data generated by the one or more sensors may comprise data indicative of the user’s breathing during the breathing exercises and/or measurement process.
  • the sensor(s) may be provided in the main housing of the breathing assistance apparatus and/or in the patient breathing conduit.
  • the sensor data may be stored, analysed, and/or processed to generate output data representing the user’s performance of the breathing exercises, which may in turn provide a measure of lung performance or lung function, including spirometry data or data indicative of or analogous to spirometry measurements.
  • Output data may also be generated representing a user’s completion of scheduled breathing exercises, and thus their compliance with a predetermined or prescribed therapy programme.
  • 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).
  • 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.
  • 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.
  • 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, or other such flow- or pressure-controlled respiratory therapies.
  • high flow therapy e.g., nasal high flow (NHF) therapy
  • PAP Positive Airway Pressure
  • CPAP Continuous Positive Airway Pressure
  • NMV non-invasive ventilation
  • bi-level PAP therapy bi-level PAP therapy, or other such flow- or pressure-controlled respiratory therapies.
  • 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.
  • the flow of gases is provided without added humidity (i.e., any humidifier in
  • the mouthpiece attachment and methods and processes of using the mouthpiece attachment, will be described in the context of an example breathing assistance apparatus 10 that is configured or operable to provide nasal high flow therapy via an unsealed patient interface. This is intended as a non-limiting example. It will be appreciated that the mouthpiece attachment may be operable with a broad range of breathing assistance apparatuses comprising flow generators.
  • FIG. 1 A schematic representation of the example breathing assistance apparatus 10 is provided in Figure 1.
  • 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.
  • 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.
  • the breathing assistance apparatus can have a connection for coupling to a flow source.
  • 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.
  • the system can include a combination of components selected from the following:
  • a conduit e.g., dry line or heated breathing tube
  • the flow source could be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas and/or a high flow apparatus with a flow generator 50B.
  • 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.
  • 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 control 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, and/or when the breathing assistance apparatus is operating in a pressure control mode - controlling the flow generator to provide a target pressure) such as a nasal mask, full face mask, or nasal pillows.
  • 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 control mode - controlling the flow generator to provide a target flow of gases
  • a non-sealing nasal cannula or a sealed (sealing) interface (for example when used in CPAP, and/or when the breathing assistance apparatus is operating in a pressure control mode - controlling the flow
  • 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).
  • 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.
  • a humidifier 52 can optionally be provided between the flow source 50 and the patient to provide humidification of the delivered gas.
  • 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).
  • 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. 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.
  • the humidifier may be optional, or it may be preferred due to the advantages of humidified gases helping to maintain the condition of the airways during therapy mode.
  • 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.
  • 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.
  • 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.
  • An optional non-return valve 23 may be provided in the breathing conduit 16.
  • 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 5 OB.
  • the breathing assistance apparatus 10 could be an integrated or a separate componentbased arrangement, generally shown in the dotted box 100 in Figure 1.
  • the apparatus or system could be a modular arrangement of components.
  • the apparatus or system may just comprise some of the components shown, not necessarily all are essential.
  • the conduit and patient interface do not have to be part of the system, and could be considered separate.
  • Breathing assistance apparatus and respiratory system will be broadly considered herein to comprise anything that provides a flow rate of gas to a patient.
  • Some such apparatus and systems include a detection system that can be used to determine if the flow rate of gas meets inspiratory demand.
  • 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.
  • the user interface 54 of the breathing assistance apparatus 10 may comprise a removable display screen or touch screen.
  • the user interface 54 of the breathing assistance apparatus may comprise a graphical user interface (GUI) presented on a display screen or touch screen.
  • GUI graphical user interface
  • 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.
  • the patient breathing conduit 16 can also be a tracheostomy interface, or other unsealed interfaces.
  • 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.
  • the humidifier 52 of the apparatus is configured to combine or introduce humidity with or into the gases flow.
  • the humidifier 52 can comprise a humidification chamber that is removable.
  • the humidification chamber may be partially or entirely removed or disconnected from the flow path and/or apparatus.
  • the humidification chamber may be removed for refilling, cleaning, replacement and/or repair for example.
  • 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.
  • 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.
  • 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.
  • 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.
  • the humidification chamber contains a volume of liquid, typically water or similar.
  • 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.
  • the humidifier is a pass-over humidifier. In another configuration, the humidifier may be a non-pass-over humidifier.
  • 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.
  • 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.
  • 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.
  • 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.
  • the gases inlet and gases outlet may be position on the same side of the chamber.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the transceiver may comprise a Wi-Fi modem.
  • 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.
  • 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.
  • NFC Near Field Communication
  • the breathing assistance apparatus 10 may comprise a high flow therapy apparatus. 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 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.
  • 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.
  • HHFNC humidified high flow nasal cannula
  • HFNO high flow nasal oxygen
  • HFT high flow therapy
  • THF tracheal high flow
  • 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.
  • 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.
  • 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.
  • HFT high flow therapy
  • 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.
  • FIG 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 of the gases flowing through the respiratory system as is the gases are delivered to a patient.
  • the control system 920 can increase or decrease the flow rate 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 for a particular patient as discussed below.
  • the flow rate can be optimized by the control system 920 to improve patient comfort and therapy.
  • the control system 920 can also generate audio and/or display/visual outputs 938, 939.
  • 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.
  • the control system 920 can automatically recommend a flow rate 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.
  • 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.
  • 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, SpO 2 ) 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, CO 2 sensor(s) inputs 915, and/or spirometer inputs 916.
  • PWM pulse
  • the control system 920 can receive inputs from the user or stored parameter values in a memory 624 (shown in FIG. 2B).
  • the control system 920 can dynamically adjust flow rate 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.
  • 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.
  • a gauge pressure sensor may be configured to sense the gauge pressure of the flow of gases and generates a representative gauge pressure variable, such as a gauge pressure signal or pressure data.
  • the gauge pressure may represent the pressure of the flow of gases in the flow path with reference or relative to atmospheric pressure.
  • the gauge pressure may represent the difference between the absolute pressure inside the flow path and the absolute pressure inside the housing (i.e. atmospheric or ambient pressure).
  • An absolute pressure sensor may be configured to sense the absolute pressure of the flow of gases and generates a representative absolute pressure variable, such as an absolute pressure signal or pressure data.
  • the absolute pressure may represent the pressure of the flow of gases in the flow path with reference or relative to a vacuum.
  • the one or more pressure sensors that are configured to sense or measure a pressure characteristic of the flow of gases may be directly in or at least partially immersed in the main or bulk flow path of the flow of gases (e.g. the sensors may be part of or exposed to a sensor passage or sensor chamber that forms part of the main or bulk flow path), or directly in or at least partially immersed in a secondary or sample flow path that is operatively or fluidly connected to the main or bulk flow path, or otherwise operatively or fluidly couple or connected to the flow of gases in the flow path.
  • the pressure sensors for sensing pressure characteristics of the flow of gases may be independently mounted within the housing of the apparatus and electrically connected or otherwise in data communication with the controller or control system, or may be mounted or coupled to a sensor circuit board or other circuit board associated with the flow path of the flow of gases.
