Measuring device and system for respiratory assistance apparatus and / or for performing diagnostics

Abstract

The invention relates to a measuring device and system for a respiratory assistance device and / or for performing diagnostics. A measuring device for use with a respiratory assist apparatus to measure lung performance. The measuring device has a body releasably connectable to a gas outlet or a breathing conduit of a breathing assistance apparatus. The body delivers the gas flow from the gas outlet to a user. The main catheter body has a connector end connectable to a respiratory assist device gas outlet to receive a gas flow, and a mouthpiece end providing fluid communication to a user's airway. The main chamber extends between the connector end and the mouthpiece end for delivering an airflow. One or more exhaust ports are disposed between two ends on the body and are in fluid communication with the main cavity.

Description

[0001] This application is a divisional application of the invention patent application No. 202211623432.9, titled "Measurement Devices and Systems for Respiratory Assistance Devices and / or for Performing Diagnostics", filed on December 16, 2022. Technical Field

[0002] The present disclosure relates to measurement devices and systems for respiratory assistance devices and / or for performing diagnostics. In particular, the present disclosure relates to measurement devices and / or systems for diagnosing or measuring lung performance or lung function. Background Art

[0003] Respiratory assistance devices are used in various environments, such as hospitals, medical facilities, residential care, or home environments, to output an air flow to a user or patient. Respiratory assistance or respiratory therapy devices can be used to output supplementary oxygen or other gases along with the air flow, and / or humidification devices for outputting heated and humidified gases. Respiratory assistance devices can allow adjustment and control of the characteristics of the air 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 air flow. Summary of the Invention

[0004] The present disclosure relates to measurement devices and systems for use with a respiratory assistance device to diagnose or measure lung performance or function.

[0005] In one configuration, the measurement device can be used to perform a vital capacity measurement, or can be used to obtain a measurement value representing, regarding, or similar to a vital capacity measurement. In this configuration, the measurement device can be considered as an alternative vital capacity meter accessory.

[0006] In another configuration, the measurement device can be used to perform other measurements or diagnostics related to the lung function or lung performance of a user.

[0007] In one configuration, the measurement device can be an auxiliary component or accessory that can be connected to the gas outlet of the respiratory assistance device, or can be connected to the end of the respiratory circuit conduit of the respiratory assistance device, or can be connected to the end of the respiratory circuit conduit connected to the respiratory assistance device, such that the measurement device receives the air flow from the respiratory assistance device.

[0008] The present disclosure provides measurement devices and systems for performing lung performance or function measurements in conjunction with a respiratory assistance device.

[0009] In one aspect, the present disclosure generally includes a respiratory assistance device configured to provide an air flow to a user for respiratory therapy. The respiratory assistance device includes: an air flow generator operable to generate an air flow along a flow path of the respiratory assistance device; a respiratory conduit for outputting the air flow to the user; a measuring device for pulmonary performance measurement fluidly connected or fluidly connectable to an end of the respiratory conduit to receive the air flow; and a controller operable to control the respiratory assistance device, the controller being configured to control the air flow into the measuring device when the user performs one or more forced exhalation actions into the measuring device to provide a controlled pneumatic resistance to the user's exhalation.

[0010] In one aspect, the present disclosure generally includes a respiratory assistance device configured to provide an air flow to a user for respiratory therapy. The respiratory assistance device includes: an air flow generator operable to generate an air flow along a flow path of the respiratory assistance device; a respiratory conduit for outputting the air flow to the user; a measuring device for pulmonary performance measurement fluidly connected or fluidly connectable to an end of the respiratory conduit to receive the air flow; and a controller operable to control the respiratory assistance device, the controller being configured to control the air flow into the measuring device when the user performs quiet breathing or tidal breathing into the measuring device to provide a controlled pneumatic resistance to the user's exhalation.

[0011] In one configuration, the controller is configured to determine a user flow signal representative of the flow rate that the user can cause to resist the air flow via the measuring device based at least on a function of a user pressure signal representative of the pressure applied by the user during exhalation into the measuring device.

[0012] In one configuration, the controller is configured to determine a user flow signal representative of the flow rate that the user can cause to resist the air flow via the measuring device based at least on a function of a flow resistance parameter associated with the measuring device.

[0013] In one configuration, the controller is configured to determine a user flow signal representative of the flow rate that the user can cause to resist the air flow via the measuring device based at least on a function of a conductance parameter.

[0014] In one configuration, the controller is configured to determine a conductance parameter based at least on a function of a flow signal representative of the flow rate of the air flow generated by the air flow generator and a user pressure signal representative of the pressure applied by the user during exhalation into the measuring device.

[0015] In one configuration, the controller is configured to determine the user pressure signal based at least on a function of a pressure signal representative of the outlet pressure of the air flow generator, a flow resistance parameter, and a flow signal representative of the flow rate of the air flow generated by the air flow generator.

[0016] In one configuration, the controller is configured to determine a user flow signal representing the flow of air that a user can cause against the airflow, at least based on a function of a flow signal representing the airflow rate generated by an airflow generator and a leakage flow signal representing the leakage flow rate through one or more exhaust ports of a measurement device.

[0017] In one configuration, the controller is configured to determine the leakage flow signal, at least based on a function of a conductance parameter and a user pressure signal representing the pressure applied by the user during exhalation into the measurement device.

[0018] In one configuration, the controller is configured to determine the user pressure signal, at least based on a function of a pressure signal representing the outlet pressure of the airflow generator, a flow resistance parameter, and a flow signal representing the airflow rate generated by the airflow generator.

[0019] In one configuration, when a user performs tidal breathing into the measurement device, the controller is configured to determine a breathing frequency signal or parameter for the user, at least partially based on or at least according to the determined user flow signal.

[0020] In one configuration, when a user performs tidal breathing into the measurement device, the controller is configured to determine a tidal volume signal or parameter for the user, at least partially based on or at least according to the determined user flow signal.

[0021] In one configuration, the controller is configured to determine a minute ventilation signal or parameter for the user, at least partially based on or at least according to the determined breathing frequency signal and tidal volume signal.

[0022] In one configuration, when a user performs tidal breathing into the measurement device, the controller is configured to determine a signal or parameter representing the ratio of the inspiratory time to the total breathing time, at least partially based on or at least according to the determined user flow signal.

[0023] In one configuration, a respiratory assistance device includes one or more sensors for sensing or determining one or more characteristics of an airflow and generating representative sensor data.

[0024] In one configuration, the one or more sensors are configured to measure or determine any one or more of the following characteristics of the airflow: flow rate, pressure, temperature, humidity.

[0025] In one configuration, the one or more sensors are external to or separated from the measurement device.

[0026] In one configuration, the one or more sensors are located in the flow path upstream of the measurement device or are configured to sense the airflow upstream of the measurement device.

[0027] In one configuration, the breathing assistance device air flow generator is enclosed or housed within the main housing of the breathing assistance device, and the one or more sensors are located within the main housing of the breathing assistance device and / or within the breathing conduit.

[0028] In one configuration, the measuring device includes a body extending between a connector end and a mouthpiece end, the body including a main chamber for air flow extending between the connector end and the mouthpiece end.

[0029] In one configuration, the body is a conduit or tubular member having an opening at each end.

[0030] In one configuration, the connector end of the body is configured to releasably connect to the end of the breathing conduit.

[0031] In one configuration, the connector end of the body is integrally or permanently connected to the end of the breathing conduit.

[0032] In one configuration, the connector end of the body includes one or more openings or ports for fluid connection to the end of the breathing conduit.

[0033] In one configuration, the mouthpiece end of the body is configured to receive a detachable mouthpiece, the detachable mouthpiece being configured to provide fluid communication to the user's airway during use.

[0034] In one configuration, the mouthpiece end of the body is a mouthpiece configured to provide fluid communication to the user's airway during use.

[0035] In one configuration, the body of the measuring device further includes one or more exhaust ports in fluid communication with the main chamber.

[0036] In one configuration, the measuring device further includes one or more anti-blocking features configured to prevent accidental blockage of the one or more exhaust ports.

[0037] In one configuration, the anti-blocking feature is arranged or configured as a clip for mounting the measuring device.

[0038] In one configuration, the one or more exhaust ports are provided on the body between the connector end and the mouthpiece end.

[0039] In one configuration, the one or more exhaust ports are exhaust holes.

[0040] In one configuration, the one or more exhaust holes include a single opening.

[0041] In one configuration, the one or more exhaust holes include multiple openings.

[0042] In one configuration, the one or more exhaust holes include multiple openings or holes in a honeycomb or mesh structure or arrangement.

[0043] In one configuration, one or more exhaust ports are flush exhaust holes provided in the wall of the body such that the flush exhaust holes are substantially flush with the outer surface of the body.

[0044] In one configuration, one or more exhaust ports are protruding exhaust holes that protrude from the wall of the body.

[0045] In one configuration, one or more of the protruding exhaust holes are shaped and / or configured to direct or deflect the exhaust exiting the exhaust hole away from the user's face when the measuring device is in use.

[0046] In one configuration, the body is defined by a longitudinal axis extending between a connector end and a mouthpiece end, and one or more of the protruding exhaust holes extend angularly relative to the longitudinal axis such that the exhaust exiting the exhaust hole is directed or deflected away from the user's face when the measuring device is in use.

[0047] In one configuration, the respiratory assistance device further includes a humidifier that is operable to heat and humidify the airflow generated by the airflow generator.

[0048] In one configuration, the humidifier is disposed in the main housing of the respiratory assistance device, and the main housing further includes an airflow generator.

[0049] In one configuration, the controller includes a patient diagnostic mode that can be used to control the airflow to provide a controlled pneumatic resistance when the measuring device is connected to the end of the breathing tube.

[0050] In one configuration, the controller includes one or more operating modes, and the one or more operating modes at least include a first mode that can be used to control the respiratory assistance device when the measuring device is not connected to the breathing tube and a second mode that can be used to control the respiratory assistance device when the measuring device is connected to the breathing tube.

[0051] In one configuration, the controller includes a plurality of operating modes, and the plurality of operating modes at least include: a treatment mode that can be used to control the respiratory assistance device to provide airflow to the user for respiratory treatment; and a patient diagnostic mode that can be used to control the airflow to provide pneumatic resistance for performing lung performance measurements when the measuring device is connected to the breathing tube.

[0052] In one aspect, the present disclosure generally includes a device for performing lung performance measurements on a user, comprising: an airflow generator operable to generate an airflow in a flow path; a measurement device in fluid communication with the flow path to receive the airflow; a controller operable to control the airflow generator to generate an airflow into the measurement device to provide a controlled pneumatic resistance in the flow path when the user performs one or more forced exhalation maneuvers into the measurement device; and one or more sensors configured to sense one or more characteristics of the airflow in the flow path when the user performs a forced exhalation maneuver into the measurement device and generate representative sensor data that can be used to derive one or more lung performance measurements.

[0053] In one aspect, the present disclosure generally includes a device for performing lung performance measurements on a user, comprising: an airflow generator operable to generate an airflow in a flow path; a measurement device in fluid communication with the flow path to receive the airflow; a controller operable to control the airflow generator to generate an airflow into the measurement device to provide a controlled pneumatic resistance in the flow path when the user performs quiet breathing or tidal breathing into the measurement device; and one or more sensors configured to sense one or more characteristics of the airflow in the flow path when the user performs quiet breathing or tidal breathing into the measurement device and generate representative sensor data that can be used to derive one or more lung performance measurements.

[0054] In one aspect, the present disclosure generally includes a measurement device for use with a respiratory assistance device to measure lung performance, the measurement device comprising: a body releasably connected to a gas outlet or a breathing conduit of the respiratory assistance device and configured to convey the airflow from the gas outlet to the user, wherein the main conduit body comprises: a connector end connectable to the gas outlet of the respiratory assistance device to receive the airflow; a mouthpiece end for providing fluid communication to the user's airway during use; a main cavity extending between the connector end and the mouthpiece end for conveying the airflow; and one or more exhaust ports provided between the two ends on the body and in fluid communication with the main cavity.

[0055] In one configuration, the body is a conduit or tubular member having openings at each end.

[0056] In one configuration, the connector end of the body is configured to be releasably connectable to the end of a gas outlet or a breathing conduit of the respiratory assistance device.

[0057] In one configuration, the connector end of the body includes one or more openings or ports for fluid connection to the gas outlet or the breathing conduit of the respiratory assistance device.

[0058] In one configuration, the mouthpiece end of the body is configured to receive a detachable mouthpiece, the detachable mouthpiece being configured to provide fluid communication to the user's airway during use.

[0059] In one configuration, the mouthpiece end of the body is a mouthpiece configured to provide fluid communication with a user's airway in use.

[0060] In one configuration, the body of the measuring device further includes one or more exhaust ports in fluid communication with the main chamber.

[0061] In one configuration, the measuring device further includes one or more anti-blocking features configured to prevent accidental blockage of the one or more exhaust ports.

[0062] In one configuration, the anti-blocking feature is arranged or configured as a clip for mounting the measuring device.

[0063] In one configuration, the one or more exhaust ports are provided on the body between the connector end and the mouthpiece end.

[0064] In one configuration, the one or more exhaust ports are exhaust holes.

[0065] In one configuration, the one or more exhaust holes include a single opening.

[0066] In one configuration, the one or more exhaust holes include multiple openings.

[0067] In one configuration, the one or more exhaust holes include multiple openings or holes in a honeycomb or mesh structure or arrangement.

[0068] In one configuration, the one or more exhaust ports are flush exhaust holes provided in the wall of the body such that the flush exhaust holes are substantially flush with the outer surface of the body.

[0069] In one configuration, the one or more exhaust ports are protruding exhaust holes protruding from the wall of the body.

[0070] In one configuration, the one or more protruding exhaust holes are shaped and / or configured to direct or deflect the exhaust leaving the exhaust holes away from the user's face when the measuring device is in use.

[0071] In one configuration, the body is defined by a longitudinal axis extending between the connector end and the mouthpiece end, and the one or more protruding exhaust holes extend at an angle relative to the longitudinal axis such that the exhaust leaving the exhaust holes is directed or deflected away from the user's face when the measuring device is in use.

[0072] In one aspect, the present disclosure generally includes a method of using a measurement device with a respiratory assistance device to measure lung performance, the method including the steps of: connecting the measurement device to a gas outlet or a breathing conduit or a flow path of the respiratory assistance device such that the measurement device receives an air flow from an air flow generator of the respiratory assistance device; operating the respiratory assistance device in a patient diagnostic mode, the patient diagnostic mode being configured to be able to determine one or more lung performance measurements; instructing a user to perform one or more forced exhalation actions into the measurement device; and using one or more sensors to determine one or more characteristics of the air flow during the forced exhalation actions.

[0073] In one aspect, the present disclosure generally includes a method of using a measurement device with a respiratory assistance device to measure lung performance, the method including the steps of: connecting the measurement device to a gas outlet or a breathing conduit or a flow path of the respiratory assistance device such that the measurement device receives an air flow from an air flow generator of the respiratory assistance device; operating the respiratory assistance device in a patient diagnostic mode, the patient diagnostic mode being configured to be able to determine one or more lung performance measurements; instructing a user to perform quiet breathing or tidal breathing into the measurement device; and using one or more sensors to determine one or more characteristics of the air flow during the quiet breathing or tidal breathing.

[0074] In one configuration, the patient diagnostic mode of the respiratory assistance device is configured to generate an air flow to a gas outlet and / or a breathing conduit connected to the measurement device.

[0075] In one configuration, the patient diagnostic mode of the respiratory assistance device is configured to generate an air flow at a constant flow rate.

[0076] In one configuration, the constant flow rate of the air flow is configured to provide a substantially constant or consistent pneumatic resistance to the user's exhalation into the measurement device.

[0077] In one configuration, the patient diagnostic mode of the respiratory assistance device is configured to generate an air flow for a fixed duration or a predetermined time period.

[0078] In one configuration, operating the respiratory assistance device in the patient diagnostic mode includes initiating or activating the patient diagnostic mode in response to a user input via a user interface.

[0079] In one configuration, a user input for initiating or activating the patient diagnostic mode is provided via a user interface of the respiratory assistance device.

[0080] In one configuration, the user interface of the respiratory assistance device includes buttons and / or touch screen interface buttons that can be operated by the user or another person to activate the patient diagnostic mode.

[0081] In one configuration, user input for initiating or activating a patient diagnostic mode is provided via a user interface of an external device that communicates data with a respiratory assistance device.

[0082] In one configuration, the user interface of the external device includes buttons and / or touchscreen interface buttons that can be operated by the user or another person to activate the patient diagnostic mode.

[0083] In one configuration, the method further includes prompting the user or another person to initiate or activate the patient diagnostic mode via the user interface.

[0084] In one configuration, prompting the user or another person to initiate or activate the patient diagnostic mode includes providing a prompt via the respiratory assistance device.

[0085] In one configuration, the prompt includes an audio prompt generated by the respiratory assistance device.

[0086] In one configuration, the prompt includes generating a visual prompt on a display or interface of the respiratory assistance device.

[0087] In one configuration, prompting the user or another person to initiate or activate the patient diagnostic mode includes providing a prompt on an external device that communicates data with the respiratory assistance device.

[0088] In one configuration, prompting the user or another person to initiate or activate the patient diagnostic mode includes prompting at periodic intervals.

[0089] In one configuration, the periodic interval is configurable.

[0090] In one configuration, the method includes configuring the periodic interval of the prompt via the user interface of the respiratory assistance device.

[0091] In one configuration, the method includes configuring the periodic interval of the prompt via the user interface or software application of an external device that communicates data with the respiratory assistance device.

[0092] In one configuration, the periodic interval of the prompt can be remotely configured by a clinician, physician, or healthcare practitioner using an external device.

[0093] In one configuration, prompting the user or another person to initiate or activate the patient diagnostic mode includes initiating or triggering the prompt in response to an input or interaction by a clinician, physician, or healthcare practitioner with a remote or external device that communicates data with the respiratory assistance device.

[0094] In one configuration, the patient diagnostic mode of the respiratory assistance device is automatically initiated or activated.

[0095] In one configuration, the patient diagnostic mode of the respiratory assistance device is automatically initiated or activated based on a periodic interval.

[0096] In one configuration, the periodic interval for automatically initiating or activating the patient diagnostic mode is configurable.

[0097] In one configuration, the method includes configuring the periodic interval of the patient diagnostic mode via the user interface of the respiratory assistance device.

[0098] In one configuration, the method includes configuring the periodic interval of the patient diagnostic mode via the user interface or software application of an external device that communicates data with the respiratory assistance device.

[0099] In one configuration, the periodic interval of the patient diagnostic mode can be remotely configured by a clinician, physician, or healthcare practitioner using an external device.

[0100] In one configuration, the respiratory assistance device includes one or more communication modules configured to provide data communication with one or more external or remote devices.

[0101] In one configuration, determining one or more characteristics of the airflow during a forced exhalation maneuver or tidal breathing includes using one or more sensors of the respiratory assistance device.

[0102] In one configuration, determining one or more characteristics of the airflow during a forced exhalation maneuver or tidal breathing includes using one or more sensors disposed in the flow path upstream of the measuring device or configured to sense the airflow upstream of the measuring device.

[0103] In one configuration, the method further includes providing instructions to the user via the user interface of the respiratory assistance device during a diagnostic session on how to connect the measuring device to the respiratory assistance device, use the measuring device, and / or perform a forced exhalation maneuver or tidal breathing into the mouthpiece.

[0104] In one configuration, the instructions are provided or presented visually on the display of the user interface and / or provided or presented audibly.

[0105] In one configuration, the method further includes: graphically presenting on the display of the user interface of the respiratory assistance device sensor data from the one or more sensors or one or more lung performance measurements generated from the sensor data.

[0106] In one configuration, the method further includes: processing the sensor data from the one or more sensors to generate lung performance measurement data and / or one or more representative graphs or sensor data and / or lung performance measurement data.

[0107] In one configuration, the method further includes: processing lung performance measurement data and / or graphics to identify or determine the user's health status

[0108] In one aspect, the present disclosure generally includes a non-transitory computer-readable medium storing computer-executable instructions that, when executed on a processing device, cause the processing device to perform any method of any one or more of the above aspects.

[0109] In one aspect, the present disclosure generally includes one or a set of application programming interfaces (APIs) embodied on a computer-readable medium for execution on a processing device in conjunction with an application that performs any method of any one or more of the above aspects.

[0110] Any aspect of the present disclosure above may also include any one or more aspects or features mentioned with respect to any one or more other aspects. BRIEF DESCRIPTION OF THE DRAWINGS

[0111] These and other features, aspects, and advantages of the present disclosure are described with reference to the drawings of certain embodiments, which are intended to schematically illustrate certain embodiments and not limit the present disclosure.

[0112] Figure 1 A respiratory assistance device configured to provide respiratory therapy to a patient is schematically shown.

[0113] Figure 2 is a front view of an exemplary respiratory assistance device, where the humidification chamber is in place and the handle / joystick is raised.

[0114] Figure 3 is with Figure 2 corresponding top view.

[0115] Figure 4 is with Figure 2 corresponding right view.

[0116] Figure 5 is with Figure 2 corresponding left view.

[0117] Figure 6 is with Figure 2 corresponding rear view.

[0118] Figure 7 is with Figure 2 corresponding left front perspective view.

[0119] Figure 8 is with Figure 2 corresponding right front perspective view.

[0120] Figure 9 is with Figure 2 corresponding bottom view.

[0121] Figure 10 Shows an example configuration of the air and oxygen inlet arrangement of a respiratory assistance device.

[0122] Figure 11 Shows another example configuration of the air and oxygen inlet arrangement of a respiratory assistance device.

[0123] Figure 12 Is a cross-sectional view showing Figure 11 further details of the air and oxygen inlet arrangement.

[0124] Figure 13 Is another cross-sectional view showing Figure 11 further details of the air and oxygen inlet arrangement.

[0125] Figure 14 Is a longitudinal cross-sectional view showing Figure 11 further details of the air and oxygen inlet arrangement.

[0126] Figure 15 Is an exploded view of the upper chassis part and the lower chassis part of the main housing of the respiratory assistance device.

[0127] Figure 16 Is a left front perspective view of the lower chassis of the main housing, showing the housing for receiving the motor / sensor module sub-assembly.

