MEASUREMENT DEVICE AND SYSTEM FOR RESPIRATORY ASSISTANCE APPLICATIONS AND / OR FOR PERFORMING DIAGNOSIS - Patent application

Abstract

A measuring device for use with a respiratory assistance apparatus to measure lung performance. The device has a body releasably connectable to a gas outlet or breathing conduit of the respiratory assistance apparatus. The body conveys a flow of gas from the gas outlet to a user. The main conduit body has a connector end connectable to the gas outlet of the respiratory assistance apparatus to receive the flow of gas and a mouthpiece end to provide fluid communication to the airway of the user. One or more main lumens extend between the connector end and the mouthpiece end to convey the flow of gas. One or more exhaust openings are provided on the body between the ends and in fluid communication with the one or more main lumens.

Description

[Technical field]

[0001] The present disclosure relates to measurement devices and systems for respiratory assistance apparatus and / or for performing diagnostics, in particular to measurement devices and / or systems for performing diagnostics or measurements of lung performance or function. [Background technology]

[0002] Respiratory support devices are used in a variety of environments, such as hospitals, medical facilities, residential care or home environments, to deliver a flow of gas to a user or patient. The respiratory support device or respiratory therapy device may be used to deliver supplemental oxygen or other gases along with the flow of gas, and / or a humidification device may be used to deliver heated and humidified gas. The respiratory support device allows for the regulation and control of characteristics of the gas flow, including flow rate, temperature, gas concentration, humidity, pressure, etc. Sensors, such as flow and / or pressure sensors, are used to measure the characteristics of the gas flow. Summary of the Invention [Means for solving the problem]

[0003] The present disclosure relates to measurement devices and systems for use with respiratory assistance apparatus to diagnose or measure lung performance or function.

[0004] In one configuration, the measurement device may be used to perform spirometry or to obtain measurements indicative of, related to, or similar to spirometry, in which case the measurement device may be considered a surrogate spirometer attachment.

[0005] In another configuration, the measurement device may be used to make other measurements or diagnostics regarding the user's pulmonary function or performance.

[0006] In one configuration, the measuring device may be an auxiliary component or attachment that may be connected to a gas outlet of the respiratory assistance apparatus or to an end of a breathing circuit conduit of or connected to the respiratory assistance apparatus so that the measuring device receives a flow of gas from the respiratory assistance apparatus.

[0007] The present disclosure provides a measurement device and system for making measurements of pulmonary performance or function using respiratory assistance apparatus.

[0008] In one aspect, the present disclosure broadly includes a respiratory assistance apparatus configured to provide a flow of gas to a user for respiratory therapy, the respiratory assistance apparatus including a flow generator operable to generate a flow of gas along a flow path of the apparatus, a respiratory conduit for delivering the flow of gas to the user, a measurement device for lung performance fluidly connected or connectable to an end of the respiratory conduit for receiving the flow of gas, and a controller operable to control the respiratory assistance apparatus, the controller configured to control the flow of gas into the measurement device to provide a controlled air resistance to the user's exhalation when the user performs one or more forced exhalation maneuvers into the measurement device.

[0009] In one aspect, the present disclosure broadly includes a respiratory assistance apparatus configured to provide a flow of gas to a user for respiratory therapy, the respiratory assistance apparatus including a flow generator operable to generate a flow of gas along a flow path of the apparatus, a respiratory conduit for delivering the flow of gas to the user, a measurement device for lung performance fluidly connected or connectable to an end of the respiratory conduit for receiving the flow of gas, and a controller operable to control the respiratory assistance apparatus, the controller configured to control the flow of gas into the measurement device to provide a controlled air resistance to the user's exhalation when the user is breathing at rest or normally spontaneously into the measurement device.

[0010] In one configuration, the controller is configured to determine a user flow signal representative of the flow that a user can induce for a flow of gas through the measuring device based on a function of at least a user pressure signal representative of the pressure applied by the user during exhalation into the measuring device.

[0011] In one configuration, the controller is configured to determine a user flow signal representative of a flow that a user can induce on a flow of gas through the measurement device based on a function of at least a flow resistance parameter for the measurement device.

[0012] In one configuration, the controller is configured to determine a user flow signal representative of a flow that a user can induce on the flow of gas through the measurement device based on at least a function of the flow conductance parameter.

[0013] In one configuration, the controller is configured to determine the flow conductance parameter based on a function of at least a flow signal representing the flow rate of the flow of gas generated by the flow generator and a user pressure signal representing the pressure applied by the user during exhalation into the measurement device.

[0014] In one configuration, the controller is configured to determine a user pressure signal based on a function of at least a pressure signal representing the pressure at the outlet of the flow generator, a flow resistance parameter, and a flow signal representing a flow rate of the flow of gas generated by the flow generator.

[0015] In one configuration, the controller is configured to determine a user flow signal representing a flow that a user can induce on the flow of gas through the measurement device based on a function of at least a flow signal representing a flow rate of the flow of gas generated by the flow generator and a leak flow signal representing a leak flow through one or more exhaust openings of the measurement device.

[0016] In one configuration, the controller is configured to determine the leak flow signal based on a function of at least the flow conductance parameter and a user pressure signal representative of pressure exerted by a user during exhalation into the measurement device.

[0017] In one configuration, the controller is configured to determine a user pressure signal based on a function of at least a pressure signal representative of the pressure at the outlet of the flow generator, a flow resistance parameter, and a flow signal representative of a flow rate of the gas flow generated by the flow generator.

[0018] In one configuration, the controller is configured to determine a user's respiratory rate signal or parameter based at least in part on or as a function of the determined user flow signal when the user breathes normally spontaneously into the measurement device.

[0019] In one configuration, the controller is configured to determine a user tidal volume signal or parameter based at least in part on or as a function of the determined user flow signal when the user breathes normally spontaneously into the measurement device.

[0020] In one configuration, the controller is configured to determine a minute ventilation signal or parameter of the user based at least in part on or as a function of at least the determined breathing rate signal and tidal volume signal.

[0021] In one configuration, the controller is configured to determine a signal or parameter representative of the ratio of inspiration time to total breathing time based at least in part on or as a function of the determined user flow signal when the user breathes normally spontaneously into the measurement device.

[0022] In one configuration, the device includes one or more sensors for sensing or determining one or more characteristics of the flow of gas and generating representative sensor data.

[0023] In one configuration, the one or more sensors are configured to measure or determine any one or more of the following characteristics of the flow of gas: flow rate, pressure, temperature, humidity.

[0024] In one configuration, the one or more sensors are external to or separate from the measuring device.

[0025] In one configuration, one or more sensors are located in the flow path upstream of the measurement device or configured to sense the flow of gas upstream of the measurement device.

[0026] In one configuration of the device, the flow generator is enclosed or housed within a main housing of the device, and the one or more sensors are located within the main housing and / or breathing conduit of the device.

[0027] In one configuration, the measurement device includes a body extending between a connector end and a mouthpiece end, the body including one or more main lumens extending between the connector end and the mouthpiece end for the flow of gas.

[0028] In one configuration, the body is a conduit or tubular component having one or more openings at each end.

[0029] In one configuration, the connector end of the body is configured to be releasably connected to an end of the respiratory conduit.

[0030] In one configuration, the connector end of the body is integrally or permanently connected to the end of the respiratory conduit.

[0031] In one configuration, the connector end of the body includes one or more openings or ports for fluidly connecting to the end of the breathing conduit.

[0032] In one configuration, the mouthpiece end of the body is configured to receive a removable mouthpiece that is configured to provide fluid communication to the user's airway in use.

[0033] In one configuration, the mouthpiece end of the body is a mouthpiece configured to provide fluid communication to the airway of a user in use.

[0034] In one configuration, the body of the measurement device further comprises one or more exhaust openings in fluid communication with the main lumen or lumens.

[0035] In one configuration, the measurement device further comprises one or more anti-occlusion features configured to prevent inadvertent obstruction of the one or more drainage openings.

[0036] In one configuration, the anti-occlusion feature is arranged or configured as a clip for attaching the measurement device.

[0037] In one configuration, one or more exhaust openings are provided on the body between the connector end and the mouthpiece end.

[0038] In one configuration, one or more of the exhaust openings is a vent.

[0039] In one configuration, one or more of the vents includes a single opening.

[0040] In one configuration, one or more of the vents includes a plurality of openings.

[0041] In one configuration, one or more of the vents includes a plurality of openings or holes in the form of a honeycomb or mesh structure or arrangement.

[0042] In one configuration, one or more of the exhaust openings are flush vents provided in a wall of the body such that the flush vent is substantially flush with an outer surface of the body.

[0043] In one configuration, one or more of the exhaust openings is a protruding vent that protrudes from a wall of the body.

[0044] In one configuration, one or more of the protruding vents are shaped and / or configured to direct or deflect any exhaust gases exiting the vent away from the user's face when the measurement device is in use.

[0045] In one configuration, the body is defined by a longitudinal axis extending between the connector end and the mouthpiece end, and one or more of the protruding vents extend at an angle to the longitudinal axis such that when the measurement device is in use, any exhaust gases exiting the vents are directed or deflected away from the user's face.

[0046] In one configuration, the apparatus further includes a humidifier operable to heat and humidify the flow of gas generated by the flow generator.

[0047] In one configuration, the humidifier is provided within a main housing of the device, the main housing further including the flow generator.

[0048] In one configuration, the controller includes a patient diagnostic mode operable to control the flow of gas to provide a controlled air resistance when the measurement device is connected to the end of the breathing conduit.

[0049] In one configuration, the controller includes one or more operating modes including at least a first mode operable to control the apparatus when the measurement device is not connected to the respiratory conduit, and a second mode operable to control the apparatus when the measurement device is connected to the respiratory conduit.

[0050] In one configuration, the controller includes a number of operating modes including at least a therapy mode operable to control the apparatus to provide a flow of gas to a user for respiratory therapy, and a patient diagnostic mode operable to control the flow of gas to provide air resistance for taking pulmonary performance measurements when the measurement device is connected to the respiratory conduit.

[0051] In one aspect, the disclosure broadly includes an apparatus for performing pulmonary performance measurements on a user, the apparatus including: a flow generator operable to generate a flow of gas in a flow path; a measurement device in fluid communication with the flow path to receive the flow of gas; a controller operable to control the flow generator to generate a flow of gas into the measurement device to provide a controlled air resistance in the flow path to the user's exhalation 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 flow of gas in the flow path when the user performs one or more forced exhalation maneuvers into the measurement device and generate representative sensor data from which one or more pulmonary performance measurements may be obtained.

[0052] In one aspect, the disclosure broadly includes an apparatus for performing pulmonary performance measurements on a user, the apparatus including: a flow generator operable to generate a flow of gas in a flow path; a measurement device in fluid communication with the flow path to receive the flow of gas; a controller operable to control the flow generator to generate a flow of gas into the measurement device to provide a controlled air resistance in the flow path to the user's exhaled breath when the user is breathing quietly or normally breathing into the measurement device; and one or more sensors configured to sense one or more characteristics of the flow of gas in the flow path when the user is breathing quietly or normally breathing into the measurement device and generate representative sensor data from which one or more pulmonary performance measurements may be obtained.

[0053] In one aspect, the present disclosure broadly includes a measurement device for use with a respiratory assistance apparatus to measure lung performance, the measurement device including a body releasably connectable to a gas outlet or respiratory conduit of the respiratory assistance apparatus and configured to deliver a flow of gas from the gas outlet to a user, the main conduit body including a connector end connectable to the gas outlet of the respiratory assistance apparatus to receive the flow of gas, a mouthpiece end for providing fluid communication to the user's airway in use, one or more main lumens extending between the connector end and the mouthpiece end, the one or more main lumens for delivering the flow of gas, and one or more exhaust openings provided on the body between the ends and in fluid communication with the one or more main lumens.

[0054] In one configuration, the body is a conduit or tubular component having one or more openings at each end.

[0055] In one configuration, the connector end of the body is configured to be releasably connectable to a gas outlet or end of a breathing conduit of a respiratory assistance device.

[0056] In one configuration, the connector end of the body includes one or more openings or ports for fluidly connecting to a gas outlet or breathing conduit of a respiratory assistance device.

[0057] In one configuration, the mouthpiece end of the body is configured to receive a removable mouthpiece that is configured to provide fluid communication to the user's airway in use.

[0058] In one configuration, the mouthpiece end of the body is a mouthpiece configured to provide fluid communication to the airway of a user in use.

[0059] In one configuration, the body of the measurement device further comprises one or more exhaust openings in fluid communication with the main lumen or lumens.

[0060] In one configuration, the measurement device further comprises one or more anti-occlusion features configured to prevent inadvertent obstruction of the one or more drainage openings.

[0061] In one configuration, the anti-occlusion feature is arranged or configured as a clip for attaching the measurement device.

[0062] In one configuration, one or more exhaust openings are provided on the body between the connector end and the mouthpiece end.

[0063] In one configuration, one or more of the exhaust openings is a vent.

[0064] In one configuration, one or more of the vents includes a single opening.

[0065] In one configuration, one or more of the vents includes a plurality of openings.

[0066] In one configuration, one or more of the vents includes a plurality of openings or holes in the form of a honeycomb or mesh structure or arrangement.

[0067] In one configuration, one or more of the exhaust openings are flush vents provided in a wall of the body such that the flush vent is substantially flush with an outer surface of the body.

[0068] In one configuration, one or more of the exhaust openings is a protruding vent that protrudes from a wall of the body.

[0069] In one configuration, one or more of the protruding vents are shaped and / or configured to direct or deflect any exhaust gases exiting the vent away from the user's face when the measurement device is in use.

[0070] In one configuration, the body is defined by a longitudinal axis extending between the connector end and the mouthpiece end, and one or more of the protruding vents extend at an angle to the longitudinal axis such that when the measurement device is in use, any exhaust gases exiting the vents are directed or deflected away from the user's face.

[0071] In one aspect, the disclosure broadly comprises a method of measuring pulmonary performance using a measurement device with a respiratory assistance apparatus, the method comprising the steps of: connecting the measurement device to a gas outlet, or breathing conduit, or flow path of the respiratory assistance apparatus such that the measurement device receives a flow of gas from a flow generator of the respiratory assistance apparatus; operating the respiratory assistance apparatus in a patient diagnostic mode configured to enable one or more pulmonary performance measures to be determined; instructing a user to perform one or more forced exhalation maneuvers into the measurement device; and determining one or more characteristics of the flow of gas using one or more sensors during the forced exhalation maneuvers.

[0072] In one aspect, the present disclosure broadly comprises a method of measuring pulmonary performance using a measurement device with a respiratory assistance apparatus, the method comprising the steps of: connecting the measurement device to a gas outlet, or breathing conduit, or flow path of the respiratory assistance apparatus such that the measurement device receives a flow of gas from a flow generator of the respiratory assistance apparatus; operating the respiratory assistance apparatus in a patient diagnostic mode configured to enable one or more pulmonary performance measures to be determined; instructing a user to breathe quietly or normally spontaneously into the measurement device; and determining one or more characteristics of the flow of gas using one or more sensors during the quiet or normal spontaneous breathing.

[0073] In one configuration, the patient diagnostic mode of the respiratory assistance apparatus is configured to generate a flow of gas to a gas outlet and / or breathing conduit connected to the measurement device.

[0074] In one configuration, the patient diagnostic mode of the respiratory assistance device is configured to generate a flow of gas at a constant rate.

[0075] In one configuration, the constant flow rate of the flow of gas is configured to provide a substantially constant or consistent air resistance to the user's exhaled breath into the measurement device.

[0076] In one configuration, the patient diagnostic mode of the respiratory assistance device is configured to generate a flow of gas for a fixed duration or predetermined period.

[0077] In one arrangement, operating the respiratory assistance device in a patient diagnostic mode includes initiating or activating the patient diagnostic mode in response to user input via a user interface.

[0078] In one configuration, user input to initiate or activate the patient diagnostic mode is provided via a user interface of the respiratory assistance device.

[0079] In one configuration, the user interface of the respiratory assistance device includes a button and / or a touch screen interface button operable by the user or another person to activate a patient diagnostic mode.

[0080] In one configuration, user input to initiate or activate the patient diagnostic mode is provided via a user interface of an external device in data communication with the respiratory assistance apparatus.

[0081] In one configuration, the user interface of the device includes a button and / or a touch screen interface button operable by the user or another to activate a patient diagnostic mode.

[0082] In one configuration, the method further includes prompting a user or other person to initiate or activate a patient diagnostic mode via a user interface.

[0083] In one configuration, prompting a user or other to initiate or activate a patient diagnostic mode includes providing a prompt via the respiratory assistance device.

[0084] In one configuration, the prompting includes generating an audio prompt by the respiratory assistance device.

[0085] In one configuration, the prompting includes generating a visual prompt on a display or interface of the respiratory assistance device.

[0086] In one configuration, prompting a user or other to initiate or activate a patient diagnostic mode includes providing a prompt on an external device in data communication with the respiratory assistance apparatus.

[0087] In one configuration, prompting a user or other to initiate or activate a patient diagnostic mode includes prompting according to periodic intervals.

[0088] In one configuration, the periodic interval is configurable.

[0089] In one configuration, the method includes configuring the periodic interval of the prompting via a user interface of the respiratory assistance device.

[0090] In one configuration, the method includes configuring the periodic interval between prompts via a user interface or software application of an external device in data communication with the respiratory assistance apparatus.

[0091] In one configuration, the periodic intervals between prompts are remotely configurable by a clinician, doctor or medical professional using an external device.

[0092] In one configuration, prompting a user or other person to initiate or activate a patient diagnostic mode includes initiating or triggering a prompt in response to input or interaction by a clinician, doctor or medical professional using a remote or external device in data communication with the respiratory assistance apparatus.

[0093] In one configuration, the patient diagnostic mode of the respiratory assistance device is automatically initiated or activated.

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

[0095] In one configuration, the periodic interval for automatically initiating or initiating the patient diagnostic mode is configurable.

[0096] In one configuration, the method includes configuring a periodic interval for the patient diagnostic mode via a user interface of the respiratory assistance device.

[0097] In one configuration, the method includes configuring the periodic interval of the patient diagnostic mode via a user interface or software application of an external device in data communication with the respiratory assistance apparatus.

[0098] In one configuration, the periodic interval of the patient diagnostic mode is remotely configurable by a clinician, doctor or medical professional using an external device.

[0099] In one configuration, the respiratory assistance apparatus includes one or more communications modules configured to provide data communication between one or more external or remote devices.

[0100] In one configuration, determining one or more characteristics of the flow of gas during a forced expiratory maneuver or normal spontaneous breathing includes using one or more sensors of the respiratory assistance device.

[0101] In one configuration, determining one or more characteristics of the flow of gas during a forced expiratory maneuver or normal spontaneous breathing includes using one or more sensors in the flow path upstream of the measuring device or one or more sensors configured to sense the flow of gas upstream of the measuring device.

[0102] In one configuration, the method further includes providing instructions to a user, via a user interface of the respiratory assistance device, on how to connect the measurement device to the device, use the measurement device, and / or perform a forced exhalation maneuver or normal spontaneous breathing into the mouthpiece during a diagnostic session.

[0103] In one configuration, the instructions are provided or presented visually and / or audibly on a display of the user interface.

[0104] In one configuration, the method further comprises graphically presenting the sensor data from the one or more sensors or one or more pulmonary performance measures generated from the sensor data on a display of a user interface of the respiratory assistance device.

[0105] In one configuration, the method further includes processing the sensor data from the one or more sensors to generate pulmonary performance measurement data and / or one or more representative graphs or graphs of the sensor data and / or the pulmonary performance measurement data.

[0106] In one configuration, the method further comprises processing the pulmonary performance measurement data and / or the graph to identify or determine a health state of the user.

[0107] In one aspect, the present disclosure broadly includes a non-transitory computer-readable medium having stored thereon computer-executable instructions that, when executed on one or more processing devices, cause the one or more processing devices to perform any method of any one or more of the aspects described above.

[0108] In one aspect, the present disclosure broadly includes an application program interface or set of application program interfaces (APIs) embodied on a computer-readable medium for execution on a processing device in conjunction with an application program that performs any of the methods of any one or more of the aspects described above.

[0109] Any aspect of the present disclosure described above may further include any one or more of the aspects or features mentioned with respect to any one or more of the other aspects.

