Respiratory systems that support respiratory physiotherapy

Abstract

This is a respiratory assist device configured to provide a gas flow. The device comprises a flow generator operable to generate a flow, a breathing conduit, a mouthpiece attachment for respiratory training connected to the breathing conduit, and a controller. The controller is configured to control the gas flow delivered to the mouthpiece attachment in order to control the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of respiratory training. Respiratory training may include normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillating positive expiratory pressure (OPEP), slow, deep inhalation, and / or pursed-lip breathing.

Description

Technical Field

[0001] The present disclosure relates to a respiratory system for assisting respiratory therapy as part of a therapy program. Respiratory therapy may include assistance with respiratory training. The respiratory system may include a respiratory assist device and a mouthpiece attachment. The respiratory system may capture data for measuring user performance and / or compliance with a therapy program or components such as respiratory training.

Background Art

[0002] Respiratory assist devices are used to provide a gas flow to a user or patient in various environments such as hospitals, medical facilities, home care, or home environments. A respiratory assist device or respiratory therapy device may be used to deliver supplemental oxygen or other gases with the gas flow and / or a humidification device may be used to deliver heated and humidified gas. The respiratory assist device may be capable of adjusting and controlling the entire characteristics of the gas flow, including flow rate, temperature, gas concentration, humidity, pressure, etc. Sensors such as flow sensors and / or pressure sensors are used to measure the characteristics of the gas flow.

Summary of the Invention

[0003] The present disclosure relates to a mouthpiece attachment and system for assisting respiratory training as part of a therapy program and for use in combination with a respiratory assist device for measuring performance and / or compliance.

[0004] In one configuration, the mouthpiece attachment may be used to perform respiratory training or to obtain measurements related to, associated with, or similar to those that indicate respiratory training. When the respiratory training is related to spirometry, the mouthpiece attachment may be considered an alternative spirometry attachment.

[0005] In one configuration, the mouthpiece attachment may be an auxiliary component or attachment that is connected to the gas outlet of the respiratory support device, or to the end of the respiratory circuit conduit of the respiratory support device, or to the respiratory support device, thereby allowing the mouthpiece attachment to receive a flow of gas from the respiratory support device. In a further configuration, the respiratory support device may be configured to operate with two or more conduits, including at least a first conduit configured to deliver a therapy (such as transnasal high-flow therapy) to which a nasal cannula can be detachably connected, and a second conduit including an integrated mouthpiece attachment.

[0006] This disclosure provides a mouthpiece attachment and system for supporting respiratory training as part of a therapeutic program and for measuring performance and / or compliance.

[0007] In a first embodiment, the Disclosure broadly includes a respiratory assist device configured to provide a gas flow, the respiratory assist device comprising a flow generator operable to generate a gas flow along a flow path of the respiratory assist device, a breathing conduit for delivering the gas flow, a mouthpiece attachment that is fluidly connected to or connectable to the patient end of the breathing conduit for receiving the gas flow, and a controller operable to control the respiratory assist device, the controller being configured to control the air resistance provided in the mouthpiece attachment by controlling the gas flow delivered to the mouthpiece attachment while the user is performing one or more steps of breathing exercises in the mouthpiece attachment, the steps of breathing exercises comprising any one or more of normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep inhalation breathing, and / or pursed-lip breathing.

[0008] In one configuration, the respiratory support device further includes a humidifier, which is appropriately positioned along the flow path of the device between the flow generator and the mouthpiece attachment.

[0009] In a certain configuration, the flow generator includes a blower and / or a turbine.

[0010] In a certain configuration, controlling air resistance involves supplying a forward flow of gas at a constant pressure or constant flow rate.

[0011] In one configuration, the respiratory support device further includes one or more sensors that detect one or more characteristics of the gas flow and generate representative sensor data.

[0012] In one configuration, one or more sensors include one or more flow sensors and / or pressure sensors, and one or more sensors are positioned between the flow generator and the outlet of the respiratory support device.

[0013] In one configuration, one or more sensors are provided within the housing of the respiratory support device, along with a flow generator and a controller.

[0014] In a certain configuration, the flow sensor is provided in the form of an ultrasonic sensor and / or a heated bead flow sensor.

[0015] In one configuration, the controller is configured to receive sensor data from one or more sensors and to determine one or more parameters of the gas flow while the user is performing one or more steps of breathing training, based at least in part on the sensor data.

[0016] In one configuration, the controller is configured to determine one or more parameters, at least in part, based on sensor data received from one or more sensors, including a user flow signal representing the user-generated flow component of the gas flow generated by the user during the execution of one or more steps of breathing training, and / or a user pressure signal representing the user-generated pressure component of the gas flow generated by the user during the execution of one or more steps of breathing training.

[0017] In one configuration, controlling the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of breathing exercises includes providing a gas flow rate sufficient to prevent the user's breath from flowing back into the outlet of the breathing aid.

[0018] In a certain configuration, the gas flow rate is sufficient to prevent backflow, but insufficient to prevent the user from performing one or more steps of breathing exercises.

[0019] In a particular configuration, controlling the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of breathing exercises includes one of the following: maintaining a fixed positive flow rate of gas flow along the path; maintaining a fixed value of zero for the flow rate of gas flow along the path; changing the flow rate of gas flow along the path to counteract the flow generated by the user's breathing; maintaining a fixed pressure value in the mouthpiece attachment; maintaining a first pressure value during the expiratory phase of breathing exercises; and maintaining a second pressure value during the inspiratory phase of breathing exercises.

[0020] In a given configuration, controlling the air resistance in the mouthpiece attachment when the user breathes against fixed positive expiratory pressure (PEP) includes providing a sufficient gas flow rate in the mouthpiece attachment to induce a predefined constant PEP.

[0021] In a certain configuration, controlling the air resistance in the mouthpiece attachment when the user breathes against oscillatory positive pressure (OPEP) includes providing a sufficient gas flow rate in the mouthpiece attachment to induce oscillatory PEP.

[0022] In one configuration, providing a flow rate of gas sufficient to induce a vibratory PEP in a mouthpiece attachment involves varying the flow rate of the gas between a first threshold that provides a predefined upper PEP value and a second threshold that provides a predefined lower PEP value.

[0023] In one configuration, the respiratory assist device further includes a flutter valve.

[0024] In one configuration, the controller is in communication with a display screen.

[0025] In one configuration, the controller is further configured to cause the display screen to display one or more text - based and / or graphical instruction steps for the user to perform one or more steps of a breathing exercise.

[0026] In one configuration, the controller is further configured to cause the display screen to display a flow and / or breathing profile that the user follows when performing one or more steps of a breathing exercise.

[0027] In one configuration, the display screen is configured to display information regarding one or more parameters of the gas flow in text and / or graphical form.

[0028] In one configuration, the controller is further configured to cause the display screen to display a comparison of the current values of one or more parameters with one or more predefined target values.

[0029] In one configuration, the controller is further configured to cause the display screen to display motivational feedback related to the step of the breathing exercise the user is performing, in text and / or graphical form.

[0030] In one configuration, the display screen is contact-sensitive and configured to receive input from the user.

[0031] In one configuration, the display screen is configured to provide one or more touch-sensitive graphical elements to allow the user to adjust one or more parameters of the gas flow provided during a breathing training step.

[0032] In a given configuration, adjustments are limited to the scope set by the healthcare professional managing the patient.

[0033] In one configuration, the display screen is configured to receive user input so that the user can adjust one or more characteristics of the gas flow provided during one or more steps of breathing exercises, and this adjustment is restricted to boundaries set by a medical professional who is supervising the user.

[0034] In one configuration, the respiratory support device further includes a wireless communication module that electrically communicates with the controller.

[0035] In one configuration, the controller is further configured to communicate data to a remote device or server via a wireless communication module for storage and / or processing.

[0036] In a given configuration, the remote device is one or more of the following: a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, or other suitable peripheral devices with prerequisite communication and processing capabilities.

[0037] In one configuration, the data communicated includes data relating to one or more characteristics of the gas flow detected by one or more sensors of the device.

[0038] In one configuration, the data communicated includes data relating to one or more parameters concerning the gas flow taken in while the user performs one or more steps of breathing training.

[0039] In one configuration, the data communicated includes determined user respiratory parameter data, which includes one or more of the user's respiratory rate, minute ventilation, and / or tidal volume.

[0040] In one configuration, the data communicated includes performance data relating to the user's breathing training program, breathing training, and / or the execution of specific steps of breathing training.

[0041] In one configuration, the data communicated includes compliance data regarding the user's compliance with the breathing training program.

[0042] In a given configuration, the data communicated includes subjective feedback data generated by the user.

[0043] In a given configuration, subjective feedback data includes at least one response to at least one questionnaire.

[0044] In a certain configuration, data is sent to a remote device or server in the form of a report or report data.

[0045] In one configuration, the controller is further configured to prompt the user to perform one or more steps of breathing exercises.

[0046] In a given configuration, prompting a user to perform one or more steps of breathing exercises includes providing prompts via a breathing assistance device.

[0047] In a given configuration, prompting the user to perform one or more steps of breathing exercises includes generating an audio prompt by the breathing assistance device.

[0048] In a given configuration, prompting the user to perform one or more steps of respiratory training includes generating visual prompts on the display or interface of the respiratory support device.

[0049] In a given configuration, prompting a user to perform one or more steps of respiratory training includes providing prompts to an external device that communicates data with the respiratory support device.

[0050] In a given configuration, the external device is one or more of the following: a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, or other suitable peripheral device with prerequisite communication and processing capabilities.

[0051] In one configuration, the controller is further configured to prompt the user to perform one or more steps of breathing exercises according to periodic intervals.

[0052] In a given configuration, periodic intervals can be constructed.

[0053] In a certain configuration, the periodic interval can be configured via the user interface of the respiratory support device.

[0054] In a certain configuration, the periodic interval can be configured via the user interface of a remote device that communicates data with the respiratory support device.

[0055] In one configuration, the periodic interval can be remotely configured by a medical professional using an external device that communicates with the respiratory support device.

[0056] In a certain configuration, the controller is configured to customize one or more of the prompt timing, format, and / or content depending on the user.

[0057] In a given configuration, the breathing training steps may further include breathing to intrapulmonary percussion ventilation (IPV) and / or breathing to continuous positive airway pressure (CPAP) with oscillation.

[0058] In one configuration, the mouthpiece attachment includes one or more exhaust openings, and the controller is configured to detect or decode user-generated pneumatic signals generated by the user operating one or more exhaust openings of the mouthpiece attachment.

[0059] In one configuration, the controller is configured to detect or decode a user-generated pneumatic signal based on at least partially analyzing one or more detected characteristics of the gas flow.

[0060] In a given configuration, one or more detected characteristics of the gas flow vary or change based on user operation of one or more exhaust openings of the mouthpiece attachment.

[0061] In one configuration, the controller is configured to detect or decode a user-generated pneumatic signal by analyzing one or more detected characteristics of the gas flow in response to fluctuations or changes in user operation of one or more discharge openings of the mouthpiece attachment.

[0062] In one configuration, the controller is configured to control or operate one or more functions of the device in response to detecting or decoding a user-generated pneumatic signal.

[0063] In a given configuration, one or more functions of the device include, as follows: starting the training mode of the device for respiratory training, stopping the training mode of the device, and / or synchronizing the gas flow characteristics with the user's respiratory cycle.

[0064] In one configuration, each controller is configured to detect or decode a number of different user-generated pneumatic signals, each generated by different user operations on one or more exhaust openings of a mouthpiece attachment.

[0065] In a second embodiment, the disclosure broadly includes a system for providing respiratory therapy and respiratory training, the system including a respiratory assist device configured to provide a flow of gas, the respiratory assist device including a flow generator operable to generate a flow of gas along a path of the device, a controller operable to control the respiratory assist device and configured to control the flow of gas supplied to a mouthpiece attachment while a user is performing one or more steps of respiratory training in a mouthpiece attachment, a wireless communication module electrically communicating with the controller, and a remote computing device, the remote computing device configured to receive data from the controller of the respiratory assist device via the wireless communication module, the data including at least data instructing the user's breathing while performing one or more steps of respiratory training.

[0066] In a given configuration, the remote device is one or more of the following: a remote data processing server, a smartphone, a tablet, a laptop, a smartwatch, a wearable device, smart glasses, an actigraphy device, or other suitable peripheral devices with prerequisite communication and processing capabilities.

[0067] This second aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to the first aspect of the Disclosure.

[0068] In a third aspect, the disclosure broadly includes a method for monitoring compliance to a respiratory training program, the method comprising providing a respiratory support device, the respiratory support device comprising a flow generator that generates a gas flow, one or more sensors that detect or determine one or more characteristics of the gas flow and generate representative sensor data, and a controller electrically connected to the flow generator, the one or more sensors, and a display screen; providing a respiratory conduit having a proximal and distal end for connection to an outlet of the respiratory support device; providing a mouthpiece attachment for connection to the distal end of the respiratory conduit; providing a user with instructions to perform one or more respiratory exercises or steps of respiratory training via a display screen of the respiratory support device; and detecting whether the user has performed one or more respiratory exercises or steps of respiratory training by identifying patient-related features in sensor data representing one or more characteristics of the gas flow.

[0069] In some configurations, the respiratory support device may further include a wireless communication module that electrically communicates with the controller.

[0070] In one configuration, the method may further include communicating data to a remote device or server via a wireless communication module for storage and / or processing.

[0071] In a given configuration, the data being communicated may include data relating to one or more characteristics of the gas flow detected by one or more sensors in the device.

[0072] In one configuration, the data communicated may include data relating to one or more parameters concerning the gas flow taken in while the user performs one or more steps of breathing training.

[0073] In one configuration, the data communicated may include determined user respiratory parameter data, which may include one or more of the user's respiratory rate, minute ventilation, and / or tidal volume.

[0074] In one configuration, the data communicated may include performance data relating to the user's breathing training program, breathing training, and / or the execution of specific steps of breathing training.

[0075] In a given configuration, the data communicated may include compliance data regarding the user's compliance with the breathing training program.

[0076] In one configuration, the method includes sending data to a remote device or server in the form of a report or report data.

[0077] This third aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to the first and / or second aspects of the Disclosure.

[0078] In a fourth aspect, the disclosure broadly includes a method for treating a respiratory disease using a respiratory support device, the method of providing a respiratory support device comprising: a flow generator operable to generate a flow of gas along a flow path of the device; a breathing conduit for delivering the flow of gas; and a mouthpiece attachment for respiratory training that is fluidly connected to or connectable to the patient end of the breathing conduit for receiving the flow of gas; and controlling the flow of gas through the mouthpiece attachment to control the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of respiratory training, the steps of which include one or more of normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep inhalation breathing, and / or pursed-lip breathing.

[0079] In a given configuration, providing a respiratory support device may include providing a respiratory support device according to a first aspect of this disclosure, and any of its related features or configurations.

[0080] This fourth aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to third aspects of the Disclosure.

[0081] In a fifth aspect, the disclosure broadly includes a method for diagnosing a respiratory disease using a respiratory support device, the method of providing a respiratory support device comprising: a flow generator operable to generate a gas flow along a flow path of the device; one or more sensors for detecting or determining one or more characteristics of the gas flow and generating representative sensor data; a breathing conduit for delivering a breathable gas flow; and a mouthpiece attachment for respiratory training that is fluidly connected to or connectable to the patient end of the breathing conduit for receiving the gas flow, and the user performing one of the respiratory training exercises While performing the above steps, the steps include controlling the gas flow through the mouthpiece attachment to control the air resistance provided in the mouthpiece attachment, which includes one or more of the following: normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep inhalation breathing, and / or pursed-lip breathing; identifying patient-related features in sensor data representing one or more characteristics of the gas flow during one or more steps of breathing training; and comparing the identified patient-related features with thresholds.

[0082] This fifth aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to fourth aspects of the Disclosure.

[0083] In a sixth aspect, the disclosure includes, broadly speaking, a respiratory training device configured to provide a breathable gas flow, the respiratory training device comprising a flow generator operable to generate a breathable gas flow along a flow path of the device, a breathing conduit for delivering the breathable gas flow, a mouthpiece attachment for respiratory training that is fluidly connected to or connectable to the patient end of the breathing conduit for receiving the breathable gas flow, and a controller operable to control the respiratory training device, the controller configured to control the gas flow to the mouthpiece attachment and thereby control the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of respiratory training in the mouthpiece attachment, the steps comprising one or more of normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep breathing, and / or pursed-lip breathing.

[0084] This sixth aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to fifth aspects of the Disclosure.

[0085] In a seventh aspect, the disclosure broadly includes a respiratory therapy device configured to provide respiratory therapy, the respiratory therapy device including a flow generator operable to generate a flow of breathable gas along a flow path of the respiratory therapy device, a breathing conduit for delivering the flow of breathable gas, a mouthpiece attachment for respiratory training that is fluidly connected to or connectable to the patient end of the breathing conduit for receiving the flow of breathable gas, and a controller operable to control the respiratory therapy device, the controller configured to control the flow of gas to the mouthpiece attachment and to control the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of respiratory training in the mouthpiece attachment, the steps including one or more of normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep breathing, and / or pursed-lip breathing.

[0086] This seventh aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to sixth aspects of the Disclosure.

[0087] In an eighth aspect, the Disclosure broadly includes a respiratory assist device configured to provide a user with a breathable gas flow, the respiratory assist device comprising a flow generator operable to generate a breathable gas flow along a flow path of the device, and a controller operable to control the respiratory assist device, the controller configured to control the gas flow and thereby control the air resistance provided to the user while the user is performing one or more steps of breathing training, the steps comprising one or more of normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep breathing, and / or pursed-lip breathing.

[0088] This eighth aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to seventh aspects of the Disclosure.

[0089] In a ninth aspect, the disclosure broadly includes a respiratory assist device configured to provide a breathable gas flow to a user, the respiratory assist device including a flow generator operable to generate a breathable gas flow along a flow path of the device and a controller operable to control the respiratory assist device, the controller configured to selectively operate the respiratory assist device in either a therapy mode in which the controller controls the gas flow to provide respiratory therapy to a user, or a training mode in which the controller controls the gas flow to control the air resistance provided to the user while the user performs one or more steps of respiratory training, the steps including one or more of normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep breathing, and / or pursed-lip breathing, the respiratory assist device is configured to connect to a mouthpiece attachment for delivering a breathable gas flow to the user when operating in training mode.

[0090] This ninth aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to eighth aspects of the Disclosure.

[0091] In a tenth aspect, the disclosure broadly includes an apparatus which includes a flow generator operable to generate a breathable gas flow along a flow path of a respiratory training device; one or more sensors for detecting or determining one or more characteristics of the gas flow and generating representative sensor data; a respiratory conduit for delivering the breathable gas flow; a mouthpiece attachment for respiratory training which is fluidically connected to or connectable to the patient end of the respiratory conduit for receiving the breathable gas flow; and a device which controls the air resistance provided on the mouthpiece attachment while the user is performing one or more steps of respiratory training. To that end, the device includes a controller configured to control the flow of gas through a mouthpiece attachment, which includes one or more of the following breathing patterns: normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), slow, deep inhalation, and / or pursed-lip breathing. The controller is further configured to identify patient-related features in sensor data representing one or more characteristics of the breathable gas flow during one or more steps of the breathing training, and to measure the user's performance during one or more steps of the breathing training from these patient-related features.

[0092] This tenth aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to ninth aspects of the Disclosure.

[0093] In an eleventh aspect, the disclosure broadly includes a system for providing respiratory therapy and respiratory training, the system including a respiratory assist device configured to provide a flow of breathable gas, the respiratory assist device including a flow generator operable to generate a flow of breathable gas along a flow path of the device, and a controller operable to control the respiratory assist device, the controller configured to control a flow of gas provided to a user performing one or more steps of respiratory training, the system further including a mouthpiece attachment for delivering a flow of breathable gas to the user, the mouthpiece attachment being fluidically connectable to a flow path of the respiratory assist device.

[0094] This eleventh aspect of the Disclosure may further include one or more of the features or configurations discussed herein in relation to any of the first to tenth aspects of the Disclosure.

[0095] In other embodiments, the Disclosure broadly includes a non-temporary computer-readable medium storing computer-executable instructions, which, when executed on one or more processing devices, cause those processing devices to perform any of the one or more methods described above.

[0096] In other embodiments, the Disclosure broadly includes a set of application program interfaces or application program interfaces (APIs) embodied on a computer-readable medium for execution on a processing device in conjunction with an application program that performs any of the methods described in any one or more embodiments above.

[0097] Any aspect of the foregoing disclosure may further include any one or more aspects, features, or configurations that are referred to in relation to any one or more other aspects of the foregoing disclosure.