[0128] Figure 17 Is a first lower side perspective view of the main housing of the respiratory assistance device, showing the internal recess of the housing for receiving the motor / sensor module sub-assembly.

[0129] Figure 18 Is a second lower side perspective view of the main housing of the respiratory assistance device, showing the recess for receiving the motor / sensor module sub-assembly.

[0130] Figure 19A Shows a block diagram of a control system that interacts with and / or provides control and indication for the various components of the respiratory assistance device.

[0131] Figure 19B Shows a block diagram of an example controller.

[0132] Figure 20 Shows a block diagram of the motor and sensor module.

[0133] Figure 21 Shows the sensing chamber of an example motor and sensor module.

[0134] Figure 22 Shows Figure 1Schematic diagram of a respiratory assistance device, wherein, in an embodiment, a measuring device is connected to the end of a respiratory catheter for measuring lung performance in the patient diagnosis mode of the device in the embodiment.

[0135] Figure 23 Shows a perspective view of the measuring device as seen from the connector end in a first exemplary embodiment.

[0136] Figure 24 Shows Figure 23 A perspective view of the measuring device as seen from the mouthpiece end.

[0137] Figure 25 Shows Figure 23 A first side elevation view of the measuring device in

[0138] Figure 26 Shows Figure 23 A second side elevation view of the measuring device in

[0139] Figure 27 Shows Figure 23 A bottom view of the measuring device in

[0140] Figure 28 Shows Figure 23 A top view of the measuring device in

[0141] Figure 29 Shows Figure 23 A first end view of the measuring device as seen from the mouthpiece end in

[0142] Figure 30 Shows the Figure 23 Second end view of the measuring device as seen from the connector end.

[0143] Figure 31 Shows the Figure 29 And Figure 30 Cross-sectional view of the measuring device along line AA in

[0144] Figure 32 Shows Figure 23 An enlarged perspective view of the connector end of the measuring device in

[0145] Figure 33 Shows a first end perspective view of a first exemplary embodiment of a detachable mouthpiece for the measuring device.

[0146] Figure 34 Shows Figure 33 Second end perspective view of the detachable mouthpiece in

[0147] Figure 35 Shows Figure 33 A side view of the detachable mouthpiece in

[0148] Figure 36 shows a cross-sectional view of a detachable mouthpiece through line DD in Figure 35

[0149] Figure 37 shows in one embodiment Figure 23 a measuring device and Figure 33 a perspective view of the detachable mouthpiece assembled together.

[0150] Figure 38 shows Figure 37 an exploded perspective view of the measuring device and the detachable mouthpiece in

[0151] Figure 39 shows a side view of the measuring device assembled with the mouthpiece shown in Figure 37

[0152] Figure 40 shows a cross-sectional view of the measuring device through line EE in Figure 39 with the assembled mouthpiece.

[0153] Figure 41 shows a side cross-sectional view of the measuring device with the assembled mouthpiece shown in Figure 39

[0154] Figure 42 is a flowchart of a process for performing lung performance measurements using a measuring device and a respiratory assistance device according to an example configuration.

[0155] Figure 43 is a flowchart of a prompt for instructing a user to perform a forced exhalation action according to an example configuration.

[0156] Figure 44 is a flowchart of a process for performing lung performance measurements using a measuring device and a respiratory assistance device according to another example configuration.

[0157] Figures 45A - 45C shows an example schematic GUI display screen prompt for instructing a user to disconnect a patient interface according to an example configuration.

[0158] Figures 46A - 46C shows an example schematic GUI display screen prompt for instructing a user to connect a measuring device attachment to a flow path of a respiratory assistance device.

[0159] Figures 47A - 47F shows an example schematic GUI display screen prompt for instructing a user to perform a forced exhalation action according to an example configuration.

[0160] Figure 48A and Figure 48B shows an example schematic GUI display screen prompt according to an example configuration for instructing a user to breathe normally after a forced exhalation action. ​​​

[0161] Figure 49 Displays an example schematic GUI display prompt instructing the user to connect the patient interface to the device for a treatment session.

[0162] Figure 50 Is a graph of example sensed flow data for healthy and patient subjects undergoing lung performance measurements using a measurement device and a respiratory assistance device.

[0163] Figure 51 Shows a perspective view of the measurement device as seen from the connector end in a second example embodiment.

[0164] Figure 52 Shows Figure 51 A perspective view of the measurement device as seen from the mouthpiece end in

[0165] Figure 53 Shows Figure 51 A first side elevation view of the measurement device in

[0166] Figure 54 Shows Figure 51 A second side elevation view of the measurement device in

[0167] Figure 55 Shows Figure 51 A top view of the measurement device in

[0168] Figure 56 Shows Figure 51 A bottom view of the measurement device in

[0169] Figure 57 Shows Figure 51 A first end view of the measurement device as seen from the mouthpiece end in

[0170] Figure 58 Shows Figure 51 A second end view of the measurement device as seen from the connector end in

[0171] Figure 59 Shows a cross-sectional view of the measurement device along line AA in Figure 57 and Figure 58

[0172] Figure 60 Shows Figure 51 An enlarged perspective view of the connector end of the measurement device in

[0173] Figure 61 Shows a first end perspective view of a detachable mouthpiece for the measurement device in a second example embodiment.

[0174] Figure 62 Shows Figure 61 A second end perspective view of the detachable mouthpiece in ​

[0175] Figure 63 shows Figure 61 a top view of the detachable nozzle in

[0176] Figure 64 shows Figure 63 a cross-sectional view of the detachable nozzle with the BB line in

[0177] Figure 65 shows Figure 61 a side view of the detachable nozzle in

[0178] Figure 66 shows Figure 65 a cross-sectional view of the detachable nozzle with the line CC in

[0179] Figure 67 shows Figure 51 the measuring device in one embodiment Figure 61 assembled with the detachable nozzle in

[0180] Figure 68 shows Figure 67 an exploded perspective view of the measuring device and the detachable nozzle in

[0181] Figure 69 shows Figure 67 a side view of the measuring device with the assembled nozzle shown in

[0182] Figure 70 shows Figure 69 a cross-sectional view of the measuring device with the assembled nozzle with the line DD in

[0183] Figure 71 shows Figure 67 a top view of the measuring device with the assembled nozzle shown in

[0184] Figure 72 shows Figure 71 a cross-sectional view of the measuring device with the assembled nozzle with the line EE in

[0185] Figure 73 shows Figure 67 a first perspective view of the measuring device with the assembled nozzle, including a clip structure, shown in

[0186] Figure 74 shows Figure 73 a second perspective view of the measuring device with the assembled nozzle and clip structure shown in

[0187] Figure 75 shows Figure 73 a side view of the measuring device with the assembled nozzle and clip structure shown in Detailed Description

[0188] Although certain examples are described below, those skilled in the art will understand that the present disclosure extends beyond the specifically disclosed examples and / or uses and their obvious variations and equivalents. Accordingly, the scope of the present disclosure should not be limited by any of the specific examples described below.

[0189] 1. Overview of Measurement Devices and Systems

[0190] Generally speaking, a measurement device is an accessory or auxiliary component for use with a respiratory assistance device to perform pulmonary performance or pulmonary function measurements and / or diagnostic measurements. The measurement device accessory is configured to be fluidly connected or coupled to the airflow generated by the respiratory assistance device, or otherwise in fluid communication with the airflow. For example, in one configuration, the measurement device accessory is configured to be attached or connected to the end or midway along the flow path of the respiratory assistance device to receive the airflow generated by the respiratory assistance device.

[0191] In one configuration, the measurement device can be attached or connected to the end of a patient breathing conduit, such as a flexible breathing conduit or tube connected to the device gas outlet.

[0192] In another configuration, the measurement device can be attached or directly connected to the gas outlet or any other accessible outlet or port along the flow path of the respiratory assistance device. In one example, the measurement device can be attached to the gas outlet or patient outlet port of the device that is normally coupled or connected to the patient breathing conduit. In another example, the respiratory assistance device can include a detachable humidification chamber that is in fluid communication with the airflow generator to receive the airflow generated by the airflow generator. The detachable humidification chamber can be connected or fluidly coupled to the airflow generator through the device gas outlet port. The gas outlet port can be the outlet of the airflow generator or can be in fluid communication with the airflow generator outlet. When the humidification chamber is detached, the gas outlet is accessible, and the measurement device can be directly attached to the gas outlet port to receive the airflow generated by the airflow generator. In other configurations, the humidifier or humidification chamber can be bypassed via a bypass conduit or other bypass configuration. For example, the measurement device can be directly attached to or indirectly attached via a breathing conduit to a bypass conduit or port or outlet that bypasses the humidifier or humidification chamber, such that the measurement device is in fluid communication with the airflow from the airflow generator outlet and the humidifier is temporarily cut off or bypassed from the flow path.

[0193] In any of the above configurations and examples, the measurement device is connected or attached to the flow path such that it is in fluid communication with the airflow generated by the airflow generator and / or the respiratory assistance device.

[0194] In one embodiment, the measuring device may include a body extending between a connector end and a mouthpiece end. The connector end and the mouthpiece end are fluidly connected by a main cavity (such as a flow channel or passageway) extending between the two ends of the body. In one configuration, the body may be a conduit-shaped, tubular, or manifold-shaped component extending between the connector end and the mouthpiece end. The body may be generally hollow. The connector end includes one or more openings or ports for fluid connection to the end of a flexible breathing conduit of a respiratory assistance device. The mouthpiece end provides or receives a mouthpiece that includes one or more openings or ports to provide fluid communication with the user's airway during use. One or more exhaust ports (such as exhaust holes) leading to the atmosphere or the surrounding environment may also be provided along the body between the connector end and the mouthpiece end. The exhaust holes may be in fluid communication with the main cavity.

[0195] In one embodiment, when the measuring device is attached or connected to the end of a flow path for use, the controller of the respiratory assistance device may manually or automatically switch to a diagnostic or measurement mode. In this diagnostic or measurement mode, the controller may prompt the user (e.g., via visual and / or auditory cues or notifications) to perform or follow one or more steps to perform one or more lung performance or lung function measurements or tests. Typically, the controller prompts the user to perform a forced exhalation action, such as exhaling forcefully into the mouthpiece. The test may include a spirometry test or action.

[0196] During the measurement or test, the controller may control the airflow generator of the respiratory assistance device to provide an airflow (e.g., air or air supplemented with one or more other gases) according to a configurable flow rate setting. The generated airflow provides, creates, and / or generates pneumatic resistance or airflow resistance in the flow path to resist the user's exhalation action. During the measurement or test, the respiratory assistance device senses one or more characteristics of the airflow in the flow path via one or more sensors. The sensor data may include signals, data, or artefacts representing the user's exhalation during the test. The sensors may be provided in the main housing of the respiratory assistance device and / or in the patient breathing conduit. The sensor data may be stored and analyzed to generate output data representing lung performance or lung function. In some configurations, the output data may include spirometry data or data representing or similar to a vital capacity measurement.

[0197] In the following description, an exemplary respiratory assistance device that can be used with a measurement device will be described. The exemplary respiratory assistance device is mainly configured for high-flow therapy or has a high-flow therapy mode. However, the measurement device can be used with any respiratory assistance device, system, or apparatus having an air flow generator (such as a blower, fan, compressor, etc.) operable to generate a controllable air flow for respiratory therapy. The respiratory assistance device can be operable or configured to provide a single type of therapy, or can be operable to provide multiple respiratory therapies. For example, the respiratory assistance device can be configured to operate in a single therapy mode, or can be configured to operate in multiple selectable therapy modes or provide multiple selectable therapy modes. As an example, the measurement device can be operated with a respiratory assistance device that provides any one or more of the following respiratory therapies and / or therapy modes: high-flow therapy, positive airway pressure (PAP) therapy, continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) therapy, bilevel PAP or bilevel therapy, or other such respiratory therapies. The measurement device can be operated with a respiratory assistance device or system that includes an active or passive humidifier in the flow path, or with a device or system without a humidifier.

[0198] 2. Overview of the Exemplary Respiratory Assistance Device

[0199] The measurement device, as well as methods and procedures for using the measurement device, will be described in the context of an exemplary respiratory assistance device 10 that is configured or operable to provide nasal high-flow therapy via a non-sealed patient interface. This is a non-limiting example. It should be understood that the measurement device can be operated with a wide range of respiratory assistance devices that include an air flow generator.

[0200] 2.1 Schematic Overview

[0201] Figure 1 A schematic diagram of the exemplary respiratory assistance device 10 is provided.

[0202] The respiratory assistance device 10 (or “respiratory system”) includes an air flow source 50 for providing a high-flow gas 31 (such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen and one or more other gases). Alternatively, the respiratory assistance device can have a connection for coupling to an air flow source. Thus, depending on the context, the air flow source can be considered as forming part of the device or being separate from the device; or even a part of the air flow source forms part of the device, and a part of the air flow source is outside the scope of the device. In short, depending on the configuration (certain components can be optional), the system can include a combination of components selected from the following:

[0203] Air flow source;

[0204] A humidifier for humidifying the air flow;

[0205] A conduit (such as a dry pipeline or a heated breathing tube);

[0206] A patient interface;

[0207] A check valve;

[0208] A filter.

[0209] The device or system will be described in more detail.

[0210] The gas flow source can be an in-wall oxygen source, an oxygen cylinder 50A, other gas cylinders, and / or a high-flow device having a gas flow generator 50B. Figure 1 A gas flow source 50 having a gas flow generator 50B is shown, with an optional air inlet 50C and an optional connection to an O2 source (such as a cylinder or an O2 generator) 50A via a shut-off valve and / or a regulator and / or other gas flow controllers 50D, but this is just an option. The gas flow generator 50B can use one or more valves to control the gas flow output to the patient 56; or alternatively, the gas flow generator 50B can include a blower. The gas flow source can be one or a combination of the described gas flow generator 50B, O2 source 50A, and air source 50C. The gas flow source 50 is shown as part of the device 10; but in the case of an external oxygen cylinder or a wall-mounted source, it can be considered a separate component, in which case the device has a connection port for connecting to such a gas flow source. The gas flow source provides a (preferably high-flow) gas flow that can be output to the patient via the output conduit 16 and the patient interface 51.

[0211] The patient interface 51 can be a non-sealing (unsealed) interface (e.g., when used in high-flow therapy), such as a non-sealing nasal cannula; or a sealing (sealed) interface (e.g., when used for CPAP), such as a nasal mask, a full-face mask, or a nasal pillow. In some embodiments, the patient interface 51 is a non-sealing patient interface, which will, for example, help prevent barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to a pressure difference relative to the atmosphere). In some embodiments, the patient interface 51 is a sealed mask that forms a seal with the patient's nose and / or mouth. The patient interface can be a nasal cannula having a manifold and nasal prongs, and / or a 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 gas flow source can provide a baseline gas flow rate in the range of, for example, between 0.5 liters per minute and 375 liters per minute, or any range within this range, or even a range with higher or lower limits. Details of the flow rate range and nature will be described later.

[0212] The humidifier 52 can be optionally disposed between the gas flow source 50 and the patient to provide humidification of the output gas. One or more sensors 53A, 53B, 53C, 53D (such as flow sensors, oxygen fraction sensors, pressure sensors, humidity sensors, temperature sensors, or other sensors) can be disposed throughout the system and / or at, on, or near the patient 56. Alternatively or additionally, sensors from which such parameters can be derived can be used. Additionally or alternatively, the sensors 53A - 53D can be one or more physiological sensors for sensing patient physiological parameters such as heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, partial pressure of CO2 in the blood. Alternatively or additionally, sensors from which these parameters can be derived can be used. Other patient sensors can include EEG sensors, torso bands for detecting respiration, and any other suitable sensors. In some configurations, the humidifier can be optional or can be preferred since humidified gas helps maintain airway conditions. One or more sensors can form part of the device or be located external to the device, and the device has an input for any external sensors. The sensors can be coupled to the controller 19 or send an output to the controller 19.

[0213] A sensor 14 can be provided for measuring the oxygen fraction in the air inhaled by the patient. This can be placed on the patient interface 51, for example, to measure or otherwise determine the oxygen fraction near (at / adjacent to / close to) the patient's mouth and / or nose. The output from the sensor 14 is sent to the controller 19 to assist in the control of the respiratory assistance device to determine if peak inspiratory demands are met and to change the operation accordingly. The controller 19 is coupled to the gas flow source 50, the humidifier 52, and the sensor 14. It controls these and other aspects of the device or system described below. The controller can operate the gas flow source to provide the output gas flow at a desired flow rate high enough to meet peak inspiratory demands. In an alternative, the sensor 14 can communicate the measured value of the oxygen fraction at the patient's mouth and / or nose to the user, and then the user inputs the information into the respiratory device / controller. Where appropriate, any disclosure / embodiment herein can be understood to have this alternative.

[0214] An optional check valve 23 can be disposed in the breathing conduit 16. A filter can be disposed at the air inlet 50C and / or at the inlet of the gas flow generator 50B to filter the incoming gas before it is pressurized by the gas flow generator 50B into the high - flow gas 31.

[0215] The respiratory assistance device 10 can be an integrated or separate component arrangement, generally as Figure 1As shown by the dashed box 100 therein. In some configurations, the device or system can be a modular arrangement of components. Additionally, the device or system can include only some of the components shown and not necessarily all of them. Further, the conduit and the patient interface do not have to be part of the system and can be considered separate. Hereinafter, it will be referred to as a respiratory assistance device or a respiratory system, but this should not be considered restrictive. The respiratory assistance device and the respiratory system will be broadly considered herein to include anything that provides a gas flow to a patient. Some such devices and systems include a detection system that can be used to determine whether the gas flow meets the inspiratory demand.

[0216] The respiratory assistance device 10 can include a device main housing 100. The device main housing 100 can accommodate an air flow generator 50B in the form of a motor / impeller arrangement, an optional humidifier 52, a controller 19, and an input / output (I / O) user interface 54. The user interface 54 can include a display and input devices (such as buttons, a touch screen (such as an LCD screen), a combination of a touch screen and buttons, etc.). The controller 19 can include one or more hardware processors and / or software processors, which can be configured or programmed to control the components of the system, including but not limited to operating the air flow generator 50B to create an air flow for output to the patient, operating the humidifier 52 to humidify and / or heat the air flow, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory assistance device 10, and outputting information to the user (such as on the display). The user can be a patient, a medical professional, or others.

[0217] Continuing to refer to Figure 1 , the patient breathing conduit 16 can be coupled to an air flow outlet (gas outlet or patient outlet port) 21 in the device main housing 100 of the respiratory assistance device 10 and can be coupled to a patient interface 17 (such as a non-sealed interface, such as a nasal cannula with a manifold and / or nasal prongs). The patient breathing conduit 16 can also be a tracheostomy interface or other non-sealed interface.

[0218] The air flow can be generated by the air flow generator 50B and can be humidified before being output to the patient through the patient breathing conduit 16. The controller 19 can control the air flow generator 50B to generate an air flow of a desired flow rate, and / or can control one or more valves to control the mixing of air and oxygen or other breathable gases. The controller 19 can control a heating element in or associated with the humidification chamber 12 to heat the gas to a desired temperature, to reach a desired temperature and / or humidity level for output to the patient. The patient breathing conduit 16 can have a heating element, such as a heating wire, to heat the air flow to the patient passing therethrough. The heating element can also be under the control of the controller 19.

[0219] The humidifier 52 of the device is configured to combine humidity with the air flow or introduce it into the air flow. Various configurations of the humidifier 52 can be adopted. In one configuration, the humidifier 52 can include a detachable humidification chamber. For example, the humidification chamber can be partially or completely detached or disconnected from the flow path and / or the device. As an example, the humidification chamber can be detached for, e.g., refilling, cleaning, replacement, and / or repair. In one configuration, the humidification chamber can be received and held in or can be received and held within the humidification compartment or bay of the device, or can be otherwise coupled to or within the device housing.

[0220] The humidification chamber of the humidifier 52 can include a gas inlet and a gas outlet to be able to connect to the gas flow path of the device. For example, the air flow from the air flow generator 50B is received into the humidification chamber via the gas inlet after being heated and / or humidified and exits the humidification chamber via the gas outlet.

[0221] The humidification chamber houses a certain volume of liquid, typically water or the like. In operation, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the humidification chamber to generate water vapor or steam to increase the humidity of the gas flowing through the humidification chamber.

[0222] In one configuration, the humidifier is a Passover humidifier. In another configuration, the humidifier can be a non-Passover humidifier.

[0223] In one configuration, the humidifier can include a heating plate, e.g., associated with or located within the humidification bay, and the humidification chamber is placed on the heating plate for heating. The humidification chamber can be provided with a heat transfer surface, such as a metal insert, plate, or the like, in the bottom surface or other surface of the humidification chamber that interfaces or engages with the heating plate of the humidifier.

[0224] In another configuration, the humidification chamber can include an internal heater or heater element inside or within the humidification chamber. The internal heater or heater element can be integrally mounted or provided inside the humidification chamber, or can be detached from the humidification chamber.

[0225] The humidification chamber can be of any suitable shape and / or size. The position, number, size, and / or shape of the gas inlet and gas outlet of the humidification chamber can be changed as needed. In one configuration, the humidification chamber can have a bottom surface, one or more side walls extending upward from the bottom surface, and an upper surface or top surface. In one configuration, the gas inlet and gas outlet can be located on the same side of the humidification chamber. In another configuration, the gas inlet and gas outlet can be on different surfaces of the humidification chamber, e.g., on opposite sides or positions, or at other different positions.

[0226] In some configurations, the gas inlet and the gas outlet may have parallel flow axes. In some configurations, the gas inlet and the gas outlet may be at the same height on the humidification chamber.

[0227] System 10 may use ultrasonic transducers, flow sensors (such as thermistor flow sensors), pressure sensors, temperature sensors, humidity sensors, or other sensors that communicate with controller 19 to monitor characteristics of the airflow and / or to operate system 10 in a manner that provides appropriate treatment. Airflow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, and the like. Sensors 53A, 53B, 53C, 53D, 14, such as pressure sensors, temperature sensors, humidity sensors, and / or flow sensors, may be placed at different locations in device main housing 100, patient conduit 16, and / or patient interface 51. Controller 19 may receive outputs from the sensors to assist in operating respiratory assistance device 10 in a manner that provides a suitable treatment, such as determining suitable target temperatures, flow rates, and / or pressures of the airflow. Providing a suitable treatment may include meeting the patient's inspiratory needs. In the illustrated embodiment, sensors 53A, 53B, and 53C are located in the device housing, sensor 53D is located in patient conduit 16, and sensor 14 is located in patient interface 51.

