Data Acquisition, Processing, Storage and Rendering System for a Respiratory Assistance Device - Patent application

Abstract

A respiratory assistance device and associated system for capturing, processing, storing and rendering data. The data may relate to a personal health questionnaire presented to a patient of the respiratory assistance device on a display screen of the respiratory assistance device. Responses to a set of questions in the questionnaire may be captured as answer data. The answer data may then be transmitted and / or processed against reference data for access and rendering as one or more data reports and / or time series charts.

Description

[Technical field]

[0001] The present disclosure relates to respiratory assistance devices and associated systems for data capture, processing, storage and rendering. [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 or respiratory therapy device may be used to deliver supplemental oxygen or other gases along with the gas flow, and / or may include a humidification device to deliver heated and humidified gas. Respiratory support devices use sensors, such as flow and / or pressure sensors, to measure characteristics of the gas flow that can allow for adjustment and control over the characteristics of the gas flow, including flow rate, temperature, gas concentration, humidity, pressure, etc. Summary of the Invention [Means for solving the problem]

[0003] In one aspect, the disclosure broadly relates to a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator for generating the flow of gas; a humidifier for heating and humidifying the flow of gas; a controller operable to control the flow generator and the humidifier; and a user interface including a display for enabling user interaction with the controller; a data server in data communication with the respiratory therapy device; and a display device in data communication with the data server, the controller of the respiratory therapy device receiving answer data based on user input to the user interface to a set of questions presented on the display related to one or more health parameters from at least one of a symptom category and a medication category, and transmitting the answer data to the data server. and a data server configured to receive response data from the respiratory therapy device and process the response data against reference data associated with the user to generate a data report accessible or rendered for display by a display device, the data report including a color-coded time series plot of the user's response data for one or more health parameters over a period of time, each plotted response of the response data being selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, the color spectrum selected for each response being a function of or based on any deviation of the response data from the reference data, and the generated data report being displayed or rendered on the display device.

[0004] In one configuration, the reference color spectrum is visually different or distinguishable from one or more deviation color spectra.

[0005] In one configuration, the reference color spectrum has high visual contrast with one or more deviation color spectra.

[0006] In one configuration, the time series plot includes a deterioration deviation color spectrum representing a worsening or exacerbation of the health parameter represented by the response data relative to the baseline data.

[0007] In one configuration, any answer data that corresponds to or matches the reference data is represented as a plotted answer colored according to the reference color spectrum, and any answer data that represents a worsening deviation from the reference data is represented as a plotted answer colored according to the worsening deviation color spectrum.

[0008] In one configuration, the time series plot further includes a favorable deviation color spectrum representing the favorable improvement of the health parameter represented by the response data relative to the baseline data.

[0009] In one configuration, any response data that corresponds to an improvement from the baseline data is represented as a plotted response color-coded according to the improvement deviation color spectrum.

[0010] In one configuration, the response data for each health parameter question includes or is convertible to a score or ranking on a scale, with each score or ranking on the scale corresponding to or assigned to a respective discrete color value in each of the reference color spectrum and one or more deviation color spectra, such that each plotted answer in the response data is assigned a discrete color value from the selected color spectrum associated with its score.

[0011] In one configuration, the scores are numerical and the scale ranges from a desirable score or ranking at one end of the scale to an undesirable score or ranking at the other end of the scale.

[0012] In one configuration, the reference color spectrum and the one or more deviation color spectra each include base or dominant colors of discrete color values ​​ranging from lighter color values ​​at one end of the spectrum to darker color values ​​at the other end of the spectrum.

[0013] In one configuration, a desirable score or ranking on the scale corresponds to or is assigned a discrete color value in the reference color spectrum and one or more deviation color spectra that is lighter than an undesirable score or ranking, or vice versa, or one or more color spectra are configured such that a desirable score or ranking on the scale corresponds to or is assigned a discrete color value that is lighter than an undesirable score or ranking, and one or more other color spectra are configured such that a desirable score or ranking on the scale corresponds to or is assigned a discrete color value that is darker than an undesirable score.

[0014] In one configuration, the base or dominant color associated with each respective reference color spectrum and one or more deviation color spectrums comprises a color, hue, tint, tone, or shade.

[0015] In one configuration, the base or predominant color associated with the reference color spectrum is a cool color, hue, tint, tone or shade, and the base or predominant color of the deterioration deviation color spectrum is a warm color, hue, tint, tone or shade.

[0016] In one configuration, each plotted answer is color-coded according to a color spectrum selected depending on whether the answer data corresponds to or deviates from the reference data, and within the selected color spectrum, based on an assigned color value that corresponds to or is a function of the desirability or position on the scale of the score or ranking associated with the answer data.

[0017] In one configuration, the response data for each health parameter question includes or is convertible to a score or ranking on a scale, with each score or ranking on the scale corresponding to or assigned a respective discrete color value in each of the reference color spectrum and one or more deviation color spectra, such that each plotted answer in the response data is assigned a discrete color value from a selected color spectrum associated with that score.

[0018] In one configuration, the discrete color values ​​of each color spectrum represent discrete scores or rankings on the scale, and the scale is defined from light color values ​​representing a desirable score or ranking at one end to dark color values ​​representing an undesirable score or ranking, or vice versa, or the scale for one or more color spectrums is defined from light color values ​​representing a desirable score or ranking at one end to dark color values ​​representing an undesirable score or ranking, and the scale for one or more other color spectrums is defined from dark color values ​​representing a desirable score or ranking at one end to light color values ​​representing an undesirable score or ranking.

[0019] In one configuration, the reference color spectrum and one or more deviation color spectra are each visually represented in the data report by a respective color key that plots the discrete color values ​​of each color spectrum in relation to their position on the scale associated with the response data.

[0020] In one configuration, the plotted responses are plotted with columns by time interval frequency along the time axis of the plot and rows by the health parameter or parameters to which the responses relate.

[0021] In one configuration, the time interval frequency is daily, such that each column of response data is associated with a particular day within a period of days, hi another configuration, the time interval frequency is weekly, such that each column of response data is associated with a particular week within a period of weeks.

[0022] In one configuration, the answer data has associated time interval data representing the time intervals during which the answer data was entered by the user, and the answers are plotted in an array, stack or column along the time axis of the time series plot according to their respective time intervals, with answers spanning time intervals aligned in rows according to their associated health parameters.

[0023] In one configuration, each plotted response is represented by a color-coded data marker within a plot of any shape or size.

[0024] In one configuration, the generated data report includes multiple distinct color-coded time series plots associated with multiple different users that are presented or displayed together.

[0025] In one configuration, the display of the user interface includes a touchscreen display providing a graphical user interface (GUI), and user input is provided via the touchscreen display and / or one or more input elements.

[0026] In one configuration, the user interface display presents a graphical user interface (GUI), the user interface including one or more input elements operable by a user to provide user input to the GUI.

[0027] In one configuration, the questions posed on the display relate to one or more health parameters from the symptoms category or medication category, or at least one health parameter from each category.

[0028] In one aspect, the disclosure broadly includes a method of generating a data report for display, the method being implemented by an electronic device including a processor having associated memory, the method including receiving or obtaining answer data into the memory, the answer data representing user input to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category of a user of a respiratory therapy device; receiving or obtaining reference data into the memory, the reference data being associated with the user; processing the answer data against the reference data to generate a data report accessible or rendered for display on a display device associated with or connected to the electronic device, the data report including a color-coded time series plot of the user's answer data for the one or more health parameters over a period of time, each plotted answer of the answer data being selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, the color spectrum selected for each answer being a function of or based on any deviation of the answer data from the reference data; and displaying the generated data report on the display device.

[0029] In one configuration, the electronic device is a computing device configured to receive response data from a data server and / or from a respiratory therapy device.

[0030] In one configuration, the electronic device is a data server configured to receive the response data directly from the respiratory therapy device over a data communications network, or indirectly via another electronic device over a data communications network.

[0031] In one configuration, the electronic device is a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator that generates the flow of gas; a humidifier that heats and humidifies the flow of gas; a controller operable to control the flow generator and the humidifier; and a touch screen that provides a graphical user interface (GUI) to enable user interaction with the controller, the controller of the respiratory therapy device configured to receive answer data based on user input to the touch screen GUI to a set of posed questions related to one or more health parameters.

[0032] In one aspect, the disclosure broadly includes a software application for generating a data report, the application including a set of instructions executed by a processor and associated memory of an electronic device to perform the steps of: receiving or retrieving answer data into memory, the answer data representing user input to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category; receiving or retrieving reference data into memory, the reference data being associated with a user; processing the answer data against the reference data to generate a data report including a color-coded time series plot of the user's answer data for the one or more health parameters over a period of time, each plotted answer of the answer data being selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, the color spectrum selected for each answer being a function of or based on any deviation of the answer data from the reference data; and outputting the data report as a data file for rendering on a display or rendering the data report on an associated display.

[0033] In one configuration, the software application further includes receiving a data request to view a data report associated with one or more users, and generating and rendering the data report on a display in response to the data request.

[0034] In one aspect, the disclosure broadly includes a graphical user interface (GUI) and a processor for displaying a data report, the GUI controlled by the processor to render the data report in the GUI, the processor configured to: obtain or receive report data into a memory representative of the data report, the report data including answer data representing user inputs to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category, and reference data associated with the user; process the report data in accordance with rendering instructions; and render the data report in the GUI based on the report data and in accordance with the rendering instructions, the rendering instructions configured to render a data report including a color-coded time series plot of the user's answer data for the one or more health parameters over a period of time, each plotted answer of the answer data being selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, the color spectrum selected for each answer being a function of or based on any deviation of the answer data from the reference data.

[0035] In one aspect, the disclosure provides a method and apparatus for delivering a flow of gas to a respective one of a plurality of users for respiratory therapy, each respiratory therapy device comprising: a flow generator for generating a flow of gas; a humidifier for heating and humidifying the flow of gas; a controller operable to control the flow generator and the humidifier; and a user interface including a display to enable user interaction with the controller; a data server in data communication with the respiratory therapy devices; and a display device in data communication with the data server, wherein the controller of the respiratory therapy devices is operable to generate symptom data and / or medication data based on user input to the user interface in response to a set of questions presented on the display associated with one or more health parameters from at least one of a symptom category and a medication category. and configured to receive response data including response data from a plurality of respiratory therapy devices for a plurality of users and transmit the response data to a data server, the data server configured to receive the response data from a plurality of respiratory therapy devices for a plurality of users and process the response data against baseline data associated with each respective user to generate a graphical dashboard accessible or rendered for display by a display device, the graphical dashboard depicting, for each user, a summary time series chart of the user's processed response data against the user's baseline data by category, each summary time series chart depicting or representing deviations of symptom data and / or medication data against their respective baseline data over a period of time, and the generated graphical dashboard being displayed or rendered on the display device.

[0036] In one configuration, the summary time series chart for each user includes a time series graph that plots both symptom data deviations and medication data deviations.

[0037] In one configuration, plots of symptom data deviation and medication data deviation are visually represented within the same time series graph, either visually distinguishable from one another or as separate data sets.

[0038] In one configuration, the plots of symptom data deviations and the plots of medication data deviations are represented in the same or different types of plots.

[0039] In one configuration, plots of symptom data deviations and medication data deviations are presented as separate plots within the same time series graph, or as combined plots within the same time series graph.

[0040] In one configuration, the plots representing the symptom data deviations and the medication data deviations are selected from any one or more of the following types of plots: dot plots, line charts or line graphs, bar charts, lollipop charts, stacked bar charts, and grouped bar charts.

[0041] In one configuration, the summary time series graph for each user includes symptom data deviations plotted as time series bar charts and medication data deviations plotted as time series line charts, or vice versa, within the same time series graph.

[0042] In one configuration, the bar and line charts representing symptom data deviations and medication data deviations are plotted against the same deviation axis so that they visually overlay one another.

[0043] In one configuration, the bar and line charts representing symptom data deviations and medication data deviations are visually distinguished from one another by color, pattern, or shading.

[0044] In one configuration, the data server is configured to process the response data to extract or generate symptom data deviations and medication data deviations in the form of category deviation parameters for plotting representing the total number of health parameters within each respective category for the user that deviate from their respective reference data for each time interval associated with the time axis of the time series graph.

[0045] In one configuration, the data server is configured to generate a symptom category deviation parameter and a medication category deviation parameter which represent or is a function of the total number of the health parameters that deviate from their reference value for each time interval, and a medication category deviation parameter which represent or is a function of the total number of the health parameters that deviate from their reference value for each time interval, where each deviation parameter is plotted on the time series graph; or a worsening deviation parameter which represents or is a function of the total number of the health parameters in the category that have worsening deviations from their reference value for each time interval, and an improvement deviation parameter which represents or is a function of the total number of the health parameters in the category that have better deviations from their reference value for each time interval, where each deviation parameter is plotted on the time series graph.

[0046] In one configuration, the data server is configured to generate a categorical deviation parameter for each time interval in response to or based on a color coding of the answer data, the answer data being color coded according to either a reference color spectrum or a deviation color spectrum depending on whether the answer deviates from the user's reference data.

[0047] In one configuration, the data server is configured to generate symptom category deviation parameters and medication category deviation parameters for each time interval based on a dataset representing associated color-coded time series plots of a user's response data for one or more health parameters over a period of time, where each plotted response of the response data is selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, and the color spectrum selected for each response is a function of or based on any deviation of the response data relative to the reference data.

[0048] In one configuration, the category deviation parameters over each time interval are based on or a function of the number of answers within each respective category that are color-coded in each of the deviation color spectra.

[0049] In one configuration, the summary time series chart for each user includes a color-coded time series plot of the user's response data for one or more health parameters over a period of time, where each plotted response of the response data is selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, where the color spectrum selected for each response is a function of or based on any deviation of the response data from the reference data.

[0050] In one configuration, the plotted responses are grouped into rows or otherwise aligned with their associated health parameters when plotted against the time axis in a color-coded time series plot.

[0051] In one configuration, the plotted responses are presented in defined category groups based on the categories associated with the health parameters to which the plotted responses relate.

[0052] In one configuration, the data server is further configured to process the response data of the multiple users to determine priorities among the users, and the generated graphical dashboard is configured to display or present summary time series charts of the multiple users based at least in part on the determined priorities of the users.

[0053] In one configuration, each user's priority represents the user's overall health status relative to other users based on the response data, and the graph dashboard is configured such that the summary time series graph is presented in an order or arrangement that prioritizes users with worse health status according to the user's priority.

[0054] In one configuration, the display of the user interface includes a touchscreen display providing a graphical user interface (GUI), and user input is provided via the touchscreen display and / or one or more input elements.

[0055] In one configuration, the user interface display presents a graphical user interface (GUI), the user interface including one or more input elements operable by a user to provide user input to the GUI.

[0056] In one configuration, the questions posed on the display relate to one or more health parameters from the symptoms category or medication category, or at least one health parameter from each category.

[0057] In one configuration, the disclosure broadly includes a method of generating a graphical dashboard for display, the method being performed by an electronic device having a processor with associated memory, the method including receiving or acquiring answer data into the memory, the answer data including symptom and / or medication data representative of user inputs to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category, the answer data associated with a plurality of users of a respective respiratory therapy device; receiving or acquiring baseline data into the memory, the baseline data associated with each respective user of the plurality of users; processing the answer data against the baseline data for each user to generate a graphical dashboard accessible or rendered for display on a display device associated with or connected to the electronic device, the graphical dashboard depicting, for each user, a summary time series chart of the user's processed answer data against the user's baseline data on a category basis, each summary time series chart depicting or representing deviations of the symptom data and / or medication data over a period of time against their respective baseline data; and displaying the generated graphical dashboard on the display device.

[0058] In one configuration, the electronic device is a computing device configured to receive response data from a data server and / or from a plurality of respiratory therapy devices.

[0059] In one configuration, the electronic device is a data server configured to receive response data directly from the multiple respiratory therapy devices over a data communications network, or indirectly via another electronic device over the data communications network.

[0060] In one aspect, the disclosure broadly includes a software application for generating a graphical dashboard, the application including a set of instructions executed by a processor and associated memory of an electronic device to perform the steps of: receiving or obtaining answer data into a memory, the answer data including symptom data and / or medication data representative of user inputs to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category, the answer data associated with a plurality of users of a respective respiratory therapy device; receiving or obtaining baseline data into a memory, the baseline data being associated with each respective user of the plurality of users; processing the answer data against the baseline data for each user to generate a graphical dashboard accessible or rendered for display on an associated display device, the graphical dashboard depicting, for each user, a summary time series chart of the user's processed answer data against the user's baseline data by category, each summary time series chart depicting or representing deviations of the symptom data and / or medication data against their respective baseline data over a period of time; and outputting the data report as a data file for rendering on the display or for rendering the data report on an associated display.

[0061] In one configuration, the software application further includes receiving a data request to view a data report associated with one or more users, and generating and rendering the data report on a display in response to the data request.

[0062] In one aspect, the disclosure broadly includes a graphical user interface (GUI) and a processor for displaying a graphical dashboard, the GUI controlled by the processor to render the graphical dashboard in the GUI, the processor configured to: acquire or receive into a memory dashboard data representing the graphical dashboard, the dashboard data including answer data including symptom data and / or medication data representing user inputs to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category, the answer data including symptom data and / or medication data representing user inputs to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category, the answer data including a plurality of users of a respective respiratory therapy device and baseline data associated with each respective user of the plurality of users; process the dashboard data in accordance with rendering instructions; and render a graphical dashboard in the GUI based on the dashboard data and in accordance with the rendering instructions, the rendering instructions configured to render, for each user, a graphical dashboard depicting, by category, a summary time series chart of the user's processed answer data against the user's baseline data, each summary time series chart depicting or representing a deviation of the symptom data and / or medication data against their respective baseline data over a period of time.

[0063] In one aspect, the disclosure broadly relates to a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator that generates the flow of gas; a humidifier that heats and humidifies the flow of gas; a controller operable to control the flow generator and the humidifier; and a user interface including a display that enables user interaction with the controller; a data server in data communication with the respiratory therapy device; and a display device in data communication with the data server, the controller of the respiratory therapy device receiving answer data based on user input to the user interface to a questionnaire including a set of questions presented on the display related to one or more health parameters from at least one of a symptom category and a medication category; receiving skipped data based on user input to the user interface to the set of presented questions, the skipped data representing any particular questions skipped by the user or the entire questionnaire skipped by the user; and receiving the answer data. and transmitting the answer data and skipped data to a data server, the data server receiving and storing the answer data and skipped data from the respiratory therapy device for a series of time intervals over a period of time; processing the answer data against reference data associated with the user to determine a deviation of the answer data against the reference data for each health parameter; and generating a data report accessible or rendered for display by a display device, the data report including one or more time series charts depicting or representing the deviation of the answer data against the reference data for the series of time intervals, at least one of the time series charts further including a skipped data graphical indicator identifying any questions in any of the time intervals that include a skipped question based on the skipped data, and a no data graphical indicator identifying any time intervals with no answer data or skipped data, thereby indicating no user interaction with the respiratory therapy device during that time interval.and generating a data report, wherein the generated data report is displayed or rendered on a display device.

[0064] In one aspect, the disclosure broadly relates to a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator that generates the flow of gas; a humidifier that heats and humidifies the flow of gas; a controller operable to control the flow generator and the humidifier; and a user interface including a display that enables user interaction with the controller; a data server in data communication with the respiratory therapy device; and a display device in data communication with the data server, the controller of the respiratory therapy device receiving answer data based on user input to the user interface to a questionnaire including a set of questions presented on the display related to one or more health parameters from at least one of a symptom category and a medication category; and receiving skipped data based on user input to the user interface to the set of questions presented, the skipped data being any particular questions skipped by the user or any questions that have been skipped by the user. and transmitting answer data and skipped data to a data server, the data server being configured to receive from the respiratory therapy device answer data and skipped data for a series of time intervals over a period of time, process the answer data against reference data associated with the user to determine a deviation of the answer data from the reference data for each health parameter, and generate a data report accessible or rendered for display by a display device, the data report including one or more time series charts depicting or representing the deviation of the answer data from the reference data over the series of time intervals, at least one of the time series charts further including a graphical indication of skipped data identifying any questions in any of the time intervals that include skipped questions based on the skipped data, and the generated data report being displayed or rendered on the display device.

[0065] In one configuration, at least one of the time series charts may further include a no data graphical indicator that identifies any time intervals where there is no response data or skipped data, thereby indicating that there was no user interaction with the respiratory therapy device during that time interval.

[0066] In one configuration, at least one of the time series charts further includes one or more graphical indicators identifying any time intervals during which the user was hospitalized or receiving hospital treatment.

[0067] In one configuration, at least one time series chart includes a color-coded time series plot of a user's response data for one or more health parameters over a period of time, where each plotted response of the response data is selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, where the color spectrum selected for each response is a function of or based on any deviation of the response data from the reference data.

[0068] In one configuration, the plotted responses are grouped into rows or otherwise aligned with their associated health parameters when plotted against the time axis in a color-coded time series plot.

[0069] In one configuration, the plotted responses are presented in defined category groups based on the categories associated with the health parameters to which the plotted responses relate.

[0070] In one configuration, the response data is plotted or populated into an array of color-coded data cells arranged along a time axis with rows by the health parameters associated with the responses and columns by the time intervals over which the responses were taken.

[0071] In one configuration, the color-coded time series plot further plots in the data cells a graphical indicator of the skipped data that corresponds to the skipped data.

[0072] In one configuration, the skipped data is plotted in the data cell according to a graphical indicator of the skipped data that corresponds to a presented key that defines the graphical indicator of the skipped data.

[0073] In one configuration, the graphical indication of the skipped data includes any one or more of the following characteristics to differentiate it from the answer data: color coding in a color different from the reference color spectrum and the deviation color spectrum, pattern, shading, instruction text, or instruction symbols.

[0074] In one configuration, the color-coded time series plot further plots a graphical indicator of no data in the data cells for time intervals during which no-answer or skipped data is received.

[0075] In one configuration, the no data graphical indication includes any one or more of color coding in a color different from the reference color spectrum and the deviation color spectrum, a pattern, a shade, an indicator text, an indicator symbol, a blank data cell, and a blank column of data cells.

[0076] In one configuration, the response data includes symptom data and medication data associated with one or more health parameters from respective symptom and medication categories, and the at least one time series chart includes a time series graph including plots representing deviations of both the symptom data and the medication data relative to their respective baseline data for a series of time intervals over the period.

[0077] In one configuration, the time series graph includes plots of symptom data deviations and medication data deviations that are visually distinguishable from one another or visually represented as separate data sets within the same time series graph.

[0078] In one configuration, the plots of symptom data deviation and medication data deviation are represented in the same or different types or plots.

[0079] In one configuration, the plots representing the symptom data deviations and the medication data deviations are selected from any one or more of the following types of plots: dot plots, line charts or line graphs, bar charts, lollipop charts, stacked bar charts, and grouped bar charts.

[0080] In one configuration, the time series graph includes symptom data deviations plotted as time series bar charts and medication data deviations plotted as time series line charts, or vice versa, within the same time series graph.

[0081] In one configuration, the time series graph further plots a graphical indicator of skipped data that indicates the time interval that contains skipped data.

[0082] In one configuration, the time series graph further plots a no data graphical indicator indicating time intervals during which no answer or skipped data was received.

[0083] In one configuration, the display of the user interface includes a touchscreen display providing a graphical user interface (GUI), and user input is provided via the touchscreen display and / or one or more input elements.

[0084] In one configuration, the user interface display presents a graphical user interface (GUI), the user interface including one or more input elements operable by a user to provide user input to the GUI.

[0085] In one configuration, the questions posed on the display relate to one or more health parameters from the symptoms category or medication category, or at least one health parameter from each category.