  • the pressure sensors may be located or configured to sense the pressure of the flow of gases at a location along the flow path before (e.g. upstream of) the humidifier or humidification chamber.
  • the pressure sensor(s) may be located or configured to sense the pressure of the flow of gases at a location along the flow path between the flow generator, e.g. blower, and humidifier chamber, for example at a location along the flow path between the blower outlet and humidifier chamber inlet (i.e. downstream of the blower and upstream of the humidifier chamber).
  • One or more pressures may also be provided for sensing other pressures associated with the apparatus, such as the ambient environment in which it is located.
  • the apparatus may be provided with an ambient pressure sensor that is configured to sense or measure the ambient or atmospheric pressure of the local ambient environment in which the apparatus is located and generates a representative ambient pressure variable, such as an ambient pressure signal or pressure data.
  • the ambient pressure sensor may be an absolute pressure located or positioned on or in the housing and which is configured to sense the ambient or atmospheric pressure of the environment the apparatus is located in.
  • the apparatus may be provided with a gauge pressure signal that generates a gauge pressure signal or data representing the gauge pressure associated with the flow of gases in the flow path.
  • the apparatus may be provided with a gauge pressure sensor configured to generate a gauge pressure signal or data representing the gauge pressure associated with the flow of gases, and an ambient pressure sensor configured to generate an ambient pressure signal or data.
  • the apparatus can be configured to utilise the ambient pressure data as an input to a correction algorithm or factor or function applied to the sensed gauge pressure signal or data.
  • the correction algorithm, factor or function may be configured to correct the sensed gauge pressure signal or data to take into account the impact of changing air density on the sensed gauge pressure signal or data.
  • FIG 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.
  • 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.
  • any of the features of the respiratory system described herein including but not limited to the humidification chamber, the flow generator, the user interface, the controller, and the patient breathing conduit configured to couple the gases flow outlet of the respiratory system to the patient interface, can be combined with any of the sensor modules described herein.
  • FIG 3 illustrates a block diagram of the motor and sensor module 2000, which can be received by the 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a sensing circuit board 404 with sensors 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 and pressure, as the gases flow, and therefore provide a better representation of the characteristics of the gases flow.
  • the gases After passing through the flow path 402 in the sensor chamber 400, the gases can exit to the humidification chamber.
  • 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.
  • 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 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.
  • a driver causes a first sensor, such as an ultrasonic transducer, to produce an ultrasonic pulse in a first direction.
  • a second sensor such as a second ultrasonic transducer, receives this pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers.
  • the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a processor or controller of the respiratory system.
  • the second sensor can transmit and the first sensor can receive a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, allowing characteristics of the gases flow, such as a flow rate or velocity, to be determined.
  • acoustic pulses transmitted by an acoustic transmitter, such as an ultrasonic transducer can be received by acoustic receivers, such as microphones. More details of an acoustic flow rate sensor are described in PCT Application Publication WO2017/095241, filed 2 December 2016, which is incorporated by reference herein in its entirety.
  • Readings from both the first and second types of sensors can be combined to determine a more accurate flow measurement. For example, a previously determined flow rate and one or more outputs from one of the types of sensor can be used to determine a predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from the other one of the first and second types of sensor, in order to calculate a final flow rate.
  • Example embodiments of the mouthpiece attachment will be described in the context of the example breathing assistance apparatus 10 described above, which is configured or operable as a flow therapy apparatus to provide nasal high flow therapy via an unsealed patient interface.
  • the mouthpiece attachment may also be used similarly with other forms or types of suitable breathing assistance apparatuses with a controllable flow generator and one or more sensors for sensing characteristics of the flow of gases.
  • 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.
  • 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.
  • 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.
  • an example embodiment of an exercise system 700 is provided using a mouthpiece attachment 1702 in combination with the breathing assistance apparatus 10.
  • the exercise system 700 in this example may comprise the breathing assistance apparatus 10 described with reference to Figure 1 in combination with a mouthpiece attachment 1702 attached to the end of the breathing conduit rather than the nasal cannula 51.
  • the mouthpiece attachment 1702 is a component that can be releasably or removably connected to an end of the patient breathing conduit 16.
  • the breathing assistance apparatus 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.
  • the mouthpiece attachment 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 comprising a flow generator.
  • the mouthpiece attachment receives a flow of gases generated by the flow generator of the breathing assistance apparatus.
  • the breathing assistance apparatus 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.
  • patient breathing information may comprise a patient flow rate signal and/or a patient pressure signal, representing the flow and/or pressure affected by the patient during performed breathing exercises.
  • the breathing assistance apparatus can be operated in a mode (e.g., an exercise mode) that delivers a flow of gases at a controlled flow rate to the mouthpiece attachment to provide a controllable pneumatic resistance.
  • a mode e.g., an exercise mode
  • Measurements may then 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. It is also envisaged that certain 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 patient interface such as a nasal cannula, nasal mask, nasal pillows, or face mask.
  • breathing exercises or techniques such as normal breathing, maximal breathing and huffing
  • the breathing assistance apparatus can be used or operated as an exercise system or in an exercise mode for respiratory physiotherapy, in addition to being operable in a therapy mode to deliver respiratory therapy (e.g., nasal high flow therapy).
  • the mouthpiece attachment 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 and/or breathing conduit. This configuration enables the mouthpiece attachment to leverage the existing sensors and sensing capability of the breathing assistance apparatus, 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 to perform measurements using the pre-existing one or more sensors of the breathing assistance apparatus.
  • 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).
  • the exercise 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.
  • 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.
  • 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
  • the second end 1708 is a mouthpiece end.
  • 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.
  • 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.
  • 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.
  • the internal diameter of the main lumen 1710 is substantially uniform along at least a portion of the length of the main body 1704.
  • 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.
  • 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.
  • 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.
  • 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.
  • This configuration can also be described as the central portion 1712 of the main lumen 1710 having a substantially uniform cross-sectional area.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the main body 1704 has a substantially circular cross-section along its length as shown in Figures 24, 25, 30 and 31 for example.
  • 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.
  • 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.
  • 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.
  • 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.
  • the first region 1720 is larger in dimension or diameter D8 than the dimension or diameter D9 of the second region 1721.
  • the connector end region indicated at 1721 has a smaller diameter or dimension than the remainder of the main body 1704.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 in other embodiments.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a respiratory patient interface e.g., nasal cannula, nasal mask, full face mask, tracheostomy interface or similar
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the connector end 1706 may be configured to attach or connect to a 20mm breathing tube used with a high flow breathing assistance apparatus.
  • 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.
  • 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 later use in a normal respiratory therapy mode.
  • 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.
  • 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.
  • the mouthpiece attachment 1702 may be provided with an integral breathing conduit extending from the connector end 1706.
  • 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.
  • 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. Mouthpiece end
  • 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.
  • 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.
  • the mouthpiece end 1708 may be any other suitable shape or configuration for receiving and retaining a releasably mouthpiece.
  • the mouthpiece attachment 1702 may be used directly without a separate removable mouthpiece.
  • 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.
  • 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.
  • 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.
  • the mouthpiece attachment 1702 may not have any exhaust vents or exhaust openings, and the system configuration may allow for this.