[0228] Device 10 may include one or more communication modules to 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, device 10 may include a wireless data transmitter and / or receiver, or transceiver 15, to enable controller 19 to receive data signals from operating sensors and / or control various components of system 10 wirelessly. Transceiver 15 or the data transmitter and / or receiver module may have antenna 15a as shown. In one example, 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 system 10. System 10 may include a wired connection, e.g., using a cable or wire, to enable controller 19 to receive data signals from operating sensors and / or control various components of device 10. Device 10 may include one or more wireless communication modules. For example, the device may include a cellular communication module, such as a 3G, 4G, or 5G module. Module 15 may be or may include a modem that enables the device to communicate with a remote server using an appropriate communication network. The communication may be two-way communication between the device and the server or other remote systems. 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 allow the device to wirelessly send information to another device, such as a smartphone or tablet, or operate the device via a LAN (local area network) or wireless LAN (WLAN). The device may additionally or alternatively include a near-field communication (NFC) module to allow data transfer and / or data communication.

[0229] The respiratory assistance device 10 may include a high-flow therapy device. As understood by those skilled in the art, the high-flow therapy discussed herein is intended to be given its typical ordinary meaning, generally referring to a respiratory system that outputs humidified breathing gas at a target flow rate that typically aims to meet or exceed the user's inspiratory flow rate via an intentionally unsealed patient interface. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. The typical flow rate for adults is generally in the range of about 15 liters per minute to about 60 liters per minute or higher, but is not limited thereto. The typical flow rate for pediatric users (e.g., neonates, infants, and children) is generally, but not limited to, in the range of about 1 liter per kilogram of user body weight per minute to about 3 liters per kilogram of user weight per minute or greater.

[0230] The high-flow therapy may also optionally include gas mixture composition, including the administration of supplemental oxygen and / or therapeutic drugs.

[0231] High-flow therapy is commonly referred to by common names such as nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or tracheal high-flow (THF). For example, in some configurations, for adult patients, "high-flow therapy" can refer to delivering gas to a patient at a flow rate greater than or equal to approximately 10 liters per minute (10 LPM), such as between approximately 10 LPM and 100 LPM, or between approximately 15 LPM and 95 LPM, or between approximately 20 LPM and 90 LPM, or between approximately 25 LPM and 85 LPM, or between approximately 30 LPM and 80 LPM, or between approximately 35 LPM and 75 LPM, or between approximately 40 LPM and 70 LPM, or between approximately 45 LPM and 65 LPM, or between approximately 50 LPM and 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, "high-flow therapy" can refer to delivering gas to a patient at a flow rate greater than 1 LPM, such as between approximately 1 LPM and 25 LPM, or between approximately 2 LPM and 25 LPM, or between approximately 2 LPM and 5 LPM, or between approximately 5 LPM and 25 LPM, or between approximately 5 LPM and 10 LPM, or between approximately 10 LPM and 25 LPM, or between approximately 10 LPM and 20 LPM, or between approximately 10 LPM and 15 LPM, or between approximately 20 LPM and 25 LPM. High-flow therapy devices for adult patients, neonates, infants, or pediatric patients can deliver gas to a patient at a flow rate between approximately 1 LPM and approximately 100 LPM or at a flow rate within any of the above sub-ranges.

[0232] High-flow therapy can effectively meet or exceed a patient's inspiratory demand, increase a patient's oxygenation, and / or reduce the work of breathing. In addition, high-flow therapy can create a flushing effect in the nasopharynx such that the anatomic dead space of the upper airway is flushed by the high-flow incoming gas stream. The flushing effect can create a reservoir of fresh gas available for each breath while minimizing rebreathing of carbon dioxide, nitrogen, etc. High-flow therapy can also increase a patient's expiratory time due to the pressure during exhalation. This reduces the patient's respiratory rate.

[0233] The patient interface for high-flow therapy can be a non-sealing interface to prevent barotrauma, which can include tissue damage to the lungs or other organs of the patient's respiratory system due to a pressure differential relative to the atmosphere. The patient interface can be a nasal cannula with a manifold and nasal prongs, and / or a non-sealing tracheostomy interface, or any other suitable type of patient interface.

[0234] 2.2 Mechanical and Electrical Aspects

[0235] Figures 2 to 18Shows an exemplary respiratory assistance device 10 having a main housing 100. The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 202. The main housing upper chassis 102 has a peripheral wall arrangement 106 (see Figure 15 ). The peripheral wall arrangement defines a humidifier compartment or humidification chamber compartment 108 for receiving a detachable humidification chamber 300. The detachable humidification chamber 300 houses a suitable liquid, such as water, for humidifying the gas that can be output to the patient.

[0236] In the form shown, the peripheral wall arrangement 106 of the main housing upper chassis 102 may include a substantially vertical left outer wall 110 oriented in the front-rear direction of the main housing 100, a substantially vertical left inner wall 112 oriented in the front-rear direction of the main housing 100, and an interconnecting wall 114 extending between and interconnecting the upper ends of the left inner wall 110 and the left outer wall 112. The main housing upper chassis 102 may also include a substantially vertical right outer wall 116 oriented in the front-rear direction of the main housing 100, a substantially vertical right inner wall 118 oriented in the front-rear direction of the main housing 100, and an interconnecting wall 120 extending between and interconnecting the upper ends of the right inner wall 116 and the right outer wall 118. The interconnecting walls 114, 120 are inclined towards the respective outer edges of the main housing 100, but may alternatively be substantially horizontal or inclined inwards.

[0237] The main housing upper chassis 102 may also include a substantially vertical rear outer wall 122. The upper part of the main housing upper chassis 102 may include a forwardly inclined surface 124. The surface 124 may have a recess 126 for receiving a display and a user interface module 54. The display may be configured to display the characteristics of the sensed gas in real time. The system may display the patient detection status of the patient interface. If no patient is detected, the controller may not output or may stop outputting the respiratory frequency value and / or other parameters for display. The controller may also optionally output a message to display at box 2708 that no patient is detected. An example of the message may be a "--" icon. An interconnecting wall 128 may extend between and interconnect the upper end of the rear outer wall 122 and the rear edge of the surface 124.

[0238] A substantially vertical wall portion 130 may extend downward from the front end of the surface 124. A substantially horizontal wall portion 132 may extend forward from the lower end of the wall portion 130 to form a flange. A substantially vertical wall portion 134 may extend downward from the front end of the wall portion 132 and terminate at a substantially horizontal bottom plate portion 136 of the humidification chamber compartment 108. The left inner wall 112, the right inner wall 118, the wall portion 134, and the bottom plate portion 136 together may define the humidification chamber compartment 108. The bottom plate portion 136 of the humidification chamber compartment 108 may have a recess 138 to receive a heater arrangement, such as a heating plate 140 or other suitable heating element for heating the liquid in the humidification chamber 300 for use during the humidification process.

[0239] The lower chassis 202 of the main housing can be attached to the upper chassis 102 by suitable fasteners or integral attachment features such as clips. The lower chassis 202 of the main housing can include: a generally vertical left outer wall 210, oriented in the front - to - rear direction of the main housing 100 and adjacent to the left outer wall 110 of the upper chassis 102; and a generally vertical right outer wall 216, oriented in the front - to - rear direction of the main housing 100 and adjacent to the right outer wall 116 of the upper chassis 102. The lower chassis 202 of the main housing can also include a generally vertical rear outer wall 222, which is adjacent to the rear outer wall 122 of the upper chassis 202.

[0240] The lower housing chassis 202 can have a lip 242, which is adjacent to the lip 142 of the upper housing chassis 102 and also forms part of a recess for receiving the handle portion 506 of the joystick 500. The lower lip 242 can include a forward - oriented projection 243, which serves as a retaining portion for retaining the handle portion 506 of the joystick 500. Instead of the joystick 500, the system can have a spring - loaded guard to hold the humidification chamber 300 in the humidification chamber compartment 108.

[0241] The lower side of the lower housing chassis 202 can include a bottom wall 230. Each of the interconnecting walls 214, 220, 228 can extend between and interconnect the generally vertical walls 210, 216, 222 and the bottom wall 230. The bottom wall 230 can include a grille 232, which includes a plurality of holes to enable drainage of liquid in the event of leakage (e.g., due to overflow) from the humidification chamber 300. The bottom wall 230 can also include an elongated front - to - rear - oriented slit 234. The slit 234 can also enable drainage of liquid in the event of leakage from the humidification chamber 300, such that the liquid does not enter the electronic device housing. In the illustrated configuration, the slit 234 can be wide and elongated relative to the holes of the grille 232 to maximize liquid drainage.

[0242] As Figures 17 to 18 shown, the lower chassis 202 can have a motor recess 250 for receiving a motor and a sensor module. The motor and sensor module can be non - detachable from the main housing 100. The motor and sensor assembly can be detachable from the main housing 100, as Figures 17 - 18As shown, a recess opening 251 may be provided near the trailing edge of the bottom wall 230 for receiving the motor / sensor module. A continuous, airtight, and unbroken peripheral wall 252 may be integrally formed with the bottom wall 230 of the lower chassis 202 and extend upward from the periphery of the opening 251. The rear portion 254 of the peripheral wall 252 has a first height, and the front portion 256 of the peripheral wall 252 has a second height greater than the first height. The rear portion 254 of the peripheral wall 252 terminates at a substantially horizontal step 258, and the step 258 terminates at the upper auxiliary rear portion 260 of the peripheral wall 252. The front portion 256 and the upper auxiliary rear portion 260 of the peripheral wall 252 terminate at the top plate 262. Except for the air flow channel, all the walls and the top plate 262 may be continuous, airtight, and unbroken. Thus, except for the air flow channel, the entire motor recess 250 may be airtight and unbroken.

[0243] The motor and sensor module may be inserted into the recess 250 and attached to the lower chassis 202. When the motor and sensor assembly is inserted into the lower chassis 202, the air flow channel tube 264 may extend through the downward extending tube 133 and be sealed by a soft seal.

[0244] The humidification chamber 300 may be fluidly coupled to the device 10 in such a way that it can linearly slide in a backward direction of the humidification chamber 300 from a position in the front part of the housing 100 towards the rear part of the housing 100 into the humidification chamber compartment 108. The gas outlet port 322 may be in fluid communication with the motor.

[0245] As Figure 8 shown, the gas inlet port 340 (humidified gas return) may include a detachable L-shaped elbow. The detachable elbow may also include a patient outlet port 344 for connection to the patient conduit 16 to output gas to the patient interface. Each of the gas outlet port 322, the gas inlet port 340, and the patient outlet port 344 may have a soft seal, such as an O-ring seal or a T-ring seal, to provide a sealed gas passage between the device 10, the humidification chamber 300, and the patient conduit 16.

[0246] The humidification chamber gas inlet port 306 may be complementary to the gas outlet port 322, and the humidification chamber gas outlet port 308 may be complementary to the gas inlet port 340. The axes of these ports may be parallel to each other so that the humidification chamber 300 can be inserted into the humidification chamber compartment 108 in a linear motion manner.

[0247] The respiratory assistance device may have an air and oxygen (or alternative auxiliary gas) inlet in fluid communication with the motor so that the motor can output air, oxygen (or alternative auxiliary gas), or a mixture thereof to the humidification chamber 300 and thus to the patient. As Figure 10As shown, the device may have a combined air / oxygen (or alternative auxiliary gas) inlet arrangement 350. The inlet arrangement may include a combined air / oxygen port 352 entering the housing 100, a filter 354, and a cover 356 having a hinge 358. The gas tube may also optionally extend laterally or in other suitable directions and may be in fluid communication with an oxygen (or alternative auxiliary gas) source. The port 352 may be in fluid connection with the motor 402. For example, the port 352 may be connected to the motor / sensor module 400 via an air flow channel between the port 352 and the inlet hole or inlet port in the motor and sensor module 400, and this air flow channel will lead to the motor.

[0248] The device may have Figures 11 to 14 the arrangement shown so that the blower can output air, oxygen (or alternative auxiliary gas), or a suitable mixture thereof to the humidification chamber 300 and thus to the patient. Such an arrangement may include an air inlet 356' in the rear wall 222 of the lower chassis 202 of the housing 100. The air inlet 356' includes a rigid plate with a grille arrangement having appropriate holes and / or slits. Sound-absorbing foam may be provided adjacent to the plate on the inner side of the plate. An air filtration box 354' may be located inside the main housing 100 near the air inlet 356' and includes an air outlet port 360 to output the filtered air to the motor via the air inlet port 404 in the motor / sensor module 400. The air filtration box 354' may include a filter configured to remove particles (such as dust) and / or pathogens (such as viruses or bacteria) from the air flow. A soft seal such as an O-ring seal may be provided between the air outlet port 360 and the air inlet port 404 to seal between the components. The device may include a separate oxygen inlet port 358' located adjacent to one side of the rear end of the housing 100, and the oxygen port 358' is used to receive oxygen from an oxygen source (such as an oxygen cylinder or a pipeline oxygen source). The oxygen inlet port 358' is in fluid communication with a valve 362. The valve 362 may suitably be an electromagnetic valve capable of controlling the amount of oxygen added to the air flow output to the humidification chamber 300. The oxygen port 358' and the valve 362 may be used with other auxiliary gases to control the addition of other auxiliary gases to the air flow. The other auxiliary gases may include any one or more of a variety of gases for gas therapy, including but not limited to heliox and nitric oxide.

[0249] As Figures 13 to 16As shown, the lower housing chassis 202 may include one or more suitable electronic boards, such as a sensing circuit board. The electronic boards may be positioned near the respective outer sidewalls 210, 216 of the lower housing chassis 202. The electronic boards may contain suitable electrical or electronic components or may be in electrical communication therewith, such as but not limited to microprocessors, capacitors, resistors, diodes, operational amplifiers, comparators, and switches. Sensors may be used with the electronic boards. Components of the electronic boards (such as but not limited to one or more microprocessors) may act as the controller 19 of the device.

[0250] One or more electronic boards may be in electrical communication with the electrical components of the device 10, including the display unit and user interface 54, the motor, the valve 362, and the heating plate 140, to operate the motor to provide a desired gas flow rate, operate the humidification chamber 300 to humidify and heat the gas flow to an appropriate level, and supply an appropriate amount of oxygen (or an appropriate amount of an alternative assist gas) to the gas flow.

[0251] The electronic boards may be in electrical communication with the connector means 274 that projects from the rear wall 122 of the upper housing chassis 102. The connector means 274 may be coupled to an alarm, a pulse oximeter port, and / or other suitable accessories. The electronic boards may also be in electrical communication with the electrical connector 276, which may also be provided in the rear wall 122 of the upper housing chassis 102 to supply mains power or battery power to the various components of the device.

[0252] As described above, operating sensors, such as flow sensors, temperature sensors, humidity sensors, and / or pressure sensors, may be placed at different locations in the respiratory assist device, the patient breathing conduit 16, and / or the endotracheal tube 51, such as as Figure 1 shown. The electronic boards may be in electrical communication with these sensors. The controller 19 may receive the outputs from the sensors to assist the controller 19 in operating the respiratory assist device 10 in a manner that provides optimal treatment, such as including meeting the inspiratory demand. In the illustrated embodiment, the sensors are positioned on the electronic boards located within the housing. The sensors are encapsulated within the housing.

[0253] As described above, the electronic boards and other electrical and electronic components may be pneumatically isolated from the gas flow path to enhance safety. The seal may also prevent water ingress.

[0254] 2.3 Control System

[0255] Figure 19A An example control system 920 is shown, which may be Figure 1Block diagram 900 of the controller 19) in which the control system can detect a patient's condition and control the operation of a respiratory system including a gas source. The control system 920 can manage the flow of gas through the respiratory system, and thus manage the flow of gas output to the patient. For example, the control system 920 can increase or decrease the flow by controlling the speed output 930 of the motor of the blower (hereinafter also referred to as the "blower motor") or the output 932 of the valve in the mixer. The control system 920 can automatically determine a setpoint or personalized value for the flow for a particular patient, as will be discussed below. The flow can be optimized by the control system 920 to improve patient comfort and treatment.

[0256] The control system 920 can also generate audio and / or display / visual outputs 938, 939. For example, the respiratory assistance device can include a display and / or a speaker. The display can indicate to the doctor any warnings or alarms generated by the control system 920. The display can also indicate control parameters that can be adjusted by the doctor. For example, the control system 920 can automatically recommend a flow for a particular patient. The control system 920 can also determine the respiratory state of the patient, including but not limited to generating the patient's respiratory rate and sending it to the display, which will be described in more detail below.

[0257] The control system 920 can change the heater control output to control one or more heating elements (e.g., to maintain a temperature setpoint of the gas output to the patient). The control system 920 can also change the duty cycle or duty ratio of the heating element. The heater control output can include a heating plate control output 934 and a heated breathing tube control output 936.

[0258] The control system 920 can determine the outputs 930 - 939 based on one or more received inputs 901 - 916. The inputs 901 - 916 can correspond to sensor measurements automatically received by the controller 600 (as Figure 19B shown). The control system 920 can receive sensor inputs including but not limited to a temperature sensor input 901, a flow sensor input 902, a motor speed input 903, a pressure sensor input 904, a gas fraction sensor input 905, a humidity sensor input 906, a pulse oximeter (e.g., SpO2) sensor input 907, stored parameters or user parameters 908, a duty cycle or pulse width modulation (PWM) input 909, a voltage input 910, a current input 911, an acoustic sensor input 912, a power input 913, a resistance input 914, a CO2 sensor input 915, and / or a spirometer input 916. The control system 920 can receive from the memory 624 (as Figure 19BThe input of user parameter values or stored parameter values as shown). The control system 920 can dynamically adjust the flow rate for the patient during patient treatment. The control system 920 can continuously detect system parameters and patient parameters. Based on the disclosure herein, one of ordinary skill in the art will understand that any other suitable inputs and / or outputs can be used with the control system 920.

[0259] Pressure sensor

[0260] In one configuration, the device can have one or more pressure sensors. One or more pressure sensors can be provided to sense or measure the pressure characteristics of the airflow in the flow path of the device and generate corresponding pressure variables, such as pressure sensor signals or data. The pressure sensor can include any type of suitable pressure sensor, including but not limited to a gauge pressure sensor and / or an absolute pressure sensor.

[0261] The gauge pressure sensor can be configured to sense the gauge pressure of the airflow and generate a representative gauge pressure variable, such as a gauge pressure signal or pressure data. The gauge pressure can represent the airflow pressure in the flow path relative to or with reference to atmospheric pressure. For example, the gauge pressure can represent the difference between the absolute pressure within the flow path and the absolute pressure within the housing (i.e., atmospheric or ambient pressure).

[0262] The absolute pressure sensor can be configured to sense the absolute pressure of the airflow and generate a representative absolute pressure variable, such as an absolute pressure signal or pressure data. The absolute pressure can represent the pressure of the airflow in the flow path relative to or with reference to a vacuum.

[0263] As will be understood by those skilled in the art, one or more pressure sensors configured to sense or measure the pressure characteristics of the airflow can be located directly in or at least partially immersed in the main flow path or body flow path of the airflow (e.g., the sensor can be part of a sensor channel or sensor chamber that constitutes the main flow path or body flow path, or be exposed to a sensor channel or sensor chamber that constitutes the main flow path or body flow path), or be located directly in or at least partially immersed in a second or sample flow path that is operatively or fluidly connected to the main flow path or body flow path, or otherwise be operatively or fluidly coupled or connected to the airflow in the flow path.

[0264] A pressure sensor for sensing the pressure characteristics of an air flow can be independently installed within the housing of the device and electrically connected or otherwise data-communicated with a controller or control system, or can be installed or coupled to a sensor circuit board or other circuit board associated with the air flow path. In one configuration, the pressure sensor can be positioned or configured to sense the air flow pressure at a location along the flow path upstream of, e.g., before, the humidifier chamber or humidifying chamber. In another configuration, the pressure sensor can be positioned or configured to sense the air flow pressure at a location along the flow path between the air flow generator (e.g., blower) and the humidifier chamber, e.g., 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).

[0265] One or more pressure sensors can also be provided to sense other pressures associated with the device, such as the ambient environment in which the device is located. In one configuration, the device can be provided with an ambient pressure sensor configured to sense or measure the ambient pressure or atmospheric pressure of the local ambient environment in which the device is located and generate a representative ambient pressure variable, such as an ambient pressure signal or pressure data. In one configuration, the ambient pressure sensor can be an absolute pressure located or positioned on or within the housing and configured to sense the ambient pressure or atmospheric pressure of the environment in which the device is located.

[0266] In one configuration, the device can be provided with a gauge pressure signaler that generates a gauge pressure signal or data representative of the gauge pressure associated with the air flow in the flow path.

[0267] In another configuration, the device can be provided with a gauge pressure sensor and an ambient pressure sensor, the gauge pressure sensor configured to generate a gauge pressure signal or data representative of the gauge pressure associated with the air flow, and the ambient pressure sensor configured to generate an ambient pressure signal or data. In this configuration, the device can be configured to utilize the ambient pressure data as an input to a calibration algorithm, factor, or function applied to sense the gauge pressure signal or data. For example, the calibration algorithm, factor, or function can be configured to calibrate the sensed gauge pressure signal or data to account for the effect of varying air density on the sensed gauge pressure signal or data.

[0268] 2.4 Controller

[0269] Figure 19B The controller 600 is shown and can be Figure 1Block diagram of an embodiment of the controller 19). The controller 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, procedures, 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 any other suitable programming language. Some or all of the programming instructions may be implemented in a dedicated circuit 628 such as an ASIC and an FPGA.

[0270] The controller 600 may also include a circuit 628 for receiving sensor signals. The controller 600 may also include a display 630 for sending the status of the patient and the respiratory assistance system. The display 630 may also display warnings and / or other alerts. The display 630 may be configured to display the sensed gas characteristics in real time or otherwise. The controller 600 may also receive user input via a user interface such as the display 630. The user interface may include buttons and / or dials. The user interface may include a touch screen.