[0086] In one aspect, the disclosure broadly includes a method of generating a data report for display, the method being implemented by an electronic device having a processor having associated memory, comprising: receiving or acquiring into the memory answer data, the answer data representing user input to a questionnaire including a set of posed questions related to one or more health parameters from at least one of symptom categories and medication categories of a user of a respiratory therapy device; receiving or acquiring into the memory skipped data, the skipped data representing any particular questions skipped by the user or the entire questionnaire being skipped by the user; receiving or acquiring into the memory baseline data, the baseline data associated with a user; and processing the answer data against the baseline data to generate a data report for a period of time. determining a deviation of the answer data relative to the reference data for each health parameter for a series of time intervals over the period; generating a data report accessible or rendered for display on a display device associated with or connected to the electronic device, the data report including one or more time series charts depicting or representing the deviation of the answer data relative to the reference data over the series of time intervals, at least one of the time series charts including a graphical indication of skipped data identifying any questions in any of the time intervals that included a skipped question based on the skipped data, and a graphical indication of no data identifying time intervals in which there is no answer or skipped data, thereby indicating there was no user interaction with the respiratory therapy device during that time interval; and displaying the generated data report on the display device.

[0087] In one aspect, the disclosure broadly includes a method of generating a data report for display, the method being implemented by an electronic device having a processor having associated memory, the method including: receiving or acquiring into the memory answer data, the answer data representing a user input to a questionnaire including a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category of a user of a respiratory therapy device; receiving or acquiring into the memory skipped data, the skipped data representing any particular questions skipped by the user or the entire questionnaire being skipped by the user; and receiving or acquiring into the memory baseline data, the baseline data representing a baseline associated with the user. the electronic device includes receiving, acquiring, or displaying the response data based on the skipped data; processing the response data against the reference data to determine a deviation of the response data against the reference data for each health parameter for a series of time intervals over a period of time; generating a data report accessible or rendered for display on a display device associated with or connected to the electronic device, the data report including one or more time series charts depicting or representing the deviation of the response data against the reference data over the series of time intervals, at least one of the time series charts including a graphical indication of skipped data identifying any questions in any of the time intervals that included a skipped question based on the skipped data; and displaying the generated data report on the display device.

[0088] In one configuration, at least one of the time series charts further includes a no data graphical indicator that identifies any time intervals where there is no response data or skipped data, thereby indicating that there was no user interaction with the respiratory therapy device during that time interval.

[0089] In one configuration, at least one of the time series charts further includes one or more graphical indicators identifying any time intervals during which the user was hospitalized or receiving hospital treatment.

[0090] In one configuration, the electronic device is a computing device configured to receive response data from a data server and / or from a respiratory therapy device.

[0091] In one configuration, the electronic device is a data server configured to receive the response data directly from the respiratory therapy device over a data communications network, or indirectly via another electronic device over a data communications network.

[0092] In one configuration, the electronic device is a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator that generates the flow of gas; a humidifier that heats and humidifies the flow of gas; a controller operable to control the flow generator and the humidifier; and a touch screen that provides a graphical user interface (GUI) to enable user interaction with the controller, wherein the controller of the respiratory therapy device is configured to receive answer data and skipped data based on user input into the touch screen GUI to a set of posed questions related to one or more health parameters.

[0093] In one aspect, the disclosure broadly includes a software application for generating a data report, the application including the steps of: receiving or retrieving into memory response data, the response data representing user input to a questionnaire including a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category of a user of a respiratory therapy device; receiving or retrieving into memory skipped data, the skipped data representing any particular questions skipped by the user or the entire questionnaire being skipped by the user; receiving or retrieving into memory baseline data, the baseline data being associated with a user; processing the response data against the baseline data to determine a deviation of the response data relative to the baseline data for each health parameter for a series of time intervals over a period of time; and generating an associated display. The method includes a set of instructions that are executed by a processor and associated memory of an electronic device to perform the steps of generating a data report that is accessible or rendered for display on the device, the data report including one or more time series charts depicting or representing deviations of answer data relative to reference data over a series of time intervals, at least one of the time series charts including a graphical indicator of skipped data that identifies any questions in any of the time intervals that include skipped questions based on the skipped data, and a graphical indicator of no data that identifies time intervals in which there is no answer or skipped data, thereby indicating that there was no user interaction with the respiratory therapy device during that time interval; and outputting the data report as a data file for rendering on a display or rendering the data report on an associated display.

[0094] In one configuration, the software application may further include receiving a data request to view a data report associated with one or more users, and generating and rendering the data report on a display in response to the data request.

[0095] In one aspect, the disclosure broadly includes a graphical user interface (GUI) and a processor for displaying a data report, the GUI being controlled by the processor to render the data report in the GUI, the processor receiving or retrieving into a memory report data representative of the data report, the report data representing a series of time intervals over a period of time and including answer data representative of user inputs to a questionnaire including a set of posed questions related to one or more health parameters from at least one of symptom categories and medication categories of a user of a respiratory therapy device, skipped data representative of questions skipped by the user or entire questionnaires being skipped by the user, and baseline data associated with the user, and generating a report in accordance with the rendering instructions. and rendering a data report in the GUI based on the report data and in accordance with the rendering instructions, the rendering instructions being configured to render a data report including one or more time series charts depicting or representing deviations of the answer data relative to the reference data over a series of time intervals, at least one of the time series charts further including a skipped data graphical indicator identifying any questions in any of the time intervals that included a skipped question based on the skipped data, and a no data graphical indicator identifying any time intervals with no answer or skipped data, thereby indicating no user interaction with the respiratory therapy device during that time interval.

[0096] In one aspect, the disclosure broadly relates to a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator for generating the flow of gas; a humidifier for heating and humidifying the flow of gas; a controller operable to control the flow generator and the humidifier; and a user interface including a display enabling user interaction with the controller; a data server in data communication with the respiratory therapy device; and a display device in data communication with the data server, wherein the controller of the respiratory therapy device receives answer data including symptom data and / or medication data based on user input to the user interface to a set of questions presented on the display related to one or more health parameters from at least one of a symptom category and a medication category; The data server is configured to transmit the response data to a data server, the data server being configured to receive the response data from the respiratory therapy device for a series of time intervals over a period of time, process the response data against reference data associated with the user to extract or generate symptom data deviations and / or medication data deviations indicative of health parameters within each respective category for the user that deviate from their respective reference data for each time interval, in the form of one or more category deviation parameters for plotting, and generate a data report accessible or rendered for display by a display device, the data report including a time series graph plotting the one or more category deviation parameters for the time intervals over the period of time.

[0097] In one configuration, the data server is configured to generate symptom category deviation parameters and medication category deviation parameters which represent or are functions of health parameters that deviate from their reference values ​​for each time interval, and one or more medication category deviation parameters which represent or are functions of health parameters that deviate from their reference values ​​for each time interval, where each deviation parameter is plotted on the time series graph; or a worsening deviation parameter which represents or is a function of the total number of health parameters in the category that have a worsening deviation from their reference values ​​for each time interval, and an improvement deviation parameter which represents or is a function of the total number of health parameters in the category that have an improvement deviation from their reference values ​​for each time interval, where each deviation parameter is plotted on the time series graph.

[0098] In one configuration, the data server is configured to generate a categorical deviation parameter for each time interval in response to or based on a color coding of the answer data, the answer data being color coded according to either a reference color spectrum or a deviation color spectrum depending on whether the answer deviates from the user's reference data.

[0099] In one configuration, the data server is configured to generate symptom category deviation parameters and medication category deviation parameters for each time interval based on a dataset representing associated color-coded time series plots of a user's response data for one or more health parameters over a period of time, where each plotted response of the response data is selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, and the color spectrum selected for each response is a function of or based on any deviation of the response data relative to the reference data.

[0100] In one configuration, the category deviation parameters over each time interval are based on or a function of the number of answers within each respective category, color-coded in a deviation color spectrum.

[0101] In one configuration, the time series graph plots both symptom category deviation parameters and medication category deviation parameters.

[0102] In one configuration, plots of symptom category deviation parameters and medication category deviation parameters are visually represented within the same time series graph, either visually distinguishable from one another or as separate data sets.

[0103] In one configuration, the plots of the symptom category deviation parameters and the medication category deviation parameters are represented in the same or different types or plots.

[0104] In one configuration, plots of symptom category deviation and medication data deviation parameters are represented by separate plots in the same time series graph or as a combined plot in the same time series graph.

[0105] In one configuration, plots of symptom category deviation parameters and medication category deviation parameters are selected from any one or more of the following types of plots: dot plot, line chart or line graph, bar chart, lollipop chart, stacked bar chart, and grouped bar chart.

[0106] In one configuration, the time series graph includes symptom category deviation parameters plotted as bar charts and medication category deviation parameters plotted as line charts, or vice versa.

[0107] In one configuration, the bar and line charts representing the symptom category deviation parameters and the medication category deviation parameters are plotted against the same deviation axis so as to visually overlay one another.

[0108] In one configuration, the bar and line charts representing the symptom category deviation parameters and the medication category deviation parameters are visually distinguished from one another by color, pattern, or shading.

[0109] In one configuration, the data server is configured to process the response data with the baseline data such that the generated category deviation parameter or parameters can represent both deterioration and improvement of the deviation parameter.

[0110] In one configuration, the data server is further configured to receive prescription data indicating time intervals during which prescription changes or updates occurred for a user, and to plot graphical indications or representations indicating prescription changes for relevant time intervals in a time series graph.

[0111] In one aspect, the disclosure broadly includes a method of generating a data report for display, the method being performed by an electronic device including a processor having associated memory, receiving or acquiring answer data into the memory, the answer data including symptom data and / or medication data based on user input to a set of posed questions associated with one or more health parameters from at least one of a symptom category and a medication category of a user of a respiratory therapy device, receiving or acquiring baseline data into the memory, the baseline data being associated with the user, and comparing the answer data against the baseline data for a series of time intervals over a period of time. processing the data to extract or generate, for the user, symptom data deviations and / or medication data deviations indicative of health parameters within each respective category that deviate from their respective reference data for each time interval, in the form of one or more category deviation parameters for plotting; generating a data report accessible or rendered for display on a display device associated with or connected to the electronic device, the data report including a time series graph plotting the one or more category deviation parameters for a plurality of time intervals over a period of time; and displaying the generated data report on the display device.

[0112] In one configuration, the electronic device is a computing device configured to receive response data from a data server and / or from a respiratory therapy device.

[0113] In one configuration, the electronic device is a data server configured to receive the response data directly from the respiratory therapy device over a data communications network, or indirectly via another electronic device over a data communications network.

[0114] In one configuration, the electronic device is a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator that generates the flow of gas; a humidifier that heats and humidifies the flow of gas; a controller operable to control the flow generator and the humidifier; and a touch screen that provides a graphical user interface (GUI) to enable user interaction with the controller, wherein the controller of the respiratory therapy device is configured to receive answer data and skipped data based on user input into the touch screen GUI to a set of posed questions related to one or more health parameters.

[0115] In one aspect, the disclosure broadly includes a software application for generating a data report, the application including the steps of: receiving or retrieving into memory answer data, the answer data including symptom data and / or medication data based on user input to a set of posed questions associated with one or more health parameters from at least one of a symptom category and a medication category for a user of a respiratory therapy device; receiving or retrieving into memory baseline data, the baseline data associated with the user; and processing the answer data against the baseline data for a series of time intervals over a period of time to generate a respective one of the health parameters within each respective category for the user for each time interval. The electronic device includes a set of instructions that are executed by a processor and associated memory of the electronic device to perform the steps of: extracting or generating symptom data deviations and / or medication data deviations indicative of health parameters that deviate from their respective reference data in the form of one or more category deviation parameters for plotting; generating a data report accessible or rendered for display on an associated display device, the data report including a time series graph plotting the one or more category deviation parameters for a plurality of time intervals over a period of time; and outputting the data report as a data file for rendering on the display or rendering the data report on the associated display.

[0116] In one configuration, the software application further includes receiving a data request to view a data report associated with one or more users, and generating and rendering the data report on a display in response to the data request.

[0117] In one aspect, the disclosure broadly includes a graphical user interface (GUI) and a processor for displaying a data report, the GUI being controlled by the processor to render the data report in the GUI, the processor being configured to: acquire or receive report data in a memory representing the data report, the report data including answer data representing user input to a set of posed questions related to one or more health parameters from at least one of symptom categories and medication categories for a user of a respiratory therapy device; process the report data in accordance with rendering instructions; and render a data report in the GUI based on the report data and in accordance with the rendering instructions, the rendering instructions being configured to render to the user a data report including a time series graph plotting one or more category deviation parameters representing health parameters for each category that deviate from their respective reference data for each time interval in the period.

[0118] In one aspect, the disclosure broadly relates to a respiratory therapy device configured to deliver a flow of gas to a user for respiratory therapy, the respiratory therapy device comprising: a flow generator for generating the flow of gas; a humidifier for heating and humidifying the flow of gas; a controller operable to control the flow generator and the humidifier; and a user interface including a display for enabling user interaction with the controller; and a data server in data communication with the respiratory therapy device, the controller of the respiratory therapy device being operable to: answer questions based on user input to the user interface in response to a set of questions presented on the display of a personal health questionnaire related to one or more health parameters from at least one of a symptom category and a medication category. The system includes a respiratory therapy device configured to receive diagnostic data and transmit the interview data to a data server, the data server configured to receive the interview data from the respiratory therapy device, process the interview data against one or more stored notification profiles linked to or assigned to the user, the one or more notification profiles each including data defining trigger criteria, and trigger one or more notifications according to the notification profile to be generated at the respiratory therapy device or an electronic device in data communication with the respiratory therapy device or the data server when respective trigger criteria for the one or more notification profiles are met by the processed interview data.

[0119] In one aspect, the disclosure broadly includes a system for processing interview data including a user's responses to a personal health interview including a set of questions related to one or more health parameters from at least one of a symptom category and a medication category, the system including a processor and a memory, the processor configured to: receive or acquire the interview data from a respiratory therapy device or an electronic device operated by the user; process the interview data against one or more stored notification profiles linked to or assigned to the user, the one or more notification profiles each including data defining trigger criteria; and trigger one or more notifications according to the notification profile to be generated at an electronic device in data communication with the processor when respective trigger criteria for the one or more notification profiles are met by the processed interview data.

[0120] In one configuration, each notification profile further includes data defining a notification message that defines the message, content or information to be conveyed in the notification.

[0121] In one configuration, the notification messages and / or trigger criteria of a notification profile are configurable or adjustable.

[0122] In one configuration, the system comprises a user interface operable to create, configure or adjust one or more notification profiles.

[0123] In one configuration, the user interface is configured to allow a user to configure or adjust trigger criteria for one or more notification profiles.

[0124] In one configuration, the one or more notification profiles assigned to a user include one or more default notification profiles that are assigned to the user based on a patient profile that defines the user.

[0125] In one configuration, the system links or assigns a user's patient profile to one or more patient groups if the user's patient profile meets the respective patient group criteria, and the one or more notification profiles assigned to the user include one or more patient group notification profiles.

[0126] In one configuration, a patient group notification profile is a notification profile that applies to all users who are members of an associated patient group based on their patient profiles.

[0127] In one configuration, the system comprises a user interface operable to create or configure patient groups and their associated patient group criteria.

[0128] In one configuration, the system comprises a user interface operable to create, configure or adjust one or more patient group notification profiles for patient groups defined in the system.

[0129] In one configuration, one or more trigger criteria of a notification profile are configurable via an operable user interface of the system.

[0130] In one configuration, one or more trigger criteria of a notification profile include criteria based or responsive at least in part to the user's interview data and associated stored criteria data, and one or more conditions.

[0131] In one configuration, one or more trigger criteria of a notification profile include criteria based at least in part on or responsive to deviation data representative of deviations of the interview data from the user's baseline data, and one or more conditions.

[0132] In one configuration, one or more trigger criteria of a notification profile include criteria based at least in part on or responsive to questionnaire data related to one or more specified health parameters associated with the personal health questionnaire and associated stored criteria data, and one or more conditions.

[0133] In one configuration, the one or more trigger criteria of the notification profile include criteria and one or more conditions based at least in part on or responsive to deviation data representative of deviations of the questionnaire data from the user's baseline data for one or more specified health parameters associated with the personal health questionnaire.

[0134] In one configuration, the trigger criteria conditions include comparing the data to one or more threshold and / or time period conditions.

[0135] In one configuration, the triggered notification includes any one or more of a visual notification, an audible notification, and / or a tactile notification.

[0136] In one aspect, the disclosure broadly includes a data server configured to process interview data including a user's responses to a personal health interview including a set of questions related to one or more health parameters of the user, the data server comprising a processor configured to: receive or retrieve the interview data from an electronic device, a database, or a respiratory therapy device; process the interview data against one or more stored notification profiles linked to or assigned to the user, the one or more notification profiles each including data defining trigger criteria; and trigger one or more notifications according to the notification profiles to be generated at an electronic device in data communication with the data server when respective trigger criteria for the one or more notification profiles are met by the processed interview data.

[0137] In one aspect, the disclosure broadly includes a system comprising a data server having associated one or more processors and memory, and a display device in data communication with the data server, the data server configured to receive answer data representing answers from a user to a set of posed questions related to one or more health parameters from at least one of a symptom category and a medication category, and process the answer data against reference data associated with the user to generate a data report accessible or rendered for display by the display device, the data report including a color coded time series plot of the user's answer data for the one or more health parameters over a period of time, each plotted answer of the answer data being selectively color coded for display according to a reference color spectrum or one or more deviation color spectrums, the color spectrum selected for each answer being a function of or based on any deviation of the answer data from the reference data, and the generated data report being displayed or rendered on the display device.

[0138] In one aspect, the 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 processing devices to perform any of the methods of one or more of the aspects described above.

[0139] In one aspect, the disclosure broadly includes a set of application program interfaces or application program interfaces (APIs) embodied on a computer-readable medium for execution on a processing device in conjunction with an application program that performs any of the methods of one or more of the above aspects.

[0140] Any aspect of the present disclosure 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, or any aspect of any data (e.g., interview data, response data, symptom data, medication data, categorical deviation parameters, baseline data and / or deviation data), data reports, graphical dashboards, summary time series charts, time series charts (e.g., color-coded time series plots and / or time series graphs), and / or associated system architecture may have any one or more of the features mentioned with respect to any other aspect described above, in any combination.

[0141] These and other features, aspects, and advantages of the present disclosure will be described with reference to drawings of several embodiments, which are intended to illustrate several embodiments and are not intended to limit the present disclosure. [Brief description of the drawings]

[0142] [Figure 1] 1 is a schematic diagram of a respiratory assistance device according to one embodiment; [Diagram 2] FIG. 2 is a front / right overhead perspective view of a respiratory aid apparatus with a humidifier liquid chamber positioned within a recess in the respiratory aid apparatus base unit, according to one embodiment. [Diagram 3] 3 is a front / left side view of the respiratory aid apparatus of FIG. 2 with the humidifier liquid chamber removed from the recess of the respiratory aid apparatus, according to one embodiment. [Figure 4] FIG. 2 is a front / right side overhead perspective view of a respiratory assistance apparatus base unit, with the humidifier liquid chamber and heater plate not shown, according to one embodiment. [Figure 4A] FIG. 2 is a front / right side bottom perspective view of a respiratory assistance apparatus, with the humidifier liquid chamber not shown, according to one embodiment. [Figure 4B] FIG. 1 is a rear view of a respiratory assistance device base unit with a battery module in place, according to one embodiment. [Diagram 5]1 is a schematic diagram of a respiratory assistance device according to one embodiment; [Figure 6] 4 is a flow chart of controller operation according to one embodiment. [Figure 6A] 4 is a flow chart of controller operation according to one embodiment. [Figure 6B] 4 is a flow chart of controller operation according to one embodiment. [Figure 7] 1 is a flowchart of a process for conditionally presenting a personal health questionnaire to a patient of a respiratory assistance device, according to one embodiment. [Figure 8] 1 is a flow chart of a process for determining deviations for answers to a personal health questionnaire based on pre-established criteria. [Figure 9] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 10] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 11] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 12] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 13] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 13A] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 14] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 14A] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 15] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 16]1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 17] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 18] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device, according to one embodiment. [Figure 19] FIG. 1 is a system architecture diagram illustrating a data system including a respiratory assistance device, a data server and a display device, according to one embodiment. [Figure 20] FIG. 20 is a system architecture diagram illustrating the data system of FIG. 19 in which a data server serves multiple respiratory assistance devices and multiple display devices, according to one embodiment. [Figure 21] 1 is a flowchart illustrating a data processing flow for personal health questionnaire data according to one embodiment. [Figure 22] FIG. 1 is a diagram of a digital patient data report including processed personal health questionnaire data rendered on a display device according to one embodiment. [Figure 23] FIG. 1 is a diagram of a digital color-coded time series plot or heat map of processed personal health questionnaire data rendered on a display device according to one embodiment. [Figure 24] FIG. 24 is an expanded view of a key to the digital color-coded time series plot or heat map of FIG. 23, according to one embodiment. [Figure 25A] 1A-1C show diagrams of various embodiments of time series graphs of categorical deviation parameters generated from personal health interview data, according to one embodiment. [Figure 25B] 1A-1C show diagrams of various embodiments of time series graphs of categorical deviation parameters generated from personal health interview data, according to one embodiment. [Figure 25C] 1A-1C show diagrams of various embodiments of time series graphs of categorical deviation parameters generated from personal health interview data, according to one embodiment. [Figure 26]FIG. 1 shows an illustration of a digital graphical dashboard depicting multiple summary time series charts for multiple patients, according to one embodiment. [Figure 27] 1 is a flowchart of a data processing flow for modifying questions within a personal health questionnaire based on a patient's physiological parameter data, according to one embodiment. [Figure 28] 1 is a flowchart of a data processing flow for triggering additional subsequent questions in a personal health interview based on or depending on answers to preceding questions, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0143] 1. Overview Patients suffering from COPD, or bronchiectasis, or other respiratory distress are often treated in hospitals with various therapies, such as bilevel pressure therapy and / or nasal high-flow therapy. Nasal high-flow therapy is one therapy commonly used to treat patients with COPD or bronchiectasis in hospitals. When these patients are discharged from the hospital, the patient's attending physician (i.e., doctor) may want the patient to continue regular high-flow therapy at home, including retirement villages or hospices, or at a location outside the hospital. In such cases, the patient's attending physician prescribes home high-flow therapy, and the patient's healthcare provider provides the patient with a nasal high-flow device suitable for home use. Alternatively, the healthcare provider may prescribe a therapy to be used at home, such as nasal high-flow at home. The patient may contact an equipment provider who can provide the patient with a medical device based on the prescription.

[0144] A prescription may be or may include a flow rate set by a clinician for a given patient. A prescription may be or may include a prescribed treatment time, such as, but not limited to, treatment hours per day or week and / or a predetermined number of treatment sessions per day or week.

[0145] The recipe may be a combination of flow rate and / or O2 concentration (i.e., O2%) and / or humidity level (e.g., dew point or RH or absolute humidity). The recipe may be loaded and stored in the memory of the device.

[0146] The prescription is preferably determined by a clinician prior to discharge or during a routine check-up. The prescription can be updated by the clinician.

[0147] Because home nasal high-flow therapy can provide respiratory support to patients, thereby eliminating the need for the patient to remain in the hospital and / or reducing the likelihood of exacerbations and therefore costly readmissions, healthcare providers often feel it is prudent (e.g., financially and / or clinically) to compensate discharged COPD patients for the cost of providing them with home nasal high-flow devices.

[0148] Unfortunately, some patients treated with home therapy, such as nasal high flow therapy, may still experience COPD exacerbations (i.e., a return or worsening of symptoms of COPD) or other deterioration of health conditions that may lead to hospitalization. Thus, being able to predict or detect (e.g., by monitoring the patient's condition) when or if a patient's condition is worsening to the point where hospitalization is required is beneficial to the patient and the caregiver's care. That is, a physician can intervene and treat a patient before he or she experiences a significant exacerbation (e.g., worsening of symptoms) of COPD that requires hospitalization, or more generally, before the patient reaches a state that requires costly hospitalization.

[0149] The patient's condition can be monitored for a period of time, and then, based on the monitoring, a prediction can be made as to whether the patient's condition has deteriorated to the point of requiring hospitalization (eg, prior to an exacerbation).

[0150] To predict a medical condition that requires hospitalization, one way to collect the necessary information is to have the patient periodically answer questions about their current health status. However, this is problematic because patients receiving home care may be too unwell or elderly or frail to regularly complete questionnaires on paper or with an additional device (e.g., mobile phone, tablet, desktop, laptop). Furthermore, even if the patient is physically well enough, they may self-diagnose, or the task may become tedious and the patient may become discouraged and stop completing it, especially if the questionnaire is not easy to use (e.g., a paper form or a poorly laid out digital questionnaire). Completing the questionnaire (filling it out in its entirety) on paper or with an additional user device (e.g., mobile phone, tablet, desktop, laptop) may be tedious for the patient, since they must use another device, and for this reason, patients often do not complete questionnaires provided on paper or other devices.