[0098] These and other features, aspects, and advantages of the Disclosure will be described with reference to drawings of specific embodiments, which are intended to schematically illustrate specific embodiments and are not intended to limit the Disclosure. [Brief explanation of the drawing]

[0099] [Figure 1] A schematic diagram of a respiratory support device configured to provide respiratory therapy to a patient is shown. [Figure 2A] A block diagram of a control system that interacts with and / or provides control and decision-making to the components of a respiratory support device is shown. [Figure 2B] An example block diagram of a controller is shown. [Figure 3] A block diagram of the motor and sensor module is shown. [Figure 4] An example shows the detection chamber of a motor and sensor module. [Figure 5] Figure 1 shows a schematic diagram of a respiratory support device, which includes an embodiment of a mouthpiece attachment connected to the end of a breathing conduit. [Figure 6] A perspective view from the connector end of a mouthpiece attachment in one exemplary embodiment is shown. [Figure 7] Figure 6 shows a perspective view of the mouthpiece attachment from the mouthpiece end. [Figure 8] Figure 6 shows the first side elevation view of the mouthpiece attachment. [Figure 9] Figure 6 shows a second side elevation view of the mouthpiece attachment. [Figure 10] Figure 6 shows a plan view of the mouthpiece attachment. [Figure 11] Figure 6 shows a bottom view of the mouthpiece attachment. [Figure 12] Figure 6 shows the first end view of the mouthpiece attachment from the end of the mouthpiece. [Figure 13] Figure 6 shows a second end view of the mouthpiece attachment from the connector end. [Figure 14] Figures 12 and 13 show a cross-sectional view of the mouthpiece attachment passing through line AA. [Figure 15] Figure 6 shows an enlarged perspective view of the mouthpiece attachment from the connector end. [Figure 16] A first end perspective view of an exemplary embodiment of a detachable mouthpiece for a mouthpiece attachment is shown. [Figure 17] Figure 16 shows a perspective view of the second end of the detachable mouthpiece. [Figure 18] Figure 16 shows a plan view of the detachable mouthpiece. [Figure 19] Figure 18 shows a cross-sectional view of the detachable mouthpiece passing through line BB. [Figure 20] Figure 16 shows a side elevation view of the detachable mouthpiece. [Figure 21] Figure 20 shows a cross-sectional view of the detachable mouthpiece passing through the CC line. [Figure 22] Figure 6 shows a perspective view of the mouthpiece attachment assembled with the detachable mouthpiece of Figure 16 in one embodiment. [Figure 23] Figure 22 shows an exploded perspective view of the mouthpiece attachment and detachable mouthpiece. [Figure 24] Figure 22 shows a side view of the mouthpiece attachment with the assembled mouthpiece. [Figure 25] Figure 24 shows a cross-sectional view of the mouthpiece attachment, which includes the assembled mouthpiece passing through the DD line. [Figure 26] Figure 22 shows a plan view of the mouthpiece attachment with the assembled mouthpiece. [Figure 27] Figure 26 shows a cross-sectional view of the mouthpiece attachment, which includes an assembled mouthpiece passing through the EE line. [Figure 28] Figure 22 shows a first perspective view of the mouthpiece attachment, which includes the assembled mouthpiece with a clip structure. [Figure 29]A second perspective view of the mouthpiece attachment, including the assembled mouthpiece and the 28 clip structure, is shown. [Figure 30] A side elevation view of the assembled mouthpiece attachment, which includes a mouthpiece and a clip structure of 28 clips, is shown. [Figure 31] This is a flowchart illustrating the process of performing measurements using a mouthpiece attachment and a respiratory support device, relating to one exemplary configuration. [Figure 32] This is a flowchart of prompts that prompt the user to perform a set of repeated breathing exercises, based on an exemplary configuration. [Figure 33] This is a flowchart illustrating the process of performing measurements using a mouthpiece attachment and a respiratory support device, relating to another similar configuration. [Figure 34A] This shows an exemplary schematic GUI display screen prompt instructing the user to disconnect the patient interface, relating to one exemplary configuration. [Figure 34B] This shows an exemplary schematic GUI display screen prompt instructing the user to disconnect the patient interface, relating to one exemplary configuration. [Figure 34C] This shows an exemplary schematic GUI display screen prompt instructing the user to disconnect the patient interface, relating to one exemplary configuration. [Figure 35A] This shows an exemplary schematic GUI display screen prompt instructing the user to connect the mouthpiece attachment to the respiratory support device's fluid path. [Figure 35B] This shows an exemplary schematic GUI display screen prompt instructing the user to connect the mouthpiece attachment to the respiratory support device's fluid path. [Figure 35C] This shows an exemplary schematic GUI display screen prompt instructing the user to connect the mouthpiece attachment to the respiratory support device's fluid path. [Figure 36A]This shows an exemplary schematic GUI display screen prompt instructing the user to perform a forced exhalation action, relating to an exemplary configuration. [Figure 36B] This shows an exemplary schematic GUI display screen prompt instructing the user to perform a forced exhalation action, relating to an exemplary configuration. [Figure 36C] This shows an exemplary schematic GUI display screen prompt instructing the user to perform a forced exhalation action, relating to an exemplary configuration. [Figure 36D] This shows an exemplary schematic GUI display screen prompt instructing the user to perform a forced exhalation action, relating to an exemplary configuration. [Figure 36E] This shows an exemplary schematic GUI display screen prompt instructing the user to perform a forced exhalation action, relating to an exemplary configuration. [Figure 36F] This shows an exemplary schematic GUI display screen prompt instructing the user to perform a forced exhalation action, relating to an exemplary configuration. [Figure 37A] This shows an exemplary schematic GUI display screen prompt instructing the user to perform normal breathing after a forced exhalation action, relating to one exemplary configuration. [Figure 37B] This shows an exemplary schematic GUI display screen prompt instructing the user to perform normal breathing after a forced exhalation action, relating to one exemplary configuration. [Figure 38] This shows an exemplary schematic GUI display screen prompt that instructs the user about non-therapeutic modes. [Figure 39] This graph shows exemplary detected flow rate data in healthy individuals and patients, measured using a mouthpiece attachment and respiratory support device. [Figure 40] This is a flowchart illustrating a method for performing respiratory training using a mouthpiece attachment and a respiratory support device, based on one exemplary configuration. [Figure 41]This is a flowchart illustrating a method for performing respiratory training using a mouthpiece attachment and a respiratory support device, relating to another exemplary configuration. [Figure 42A] This graph shows exemplary user-generated flow rate data for healthy individuals and patients undergoing respiratory training using a mouthpiece attachment and respiratory support device. [Figure 42B] This graph shows exemplary user-generated flow rate data for healthy individuals and patients undergoing respiratory training using a mouthpiece attachment and respiratory support device. [Modes for carrying out the invention]

[0100] While certain embodiments are described below, those skilled in the art will understand that this disclosure extends beyond the specifically disclosed embodiments and / or uses, as well as obvious variations and equivalents thereof. Therefore, the scope of this disclosure disclosed herein is not intended to be limited by the specific embodiments described below. 1. Overview of the mouthpiece attachment and system

[0101] A mouthpiece attachment (or mouthpiece) is an attachment or auxiliary component for use with a respiratory support device, respiratory system, training system, or training device. Unless otherwise specified in the context, the terms “system” or “device” may refer to one or more of the following: a respiratory support device, respiratory system, training system, training device, or other device or system equipped with a flow generator. Furthermore, when describing the features of a respiratory support device or respiratory system in the following description, such features may also apply to devices or systems that can selectively operate in either a respiratory therapy mode or a training mode, and may also apply to dedicated training systems or training devices.

[0102] The mouthpiece attachment is configured to fluidly couple to, or to fluidly communicate with, a gas flow generated by a respiratory support device or a device generally equipped with a flow generator. For example, in one configuration, the mouthpiece attachment is configured to fluidly couple to or connect to the end or part of the flow path of a respiratory support device in order to receive a gas flow generated by the respiratory support device. In one configuration, the mouthpiece attachment can be detachably connected to the respiratory support device. In a further configuration, the mouthpiece attachment can be detachably connected to the flow path of a respiratory support device or device via one or more intermediate flow path components, including but not limited to humidifiers, connectors, ports, bypass circuits or ports, couplers, breathing conduits.

[0103] In one configuration, the mouthpiece attachment may be connected to the end of a patient breathing conduit, such as a flexible breathing conduit connected to the gas outlet of the device.

[0104] In other configurations, the mouthpiece attachment may instead be permanently attached to (or integrally formed with) the flexible breathing conduit.

[0105] In other configurations, the mouthpiece attachment may be directly connected to a gas outlet or any other accessible outlet or port along the flow path of the respiratory support device. In one embodiment, the mouthpiece attachment may be mounted to the gas outlet of the device, which is typically connected to the patient's respiratory conduit. In another embodiment, the respiratory support device may include a removable humidifier chamber that is in fluid communication with a flow generator to receive a gas flow generated by the flow generator. The removable humidifier chamber may be connected to or fluidly coupled to the flow generator by the device's gas outlet port. The gas outlet port may be the outlet of the flow generator or be in fluid communication with the outlet of the flow generator. When the humidifier chamber is removed, the gas outlet port becomes accessible, and the mouthpiece attachment can be mounted directly to the gas outlet to receive a gas flow generated by the flow generator. In other configurations, the humidifier or humidifier chamber may be bypassed via a bypass conduit or other bypass configuration. For example, the mouthpiece attachment may be mounted directly or indirectly via a breathing conduit to a bypass conduit, port, or outlet that bypasses the humidifier or humidifier chamber, thereby enabling the mouthpiece attachment to communicate with the gas flow from the flow generator outlet, and furthermore, temporarily excluding or bypassing the humidifier from the flow path.

[0106] In any of the above configurations and embodiments, the mouthpiece attachment is connected to the flow path so as to be in fluid communication with the gas flow generated by the flow generator and / or respiratory support device.

[0107] In one embodiment, the mouthpiece attachment includes a body extending between a connector end and a mouthpiece end. The ends of the connector and mouthpiece are fluidly connected by one or more main lumens (e.g., channels or passages) extending between the ends of the body. In one configuration, the body may be a tubular component extending between the connector end and the mouthpiece end. The body may be substantially hollow. The connector end includes one or more openings or ports for fluidly connecting to one end of a flexible breathing conduit connected to a respiratory assist device. The mouthpiece end may provide or receive a mouthpiece that includes one or more openings or ports providing fluid communication with the user's airway when in use. One or more exhaust openings (e.g., vents) to the surrounding environment may also be provided along the body between the connector and the mouthpiece end. One or more vents may be in fluid communication with the main lumens.

[0108] In one embodiment, once the mouthpiece attachment is connected to the end of the flow path for use, the respiratory assist device controller may manually or automatically activate a training mode. In this training mode, the controller may prompt the user to perform or follow one or more steps to perform a respiratory training or a series of respiratory training (e.g., via visual and / or auditory prompts or notifications).

[0109] During breathing exercises, the respiratory support device controller can control the flow generator to control the flow of gas (e.g., air, or air to which one or more other gases such as oxygen have been added) according to configurable flow rate settings or pressure settings (i.e., the gas flow can be flow-controlled or pressure-controlled). The gas flow provides controllable air resistance within the flow path for the user's breathing exercises.

[0110] In some sense, the term “air resistance” as used in this disclosure may mean, unless otherwise indicated in the context, the characteristics of the gas flow supplied to the user (e.g., via the respiratory patient interface and / or mouthpiece attachment), and may also correspond to or be defined by one or more characteristics of the gas flow (e.g., flow rate or pressure). For example, the flow rate and / or pressure of a controlled gas flow may define the nature of air resistance. For example, fixed or variable (e.g., oscillating) air resistance may correspond to fixed or variable (e.g., oscillating) pressure characteristics and / or flow rate characteristics in the gas flow. In this sense, controlling the “air resistance” provided in the respiratory patient interface and / or mouthpiece attachment may also be considered as controlling one or more characteristics of the gas flow provided in the respiratory patient interface and / or mouthpiece attachment when the user performs respiratory training.

[0111] In one embodiment, the controller of the respiratory support device may also be configured to acquire measurement data during the measurement process. The measurement data may constitute or represent one or more characteristics of the gas flow (e.g., airflow measurements) and / or user respiratory information or measurements. In one configuration, the measurement data may be acquired during the performance of respiratory training. For example, the controller may operate the measurement process concurrently while the user is performing respiratory training in the device's training mode.

[0112] In one exemplary configuration of the measurement process, a respiratory support device may acquire measurement data by detecting one or more characteristics of the gas flow in a channel via one or more sensors. Sensor data generated by one or more sensors may include data indicating the user's breathing during respiratory training and / or the measurement process. Sensors may be located within the main housing of the respiratory support device and / or within the patient's respiratory conduit. Sensor data may be stored, analyzed, and / or processed to generate output data representing the user's respiratory training performance, and further, these may provide measurements of lung performance or lung function, including spirometry data or data indicating or similar to spirometry measurements. Output data may also be generated to represent the user's completion of scheduled respiratory training and, consequently, compliance with a given or prescribed therapy program.

[0113] The following description describes an exemplary respiratory support device that can be used in conjunction with a mouthpiece attachment. This exemplary respiratory support device may be primarily configured for high-flow therapy, or may have a high-flow therapy mode (e.g., a nasal high-flow therapy mode). However, the mouthpiece attachment may be used in conjunction with any respiratory support device, system, or device having a flow generator (e.g., including blowers, fans, compressors, etc.) capable of generating a controllable gas flow for respiratory therapy, or with any other device or system including a flow generator. The respiratory support device may be capable of operating or configured to provide a single type of therapy, or to provide multiple different respiratory therapies. For example, the respiratory support device may be configured to operate in a single therapy mode, or to operate or provide multiple selectable therapy modes. For example, a respiratory support device may provide one or more of the following respiratory therapies and / or therapy modes, namely 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, biphasic PAP therapy, or other such flow- or pressure-controlled respiratory therapies. The mouthpiece attachment may connect to a respiratory support device or system that includes an active or passive humidifier in the airway, or to a device or system that does not have a humidifier. When the device is operating in training mode, the gas flow is provided without adding humidity (i.e., all humidifiers in the device are turned off, deactivated, or disconnected). For example, the gas flow is provided at substantially ambient humidity. 2. Exemplary Examples of Respiratory Assistance Devices

[0114] A mouthpiece attachment, and a method and process for using the mouthpiece attachment, will be described in the context of an exemplary respiratory support device 10 configured or operable to provide nasal high-flow therapy via an open patient interface. This is intended as a non-limiting embodiment. It will be understood that the mouthpiece attachment may be operable in conjunction with a wide range of respiratory support devices, including flow generators. 2.1. General overview

[0115] A schematic representation of an exemplary respiratory support device 10 is provided in Figure 1.

[0116] The breathing apparatus 10 (or, “breathing system”) includes a flow source 50 for supplying a high-flow gas 31, such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen with one or more other gases. Alternatively, the breathing assistance device may have a connection for coupling to the flow source. Thus, the flow source may, depending on the context, be considered to form part of the apparatus or to be separate from the apparatus, and in some cases, part of the flow source may form part of the apparatus and part of the flow source may be outside the apparatus. In short, depending on the configuration (some components are optional), the system is, • Source of the flow • Humidifier for humidifying gas flow • Conduit (e.g., a drying wire or heated breathing tube), • Patient interface, • Check valve, and / or • May include combinations of components selected from the filter.

[0117] The device or system will be described in more detail.

[0118] The flow source can be a high-flow device comprising an in-wall oxygen supply unit, an oxygen tank 50A, a tank for other gases, and / or a flow generator 50B. Figure 1 shows a flow source 50 with a flow generator 50B, which has an optional air inlet 50C and an optional connection to an O2 source (such as a tank or O2 generator) 50A via a shut-off valve and / or regulator and / or other gas flow control 50D, but this is only one option. The flow generator 50B can control the flow delivered to the patient 56 using one or more valves, and the flow generator 50B may be equipped with a blower as appropriate. The flow source can be one or a combination of the flow generator 50B, O2 source 50A, and air source 50C, as described above. Although the flow source 50 is shown as part of the device 10, in the case of an external oxygen tank or in-wall outlet source, it can be considered a separate component, in which case the device has a connection port for connecting to such a flow source. The flow source supplies gas at a (preferably high) flow rate that can be delivered to the patient via the delivery conduit 16 and the patient interface 51.

[0119] The patient interface 51 may be an unsealed (non-sealing) interface, such as an unsealed nasal cannula (e.g., when used in high-flow therapy and / or when the respiratory support device is operating in flow control mode—controlling the flow generator to deliver a target gas flow), or a sealed interface, such as a nasal mask, full-face mask, or nasal pillow (e.g., when used in CPAP and / or when the respiratory support device is operating in pressure control mode—controlling the flow generator to deliver a target pressure). In some embodiments, the patient interface 51 is an unsealed patient interface, which contributes to preventing, for example, barotrauma (tissue damage to the lungs or other respiratory organs due to the pressure difference with atmospheric pressure). In some embodiments, the patient interface 51 is a sealing mask that seals 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 pillow mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The flow source can provide a base gas flow rate, for example, between 0.5 liters / min and 375 liters / min, or any range within that range, and in some cases, within an upper or lower limit. Details of the flow rate range and properties will be described later.

[0120] Where appropriate, a humidifier 52 may be provided between the flow source 50 and the patient to provide humidification of the delivered gas. In some configurations, the humidifier is configured to be removed from the respiratory support device or isolated within the device during training mode. Additionally or alternatively, the device's humidifier may be turned off or deactivated so as not to add moisture to the gas flow when the device is operating in training mode.

[0121] One or more sensors 53A, 53B, 53C, 53D, such as flow sensors, oxygen fraction sensors, pressure sensors, humidity sensors, temperature sensors, or other sensors, may be placed on or near the patient in the system and / or in the patient 56. Alternatively or additionally, sensors capable of deriving such parameters may be used. Additionally or alternatively, sensors 53A-53D may be one or more physiological sensors for detecting patient physiological parameters such as heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, and partial pressure of CO2 in the blood. Alternatively or additionally, sensors capable of deriving such parameters may be used. Other patient sensors include EEG sensors, body bands for detecting respiration, and other suitable sensors. In some configurations, a humidifier may be optional or may be preferred as the humidifying gas helps maintain the condition of the airway during the therapy mode. One or more sensors may form part of the device or be located outside the device, and the device may have inputs for any external sensors. The sensors can be coupled to the controller 19, or their outputs can be transmitted to the controller.

[0122] Sensor 14 may be provided to measure the oxygen fraction of the air inhaled by the patient. It may be located on the patient interface 51 to measure, or otherwise determine, the oxygen fraction in the vicinity of the patient's mouth and / or nose (at / near the patient / close to the patient). The output from sensor 14 is sent to a controller 19 that assists in controlling the respiratory support device to determine whether the maximum inspiratory flow rate demand is met and to modify its operation accordingly. Controller 19 is coupled to the flow source 50, the humidifier 52, and sensor 14. The controller controls these and other embodiments of the device or system described later. The controller can operate the flow source to provide a gas delivery flow rate at a desired flow rate that is high enough to meet the maximum inspiratory flow rate demand. Sensor 14 communicates the measured oxygen fraction at the patient's mouth and / or nose to the user, who then inputs this information into the respiratory device / controller. All of the following disclosures / embodiments may be taken as having alternative means where appropriate.

[0123] An optional check valve 23 may be provided in the breathing conduit 16. One or more filters may be provided at the air inlet 50C and / or the inlet to the flow generator 50B to filter the incoming gas before it is pressurized into a high-flow gas 31 by the flow generator 50B.

[0124] The respiratory support device 10 can generally be arranged as an integrated unit or as separate components, as shown in the dotted box 100 in Figure 1. In some configurations, the device or system can be arranged in a modular manner. Furthermore, the device or system may include only some of the illustrated components, and not all of them are necessarily required. Also, the conduit and patient interface do not have to be part of the system and can be considered separate. Hereinafter, these will be referred to as respiratory support devices or respiratory systems, but this will not be interpreted restrictively. In this specification, “respiratory support devices” and “respiratory systems” are considered broadly to include all devices that supply gas flow to a patient. Some such devices and systems may include a detection system that can be used to determine whether the gas flow rate is meeting the inspiratory flow rate requirements.

[0125] The respiratory device 10 may include a main unit housing (not shown). The main unit housing may include a flow generator 50B, which may 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 may include a display and input device(s), such as buttons, a touchscreen (e.g., an LCD screen), or a combination of a touchscreen and buttons(s). The controller 19 may include one or more hardware and / or software processors, which may be configured or programmed to control components of the system, including, but not limited to, operating the flow generator 50B to generate a gas flow for delivery to the patient, operating the humidifier 52 to humidify and / or heat the gas flow, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory support device 10, and outputting information to the user (e.g., on a display). The user may be a patient, a healthcare worker, or others.

[0126] In one configuration, the user interface 54 of the respiratory support device 10 may include a detachable display screen or touchscreen.

[0127] In one configuration, the user interface 54 of the respiratory support device may include a graphical user interface (GUI) presented on a display screen or touch screen.

[0128] Continuing to refer to Figure 1, the patient breathing conduit 16 is connected to the gas outlet (gas outlet) 21 in the main unit housing of the respiratory support device 10 and can be connected to a patient interface 51, such as an unsealed 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 interface.

[0129] The gas flow can be generated by a flow generator 50B and 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 gas flow of a desired flow rate and / or control one or more valves to control the mixing of air with oxygen or other breathable gas. The controller 19 can heat the gas to a desired temperature to achieve a desired level of temperature and / or humidity for delivery to the patient by controlling a heating element in or associated with the humidification chamber 12. The patient breathing conduit 16 may have a heating element, such as a heater wire, to heat the gas flow passing through the patient. The heating element may also be under the control of the controller 19.

[0130] The humidifier 52 of this device is configured to combine or introduce humidity into the gas flow. Various configurations of the humidifier 52 can be employed. In one configuration, the humidifier 52 may include a removable humidification chamber. For example, the humidification chamber may be partially or entirely removed or disconnected from the flow path and / or the device. As an example, the humidification chamber may be removed for, for example, refilling, cleaning, replacement and / or repair. In one configuration, the humidification chamber may be received and held by or inside a humidification compartment or bay of the device, or may be coupled to or inside the housing of the device by other means.

[0131] Those skilled in the art will understand that adding humidity to a gas flow can prevent, or at least minimize, the drying of the user's airway when receiving the gas flow. For example, adding humidity can mimic the natural humidification of air / gas that occurs when a user normally breathes. Adding humidity can contribute to improved user comfort when receiving a gas flow.

[0132] The humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet that allow connection to the gas flow path of the device. For example, a gas flow from the flow generator 50B is received into the humidification chamber through its gas inlet, heated and / or humidified, and then exits the chamber through its gas outlet.

[0133] A humidifying chamber typically contains a certain amount of liquid, such as water. During operation, the liquid in the humidifying chamber is controlled by one or more heaters or heating elements attached to the chamber to generate water vapor or steam, which increases the humidity of the gas flowing through the chamber.

[0134] In one configuration, the humidifier is a passover type humidifier. In other configurations, the humidifier may be a non-passover type humidifier.

[0135] In one configuration, the humidifier 52 may include, for example, a heater plate associated with or provided within a humidification bay on which a chamber is placed for heating. The chamber may include a heat transfer surface provided on the base or other surface of the chamber that joins or engages with the heater plate of the humidifier 52, such as a metal insert, plate, or the like.

[0136] In other configurations, the humidification chamber may be equipped with an internal heater or heater element inside or within the chamber. The internal heater or heater element may be integrally mounted within the chamber, provided within the chamber, or detachable from the chamber.

[0137] The humidification chamber may have any suitable shape and / or size. The location, number, size, and / or shape of the chamber's gas inlet and gas outlet may be modified as needed. In one configuration, the humidification chamber may have a base surface, one or more side walls extending upward from the base surface, and a top or apex surface. In one configuration, the gas inlet and gas outlet may be located on the same side of the chamber. In other configurations, the gas inlet and gas outlet may be located on different surfaces of the chamber, such as on opposite sides or in different positions, or in other different positions.

[0138] In some configurations, the gas inlet and gas outlet may have parallel flow axes. In some configurations, the gas inlet and gas outlet may be positioned at the same height on the chamber.

[0139] System 10 can be operated in a manner that monitors the characteristics of the gas flow and / or provides appropriate therapy by using ultrasonic transducers, flow sensors such as thermistor flow sensors, pressure sensors, temperature sensors, humidity sensors, or other sensors in communication with the controller 19. The characteristics of the gas flow may include gas concentration, flow rate, pressure, temperature, humidity, or other characteristics. Sensors 53A, 53B, 53C, 53D, 14, such as pressure sensors, temperature sensors, humidity sensors, and / or flow sensors, can be placed in various locations within the main unit housing 100, the patient conduit 16, and / or the patient interface 51. The controller 19 can receive outputs from the sensors to assist in operating the respiratory support device 10 in a manner that provides appropriate therapy, such as determining appropriate target temperature, flow rate, and / or pressure of the gas flow. Providing appropriate therapy may include meeting the patient's inspiratory flow demands. In the illustrated embodiment, sensors 53A, 53B, and 53C are located within the housing of the device, sensor 53D is located within the patient conduit 16, and sensor 14 is located within the patient interface 51.