[0271] 2.5 Motor and Sensor Module

[0272] Any feature of the respiratory system described herein, including but not limited to the humidification chamber, the airflow generator, the user interface, the controller, and the patient breathing conduit configured to couple the airflow outlet of the respiratory system to the patient interface, may be combined with any sensor module described herein.

[0273] Figure 20 A block diagram of the motor and sensor module 2000 is shown. The motor and sensor module may be received by a recess 250 in a respiratory assistance device, such as Figure 17 and Figure 18 shown. The motor and sensor module may include a blower 2001 that transports room air for output to the patient. The blower 2001 may be a centrifugal blower.

[0274] One or more sensors (e.g., Hall effect sensors) may be used to measure the motor speed of the blower motor. The blower motor may include a brushless DC motor, and the motor speed may be measured from the brushless DC motor without using a separate sensor. For example, during the operation of the brushless DC motor, the back EMF may be measured from the unpowered windings of the motor, from which the motor position may be determined, and then the motor position may be used to calculate the motor speed. In addition, a motor driver may be used to measure the motor current, and the motor current may be used together with the measured motor speed to calculate the motor torque. The blower motor may include a low inertia motor.

[0275] Indoor air can enter the indoor air inlet 2002, and the indoor air inlet enters the blower 2001 through the inlet port 2003. The inlet port 2003 may include a valve 2004, and pressurized gas can enter the blower 2001 through the valve 2004. The valve 2004 can control the oxygen flow entering the blower 2001. The valve 2004 can be any type of valve, including a proportional valve or a two-way valve. In some embodiments, the inlet port does not include a valve.

[0276] The blower 2001 can operate at a motor speed greater than 1000 RPM and less than 30000 RPM, greater than 2000 RPM and less than 21000 RPM, or between any of the foregoing values. The operation of the blower 2001 mixes the gas entering the blower 2001 through the inlet port 2003. Using the blower 2001 as a mixer can reduce the pressure drop that would occur in a system with a separate mixer (such as a static mixer including baffles) because mixing requires energy.

[0277] The mixed air can leave the blower 2001 through the conduit 2005 and enter the flow path 2006 in the sensor chamber 2007. A sensing circuit board with sensors 2008 can be positioned within the sensor chamber 2007 such that the sensing circuit board is at least partially immersed in the air flow. At least some of the sensors 2008 on the sensing circuit board can be positioned within the air flow to measure the gas properties within the air flow. After passing through the flow path 2006 in the sensor chamber 2007, the gas can leave 2009 and reach the humidification chamber.

[0278] Positioning the sensors 2008 downstream of the combined blower and mixer 2001 can improve the measurement accuracy relative to systems that position the sensors upstream of the blower and / or mixer, such as measuring the fractional concentration of a gas, including the oxygen concentration. Such positioning can achieve a repeatable flow pattern. In addition, positioning the sensors downstream of the combined blower and mixer avoids the pressure drop that would occur when sensing is performed before the blower and a separate mixer (such as a static mixer with baffles) is required between the inlet and the sensing system. The mixer introduces a pressure drop across the mixer. Positioning the sensing after the blower can make the blower a mixer, while a static mixer reduces pressure, whereas a blower increases pressure. In addition, since the sensors being immersed in the air flow means that the sensors are more likely to be in the same conditions as the air flow, such as temperature and pressure, immersing at least a portion of the sensing circuit board and the sensors 2008 in the flow path can improve the measurement accuracy and thus provide a better representation of the air flow characteristics.

[0279] Reference Figure 21 , the gas leaving the blower can enter the flow path 402 in the sensor chamber 400, and the sensor chamber 400 can be located within the motor and the sensor module and can beFigure 20 The sensor chamber 2007. The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape without sharp turns. The flow path 402 can have curved ends with a relatively straight portion therebetween. By partially overlapping the measurement area with the flow path to form a measurement portion of the flow path, the curved flow path shape can reduce the pressure drop in the air flow without reducing the sensitivity of the air flow measurement.

[0280] A sensing circuit board 404 having sensors (such as acoustic transmitters and / or receivers, humidity sensors, temperature sensors, pressure sensors, thermistors, etc.) can be positioned in the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in the flow path 402. Since sensors immersed in the air flow are more likely to be in the same conditions as the air flow, such as temperature and pressure, immersing at least a portion of the sensing circuit board and the sensors in the flow path can improve the measurement accuracy and thus provide a better representation of the air flow characteristics. After passing through the flow path 402 in the sensor chamber 400, the gas can leave and reach the humidification chamber. Alternatively, one or more pressure sensors can be provided on one or more separate circuit boards, and the circuit boards are positioned or arranged such that the pressure sensors can measure or sense pressure characteristics related to the air flow and / or the ambient pressure.

[0281] At least two different types of sensors can be used to measure the air flow rate. The first type of sensor can include a thermistor, and the flow rate can be determined by monitoring the heat transfer between the air flow and the thermistor. When the gas flows around the thermistor, the thermistor flow sensor can keep the thermistor operating at a constant target temperature within the air flow. The sensor can measure the amount of power required to keep the thermistor at the target temperature. The target temperature can be configured to be higher than the air flow temperature, so more power is required to keep the thermistor at the target temperature for a higher flow rate.

[0282] The thermistor flow sensor can also maintain multiple (e.g., two, three, or more) constant temperatures on the thermistor to avoid the difference between the target temperature and the air flow temperature being too small or too large. Multiple different target temperatures can allow the thermistor flow sensor to be accurate over a wide temperature range of the gas. For example, the thermistor circuit can be configured to be able to switch between two different target temperatures such that the air flow temperature always falls within a certain range (e.g., not too close but not too far) relative to one of the two target temperatures. The thermistor circuit can be configured to operate at a first target temperature of about 50°C to about 70°C, or about 66°C. The first target temperature can be associated with a desired air flow temperature range of about 0°C to about 60°C, or about 0°C to about 40°C. The thermistor circuit can be configured to operate at a second target temperature of about 90°C to about 110°C, or about 100°C. The second target temperature can be associated with a desired air flow temperature range of about 20°C to about 100°C, or about 30°C to about 70°C.

[0283] The controller can be configured to adjust the thermistor circuit to change between at least a first and a second target temperature mode by connecting or bypassing resistors within the thermistor circuit. The thermistor circuit can be arranged in a Wheatstone bridge configuration, including a first voltage dividing arm and a second voltage dividing arm. The thermistor can be located on one of the voltage dividing arms. More details of the thermistor flow sensor are described in PCT application publication WO2018 / 052320 filed on September 3, 2017, which is incorporated herein by reference in its entirety.

[0284] A second type of sensor can include an acoustic sensor assembly. Acoustic sensors including an acoustic transmitter and / or receiver can be used to measure the time of flight of an acoustic signal to determine the gas velocity and / or composition for use in a respiratory assistance device. In one ultrasonic sensing (including an ultrasonic transmitter and / or receiver) topology, a driver causes a first sensor such as an ultrasonic transducer to generate an ultrasonic pulse in a first direction. A second sensor such as a second ultrasonic transducer receives the pulse and provides a measurement of the time of flight of the pulse between the first and the second ultrasonic sensors. Using this time of flight measurement, the speed of sound of the air flow between the ultrasonic transducers can be calculated by a processor or controller of the respiratory system. The second sensor can transmit and the first sensor can receive a pulse in a second direction opposite to the first direction to provide a second time of flight measurement, thereby allowing determination of air flow characteristics such as flow or velocity. In another acoustic sensing topology, an acoustic pulse emitted by an acoustic transmitter (e.g., an ultrasonic transducer) can be received by an acoustic receiver (e.g., a microphone). More details of the acoustic flow sensor are described in PCT application publication WO2017 / 095241 filed on December 2, 2016, which is incorporated herein by reference in its entirety.

[0285] Readings from a first type of sensor and a second type of sensor can be combined to determine a more accurate airflow measurement. For example, a predicted current flow can be determined using a previously determined flow rate and one or more outputs from a sensor of one of the two types. Then, one or more outputs from the other of the first type and the second type of sensor can be used to update the predicted current flow rate in order to calculate a final flow rate.

[0286] 3. Exemplary Measurement Device Embodiments

[0287] Exemplary embodiments of a measurement device for performing lung performance or lung function measurements and / or diagnoses will be described in the context of the exemplary respiratory assistance device 10 described above, which is configured or operable as an airflow treatment device to provide nasal high flow therapy via a non-sealed patient interface. However, as previously explained, the measurement device can similarly be used with any form or type of respiratory assistance device having a controllable airflow generator and one or more sensors for sensing airflow characteristics.

[0288] Reference Figure 22 , an example embodiment of a measurement system 700 for performing lung performance or lung function measurements and / or patient diagnoses and / or patient evaluations is provided. The measurement device 702 is used in combination with the respiratory assistance device 10 to provide the measurement system 700. As shown, in this example, the measurement device 702 is a component or accessory that is releasably or detachably connected or attached to the end of the patient breathing conduit 16. Once the measurement device is connected or attached to the breathing conduit 16, the respiratory assistance device can be operated in a device or patient diagnostic mode, whereby one or more lung function measurements or evaluations can be performed on the patient. Example embodiments of the configuration of the measurement device, the device or patient diagnostic mode, and the process of using the measurement device in combination with the respiratory assistance device will be described in further detail below.

[0289] In an exemplary configuration, a measurement device is configured to be attached or connected or otherwise fluidly coupled to an air flow or flow path generated by a respiratory assistance device including an air flow generator. The respiratory assistance device includes one or more sensors that measure or sense air flow characteristics. The respiratory assistance device may operate in a mode of outputting an air flow to the measurement device at a controlled flow rate to provide a desired pneumatic resistance. Then, when a user performs one or more exhalation actions into a mouthpiece of the measurement device, lung performance measurements may be performed based on recording and processing sensor data from one or more sensors of the device. In this configuration, when used with a measurement device attachment, the respiratory assistance device may be used or operate as a diagnostic or measurement system. In this example configuration, the measurement device is not necessarily required to have any sensors or electronics because the measurement data is obtained from one or more sensors of the respiratory assistance device and / or the breathing conduit. This configuration enables the measurement device attachment to utilize the existing sensors and sensing capabilities of the respiratory assistance device, which will be further explained below. This configuration allows for the manufacture of a low-cost measurement device attachment that is primarily mechanical components and can be used with a respiratory assistance device to utilize one or more existing sensors of the respiratory assistance device to perform lung performance measurements, i.e., the measurement device does not need to have its own sensors or sensing capabilities. Additionally, this configuration enables the measurement device to utilize the pneumatic resistance provided by the air flow generated by the air flow generator.

[0290] In the embodiment described below, a measurement system 700 employs a measurement device 702 attached to a flow path of a respiratory assistance device 10 and utilizes the existing flow path sensors of the respiratory assistance device to measure or sense one or more characteristics of the air flow during a diagnostic mode when a user performs a forced exhalation lung action into the measurement device. For example, the sensors may include sensors for sensing any one or more of the following air flow characteristics: flow rate, pressure, temperature, humidity, gas concentration, or any other characteristic useful in lung performance assessment. The sensor data obtained from the sensors during the diagnostic mode may be processed and / or analyzed to generate one or more lung performance measurements, metrics, and / or evaluations. In this embodiment, the sensors are located external to the measurement device 702 and are typically located in the main housing 100 of the respiratory assistance device and / or along the patient breathing conduit 16.

[0291] 3.1. First Example Embodiment - Mechanical Construction of the Measurement Device

[0292] Reference Figures 23 - 32 will be further described in detail the first example embodiment of the measurement device 702. In this embodiment, the measurement device 702 includes a body 704 extending between a first end 706 and a second end 708. The first end 706 of the body is a connector end and the second end 708 is a mouthpiece end.

[0293] In this embodiment, the body 704 is a component in the form of a catheter, tube, or tubular or manifold component. The body has a main cavity extending between a connector end 706 and a nozzle end 708 to allow air flow to flow or be conveyed along the body 704 between the two ends of the body. The main cavity is in the form of a channel, flow path, or internal space extending between the openings at the connector end 706 and the nozzle end 708.

[0294] The body and the main cavity

[0295] Reference Figure 31 , in this embodiment, the body 704 includes a single main cavity, generally denoted as 710. The main cavity 710 is a channel or flow path extending along the length of the body between the open ends 706, 708 of the body. The shape and / or dimensions of the main cavity 710 may be uniform or non-uniform along the length of the body 704. For example, the internal dimensions or inner diameter of the main cavity 710 may be uniform or vary along the length of the body 704. The main cavity 710 is generally defined by the surrounding peripheral wall of the body and / or any internal features within the body.

[0296] In the present embodiment, the inner diameter of at least a portion of the main cavity 710 varies along the length of the body 704. Referring to Figure 31 , the diameter of the central portion (generally denoted as 712) of the main cavity widens from the connector end 706 to the nozzle end 708. For example, the diameter shown at D1 at or near the connector end is smaller than the diameter shown at D2 at or near the nozzle end. As shown, in the present embodiment, the diameter gradually or progressively widens from D1 to D2. In one example, the dimension or diameter D1 may be about 13 mm, while the dimension or diameter D2 may be about 20 mm, but it should be understood that alternative dimensions or diameters may be used depending on the characteristics of the respiratory catheter used for connection and / or other design factors. This configuration may also be described as the diameter or cross-sectional area of a portion of the main cavity 712 tapering or narrowing from the nozzle end 708 towards the connector end 706. In other embodiments, it will be understood that the inner profile, inner cross-sectional area, or inner diameter of the main cavity 710 may vary in alternative arrangements or configurations, including widening, narrowing, or a combination of both along one or more parts or the entire length of the body 704. The change or transition in the diameter or profile of the main cavity 710 may be gradual or progressive, or more abrupt, or have stepped changes.

[0297] In this embodiment, the body 704 is an elongate component. The body 704 is generally hollow and is defined by a catheter wall or peripheral wall extending between the body ends 706, 708. In the present embodiment, the body has a generally circular cross-section along its length, for example Figure 23 , Figure 24 , Figure 29 and Figure 30 shown. In one configuration, as Figures 25 - 28As shown, the outer dimension or outer diameter of the body 704 may be substantially uniform along its length. In an alternative configuration, the outer dimension and outer diameter of the body may vary along its length.

[0298] In this embodiment, the body has a generally cylindrical form factor or shape, and the outer surface is defined by a circular cross-sectional profile or shape along its length. It should be understood that in other embodiments, the body may be provided in alternative shapes or configurations. For example, the cross-sectional profile of the outer surface of the body may be circular, oval, rectangular, square, any shape, or any suitable shape, or a combination of shapes, along the length of the body.

[0299] In this embodiment, the body 704 and the main cavity may be generally defined or aligned along or with respect to a central longitudinal axis. The body and the main cavity are straight and extend in a single axis or dimension. In alternative embodiments, it should be understood that the body and / or the main cavity may have alternative shapes and configurations, such as but not limited to curved, arcuate, elbow configurations, or may have a non-linear profile that does not conform to or align with a single longitudinal axis or dimension. It should be understood that various shapes and configurations of the body may have a main cavity that provides fluid communication between the connector end and the mouthpiece end of the body.

[0300] Connector end

[0301] Reference Figure 22 and Figures 30 - 32 , the connector end 706 of the measuring device 702 will be described in more detail.

[0302] In this embodiment, the connector end 706 is configured to releasably connect or attach to the end of the breathing conduit 16 or breathing tube of the respiratory assistance device 10. It should be understood that the breathing conduit 16 of the respiratory assistance device is typically a flexible conduit that is attached or connected at one end to the gas outlet 21 of the respiratory assistance device to provide fluid connection or fluid communication with the airflow generated by the airflow generator 11 of the device. The other end of the breathing conduit 16 typically provides a connector for releasably connecting or coupling to a patient interface (such as a nasal cannula, nasal mask, full face mask, tracheostomy interface, etc.) to output airflow to the patient's airway, for example, when the respiratory assistance device is used for respiratory therapy (such as high flow therapy, PAP therapy, etc.) in a normal treatment mode. In this embodiment, the connector end 706 of the measuring device 702 is configured or arranged to releasably connect or attach to the connector or end of the breathing conduit such that the measuring device is in fluid communication with the airflow conveyed along the breathing conduit.

[0303] In the present embodiment, the connector end 706 of the measuring device 702 includes a connection structure or arrangement, generally designated as 714, 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 or attaching to the connector end 706 of the measuring device 702 so as to couple the two components together in a releasable manner. In this embodiment, the connection structure 714 may be provided by a pair of opposing resilient clamping protrusions that releasably engage or clamp into corresponding formations or notches or catches or complementary ends or connectors of the breathing conduit 16. It should be understood that the connector end 706 may be configured, arranged, or provided with any suitable form of mechanical releasable fastening or coupling to complement the end or connector of the breathing conduit, including but not limited to threads, rotational locking or coupling, clip fitting, snap-fit connection, push-fit connection, interference fit connection, latch connection, etc.

[0304] In some embodiments, the connector end 706 may be provided with a connection structure suitable for compatibly connecting to the end of one or more specific types of breathing conduits (including branded or manufacturer-specific breathing conduits). For example, in one embodiment, the connector end 706 may be configured to attach or connect to a 20 mm breathing tube used with a high-flow respiratory assistance device. In other embodiments, the connector end 706 may be provided with a universal or all-purpose connection structure or arrangement that is operable or capable of coupling to the ends of a variety of or a wide range of different types of breathing conduits.

[0305] In the illustrated embodiment, the connector end 706 is configured to releasably connect or couple to the end or connector of the breathing conduit 16. This allows the measuring device to be connected to the breathing conduit to perform patient diagnostic measurements in the patient diagnostic mode of the device and then detached after the measurement, such that the breathing conduit can be connected or reconnected to a patient interface for normal respiratory therapy mode.

[0306] In an alternative embodiment, the connector end 706 of the measuring device may be configured to have a non-releasable permanent connection to the breathing tube 16 such that the components cannot be released from each other without breaking. Alternatively, a semi-permanent connection may be provided between the connector end 706 of the measuring device and the breathing conduit 16, such that tools, etc. are required to release the components from each other.

[0307] In a further alternative embodiment, the measuring device 702 may be provided with an integral breathing conduit extending from the connector end 706. In such an embodiment, the measuring device 702 is combined with an integral flexible conduit extending from the connector end. The integral flexible conduit may terminate in a connector end that may be releasably connected or attached to the gas outlet 21 of a respiratory assistance device.

[0308] In another embodiment, the measuring device 702 can be configured to releasably directly connect or attach to the gas outlet 16 of the respiratory assistance device without an intervening breathing conduit. In another embodiment, if the humidifier chamber is detached from the device, the measuring device 702 can be configured to releasably directly connect or attach to the gas flow generator outlet or gas outlet port 322. In another embodiment, the humidifier or humidifier chamber can be bypassed via a bypass conduit or other bypass configuration. For example, the measuring device can be directly or indirectly attached via a breathing conduit to a bypass conduit or port or outlet that bypasses the humidifier or humidifier chamber such that the measuring device is in fluid communication with the gas flow from the gas flow generator outlet and the humidifier is temporarily cut off or bypassed from the flow path.

[0309] Mouthpiece end

[0310] Reference Figure 29 And Figure 31 , the mouthpiece end 708 of the measuring device 702 will be described in more detail.

[0311] In this embodiment, the mouthpiece end 708 is the portion configured to releasably receive and hold an optional detachable mouthpiece, which will be further explained in detail later. In the present embodiment, the mouthpiece end 708 is an open cylindrical portion at the end of the body 704. In the present embodiment, the mouthpiece end 708 has no threads, but can be threaded in other embodiments. However, it should be understood that the mouthpiece end can be any other suitable shape or configuration for receiving and holding a releasable mouthpiece.

[0312] In an alternative embodiment, the measuring device 702 can be used directly without a separate detachable mouthpiece. In such an embodiment, the mouthpiece can be integrally formed with the mouthpiece end 708, or the mouthpiece end 708 itself can be configured as a mouthpiece or used as a mouthpiece that is in fluid communication with the airway of the user or patient when the user's or patient's mouth seals around the mouthpiece during use. It should be understood that the shape and configuration of the mouthpiece portion of the body or the mouthpiece end can be cylindrical, oval, elliptical, mouth-shaped, or any other suitable shape for the user's mouth.

[0313] Exhaust hole

[0314] In this embodiment, the measuring device 702 includes one or more exhaust ports that are in fluid communication with the main chamber. The exhaust ports provide a path for airflow and / or exhaled breath from the user or patient to escape to the atmosphere or the surrounding environment during use of the measuring device. In the absence of one or more exhaust ports, complete blockage of the flow path may occur in certain system configurations when the user places their mouth on the mouthpiece or otherwise forms a seal around the mouthpiece during use. In an alternative embodiment, the measuring device may not have any exhaust holes or ports, and the system configuration may allow for this. For example, exhaust holes, exhaust ports, and / or relief valves may be provided in the flow path upstream of the measuring device.

[0315] Reference Figures 23 - 27 and Figures 29 - 31 , an example of the exhaust port configuration of this embodiment will be described in further detail. In the illustrated embodiment, the measuring device 702 is provided with an exhaust port 716. The exhaust port 716 is located between the connector end 706 and the mouthpiece end 708. In this embodiment, the exhaust port 716 extends or branches out from the body 704 of the measuring device. In this embodiment, the exhaust port is in the form of or includes an exhaust hole. In this embodiment, the exhaust port 716 includes a single exhaust hole. In this embodiment, the exhaust port is a protruding exhaust hole 718 that extends or projects from the wall of the body 704 and terminates at an opening 720. The protruding exhaust hole 718 may be integrally formed with the rest of the body; or it may be formed as a separate component and then joined, molded, or otherwise connected into the body 704.

[0316] Reference Figure 31 , the protruding exhaust hole 718 includes a cavity generally designated as 722. The exhaust cavity 722 is in fluid connection or fluid communication with the main chamber 710 of the body 704. As shown, the auxiliary or exhaust cavity 722 branches from the main chamber 710. In the present embodiment, the exhaust cavity is a channel or flow path formed by the wall of the protruding exhaust hole 718. The protruding exhaust hole 718 may be a duct-type component or part that extends from the body 704. The exhaust cavity 722 is in fluid connection or joined to the main chamber through an opening or port (generally designated as 724) formed in the wall of the body or through the construction of the protruding exhaust hole 718 at a wall region of the body.