[0151] The present disclosure provides a system that captures digital data of personal health questionnaire data from a user or patient of a respiratory assistance device and remotely stores and processes the raw data by a remote or cloud-based data server system. The data server is accessible to a healthcare provider to access a digital patient data report compiled based on the processed data, including coded time series charts for graphical rendering. The time series charts can be generated dynamically or in real-time when requested, and their format and content are configurable based on user preference settings. The graphical time series charts may be interactive. In some configurations, a graphical dashboard is generated depicting multiple summary graphical data extracts or time series charts of multiple patients for efficient review and monitoring by a healthcare provider who is responsible for multiple patients. The graphical charts can process the raw data to present or identify deviations (e.g., worsening health parameters or health conditions, and / or alternatively improving health parameters or health conditions) for easy review by a healthcare provider. The coding of data for graphical representation can provide efficient transmission and rendering for display in some configurations compared to raw data.

[0152] The present disclosure provides systems and methods that enable a healthcare provider to remotely capture health status information from multiple patients while the patients are using a respiratory support device for respiratory therapy at home, review the captured data in data reports, and / or receive default and / or custom notifications based on the captured data. This remote digital data capture, processing, and reporting may enable healthcare providers to more effectively and efficiently review the patients for whom they are responsible, triage patients in terms of priority, modify or adjust a patient's prescribed therapy or otherwise change an intervention or treatment, and / or generally monitor a patient's condition, risk of exacerbation, and / or the effectiveness of a patient's prescribed therapy.

[0153] In the following, an example of a respiratory assistance device that captures a personal health questionnaire from a patient or user is described. The personal health questionnaire may be a digital questionnaire that includes a series or set of questions related to one or more health parameters (e.g., symptoms and medications used), including objective and / or subjective questions. This is followed by an example description of the process of processing the personal health questionnaire data, parameter generation and data coding, as well as rendering of data reports, time series charts and / or graphical dashboards.

[0154] 2.Example of breathing assistance device 1 illustrates a respiratory support apparatus as a high-flow apparatus for delivering a flow of gas (which may include one or more gases) to a patient for high-flow therapy. The respiratory support apparatus may also be referred to herein as a "respiratory therapy device."

[0155] Alternatively or additionally, the apparatus may be, for example, a CPAP apparatus and / or a bi-level device and / or a non-invasive ventilation (NIV) apparatus (or any combination thereof), and the apparatus may be, for example, capable of providing, or being selectively operated in a mode that provides, CPAP therapy and / or bi-level pressure therapy and / or NIV therapy (or any combination thereof).

[0156] Depending on the type of therapy, different patient interfaces may be provided, for example, a non-sealing interface may be provided for high-flow therapy and a sealing interface may be provided for CPAP therapy.

[0157] An exemplary device for providing CPAP therapy is described in International Publication WO 2011 / 056080, filed October 8, 2010, the contents of which are incorporated herein by reference in their entirety.

[0158] The respiratory assistance device comprises a gas supply and optionally a gas humidification device. The respiratory assistance device is operable to provide respiratory assistance to a patient or user who requires a supply of gas (humidified or otherwise) at positive pressure for the treatment of disorders such as obstructive sleep apnea (OSA), snoring or chronic obstructive pulmonary disease (COPD). The respiratory assistance device typically includes a humidifier chamber as a humidifier liquid chamber to form a combined assisted breathing unit and humidifier.

[0159] When used with a humidifier, a respiratory support device typically has a structure in which gas is delivered from an assisted breathing unit or blower unit to a liquid chamber downstream of the blower. As the gas passes through the liquid chamber it becomes saturated with liquid vapor (e.g. water vapor). A flexible tubular gas conduit delivers the gas from the humidifier chamber downstream to the user or patient.

[0160] High-flow devices can be used to deliver high flow gas flows or high-flow therapy to patients to assist breathing and / or treat respiratory disorders including chronic obstructive pulmonary disease (COPD) or respiratory distress syndrome or dyspnea, or bronchiectasis. High-flow devices include a gas supply and typically include a humidification device. High-flow devices can provide respiratory assistance to patients.

[0161] CPAP devices can be used to deliver continuous positive airway pressure or CPAP therapy to a patient (as described in more detail below).

[0162] The bi-level device can be used to deliver bi-level pressure to a patient or bi-level therapy to a patient (as described in more detail below).

[0163] A respiratory assistance device typically has one or more accessories, such as a breathing conduit and a patient interface, such as a cannula or mask, for delivering gas to the patient. The conduit allows gas to be delivered from a housing of the respiratory assistance device to the patient. For example, the device may be placed on a floor or other supporting surface, and the patient may be in bed.

[0164] The respiratory aid device may have a recess for receiving a humidifier liquid chamber. The liquid chamber receives liquid, for example, from a flexible liquid bag that delivers liquid to the humidifier liquid chamber via one or more tubes. Alternatively, the liquid chamber may be removed and refilled as needed. The recess houses a heater plate that heats the liquid chamber to humidify gas passing through the liquid chamber. The humidified gas is then delivered to the patient.

[0165] 1 illustrates an example respiratory assistance device 10. The respiratory assistance device 10 is configured to provide high-flow therapy and function as a high-flow device.

[0166] Respiratory assistance apparatus 10 may alternatively or additionally be configured to provide pressure therapy and may function as a pressure therapy device.

[0167] The respiratory support device 10 can be configured to provide a high flow rate of gas when in a high-flow mode. The respiratory support device 10 can be configured to operate in a pressure therapy mode to provide pressure therapy. The pressure therapy can be bi-level positive pressure therapy or continuous positive pressure therapy. For example, in bi-level pressure therapy, the device 10 is configured to provide a gas flow such that the patient experiences an inspiratory pressure and an expiratory pressure, both pressures being positive. In continuous pressure therapy, the device 10 is configured to deliver gas at a constant pressure that can be set by a user. The level or pressure can be set by a healthcare provider (e.g., a physician). To deliver high-flow therapy, a non-sealing patient interface is used, such as a nasal cannula. Conversely, to deliver pressure therapy, a sealing patient interface is used (e.g., a nasal mask or a full-face mask or nasal pillows).

[0168] Generally, the device 10 comprises a main housing 100 which houses a flow generator 11, a humidifier 12, a controller 13 and a user I / O interface 14.

[0169] In some embodiments, the user I / O interface comprises a display and one or more user input devices or elements that a user can manipulate to provide user input. The user input devices or elements may include, for example, one or more buttons, switches, or dials (e.g., mechanical, touch, capacitive, etc.), and / or a touch screen. In embodiments in which the user interface includes a touch screen display, user input may be provided via touch interaction with one or more graphical input elements presented in a graphical user interface (GUI) on the display.

[0170] In some embodiments, the user I / O interface may be part of an auxiliary device, which may be, for example, a phone, a tablet, or a computer. The auxiliary device may be configured to communicate directly with the apparatus or may be configured to communicate with the apparatus via one or more servers or data networks.

[0171] In some embodiments, medical interview questions may be presented to a user I / O interface of the auxiliary device, and the user may answer the questions on the auxiliary device.

[0172] In some embodiments, the answers to the questions can be stored on the auxiliary device and transmitted to the device (e.g., at the end of the interview, or as each question is answered, or at a later time), which in some embodiments can then upload the answers to the questions (along with other information, e.g., patient parameters) to a patient and device management platform.

[0173] The auxiliary device can upload the answers to the questions (optionally along with other information from the apparatus, such as patient parameters) to a patient and device management platform.

[0174] In some embodiments, a touchscreen may be provided as or as part of the user I / O interface 14. As mentioned above, in some configurations, the touchscreen may be the primary or only user input device, and the user interacts with the graphical user interface via touch interactivity with the touchscreen (e.g., touch, push, flick, swipe, single or multi-finger gestures or interactions, e.g., pinch-to-zoom, etc.). In other configurations, one or more additional user input elements or devices, such as buttons, dials, switches, etc. (whether mechanical or touch-sensitive), may be provided in combination with the touchscreen. Such additional user input elements or devices may typically be co-located with the touchscreen, such as adjacent or proximate to or around the periphery of the touchscreen, or may be located separate from the touchscreen in another accessible portion or surface of the housing of the respiratory assistance apparatus. One or more additional user input elements or devices can be used in combination with or as an alternative to touch interactivity with the touchscreen, to interact with a displayed GUI on the touchscreen, e.g., to navigate menus, functions, input information or responses, configure settings and user preferences, and / or interact with any other control or device functionality.

[0175] In some embodiments, the controller may consist of multiple controllers for controlling different components of the device 10 .

[0176] The multiple controllers may include one or more of a controller for a user I / O interface, a controller for controlling a flow generator and / or a humidifier, and a controller for receiving sensor input.

[0177] In some embodiments, the controller that controls the flow generator and the humidifier is configured to receive inputs from other controllers (e.g., a controller that receives sensor inputs, and a user controller for a user I / O interface).

[0178] The multiple controllers may be configured to communicate with each other (eg, via a bus) and / or with a master controller.

[0179] The flow generator 11 may include a motor / impeller arrangement, such as a blower or pump, or may include a compressor or other suitable component that generates a flow of gas.

[0180] The controller 13 is configured or programmed to control the components of the device, such as operating the flow generator 11 to generate a flow of gas (gas flow) for delivery to the patient, operating the humidifier 12 to humidify and / or heat the generated gas flow, receiving user input from the user interface 14 for reconfiguration and / or user-defined operation of the device 10, and outputting information to a user via the user interface 14 (e.g., on a display).

[0181] In some embodiments, the controller is configured to receive a start-up input / request via a user interface, which activates the device to begin interrogating a user.

[0182] The user may be a patient, a health care provider, or any other person interested in using the device. In one example where the device is used outside a hospital environment, such as at home, or in a hospice or retirement village or other non-hospital environment, the user of the device 10 is the patient. The patient uses the device to receive high flow or pressure therapy as prescribed by a health care provider (e.g., a physician).

[0183] In connection with answering the questions (as described elsewhere), it will be appreciated that the user will preferably be the patient, as the questions relate to health parameters of the patient.

[0184] Connected to a gas flow output or patient outlet port 30 (i.e., outlet port) in the housing 100 of the respiratory assistance device 10 is a patient breathing conduit 16 which is connected to a patient interface 17, such as a nasal cannula comprising a manifold 19 and nasal prongs 18. In some embodiments, the nasal cannula may be sealed or may not be sealed (e.g., when used to provide high-flow therapy).

[0185] Additionally or alternatively, the patient respiratory conduit 16 may be connected to a face mask (eg, an occlusive mask if pressure therapy such as CPAP or bi-level pressure therapy is provided).

[0186] Additionally or alternatively, the patient respiratory conduit may be connected to a nasal pillows mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface.

[0187] The possibly humidified gas flow generated by the respiratory assistance device 10 is delivered to the patient via a patient breathing conduit 16 (optionally via a humidifier) ​​through a patient interface 17. The patient breathing conduit 16 may have a heater wire 16a which heats the gas flow to the patient. The heater wire 16a is controlled by the controller 13. Alternatively, the patient assistance device is provided with a separate heater wire controller which controls the output (e.g. power or current or voltage) to the heater wire.

[0188] The patient breathing conduit 16 and / or the patient interface 17 may be considered part of, or alternatively peripheral to, the respiratory assistance apparatus 10. The respiratory assistance apparatus 10, the breathing conduit 16 and the patient interface 17 may together form a respiratory assistance system, for example, a flow therapy system that provides high-flow respiratory assistance, i.e., high-flow respiratory therapy, to a patient, as shown in FIG.

[0189] In some embodiments, the controller 13 controls the flow generator 11 to generate a gas flow at a desired rate.

[0190] In some embodiments, the controller controls one or more valves to control the mixture of air and oxygen or other alternative gases.

[0191] In some embodiments, the controller controls the humidifier 12 to humidify and / or heat the gas flow to a desired level and / or in accordance with the temperature and / or humidity level settings of the therapy being provided. For example, the controller may control power applied to a heater plate of the humidifier and / or a heater element in the patient breathing conduit to achieve a desired temperature and / or humidity setting for the gas flow to the patient, the control based at least in part on one or more temperature and / or humidity sensors positioned to sense or measure the temperature and / or humidity of the gas flow generated by the device.

[0192] The flow of gas is directed to the patient through a patient breathing conduit 16 and a patient interface 17. As mentioned above, the controller 13 may also control the heating element in the humidifier 12 and the heating element 16a in the patient breathing conduit 16 to humidify and / or heat the gas to a desired temperature to achieve a desired level of therapy and / or comfort for the patient.

[0193] The controller 13 may be programmed with a suitable target temperature for the gas stream, or the controller 13 may determine a suitable target temperature for the gas stream.

[0194] The controller 13 controls the flow generator to generate a gas flow at a desired flow rate when in a high-flow therapy mode based on feedback from a flow sensor. Alternatively, the controller 13 is configured to control the flow generator to generate a gas flow at a desired pressure when in a pressure therapy mode based on feedback from a pressure sensor, (e.g., a differential pressure sensor).

[0195] Operational sensors 3a, 3b, 3c, 20 and 25, such as flow, temperature, humidity and / or pressure sensors, may be located at various locations within the respiratory assistance apparatus 10 and / or the patient breathing conduit 16 and / or the patient interface 17.

[0196] In some embodiments, at least one of the operation sensors 3a, 3b, 3c, 20 and 25 may be provided in a sensor module. The sensor module may be located in the gas flow path. The sensor module may be located in the gas flow path between a flow generator (e.g., a blower) and a humidifier.

[0197] At least one of the motion sensors 3a, 3b, 3c, 20 and 25 may be provided in the gas flow path to sense a parameter of the gas flow.

[0198] In some embodiments, the device can measure or determine one or more patient parameters. The patient parameters may be, for example, one or more of a respiration rate, a patient's oxygen saturation, and / or other physiological parameters or indices (e.g., a respiration rate relative to oxygenation (ROX) index). The patient parameters may be or relate to one or more physiological parameters of the patient. The patient parameter or parameters may be measured by a patient sensor (as described below) or determined based on a sensor from the device.

[0199] In some embodiments, the respiration rate can be determined based on a flow signal from a flow sensor. The respiration rate can be determined, for example, as disclosed in International Publication WO 2019 / 102384, filed November 22, 2018, the contents of which are incorporated herein by reference.

[0200] In some embodiments, the controller of the device can be configured to receive and / or determine patient respiration rate data. In one configuration, the respiration rate can be determined by the controller as a function of, for example, two or more of the following sensed or measured gas flow or device parameters: gas flow pressure, gas flow rate, and / or flow generator motor speed. In another configuration, the controller may receive patient respiration rate data from an external device or sensor, such as, but not limited to, a pulse oximeter or a wearable sensor.

[0201] Also included is a patient sensor 26. The patient sensor 26 may be a sensor attached to or associated with the patient to measure patient parameters. In one example, the patient sensor 26 is a pulse oximeter that measures the patient's oxygen saturation, or SpO2, value. Output from the sensor is received by the controller 13 and may help the controller 13 operate the respiratory assistance device 10 to provide optimal therapy.

[0202] In some configurations, providing optimal therapy includes meeting or exceeding the patient's inspiratory flow rate. The device 10 may have a transmitter and / or receiver 15 (e.g., as part of a network interface, described in more detail below) that enables the controller 13 to receive signals 8 from the sensors and / or control various components of the respiratory support device 10, including but not limited to the flow generator 11, the humidifier 12 and the heater wires 16a, or accessories or peripheral devices associated with the respiratory support device 10.

[0203] Additionally or alternatively, the transmitter and / or receiver 15 may send data to an external or remote service or platform or data server. For example, a remote patient and device management platform. The patient and device management platform may be any one or combination of a remote device, data server, application, cloud service or platform (e.g., distributed computer system resources) or any other suitable hardware and software platform. In one embodiment, the transmitter and / or receiver 15 may enable remote control of the apparatus 10.

[0204] In one embodiment, the transmitter and / or receiver 15 may include a GSM module or chip, or any other suitable data, mobile or cellular communication module. The transmitter and / or receiver 15 of the device may include one or more communication modules. In one example configuration, the device may include a GSM module and one or more other additional communication modules, such as, but not limited to, a Bluetooth module, a Wifi module, a ZigBee module, a Z-wave module, an NFC module, an RFID module, a satellite module, a LAN or WLAN module, an infrared module, a radio module, a modem module, or any other communication module. In other configurations, the device may include any combination of one or more of the aforementioned communication modules, with or without a GSM module.

[0205] The respiratory assistance device 10 may be any suitable type of device, but in some configurations may deliver a high flow gas flow or high flow therapy (e.g., air, oxygen, other gas mixtures, or some combination thereof) to a patient to assist breathing and / or treat respiratory disorders. In some configurations, the gas is or includes oxygen. In some configurations, the gas includes a blend of oxygen and ambient air. High flow therapy as discussed herein is intended to be given its ordinary meaning as understood by those skilled in the art, generally referring to a respiratory assistance system that delivers a target flow of respiratory gas (preferably humidified gas) through an intentionally unsealed patient interface, generally at a flow rate intended to meet or exceed the patient's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from, but are not limited to, about 15 liters per minute (LPM) to about 70 liters per minute, or more. Typical flow rates for pediatric patients (neonates, infants, children, etc.) often range from, but are not limited to, about 1 liter / minute per kilogram of patient weight to about 3 liters / minute per kilogram of patient weight, or more. High flow therapy can also optionally include administration of a gas mixture composition including supplemental oxygen and / or therapeutic agents. High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT), or tracheal high flow (THF), among other common names.

[0206] 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, such as about 10 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. In some configurations, for neonatal, infant or pediatric patients, "high flow therapy" can refer to the delivery of gas to the patient at a flow rate greater than 1 LPM, such as about 1 LPM to about 25 LPM, or about 2 LPM to about 25 LPM, or about 2 LPM to about 5 LPM, or about 5 LPM to about 25 LPM, or about 5 LPM to about 10 LPM, or about 10 LPM to about 25 LPM, or about 10 LPM to about 20 LPM, or about 10 LPM to 15 LPM, or about 20 LPM to 25 LPM. In adult, neonatal, infant or pediatric patients, high flow therapy devices can, in some configurations, deliver gas to the patient at a flow rate of about 1 LPM to about 100 LPM, or any of the subranges outlined above. The delivered gas can include a percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas can be from about 20% to about 100%, or from about 30% to about 100%, or from about 40% to about 100%, or from about 50% to about 100%, or from about 60% to about 100%, or from about 70% to about 100%, or from about 80% to about 100%, or from about 90% to about 100%, or about 100%, or 100%.

[0207] High-flow therapy has been found to be effective in meeting or exceeding a patient's inspiratory flow, increasing a patient's oxygenation, and / or reducing the patient's workload. Additionally, high-flow therapy can create a flushing effect in the nasopharynx such that the anatomical dead space in the upper airway is flushed by the incoming high flow gas stream. This provides a reservoir of fresh gas available for every breath while reducing rebreathing of carbon dioxide, nitrogen, etc.

[0208] One example for high-flow therapy is the use of a non-occlusive or non-sealing user interface, such as a nasal cannula. For CPAP or other pressure therapies, an occlusive interface is typically used, such as a nasal mask, full face mask, or nasal pillows.

[0209] The patient interface 17 may be a non-sealing interface to prevent barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to pressure differentials relative to the atmosphere) when the device is providing high-flow therapy. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or a face mask, and / or a nasal pillows mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The patient interface may include headgear configured to maintain the interface on the user's face.

[0210] As described below, respiratory assistance apparatus 10 may include a variety of features that aid in the function, use and / or construction of respiratory assistance apparatus 10.

[0211] 2-4B, the respiratory assistance apparatus 10 in a first configuration includes a respiratory assistance apparatus base unit 50 having a main housing 100. The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 104.

[0212] The main housing of the base unit 50 has a peripheral wall arrangement that defines a recess 108 that provides a humidifier liquid chamber bay that receives a removable liquid chamber 151. The removable liquid chamber 151 contains a suitable liquid, such as water, that humidifies the gases delivered to the patient.

[0213] The base unit 50 of the device 10 can have a movable finger guard 141 that protects a user from touching the base flange 155 of the liquid chamber when the liquid chamber is in place in the recess 108 and when the finger guard barrier 141a is in the covering position as shown in Figure 2. The barrier 141a is movable between a covering position and a lowered access position in which the recess 108 is less or not covered by the barrier 141a.

[0214] In the illustrated form, the peripheral wall arrangement of the main housing lower chassis 104 includes a substantially vertical left outer wall 109 oriented in the fore-aft direction of the main housing 100, a substantially vertical right outer wall 111, and a substantially vertical rear outer wall extending between and connecting the walls 109, 111. A bottom wall 115 extends between and connects the lower ends of the walls 109, 111, 113 to form the base of the apparatus and a substantially horizontal floor portion of the fluid chamber bay.

[0215] The floor portion of the recess 108 has a receiving portion 108a for receiving a heater arrangement, such as a heater plate 140 or other suitable heating element, for heating the liquid in the liquid chamber 151 used during the humidification process. The heater plate typically has a shape that substantially corresponds to the shape of the base 154 of the liquid chamber 151, such as, for example, a circular shape. The heater plate 140 is resiliently mounted, for example, to a biasing device such as a spring. The resiliently mounted allows the heater plate to move downward to accommodate the liquid chamber 151 in the recess 108 when the liquid chamber is inserted into the recess 108, while maintaining good contact between the heater plate 140 and the base of the liquid chamber.

[0216] The main housing lower chassis 104 can be attached to the upper chassis 102 either by suitable fasteners or built-in attachment features, such as clips. When the main housing lower chassis 104 is attached to the main housing upper chassis 102, the walls of the upper and lower chassis engage one another.

[0217] The lower chassis 104 has a motor recess for receiving a motor module, which may be permanently inserted into the recess or may be removable from the recess. A recess opening is provided adjacent its rear edge in the bottom wall 115 to receive a removable motor module. A motor module base 123 covers the opening into the motor recess. The base may be secured after assembly of the base to lock the motor module in the motor recess and prevent tampering with the motor. The motor module includes a motor forming a blower to provide gas flow and may include one or more sensors to sense a characteristic of the gas passing through the motor module. The motor module may include a sensor to sense a parameter of the gas passing through the motor module. In one example, the motor module may include a sensing module supporting multiple sensors, such as a flow sensor, a differential pressure sensor, a gas composition sensor, a humidity sensor, and / or any other sensor. The sensor is arranged in electronic communication with the controller such that the controller may receive the sensor output for use by the controller in controlling the device and its components.

[0218] Suitable tubing and / or gas flow passages are provided in the motor module and housing of the base unit 50 of the device 10 to deliver gas from one or more gas inlets in the device's base unit 50 to the gas inlet port 157 of the liquid chamber 151 to humidify the gas. Gas is delivered from the gas outlet port 159 of the liquid chamber 151 (via the humidified gas inlet port 163) to the patient outlet port 30 and thence via the patient breathing conduit 16 and patient interface 17 to the patient.

[0219] The housing may comprise two gas inlets 27, 28. The first inlet may be an ambient air inlet and the second inlet may be for an auxiliary gas, e.g. oxygen or heliox or another auxiliary gas. In the example shown, the auxiliary gas is oxygen. The auxiliary gas source may comprise a valve controlled by the controller 13 to regulate the amount of auxiliary gas introduced into the device 10. The air and auxiliary gas are mixed by a flow generator, i.e. a blower.

[0220] The motor recess comprises a recess opening in the bottom wall 115 of the housing. Alternatively, the recess opening can be in a different portion of the housing, such as the side, front or top of the housing.

[0221] The base unit 50 of the device 10 may have a battery module 125 to provide power to the device in the event of a power outage or for portable use. The battery module includes a battery cover 126 that houses a battery. The battery in the battery module 125 may be replaceable.

[0222] The battery module 125 can provide power in the event that the utility power is disconnected. In some embodiments, the controller is configured to detect the disconnection of the utility power and automatically switch to drawing power from the battery module 125 to provide the functionality of the respiratory assistance device.