  • exhaust vents, exhaust openings, and/or pressure relief valves may be provided in the flow path upstream of the mouthpiece attachment.
  • 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.
  • the one or more exhaust openings 1716 are provided in and/or along the main body 1704 of the mouthpiece attachment 1702.
  • 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.
  • 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.
  • 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.
  • one or more protruding exhaust vents may project from the surface wall or the main body.
  • 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.
  • the total cross-sectional area of the exhaust opening or openings 1716 may be configured to suit the desired exhaust flow requirements.
  • 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.
  • the diameter of the openings may be customised or configured to suit the required exhaust flow requirements.
  • each of the exhaust openings 1716 is a circular hole or aperture having a diameter of approximately 5mm.
  • the opening area of each exhaust opening is approximately 19.6mm 2 .
  • the inner cross-sectional area of the main lumen is approximately 397.6mm 2 as defined by the internal diameter D6 of 22.5mm.
  • 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.
  • 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.
  • 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.
  • the line array of exhaust openings 1716 extends in a direction aligned with the longitudinal axis of the main body 1704.
  • 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 embodiments.
  • 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 embodiments.
  • exhaust openings 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 embodiments.
  • the exhaust openings are arranged in an array such as a linear array or non-linear array, or any other pattern or configuration.
  • 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.
  • the exhaust openings may be provided circumferentially about the circumference of the main body.
  • 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.
  • exhaust openings or arrays of exhaust openings may be provided 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.
  • the exhaust openings may be provided on opposite or opposing sides, or on multiple sides of the main body 1704.
  • the location of the one or more exhaust openings or arrays or exhaust openings along and/or about the main body 1704 may vary.
  • the exhaust opening or openings may be centrally located or located in a middle region of the mouthpiece attachment 1702 or main body 1704.
  • 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.
  • 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.
  • the properties of the one or more exhaust openings 1716 may be varied in different embodiments including, but not limited to, the number, shape, opening area, arrangement, uniformity, circumference, and/or diameter for example.
  • 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 embodiment 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.
  • the mouthpiece end 1708 of the main body 1704 may itself be a mouthpiece, or may have an integrated mouthpiece.
  • 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.
  • 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.
  • the removable mouthpiece 1730 may provide certain advantages in some scenarios or circumstances from a usability, manufacturing and/or hygiene viewpoints.
  • the removable mouthpiece 730 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.
  • 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.
  • 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.
  • the attachment portion or region 1734 of the mouthpiece 1730 is a cylindrical conduit portion.
  • the outer diameter D10 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.
  • the relative dimensions of the outer diameter D10 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 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.
  • 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.
  • 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 embodiments including, but not limited to, snap-fit, screw-thread, fastening or clipping systems, or the like.
  • the removable mouthpiece in this embodiment comprises a single main lumen or passage indicated at 1736 extending between its ends.
  • 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.
  • 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.
  • a plurality or multiple lumens e.g., channels or passages
  • 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.
  • 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.
  • the mouthpiece portion 1732 may be circular, elliptical, oval, mouth-shaped, or any other suitable shape in cross-section.
  • the removable mouthpiece 1730 in this embodiment is a substantially straight or elongate component defined about a central longitudinal axis.
  • the mouthpiece may have any suitable shape, including having one or more arcs or bends, and/or may be elbow-like in general shape.
  • the removable mouthpiece 1730 is arranged to be a releasable component of the mouthpiece attachment 1702.
  • 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 embodiments. 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 embodiments may have some resilient flexibility to enable provide or form a snap-fit clip or clipping arrangement.
  • 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 embodiments, the antiocclusion features may have a dual purpose or function, such as also forming a clip, but in other embodiments the anti-occlusion features may have the sole function of preventing blockage of the exhaust openings during use.
  • the example embodiment of the mouthpiece attachment 1702 described above may be formed of any suitable materials.
  • the main body 1704 may be primarily formed of a rigid or semi-rigid 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the materials used and/or thickness of the materials used to form the mouthpiece attachment 1702 may depend on the circumstances of use.
  • 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.
  • 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.
  • 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.
  • 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).
  • the mouthpiece attachment may be formed of materials more suited to a disposable item.
  • a patient may be required to perform a programme of breathing exercises for respiratory physiotherapy.
  • patients may be provided with a standalone passive mechanical device through which they are required to exhale.
  • 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 existing 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 associated exercise mode that can be initiated while the patient performs the breathing exercises with the mouthpiece attachment or other patient interface connected to the flow of gases generated by the breathing assistance apparatus.
  • the flow generator is operable to provide a controlled flow of gases to control a pneumatic resistance to a patient’s breathing exercises.
  • Sensors onboard the breathing assistance apparatus can be leveraged to provide a measure of a patients 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.
  • the breathing assistance apparatus may be capable of one or more modes of operation.
  • the breathing assistance apparatus can have one or more therapy modes for providing a flow of gases with specific properties (e.g., flow rate and/or pressure) suitable for high flow therapy, CPAP, bi-level PAP/NIV, or other such respiratory therapy.
  • the breathing assistance apparatus further comprises an exercise mode, which may be initiated when the breathing assistance apparatus is used with the mouthpiece attachment 1702 or a respiratory patient interface to undertake breathing exercises.
  • 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 provided to the user.
  • the one or more sensors of the apparatus 10 are 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.
  • 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 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 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 has been connected to the breathing assistance apparatus and/or breathing conduit. Additionally or alternatively, the user may generate a pneumatic signal via manipulation of the one or more exhaust openings/vents of the mouthpiece attachment to trigger initiation of the exercise mode, as will be discussed in more detail later.
  • a data network e.g., a Wi-Fi network
  • 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.
  • 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).
  • 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 apparatus 10.
  • 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.
  • 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 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.
  • 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.
  • the exercise mode may be initiated manually.
  • a user may manually select the exercise mode via input to the apparatus.
  • a medical professional may initiate the exercise mode via remote control as discussed above.
  • the exercise mode may be initiated automatically, either locally by the local controller 19 of the 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 apparatus 10 and remote device, system or server.
  • 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 apparatus 10 and/or any remote device, server or system in data communication with the apparatus 10.
  • the visual prompts may be displayed on a display or touch-screen display of the 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.
  • 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.
  • 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.
  • 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.
  • 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 method in this example is 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, exercise system and/or mouthpiece attachment described previously.
  • the breathing assistance apparatus 10 may start the exercise mode when the mouthpiece attachment 1702 is connected.
  • 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.
  • the breathing assistance apparatus 10 may initiate the exercise mode upon start-up.
  • the apparatus may be provided as a dedicated exercise system or device having only a single mode, the single mode being an exercise mode, i.e., in this example configuration the apparatus may not provide any therapy modes.
  • 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 schedule or other criteria being satisfied, as described above).
  • the user or medical professional may be prompted to initiate the exercise mode in response to a prompt (such as a reminder).
  • 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.
  • 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.
  • GUI graphical user interface
  • 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.
  • a user may respond to the prompts, instructions and/or guidance with voice- activated commands or responses.
  • GUI screen prompts for the steps in the exercise method 750 are described below by way of example only. It will be appreciated that numerous variations in the GUI screen prompts are possible, and 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.
  • 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.