[0317] In Figure 31 the illustrated embodiment, the protruding exhaust hole 718 includes a single exhaust cavity 722. In an alternative embodiment, multiple cavities may extend along the length of the protruding exhaust hole 718. For example, an array or network arrangement of multiple cavities may be provided within the protruding exhaust hole.

[0318] In this embodiment, the protruding exhaust hole 718 is a cylindrical member or has a generally circular cross-section along its length between the connection end at the wall of the main body 704 and the termination end at the opening 720. However, it should be understood that in alternative embodiments, the cross-sectional shape or profile can be changed as needed.

[0319] The inner diameter or size of the protruding exhaust hole 718 can be generally similar to the inner diameter or size of the main body, or alternatively can be smaller as shown.

[0320] In this embodiment, the protruding exhaust hole 718 extends from the main body 704 at an angle. Referring to Figure 31 , in this embodiment, the main body 704 of the measuring device 702 is a generally straight member. The main body 704 is defined by or relative to a longitudinal axis BB that extends centrally through the main body. In this embodiment, the protruding exhaust hole 718 can be defined relative to a related longitudinal axis CC that extends through the center. In this embodiment, the protruding exhaust hole 718 extends at an angle 726 as shown, which is the angle between the related longitudinal axes BB and CC of the main body 704 and the protruding exhaust hole 718. In this embodiment, the angle 726 or the angular direction of the protruding exhaust hole 718 can be an acute angle in the direction towards the mouthpiece end 708. In another embodiment, the protruding exhaust hole 718 can be configured to extend at an acute angle towards the connector end 706 of the main body. In another embodiment, the protruding exhaust hole can extend at a perpendicular or normal angle relative to the main body, i.e., the angle 726 can be approximately 90 degrees.

[0321] In this embodiment, the protruding exhaust hole 718 is configured to direct any exhaled gas or exhaust from the measuring device away from the user's face during use. For example, in the illustrated embodiment, the measuring device 702 can be oriented during use such that the protruding exhaust hole 718 extends downward to direct any exhaust, for example, under the user's chin, away from the face, eyes, and / or nose. In an alternative configuration, the protruding exhaust hole 718 can alternatively be oriented or angled towards the connector end to direct any exhaust away from the user's face, regardless of the orientation of the protruding exhaust hole.

[0322] It should be understood that the length, shape, and angle of the protruding exhaust hole relative to the main body of the measuring device can vary in other configurations or alternative embodiments. As shown, the protruding exhaust hole can be generally straight. Alternatively, the protruding exhaust hole can be arcuate, curved, bent, or any other suitable shape. In some embodiments, the protruding exhaust hole can have one or more arcuate or bent portions to redirect the exhaust flow to a desired direction, such as away from the user's face during use.

[0323] In an alternative embodiment, the exhaust port(s) may not protrude from the wall of the body. For example, one or more exhaust ports may be provided that do not protrude from or are flush with the peripheral wall of the body 704. For example, a flush exhaust port may include a hole or vent hole formed directly in the wall of the body 704.

[0324] In summary, the nature of the one or more exhaust ports (whether protruding or non-protruding) may vary, including but not limited to, for example, length, shape, width, area, cross-sectional area, perimeter, diameter, single or multiple cavities.

[0325] In one configuration, the one or more exhaust ports may be a single exhaust hole including a single opening. In another configuration, the one or more exhaust ports may be an exhaust hole including multiple openings. In yet another configuration, the one or more exhaust ports may include an exhaust hole having multiple openings arranged in the form of a honeycomb or mesh structure. It should be understood that various opening and exhaust hole configurations are possible.

[0326] In some configurations, the measuring device 702 may include a mixture of different types of exhaust ports. Some exhaust ports may be protruding exhaust holes, while other exhaust ports may be flush exhaust holes. For example, some exhaust ports may include a single opening, while other exhaust ports may include multiple openings or may include an arrangement of openings or ports or holes forming a mesh or honeycomb exhaust hole arrangement.

[0327] In the illustrated embodiment, a single exhaust port 716 in the form of a protruding exhaust hole 718 is provided on one side surface of the body 704 of the measuring device 702. In other embodiments, any type of multiple exhaust ports may be provided on one or more sides or side surfaces of the body 704. In some embodiments, the exhaust ports may be provided on opposite or opposing sides of the body 704 or on multiple sides of the body. In some embodiments, multiple spaced-apart exhaust ports may be provided in one or more straight lines along the length of the body 704 on one or more sides. In other embodiments, the exhaust ports may surround the circumference of the body 704. For example, the exhaust ports may be in the form of an annular exhaust hole formed around the circumference of the body. The annular exhaust hole may include an arrangement of multiple holes or orifices passing through the wall of the body 704.

[0328] The location of the one or more exhaust ports along the length of the body 704 may vary. In one configuration, the exhaust port may be centrally located or in the middle region of the measuring device. In other configurations, the exhaust port may be located at or near the connector end 706 or the nozzle end 708 of the body. In other configurations, multiple exhaust ports may be spaced along the total or full length of the body 704, whether on the same side surface or on different side surfaces of the body.

[0329] Detachable nozzle

[0330] As discussed, in some embodiments, the nozzle end 708 of the body itself can be a nozzle, or can have an integral nozzle. In this embodiment, the measuring device is provided with a releasable or detachable nozzle that is received or attached onto or into the nozzle end 708 of the body 704.

[0331] Reference Figures 33 - 41 , embodiments of the measuring device 702 with a detachable nozzle 730 will be described in further detail by way of example. The nozzle 730 can be optional in the sense that the nozzle end 708 of the body 704 of the measuring device can function as a nozzle. However, from the viewpoints of usability, manufacturing, and / or hygiene, the detachable nozzle 730 can provide certain advantages in some scenarios or situations.

[0332] In this embodiment, the detachable nozzle 730 is a cylindrical conduit or tubular member having a nozzle portion 732 at one end for the user's mouth and an attachment portion 734 at the other end for releasably connecting or attaching to the nozzle end 708 of the measuring device 702.

[0333] See Figure 35 , in this embodiment, the outer diameter D3 or circumference of the attachment portion 734 of the nozzle 730 is reduced or smaller relative to the diameter D4 or circumference of the nozzle portion 732. In this embodiment, the diameter D4 of the nozzle portion 732 of the nozzle 730 is substantially similar to or the same as the diameter of the body 704 of the measuring device. The reduced diameter D3 of the attachment portion 734 is sized or selected to be complementary to the inner diameter D2 of the nozzle end 708 of the body (see Figure 31 ), such that the attachment portion 734 can be inserted or pushed into the socket or port or opening provided by the nozzle end 708, as shown by the arrow F in Figure 38 . In the present embodiment, the relative dimensions of the outer diameter or circumference of the attachment portion 734 of the nozzle and the inner diameter of the nozzle end 708 of the body 704 of the measuring device can be configured to provide a push fit, friction fit, or interference fit, so that the detachable nozzle can be properly received and held in the measuring device during use. The user can apply sufficient hand force or pulling force in the direction G (see Figure 38 ) to detach or pull out the detachable nozzle 730 from the nozzle end 708 of the measuring device, for example, for replacement, cleaning, repair, and / or disposal.

[0334] Reference Figures 37 - 41 , an assembled and disassembled measuring device 702 with a detachable nozzle 730 is shown by way of example. Figure 38 An exploded view of the measuring device 702 is shown, in which the nozzle 730 is detached or disconnected from the nozzle end 708. Figure 37 And Figures 39 - 41Shows various perspective, elevation, and cross-sectional views of the measuring device 702, where a detachable nozzle is mounted, assembled, or inserted into the nozzle end 706 of the body 704 to be ready for use.

[0335] It will be understood that any other suitable releasable or detachable coupling or connection arrangement or structure for connecting the detachable nozzle 730 to the end of the measuring device 702 can be used in alternative embodiments, including but not limited to snap-fit, threaded, fastening, or clamping systems, etc.

[0336] Referring Figure 36 to the cross-sectional view in, the detachable nozzle in this embodiment includes a single main cavity or passage extending between two ends, denoted by 736. Referring Figure 41 to, the nozzle cavity 736 provides fluid communication with the main cavity (e.g., main cavity 710) of the measuring device body 704, so that the detachable nozzle can deliver an air stream to the user during use. In this embodiment, the inner diameter D5 of the nozzle is uniform along its length. Thus, it is defined that the peripheral wall of the nozzle 730 has a reduced thickness in the attachment region 734 relative to the nozzle portion 732, which results in the outer diameter D3 of the attachment portion 734 being reduced relative to the nozzle portion 732 (as Figure 35 shown).

[0337] In an alternative embodiment, the nozzle may be provided with a plurality of cavities (e.g., flow channels or passages) extending along the length of the nozzle, such as in an array or mesh or honeycomb arrangement.

[0338] In this embodiment, the detachable nozzle 730 is elongated and cylindrical, having a circular cross-sectional shape along its length. However, it should be understood that in other embodiments, the cross-sectional shape may be non-uniform. For example, the shape of the attachment portion 734 may be complementary or adapted to the nozzle end 708 of the measuring device 702, and the nozzle portion 732 may be any other suitable shape or profile for the user to seal their mouth around or over it. For example, the cross-section of the nozzle portion 732 may be circular, oval, ovoid, or any other suitable shape.

[0339] In this embodiment, the detachable nozzle 730 is a generally straight component. However, it should be understood that the nozzle can have any suitable shape, including having one or more arcuate or curved portions, or can be of an overall elbow shape.

[0340] As discussed, in this embodiment, the detachable nozzle 730 is arranged as a releasable component of the measuring device 702. However, in other embodiments, the above-mentioned nozzle can alternatively be integrally formed with or extend from the body 704 of the measuring device 702. It should be understood that any characteristics and aspects of the above-mentioned detachable nozzle can equally apply to an integral or permanent nozzle portion of the body 704.

[0341] 3.2. Second Example Embodiment - Mechanical Structure of the Measuring Device

[0342] Reference Figures 51 - 60 , a second example embodiment of the measuring device 1702 will be described in further detail. The second example embodiment of the measuring device 1702 can be used in a manner similar to the first example embodiment of the measuring device 702. For example, returning to Figure 22 , the measuring device 1702 can be attached or connected to the respiratory assistance device 10 in the same manner as the measuring device 702 to provide a similar measuring system 700. The overall configurations of the exemplary measuring devices 702 and 1702 are similar, but the differences will be highlighted in the following description. It should be understood that the alternatives or variations described with respect to any example embodiment can be applied to both embodiments.

[0343] In this embodiment, the measuring device 1702 includes a body 1704 that extends between a first end 1706 and a second end 1708. The first end 1706 of the body is a connector end, and the second end 1708 is a mouthpiece end.

[0344] In this embodiment, the body 1704 is a component in the form of a conduit, tube, or tubular member or manifold member. The body has a main cavity that extends between the connector end 1706 and the mouthpiece end 1708 to allow air flow to flow or be conveyed along the body 1704 between the two ends. The main cavity is in the form of a channel, flow path, or internal space that extends between the openings at the connector end 1706 and the mouthpiece end 1708.

[0345] The Body and the Main Cavity

[0346] Reference Figure 59 , in this embodiment, the body 1704 includes a single main cavity, generally denoted as 1710. The main cavity 1710 is a channel or flow path that extends along the length of the body 1704 between the open ends 1706, 1708 of the body. The shape and / or size of the main cavity 1710 can be uniform or non-uniform along the length of the body 1704. For example, the internal dimensions or inner diameter of the main cavity 1711 can be uniform or vary along the length of the body 1702. The main cavity 1712 is generally defined by the surrounding circumferential wall of the body and / or any internal features within the body.

[0347] In the present embodiment, the inner diameter of the main cavity 1710 is substantially uniform along at least a portion of the length of the body 1704. Reference Figure 59, the central portion of the main cavity (generally denoted as 1712) between the connector end 1706 and the nozzle end 1708 has a substantially uniform diameter, as shown by D6. In the present embodiment, the inner diameter D7 of the main cavity 1710 at the nozzle end 1708 or in the nozzle end region 1713 near the nozzle end 1718 is wider or larger than the inner diameter D6 in the central region 1712 of the main cavity 1712. In the present exemplary embodiment, the inner diameter D6 of the main cavity in the central region 1712 steps or transitions to a larger diameter D7 in the nozzle end region 1713.

[0348] In one example, the inner dimension or inner diameter D6 in the central region 1712 of the main cavity 1710 may be approximately 22.5 mm, while the inner dimension or inner diameter D7 in the nozzle end region 1713 may be approximately 25 mm. However, it should be understood that alternative dimensions or diameters may be used depending on the characteristics of the breathing conduit used for connection.

[0349] This configuration may also be described as the central portion 1712 of the main cavity 1710 having a substantially uniform cross-sectional area. In other embodiments, it should be understood that the inner profile, inner cross-sectional area, or inner diameter of the main cavity 1710 may vary in alternative arrangements or configurations, including widening, narrowing, or combinations in one or more portions along the entire length of the body 1704. The change or transition in the diameter, profile, or cross-sectional area of the main cavity 1710 may be gradual or progressive, or more abrupt, or have a stepped change.

[0350] In this embodiment, the difference in the inner diameter, inner dimension, or inner cross-sectional area between the central region 1712 and the nozzle end region 1713 is defined by the thickness of the peripheral wall of the body 1704. In this embodiment, the outer dimension or outer diameter of the body 1704 of the measuring device 1712 is substantially uniform along the central region 1712 and the nozzle end region 1713, as shown by the diameter D8. Thus, the thickness of the peripheral wall of the body 1704 in the central region 1712 is greater than the thickness of the peripheral wall of the body in the nozzle end region 1713, thereby creating the above-mentioned inner diameters D6 and D7.

[0351] In this embodiment, the body 1704 is an elongate member. The body 1704 is substantially hollow and is defined by a conduit or peripheral wall extending between the two ends 1706, 1708 of the body. In this embodiment, the body 1704 has a substantially circular cross-section along its length, such as Figure 51 , Figure 52 , Figure 57 and Figure 58 shown.

[0352] In one configuration, the outer dimension or outer diameter of the body 1704 may be substantially uniform along its length. In an alternative configuration, the outer dimension or outer diameter of the body 1704 may vary along its length.

[0353] In this embodiment, the body 1704 includes a first region 1720 and a second region 1721, as Figure 59 shown. The first region 1720 is cylindrical and is defined by the outer diameter or outer dimension shown as D8. The second region 1721 is cylindrical and is defined by the outer diameter or outer dimension indicated by D9. In this example, the first region 1720 extends from the mouthpiece end 1708 and terminates at an intermediate position 1722 near the connector end 1706, and the second region 1721 extends from the intermediate position 1721 to the connector end 1706. In this example, 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.

[0354] In this embodiment, the dimension or diameter D8 of the first region 1720 is greater than the dimension or diameter D9 of the second region 1721. For example, in this embodiment, the diameter or dimension of the connector end region represented by 1721 is smaller 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 steps down or transitions to the second region 1721 of the body having a smaller diameter or dimension D9. In this embodiment, the cylindrical or cylindrical wall defining the first region 1720 steps down or transitions to the cylindrical or cylindrical wall defining the second region 1721 at the intermediate position or shoulder 1722. In this embodiment, the cylindrical or cylindrical wall defining the first region 1720 is longer and has a larger diameter than the cylindrical or cylindrical wall defining the second region 1721. In this embodiment, the size and configuration of the connector end region of the second region 1721 can be configured to complementarily engage or connect with the end of the breathing tube 16 of the breathing assistance device 10 as Figure 22 shown.

[0355] In one example, the outer dimension or outer diameter D8 of the first region 1720 of the body 1704 can be approximately 27.5 mm, and the dimension or diameter D9 of the second region 1721 defining the connector end region can be approximately 20.8 mm. However, it should be understood that alternative sizes or diameters can be used depending on the characteristics of the breathing tube used for connection and / or other design factors.

[0356] In this embodiment, the body 1704 has a generally cylindrical shape factor or shape, and the outer surface is defined by a circular cross-sectional profile or shape along the length. It should be understood that in other embodiments, the body 1704 can be provided in an alternative shape or configuration. For example, the cross-sectional profile of the outer surface of the body can be circular, oval, rectangular, square, any shape, or any suitable shape, or a combination of shapes and dimensions, along the length of the body.

[0357] In this embodiment, the body 1704 and the main chamber 1710 may be generally defined or aligned along a central longitudinal axis or relative to a central longitudinal axis. The body and the main chamber are straight and extend in a single axis or dimension. In alternative embodiments, it should be understood that the body and / or the main chamber may have alternative shapes and configurations, such as but not limited to curvilinear, arcuate, elbow configurations, or may have a non-linear profile that does not conform to or align with a single longitudinal axis or dimension. It should be understood that various shapes and configurations of the body may have a main chamber that provides fluid communication between the connector end and the mouthpiece end of the body.

[0358] Connector end

[0359] Reference Figure 22 and Figures 58 - 60 the connector end 1706 of the measuring device 1702 will be described in more detail.

[0360] In this embodiment, the connector end 1706 is configured to releasably connect or attach to the end of the breathing conduit 16 or breathing tube of the respiratory assistance device 10. It should be understood that the breathing conduit 16 of the respiratory assistance device is typically a flexible conduit that is attached or connected at one end to the gas outlet 21 of the respiratory assistance device to provide fluid connection or fluid communication with the airflow generated by the device's airflow generator 11. The other end of the breathing conduit 16 typically provides a connector for releasably connecting or coupling to a patient interface (such as a nasal cannula, nasal mask, full face mask, tracheostomy interface, etc.) to output airflow to the patient's airway, for example, when the respiratory assistance device is used for respiratory therapy (such as high flow therapy, PAP therapy, etc.) in a normal treatment mode. In this embodiment, the connector end 1706 of the measuring device 1702 is configured or arranged to releasably connect or attach to the connector or end of the breathing conduit such that the measuring device is in fluid communication with the airflow conveyed along the breathing conduit.

[0361] In the present embodiment, the connector end 1706 of the measuring device 1702 includes a connection structure or arrangement, generally designated 1714, which is 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 configuration for engaging or attaching to the connector end 1706 of the measuring device 1702 to couple the two components together in a releasable manner. In this embodiment, the connection structure 1714 may be provided by a pair of opposing resilient clamping protrusions that releasably engage or clamp into corresponding formations or notches or snaps or complementary ends or connectors of the breathing conduit 16. It should be understood that the connector end 1706 may be configured, arranged, or provided with any suitable form of mechanical releasable fastening or coupling to complement the end or connector of the breathing conduit, including but not limited to threads, rotational locking or coupling, clip mating, snap fit connection, push fit connection, interference fit connection, latch connection, etc.

[0362] In some embodiments, the connector end 1706 may be provided with a connection structure adapted to compatibly connect to the end of one or more specific types of breathing conduits (including branded or manufacturer-specific breathing conduits). For example, in one embodiment, the connector end 1706 may be configured to attach or connect to a 20 mm breathing tube for use with a high-flow breathing assistance device. In other embodiments, the connector end 1706 may be provided with a universal or all-purpose connection structure or configuration that is operable or capable of coupling to the ends of various or a wide range of different types of breathing conduits.

[0363] In the illustrated embodiment, the connector end 1706 is configured to releasably connect or couple to the end or connector of the breathing conduit 16. This allows the measuring device 1702 to be connected to the breathing conduit to perform patient diagnostic measurements in the patient diagnostic mode of the device and then be disassembled after the measurement, such that the breathing conduit can be connected or reconnected to the patient interface for the normal breathing treatment mode.

[0364] In an alternative embodiment, the connector end 1706 of the measuring device may be configured to have a non-releasable permanent connection to the breathing tube 16 such that the components cannot be released from each other without breaking. Alternatively, a semi-permanent connection may be provided between the connector end 1706 of the measuring device and the breathing conduit 16 such that tools or the like are required to release the components from each other.

[0365] In a further alternative embodiment, the measuring device 1702 may be provided with an integral breathing conduit extending from the connector end 1706. In such an embodiment, the measuring device 1702 is combined with an integral flexible conduit extending from the connector end. The integral flexible conduit may terminate at a connector end that may be releasably connected or attached to the gas outlet 21 of the breathing assistance device.

[0366] In another embodiment, the measuring device 1702 may be configured to releasably directly connect or attach to the gas outlet 16 of the breathing assistance device without an intervening breathing conduit. In another embodiment, if the humidifier chamber is removed from the device, the measuring device 1702 may be configured to releasably directly connect or attach to the air flow generator outlet or gas outlet port 322. In another embodiment, the humidifier or humidifier chamber may be bypassed via a bypass conduit or other bypass configuration. For example, the measuring device may be directly or indirectly attached via a breathing conduit to a bypass conduit or port or outlet that bypasses the humidifier or humidifier chamber such that the measuring device is in fluid communication with the air flow from the air flow generator outlet and the humidifier is temporarily cut off or bypassed from the flow path.

[0367] Mouthpiece end

[0368] ReferenceFigure 57 and Figure 59 the nozzle end 1708 of the measuring device 1702 will be described in more detail.

[0369] In this embodiment, the nozzle end 1708 is the part configured to releasably receive and hold an optional detachable nozzle, which will be further explained in detail later. In the present embodiment, the nozzle end 1708 is an open cylindrical part at the end of the body 1704. In the present embodiment, the nozzle end 1708 has no threads, but may have threads in other embodiments. However, it should be understood that the nozzle end 1708 can be any other suitable shape or configuration for receiving and holding a releasable nozzle.

[0370] In an alternative embodiment, the measuring device 1702 can be used directly without a separate detachable nozzle. In such an embodiment, the nozzle can be integrally formed with the nozzle end 1708, or the nozzle end 1708 itself can be configured as or used as a nozzle to be in fluid communication with the airway of the user or patient when the mouth of the user or patient seals around the nozzle during use. It should be understood that the shape and configuration of the nozzle portion of the body or the nozzle end can be cylindrical, oval, elliptical, mouth-shaped, or any other suitable shape suitable for the user's mouth.