[0223] When the battery module 125 is utilized to power the device, the device can operate for a predetermined amount of time, for example, between 30 minutes and 1 hour.

[0224] In the illustrated configuration, the battery cover 126 of the battery module 125 is coupled to the exterior of the rear wall 113 of the device housing 100. This provides a large surface area for cooling the battery and reduces the amount of heat that enters the device from the battery. Additionally, this configuration reduces the impact on the battery of heat generated by the device components, especially when the battery is being charged. In an alternative configuration, the battery may be mounted inside the main housing.

[0225] The housing may be provided with a battery cover 126 to cover the installed battery. Alternatively, the battery may be attached directly to the housing 100 without a cover. The battery, and therefore the battery cover 126, may be sized so that it does not extend beyond the bottom wall 115 of the housing. Alternatively, the battery cover 126 may extend beyond the bottom wall 115 of the housing to accommodate a longer, larger battery.

[0226] As shown in FIG. 3, the base unit 50 of the device 10 has a mounting mechanism 127 for mounting the device to a support device.

[0227] The mounting mechanism 127 may be integrally formed with a portion of the main housing of the base unit 50 of the device 10. In the illustrated form, the mounting mechanism 127 is integrally formed with the lower chassis 104 on the left side wall 109 of the housing. The mounting mechanism 127 may instead be integrally formed with any of the other walls of the housing, such as the back wall, right side wall, or other walls.

[0228] The main housing of the device may be formed from any suitable material that allows for the attachment mechanism 127 to be integrally formed therewith. For example, the housing may be formed from polycarbonate.

[0229] 3 shows a humidifier liquid chamber 151 (i.e., reservoir) for use with respiratory assistance apparatus 10. Chamber 151 is a removable liquid chamber that is filled with a liquid, such as water, for humidification of respiratory gases. Liquid chamber 151 is removable from base unit 50 of respiratory assistance apparatus 10 for easier refilling or disposal.

[0230] The liquid chamber 151 has a body 152 having a peripheral wall 153 and a roof 156. The body defines an internal chamber for receiving liquid. A base 154 is provided at the lower end of the peripheral wall and includes a base flange 155 projecting outwardly from the lower end of the peripheral wall 153. First and second base unit connection ports including a liquid chamber gas inlet port 157 and a liquid chamber gas outlet port 159 communicate with the internal chamber of the liquid chamber 151. The respiratory assistance apparatus base unit 50 includes complementary chamber connection ports including a gas outlet port 161 and a humidified gas inlet port 163. When the liquid chamber is received within the recess 108 and engaged with the housing 100, the liquid chamber gas inlet port 157 connects to the gas outlet port 161 which receives gas from the motor module via a gas flow passageway, and the liquid chamber gas outlet port 157 connects to the humidified gas inlet port 163 for delivering humidified gas from the liquid chamber to the patient outlet port 30.

[0231] The liquid chamber may have a generally circular perimeter shape, or may be any other suitable shape, with the shape of the recess 108 being modified as required.

[0232] In the illustrated form, the liquid chamber 151 has a substantially cylindrical shape.

[0233] The base 154 of the liquid chamber is thermally conductive. In particular, the base 154 of the liquid chamber 151 is made from a highly thermally conductive material, which allows heating of the liquid within the chamber when in contact with the heater plate 140 of the base unit 50 of the respiratory assistance apparatus 10 during use.

[0234] The liquid chamber 151 can be fluidly coupled to the base unit 50 of the device 10 in a direction of rearward insertion of the liquid chamber 151 into the recess 108 from a location at the front of the housing 100 toward the rear of the housing 100. A gas outlet port 161 is in fluid communication with the gas flow path from the motor / impeller unit via a fixed L-shaped elbow.

[0235] The humidified gas inlet port 163 is embodied in a removable component that includes a removable elbow 171 that can be removably connected to the housing. The removable elbow 171 is L-shaped and further includes an upstanding patient outlet port 30 that couples to the patient breathing conduit 16 for delivering gas to the patient interface 17. In a different configuration, the removable component may not have an elbow shape and instead may have aligned inlet and outlet ports, for example.

[0236] The gas inlet port 157 of the liquid chamber is complementary to the gas outlet port 161 of the respiratory support apparatus base unit 50, and the gas outlet port 159 of the liquid chamber is complementary to the humidified gas inlet port 163 of the respiratory support apparatus base unit 50. The axes of the ports are parallel and / or horizontal, allowing the liquid chamber 151 to be inserted into the recess 108 with a substantially linear motion to form a gas connection between the ports.

[0237] The chamber connection ports 161 , 163 are parallel cylindrical features that extend from the housing of the respiratory assistance apparatus base unit 50 .

[0238] In some embodiments, the base unit connection ports 157, 159 of the humidification chamber (e.g., liquid chamber) are pneumatically connected to the chamber connection ports 161, 163 of the device 50 when the humidification chamber is provided in the liquid chamber bay (e.g., as described in more detail above).

[0239] The chamber connection ports 161, 163 (which in the illustrated form are male connection members) of the respiratory assistance apparatus base unit 50 are concentrically inserted into the base unit connection ports 157, 159 (which in the illustrated form are female connection members) of the liquid chamber. The recess 108 may include one or more rails that help hold the liquid chamber in place within the recess 108.

[0240] Respiratory support apparatus 10 may have any one or more of the features and / or functions of respiratory support apparatus described and illustrated in PCT Patent Application Publication No. WO 2016 / 207838, filed June 24, 2016, the contents of which are incorporated herein by reference in their entirety.

[0241] To prevent gas from escaping from either of the two connections (port 157 to port 161 and port 159 to port 163), one or more sealing elements are provided at each connection. The one or more sealing elements may be on the outer surface of the male port and seal against the inner surface of the female port. In one configuration, the liquid chamber gas inlet port 157 and the liquid chamber gas outlet port 159 are female ports and the housing ports, i.e. gas outlet port 161 and humidified gas inlet port 163, are male ports. Alternatively, the liquid chamber ports 157, 159 may be male ports and the respiratory aid base unit 50 ports 161, 163 may be female ports.

[0242] The screen 212 (see Figures 2 and 3) is located on the housing (e.g., on the top, side) and is fixed in position. However, the screen 212 may be adjustable in position (e.g., hinged). The screen may also be referred to as a "display."

[0243] The screen 212 as shown in Figures 2 and 3 is rectangular, but can be different shapes (e.g., square, circular). The screen 212 is either mains powered or battery powered. The screen 212 is located on the top surface of the housing and is angled to improve visibility of the screen to the patient. Additionally, having the screen 212 located on the top surface of the housing makes the screen and screen content more easily viewable by the patient (e.g., in a home environment).

[0244] In some embodiments, the screen 212 is a color screen, preferably a color touch screen (e.g., resistive, capacitive). The screen 212 is large in size to make the content presented on the screen more visible to the patient. These patients may be very unwell, e.g., COPD patients, and are often elderly. A large, high-resolution screen 212 helps to easily communicate the interview and the contents of the interview to the patient. This makes the interview more interesting because it is easier to see. A large touch screen 212 also improves the readability of the presented content, which further helps make the content more interesting.

[0245] The high resolution color touch screen 212 allows for the presentation of a variety of questions that may require presentation of colors or shades of colors (e.g., sputum color). The screen 212 being a touch screen also allows for easier interaction with the patient, as it is simpler and more intuitive to use, as the touch screen requires the user to touch the screen 212 and make gestures on the screen to input information. The touch screen eliminates the need for the use of buttons or dials that may require complex sequences to be pressed to input data, e.g., respond to a medical questionnaire.

[0246] The resolution of the screen 212 is large enough to make the presented content easy to read and interact with, which can be especially important for elderly patients and / or patients with co-morbidities, where a larger screen presents questions and answers more clearly compared to a smaller screen.

[0247] In one example, the touch screen has a resolution of at least 300 x 150 pixels. In one example, the touch screen has a resolution of 400 x 250 pixels. More preferably, the screen has a resolution of 480 x 272 pixels.

[0248] The touch screen may have a resolution of at least 600x400 pixels.

[0249] The touch screen may be at least 3.5 inches in diagonal dimension.

[0250] The touch screen may be at least 4 inches in diagonal dimension.

[0251] The touch screen may be 4.2 inches diagonally.

[0252] The touch screen can be up to 7 inches in diagonal dimension.

[0253] The touch screen can be an OLED or TFT LCD screen.

[0254] In the alternative, the user interface may include a color touch screen or display along with a number of manipulable input elements, such as buttons, dials, or switches. The input elements may be mechanical and / or touch-sensitive. Combining a touch screen with manipulable input elements allows the patient to input information using a combination of buttons or switches or dials and the touch screen.

[0255] The removable elbow 171 is removable from the housing 100 when the shroud 190 is attached to the housing. The respiratory assistance apparatus 10 may include features of a respiratory assistance device, particularly a high-flow device, as described in International Publication No. WO 2020 / 095186, filed November 5, 2019, the contents of which are incorporated herein by reference in their entirety.

[0256] The apparatus may include a valve that allows auxiliary gas to be introduced into the blower.

[0257] 5 is a schematic diagram of a respiratory assistance device 5700. In particular, the respiratory assistance device (which may be the respiratory assistance device 10 as described above) may be similar to other respiratory devices described above. The respiratory assistance device includes a housing 5702 (e.g., housing 100) that includes a controller 5704 (e.g., controller 13), a switch 5706, a speaker 5708, a flow generator 5710 (e.g., flow generator 11), a display 5712 (e.g., touch-enabled screen 212), a network interface 5714 (e.g., transmitter and / or receiver 15) and a humidifier 5716 (e.g., humidifier 12).

[0258] 1-4B, the housing 5702 has a fluid inlet and a fluid outlet. Similarly, the flow generator 5710, whether mains powered or battery powered, is located within the housing 5702 downstream of and in fluid communication with the fluid inlet. Similarly, the humidifier 5716, whether mains powered or battery powered, is located within the housing 5702 downstream of and in fluid communication with the flow generator 5710, and upstream of and in fluid communication with the fluid outlet. Additionally, whether mains powered or battery powered, the humidifier 5716 includes a heater (e.g., a heating plate, a heating element).

[0259] The controller is in electronic communication with the flow generator, the display, the network interface and the heater plate. The controller comprises an electronic processor (e.g., logic controller, multi-core processor) and non-transitory memory (e.g., flash memory) in communication with the electronic processor. The controller controls the activation / deactivation and operation of the flow generator 5710, the heater plate of the humidifier 5716 and the screen 212.

[0260] The switch 5706 (e.g., analog, digital) is located on the housing 5702, but may not be located on the housing 5702 (e.g., located on the power cord) or may be incorporated as a software implemented switch (e.g., on the screen 212). The switch 5706 is a power switch that toggles between on and off modes, which may be based on a manual input (e.g., user input, patient input) electrically and / or mechanically coupled to the controller 5704. The respiratory assistance device 5700 may be activated based on the switch 5706 switching from off mode to on mode, and deactivated based on the switch 5706 switching from on mode to off mode. The switch 5706 may be embodied in many physical, electronic or visual ways. For example, the switch 5706 may be embodied as a physical or visual button, knob, dial, rocker, toggle or lever. The switch 5706 may be omitted.

[0261] A speaker 5708 is located on the housing 5702 and is configured to output audio content (e.g., sounds, speech, music). The speaker 5708 may be mono or stereo. The speaker 5708 may be mains or battery powered. In some embodiments, the speaker 5708 is not present.

[0262] The display 5712 (e.g., screen 212) is located on the housing 5702 (e.g., on the top, side) and is fixed in position. However, the display 5712 may be adjustable in position (e.g., hinged). The screen 212 may be grayscale or color. The screen 212 may be a touch screen (e.g., resistive, capacitive). The screen 212 is rectangular, but can be different shapes (e.g., square, circular). The screen 212 may be mains powered or battery powered.

[0263] In some embodiments, the device allows for insertion of a USB or memory storage device that can be used to download data (e.g., responses to questions) and then plugged into a computer, such as a PC or laptop, which can then be used to transmit the responses to a patient and device management platform, such as a server for patient and device management.

[0264] In some embodiments, the device includes a network interface 5714. As described, the network interface includes one or more communication modules that enable data communication or data links with one or more external devices, systems, or servers. The network interface is located within the housing, but can also be located outside the housing. The network interface can include one or more of a wireless signal receiver, a wireless signal transmitter, and a wireless signal transceiver, each having a wireless signal radio antenna or an optical signal modulator depending on the signal modality (e.g., radio, optical), but wired communication (e.g., wired network card) is also possible. The network interface is configured to communicate over Wi-Fi, Li-Fi, Bluetooth, ZigBee, Z-Wave, cellular, or satellite networks, whether over a local area, wide area, personal area, or other area network. For example, the network interface can communicate with a patient and device management platform (e.g., a server), or a computing device (e.g., a smartphone, a tablet, a wearable, a medical monitor) that is local or remote to the network interface. It should be noted that the network interface may include a first transceiver of a first modality (e.g., Wi-Fi) and a second transceiver of a second modality (e.g., Bluetooth). For example, the network interface may include a cellular modem (3G, 4G, 5G, 6G), a Wi-Fi card, and a Bluetooth chip. In some embodiments, there is no network interface.

[0265] The controller's memory contains instructions executable by the electronic processor which, when executed by the electronic processor, cause the controller to perform various operations as further described below.

[0266] For example, the instructions may cause the controller to (a) activate the heater plate upon activation of the respiratory assistance device, (b) request the screen 212 to display a user interface presenting a number of user health questions (e.g., related to the patient's disease progression or the patient's health status) and a number of user input elements through which the user inputs are received, (c) disable or prevent the flow generation from being activated until the predetermined number of user inputs are received, and (d) transmit the predetermined number of user inputs to a patient and device management platform (e.g., a server, web application, database, virtual server, cloud service) via a network interface. The controller may receive the predetermined number of user inputs before the heater plate of the humidifier reaches a predetermined temperature (e.g., a gas temperature of about 37 degrees). The user health questions and user input elements may be displayed upon startup of the controller.

[0267] For example, the instructions may cause the controller to (a) request the screen 212 to display a user interface presenting a plurality of requests for user health information and a plurality of user input elements, where the user health information is received by the controller as user input. The requests for user health information and the user input elements may be displayed upon startup of the controller. The predetermined plurality of user inputs may be all of the user inputs.

[0268] The controller may be configured to sequentially communicate two or more questions to the screen 212, which may be configured to sequentially present the two or more questions to the user. After a response to each presented question is received at the screen 212, the screen 212 is configured to communicate each response to the controller.

[0269] The controller may also be configured to lock access to any other modes, functions until a response to each question is received. Alternatively, the controller may restrict access to an operational mode until a response to each question is received. Alternatively, the controller may be configured to disable operation of the flow generator and heater plate until an answer to each question is received. However, the controller may allow a user bypass of responding to the questionnaire, or may automatically bypass presentation of the questionnaire if the user (e.g., patient) responds to the questionnaire at least once per day.

[0270] 3. Example Data Systems and Methods 3.1 Overview of data acquisition by respiratory support devices The respiratory assistance device is configured to provide a personal health questionnaire to the patient or user. The personal health questionnaire is a digital questionnaire including a set of questions that are presented to the user on a display screen of the respiratory assistance device, providing answer options to the patient. The questions relate to a set of health parameters of the patient. Responses entered by the patient (via interaction with a user interface, e.g., a touch screen GUI or other user input element) are captured as response data to the personal health questionnaire. Typically, this personal health questionnaire is captured or presented periodically according to a time interval frequency, e.g., daily, weekly, or other configurable time interval.

[0271] In one configuration, the questions can be categorized into groups: symptom category questions regarding the patient's breathing or related symptoms, and medication category questions regarding how much medication the patient is using. The answer data can include symptom data representing answers to the symptom questions, and medication data representing answers to the medication questions. The captured answer data is then sent or transmitted to a data server for processing, as described in more detail below.

[0272] In some embodiments, each time a patient activates the respiratory assistance device, the device may present a series of questions on one or more touch screens.

[0273] The questions form part of a consultation (consultation form). The respiratory assistance device records the patient's answers to the questions. In one embodiment, the questions relate to "health parameters". In some embodiments, the questions relate to non-health related parameters.

[0274] In some embodiments, the health parameter may be a subjective factor related to the patient's perception of their health, for example, it may be the patient's overall feeling.

[0275] In some embodiments, the health parameters may be based on patient parameters (eg, patient parameters measured by a device, such as respiratory rate, oxygen saturation, etc., as described in more detail below).

[0276] Health parameters may be subjective qualitative factors based on the patient's perception of his / her own health, such as sore throat, degree of dyspnea, and severity and / or type and / or frequency of coughing, etc. Health parameters may also be objective quantitative factors that are directly measurable, such as color of sputum (based on a color chart), medication use (e.g. frequency and amount of antibiotics, steroids, inhalers, etc.).

[0277] The health parameter may be determined based on the answer to a single question, or may be determined based on the answers to at least two questions.

[0278] At least some of the health parameters are indicative of COPD symptoms that may occur frequently in COPD patients. COPD is chronic obstructive pulmonary disease. COPD is a respiratory disease characterized by inflammation of the airways. At least some of the health parameters may be indicative of other obstructive pulmonary diseases. At least some of the health parameters may also be indicative of dyspnea and / or respiratory distress, and / or bronchiectasis.

[0279] The respiratory assistance device may include one or more touch screens that display after the device is powered on (e.g., started up). In some embodiments, the or each touch screen displays questions. Alternatively, the questions may be implemented as multiple pages that can be scrolled through. Alternatively, the questions may be presented as a single document that is scrolled through to answer the questions. Alternatively, each screen displays a separate question, and each time the patient answers a question, the next question is presented on the screen.

[0280] In some embodiments, the questions are displayed in a user I / O interface (as described in more detail below).

[0281] In some embodiments, the respiratory assistance device may include an internal clock that may maintain a current date and time. The internal clock may be part of the controller of the respiratory assistance device and / or part of the patient and device management platform.

[0282] The questionnaire can be presented based on the current date and time. For example, the questionnaire may be presented daily or weekly based on information from an internal clock, or based on any other configurable frequency set, for example, by a healthcare provider.

[0283] In one example embodiment, the questionnaire is presented once when the device is switched on.

[0284] The questionnaire may be presented on first use, on a daily basis (eg, by day of the week), or at predetermined intervals.

[0285] In some embodiments, the internal clock is a real-time clock (RTC).

[0286] In some embodiments, after the patient has answered the final questions in the questionnaire, the respiratory assistance device will display a therapy control screen, which the patient can use to begin therapy.

[0287] In some embodiments, for example, a patient may skip the questionnaire if they are too unwell to complete it. If the patient skips the questionnaire, the device allows the patient to begin treatment without having to complete the questionnaire. For example, the touch screen may display a treatment control screen that the patient can use to begin treatment.

[0288] The therapy control screen may present a number of selectable operating parameters of the respiratory assistance device, such as the flow rate or temperature of the gas delivered to the patient (ie, patient end temperature), O2 concentration, or other such operating parameters.

[0289] The patient may be required to complete a questionnaire (e.g., including multiple questions) and respond to each question of the questionnaire presented on the screen of the respiratory support device. The patient may be able to skip a questionnaire if they have completed the questionnaire at least once a day.

[0290] In some embodiments, the controller may track responses to questions from the patient. After all questions in the interview have been answered, the controller may determine that the interview is complete.

[0291] As mentioned above, after the patient has answered the final question in the interview, the controller may determine that the interview is complete.

[0292] In some embodiments, questions are presented on a touch screen while the respiratory assistance device is being set up.

[0293] 3.2 Operation of the controller that presents the health questionnaire and captures the response data Figure 6 is a flow chart for controller operation. As shown in block 5602 of Figure 6, the respiratory assistance device may receive a start-up / power-up command to initiate the device. The start-up / power-up command may be received by the device via a user interface of the screen 212. In some embodiments, when power is provided to the device, the screen is configured to operate such that a user can interact with the screen. Additionally or alternatively, the start-up / power-up command may be received by the device via a switch (e.g., a button).

[0294] Startup may include turning on the respiratory assistance device or operating the respiratory assistance device. As indicated by block 5604, start-up / activation may include activating the device to begin interrogating the user, which may result in one or more questions being output to the screen 212 and one or more questions being presented to the patient on the touch screen (see block 5606).

[0295] In some embodiments, the respiratory assistance device enters a warm-up and / or drying mode, which activates the device to begin interrogating the user.

[0296] In some embodiments, as described in more detail below, start-up can include the presentation of a treatment control screen that the patient can use to begin treatment.

[0297] The questions can have a first question and a second question, where the first question precedes the second question. Correspondingly, the potential answers can include a first potential answer input and a second potential answer, where the first potential answer precedes the second potential answer, where the first potential answer corresponds to the first question, and the second potential answer corresponds to the second question. Thus, the second question can be dependent on the content of the first question (e.g., the first potential answer is from the first user session and the second potential answer is from the second user session, where the first user session precedes the second user session), regardless of whether the first potential question and the second potential question are from the same user session. For example, this content dependency can be based on a for loop, a while loop, a counter, an if-then logic tree, or other logical expressions, regardless of whether the second question is obtained or generated from the respiratory assistance device 5700 (the respiratory assistance device 5700 can be the respiratory assistance device 10 as described above) or from the patient and device management platform (e.g., a server in communication with the respiratory assistance device 5700).

[0298] In some embodiments, the answer to a previous question (e.g., a first question) may determine the content of a subsequent question (e.g., a second question). For example, the answer to a previous question may update a particular question in the health questionnaire and / or the update order of the questions in the health questionnaire.

[0299] In some embodiments, after a question (e.g., a first question) is answered, the health parameters may be updated, and a determination of the content of a subsequent question (e.g., a second question) may be based on the health parameters (e.g., the updated health parameters).

[0300] A health care provider (eg, a physician) may be able to generate a health questionnaire for a patient by selecting one or more predefined questions from a database of questions.

[0301] The database of questions can be presented to the healthcare provider as a list (eg, a tick box interface) and the healthcare provider can select multiple questions from the database of questions to form a consultation.

[0302] The database of questions may be located on the patient and device management platform and / or the device.

[0303] In some embodiments, the database of questions can be customized based on a worsening of one or more symptoms, for example, if a patient is exhibiting a worsening symptom related to sputum color, the database of questions can be customized to include questions related to upper respiratory tract health.

[0304] If a healthcare provider (e.g., a physician) selects one or more predefined questions remotely (i.e., not on the device) from a database of questions, once the healthcare provider selects the questions, the selected questions may be transmitted to the device and stored on the device.

[0305] In some embodiments, the device may periodically communicate with the patient and device management platform to obtain any updates to the questionnaire and / or any questions. Additionally or alternatively, the patient and device management platform may communicate with the device to notify the device that updates to the questionnaire and / or any questions are available and to send the updated questionnaire and / or questions.

[0306] In some embodiments, questions (as part of the health interview) may be based on the patient's condition (e.g., COPD, bronchiectasis, etc.). Questions may be added to or removed from the health interview based on the patient's condition. For example, if the patient has bronchiectasis, the health interview may include questions related to sputum color and whether the patient is taking antibiotics.

[0307] A healthcare provider (e.g., a physician) can select a question from a list that is related to the patient's condition to add to the health interview. Alternatively or additionally, the healthcare provider (e.g., a physician) can select a patient's condition and the health interview can be automatically updated based on the selection. In some embodiments, the database of questions can be customized based on the patient's condition (e.g., chronic obstructive pulmonary disease (COPD) or respiratory distress syndrome or dyspnea, bronchiectasis, etc.). For example, if the patient has COPD, the database of questions can be customized to include questions related to COPD.

[0308] In some embodiments, the health interview questions are ordered such that questions related to COPD status are displayed first, followed by questions related to bronchiectasis status.

[0309] In some embodiments, a general health questionnaire is presented prior to the questions related to COPD status and the questions related to bronchiectasis status.

[0310] For example, questions related to COPD may include questions regarding daily sputum volume, sputum color and / or coughing.

[0311] For example, questions related to bronchiectasis may include questions regarding steroid use and / or inhaler use.

[0312] In some embodiments, a patient's predefined condition (e.g., COPD or bronchiectasis) can be determined based on answers to questions related to the predefined condition. For example, if answers to questions related to bronchiectasis are below baseline and / or worsening, this may indicate that the patient has bronchiectasis.