[0140] The device 10 may include one or more communication modules that enable data communication or connection with one or more external devices or servers via a data or communication link or data network, whether wired, wireless, or a combination thereof. For example, in one configuration, the device 10 may include a wireless data transmitter and / or receiver, or transceiver 15, to enable the controller 19 to receive data signals wirelessly from the motion sensor and / or to control various components of the system 10. As shown in the figure, the transceiver 15 or the data transmitter and / or receiver module may have an antenna 15a. In one embodiment, the transceiver may include a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may transmit data to a remote server or enable remote control of the system 10. The system 10 may include, for example, a wired connection using a cable or wire to enable the controller 19 to receive data signals 8 from the motion sensor and / or to control various components of the device 10. The device 10 may include one or more wireless communication modules. For example, the device may include a cellular communication module, such as a 3G module, a 4G module, or a 5G module. Module 15 may be or include a modem that enables the device to communicate with a remote server using a suitable communication network. The communication may be bidirectional communication between the device and the server or other remote system. The device 10 may also include other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module. The Bluetooth and / or Wi-Fi modules enable the device to wirelessly transmit information to other devices, such as smartphones, tablets, laptops, smartwatches, wearable devices, smart glasses, and actigraphy devices, or to operate via a LAN (Local Area Network) or Wi-Fi (WLAN). Additionally or alternatively, the device may include a Near Field Communication (NFC) module to enable data transfer and / or data communication.

[0141] The respiratory support device 10 may include a high-flow therapy device. High-flow therapy as considered herein is intended to be given a typical, ordinary meaning as understood by those skilled in the art, and generally refers to a respiratory system that delivers a target flow rate of humidified respiratory gas through a patient interface that is not intentionally sealed, at a flow rate that meets or exceeds the user's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults are, but are not limited to, approximately 15 liters per minute to approximately 60 liters per minute or more. Typical flow rates for children (neonatal, infant, child, etc.) are often, but are not limited to, approximately 1 liter per minute per kg of body weight to approximately 3 liters per minute per kg of body weight or more.

[0142] High-flow therapy may also optionally include the administration of gas mixtures containing supplemental oxygen and / or therapeutic agents.

[0143] High-flow therapy is often referred to by other generic names such as nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen therapy (HFNO), high-flow therapy (HFT), or tracheostomy high-flow (THF). For example, in some configurations, for adult patients, "high-flow therapy" may refer to the delivery of gas to the patient at a flow rate of approximately 10 liters per minute (10 LPM) or more, for example, approximately 10 LPM to 100 LPM, or approximately 15 LPM to 95 LPM, or approximately 20 LPM to 90 LPM, or approximately 25 LPM to 85 LPM, or approximately 30 LPM to 80 LPM, or approximately 35 LPM to 75 LPM, or approximately 40 LPM to 70 LPM, or approximately 45 LPM to 65 LPM, or approximately 50 LPM to 60 LPM. In some configurations, “high-flow therapy” for neonates, infants, or children may refer to the delivery of gas to the patient at a flow rate greater than 1 LPM, for example, about 1 LPM to about 25 LPM, or about 2 LPM to about 25 LPM, or about 2 LPM to about 5 LPM, or about 5 LPM to about 25 LPM, or about 5 LPM to about 10 LPM, about 10 LPM to about 25 LPM, or about 10 LPM to about 20 LPM, or about 10 LPM to about 15 LPM, or about 20 LPM to about 25 LPM. High-flow therapy devices with adult patients, neonates, infants, or pediatric patients may deliver gas to the patient at a flow rate of about 1 LPM to about 100 LPM, or at any of the subranges outlined above.

[0144] High-flow therapy can be effective in increasing patient oxygenation and / or reducing respiratory effort by matching or exceeding the patient's inspiratory flow requirements. Furthermore, high-flow therapy can induce nasopharyngeal flushing, where anatomical dead spaces in the upper airway are flushed by the high inflow gas flow. This flushing effect can create a reservoir of fresh gas available with each breath, while minimizing rebreathing of carbon dioxide, nitrogen, etc. High-flow therapy can also increase the patient's expiratory time through exhalation pressure, which consequently reduces the patient's respiratory rate.

[0145] The flow rate may be set by a medical professional to achieve flushing of the patient's upper airway and / or to meet or exceed the patient's inspiratory flow rate requirements and / or to yield at least some of the benefits of high-flow therapy (HFT) as described herein.

[0146] The patient interface for use in high-flow therapy may be an unsealed interface to prevent barotrauma, which may include tissue damage to the patient's lungs or other organs of the respiratory system caused by the pressure difference compared to air. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or an unsealed tracheostomy interface, or other appropriate type of patient interface. 2.2. Control System

[0147] Figure 2A shows a block diagram 900 of an exemplary control system 920 (which can be the controller 19 in Figure 1) that can detect the patient's condition and control the operation of the respiratory system, including the gas source. The control system 920 can manage the flow rate of gas flowing through the respiratory system when the gas is delivered to the patient. For example, the control system 920 can increase or decrease the flow rate by controlling the output of the motor speed of the blower (hereinafter also referred to as the "blower motor") 930 or the output of the valve 932 in the blender. As will be described later, the control system 920 can automatically determine a set value or an individualized value for the flow rate for a particular patient. The flow rate can be optimized by the control system 920 to improve patient comfort and treatment.

[0148] The control system 920 can also generate voice and / or display / visual outputs 938, 939. For example, the respiratory support device may include a display and / or speaker. The display can notify a physician of warnings or alarms generated by the control system 920. The display can also display control parameters that can be adjusted by a physician. For example, the control system 920 can automatically recommend a flow rate for a particular patient. The control system 920 can also determine the patient's respiratory status and transmit it to the display, including but not limited to generating the patient's respiratory rate, which will be described in more detail below.

[0149] The control system 920 can modify the heater control output to control one or more heating elements (for example, to maintain a temperature setpoint for the gas delivered to the patient). The control system 920 can also modify the operation or duty cycle of the heating elements. The heater control output may include heater plate control outputs 934 and heated breathing tube control outputs 936.

[0150] The control system 920 can determine outputs 930 to 939 based on one or more received inputs 901 to 916. Inputs 901 to 916 can correspond to sensor measurements automatically received by the controller 600 (shown in Figure 2B). The control system 920 can receive sensor inputs including, but not limited to, temperature sensor input 901, flow sensor input 902, motor speed input 903, pressure sensor input 904, gas fraction sensor input 905, humidity sensor input 906, pulse oximeter (e.g., SpO2) sensor input 907, stored or user parameters 908, duty cycle or pulse width modulation (PWM) input 909, voltage input 910, current input 911, acoustic sensor input 912, power input 913, resistance input 914, CO2 sensor input 915, and / or spirometry input 916. The control system 920 can receive user input or parameter values ​​stored in memory 624 (shown in Figure 2B). The control system 920 can dynamically adjust the patient's flow rate over the course of therapy. The control system 920 can continuously detect system parameters and patient parameters. Those skilled in the art will understand, based on the disclosure herein, that any other suitable inputs and / or outputs can be used with the control system 920. One or more pressure sensors

[0151] In one configuration, the device may include one or more pressure sensors. One or more pressure sensors may be provided to detect or measure the pressure characteristics of the gas flow in the device's passage and to generate respective pressure variables, such as pressure sensor signals or data. The pressure sensors may include, but are not limited to, any type of suitable pressure sensor, including gauge pressure sensors and / or absolute pressure sensors.

[0152] A gauge pressure sensor may be configured to detect the gauge pressure of a gas flow and generate representative gauge pressure variables, such as a gauge pressure signal or pressure data. Gauge pressure can represent the pressure of the gas flow in a channel, either relative to or with respect to atmospheric pressure. For example, gauge pressure may represent the difference between the absolute pressure in the channel and the absolute pressure in the housing (i.e., atmospheric pressure or ambient pressure).

[0153] An absolute pressure sensor may be configured to detect the absolute pressure of a gas flow and generate representative absolute pressure variables, such as an absolute pressure signal or pressure data. Absolute pressure can represent the pressure of the gas flow in a flow path, either with respect to or relative to atmospheric pressure.

[0154] As will be understood by those skilled in the art, one or more pressure sensors configured to detect or measure the pressure characteristics of a gas flow may be placed directly in or at least partially immersed in a main or bulk flow channel of the gas flow (for example, the sensors may be part of or exposed to a sensor passage or sensor chamber that forms part of the main or bulk flow channel), or placed directly in or at least partially immersed in a secondary or sample flow channel that is operably or fluidly connected to the main or bulk flow channel, or otherwise operably or fluidly coupled or connected to the gas flow in the channel.

[0155] Pressure sensors for detecting the pressure characteristics of a gas flow may be independently mounted within the housing of the device and be electrically connected to or otherwise able to communicate data with a controller or control system, or they may be mounted on or coupled to a sensor circuit board or other circuit board related to the gas flow path. In one configuration, the pressure sensor may be positioned or configured to detect the pressure of the gas flow at a location along the flow path in front of (e.g., upstream of) the humidifier or humidification chamber. In another configuration, the pressure sensor(s) may be positioned or configured to detect the pressure of the gas flow at a location along the flow path between a flow generator, such as a blower, and the humidifier chamber, for example, at a location along the flow path between the blower outlet and the humidifier chamber inlet (i.e., downstream of the blower and upstream of the humidifier chamber).

[0156] One or more pressure sensors may also be provided to detect other pressures related to the device, such as the pressure of the surrounding environment in which the device is installed. In one configuration, the device may include an ambient pressure sensor configured to detect or measure the ambient or atmospheric pressure of the local environment in which the device is installed and to generate representative ambient pressure variables, such as ambient pressure signals or pressure data. In one configuration, the ambient pressure sensor may be an absolute pressure sensor, disposed or positioned on or inside the housing and configured to detect the ambient or atmospheric pressure of the environment in which the device is installed.

[0157] In one configuration, the device may include a gauge pressure signal that generates a gauge pressure signal or data representing the gauge pressure related to the flow of gas in the flow path.

[0158] In other configurations, the device may include a gauge pressure signal sensor configured to generate a gauge pressure signal or data representing a gauge pressure related to the gas flow, and an ambient pressure sensor configured to generate an ambient pressure signal or data. In such a configuration, the device may be configured to use the ambient pressure data as input to a correction algorithm, coefficient, or function applied to the detected gauge pressure signal or data. For example, the correction algorithm, coefficient, or function may be configured to correct the detected gauge pressure signal or data to take into account the effect of changes in air density on the detected gauge pressure signal or data. 2.3. Controller

[0159] Figure 2B shows a block diagram of one embodiment of the controller 600 (which may be controller 19 in Figure 1). The control system 600 may include programming instructions for detecting input conditions and controlling output conditions. The programming instructions may be stored in the memory 624 of the controller 600. The programming instructions may correspond to the methods, processes, and functions described herein. The programming instructions may be executed by one or more hardware processors 622 of the controller 600. The programming instructions may be implemented in C, C++, Java, or other suitable programming language. Some or all of the programming instructions may be implemented in application-specific circuits 628 such as ASICs and FPGAs.

[0160] The controller 600 may also include a circuit 628 for receiving sensor signals. The controller 600 may further include a display 630 for transmitting the status of the patient and the respiratory support system. The display 630 may also display warnings and / or other alerts. The display 630 may be configured to display the characteristics of the detected gas(s) in real time or otherwise. The controller 600 may also receive user input through a user interface such as the display 630. The user interface may include buttons and / or dials. The user interface may include a touchscreen. 2.4. Motor / Sensor Module

[0161] Any of the functions of the respiratory system described herein, including but not limited to a humidifying chamber, flow generator, user interface, controller, and patient respiratory conduit configured to connect the gas outlet of the respiratory system to the patient interface, can be combined with any of the sensor modules described herein.

[0162] Figure 3 shows a block diagram of a motor / sensor module 2000 that can be received by a recess 250 in the respiratory support device. The motor and sensor module may include a blower 2001 that draws in room air for delivery to the patient. The blower 2001 may be a centrifugal blower.

[0163] One or more sensors (e.g., Hall effect sensors) may be used to measure the motor speed of a blower motor. The blower motor may include a brushless DC motor, in which case the motor speed can be measured without using a separate sensor. For example, during operation of a brushless DC motor, a rear EMF can measure the back electromotive force from the motor's non-energized winding, from which the motor position can be determined, and furthermore, the motor speed can also be calculated. In addition, the motor current may be measured using a motor driver, and the motor torque can be calculated together with the measured motor speed. The blower motor may include a low-inertia motor.

[0164] Indoor air can enter the indoor air inlet 2002 and further enter the blower 2001 through the inlet port 2003. The inlet port 2003 may include a valve 2004 through which pressurized gas can enter the blower 2001. The valve 2004 can control the flow of oxygen to 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.

[0165] The blower 2001 can operate at a motor speed between 1,000 RPM and less than 30,000 RPM, 2,000 RPM and less than 21,000 RPM, or any of the aforementioned values. The blower 2001 is operated to mix the gas entering the blower 2001 through the inlet port 2003.

[0166] The mixed air can exit the blower 2001 through the conduit 2005 and enter the flow path 2006 in the sensor chamber 2007. A sensing circuit board equipped with sensors 2008 can be positioned within the sensor chamber 2007 such that the sensing circuit board is at least partially immersed in the gas flow. At least some of the sensors 2008 on the sensing circuit board can be positioned within the gas flow to measure the gas characteristics within the gas flow. After passing through the flow path 2006 in the sensor chamber 2007, the gas can exit into the humidification chamber 2009.

[0167] By positioning sensor 2008 downstream of the blower and mixer 2001 combination, measurement accuracy, such as the measurement of gas fraction concentration including oxygen concentration, can be improved compared to systems where the sensor is positioned upstream of the blower. This positioning allows for a reproducible flow profile. Furthermore, positioning the sensor downstream of the blower and mixer combination avoids the pressure drop that would otherwise occur. This is because if detection is performed before the blower, another mixer, such as a static mixer with a baffle, would be required between the inlet and the detection system. A mixer can introduce a pressure drop throughout the entire mixer. Positioning the detector after the blower allows the blower to function as a mixer. Additionally, immersing the sensor in the flow increases the likelihood that the sensor will be subjected to the same temperature and pressure conditions as the gas flow, meaning it can more accurately represent the characteristics of the gas flow. Therefore, immersing at least a portion of the detection circuit board and sensor 2008 in the flow path can improve the measurement accuracy of the sensor.

[0168] Referring to Figure 4, the gas exiting the blower can enter the flow path 402 within the sensor chamber 400, which can be positioned within the motor / sensor module and can be the sensor chamber 2007 shown in Figure 3. The flow path 402 may have a curved shape. The flow path 402 can be configured to have a curved shape without sharp curves. The flow path 402 may have curved ends and straight sections between these curved ends. The curved flow path shape can reduce the pressure drop of the gas flow without reducing the sensitivity of flow measurement by partially aligning the measurement area with the flow path to form the measurement portion of the flow path.

[0169] A detection circuit board 404, equipped with sensors such as an acoustic transmitter and / or receiver, a humidity sensor, a temperature sensor, a pressure sensor, and a thermistor, can be positioned within the sensor chamber 400 such that the detection circuit board 404 is at least partially immersed in the flow path 402. Sensors immersed in the flow are more likely to be subjected to the same conditions as the gas flow, such as temperature and pressure, and can therefore more accurately represent the characteristics of the gas flow. By immersing the detection circuit board and at least a portion of the sensors in the flow path, measurement accuracy can be improved. After passing through the flow path 402 in the sensor chamber 400, the gas can exit into the humidification chamber. Alternatively, one or more pressure sensors may be provided on one or more separate circuit boards, positioned or arranged so that the pressure sensors can measure or detect pressure characteristics related to the gas flow and / or ambient pressure.

[0170] The gas flow can be measured using at least two different types of sensors. The first type of sensor may include a thermistor, which can determine the flow rate by monitoring the heat transfer between the gas flow and the thermistor.

[0171] A second type of sensor may include an acoustic sensor assembly. An acoustic sensor, including an acoustic transmitter and / or receiver, can be used to measure the time of flight of an acoustic signal to determine the velocity and / or composition of a gas, which can be used in respiratory assist devices. In one ultrasonic sensing topology (including an ultrasonic transmitter and / or receiver), a driver generates an ultrasonic pulse in a first direction to a first sensor, such as an ultrasonic transducer. A second sensor, such as a second ultrasonic transducer, receives this pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers. This time-of-flight measurement can be used to calculate the sound velocity of the gas flow between the ultrasonic transducers in a respiratory system processor or controller. The second sensor then transmits a pulse in a second direction opposite to the first direction, and the first sensor receives the pulse, providing a second measurement of the time of flight, allowing for the determination of gas flow characteristics, such as flow rate or velocity. In another acoustic sensing topology, an acoustic pulse transmitted by an acoustic transmitter, such as an ultrasonic transducer, can be received by an acoustic receiver, such as a microphone. Details of the acoustic flow sensor are described in PCT application publication WO2017 / 095241, filed on 2 December 2016, which is incorporated herein by reference in its entirety.

[0172] By combining readings from both the first and second types of sensors, a more accurate flow determination can be made. For example, the previously determined flow rate and one or more outputs from either type of sensor can be used to determine the predicted current flow rate. Then, in order to calculate the final flow rate, the predicted current flow rate can be updated using one or more outputs from the other of the first and second types of sensors. 3. Embodiment of an Exemplary Mouthpiece Attachment

[0173] Exemplary embodiments of the mouthpiece attachment will be described in the context of the above-described exemplary respiratory support device 10, which can be configured or operated as a flow therapy device for providing nasal high-flow therapy via an open patient interface. However, as previously described, the mouthpiece attachment may also be used in other forms or types of suitable respiratory support devices comprising a controllable flow generator and one or more sensors for detecting the characteristics of the gas flow.

[0174] In one configuration, the mouthpiece attachment is automatically identified by the respiratory support device, for example, by an RFID tag, NFC chip, Bluetooth beacon, or other appropriate means, if it is connected to or in close proximity to the respiratory support device. Alternatively, the mouthpiece attachment may be identified based on pressure and / or flow characteristics. For example, in one configuration, a specific flow rate is provided by a flow generator, the pressure is measured, and the identification information of the attached mouthpiece is determined. In a further configuration, the mouthpiece attachment is identified based on the relationship between flow rate and motor speed. For example, the motor speed required to generate a predetermined flow rate identifies the mouthpiece attachment.

[0175] Referring to Figure 5, an exemplary embodiment of the training system 700 is provided. The training system 700 is provided in combination with a mouthpiece attachment 1702 in conjunction with the respiratory support device 10. Specifically, the training system 700 in this embodiment may include the respiratory support device 10 described with reference to Figure 1, in combination with a mouthpiece attachment 1702 attached to the end of the respiratory conduit, rather than a nasal cannula 51. As shown in the figure, in this embodiment, the mouthpiece attachment 1702 is a component that can be releasably or detachably connected to the end of the patient respiratory conduit 16. When the mouthpiece attachment is connected to the respiratory conduit 16, the respiratory support device may operate in a training mode in which the patient is guided through one or more breathing exercises. Exemplary embodiments of the configuration, apparatus, training modes, and process of using the mouthpiece attachment with the respiratory support device are described in further detail below.

[0176] In one exemplary configuration, the mouthpiece attachment is configured to be connected or fluidically coupled, either directly or indirectly, to a flow path of a respiratory assist device, including a flow generator, via a breathing conduit. In this configuration, the mouthpiece attachment receives a flow of gas generated by the flow generator of the respiratory assist device.

[0177] A respiratory support device includes one or more sensors that measure or detect the characteristics of gas flow. One or more sensors may generate sensor data representing one or more characteristics of the gas flow. The sensor data may be processed or analyzed to extract or generate patient respiratory information or characteristics from the sensor data. For example, patient respiratory information may include patient flow signals and / or patient pressure signals that represent the flow and / or pressure exerted by the patient during the respiratory training performed.

[0178] The respiratory support device can be operated in a mode (e.g., training mode) that delivers a controlled flow of gas to the mouthpiece attachment and provides controllable air resistance.

[0179] Next, when a user performs one or more breathing exercises with the mouthpiece attachment, the measured values ​​can be captured by recording and processing sensor data from one or more sensors of the device. Furthermore, for certain breathing exercises or techniques (such as normal breathing, maximal breathing, and huffing), the use of the mouthpiece attachment may not be required during the training mode; instead, the user is expected to interact with the respiratory support device via another appropriate patient interface, such as a nasal cannula, nasal mask, nasal pillow, or face mask.

[0180] In one configuration, the respiratory support device can operate in a therapeutic mode for delivering respiratory therapy (e.g., nasal high-flow therapy), as well as be used or operated as a training system for respiratory physiotherapy, or in training mode. In this exemplary configuration, since measurement data is acquired from one or more sensors on the respiratory support device and / or respiratory conduit, the mouthpiece attachment does not necessarily need to be equipped with sensors or electronics. As will be further described below, this configuration allows the mouthpiece attachment to leverage the existing sensors and sensing capabilities of the respiratory support device. This configuration allows for the manufacture of a low-cost mouthpiece attachment, which is primarily a mechanical component, and can be used in conjunction with the respiratory support device to perform measurements using one or more of the existing sensors on the respiratory support device. For example, in this configuration, the mouthpiece attachment does not require an onboard sensor or sensing capability, which would significantly increase the cost of the component. In addition, the mouthpiece attachment can, in some cases, leverage the air resistance provided by the gas flow generated by a flow generator, without requiring complex and expensive additional elements (such as valves) to provide air resistance.

[0181] In the embodiments described below, the training system 700 employs a mouthpiece attachment 1702 connected to the flow path of the respiratory support device 10 and utilizes the existing flow path sensors of the respiratory support device to measure or detect one or more characteristics of the gas flow during the training mode as the user performs breathing exercises with the mouthpiece attachment. The sensors may include sensors that detect any one or more of the following gas flow characteristics, such as flow rate, pressure, temperature, humidity, gas concentration, or any other characteristics that can be used to identify the patient's breathing information or characteristics during breathing exercises. Sensor data acquired from the sensors during the training mode can be processed and / or analyzed to generate, extract, or identify one or more measurements, metrics, features, and / or evaluations related to the patient's breathing. In this embodiment, the sensors are located outside the mouthpiece attachment 1702 and are preferably located inside the main housing 100 of the respiratory support device and / or along the patient's breathing conduit 16. 3.1. Exemplary Embodiments - Mechanical Configuration of Mouthpiece Attachment

[0182] Referring to Figures 6-15, an exemplary embodiment of the mouthpiece attachment 1702 will be described in further detail.