[0371] Exhaust hole

[0372] In this embodiment, the measuring device 1702 includes one or more exhaust ports that are in fluid communication with the main chamber of the measuring device 1701. During use of the measuring device, the exhaust ports provide a path for the airflow and / or exhalation from the user or patient to escape to the atmosphere or the surrounding environment. In the absence of one or more exhaust ports, complete blockage of the flow path may occur in certain system configurations when the user places the mouth on the nozzle or otherwise forms a seal around the nozzle during use. In an alternative embodiment, the measuring device 1702 may not have any exhaust holes or ports, and the system configuration may allow this. For example, exhaust holes, exhaust ports, and / or pressure relief valves may be provided in the flow path upstream of the measuring device.

[0373] Reference Figures 51 - 55 and Figure 59 An example configuration of the exhaust port of this embodiment will be described in further detail. In the illustrated embodiment, the measuring device 1702 is provided with one or more exhaust ports 1716. The one or more exhaust ports 1716 are located between the connector end 706 and the nozzle end 708. In this embodiment, the one or more exhaust ports 1716 are provided in and / or along the body 704 of the measuring device 1702.

[0374] In this embodiment, the exhaust port 1716 is in the form of a flush exhaust hole or includes a flush exhaust hole. A flush exhaust hole is a through-hole, opening, or orifice that extends through the peripheral wall of the main body 1704 of the measuring device 1702. The flush exhaust hole may be substantially flush with the outer surface (e.g., a cylindrical surface) of the main body 1704 of the measuring device. Refer to Figure 59 , in the present embodiment, the exhaust port 1716 extends through from the outer surface of the wall of the main body to the inner surface (i.e., through the entire thickness of the wall), thereby providing a path for gas and / or exhaled breath in the main chamber to escape or be discharged from the device into the atmosphere or the surrounding environment. As shown in the figure, in this embodiment, the exhaust port is not protruding or is flush with the peripheral wall of the main body 1704 and includes a hole or exhaust hole directly formed in the wall of the main body.

[0375] In this embodiment, the shape of the exhaust port 1716 is circular, but it should be understood that in alternative embodiments, any other shape or profile or combination of different shapes or profiles may be used for the exhaust port or hole. If multiple exhaust ports 1716 are provided, these exhaust ports may be uniform in shape and / or size, or alternatively they may be a combination of different shapes and / or sizes.

[0376] The total cross-sectional area of the exhaust port 1716 can be configured to suit the desired exhaust flow rate requirements. For example, the size or dimensions of the exhaust port 1716 can be configured to suit the exhaust flow rate requirements relative to the size and characteristics of the entire measuring device 1702. For example, for a circular exhaust port 1716, the diameter of the opening can be customized or configured to suit the required exhaust flow rate requirements.

[0377] By way of example only, in this exemplary embodiment, each exhaust port 1716 is a round hole or orifice with a diameter of approximately 5 mm. Therefore, the opening area of each exhaust port is approximately 19.6 mm 2 . In this example, the inner cross-sectional area of the main chamber is approximately 397.6 mm 2 , which is defined by an inner diameter D6 of 22.5 mm. Therefore, the opening area of each exhaust port 1716 is approximately 5% of the cross-sectional area of the main chamber of the main body of the measuring device 1702. In addition, in this example, the total exhaust port area provided by three uniform exhaust ports 1716 is approximately equal to 15% of the cross-sectional area of the main chamber of the measuring device 1702.

[0378] In the illustrated embodiment, the exhaust ports 1716 include a linear arrangement, a line, or a linear array of equally spaced exhaust ports 1716 disposed along one side surface or region of the body 1704 of the measuring device 1702. In the present embodiment, the linear array of exhaust ports 1716 extends in a direction aligned with the longitudinal axis of the body 1704. In this exemplary embodiment, there are three exhaust ports, but it should be understood that the number of exhaust ports 1716 in the array can vary, and the spacing can be uniform or non-uniform in other embodiments. In this exemplary embodiment, the linear array of discharge ports 1716 is closer to the nozzle end 1708 of the body 1704 relative to the connector end 1706, but alternatively, in other embodiments, the exhaust ports 1716 can be centered or closer to the connector end of the body.

[0379] There can be a single exhaust port or multiple exhaust ports. The number, arrangement, or pattern of one or more exhaust ports can vary in different embodiments. In some configurations, the exhaust ports can be arranged in a 1D array (e.g., a linear array as shown), a 2D array, a multi-dimensional array, or any other pattern or configuration. In some configurations, the exhaust ports can be provided along one or more lines extending along the length of the body 1704 on one or more sides or surface regions. In some configurations, one or more lines of the exhaust ports are aligned with the longitudinal axis as shown, or they can extend in other directions.

[0380] In some configurations, the exhaust ports can be circumferentially provided around the circumference of the body. For example, the exhaust ports can be provided in the form of one or more annular exhaust holes or an annular array of spaced exhaust ports around the circumference of the body 1704. The annular array of spaced exhaust ports or holes in the wall of the body can extend around the entire circumference or at least a portion of the circumference of the body.

[0381] There can be one or more exhaust ports or arrays of exhaust ports extending along and / or around the surface of the body 1704, including extending along or around any one or more regions, sides, or surfaces of the body. In some embodiments, the exhaust ports can be provided on opposite or opposing sides of the body 1704 or on multiple sides of the body.

[0382] The position of one or more exhaust ports or arrays of exhaust ports along and / or around the body 704 can vary. In one configuration, the exhaust ports can be centered or located in the middle region of the measuring device 1702 or the body 1704. In other configurations, the exhaust ports can be provided at or near the connector end 1706 or the nozzle end 1708 of the body 1704. In additional configurations, multiple exhaust ports can be spaced along the entire length or full length of the body 1704, whether on the same side surface or different side surfaces of the body.

[0383] In summary, the nature of the one or more exhaust ports 1716 can vary in different embodiments, including but not limited to, for example, the number, shape, opening area, arrangement, uniformity, perimeter, and / or diameter.

[0384] In some configurations, the measuring device 1702 can include a mixture of different types of exhaust ports. Some exhaust ports can be protruding exhaust holes of the type described for the measuring device 702 of the first exemplary embodiment, while other exhaust ports can be flush exhaust holes or exhaust ports of the type described for the measuring device 1702 of the second exemplary embodiment. Some exhaust ports can include a single opening, and other exhaust ports can include multiple openings or can include, for example, an arrangement of openings or ports or holes forming a mesh or honeycomb exhaust hole arrangement flush with the outer surface of the body.

[0385] Detachable nozzle

[0386] As discussed, in some embodiments, the nozzle end 1708 of the body 1704 itself can be a nozzle or can have an integral nozzle. In this embodiment, the measuring device 1702 is provided with a releasable or detachable nozzle that is received or attached to or in the nozzle end 1708 of the body 1704.

[0387] Reference Figures 61 - 72 , embodiments of the measuring device 1702 having a detachable nozzle 1730 will be described in further detail by way of example. The detachable nozzle 1730 can be optional in the sense that the nozzle end 1708 of the body 1704 of the measuring device 1702 can function as a nozzle. However, from the viewpoints of usability, manufacturing, and / or hygiene, the detachable nozzle 1730 can provide certain advantages in some scenarios or situations.

[0388] In this embodiment, the detachable nozzle 730 is a hollow conduit member having a nozzle portion 1732 at one end for the user's mouth and an attachment portion 1734 at the other end for releasably connecting or attaching to the nozzle end 1708 of the measuring device 1702.

[0389] In this exemplary embodiment, the nozzle portion or nozzle area 1732 of the nozzle 1730 includes an oval or elliptical shape or cross-sectional profile along at least a portion of its length. The nozzle portion or nozzle area extends between a first end or first point 1736 shown at 1736 and a second end or second point 1738 shown at 1738. The first end or first point 1736 is located at an intermediate position along the length of the nozzle 1730 and defines the boundary or transition between the nozzle portion 1732 and the attachment portion 1734. In this example embodiment, as the nozzle portion or nozzle area 1732 extends towards the open oval or elliptical opening at the second end 1738, the nozzle portion or nozzle area 1732 gradually transitions in shape or cross-section from a circular cross-section at the first end 1736 to an oval or elliptical shape.

[0390] In this exemplary embodiment, the attachment portion or attachment region 1734 of the mouthpiece 1730 is a cylindrical conduit portion. Referring to Figure 63 , in this embodiment, the outer diameter D10 of the attachment portion 1734 of the mouthpiece 1730 is sized or selected to be complementary to the inner diameter D7 of the mouthpiece end 1708 of the body (see Figure 59 ), such that the attachment portion 1734 can be inserted or plugged into the socket or port or opening provided by the mouthpiece end 1708, as shown by the arrow F in Figure 68 . In this embodiment, the relative dimensions of the outer diameter D10 or circumference of the attachment portion 1734 of the mouthpiece 1730 and the inner diameter D7 of the mouthpiece end 1708 of the body 1704 of the measuring device 1702 can be configured to provide a push fit, friction fit, or interference fit, such that the detachable mouthpiece can be properly received and held in the measuring device during use. The user can apply sufficient manual force or pulling force in the direction G (see Figure 68 ) to detach or pull out the detachable mouthpiece 1730 from the mouthpiece end 1708 of the measuring device, for example, for replacement, cleaning, repair, and / or disposal.

[0391] Referring to Figures 67 - 72 , an assembled and disassembled measuring device 1702 with a detachable mouthpiece 1730 is shown by way of example. Figure 68 A disassembled view of the measuring device 1702 is shown, in which the mouthpiece 1730 is detached or disconnected from the mouthpiece end 1708. Figure 67 And Figures 69 - 72 show various perspective views, elevation views, and cross-sectional views of the measuring device 1702, in which the detachable mouthpiece 1730 is installed, assembled, or inserted into the mouthpiece end 1708 of the body 1704 in readiness for use.

[0392] It should be understood that any other suitable releasable or detachable coupling or connection arrangement or structure for connecting the detachable mouthpiece 1730 to the end of the measuring device 1702 can be used for alternative embodiments, including but not limited to snap fits, threads, fastening, or clamping systems, etc.

[0393] Referring to Figure 64 and Figure 66 , the detachable mouthpiece in this embodiment includes a single main cavity or channel extending between the two ends, denoted as 1736. Referring to Figure 70 and Figure 72 , the mouthpiece cavity 1736 provides fluid communication with the main cavity (e.g., main cavity 1710) of the body 1704 of the measuring device 1702, such that the detachable mouthpiece can deliver an air stream to the user during use.

[0394] In an alternative embodiment, the mouthpiece may be provided with a plurality of cavities (such as flow channels or passages) extending along its length, for example, arranged in an array, mesh, or honeycomb pattern.

[0395] In this exemplary embodiment, the detachable mouthpiece 1730 is elongated and the cross-sectional shape varies along at least a portion of its length. It should be understood that various shapes or cross-sectional profiles may be used to create the mouthpiece 1730. In one example, the shape of the attachment portion 1734 may be complementary or adapted to the mouthpiece end 1708 of the measuring device 1702 to allow attachment, and the mouthpiece portion 1732 may be any other suitable shape or profile for the user to seal their mouth around or over it. For example, the cross-section of the mouthpiece portion 1732 may be circular, oval, egg-shaped, mouth-shaped, or any other suitable shape.

[0396] In this embodiment, the detachable mouthpiece 1730 is a generally straight or elongated member defined about a central longitudinal axis. However, it should be understood that the mouthpiece may have any suitable shape, including having one or more arcuate or curved portions, and / or may generally be elbow-shaped.

[0397] As discussed, in this embodiment, the detachable mouthpiece 1730 is arranged as a releasable component of the measuring device 1702. However, in other embodiments, the above-mentioned mouthpiece 1730 may alternatively be integrally formed with or extend from the end of the body 1704 of the measuring device 1702. It should be understood that any properties and aspects of the above-mentioned detachable mouthpiece 1730 may equally apply to an integral or permanent mouthpiece portion of the body 704.

[0398] Anti-blocking features

[0399] Reference Figures 73 - 75 , in some embodiments, the measuring device 1702 may optionally include one or more anti-blocking features, structures, or protrusions 1740 near, around, or adjacent to the exhaust port 1716 to help prevent the exhaust port from being accidentally or inadvertently blocked or covered by the patient during use. For example, the anti-blocking feature 1740 may help prevent the user or patient from accidentally or inadvertently covering or blocking one or more flush exhaust ports 1716 during use.

[0400] In this exemplary embodiment, the anti-blocking feature includes a pair of spaced-apart walls or surfaces 1740 that project or extend from the wall of the body 1704 on each side along the straight line of the exhaust port 1716. The pair of walls project above the surface of the body 1704 and the exhaust port 1716 and are arranged to prevent accidental or inadvertent blocking or covering of the exhaust port during use.

[0401] In this exemplary embodiment, the anti-blocking protruding wall 1740 is curved or has an arcuate profile and is arranged to together form a clip or attachment mechanism that can be used to clamp, attach, or mount the measuring device 1702 to a carrier or a breathing assistance device when not in use. For example, a pair of protruding curved walls 1740 face each other and form a cylindrical clamping orifice or clamping area above the exhaust port for clamping or mounting onto a cylindrical component of complementary size and shape of a carrier or a breathing assistance device or some other complementary mounting structure or component. The protruding walls can be rigid or semi-rigid and can have some elastic flexibility in some embodiments to be able to provide or form a snap-fit clip or clamping device.

[0402] It should be understood that the anti-blocking feature can be any other shape, size, or arrangement relative to the exhaust port that is sufficient to help prevent blocking or covering of the exhaust port during use. There can be one anti-blocking feature or multiple anti-blocking features. In some embodiments, the anti-blocking feature can have a dual purpose or function, such as also being used to form a clip, but in other embodiments the anti-blocking feature can have the sole function of preventing blocking of the exhaust port during use.

[0403] 3.3. Materials - Mechanical Construction of the Measuring Device

[0404] The exemplary embodiments of the above-described measuring devices 702, 1702 can be formed from any suitable material.

[0405] In one embodiment, the bodies 704, 1704 can be mainly formed of a rigid or semi-rigid material or a combination of materials, such as but not limited to plastics or plastic polymers, such as but not limited to polycarbonate (PC), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene (ABS), or cardboard, glass, metal, or any other suitable rigid or semi-rigid material.

[0406] The bodies 704, 1704 of the measuring devices 702, 1702 can be made of the same or similar material as the detachable mouthpieces 730, 1730, or these components can be made of different materials. For example, in one embodiment, the bodies 704, 1704 can be mainly formed of a plastic polymer, and the detachable mouthpiece can be formed of the same or a different plastic polymer. In another embodiment, the bodies 704, 1704 can be mainly formed of a plastic polymer, and the detachable mouthpiece can be formed of, for example, cardboard or heavy paper.

[0407] The material and / or thickness of the material used to form the measuring devices 702, 1702 can depend on the usage. In some embodiments, the entire measuring device including the body 704, 1704 and the detachable mouthpiece 730, 1730 can be made of a low-cost or low-grade material more suitable for disposable items. In other embodiments, the body 704, 1704 can be configured as a reusable and / or multi-user component formed of a more durable or longer-lasting material (such as plastic), but a low-cost material can be used for the detachable mouthpiece, such as cardboard or a thinner or lower-grade or lower-cost plastic, since the mouthpiece can be configured as a disposable or single-user discardable item.

[0408] It should be understood that a series of different measuring devices can be formed of different materials. Some measuring devices or their specific components can be formed of higher-grade and / or more durable materials for longer or multiple uses, while other measuring devices or at least their specific components (such as the detachable mouthpiece) can be formed of low-cost and / or disposable and / or less durable single-use type materials, such as but not limited to cardboard or lower-grade or thinner plastics.

[0409] In some embodiments, the measuring device or its component (such as the detachable mouthpiece) can be configured to be suitable for delivery and / or sent to the end user for a specified number of uses or a fixed lifespan (such as having an expiration date or shelf life). In such cases, the measuring device can be formed of a material more suitable for disposable items.

[0410] 3.4. Patient Diagnostic Mode of the Respiratory Assistance Device

[0411] As Figure 22 discussed and shown, the measuring devices 702, 1702 are used with the respiratory assistance device 10, which includes an air flow generator operable to generate an air flow (such as atmospheric air or pressurized air, air supplemented with oxygen or other supplementary gases, or any other suitable gas combination), and has one or more sensors for sensing, measuring, or detecting one or more properties or characteristics of the air flow. The measuring devices 702, 1702 are provided as supplementary components that can be selectively attached to the flow path of the respiratory assistance device to perform one or a series of pulmonary performance or function measurements or evaluations.

[0412] A breathing assistance device can have one or more operating modes. In this embodiment, the breathing assistance device has one or more treatment modes for imparting to the airflow specific properties (such as flow rate and / or pressure control) suitable for high-flow therapy, CPAP, bi-level PAP, or other such respiratory therapies. In this embodiment, the breathing assistance device further includes a patient diagnostic mode that can be initiated or operated when the breathing assistance device is used in conjunction with measurement devices 702, 1702 for pulmonary performance measurement or assessment. In one exemplary configuration, the breathing assistance device can operate in a first mode (e.g., a treatment mode), and then switch to a second mode (e.g., a patient diagnostic mode or a measurement mode or a spirometry mode) when the measurement devices 702, 1702 are attached for pulmonary performance measurement. In another exemplary configuration, the breathing assistance device can be initiated in the second mode or the patient diagnostic mode upon device startup. In another exemplary configuration, the device can be provided as a dedicated measurement system or device having only a single mode, which is a diagnostic or measurement mode, i.e., in this exemplary configuration the device may not provide any treatment modes.

[0413] As will be further explained in detail later, in the patient diagnostic mode, the user can be instructed or prompted to perform various pulmonary performance actions (such as forced exhalation or expiration, or quiet tidal breathing) in the mouthpieces of the measurement devices 702, 1702, while the device's airflow generator is controlled to produce an airflow to provide pneumatic or air resistance to the user's forced exhalation or quiet tidal breathing. One or more sensors of the device 10 are used to sense or measure one or more properties or characteristics of the airflow during the pulmonary performance actions. The sensor data can then be processed or filtered or otherwise analyzed to generate data representative of pulmonary performance or lung function.

[0414] In this embodiment, the breathing assistance device 10 can be configured to initiate or activate the patient diagnostic mode in response to an input made by the user at the user interface of the device 10, or the patient diagnostic mode can be remotely initiated or activated by another external device or system that communicates or connects with the device 10 via a data link or data network.

[0415] As an example, the user interface of the device 10 can have an operable button (whether mechanical or touch-sensitive) or a touchscreen-type interface or button that is operable to initiate or start the patient diagnostic mode. Additionally or alternatively, the device 10 can be controlled via a user smart device that communicates with the device (e.g., via Bluetooth, Wi-Fi, infrared, or the like). For example, a smartphone application can be provided to remotely control the device, and the smartphone application can provide a button or a graphical user interface that is operable to initiate the patient diagnostic mode on the device 10.

[0416] The remote initiation or triggering of the patient diagnostic mode can be performed by a remote user (such as a clinician, healthcare provider, or physician) providing user input to a remote electronic device or server that communicates data with the respiratory assistance device 10. As an example, the remote or external device or server can have a software application running thereon that provides actionable commands or a graphical user interface (GUI) with buttons or GUI elements that can be triggered (e.g., via cursor clicks or touchscreen operations) to initiate the patient diagnostic mode on device 10 via control signals or command data sent over a data network. The remote device or server can have any suitable user interface for receiving user input from a clinician, etc., including mechanical or touch-sensitive buttons or interfaces, or an electronic GUI displayed on a display screen in the case of a software application, as described above.

[0417] It should be understood that device 10 and / or the remote device or server or system can receive user input in other ways to trigger the patient diagnostic mode, including voice or audible controls or commands issued via a voice interface or voice assistance device.

[0418] In one embodiment, the patient diagnostic mode can be manually initiated or triggered in response to device input or control by the user or remote actuation from a clinician, etc. Additionally or alternatively, the patient diagnostic mode can be automatically triggered locally by the local controller 19 of device 10 or remotely by a processor of a remote device, system, or server. The automatic triggering or actuation of the patient diagnostic mode can be performed according to a configurable schedule or periodic intervals. The configurable schedule or periodic intervals can be configured by the user or a remote clinician via the respective user interfaces and / or software applications of device 10 and the remote device, system, or server.

[0419] In one embodiment, the device and / or the remote device, system, or server can be configured to prompt or remind the user or a remote clinician to start or initiate the patient diagnostic mode. The prompt or reminder can be a visual prompt and / or an audio prompt, such as via the user interface of device 10 and / or any remote device, server, or system that communicates data with device 10. As an example, the visual prompt can be displayed on the display or touchscreen display of device 10 or a remote device, and any audible prompt can be provided via an audio output device or speaker in the device or remote device. The user or a remote clinician can respond to the prompt to trigger or initiate the patient diagnostic mode. In some cases, the user can be prompted or contacted via mail, phone, email, SMS, or other communication methods to prompt the user to take the patient diagnostic approach.

[0420] In some configurations, prompts can be automatically generated according to a preset or configurable schedule or at periodic intervals. The device can be provided with an initial default schedule or periodic interval during manufacturing. The schedule or periodic interval can be configured by the user or a remote clinician via an interface or software application of the device and a remote device, server, or system. Alternatively, when needed, the remote clinician can initiate a prompt on the device 10 in a manual or ad hoc manner via an interface or software application of the remote device, system, or server.

[0421] 3.5 Measurement Methods and Procedures

[0422] Reference Figures 42 - 50 , examples of measurement or diagnostic methods or procedures 750, 750A for using the measurement device 702 with the respiratory assistance device 10 in a patient diagnostic mode will be described in further detail. The patient diagnostic mode can also be referred to as a measurement mode or a spirometry mode or "spirometer login". The measurement process or method in this example is mainly implemented by algorithms or computational instructions executed by a processor or controller of the respiratory assistance device 10 when entering the patient diagnostic mode. The principles of the exemplary diagnostic methods or procedures 750, 750A can be applied to any example, configuration, or variant of the above-described respiratory devices, measurement systems, and / or measurement devices.

[0423] It should be understood that the individual steps in the example processes to be described are not necessarily to be operated in the order described. Certain steps can occur in parallel, overlap, or in a different order without affecting the overall process. Depending on the specific configuration and / or operation of the respiratory device, measurement system, and / or measurement device, some steps may be unnecessary or can be changed.