[0313] A healthcare provider (e.g., a physician) may be able to add custom questions to the health questionnaire, which may include custom questions and associated answers related to information the physician may want to track.

[0314] A healthcare provider (eg, a physician) may be able to add custom questions to a database of questions.

[0315] A healthcare provider can generate the health questionnaire directly on the device or from an auxiliary device (such as a mobile device connected to the patient and device management platform).

[0316] The patient then enters his / her response to each question via the touch screen (see block 5608). The patient's responses (answer data) are then processed (5910). This processing may include plotting or graphing the set of responses, or sending the data set of responses (answer data) to the patient and device management platform, an external storage device, a mobile device, or an insurance company, equipment provider, or healthcare provider, as described below. Analysis or processing of the data set (answer data) may be performed at any stage, for example by the patient and device management platform. In some embodiments, after the patient has answered the last question of the questionnaire, the respiratory assistance device displays a therapy control screen that the patient can use to start therapy.

[0317] In some embodiments, the patient and device management platform may store a patient profile including one or more of the patient details, baseline data for the patient's health parameters, the patient's respiratory support device serial number and / or prescription settings.

[0318] 3.3 Health Questionnaire During the Warm-up Process In some embodiments, the questionnaire is presented to the user during the warm-up process 5611, for example on a touch screen, as shown in FIG. 6A.

[0319] The warm-up process involves activating a heater plate in the respiratory assistance device to warm the contents of the humidification chamber.

[0320] The warm-up process may include warming the heater plate of the respiratory assistance device to a specific temperature. For example, the specific temperature may be a predetermined temperature (e.g., a standby temperature). The predetermined temperature may be below an operating temperature of the heater plate when the humidifier is providing humidification. The specific temperature may be approximately 35°C.

[0321] Controlling the heater plate includes controlling the power supplied to the heater plate.

[0322] The device heater plate can be equipped with a heater plate temperature sensor and the controller can control the heater plate temperature, for example via closed loop control, to a particular temperature for the warm-up process.

[0323] In some embodiments, the warm-up process may include heating a heater plate of the respiratory assistance device to reach a particular temperature.

[0324] In some embodiments, the warm-up process may include heating a heater plate of the respiratory assistance device to control the chamber outlet temperature to a particular temperature.

[0325] The chamber outlet as described elsewhere is the outlet of the humidification chamber, optionally measured at an elbow located after the chamber outlet of the humidification chamber.

[0326] The particular temperature may be based on one or more temperature setpoints of the device (as one or more operating parameters of the device for the therapy). The setpoints, e.g., a desired chamber outlet temperature, a desired dew point temperature (at the chamber outlet or end of the breathing conduit), or a desired patient end temperature (at the end of the breathing conduit), may be entered by the user via a therapy control screen as described elsewhere.

[0327] The temperature setpoint or setpoints may correspond to a required relative humidity or a required absolute humidity, optionally, the relative humidity is between about 90% and about 100%, or about 100%.

[0328] In some embodiments, the warm-up process may include warming a heater plate of the respiratory assistance device to achieve humidity of the gas (e.g., at the chamber outlet or at the end of the breathing conduit).

[0329] The device may provide an audible or visual indication, such as a visual indication, when the warm-up process is complete.

[0330] In some embodiments, the warm-up process can include operating a flow generator (e.g., a blower) at a predetermined flow rate or a predetermined flow generator power (e.g., a predetermined motor speed). During the warm-up process, no therapeutic gas flow is provided to the patient.

[0331] The interview and the questions that make up the interview are presented on the touch screen (or other user input / output interface) of the respiratory assistance device during the warm-up process (e.g., as shown in FIG. 6A), which is advantageous since the patient will likely be waiting until the warm-up process is complete.

[0332] The warm-up process may last for several minutes, e.g., 5 to 25 minutes, providing a suitable period of time during which flow therapy is not being used by the patient, thereby allowing the patient free time to respond to questions (i.e., respond to questions presented on the touch screen).

[0333] Presenting the questions to the user during the warm-up process allows the patient to use the time they would normally spend waiting for the machine to warm up to answer the questions. By utilizing the warm-up process to present the questions, the likelihood that the patient will answer the questions can be increased.

[0334] In some embodiments, the therapy control screen may be presented upon start-up of the device.

[0335] In some embodiments, the warm-up process may be run upon start-up of the device.

[0336] In some embodiments, the warm-up process can be manually activated by a user.

[0337] In some embodiments, the warm-up process is activated when a user starts a treatment (eg, via a treatment control screen).

[0338] In some embodiments, the respiratory assistance device displays a therapy control screen on start-up, which the patient can use to initiate therapy (as described above). Once the user has entered one or more operating parameters of the respiratory assistance device on the therapy control screen (e.g., the flow rate or temperature of the gas provided to the patient (i.e., patient end temperature), O2 concentration, or other such operating parameters), the device goes through a warm-up process and can optionally display a questionnaire (e.g., as described above).

[0339] 3.4 Health Questionnaire During the Drying Process In some embodiments, the questionnaire is presented to the user during the drying process 5612, for example on a touch screen, as shown, for example, in FIG. 6B.

[0340] The drying process may be configured to evaporate any condensed water remaining in the apparatus and / or the patient breathing conduit and / or the patient interface.

[0341] The drying process may be as described in WO 2006 / 126900, filed May 26, 2006, the contents of which are incorporated herein by reference in their entirety.

[0342] In one embodiment, a safety message or notice is presented on the display screen of the respiratory assistance device before and / or during the drying mode. The safety message may indicate to the patient or user not to wear the user interface (e.g., nasal cannula) during the drying mode, i.e., not to use the device for respiratory therapy during the drying mode. In one configuration, the safety message or notice may include a confirmation button or tab or icon or GUI element that is presented or available to the user to confirm the message or notice. By confirming the message in response, the user is confirming that the cannula is off, i.e., not in use. Once the safety message is confirmed by the user, a personal health questionnaire may be presented to the user, for example, on a display.

[0343] The drying process may include activating a heater wire 16a in the patient breathing conduit 16 while the flow generator provides gas as a set flow rate or a predetermined motor speed. The set flow rate may be lower than the therapeutic gas flow being provided to the patient. The predetermined motor speed may be about 1000 RPM to about 3000 RPM or less than about 2000 RPM.

[0344] Additionally or alternatively, the drying process may include controlling a heater plate of the humidifier to a predetermined value, which may be low enough to prevent the humidifier from generating humidity, or alternatively, the heater plate may be turned off during the drying process.

[0345] The heater wire 16a may be controlled to a predetermined temperature, for example at the end of the patient breathing conduit, or may be controlled to a predetermined duty cycle or to a predetermined power.

[0346] The predetermined duty cycle may be 100%.

[0347] The given temperature may be greater than 45°C.

[0348] The drying process can be configured to operate for about 20 minutes to about 40 minutes, or about 15 minutes.

[0349] The drying process can occur at the end of a treatment session, the patient (or other medical personnel) can indicate when a treatment session is complete, or in some embodiments, the treatment session can have one or more conditions (e.g., elapsed time) that are met to signal the end of the treatment session.

[0350] The drying process may be activated manually by the patient or healthcare provider, or may be activated automatically at the end of a treatment session.

[0351] In some embodiments, the end of treatment may be determined by detecting that the user has removed the patient interface. The device may detect that the user has removed the patient interface based on a flow signal measured from the flow sensor. Optionally, the end of treatment may be determined by detecting that the user has removed the patient interface and a predetermined period of time has elapsed.

[0352] In some embodiments, the device can detect when the user removes the patient interface when no breathing is detected. Breathing can be detected based on a flow signal measured from the flow sensor.

[0353] 3.5 Conditional Presentation of Health Questionnaire 7 is a flow chart of a process for conditionally presenting a personalized health questionnaire to a patient of a respiratory assistance device. In particular, process 5800 is performed via a respiratory assistance device 5700 and a patient and device management platform, as described above. Respiratory assistance device 5700 may be respiratory assistance device 10, as described above.

[0354] The term "block" herein may refer to one or more steps performed by the apparatus 5700 (eg, by a controller).

[0355] In block 5802, the respiratory assistance apparatus 5700 (which may be the respiratory assistance apparatus 10 as described above) displays a number of health questions on a display 5712 (same as display 212) via a controller 5704 (same as controller 13) to the patient (or a caregiver or physician if the patient is incapacitated) upon start-up of the respiratory assistance apparatus 5700, as shown in Figures 9-13, 13A, 14, 14A, and 15-18. This start-up may include booting up the respiratory assistance apparatus 5700 (e.g., controller 5704) or, if the respiratory assistance apparatus 5700 (e.g., controller 5704) is already booted and running, operating the respiratory assistance apparatus 5700 (e.g., flow generator 5710, humidifier 5716) prior to use. In some embodiments, the start-up may include a warm-up process (as described above).

[0356] In some embodiments, the respiratory assistance device 5700 may be configured to present a personal health questionnaire during a therapy session, ie when the device is providing high flow or pressure therapy to the patient.

[0357] In some embodiments, the respiratory assistance device 5700 may be configured to present, or prompt the patient to complete, a personal health questionnaire based at least in part on one or more patient parameters as measured by one or more sensors during a treatment session and / or as determined by a controller of the device, including but not limited to respiratory rate, ROX index, and SpO2, measured or determined for the patient during a treatment session. 2 Data may include: the number of patients, the number of patients, the number of patients, the number of patients, and the number of patients. In one configuration, the respiratory assistance device may be configured to present or initiate a personal health questionnaire based on a deterioration of one or more of the measured or determined patient parameters. For example, if one or more of the patient parameters exceed one or more predefined thresholds and / or if a deterioration trend is detected, the device may be triggered to present the personal health questionnaire. The thresholds may be general or configurable patient-specific thresholds. In some embodiments, a deterioration (e.g., against a threshold or trend analysis) of one or more measured or determined patient parameters may also or alternatively cause or trigger a change in the frequency with which the patient is presented with or prompted to complete the health questionnaire. In some embodiments, a deterioration (e.g., against a threshold or trend analysis) of one or more measured or determined patient parameters may also or alternatively cause or trigger a change in the type, number and / or nature of questions presented in the personal health questionnaire.

[0358] In situations where the network interface 5714 is not present or is unable to establish a network connection, the controller 5704 can still present the personal health questionnaire and the answers can be later downloaded to a removable memory (e.g., flash card, flash drive) or retrieved (e.g., for maintenance) from the memory of the respiratory assistance device 5700 itself. The humidifier 5716 can be the same as the humidifier 12 as described above. The flow generator 5710 can be the same as the flow generator 11 described above.

[0359] In block 5804, the respiratory assistance device 5700 (e.g., controller 5704) displays a skip question user interface element (e.g., graphic, text, icon) on the display 5712 via the controller 5704. Alternatively, the controller 5704 can determine if the activation is the second or more activations within a predetermined interval, e.g., one day, and then bypass the presentation of the question. Further, the controller 5704 can be programmed to request the display 5712 (e.g., a touch screen such as screen 212) to present the questions and potential answers such that at least one of the questions or at least one of the potential answers differs between at least two instances of the flow generator 5710 being activated over a predetermined period of time (e.g., at least two days).

[0360] At block 5806, the respiratory assistance device 5700 (e.g., controller 5704) determines (e.g., controller 5704) whether a skip questionnaire user input element has been enabled (e.g., via touch selection). If enabled, block 5808 is executed. If not enabled, block 5812 is executed. Note that this skip functionality can be employed on a per-question basis (e.g., skipping the entire questionnaire if the patient is too unwell to complete the questionnaire) or on a question-by-question basis (e.g., skipping certain or any questions).

[0361] The skip information may be tracked and itself may be a data point that is subsequently identified by the patient and device management platform, e.g., a server. For example, the skipped questionnaires (i.e., all questions in the questionnaire) or the skipped questions may be captured as skipped data. The skipped data may identify which questions in the questionnaire were skipped or whether the entire questionnaire for a time interval (e.g., a particular day) was skipped. This skipped data forms part of the questionnaire data for a time interval that is sent to a data server for processing. For example, the questionnaire data for a daily or weekly questionnaire may include the response data to the personal health questionnaire and any skipped data.

[0362] Further, in some circumstances, skipping is not permitted or prevented. For example, if the interview is completed the first time the respiratory assistance device 5700 is turned on or started during a calendar day, the controller 5704 allows for the question or interview to be skipped if the respiratory assistance device 5700 is turned off and started a second time in that calendar day. In some embodiments, the interview may need to be completed once per calendar day, as controlled by the controller 5704.

[0363] In some circumstances, the patient and device management platform, e.g., a server, can send a signal that allows the controller 5704 to skip if the server receives an answer to a question at least once a day. In some circumstances, the question may be required to be completed at predetermined intervals (e.g., every two or three days), or may be set by a physician, or may be defined by clinical practice.

[0364] At block 5808, the respiratory assistance apparatus 5700 (e.g., controller 5704) skips the personal health questionnaire via the controller 5704 and presents a menu via the display 5712 for control (e.g., via touch selection) of the respiratory assistance apparatus 5700 (e.g., flow generator 5710, humidifier 5716). For example, this may allow the questionnaire to be skipped before activating the flow generator 5710. However, the controller 5704 may be programmed to prevent or prevent skipping the questionnaire before activating the flow generator 5710.

[0365] At block 5810, the respiratory assistance device 5700 (e.g., controller 5704) enables the flow generator 5710 or humidifier 5716 to be used to provide respiratory assistance to the patient. For example, the patient can navigate menus via the display 5712 to control (e.g., via touch selection) the respiratory assistance device 5700 (e.g., flow generator 5710, humidifier 5716).

[0366] At block 5812, the respiratory assistance device 5700 (e.g., controller 5704) receives a set of responses or answers (answer data) to the personal health questionnaire from the patient. Such receiving may be performed via the patient touch-selecting various user input elements (e.g., graphics, text, icons) displayed on the display 5712 via the controller 5704.

[0367] At block 5814, the respiratory assistance device 5700 (e.g., controller 5704) transmits (e.g., wired, wireless, waveguide, encrypted, decrypted, unencrypted) the set of responses (response data) to the patient and device management platform via the network interface 5714. The patient and device management platform may be or be hosted by any suitable platform, e.g., a data server, a server web application, a database, a cloud service, a virtual server.

[0368] The patient and device management platform is remote from the respiratory assistance device 5700 such that it can receive the set of answers and process the set of answers as described below. The controller 5704 can request the network interface 5714 to transmit the set of answers (e.g., a predetermined plurality of user touch inputs) to the patient and device management platform one at a time after each answer in the set of answers is received via the controller 5704 (e.g., a response transmission followed by another response transmission). The controller 5704 can request the network interface 5714 to transmit the set of answers (e.g., a predetermined plurality of user touch inputs) to the patient and device management platform after all of the answers (e.g., user touch inputs) are received via the controller 5714 (e.g., a single transmit operation, a single packet). The controller 5704 can request the network interface 5714 to transmit the set of answers (e.g., a predetermined plurality of user touch inputs) to the server in groups after the group of answers is received via the controller (e.g., transmit after each answer 2, 3, 4, 5, 6, 7, etc.). Note that the controller 5704 may request the network interface 5714 to transmit the answer set along with a patient or machine identifier to enable valid identification and subsequent processing of the answer set.

[0369] In some embodiments, the set of answers is stored in the memory of the device. Optionally, the set of answers can be provided to a patient and device management platform for storage.

[0370] In some embodiments, the device may be configured to store the response and transmit the response to the patient and device management platform once every predetermined time period (e.g., once a day), potentially resulting in lower data transmission costs due to less frequent data transfers required to generate a connection between the device and the patient and device management platform versus more frequent transmissions.

[0371] In some embodiments, the device can be configured to store the answer and transmit the answer to the patient and device management platform when the drying process is activated (automatically or by the user).

[0372] In block 5816, the patient and device management platform takes action based on the set of responses being processed. For example, such actions may include identifying a patient or machine identifier (e.g., alphanumeric, barcode) associated with the patient's responses, matching the patient or machine identifier associated with the patient's responses with a patient or machine identifier (e.g., alphanumeric, barcode, or serial number) stored via or accessible to the patient and device management platform, locating a patient or machine profile (e.g., data structure, database record) based on the patient or machine identifier, writing the patient's responses to the patient or machine profile, retrieving the patient or machine profile including the patient's responses, and performing one or more analytical functions on the patient or machine profile (e.g., plotting the patient's responses against time, predicting no change or positive or negative change to the patient's health status based on the patient's responses), as described further below. For example, the patient and device management platform may merge or fuse interview data (e.g., response data provided from responses to the interview) with sensor data (e.g., provided by the respiratory support device 5700), and such fusion may be readily available. For example, a patient and device management platform, e.g., a server, can be programmed to detect changes in answers to questionnaires over time and turn them into data points, which may be readily implementable.

[0373] In some embodiments, the sensor data may be one or more patient parameters, such as the patient's respiratory rate (as described in more detail elsewhere herein) or oxygen saturation.

[0374] At block 5818, responding may include the server plotting or graphing the answers or set of processed answers against the baseline data in one or more time series charts, graphs, or plots, as shown in Figures 22-26. The charts, graphs, and / or plots may provide a graphical display of the patient's health parameters and changes in the patient's health parameters. The charts, graphs, and / or plots may also indicate the patient's health status.

[0375] The charts, graphs and / or plots may be part of a report (eg, a data report) that is presented to a user (eg, a patient, a caregiver, or a healthcare provider).

[0376] In some embodiments, a set of answers to multiple questions in a personal health questionnaire (including, for example, past health questionnaires which may be stored in memory of the device and / or patient and device management platform), optionally the multiple answers or sets of answers may be plotted or graphed and / or form part of a report.

[0377] In some embodiments, the device is configured to generate and / or display on a screen a report.

[0378] In some embodiments, the patient and device management platform is configured to generate a report and the device is configured to display the report on a screen of the device.

[0379] In some embodiments, the patient and device management platform is configured to generate a report and the apparatus is configured to provide the report to a healthcare provider.

[0380] In block 5820, the response may include the patient and device management platform, e.g., a data server, notifying a non-patient (e.g., family member, physician, caregiver) via a computing device (e.g., smartphone, tablet, wearable, workstation) in signal communication (wired, wireless, waveguide) with the patient and device management platform, e.g., server. Such notification may include text, graphics, audio, video, or other forms of content. For example, such notification may be manifested via a mobile app, a dedicated software application, a browser-navigable portal, or other forms of software. As described further below, the notification may be prompted or generated based on a set of answers that do or do not meet a predefined threshold. For example, a threshold may be met based on a predefined deviation from a baseline value established by the patient's physician.

[0381] In some embodiments, the baseline value may be set by a physician (or other healthcare provider) based on an initial set of patient tests.

[0382] In block 5822, the response may include the patient and device management platform, e.g., a data server, notifying the patient (or a caregiver in close proximity to the patient) via a computing device (e.g., smartphone, tablet, wearable, workstation) in signal communication (e.g., wired, wireless, waveguide) with the patient and device management platform, e.g., the data server, or via the respiratory assistance device 5700 in signal communication with the data server via a network interface 5714. Such a notification may be generated based on the set of answers and may include text, graphics, audio, video, or other forms of content. For example, such a notification may be manifested via a mobile app, a dedicated software application, a browser-navigable portal, or other forms of software. For example, such a notification may be output via speaker 5708 or display 5712. The notification may be prompted or generated based on a set of answers that do or do not meet a predefined threshold, as described further below. For example, the threshold may be met based on a predefined deviation from a baseline value set by the patient's physician. In some embodiments, the notification may be provided on the device or to a healthcare provider.

[0383] After the interview is completed, the controller 5704 can control the display 5712 to present a screen (e.g., page) after the controller 5704 receives a set of answers, whether before, during, or after transmission to the patient and device management platform, e.g., a data server. The screen presents a menu for controlling or activating the flow generator 5710 or humidifier 5716, or for inputting operating parameters of the flow generator 5710 or humidifier 5716. It should be noted that although the process 5800 is performed via the respiratory assistance apparatus 5700 and the patient and device management platform, in some circumstances the process 5800 can be performed locally. For example, instead of transmitting a set of answers to the patient and device management platform, the respiratory assistance apparatus 5700 (i.e., the respiratory assistance apparatus 10) can be programmed to perform a similar process locally and then take action as described herein. For example, the respiratory assistance apparatus 5700 can perform block 5820 or 5822.

[0384] 3.6 Determining the deviation of responses based on pre-set criteria 8 is a flow chart of a process for determining deviations for answers to a personal health questionnaire based on pre-established criteria. In particular, process 5900 is performed via respiratory assistance device 5700 and a server, as described above.

[0385] In block 5902, a user (doctor, nurse) operates a computing device (e.g., smartphone, tablet, wearable, workstation) in signal communication (e.g., wired, wireless, waveguide) with a patient and device management platform (e.g., server web, application, database, cloud service). Thus, the user accesses a patient or machine profile via the server (e.g., browser session, dedicated software application session) and sets a number of reference values ​​for a number of questions of a personal health questionnaire associated with a patient or machine identifier. For example, the patient and device management platform, e.g., data server, can present a browser-based user interface on the computing device operated by the user, where the user interface is programmed to receive a number of user inputs (e.g., alphanumeric, binary or Boolean values ​​entered or selected via text boxes, check boxes, drop-down menus, radio buttons, sliders, dials) corresponding to reference values ​​such that the reference values ​​correspond one-to-one to the questions, such that answers to the questions can later be measured against the reference values, as set by the user.

[0386] At block 5904, the respiratory assistance apparatus 5700 (e.g., controller 5704) displays a personal health questionnaire to the patient (or caregiver or physician) via the controller 5704 on the display 5712 upon start-up of the respiratory assistance apparatus 5700, as shown in Figures 9-18. This start-up may include booting up the respiratory assistance apparatus 5700 (e.g., controller 5704) or operating the respiratory assistance apparatus 5700 (e.g., flow generator 5710, humidifier 5716) prior to use if the respiratory assistance apparatus 5700 (e.g., controller 5704) is already booted and running. The questionnaire includes one or more questions that are presented on the screen 212, i.e., the display 5712.

[0387] At block 5906, the respiratory assistance device 5700 (e.g., controller 5704) receives a number of responses to the personal health questionnaire from the patient. Such receipt may be performed via the patient touch-selecting various user input elements (e.g., graphics, text, icons) displayed on the display 5712 via the controller 5704. The patient may also respond to the questions by performing gestures or touching or pressing portions of the display.

[0388] In block 5908, the respiratory assistance device 5700 (e.g., controller 5704) transmits (e.g., wired, wireless, waveguide, encrypted, decrypted, unencrypted) the response (e.g., response data) via the network interface 5714 from the respiratory assistance device 5700 to a remote patient and device management platform (e.g., server) such that the patient and device management platform can receive the response and process the response, as described below. The controller 5704 can request the network interface 5714 to transmit the responses (e.g., a given plurality of user touch inputs) to the server one at a time after each of the responses is received via the controller 5704 (e.g., a response transmission followed by another response transmission). The controller 5704 can request the network interface 5714 to transmit the responses (e.g., a given plurality of user touch inputs) to the patient and device management platform after all of the responses (e.g., user touch inputs) are received via the controller 5714 (e.g., a single transmit operation, a single packet). The controller 5704 can request the network interface 5714 to transmit answers (e.g., a predetermined plurality of user touch inputs) to the patient and device management platform, e.g., a server, in groups after a group of answers is received via the controller (e.g., every 2nd, 3rd, 4th, 5th, 6th, 7th, etc. answer). Note that the controller 5704 can request the network interface 5714 to transmit the answers along with a patient or machine identifier to enable valid server-based identification and subsequent processing of the answers.

[0389] In block 5910, the patient and device management platform, e.g., a server, receives the response from the network interface 5714, identifies a patient or machine identifier (e.g., alphanumeric, barcode) associated with the patient's response, matches the patient or machine identifier associated with the patient's response to a patient or machine identifier (e.g., alphanumeric, barcode) stored via or accessible by the server, locates a patient or machine profile (e.g., data structure, database record) based on the patient or machine identifier, writes the patient's response to the patient or machine profile, retrieves previously established baseline values, reads the patient or machine profile including the patient's response, performs a comparison of the response to the baseline values ​​(e.g., baseline value against the response, or answer against the baseline value), and determines a number of deviations (e.g., binary, Boolean, alphanumeric) of the response to the baseline value (if such deviations exist). Some of the deviations may include a degree of deviation (e.g., 5 points above the baseline value, or 10% below the baseline value).