  • an ‘exercise session’ is intended to mean a use session with the breathing assistance apparatus in which the user operates the apparatus in the exercise mode to carry out breathing exercises or a programme of breathing exercises.
  • the visual and/or audible instructions, prompts and/or guidance may provide information to the user about any one or more of the following:
  • the operating mode of the apparatus e.g., exercise mode
  • the user may power on or start the breathing assistance apparatus 10.
  • the user may be asked via a GUI on the display of the apparatus 10 to respond to a patient health questionnaire or enquiry.
  • the user will then follow the screen prompts and questions presented on the GUI and enter their answers for processing.
  • Examples of a patient health questionnaire or enquiry process that may be carried out is provided in PCT Application No. PCT/IB2020/060335 (published as W02021/090184), filed 4 November 2020, which is incorporated by reference herein in its entirety.
  • the patient may be prompted to perform one or more breathing exercises or one or more steps of a breathing exercise, and the apparatus will enter the exercise mode (step 752 of method 750).
  • the user or patient is 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.
  • a respiratory patient interface 51 may still be connected to the breathing conduit 16 if the breathing assistance apparatus was last used in a therapy mode in a previous therapy session (e.g., from a previous day or earlier in the day).
  • Figures 34A-34C show schematic examples of one or more GUI display screen prompts 754A, 754B, 754C that may be displayed on the display of the user interface of the apparatus during step 754.
  • GUI display screen prompts 754A, 754B, 754C may be displayed on the display of the user interface of the apparatus during step 754.
  • Various different variations are possible, as will be appreciated.
  • Example screen prompt 754A in Figure 34A includes a text and/or graphics field 7541 describing or indicating the current operating mode (in this example, exercise mode).
  • a main instruction text and/or graphics field 7542 includes text and/graphics instructing the user to disconnect the patient interface, which in this example is a nasal cannula.
  • One or more secondary or additional text and/or graphics fields 7543 may also be provided that show additional instructions or detail about how to carry out the main instruction, for example.
  • the example screen prompt 754B in Figure 34B shows a variant in which there is a single main instruction text and/or graphics field 7544.
  • the example screen prompt 754C in Figure 34C shows a variant in which there is an animation field or region 7545 which may display a 2D or 3D graphic, image, animation, or video depicting or indicative of the instructions, i.e., to assist in guiding the user through the actions required to complete the step or instructions, which in this case is removing or disconnecting the patient interface from the breathing conduit.
  • an animation field or region 7545 which may display a 2D or 3D graphic, image, animation, or video depicting or indicative of the instructions, i.e., to assist in guiding the user through the actions required to complete the step or instructions, which in this case is removing or disconnecting the patient interface from the breathing conduit.
  • 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.
  • 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.
  • a user may vocally interact with the prompts (such as confirming they have been understood the instructions and followed them).
  • 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.
  • FIGS 35A-35C show schematic examples of one or more GUI display screen prompts 756A, 756B, 756C that may be displayed on the display of the user interface of the apparatus during step 756.
  • GUI display screen prompts 756A, 756B, 756C may be displayed on the display of the user interface of the apparatus during step 756.
  • Various different variations are possible, as will be appreciated.
  • Example screen prompt 756A in Figure 35 A includes text and/or graphics field 7541 describing or indicating the current operating mode (in this example, exercise mode).
  • a main instruction text and/or graphics field 7562 includes text and/graphics instructing the user to connect the mouthpiece attachment 1702 to the breathing conduit 16.
  • One or more secondary or additional text and/or graphics fields 7563 may also be provided that show additional instructions about how to carry out the main instruction, for example.
  • the example screen prompt 756B in Figure 35B shows a variant in which there is a single main instruction text and/or graphics field 7564.
  • the example screen prompt 756C in Figure 35C shows a variant in which there is an animation field 7565 which may display a 2D or 3D graphic, image, animation or video depicting or indicative of the instructions.
  • the animation field may assist in guiding the user through the actions required to complete the step or instructions, which in this case is connecting the mouthpiece attachment 1702 to the apparatus 10.
  • 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 for the exercises, as previously described.
  • 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. It is envisaged that this 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • the flow rate setting (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 may vary depending on the particular breathing exercise step being undertaken. For example, the flow rate setting will 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 may be universally set based on an industry standard related to the pneumatic resistance required for breathing exercises or each specific breathing exercise.
  • the breathing assistance apparatus during exercise mode, may be configured or operable to control the composition of gases delivered during an exercise session.
  • 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.
  • 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.
  • the breathing assistance apparatus 10 delivers a non-humified flow of gases (i.e., the flow of gases is provided at substantially ambient humidity).
  • the breathing assistance apparatus may not have a humidifier.
  • the humidifier may be switched off or deactivated or disconnected.
  • 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.
  • the user may be instructed to perform normal breathing, tidal breathing, or maximal breathing into the mouthpiece of the mouthpiece attachment against a pneumatic resistance created by the flow of gases.
  • the breathing exercises may be similar to those conducted during spirometry assessments and/or measurements.
  • the breathing exercises may comprise any one or more of the following (discussed in further detail later):
  • IPV intrapulmonary percussive ventilation
  • normal breathing is intended to mean when the user breathes normally (which will be restfully), i.e., without instructions to breathe deeply or forcefully.
  • 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.
  • 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.
  • maximal 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.
  • 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), and these will be explained in further detail later.
  • a specific respiratory therapy e.g., PEP, OPEP, IPV, CPAP with oscillations
  • 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.
  • 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.
  • Figures 36A-36F show schematic examples of one or more GUI display screen prompts 760A, 760B, 760C, 760D, 760E, 760F that may be displayed on the display of the user interface of the apparatus during step 760.
  • GUI display screen prompts 760A, 760B, 760C, 760D, 760E, 760F may be displayed on the display of the user interface of the apparatus during step 760.
  • Various different variations are possible, as will be appreciated.
  • Example screen prompt 760A in Figure 36A includes text and/or graphics field 7541 describing or indicating the current operating mode, in this example, an exercise mode.
  • a main instruction text and/or graphics field 7602 includes text and/graphics instructing the user to perform a breathing exercise with the mouthpiece attachment 1702, breathing against a flow of gases.
  • One or more secondary or additional text and/or graphics fields 7603 may also be provided that show additional detail about how to carry out the main instruction, for example.
  • the example screen prompt 760B in Figure 36B shows a variant in which there is a single main instruction text and/or graphics field 7604.
  • the example screen prompt 760C in Figure 36C shows a variant in which there is an animation field or region 7605 which may display a 2D or 3D graphic, image, animation, or video depicting or indicative of the instructions, i.e., to assist in guiding the user through the actions required to complete the step or instructions, which in this case is performing one or more breathing exercises.
  • an animation field or region 7605 which may display a 2D or 3D graphic, image, animation, or video depicting or indicative of the instructions, i.e., to assist in guiding the user through the actions required to complete the step or instructions, which in this case is performing one or more breathing exercises.
  • the countdown timer may provide guidance to the user as to how long they need to perform a step of a breathing exercise for.