[0424] Initiating the Patient Diagnostic Mode

[0425] Reference Figure 42, in this embodiment, the patient diagnostic mode of the respiratory assistance device 10 is initiated in response to manual actuation by a local user or patient, remote actuation by a remote clinician, etc., or in response to an automatic trigger. The diagnostic process 750 begins at 752. As previously described, in response to a prompt or reminder, the user or clinician may be prompted to initiate or start the patient diagnostic mode. Once in the patient diagnostic mode, the respiratory assistance device 10 may be configured to provide the user with one or more prompts, guidance, or instructions regarding some or all of the steps in the diagnostic assessment process, as described below. For example, the instructions or guidance may be visual instructions in the form of text and / or images given via a graphical user interface (GUI) on the device display, and / or audible instructions provided via the device speaker. The following describes various GUI screen prompts for the steps in the diagnostic method 750 by way of example only. It should be understood that various variations of the GUI screen prompts are possible, and the GUI screen prompts may be provided alone or in combination with audio prompts or instructions via a speaker or audio output device.

[0426] As will be further explained below, in some configurations, the device may give step-by-step instructions or prompts on how to use the measuring device during the diagnostic mode or diagnostic session. By way of example only, visual and / or audible instructions, prompts, or guidance may be provided to the user regarding any one or more of the following: information about the device operating mode (e.g., treatment or diagnostic mode); information about how to disconnect the patient interface from the device and / or the breathing conduit; information about how to connect or attach the measuring device to the gas outlet, breathing conduit, or flow path of the device; information about how to perform a forced exhalation maneuver; and information about how to perform normal (tidal) breathing at the end of the diagnostic session after the forced exhalation maneuver. The information may be provided using any combination of text, numbers, characters, images, icons, graphics, animations, videos, and / or audio.

[0427] In a typical example, a user can power on or start the respiratory assistance device 10 to prepare for a treatment session. At this time, the user may already have donned the patient interface, such as a nasal cannula. If this is the user's first treatment session of the day, or if the user is otherwise prompted, the user may be requested to respond to a patient health questionnaire or inquiry via a GUI on the display of the device 10. The user then typically follows the on-screen prompts and questions displayed on the GUI and enters the user's answers for processing. An example of an executable patient health questionnaire or inquiry process is provided in PCT Application Publication WO2021 / 090184, filed Nov. 4, 2020, which is hereby incorporated by reference in its entirety. After completion of the questionnaire, the patient may be prompted or requested to perform a diagnostic test or assessment (e.g., a spirometry test or other lung performance or lung function test), and at step 752 the device will enter a patient diagnostic mode (e.g., a spirometry mode or a measurement mode). In one configuration, the patient diagnostic mode may be triggered or prompted at least in part by the patient's response or answers to the questionnaire or health inquiry, but this is not required. In another configuration, the patient diagnostic mode may be prompted in any of the previously described ways, regardless of whether the user performs the questionnaire or health inquiry.

[0428] Instruct the user to disassemble and disconnect the patient interface

[0429] After initiating the patient diagnostic mode, at step 754 the user or patient is instructed to disassemble the patient interface 51 (e.g., a nasal cannula or other interface, depending on the treatment) from the face and disconnect it from the end of the breathing conduit 16. For example, prior to initiation of the patient diagnostic mode, if the user has been using the respiratory device in a treatment mode or if the user is about to start a new treatment session, the user may already have donned the patient interface. Alternatively, the user may simply be prompted to disconnect or disassemble the patient interface from the end of the breathing conduit 16, which in itself implies that if the patient interface was previously used in a treatment session or the patient interface was previously donned in preparation for a new treatment session then the disassembly of the patient interface from the face is involved or required. In some cases, the patient diagnostic mode may be entered directly at startup, and in such cases the patient interface has not yet been donned by the user, so the user only needs to disconnect the patient interface from the end of the breathing conduit 16 or otherwise confirm that the patient interface is not connected to the breathing conduit 16.

[0430] Figures 45A - 45C Schematic examples of one or more GUI display prompts 754A, 754B, 754C are shown, which may be displayed on the display of the user interface of the device during step 754. It should be understood that there can be various different variations. Figure 45AThe example screen prompt 754A therein includes a text and / or graphical field 7541 that describes or represents the current operating mode, i.e., the patient diagnosis mode or the spirometry mode. The main instruction text and / or graphical field 7542 includes text and / or graphics instructing the user to disconnect the patient interface, which is a nasal cannula in this example. For example, one or more auxiliary or additional text and / or graphical fields 7543 may also be provided to show additional instructions or details on how to perform the main instruction. Figure 45B The example screen prompt 754B therein shows a variant where there is a single main instruction text and / or graphical field 7544. Figure 45C The example screen prompt 754C therein shows a variant where there is an animated field or area 7545, and a 2D or 3D graphic, image, animation, or video depicting or representing the instruction can be shown, i.e., to help guide the user to perform the actions required to complete the step or instruction, which in this case is to disassemble or disconnect the patient interface from the breathing catheter. The GUI display prompt can include any combination of text, image, animation, video, and / or graphics to provide the user with information and / or guidance related to the instructions or prompts for each step.

[0431] In one example configuration, before moving to the next step 756 in the process of prompting the user to attach the measuring device 702 to the breathing catheter 16, the device can also execute a breath detection algorithm to confirm or ensure that the patient has disassembled the patient interface and / or is not connected to a breathing assistance device. In this example configuration, the breath detection algorithm can be used as a gate to prevent further steps in the diagnostic method process 750 from being executed until the algorithm detects or confirms that the patient interface has been successfully disconnected from the breathing catheter. An exemplary breath detection algorithm executable by the device is provided in PCT application publication WO2020 / 178746 filed on March 4, 2020, which is incorporated herein by reference in its entirety.

[0432] Connect the measuring device

[0433] The next step 756 in the diagnostic method 750 is to prompt the user to connect or attach the measuring device 702 to the end of the breathing catheter 16 of the device 10 (or other gas outlet along the flow path) in the manner previously described. Before or after connecting the measuring device 702 to the end of the breathing catheter 16, the user can pre-assemble or install the detachable mouthpiece 730. For example, in some configurations, the device 10 can instruct the user to connect the measuring device 702 to the breathing catheter and can provide information or guidance on how to connect the components.

[0434] Figures 46A - 46CShows a schematic example of one or more GUI display prompts 756A, 756B, 756C, which can be displayed on the display of the device's user interface during step 756. It should be understood that there can be various different variations. Figure 46A The example screen prompt 756A in Figure 46A includes a text and / or graphic field 7541 that describes or represents the current operating mode (i.e., the patient diagnosis mode or the spirometry mode). The main instruction text and / or graphic field 7562 includes text and / or graphics instructing the user to connect or attach the measuring device 702 to the breathing conduit 16. One or more auxiliary or additional text and / or graphic fields 7563 can also be provided to show additional instructions or details on how to perform the main instruction. Figure 46B The example screen prompt 756B in Figure 46B shows a variation in which there is a single main instruction text and / or graphic field 7564. Figure 46C The example screen prompt 756C in Figure 46C shows a variation in which there is an animation field or area 7565, and a 2D or 3D graphic, image, animation, or video depicting or representing the instruction can be displayed, i.e., to help guide the user to perform the actions required to complete the step or instruction, which in this case is to connect the measuring device to the device.

[0435] Start the airflow to generate pneumatic resistance

[0436] The next step 758 in the diagnostic process 750 performed in the patient diagnosis mode is that the controller is configured to control or start the airflow generator 11 of the breathing assistance device 10 to output the airflow along the flow path to the gas outlet 21 so as to flow through the breathing conduit and into the measuring device 702. As described above, the airflow flowing into the measuring device provides pneumatic resistance for lung performance measurement or evaluation.

[0437] In this embodiment, the patient diagnosis mode can be configured to provide the airflow at a fixed or constant predetermined or configurable flow rate setting, thereby providing a constant or fixed air resistance or pneumatic resistance. The airflow can be provided for a predetermined or configurable period of time, or until the user completes the measurements required for the diagnostic session (i.e., one or more lung performance actions are performed). The flow rate setting can vary depending on the patient and / or the specific lung performance measurement or evaluation being performed, or the flow rate setting can be generally set or configured based on measurements or industry standards related to the resistance required for the specific lung performance measurement or evaluation.

[0438] In some embodiments, the patient diagnostic mode can be configured or operable to control the composition of the gas output during the measurement process. In some configurations, the respiratory assistance device is controlled to output an air stream or an ambient air stream (i.e., if a supplemental gas such as oxygen is available, the supplemental gas is closed off or the supplemental gas flow rate is reduced to zero via, for example, a controllable valve). In other configurations, the air stream can be air augmented with a supplemental gas (such as oxygen), and the oxygen fraction of the air stream can be controlled to a specific oxygen concentration setting. It should be understood that any suitable composition of one or more gases can be output.

[0439] In some configurations, the respiratory assistance device 10 can output a non-humidified air stream. For example, the respiratory assistance device may not have a humidifier, or the humidifier may be turned off. In other configurations, the air stream can be humidified by the humidifier 52 of the respiratory assistance device.

[0440] Instruct the user to perform a forced exhalation action against the air stream

[0441] Once the air stream is output to the measurement device 702, the user is prompted or instructed to perform one or more forced exhalation actions on the mouthpiece of the measurement device 702, as shown in step 760. As an example, the user can be instructed to perform a forced blow or exhalation against the pneumatic resistance generated by the air stream into the mouthpiece of the measurement device. In one example, the forced exhalation can be similar to the exhalation performed during a spirometry assessment and / or measurement.

[0442] In an exemplary configuration, the device can prompt the user to exhale for a fixed time period, such as a specific time period. Merely by way of example, the time period can be 1, 2, 3 or more seconds, or some other specified time period depending on the assessment being performed. By way of example, the user can be prompted to inhale and then exhale as forcefully as possible into the mouthpiece of the measurement device for a specific time period or until out of breath. A countdown timer can be displayed to the user to show how long they need to exhale into the measurement device.

[0443] Figures 47A - 47F Schematic examples of one or more GUI display prompts 760A, 760B, 760C, 760D, 760E, 760F are shown, which can be displayed on the display of the user interface of the device during step 760. It should be understood that there can be various different variations. Figure 47AThe example on-screen prompt 760A therein includes a text and / or graphical field 7541 that describes or represents the current operating mode, i.e., the patient diagnosis mode or the spirometry mode. The main instruction text and / or graphical field 7602 includes text and / or graphics that instruct the user to resist the airflow and perform a forced exhalation or expiration action into the measuring device 702. For example, one or more auxiliary or additional text and / or graphical fields 7603 may also be provided to show additional instructions or details on how to perform the main instruction. Figure 47B The example on-screen prompt 760B therein shows a variant in which there is a single main instruction text and / or graphical field 7604. Figure 47C The example on-screen prompt 760C therein shows a variant in which there is an animation field or area 7605, and a 2D or 3D graphic, image, animation, or video depicting or representing the instruction can be shown, i.e., to help guide the user to perform the actions required to complete the step or instruction, which in this case is to perform one or more exhalation or expiration actions.

[0444] The example on-screen prompts 760D, 760E, 760F depict a sequence of on-screen prompts in the format of the on-screen prompt 760A, wherein the auxiliary or additional text and / or graphical area 7603 includes a countdown timer. In some configurations, the countdown timer can provide guidance to the user on how long the forced exhalation action needs to be performed. In this example, the countdown is provided with text and numbers, but it should be understood that the countdown timer can be provided in the form of an animation, graphic, or video alone or in combination with text and numerical information.

[0445] Collect, store, and / or analyze sensor data

[0446] As the user or patient performs the exhalation action, the patient diagnosis mode is configured to sense or measure one or more characteristics of the airflow via one or more sensors of the breathing assistance device, as shown in step 762. In particular, the controller receives or obtains sensor data from one or more sensors during the patient's exhalation action.

[0447] In an exemplary embodiment, the controller of the breathing assistance device is configured to sample the flow signals of one or more flow sensors of the device. As discussed, the device may include one or more flow sensors or configurations arranged to sense the airflow rate and generate a representative flow signal or flow data. In other embodiments, one or more other characteristics of the airflow may be sensed and measured during the exhalation action, including but not limited to pressure, temperature, humidity, gas concentration, or any other characteristic that can be directly or indirectly used to analyze lung performance.

[0448] Repeat the exhalation action

[0449] In some configurations, when in patient diagnostic mode, the device can be configured to instruct the user to perform repeated or multiple exhalation actions during a diagnostic session. In one example, the user can be instructed to perform multiple forced exhalations spaced apart by a predetermined time interval. For example, three or some other specified number of forced exhalations can be performed in a uniform or non-uniform interval manner or according to a preconfigured time interval or time format, and sensor data for each exhalation action is extracted or stored from one or more relevant sensors to create multiple sets of exhalation measurement data, one set of exhalation measurement data for each exhalation action.

[0450] In some configurations, the device can be configured to detect or identify the initiation or start of a patient's forced exhalation by processing and / or monitoring sensor data. For example, the device can be configured to process a flow signal or flow data received during diagnostic mode to identify an offset of the flow relative to a threshold or range, or to identify a significant deviation that otherwise indicates that the user has started to resist the airflow to perform a forced exhalation action into the measuring device 702. Once the initiation or start of a forced exhalation action is detected, the device can trigger a countdown timer and / or other display GUI screen prompts or other instructions to require the user to continue the forced exhalation within each required action time period.

[0451] Additionally or alternatively, forced exhalation detection or identification can be used to count the number of repeated exhalation actions that the user has performed during a diagnostic session. The action count can be compared to a required minimum number or other threshold and can be used to prompt the user to continue the forced exhalation action until the required number has been registered. Each forced exhalation action will have its own corresponding associated measurement data set (e.g., sensor data) collected from one or more sensors for subsequent processing.

[0452] Then, the exhalation measurement data sets from each action can be combined or totaled or otherwise processed to create an average data set. Alternatively, other statistical analyses can be applied to the measurement data to extract a filtered or robust data set with reduced noise or less affected by anomalies (e.g., the user makes an error while correctly following the instructions or performing the operation). In some configurations, the highest quality or best measurement data set can be selected from the collection of exhalation measurement data for subsequent lung performance processing and analysis. For example, if the user is required to perform at least three separate exhalation actions, the sensor data sets from each exhalation action can be processed relative to each other to select the best or highest quality data set from the three or more data sets from the diagnosis. The highest quality measurement data set can be selected based on one or more criteria, such as but not limited to those already mentioned.

[0453] Reference Figure 43 、 Figure 48A and Figure 48B, a more detailed description of an example of the process of prompting the user to perform a forced exhalation action in step 760 of diagnostic method 750 will be provided.

[0454] In this exemplary configuration, as shown in sub-step 760A, the user is instructed to perform a forced exhalation for x seconds through or into the mouthpiece of the measuring device 702.

[0455] Then, the user is instructed to repeat the forced exhalation for x seconds y times, as shown in sub-step 706B. The variables x and y can be configured or set as needed. In one example, the device is configured such that the user is prompted to perform a minimum number of forced exhalation actions during a diagnostic session, such as at least three times or some other suitable number.

[0456] After the user has performed the required number of repeated forced exhalation actions (which can optionally be automatically detected by the device as described above or otherwise confirmed by user input), the user is prompted to breathe normally for a specific period of time, as shown in sub-step 760C, to complete or end the diagnostic session. For example, the user can be prompted to perform normal or tidal breathing for z minutes (e.g., at least 2 minutes or some other period). It should be understood that the variable z can be configured or changed as needed. In one embodiment, during this final breathing session 760C, sensor data can be recorded and stored. Then, the stored sensor data for normal breathing can be further processed and / or used to extract or calculate one or more tidal breathing measurements or parameters for the patient, as further explained below.

[0457] Figure 48A and Figure 48B shows schematic examples of one or more GUI display prompts 770A and 770B that can be displayed on the display of the user interface during sub-step 760C. It should be understood that various different variations are possible. Figure 48A The example screen prompt 770A in includes a text and / or graphic field 7541 that describes or represents the current operating mode (i.e., patient diagnostic mode or spirometry mode). The main instruction text and / or graphic field 7702 includes text and / or graphics that instruct the user to breathe normally. For example, one or more auxiliary or additional text and / or graphic fields 7703 can also be provided to show additional instructions or details on how to perform the main instruction. In this example, the display area 7703 can include a countdown timer to show how long the user should continue to breathe normally before the end of the diagnostic session. Figure 48B The example screen prompt 770B in shows a variation where there is an animated field or area 7705 that can display 2D or 3D graphics, images, animations, or videos depicting or representing the instruction, i.e., to help guide the user to perform the actions required to complete the step or instruction, which in this case is to breathe normally within a preset or specified period of time.

[0458] Lung performance assessment based on sensor data

[0459] One or more processing algorithms may be applied to sensor data or measurement data from an exhalation action to extract, identify, or analyze one or more features representing lung performance. In one example, lung performance measurements or data similar to or representing spirometry measurements or data may be extracted or identified from the sensor data.

[0460] For example, in one configuration, airflow sensor data in the breathing assistance device flow path is collected and stored during an exhalation action. This flow data may represent measurement data representing lung performance. As the user performs a forced exhalation through or into a measurement device in fluid communication with the breathing assistance device flow path, the flow data (sensed in the breathing assistance device) fluctuates. The fluctuations in the flow signal or data enable the identification and extraction of one or more features representing lung performance from the flow signal through further processing of a flow data set (e.g., sensor data) associated with the exhalation action.

[0461] Reference Figure 44 , shows another example diagnostic method or process 750A, which is Figure 42 a modified version of the illustrated diagnostic method 750. The same reference numerals represent the same steps. The modified diagnostic method 750A includes optional additional steps 764, which involve any one or more of the following: processing and / or analyzing measurement data (sensor data) collected during a forced exhalation action to generate lung 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. As an example, the sensor data or measurement data may be stored and processed by a controller of the breathing assistance device, and / or transmitted to an external device or server or system for storage and / or further processing and / or extraction of the user's lung performance parameters or measurements. The generated sensor data and / or lung performance measurements, whether presented in graphical, numerical, or any other format, may be displayed to the user on a display of the breathing assistance device, and / or transmitted to one or more external or remote devices, systems, or servers (e.g., a cloud platform) for storage, access, display, and / or viewing by, for example, a clinician or other authorized personnel.

[0462] In one configuration, the raw measurement data or sensor data may be processed by a controller of the breathing assistance device to generate one or more lung performance measurements or data.

[0463] In another configuration, the raw measurement data or sensor data can be sent to an external or remote electronic device (e.g., a smartphone, a tablet, a PC, a wearable device, a remote server, a remote system, the cloud, or other processing devices) for processing to generate one or more lung performance measurements or data. The raw measurement data or sensor data can be sent in real time during the diagnostic mode or at the end or termination of the diagnostic mode.

[0464] In another configuration, the raw measurement data or sensor data can be processed partly by the controller of the respiratory assistance device and partly by an external or remote electronic device (e.g., a smartphone, a tablet, a PC, a wearable device, a remote server, a remote system, the cloud, or other processing devices).

[0465] In a configuration where the raw measurement data or sensor data or partly processed measurement data or sensor data is processed by an external or remote electronic device (e.g., a smartphone, a tablet, a PC, a wearable device, a remote server, a remote system, the cloud, or other processing devices), the external or remote device or system can send the processed data (e.g., lung performance measurements or data) back to the respiratory assistance device or other devices for storage and / or display, and / or retain or store the processed data, and / or perform further actions or processing (including displaying the processed data or results on a relevant display screen).

[0466] In an example configuration, the controller of the respiratory assistance device can be configured to send the measurement data or sensor data to the user's electronic device (e.g., a smartphone or a tablet, etc.). The user's electronic device can perform processing on the raw measurement data or sensor data to generate lung performance measurements or data, and then can send 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, wired) with the user's electronic device (e.g., a smartphone or a tablet or a similar device). The user's electronic device can have additional remote data communication capabilities (e.g., Wifi, cellular, 4G, LTE, 5G, LAN), and can then transfer or send the raw data or processed data to a remote server or system, thereby acting as a repeater or transmitter for the respiratory assistance device or as a data communication bridge between the respiratory assistance device and the remote server or system.

[0467] Diagnostic process completed – Switch to treatment mode

[0468] In some configurations, at the end of a diagnostic method or procedure 750, 750A, the device can automatically or in response to a user manual input or control switch to another mode or switch back to the normal mode, such as the treatment mode. For example, after sufficient measurement data has been obtained from a diagnostic session for processing, or after the measurement data has been processed into result data for display, storage, and / or transmission, the device can switch to the treatment mode.

[0469] In one example configuration, the user can be prompted or notified on the GUI or display screen that the device has switched to the treatment mode or is no longer in the diagnostic mode. Figure 49 A schematic example of a GUI display screen prompt 780 that can be displayed on the display of the user interface of the device is shown. It should be understood that various different variations are possible. Figure 49 The example screen prompt 780 in [description] includes a text and / or graphic field 781 that describes or indicates that the device has switched to the treatment mode for a new treatment session (i.e., for outputting an airflow for respiratory treatment). A main instruction text and / or graphic field 782 can also be provided, and can include text and / or graphics that notify the user of the device status and / or treatment start instructions. For example, the display area or field 782 can indicate that the device is ready to start treatment and / or can prompt the user to disconnect the measuring device 702 from the device and / or the breathing conduit, and connect or reconnect the patient interface to the breathing conduit. Once the patient interface is connected to the breathing conduit, the user can don the patient interface and start a treatment session with the device.

[0470] Example of lung performance characteristic extraction

[0471] Reference Figure 50 , shows an example of a flow data signal and fluctuations caused by a forced exhalation action in the measuring device. In this embodiment, the airflow is set to provide a pneumatic resistance at a flow rate of 70 L / min. It should be understood that other non-zero flow rates or flow rate ranges can be applicable for generating suitable measurement data during the use of the measuring device with the respiratory assistance device in the diagnostic mode.