[0390] Alternatively, the process of determining deviations against a baseline value may be implemented and executed by the controller of the respiratory assistance apparatus instead of the patient and device management platform.

[0391] In some embodiments, at block 5910, the patient and device management platform and / or the apparatus may determine a deterioration in the patient's health.

[0392] If a patient's health parameters are not stable, the patient may be considered unstable.

[0393] A deterioration in a patient's health may indicate that the patient is at risk of developing or is at risk of an exacerbation.

[0394] The exacerbation may be an exacerbation of COPD.

[0395] A deterioration in the patient's health may indicate another health problem, e.g., cold, hay fever, allergic reaction, etc.

[0396] By indicating a patient's declining health, healthcare providers can act to mitigate further deterioration, which may help to avoid undesirable outcomes (e.g., hospitalization).

[0397] The patient and device management platform and / or the apparatus may determine a patient's health instability based on the answer to the user question and one or more previous answers to the user question.

[0398] A patient may be determined to be deteriorating if there is a deterioration in at least one health parameter (optionally relative to a baseline value).

[0399] A patient may be determined to be deteriorating if there is a deterioration in two or more health parameters (optionally relative to baseline values) for at least two days.

[0400] Additionally or alternatively, a patient may be determined to be deteriorating if there is a deterioration in one or more patient parameters (e.g., blood oxygen level or respiratory rate) and / or one or more patient parameters fall below a threshold and / or one or more parameters change above a threshold.

[0401] A patient may be determined to be deteriorating if there is a deterioration from baseline in one or more patient parameters (eg, blood oxygen level or respiratory rate).

[0402] For example, if SpO2 deteriorates or falls below a threshold of, say, 85%, the patient may be determined to be deteriorating.

[0403] For example, if the respiratory rate increases by a threshold amount, say 25%, the patient may be determined to be deteriorating.

[0404] In some embodiments, a patient may be determined to be deteriorating if, for at least two days, there are both of the following: A deterioration (optionally from a baseline value) of one or more health parameters, and a deterioration (optionally from a baseline value) of one or more patient parameters, and / or one or more patient parameters fall below a threshold value, and / or one or more patient parameters change above a threshold value.

[0405] For example, in the SpO2 and respiration rate example above, a further deterioration of at least one health parameter may be required for the patient to be deemed to be deteriorating.

[0406] At block 5912, the patient and device management platform (e.g., a server) takes action based on the deviations (or lack thereof) being processed. For example, the patient and device management platform may perform one or more analytical functions (e.g., plotting patient responses against time), as further described below.

[0407] In block 5914, the response may include the server plotting or graphing the set of answers or processed answer data against the baseline data so that deviations are visually identifiable or visually clear, as shown in Figures 22-26.

[0408] In block 5916, the response can include the patient and device management platform (e.g., a server) notifying non-patients (e.g., family members, physicians, caregivers) via computing devices (e.g., smartphones, tablets, wearables, workstations) in signal communication (wired, wireless, waveguide) with the server. Such notifications can be generated based on the deviation (or lack thereof) and can include text, graphics, audio, video, or other forms of content. For example, such notifications can be manifested via a mobile app, a dedicated software application, a browser-navigable portal, or other forms of software.

[0409] In block 5918, the response may include the patient and device management platform (e.g., a server) notifying the patient (or a caregiver in close proximity to the patient) via a computing device (e.g., smartphone, tablet, wearable, workstation) in signal communication (e.g., wired, wireless, waveguide) with the server, or via a respiratory support device 5700 in signal communication with the server via a network interface 5714. Such a notification may be generated based on the deviation (or lack thereof) and may include text, graphics, audio, video, or other forms of content.

[0410] In some embodiments, the response may include notifying the patient and / or notifying non-patients (eg, family members, physicians, caregivers) based on a determination that the patient is deteriorating.

[0411] In situations where patient or caregiver notification is desired, the network interface 5714 can receive a message (patient or caregiver notification) from the server, where the message is based on a predetermined number of user inputs (patient questionnaire responses) previously sent to the server via the network interface 5714. For example, such notification can be manifested via a mobile app, a dedicated software application, a browser-navigable portal, or other form of software. The message can include video content that is output via the display 5712. If the housing 100 contains a speaker 5708, the message can include audio content that is output via the speaker 5708.

[0412] In situations where the respiratory assistance apparatus 5700 has multiple network interfaces 5714 (e.g., Wi-Fi, Bluetooth), the respiratory assistance apparatus 5700 may send a second message (e.g., a patient or caregiver notification) to a computing device (e.g., a smartphone, tablet, medical accessory) in response to a first message (a patient or caregiver notification from a server responsive to a patient questionnaire). The second message may be sent over the second network interface (e.g., Bluetooth) and still be associated with a given number of user inputs sent to the server via the first network interface (e.g., Wi-Fi). The second network interface (e.g., Bluetooth) may be local to the computing device, where the computing device is other than the server.

[0413] The message from the patient and device management platform may provide information that the patient's health parameter has deteriorated over a predetermined period of time (e.g., at least 2 days, 3 days, 4 days, 5 days, 6 days, 7 days) as determined based on at least one of a predetermined plurality of user inputs. For example, the message may provide information that the patient's health parameter has deteriorated relative to a baseline value that may or may not be set at a factory. For example, as described herein, a physician may operate a computing device (e.g., phone, tablet, workstation) to set the baseline value, the computing device being in communication with a server but remote from the patient and device management platform, e.g., the server.

[0414] The message from the patient and device management platform may be a notification that the patient is deteriorating.

[0415] The steps of Figure 8 have been described with respect to the respiratory assistance device's interaction with the patient and the device management platform. However, in alternative embodiments, the steps described in blocks 5902, 5904, 5906, 5910, and 5912 may be performed solely by the respiratory assistance device 5700 (i.e., the respiratory assistance device 10). For example, the processing in block 5910 may be performed by a controller of the respiratory assistance device, and the options in block 5912 may be performed by a controller of the respiratory assistance device. For example, block 5918 may include presenting a notification to the patient on a display of the respiratory assistance device.

[0416] In a further alternative embodiment, the response to the question can be received at the controller of the device (5906). The question can be sent to a user device (e.g., tablet or cell phone) or the question can be downloaded to a USB and then transferred to a PC laptop for further processing. Block 5910 can be performed by the user device or by the PC laptop. Additionally, the functions described in blocks 5914 and 5918 can be performed by the user device or the laptop or PC. The user device or the PC laptop can be in signal communication with a non-patient device, for example, a physician's server or a physician's computing device. The notification in block 5916 can be provided by the user device or the laptop or PC to a non-patient device to inform the non-patient regarding the patient's health condition.

[0417] 3.7 User interface for presenting personal health questionnaire questions 9-18 show a user interface for presenting a personal health questionnaire in a respiratory assistance device. The user interface includes multiple screens (e.g., pages) on which multiple questions and multiple potential answers are arranged. However, the user interface includes a single screen presenting the questions and potential answers. Although FIGS. 9-18 show a user interface including multiple screens (e.g., pages) presented in sequence as shown in FIGS. 9-18, this order is exemplary and can be changed. For example, the screen shown in FIG. 15 (or any other FIG. 11-18) can be presented before the screen in FIG. 16 (or any other FIG. 11-18) or after the screen in FIG. 18 (or any other FIG. 11-18). The display 5712 displays a user interface including the screens of FIGS. 9-18 included in the personal health questionnaire as described herein. Additionally, FIGS. 9-18 can be embodied as a single screen that is touch scrollable vertically or horizontally. Alternatively, each question may be presented as a separate scrollable page.

[0418] 9 shows a start-up screen. The start-up screen may be the first screen a patient sees when powering on a respiratory assistance device, as described herein. The start-up screen also shows a set of manufacturer and device identification information (e.g., text, graphics).

[0419] 10 shows an introduction screen after the start-up screen. The introduction screen displays a greeting message (or other introductory or welcoming message). The greeting message indicates that an interview has begun. The greeting message begins in the middle of the left vertical plane of the display 5712 for ease of viewing, although this positioning can be changed (e.g., non-middle, right vertical, spanning between the left and right vertical planes, top horizontal plane, center of the display).

[0420] FIG. 11 illustrates a general health screen presenting a question (e.g., a request for user health information, health question) asking about the patient's general health at a given time. The question is alphanumeric, but may additionally or alternatively include pictorial content. The question includes a question end mark, but this may be omitted (e.g., select one from the following options). The given day or time is dynamic and changes based on when this question is displayed. This change may occur based on the time / date tracked via the controller 5704 (e.g., an internal clock). For example, a first set period may correspond to morning, a second set period may correspond to afternoon, and a third set period may correspond to night. This time dynamic change feature may be omitted (e.g., how are you feeling now). Nevertheless, the question relates to a general health parameter as described herein, and an answer of "bad" suggests a deterioration in the patient's health, regardless of whether the question relates to a baseline value.

[0421] The general health screen presents a set of user input elements (e.g., rectangular graphics with embedded or overlaid text) associated with a question and representing potential answers to the question, one of which may be selected exclusively over the others (although this may change depending on the circumstances where multiple answers may be entered non-exclusively). As shown, a first input element indicates the current position or unchanging state of the health parameter (e.g., fair), a second input element indicates an improvement (e.g., good) of the health parameter, and a third input element indicates a deterioration (e.g., poor) of the health parameter. The set of user input elements may be between two and nine, although fewer or more user input elements are possible. The set of user input elements may be text strings and graphics, whether defining a single content set (e.g., text integrally embedded within a graphic) or multiple content sets. These user input elements are nevertheless visually identical to one another, but in terms of the content of the potential answers, at least two user input elements in the set of user input elements may be visually distinguishable from one another. For example, such visual distinctions may exist based on graphic background or foreground color, a shade of a graphic background or foreground color, graphic shape, graphic size, font type, font size, font color, a shade of a font color, font alignment, or other graphic or font characteristics.

[0422] In one embodiment, the patient health questionnaire can be configured to automatically fill or complete the questionnaire data if the patient indicates that they are feeling the same as they did the previous day or when they completed the previous questionnaire. For example, in one such embodiment, the first question screen of the questionnaire may be a comparative health question based on the most recent historical questionnaire conducted by the patient. For example, when a daily health questionnaire is presented to a patient, the first question screen may simply ask, "Are you feeling different from yesterday?" or "Are you feeling the same as yesterday?" and may provide the patient with a binary answer option of "yes" and "no." If the patient's answer indicates that they are feeling the same or unchanged as they did the previous day, the health questionnaire data may be automatically filled or completed with the stored answer data from the previous day or other relevant comparative period (i.e., the previous answer data is copied over as the current questionnaire answer data).

[0423] The user interface can present questions and potential answers based on the user scrolling via a touch screen and submitting the answers when the questionnaire is completed.

[0424] FIG. 12 shows a sore throat screen presenting a question similar to FIG. 15. However, unlike the question and potential answers of FIG. 15, the question and potential answers of FIG. 12 relate to a patient's sore throat parameters. The question of FIG. 12 includes multiple possible questions, each with an associated icon. The icons are color-coded with respect to the patient's condition associated with the answer, and have facial expressions associated with the patient's condition associated with the answer (as described in more detail below). If the patient's physician sets a baseline, for example a center (light green) answer, then the patient's selection of anything to the left of that answer (yellow or orange answers) would indicate a deterioration in the patient's health. Note that the baseline may be visually distinct (e.g., green) from other potential answers.

[0425] At least one user input element (e.g., left-most or right-most) of the graphical group corresponds to alphanumeric text content other than the question (e.g., neither extreme nor entirely), and that alphanumeric content is positioned (e.g., in a vertical or horizontal orientation) outside of the at least one user input element (e.g., a graphical tooltip, a graphical label).

[0426] A face such as that shown in Figure 12 can have a wide range of expressions corresponding to different indications of comfort. For example, the facial expressions can range from a sad or unhappy face (corresponding to a negative response to the question) to a smiling or happy face (corresponding to a positive response to the question). The facial expressions can also have a neutral face (corresponding to a neutral response to the question).

[0427] Figure 13 shows a respiration screen posing similar questions as Figures 11 and 12. However, unlike the questions and potential answers of Figures 11 and 12, the questions and potential answers of Figure 13 relate to the patient's respiration parameters.

[0428] Figure 13A shows a Fatigue screen posing a similar question to Figures 11-13. However, unlike the questions and potential answers of Figures 11-13, the questions and potential answers of Figure 13A relate to how tired the patient feels.

[0429] Figure 14 shows a cough screen posing a similar question to Figures 11-13 A. However, unlike the questions and potential answers of Figures 11-13 A, the questions and potential answers of Figure 14 relate to the patient's cough parameters.

[0430] Figure 14A shows another cough screen posing a similar question as Figures 11-14. However, unlike the questions and potential answers of Figures 11-14, the questions and potential answers of Figure 14A relate to the severity of the patient's cough.

[0431] Figure 15 shows a sputum color screen posing a similar question to Figures 11-14A. However, unlike the questions and potential answers of Figures 11-14A, the questions and potential answers of Figure 15 relate to questions related to the patient's sputum color parameters.

[0432] FIG. 16 illustrates an antibiotic screen presenting a similar question to FIGS. 11-15. However, unlike the questions and potential answers of FIGS. 11-15, the questions and potential answers of FIG. 16 relate to questions related to a patient's antibiotic usage parameters. If the patient was not taking antibiotics, selecting the answer that they are taking suggests a deterioration in the patient's health. Note further that the potential answers are binary, although this can be changed as desired. For example, FIG. 16 illustrates a pair of user input elements corresponding to questions related to a patient's antibiotic usage parameters. The inputs from these user input elements are associated with a pair of data points (e.g., taking or not taking) that are mutually exclusive of one another.

[0433] FIG. 17 shows a steroid screen presenting similar questions as in FIGS. 11-16. However, unlike the questions and potential answers in FIGS. 11-16, the questions and potential answers in FIG. 17 relate to questions related to the patient's steroid use parameters. If the patient was not taking steroids, selecting the answer that they were taking would suggest a decline in the patient's health.

[0434] FIG. 18 shows an inhaler usage screen posing similar questions as in FIGS. 11-17. However, unlike the questions and potential answers in FIGS. 11-17, the questions and potential answers in FIG. 18 relate to questions related to the patient's inhaler usage parameters. If the patient's physician has set a baseline of, for example, 1-3 times per day, then any answer to the left of that would suggest a deterioration in the patient's health.

[0435] It will be appreciated that various questions may be presented to the patient as part of the personal health interview. The questions may relate to various health parameters from any one or more categories, including, for example, the symptoms category and the medication category. The questions may relate to any one or more of the patient's breathing, the patient's fatigue, the patient's throat and muscles, the location of the patient's fever and / or shivering, the patient's infection, and any other subjective or objective health parameters in the symptoms or medication category or any other relevant health interview category or subcategory. Further examples of possible questions that may be presented to the user in or as part of the personal health interview are provided in the following paragraphs.

[0436] Questions about hospitalization In some embodiments, the personal health interview may include a question asking about a recent respiratory-related hospitalization or hospitalization or inpatient treatment, such as "Were you hospitalized?" or a similar such question. The patient may be presented with a binary answer option indicating "yes" or "no" for selection. If the patient answers "no", the interview moves to the next health parameter question in the series. If the patient answers "yes", indicating that they have been hospitalized or have recently received inpatient treatment, the interview may then present one or more additional follow-on questions related to the patient's recent hospitalization. The one or more follow-on questions may include, for example, but are not limited to, questions such as "How long were you hospitalized?", "When were you hospitalized?", "Are you able to perform daily activities?", "How is your mobility?", etc., where the questions provide various response options for the patient to select. In some configurations, one or more of these follow-on questions triggered after the patient acknowledges a recent hospitalization may be configured to be presented again in the personal health interview for a configurable period of time (e.g., two weeks or one month after the hospitalization). The configurable time period for presenting these follow-up questions may be a default time period or may be adjusted or set by the patient's healthcare provider.

[0437] Environmental Questions In some embodiments, the personal health interview may include one or more questions related to the patient's environment and / or surroundings. Examples of such questions may include, but are not limited to, the following: "How's the weather?" - Example answer options: "cold", "hot", "rainy", "humid", etc. "What kind of physical environment are you in?" - Example answer options: "Single-family home", "Apartment", "Hospital", "Damp room", "Dry room", etc. "Has anyone in your community, family, workplace and / or household had influenza?" - Example response options: "Yes" or "No"

[0438] The various environmental questions or questions may be accompanied by a wide range of selectable answer options. As noted above, some questions may have binary response options indicating "yes" or "no," while other questions may provide a wide range of selectable response options, including absolute answers, ranked or scored answers, or any other suitable response options.

[0439] In some embodiments, the interview may have one or more primary environmental questions, which may have one or more associated follow-on or secondary questions that may be triggered to be presented to the patient depending on or conditional on the patient's response to the primary environmental questions. In one example, as described above, the patient may be presented with a primary environmental question asking "How is the weather?" If the patient responds with "It's cold" or "It's raining", this may trigger one or more follow-on or secondary questions to be presented, such as, but not limited to, "Do you think the weather is making you feel sick?" In another example, as described above, the patient may be presented with a primary environmental question asking "Does anyone in your area, family, work and / or home have the flu?" If the patient responds to indicate that someone in their work or home has the flu, this may trigger one or more follow-on or secondary questions to be presented, such as, but not limited to, "Do you think you have flu symptoms?"

[0440] Medication-related questions In some embodiments, the personal health questionnaire may be configured to automatically adjust, modify or augment the questionnaire in response to or conditional upon processing and / or analysis of questionnaire data from current and / or previous questionnaires.

[0441] In one configuration example, the personal health interview may be tailored in response to detecting an increase in medication use as indicated by the patient's previous responses related to medication use to present one or more additional questions regarding the patient's perception of the efficacy or effectiveness of one or more medications the patient is using.

[0442] For example, if a patient is using or has started using antibiotics, this information is captured by the patient's response or answer to a question posed regarding antibiotic use. Response data related to antibiotic use data may be processed in conjunction with or based on one or more predefined or configurable conditions, criteria, trend analyses, and / or thresholds (e.g., a criterion may indicate an increase or initiation of antibiotic use). If a criterion is met, the personal health interview may be automatically adjusted to include one or more additional follow-on questions regarding whether the patient feels that antibiotics are improving their condition.

[0443] The above also applies to any other medication-related questions. For example, if the response data to a question related to a particular medication indicates a significant change in use (e.g., an increase or decrease based on predetermined or configurable criteria or conditions), this can trigger the presentation of one or more additional follow-on questions related to the patient's view of the medication's effectiveness or efficacy for the patient's condition, or how the patient feels in general. In particular, the additional follow-on questions related to the medication's effectiveness or efficacy are triggered conditionally or based on analysis or processing of the patient's response data related to the patient's use of the drug.

[0444] Intended Use Questions In some embodiments, the personal health questionnaire can be configured to present the patient with questions related to the patient's intended use of the respiratory assistance device. Intended use responses to such questionnaires can be recorded in the questionnaire data. The intended use responses in the questionnaire data can then be processed. In one configuration, based on the intended use responses and optionally other questionnaire data or other data related to the patient or the patient's therapy (e.g., prescription data, compliance data and / or actual use data), one or more prompts, alerts, notifications and / or messages can be triggered for the patient and / or the patient's healthcare provider. Additionally or alternatively, based on the intended use responses and optionally other questionnaire data or other patient data, the questionnaire can present the patient with one or more follow-on questions related to the patient's use of the device.

[0445] For example, at the start of a course of treatment with the respiratory support device (e.g., as prescribed by a health care provider), the personal health interview can include one or more questions related to how often the patient intends to use the respiratory support device. The questions can relate to the intended frequency of use (e.g., daily, twice a day, every three days, etc.), the intended length of use in each treatment session (e.g., 3 hours per session, 8 hours per session, etc.), a combination (e.g., 8 hours per day cumulatively over one or more treatment sessions), and / or any other suitable metric of intended use. The one or more questions can be provided with a range of selectable answer options or free-form text and / or numeric fields for the patient to enter their response data. The patient's response of intended use can be, for example, more or less than prescribed for the patient.

[0446] In one configuration, the intended usage answer data may be processed by the respiratory assistance device and / or data server (e.g., patient and device management platform) along with other data, such as actual usage data recorded or stored on the respiratory assistance device and / or data server, and may trigger one or more notifications, prompts, messages, or alerts if the data meets certain predefined and / or configurable trigger criteria or conditions. For example, if a patient responds to an intended usage question to indicate that they intend to use the respiratory assistance device for 8 hours per day, but the respiratory assistance device detects only 3 hours of usage per day as indicated by the stored actual usage data, this may trigger a message, alert, notification, or prompt to the patient and / or the patient's healthcare provider that the patient's actual usage is below or significantly below intended and / or prescribed usage.

[0447] Additionally or alternatively, the respiratory assistance device may trigger one or more additional intended use questions to be presented to the patient in the personal health interview if the patient's intended and actual usage data meet certain predefined and / or configurable triggering criteria or conditions. For example, if the patient's actual usage is identified or determined to be below or significantly below the patient's intended usage according to the triggering criteria or conditions, the system may be configured to present the patient with one or more additional questions in the personal health interview that determine information or data regarding why the patient is not using the respiratory assistance device as much as intended.

[0448] Feedback questions on the questionnaire In some embodiments, the personal health questionnaire can be configured to present the patient with one or more questions that determine the patient's feedback regarding the usefulness of the questions. By way of example, the one or more feedback questions can include, but are not limited to, questions such as: · "Is there anything else you think I should ask?" "Were there any symptoms that were not identified in the medical questionnaire?" "Have you noticed any changes in your habits (e.g. exercise or food and drink intake) that were not captured in the questionnaire?"

[0449] The above feedback questions may be presented with a free-form text response field for the patient to enter their feedback and / or with predefined answer options, depending on the nature of the feedback question.

[0450] Patient Comfort Questions In some embodiments, the personal health questionnaire can be configured to present one or more questions related to the patient's comfort during respiratory therapy with the respiratory assistance device. For example, the patient can be presented with one or more questions such as, but not limited to, "Do you feel comfortable with the treatment?" The patient can be presented with a range of different selectable answer options. In some configurations, the answer options may be binary answers such as "yes" and "no", while in other configurations the patient may be able to answer their comfort level on a scale or from a range of comfort levels. This patient comfort answer data can be included in the questionnaire data and later processed for display or rendering in one or more reports or graphs, like other questionnaire data.

[0451] Other example questions It will be appreciated that a wide variety of different questions may be presented in a patient health interview: some questions may be presented in every interview, while other questions may be configured to be presented or included in the interview at a specified lesser frequency based on time or number of interviews (e.g., a question may be presented every two weeks or every month, or every fifth interview).

[0452] Below are some further examples of questions that can be posed to a user and possible answer options that can be presented for selection.

[0453] Since your last [biweekly / monthly] checkup, have you had to have any unscheduled COPD-related medical appointments? Select all that apply. Answer options: Prefer not to answer, No, family doctor, emergency department visit, hospitalization. ·How would you rate your health? Answer options: Prefer not to say, poor, average, good, fair good, excellent. Since your last [biweekly / monthly] health check, has your health condition affected your ability to carry out physical work? Answer options: Prefer not to answer, Not at all, A little, Moderately, Quite a bit, Extremely. Since your last [biweekly / monthly] health check, how much has your condition affected your mental health? Answer options: Prefer not to answer; Not at all; A little; Moderately; Quite a lot; Extremely. Since your last [biweekly / monthly] health check, has your health condition affected your social activities? Answer options: Prefer not to answer; Not at all; A little; Moderately; Quite a lot; Extremely. How would you rate your experience with treatment? Answer options: Prefer not to say, Poor, Average, Good, Very good, Excellent.

[0454] Questions based on previous answers As discussed above, there are various examples in which an answer to a question can then trigger the presentation of one or more additional or subsequent questions in the patient health interview. For example, the presentation of some questions may be contingent on or conditional on the patient's answer to one or more preceding questions in the questionnaire.