[0183] In this embodiment, the mouthpiece attachment 1702 includes a body 1704 extending between a first end 1706 and a second end 1708. The first end 1706 of the body is the connector end, and the second end 1708 is the mouthpiece end.

[0184] In this embodiment, the body 1704 is a component in the form of a conduit, tube, or tubular component, or a manifold component. The body has one or more main lumens extending between its connector end 1706 and mouthpiece end 1708, thereby allowing a gas flow to flow or be transported along the body 1704 between its ends. The one or more main lumens take the form of a passage, channel, or internal space extending between the openings of the connector end 1706 and the mouthpiece end 1708. Main unit and main lumens

[0185] Referring to Figure 14, in this embodiment, the body 1704 includes a single main lumen, the entire of which is indicated by 1710. The main lumen 1710 is a passage or channel that extends along the length of the body 1704 between the open ends 1706, 1708 of the body. The shape and / or dimensions of the main lumen 1710 may be uniform or non-uniform along the length of the body 1704. For example, the internal dimensions or diameter of the main lumen 1710 may be uniform or vary along the length of the body 1704. The main lumen 1710 is generally defined by the peripheral wall around the body and / or any internal morphological portions within the body.

[0186] In this embodiment, the inner diameter of the main lumen 1710 is substantially uniform along at least a portion of the length of the body 1704. Referring to Figure 14, the central portion of the main lumen, which is entirely indicated by 1712 and is located between the connector end 1706 and the mouthpiece end 1708, has a substantially uniform diameter, as indicated by D6. In this embodiment, the inner diameter D7 of the main lumen 1710 is wider or larger at the mouthpiece end region 1713, which is located at or leading towards the mouthpiece end 1708, compared to the inner diameter D6 of the central region 1712 of the main lumen 1710. In this exemplary embodiment, the inner diameter D6 of the main lumen in the central region 1712 gradually changes to a larger diameter D7 in the mouthpiece end region 1713.

[0187] In one embodiment, the internal dimension or diameter D6 in the central region 1712 of the main lumen 1710 may be approximately 22.5 mm, and the internal dimension or diameter D7 in the mouthpiece end region 1713 may be approximately 25 mm, but it will be understood that alternative dimensions or diameters may be used depending on the characteristics of the connected breathing conduit.

[0188] This configuration could also be said to have a substantially uniform cross-sectional area in the central portion 1712 of the main lumen 1710. In other embodiments, it will be understood that the internal profile, cross-sectional area, or diameter of the main lumen 1710 can vary in alternative arrangements or configurations, including widening, narrowing, or combinations thereof along one or more portions or the entire length of the body 1704. Variations or transitions in the diameter, profile, or cross-sectional area of ​​the main lumen 1710 can be gradual or progressive, or more abrupt or stepwise.

[0189] In this embodiment, the difference in inner diameter, dimension, or cross-sectional area between the central region 1712 and the mouthpiece end region 1713 is defined by the thickness of the circumferential wall of the main body 1704. In this embodiment, the outer dimension or diameter of the main body 1704 of the mouthpiece attachment 1712 is substantially uniform along the central region 1712 and the mouthpiece end region 1713, as indicated by diameter D8. Therefore, the thickness of the circumferential wall of the main body 1704 in the central region 1712 is greater than the thickness of the circumferential wall of the main body in the mouthpiece end region 1713, thereby forming the inner diameters D6 and D7 discussed above.

[0190] In this embodiment, the body 1704 is an extension component. The body 1704 is substantially hollow and is defined by one or more conduits or circumferential walls extending between the ends 1706, 1708 of the body. In this embodiment, the body 1704 has a substantially circular cross-section along its length, for example, as shown in Figures 24, 25, 30, and 31.

[0191] In one configuration, the external dimensions or diameter of the body 1704 may be substantially uniform along its length. In an alternative configuration, the external dimensions or diameter of the body 1704 may vary substantially along its length.

[0192] In this embodiment, as shown in Figure 14, the body 1704 includes a first region 1720 and a second region 1721. The first region 1720 is cylindrical and is defined by the outer diameter or dimension indicated by D8. The second region 1721 is cylindrical and is defined by the outer diameter or dimension indicated by D9. In this embodiment, the first region 1720 extends from the mouthpiece end 1708 toward the connector end 1706 to an intermediate position 1722, and the second region 1721 extends from the intermediate position 1722 toward the connector end 1706. In this embodiment, the first region 1720 includes the mouthpiece end region 1713 and the central region 1712 of the body 1704, and the second region 1721 includes or defines the connector end region.

[0193] In this embodiment, the first region 1720 has a dimension or diameter D8 that is larger than the dimension or diameter D9 of the second region 1721. For example, in this embodiment, the connector end region indicated by 1721 has a smaller diameter or dimension than the rest of the body 1704. In this embodiment, the first region 1720 of the body 1704 has a larger diameter or dimension D8 and gradually decreases or transitions to the second region 1721 of the body, which has a smaller diameter or dimension D9. In this embodiment, the cylinder or cylindrical wall defining the first region 1720 gradually decreases or transitions at an intermediate position or shoulder 1722 to the cylinder or cylindrical wall defining the second region 1721. In this embodiment, the cylinder or cylindrical wall defining the first region 1720 is longer and has a larger diameter than the cylinder or cylindrical wall defining the second region 1721. In this embodiment, as shown in Figure 5, the dimensions and configuration of the connector end region of the second region 1721 may be configured to complementarily engage or connect to the end of the respiratory conduit 16 of the respiratory support device 10.

[0194] In one embodiment, the outer dimensions or diameter D8 of the first region 1720 of the main body 1704 may be approximately 27.5 mm, and the dimensions or diameter D9 of the second region 1721 defining the connector end region may be approximately 20.8 mm, however, it will be understood that alternative dimensions or diameters may be used depending on the characteristics of the breathing conduit to be connected and / or other design factors.

[0195] In this embodiment, the body 1704 has a substantially cylindrical form factor or shape, and its outer surface is defined by a circular cross-sectional profile or shape along its length. In other embodiments, it will be understood that the body 1704 may be provided in a different shape or configuration. For example, the cross-sectional profile of the outer surface of the body may be circular, elliptical, rectangular, square, any or any preferred shape, or a combination of shape and size along the length of the body.

[0196] In this embodiment, the body 1704 and the main lumen 1710 may generally be defined or aligned along or with respect to the central longitudinal axis. The body and main lumen are linear and extend in a single axis or dimension. In alternative embodiments, it will be understood that the body and / or main lumen may have alternative shapes and configurations, such as curved, arched, or elbowed shapes, or may have non-linear profiles that do not conform to or align with a single longitudinal axis or dimension. It will be understood that various shapes and configurations of the body may include a main lumen that fluidly communicates between the connector end of the body and the mouthpiece end. Connector end

[0197] Refer to Figures 5 and 13-15 to further describe the connector end 1706 of the mouthpiece attachment 1702.

[0198] In this embodiment, the connector end 1706 is configured to be detachably connected to or attached to the end of the respiratory conduit 16 or tube of the respiratory support device 10. As you can see, the respiratory conduit 16 of the respiratory support device is typically a flexible conduit, one end of which is attached to or connected to the gas outlet 21 of the respiratory support device, thereby fluidically connecting to or communicating with the gas flow generated by the device's flow generator 11. Typically, the other end of the respiratory conduit 16 provides a connector for detachably connecting to or coupling to a respiratory patient interface (e.g., nasal cannula, nasal mask, full-face mask, tracheostomy interface, etc.) to deliver the gas flow to the patient's airway when the respiratory support device is used for respiratory therapy (e.g., high-flow therapy, PAP therapy, etc.) in a typical therapy mode. In this embodiment, the connector end 1706 of the mouthpiece attachment 1702 is configured or positioned to be detachably connected or attached to the connector or end of the breathing conduit so that the mouthpiece attachment is in fluid communication with the flow of gas being transported along the breathing conduit.

[0199] In this embodiment, the connector end 1706 of the mouthpiece attachment 1702 includes a connection structure or arrangement, shown collectively 1714, configured to provide a releasable fluid connection to the end or connector of the breathing conduit 16. The end or connector of the breathing conduit may include a complementary connection structure or arrangement for engaging and mounting with the connector end 1706 of the mouthpiece attachment 1702 to releasably join two components. In this embodiment, the connection structure 1714 may be provided by a pair of opposing elastic clipping projections that releasably engage or clip to the corresponding forming or indent or receiving portion or complementary end or connector of the breathing conduit 16. It will be understood that the connector end 1706 may be configured, arranged or provided with any preferred form of mechanically detachable fastening or coupling, including but not limited to threaded, rotary locking or coupling, clip connector, snap-fit ​​connection, push-fit connection, interference-mating connection, latch connection, etc., to complement the end or connector of the breathing conduit.

[0200] In some embodiments, the connector end 1706 may be provided with a connection structure compatible with connections to the ends of one or more specific types of breathing conduits, including brand or manufacturer-specific breathing conduits. For example, in one embodiment, the connector end 1706 may be configured to attach to or connect to a 20 mm breathing tube used in high-flow respiratory assist devices. In other embodiments, the connector end 1706 may be provided with a general-purpose or universal connection structure or configuration that can operate or be coupled to the ends of various or wide-ranging different types of breathing conduits.

[0201] In the illustrated embodiment, the connector end 1706 is configured to be detachably connected or coupled to the end or connector of the respiratory conduit 16. This allows the mouthpiece attachment 1702 to be connected to the respiratory conduit to assist patient respiratory training in the device's training mode, and then removed after the training session, so that the respiratory conduit can be connected to or reconnected to the patient interface for later use in normal respiratory therapy mode.

[0202] In an alternative embodiment, the connector end 1706 of the mouthpiece attachment can be configured as a permanent, non-removable connection to the breathing tube 16, in which case the components would break if separated from each other. Alternatively, a semi-permanent connection may be provided between the connector end 1706 of the mouthpiece attachment and the breathing conduit 16, in which case tools or the like would be required to remove the components from each other.

[0203] In a further alternative embodiment, the mouthpiece attachment 1702 may be provided with an integrated breathing conduit extending from the connector end 1706. In such an embodiment, the mouthpiece attachment 1702 may be provided with an integrated flexible conduit extending from the connector end. The integrated flexible conduit may terminate at a connector end that can be releasably connected to or attached to the gas outlet 21 of the respiratory support device.

[0204] In another embodiment, the mouthpiece attachment 1702 may be configured to be directly and detachably connected to or attached to the gas outlet 16 of the respiratory support device without an intermediate breathing conduit. In another embodiment, the mouthpiece attachment 1702 may be configured to be detachably connected to or directly attached to the flow generator outlet or gas outlet port when the humidifier chamber is removed from the device. 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 be directly or indirectly via a breathing conduit to a bypass conduit, port, or outlet that bypasses the humidifier or humidifier chamber, thereby allowing the mouthpiece attachment to fluidly communicate with the gas flow from the flow generator outlet, and furthermore, temporarily blocking or bypassing the humidifier from the flow path. Mouthpiece edge

[0205] Referring to Figures 12 and 14, the mouthpiece end 1708 of the mouthpiece attachment 1702 will be described in more detail.

[0206] In this embodiment, the mouthpiece end 1708 is a portion configured to releasably receive and hold an optional detachable mouthpiece, which will be described in more detail later. In this embodiment, the mouthpiece end 1708 is an open cylindrical portion at the end of the body 1704. In this embodiment, the mouthpiece end 1708 is not threaded, but in other embodiments it may be threaded. However, it will be understood that the mouthpiece end 1708 may be of other suitable shape or configuration for receiving and holding a detachable mouthpiece.

[0207] In an alternative embodiment, the mouthpiece attachment 1702 may be used directly without a separate detachable mouthpiece. In such an embodiment, the mouthpiece may be formed integrally with the mouthpiece end 1708, or the mouthpiece end 1708 itself may constitute the mouthpiece, or it may be used as a mouthpiece for fluid communication with the user's or patient's airway when the mouth is sealed around the mouthpiece during use. The shape and configuration of the mouthpiece portion or the end of the body may be cylindrical, elliptical, oblong, mouth-shaped, or other suitable shape for the user's mouth. Exhaust vent

[0208] In this embodiment, the mouthpiece attachment 1702 includes one or more exhaust openings that are in fluid communication with the main lumen of the mouthpiece attachment 1702. The one or more exhaust openings provide a path for gases and / or exhaled air from the user or patient to escape to the atmosphere or the surrounding environment during use of the mouthpiece attachment. If there is no one or more exhaust openings, depending on the system configuration, the flow path may be completely blocked if the user places their mouth on the mouthpiece or creates a seal around the mouthpiece during use. In alternative embodiments, the mouthpiece attachment 1702 may not have an exhaust port or exhaust opening, and this may be permissible depending on the system configuration. For example, an exhaust port, exhaust opening, and / or pressure relief valve may be provided in the flow path upstream of the mouthpiece attachment.

[0209] Referring to Figures 6-10 and 14, an exemplary configuration of the discharge opening in this embodiment will be described in further detail. In the illustrated embodiment, the mouthpiece attachment 1702 is provided with one or more discharge openings 1716. The one or more discharge openings 1716 are located between the connector end 706 and the mouthpiece end 1708. In this embodiment, the one or more discharge openings 1716 are provided within and / or along the body 1704 of the mouthpiece attachment 1702.

[0210] In this embodiment, the exhaust opening 1716 is or includes a flush vent. A flush vent is a through-hole, opening, or aperture that penetrates the peripheral wall of the body 1704 of the mouthpiece attachment 1702. The flush vent may be substantially the same height as the outer surface (e.g., cylindrical surface) of the body 1704 of the mouthpiece attachment 1702. Referring to Figure 14, in this embodiment, the exhaust opening 1716 extends from the outer surface to the inner surface of the body wall (i.e., across the entire thickness of the wall), thereby providing a passage(s) or route (passage) for releasing or exhausting gas and / or exhaled air from the main lumen from the device to the ambient atmosphere or environment. As shown, in this embodiment, the exhaust opening does not protrude from the peripheral wall of the body 1704, i.e., it is the same height and includes a hole or ventilation section formed directly within the body wall. However, in alternative embodiments, one or more protruding exhaust ports may extend from the surface wall or body.

[0211] In this embodiment, the shape of the discharge opening 1716 is circular, but it will be understood that in alternative embodiments, other shapes or profiles, or combinations of different shapes or profiles, may be used for the discharge opening or hole. If multiple discharge openings 1716 are provided, they may be uniform in shape and / or size, or they may be a combination of different shapes and / or sizes.

[0212] The total cross-sectional area of ​​one or more exhaust openings 1716 can be configured to suit desired exhaust flow requirements. For example, the size or dimensions of the exhaust openings 1716 can be configured to suit exhaust flow requirements, depending on the overall size and characteristics of the mouthpiece attachment 1702. For example, in the case of a circular exhaust opening 1716, the diameter of the opening can be customized or configured to suit exhaust flow requirements.

[0213] As an example, in this embodiment, each discharge opening 1716 is a circular hole or aperture with a diameter of approximately 5 mm. Therefore, the opening area of ​​each discharge opening is approximately 19.6 mm². 2 In this embodiment, the internal cross-sectional area of ​​the main lumen is approximately 397.6 mm², given that the inner diameter D6 is 22.5 mm². 2 Therefore, each exhaust opening 1716 has an opening area of ​​approximately 5% of the cross-sectional area of ​​the main lumen of the mouthpiece attachment 1702 body. Furthermore, in this embodiment, the total exhaust opening area 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.

[0214] In the illustrated embodiment, the discharge openings 1716 include a linear arrangement, a straight line, or a linear array of equally spaced discharge openings 1716 provided along one side or region of the body 1704 of the mouthpiece attachment 1702. In this exemplary embodiment, the linear array of discharge openings 1716 extends in a direction coinciding with the longitudinal axis of the body 1704. In this exemplary embodiment, there are three discharge openings, but it will be understood that the number of discharge openings 1716 in the array is variable, and in other embodiments, the spacing may be uniform or non-uniform. In this exemplary embodiment, the linear array of discharge openings 1716 is located closer to the mouthpiece end 1708 of the body 1704 than to the connector end 1706, but instead, in other embodiments, the discharge openings 1716 may be located in the center of the body or near the connector end.

[0215] The discharge openings may be single or multiple. The number, arrangement, or pattern of one or more discharge openings may vary in various embodiments. In some configurations, the discharge openings are arranged in arrays such as linear or nonlinear arrays, or in other patterns or configurations. In some configurations, the discharge openings may be provided as one or more lines along one or more sides or surface areas along the length of the body 1704. In some configurations, one or more lines of discharge openings may be arranged along the longitudinal axis as shown, or may extend in other directions.

[0216] In some configurations, the exhaust openings may be provided circumferentially along the outer circumference of the main body. For example, the exhaust openings may be provided in the form of one or more annular ventilation sections or an annular array of spaced-out exhaust openings centered on the circumference of the main body 1704. One or more annular arrays of spaced-out exhaust openings or holes within the wall of the main body may extend around the entire outer circumference of the main body or around at least one or more portions.

[0217] One or more discharge openings, or arrays of discharge openings, may exist along and / or extending from the surface of the body 1704, including cases where they are provided along or around any one or more areas, sides, or surfaces of the body. In some embodiments, the discharge openings may be provided on opposite or opposing sides, or multiple sides, of the body 1704.

[0218] The location of one or more exhaust openings, arrays, or exhaust openings along and / or around the main body 1704 may vary. In one configuration, one or more exhaust openings may be located in the center of the mouthpiece attachment 1702 or the main body 1704, or in an intermediate area thereof. In another configuration, one or more exhaust openings may be located at or toward either the connector end 1706 or the mouthpiece end 1708 of the main body 1704. In yet another configuration, multiple exhaust openings may be spaced along most of the length of the main body 1704, or along its entire length, whether on the same or different sides of the main body 1704.

[0219] In general, the characteristics of one or more discharge openings 1716 may vary in various embodiments, but are not limited to, for example, the number, shape, opening area, arrangement, uniformity, circumference, and / or diameter.

[0220] In some configurations, the mouthpiece attachment 1702 may include a mixture of different types of exhaust openings. Some exhaust openings may be protruding vents as described above, while others may be flush vents or the types of exhaust openings described for the mouthpiece attachment 1702 of this embodiment. Some exhaust openings may include a single opening, while others may include multiple openings or, for example, an array of openings, ports, or holes that form a mesh-like or honeycomb-like ventilation arrangement flush with the outer surface of the body. Detachable mouthpiece

[0221] As discussed above, in some embodiments, the mouthpiece end 1708 of the main body 1704 may be a mouthpiece itself or may have an integrated mouthpiece. In this embodiment, the mouthpiece attachment 1702 is provided with a releasable or detachable mouthpiece that is received by the mouthpiece end 1708 of the main body 1704, or attached to or inside this mouthpiece end.

[0222] Referring to Figures 16-27, one embodiment of the mouthpiece attachment 1702 with a detachable mouthpiece 1730 will be described in further detail as an example. The mouthpiece 1730 may be optional in the sense that the mouthpiece end 1708 of the body 1704 of the mouthpiece attachment 1702 can function as a mouthpiece. However, the detachable mouthpiece 1730 may offer certain advantages in terms of usability, manufacture, and / or hygiene in some scenarios or situations.

[0223] In this embodiment, the detachable mouthpiece 730 is a hollow conduit component having a mouthpiece portion 1732 for the user's mouth at one end and a mounting portion 1734 at the other end for detachably connecting to or attaching to the mouthpiece end 1708 of the mouthpiece attachment 1702.

[0224] In this exemplary embodiment, the mouthpiece portion or region 1732 of the mouthpiece 1730 includes an elliptical or oblong 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 by 1736 and a second end or point indicated by 1738. The first end or point 1736 is located midway along the length of the mouthpiece 1730 and defines the boundary or transition between the mouthpiece portion 1732 and the mounting portion 1734. In this exemplary embodiment, the shape or cross-section of the mouthpiece portion or region 1732 gradually transitions to an elliptical or oblong shape as it extends from the circular cross-section of the first end at 1736 toward the open elliptical or oblong opening of the second end at 1738.

[0225] In this exemplary embodiment, the mounting portion or area 1734 of the mouthpiece 1730 is a cylindrical conduit portion. Referring to Figure 18, in this embodiment, the outer diameter D10 of the mounting portion 1734 of the mouthpiece 1730 is dimensioned or selected to complement the inner diameter D7 of the mouthpiece end of the body 1708 (see Figure 14), thereby allowing the mounting portion 1734 to be inserted into or fitted into a socket, port, or opening provided by the mouthpiece end 1708, as indicated by arrow F in Figure 23. In this embodiment, the relative dimensions between the outer diameter D10 or outer circumference of the mounting portion 1734 of the mouthpiece 1730 and the inner diameter D7 of the mouthpiece end 1708 of the body 1704 of the mouthpiece attachment 1702 may be configured to provide a press fit, friction fit, or interference fit, thereby ensuring that the detachable mouthpiece is properly received and held within the mouthpiece attachment during use. The user may, for example, apply sufficient manual or tensile force in direction G (see Figure 23) to remove or pull out the detachable mouthpiece 1730 from the mouthpiece end 1708 of the mouthpiece attachment for replacement, cleaning, repair, and / or disposal.

[0226] Refer to Figures 22-27 to illustrate assembled and disassembled mouthpiece attachments 1702 equipped with a detachable mouthpiece 1730 as examples. Figure 23 shows an exploded assembly diagram of the mouthpiece attachment 1702 with the mouthpiece 1730 removed from or cut off from the mouthpiece end 1708. Figures 22 and 24-27 show various perspective, elevation, and cross-sectional views of the mouthpiece attachment 1702 ready for use, with the detachable mouthpiece 1730 attached, assembled, or inserted into the mouthpiece end 1708 of the main body 1704.

[0227] In alternative embodiments, it will be understood that any other suitable releaseable or detachable coupling or connection arrangement or structure for connecting the detachable mouthpiece 1730 to the end of the mouthpiece attachment 1702 may be used, but are not limited to, snap-fit, threaded, fastening, or clipping systems.

[0228] Referring to the cross-sectional views in Figures 19 and 21, the detachable mouthpiece of this embodiment includes a single main lumen or passage, indicated by 1736, extending between its ends. Referring to Figures 25 and 27, the mouthpiece lumen 1736 provides fluid communication to one or more main lumens (e.g., main lumen 1710) of the body 1704 of the mouthpiece attachment 1702, thereby enabling the detachable mouthpiece to deliver a gas flow to the user during use.

[0229] In an alternative embodiment, the mouthpiece may be provided with multiple lumens (e.g., channels or passages) extending along its length, for example, in an array, mesh, or honeycomb arrangement.

[0230] In this exemplary embodiment, the detachable mouthpiece 1730 is elongated, and its cross-sectional shape changes along at least a portion of its length. It will be understood that various shapes or cross-sectional profiles can be used to create the mouthpiece 1730. In one embodiment, the shape of the mounting portion 1734 can complement or fit the mouthpiece end 1708 of the mouthpiece attachment 1702 to enable attachment, and the mouthpiece portion 1732 may be any other suitable shape or profile for the user to seal the mouth around or over the entire mouth. For example, the cross-section of the mouthpiece portion 1732 may be circular, elliptical, oblong, mouth-shaped, or any other suitable shape.