[0110] These and other features, aspects, and advantages of the present disclosure will be described with reference to drawings of specific embodiments, which are intended to illustrate specific embodiments and are not intended to limit the disclosure. [Brief description of the drawings]

[0111] [Figure 1] 1 illustrates generally a respiratory assistance device configured to provide respiratory therapy to a patient. [Diagram 2] FIG. 1 is a front view of an exemplary respiratory assistance device with a humidification chamber in place and a raised handle / lever. [Diagram 3] FIG. 3 is a plan view corresponding to FIG. 2. [Figure 4] FIG. 3 is a right side view corresponding to FIG. 2. [Diagram 5] FIG. 3 is a left side view corresponding to FIG. 2. [Figure 6] FIG. 3 is a rear view corresponding to FIG. 2. [Figure 7] FIG. 3 is a left front perspective view corresponding to FIG. 2. [Figure 8] FIG. 3 is a right front perspective view corresponding to FIG. 2. [Figure 9] FIG. 3 is a bottom view corresponding to FIG. 2. [Figure 10] 1 shows an exemplary configuration of air and oxygen inlet arrangements for a respiratory assistance device. [Figure 11] 1 shows another exemplary configuration of the air and oxygen inlet arrangement of the respiratory assistance device. [Figure 12] FIG. 12 is a cross-sectional view showing further details of the air and oxygen inlet arrangement of FIG. [Figure 13] FIG. 12 is another cross-sectional view showing further details of the air and oxygen inlet arrangement of FIG. [Figure 14] FIG. 12 is a longitudinal section showing further details of the air and oxygen inlet arrangement of FIG. [Figure 15] FIG. 2 is an exploded view of the upper and lower chassis components of the main housing of the respiratory assistance device. [Figure 16]FIG. 13 is a front left perspective view of the lower chassis of the main housing showing the housing for receiving the motor / sensor module subassembly. [Figure 17] FIG. 1 is a first bottom perspective view of the main housing of the respiratory assistance device showing a recess within the housing for the motor / sensor module subassembly. [Figure 18] FIG. 13 is a second bottom perspective view of the main housing of the respiratory assistance apparatus showing the recess for the motor / sensor module subassembly. [Figure 19A] A block diagram of a control system that interacts with and / or provides control and direction to components of the respiratory assistance apparatus is shown. [Figure 19B] FIG. 2 illustrates a block diagram of an exemplary controller. [Figure 20] FIG. 2 shows a block diagram of the motor and sensor module. [Figure 21] 1 illustrates a sensing chamber of an exemplary motor and sensor module. [Figure 22] FIG. 2 shows a schematic diagram of the respiratory assistance apparatus of FIG. 1 with an embodiment of a measurement device connected to the end of a respiratory conduit for measuring lung performance in a patient diagnostic mode of the apparatus in one embodiment. [Figure 23] FIG. 2 shows a perspective view from the connector end of a measuring device in a first exemplary embodiment. [Figure 24] FIG. 24 shows a perspective view from the mouthpiece end of the measurement device of FIG. 23. [Diagram 25] FIG. 24 shows a first side view of the measuring device of FIG. 23. [Figure 26] FIG. 24 shows a second side view of the measuring device of FIG. 23. [Figure 27] FIG. 24 shows a bottom view of the measuring device of FIG. 23. [Figure 28] 24 shows a plan view of the measuring device of FIG. 23. [Figure 29] FIG. 24 shows a first end view of the measurement device of FIG. 23 from the mouthpiece end. [Diagram 30] FIG. 24 shows a second end view of the measuring device of FIG. 23 from the connector end. [Diagram 31] 31 shows a cross-sectional view of the measuring device through line AA in FIGS. 29 and 30. FIG. [Diagram 32] 24 shows an enlarged perspective view of the connector end of the measurement device of FIG. 23. [Diagram 33] FIG. 2 shows a first end perspective view of a first exemplary embodiment of a removable mouthpiece for a measurement device. [Diagram 34] FIG. 34 shows a second end perspective view of the removable mouthpiece of FIG. 33. [Diagram 35] FIG. 34 shows a side view of the removable mouthpiece of FIG. [Diagram 36] 36 shows a cross-sectional view of the removable mouthpiece through line DD in FIG. 35. [Figure 37] 34 shows a perspective view of the measurement device of FIG. 23 assembled with the removable mouthpiece of FIG. 33 in one embodiment. [Figure 38] FIG. 38 shows an exploded perspective view of the measurement device and removable mouthpiece of FIG. 37. [Figure 39] FIG. 38 shows a side view of a measurement device assembled with the mouthpiece of FIG. 37. [Diagram 40] 39 shows a cross-sectional view of the measurement device with the mouthpiece assembled thereto, taken through line EE in FIG. [Diagram 41] FIG. 40 shows a side cross-sectional view of the measurement device with the assembled mouthpiece of FIG. 39. [Diagram 42] FIG. 1 is a flow diagram of a process for making pulmonary performance measurements using a measurement device and a respiratory assistance apparatus, according to one exemplary configuration. [Diagram 43] FIG. 13 is a flow diagram of a prompt to instruct a user to perform a forced exhalation maneuver, according to one exemplary configuration. [Diagram 44] FIG. 11 is a flow diagram of a process for making pulmonary performance measurements using a measurement device and a respiratory assistance apparatus according to another exemplary configuration. [Fig. 45A-45C] 13 illustrates an exemplary schematic GUI display screen prompt instructing a user to disconnect the patient interface, according to an exemplary configuration. [Figures 46A-46C]13 shows an exemplary schematic GUI display screen prompt instructing a user to connect a measurement device attachment to a fluid path of a respiratory assistance apparatus. [Figures 47A-47C] 13 illustrates an exemplary schematic GUI display screen prompt instructing a user to perform a forced exhalation maneuver according to an exemplary configuration. [Fig. 47D-47F] 13 illustrates an exemplary schematic GUI display screen prompt instructing a user to perform a forced exhalation maneuver according to an exemplary configuration. [Fig. 48A-48B] 13 illustrates an exemplary schematic GUI display screen prompt instructing a user to breathe normally following a forced exhalation maneuver, according to an exemplary configuration. [Figure 49] 13 shows an exemplary schematic GUI display screen prompt instructing a user to connect a patient interface to the device for a treatment session. [Figure 50] 1 is a graph of exemplary sensed respiratory data for healthy and sick subjects performing pulmonary performance measurements using a measurement device and a respiratory assistance apparatus; [Figure 51] 13 shows a perspective view from the connector end of a measuring device in a second exemplary embodiment. [Figure 52] FIG. 52 shows a perspective view from the mouthpiece end of the measurement device of FIG. 51. [Diagram 53] FIG. 52 shows a first side view of the measuring device of FIG. 51. [Figure 54] 52 shows a second side view of the measuring device of FIG. 51. [Figure 55] 52 shows a plan view of the measuring device of FIG. 51. [Figure 56] 52 shows a bottom view of the measuring device of FIG. 51. [Figure 57] FIG. 52 shows a first end view of the measurement device of FIG. 51 from the mouthpiece end. [Figure 58] 52 shows a second end view of the measuring device of FIG. 51 from the connector end. [Figure 59] 57 and 58 through line AA. [Figure 60] 52 shows an enlarged perspective view of the connector end of the measurement device of FIG. 51. [Figure 61] FIG. 2 shows a first end perspective view of a second exemplary embodiment of a removable mouthpiece for a measurement device. [Figure 62] FIG. 62 shows a second end perspective view of the removable mouthpiece of FIG. 61. [Figure 63] FIG. 62 shows a plan view of the removable mouthpiece of FIG. [Figure 64] 64 shows a cross-sectional view of the removable mouthpiece taken through line BB in FIG. 63. [Figure 65] FIG. 62 shows a side view of the removable mouthpiece of FIG. [Figure 66] 66 shows a cross-sectional view of the removable mouthpiece taken through line CC of FIG. 65. [Figure 67] 62 shows a perspective view of the measurement device of FIG. 51 assembled with the removable mouthpiece of FIG. 61 in one embodiment. [Figure 68] 68 shows an exploded perspective view of the measurement device and removable mouthpiece of FIG. 67. [Figure 69] FIG. 68 shows a side view of a measuring device assembled with the mouthpiece of FIG. [Figure 70] 69 shows a cross-sectional view of the measuring device with the mouthpiece assembled thereto, taken along line DD in FIG. [Figure 71] FIG. 68 shows a plan view of a measuring device assembled with the mouthpiece of FIG. [Figure 72] 72 shows a cross-sectional view of the measuring device with the mouthpiece assembled thereto, taken through line EE of FIG. 71. [Figure 73] FIG. 68 shows a first perspective view of a measurement device having an assembled mouthpiece of FIG. 67 including a clip structure. [Figure 74] FIG. 74 shows a second perspective view of the measurement device with the assembled mouthpiece and clip arrangement of FIG. 73. [Figure 75] FIG. 74 shows a side view of the measurement device with the assembled mouthpiece and clip structure of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0112] Although specific examples are described below, those skilled in the art will appreciate that the disclosure extends beyond the specifically disclosed examples and / or uses and their obvious modifications and equivalents. Thus, it is not intended that the scope of the disclosure disclosed herein should be limited by any specific examples described below.

[0113] 1. Overview of the measurement device and system A measuring device is an attachment or auxiliary component for use with a respiratory aid apparatus to generally perform measurements and / or diagnostic measurements of lung performance or function. The measuring device attachment is configured to fluidly connect or couple to or otherwise be in fluid communication with a flow of gas produced by the respiratory aid apparatus. For example, in one configuration, the measuring device attachment is configured to attach or connect to an end of or partway along a flow path of the respiratory aid apparatus to receive the flow of gas produced by the respiratory aid apparatus.

[0114] In one configuration, the measurement device may be attached or connected to the end of a patient respiratory conduit, such as a flexible respiratory conduit or tubing that is connected to the gas outlet of the apparatus.

[0115] In another configuration, the measurement device can be attached or connected directly to the gas outlet or any other accessible outlet or port along the flow path of the respiratory aid apparatus. In one example, the measurement device can be attached to the gas outlet or patient outlet port of the apparatus, which typically mates or connects with the patient breathing conduit. In another example, the respiratory aid apparatus can include a removable humidification chamber in fluid communication with the flow generator to receive the flow of gas generated by the flow generator. The removable humidification chamber can be connected or fluidly coupled to the flow generator by a gas outlet port of the apparatus. The gas outlet port can be the outlet of the flow generator or can be in fluid communication with the flow generator outlet. When the humidification chamber is removed, the gas outlet port becomes accessible and the measurement device can be attached directly to the gas outlet port to receive the flow of gas generated by the flow generator. In other configurations, the humidifier or humidifier chamber can be bypassed via a bypass conduit or other bypass configuration. For example, the measurement device may be attached directly or indirectly via a breathing conduit to a bypass conduit or port or outlet that bypasses the humidifier or humidifier chamber, the measurement device being in fluid communication with the flow of gas from the flow generator outlet and the humidifier being temporarily blocked or bypassed from the flow path.

[0116] In any of the above configurations and examples, the measurement device is connected or attached to the flow path so as to be in fluid communication with the flow of gas produced by the flow generator and / or the respiratory assistance apparatus.

[0117] In one embodiment, the measurement 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 one or more main lumens (e.g., channels or passages) extending between the ends of the body. In one configuration, the body may be a conduit, tubular or manifold component extending between the connector end and the mouthpiece end. The body may be substantially hollow. The connector end includes one or more openings or ports for fluidly connecting to an end of a flexible respiratory conduit of a respiratory assistance device. The mouthpiece end provides or accepts a mouthpiece that includes one or more openings or ports for providing fluid communication with a user's airway in use. One or more exhaust openings (e.g., vents) to atmosphere or the surrounding environment may also be provided along the body between the connector end and the mouthpiece end. The one or more vents may be in fluid communication with the main lumen.

[0118] In one embodiment, when the measurement device is attached or connected to the end of the flow path for use, the controller of the respiratory assistance apparatus can manually or automatically switch to a diagnostic or measurement mode. In this diagnostic or measurement mode, the controller can prompt the user (e.g., via visual and / or audible prompts or notifications) to take or follow one or more steps to perform one or more lung function or performance measurements or tests. Typically, the controller prompts the user to perform a forced exhalation maneuver, such as forcing an exhale into a mouthpiece. The test may include a spirometry type test or maneuver.

[0119] During the measurement or testing, the controller may control a flow generator of the respiratory assistance device to provide a flow of gas (e.g., air or air supplemented with one or more other gases) according to a configurable flow rate setting. The generated flow of gas provides, creates, and / or generates an air resistance or airflow resistance in the flow path to the user's exhalation maneuver. During the measurement or testing process, the respiratory assistance device senses one or more characteristics of the flow of gas in the flow path via one or more sensors. The sensor data may include signals, data, or artifacts indicative of the user's exhalation during the testing process. The sensors may be provided in a main housing of the respiratory assistance device and / or in a patient breathing conduit. The sensor data may be stored and analyzed to generate output data indicative of lung performance or function. The output data may in some configurations include spirometry data or data indicative of or similar to spirometry.

[0120] In the following description, an exemplary respiratory assistance apparatus that may be used with the measurement device is described. The exemplary respiratory assistance apparatus is configured primarily for high-flow therapy or has a high-flow therapy mode. However, the measurement device may be used with any respiratory assistance apparatus, system, or device that has a flow generator (e.g., a blower, fan, compressor, etc.) operable to generate a controllable flow of gas for one or more respiratory therapies. The respiratory assistance apparatus may be operable or configured to provide a single type of therapy, or may be operable to provide multiple or multiple respiratory therapies. For example, the respiratory assistance apparatus may be configured to operate in a single therapy mode, or may be configured to operate in or provide multiple or multiple selectable therapy modes. By way of example, the measurement device may operate with a respiratory assistance apparatus 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 may operate with respiratory assistance devices or systems that include an active or passive humidifier in the flow path, or devices or systems without a humidifier.

[0121] 2. Overview of Exemplary Respiratory Assistance Device The measurement device and methods and processes for using the measurement device are described in relation to an exemplary respiratory assistance apparatus 10 configured or operable to provide nasal high flow therapy through an unsealed patient interface. This is intended as a non-limiting example. It will be appreciated that the measurement device may be operable with a wide range of respiratory assistance apparatus, including flow generators.

[0122] 2.1 Overview A schematic diagram of an exemplary respiratory assistance device 10 is provided in FIG.

[0123] The respiratory aid apparatus 10 (or "respiratory system") includes a flow source 50 for supplying a high flow gas 31, such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen with one or more other gases. Alternatively, the respiratory aid apparatus may have a connection for coupling to the flow source. Thus, the flow source may form part of the apparatus or be considered separate therefrom, depending on the circumstances, or even with part of the flow source forming part of the apparatus and part of the flow source being external to the apparatus. In summary, depending on the configuration (some components may be optional), the system may include a combination of components selected from the following: Flow Source Humidifiers for humidifying the gas stream Conduits (e.g. dry lines or heated breathing tubes) Patient Interface -Check valve ·filter

[0124] The device or system will now be described in more detail.

[0125] The flow source may be a high-flow device with an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gases, and / or a flow generator 50B. FIG. 1 shows a flow source 50 with a flow generator 50B, an optional air inlet 50C, and an optional connection to an O2 source (such as a tank or O2 generator) 50A via a fire water shutoff valve and / or regulator and / or other gas flow control 50D, but this is only one option. The flow generator 50B may control the flow delivered to the patient 56 using one or more valves, or optionally, the flow generator 50B may include a blower. The flow source may be one or a combination of the flow generator 50B, O2 source 50A, and air source 50C, as described. The flow source 50 is shown as part of the device 10, but in the case of an external oxygen tank or an in-wall source, it may be considered a separate component, in which case the device has a connection port for connecting to such a flow source. The flow source provides a (preferably high) flow of gas that can be delivered to the patient via the delivery conduit 16 and the patient interface 51.

[0126] The patient interface 51 may be a non-sealing (non-sealing) interface such as a non-sealing nasal cannula (e.g., when used in high-flow therapy) or a sealing (sealing) interface such as a nasal mask, full face mask, or nasal pillows (e.g., when used in CPAP). In some embodiments, the patient interface 51 is a non-sealing patient interface, which helps to prevent, for example, barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to pressure differentials relative to the atmosphere). In some embodiments, the patient interface 51 is a sealing mask that seals against the patient's nose and / or mouth. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or a face mask, and / or a nasal pillows mask, and / or a nasal mask, and / or a tracheotomy interface, or any other suitable type of patient interface. The flow source may provide a base gas flow rate, for example, from 0.5 liters / minute to 375 liters / minute, or any range within that range, or a range with higher or lower limits. The ranges and nature of the flow rates are described in more detail below.

[0127] A humidifier 52 may be provided between the flow source 50 and the patient as needed to provide humidification of the delivered gas. One or more sensors 53A, 53B, 53C, 53D, such as flow rate, oxygen fraction, pressure, humidity, temperature or other sensors, may be located throughout the system and / or at, on or near the patient 56. Alternatively or additionally, sensors capable of deriving such parameters may be used. Additionally or alternatively, the sensors 53A-53D may be one or more physiological sensors for sensing patient physiological parameters such as heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiration rate, partial pressure of CO2 in the blood, etc. Alternatively or additionally, sensors capable of deriving such parameters may be used. Other patient sensors may include EEG sensors, torso bands for detecting respiration, and any other suitable sensors. In some configurations, the humidifier may be optional or may be preferred due to the benefits of humidified gas to help maintain airway conditions. One or more of the sensors may form part of the device or may be external to the device, with the device having an input for any external sensor. The sensors may be coupled to the controller 19 or may send their output to the controller 19.

[0128] The sensor 14 may be provided to measure the oxygen percentage of the air the patient inhales. This may be located on the patient interface 51, for example, to measure or otherwise determine the percentage of oxygen proximate (at / near / near) the patient's mouth and / or nose. The output from the sensor 14 is sent to the controller 19 to help control the respiratory assistance device, determine if peak inhalation demands are being met, and modify operation accordingly. The controller 19 is coupled to the 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 may operate the flow source to provide a flow of gas delivered at a desired flow rate high enough to meet the peak inhalation demands. In an alternative, the sensor 14 may communicate a measurement of the oxygen percentage at the patient's mouth and / or nose to a user who then inputs that information into the respiratory device / controller. Any of the following disclosures / embodiments may be construed as having alternative forms thereof, as appropriate.

[0129] An optional check valve 23 may be provided in the breathing conduit 16. One or more filters may be provided at the air inlet 50C and / or at the inlet to the flow generator 50B to filter the incoming gas before it is pressurized into high flow gas 31 by the flow generator 50B.

[0130] The respiratory support device 10 may be an integrated or separate component-based arrangement, generally shown in the dotted box 100 of FIG. 1. In some configurations, the device or system may be a modular arrangement of components. Furthermore, the device or system may include only some of the components shown, not all of which are required. The conduits and patient interfaces need not be part of the system and may be considered separate. Hereinafter, but without limitation, referred to as a respiratory support device or breathing system. Respiratory support devices and breathing systems are considered broadly herein to include anything that provides a flow of gas to a patient. Some such devices and systems include a detection system that may be used to determine whether the flow of gas meets the inhalation demand.

[0131] The respiratory assistance apparatus 10 may include a main device housing 100. The main device housing 100 may house a flow generator 50B, which may be in the form of a motor / impeller arrangement, an optional humidifier 52, a controller 19, and an input / output I / O user interface 54. The user interface 54 may include a display and input devices such as buttons, a touch screen (e.g., an LCD screen), a combination of a touch screen and buttons, etc. The controller 19 may include one or more hardware and / or software processors and may be configured or programmed to control components of the system, including but not limited to operating the flow generator 50B to generate a flow of gas for delivery to the patient, operating the humidifier 52 to humidify and / or heat the gas flow, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory assistance apparatus 10, and outputting information to a user (e.g., on a display). The user may be a patient, a medical professional, etc.

[0132] 1, the patient breathing conduit 16 may be coupled to a gas outlet (gas outlet or patient outlet port) 21 in the main device housing 100 of the respiratory assistance apparatus 10 and may be coupled to a patient interface 17, such as a non-sealing interface, such as a nasal cannula having a manifold and nasal prongs. The patient breathing conduit 16 may also be a tracheostomy interface or other non-sealing interface.

[0133] The gas flow may be generated by a flow generator 50B and may be humidified before being delivered to the patient via the patient breathing conduit 16 through the patient interface 51. The controller 19 may control the flow generator 50B to generate a gas flow at a desired flow rate and / or may control one or more valves to control the mixture of air and air or other breathable gas. The controller 19 may control a heating element in or associated with the humidification chamber 12 to heat the gas to a desired temperature that achieves a desired level of temperature and / or humidity for delivery to the patient. The patient breathing conduit 16 may have a heating element, such as a heater wire, to heat the gas flow passing to the patient. The heating element may also be under the control of the controller 19.

[0134] The humidifier 52 of the device is configured to combine or introduce humidity into the gas flow. Various humidifier 52 configurations can be used. In one configuration, the humidifier 52 can include a removable humidification chamber. For example, the humidification chamber can be partially or entirely removed or disconnected from the flow path and / or the device. By way of example, the humidification chamber can be removed, for example, for refilling, cleaning, replacement and / or repair. In one configuration, the humidification chamber can be received or held by or within a humidification compartment or bay of the device, or can be coupled on or within a housing of the device.

[0135] The humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet to allow connection to a gas flow path of the apparatus, for example, a flow of gas from the flow generator 50B may be received into the humidification chamber via its gas inlet and, after being heated and / or humidified, may exit the chamber via its gas outlet.

[0136] The humidification chamber contains a volume of liquid, typically water, etc. During operation, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the chamber, generating water vapor or steam to increase the humidity of the gas flowing through the chamber.

[0137] In one configuration, the humidifier is a pass-over humidifier. In another configuration, the humidifier can be a non-pass-over humidifier.

[0138] In one configuration, the humidifier may include, for example, a heater plate associated with or within a humidification bay in which the chamber is placed for heating. The chamber may be provided with a heat transfer surface, e.g., a metal insert, plate, etc., on a base or other surface of the chamber that interfaces or engages with the heater plate of the humidifier.

[0139] In another configuration, the humidification chamber may include an internal heater or heater element inside or within the chamber. The internal heater or heater element may be integrally attached or provided inside the chamber, or may be removable from the chamber.

[0140] The humidification chamber may be of any suitable shape and / or size. The location, number, size and / or shape of the gas inlet and gas outlet of the chamber may be varied as needed. In one configuration, the humidification chamber may have a base surface, one or more side walls extending upward from the base surface, and a top surface or upper surface. In one configuration, the gas inlet and gas outlet may be positioned on the same side of the chamber. In another configuration, the gas inlet and gas outlet may be on different surfaces of the chamber, such as on opposing sides or positions, or in other different positions.

[0141] In some configurations, the gas inlet and the gas outlet may have parallel flow axes, hi some configurations, the gas inlet and the gas outlet may be positioned at the same height above the chamber.

[0142] The system 10 may use ultrasonic transducers, flow sensors such as thermistor flow sensors, pressure sensors, temperature sensors, humidity sensors or other sensors in communication with the controller 19 to monitor characteristics of the gas flow and / or operate the system 10 to provide a suitable therapy. The gas flow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, etc. Sensors 53A, 53B, 53C, 53D, 14 such as pressure, temperature, humidity and / or flow rate sensors may be located at various locations within the main device housing 100, the patient conduit 16 and / or the patient interface 51. The controller 19 may receive outputs from the sensors to assist in operating the respiratory assistance apparatus 10 to provide a suitable therapy, for example, to determine a suitable target temperature, flow rate and / or pressure of the gas flow. Providing a suitable therapy may include meeting the inhalation demands of the patient. In the illustrated embodiment, sensors 53A, 53B and 53C are positioned within the housing of the device, sensor 53D is positioned within the patient conduit 16 and sensor 14 is positioned within the patient interface 51.

[0143] The device 10 may include one or more communication modules that enable data communication or connection with one or more external devices or servers via a data or communication link or data network, whether wired, wireless, or a combination thereof. In one configuration, for example, the device 10 may include a wireless data transmitter and / or receiver or transceiver 15 to enable the controller 19 to wirelessly receive data signals from the motion sensors and / or control various components of the system 10. The transceiver 15 or data transmitter and / or receiver module may have an antenna 15a as shown. In one example, the transceiver may include a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may deliver data to a remote server or enable remote control of the system 10. The system 10 may include a wired connection, for example using a cable or wire, to enable the controller 19 to receive data signals 8 from the motion sensors and / or control various components of the device 10. The device 10 may include one or more wireless communication modules. For example, the device may include a cellular communication module, such as a 3G, 4G or 5G module. The module 15 may be or may include a modem that allows the device to communicate with a remote server using a suitable communication network. The communication may be a two-way communication between the device and the server or other remote system. The device 10 may include other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module. The Bluetooth and / or WiFi module allow the device to wirelessly transmit information to another device, such as a smartphone or tablet, or to operate over a LAN (Local Area Network) or a wireless LAN (WLAN). The device may additionally or alternatively include a Near Field Communication (NFC) module that allows data transfer and / or data communication.