[0455] One example configuration of the above process is described with reference to FIG. 28. The example process 650 of FIG. 28 begins with a processor (e.g., a data server and / or a process of the respiratory assistance device) receiving or acquiring incoming interview data including the patient's answers to the questions posed, as shown in step 652. The received interview data is then processed with respect to one or more trigger criteria, as shown in step 654. If the patient's answers in the interview data satisfy any one or more trigger criteria, the controller is configured to modify the patient health interview presented to the patient according to respective stored modification rules associated with the trigger criteria, as shown in step 656. For example, a particular main or primary question in the interview may have a trigger criterion that triggers one or more additional subsequent secondary questions to be presented to the patient depending on the patient's answer to the initial primary question. In this example, the trigger criterion specifies an answer or multiple answer types that trigger the subsequent or additional questions to be presented, and the associated modification rules define the particular subsequent or additional questions to be inserted into the interview for presentation if the criterion is met. Once any modification rules have been implemented, the modified Patient Health Questionnaire is presented to the patient, as shown in step 658. This final step may involve the questionnaire dynamically modifying the next question or questions posed based on or in response to the answers to the preceding question or questions, i.e., the content of the questionnaire (the nature and type of questions posed) may change dynamically as it progresses in response to the patient's answers.

[0456] Battery Mode When the respiratory assistance device is operating on battery power in battery mode, the personal health questionnaire can still be presented on the respiratory assistance device's display and patient responses can be captured and stored as answer data.

[0457] 3.8 Patient Reference Data As described above, a user of the respiratory assistance device is provided with a questionnaire formed of one or more questions on an integrated touch screen of the respiratory assistance device. The questionnaire is received on the one or more touch screens through which the user also provides his or her responses. The responses (answer data) are then processed and one or more reports are generated for display, including charts, graphs, plots or other graphical forms of data to visually represent the health parameters recorded by the patient.

[0458] As shown in FIG. 8, in some embodiments, a baseline value 5902 of the patient's health status is first established. For example, this baseline status of the patient's health parameters may be established independently by a healthcare provider or by the patient answering one or more questions of a medical interview from the device. In such embodiments where a baseline status of the patient's health parameters is established, the healthcare provider (and / or the patient) may be able to determine a change from the baseline value, whether it is an improvement in one or more health parameters or a deterioration in one or more health parameters. In one embodiment, the predetermined baseline value for a particular patient may be stored locally on the respiratory assistance device or may be accessed from a remote device (e.g., a server). In one configuration, the baseline value may be represented by baseline data stored for the patient's profile in the patient and device management platform. This baseline data may then be accessed by the respiratory assistance device and / or retrieved from the patient and device management platform.

[0459] Each health parameter may have an associated reference value.

[0460] The baseline values ​​for the health parameters may be dynamically and / or automatically adjusted or updated (eg, by the device and / or by a patient and device management system).

[0461] The baseline may be updated based on answers to one or more questions as part of a health interview over a period of time.

[0462] In some embodiments, the baseline value of a health parameter may be updated based on a period of consistent responses to questions or interviews by the patient. In one configuration, the baseline value of a health parameter may be updated if the responses to one or more questions related to that health parameter are all the same or within a predetermined deviation threshold of the baseline value. In another configuration, the baseline value of a health parameter or health parameters may be automatically updated if their respective answers (e.g., answer data to questions related to the health parameter) indicate a consistent new value over a predetermined and / or configurable period of time and / or a predetermined and / or configurable number of completed interviews (e.g., the baseline value for a health parameter may be updated to a most recent answer value if the answers have been consistent over a predetermined number of consecutive completed interviews and / or over a predetermined number of days, weeks and / or a predetermined time interval).

[0463] The baseline value may be updated if the answers to one or more questions related to the health parameter indicate a different baseline value. The baseline value may be updated to a different baseline value if the answers to one or more questions related to the health parameter indicate a different baseline value over a given time or a given number of responses to the health interview.

[0464] In some embodiments, the baseline may be cycled towards different baseline values.

[0465] For example, if a patient responds that they cough occasionally (i.e., FIG. 14) 10 consecutive times, the criterion associated with this patient parameter may be updated to cough occasionally.

[0466] In some embodiments, before the baseline values ​​are automatically updated, the patient may be prompted as to whether or not they want the baseline values ​​to be updated, for example, in some configurations any proposed automatic adjustments or updates to the baseline data may require approval from the patient.

[0467] In some embodiments, before the baseline values ​​are automatically updated, a healthcare provider (e.g., a physician) may be prompted as to whether or not they want the baseline values ​​to be updated. For example, in some configurations, any proposed automatic adjustments or updates to the baseline data may require healthcare provider approval before being updated.

[0468] In some embodiments, the baseline data may be updated periodically (e.g., every six months). For example, new or novel baseline data for a patient may be obtained by a healthcare provider and / or may be established from a patient completing a patient health questionnaire and / or may be determined based on analysis of previous historical questionnaire data associated with a previously completed patient health questionnaire.

[0469] In some embodiments, a healthcare provider may be able to select a particular set of interview data associated with a particular completed patient health interview to be used as the new patient baseline data. In one configuration, a healthcare provider may be able to select a desired set of interview data via interaction with one or more patient data reports or graphical data extracts (e.g., time series charts, time series graphs, heat maps, etc., examples of which are described further below). In one example, a healthcare provider may select or designate a particular column of a patient's heat map (see Figures 22-24, described below) as the new baseline data for the patient. A healthcare provider may interact with a GUI displaying the heat map and interact with one or more GUI elements to designate or select a desired column of data from the patient's heat map as the new patient baseline data. The interview data from the selected column of the heat map is associated with the patient's interview questionnaire responses over a particular day, week, or time interval. A healthcare provider may select or designate the interview data for a particular time interval as representative of the patient's current baseline values. The interview data associated with the completed questionnaire from the selected column or time interval of the heatmap (e.g., a particular day or week along the timeline) is then loaded as the patient's new baseline data, i.e., the baseline value associated with each health parameter question is reset to be equal to its respective answer in the selected column of the heatmap. It will be appreciated that the healthcare provider can also operate or instruct the system, via other input commands or interactions with the patient and device management platform's control or configuration interface, to reset the patient's baseline data to correspond to a particular set of interview data from a particular day, week, or other time interval.

[0470] The baseline data may be updated or adjusted by a healthcare provider through interaction with the respiratory assistance device and / or through interaction with the patient and device management platform.

[0471] In some embodiments, a temporal event-based baseline value may be used for a patient, conditional on a particular event, and such baseline value may remain at the baseline value for a configurable or predetermined period of time before reverting back to the patient's normal or typical baseline data. For example, a healthcare provider may be able to configure the system to load or specify a "post-discharge" baseline value for a patient that applies for a particular period of time (e.g., a particular number of days or weeks) after the patient leaves or is discharged from the hospital following an exacerbation event. Once the particular period has passed, the patient's baseline data may revert or be modified to revert to the patient's normal or normal baseline data.

[0472] In some embodiments, the system (e.g., respiratory assistance device and / or patient and device management platform) can process the interview data and detect or identify that the patient's answers (e.g., answer data) to one or more questions in the patient health interview have stabilized according to a predetermined or configurable criterion or condition. In one example, the answer data may be considered stable or stabilized based on an analysis of the deviation of the answer data relative to a moving average. For example, the answer data may be determined to be stable if the deviation from the moving average is detected to be less than a threshold value. In one configuration, the system can be configured to trigger an alert, notification, or message to be sent or pushed to the healthcare provider when a certain number (e.g., one, some, or all) of the answers are detected or identified as stable, prompting or asking the healthcare provider whether or not they would like to update the patient's baseline data (or a portion of the baseline data) to the latest interview data. The alert, notification, or message can be sent or pushed to the healthcare provider's electronic device (e.g., smartphone, tablet, wearable, computer, etc.) and / or provided to a user interface, portal, or dashboard of the patient and device management platform. In response to the notification, the healthcare provider can then instruct the system to update some or all of the baseline data to the identified stabilized interview data.

[0473] In some embodiments, the data reports generated by the system may plot time series charts or graphs displaying the baseline data over time. For example, one or more graphs may be generated that plot changes in the baseline data for one or more health parameters over time to show changes or trends in the patient's health over time. These baseline time series charts may be plotted separately as their own graphs or may be integrated with other interview data time series charts (e.g., time series graphs and / or heat maps, as described below with respect to Figures 22-26).

[0474] 3.9 System Architecture An example overall configuration and / or architecture of a system 500 implementing the capture, transmission, processing, storage, retrieval and / or display of data associated with the personal health questionnaire described above is described in further detail with reference to Figures 19 and 20. It will be appreciated that any one or more of the features, aspects and alternatives of the systems and processes described above may be applied to this example configuration.

[0475] In this embodiment, the system 500 includes one or more respiratory assistance apparatus 502 (also referred to herein as "respiratory therapy devices"). The respiratory assistance apparatus 502 may be, for example, the respiratory assistance apparatus 10 or 5700 described above. The respiratory assistance apparatus 502 is operable to provide respiratory therapy to a patient or user 504, as previously described.

[0476] The respiratory assistance device 502 is operable to present the patient 504 with a personal health questionnaire, as described above. The personal health questionnaire may include a series of questions, as previously described. User input to the questions, via a user interface of the respiratory assistance device 502, is captured as answer data at the device. Additionally, if the entire questionnaire or specific questions within the questionnaire are skipped by the user, such data is captured as skipped data.

[0477] The respiratory assistance device 502 is in data communication with the data server 506 via a data network 508 or data link as previously described. The respiratory assistance device 502 is configured to transmit or send the captured answer data and / or skipped data for each personal health questionnaire to the data server 506 for storage and processing. The answer data and / or skipped data may collectively be referred to as questionnaire data. Unless the context indicates otherwise, the terms "data server" and "patient and device management platform" may be used interchangeably in this disclosure.

[0478] The data server 506 may be, for example, a cloud service or platform, or any other suitable data processing server, service, or platform. The data server 506 may be a subscription-based third-party platform, or a proprietary system, or a combination thereof. The data server 506 may perform, provide, or host the functionality of the patient and device management platform described above. In some configurations, the data server comprises at least one processor or processor device and a memory.

[0479] The data server 506 is configured to obtain, access, and / or store baseline data representative of the patient's baseline health status with respect to one or more health parameters responsive to questions in the patient health interview. As discussed above, the initial baseline data may be provided by the patient via the respiratory assistance device or by a healthcare provider, or may be pre-set or pre-configured baseline data. The data server may obtain or receive updated baseline data dynamically or periodically, or may be configured to update and / or adjust the baseline data itself over time during processing of incoming interview data based on automatic update rules or algorithms, periodically, on-demand, or upon request.

[0480] In this embodiment, the data server 506 receives or obtains captured raw interview data for each personal health interview conducted or a representative set of interview data over a configurable time interval of interest (e.g., daily or every 3 days, weekly, or any other suitable time interval frequency). The interview data may include identifying information or data relating to either the respiratory assistance device and / or the patient, which enables the data server to store or link the raw interview data to the associated patient's profile in database 507 or other electronic storage device of or linked to the data server. The interview data may also include timestamp or time data representative of or indicative of the time interval (e.g., date and / or time) at which the interview data was captured.

[0481] In this embodiment, the data server 506 is configured to process the interview data and associated baseline data for the patient to generate one or more data reports representative of the patient's personal health status as represented by the interview data. In one configuration, the one or more data reports include one or more time series charts, e.g., graphs or plots, of the interview data over a series of time intervals spanning a particular period or moving window of the interview data for the patient.

[0482] The data server 506 may be configured to process the interview data in real time to dynamically generate one or more data reports upon request. Additionally or alternatively, the data server 506 may pre-process the interview data as it arrives into a processed format ready to be rendered into one or more data reports for display, or into static or updated pre-compiled data reports ready for retrieval and display.

[0483] In this embodiment, one or more data reports relating to the patient may be accessed or obtained by the healthcare provider 510 via a display device 512 in data communication with the patient and device management platform provided on the data server 506. The healthcare provider 510 may access the data reports via any electronic device (e.g., PC, tablet, smart phone, wearable, etc.) having a display screen and capable of data access to the data server 506. By way of example, the display device 512 may access the patient and device management platform via a web browser or website interface, or via a software application program, user access portal or interface running on the display device, or via any suitable host-client architecture configuration. It will be appreciated that in some configurations, the patient 504 may also access to view their own data reports via the respiratory assistance device's GUI, and / or any other suitable electronic device having a display screen and data communication with the data server 506.

[0484] The healthcare provider's display device 512 may obtain or access a data report (pre-compiled or generated in real time) generated by the patient and device management platform 506 for the patient 504 for display, or may obtain or access raw or pre-processed data representing the data report for further local processing of the data report for display.

[0485] With reference to FIG. 20, the overall system 500 will be further described in the context of a system for managing personal health questionnaire data for a number of different patients. Like numbers represent like components. As shown, in some embodiments, the patient and device management platform 506 is configured as a data server for a number of patients 502a-502d, each operating their own respiratory assistance device 504a-504d. The patient and device management platform 506 may be configured to provide services to any number of individual patients. Similarly, the patient and device management platform 506 may be accessed by a number of different healthcare providers 510a, 510b via their respective display devices 512a, 512b. It will be appreciated that the number of different healthcare providers accessing the patient and device management platform may vary as desired.

[0486] As an example, each different healthcare provider 512a, 512b may have a group of one or more patients that they are monitoring and / or treating, and may have access or permissions to access or request records and / or data reports associated with each of them via the patient and device management platform 506. In one configuration, the data reports may be generated in real-time or dynamically by the patient and device management platform 506 in response to a data request from a display device 512 operated by the healthcare provider.

[0487] In some configurations, the patient's respiratory assistance apparatus 502 can be in data communication with one or more other local electronic devices, whether portable or non-portable. For example, the respiratory assistance apparatus 502 can be data linked or in data communication (e.g., via Bluetooth, or Wifi, or any other suitable data communication protocol) with the patient's smartphone, tablet, wearable, and / or personal computer (PC). The linked electronic devices can themselves also be in data communication with the data server 506 via a data network 508. In some embodiments, the patient's linked electronic devices (e.g., smartphone, tablet, and / or PC) can be configured to receive or acquire the interview data captured by the respiratory assistance apparatus. The linked electronic devices can be configured to process the interview data (along with stored or acquired reference data) partially or entirely (according to a process described in the data server), and then present the processed data (e.g., data reports and / or time series charts) to the patient on a display screen of the electronic device. Additionally or alternatively, processed data (e.g., data reports and / or time series charts) in the linked electronic device may be transmitted back to the respiratory assistance device 502 for display on a user interface (e.g., a touch screen display).

[0488] Additionally or alternatively, the linked electronic devices may be configured to relay or transmit the raw interview data and / or the partially processed data and / or the fully processed data over a data network to the data server 506, which may further process the data, store the data, and / or provide access to the data or the processed data (e.g., data reports and / or time series graphs) for review by the healthcare provider (e.g., on his or her display device 512).

[0489] Additionally or alternatively, the linked electronic device may be configured to receive processed data (data reports and / or time series charts) from the data server 506. The processed data may be requested by the linked electronic device or may be pushed to the electronic device automatically, periodically, or based on an ad-hoc or manual trigger. The processed data received by the linked electronic device may be presented or displayed for viewing or interaction on the display of the linked electronic device and / or relayed or transmitted to the respiratory assistance apparatus 502 for viewing and / or interaction on the touch screen display of the apparatus.

[0490] In some configurations, the patient's linked electronic devices may be in data communication with the respiratory assistance device 502 , the data server 506 , and the healthcare provider's display device 512 , either directly or via a data network 508 .

[0491] In some configurations, the patient's linked electronic device (e.g., smartphone, tablet, wearable, computer, etc.) can be configured or operable to present the patient health questionnaire to the patient or user in a manner similar to the respiratory assistance device. In this configuration, the patient can complete the patient health questionnaire via his or her linked electronic device, which can receive, store, process, and / or transmit the questionnaire data to the respiratory assistance device and / or a data server for further processing. The digital patient health questionnaire can be presented on the display of the linked electronic device via a dedicated software application program or via an interface such as a website or browser interface. In some configurations, a software application (e.g., smartphone application) running on the linked electronic device can transmit the patient questionnaire data to the respiratory assistance device, which then relays the questionnaire data to the data server for processing. In other configurations, the linked electronic device may transmit the patient questionnaire data directly to the data server for processing.

[0492] 3.10 Processing of interview data into data reports 21, an embodiment of a data processing flow 520 performed by the system 500 to generate a patient data report including one or more time series charts is described. In this example embodiment, the data processing flow 520 is implemented in a patient and device management platform (e.g., data server 506), although it will be appreciated that in alternative configurations the data processing flow or one or more stages thereof may be performed locally in the respiratory assistance apparatus 502 or display device 512. It will be appreciated that in alternative configurations one or more of the steps or stages of the data process flow may be performed in a different order or in parallel.

[0493] The data processing flow 520 can be initiated in response to a data request and / or automatically in response to new incoming interview data. For example, in one mode, the data processing flow 520 executes dynamically in real time in response to a request for a data report or data access by the display device 512 operated by the healthcare provider 510. In another mode, the data processing flow 520 executes automatically upon receipt of new incoming interview data, such that an updated data report or processed data for such a report is updated and synchronized with the latest incoming interview data, ready to be retrieved and displayed at a later time.

[0494] When executed, the data process flow 520 begins by receiving and / or acquiring interview data for a patient at step 522. The interview data includes interview data associated with a series of time intervals over a period of time. In one configuration, the period of time can extend from the most recent or most recent interview time interval back to a configurable or pre-set previous time interval. In other configurations, the period of time may be configurable via configurable start and end time intervals (e.g., start and end dates).

[0495] For purposes of this description, the time intervals will be daily and the time periods span a calendar month of data. However, it will be understood that the data process flow can be applied to any configurable time interval frequency and period (e.g., weekly over several weeks or months). For example, the time interval frequency and period settings can be configured or selected by a healthcare provider depending on the healthcare provider's desired viewing preferences regarding the time period of data to be viewed and / or the granularity and / or resolution of the data to be viewed.

[0496] The data server 506 may receive or retrieve interview data for a patient from a database 507 or electronic data storage device of or associated with the data server. In this example, each set of interview data spanning a time interval in the chronological order (e.g., a day) may include answer data including answers to each of the questions in the interview, and / or skipped data identifying any one or more questions skipped by the patient. In some cases, the skipped data may represent the entire interview (i.e., all questions were skipped by the patient). As noted above, each day of interview data also includes a timestamp identifying the time interval during which it was captured. In this example, the timestamp may be the date and / or time the interview data was captured. The interview data also includes sufficient ID information (e.g., patient ID, or respiratory support device ID or serial number) to directly or indirectly link or associate the data with a patient.

[0497] In this embodiment, the personal health questionnaire includes a series of questions categorized or grouped into one or more categories of health parameters. In one configuration, the questions are grouped into a symptom category related to the patient's symptoms and a medication category related to the medications the patient is taking. In this configuration, the answer data can be delineated into symptom data, which is answer data related to questions in the symptom category, and medication data, which is answer data related to questions in the medication category.

[0498] By way of example, in one embodiment, the symptom category questions may relate to, but are not limited to, any one or more of the following health parameters: difficulty in breathing, sputum production, sputum consistency, sputum color, cough, fatigue, wheezing severity, chest tightness, nasal congestion, and fever.

[0499] By way of example, in one embodiment, questions in the medication category may relate to, but are not limited to, any one or more of the following health parameters: antibiotics, steroids, and inhaler or nebulizer use.

[0500] Once the questionnaire data for the patient is received, the data process flow 520 proceeds to receive or obtain baseline data for the patient, as shown in step 524. The baseline data for the patient may be stored in database 507 or other electronic data storage device of or accessible to data server 506. The baseline data for each patient may include baseline values ​​or scores or answers for each question in the personal health questionnaire. As discussed above, the baseline data for each patient may be customized to the patient's baseline health status. The baseline data may be updated or refreshed periodically or continuously based on the incoming questionnaire data, as previously discussed.

[0501] The data process flow 520 then processes the interview data against the baseline data to determine deviation data, as shown in step 526. The deviation data may indicate any deviation of the interview data from the baseline data for each time interval. The deviation data may be per question and / or per category. The deviation data may indicate a worsening, no change, or an improvement in the patient's health parameters and / or overall health status based on a comparison of the response data to the baseline data at the question and / or category level.

[0502] In this example embodiment, each question presented to the patient provides multiple or extensive answers from which to choose, as described above. The answer data for each question is configured to directly represent or correspond to a score or ranking on a respective scale or answer scale, or to be mapped or converted to a corresponding score or ranking on a scale. The scale includes a series of scores or rankings ranging from a desirable score (e.g., indicating "good" health) at one end to an undesirable score (indicating "poor" health) at the other end. The score or ranking scale may be numeric or absolute, or a Likert-type scale, depending on the nature of the question and the metric for evaluation. The scale may be linear, progressive, logarithmic, or arbitrary. Reference data is provided for each question against a corresponding scale. In this embodiment, the data process flow 520 is configured to determine deviation data based on comparing the answer data against the reference data with reference to the scale for each question. In one configuration, the deviation data may represent a condensed version or representation of the interview data against the reference data for each patient.

[0503] After determining or calculating the deviation data, the data process flow then proceeds to generate time series chart data based on the interview data, the baseline data and / or the deviation data, as shown in step 528. The data process flow may generate the time series chart data in one or more different formats depending on the nature and type of time series chart to be generated for display. In one configuration, the time series chart data includes coded or processed data sets of the interview data, the baseline data and / or the deviation data. In one configuration, the time series chart data is in the form of metadata associated, tagged or coded with the interview data, the baseline data and / or the deviation data.

[0504] In one configuration, the data process flow 528 is configured to color code the interview data based on deviation data. The color code data can represent or form part of the time series chart data. The color code is selected according to a reference color spectrum and one or more deviation color spectrums. In one configuration, there is a "worsening" deviation color spectrum that indicates a deterioration of the health parameter relative to the reference, and an "improvement" deviation color spectrum that indicates an improvement of the health parameter relative to the reference. The color code of the interview data selects distinct color spectrums to apply to the response data in a color-coded time series plot, as will be described in more detail below.

[0505] In another configuration, the data process flow 528 is configured to generate category deviation parameters that represent or are a function of the total number of health parameters in each category that have deviated (worsened or improved). In one form, there is an "improvement" category deviation parameter that represents the total number of health parameters in the category that have improved compared to the baseline, and a "deterioration" category deviation parameter that represents the total number of health parameters in the category that have deteriorated compared to the baseline. The category deviation parameters can represent a data set for each time interval of the interview data. The category deviation parameters can represent or form part of the time series chart data.

[0506] The time series chart data may be stored in a database against the patient profile, either as a separate data set or as metadata or associated data against the interview data, norm data and / or deviation data. The time series chart data may be retrieved or accessed at any time for generating or rendering one or more data reports, including generating or rendering one or more time series charts based at least in part on the time series chart data.

[0507] Data processing flow 520 includes generating one or more data reports and / or one or more time series charts of the interview data based at least in part on the time series chart data, as shown at 530. These data reports and / or time series charts may be pre-compiled prior to acquisition or may be dynamically generated in real time, for example, upon request. Examples of data reports and / or time series charts are described in more detail below.

[0508] 3.11 Data reports including multiple time series charts 22 illustrates an example of one form or format or layout of a data report 540 that may be generated or rendered based at least in part on the processed interview data, the norm data and / or the deviation data. In this example, the data report includes multiple time series charts, although it will be appreciated that in alternative configurations the data report may include a single time series chart.

[0509] In this example data report 540, a patient information section is provided as shown in the dotted area indicated at 542. This patient information may include patient data such as name, date of birth, contact details, patient ID data, or any other desired patient information.

[0510] A first time series chart in the form of a color-coded time series plot is provided or rendered in the section shown in the dotted area indicated at 546. In this embodiment, the color-coded time series plot is configured to plot daily interview data over a period of time (e.g., a month), with each response displayed according to a color spectrum that depends on or is a function of any deviation from a determined baseline value, or according to the color-coded data described above. The color-coded spectrum represents or conveys both the overall desirability of the response on that scale and any deviation from the baseline value.