  • the countdown is provided with text and numerals, but it will be appreciated that a countdown timer may be provided with animations, graphics, or videos either alone or in combination with text and numerical information.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Exercise sessions comprising a plurality of breathing exercises
  • the apparatus may be configured, while in the exercise mode, to instruct the user to perform repeated or multiple breathing exercises in a session.
  • 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.
  • 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.
  • 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.
  • 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.
  • the sets of measurement data from each breathing exercise may then be combined, aggregated or otherwise processed to create an averaged set of data.
  • 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.
  • the highest quality or best set of measurement data may be selected from the sets of measurement data for subsequent processing and analysis. For example, if the user is required to carry out at least three breathing exercises in an exercise session, the sets of sensor data from each breathing exercise may be analysed to select the best or highest quality data of the three or more sets of data from the exercise session. The highest quality set of measurement data may be selected based on one or more criteria.
  • the selection criteria may consider one or more factors such as, but not limited to, whether the data comprising minimal noise or has a high signal-noise ratio (e.g., a strong breathing signal relative to some noise), and/or whether the data is a good fit to the expected pattern of a breathing exercise (e.g., avoiding data in which the breathing exercise appears to have been stopped early by the patient).
  • factors such as, but not limited to, whether the data comprising minimal noise or has a high signal-noise ratio (e.g., a strong breathing signal relative to some noise), and/or whether the data is a good fit to the expected pattern of a breathing exercise (e.g., avoiding data in which the breathing exercise appears to have been stopped early by the patient).
  • 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.
  • 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.
  • the user is prompted to breathe normally for a specific time period, as shown at sub-step 760C to complete the exercise session.
  • 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).
  • normal breathing is different to tidal breathing, which is typically more deep, focused breathing (although still relaxed, and non-forceful).
  • the variable z may be configured as desired.
  • 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.
  • Figures 37A and 37B show schematic examples of one or more GUI display screen prompts 770A and 770B that may be displayed on the display of the user interface during sub-step 760C.
  • GUI display screen prompts 770A and 770B may be displayed on the display of the user interface during sub-step 760C.
  • Various different variations are possible, as will be appreciated.
  • Example screen prompt 770A in Figure 37A includes text and/or graphics field 7541 describing or indicating the current operating mode, in this case an exercise mode.
  • a main instruction text and/or graphics field 7702 includes text and/graphics instructing the user to breathe normally.
  • One or more secondary or additional text and/or graphics fields 7703 may also be provided that show additional details about how to carry out the main instruction, for example.
  • the display region 7703 may comprise a countdown timer which displays how long the user should continue to breathe normally, before the exercise session ends.
  • the example screen prompt 770B in Figure 37B shows a variant in which there is an animation field or region 7705 which may display a 2D or 3D graphic, image, animation or video depicting or indicative of the instructions to assist in guiding the user through the actions required to complete the step or instructions, which in this case is breathing normally for a preset or specified period of time.
  • an animation field or region 7705 which may display a 2D or 3D graphic, image, animation or video depicting or indicative of the instructions to assist in guiding the user through the actions required to complete the step or instructions, which in this case is breathing normally for a preset or specified period of time.
  • 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.
  • 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.
  • 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.
  • processing and/or analysing the measurement data e.g., sensor data
  • the breathing exercises 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.
  • the measurement 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 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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. Switching to another non-therapy mode following completion of an exercise session in exercise mode
  • the apparatus may switch to another non-therapy mode, either automatically or in response to manual input or control by the user.
  • the breathing assistance apparatus may switch to another non-therapy mode.
  • non-therapy modes include:
  • a drying mode (a mode where the flow generator is driven at high speeds to dry out any moisture lingering in the flow path and/conduit of the apparatus), and/or
  • a disinfection mode (a mode wherein the humidification chamber and breathing conduit are disconnected and a disinfection conduit/kit is connected so as to form a loop between the flow generator outlet and outlet elbow and driven to a high temperature in order to disinfect the outlet elbow).
  • the user may be prompted by the display screen GUI that the apparatus has switched to another non-therapy mode, and is no longer in the exercise mode.
  • FIG 38 shows one schematic example of a GUI display screen prompt 780 that may be presented on the display of the apparatus.
  • Example screen prompt 780 in Figure 38 includes text and/or graphics field 781 describing or indicating that the apparatus has switched to another non- therapy mode.
  • a main instruction text and/or graphics field 782 may also be provided, and may include text and/or graphics informing the user about the status of the apparatus and/or instructions on initiating the non-therapy mode.
  • the display field 782 may indicate that the apparatus is ready for non-therapy mode to be started. Extracting or generating user performance features and/or breathing data from the sensor data
  • the flow rate data signal and the fluctuations caused by breathing exercises (in this case forced expiratory manoeuvres) into the mouthpiece attachment is shown.
  • the flow of gases was set to provide pneumatic resistance at a flow rate of 70 L/min.
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • a much lower flow rate e.g., approximately 10 L/min
  • a much lower flow rate 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.
  • FIG. 39 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.
  • 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.
  • 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.
  • the sensor data e.g., flow rate or other sensor data
  • the processed user performance measurement data may be graphed or represented graphically for display on a user interface (e.g., GUI display).
  • the graphs may be further processed to identify and/or determine the health status of a user, e.g., whether they are healthy or sick.
  • Examples of user performance measurements and/or breathing data that may be extracted or identified from the measurement data (e.g., sensor data, such as the flow rate signal or flow rate data) from the exercise session are further explained below.
  • the pressure P pa tient (e.g., patient or user pressure signal) exerted by a patient during the breathing exercises may be computed from the flow rate signal, for example by applying the following equation:
  • Pbiower is the pressure measured at the output of the breathing assistance apparatus using a pressure sensor located in the flow path downstream of the flow generator
  • R is the resistance to flow between the flow generator output and the patient (including the resistance due to the connected mouthpiece attachment)
  • Q or Qrotai i s the How generator output flow rate (e.g. 70 L/min in the example above with reference to Figure 39 but could be any other suitable flow rate)
  • m preferably has a value of 2, but any value between 1 and 2 may be suitable.
  • the value of m may be pre-determined and is a quantifier of how laminar or turbulent the flow through the mouthpiece attachment is.
  • the flow conductance (C) between the flow generator output and the patient can be represented as:
  • the flow Qpatient e.g., patient or user flow rate signal
  • Rp a tient i s the known flow resistance of the mouthpiece attachment at the flow rate Q (i.e., the flow resistance between the connector end of the mouthpiece attachment and the mouthpiece of the mouthpiece attachment), and again m has a value of 2, but any value between 1 and 2 may be suitable.
  • n has the same definition as the previous components m and .
  • the controller is able to estimate the Qpatient signal:
  • C Threshoid has a pre-defined value. For example, 83.2 L/min/cmFbO 1711 .
  • the threshold may have to be satisfied for a minimum period of time (e.g., in seconds), to ensure accuracy.
  • FEV 1 value or FEV 1 analogue may be computed by analysing the first second of flow rate data once a patient has begun exhaling in an exhalation manoeuvre.
  • FEV2 and FEV3 values or analogues may be computed by analysing the first two and three seconds (respectively) of flow rate data once a patient has begun exhaling in an exhalation manoeuvre.