[0144] The respiratory assistance device 10 may include a high-flow therapy device. High-flow therapy as discussed herein is intended to be given its typical ordinary meaning as understood by those skilled in the art and generally refers to a respiratory system that delivers a targeted flow of humidified respiratory gas through an intentionally unsealed patient interface at a flow rate generally intended to meet or exceed the inspiratory flow of the user. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from about 15 liters / minute to about 60 liters / minute or more. Typical flow rates for pediatric users (e.g., neonates, infants and children) often range from about 1 liter / minute per kilogram of user body weight to about 3 liters / minute per kilogram of user body weight or more, but are not limited to these.

[0145] High flow therapy may also optionally include gas mixture compositions including supplemental oxygen therapy and / or administration of therapeutic agents.

[0146] High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT), or high flow tracheal (THF), among other common names. For example, in some configurations, for an adult patient, "high flow therapy" can refer to the delivery of gas to a patient at a flow rate of about 10 liters per minute (10 LPM) or greater, e.g., from about 10 LPM to about 100 LPM, or from about 15 LPM to about 95 LPM, or from about 20 LPM to about 90 LPM, or from about 25 LPM to about 85 LPM, or from about 30 LPM to about 80 LPM, or from about 35 LPM to about 75 LPM, or from about 40 LPM to about 70 LPM, or from about 45 LPM to about 65 LPM, or from about 50 LPM to about 60 LPM. In some configurations, for neonatal, infant or child patients, "high flow therapy" can refer to the delivery of gas to the patient at a flow rate of greater than 1 LPM, such as from about 1 LPM to about 25 LPM, or from about 2 LPM to about 25 LPM, or from about 2 LPM to about 5 LPM, or from about 5 LPM to about 25 LPM, or from about 5 LPM to about 10 LPM, or from about 10 LPM to about 25 LPM, or from about 10 LPM to about 20 LPM, or from about 10 LPM to 15 LPM, or from about 20 LPM to 25 LPM. High flow therapy devices for adult, neonatal, infant or child patients can deliver gas to the patient at a flow rate of from about 1 LPM to about 100 LPM or any of the subranges outlined above.

[0147] High-flow therapy can be effective in meeting or exceeding the inspiratory demands of a patient, increasing the oxygenation of the patient, and / or reducing the work of breathing. In addition, high-flow therapy can create a flushing effect in the nasopharynx such that the anatomical dead space of the upper airway is washed away by the high inflow gas flow. The flushing effect can create a reservoir of fresh gas available with every breath while minimizing rebreathing of carbon dioxide, nitrogen, etc. High-flow therapy can also increase the patient's expiratory time due to pressure during exhalation. This reduces the patient's respiratory rate.

[0148] A patient interface for use in high flow therapy may be a non-sealing interface to prevent barotrauma, which may include tissue damage to the lungs or other organs of the patient's respiratory system due to pressure differentials relative to the atmosphere. The patient interface may be a nasal cannula having a manifold and nasal prongs and / or a non-sealing tracheotomy interface or any other suitable type of patient interface.

[0149] 2.2 Mechanical and Electronic Aspects 2-18 illustrate an exemplary respiratory assistance apparatus 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 FIG. 15). The peripheral wall arrangement defines a humidifier or humidification chamber bay 108 for receiving a removable humidification chamber 300. The removable humidification chamber 300 contains a suitable liquid, such as water, for humidifying gases that can be delivered to a patient.

[0150] In the illustrated form, the perimeter wall arrangement 106 of the main housing top chassis 102 may include a substantially vertical left outer wall 110 oriented in the fore-aft direction of the main housing 100, a substantially vertical left inner wall 112 oriented in the fore-aft 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 top chassis 102 may further include a substantially vertical right outer wall 116 oriented in the fore-aft direction of the main housing 100, a substantially vertical right inner wall 118 oriented in the fore-aft 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 angled toward the respective outer edges of the main housing 100, but may alternatively be substantially horizontal or angled inwardly.

[0151] The main housing top chassis 102 may further include a substantially vertical rear outer wall 122. The top of the main housing top chassis 102 may include a forwardly sloping surface 124. The surface 124 may have a recess 126 for receiving the display and user interface module 54. The display may be configured to display the characteristics of the detected gas in real time. The system may display a patient detection status of the patient interface. If no patient is detected, the controller may not output or may stop outputting the respiration value and / or other parameters for display. The controller may also optionally output a message for display that no patient is detected in block 2708. An example of a message may be a "--" icon. An interconnecting wall 128 may extend between and interconnect the top end of the rear outer wall 122 and the rear edge of the surface 124.

[0152] A substantially vertical wall portion 130 may extend downwardly from a front end of the surface 124. A substantially horizontal wall portion 132 may extend forwardly from a lower end of the wall portion 130 to form a ledge. A substantially vertical wall portion 134 may extend downwardly from a front end of the wall portion 132 and terminate in a substantially horizontal floor portion 136 of the humidification chamber bay 108. The left inner wall 112, the right inner wall 118, the wall portion 134 and the floor portion 136 may together define the humidification chamber bay 108. The floor portion 136 of the humidification chamber bay 108 may have a recess 138 for receiving a heater arrangement, such as a heater plate 140 or other suitable heating element for heating liquid in the humidification chamber 300 for use during a humidification process.

[0153] The main housing lower chassis 202 may be attachable to the upper chassis 102 by either suitable fasteners or integrated attachment features such as, for example, clips. The main housing lower chassis 202 may include a substantially vertical left outer wall 210 oriented in the fore-aft direction of the main housing 100 and adjacent the left outer wall 110 of the upper chassis 102, and a substantially vertical right outer wall 216 oriented in the fore-aft direction of the main housing 100 and adjacent the right outer wall 116 of the upper chassis 102. The main housing lower chassis 202 may further include a substantially vertical rear outer wall 222 contiguous with the rear outer wall 122 of the upper chassis 102.

[0154] The lower housing chassis 202 may have a lip 242 that is continuous with the lip 142 of the upper housing chassis 102 and also forms part of a recess for receiving the handle portion 506 of the lever 500. The lower lip 242 may include a forwardly directed protrusion 243 that acts as a retainer for the handle portion 506 of the lever 500. In place of the lever 500, the system may have a spring-loaded guard to retain the humidification chamber 300 in the humidification chamber bay 108.

[0155] The underside of the lower housing chassis 202 may include a bottom wall 230. Each interconnecting wall 214, 220, 228 may extend between and interconnect the substantially vertical walls 210, 216, 222 and the bottom wall 230. The bottom wall 230 may include a grille 232 including a plurality of openings to allow drainage of liquid in the event of leakage (e.g., from spillage) from the humidification chamber 300. The bottom wall 230 may additionally include an elongated front-to-back oriented slot 234. The slot 234 may additionally allow drainage of liquid in the event of leakage from the humidification chamber 300 without the liquid entering the electronics housing. In the illustrated configuration, the slot 234 may be wide and elongated relative to the openings of the grille 232 to maximize drainage of liquid.

[0156] As shown in FIGS. 17-18, the lower chassis 202 may have a motor recess 250 for receiving a motor and sensor module. The motor and sensor module may be non-removable from the main housing 100. The motor and sensor module may be removable from the main housing 100 as shown in FIGS. 17-18. The bottom wall 230 may be provided with a recess opening 251 adjacent its rear edge for receiving the motor / sensor module. A continuous gas impermeable non-breakable peripheral wall 252 may be integrally formed with the bottom wall 230 of the lower chassis 202 and extend upwardly from a perimeter of the opening 251. A rear portion 254 of the peripheral wall 252 has a first height and a 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 in a substantially horizontal step 258 which terminates in an upper auxiliary rear portion 260 of the peripheral wall 252. The forward portion 256 and the upper auxiliary rear portion 260 of the peripheral wall 252 terminate at a ceiling 262. All of the walls and ceiling 262 are continuous, gas impermeable, and may be unbroken except for the gas flow paths. Thus, the entire motor recess 250 may be gas impermeable and unbroken except for the gas flow paths.

[0157] The motor and sensor module can be inserted into the recess 250 and attached to the lower chassis 202. When the motor and sensor module is inserted into the lower chassis 202, the gas flow tube 264 can extend through the downward extension tube 133 and be sealed by a soft seal.

[0158] The humidification chamber 300 can be fluidly coupled to the apparatus 10 with a linear slide-on motion from a position at the front of the housing 100 toward the rear of the housing 100 to the rear of the humidification chamber 300 into the chamber bay 108. The gas outlet port 322 can be in fluid communication with the motor.

[0159] 8 may include a removable L-shaped elbow. The removable elbow may further include a patient outlet port 344 for coupling to the patient conduit 16 to deliver gas to the patient interface. The gas outlet port 322, the gas inlet port 340 and the patient outlet port 344 may each have a soft seal, such as an O-ring seal or a T-seal, to provide a sealed gas passageway between the device 10, the humidification chamber 300 and the patient conduit 16.

[0160] 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 one another to allow the humidification chamber 300 to be inserted into the chamber bay 108 with a linear motion.

[0161] The respiratory assistance device may have air and oxygen (or alternative auxiliary gas) inlets in fluid communication with the motor to enable the motor to deliver air, oxygen (or alternative auxiliary gas) or a mixture thereof to the humidification chamber 300 and thereby to the patient. As shown in FIG. 10, the device may have a combined air / oxygen (or alternative auxiliary gas) inlet arrangement 350. This arrangement may include a combined air / oxygen port 352 into the housing 100, a filter 354, and a cover 356 with a hinge 358. The gas tube may optionally also extend laterally or in another suitable direction to be in fluid communication with an oxygen (or alternative auxiliary gas) source. The port 352 may be fluidly coupled to the motor 402. For example, the port 352 may be coupled to the motor / sensor module 400 via a gas flow path between the port 352 and an inlet opening or port in the motor and sensor module 400, which in turn leads to the motor.

[0162] The device may have the arrangement shown in Figs. 11-14 to enable the blower to deliver air, oxygen (or alternative auxiliary gas) or a suitable mixture thereof to the humidification chamber 300 and thereby to the patient. This 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' comprises a rigid plate having a suitable grill arrangement of openings and / or slots. Sound deadening foam may be provided adjacent to the plate on the inside of the plate. An air filter box 354' may be positioned inside the main housing 100 adjacent to the air inlet 356' and may include an air outlet port 360 for delivering filtered air to the motor via the air inlet port 404 in the motor / sensor module 400. The air filter box 354' may include a filter configured to remove particulates (e.g., dust) and / or pathogens (e.g., viruses or bacteria) from the gas 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 provide a seal between the components. The device may include a separate oxygen inlet port 358' positioned adjacent one side of the housing 100 at its rear end for receiving oxygen from an oxygen source, such as a tank or a piped oxygen source. The oxygen inlet port 358' is in fluid communication with a valve 362. The valve 362 may suitably be a solenoid valve that allows control of the amount of oxygen added to the gas stream delivered to the humidification chamber 300. The oxygen port 358' and valve 362 may be used with other supplemental gases to control the addition of other supplemental gases to the gas stream. The other supplemental gases may include any one or more of a number of gases useful in gas therapy, including, but not limited to, heliox and nitric oxide.

[0163] As shown in Figures 13-16, 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 adjacent to respective exterior walls 210, 216 of the lower housing chassis 202. The electronic boards may include or be in electrical communication with suitable electrical or electronic components, such as, but not limited to, microprocessors, capacitors, resistors, diodes, operational amplifiers, comparators, and switches. Sensors may be used in conjunction with the electronic boards. Components of the electronic boards, such as, but not limited to, one or more microprocessors, may function as the controller 19 of the device.

[0164] One or more of the electronic boards can be in electrical communication with the electrical components of the device 10, including the display unit and user interface 54, the motor, the valves 362 and the heater plate 140, to operate the motor, provide the desired flow rate of gas, operate the humidification chamber 300, humidify and heat the gas stream to an appropriate level, and supply an appropriate amount of oxygen (or alternative amount of auxiliary gas) to the gas stream.

[0165] The electronic board may be in electrical communication with a connector arrangement 274 that protrudes from the rear wall 122 of the upper housing chassis 102. The connector arrangement 274 may be coupled to an alarm, a pulse oximetry port, and / or other suitable accessories. The electronic board may also be in electrical communication with an electrical connector 276 that may also be provided in the rear wall 122 of the upper housing chassis 102 to provide mains or battery power to the components of the device.

[0166] As discussed above, operational sensors such as flow, temperature, humidity and / or pressure sensors may be located at various locations on the respiratory assistance apparatus, the patient breathing conduit 16 and / or the cannula 51 as shown in FIG. 1. The electronics board may be in electrical communication with these sensors. Output from the sensors may be received by the controller 19 to assist the controller 19 in operating the respiratory assistance apparatus 10 to provide optimal therapy including, for example, meeting inspiration demand. In the illustrated embodiment, the sensors are positioned on an electronics board positioned within the housing. The sensors are enclosed within the housing.

[0167] As outlined above, electronic boards and other electrical and electronic components can be pneumatically isolated from the gas flow path for improved safety. The seal also prevents the ingress of water.

[0168] 2.3 Control System FIG. 19A shows a block diagram 900 of an exemplary control system 920 (which may be the controller 19 of FIG. 1) that can detect a patient's condition and control the operation of the respiratory system, including the gas source. The control system 920 can manage the flow rate of gas through the respiratory system so that gas is delivered to the patient. For example, the control system 920 can increase or decrease the flow rate by controlling the output of the motor speed of a blower (hereinafter also referred to as a "blower motor") 930 or the output of a valve 932 in a blender. The control system 920 can automatically determine a set value or a personalized value of the flow rate for a particular patient, as described below. The flow rate can be optimized by the control system 920 to improve patient comfort and treatment.

[0169] The control system 920 may also generate audio and / or display / visual outputs 938, 939. For example, the respiratory assistance device may include a display and / or speaker. The display may show the physician any warnings or alarms generated by the control system 920. The display may also show control parameters that may be adjusted by the physician. For example, the control system 920 may automatically recommend a flow rate for a particular patient. The control system 920 may also determine the patient's respiratory status, including but not limited to generating a patient's respiratory rate, and transmit that to a display, which will be described in more detail below.

[0170] The control system 920 can vary the heater control output to control one or more of the heating elements (e.g., to maintain a temperature set point of the gas delivered to the patient). The control system 920 can also change the operation or duty cycle of the heating elements. The heater control outputs can include a heater plate control output 934 and a heated breathing tube control output 936.

[0171] The control system 920 can determine outputs 930-939 based on one or more received inputs 901-916. The inputs 901-916 may correspond to sensor measurements automatically received by the controller 600 (shown in FIG. 19B). 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 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 input from a user or parameter values ​​stored in memory 624 (shown in FIG. 19B). The control system 920 can dynamically adjust the patient flow rate over the patient's treatment time. The control system 920 can continuously sense system parameters and patient parameters. Those skilled in the art will understand based on the disclosure herein that any other suitable inputs and / or outputs can be used with the control system 920.

[0172] One or more pressure sensors In one configuration, the device may have one or more pressure sensors that are provided to sense or measure a pressure characteristic of the flow of gas in a flow path of the device and generate a respective pressure variable, such as a pressure sensor signal or data. The pressure sensors may include any type of suitable pressure sensor, including, but not limited to, a gauge pressure sensor and / or an absolute pressure sensor.

[0173] The gauge pressure sensor can be configured to sense a gauge pressure of the flow of gas and generate a representative gauge pressure variable, such as a gauge pressure signal or pressure data. The gauge pressure can represent the pressure of the flow of gas in the flow path referenced to or relative to atmospheric pressure. For example, the gauge pressure can represent the difference between the absolute pressure in the flow path and the absolute pressure in the housing (i.e., atmospheric or ambient pressure).

[0174] The absolute pressure sensor can be configured to sense the absolute pressure of the flow of gas and generate a representative absolute pressure variable, such as an absolute pressure signal or pressure data, which can represent the pressure of the flow of gas in a flow path referenced to or relative to a vacuum.

[0175] As will be appreciated by those skilled in the art, one or more pressure sensors configured to detect or measure pressure characteristics of a gas flow may be directly or at least partially immersed within a main or bulk flow path of the gas flow (e.g., the sensor may be part of or exposed to a sensor passage or sensor chamber that forms part of the main or bulk flow path), or directly or at least partially immersed within a secondary or sample flow path that is operably or fluidly connected to the main or bulk flow path, or may be operably or fluidly coupled or connected to the flow of gas in the flow path.

[0176] A pressure sensor for sensing pressure characteristics of the gas flow may be mounted independently within the housing of the device and electrically connected or otherwise in data communication with a controller or control system, or may be mounted or coupled to a sensor circuit board or other circuit board associated with the gas flow path. In one configuration, the pressure sensor may be positioned or configured to sense the pressure of the gas flow at a location along the flow path before (e.g., upstream of) the humidifier or humidification chamber. In another configuration, the pressure sensor may be positioned or configured to sense the pressure of the gas flow at a location along the flow path between a flow generator, e.g., a blower, and the humidifier chamber, e.g., 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).

[0177] The one or more pressures may also be provided to sense other pressures associated with the device (e.g., the surrounding environment in which the device is located). In one configuration, the device may include an ambient pressure sensor configured to sense or measure the ambient or atmospheric pressure of the local surrounding 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 may be absolute pressure, located or positioned on or within the housing and configured to sense the ambient or atmospheric pressure of the environment in which the device is located.

[0178] In one configuration, the device may be provided with a gauge pressure signal that generates a gauge pressure signal or data representative of a gauge pressure associated with the flow of gas in the flow passage.

[0179] In another configuration, the device may include a gauge pressure sensor configured to generate a gauge pressure signal or data representative of a gauge pressure associated with a flow of a gas, and an ambient pressure sensor configured to generate an ambient pressure signal or data. In such a configuration, the device may be configured to utilize the ambient pressure data as an input to a correction algorithm, coefficient, or function that is applied to the sensed gauge pressure signal or data. For example, the correction algorithm, coefficient, or function may be configured to correct the sensed gauge pressure signal or data to account for the effect of changes in air density on the sensed gauge pressure signal or data.

[0180] 2.4 Controller FIG. 19B shows a block diagram of one embodiment of a controller 600 (which may be controller 19 of FIG. 1). The controller 600 may include programming instructions for detecting input conditions and controlling output conditions. The programming instructions may be stored in memory 624 of the controller 600. The programming instructions may correspond to the methods, processes and functions described herein. The programming instructions may be executed by one or more hardware processors 622 of the controller 600. The programming instructions may be implemented in C, C++, JAVA, or any other suitable programming language. Some or all portions of the programming instructions may be implemented in application specific circuitry 628, such as ASICs and FPGAs.

[0181] The controller 600 may also include circuitry 628 for receiving sensor signals. The controller 600 may further include a display 630 for transmitting the status of the patient and the respiratory assistance system. The display 630 may also show warnings and / or other alerts. The display 630 may be configured to display the characteristics of the detected gas 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.

[0182] 2.5 Motor and Sensor Module Any of the features of the respiratory system described herein may be combined with any of the sensor modules described herein, including, but not limited to, a humidification chamber, a flow generator, a user interface, a controller, and a patient respiratory conduit configured to couple a gas outlet of the respiratory system to a patient interface.

[0183] Figure 20 shows a block diagram of a motor and sensor module 2000 that may be received by the recess 250 of the respiratory assistance device (shown in Figures 17 and 18). The motor and sensor module may include a blower 2001 that draws in room air for delivery to the patient. The blower 2001 may be a centrifugal blower.

[0184] 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 that allows the motor speed to be measured without the use of a separate sensor. For example, during operation of the brushless DC motor, a back EMF may be measured from a non-excited winding of the motor, from which a motor position may be determined, and the motor position may be used to calculate the motor speed. In addition, a motor driver may be used to measure the motor current, which may be used along with the measured motor speed to calculate the motor torque. The blower motor may include a low inertia motor.

[0185] Room air can enter room air inlet 2002 and enter blower 2001 through inlet port 2003. Inlet port 2003 can include a valve 2004 that allows pressurized gas to enter blower 2001. Valve 2004 can control the flow of oxygen to blower 2001. Valve 2004 can be any type of valve including a proportional valve or a binary valve. In some embodiments, the inlet port does not include a valve.

[0186] The blower 2001 can operate at a motor speed of greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 21,000 RPM, or between any of the aforementioned 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 otherwise occur in a system with a separate mixer, such as a static mixer that includes baffles, because mixing requires energy.

[0187] The mixed air can exit the blower 2001 through a conduit 2005 and enter a flow path 2006 in a sensor chamber 2007. A sensing circuit board having a sensor 2008 can be positioned in the sensor chamber 2007 such that the sensing circuit board is at least partially immersed in the gas flow. At least a portion of the sensor 2008 on the sensing circuit board can be positioned in the gas flow to measure gas properties in the flow. After passing through the flow path 2006 in the sensor chamber 2007, the gas can exit to a humidification chamber (2009).

[0188] Positioning the sensor 2008 downstream of the combined blower and mixer 2001 can increase the accuracy of measurements, such as measurements of gas fraction concentrations, including oxygen concentration, relative to systems in which the sensor is positioned upstream of the blower and / or mixer. Such positioning results in repeatable flow profiles. Additionally, positioning the sensor downstream of the combined blower and mixer avoids the pressure drop that would otherwise occur if sensing were performed before the blower because a separate mixer, such as a static mixer with baffles, would be required between the inlet and the sensing system. The mixer can introduce a pressure drop across the mixer. Positioning the sensing after the blower can allow the blower to be the mixer, as opposed to a static mixer that reduces pressure, whereas a blower increases pressure. Immersing at least a portion of the sensing circuit board and sensor 2008 within the flow path can also increase the accuracy of the measurement, as the sensor being immersed within the flow means that it is more likely to be subjected to the same conditions, such as temperature and pressure, as the gas flows, and therefore provides a better representation of the gas flow characteristics.

[0189] 21, gas exiting the blower may enter a flow path 402 in a sensor chamber 400, which may be positioned in the motor and sensor module, which may be the sensor chamber 2007 of FIG. 20. The flow path 402 may have a curved shape. The flow path 402 may be configured to have a curved shape without sharp turns. The flow path 402 may have curved ends with straighter sections between the curved ends. The curved flow path shape may reduce the pressure drop of the gas flow without reducing the sensitivity of the flow measurement by partially coinciding a measurement area with the flow path to form the measurement portion of the flow path.

[0190] 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 within the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed within the flow path 402. Immersing at least a portion of the sensing circuit board and sensors within the flow path can increase the accuracy of the measurements, since sensors immersed within the flow are more likely to experience the same conditions, such as temperature and pressure, as the gas flows, and therefore provide a better representation of the characteristics of the gas flow. After passing through the flow path 402 within the sensor chamber 400, the gas can exit to a humidification chamber. Alternatively, one or more of the pressure sensors can be provided on one or more separate circuit boards that are positioned or located to allow the pressure sensors to measure or sense pressure characteristics associated with the flow of the gas and / or the ambient pressure.