[0231] In this embodiment, the detachable mouthpiece 1730 is a substantially linear or elongated component defined about a central longitudinal axis. However, it will be understood that the mouthpiece may have any suitable shape, including having one or more arcs or bends, and / or the overall shape may be elbow-shaped.

[0232] As discussed above, in this embodiment, the detachable mouthpiece 1730 is positioned to be a releasable component of the mouthpiece attachment 1702. However, in other embodiments, the mouthpiece 1730 may instead be formed integrally with or extend from the end of the body 1704 of the measurement 1702. Any of the characteristics and embodiments of the detachable mouthpiece 1730 described above may also apply to an integrated or permanent mouthpiece portion of the body 1704. Anti-occlusion shape

[0233] Referring to Figures 28-30, in some embodiments, the mouthpiece attachment 1702 may include, as appropriate, one or more anti-obstruction shapes, forms, or projections 1740 near, around, or near the discharge opening 1716, which help prevent the opening from being accidentally or unintentionally blocked or covered by the patient during use. For example, the anti-obstruction shapes 1740 may help prevent the user or patient from accidentally or unintentionally covering or blocking one or more of the flush discharge openings 1716 with their fingers and / or hands during use.

[0234] In this exemplary embodiment, the anti-blocking shape includes a pair of separated walls or surfaces 1740 that project or extend from the walls of the body 1704 along each side of the linear array of discharge openings 1716. The pair of walls project over the body 1704 and the surfaces of the discharge openings 1716 and are arranged to prevent the discharge openings from being accidentally or unintentionally blocked or covered during use.

[0235] In this exemplary embodiment, the anti-obstruction protruding wall 1740 is curved or has an arc-shaped profile and is arranged to form a clip or attachment mechanism that can be used to clip, attach, or mount the mouthpiece attachment 1702 to a transport stand or respiratory assist device when not in use. For example, a pair of curved protruding walls 1740 face each other and form a cylindrical clipping aperture or area above the exhaust opening for clipping or mounting to a cylindrical component of complementary size and shape to the transport stand or respiratory assist device, or to some other complementary mounting structure or component. The protruding wall may be rigid or semi-rigid and, in some embodiments, may have some elastic flexibility to provide or form a snap-fit ​​clip or clipping arrangement.

[0236] It will be understood that other shapes, sizes, or arrangements of the anti-blocking shape relative to the discharge opening are also conceivable, as long as they are sufficient to prevent the discharge opening from being blocked or covered during use. There may be one, multiple, or even more anti-blocking shapes. In some embodiments, the anti-blocking shape may have a dual purpose or function, such as forming a clip, while in other embodiments, the anti-blocking shape may have a single function, such as preventing the discharge opening from being blocked during use. 3.2. Materials - Mechanical structure of the mouthpiece attachment

[0237] The embodiment of the mouthpiece attachment 1702 described above can be formed from any suitable material.

[0238] In one embodiment, the body 1704 may be formed primarily of rigid or semi-rigid plastics or plastic polymers (not limited to polycarbonate (PC), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene (ABS), etc.), or combinations thereof, or of corrugated cardboard, glass, metal, or other suitable rigid or semi-rigid materials.

[0239] The body 1704 of the mouthpiece attachment 1702 may be formed from the same or similar material as the detachable mouthpiece 1730, or these components may be formed from different materials. For example, in one embodiment, the body 1704 may be formed primarily from a plastic polymer, and the detachable mouthpiece may be formed from the same or a different plastic polymer. In another embodiment, the body 1704 may be formed primarily from a plastic polymer, and the detachable mouthpiece may be formed from, for example, cardboard or thick paper.

[0240] The materials used to form the mouthpiece attachment 1702 and / or the thickness of those materials may vary depending on the usage. In some embodiments, the entire mouthpiece attachment, including the body 1704 and the detachable mouthpiece 1730, may be formed from low-cost or low-quality materials suitable for disposable articles. In other embodiments, the body 1704 may be configured as a multi-use and / or multi-user component formed from a more durable or longer-lasting material such as plastic, while the mouthpiece may be configured as a single-use or single-user disposable article; therefore, low-cost materials such as cardboard or thinner, lower-quality, or lower-cost plastic may be used for the detachable mouthpiece.

[0241] It will be understood that various mouthpiece attachments can be formed from various materials. Some mouthpiece attachments, or certain components thereof, may be formed from higher-grade and / or more durable materials for longer-term or more-use, while other mouthpiece attachments, or at least certain components thereof (e.g., detachable mouthpieces), may be formed from lower-cost and / or disposable and / or less durable single-use materials, such as cardboard or lower-grade or thinner plastics, but not limited to these.

[0242] In some embodiments, the mouthpiece attachment or its components (e.g., a detachable mouthpiece) may be configured to be suitable for delivery and / or shipment to an end user for use a specified number of times or a fixed lifespan (e.g., with an expiration date or expiration date). In such scenarios, the mouthpiece attachment may be formed from a material suitable for disposable articles. 3.3. Training Modes for Respiratory Support Devices

[0243] As part of a therapeutic program, patients may be required to perform respiratory training programs for respiratory physiotherapy. Currently, patients may be provided with a standalone passive mechanical device necessary for expelling exhaled air. Such a passive mechanical device may include an adjustable or replaceable flow-limiting component that can be configured to provide fixed or variable resistance to the flow from the patient's exhaled air, offering physiotherapy benefits.

[0244] At least some embodiments of this disclosure provide a simple, low-cost mechanical attachment (e.g., a mouthpiece attachment) for use with existing respiratory support devices to provide respiratory training for respiratory physiotherapy. The respiratory device controller, software, and / or firmware may be configured to provide relevant training modes that can be initiated while the patient is performing respiratory training, using a mouthpiece attachment or other patient interface connected to the gas flow generated by the respiratory support device. In the training mode, the flow generator is operable to provide a controlled gas flow to control the air resistance to the patient's respiratory training. By utilizing sensors mounted on the respiratory support device, it may be possible to measure the patient's performance in respiratory training, evaluate the patient's respiration during training, and / or assess the patient's compliance with the respiratory training program.

[0245] The respiratory support device may be capable of one or more operating modes. In this embodiment, the respiratory support device may have one or more therapy modes for providing a gas flow with specific characteristics (such as flow rate and / or pressure) suitable for high-flow therapy, CPAP, biphasic PAP / NIV, or other respiratory therapies. In this embodiment, the respiratory support device further includes a training mode that can be activated when performing respiratory training in conjunction with the mouthpiece attachment 1702 or the respiratory patient interface.

[0246] As will be described in more detail below, in training mode, while the device's flow generator is operated to control the air pressure resistance provided to the user, the user may be instructed or prompted to perform one or more different steps of breathing training into the mouthpiece of the mouthpiece attachment 1702. One or more sensors of the device 10 are used to detect one or more characteristics or features of the gas flow during breathing training. The sensor data may then be processed or filtered, or otherwise analyzed / processed to generate data indicating the performance of the breathing training and / or compliance with the breathing training program.

[0247] In one embodiment, the respiratory support device 10 may be configured to start or activate a training mode in response to user input to the user interface of the device 10. Additionally or alternatively, the training mode may be started remotely by another external device or system communicating data with the device 10 via a data network (e.g., a Wi-Fi network). Additionally or alternatively, the training mode may be started when it is detected that the mouthpiece attachment has been connected to the respiratory support device and / or breathing conduit. Additionally or alternatively, the user may trigger the start of the training mode by generating an air pressure signal by operating one or more exhaust openings / ventilators of the mouthpiece attachment, which will be further detailed later.

[0248] For example, the user interface of device 10 may have an operable button (mechanical or contact-sensitive) that can be operated to activate a training mode, or a touchscreen interface or buttons (e.g., GUI). Additionally or alternatively, device 10 may be controlled via a user's smart device that is communicating with the device via data (e.g., Bluetooth, Wi-Fi, or infrared). For example, a smartphone application may be provided for remote control of the device, and this smartphone application may provide an operable GUI button on device 10 to activate a training mode.

[0249] Remote start of the training mode can be performed by a remote user, such as a medical professional, who provides user input to a remote electronic device or server that is in data communication with the respiratory assist device 10. As an example, the remote device or server may have a software application that can provide an operable command to remotely start the training mode of the device 10 via a control signal or command data transmitted over a data network, or a GUI with operable GUI elements / buttons. The remote device or server may have any suitable form of user interface for receiving user input from a medical professional or other user, such as one or more mechanical or touch-detectable buttons or interfaces, and / or an electronic GUI displayed on a display screen.

[0250] It will be understood that the device 10 and / or the remote device, or server, or system can receive user input through other means, including voice or audible controls, or commands via a voice interface or voice assistant device, to start the training mode.

[0251] In one embodiment, the training mode can be started manually. For example, a user can manually select the training mode via an input to the device. Additionally or alternatively, as previously discussed, a medical professional can start the training mode via remote control. Additionally or alternatively, the training mode can be started either locally by the local controller 19 of the device 10 or remotely by a processor of a remote device, system, or server. Automatic start of the training mode can occur according to a configurable schedule or at regular intervals. The configurable schedule or regular intervals can be configured by the user or a remote medical professional via the respective user interfaces and / or software applications of the device 10 and the remote device, system, or server.

[0252] In one embodiment, the device and / or remote device, system, or server can be configured to prompt or notify a user or a remote medical professional to initiate a training mode. This prompt or reminder can be, for example, a visual prompt and / or an audio prompt provided via the user interface of device 10 and / or any remote device, server, or system that communicates with device 10 over data. By way of example, the visual prompt can be displayed on the display of device 10 or a remote device or a touchscreen display, and the audio prompt can be provided via the audio output device (e.g., speaker, etc.) of the device or remote device. The user or remote medical professional can initiate the training mode in response to one or more prompts. In some scenarios, the user can be prompted to conduct a training session, including one or more respiratory training programs, via a telephone, email, SMS, smartphone application message or notification, or other suitable electronic communication method.

[0253] In some configurations, the prompts can be generated automatically according to a default or configurable schedule (e.g., at regular intervals). The device can be provided with an initial default schedule at the time of manufacture or at regular intervals. The schedule or regular intervals can be configured by the user or a remote medical professional via the interface or software application of the device and remote devices, servers or systems. Alternatively, the remote medical professional can trigger the prompts on device 10 manually or ad hoc as needed via the interface or software application of the remote device, system or server. 3.4. Methods related to the training mode

[0254] Referencing Figures 31-39, exemplary methods 750, 750A of using a mouthpiece attachment 1702 with a respiratory assist device 10 in training mode will be described in further detail. The methods of this embodiment are primarily implemented by computing instructions or software executed on the processor or controller of the respiratory assist device 10 when the respiratory assist device 10 enters training mode. The principles of exemplary methods 750, 750A may be applied to any of the embodiments, configurations, or variations of the respiratory assist device, training system, and / or mouthpiece attachment described above.

[0255] It will be understood that the various steps of the exemplary method described do not necessarily have to be performed in the order described. Some steps may be performed in parallel, overlap with other steps, or in a different order than shown in the diagram, without affecting the overall method. Depending on the specific configuration and / or operation of the respiratory support device, training system, and / or mouthpiece attachment, some steps may be unnecessary or modified. Activating patient training mode

[0256] In one exemplary configuration, the respiratory support device 10 may initiate a training mode when the mouthpiece attachment 1702 is connected. For example, the respiratory support device 10 may automatically initiate a training mode when the mouthpiece attachment is detected in the airway, or when the user selects a training mode via input on the device's user interface (e.g., GUI). In another exemplary configuration, the respiratory support device 10 may initiate a training mode upon startup. In yet another exemplary configuration, the device may be provided as a dedicated training system or device having only one mode, which is the training mode; that is, in this exemplary configuration, the device may not offer any therapeutic modes.

[0257] Referring to Figure 15, in this embodiment, Method 750 begins in step 752 when the training mode of the respiratory support device 10 is activated in response to manual activation by a local user or patient, remote activation by a remote medical professional, or automatic activation (for example, based on the meeting of a schedule or other criteria, as described above). As previously stated, the user or medical professional may be prompted to activate the training mode in response to a prompt (such as a reminder). Once in training mode, the respiratory support device 10 may be configured to provide the user with one or more prompts, instructions, and / or other forms of guidance regarding some or all steps of the Method, as described below.

[0258] Prompts, instructions, and / or guidance may relate to the configuration of the respiratory assist device and / or mouthpiece attachment, and / or to the execution of one or more steps of respiratory training. Prompts, instructions, and / or guidance may be visual, consisting of text and / or graphic images, and may be displayed via a graphical user interface (GUI) on the device's display. Additionally or alternatively, prompts, instructions, and / or guidance may take the form of audible audio prompts, for example, provided via the device's speaker. It is also assumed that such visual and / or auditory prompts, instructions, and / or guidance may be provided by a suitable external electronic device that communicates with the respiratory assist device, such as a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, or similar device. In some configurations, the user may respond to prompts, instructions, and / or guidance using voice-activated commands or responses. Various GUI screen prompts for the steps of training method 750 are described below, purely as examples. It will be understood that GUI screen prompts can take on various forms and can be provided alone or in combination with voice prompts, guidance, and / or instructions via a speaker or audio output device.

[0259] As will be further described below, in some configurations, the device may provide step-by-step instructions, prompts, and / or guidance on how to use the mouthpiece attachment during training mode or training sessions. In this context, “training session” means a session in which the user operates the respiratory support device in training mode to perform respiratory training or a respiratory training program.

[0260] For illustrative purposes only, visual and / or auditory instructions, prompts, and / or guidance may provide the user with information relating to one or more of the following:

[0261] • Device operating mode (e.g., training mode), • Method for detaching the patient interface from the device and / or respiratory conduit. • A method of connecting or attaching a mouthpiece attachment to the gas outlet, breathing conduit, or flow path of the device. • How to perform breathing exercises (multiple exercises possible), and / or • A method of performing normal or spontaneous breathing at the end of a training session, following breathing exercises.

[0262] The above information can be provided using any combination of text, numbers, letters, images, icons, graphics, animations, videos, and / or audio.

[0263] In one embodiment, the user can turn on or activate the respiratory support device 10. The user may be prompted to answer a patient health questionnaire or inquiry via a GUI on the display of the device 10. The user then inputs and processes answers according to the screen prompts and questions presented on the GUI. Embodiments of a patient health questionnaire or inquiry process that may be implemented are described in PCT application PCT / IB2020 / 060335 (published as WO2021 / 090184), filed on 4 November 2020, which is incorporated herein by reference in its entirety. After completion of the questionnaire, the patient may be prompted to perform one or more respiratory exercises, or one or more steps of respiratory exercises, and the device enters training mode (step 752 of method 750). Command to disconnect the patient interface to the user.

[0264] After the training mode is activated, in step 754, the user or patient is instructed to remove any respiratory patient interface 51 (e.g., a nasal cannula, face mask, or other interface (depending on the type of therapy)) that may be connected to the respiratory conduit 16 of the respiratory support device, or to ensure that no respiratory patient interface 51 is connected to the respiratory conduit 16. For example, if the respiratory support device was last used in therapy mode during the previous therapy session (e.g., the previous day or earlier in the day), the respiratory patient interface 51 may remain connected to the respiratory conduit 16.

[0265] Figures 34A–34C show schematic embodiments of one or more GUI display screen prompts 754A, 754B, and 754C that may be displayed on the device's user interface display during step 754. As you can see, various variations are possible.

[0266] The exemplary screen prompt 754A in Figure 34A includes a text field and / or graphics field 7541 that describes or instructs the current operating mode (in this embodiment, training mode). The primary instruction text and / or graphics field 7542 includes text and / or graphics that instruct the user to disconnect the patient interface (in this embodiment, the nasal cannula). One or more secondary or additional text and / or graphics fields 7543 may also be provided, for example, showing additional instructions or details on how to perform the primary instructions.

[0267] The exemplary screen prompt 754B in Figure 34B shows a variant form in which there is only one primary instruction text and / or graphics field 7544.

[0268] The exemplary screen prompt 754C in Figure 34C shows a variant form that includes an animation field or region 7545, which may display two-dimensional or three-dimensional graphics, images, animations, or videos that depict or indicate instructions, that is, in this case, help guide the user through the actions required to complete a step or instruction, such as removing or disconnecting the patient interface from the respiratory conduit.

[0269] GUI display screen prompts may include any combination of text, images, animations, videos, and / or other graphics to provide the user with instructions or information and / or guidance regarding each step or prompt. Prompts may also be presented audibly by speakers within the device.

[0270] In one configuration, the prompt is provided by a suitable external electronic device that communicates with the respiratory assist device, such as a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, or similar such device. The prompt can be provided via the display screen of the external electronic device and / or one or more speakers.

[0271] In one configuration, the user can interact with the prompt verbally (such as understanding an instruction and confirming compliance). Connection of the mouthpiece attachment

[0272] The next step 756 of the training method 750 includes prompting the user to connect the mouthpiece attachment 1702 to the end of the breathing conduit 16 of the device 10 (or other gas outlet along the flow path) in the manner described above. The user can pre-assemble or attach the detachable mouthpiece 1730 before or after connecting the mouthpiece attachment 1702 to the end of the breathing conduit 16. In some configurations, the device 10 can instruct the user to connect the mouthpiece attachment 1702 to the breathing conduit 16, for example, and provide information or guidance regarding how to connect the components.

[0273] Figures 35A - 35C show schematic examples of one or more GUI display screen prompts 756A, 756B, 756C that can be displayed on the display of the device's user interface during step 756. As can be seen, various variations are envisioned.

[0274] The exemplary screen prompt 756A in Figure 35A includes a text field and / or graphics field 7541 that describes or instructs the current operating mode (in this embodiment, the training mode). The primary instruction text and / or graphics field 7562 includes text and / or graphics that instruct 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, for example, showing additional instructions on how to perform the primary instruction.

[0275] The exemplary screen prompt 756B in Figure 35B shows a variant form in which there is only one primary instruction text and / or graphics field 7564.

[0276] The exemplary screen prompt 756C in Figure 35C shows a variant that includes an animation field 7565 which may display two-dimensional or three-dimensional graphics, images, animations, or videos that depict or indicate instructions. The animation field may help guide the user through the actions required to complete a step or instruction (in this case, connecting the mouthpiece attachment 1702 to the device 10). Initiation of gas flow that creates air resistance

[0277] In the next step 758 of training method 750, the controller is configured to control the flow generator 11 of the respiratory assist device 10 to deliver a desired gas flow along the flow path to the gas outlet 21. The gas flow flows through the breathing conduit 16 to the mouthpiece attachment 1702. As previously stated, the gas flow to the mouthpiece attachment 1702 provides controllable air resistance for training.

[0278] In this embodiment, the training mode may be configured to provide a gas flow at a constant, predetermined, or configurable flow rate and / or pressure in order to provide substantially constant air resistance. It is also assumed that this gas flow can be controlled to zero (i.e., the flow generator 11 stops providing gas flow to the mouthpiece attachment).

[0279] In one configuration, when the user breathes (inhales and exhales) into the mouthpiece attachment while a gas flow is being supplied, variations occur in the gas flow characteristics. These gas flow characteristics may include, for example, the flow rate characteristics or the pressure characteristics of the gas flow. As will be described later, these variations indicate the user's breathing and can be detected and / or identified in sensor data detected during training mode.

[0280] The gas flow may be controlled over a predetermined or configurable period. The gas flow may be provided until the user completes the breathing exercises required for the training session, or until some other criterion is detected or met. In one embodiment, the user may notify or confirm the end of the training session through input to the device's user interface (e.g., GUI) (e.g., by pressing a "End Session" button on the GUI). In another embodiment, if the device does not detect breathing activity within a predetermined time, the training session may be considered to have ended, and it may be inferred that the device is no longer in use.

[0281] Flow rates (and associated air resistance) may be modified depending on the patient or patient characteristics, including but not limited to the patient's age, sex, height, weight, disease progression, and / or other relevant parameters that may affect or represent respiratory capacity and strength. Additionally or alternatively, flow rates may vary depending on the specific step of the respiratory training being performed. For example, flow rates may change depending on the type of respiratory training being performed (e.g., forced exhalation, breathing against vibrational pressure, resting breathing, or other types of breathing). Additionally or alternatively, flow rates may be set uniformly based on the air resistance required for the respiratory training or industry standards associated with each specific respiratory training.

[0282] In some embodiments, the respiratory support device may be configured or operable to control the composition of the gas delivered during a training session in training mode. In some configurations, the gas flow may be air enhanced with an auxiliary gas such as oxygen, and furthermore, the oxygen fraction of the gas flow may be controlled to match a specific oxygen concentration setting. In other configurations, the respiratory support device is controlled to deliver an airflow (i.e., if an auxiliary gas such as oxygen is available, the auxiliary gas may be stopped or its flow rate reduced to zero, for example, via a controllable valve). It will be understood that any preferred composition of one or more gases may be delivered.

[0283] During training mode, the respiratory support device 10 delivers a gas flow that is not humidity-controlled (i.e., the gas flow is supplied at substantially ambient humidity). In one embodiment, the respiratory support device may not have a humidifier. In another embodiment, the humidifier may be powered off, disabled, or disconnected. Instructions for users on how to perform breathing exercises

[0284] Once the gas flow is delivered via the mouthpiece attachment 1702, the user may be prompted to perform one or more breathing exercises using the mouthpiece of the mouthpiece attachment 1702, as shown in step 760.

[0285] In one embodiment, the user may instruct the mouthpiece of the mouthpiece attachment to perform normal breathing, spontaneous breathing, or maximal breathing against the air resistance caused by the gas flow.

[0286] In another embodiment, breathing exercises may be similar to those performed during spirometry evaluation and / or measurement.

[0287] In another embodiment, breathing training is performed. • Normal breathing, • Spontaneous breathing, · maximum respiration, Huffing, • Respiration in response to fixed positive expiratory pressure (PEP) • Respiration in response to Oscillating Positive Pressure Exhalation (OPEP) • Respiration for intrapulmonary percussion ventilation (IPV) • Respiration for continuous positive airway pressure (CPAP) with vibration • Slow, deep breathing, and / or • May include one or more types of pursed-lip breathing (see below for details).

[0288] In this disclosure, “normal breathing” means the state in which the user is breathing normally (in a relaxed state), that is, the state in which the user is not instructed to breathe deeply or forcefully.

[0289] In this disclosure, “spontaneous breathing” refers to a state in which the user is breathing deeply. This can be understood as a more “conscious” or active breathing, accompanied by relaxed exhalation, involving deep, slow breaths (i.e., breathing, including exhalation, is not forced). The difference between normal breathing and spontaneous breathing can be subtle. Both are peaceful or relaxed forms of breathing. However, the important difference is that normal breathing should aim to be as unconscious as possible, that is, without the user “thinking” too much, whereas spontaneous breathing in the context of this disclosure is deep breathing with particular emphasis on inhalation.