  • FVC may be computed by determining the total volume of air exhaled over a full exhalation manoeuvre. This may, for example, involve integrating the processed patient flow rate signal (Q pa tient) between the start and finish of an exhalation. Alternatively, the patient flow rate signal may instead be represented by negative fluctuations in the unprocessed sensed raw flow rate signal, and the FVC may be computed from these negative fluctuations.
  • An FEVi/FVC ratio - another performance metric - may be readily computed from the FEVi and FVC values described above.
  • PEF may be computed by identifying a peak patient flow, corresponding to the highest peak in the processed patient flow rate signal Q pa tient or alternatively the deepest ‘trough’ in the raw flow rate signal, as seen in Figure 23.
  • some measurements can be computed from Qpatient signal(s) generated during normal breathing or alternatively tidal breathing by the patient into the mouthpiece attachment.
  • the flow generator output flow rate Q may be lower compared to the forced exhalation breathing exercise, and may be 10 E/min or some other suitable flow rate for example.
  • Examples of other measurements that can be extracted or determined during the normal breathing or tidal breathing into the mouthpiece attachment may include any one or more of the following:
  • Respiratory rate may be computed via zero-crossing detection, peak detection, frequency analysis, or other suitable means of identifying the time period of processed patient flow rate signal Q patient-
  • Tidal volume may be computed by integrating the Qpatient signal over one or more breathing cycles contained in the signal.
  • Minute ventilation may be computed using the RR and VT parameters above,
  • the inspiratory time to breath time ratio may be computed by identifying the time periods of inspiration and total breath time via zeros crossings or some other suitable means of identifying the time period of processed patient flow rate Signal Q p at ient-
  • any of the above user performance or breathing data metrics or features may be particularly useful for analysing the status or symptoms of a patient with COPD, asthma, bronchiectasis, or other respiratory condition that affects lung health or performance.
  • One or more of these features, or other suitable user performance or breathing parameters may be used to help guide selection of suitable therapy settings (e.g., a prescription for respiratory therapy) for a breathing assistance apparatus (e.g., a respiratory therapy device).
  • suitable therapy settings e.g., a prescription for respiratory therapy
  • a breathing assistance apparatus e.g., a respiratory therapy device
  • FiO2 fraction of inspired oxygen
  • flow rate settings may be at least partially informed by one or more performance and/or breathing parameters determined using the mouthpiece attachment connected to the breathing assistance apparatus operating in an exercise mode.
  • Upper and/or lower boundaries for said therapy settings or prescription may also be selected based at least partly on the performance and/or breathing parameters or metrics generated during an exercise session using the exercise mode of the apparatus.
  • a medical professional may receive and review the user’s performance and/or breathing metrics, measurements, results or features generated, and then propose a prescription to the patient at least partly based on the measurement results.
  • the prescription may define or comprise any one or more of the following settings or characteristics for the flow of gases provided in the respiratory therapy for therapy mode: flow rate, oxygen concentration (e.g., FiCF), and/or humidity level.
  • Any one or more of the user performance and/or breathing measurements, features, values or indicators in the result data that are extracted, identified, or calculated from an exercise session with the mouthpiece attachment may be represented, stored, recorded or displayed on their own or as a ratio, percentage, or fraction relative to the expected value of a healthy member of the population group the user belongs to or relative to some other baseline value or parameter.
  • PEF may be represented as a ‘PEF as a percentage of a healthy adult male or female’.
  • the indicator values expected for a healthy adult male or female can be stored in look-up tables or other suitable data structures which may be stored in memory of the apparatus or other accessible remote memory or data storage (e.g., cloud or remote server data storage).
  • any one or more of the individual user performance measurements, indicators, features, or values in the result data may be combined in any one or more desirable ratios or functions relative to each other to generate new useful performance metrics or ratios.
  • calculating the ratio or value of FEV 1/FVC may be useful as a spirometry assessment.
  • FEV1/FVC may desirably be between 70- 80% (or 0.7-0.8) to indicate good health.
  • 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, and peak inspiratory flow.
  • example exercise methods 1490 and 1500 will be described in further detail.
  • 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, exercise system and/or mouthpiece attachment described above.
  • any of the steps disclosed in relation to methods 1490 and 1550 may be combined with, supplemented by and/or swapped interchangeably with the steps of methods 750 and 750 A described above.
  • the method 1490 starts at step 1491 with a prompt to initiate the breathing exercise session.
  • 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).
  • the exercise mode may be automatically triggered remotely by a supervising medical professional or according to a pre-programmed condition.
  • 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 to the breathing exercise(s). It is envisaged that the target pneumatic resistance will depend upon the particular step of the breathing exercise or type of breathing exercise being performed as set out below.
  • the breathing exercises include one or more of the following steps (e.g., types of breathing exercise): normal breathing, tidal breathing, • maximal breathing,
  • huffing i.e., huff coughing — a medical exercise that involves taking a breath in, holding it, and exhaling forcefully but slowly and continuously
  • IPV intrapulmonary percussive ventilation
  • a breathing exercise or programme of breathing exercises may comprise any one or more of the above steps (e.g., 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.
  • breathing exercises that may be prescribed for the user to perform in a breathing exercise programme.
  • 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.
  • some of the breathing exercises involve the user breathing against a flow of gases provided in accordance with PEP therapy, OPEP therapy, IPV therapy, and/or CPAP with oscillations therapy.
  • the 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.
  • 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).
  • 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.
  • 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.
  • a visual and/or audible prompt provided by the apparatus
  • 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.
  • 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, as will be discussed further below.
  • 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).
  • the frequency of the positive pressure oscillations in IPV may be approximately 2-4Hz, compared with approximately 10Hz for OPEP.
  • 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).
  • 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).
  • the oscillating pressure waveform representing the oscillating pressure is always above zero (i.e., a positive pressure).
  • the oscillating pressure may have a minimum that is zero or near zero, but is never a negative pressure.
  • 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 heightened resistance to their normal breathing.
  • 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.
  • the controller may operate to shut down or otherwise block output from the flow generator.
  • the only flow of gases through the flow path of the apparatus is that induced by the user (either during exhalation or inhalation). For example, there would be zero flow through the apparatus until the patient breathes. This mode of operation is particularly useful for breathing exercises related to incentive spirometry.
  • the controller may operate in a pressure-controlled mode while the patient is performing breathing exercises.
  • 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, and CPAP with oscillations therapy.
  • 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.
  • Bi-level pressure e.g. BiPAP
  • BiPAP may also be provided, with a higher pressure provided during inspiration (as compared to expiration), partially mimicking cough-assist devices and helping to promote mucus clearance.
  • the nature of the controlled pneumatic resistance provided via the flow of gases may at least partly depend on the type or step of the 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 (pneumatic resistance) in the flow of gases.
  • the controller may provide the desired pneumatic resistance for a breathing exercise using any one or more of the following control techniques:
  • 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.
  • the constant PEP is provided only during the exhalation phase of the user’s breathing 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.
  • 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.
  • 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.
  • 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.
  • a user may be prompted or otherwise guided to either attach, detach or bypass the mouthpiece attachment from the breathing assistance apparatus.
  • 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.
  • 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.
  • 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.
  • GUI graphical user interface
  • the breathing assistance apparatus may be configured to provide real-time instructions to the user to following 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.