[0191] The gas flow rate can be measured using at least two different types of sensors. The first type of sensor can include a thermistor, which can determine the flow rate by monitoring heat transfer between the gas flow and the thermistor. A thermistor flow sensor can operate the thermistor at a constant target temperature in the flow as the gas flows around and past the thermistor. The sensor can measure the amount of power required to maintain the thermistor at the target temperature. The target temperature can be configured to be higher than the temperature of the gas flow such that more power is required to maintain the thermistor at the target temperature at higher flow rates.

[0192] The thermistor flow sensor can also maintain multiple (e.g., two, three or more) constant temperatures on the thermistor to avoid too small or too large a difference between the target temperature and the gas flow temperature. The 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 temperature of the gas flow always falls within a certain range (e.g., not too close, but not too far) 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 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 flow temperature range of about 20°C to about 100°C, or about 30°C to about 70°C.

[0193] The controller may be configured to adjust the thermistor circuit to change between at least a first target temperature mode and a second target temperature mode by connecting or bypassing a resistor in the thermistor circuit. The thermistor circuit may be arranged as a Wheatstone bridge configuration including a first voltage divider arm and a second voltage divider arm. The thermistor may be located in one of the voltage divider arms. Further details of the thermistor flow sensor are described in PCT Publication WO 2018 / 052320, filed September 3, 2017, which is incorporated herein by reference in its entirety.

[0194] A second type of sensor may include an acoustic sensor assembly. Acoustic sensors including acoustic transmitters and / or receivers may be used to measure the time of flight of an acoustic signal to determine gas velocity and / or composition and may be used in respiratory assistance devices. In one ultrasonic sensing (including ultrasonic transmitters and / or receivers) topology, a driver causes a first sensor, such as an ultrasonic transducer, to generate an ultrasonic pulse in a first direction. A second sensor, such as a second ultrasonic transducer, receives the pulse and provides a measurement of the time of flight of the pulse between the first ultrasonic transducer and the second ultrasonic transducer. Using this time of flight measurement, the speed of sound of the gas flow between the ultrasonic transducers may be calculated by a processor or controller of the respiratory system. To provide a second measurement of the time of flight, the second sensor may transmit a pulse in a second direction opposite the first direction, and the first sensor may receive the pulse, allowing a characteristic of the gas flow, such as flow rate or velocity, to be determined. In another acoustic sensing topology, an acoustic pulse transmitted by an acoustic transmitter, such as an ultrasonic transducer, may be received by an acoustic receiver, such as a microphone. Further details of the acoustic flow sensor are described in PCT Publication WO 2017 / 095241, filed December 2, 2016, which is incorporated by reference in its entirety.

[0195] Readings from both the first and second types of sensors can be combined to determine a more accurate flow measurement. For example, a previously determined flow rate and one or more outputs from one of the types of sensors can be used to determine a predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from the other of the first and second types of sensors to calculate a final flow rate.

[0196] 3. Exemplary Measuring Device Embodiments Exemplary embodiments of a measurement device for use in measuring and / or diagnosing pulmonary performance or function are described in conjunction with the exemplary respiratory assistance apparatus 10 described above, which is configured or operable as a flow therapy device providing nasal high flow therapy via an unsealed patient interface. However, as previously described, the measurement device may likewise be used with any form or type of respiratory assistance apparatus having a controllable flow generator and one or more sensors for sensing characteristics of a flow of gas.

[0197] With reference to FIG. 22, an exemplary embodiment of a measurement system 700 for performing pulmonary performance or function measurements and / or patient diagnosis and / or patient evaluation is provided. The measurement system 700 is provided using a measurement device 702 in combination with a respiratory assistance apparatus 10. As shown, in this example, the measurement device 702 is a component or attachment that can be releasably or removably connected or attached to an end of the patient respiratory conduit 16. Once the measurement device is connected or attached to the respiratory conduit 16, the respiratory assistance apparatus can operate in an apparatus or patient diagnostic mode such that one or more pulmonary function measurements or evaluations can be performed on the patient. Exemplary embodiments of the measurement device, the configuration of the apparatus or patient diagnostic mode, and the process of using the measurement device in conjunction with the respiratory assistance apparatus are described in further detail below.

[0198] In one exemplary configuration, the measurement device is configured to attach or connect or otherwise fluidly couple to a flow path or flow of gas generated by a respiratory aid apparatus including a flow generator. The respiratory aid apparatus includes one or more sensors that measure or sense characteristics of the flow of gas. The respiratory aid apparatus can be operated in a mode that delivers a flow of gas to the measurement device at a controlled flow rate to provide a desired air resistance. A pulmonary performance measurement can then be made based on recording and processing sensor data from one or more sensors of the apparatus when a user performs one or more exhalation maneuvers into the mouthpiece of the measurement device. In this configuration, the respiratory aid apparatus can be used or operated as a diagnostic or measurement system when used with the measurement device attachment. In this exemplary configuration, the measurement device does not necessarily have to have sensors or electronics, since the measurement data is obtained from one or more sensors of the respiratory aid apparatus and / or the respiratory conduit. This configuration allows the measurement device attachment to leverage the existing sensor and sensing capabilities of the respiratory aid apparatus, as described further below. This configuration allows for a lower cost measurement device attachment to be manufactured that is primarily mechanical in components and can be used with a respiratory assistance apparatus to make pulmonary performance measurements using one or more existing sensors in the respiratory assistance apparatus, i.e., the measurement device does not require on-board sensors or sensing capabilities. In addition, this configuration allows the measurement device to take advantage of the air resistance provided by the flow of gas generated by the flow generator.

[0199] In the embodiment described below, the measurement system 700 uses a measurement device 702 attached to the flow path of the respiratory assistance apparatus 10 and leverages existing flow path sensors of the respiratory assistance apparatus to measure or sense one or more characteristics of the flow of gas during a diagnostic mode in which the user performs a forced exhalation lung maneuver into the measurement device. The sensors may include, for example, sensors for sensing any one or more of the following gas flow characteristics: flow rate, pressure, temperature, humidity, gas concentration or any other characteristic useful in lung performance assessment. 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 assessments. In this embodiment, the sensors are external to the measurement device 702 and are typically located within the main housing 100 of the respiratory assistance apparatus and / or along the patient breathing conduit 16.

[0200] 3.1. First Exemplary Embodiment—Mechanical Configuration of the Measuring Device A first exemplary embodiment of a measuring device 702 will be described in further detail with reference to Figures 23-32. In this embodiment, the measuring 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.

[0201] In this embodiment, the body 704 is a component in the form of a conduit, tube or tubular component or a manifold component. The body has one or more main lumens extending between its connector end 706 and mouthpiece end 708 to allow a flow of gas to flow or be conveyed along the body 704 between its ends. The one or more main lumens are in the form of a passage or channel or interior space extending between openings at the connector end 706 and the mouthpiece end 708.

[0202] Body and main lumen 31 , in this embodiment, the body 704 includes a single main lumen, generally indicated at 710. The main lumen 710 is a passageway or channel that extends along the length of the body 704 between the open ends 706, 708 of the body. The shape and / or size of the main lumen 710 may be uniform or non-uniform along the length of the body 704. For example, the internal dimension or diameter of the main lumen 710 may be uniform or vary along the length of the body 704. The main lumen 710 is generally defined by the circumferential wall of the body and / or any internal features within the body.

[0203] In this embodiment, the inner diameter of at least a portion of the main lumen 710 varies along the length of the body 704. With reference to FIG. 31, a central portion of the main lumen, generally indicated at 712, widens in diameter from the connector end 706 to the mouthpiece end 708. For example, the diameter indicated at D1 at or toward the connector end is smaller than the diameter indicated at D2 at or toward the mouthpiece end. As shown, in this embodiment, the diameters widen progressively or gradually from D1 to D2. In one example, the dimension or diameter D1 may be approximately 13 mm and the dimension or diameter D2 may be approximately 20 mm, although it should be understood that alternative dimensions or diameters may be used depending on the characteristics of the respiratory conduit for connection and / or other design factors. This configuration may also be described as a portion of the main lumen 712 that tapers or narrows in diameter or cross-sectional area from the mouthpiece end 708 to the connector end 706. It should be understood that in other embodiments, the interior profile, cross-sectional area or diameter of the main lumen 710 may vary in alternative arrangements or configurations, including expanding, contracting, or combinations thereof, along one or more portions or the entire length of the body 704. The variation or transition in diameter or profile of the main lumen 710 may involve a gradual or gradual or a more sharp or step change.

[0204] In this embodiment, the body 704 is an elongated component. The body 704 is substantially hollow and defined by a conduit or peripheral wall extending between the ends 706, 708 of the body. In this embodiment, the body has a substantially circular cross-section along its length, as shown, for example, in Figures 23, 24, 29 and 30. In one configuration, the outer dimension or diameter of the body 704 may be substantially uniform along its length, as shown in Figures 25-28. In an alternative configuration, the outer dimension or diameter of the body may vary along its length.

[0205] In this embodiment, the body has a substantially cylindrical form factor or shape, and the exterior surface is defined by a circular cross-sectional profile or shape along its length. It will be appreciated that in other embodiments, the body may be provided in alternative shapes or configurations. For example, the cross-sectional profile of the exterior surface of the body may be circular, elliptical, rectangular, square, any or any suitable shape or combination of shapes along the length of the body.

[0206] In this embodiment, the body 704 and main lumen may be generally defined or aligned along or with reference to a central longitudinal axis. The body and main lumen are linear and extend in a single axis or dimension. It will be appreciated that in alternative embodiments, the body and / or main lumen may have alternative shapes and configurations, such as, but not limited to, curved, arcuate, elbow configurations, or may otherwise have non-linear profiles that do not coincide or align with a single longitudinal axis or dimension. It will be appreciated that various shapes and configurations of the body may be provided with a main lumen that provides fluid communication between the connector end and the mouthpiece end of the body.

[0207] Connector End 22 and 30-32, the connector end 706 of the measuring device 702 will now be described in more detail.

[0208] In this embodiment, the connector end 706 is configured to be releasably connected or attached to an end of a respiratory conduit 16 or tube of the respiratory assistance apparatus 10. As will be appreciated, the respiratory conduit 16 of the respiratory assistance apparatus is typically a flexible conduit attached or connected at one end to a gas outlet 21 of the respiratory assistance apparatus so as to be fluidly connected or in fluid communication with a flow of gas generated by a flow generator 11 of the apparatus. The other end of the respiratory conduit 16 typically provides a connector for releasably connecting or coupling to a patient interface (e.g., nasal cannula, nasal mask, full face mask, tracheotomy interface, etc.) to deliver a flow of gas to the patient's airway when the respiratory assistance apparatus is used for respiratory therapy (e.g., high flow therapy, PAP therapy, etc.), e.g., in normal therapy mode. In this embodiment, the connector end 706 of the measuring device 702 is configured or arranged to be releasably connected or attached to a connector or end of the respiratory conduit so as to be fluidly connected to the flow of gas conveyed along the respiratory conduit.

[0209] In this embodiment, the connector end 706 of the measuring device 702 includes a connection structure or arrangement, generally indicated at 714, configured to provide a releasable fluid connection to an end or connector of the respiratory conduit 16. The end or connector of the respiratory conduit may include a complementary connection structure or arrangement to engage and attach with the connector end 706 of the measuring device 702 to releasably couple the two components together. In this embodiment, the connection structure 714 may be provided by a pair of opposing resilient clip-on protrusions that releasably engage or clip to a corresponding formation or recess or catch or complementary end or connector of the respiratory conduit 16. It will be appreciated that the connector end 706 may be configured, arranged or provided with any suitable form of mechanically releasable fastening or coupling to complement the end or connector of the respiratory conduit, including but not limited to threaded, rotating lock or coupling, clip fitting, snap-fit ​​connection, push-fit connection, interference fit connection, latch connection, etc.

[0210] In some embodiments, the connector end 706 may be provided with a connection structure adapted for connection to the end of one or more specific types of respiratory conduits, including brand or manufacturer specific respiratory conduits. For example, in one embodiment, the connector end 706 may be configured to attach to or connect to a 20mm respiratory tube used with a high flow respiratory support device. In other embodiments, the connector end 706 may comprise a generic or universal connection structure or configuration that is operable or capable of coupling to the end of a variety or a wide range of different types of respiratory conduits.

[0211] In the embodiment shown, the connector end 706 is configured to releasably connect or mate with an end or connector of the respiratory conduit 16. This allows the measurement device to be connected to the respiratory conduit to take patient diagnostic measurements in a patient diagnostic mode of the apparatus, and then detached following the measurement, leaving the respiratory conduit which can be connected or reconnected to the patient interface for normal respiratory therapy mode.

[0212] In an alternative embodiment, the connector end 706 of the measurement device may be configured to have a non-releasable permanent connection to the respiratory tube 16, such that the components cannot be disengaged from one another without damage. Alternatively, a semi-permanent connection may be provided between the connector end 706 of the measurement device and the respiratory conduit 16, such that tools or the like are required to disengage the components from one another.

[0213] In a further alternative embodiment, the measuring device 702 may comprise 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 the breathing assistance apparatus.

[0214] In another embodiment, the measuring device 702 may be configured to releasably connect or attach directly to the gas outlet 16 of the respiratory assistance apparatus without an intermediate respiratory conduit. In another embodiment, the measuring device 702 may be configured to releasably connect or attach directly to the flow generator outlet or gas outlet port 322 when the humidifier chamber is removed from the apparatus. In another embodiment, the humidifier or humidifier chamber may be bypassed via a bypass conduit or other bypass configuration. For example, the measuring device may be attached directly or indirectly via a respiratory conduit to a bypass conduit or port or outlet that bypasses the humidifier or humidifier chamber, the measuring device being in fluid communication with the flow of gas from the flow generator outlet and the humidifier being temporarily blocked or bypassed from the flow path.

[0215] Mouthpiece end 29 and 31, the mouthpiece end 708 of the measuring device 702 will now be described in more detail.

[0216] In this embodiment, mouthpiece end 708 is a portion configured to releasably receive and hold an optional removable mouthpiece, which will be described in more detail below. In this embodiment, mouthpiece end 708 is an open cylindrical portion at the end of body 704. Mouthpiece end 708 is non-threaded in this embodiment, but may be threaded in other embodiments. However, it will be understood that the mouthpiece end may be any other suitable shape or configuration for receiving and holding a removable mouthpiece.

[0217] In alternative embodiments, the measurement device 702 may be used directly without a separate, removable mouthpiece. In such embodiments, the mouthpiece may be integrally formed with the mouthpiece end 708, or the mouthpiece end 708 may itself be configured as a mouthpiece or may be used as a mouthpiece for fluid communication with the airways of a user or patient when the user or patient seals their mouth around the mouthpiece in use. It will be understood that the shape and configuration of the end of the mouthpiece portion or body may be cylindrical, oval, elliptical, mouth-shaped, or any other suitable shape suitable for the user's mouth.

[0218] Exhaust vent In this embodiment, the measurement device 702 includes one or more exhaust openings in fluid communication with the main lumen. The exhaust openings or openings provide a path for the flow of gas and / or exhaled air from the user or patient to escape to the atmosphere or surrounding environment during use of the measurement device. In the absence of one or more exhaust openings, in some system configurations, a complete blockage of the flow path may occur when the user places their mouth on the mouthpiece or otherwise creates a seal around the mouthpiece during use. In alternative embodiments, the measurement device may not have any exhaust vents or exhaust openings, and the system configuration may allow for this. For example, exhaust vents, exhaust openings and / or pressure relief valves may be provided in the flow path upstream of the measurement device.

[0219] With reference to Figures 23-27 and 29-31, examples of exhaust opening configurations will be described in further detail for this embodiment. In the illustrated embodiment, the measurement device 702 includes an exhaust opening 716. The exhaust opening 716 is located between the connector end 706 and the mouthpiece end 708. In this embodiment, the exhaust opening 716 extends or branches from the body 704 of the measurement device. In this embodiment, the exhaust opening is in the form of or includes a vent. In this embodiment, the exhaust opening 716 includes a single vent. In this embodiment, the exhaust opening is a protruding vent 718 that extends or protrudes from the wall of the body 704 and terminates in one or more openings 720. The protruding vent 718 may be integrally formed with the remainder of the body or may be formed as a separate component that is later bonded, molded or otherwise connected within the body 704.

[0220] 31 , the protruding vent 718 includes a lumen generally indicated at 722. The exhaust lumen 722 is fluidly connected or in fluid communication with the main lumen 710 of the body 704. As shown, the secondary or exhaust lumen 722 branches off from the main lumen 710. In this embodiment, the exhaust lumen is a passageway or channel formed by the wall of the protruding vent 718. The protruding vent 718 may be a conduit type component or portion extending from the body 704. The exhaust lumen 722 is fluidly connected or coupled to the main lumen at the wall region of the body through an opening or port generally indicated at 724 that is formed in the wall of the body due to or by the formation of the protruding vent 718.

[0221] 31, the protruding vent 718 includes a single exhaust lumen 722. In alternative embodiments, multiple or multiple lumens may extend along the length of the protruding vent 718. For example, an array or mesh arrangement of multiple lumens may be provided within the protruding vent.

[0222] In this embodiment, the protruding vent 718 is a cylindrical component or has a substantially circular cross-section along its length between its connection end in the wall of the body 704 and its termination at the opening 720. However, it should be understood that the cross-sectional shape or profile may be varied as desired in alternative embodiments.

[0223] The inner diameter or dimension of the protruding vent 718 may be substantially similar to the inner diameter or dimension of the body, or alternatively may be smaller as shown.

[0224] In this embodiment, the protruding vent 718 extends at an angle from the body 704. Referring to FIG. 31, in this embodiment, the body 704 of the measuring device 702 is a substantially linear component. The body 704 is defined by or relative to a longitudinal axis BB that extends through the center of the body. In this embodiment, the protruding vent 718 may be defined relative to an associated longitudinal axis CC that extends through its center. In this embodiment, the protruding vent 718 extends at an angle indicated at 726, which is the angle between the relative longitudinal axes BB and CC of the body 704 and the protruding vent 718, respectively. In this embodiment, the angle 726 or angular orientation of the protruding vent 718 may be acute in a direction toward the mouthpiece end 708. In another embodiment, the protruding vent 718 may be configured to extend at an acute angle toward the connector end 706 of the body. In another embodiment, the protruding vent may extend perpendicular or at a right angle to the body, ie, angle 726 may be approximately 90 degrees.

[0225] In this embodiment, the protruding vent 718 is configured to direct any exhaled or exhausted gases from the measurement device away from the user's face during use. For example, in the illustrated embodiment, the measurement device 702 may be oriented such that, during use, the protruding vent 718 extends downward to direct any exhausted gases under the user's chin, for example, away from the user's face, eyes, and / or nose. In an alternative configuration, the protruding vent 718 may alternatively be oriented or angled towards the connector end to direct any exhausted gases away from the user's face, regardless of the orientation of the protruding vent.

[0226] It will be understood that the length, shape and angle of the protruding vent relative to the body of the measurement device may vary in other configurations or alternative embodiments. The protruding vent may be substantially straight as shown. Alternatively, the protruding vent may be arcuate, curved, bent or any other suitable shape. The protruding vent may have one or more arcs or bends in some embodiments to redirect the flow of exhaust gas in a required direction, for example away from the user's face when in use.

[0227] In alternative embodiments, the exhaust opening or openings may not protrude from the wall of the body. For example, one or more exhaust openings may be provided that do not protrude through or are flush with the peripheral wall of the body 704. For example, a flush exhaust opening may include a hole or vent formed directly in the wall of the body 704.

[0228] Generally, the characteristics of the one or more drainage openings, whether protruding or not, can be varied, including, but not limited to, for example, length, shape, width, area, cross-sectional area, circumference, diameter, single or multiple lumens.

[0229] In one configuration, one or more of the exhaust openings may be a single vent including a single opening. In another configuration, one or more of the exhaust openings may be a vent including a plurality or multiple openings. In another configuration, one or more of the exhaust openings may include a vent having multiple openings in the form of a honeycomb or mesh structure arrangement. It will be understood that a variety of opening and vent configurations are possible.

[0230] In some configurations, the measurement device 702 may include a mix of different types of exhaust openings. Some exhaust openings may be protruding vents and others may be flush vents. Some exhaust openings may include a single opening and others may include multiple openings or may include an arrangement of openings or ports or holes forming, for example, a mesh or honeycomb vent arrangement.

[0231] In the illustrated embodiment, a single exhaust opening 716 in the form of a protruding vent 718 is provided on one side of the body 704 of the measurement device 702. In other embodiments, multiple exhaust openings of any type may be provided on one or more sides or surfaces of the body 704. In some embodiments, the exhaust opening may be provided on opposite or opposing sides or multiple sides of the body 704. In some embodiments, multiple spaced apart exhaust openings may be provided in one or more lines along the length of the body 704 on one or more sides. In still other embodiments, the exhaust opening may circumscribe the circumference of the body 704. For example, the exhaust opening may be in the form of an annular vent formed around the circumference of the body. The annular vent may include an arrangement of multiple holes or openings through the wall of the body 704.

[0232] The location of the one or more exhaust openings along the length of the body 704 may vary. In one configuration, the exhaust opening or openings are located in the center or in a mid-region of the measurement device. In another configuration, the exhaust opening or openings may be located at or near either the connector end 706 or the mouthpiece end 708 of the body. In yet other configurations, multiple exhaust openings may be spaced along the bulk or length of the body 704, whether on the same or different sides of the body.

[0233] Removable mouthpiece As mentioned above, in some embodiments, the mouthpiece end 708 of the body may itself be a mouthpiece or may have an integrated mouthpiece. In this embodiment, the measurement device is provided with a releasable or removable mouthpiece that is received or attached to the mouthpiece end 708 of the body 704.

[0234] 33-41, an embodiment of a measuring device 702 having a removable mouthpiece 730 will be described in further detail by way of example. The mouthpiece 730 may be optional in the sense that the mouthpiece end 708 of the body 704 of the measuring device may act as a mouthpiece. However, a removable mouthpiece 730 may provide certain advantages in some scenarios or situations from the standpoint of usability, manufacturing and / or hygiene.

[0235] In this embodiment, the removable mouthpiece 730 is a cylindrical conduit or tubular component having a mouthpiece portion 732 for the user's mouth at one end and an attachment portion 734 at the other end for releasably connecting to or attaching to the mouthpiece end 708 of the measurement device 702.