[0290] In this disclosure, “maximum respiration” means that the user takes a deep breath and exhales forcefully (forceful exhalation is a key difference from spontaneous breathing). For example, the user essentially tries to exert maximum force in their lungs during maximum respiration.

[0291] Some of the breathing exercises described above involve breathing against a gas flow provided according to a specific respiratory therapy (e.g., PEP, OPEP, IPV, CPAP with vibration), which will be discussed in more detail later.

[0292] In one exemplary configuration, the device may prompt the user to exhale at regular intervals, for example, for a specific period of time. This period may be, for example, one second, two seconds, three seconds, or longer, or other periods specified depending on the evaluation and / or training being performed. For example, the user may be prompted to inhale and then exhale as forcefully as possible into the mouthpiece of the mouthpiece attachment for a specific duration or until they become breathless. A countdown timer indicating the time required to exhale into the mouthpiece attachment may be displayed to the user (for example, via the respiratory assistance device's GUI display).

[0293] Figures 36A–36F show schematic embodiments of one or more GUI display screen prompts 760A, 760B, 760C, 760D, 760E, and 760F that may be displayed on the user interface display of the device during step 760. As you can see, various variations are possible.

[0294] The exemplary screen prompt 760A in Figure 36A includes a text field and / or graphics field 7541 that describes or instructs the current operating mode (in this embodiment, the training mode). The primary instruction text and / or graphics field 7602 includes text and / or graphics that instruct the user to perform breathing exercises in response to a gas flow using the mouthpiece attachment 1702. One or more secondary or additional text and / or graphics fields 7603 may also be provided, for example, that provide additional details on how to perform the primary instruction.

[0295] The exemplary screen prompt 760B in Figure 36B shows a variant form in which there is only one primary instruction text and / or graphics field 7604.

[0296] The exemplary screen prompt 760C in Figure 36C shows a variant form that includes an animation field or region 7605, which may display two-dimensional or three-dimensional graphics, images, animations, or videos that depict or indicate instructions, that is, in this case, help guide the user through the actions required to complete a step or instruction, such as performing one or more breathing exercises.

[0297] The respective exemplary screen prompts 760D, 760E, and 760F in Figures 36D, 36E, and 36F show a series of screen prompts in the form of screen prompt 760A, where a secondary or additional text and / or graphics area 7603 includes a countdown timer. The countdown timer may provide the user with guidance on the amount of time required to perform the breathing exercise steps. In this embodiment, the countdown is provided with text and numbers, but it will be understood that the countdown timer may also be provided with animation, graphics, or video, either alone or in combination with text and numerical information. Sensor data collection, storage, and / or analysis

[0298] When a user or patient performs breathing exercises, the respiratory support device is configured to detect or measure one or more characteristics of the gas flow via one or more sensors of the respiratory support device, as shown in step 762. Specifically, the controller of the respiratory support device receives or retrieves sensor data from one or more sensors while the patient is performing breathing exercises, while operating in training mode.

[0299] In one exemplary embodiment, the controller of the respiratory assist device is configured to sample flow signals from one or more flow sensors in the device. As discussed above, the device may include one or more flow sensors or configurations arranged to detect the flow rate of the gas flow and generate a representative flow signal or flow data. In other embodiments, during respiratory training, one or more other characteristics of the gas flow may be detected and measured, including, but not limited to, pressure, temperature, humidity, gas concentration, or other characteristics that may be directly or indirectly useful for analyzing user performance and / or user respiratory information. Training sessions including multiple breathing exercises

[0300] In some configurations, the device may be configured to instruct the user to perform repetitive or multiple breathing exercises during a session while in training mode. In one embodiment, the user may be instructed to perform multiple breathing exercises at predetermined time intervals. For example, multiple or consecutive (e.g., two, three, or other specified number) breathing exercises may be performed at uniform or non-uniform intervals, or according to pre-set time intervals. In one configuration, sensor data for each breathing exercise is received from one or more associated sensors, and multiple measurement datasets are created, one set for each breathing exercise.

[0301] In some configurations, the device may be configured to detect the start of a respiratory training session initiated by a patient by processing and / or monitoring sensor data. For example, the device may be configured to process flow rate data received during the training mode to identify a flow rate offset to a threshold or range, or to identify a significant deviation that otherwise indicates that the user has started a respiratory training session using the mouthpiece attachment 1702. Upon detecting the start of a respiratory training session, the device may trigger a countdown timer and / or other display GUI screen prompts or other instructions to prompt the user to continue the respiratory training session for the required time.

[0302] Additionally or alternatively, breathing training detection can be used to count the number of repetitions of breathing training performed by a user during a training session. The number of training sessions can be compared to a minimum required number or other performance or compliance thresholds and can be used to prompt the user to continue breathing training until the required number is recorded. Each breathing training session detected within a session may have its own set of relevant measurement data (e.g., sensor data) collected from one or more sensors for subsequent processing.

[0303] Next, the sets of measurement data from each breathing exercise can be combined, aggregated, or otherwise processed to create an averaged set of data. Alternatively, other statistical analyses can be applied to the measurement data to extract a filtered dataset that is less affected by anomalies, such as when the user does not follow instructions or performs the exercise incorrectly. In some configurations, the highest quality or best set of measurement data can be selected from the sets of measurement data for use in subsequent processing and analysis. For example, if a user is required to perform at least three breathing exercises in a training session, the set of sensor data from each breathing exercise can be analyzed to select the best or highest quality data from three or more sets of data from the training session. The highest quality set of measurement data can be selected based on one or more criteria. For example, selection criteria may include, but are not limited to, whether the data contains minimal noise or has a high signal-to-noise ratio (e.g., a strong breathing signal compared to some noise), and / or whether the data fits well with the expected pattern of breathing exercises (e.g., avoiding data that suggests the patient stopped breathing exercises prematurely). An example of guiding a user to perform breathing exercises.

[0304] Referring to Figures 32, 37A, and 37B, an embodiment of the process in which the user is prompted to perform breathing exercises in step 760 of the training method 750 will be described in more detail.

[0305] In this exemplary configuration, as shown in substep 760A, the user is instructed to perform breathing exercises for x seconds using the mouthpiece of the mouthpiece attachment 1702.

[0306] Next, as shown in substep 706B, the user is instructed to repeat the breathing exercise y times for x seconds. The variables x (duration of the training or training step) and y (number of repetitions of the training or training step) can be configured or set as needed. In one embodiment, the device is configured to prompt the user to perform a minimum number of breathing exercises required during a training session, for example, at least 3 or any other appropriate number of breathing exercises.

[0307] After the user has performed the required number of breathing exercises (which are, as appropriate, automatically detected by the device as described above, or confirmed by user input in other ways), the user is prompted to breathe normally for a specific period of time, as shown in substep 760C, and the training session is completed. For example, the user may be prompted to breathe normally, or alternatively, spontaneously, for z minutes (e.g., at least 2 minutes or other time). As discussed above, normal breathing differs from spontaneous breathing, which is usually deeper and more focused (but still relaxed and effortless). It will be understood that the variable z can be configurable as needed. In one embodiment, sensor data may be recorded and stored during the end of breathing session 760C. The stored sensor data regarding normal or spontaneous breathing may then be further processed and / or used to extract or calculate one or more measurements or parameters of the patient's normal or spontaneous breathing, as will be further described below.

[0308] Figures 37A and 37B show schematic embodiments of one or more GUI display screen prompts 770A and 770B that may be displayed on the user interface display during substep 760C. As you can see, various variations are possible.

[0309] The exemplary screen prompt 770A in Figure 37A includes a text field and / or graphics field 7541 that describes or instructs the current operating mode (in this case, training mode). The primary instruction text and / or graphics field 7702 includes text and / or graphics that instruct the user to breathe normally. One or more secondary or additional text and / or graphics fields 7703 may also be provided, for example, that provide additional details on how to perform the primary instruction. In this embodiment, the display area 7703 may include a countdown timer that shows how long the user should continue breathing normally until the training session ends.

[0310] The exemplary screen prompt 770B in Figure 37B shows a variant form that includes an animation field or region 7705, which may display a two-dimensional or three-dimensional graphic, image, animation, or video that depicts or indicates an instruction, in which case it is breathing normally for a predetermined or specified period of time, and helps guide the user through the actions required to complete the step or instruction. Evaluation of user performance based on sensor data and / or measurement data

[0311] One or more processing algorithms can be applied to sensor data and / or measurement data from respiratory training to extract, identify, or analyze one or more features that indicate user performance and / or compliance with a defined respiratory training therapy program.

[0312] For example, in one configuration, detected flow rate data of the gas flow in the respiratory support device's fluid pathway is collected and stored during breathing exercises. This flow rate data may represent measurement data indicating the user's performance and / or respiration. The flow rate data (detected by the respiratory support device) fluctuates as the user performs breathing exercises through or into a mouthpiece attachment that is in fluid communication with the respiratory support device's fluid pathway. By further processing the flow rate signal or data fluctuations, it becomes possible to identify and extract one or more features from the flow rate signal that indicate the user's performance and / or respiration.

[0313] Referring to Figure 33, another exemplary training method 750A is shown, which is a modified version of training method 750 shown in Figure 31. The same reference numbers represent the same steps. The modified training method 750A includes an optional additional step 764 relating to one or more of the following: processing and / or analyzing measurement data (e.g., sensor data) collected during breathing training 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.

[0314] For example, measurement data (e.g., sensor data) may be stored and processed by the respiratory support device controller, and / or transmitted to an external device, server, or system for storage, further processing, and / or extraction and analysis of user performance and / or measurement values. The generated sensor data and / or user performance and / or respiratory measurement values ​​may be displayed to the user on the respiratory support device's display, whether in graph, numerical, or other form, 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 authorized person.

[0315] In one configuration, raw sensor data may be processed by the respiratory support device controller to generate one or more user performance measurements and / or respiratory data.

[0316] In an alternative configuration, raw sensor data may be transmitted to an external or remote electronic device (e.g., a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, PC, remote server, remote system, cloud server platform, or other processing device) for further processing to generate one or more user performance measurements and / or respiratory data. Raw sensor data may be transmitted in real time during a training session, or at the end or after the training session has concluded.

[0317] In another configuration, raw sensor data may be partially processed by the respiratory assistance device controller and partially processed by an external or remote electronic device (e.g., a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, PC, remote server, remote system, cloud server platform, or other processing device).

[0318] In a configuration where raw or partially processed sensor data is processed by an external or remote electronic device (e.g., a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, PC, wearable, remote server, remote system, cloud server platform, or other processing device), the external or remote device or system may transmit the processed data to the respiratory assist device or another local device for storage and / or display. For example, the respiratory assist device 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 respiratory assist device or other local device.

[0319] In one exemplary configuration, the respiratory assistance device controller may be configured to transmit sensor data to the user's electronic device (e.g., a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, or similar device). The user's electronic device may process the raw sensor data to generate user performance measurements and / or respiratory data, and then transmit the processed data to a remote server or system for further processing, storage, and / or display. In some configurations, the respiratory assistance device may only have short-range data communication capabilities (e.g., Bluetooth, NFC, infrared technology, or a physical wired connection) to the user's local electronic device (e.g., a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, or similar device). The user's electronic device may have additional long-range data communication capabilities (e.g., Wi-Fi, cellular, 4G, 4G LTE, and / or 5G technology) and may function as a relay or transmitter for the respiratory assistance device by transmitting raw or processed data to a remote server or system. Switch to a different non-therapeutic mode after the training session in training mode is complete.

[0320] In some configurations, upon completion of training method(s) 750, 750A, the device can switch to another non-therapeutic mode automatically, or according to user manual input or control.

[0321] In one exemplary configuration, after the training session is completed, the respiratory support device may switch to another non-therapeutic mode. Some examples of other non-therapeutic modes are: • Drying mode (a mode in which the flow generator is driven at high speed to dry any remaining moisture in the flow paths and conduits of the device), and / or • Includes a disinfection mode (a mode in which the humidifying chamber and breathing conduit are removed, the disinfection conduit / kit is connected to form a loop between the flow generator outlet and the outlet elbow, and the system is driven to a high temperature to disinfect the outlet elbow).

[0322] In one exemplary configuration, the user may be notified via a display screen GUI that the device has switched to a different non-therapeutic mode and is no longer in training mode.

[0323] Figure 38 shows a schematic embodiment of a GUI display screen prompt 780 that may be presented on the device's display. As you can see, various variations are conceivable. The exemplary screen prompt 780 in Figure 38 includes a text and / or graphics field 781 that explains or indicates that the device has switched to another non-therapeutic mode. A primary instruction text and / or graphics field 782 may also be provided, which may include text and / or graphics that inform the user of the device status and / or instructions regarding the initiation of a non-therapeutic mode. For example, the display field 782 may indicate that the device is ready to start a non-therapeutic mode. Extraction or generation of user performance features and / or respiratory data from sensor data

[0324] Referring to Figure 39, an example of the flow rate data signal and the fluctuations that occur in the mouthpiece attachment due to respiratory training (in this case, forced exhalation). In this embodiment, the gas flow was set to provide air resistance at a flow rate of 70 L / min. It will be understood that other flow rates or ranges of flow rates may be suitable for generating appropriate measurement data while the respiratory support device is using the mouthpiece attachment in training mode. Furthermore, it is assumed that controllable air resistance can be provided in the form of fixed or variable (e.g., vibration) pressure (e.g., in the case of respiratory training, including PEP, OPEP, IPV, and / or CPAP therapy with vibration).

[0325] In this exemplary configuration, a flow rate of approximately 70 L / min has the advantage of preventing the user's exhaled breath from flowing back into the device 10. In different configurations, other flow rates can also adequately provide this advantage, and it will be understood that the flow rate may be selected based on a balance of one or more factors and / or to suit specific criteria or a particular configuration of the respiratory assist device and / or mouthpiece attachment. For example, in some configurations, the flow rate may be configured to provide sufficient air resistance to perform the required user performance measurements and / or breathing exercises and / or to avoid backflow into the device, which could lead to condensation on sensors within the respiratory assist device and subsequent bacterial contamination.

[0326] Additionally or alternatively, the flow rate selected for use may be a function of, or at least partially based on, the pneumatic characteristics of the configuration of the respiratory assist device and / or mouthpiece attachment (e.g., including the flow resistance of the flow path after the flow generator and / or the output flow path). For example, the flow rate may be configured or selected at least partially based on the pneumatic characteristics of one or more of the output flow path, breathing conduit, and / or mouthpiece attachment of the respiratory assist device. For example, in a respiratory assist device with a check valve in the flow path, a much lower flow rate (e.g., about 10 L / min) may be preferable or sufficient for collecting the necessary measurement data and / or for performing at least some types of respiratory training when performing a training mode with the mouthpiece attachment attached.

[0327] Figure 790 shows an example of fluctuations in detected flow data resulting from breathing exercises (in this case, forced exhalation) performed by a healthy individual using a mouthpiece attachment, while figure 792 shows fluctuations in detected flow data from a diseased individual. As illustrated in Figure 39, healthy individuals exhibit larger and more abrupt decreases in detected gas flow rates compared to diseased individuals or those with reduced lung function or performance.

[0328] In one exemplary configuration, sensor data (e.g., flow rate or other sensor data) may represent user performance measurement data and / or respiratory data, and / or sensor data may be processed to extract one or more user performance measurement data values ​​and / or respiratory information.

[0329] In one exemplary configuration, sensor data (e.g., flow rate or other sensor data), processed user performance measurement data, and / or respiratory data may be graphed or graphically represented for display on a user interface (e.g., a GUI display). In such a configuration, the graphs may be further processed to identify and / or determine the user's health status (e.g., whether they are healthy or ill).

[0330] Examples of user performance measurements and / or respiratory data that can be extracted or identified from measurement data from training sessions (e.g., sensor data such as flow signals or flow data) are described further below.

[0331] The pressure a patient applies during breathing exercises JPEG2026522461000002.jpg510 (for example, patient or user pressure signal) can be calculated from the flow signal by applying, for example, the following formula:

[0332]

number

number

number

[0333] The flow conductance (C) between the output of the flow generator and the patient (including the effect of the connected mouthpiece attachment) can be expressed as follows:

[0334]

number

number

number

number

number

[0335]

number

number

number

number

number

number

number

number

number

[0336] From the detection data generated during training mode, it is possible to extract several clinically useful performance metrics (e.g., features or feature indicators, and their analogues). These may include FEV1, FEV2, FEV3 (fractional expiratory volume over 1, 2, and 3 seconds, respectively), FVC (forced vital capacity), and PEF (maximum expiratory flow rate).

[0337] • The FEV1 value or FEV1-like value can be calculated by analyzing the flow rate data for the first second after the patient begins exhaling during expiratory motion.

[0338] Similarly, FEV2 and FEV3 values, or similar values, can be calculated by analyzing flow data for the first two and three seconds (respectively) after the patient begins exhaling during expiratory motion.

[0339] FVC can be calculated by determining the total expiratory volume over the entire expiratory motion. This is, for example, the processed patient flow signal between the start and end of exhalation.

number

[0340] The FEV1 / FVC ratio (another performance metric) can be easily calculated from the aforementioned FEV1 and FVC values.

[0341] As can be seen in Figure 23, PEF is the processed patient flow signal.

number

[0342] The aforementioned disclosure describes respiratory training, including forced exhalation measurement, but some measurements are generated when the patient breathes normally or spontaneously into the mouthpiece attachment.

number

number

[0343] • Tidal volume (V T) over one or more respiratory cycles included in the signal

number

[0344] • Minute ventilation (MV) is the same as RR and V above. T It can be calculated using parameters, that is

number

number

[0345] The user performance or respiratory data metrics or characteristics described above, individually or in combination, are particularly useful for analyzing the condition or symptoms of patients with COPD, asthma, bronchiectasis, or other respiratory diseases affecting lung health or performance. One or more of these characteristics, or other appropriate user performance or respiratory parameters, may be used to guide the selection of suitable therapeutic settings (e.g., respiratory therapy prescriptions) for respiratory support devices (e.g., respiratory therapy devices). For example, FiO1 (fraction of inhaled oxygen) and / or flow rate settings may be determined, at least in part, by one or more performance and / or respiratory parameters, which are determined using a mouthpiece attachment connected to a respiratory support device operating in training mode. The upper and / or lower limits of the therapeutic settings or prescriptions may also be selected, at least in part, based on the performance and / or respiratory parameters or metrics generated during training sessions using the device's training mode.

[0346] In one exemplary configuration, once a medical professional receives and reviews the user's performance and / or respiratory metrics, measurements, results, or generated characteristics, they can then propose a prescription to the patient, at least in part, based on the measurement results. The prescription may define or include one or more settings or characteristics relating to the gas flow provided in the respiratory therapy mode, such as flow rate, oxygen concentration (e.g., FiO2), and / or humidity level. Expression of user performance and / or respiratory measurement values

[0347] Any one or more user performance and / or respiratory measurements, features, values, or indicators in the resulting data extracted, identified, or calculated from a training session using a mouthpiece attachment may be expressed, stored, recorded, or displayed individually, or as a ratio, percentage, or fraction to the expected value for a healthy individual in the population to which the user belongs, or to any other baseline value or parameter.

[0348] For example, PEF may be expressed as "PEF as the proportion of healthy adult males or adult females." The indicator values ​​expected for healthy adult males or females can be stored in a lookup table or other appropriate data structure, which may be stored in the device's memory or other accessible remote memory or data storage (e.g., cloud or remote server data storage).

[0349] In further embodiments, one or more individual user performance measurements, indicators, features, or values ​​within the resulting data can be combined in any one or more desired ratios or functions relative to each other to generate new useful performance metrics or ratios. For example, calculating the FEV1 / FVC ratio or value can be useful as a spirometry assessment. In one embodiment, an FEV1 / FVC of 70-80% (or 0.7-0.8) may be desirable to indicate good health. Patient's physiological parameters

[0350] In one exemplary configuration, if the patient is instructed or prompted to take multiple breaths at the end of a training session (see, for example, substep 760C above in Figure 32), one or more patient physiological parameters can be estimated, calculated, or extracted from sensor data recorded over multiple breathing exercises. These parameters may include, for example, one or more of the following: tidal volume, respiratory rate, minute ventilation, and maximum inspiratory flow rate. Further exemplary training methods

[0351] Further exemplary training methods 1490 and 1500 will be described in more detail with reference to Figures 40 and 41. Similar to the embodiments described above, the training methods of these embodiments are implemented primarily by algorithms or computing instructions executed by the processor or controller of the respiratory assist device 10 when the respiratory assist device enters training mode. The principles of exemplary methods 1490 and 1500 may be applied to any of the embodiments, configurations, or variations of the respiratory assist device, training system, and / or mouthpiece attachment described above.

[0352] It will be understood that the various steps of the exemplary methods 1490 and 1500 described herein do not necessarily have to be performed in the order described. Some steps may be performed in parallel, overlapping, or in a different order without affecting the overall process. Depending on the specific configuration and / or operation of the respiratory support device, training system, and / or mouthpiece attachment, some steps may be unnecessary or modified. Furthermore, any steps disclosed in connection with methods 1490 and 1550 may be combined with, supplement, and / or interchangeably replaced with the steps of methods 750 and 750A described above.

[0353] Referring to Figure 40, Method 1490 begins with step 1491, which is a prompt to start a breathing training session. As described above, this prompt may be manually generated by the user or provided to the user via the device 10 and / or other external devices (such as a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, or actigraphy device). Alternatively, the training mode may be triggered remotely or automatically by a supervising medical professional, or according to pre-programmed conditions. Next, in step 1492, the breathing training session begins, where the controller is configured to control the respiratory assist flow generator 11 to provide the desired air resistance for the breathing training(s). It is assumed that the target air resistance will vary depending on the specific step of the breathing training or the type of breathing training being performed, as shown below.

[0354] In one exemplary embodiment, breathing training includes: • Normal breathing, • Spontaneous breathing, · maximum respiration, • Huffing (i.e., huff-cuff - a medical exercise involving inhaling, holding your breath, and exhaling forcefully, slowly, and continuously) • Respiration in response to fixed positive expiratory pressure (PEP) • Respiration in response to Oscillating Positive Pressure Exhalation (OPEP) • Respiration for intrapulmonary percussion ventilation (IPV) • Respiration for continuous positive airway pressure (CPAP) with vibration • Slow, deep breathing, and / or • Includes one or more steps of pursed-lip breathing (such as a type of breathing exercise).

[0355] It will be understood by those skilled in the art that respiratory training or a respiratory training program may include any one or more of the steps described above (e.g., the type of respiratory training). These steps can be performed in any order, and the exact combination, duration, and order ultimately depend on the patient's condition and / or the prescribed respiratory training program.