  • 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.
  • a user could be provided with real-time feedback relating to a breathing exercise.
  • 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.
  • ‘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.
  • 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.
  • the feedback may comprise information relating to one or more parameters of the flow of gases.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 exercise step, or all steps, depending on whether they are struggling to perform the exercise or alternatively need a more challenging exercise.
  • the user-adjustments may be confined by boundaries and/or thresholds configured by a medical professional that is managing the user.
  • 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.
  • 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.
  • the encouragement feedback may comprise positive affirmation or message to the user, to encourage them to complete or continue the breathing exercise.
  • 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.
  • any suitable external electronic device such as a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or similar such device.
  • user input or interaction e.g., adjustments to parameters as discussed above may also be provided through such external electronic devices.
  • 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.
  • 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.
  • 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 steps or types of breathing exercises described above (e.g., normal breathing, tidal breathing, maximal breathing, huffing, breathing against a fixed positive expiratory pressure (PEP), breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against continuous positive airway pressure (CPAP) with oscillations, slow and deep inhalation, and/or pursed lip breathing).
  • 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.
  • spirometry-like measurement steps may be performed before and/or after a specific breathing exercise step and/or entire exercise session, to determine spirometry-like metrics (FEV i, FVC, etc.) and may be indicative of the efficacy of the current breathing exercise programme.
  • the spirometry-like metrics may be determined from the measurement data (e.g., flow rate data and/or pressure data of the flow of gases) captured as the user performs exhalation manoeuvres, as previously described.
  • 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.
  • the measurement data and/or any other data generated or extracted from the measurement data discussed above 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).
  • an external computing device such as a remote server or personal computing device for processing or analysis (e.g., by a medical professional).
  • the patient-generated characteristics of the flow of gases e.g., patientgenerated flows and/or pressures
  • 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.
  • 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.
  • 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.
  • 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.
  • this 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.
  • 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).
  • this 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.
  • 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.
  • 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.
  • Example plots of processed patient-generated flows (e.g., user flow rate signals) is shown in Figures 42A and 42B.
  • the breathing exercise is a thoracic expansion exercise which comprises alternating phases of normal breathing and tidal breathing (which is deeper and slower than normal breathing, as explained previously).
  • a positive flow rate in the plots is indicative of an inhalation, and a negative flow rate is indicative of an exhalation.
  • Figure 42A demonstrates a flow rate swing between approximately +50 and -50 E/min during the normal breathing phases 1602a of an active breathing cycle, representing a nominal healthy patient.
  • the flow rate swing for the tidal breathing phases is shown at 1604a.
  • Figure 42B represents the flow swings for a nominal COPD patient. It can be seen that the breathing of the nominal COPD patient is ‘sharper’ during normal breathing phases 1602b and the flow swing during tidal breathing phases 1604b is significantly asymmetrical (indicating a weaker ability to exhale forcefully).
  • the method 1500 begins at step 1501 with a prompt to initiate the breathing exercise session.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a high number e.g., exceeding a high-priority threshold
  • 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.
  • 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.
  • regular intervals e.g., as part of a weekly, fortnightly, or monthly report
  • 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.
  • 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.
  • 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.
  • breathing exercise parameters e.g., flow rates, pressures, phasing of breath exercise steps
  • 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, and/or CPAP with oscillations therapy).
  • therapies e.g., PEP, OPEP, IPV, and/or CPAP with oscillations therapy.
  • characteristics of the flow of gases provided by the breathing assistance apparatus may be dependent 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).
  • 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.
  • 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.
  • PEP positive expiratory pressure
  • OPEP oscillating positive expiratory pressure
  • 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.
  • 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.
  • 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), some examples of which are provided below. It will be appreciated that the apparatus and/or system may comprise any one or more of these methods or configurations.
  • Apparatus prompts - first example configuration
  • the breathing assistance apparatus may prompt the user (e.g., visually and/or audibly using any of the previous apparatus features discussed) when to inhale and/or exhale, and the flow of gases is controlled in accordance with the breathing exercise therapy (e.g., PEP, OPEP, IPV therapy) in accordance/synchronised with those prompts.
  • the breathing exercise therapy e.g., PEP, OPEP, IPV therapy
  • the characteristics of the flow of gases provided is controlled on the assumption that the user is breathing (i.e., timing their inhalation and exhalation) in accordance with the prompts.
  • the user may actively generate a breathing cycle signal that identifies their breathing cycle as they carry out the breathing exercise.
  • the breathing cycle signal may comprise information or data that represents any one or more of the following: commencing an inhalation phase, commencing an exhalation phase, and/or switching between inhalation or exhalation (or vice versa).
  • the breathing assistance apparatus may be configured to receive and process the breathing cycle signal and control the flow of gases provided during the breathing exercise in accordance with the therapy (e.g., PEP, OPEP, IPV therapy) and any breath synchronisation required for that therapy.
  • the therapy e.g., PEP, OPEP, IPV therapy
  • the user may generate a breathing cycle signal that is indicative of the user commencing an exhalation, and the apparatus may then provide a fixed positive expiratory pressure (PEP therapy) or oscillating positive expiratory pressure (OPEP or as part of IPV therapy) during the user’s exhalation phase.
  • PEP therapy fixed positive expiratory pressure
  • OPEP oscillating positive expiratory pressure
  • the user may also generate a breathing cycle signal that identifies the end of the exhalation phase and/or start of the next inhalation phase, at which the apparatus can respond by ceasing the fixed or oscillating positive expiratory pressure (e.g., in the case of PEP or OPEP therapy) for the inhalation phase or may modify the characteristics of the oscillating positive pressure for the inhalation phase (e.g., in the case of IPV therapy). Examples of pneumatic and other user input of the breathing cycle signal are explained below.
  • the user may generate the breathing cycle signal pneumatically via manipulating one or more characteristics of the flow of gases via interaction with or manipulation of the mouthpiece attachment or patient respiratory interface (depending on which is being used for the breathing exercise) and/or the breathing conduit.
  • This user-generated pneumatic signal can be generated by the user to provide the apparatus with input and/or feedback on the user’s breathing cycle.
  • the user may manipulate (e.g., close/cover/block) the one or more exhaust vents (e.g., exhaust openings 1716) of the mouthpiece attachment to thereby create a detectable change in one or more characteristics of the flow of gases that is detectable by the one or more sensors of the apparatus, i.e., to create a detectable pneumatic signal in the flow of gases.
  • the nature or sequence of manipulation of the exhaust vents may effectively pneumatically code or embed a detectable signal in one or more characteristics of the flow of gases that can be decoded, detected or identified by the controller of the apparatus.
  • the manipulation of the exhaust vents of the mouthpiece may generate a detectable change or specific pressure signal profile in the flow of gases sensed by the pressure sensors of the apparatus (e.g., manipulation of the mouthpiece exhaust vents may create a detectable back-pressure in the flow of gases).
  • blocking the exhaust vent(s) in the mouthpiece briefly or for a specific time period and/or multiple blocks in a sequence or other pattern may generate changes such as spike(s), pulse-type signal(s), and/or other signal profile(s) in the pressure signal of the flow of gases.