[0236] 35, in this embodiment, the attachment portion 734 of the mouthpiece 730 is of a reduced or smaller outer diameter D3 or circumference relative to the diameter D4 or circumference of the mouthpiece portion 732. In this embodiment, the diameter D4 of the mouthpiece portion 732 of the mouthpiece 730 is substantially similar or the same as the diameter of the body 704 of the measuring device. The reduced diameter D3 of the attachment portion 734 is dimensioned or selected to complement the inner diameter D2 of the mouthpiece end 708 of the body (see FIG. 31) so that the attachment portion 734 can be inserted or plugged into a socket or port or opening provided by the mouthpiece end 708, as shown by arrow F in FIG. 38. In this embodiment, the relative dimensions of the outer diameter or circumference of the attachment portion 734 of the mouthpiece and the inner diameter of the mouthpiece end 708 of the body 704 of the measuring device can be configured to provide a press fit, friction fit or interference fit, such that the removable mouthpiece can be properly received and retained within the measuring device during use. For example, sufficient hand or pulling force in direction G (see FIG. 38 ) may be applied by the user to remove or pull the removable mouthpiece 730 from the mouthpiece end 708 of the measurement device for replacement, cleaning, repair and / or disposal.

[0237] Referring to Figures 37-41, an example assembled and disassembled measuring device 702 is shown having a removable mouthpiece 730. Figure 38 shows an exploded view of the measuring device 702 with the mouthpiece 730 removed or disconnected from the mouthpiece end 708. Figures 37 and 39-41 show various perspective, elevational and cross-sectional views of the measuring device 702 with the removable mouthpiece installed, assembled or inserted into the mouthpiece end 708 of the body 704 and ready for use.

[0238] It will be understood that any other suitable releasable or removable coupling or connection arrangement or structure for connecting the removable mouthpiece 730 to the end of the measurement device 702 may be used in alternative embodiments, including, but not limited to, snap fits, threads, fastening or clipping systems, etc.

[0239] Referring to the cross-sectional view of FIG. 36, the removable mouthpiece in this embodiment includes a single main lumen or passageway, indicated at 736, extending between its ends. Referring to FIG. 41, the mouthpiece lumen 736 provides fluid communication to one or more main lumens (e.g., main lumen 710) of the body 704 of the measurement device, such that the removable mouthpiece can deliver a flow of gas to a user during use. In this embodiment, the mouthpiece has an inner diameter D5 that is uniform along its length. Thus, the peripheral wall defining the mouthpiece 730 has a reduced thickness at the attachment region 734 relative to the mouthpiece portion 732, which creates a reduced outer diameter D3 of the attachment portion 734 relative to the mouthpiece portion 732 (as shown in FIG. 35).

[0240] In alternative embodiments, the mouthpiece may include a plurality or multiple lumens (eg, channels or passageways) extending along the length of the mouthpiece, for example in an array or mesh or honeycomb type arrangement.

[0241] The removable mouthpiece 730 in this embodiment is elongated and cylindrical, with a circular cross-sectional shape along its length. However, it will be understood that the cross-sectional shape may be non-uniform in other embodiments. For example, the shape of the attachment portion 734 may complement or match the mouthpiece end 708 of the measurement device 702, and the mouthpiece portion 732 may be any other suitable shape or profile for a user to seal around or over their mouth. For example, the mouthpiece portion 732 may be circular, elliptical, oval, or any other suitable shape in cross-section.

[0242] The removable mouthpiece 730 in this embodiment is a substantially straight component, however, it will be appreciated that the mouthpiece may have any suitable shape, including having one or more arcs or bends, or may be generally elbow-shaped.

[0243] As mentioned above, in this embodiment, the removable mouthpiece 730 is arranged to be a releasable component of the measurement device 702. However, in other embodiments, the mouthpiece described above may alternatively be integrally formed with or extend from the body 704 of the measurement device 702. It will be understood that any of the features and aspects of the removable mouthpiece described above may be equally applied to an integral or permanent mouthpiece portion of the body 704.

[0244] 3.2. Second Exemplary Embodiment—Mechanical Configuration of the Measuring Device With reference to Figures 51-60, a second exemplary embodiment of the measuring device 1702 will be described in more detail. This second exemplary embodiment of the measuring device 1702 can be used in a similar manner to the first exemplary 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 apparatus 10 in the same manner as the measuring device 702 to provide a similar measuring system 700. The overall configuration of the exemplary measuring devices 702 and 1702 is similar, but the differences are highlighted in the following description. It will be understood that alternatives or variations described with respect to either exemplary embodiment can be applied to both embodiments.

[0245] In this embodiment, the measuring device 1702 includes a body 1704 extending 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.

[0246] In this embodiment, the body 1704 is a component in the form of a conduit, tube or tubular component or a manifold component. The body has one or more main lumens extending between its connector end 1706 and mouthpiece end 1708 to allow a flow of gas to flow or be conveyed along the body 1704 between its ends. The one or more main lumens are in the form of a passage or channel or interior space extending between openings in the connector end 1706 and the mouthpiece end 1708.

[0247] Body and main lumen 59, in this embodiment, the body 1704 includes a single main lumen, generally indicated at 1710. The main lumen 1710 is a passageway or channel that extends along the length of the body 1704 between the open ends 1706, 1708 of the body. The shape and / or dimensions of the main lumen 1710 may be uniform or non-uniform along the length of the body 1704. For example, the internal dimension or diameter of the main lumen 1710 may be uniform or vary along the length of the body 1704. The main lumen 1710 is generally defined by the circumferential wall of the body and / or any internal features within the body.

[0248] In this embodiment, the inner diameter of the main lumen 1710 is substantially uniform along at least a portion of the length of the body 1704. With reference to FIG. 59 , a central portion of the main lumen, generally indicated at 1712 between the connector end 1706 and the mouthpiece end 1708, has a substantially uniform diameter, as indicated by D6. In this embodiment, the inner diameter D7 of the main lumen 1710 flares out or is larger at or toward the mouthpiece end region 1713 relative to the inner diameter D6 of the central region 1712 of the main lumen 1710. In this exemplary embodiment, the inner diameter D6 of the main lumen in the central region 1712 steps or transitions to the larger diameter D7 in the mouthpiece end region 1713.

[0249] In one example, the internal dimension or diameter D6 at the central region 1712 of the main lumen 1710 may be approximately 22.5 mm and the internal dimension or diameter D7 at the mouthpiece end region 1713 may be approximately 25 mm, although it will be understood that alternative dimensions or diameters may be used depending on the characteristics of the respiratory conduit for connection.

[0250] This configuration may also be described as a central portion 1712 of the main lumen 1710 having a substantially uniform cross-sectional area. It should be understood that in other embodiments, the interior profile, cross-sectional area or diameter of the main lumen 1710 may vary in alternative arrangements or configurations, including expanding, contracting, or combinations thereof, along one or more portions or the entire length of the body 704. The variation or transition in diameter or profile or cross-sectional area of ​​the main lumen 1710 may be gradual or gradual or involve a more abrupt or step change.

[0251] In this embodiment, the difference in inner diameter, size or cross-sectional area of ​​the central region 1712 and the mouthpiece end region 1713 is determined by the thickness of the peripheral wall of the body 1704. In this embodiment, the outer dimension or diameter of the body 1704 of the measuring device 1712 is substantially uniform along the central region 1712 and the mouthpiece end region 1713, as shown by diameter D8. Thus, the thickness of the peripheral wall of the body 1704 at the central region 1712 is greater than the thickness of the peripheral wall of the body at the mouthpiece end region 1713, thereby forming the inner diameters D6 and D7 discussed above.

[0252] In this embodiment, the body 1704 is an elongated component. The body 1704 is substantially hollow and defined by one or more conduits or one or more peripheral walls extending between the ends 1706, 1708 of the body. In this embodiment, the body 1704 has a substantially circular cross-section along its length, as shown, for example, in Figures 51, 52, 57 and 58.

[0253] In one configuration, the outer dimension or diameter of the body 1704 can be substantially uniform along its length. In an alternative configuration, the outer dimension or diameter of the body 1704 can vary along its length.

[0254] In this embodiment, the body 1704 includes a first region 1720 and a second region 1721 as shown in FIG. 59. The first region 1720 is cylindrical and defined by an outer diameter or dimension indicated at D8. The second region 1721 is cylindrical and defined by an outer diameter or dimension indicated at D9. In this example, the first region 1720 extends from the mouthpiece end 1708 and terminates at an intermediate location 1722 towards the connector end 1706, and the second region 1721 extends from the intermediate location 1722 to the connector end 1706. In this example, the first region 1720 includes the mouthpiece end region 1713 and the central region 1712 of the body 1704, and the second region 1721 includes or defines the connector end region.

[0255] 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 connector end region designated 1721 has a smaller diameter or dimension than the remainder of the body 1704. In this embodiment, the first region 1720 of the body 1704 is of 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 cylinder or cylindrical wall defining the first region 1720 steps down or transitions at an intermediate location or shoulder 1722 to the cylinder or cylindrical wall defining the second region 1721. In this embodiment, the cylinder or cylindrical wall defining the first region 1720 is longer and of a larger diameter than the cylinder or cylindrical wall defining the second region 1721. In this embodiment, the dimensions and configuration of the connector end region of the second region 1721 may be configured for complementary engagement or connection to the end of the respiratory conduit 16 of the respiratory assistance device 10, as shown in FIG.

[0256] In one example, the outer dimension or diameter D8 of the first region 1720 of the body 1704 may be approximately 27.5 mm and the dimension or diameter D9 of the second region 1721 defining the connector end region may be approximately 20.8 mm, although it should be understood that alternative dimensions or diameters may be used depending on the characteristics of the respiratory conduit for connection and / or other design factors.

[0257] In this embodiment, the body 1704 has a substantially cylindrical form factor or shape, with the exterior surface defined by a circular cross-sectional profile or shape along its length. It will be understood that the body 1704 may be provided in alternative shapes or configurations in other embodiments. For example, the cross-sectional profile of the exterior surface of the body may be circular, oval, rectangular, square, any or any suitable shape or combination of shapes and sizes along the length of the body.

[0258] In this embodiment, the body 1704 and main lumen 1710 may be generally defined or aligned along or with reference to a central longitudinal axis. The body and main lumen are linear and extend in a single axis or dimension. It will be appreciated that in alternative embodiments, the body and / or main lumen may have alternative shapes and configurations, such as, without limitation, curved, arcuate, elbow configurations, or may otherwise have non-linear profiles that do not coincide or align with a single longitudinal axis or dimension. It will be appreciated that various shapes and configurations of the body may be provided with a main lumen that provides fluid communication between the connector end and the mouthpiece end of the body.

[0259] Connector End 22 and 58-60, the connector end 1706 of the measuring device 1702 will now be described in more detail.

[0260] In this embodiment, the connector end 1706 is configured to be releasably connected or attached to an end of a respiratory conduit 16 or tube of the respiratory assistance apparatus 10. As will be appreciated, the respiratory conduit 16 of the respiratory assistance apparatus is typically a flexible conduit attached or connected at one end to a gas outlet 21 of the respiratory assistance apparatus so as to be fluidly connected or in fluid communication with a flow of gas generated by a flow generator 11 of the apparatus. The other end of the respiratory conduit 16 typically provides a connector for releasably connecting or coupling to a patient interface (e.g., nasal cannula, nasal mask, full face mask, tracheotomy interface, etc.) to deliver a flow of gas to the patient's airway when the respiratory assistance apparatus is used for respiratory therapy (e.g., high flow therapy, PAP therapy, etc.), e.g., in normal therapy mode. In this embodiment, the connector end 1706 of the measuring device 1702 is configured or arranged to be releasably connected or attached to a connector or end of the respiratory conduit so as to be fluidly connected or in fluid communication with a flow of gas conveyed along the respiratory conduit.

[0261] In this embodiment, the connector end 1706 of the measuring device 1702 includes a connection structure or arrangement, generally indicated at 1714, configured to provide a releasable fluid connection to an end or connector of the respiratory conduit 16. The end or connector of the respiratory conduit may include a complementary connection structure or arrangement to engage and attach with the connector end 1706 of the measuring device 1702 to releasably couple the two components together. In this embodiment, the connection structure 1714 may be provided by a pair of opposing resilient clip-fastening protrusions that releasably engage or clip to a corresponding formation or recess or catch or complementary end or connector of the respiratory conduit 16. It will be understood that the connector end 1706 may be configured, arranged or provided with any suitable form of mechanically releasable fastening or coupling to complement the end or connector of the respiratory conduit, including but not limited to threaded, rotating lock or coupling, clip fitting, snap-fit ​​connection, push-fit connection, interference fit connection, latch connection, etc.

[0262] In some embodiments, the connector end 1706 may be provided with a connection structure adapted for connection to the end of one or more specific types of respiratory conduits, including brand or manufacturer specific respiratory conduits. For example, in one embodiment, the connector end 1706 may be configured to attach or connect to a 20 mm respiratory tube used with a high flow respiratory support device. In other embodiments, the connector end 1706 may comprise a generic or universal connection structure or configuration that is operable or capable of coupling to the end of a variety or a wide range of different types of respiratory conduits.

[0263] In the embodiment shown, the connector end 1706 is configured to releasably connect or mate with an end or connector of the respiratory conduit 16. This allows the measurement device 1702 to be connected to the respiratory conduit to take patient diagnostic measurements in a patient diagnostic mode of the apparatus, and then detached following the measurement, leaving the respiratory conduit that can be connected or reconnected to a patient interface for normal respiratory therapy mode.

[0264] In an alternative embodiment, the connector end 1706 of the measurement device may be configured to have a non-releasable permanent connection to the respiratory tube 16, such that the components cannot be disengaged from one another without damage. Alternatively, a semi-permanent connection may be provided between the connector end 1706 of the measurement device and the respiratory conduit 16, such that tools or the like are required to disengage the components from one another.

[0265] In a further alternative embodiment, the measuring device 1702 may comprise 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 in a connector end that may be releasably connected or attached to the gas outlet 21 of the breathing assistance apparatus.

[0266] In another embodiment, the measuring device 1702 may be configured to releasably connect or attach directly to the gas outlet 16 of the respiratory assistance apparatus without an intermediate respiratory conduit. In another embodiment, the measuring device 1702 may be configured to releasably connect or attach directly to the flow generator outlet or gas outlet port 322 when the humidifier chamber is removed from the apparatus. In another embodiment, the humidifier or humidifier chamber may be bypassed via a bypass conduit or other bypass configuration. For example, the measuring device may be attached directly or indirectly via a respiratory conduit to a bypass conduit or port or outlet that bypasses the humidifier or humidifier chamber, the measuring device being in fluid communication with the flow of gas from the flow generator outlet and the humidifier being temporarily blocked or bypassed from the flow path.

[0267] Mouthpiece end 57 and 59, the mouthpiece end 1708 of the measuring device 1702 will now be described in more detail.

[0268] In this embodiment, mouthpiece end 1708 is a portion configured to releasably receive and hold an optional removable mouthpiece, which will be described in more detail below. In this embodiment, mouthpiece end 1708 is an open cylindrical portion at the end of body 1704. Mouthpiece end 1708 is non-threaded in this embodiment, but may be threaded in other embodiments. However, it will be understood that mouthpiece end 1708 may be any other suitable shape or configuration for receiving and holding a removable mouthpiece.

[0269] In alternative embodiments, the measurement device 1702 may be used directly without a separate, removable mouthpiece. In such embodiments, the mouthpiece may be integrally formed with the mouthpiece end 1708, or the mouthpiece end 1708 may itself be configured as a mouthpiece or may be used as a mouthpiece for fluid communication with the airways of a user or patient when the user or patient seals their mouth around the mouthpiece in use. It will be understood that the shape and configuration of the end of the mouthpiece portion or body may be cylindrical, oval, elliptical, mouth-shaped, or any other suitable shape suitable for the user's mouth.

[0270] Exhaust vent In this embodiment, the measuring device 1702 includes one or more exhaust openings in fluid communication with the main lumen of the measuring device 1702. The exhaust openings or openings provide a path for the flow of gas and / or exhaled air from the user or patient to escape to the atmosphere or surrounding environment during use of the measuring device. In the absence of one or more exhaust openings, in some system configurations, a complete blockage of the flow path may occur when the user places their mouth on the mouthpiece or otherwise creates a seal around the mouthpiece during use. In alternative embodiments, the measuring device 1702 may not have any exhaust vents or exhaust openings, and the system configuration may allow for this. For example, exhaust vents, exhaust openings and / or pressure relief valves may be provided in the flow path upstream of the measuring device.

[0271] Exemplary configurations of exhaust openings are described in further detail for this embodiment with reference to Figures 51-55 and 59. In the illustrated embodiment, the measuring device 1702 includes one or more exhaust openings 1716. The one or more exhaust openings 1716 are located between the connector end 706 and the mouthpiece end 708. In this embodiment, the one or more exhaust openings 1716 are provided within and / or along the body 704 of the measuring device 1702.

[0272] In this embodiment, the exhaust opening 1716 is in the form of or includes a flush vent. A flush vent is a through hole, opening or aperture that extends through the circumferential wall of the body 1704 of the measuring device 1702. A flush vent may be substantially flush with the outer surface (e.g., cylindrical surface) of the body 1704 of the measuring device 1702. With reference to FIG. 59, in this embodiment, the exhaust opening 1716 extends from the outer surface to the inner surface (i.e., through the entire thickness of the wall) of the body, thereby providing a passage or pathway for gases in the main lumen and / or exhaled gas to escape or vent from the device to the surrounding atmosphere or environment. As shown, in this embodiment, the exhaust opening does not protrude or is flush with the circumferential wall of the body 1704 and includes a hole or vent formed directly in the wall of the body.

[0273] In this embodiment, the exhaust opening 1716 is circular in shape, however, it should be understood that in alternative embodiments, any other shape or profile or combination of different shapes or profiles can be used for the exhaust openings or holes. If multiple exhaust openings 1716 are provided, these can be uniform in shape and / or size, or alternatively, they can be a combination of different shapes and / or sizes.

[0274] The exhaust opening or total cross-sectional area of ​​the openings 1716 can be configured to meet the desired exhaust flow requirements. For example, the size or dimensions of the exhaust openings 1716 can be configured to meet the exhaust flow requirements relative to the overall size and characteristics of the measurement device 1702. For example, in the case of a circular exhaust opening 1716, the diameter of the opening can be customized or configured to meet the required exhaust flow requirements.

[0275] By way of example only, in this exemplary embodiment, each of the exhaust openings 1716 is a circular hole or opening having a diameter of about 5 mm. Thus, the opening area of ​​each exhaust opening is about 19.6 mm. 2In this example, the inner cross-sectional area of ​​the main lumen is approximately 397.6 mm, as defined by the inner diameter D6 of 22.5 mm. 2 Thus, each exhaust opening 1716 has an opening area that is about 5% of the cross-sectional area of ​​the main lumen of the body of the measurement device 1702. Furthermore, in this example, the total exhaust opening area as provided by the three uniform exhaust openings 1716 is about 15% of the cross-sectional area of ​​the main lumen of the measurement device 1702.

[0276] In the illustrated embodiment, the exhaust openings 1716 include a linear arrangement, line, or linear array of uniformly spaced exhaust openings 1716 disposed along one side or region of the body 1704 of the measurement device 1702. In this exemplary embodiment, the linear array of exhaust openings 1716 extends in a direction aligned with the longitudinal axis of the body 1704. In this exemplary embodiment, there are three exhaust openings, but it will be understood that the number of exhaust openings 1716 in the array may vary and the spacing may be uniform or non-uniform in other embodiments. In this exemplary embodiment, the linear array of exhaust openings 1716 is located closer to the mouthpiece end 1708 of the body 1704 than the connector end 1706, but alternatively, the exhaust openings 1716 may be located at or near the center of the connector end of the body in other embodiments.

[0277] There may be a single exhaust opening or multiple exhaust openings. The number, arrangement or pattern of the one or more exhaust openings may vary in different embodiments. In some configurations, the exhaust openings may be arranged in a 1D array (e.g., a line array as shown) or a 2D or multi-dimensional array or any other pattern or configuration. In some configurations, the exhaust openings may be provided in one or more lines extending along the length of the body 1704 on one or more sides or surface areas. In some configurations, the one or more lines of exhaust openings may be aligned with the longitudinal axis as shown or extend in other directions.

[0278] In some configurations, the exhaust openings may be provided circumferentially around the circumference of the body. For example, the exhaust openings may be provided in the form of one or more annular vents or annular arrays of exhaust openings spaced apart around the circumference of the body 1704. The one or more annular arrays of spaced apart exhaust openings or holes in the wall of the body may extend around the entire circumference of the body or at least one or more portions of the circumference.

[0279] There may be one or more exhaust openings or an array of exhaust openings extending along and / or around a surface of the body 1704, including along or around any one or more regions, sides, or surfaces of the body. In some embodiments, the exhaust openings may be provided on opposing sides or opposing sides or multiple sides of the body 1704.

[0280] The location of the one or more exhaust openings or array or exhaust openings along and / or around the body 704 may vary. In one configuration, the exhaust opening or opening may be located at the center or an intermediate region of the measurement device 1702 or body 1704. In another configuration, the exhaust opening or opening may be located at or near either the connector end 1706 or the mouthpiece end 1708 of the body 1704. In yet other configurations, multiple exhaust openings may be spaced along the bulk or length of the body 704, whether on the same or different sides of the body.

[0281] In general, characteristics of the one or more exhaust openings 1716 may be varied in different embodiments, including, but not limited to, number, shape, opening area, arrangement, uniformity, circumference, and / or diameter.

[0282] In some configurations, the measuring device 1702 may include a mix of different types of exhaust openings. Some exhaust openings may be protruding vents of the type described with respect to the measuring device 702 of the first exemplary embodiment, and other exhaust openings may be flush vents or exhaust openings of the type described with respect to the measuring device 1702 of this second exemplary embodiment. Some exhaust openings may include a single opening, and other exhaust openings may include multiple openings, or may include an arrangement of openings, or ports, or holes that form, for example, a mesh or honeycomb vent arrangement that is flush with the exterior surface of the body.

[0283] Removable mouthpiece As mentioned above, in some embodiments, the mouthpiece end 1708 of the body 1704 may itself be a mouthpiece or may have an integrated mouthpiece. In this embodiment, the measurement device 1702 is provided with a releasable or removable mouthpiece that is received in or attached to the mouthpiece end 1708 of the body 1704.

[0284] 61-72, an embodiment of a measuring device 1702 having a removable mouthpiece 1730 will be described in further detail by way of example. The mouthpiece 1730 may be optional in the sense that a mouthpiece end 1708 of the body 1704 of the measuring device 1702 may act as a mouthpiece. However, a removable mouthpiece 1730 may provide certain advantages in some scenarios or situations from the standpoint of usability, manufacturing and / or hygiene.

[0285] In this embodiment, the removable mouthpiece 730 is a hollow conduit component having a mouthpiece portion 1732 for the user's mouth at one end and an attachment portion 1734 at the other end for releasably connecting to or attaching to the mouthpiece end 1708 of the measurement device 1702.