[0356] The list of examples above is provided to illustrate the types of “breathing exercises” that may be prescribed for a user to perform in a breathing exercise program. Some of the breathing exercises described above include components of respiratory therapy and / or are defined based on respiratory therapy provided during breathing exercises. For example, some breathing techniques involve the user breathing against a gas flow provided according to PEP therapy, OPEP therapy, IPV therapy, and / or CPAP therapy with vibration. The mouthpiece attachments of the above types may be used in conjunction with one or more breathing assist devices of the breathing exercises described.

[0357] Those skilled in the art will understand that OPP therapy is a form of respiratory therapy aimed at removing and fluidizing mucus in the patient's airways by having the patient breathe against oscillatory positive pressure (only during the expiratory phase of the patient's respiratory cycle). In a first exemplary configuration, respiratory training including OPP therapy may include a respiratory support device providing a gas flow having continuous oscillatory positive pressure over the user's respiratory cycle(s). The oscillatory positive pressure is provided by the device's flow generator at an appropriate expiratory pressure level, which may be lower than the CPAP pressure level so as not to place an excessive burden on the user's breathing. In this first exemplary configuration, the user may be instructed (e.g., via visual and / or auditory prompts provided by the device) to inhale through the nose with the mouthpiece in place, or to remove the mouthpiece during inhalation and then exhale through the mouthpiece against the oscillatory positive pressure.

[0358] In a second exemplary configuration, the device may be configured to detect the user's respiratory cycle or stage (e.g., whether they are inhaling or exhaling) while the user is using the mouthpiece. Based on the detected respiratory cycle, the flow generator of the respiratory assist device is controlled to provide oscillating positive pressure or any pressure only during exhalation. This configuration provides respiration-synchronized OPP therapy. In other exemplary configurations, the oscillating positive pressure exhalation pressure may be synchronized with the exhalation stage of the user's respiratory cycle using other techniques and / or user input, as will be further discussed below.

[0359] Those skilled in the art will understand that IPV is similar to OEP therapy, but typically uses lower frequency vibrations than PEP, and that IPV vibrations are synchronized with respiration (i.e., positive pressure vibrations are provided throughout the entire respiratory cycle in both the inspiratory and expiratory phases, but may have different characteristics in each phase, whereas OEP is intended to be provided only in the expiratory phase). For example, the frequency of positive pressure vibrations in IPV is approximately 2–4 Hz, while in OEP it may be approximately 10 Hz. In respiratory training with either OEP or IPV therapy, the provided positive pressure includes the baseline positive pressure, and since the vibrations occur around that baseline pressure, the positive pressure vibrations will always be positive (i.e., above zero).

[0360] Respiratory training for CPAP with vibration involves providing a continuous mean-like vibrational pressure throughout the patient's entire respiratory cycle (e.g., during inspiration and expiration). Specifically, the vibrational pressure waveform representing the vibrational pressure is always above zero (i.e., positive pressure). In some cases, the vibrational pressure may have a minimum value of zero or near zero, but it will never be negative.

[0361] In one exemplary configuration, depending on a particular step of the breathing exercise being performed, the controller may operate in a flow control mode to provide a constant positive flow to the flow path sufficient to prevent backflow into the device, but not so high that the user experiences significant resistance to normal breathing.

[0362] In another exemplary configuration, depending on a particular step of the breathing exercise being performed, the controller may operate in a flow control mode to provide a desired level of air resistance to the device's flow path, which may be higher than the anti-backflow flow rate.

[0363] In another exemplary configuration, the controller may operate to shut down or otherwise block the output from the flow generator. In this configuration, the only gas flow through the device's pathways is that induced by the user (during exhalation or inhalation). For example, there is no flow through the device until the patient breathes. This mode of operation is particularly useful in respiratory training associated with incentive spirometry.

[0364] In another exemplary configuration, the controller may operate in pressure control mode while the patient is performing breathing exercises. In one configuration, the controller may control the pressure of the gas flow during the inspiratory phase, during the expiratory phase, or throughout the entire breathing cycle, according to a pressure setting configured for breathing exercises with respiratory therapies, including, but not limited to, PEP, OPEP, IPV, and CPAP therapy with vibration. For example, the controller may be configured to provide the patient with a consistent or oscillating positive expiratory pressure (PEP) while the patient is performing breathing exercises, including, but not limited to, PEP, OPEP, and IPV therapy, as described above. In another embodiment, biphasic pressure (e.g., BiPAP) may also be provided, with a higher pressure (compared to expiratory) provided during inspiration, thereby partially mimicking a sputum clearance device and helping to facilitate mucus removal.

[0365] As discussed above, the nature of the controlled air resistance provided through the gas flow may depend at least in part on the type or step of breathing training being performed (some examples of breathing training types are listed above). The controller of the breathing assistance device controls the flow generator to control one or more properties of the gas flow (e.g., flow rate and / or pressure) to provide the gas flow with the desired properties (air resistance). In some exemplary configurations, the controller may use one or more of the following control techniques to provide the desired air resistance for breathing training.

[0366] • Maintaining a fixed positive flow rate for the gas flow along the channel, • Maintaining a fixed value of zero for the gas flow rate along the flow path, • To counteract the flow caused by the user's breathing, the flow rate of gas along the channel is changed, • Maintaining a fixed pressure value in the mouthpiece attachment, • Maintain a first pressure value during the exhalation phase of breathing exercises, and maintain a second pressure value during the inhalation phase of breathing exercises.

[0367] In one exemplary configuration in which a user performs breathing training against fixed positive expiratory pressure (PEP), the device controller is configured to provide a gas flow rate sufficient to induce a predefined constant PEP in the mouthpiece attachment. In some configurations, the constant PEP is provided only during the expiratory phase of the user's breathing cycle. Alternatively, if a constant pressure is provided continuously throughout the entire breathing cycle, the user may inhale through the nose during the inspiratory phase, or remove the mouthpiece and then exhale through the mouthpiece during the expiratory phase.

[0368] In one exemplary configuration in which a user performs breathing training against vibrating positive expiratory pressure (OPEP), the device controller is configured to provide a gas flow rate sufficient to induce vibrating PEP in the mouthpiece attachment. In one embodiment, providing a gas flow rate sufficient to induce vibrating PEP in the mouthpiece attachment involves varying or vibrating the gas flow rate between a first threshold or value that provides a predefined upper PEP value and a second threshold or value that provides a predefined lower PEP value. In some configurations, vibrating PEP is provided only during the expiratory phase of the user's breathing cycle. Alternatively, if vibrating pressure is provided continuously throughout the entire breathing cycle, the user may inhale through the nose during the inspiratory phase or remove the mouthpiece and then exhale through the mouthpiece during the expiratory phase.

[0369] Furthermore, depending on the specific step of the respiratory training being performed, the user may be prompted or guided to either attach, detach, or bypass the mouthpiece attachment to the respiratory support device. For example, in some scenarios, one or more respiratory training steps may be performed without the mouthpiece attachment, instead via, for example, a nasal interface or another respiratory patient interface.

[0370] Upon entering training mode, in step 1493, the respiratory support device 10 may be configured to provide the user with one or more instructions relating to several parts of the first respiratory training step. As described above, the instructions may be visual, for example, text and / or images displayed as part of a graphical user interface (GUI) on the device's display, and / or audio instructions provided through the device's speaker.

[0371] In one exemplary configuration, the respiratory support device may be configured to provide the user with real-time instructions to follow while performing one or more steps of a respiratory training. These real-time instructions may include, for example, a display of a flow and / or respiratory profile for the user to follow while performing the training. For example, the flow and / or respiratory profile may display or define the target inspiratory and / or expiratory time or timing, and / or the target user-generated flow rate and / or pressure that the user generates during the respiratory training.

[0372] It is further intended that the user be provided with real-time feedback regarding breathing exercises. In one embodiment, the feedback may include visual prompts indicating whether the user's expiratory flow rate is sufficient and how long exhalation should be continued, in the context of the breathing exercise step or type. In this embodiment, "sufficient" may mean the threshold of flow required to obtain beneficial effects from the breathing exercise. The threshold may vary depending on the patient and their characteristics. The threshold may be configurable by a healthcare professional as part of a defined breathing exercise program. This threshold may be loaded into the memory of the device's controller.

[0373] In one exemplary configuration, the device's display may show real-time feedback regarding the user's performance of one or more steps in breathing exercises. This feedback may be displayed in text and / or graphic form. In one configuration, the feedback may include information relating to one or more parameters of the gas flow. For example, one or more parameters of the gas flow may be user-generated flow rate and / or user-generated pressure data or signals extracted or processed from sensor data recorded during breathing exercises, or any other arbitrary user performance-related parameters relating to the gas flow. In one embodiment, the device's display may be configured to display information representing one or more parameters of the gas flow against one or more predefined target values ​​or thresholds. For example, the device may display user-generated flow rate and / or user-generated pressure signals (by graph, numerical values, and / or text) against one or more target values ​​or thresholds when performing breathing exercises.

[0374] The display may be configured to allow the user to adjust respiratory training parameters themselves without the involvement of a supervising medical professional. For example, the user may want to make slight adjustments (i.e., increase or decrease) to the pneumatic resistance (either flow control or pressure control) provided by the flow generator during certain training steps or all steps, depending on whether they are having difficulty performing the training or require more challenging training. In one exemplary configuration, user adjustments may be limited by boundaries and / or thresholds configured by the medical professional managing the user.

[0375] In one exemplary configuration, real-time feedback may include one or more of the following: a visualization of user-induced gas flow, training progress, a timer, and / or other appropriate graphics, which may take the form of a “progress bar” or meter, as appropriate. These visualizations can guide or instruct the user to properly perform or complete breathing exercises and / or training sessions according to a given program.

[0376] In one exemplary configuration, real-time feedback displayed on the device's display may include motivational or positive feedback related to the user's performance in one or more steps of the breathing exercise. This motivational feedback may be provided in text and / or graphic form. In one embodiment, this motivational feedback may include positive words or messages to encourage the user to complete or continue the breathing exercise.

[0377] Furthermore, instructions for performing breathing exercises and / or the real-time feedback discussed herein may be provided via the display and / or speaker of any suitable external electronic device, such as a smartphone, tablet, laptop, smartwatch, wearable device, smart glasses, actigraphy device, or similar device. Similarly, user input or interaction (e.g., adjustment of parameters discussed herein) may also be provided through such external electronic devices.

[0378] In step 1494, further instructions are provided for the second breathing exercise step. This continues for all steps of one or more breathing exercises up to step 1495. As previously described in detail, during each of steps 1492-1495, one or more flow and pressure sensors in the respiratory support device 10 capture measurement data representing the user's performance.

[0379] In one exemplary configuration, as described above, the measurement data may include gas flow rate data and / or pressure data detected or taken in while the user is performing breathing exercises and / or during specific steps of the breathing exercises. This measurement data may be taken in during any or all of the aforementioned steps or types of breathing exercises (e.g., normal breathing, spontaneous breathing, maximal breathing, huffing, breathing to fixed positive expiratory pressure (PEP), breathing to oscillatory positive expiratory pressure (OPEP), breathing to intrapulmonary percussion ventilation (IPV), breathing to oscillatory continuous positive airway pressure (CPAP), slow, deep inhalation breathing, and / or pursed-lip breathing). The measured data may be processed to determine user breathing parameters or metrics, such as respiratory rate, tidal volume, and / or minute ventilation, when the user is performing one or more breathing exercises, but not limited to these.

[0380] Additionally or alternatively, spirometry-like measurement procedures can be performed before and / or after specific breathing training steps and / or entire training sessions to determine spirometry-like metrics (such as FEV1 and FVC), which can serve as indicators of the effectiveness of the current breathing training program. As mentioned above, spirometry-like metrics can be determined from measurement data (e.g., gas flow rate data and / or pressure data) taken up when the user performs an expiratory motion.

[0381] In step 1496, this measurement data is processed by the controller to determine a performance metric, which may include data indicating patient-generated characteristics or parameters related to gas flow during the breathing training steps. As previously stated, patient-generated characteristics related to gas flow may include patient-generated flow or pressure represented by data, such as user flow signal and / or user pressure signal.

[0382] Additionally or alternatively, measurement data and / or other data generated or extracted from the measurement data discussed herein (including, but not limited to, patient-generated characteristics or parameters relating to gas flow, user respiratory parameters or metrics, spirometry-like metrics, etc.) may be transmitted to an external computing device, such as a remote server or personal computing device, for processing or analysis (e.g., by a medical professional).

[0383] In step 1497, patient-generated characteristics relating to gas flow (e.g., patient-generated flow rate and / or pressure) and / or other parameters taken or determined are also evaluated. For example, this evaluation may be performed by referring to, or at least in part to, a comparison of the data with predefined magnitude and / or time thresholds. In a particular case of the user flow signal, this may be useful in determining whether a target or threshold user flow rate was achieved and maintained for a sufficient period of time during the respiratory training and / or a particular step of the respiratory training.

[0384] The results or performance data from this assessment in Step 1497, either raw or / or processed, as appropriate, may be sent to a supervising healthcare professional or other healthcare professional for further analysis and decision-making. This may include uploading the assessment results and / or measurement data to the patient's electronic medical record or another database for storage and verification. Electronically transmitting the patient's respiratory performance assessment(s) and / or measurement data as described above can support more effective home care and, in some cases, eliminate or at least reduce the need for regular clinic visits.

[0385] In one configuration, the evaluation step may include generating a diagnosis of the patient's respiratory disease based on raw or processed data generated during breathing training or a training session. In one embodiment, this method may include identifying or extracting patient-related features in sensor data that represent one or more characteristics of the gas flow during breathing training. The patient-related features may be user-generated flow rates or user-generated pressure signals. The patient-related features may be compared to one or more thresholds.

[0386] By enabling two-way electronic data transmission between the user and the supervising healthcare professional via the respiratory support device (routed, as appropriate, via the personal electronic or computing device of the type described above), feedback between the patient and the healthcare professional becomes even easier. In one embodiment, this data transmission allows the supervising healthcare professional to understand the patient's current health status and fitness, and may enable the healthcare professional to more frequently fine-tune or adjust the patient's respiratory training program. For example, a respiratory training program may include one or more parameters from among the following: the frequency of training sessions (e.g., daily, twice a day, every other day, etc.), the respiratory training and training components to be performed in the training session(s), and the parameters of each respiratory training or training step (e.g., pressure level, flow rate, air resistance(s), duration, etc.). In another embodiment, this data transmission enables the healthcare professional to provide feedback to the patient and / or provide further instructions regarding new training in a particular respiratory training or program. In yet another embodiment, this data transmission enables the user to provide subjective feedback on the respiratory training program and / or specific procedures or aspects of one or more respiratory training sessions. In one configuration, the user may be required to complete an electronic questionnaire that includes subjective feedback on breathing exercises and / or questions regarding their performance. The user's response data to the questionnaire may be transmitted for remote processing. The questionnaire may be completed, for example, at the end of a training session or at the end of a session using a respiratory support device.

[0387] Exemplary plots of processed patient-generated flow (e.g., user flow signal) are shown in Figures 42A and 42B. These graphs were generated using an active test lung model and illustrate how respiratory flow manifests in nominally healthy and COPD patients during respiratory training. In these exemplary plots, the respiratory training is chest expansion training, which includes alternating stages of normal breathing and spontaneous breathing (which, as mentioned above, is deeper and slower than normal breathing). Positive flow rates in the plots indicate inspiration, and negative flow rates indicate expiration.

[0388] Figure 42A illustrates a flow rate fluctuation of approximately +50 L / min to -50 L / min during the normal respiratory stage 1602a of the active respiratory cycle, representing a nominally healthy patient. Flow rate fluctuations during the spontaneous respiratory stage are shown in 1604a.

[0389] For comparison, Figure 42B shows the flow rate fluctuations of a nominal COPD patient. It can be seen that the respiration of a nominal COPD patient is "sharp" during the normal breathing stage 1602b, and furthermore, the flow rate fluctuations during the spontaneous breathing stage 1604b are remarkably asymmetrical (indicating a weaker ability to forcefully exhale).

[0390] Referring to Figure 41, Method 1500 begins in step 1501 with a prompt to start a breathing training session. As described above with respect to Process 1490, the breathing training session begins in step 1502, and the user is further guided through the execution of a series of n-step breathing training steps in step 1503. In step 1504, flow and / or pressure data are processed to identify features that can indicate whether a breathing training step has been performed, or has been performed properly. The controller may identify certain features (e.g., magnitude of patient-generated flow and / or patient-generated pressure) that indicate whether the user has attempted or completed a breathing training step or any step within the session. Calculating or detecting specific features that can be used to identify whether the patient has attempted or completed a training or training step may be useful when the supervising healthcare professional focuses more on whether the user is engaged in a prescribed breathing training program than on closely tracking the patient's success in performing individual breathing training or training steps.

[0391] Next, in step 1505, data representing the identified characteristics and / or training performance metrics is recorded and made available to the supervising healthcare professional in step 1506. The identified characteristics and / or training performance metrics can be compiled as a record, such as a report, before or after communication with the supervising healthcare professional. For example, the data may be compiled on a report on the patient's local device (the respiratory support device itself, or a local personal computing device communicating with the respiratory support device) before communication, or on the healthcare professional's local electronic device after communication.

[0392] If, as appropriate, a prompt to start a training session is generated in step 1507, but no corresponding activity by the user is detected, it is flagged and reported to the supervising healthcare professional. In this scenario, the report can be used to flag non-compliant patients (patients who may not be participating in the training program for various reasons). For example, report data may be generated that includes information (e.g., compliance data) that identifies whether the patient has not started or complied with individual training sessions and / or the entire prescribed training program. In some configurations, if a certain threshold of non-compliance is reached (e.g., if it is detected that the patient has skipped a certain threshold number of training sessions), report data may be sent and / or a notification may be generated to the healthcare professional.

[0393] Additionally or alternatively, report data can be generated that includes information (e.g., performance data) indicating whether the patient is experiencing difficulties during any step 1507 or has failed to complete one or more breathing exercises and / or training steps. This report data pertains to patients who are attempting to adhere to the training program but are experiencing difficulties. This type of report data can also be generated by processing measurement data taken during the training session. In some configurations, if a specific threshold for the level of difficulty experienced by the patient is detected, report data may be transmitted and / or a notification to a healthcare professional may be generated.

[0394] For example, measurement data may be processed to identify whether a patient is experiencing difficulty with breathing exercises and / or specific steps of the exercises. Identifying difficulty may be based on one or more factors, but is not limited to, the patient not generating sufficient flow during the exercise or repeatedly skipping exercises or exercise steps (e.g., not attempting the exercise session, or in some cases, discontinuing it prematurely). Report data may include data identifying individual exercises or exercise steps in which the patient is experiencing difficulty. In some configurations, a prioritized notification and / or alert system may be triggered, in which case the priority associated with notifications and / or alerts to healthcare professionals is based on the number of identified failed or partially failed exercises and / or exercise steps compared to one or more thresholds. For example, high-priority notifications and / or alerts may be triggered when a large number of failed or partially failed exercises and / or exercise steps (e.g., exceeding a high-priority threshold) are detected, while low-priority notifications and / or alerts may be triggered when a small number of failed or partially failed exercises and / or exercise steps (e.g., according to a low-priority threshold) are detected.

[0395] These various reports, report data, and / or associated notifications / alerts, as described above in any step 1507, may be generated and / or sent in real time, may be bundled and sent at regular, customizable intervals (e.g., as part of weekly, bi-weekly, or monthly reports), may be sent based on one or more threshold criteria, and / or based on requests from healthcare professionals, and / or possibly patients.

[0396] Methods 1490 and 1500 described herein may enable improved monitoring of user compliance and adherence to a prescribed training program. Supervising medical professionals or physiotherapists can assist patients in performing breathing exercises correctly and regularly (according to the program) by evaluating the user's performance in breathing exercises (and, if applicable, individual steps of breathing exercises) and overall compliance with the prescribed training program. For example, if a medical professional receives a report indicating that a patient has not followed the training program or has not properly performed one or more steps of the training program, the medical professional can follow up with the patient. This follow-up can be in person or remotely. For example, the follow-up may be conducted via prompts generated and displayed on the respiratory support device 10 associated with the patient, or on one or more other appropriate computing or electronic devices. Furthermore, the demonstrated user performance may allow the medical professional to modify the program and / or adjust the guidance provided to the user for one or more steps of breathing exercises.

[0397] Methods 1490 and 1500 described above can further enable remote adjustment of respiratory training parameters (e.g., flow rate, pressure, and respiratory training step stages) provided by the respiratory support device in response to user feedback and performance metrics. Patient compliance may decrease if the respiratory training program does not show significant improvement in the user, or if the user complains of discomfort or shows signs of difficulty upon completion of the training. Requiring a meeting with a supervising healthcare professional solely to adjust physiotherapy equipment can be an obstacle to addressing such problems. Remote, two-way communication of data and feedback between the user / patient and the supervising healthcare professional, and remote updates of device settings, can eliminate the need for such visits. Therefore, providing patient-specific feedback before, during, and after respiratory training can improve compliance. Synchronize breathing exercises with the user's breathing cycle.

[0398] As discussed above, some respiratory training may involve the user breathing against a gas flow provided according to one or more therapies (e.g., PEP, OPEP, IPV, and / or CPAP therapy with vibration) using a mouthpiece attachment or patient interface. In some such respiratory training, the characteristics of the gas flow provided by the respiratory support device may depend on or correspond to the user's respiratory cycle (e.g., inspiratory and expiratory phases). These respiratory training may require some form of respiratory detection or synchronization (i.e., input or identification of respiratory cycle phase regarding whether the user is inspiratory or expiratory). Examples of gas flow characteristics or respiratory training therapy settings that may change based on the user's respiratory cycle include, but are not limited to, the pressure, flow rate, and / or vibration characteristics of the positive pressure provided, and further, the relevant characteristics and / or settings depend on the nature of the therapy provided during the respiratory training.

[0399] In one embodiment, breathing training may include PEP or OEP therapy, in which the user breathes against fixed positive expiratory pressure (PEP) or oscillatory positive expiratory pressure (OPEP) only during exhalation. In this type of breathing training, a method is needed to detect whether the user is exhaling.

[0400] In another embodiment, breathing training may include IPV therapy, in which the person breathes against a first type of vibrational pressure during inspiration and against a second (appropriately different) type of vibrational pressure during expiration. In this breathing training, a method is needed to detect when the user is in inspiration and / or expiration.