[0472] In this example configuration, a flow rate of approximately 70 L / min can provide the advantage of preventing the user's exhaled air from flowing back into the device 10. It should be understood that in other different configurations, other flow rates can also provide such an advantage, and the flow rate can be selected based on balancing one or more factors and / or specific criteria or specific configurations suitable for the respiratory assistance device and / or the measuring device. For example, in some configurations, the flow rate can be configured to provide sufficient pneumatic resistance for performing the required lung performance measurements and to prevent backflow into the device.

[0473] The selected flow rate for use can additionally or alternatively be a function of the pneumatic characteristics of the configuration of the breathing assistance device and / or the measuring device (e.g., including the flow resistance of the flow path or the output flow path after the air flow generator) or at least partially based on such pneumatic characteristics. For example, the flow rate can be configured or selected at least partially based on the pneumatic characteristics in one or more of the following: the output flow path of the breathing assistance device, the breathing catheter, and / or the measuring device. For example, in a breathing assistance device having a check valve in the flow path, when a measuring device is attached and operating in the diagnostic mode, a much lower flow rate (e.g., about 10 L / min) may be suitable or sufficient to collect the required measurement data.

[0474] An example of the sensed flow rate data fluctuations caused by a healthy person forcefully exhaling into the measuring device is shown at 790, and the sensed flow rate data fluctuations of a patient are shown at 792. As Figure 50 shown, compared to a patient or a person with reduced or impaired lung function or performance, a healthy person causes a greater and more rapid decrease in the sensed air flow rate. In one example configuration, the sensor data (e.g., flow sensor data) can represent lung performance measurement data and / or can be processed to extract one or more lung performance measurement data values. In an exemplary configuration, the sensor data (e.g., flow or other sensor data) and / or the processed lung performance measurement data can be graphed or graphically represented for display on a user interface. In such a configuration, the graph can be further processed to identify and / or determine the health status of the user, e.g., whether healthy or sick.

[0475] Examples of lung performance measurement values that can be extracted or identified from the measurement data (e.g., sensor data such as a flow signal or flow data) of a diagnostic session are further explained below.

[0476] The pressure P exerted by the patient during an exhalation action patient can be calculated from the flow signal, for example, by applying the following equation:

[0477]

[0478] where P blower is the pressure measured at the output port of the breathing assistance device using a pressure sensor located in the flow path downstream of the air flow generator, R is the resistance to the air flow between the output port of the air flow generator and the patient (including the resistance due to the attached measuring device), Q or Q Total is the output flow rate of the air flow generator (e.g., 70 L / min in the example referred to above Figure 50 , but can be any other suitable flow rate), and the preferred value of n1 is 2, but any value between 1 and 2 can be suitable. The value of n1 can be pre-determined and is a quantified value of the laminar or turbulent degree of the air flow through the measuring device attachment.

[0479] The flow conductance (C) between the output port of the gas flow generator and the patient (including the influence of the connected measuring device) can be expressed as:

[0480]

[0481] Using the patient pressure value P patient , the flow rate Q that the patient can resist against the respiratory assistance device can be calculated as follows paient :

[0482]

[0483] where R Patient is the known flow resistance of the measuring device at the flow rate Q (i.e., the flow resistance between the connector end of the measuring device and the nozzle of the measuring device), and n2 still has a value of 2, but any value between 1 and 2 can be suitable.

[0484] Alternative methods or embodiments for extracting the Q Patient signal can also be implemented, as will be described with reference to equations (4)-(6) below. First, the leakage flow rate (Q leak ) through the exhaust hole or exhaust port of the measuring device can be estimated as:

[0485]

[0486] where n has the same definition as the previous components n1 and n2. Given that Q Total can be directly measured using one or more flow sensors downstream of the gas flow generator / blower, the controller can estimate the Q Patient signal:

[0487] Q Patient = Q Total - Q Leak (5)

[0488] Since the value of Q Leak is particularly important in this alternative method, it is important to detect the presence of a leakage air flow (i.e., determine whether the exhaust hole of the measuring device is covered / blocked) in certain configurations. This can be achieved by checks such as the following:

[0489]

[0490] where the threshold flow conductance C threshold has a predetermined value. For example, 83.2 L / min / cmH2O 1 / n . The threshold must be met within a minimum time period (e.g., in seconds) to ensure accuracy.

[0491] A variety of clinically useful pulmonary performance metrics can be extracted from the sensed data generated during the diagnostic mode, such as features or feature metric values and simulated values. These can include FEV1, FEV2, FEV3 (fraction of exhaled volume in 1, 2, and 3 seconds respectively), FVC (forced vital capacity), PEF (peak expiratory flow), or others.

[0492] Once the patient starts exhaling during an exhalation maneuver, the FEV1 value or FEV1 simulated value can be calculated by analyzing the flow data for the first second.

[0493] Similarly, once the patient starts exhaling during an exhalation maneuver, the FEV2 and FEV3 values or simulated values can be calculated by analyzing the flow data for the first two and three seconds respectively.

[0494] The FVC can be calculated by determining the total volume exhaled during the entire exhalation maneuver. For example, this can involve integrating the patient flow signal Q paient processed between the start and end of exhalation. Alternatively, the patient flow signal can instead be represented by negative fluctuations in the unprocessed sensed raw flow signal, and the FVC can be calculated based on these negative fluctuations.

[0495] The FEV1 / FVC ratio (another pulmonary performance metric) can be easily calculated based on the above FEV1 and FVC values.

[0496] The PEF can be calculated by identifying the peak patient flow, which corresponds to the highest peak in the processed patient flow signal Q paient or alternatively corresponds to the deepest "valley" in the raw flow signal, as Figure 50 shown.

[0497] Although the previous disclosure has described forced exhalation measurements, some measurements can be calculated based on the Q paient signal generated by the patient during quiet breathing or tidal breathing in the measuring device. Compared to the forced exhalation measurement mode, in the tidal breathing mode, the airflow generator output flow Q can be lower and can be, for example, 10 L / min or some other suitable flow. Examples of other measurements that can be extracted or determined during the tidal (quiet) breathing mode in the measuring device can include any one or more of the following:

[0498] The respiratory rate (RR) can be calculated by zero-crossing detection, peak detection, frequency analysis, or other suitable means for identifying the period of the processed patient flow signal Q patient .

[0499] The tidal volume (V patient can be calculated by integrating the QT )。

[0500] The above RR and V T parameters can be used to calculate the minute ventilation (MV), i.e.,

[0501] The inspiratory time period and the total respiratory time can be identified to calculate the ratio of inspiratory time to respiratory time (Ti / Ttot) by means of a zero-crossing method or some other suitable means for identifying the processed patient flow signal Q patient for a period of time.

[0502] Any one of these lung performance metrics or characteristics, either alone or in combination, is particularly useful for analyzing the status or symptoms of patients with COPD, asthma, bronchiectasis, or other respiratory diseases that affect lung health or performance. One or more of these characteristics or other suitable lung performance parameters can be used to help guide the selection of appropriate treatment settings (e.g., respiratory therapy prescriptions) for respiratory assist devices (e.g., respiratory therapy devices). For example, the FiO2 and / or flow settings can be informed, at least in part, by one or more lung performance parameters determined using a measuring device connected to a respiratory assist device operating in a diagnostic mode. The upper and / or lower bounds of the treatment setting or prescription can also be selected, at least in part, based on the lung performance parameters or metrics generated during the diagnostic mode.

[0503] In one example configuration, a clinician can receive and review the generated lung performance metrics, measurements, results, or characteristics and then provide a prescription to the patient, at least in part, based on the measurements. The prescription can define or include any one or more of the following settings or characteristics of the airflow provided during respiratory therapy: flow, oxygen concentration, and humidity level.

[0504] Table line of lung performance measurement

[0505] Any one or more of the lung performance measurements, characteristics, values, or metrics in the result data extracted, identified, or calculated from a diagnostic session with a measuring device can be presented, stored, recorded, or displayed in their native form, or as a ratio, percentage, or fraction relative to the expected values of healthy members of the user's population group or relative to some other baseline value or parameter.

[0506] For example, the PEF can be presented as "PEF as a percentage of healthy adult males or females". The expected metric values for healthy adult males or females can be stored in a lookup table or other suitable data structure, which can be stored in the memory of the device or other accessible remote memory or data repository (e.g., cloud or remote server data repository).

[0507] In another example, any one or more of the various lung performance measurements, metrics, characteristics, or values in the result data can be combined in any one or more desired ratios or functions relative to each other to generate a new and useful lung performance metric or ratio. For example, calculating the ratio or value of FEV1 / FVC can be used as a spirometry assessment. As an example, FEV1 / FVC can preferably be between 70 - 80% (or 0.7 - 0.8) to indicate good health.

[0508] Patient physiological parameters

[0509] In one example configuration, if the patient is instructed or prompted to take multiple breaths (e.g., see sub-step 760C in Figure 43 ), then one or more patient physiological parameters can be estimated, calculated, or extracted from the sensor data recorded during the multiple breath maneuvers. For example, these parameters can include any one or more of the following: tidal volume, respiratory rate, minute ventilation, and peak inspiratory flow.

[0510] 4. Terms

[0511] Unless the context otherwise indicates, the phrase "breathing assistance device" as used in the specification and claims is intended to refer to any type of breathing assistance device or respiratory device, apparatus, or system that is operable to provide breathing support or respiratory therapy to a user or patient by providing an airflow to the user or patient.

[0512] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprising," "including," and the like shall be construed in an inclusive sense, rather than an exclusive or exhaustive sense; that is, in the sense of "including, but not limited to."

[0513] Although the present disclosure has been described in the context of certain embodiments and examples, those skilled in the art will understand that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and their obvious variations and equivalents. Additionally, while several variations of the embodiments of the present disclosure have been shown and described in detail, other variations that fall within the scope of the present disclosure will be apparent to those skilled in the art. It is also contemplated that various combinations or sub - combinations of the specific features and aspects of the embodiments can be made and still fall within the scope of the present disclosure. For example, the features described in connection with one embodiment above can be used with different embodiments described herein, and such combination still falls within the scope of the present disclosure. It should be understood that the various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form varying patterns of embodiments of the present disclosure. Accordingly, the scope of the present disclosure should not be limited by the above - described specific embodiments. Thus, unless otherwise stated or unless clearly incompatible, each embodiment of the present invention may include one or more features different from those of other embodiments of the present invention disclosed herein in addition to the essential features described herein.

[0514] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or instance should be understood to be applicable to any other aspect, embodiment, or instance described in this section or elsewhere in this specification, unless incompatible. All features disclosed in this specification (including any accompanying claims, abstract, and drawings) and / or all steps of any method or process disclosed may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The protection is not limited to the details of any of the foregoing embodiments. The protection extends to any novel one or any novel combination of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one or any novel combination of the steps of any method or process disclosed.

[0515] In addition, certain features described in the context of separate respective embodiments in the present disclosure can also be implemented in a single embodiment in combination. Conversely, the various features described in the context of a single embodiment can also be implemented separately or in any suitable sub - combination in multiple embodiments. Additionally, although the features may be described above as acting in certain combinations, in some cases one or more features from the claimed combination can be deleted from the combination, and the combination can be claimed as a sub - combination or a variation of a sub - combination.

[0516] In addition, although operations may be shown in a particular order in the figures or described in the specification, it is not necessary to perform the operations in the particular order shown or in sequential order, nor is it necessary to perform all the operations to achieve the desired result. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, concurrently with, or between any of the described operations. Further, the operations may be rearranged or resequenced in other embodiments. Those skilled in the art will understand that in some embodiments, the actual steps taken in the processes shown and / or disclosed may differ from those shown in the figures. Depending on the embodiment, some of the steps described above may be removed, and other steps may be added. Additionally, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Moreover, the separation of the various system components in the above-described embodiments should not be understood to be required in all embodiments; it should be understood that the described components and systems may generally be integrated together in a single product or packaged into multiple products.

[0517] For purposes of the present disclosure, certain aspects, advantages, and novel features are described herein. Not all of these advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will understand that the present disclosure may be embodied or implemented in a manner that achieves one or a set of advantages taught herein, without necessarily achieving other advantages taught or suggested herein.

[0518] Conditional language, such as "can," "could," "may," or "might," unless specifically stated otherwise or otherwise understood within the context in which it is used, is generally intended to indicate that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language generally does not imply that the features, elements, and / or steps are required in any way for one or more embodiments, nor does it generally imply that one or more embodiments must include logic for determining whether such features, elements, and / or steps are included in or will be performed in any particular embodiment, with or without user input or prompting.

[0519] Degree language used herein, such as the terms "about," "approximately," "substantially," and "nearly" as used herein, mean values, quantities, or characteristics that are close to the recited values, quantities, or characteristics and still perform the desired function or achieve the desired result. For example, the terms "about," "approximately," "substantially," and "nearly" may refer to within 10%, 5%, 1%, 0.1%, and 0.01% of the recited quantity.

[0520] The scope of the present disclosure is not limited by the specific embodiments disclosed in this section or elsewhere in this specification, and may be defined by the claims in this section or elsewhere in the specification or in the claims to be presented in the future. The language of the claims will be construed broadly based on the language used in the claims, and will not be limited to the examples described in this specification or as being construed as non-exclusive during the examination of this application.

Claims

1. An apparatus for performing pulmonary performance measurements on a user, comprising: An air flow generator, operable to generate an air flow in a flow path; A measuring device, in fluid communication with the flow path to receive the air flow; A controller, operable to control the air flow generator to generate an air flow into the measuring device when the user performs one or more forced exhalation actions into the measuring device to provide a controlled pneumatic resistance to the user's exhalation in the flow path; and One or more sensors, configured to sense one or more characteristics of the air flow in the flow path when the user performs a forced exhalation action into the measuring device, and generate representative sensor data that can be used to derive one or more lung performance measurements (for the modification basis, please refer to the parent case specification [0521]-[0563] and the original claims 3-10).

2. An apparatus for performing pulmonary performance measurements on a user, comprising: An air flow generator, operable to generate an air flow in a flow path; A measuring device, in fluid communication with the flow path to receive the air flow; A controller, operable to control the air flow generator to generate an air flow into the measuring device when the user performs quiet breathing or tidal breathing into the measuring device to provide a controlled pneumatic resistance to the user's exhalation in the flow path; and One or more sensors, configured to sense one or more characteristics of the air flow in the flow path when the user performs quiet breathing or tidal breathing into the measuring device, and generate representative sensor data that can be used to derive one or more lung performance measurements.

3. The apparatus according to claim 1 or 2, wherein, The controller is configured to determine a user flow signal representing the flow rate that the user can cause to resist the air flow via the measuring device based at least on a function of a user pressure signal representing the pressure applied during the user's exhalation into the measuring device.

4. The apparatus according to claim 1 or 2, wherein, The controller is configured to determine a user flow signal representing the flow rate that the user can cause to resist the air flow via the measuring device based at least on a function of a flow resistance parameter associated with the measuring device.

5. The apparatus according to claim 1 or 2, wherein, The controller is configured to determine a user flow signal representing the flow rate that the user can cause to resist the air flow via the measuring device based at least on a function of a conductance parameter.

6. The apparatus according to claim 5, wherein, The controller is configured to determine a conductance parameter based at least on a function of a flow signal representing the flow rate of the air flow generated by the air flow generator and a user pressure signal representing the pressure applied by the user during exhalation into the measuring device.

7. The apparatus according to claim 3, wherein, The controller is configured to determine the user pressure signal based at least on a function of a pressure signal representing the outlet pressure of the air flow generator, a flow resistance parameter, and a flow signal representing the flow rate of the air flow generated by the air flow generator.

8. The apparatus according to claim 6, wherein, The controller is configured to determine the user pressure signal based at least on a function of a pressure signal representing the outlet pressure of the air flow generator, a flow resistance parameter, and a flow signal representing the flow rate of the air flow generated by the air flow generator.

9. The apparatus according to claim 1 or 2, wherein, The controller is configured to determine a user flow signal representing the flow rate that the user can cause to resist the air flow via the measuring device based at least on a function of a flow signal representing the flow rate of the air flow generated by the air flow generator and a leakage flow signal representing the leakage flow rate through one or more exhaust ports of the measuring device.

10. The apparatus according to claim 9, wherein, The controller is configured to determine the leakage flow signal based at least on a function of a conductance parameter and a user pressure signal representing the pressure applied by the user during exhalation into the measuring device.

11. The apparatus according to claim 10, wherein, The controller is configured to determine the user pressure signal based at least on a function of a pressure signal for representing the outlet pressure of the airflow generator, a flow resistance parameter, and a flow signal for representing the airflow rate generated by the airflow generator.

12. The apparatus according to claim 3, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a breathing frequency signal or parameter for the user based at least in part on or at least according to the determined user flow signal.

13. The apparatus according to claim 4, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a breathing frequency signal or parameter for the user based at least in part on or at least according to the determined user flow signal.

14. The apparatus according to claim 5, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a breathing frequency signal or parameter for the user based at least in part on or at least according to the determined user flow signal.

15. The apparatus according to claim 9, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a breathing frequency signal or parameter for the user based at least in part on or at least according to the determined user flow signal.

16. The apparatus according to claim 2, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a tidal volume signal or parameter for the user based at least in part on or at least according to the determined user flow signal representing the flow rate at which the user can cause a resistive airflow via the measuring device.

17. The apparatus according to claim 16, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a breathing frequency signal or parameter for the user based at least in part on or at least according to the determined user flow signal; wherein the controller is configured to determine a minute ventilation signal or parameter for the user based at least in part on or at least according to the determined breathing frequency signal and the determined tidal volume signal.

18. The device according to claim 3, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a signal or parameter for representing the ratio of the inspiratory time to the total breathing time based at least in part on or at least according to the determined user flow signal.

19. The device according to claim 4, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a signal or parameter for representing the ratio of the inspiratory time to the total breathing time based at least in part on or at least according to the determined user flow signal.

20. The device according to claim 5, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a signal or parameter for representing the ratio of the inspiratory time to the total breathing time based at least in part on or at least according to the determined user flow signal.

21. The device according to claim 9, wherein, When the user performs tidal breathing into the measuring device, the controller is configured to determine a signal or parameter for representing the ratio of the inspiratory time to the total breathing time based at least in part on or at least according to the determined user flow signal.

22. The device according to claim 1 or 2, wherein, The one or more sensors are configured to measure or determine any one or more of the following characteristics of the airflow: flow rate, pressure, temperature, humidity.

23. The device according to claim 1 or 2, wherein, The one or more sensors are external to or separated from the measuring device.

24. The device according to claim 1 or 2, wherein, The one or more sensors are located in the flow path upstream of the measuring device or are configured to sense the airflow upstream of the measuring device.

25. The device according to claim 1 or 2, wherein, The airflow generator is enclosed or housed in the main housing of the device, and the one or more sensors are located within the main housing of the device.

26. The device according to claim 1 or 2, wherein, The measuring device includes a body extending between a connector end and a mouthpiece end, the body including a main chamber for airflow extending between the connector end and the mouthpiece end.

27. The device according to claim 26, wherein, The body is a conduit or tubular member having an opening at each end.

28. The device according to claim 26, wherein, The connector end of the body is configured to releasably connect to the end of a breathing conduit for outputting airflow to a user.

29. The device according to claim 26, wherein, The connector end of the body is integrally or permanently connected to the end of a breathing conduit for outputting airflow to a user.

30. The device according to claim 26, wherein, The connector end of the body includes one or more openings or ports for fluid connection to the end of a breathing conduit for outputting airflow to a user.

31. The device according to claim 26, wherein, The mouthpiece end of the body is configured to receive a detachable mouthpiece, the detachable mouthpiece being configured to provide fluid communication to a user's airway in use.

32. The device according to claim 26, wherein, The mouthpiece end of the body is a mouthpiece configured to provide fluid communication to a user's airway in use.

33. The device according to claim 26, wherein, The body of the measuring device further includes one or more exhaust ports in fluid communication with the main chamber.

34. The device according to claim 33, wherein, The measuring device further includes one or more anti-blocking features configured to prevent accidental blockage of the one or more exhaust ports.

35. The device according to claim 34, wherein, The anti-blocking feature is arranged or configured as a clip for mounting the measuring device.

36. The device according to claim 33, wherein, The one or more exhaust ports are provided on the body between the connector end and the mouthpiece end.

37. The device according to claim 33, wherein, The one or more exhaust ports are exhaust holes.

38. The device according to claim 37, wherein, The one or more exhaust holes include a single opening.

39. The device according to claim 37, wherein, The one or more exhaust holes include multiple openings.

40. The device according to claim 37, wherein, The one or more exhaust holes include multiple openings or holes in a honeycomb or mesh structure or arrangement.

41. The device according to claim 33, wherein, The one or more exhaust ports are flush exhaust holes provided in the wall of the body such that the flush exhaust holes are substantially flush with the outer surface of the body.

42. The device according to claim 33, wherein, The one or more exhaust ports are protruding exhaust holes protruding from the wall of the body.

43. The device according to claim 42, wherein, The one or more protruding exhaust holes are shaped and / or configured to direct or deflect the exhaust leaving the exhaust holes away from the user's face when the measuring device is in use.

44. The device according to claim 43, wherein, The body is defined by a longitudinal axis extending between the connector end and the mouthpiece end, and the one or more protruding exhaust holes extend angularly relative to the longitudinal axis such that the exhaust leaving the exhaust holes is directed or deflected away from the user's face when the measuring device is in use.

45. The device according to claim 1 or 2, wherein, The device further includes a humidifier operable to heat and humidify the airflow generated by an airflow generator.

46. The device according to claim 45, wherein, The humidifier is provided in the main housing of the device, the main housing further including an airflow generator.

47. The device according to claim 1 or 2, wherein, The controller includes a patient diagnosis mode operable to control the airflow to provide a controlled pneumatic resistance when the measuring device is connected to a flow path.

48. The device according to claim 1 or 2, wherein, The controller includes one or more operating modes, the one or more operating modes at least including a first mode operable to control the device when the measuring device is not connected to a flow path and a second mode operable to control the device when the measuring device is connected to a flow path.

49. The respiratory assistance device according to claim 1 or 2, wherein, The controller includes a plurality of operating modes, the plurality of operating modes at least including: a treatment mode operable to control the device to provide airflow to a user for respiratory therapy; and a patient diagnosis mode operable to control the airflow to provide a pneumatic resistance for performing lung performance measurements when the measuring device is connected to a flow path.

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