[0286] In this exemplary embodiment, mouthpiece portion or region 1732 of mouthpiece 1730 includes an oval or elliptical shape or cross-sectional profile along at least a portion of its length. The mouthpiece portion or region extends between a first end or point indicated at 1736 and a second end or point indicated at 1738. The first end or point 1736 is at an intermediate location along the length of mouthpiece 1730 and defines a boundary or transition between mouthpiece portion 1732 and attachment portion 1734. In this exemplary embodiment, mouthpiece portion or region 1732 gradually transitions in shape or cross-section from a circular cross-section at the first end at 1736 to an oval or elliptical shape as it extends toward an open oval or egg-shaped opening at second end 1738.

[0287] In this exemplary embodiment, the attachment portion or region 1734 of the mouthpiece 1730 is a cylindrical conduit portion. Referring to Fig. 63, in this embodiment, the outer diameter D10 of the attachment portion 1734 of the mouthpiece 1730 is sized or selected to complement the inner diameter D7 of the mouthpiece end 1708 of the body (see Fig. 59) so that the attachment portion 1734 can be inserted or plugged into a socket or port or opening provided by the mouthpiece end 1708, as shown by arrow F in Fig. 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 press fit, friction fit or interference fit, such that the removable mouthpiece can be properly received and retained within the measuring device during use. For example, sufficient manual or tensile force in direction G (see FIG. 68 ) may be applied by the user to remove or pull the removable mouthpiece 1730 from the mouthpiece end 1708 of the measurement device for replacement, cleaning, repair and / or disposal.

[0288] 67-72, an example assembled and disassembled measuring device 1702 is shown having a removable mouthpiece 1730. FIG 68 shows an exploded view of the measuring device 1702 with the mouthpiece 1730 removed or disconnected from the mouthpiece end 1708. FIG 67 and FIG 69-72 show various perspective, elevational and cross-sectional views of the measuring device 1702 with the removable mouthpiece 1730 installed, assembled or inserted into the mouthpiece end 1708 of the body 1704 and ready for use.

[0289] It will be understood that any other suitable releasable or removable coupling or connection arrangement or structure for connecting the removable mouthpiece 1730 to the end of the measurement device 1702 may be used in alternative embodiments, including, but not limited to, snap fits, threads, fastening or clipping systems, etc.

[0290] 64 and 66, the removable mouthpiece of this embodiment includes a single main lumen or passageway extending between its ends, indicated at 1736. With reference to FIGS. 70 and 72, the mouthpiece lumen 1736 provides fluid communication to one or more main lumens (e.g., main lumen 1710) of the body 1704 of the measurement device 1702, such that the removable mouthpiece can deliver a flow of gas to a user during use.

[0291] In alternative embodiments, the mouthpiece may include a plurality or multiple lumens (eg, channels or passageways) extending along its length, for example in an array or mesh or honeycomb type arrangement.

[0292] In this exemplary embodiment, the removable mouthpiece 1730 is elongated and varies in cross-sectional shape along at least a portion of its length. It will be appreciated that a variety of shapes or cross-sectional profiles may be used to create the mouthpiece 1730. In one example, the shape of the attachment portion 1734 may complement or match the mouthpiece end 1708 of the measurement device 1702 to allow attachment, and the mouthpiece portion 1732 may be any other suitable shape or profile for a user to seal around or over their mouth. For example, the mouthpiece portion 1732 may be circular, elliptical, oval, mouth-shaped, or any other suitable shape in cross-section.

[0293] The removable mouthpiece 1730 in this embodiment is a substantially straight or elongated component defined about a central longitudinal axis, however, it will be understood that the mouthpiece may have any suitable shape, including having one or more arcs or bends, and / or may be generally elbow-shaped.

[0294] As mentioned above, in this embodiment, the removable mouthpiece 1730 is arranged to be a releasable component of the measurement device 1702. However, the above-mentioned mouthpiece 1730 may alternatively be integrally formed with or extend from an end of the body 1704 of the measurement device 1702 in other embodiments. It will be understood that any of the features and aspects of the removable mouthpiece 1730 described above may be equally applied to an integral or permanent mouthpiece portion of the body 704.

[0295] Anti-occlusion features 73-75, in some embodiments, the measurement device 1702 may optionally include one or more anti-occlusion features, formations or protrusions 1740 near, around or adjacent the exhaust openings 1716 to help prevent the openings from being accidentally or inadvertently blocked or covered during use by the patient. For example, the anti-occlusion feature 1740 may help prevent a user or patient from accidentally or inadvertently covering or blocking one or more of the flush exhaust openings 1716 with their fingers and / or hands during use.

[0296] In this exemplary embodiment, the anti-clogging feature includes a pair of spaced apart walls or surfaces 1740 that protrude or extend from a wall of the body 1704 along each side of the linear arrangement of the exhaust opening 1716. The pair of walls protrude above the surface of the body 1704 and the exhaust opening 1716 and are positioned to prevent accidental or inadvertent blocking or covering of the exhaust opening during use.

[0297] In this exemplary embodiment, the anti-occlusion protruding walls 1740 have a curved or arcuate profile and are arranged to collectively form a clip or attachment mechanism that can be used to clip, attach or mount the measurement device 1702 to a carry stand or respiratory support apparatus when not in use. For example, a pair of protruding curved walls 1740 face each other and form a cylindrical clip-on opening or area above the discharge opening for clipping or attaching to a complementary sized and shaped cylindrical component of a carry stand or respiratory support apparatus or some other complementary mounting structure or component. The protruding walls can be rigid or semi-rigid and in some embodiments can have a degree of resilient flexibility to allow for providing or forming a snap-fit ​​clip or clipping arrangement.

[0298] It will be understood that the anti-occlusion feature may be of any other shape, size, or arrangement relative to the exhaust opening that is sufficient to assist in preventing blockage or covering of the exhaust opening during use. There may be one anti-occlusion feature or multiple anti-occlusion features. In some embodiments, the anti-occlusion feature may have a dual purpose or function, such as forming a clip, while in other embodiments, the anti-occlusion feature may have the sole function of preventing blockage of the exhaust opening during use.

[0299] 3.3. Materials - Mechanical construction of the measuring device The exemplary embodiments of the measuring devices 702, 1702 described above may be formed from any suitable material.

[0300] In one embodiment, the body 704, 1704 may be formed primarily from a rigid or semi-rigid material or combination of materials such as, but not limited to, a plastic or plastic polymer, such as, but not limited to, polycarbonate (PC), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene (ABS), or cardboard, glass, metal, or any other suitable rigid or semi-rigid material.

[0301] The body 704, 1704 of the measurement device 702, 1702 may be made of the same or similar material as the removable mouthpiece 730, 1730, or these components may be formed of different materials. For example, in one embodiment, the body 704, 1704 may be formed primarily of a plastic polymer and the removable mouthpiece may be formed from the same or a different plastic polymer. In another embodiment, the body 704, 1704 may be formed primarily of a plastic polymer and the removable mouthpiece may be formed from, for example, cardboard or cardboard.

[0302] The material used to form the measurement device 702, 1702 and / or the thickness of the material used may depend on the context of use. In some embodiments, the entire measurement device including the body 704, 1704 and the removable mouthpiece 730, 1730 may be made from a lower cost or lower grade material more suitable for a disposable item. In other embodiments, the body 704, 1704 may be configured as a multi-use and / or multi-user component formed of a more durable or long-lasting material such as plastic, while the mouthpiece may be configured as a one-time or single-user disposable item, so that a lower cost material such as cardboard or a thinner or lower grade or lower cost plastic may be used for the removable mouthpiece.

[0303] It will be appreciated that various different measurement devices may be formed from different materials: some measurement devices or certain components thereof may be formed from higher grade and / or more durable materials for longer or multiple uses, while other measurement devices or at least certain components thereof (e.g., removable mouthpieces) may be formed from lower cost and / or disposable and / or less durable single-use type materials, such as, but not limited to, cardboard or lower grade or thinner plastics.

[0304] In some embodiments, the measurement device or components thereof (e.g., a removable mouthpiece) may be configured for delivery and / or shipping to an end user for use a specified number of times or for a fixed life span (e.g., having an expiration or use-by date). In such a scenario, the measurement device may be formed from materials more suitable for a disposable item.

[0305] 3.4. Patient diagnosis mode of respiratory support device 22, the measurement device 702, 1702 is for use in conjunction with a respiratory assistance apparatus 10 having a flow generator operable to generate a flow of gas (e.g., atmospheric or pressurized air, air augmented with oxygen or other auxiliary gases, or any other suitable combination of gases) and having one or more sensors for sensing, measuring or detecting one or more properties or characteristics of the flow of gas. The measurement device 702, 1702 is provided as an auxiliary component that can be selectively attached to a flow path of the respiratory assistance apparatus to provide a measurement or assessment of one or a range of pulmonary performance or function.

[0306] The respiratory aid device may have one or more operating modes. In this embodiment, the respiratory aid device has one or more therapy modes for providing a flow of gas with certain characteristics (e.g., flow rate and / or controlled pressure) suitable for high-flow therapy, CPAP, bilevel PAP or other such respiratory therapy. In this embodiment, the respiratory aid device further includes a patient diagnostic mode, which may be initiated or operated when the respiratory aid device is used with the measuring device 702, 1702 to perform pulmonary performance measurements or assessments. In one exemplary configuration, the respiratory aid device may operate in a first mode (e.g., therapy mode) and then switch to a second mode (e.g., patient diagnostic mode or measurement mode or spirometry mode) when the measuring device 702, 1702 is attached to perform pulmonary performance measurements. In another exemplary configuration, the respiratory aid device may be initiated in the second or patient diagnostic mode upon start-up of the device. In another exemplary configuration, the device may 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 therapeutic modes.

[0307] As will be described in more detail below, in the patient diagnostic mode, the user may be instructed or prompted to perform various lung performance maneuvers (e.g., forced expiration or expiration, or quiet normal spontaneous breathing) into the mouthpiece of the measurement device 702, 1702, while the flow generator of the apparatus is controlled to generate a flow of gas to provide air or air resistance to the user's forced expiration or quiet normal spontaneous breathing. One or more sensors of the apparatus 10 are used to sense or measure one or more characteristics or features of the flow of gas during the lung performance maneuvers. The sensor data may then be processed or filtered or otherwise analyzed to generate data indicative of lung performance or lung function.

[0308] In this embodiment, the respiratory assistance apparatus 10 may be configured to initiate or activate the patient diagnostic mode in response to a user input to a user interface of the apparatus 10, or the patient diagnostic mode may be triggered or activated remotely by another external device or system in data communication or connection with the apparatus 10 via a data link or data network.

[0309] By way of example, the user interface of the device 10 may include an operable button (whether mechanical or touch sensitive) or a touch screen interface or button operable to trigger or initiate a patient diagnosis mode. Additionally or alternatively, the device 10 may be controlled via a user's smart device in data communication with the device (e.g., via Bluetooth, Wi-Fi, infrared, etc.). For example, a smartphone application may be provided for remotely controlling the device, and the smartphone application may provide a button or graphical user interface operable to trigger a patient diagnosis mode on the device 10.

[0310] Remote initiation or triggering of the patient diagnostic mode may be performed by a remote user, such as a clinician, health care provider, or physician, providing user input to a remote electronic device or server in data communication with the respiratory assistance apparatus 10. By way of example, the remote or external device or server may have a running software application that provides an operable command or graphical user interface (GUI) having buttons or GUI elements that are triggerable (e.g., via cursor click or touch screen action) to initiate the patient diagnostic mode on the apparatus 10 remotely via control signal or command data transmitted over a data network. The remote device or server may have any form of suitable user interface for receiving user input from a clinician or the like, including mechanical or touch-sensitive buttons or interfaces, or an electronic GUI that is displayed on a display screen within the context of the software application, as will be described.

[0311] It will be understood that the apparatus 10 and / or a remote device or server or system may receive user input to trigger the patient diagnosis mode in other manners, including voice or audible control or command via a voice interface or voice assistant device.

[0312] In one embodiment, the patient diagnostic mode may be initiated or triggered manually via user input or device controls or in response to remote actuation, such as from a clinician. Additionally or alternatively, the patient diagnostic mode may be triggered automatically, either locally by the local controller 19 of the device 10 or remotely by a processor of a remote device, system or server. The automatic triggering or actuation of the patient diagnostic mode may occur according to a configurable schedule or periodic interval. The configurable schedule or periodic interval may be configured by a user or by a remote clinician via the respective user interfaces and / or software applications of the device 10 and the remote device, system or server.

[0313] In one embodiment, the device and / or remote device, system or server may be configured to prompt or remind the user or remote clinician to start or initiate the patient diagnosis mode. The prompt or reminder may be, for example, a visual prompt and / or an audio prompt via a user interface of the device 10 and / or any remote device, server or system in data communication with the device 10. By way of example, a visual prompt may be displayed on a display or touch screen display of the device 10 or the remote device, and any audible prompt may be provided via an audio output device or speaker of the device or remote device. The user or remote clinician may trigger or initiate the patient diagnosis mode in response to one or more prompts. In some scenarios, the user may be prompted or contacted to perform the patient diagnosis method by mail, telephone, email, SMS or other communication method.

[0314] In some configurations, the prompts may be generated automatically according to a preset or configurable schedule or periodic interval. The device may be provided with an initial default schedule or periodic interval during manufacture. The schedule or periodic interval may be configured by a user or remote clinician via the device and a remote device, server or system interface or software application. Alternatively, a remote clinician may be able to trigger prompts on the device 10 manually or in an ad-hoc manner as needed via a remote device, system or server interface or software application.

[0315] 3.5. Measurement methods and processes 42-50, an exemplary measurement or diagnostic method or process 750, 750A of using a measurement device 702 with the respiratory assistance apparatus 10 in a patient diagnostic mode will be described in further detail. The patient diagnostic mode may also be referred to as a measurement mode or a spirometry mode or a "spirometer check-in". The measurement process or method in this example is implemented primarily by algorithms or computing instructions executed by a processor or controller of the respiratory assistance apparatus 10 when entering the patient diagnostic mode. The principles of the exemplary diagnostic method or process 750, 750A may be applied to any of the examples, configurations or variations of the respiratory apparatus, measurement systems and / or measurement devices described above.

[0316] It should be understood that the various steps in the described exemplary processes do not necessarily have to operate in the order described. Some steps may be performed in parallel, overlapping, or in a different order without affecting the overall process. Some steps may not be required or may be modified depending on the specific configuration and / or operation of the respiratory apparatus, measurement system, and / or measurement device.

[0317] Entering Patient Diagnostic Mode Referring to FIG. 42, in this embodiment, the diagnostic process 750 begins at 752 by a patient diagnostic mode of the respiratory assistance apparatus 10 being triggered in response to a manual actuation by a local user or patient, or remotely, such as by a remote clinician, or in response to an automatic trigger. As previously described, the user or clinician may be prompted to initiate or initiate the patient diagnostic mode in response to a prompt or reminder. Once in the patient diagnostic mode, the respiratory assistance apparatus 10 may be configured to provide one or more prompts or guidance or instructions to the user regarding some or all steps of the diagnostic evaluation process, as described below. The instructions or guidance may be visual, for example, by text and / or images via a graphical user interface (GUI) on the display of the device and / or audible instructions provided via a speaker of the device. Various GUI screen prompts for steps in the diagnostic method 750 are described below by way of example only. It will be appreciated that numerous variations of the GUI screen prompts are possible and that the GUI screen prompts may be provided alone or in combination with audio prompts or instructions via a speaker or audio output device.

[0318] As will be further described below, in some configurations, the device may present step-by-step instructions or prompts on how to use the measurement device during a diagnostic mode or session. By way of example only, the visual and / or audio instructions, or prompts, or guidance may provide the user with any one or more of the following information regarding the operating mode of the device (e.g., therapeutic or diagnostic mode), how to disconnect the patient interface from the device and / or breathing conduit, how to connect or attach the measurement device to the gas outlet, breathing conduit or flow path of the device, how to perform a forced exhalation maneuver, and how to perform a normal (normal spontaneous) breath at the end of the diagnostic session following the forced exhalation maneuver. Information may be provided using any combination of text, numbers, characters, images, icons, graphics, animations, video, and / or audio.

[0319] In one typical example, a user may power on or start the respiratory assistance device 10 in preparation for a treatment session. At this point, the user may don a patient interface, such as a nasal cannula. If it is the user's first treatment session of the day or if the user is otherwise prompted, the user may be asked 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 screen prompts and questions presented on the GUI and inputs the answers for processing. An example of a patient health questionnaire or inquiry process that may be performed is provided in PCT Publication WO 2021 / 090184, filed November 4, 2020, which is incorporated herein by reference in its entirety. Following completion of the questionnaire, the patient may be prompted or asked to perform a diagnostic test or evaluation (e.g., a spirometry test or other pulmonary function or performance test), and the device will enter a patient diagnostic mode (e.g., a spirometry mode or measurement mode) at step 752. In one configuration, the patient diagnostic mode may be triggered or prompted, at least in part, due to a patient's response or answer to a questionnaire or health survey, but not necessarily so, In another configuration, the patient diagnostic mode may be prompted in any of the manners described above, regardless of whether a questionnaire or health survey is administered by the user.

[0320] Instruct the user to remove and disconnect the patient interface. After initiation of the patient diagnostic mode, the user or patient is instructed to remove the patient interface 51 (e.g., nasal cannula or other interface, depending on the treatment) from their face and disconnect it from the end of the respiratory conduit 16 in step 754. For example, if the user was previously using a breathing apparatus in a treatment mode before the patient diagnostic mode was initiated or if the user is about to begin a new treatment session, the user may be donning the patient interface. Alternatively, the user may simply be prompted to disconnect or remove the patient interface from the end of the respiratory conduit 16, which essentially involves or requires removing the patient interface from their face if the patient interface was previously used in a treatment session or is being donned in preparation for a new treatment session. In some circumstances, the patient diagnostic mode may be entered directly at start-up, in which the patient interface may not be worn by the user, and therefore the user need only disconnect the patient interface from the end of the respiratory conduit 16 or otherwise ensure that the patient interface is not connected to the respiratory conduit 16.

[0321] 45A-C show schematic examples of one or more GUI display screen prompts 754A, 754B, 754C that may be displayed on the display of the device's user interface during step 754. As will be appreciated, various different variations are possible. The example screen prompt 754A of FIG. 45A includes a text and / or graphic field 7541 that describes or indicates the current mode of operation, i.e., patient diagnosis mode or spirometry mode. A primary instruction text and / or graphic field 7542 includes text and / or graphics that instruct the user to disconnect the patient interface, which in this example is a nasal cannula. One or more secondary or additional text and / or graphic fields 7543 may also be provided, for example showing additional instructions or details on how to perform the primary instruction. The example screen prompt 754B of FIG. 45B shows a variation in which there is a single primary instruction text and / or graphic field 7544. The example screen prompt 754C in Fig. 45C shows a variation in which there is an animation field or area 7545 that may display 2D or 3D graphics, images, animations or videos depicting or showing instructions to help guide the user through the actions required to complete the steps or instructions, i.e., in this case, removing or disconnecting the patient interface from the respiratory conduit. The GUI display screen prompts may include any combination of text, images, animations, videos and / or graphics to provide the user with information and / or guidance regarding the instructions or prompts for each step.

[0322] In one exemplary configuration, the apparatus may additionally execute a breath detection algorithm to confirm or ensure that the patient has removed the patient interface and / or is not connected to a respiratory assistance device before proceeding to the next step 756 in the process of prompting the user to attach the measurement device 702 to the respiratory conduit 16. In this exemplary configuration, the breath detection algorithm may act as a gate to prevent further steps in the diagnostic method process 750 from being executed until successful disconnection of the patient interface from the respiratory conduit is detected or confirmed by the algorithm. An exemplary breath detection algorithm that may be executed by the apparatus is provided in PCT Publication WO 2020 / 178746, filed March 4, 2020, which is incorporated herein by reference in its entirety.

[0323] Connected measuring devices In a next step 756 of the diagnostic method 750, the user is prompted to connect or attach the measuring device 702 to the end of the breathing conduit 16 (or other gas outlet along the flow path) of the apparatus 10 in the manner previously described. The user may pre-assemble or install the removable mouthpiece 730 before or after connecting the measuring device 702 to the end of the breathing conduit 16. The apparatus 10 may, for example, prompt the user to connect the measuring device 702 to the breathing conduit, and in some configurations may provide information or guidance on how to connect the components.

[0324] 46A-C show schematic examples of one or more GUI display screen prompts 756A, 756B, 756C that may be displayed on the display of the device's user interface during step 756. As will be appreciated, various different variations are possible. The exemplary screen prompt 756A of FIG. 46A includes a text and / or graphic field 7541 that describes or indicates the current mode of operation, i.e., patient diagnosis mode or spirometry mode. A primary instruction text and / or graphic field 7562 includes text and / or graphics that instruct the user to connect or attach the measurement device 702 to the respiratory conduit 16. One or more secondary or additional text and / or graphic fields 7563 may also be provided, for example showing additional instructions or details on how to perform the primary instruction. The exemplary screen prompt 756B of FIG. 46B shows a variation in which there is a single primary instruction text and / or graphic field 7564. The example screen prompt 756C in FIG. 46C shows a variation, namely, in this case where there is an animation field or area 7565 that can display 2D or 3D graphics, images, animations or videos depicting or showing instructions to help guide the user through the actions required to complete the steps or instructions of connecting a measurement device to an apparatus.

[0325] The flow of gas begins to create air resistance. The next step 758 in the diagnostic process 750 performed in the patient diagnostic mode is for the controller to be configured to control or initiate the flow generator 11 of the respiratory assistance apparatus 10 to deliver a flow of gas along the flow path to the gas outlet 21 such that the flow of gas flows through the respiratory conduit to the measuring device 702. The flow of gas to the measuring device provides air resistance for lung performance measurement or assessment, as previously described.

[0326] In this embodiment, the patient diagnostic mode may be configured to provide a flow of gas at a fixed or constant, pre-defined or configurable flow rate setting to provide a constant or fixed air resistance or resistance. The flow of gas may be provided for a pre-defined or configurable period of time or until the user completes the measurements required for the diagnostic session (i.e., performs one or more pulmonary performance maneuvers). The flow rate setting may vary depending on the patient and / or the particular pulmonary performance measurement or assessment being made, or the flow rate setting may be universally set or configured based on measurements or industry standards related to the resistance required for the particular pulmonary performance measurement or assessment.

[0327] In some embodiments, the patient diagnostic mode may be configured or operable to control the composition of the gas delivered during the measurement process. In some configurations, the respiratory support device is controlled to deliver a flow of air or ambient air (i.e., if auxiliary gases such as oxygen are available, they are turned off or their flow rates are reduced to zero, e.g., via a controllable valve). In other configurations, the flow of gas may be air augmented with an auxiliary gas such as oxygen, and the oxygen percentage of the flow of gas may be controlled to a specific oxygen concentration setting. It is understood that any suitable composition of one or more gases may be delivered.