  • These changes can be detected and/or identified by the controller as a breathing cycle signal (e.g., status change from inhalation to exhalation or vice versa, starting exhalation, and/or starting inhalation).
  • a single short block (quick ‘single tap’ gesture), a sequence of two short blocks (quick ‘double-tap’ gesture), or a single long block (e.g., 1-2 seconds ‘long press’ gesture) of the exhaust vent(s) may indicate a status change or switch from inhalation to exhalation or vice versa, start of exhalation, or start of inhalation.
  • a single short block may signal the start of inhalation
  • a sequence of two short blocks may signal the start of exhalation, or vice versa.
  • the controller of the apparatus could be configured to detect a range of different pneumatic signals (single-tap, double-tap, long press) based on predetermined changes or sensor signal profiles in the flow of gases (e.g., pressure and/or flow rate signal profiles), with each different pneumatic signal representing a different respective user interaction or input about their breathing cycle (e.g., start of inhalation, start of exhalation, and/or switch from inhalation to exhalation or vice versa).
  • the range of pneumatic signals may range from simple (e.g., single-tap, double-tap, long press) to more complex pneumatic signals coded by more complex sequences or patterns of short and/or long blocks.
  • the pneumatic signals described above may also be generated by the user manipulating an exhaust vent or other gases outlet or component of a patient respiratory interface (e.g., nasal cannula, nasal mask, nasal pillows, or face mask) being used during the breathing exercise.
  • a patient respiratory interface e.g., nasal cannula, nasal mask, nasal pillows, or face mask
  • the user may generate the breathing cycle signal via operation of one or more electronic button(s) to indicate their breathing cycle (e.g., switching from inhalation to exhalation or vice versa, starting inhalation, and/or starting exhalation).
  • one or more electronic button(s) to indicate their breathing cycle (e.g., switching from inhalation to exhalation or vice versa, starting inhalation, and/or starting exhalation).
  • the electronic button may be provided by or on the apparatus, mouthpiece attachment, breathing conduit, respiratory patient interface, and/or a remote device in data communication with the controller of the apparatus.
  • the electronic button may be a physical button (e.g., a mechanical button or touch-sensitive button) provided on any of the apparatus, mouthpiece attachment, breathing conduit, respiratory patient interface, and/or a remote device in data communication with the controller of the apparatus.
  • a physical button e.g., a mechanical button or touch-sensitive button
  • the electronic button may be a graphical button provided on a GUI of a display screen (e.g., touch screen) of the apparatus or a remote device in data communication with the controller of the apparatus.
  • the user may operate or manipulate the electronic button to indicate their breathing cycle phase using a similar configuration or signalling protocol to that described above with respect to the pneumatic signal (e.g., single tap, double tap, long press).
  • one or more labelled or dedicated electronic buttons may be provided for the user to indicate their different breathing cycle phases as they perform the breathing exercises.
  • a dedicated button might be provided for any or each of the following: user inhaling or starting to inhale, user exhaling or starting to exhale, and/or user switching from inhalation to exhalation or vice versa.
  • 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 therapy).
  • the breathing exercise therapy e.g., PEP, OPEP, IPV therapy.
  • 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.
  • the controller may be configured to to detect the entire breathing cycle signal of the user.
  • 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. Ill
  • 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.
  • the user-generate pneumatic signal functionality described above may also provide a mechanism for the user to provide additional user input, interaction or feedback to the breathing assistance apparatus.
  • the user may manipulate the one or more exhaust openings/vents of the mouthpiece attachment to generate a user control signal that is detectable by the controller and can trigger the controller to initiate the exercise mode so that the user can commence an exercise session in accordance with their breathing exercise programme.
  • the user may block (e.g., single tap, double tap, long press examples previously provided) the one or more exhaust openings/vent to generate a detectable change in one or more characteristics of the flow of gases to trigger the controller to start of an exercise session in exercise mode.
  • the pneumatically generated user control signal may also be configured to signal the end of an exercise session, or provide other feedback or input to the apparatus that can be used for control purposes or to control one or more functions or processes of the controller.
  • breathing assistance apparatus as used in the specification and claims is intended to mean, unless the context suggests otherwise, any type of breathing assistance or respiratory apparatus, device, or system, that is operable to provide respiratory support or respiratory therapy to a user or patient by providing a flow of gases to the user or patient.
  • medical professional as used in this specification and claims is intended to refer broadly to any person or agency or organisation assisting a patient with their healthcare including, but not limited to, clinicians, physiotherapists, therapists, doctors, nurses, healthcare providers/practitioners, physicians, or the like.
  • each embodiment of this invention may comprise, additional to its essential features described herein, one or more features as described herein from each other embodiment of the invention disclosed herein.
  • Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith.
  • Conditional language such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.

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Abstract

L'invention concerne un appareil d'assistance respiratoire conçu pour fournir un flux de gaz. L'appareil comprend un générateur d'écoulement qui peut fonctionner pour générer un écoulement d'un conduit respiratoire, une fixation d'embout buccal pour des exercices respiratoires qui est reliée au conduit respiratoire ; et un dispositif de commande. Le dispositif de commande est conçu pour commander l'écoulement de gaz délivrés à la fixation d'embout buccal pour commander une résistance pneumatique disposée au niveau de la fixation d'embout buccal pendant qu'un utilisateur effectue une ou plusieurs étapes d'un exercice respiratoire. L'exercice respiratoire peut comprendre : la respiration normale, la respiration courante, la respiration maximale, l'inspiration, la respiration contre une pression expiratoire positive fixe (PEP), la respiration contre une pression expiratoire positive oscillante (OPEP), l'inhalation lente et profonde, et/ou la respiration à lèvres pincées.
PCT/IB2024/056054 2023-06-21 2024-06-21 Système respiratoire pour faciliter la physiothérapie respiratoire WO2024261699A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5357975A (en) * 1991-02-28 1994-10-25 Isoraw S.A. Device for measuring the flow-volume of pulmonary air
US6273088B1 (en) * 1997-06-13 2001-08-14 Sierra Biotechnology Company Lc Ventilator biofeedback for weaning and assistance
US10029058B2 (en) * 2011-09-13 2018-07-24 Resmed Limited Vent arrangement for respiratory mask
US20180318642A1 (en) * 2015-10-30 2018-11-08 Koninklijke Philips N.V. Breathing training, monitoring and/or assistance device
US20230181050A1 (en) * 2020-06-17 2023-06-15 HAPPLYZ Medical Method for generating a respiratory datum and associated device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5357975A (en) * 1991-02-28 1994-10-25 Isoraw S.A. Device for measuring the flow-volume of pulmonary air
US6273088B1 (en) * 1997-06-13 2001-08-14 Sierra Biotechnology Company Lc Ventilator biofeedback for weaning and assistance
US10029058B2 (en) * 2011-09-13 2018-07-24 Resmed Limited Vent arrangement for respiratory mask
US20180318642A1 (en) * 2015-10-30 2018-11-08 Koninklijke Philips N.V. Breathing training, monitoring and/or assistance device
US20230181050A1 (en) * 2020-06-17 2023-06-15 HAPPLYZ Medical Method for generating a respiratory datum and associated device

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