[0401] In the case of respiratory training with therapy that requires respiratory detection and / or respiratory synchronization, the respiratory support device may include one or more methods or configurations for detecting or identifying the user's respiratory cycle (i.e., the inspiratory and expiratory phases), some examples of which are shown below. It will be understood that the device and / or system may include one or more of these methods or configurations. Device prompt - First exemplary configuration

[0402] In the first exemplary configuration, the respiratory support device can prompt the user (e.g., visually and / or audibly using one of the device functions described above) for the timing of inspiration and / or expiration, and the gas flow is controlled in accordance with / synchronized respiratory training therapy (e.g., PEP, OPEP, IPV therapy) according to those instructions. In this exemplary configuration, the characteristics of the provided gas flow are controlled on the premise that the user is breathing according to prompts (i.e., synchronizing inspiration and expiration). Respiratory cycle signals - Second exemplary configuration

[0403] In a second exemplary configuration, the user may actively generate a respiratory cycle signal to identify their own respiratory cycle while performing respiratory training. The respiratory cycle signal may include information or data representing one or more of the following: the start of the inhalation phase, the start of the expiratory phase, and / or the switching between inspiration and expiration (or vice versa). The respiratory support device may be configured to receive and process the respiratory cycle signal and further control the flow of gas supplied during respiratory training according to the therapy (e.g., PEP, OEP, IPV therapy) and any respiratory synchronization required for that therapy. For example, the user may generate a respiratory cycle signal indicating that the user has started expiring, and the device may then provide fixed positive expiratory pressure (PEP therapy) or oscillatory positive expiratory pressure (as part of OEP or IPV therapy) during the user's expiratory phase. The user may also generate respiratory cycle signals that identify the end of the expiratory phase and / or the start of the next inspiratory phase, to which the device may respond by fixing the inspiratory phase or stopping the oscillatory positive pressure expiratory pressure (e.g., in PEP or OEP therapy), or by modifying the characteristics of the oscillatory positive pressure in the inspiratory phase (e.g., in IPV therapy). Examples of respiratory cycle signal pneumatics and other user inputs are described below. Respiratory cycle signal - User input via pneumatic signal

[0404] In one embodiment of the second exemplary configuration, the user may pneumatically generate a respiratory cycle signal by manipulating one or more characteristics of the gas flow through interaction with or manipulation of a mouthpiece attachment or patient respiratory interface (depending on which one is used in respiratory training) and / or a respiratory conduit. This user-generated pneumatic signal may be generated by the user to provide the device with input and / or feedback regarding the user's respiratory cycle.

[0405] In one embodiment, the user can operate one or more exhaust ports (e.g., exhaust openings 1716) of the mouthpiece attachment (e.g., close / cover / block) to cause a detectable change in one or more characteristics of the gas flow detectable by one or more sensors of the device, thereby generating a detectable pneumatic signal in the gas flow. Depending on the nature of the exhaust ports or the sequence of operations, the detectable signal can be effectively coded or embedded pneumatically in one or more characteristics of the gas flow that can be decoded, detected, or identified by the device's controller.

[0406] In one exemplary configuration, manipulating the mouthpiece exhaust port may generate detectable changes or specific pressure signal profiles within the gas flow detected by the device's pressure sensor (for example, manipulating the mouthpiece exhaust port may generate detectable back pressure in the gas flow). For example, blocking the mouthpiece exhaust port(s) for a short period or over a predetermined time, and / or blocking them multiple times in a continuous or other pattern, may generate changes in the gas flow pressure signal, such as spikes(s), pulsed signals(s), and / or other signal profiles(s). These changes are detectable and / or identifiable by the controller as respiratory cycle signals (such as changes in state from inspiration to expiration or vice versa, the start of expiration, and / or the start of inspiration).

[0407] In one embodiment, a single short block of the exhaust port(s) (a quick "single tap" gesture), two consecutive short blocks (a quick "double tap" gesture), or one long block (e.g., a "long press" gesture lasting 1-2 seconds) may indicate a change or switch in state from inhalation to exhalation, or vice versa, the start of exhalation, or the start of inhalation. In another embodiment, 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.

[0408] The device's controller can be configured to detect various different pneumatic signals (single tap, double tap, long press) based on predetermined changes in the gas flow or sensor signal profiles (e.g., pressure and / or flow rate signal profiles), and it will be understood that each different pneumatic signal represents a different user operation or input related to the breathing cycle (e.g., initiation of inspiration, initiation of expiration, and / or switching from inspiration to expiration, or vice versa). The range of pneumatic signals can vary widely, from simple ones (e.g., single tap, double tap, long press) to more complex pneumatic signals coded in more intricate sequences or patterns of short and / or long blocks.

[0409] Alternatively, the aforementioned pneumatic signals may also be generated by the user manipulating the exhaust port or other gas outlet or component of the patient breathing interface used during breathing exercises (e.g., nasal cannula, nasal mask, nasal pillow, face mask). Respiratory cycle signal - User input via electronic buttons (multiple buttons possible)

[0410] In another embodiment of the second exemplary configuration, the user may generate respiratory cycle signals and direct respiratory cycles (such as switching from inspiration to expiration or vice versa, initiation of inspiration, and / or initiation of expiration) by operating one or more electronic buttons.

[0411] Electronic buttons may be provided by, or on, the device, mouthpiece attachment, respiratory conduit, respiratory patient interface, and / or a remote device that communicates data with the device's controller.

[0412] In one exemplary configuration, the electronic button may be a physical button (e.g., a mechanical button or a contact-sensitive button) provided on any of the following: the device, a mouthpiece attachment, a respiratory conduit, a respiratory patient interface, and / or a remote device that communicates data with the device's controller.

[0413] In another exemplary configuration, the electronic button may be a graphical button located on the GUI of the device's display screen (e.g., a touchscreen), or a remote device that communicates data with the device's controller.

[0414] In one embodiment, the user can operate an electronic button (single tap, double tap, long press, etc.) using a configuration or signaling protocol similar to those described above with respect to pneumatic signals to indicate respiratory cycle stages. In other embodiments, when performing respiratory training, one or more labeled or dedicated electronic buttons may be provided for the user to indicate different respiratory cycle stages. For example, a dedicated button may indicate the user inhaling or initiating inhalation, the user exhaling or initiating exhalation, and / or the user switching from inhalation to exhalation or vice versa. Respiratory cycle - Automated respiration detection - Third exemplary configuration

[0415] In a third exemplary configuration, the respiratory support device controller may automatically detect the user's respiratory cycle and automatically synchronize the gas flow characteristics to be provided according to respiratory training therapy (e.g., PEP, OPEP, IPV therapy).

[0416] Those skilled in the art will understand that respiratory detection algorithms are known for enabling the detection of a user's respiratory cycle (e.g., inspiratory and expiratory phases) in respiratory assistance devices. Some such algorithms are based on processing the characteristics of the gas flow and detecting the user's real-time respiration from sensor signals (e.g., pressure and / or flow rate signals) that detect the characteristics of the gas flow. Other such algorithms may have a dedicated respiratory detection sensor or may receive other data indicating the user's real-time respiration or respiratory cycle. In one embodiment, the controller may be configured to detect the entire user's respiratory cycle signal. In another embodiment, the controller may be configured to detect only certain features of the respiratory cycle necessary to identify a particular respiratory phase of the user. One exemplary function is to detect a zero crossing indicating a transition from inspiration to expiration or vice versa. Another exemplary function may be to detect a positive or negative user flow that can indicate whether the current phase is expiration or inspiration.

[0417] In this configuration, the respiratory support device controller can execute one or more respiratory detection algorithms, or it can receive respiratory data from an external device or sensor and generate a respiratory cycle signal. The controller can then synchronize and / or adjust the gas flow characteristics according to the user's respiratory cycle and the respiratory training therapy settings. Typical user input to the device via user-generated pneumatic signal

[0418] In one embodiment, the user-generated pneumatic signal function described above may also provide a mechanism for the user to provide additional user input, interaction, or feedback to the respiratory assist device.

[0419] In one embodiment, the user can operate one or more exhaust openings / ventilators of the mouthpiece attachment to generate a user control signal detectable by the controller, and further trigger the controller to start a training mode, so that the user can start a training session according to a breathing training program.

[0420] For example, as discussed above, a user can generate a detectable change in one or more characteristics of the gas flow by blocking one or more exhaust openings / ventilators (e.g., the single-tap, double-tap, and long-press embodiments previously provided), triggering the controller to initiate a training session in training mode. The pneumatic generation user control signal may also be configured to notify the end of a training session or to provide the device with other feedback or inputs that can be used for control purposes or to control one or more functions or processes of the controller. 4. Terminology

[0421] As used herein and in the claims, the term “breathing assistance apparatus” is intended to mean any type of breathing assistance or respiratory device, device, or system capable of providing respiratory support or respiratory therapy to a user or patient by providing a flow of gas, unless the context otherwise suggests.

[0422] As used herein and in the claims, the term “medical professional” is intended to mean any individual, institution, or organization that assists in the medical care of a patient, including, but not limited to, clinicians, physiotherapists, therapists, physicians, nurses, healthcare providers / practitioners, and other similar individuals, institutions, or organizations.

[0423] Unless the context clearly indicates otherwise, words such as “comprise” and “comprising” throughout this description and the claims should be interpreted in a comprehensive sense, not in an exclusive or exhaustive sense, i.e., “including, but not limited to.”

[0424] While this disclosure has been described in the context of certain embodiments and examples, it will be understood by those skilled in the art that this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as obvious variations and equivalents thereof. Furthermore, while some variations of the embodiments of this disclosure have been shown and described in detail, other variations that fall within the scope of this disclosure will be readily apparent to those skilled in the art. Moreover, various combinations or subcombinations of specific features and aspects of the embodiments are intended to remain within the scope of this disclosure. For example, features described above in relation to one embodiment can be used with different embodiments described herein, and such combinations remain within the scope of this disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for each other to form various forms of implementation of this disclosure. Accordingly, the scope of the disclosure herein is not intended to be limited by the specific implementations described above. Accordingly, unless otherwise stated or unless obviously incompatible, each embodiment of the present invention may include, in addition to its essential features described herein, one or more features described herein from other embodiments of the present invention disclosed herein.

[0425] Features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example shall be understood to be applicable to other aspects, embodiments, or examples described in this section or elsewhere in this specification, unless they are incompatible. All features disclosed herein (including the appended claims, abstract, and aspects) and / or all steps of any method or process so as to be disclosed may be combined in any combination, except for combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of the embodiments described above. Protection extends to novel or novel combinations of features disclosed herein (including the appended claims, abstract, and aspects), or novel or novel combinations of steps of any method or process so as to be disclosed.

[0426] Furthermore, certain features described in this disclosure in the context of separate implementations can be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation can be implemented separately or in any appropriate subcombination in multiple implementations. Moreover, although features have been described above as being able to act in a particular combination, in some cases, one or more features may be extracted from a claimed combination and claimed as a subcombination or a variation of a subcombination.

[0427] Furthermore, while operations may be depicted in a specific order in the drawings or described in the specification, such operations do not need to be performed in the specific order or sequentially shown to achieve the desired result, and not all operations need to be performed. Other operations not depicted or described may be incorporated into the methods and processes of the embodiments. For example, one or more additional operations may be performed before, after, simultaneously with, or in between the described operations. Furthermore, in other embodiments, operations may be rearranged or changed in order. Those skilled in the art will understand that in some embodiments, the steps actually taken in the illustrated and / or disclosed processes may differ from those shown in the drawings. In some embodiments, some of the steps described above may be omitted, or other steps may be added. Furthermore, additional embodiments may be formed by combining features and attributes of the particular embodiments disclosed above in different ways, all of which are included within the scope of this disclosure. Also, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and system components can generally be integrated together in a single product or packaged in multiple products.

[0428] For the purposes of this disclosure, specific embodiments, advantages, and novel features are described herein. Such advantages are not necessarily achieved according to a particular embodiment. Therefore, for example, a person skilled in the art will recognize that this disclosure may be embodied or implemented in a manner that achieves one or more advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0429] Conditional expressions such as "can," "could," "might," or "may" are generally intended to indicate that certain features, elements, and / or steps are included in certain examples and not included in others, unless otherwise specified or understood in the context in which they are used. Therefore, such conditional language does not generally mean that features, elements, and / or steps are required in some way for one or more embodiments, or that one or more embodiments include logic for determining whether these features, elements, and / or steps are included in a particular embodiment or should be implemented in its implementation, with or without user input or instructions.

[0430] As used herein, terms indicating degree, such as “approximately,” “about,” “generally,” and “substantially,” represent values, quantities, or characteristics close to the stated value, quantity, or characteristic that would otherwise perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may indicate quantities within the ranges of less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity.

[0431] The scope of this disclosure is not intended to be limited by any specific disclosure of embodiments in this section or elsewhere in this specification, but may be defined by claims presented or hereafter presented in this section or elsewhere in this specification. The language of the claims should be interpreted broadly based on the language adopted in the claims, and should not be limited to the embodiments described herein or during the practice of this application, and these embodiments should be interpreted as non-exclusive.

Claims

1. A respiratory support device configured to provide a gas flow, A flow generator that can operate to generate the gas flow along the flow path of the respiratory support device, A breathing conduit for delivering the aforementioned gas flow, A mouthpiece attachment is fluidically connected to or connectable to the patient end of the respiratory conduit in order to receive the flow of the gas, The respiratory assist device includes a controller configured to control the respiratory assist device, the controller being configured to control the flow of the gas delivered to the mouthpiece attachment, thereby controlling the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of respiratory training in the mouthpiece attachment, the steps of respiratory training are Normal breathing, Spontaneous breathing, maximum respiration, Huffing, Respiration in response to fixed positive expiratory pressure (PEP), Respiration in response to Oscillatory Positive Pressure Exhalation (OPEP), Slow, deep breathing, and / or A respiratory support device that includes one or more types of breathing, such as pursed-lip breathing.

2. The respiratory assist device according to claim 1, wherein controlling the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of the respiratory training provides a positive flow of gas at a constant pressure or constant flow rate.

3. Furthermore, the respiratory assistance device according to claim 1 or 2, further comprising one or more sensors for detecting one or more characteristics of the gas flow and generating representative sensor data.

4. The one or more sensors described above are Flow sensor, and / or Includes one or more pressure sensors, The respiratory support device according to claim 3, wherein one or more sensors are positioned between the flow generator and the outlet of the respiratory support device.

5. The aforementioned controller, Receiving sensor data from one or more of the aforementioned sensors, The respiratory assist device according to claim 3 or 4, configured to perform the following: determine one or more parameters relating to the gas flow while the user performs any of the one or more steps of the respiratory training, based at least in part on the sensor data.

6. The controller, based at least partially on the sensor data received from one or more sensors, A user flow signal representing the user-generated flow component of the gas flow generated by the user during the execution of one or more steps of the breathing exercise, and / or The respiratory assistance device according to claim 5, configured to determine one or more parameters called a user pressure signal, which represents a user-generated pressure component of the gas flow generated by the user during the execution of one or more steps of the respiratory training.

7. The respiratory assist device according to any one of the prior claims, wherein controlling the air resistance provided in the mouthpiece attachment while the user is performing the one or more steps of the breathing exercise provides a gas flow of sufficient flow rate to prevent the user's breath from flowing back into the outlet of the respiratory assist device.

8. The respiratory assist device according to claim 7, wherein the flow rate of the gas is sufficient to prevent backflow but is insufficient to prevent the user from performing the one or more steps of the respiratory training.

9. Controlling the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of the breathing exercise is: Maintaining a fixed positive flow rate of the gas flow along the aforementioned flow path, Maintaining a fixed value of zero for the flow rate of the gas along the aforementioned flow path, In order to counteract the flow caused by the user's breathing, the flow rate of the gas along the flow path is changed, Maintaining the pressure in the mouthpiece attachment at a fixed value, A respiratory assist device according to any one of the prior claims, comprising maintaining a first value of pressure during the exhalation phase of the respiratory training, and maintaining a second value of pressure during the inhalation phase of the respiratory training.

10. A respiratory assist device according to any one of the prior claims, wherein controlling the air resistance in the mouthpiece attachment when the user breathes against fixed positive expiratory pressure (PEP) includes providing a flow rate of gas sufficient to induce a predefined constant PEP in the mouthpiece attachment.

11. A respiratory assist device according to any one of the prior claims, wherein controlling the air resistance in the mouthpiece attachment when the user breathes against an oscillatory positive pressure (OPEP) includes providing a flow rate of gas sufficient to induce an oscillatory PEP in the mouthpiece attachment.

12. The respiratory assist device according to claim 11, wherein providing a flow rate of the gas flow in the mouthpiece attachment sufficient to induce a vibratory PEP involves varying the flow rate of the gas flow between a first threshold that provides a predefined upper PEP value and a second threshold that provides a predefined lower PEP value.

13. The respiratory assistance device according to any one of the prior claims, wherein the controller communicates with a display screen.

14. The respiratory assistance device according to claim 13, wherein the controller is further configured to cause one or more text-based and / or graphical instruction steps for the user to perform one or more steps of the respiratory training on a display screen.

15. The respiratory assist device according to claim 13 or 14, wherein the controller is further configured to display on the display screen a flow and / or respiratory profile that the user follows when performing the one or more steps of the respiratory training.

16. The respiratory assist device according to any one of claims 13 to 15, wherein the display screen is configured to display information regarding one or more parameters of the gas flow in text and / or graphical form.

17. The respiratory assistance device according to claim 16, wherein the controller is further configured to display a comparison of the current value of one or more parameters with one or more predefined target values ​​on the display screen.

18. The respiratory assistance device according to any one of claims 13 to 17, wherein the controller is further configured to display on the display screen, in text and / or graphical form, motivational feedback relating to the breathing exercise steps being performed by the user.

19. The respiratory assist device according to any one of claims 13 to 18, wherein the display screen is configured to receive user input so that the user can adjust one or more characteristics of the gas flow provided during one or more steps of the respiratory training, and the adjustment is limited to boundaries configured by a medical professional managing the user.

20. Furthermore, the respiratory assistance device according to any one of the prior claims, further comprising a wireless communication module that electrically communicates with the controller.

21. Furthermore, the respiratory assistance device according to claim 20, configured to communicate data to a remote device or server via the wireless communication module for storage and / or processing.

22. The respiratory assistance device according to claim 21, wherein the data to be communicated includes data relating to one or more characteristics of the gas flow detected by one or more sensors of the device.

23. The respiratory assist device according to claim 21 or 22, wherein the data to be communicated includes data relating to one or more parameters relating to the gas flow taken in while the user performs one or more steps of the respiratory training.

24. The respiratory support device according to any one of claims 21 to 23, wherein the data to be communicated includes determined user respiratory parameter data, which includes one or more of the user's respiratory rate, minute ventilation, and / or tidal volume.

25. The respiratory assist device according to any one of claims 21 to 24, wherein the data transmitted includes a respiratory training program by the user, the respiratory training, and / or performance data relating to the execution of specific steps of the respiratory training.

26. The respiratory assistance device according to any one of claims 21 to 25, wherein the data to be communicated includes compliance data relating to the user's compliance with the respiratory training program.

27. The respiratory support device according to any one of claims 21 to 26, wherein the data is transmitted to the remote device or server in the form of a report or report data.

28. The respiratory assist device according to any one of the prior claims, wherein the controller is further configured to prompt the user to perform one or more steps of the respiratory training.

29. The respiratory assist device according to claim 28, wherein prompting a user to perform one or more steps of the respiratory training includes providing the prompt via the respiratory assist device.

30. The respiratory assist device according to claim 28 or 29, wherein prompting a user to perform one or more steps of the respiratory training includes generating an audio prompt by the respiratory assist device.

31. The respiratory assist device according to any one of claims 28 to 30, wherein prompting the user to perform one or more steps of the respiratory training includes generating a visual prompt on the display or interface of the respiratory assist device.

32. The respiratory assist device according to any one of claims 28 to 31, wherein prompting a user to perform one or more steps of the respiratory training includes providing the prompt to an external device that communicates data with the respiratory assist device.

33. The respiratory assist device according to any one of claims 28 to 32, wherein the controller is configured to prompt the user to perform one or more steps of the respiratory training according to periodic intervals.

34. The respiratory support device according to claim 33, wherein the periodic interval is configurable.

35. The respiratory support device according to claim 34, wherein the periodic interval can be configured via the user interface of the respiratory support device.

36. The respiratory support device according to claim 34, wherein the periodic interval can be configured via a user interface of a remote device that communicates data with the respiratory support device.

37. The respiratory support device according to any one of claims 33 to 36, wherein the periodic interval can be configured remotely by a medical professional using an external device that communicates data with the respiratory support device.

38. The aforementioned breathing exercise step further includes: Respiration for intrapulmonary percussion ventilation (IPV), and / or A respiratory support device according to any one of the prior claims, comprising one or more of the following: breathing for continuous positive airway pressure (CPAP) with vibration.

39. The respiratory assist device according to any one of the prior claims, wherein the mouthpiece attachment includes one or more exhaust openings, and the controller is configured to detect or decode user-generated pneumatic signals generated by a user operating the one or more exhaust openings of the mouthpiece attachment.

40. The respiratory assist device according to claim 39, wherein the controller is configured to detect or decode the user-generated pneumatic signal based on at least partially analyzing one or more detected characteristics of the gas flow.

41. The respiratory assist device according to claim 40, wherein the one or more detected characteristics of the gas flow vary or change based on user operation of the one or more exhaust openings of the mouthpiece attachment.

42. The respiratory assist device according to claim 40 or 41, wherein the controller is configured to detect or decode the user-generated air pressure signal by analyzing one or more detected characteristics of the gas flow with respect to fluctuations or changes corresponding to user operation of one or more discharge openings of the mouthpiece attachment.

43. The respiratory assist device according to any one of claims 39 to 42, wherein the controller is configured to control or operate one or more functions of the device in response to detecting or decoding the user-generated pneumatic signal.

44. The one or more functions of the aforementioned device are: To start the training mode of the aforementioned respiratory training device, To stop the training mode of the aforementioned device, and / or The respiratory assistance device according to claim 43, further comprising one or more of the following: synchronizing the characteristics of the gas flow with the user's respiratory cycle.

45. The respiratory assist device according to any one of claims 39 to 44, each controller is configured to detect or decode a plurality of different user-generated air pressure signals generated by different user operations on the one or more exhaust openings of the mouthpiece attachment.

46. A method for treating a respiratory disease using a respiratory support device, wherein the method is: To provide a respiratory support device, the respiratory support device is A flow generator that can operate to generate a gas flow along the flow path of the aforementioned apparatus, A breathing conduit for delivering the aforementioned gas flow, To provide a respiratory training mouthpiece attachment that is fluidly connected to or connectable to the patient end of the respiratory conduit in order to receive the flow of the gas, The process includes controlling the flow of gas through the mouthpiece attachment in order to control the air resistance provided in the mouthpiece attachment while the user is performing one or more steps of breathing exercises, and the steps include: Normal breathing, Spontaneous breathing, maximum respiration, Huffing, Respiration in response to fixed positive expiratory pressure (PEP), Respiration in response to Oscillatory Positive Pressure Exhalation (OPEP), Slow, deep breathing, and / or A method that includes one or more types of breathing with pursed lips.

47. The method according to claim 46, comprising providing the respiratory support device according to any one of claims 1 to 45.

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