[0328] In some configurations, the respiratory aid apparatus 10 may deliver a flow of gas that is not humidified. For example, the respiratory aid apparatus may not have a humidifier or the humidifier may be switched off. In other configurations, the flow of gas may be humidified by the respiratory aid apparatus's humidifier 52.

[0329] User instructed to perform a forced expiratory maneuver on the flow of gas Once the flow of gas has been delivered to the measuring device 702, the user is prompted or instructed to perform one or more forced exhalation maneuvers into the mouthpiece of the measuring device 702, as shown in step 760. As an example, the user may be instructed to perform a forced blow or exhale into the mouthpiece of the measuring device against the air resistance created by the flow of gas. In one example, the forced exhalation may be similar to that performed during a spirometry assessment and / or measurement.

[0330] In one exemplary configuration, the device may prompt the user to exhale for a fixed period of time, such as a specific period of time. The period may be, by way of example only, 1 second, 2 seconds, 3 seconds or more, or some other specified period of time depending on the assessment being made. As an example, the user may be prompted to inhale and then exhale as hard as possible into the mouthpiece of the measuring device for a specific period of time or until out of breath. A countdown timer may be displayed to the user to indicate how long the user has to exhale into the measuring device.

[0331] 47A-47F show schematic examples of one or more GUI display screen prompts 760A, 760B, 760C, 760D, 760E, 760F that may be displayed on the display of the device's user interface during step 760. As will be appreciated, various different variations are possible. The exemplary screen prompt 760A of FIG. 47A includes a text and / or graphic field 7541 that describes or indicates the current mode of operation, i.e., patient diagnosis mode or spirometry mode. A primary instruction text and / or graphic field 7602 includes text and / or graphics that instruct the user to perform a forced exhalation or exhalation maneuver into the measurement device 702 against the flow of gas. One or more secondary or additional text and / or graphic fields 7603 may also be provided, for example showing additional instructions or details on how to perform the primary instruction. The exemplary screen prompt 760B of FIG. 47B shows a variation in which there is a single primary instruction text and / or graphic field 7604. The example screen prompt 760C in FIG. 47C shows a variation in which there is an animation field or area 7605 that can display 2D or 3D graphics, images, animations or videos that depict or show instructions, i.e., in this case assisting in guiding the user through the actions required to complete the steps or instructions of performing one or more exhalation or breath maneuvers.

[0332] Exemplary screen prompts 760D, 760E, 760F show a series of screen prompts in the format of screen prompt 760A, with secondary or additional text and / or graphic area 7603 including a countdown timer, which in some configurations may provide guidance to the user as to the time that a forced exhalation maneuver should be performed. In this example, the countdown is provided with text and numbers, however, it should be understood that the countdown timer may be provided within an animation or graphic or video, alone or in combination with the text and number information.

[0333] Collected, stored and / or analyzed sensor data As the user or patient performs one or more exhalation maneuvers, the patient diagnostic mode is configured to sense or measure one or more characteristics of the flow of gas via one or more sensors in the respiratory assistance device, as shown in step 762. In particular, the controller receives or retrieves sensor data from the one or more sensors during the exhalation maneuvers performed by the patient.

[0334] In one exemplary embodiment, the controller of the respiratory assistance device is configured to sample the flow signal of one or more flow sensors of the device. As discussed, the device may include one or more flow sensors or arrangements arranged to sense the flow rate of the gas flow and generate a representative flow signal or flow data. In other embodiments, one or more other characteristics of the gas flow may be sensed and measured during the exhalation maneuver, including but not limited to pressure, temperature, humidity, gas concentration, or any other characteristic that may be directly or indirectly useful for analyzing lung performance.

[0335] Repeated expiratory maneuvers In some configurations, the device may be configured to prompt the user to perform repeated or multiple exhalation maneuvers in a diagnostic session while in the patient diagnostic mode. In one example, the user may be instructed to perform multiple forced exhalations spaced apart by predetermined time intervals. For example, three or some other specified number of forced exhalations may be performed in an evenly or unevenly spaced manner or according to a preconfigured time interval or format, and sensor data for each exhalation maneuver is extracted or stored from one or more associated sensors to create multiple sets of exhalation measurement data, one set for each exhalation maneuver.

[0336] In some configurations, the device may be configured to detect or identify the initiation or beginning of a forced exhalation by the patient by processing and / or monitoring the sensor data. For example, the device may be configured to process the flow signal or flow data received during a diagnostic mode to identify an offset of the flow rate against a threshold or range, or to otherwise identify a significant deviation that indicates the user is beginning a forced exhalation maneuver against the flow of gas into the measurement device 702. Upon detecting the start of a forced exhalation maneuver, the device may trigger a countdown timer and / or other display GUI screen prompt or other instruction to request the user to continue the forced exhalation for the required duration of each maneuver.

[0337] Additionally or alternatively, forced exhalation detection or identification may be used to count the number of repeated exhalation maneuvers performed by a user in a diagnostic session. The maneuver count may be compared to a required minimum number or other threshold and may be used to prompt the user to continue forced exhalation maneuvers until the required number is registered. Each forced exhalation maneuver has its own respective set of associated measurement data (e.g., sensor data) collected from one or more sensors for subsequent processing.

[0338] The sets of breath measurement data from each maneuver may then be combined, aggregated, or otherwise processed to create a set of averaged data. Alternatively, other statistical analyses may be applied to the measurement data to extract a filtered or robust set of data with reduced noise or less impacted by anomalies such as the user failing to follow instructions or perform the maneuver correctly. In some configurations, the highest quality or best set of measurement data may be selected from the set of breath measurement data for subsequent processing and analysis for lung performance. For example, if the user is required to perform at least three separate breath maneuvers, the sets of sensor data from each breath maneuver may be processed against each other to select the best or highest quality of the three or more sets of data from the diagnosis. The highest quality set of measurement data may be selected based on one or more criteria, such as, but not limited to, the criteria already mentioned.

[0339] 43, 48A and 48B, a more detailed description of one example of a process for prompting a user to perform a forced exhalation maneuver at step 760 of diagnostic method 750 is provided.

[0340] In this exemplary configuration, the user is instructed to forcefully exhale through or into the mouthpiece of the measurement device 702 for x seconds, as shown in sub-step 760A.

[0341] The user is then instructed to repeat the forced exhalation for x seconds y times, as shown in sub-step 706B. The variables x and y may be configured or set as desired. In one example, the device is configured such that the user is prompted to perform a minimum number of forced exhalation maneuvers in a diagnostic session, for example at least three, or some other suitable number.

[0342] After the user has performed the required number of repetitive forced exhalation maneuvers (which may be optionally automatically detected by the device as described above or may otherwise be confirmed by user input), the user is prompted to breathe normally for a certain period of time, as shown in sub-step 760C, to complete or end the diagnostic session. For example, the user may be prompted to breathe normally or normally spontaneously for z minutes (e.g., at least 2 minutes or some other period of time). It will be understood that the variable z may be configured or modified as desired. In one embodiment, during this end-of-breath session 760C, sensor data may be recorded and stored. The stored sensor data for normal breathing may then be further processed and / or used to extract or calculate one or more normal spontaneous breathing measurements or parameters for the patient, as further described below.

[0343] 48A and 48B show schematic examples of one or more GUI display screen prompts 770A and 770B that may be displayed on the display of the user interface during sub-step 760C. As will be appreciated, various different variations are possible. The exemplary screen prompt 770A of FIG. 48A includes a text and / or graphic field 7541 that describes or indicates the current mode of operation, i.e., patient diagnosis mode or spirometry mode. A primary instruction text and / or graphic field 7702 includes text and / or graphics that instruct the user to breathe normally. One or more secondary or additional text and / or graphic fields 7703 may also be provided, e.g., showing additional instructions or details on how to perform the primary instruction. In this example, the display area 7703 may include a countdown timer that indicates the amount of time the user should continue breathing normally before the diagnostic session is terminated. The example screen prompt 770B in FIG. 48B shows a variation in which there is an animation field or area 7705 that can display 2D or 3D graphics, images, animations or videos that depict or show instructions, i.e., to help guide the user through the actions required to complete a step or instruction (in this case, breathing normally for a pre-set or specified period of time).

[0344] Lung performance assessment from sensor data One or more processing algorithms can be applied to the measurement data from the sensor or exhalation maneuver to extract, identify or analyze one or more features indicative of lung performance. In one example, lung performance measurements or data similar to or indicative of spirometry measurements or data can be extracted from or identified within the sensor data.

[0345] As an example, in one configuration, sensed flow data of the flow of gas in a flow path of a respiratory assistance device is collected and stored during one or more exhalation maneuvers. This flow data can represent measurement data indicative of lung performance. The flow data (sensed in the respiratory assistance device) varies as a user performs a forced exhalation through or into a measurement device in fluid communication with the flow path of the respiratory assistance device. The variation in the flow signal or data allows one or more features indicative of lung performance to be identified and extracted from the flow signal through further processing of a set of flow data (e.g., sensor data) associated with the exhalation maneuvers.

[0346] Referring to Fig. 44, another exemplary diagnostic method or process 750A is shown, which is a modified version of the diagnostic method 750 shown in Fig. 42. Like reference numbers represent like steps. The modified diagnostic method 750A includes an optional additional step 764 of any one or more of processing and / or analyzing the measurement data (sensor data) collected during the forced exhalation maneuver to generate pulmonary performance results or outcome 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 the controller of the respiratory assistance apparatus, and / or transmitted to an external device or server or system for storage and / or further processing and / or extraction of the user's pulmonary performance parameters or measurements. The generated sensor data and / or pulmonary performance measurements, whether represented graphically, numerically or in any other format, may be displayed to the user on the display of the respiratory assistance device and / or may be transmitted to one or more external or remote devices, systems or servers (e.g., a cloud platform) for storage, access, display and / or viewing, for example, by a clinician or other authorized person.

[0347] In one configuration, the raw measurements or sensor data may be processed by a controller of the respiratory assistance device to generate one or more pulmonary performance measurements or data.

[0348] In another configuration, the raw measurements or sensor data may be transmitted to an external or remote electronic device (e.g., a smart phone, tablet, PC, wearable, remote server, remote system, cloud or other processing device) for processing to generate one or more pulmonary performance measurements or data. The raw measurements or sensor data may be transmitted in real-time during the diagnostic mode or at the end or termination of the diagnostic mode.

[0349] In another configuration, the raw measurements or sensor data may be partially processed by the controller of the respiratory assistance apparatus and partially processed by an external or remote electronic device (e.g., a smartphone, tablet, PC, wearable, remote server, remote system, cloud or other processing device).

[0350] In configurations where the raw or partially processed measurements or sensor data are processed by an external or remote electronic device (e.g., a smartphone, tablet, PC, wearable, remote server, remote system, cloud or other processing device), the external or remote device or system may transmit the processed data (e.g., pulmonary performance measurements or data) to the respiratory assistance apparatus or another device 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 an associated display screen.

[0351] In one exemplary configuration, the controller of the respiratory assistance apparatus may be configured to transmit the measurements or sensor data to a user's electronic device (such as, for example, a smartphone or tablet). The user's electronic device may perform processing of the raw measurements or sensor data to generate pulmonary performance measurements or data, and then transmit the processed data to a remote server or system for further processing, storage, and / or display. In some configurations, the respiratory assistance apparatus may only have short-range data communication capabilities (e.g., Bluetooth, NFC, infrared, wired) with the user's electronic device (such as, for example, a smartphone or tablet). The user's electronic device may have additional long-range data communication capabilities (e.g., Wifi, cellular, 4G, LTE, 5G, LAN) and may then transmit or send the raw or processed data to a remote server or system, thereby acting as a repeater or transmitter for the respiratory assistance apparatus or a data communication bridge between the respiratory assistance apparatus and a remote server or system.

[0352] Completion of diagnostic process - switching to treatment mode In some configurations, upon completion of the diagnostic method or process 750, 750A, the device may automatically or in response to manual input or control by a user switch to another mode or return to a normal mode, such as a therapeutic mode. For example, the device may switch to a therapeutic mode after sufficient measurement data from a diagnostic session has been captured for processing or after the measurement data has been processed into result data for display, storage and / or transmission.

[0353] In one exemplary configuration, the user may be prompted or informed on a GUI or display screen that the device has switched to a therapy mode or is no longer in a diagnostic mode. FIG. 49 shows one schematic example of a GUI display screen prompt 780 that may be displayed on a display of a user interface of the device. As will be appreciated, a variety of different variations are possible. The exemplary screen prompt 780 of FIG. 49 includes a text and / or graphic field 781 that explains or indicates that the device has switched to a therapy mode ready for a new therapy session (i.e., for delivering a flow of gas for respiratory therapy). A main instruction text and / or graphic field 782 may also be provided and may include text and / or graphics that inform the user about the status of the device and / or instructions for initiating therapy. For example, the display area or field 782 may indicate that the device is ready to begin therapy and / or prompt the user to disconnect the measurement device 702 from the device and / or respiratory conduit and connect or reconnect the patient interface to the respiratory conduit. Once the patient interface is connected to the respiratory conduit, the user can don the patient interface and begin a treatment session with the device.

[0354] Example of lung performance feature extraction Referring to Figure 50, an example of flow data signals and fluctuations caused by a forced exhalation maneuver into a measurement device is shown. In this example, the flow of gas was set to provide air resistance at a flow rate of 70 L / min. It will be appreciated that other non-zero flow rates or ranges of flow rates may be suitable to generate suitable measurement data while using the measurement device with a respiratory assistance apparatus in a diagnostic mode.

[0355] In this exemplary configuration, a flow rate of about 70 L / min may provide the advantage of avoiding backflow of the user's exhaled breath into the apparatus 10. It will be appreciated that other flow rates may provide this advantage in different configurations, and the selected flow rate may be based on balancing one or more factors and / or may be adapted to particular criteria or configurations of the respiratory assistance apparatus and / or measurement device. For example, in some configurations, the flow rate may be configured to provide sufficient air pressure resistance to make the required pulmonary performance measurements and avoid backflow into the apparatus.

[0356] The flow rate selected for use may additionally or alternatively be a function of or at least partially based on pneumatic characteristics of the respiratory assistance apparatus and / or measuring device configuration, including, for example, flow resistance of the flow path after the flow generator or the output flow path. For example, a breath may be configured or selected based at least partially on one or more of the following pneumatic characteristics: the output flow path of the respiratory assistance apparatus, the breathing conduit and / or the measuring device. For example, in a respiratory assistance apparatus having a check valve in the flow path, a much lower flow rate (e.g., about 10 L / min) may be suitable or sufficient to collect the necessary measurement data when operating in a diagnostic mode with a measuring device attached.

[0357] An example of a variation in the sensed flow data caused by a healthy person performing a forced exhalation into the measurement device is shown at 790, and a variation in the sensed flow data of a sick person is shown at 792. As shown in FIG. 50, a healthy person causes a larger and more rapid decrease in the sensed flow rate of the flow of gas compared to a sick person or a person with impaired lung function or reduced lung performance. In one exemplary configuration, the sensor data, e.g., flow sensor data, may represent pulmonary performance measurement data and / or may be processed to extract one or more pulmonary performance measurement data values. In one exemplary configuration, the sensor data (e.g., flow or other sensor data) and / or the processed pulmonary performance measurement data may be graphed or represented graphically for display on a user interface. In such a configuration, the graph may be further processed to identify and / or determine the health status of the user, e.g., whether the user is healthy or sick.

[0358] Examples of pulmonary performance measures that may be extracted or identified from measurement data (eg, sensor data such as flow signals or flow data) from a diagnostic session are described further below.

[0359] The pressure exerted by the patient during the expiratory maneuver P patient can be calculated from the flow signal, for example, by applying the following formula:

number

[0360] Here, P blower is the pressure measured at the output of the respiratory assistance device using a pressure sensor located in the flow path downstream of the flow generator, R is the resistance to flow between the output of the flow generator and the patient (including resistance due to any connected measuring devices), and Q or Q Totalis the output flow rate of the flow generator (e.g., 70 L / min in the example above with reference to FIG. 50, but could be any other suitable flow rate), and n1 preferably has a value of 2, although any value between 1 and 2 may be suitable. The value of n1 may be predetermined and is a quantity of how laminar or turbulent the flow through the measurement device attachment is.

[0361] The conductance (C) to the flow between the flow generator output and the patient (including the effect of any connected measurement devices) can be expressed as:

number

[0362] Patient pressure value P patient The flow rate Q that the patient can induce on the respiratory support device using patient can be calculated as follows:

number

[0363] Here, R Patient is the known flow resistance of the measurement device at flow rate Q (i.e. the flow resistance between the connector end of the measurement device and the mouthpiece of the measurement device), and again, n2 has a value of 2, although any value between 1 and 2 may be suitable.

[0364] As explained with reference to the following equations (4) to (6), Q Patient Alternative approaches or embodiments for extracting the signal may also be implemented. First, the leak flow (Q Leak ) can be estimated as follows:

number

[0365] where n has the same definition as the previous components n1 and n2. TotalAssuming that Q can be measured directly using one or more flow sensors downstream of the flow generator / blower, the controller can then Patient The signal can be estimated. Q Patient =Q Total -Q Leak (5)

[0366] Q Leak The value of is particularly significant in this alternative approach, so in some configurations it may be important to detect whether a leak flow is present (i.e., to determine whether one or more exhaust vents of the measurement device are covered / blocked). This can be accomplished through checks such as:

number

[0367] Here, the threshold conductance C Threshold has a predetermined value. For example, 83.2 L / min / cmH20 1 / n The threshold may have to be met for a minimum period of time (e.g., in seconds) to ensure accuracy.

[0368] A number of clinically useful pulmonary performance metrics, such as features or feature indices and the like, can be extracted from the sensed data generated during the diagnostic mode. These may include FEV1, FEV2, FEV3 (fractional expiratory volume at 1, 2, and 3 seconds, respectively), FVC (forced vital capacity), PEF (peak expiratory flow), or others. · FEV1 values ​​or FEV1 analogs may be calculated by analyzing the first second of flow data as the patient begins exhalation in the expiratory maneuver. Similarly, FEV2 and FEV3 values ​​or similar values ​​can be calculated by analyzing the first 2 and 3 seconds (respectively) of flow data after the patient begins exhalation in the expiratory maneuver. FVC may be calculated by determining the total volume of air exhaled over a complete expiratory maneuver. This can be done, for example, by measuring the processed patient flow signal (Q patient Alternatively, the patient flow signal may instead be represented by negative variations in the unprocessed sensed raw flow signal, and the FVC may be calculated from these negative variations. Another pulmonary performance metric, the FEV1 / FVC ratio, can be easily calculated from the FEV1 and FVC values ​​above. PEF is the processed patient flow signal Q as seen in Figure 50. patient This may be calculated by identifying the peak patient flow, which corresponds to the highest peak in the flow signal or, alternatively, the deepest "trough" in the raw flow signal.

[0369] Although the above disclosure describes forced expiratory measurements, some measurements were made using Q measurements generated during quiet breathing or normal spontaneous breathing by the patient. patient The measured value of the flow rate Q may be calculated from the signal in the measurement device. In this normal spontaneous breathing mode, the output flow rate Q of the flow generator may be lower compared to the forced expiratory measurement mode, for example 10 L / min or some other suitable flow rate. Examples of other measurements that may be extracted or determined in the measurement device during normal spontaneous (quiet) breathing mode may include any one or more of the following: Respiratory rate (RR) can be measured using zero crossing detection, peak detection, frequency analysis or processed patient flow signal Q patient may be calculated via other suitable means of identifying the period of time. - Tidal volume (V T ) is the Q patient It can be calculated by integrating the signal. Minute ventilation (MV) is calculated by the above RR and V T It can be calculated using the parameters:

number

[0370] Any of these pulmonary performance metrics or features, individually or in combination, are particularly useful for analyzing the condition or symptoms of patients with COPD, asthma, bronchiectasis, or other respiratory conditions that affect lung health or performance. One or more of these features or other suitable pulmonary performance parameters may be used to help guide the selection of suitable treatment settings (e.g., respiratory therapy prescriptions) for a respiratory assistance apparatus (e.g., a respiratory therapy device). For example, the FiO2 and / or flow settings may be at least partially informed by one or more pulmonary performance parameters determined using a measurement device connected to the respiratory assistance apparatus operating in a diagnostic mode. Upper and / or lower limits for that setting or treatment may be selected based at least in part on the pulmonary performance parameters or metrics generated during the diagnostic mode.

[0371] In one exemplary configuration, a clinician can receive and review the lung performance metrics, measurements, generated results or characteristics and then suggest a prescription to the patient based at least in part on the measurement results. The prescription may define or include any one or more of the following settings or characteristics for the flow of gas provided in the respiratory therapy: flow rate, oxygen concentration, and humidity level.

[0372] Expression of pulmonary performance measurements Any one or more of the pulmonary performance measurements, features, values ​​or indicators within the result data extracted, identified or calculated from a diagnosis or diagnostic session using a measurement device may be expressed, stored, recorded or displayed as a ratio, percentage or proportion relative to itself or to an expected value or some other baseline value or parameter for healthy members of the population group to which the user belongs.

[0373] For example, the PEF may be expressed as "PEF as a percentage of a healthy adult male or female." Expected indicator values ​​for a healthy adult male or female may be stored in a look-up table or other suitable data structure, which may be stored in-memory of the device or other accessible remote memory or data storage (e.g., a cloud or remote server data storage).

[0374] In a further example, any one or more of the individual pulmonary performance measures, indicators, features or values ​​within the outcome data may be combined in any one or more desired ratios or functions relative to one another to generate new useful pulmonary performance metrics or ratios. For example, calculating a ratio or value of FEV1 / FVC may be useful as a spirometry assessment. By way of example, FEV1 / FVC may desirably be 70-80% (or 0.7-0.8) to indicate good health.

[0375] Patient physiological parameters In an exemplary configuration, if the patient is instructed or prompted to take multiple breaths at the end of the diagnostic period (see, e.g., substep 760C in FIG. 43 above), one or more patient physiological parameters may be estimated or calculated or extracted from the sensor data recorded over the multiple breathing maneuvers. These parameters may include, for example, any one or more of tidal volume, respiratory rate, minute ventilation, and peak inspiratory flow.

[0376] 4. Terminology The phrase "respiratory assistance apparatus" as used in this specification and claims, unless the context indicates otherwise, is intended to mean any type of respiratory assistance or breathing apparatus, device or system operable to provide respiratory assistance or respiratory therapy to a user or patient by providing a flow of gas to the user or patient.

[0377] Unless the context clearly dictates otherwise, throughout this specification and the claims, the words "comprise", "including", and the like are to be construed in their inclusive sense, i.e., "including but not limited to," as opposed to their exclusive or exhaustive sense.

[0378] Although the present disclosure has been described in connection with certain embodiments and examples, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as obvious modifications and equivalents thereof. In addition, while several variations of the embodiments of the present disclosure have been shown and described in detail, other modifications that are within the scope of the present disclosure will be readily apparent to those skilled in the art. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still be within the scope of the present disclosure. For example, features described above in connection with one embodiment may be used with different embodiments described herein, and the combinations will still be within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for each other to form various aspects of the embodiments of the present disclosure. Therefore, it is not intended that the scope of the disclosure herein should be limited by the specific embodiments described above. Thus, unless otherwise stated or clearly contradictory, each embodiment of the present invention may include, in addition to its essential features described herein, one or more features described herein from each of the other embodiments of the present invention disclosed herein.

[0379] It should be understood that features, materials, properties or groups described in connection with a particular aspect, embodiment or example are applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification, unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all of the steps of any method or process so disclosed may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel one or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings) or any novel one or any novel combination of steps of any method or process so disclosed.

[0380] Moreover, certain features that are described in the present disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination, one or more features from a claimed combination may in some cases be deleted from the combination, and the combination may be claimed as a subcombination or a variation of the subcombination.

[0381] Furthermore, although operations may be shown in the figures or described herein in a particular order, such operations need not be performed in the particular order shown or sequential order, or all of the operations need not be performed, to achieve desired results. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or during any of the described operations. Furthermore, operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may differ from those shown in the figures. Depending on the embodiment, some of the steps described above may be eliminated and other steps may be added. Furthermore, the features and attributes of certain embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. It should also be understood that the separation of various system components in the above-described implementations should not be understood as requiring such separation in all implementations, and that the described components and systems may generally be integrated together in a single product or packaged in multiple products.

[0382] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved by any particular embodiment. Thus, for example, one skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0383] Conditional language such as "can," "could," "could" or "may," unless otherwise specified or understood within the context in which it is used, is intended to generally convey that certain embodiments include certain features, elements, and / or steps, but other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are to be included in or performed in any particular embodiment, with or without user input or prompting.

[0384] Language of degree as used herein, such as the terms "approximately," "about," "generally," and "substantially," refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10% of a stated amount, within 5%, within 1%, within 0.1%, and within 0.01%.

[0385] The scope of the disclosure is not intended to be limited by the specific disclosure of embodiments in this section or elsewhere herein, but may be defined by the claims as they are presented in this section or elsewhere herein or as they may be presented in the future. The language of the claims is to be interpreted broadly based on the language used in the claims and is not limited to the examples described herein or during the prosecution of this application, which examples are to be construed as non-exclusive.

Claims

1. 1. A respiratory assistance apparatus configured to provide a flow of gas to a user for respiratory therapy, comprising: a flow generator operable to generate a flow of gas along a flow path of the device; a breathing conduit for delivering said flow of gas to a user; a measuring device for lung performance fluidly connected or connectable to an end of the respiratory conduit to receive the flow of gas; a controller operable to control the respiratory assistance apparatus, the controller being configured to control the flow of gas into the measuring device to provide a controlled air resistance to a user's exhaled breath when the user performs one or more forced exhalation maneuvers into the measuring device; Respiratory support devices including:

2. 1. A respiratory assistance apparatus configured to provide a flow of gas to a user for respiratory therapy, comprising: a flow generator operable to generate a flow of gas along a flow path of the device; a breathing conduit for delivering said flow of gas to a user; a measuring device for lung performance fluidly connected or connectable to an end of the respiratory conduit to receive the flow of gas; a controller operable to control the respiratory assistance apparatus, the controller being configured to control the flow of gas into the measuring device to provide a controlled air resistance to the exhaled breath of a user when the user is breathing tidal or normally spontaneously into the measuring device; Respiratory support devices including:

3. 3. A respiratory assistance apparatus as described in claim 1 or 2, wherein the controller is configured to determine a user flow signal representative of the flow that the user can induce for the flow of gas through the measuring device based on a function of at least a user pressure signal representative of the pressure exerted by the user during exhalation into the measuring device.

4. A respiratory assistance apparatus as described in any one of claims 1 to 3, wherein the controller is configured to determine a user flow signal representative of the flow that the user can induce for the flow of gas through the measuring device based on a function of at least a flow resistance parameter related to the measuring device.

5. A respiratory assistance apparatus as described in any one of claims 1 to 4, wherein the controller is configured to determine a user flow signal representative of the flow that the user can induce to the flow of gas through the measuring device based on at least a function of a flow conductance parameter.

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

7. 7. A respiratory assistance device as described in claim 3 or 6, wherein the controller is configured to determine the user pressure signal based on a function of at least a pressure signal representative of the pressure at the outlet of the flow generator, a flow resistance parameter, and a flow signal representative of the flow rate of the flow of gas generated by the flow generator.

8. 3. A respiratory assistance apparatus as described in claim 1 or 2, wherein the controller is configured to determine a user flow signal representative of a flow that the user can induce for the flow of gas through the measuring device based on a function of at least a flow signal representative of the flow rate of the flow of gas generated by the flow generator and a leak flow signal representative of a leak flow through one or more exhaust openings of the measuring device.

9. 9. The respiratory assistance apparatus of claim 8, wherein the controller is configured to determine the leak flow signal based on a function of at least a flow conductance parameter and a user pressure signal representative of the pressure exerted by the user during exhalation into the measuring device.

10. 10. The respiratory assistance apparatus of claim 9, wherein the controller is configured to determine the user pressure signal based on a function of at least a pressure signal representative of the pressure at the outlet of the flow generator, a flow resistance parameter, and a flow signal representative of the flow rate of the flow of gas produced by the flow generator.

11. A respiratory assistance apparatus as described in any one of claims 3 to 5 or 8, wherein the controller is configured to determine a respiratory rate signal or parameter of the user based at least in part on or as a function of at least the determined user flow signal when the user performs normal spontaneous breathing into the measuring device.

12. A respiratory assistance apparatus as claimed in any one of claims 2 to 11, wherein the controller is configured to determine a tidal volume signal or parameter of the user based at least in part on or as a function of at least the determined user flow signal when the user breathes normally spontaneously into the measuring device.

13. 13. A respiratory assistance device as described in claim 12 when dependent on claim 11, wherein the controller is configured to determine a minute ventilation signal or parameter of the user based at least in part on or as a function of at least the determined respiratory rate signal and tidal volume signal.

14. A respiratory assistance apparatus as described in any one of claims 3 to 5 or 8, wherein the controller is configured to determine a signal or parameter representative of a ratio of inspiration time to total breathing time based at least in part on or as a function of at least the determined user flow signal when the user breathes normally spontaneously into the measuring device.

15. A respiratory aid apparatus as claimed in any preceding claim, including one or more sensors for sensing or determining one or more characteristics of the flow of gas and generating representative sensor data.

16. 16. A respiratory assistance apparatus as described in claim 15, wherein the one or more sensors are configured to measure or determine any one or more of the following characteristics of the flow of gas: flow, pressure, temperature, humidity.

17. 17. Respiratory assistance apparatus according to claim 15 or 16, wherein the one or more sensors are external to or separate from the measuring device.

18. A respiratory assistance apparatus as described in any one of claims 15 to 17, wherein the one or more sensors are located in the flow path upstream of the measuring device or configured to sense the flow of the gas upstream of the measuring device.

19. A respiratory assistance device as described in any one of claims 15 to 18, wherein the device, the flow generator, is enclosed or contained within a main housing of the device and the one or more sensors are located within the main housing and / or breathing conduit of the device.

20. A respiratory assistance apparatus as described in any one of claims 1 to 19, wherein the measuring device includes a body extending between a connector end and a mouthpiece end, the body including one or more main lumens extending between the connector end and the mouthpiece end for the flow of the gas.

21. 21. A respiratory assistance apparatus as claimed in claim 20, wherein the body is a conduit or tubular component having one or more openings at each end.

22. 22. A respiratory assistance apparatus as claimed in claim 20 or 21, wherein the connector end of the body is configured to be releasably connected to an end of the respiratory conduit.

23. 22. A respiratory assistance apparatus as claimed in claim 20 or 21, wherein the connector end of the body is integrally or permanently connected to an end of the respiratory conduit.

24. A respiratory assistance apparatus as claimed in any one of claims 20 to 23, wherein the connector end of the body includes one or more openings or ports for fluidly connecting to an end of the respiratory conduit.

25. A respiratory assistance device as claimed in any one of claims 20 to 24, wherein the mouthpiece end of the body is arranged to receive a removable mouthpiece which is arranged in use to provide fluid communication to the user's airway.

26. A respiratory aid apparatus according to any one of claims 20 to 24, wherein the mouthpiece end of the body is a mouthpiece arranged to provide fluid communication to the user's airway in use.

27. A respiratory assistance apparatus according to any one of claims 20 to 26, wherein the body of the measuring device further comprises one or more exhaust openings in fluid communication with the one or more main lumens.

28. 28. A respiratory assistance apparatus as claimed in claim 27, wherein the measurement device further comprises one or more anti-occlusion features configured to prevent inadvertent occlusion of the one or more exhaust openings.

29. 29. A respiratory assistance apparatus as claimed in claim 28, wherein the anti-occlusion feature is arranged or configured as a clip for attaching the measurement device.

30. A respiratory aid apparatus as claimed in any one of claims 27 to 29, wherein the one or more exhaust openings are provided on the body between the connector end and the mouthpiece end.

31. A respiratory aid apparatus as claimed in any one of claims 27 to 30, wherein one or more of the exhaust openings is a vent.

32. 32. A respiratory assistance apparatus as claimed in claim 31 , wherein one or more of the vents comprises a single opening.

33. 33. A respiratory assistance apparatus as claimed in claim 31 or 32, wherein one or more of the vents comprises a plurality of openings.

34. A respiratory aid apparatus as claimed in any one of claims 31 to 33, wherein one or more of the vents comprises a plurality of openings or holes in the form of a honeycomb or mesh structure or arrangement.

35. A respiratory assistance device as claimed in any one of claims 27 to 34, wherein one or more of the exhaust openings are flush vents provided in a wall of the body, whereby the flush vents are substantially flush with an outer surface of the body.

36. A respiratory aid apparatus as claimed in any one of claims 27 to 35, wherein one or more of the exhaust openings is a protruding vent protruding from a wall of the body.

37. 37. A respiratory assistance apparatus as described in claim 36, wherein one or more of the protruding vents are shaped and / or configured to direct or deflect any exhaust gases exiting the vent away from the user's face when the measurement device is in use.

38. 38. A respiratory assistance apparatus as described in claim 37, wherein the body is defined by a longitudinal axis extending between the connector end and the mouthpiece end, and the one or more of the protruding vents extend at an angle to the longitudinal axis such that when the measurement device is in use, any exhaust gases exiting the vent are directed or deflected away from the user's face.

39. A respiratory aid apparatus as claimed in any preceding claim, further comprising a humidifier operable to heat and humidify the flow of gas produced by the flow generator.

40. 40. A respiratory assistance apparatus as claimed in claim 39, wherein the humidifier is provided within a main housing of the apparatus, the main housing further containing the flow generator.

41. A respiratory assistance apparatus as described in any one of claims 1 to 40, wherein the controller includes a patient diagnostic mode operable to control the flow of gas to provide the controlled air resistance when the measuring device is connected to an end of the respiratory conduit.

42. A respiratory assistance apparatus as described in any one of claims 1 to 41, wherein the controller comprises one or more operating modes including at least a first mode operable to control the apparatus when the measuring device is not connected to the respiratory conduit and a second mode operable to control the apparatus when the measuring device is connected to the respiratory conduit.

43. A respiratory assistance apparatus as described in any one of claims 1 to 42, wherein the controller includes a plurality of operational modes including at least a therapy mode operable to control the apparatus to provide a flow of gas to a user for respiratory therapy, and a patient diagnostic mode operable to control the flow of gas to provide air resistance for taking pulmonary performance measurements when the measurement device is connected to the respiratory conduit.

44. 1. An apparatus for administering a pulmonary performance measurement to a user, comprising: a flow generator operable to generate a flow of gas in the flow passage; a measurement device in fluid communication with the flow path to receive the flow of gas; a controller operable to control the flow generator to generate a flow of gas into the measurement device to provide a controlled air resistance in the flow path to a user's exhaled breath when the user performs one or more forced exhalation maneuvers into the measurement device; one or more sensors configured to sense one or more characteristics of the flow of gas in the flow path when the user performs the forced exhalation maneuver into the measurement device and to generate representative sensor data from which one or more pulmonary performance measures may be derived; An apparatus comprising:

45. 1. An apparatus for administering a pulmonary performance measurement to a user, comprising: a flow generator operable to generate a flow of gas in the flow passage; a measurement device in fluid communication with the flow path to receive the flow of gas; a controller operable to control the flow generator to generate a flow of gas into the measurement device to provide a controlled air resistance in the flow path to the user's exhaled breath when the user is breathing tidal or normally spontaneously into the measurement device; one or more sensors configured to sense one or more characteristics of the flow of gas in the flow path when the user breathes tidal or normal spontaneously into the measurement device and generate representative sensor data from which one or more lung performance measurements may be derived; An apparatus comprising:

46. 1. A measuring device for use with a respiratory assistance apparatus to measure lung performance, comprising: a body releasably connectable to a gas outlet or breathing conduit of said breathing assistance device and configured to deliver a flow of gas from said gas outlet to a user; The main conduit body includes: a connector end connectable to the gas outlet of the respiratory assistance device to receive the flow of gas; a mouthpiece end for providing fluid communication to the airway of the user in use; one or more main lumens extending between the connector end and the mouthpiece end for carrying the flow of gas; one or more exhaust openings provided on the body between its ends and in fluid communication with the one or more main lumens; a measuring device.

47. 47. The measurement device of claim 46, wherein the body is a conduit or tubular component having one or more openings at each end.

48. 48. A measurement device as claimed in claim 46 or 47, wherein the connector end of the body is adapted to be releasably connectable to an end of the gas outlet or breathing conduit of the respiratory assistance apparatus.

49. A measuring device as claimed in any one of claims 46 to 48, wherein the connector end of the body includes one or more openings or ports for fluidly connecting to the gas outlet or breathing conduit of the respiratory assistance apparatus.

50. 50. A measurement device according to any one of claims 46 to 49, wherein the mouthpiece end of the body is configured to receive a removable mouthpiece which is configured, in use, to provide fluid communication to the user's airway.

51. 50. A measurement device according to any one of claims 46 to 49, wherein the mouthpiece end of the body is a mouthpiece arranged to provide fluid communication to the airways of the user in use.

52. A measuring device according to any one of claims 46 to 51, wherein the body of the measuring device further comprises one or more drain openings in fluid communication with the one or more main lumens.

53. 53. The measurement device of claim 52, further comprising one or more anti-occlusion features configured to prevent inadvertent obstruction of the one or more drainage openings.

54. 54. The measurement device of claim 53, wherein the anti-occlusion feature is arranged or configured as a clip for attaching the measurement device.

55. A measuring device according to any one of claims 52 to 54, wherein the one or more exhaust openings are provided on the body between the connector end and the mouthpiece end.

56. A measuring device according to any one of claims 52 to 55, wherein one or more of the exhaust openings is a vent.

57. 57. The measurement device of claim 56, wherein one or more of the vents includes a single opening.

58. 58. The measurement device of claim 56 or 57, wherein one or more of the vents includes a plurality of openings.

59. A measurement device according to any one of claims 56 to 58, wherein one or more of the vents comprises a plurality of openings or holes in the form of a honeycomb or mesh structure or arrangement.

60. A measuring device according to any one of claims 56 to 59, wherein one or more of the exhaust openings are flush vents provided in a wall of the body, whereby the flush vents are substantially flush with an outer surface of the body.

61. A measuring device according to any one of claims 56 to 60, wherein one or more of the exhaust openings is a protruding vent protruding from a wall of the body.

62. 62. The measurement device of claim 61 , wherein one or more of the protruding vents are shaped and / or configured to direct or deflect any exhaust gases exiting the vent away from a user's face when the measurement device is in use.

63. 63. The measurement device of claim 62, wherein the body is defined by a longitudinal axis extending between the connector end and the mouthpiece end, and the one or more of the protruding vents extend at an angle to the longitudinal axis such that any exhaust gases exiting the vents are directed or deflected away from the user's face when the measurement device is in use.

64. 1. A method for measuring lung performance using a measurement device with a respiratory assistance apparatus, comprising: connecting a measuring device to a gas outlet or breathing conduit or flow path of a respiratory assistance apparatus such that the measuring device receives a flow of gas from a flow generator of the respiratory assistance apparatus; operating the respiratory assistance device in a patient diagnostic mode configured to enable one or more pulmonary performance measures to be determined; prompting a user to perform one or more forced exhalation maneuvers into the measurement device; determining one or more characteristics of the flow of gas using one or more sensors during the forced expiratory maneuver; The method includes:

65. 1. A method for measuring lung performance using a measurement device with a respiratory assistance apparatus, comprising: connecting a measuring device to a gas outlet or breathing conduit or flow path of a respiratory assistance apparatus such that the measuring device receives a flow of gas from a flow generator of the respiratory assistance apparatus; operating the respiratory assistance device in a patient diagnostic mode configured to enable one or more pulmonary performance measures to be determined; instructing a user to breathe quietly or normally into the measuring device; determining one or more characteristics of the flow of gas using one or more sensors during said tidal breathing or normal spontaneous breathing; The method includes:

66. 66. A method according to claim 64 or 65, wherein the patient diagnostic mode of the respiratory assistance apparatus is configured to generate a flow of gas to the gas outlet and / or breathing conduit connected to the measuring device.

67. 67. The method of claim 66, wherein the patient diagnostic mode of the respiratory assistance device is configured to generate the flow of gas at a constant rate.

68. 67. The method of claim 66, wherein the constant flow rate of the flow of gas is configured to provide a substantially constant or consistent air resistance to a user's exhaled breath into the measurement device.

69. 69. A method according to claim 67 or 68, wherein the patient diagnostic mode of the respiratory assistance device is configured to generate a flow of gas for a fixed duration or predetermined period.

70. 70. A method according to any one of claims 64 to 69, wherein operating the respiratory assistance device in the patient diagnostic mode comprises initiating or initiating the patient diagnostic mode in response to user input via a user interface.

71. 71. The method of claim 70, wherein the user input to initiate or activate the patient diagnostic mode is provided via a user interface of the respiratory assistance device.

72. 72. The method of claim 71, wherein the user interface of the respiratory assistance device includes a button and / or a touch screen interface button operable by a user or other person to activate the patient diagnostic mode.

73. 71. The method of claim 70, wherein user input to initiate or activate the patient diagnostic mode is provided via a user interface of an external device in data communication with the respiratory assistance apparatus.

74. 74. The method of claim 73, wherein the user interface of the device includes a button and / or a touch screen interface button operable by a user or other person to activate the patient diagnostic mode.

75. 75. The method of any one of claims 70 to 74, further comprising prompting a user or other person to initiate or activate the patient diagnostic mode via the user interface.

76. 76. The method of claim 75, wherein prompting a user or other to initiate or activate the patient diagnostic mode comprises providing a prompt via the respiratory assistance device.

77. 77. The method of claim 76, wherein prompting includes generating an audio prompt by the respiratory assistance device.

78. 78. A method according to claim 76 or 77, wherein prompting comprises generating a visual prompt on a display or interface of the respiratory assistance device.

79. 76. The method of claim 75, wherein prompting a user or other to initiate or activate the patient diagnostic mode comprises providing a prompt on an external device in data communication with the respiratory assistance apparatus.

80. A method according to any one of claims 75 to 79, wherein prompting a user or other to initiate or activate the patient diagnostic mode comprises prompting according to periodic intervals.

81. 81. The method of claim 80, wherein the periodic interval is configurable.

82. 82. The method of claim 81, comprising configuring the periodic interval of the prompting via a user interface of the respiratory assistance device.

83. 82. The method of claim 81, comprising configuring the periodic interval of the prompting via a user interface or software application of an external device in data communication with the respiratory assistance apparatus.

84. 84. The method of claim 83, wherein the periodic intervals of the prompting are remotely configurable by a clinician, physician, or medical professional using the external device.

85. A method according to any one of claims 75 to 79, wherein prompting a user or other to initiate or activate the patient diagnostic mode comprises initiating or triggering a prompt in response to input or interaction by a clinician, doctor or medical professional using a remote or external device in data communication with the respiratory assistance apparatus.

86. 70. A method according to any one of claims 64 to 69, comprising automatically initiating or initiating the patient diagnostic mode of the respiratory assistance device.

87. 87. A method according to claim 86, comprising automatically initiating or initiating the patient diagnostic mode of the respiratory assistance device based on periodic intervals.

88. 90. The method of claim 87, wherein the periodic interval for automatically initiating or initiating the patient diagnostic mode is configurable.

89. 90. The method of claim 88, comprising configuring the periodic interval of the patient diagnostic mode via a user interface of the respiratory assistance device.

90. 90. The method of claim 88, comprising configuring the periodic interval of the patient diagnostic mode via a user interface or software application of an external device in data communication with the respiratory assistance apparatus.

91. 91. The method of claim 90, wherein the periodic interval of the patient diagnostic mode is remotely configurable by a clinician, physician, or medical professional using the external device.

92. A method according to any one of claims 64 to 91, wherein the respiratory assistance apparatus includes one or more communications modules configured to provide data communication between one or more external or remote devices.

93. A method according to any one of claims 64 to 92, wherein determining one or more characteristics of the flow of gas during the forced expiratory maneuver or normal spontaneous breathing comprises using one or more sensors of the respiratory assistance device.

94. 94. A method according to any one of claims 64 to 93, wherein determining one or more characteristics of the flow of gas during the forced expiratory maneuver or normal spontaneous breathing comprises using one or more sensors in the flow path upstream of the measuring device or one or more sensors configured to sense the flow of gas upstream of the measuring device.

95. A method according to any one of claims 64 to 94, further comprising providing a user, via a user interface of the respiratory assistance device, with instructions on how to connect the measuring device to the device, use the measuring device and / or perform the forced expiratory maneuver or normal spontaneous breathing into the mouthpiece during a diagnostic session.

96. 96. The method of claim 95, wherein the instructions are provided or presented visually and / or audibly on a display of the user interface.

97. 97. A method according to any one of claims 64 to 96, further comprising graphically presenting sensor data from the one or more sensors or one or more pulmonary performance measures generated from the sensor data on a display of a user interface of the respiratory assistance device.

98. 98. The method of any one of claims 64 to 97, further comprising processing sensor data from the one or more sensors to generate pulmonary performance measurement data and / or one or more representative graphs or the sensor data and / or pulmonary performance measurement data.

99. 99. The method of claim 98, further comprising processing the pulmonary performance measurement data and / or graphs to identify or determine a health state of a user.

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