[0511] As mentioned above, the time interval at which the patient health questionnaire is presented to capture new questionnaire data can be configured by the healthcare provider. In the embodiment described below, the time interval is a daily questionnaire representing questionnaire data captured daily, but alternatively the time interval may be a weekly questionnaire representing weekly questionnaire data, or any other suitable configurable time interval or frequency. The time interval or frequency at which the questionnaire is presented may be a function of any time unit, such as, but not limited to, days (e.g., once a day or once every three days, etc.), weeks (e.g., once a week or once every two weeks, etc.), or months (e.g., once a month).

[0512] A second time series chart in the form of a time series plot is provided or rendered in the section shown in the dotted area indicated at 544. In this embodiment, the time series graph plots one or more category deviation parameters representative of the overall deviation of each category of answers at each time interval.

[0513] Further explanation of each time series chart is as follows:

[0514] 3.12 Color-coded time series plots (color heat maps) 23 and 24, an example color-coded time series plot 550 of the type shown in data report area 546 of FIG. 22 is described in more detail.

[0515] Response data In this example, color-coded time series plot 550 is configured to plot patient response data for one or more health parameters over a period of time. In this embodiment, color-coded time series plot 550 is in the form of a heat map, e.g., a color heat map. The heat map may be, for example, a cluster heat map.

[0516] Each plotted answer in the answer data in the heat map 550 is selectively color-coded for display based on a reference color spectrum and one or more deviation color spectra. The color spectrum selected for each answer is a function of or based on any deviation of the answer data from the reference data. As explained, the color-coding data defines the color spectrum selected for each answer.

[0517] In this example, the answer data is selectively color coded according to one of three color spectrums, namely, a baseline color spectrum 552, a deviation for the worse color spectrum 554, and a deviation for the better color spectrum 556, as shown in the dotted line section of the key section of the heat map 550. In other examples or configurations, the selective color coding may be according to a baseline color spectrum and only one overall deviation color spectrum (which may represent deviation for the worse, deviation for the better, or both).

[0518] The baseline color spectrum 552 represents response data that corresponds to the patient's baseline data for the associated health parameter. The worsening deviation color spectrum 554 represents a worsening or worsening of the health parameter represented by the response data relative to the baseline data. The better deviation color spectrum 556 represents an improvement of the health parameter represented by the response data relative to the baseline data.

[0519] The baseline color spectrum 552 allows the healthcare provider to quickly see how severe the patient's symptoms and medication usage are at baseline. The worsening deviation color spectrum 554 and the improvement deviation color spectrum 556 allow the healthcare provider to quickly see how severe or improving the patient's above or below baseline symptoms and medication usage are, respectively.

[0520] In this example, the reference color spectrum 552 is visually different or distinguishable from the one or more deviant color spectra 554, 556. The reference color spectrum 552 has high visual contrast with the one or more deviant color spectra 554, 556. The deviant color spectra 554, 556 are also visually different or distinguishable from each other.

[0521] In this example, response data for health parameters that correspond or match the reference data is represented as plotted responses colored according to the reference color spectrum 552. Response data representing worsening deviations of the health parameters from the reference data is represented as plotted responses colored according to the worsening deviations color spectrum 554. Response data representing better deviations of the health parameters from the reference data is represented as plotted responses colored according to the better deviations color spectrum 556.

[0522] By way of example, the color coding of response data for the symptom health parameter "stuffy nose" is described in further detail with reference to Figure 23. Response data relating to the "stuffy nose" health parameter is plotted along a time axis 560 of the heat map 550 in a data row generally designated 566. Response data in data cells designated within dotted box 552a is color coded in the reference color spectrum 552. Response data in data cells designated by dotted box 554a is color coded in the worse deviation color spectrum 554. Response data in data cells designated by dotted box 556a is color coded in the better deviation color spectrum 556.

[0523] As discussed, the response data for each health parameter question includes or is convertible to a score or ranking or grade on a scale. As will be appreciated, the response data for each question (depending on the nature of the question) may be numeric or non-numeric, including Likert scale type answers, and each may directly represent or be mapped, converted, or convertible to a score or ranking on a scale.

[0524] In one configuration, the scale may be a multi-level numerical scale of discrete values, for example a 5-level numerical scale from 0 to 4 (e.g., a score or ranking selected from 0, 1, 2, 3, or 4) or 1 to 5 (e.g., a score or ranking selected from 1, 2, 3, 4, or 5), or any other suitable or desirable multi-level discrete scale, whether numeric or non-numeric.

[0525] Each score or ranking on the scale corresponds to or is assigned a respective discrete color value in each of the reference color spectrum 552 and one or more deviation color spectrums 554, 556. For example, if the scale is a 5-point scale from 1 to 5, then each respective score 1, 2, 3, 4 and 5 corresponds to or is assigned or mapped to a corresponding discrete color value in each of the color spectrums. Questions that include non-numeric answer options or Likert scale type answers are also converted to scores or rankings on a scale.

[0526] In this embodiment, the size of each of the color spectrums is at least as large as the maximum scale associated with any of the questions. For example, if the maximum scale includes five levels, then each color spectrum also has five color values. Questions with answers that map to smaller scales or binary values ​​still map to assigned discrete color values ​​within the larger color spectrum. In one configuration, the smaller scales (e.g., a three-level scale) may be mapped to the center of the color spectrum, or may be mapped to the lower or upper ends of the scale, or may be mapped at equal intervals across the scale. In another configuration, questions with binary answers or binary values ​​(e.g., "yes" or "no") may be mapped to color values ​​that are the respective extremes of each color spectrum.

[0527] In this embodiment, each of the color spectrums 552, 554, 556 is the same size, i.e., contains the same number of discrete color values ​​or steps.

[0528] In one configuration, the scale is defined to span or lie between a first desirable score or ranking or stage at one end (e.g., the start of the scale) to an undesirable score or ranking or stage at the other end of the scale (e.g., the end of the scale). The desirable score or ranking or stage may represent a good or better health state for the health parameter associated with the question. The undesirable score or ranking or stage may represent a poor or worse health state for the health parameter associated with the question. Depending on the size of the scale, there may also be one or more intermediate scores or rankings or stages progressing between the scores or rankings or stages at each end.

[0529] In this embodiment, the reference color spectrum 552 and the one or more deviation color spectrums 554, 556 each include a range of discrete color values ​​of the base or predominant color ranging from lighter color values ​​at one end of the spectrum to darker color values ​​at the other end of the spectrum.

[0530] In one configuration, desirable scores or rankings or stages on this scale correspond to, are assigned or mapped to discrete color values ​​in a reference color spectrum 552 and one or more deviation color spectrums 554, 556 that are lighter compared to undesirable scores or rankings or stages.

[0531] In another configuration, a desirable score or ranking or stage on the scale corresponds to, is assigned or mapped to a discrete color value in the reference color spectrum 552 and one or more deviation color spectrums 554, 556 that are darker compared to an undesirable score or ranking or stage.

[0532] In another configuration, one or more color spectra may map or assign desirable scores or rankings or stages to discrete color values ​​that are lighter compared to undesirable scores or rankings or stages, and one or more other color spectra may map or assign desirable scores or rankings or stages to discrete color values ​​that are darker compared to undesirable scores or rankings or stages. For example, the reference color spectrum 552 and the worse deviation color spectrum 554 are configured to map or assign desirable scores or rankings or stages to discrete color values ​​that are lighter compared to undesirable scores or rankings or stages, and the better deviation color spectrum 556 is configured to map or assign desirable scores or rankings or stages to discrete color values ​​that are darker compared to undesirable scores or rankings or stages.

[0533] In this embodiment, the base or predominant colors associated with each respective reference color spectrum 552 and one or more deviation color spectrums 554, 556 include configurable or predefined colors, hues, shades, tones or shades. By way of example, the base or predominant colors may be selected from any one or combination of the following: any color defined or formed from a mixture of primary colors, black and white. The accompanying drawings show (when viewed as color drawings) an example color spectrum formed from the base or predominant colors blue, orange and green. If the accompanying drawings are viewed (converted or rendered) as black and white drawings or in grayscale, the color spectrum will no longer be visually distinguishable and will appear as various shades of black, white and / or gray, i.e., may be viewed or recognized in the present disclosure as, for example, a "shade spectrum."

[0534] In some configurations, the color spectrum may have associated indicia or text or numbers or markers representing a position, stage, score or ranking on an associated scale. In some configurations, indicia coded into each answer data may indicate an improvement or deterioration of the answer on that scale. In one example, the indicia or test or numbers or markers may vary in size depending on whether they represent an answer that is improving or worsening. In another example, an indicia in the form of a cross may be presented to represent deterioration and a scale may represent improvement. In some configurations, the number of crosses or scales may represent the degree of improvement or deterioration. In another example, the lightness of the shade may indicate an improvement or deterioration of the answer. For example, depending on the color spectrum, a darker shade may indicate deterioration and a lighter shade may indicate an improvement or vice versa.

[0535] In one configuration, the base or predominant color associated with the reference color spectrum 552 is a cool color, hue, tint, tone or shade, the base or predominant color of the deterioration deviation color spectrum 554 is a warm color, hue, tint, tone or shade, and the base or predominant color associated with the improvement deviation color spectrum 556 is a cool color, hue, tint, tone or shade.

[0536] In one configuration, the color spectrums 552, 554, 556 may be defined by warm or cool base or dominant colors, provided that they are all visually distinct or different from one another.

[0537] In one configuration, the color spectra 552, 554, 556 may be defined by a base or predominant color that is symbolic or representative of the spectrum itself. For example, the reference color spectrum 552 may be defined by a base or predominant color, such as blue or another neutral color, the worsening color deviation spectrum 554 may be defined by a base or predominant color, such as red, and the improving deviation color spectrum 556 may be defined by a base or predominant color, such as green.

[0538] As discussed above, each plotted answer in the heat map 550 is colored according to a color spectrum selected depending on whether the answer data corresponds to or deviates from the reference data. The answers are colored within the selected color spectrum based on an assigned color value that corresponds to or is a function of the desirability or position of the score, ranking or stage associated with the answer data on the scale. As discussed, the answer data for each health parameter question includes or is convertible to a score or ranking or stage on a scale, and each score or ranking or stage on the scale corresponds to or is assigned or mapped to a respective discrete color value in each of the reference color spectrum 552 and one or more deviation color spectrums 554, 556. The discrete color values ​​in each color spectrum represent discrete scores or rankings or stages on the scale.

[0539] In some embodiments, text or numbers representing each answer, or an optional indicia in the form of a score, ranking or grade of the answer on the scale, may be displayed within each plotted color-coded data cell, as shown in example heatmap 550 in Figures 22 and 23. In other embodiments, the plotted data cells may simply be colored data cells that are colored according to the color coding of the answer they represent.

[0540] In one configuration, the scale can be defined by light color values ​​representing desirable scores or rankings or stages at one end to dark color values ​​representing undesirable scores or rankings or stages, or vice versa. In some configurations, the color values ​​within each color spectrum correspond to or are consistent with a format, i.e., lighter color values ​​represent better or more desirable answers and darker color values ​​represent worse or less desirable answers, or vice versa. In other configurations, there may be a mixture of color spectrum formats, with some color spectrums progressing from light to dark color values ​​representing worse answers and others progressing from light to dark values ​​representing better turns. In some configurations, the nature of the color spectrum may determine the nature of the color spectrum format. For example, the reference color spectrum 552 and the worsening deviation color spectrums 552, 554 may progress from light to dark color values ​​representing worse answers, while the betterment deviation color spectrum may progress from light to dark color values ​​representing better answers.

[0541] In one configuration, each discrete color value within each respective color spectrum is defined by the variance of one or more color characteristics of the base or predominant color. For example, the color characteristics may be intensity, hue, shade, lightness, etc. In such a configuration, each distinct color value within the color spectrum is a function of or defined by the variance of each of the one or more color characteristics of the base or predominant color. In one example, the color spectrum may include five distinct color values, each corresponding to a respective one of five distinct rankings, scores, or stages on the answer scale. By way of example, if the color values ​​are defined based on the color characteristic of lightness, for example, color value 1 corresponding to stage 1 on the answer scale may correspond to 20% lightness of the base or predominant color defining the color spectrum, color value 2 corresponding to stage 2 is 40% lightness, color value 3 corresponding to stage 3 is 60% lightness, color value 4 corresponding to stage 4 is 80% lightness, and color value 5 corresponding to stage 5 is 100% lightness.

[0542] As shown in Figures 23 and 24, in this embodiment, each of the reference color spectrum 552 and one or more deviation color spectrums 554, 556 are each visually represented in the data report by a respective color key that depicts the discrete color values ​​of each color spectrum in relation to their position on the scale associated with the response data. The key indicates the order or progression of each discrete color value within each respective color spectrum.

[0543] 23, in this embodiment, color heatmap 550 includes responses plotted in columns by time interval frequency along the plot's time axis 560 and rows by the health parameter axis 562 to which the responses relate. Color heatmap 550 can be thought of as a two-dimensional (2D) array or matrix of data cells.

[0544] In one configuration, the answer data has associated time interval data representing the time intervals over which the answer data was entered by the user, and the answers are plotted as data cells in an array, stack or column along the time axis 560 of the time series plot according to their respective time intervals, and answers spanning time intervals are aligned in rows according to their associated health parameters on the health parameter axis 562.

[0545] In this example, the horizontal time axis 560 extends over a one-month period, although it will be appreciated that the length or duration of the axis may be configurable by the end user to capture different ranges of personal health questionnaire data (specified by start and end dates, or, for example, a particular number of days or time window). As shown, the time axis includes tick labels representing the time interval during which each column of data was captured. In this example, the tick labels represent the dates or calendar days the data was captured.

[0546] In this example, a vertical health parameter axis 562 defines each health parameter question to which the response data pertains. As shown, the axis tick labels for each row of data define the health parameters associated with each row of response data. Optionally, text or information indicating the response scale or range of answer options available to the user for each health parameter question may also be displayed adjacent to the health parameter label.

[0547] In this example, the vertical health parameter axis 562 is configured to group rows of health parameter label or response data by category. As shown, health parameter questions related to symptoms are grouped together and labeled with a category heading, and health parameter questions related to medications are grouped together and labeled with a category heading.

[0548] In this example, the heatmap includes closely spaced individual plotted data cells, in an alternative configuration the data cells may be contiguous with no spacing between the data cells in the rows and / or columns.

[0549] In this example, the answer data is plotted in its corresponding data cell of the heat map 550 based on its associated time interval and health parameter coordinates. The data cell of each answer is colored according to its selected color spectrum based on its deviation (if any) from the reference data. In this example, an answer is colored in the reference color spectrum 552 if it matches the reference, in the worse deviation color spectrum 554 if it is worse than the reference, and in the better deviation color spectrum 556 if it is better than the reference. The particular color value assigned to the answer from the selected color spectrum is then determined by the color value assigned to the score, ranking, or stage that the answer represents on the answer scale. As discussed above, the selection of the color spectrum and the assignment of color values ​​within the selected color spectrum are based on the answer data and the reference data and / or the deviation data representing any deviation from the reference data. As discussed above, this assignment of colors to the data cells can be represented by the color coding assigned to the processed answer data.

[0550] In this example, each data cell is color coded to display a color value of its selected color spectrum, and optionally also displays a representation of the answer within the data cell (e.g., text, number, score, scale or ranking). However, it will be appreciated that in an alternative arrangement, the data cells may simply be color coded without any additional representation within the data cell, as the color coding itself can represent both the nominal answer to the answer scale, and any deviation (e.g., worsening or improving) from the baseline value.

[0551] The color-coded data cells representing answers in heatmap 550 may be of any suitable shape or size. In Figure 23, the individual data cells or data markers are plotted as small boxes, but may alternatively be other shapes, sizes, or formats.

[0552] Skipped and No Data In this embodiment, the heat map 550 is also optionally configured to display a representation or indication in the data cells indicating skipped data, i.e., questions or entire interviews skipped by the user. In this example, referring to Figs. 23 and 24, the skipped data representation is depicted in key 564. As shown in the heat map example, July 18 and 22 contain skipped interviews (i.e., all questions skipped), which is represented by a cross and no color coding in each of the data cells for these days. In other scenarios, only one or a few of the questions for a day may be skipped, represented by a cross in the column of data cells representing each day. It will be appreciated that any suitable symbols, text, icons and / or color coding may be used to depict or represent the skipped data.

[0553] The indication of skipped data in the heat map may enable a healthcare provider (e.g., a physician) to quickly ascertain whether a patient skipped the questionnaire on a given day but still used their device for treatment on that day. If a patient who normally completes the questionnaire chooses to skip the questionnaire over a series of consecutive days, this may indicate a rapid deterioration in the patient's condition, which may trigger a healthcare provider to intervene.

[0554] In some configurations, an increase in questionnaires or increased compliance with the patient health questionnaire by a patient can be detected or identified based on the questionnaire data, including the response data and any skipped data (i.e., skipped questionnaires and / or skipped questions within the questionnaire). For example, a patient may change from low compliance or interaction with completing the questionnaire to high compliance or interaction with completing the questionnaire, and this change can be detected or identified. In one configuration, lower compliance with completing the questionnaire may be represented, for example, by a higher level or frequency of skipped questionnaires and / or a consecutive series of skipped questionnaires over a particular period of time (e.g., a particular number of consecutive days or weeks, or other relevant time interval). Higher compliance with completing the questionnaire may be represented, for example, by a lower level or frequency of skipped questionnaires and / or a consecutive series of completed or at least partially completed questionnaires over a particular period of time (e.g., a particular number of consecutive days or weeks, or other relevant time interval).

[0555] In some embodiments, the data server 506 can process the interview data (e.g., answer data and any skipped data) to identify or detect any significant changes in interview completion compliance. For example, the data server 506 can be configured to identify a significant increase in interview completion compliance based on one or more thresholds and / or if the patient moves from a low compliance status or category to a high compliance status or category based on objective criteria or against their own baseline or historical data regarding interview completion compliance. These thresholds and / or categories and / or criteria for identifying a significant change in interview completion compliance can be pre-programmed or configurable by the healthcare provider, for example. Date and / or time data associated with any such detected change in interview completion behavior can be recorded or marked for subsequent reporting, alerting and / or notification to the healthcare provider. For example, an increase in interview compliance may indicate a worsening of the patient's condition. A patient may be more likely to engage in a patient health interview when feeling worse than usual.

[0556] In one configuration example, the data server 506 can generate data indicative of a detected change (e.g., increase) in the patient's compliance with the questionnaire completion and can visually flag, mark, and / or notify this change in the patient's compliance or engagement behavior in any of the generated data reports, time series plots (e.g., heat maps), and / or time series graphs, or can send a message, alert, or notification to the healthcare provider indicating the change. In one example, the response data or column of data cells in the heat map 550 for the day or time interval associated with the detected increase in the questionnaire completion behavior can be highlighted, shaded, or otherwise visually identified or marked with a symbol, overlay element, background element, or graphical indicator to alert the healthcare provider of the change. In another example, a message or notification regarding the change in behavior (and thus a possible deterioration in the patient's condition) can be displayed on the healthcare provider's dashboard or home page when the healthcare provider logs in to or otherwise accesses a healthcare provider portal of the data server 506 (e.g., a patient and device management platform).

[0557] In this embodiment, the heat map 550 is also optionally configured to display a representation or indication in the data cells indicating "no data" or "no device interaction." With reference to FIG. 23, the dates July 30 to August 1 depict a textual representation indicating that no data is associated with those days. This "no data" indication is separate from skipped data. Skipped data represents that the user or patient interacted with their respiratory support device on those days but chose to skip the questionnaire or a particular question within the questionnaire. In contrast, "no data" indicates that the user or patient did not interact with the respiratory support device at all during that day (e.g., started or used the respiratory support device). The heat map may represent this lack of interaction using any suitable form of graphical indication of no data, such as text, symbols, icons, markers, color coding, etc. In the example shown in FIG. 23, the graphical indication of no data is depicted by a blank column of data cells over the relevant days or time intervals and the textual indication "no data."

[0558] The no data indicator allows a healthcare provider to quickly ascertain if a patient has not operated their respiratory support device at all on a given day. This may indicate that the patient has been hospitalized, which may indicate to the healthcare provider that the settings on the device need to be adjusted when the patient returns home and begins using their device again. The no data indicator allows the healthcare provider to assess the patient's engagement with the respiratory support device. Based on the displayed no data indicator in the chart, the healthcare provider may be able to quickly determine that there has been no use of the device for one or more consecutive days, and can take appropriate action based on this gained knowledge.

[0559] In some configurations, the data server 506 is configured to receive data from the respiratory assistance device indicating which time intervals had no user interaction, i.e., no data. This may be a separate data set that is sent the next time the respiratory assistance device comes "online" and communicates data with the data server. Alternatively, the no data information may be inferred or determined by the data server if no interview data is received for a particular time interval or intervals. In one configuration, each time interval (e.g., a day) may have a default "no data" status until it is subsequently updated with a set of interview data received by the data server.

[0560] In some embodiments, the color coding of the answer data based on the baseline data and / or deviation data represents a condensed data set of the answer data and baseline data. The color coding data associated with each answer encodes both the answer and any deviation from the baseline. For example, the color value coded to an answer may represent both a selected color spectrum (indicating any deviation from the baseline value) and the actual answer on the answer scale (as each color value maps to a ranking, score, or grade on the answer scale).

[0561] Patient physiological parameter data, treatment setting data and / or gas flow data In some embodiments, any of the time series charts disclosed herein (e.g., color-coded time series plots or color heat maps such as 550, and / or time series plots or graphs such as 570) can be configured to further plot data or data types related to or indicative of one or more measured, sensed, or determined patient parameters, and / or treatment settings, and / or gas flow characteristics.

[0562] By way of example, as described above, the device controller may be configured to monitor respiratory rate, oxygen saturation, tidal volume, spirometry data and / or other related parameters or indices (e.g., ROX index), and / or therapy setting data and / or gas flow data (e.g., pressure, flow rate, fraction of inspired oxygen, FiO 2 Data and / or fractional delivered oxygen FdO 2 The patient may be configured to sense, receive, or determine data over time indicative of one or more physiological parameters of the patient, such as physiological data.

[0563] In one configuration, a color heat map such as 550 may further plot any one or more of patient parameter data and / or device treatment setting data and / or gas flow data alongside response data from the patient health interview in the color heat map.

[0564] In one configuration, one or more additional data rows for patient parameter data, therapy setting data, and / or gas flow data in the heat map may be grouped and plotted under their own category headings, such as "Patient Parameters," "Therapy Settings," "Gas Flow Parameters," etc., in the color heat map, similar to the format used for the symptom and medication data rows and headings in the heat map. In other configurations, the patient parameter data, therapy setting data, and / or gas flow data may be plotted against the time axis 560 at any other suitable or desired location or data row along the vertical axis 562 of the color heat map 550.

[0565] In one configuration, a time series graph or plot such as 570 (e.g., line and / or bar plot or graph) may further plot any one or more of the patient parameter data and / or device treatment setting data or gas flow data as additional line graphs and / or bar graphs alongside the response data from the patient health interview.

[0566] Several illustrative examples of plotting or rendering this additional data in their own respective rows of color heatmap 550 alongside the patient health questionnaire response data are described below, with the understanding that the examples may be applied to or used with any of the additional data types described. It will also be understood that any of the additional data types (e.g., patient parameters, treatment settings and / or gas flow parameters) described above or in subsequent examples may also be plotted on any of the other time series graphs (e.g., bar and / or line plots such as 570).

[0567] In one embodiment, a user interface is provided in the system (e.g., a patient and device management platform or dashboard) that allows a user, such as a healthcare provider, to select or configure which parameters to display or plot in the time series chart (e.g., color heat maps such as 550 and / or time series graphs such as 570). For example, the healthcare provider can configure which health parameters to display from symptoms and medication categories. The healthcare provider can also configure which one or more additional data types or parameters to plot or display in the time series chart from measured or determined patient parameter data and / or device treatment setting data and / or gas flow data, examples of which are described above and further below.

[0568] Respiratory rate data In one example configuration, the color heatmap 550 can be further configured to plot data representing the patient's respiration rate in the data rows of the heatmap. In one example, the raw respiration rate data can be processed, transformed, mapped, or converted into a format suitable for plotting in the data cells of the heatmap rows. In one configuration, the patient's respiration rate data over a treatment session or discrete time interval corresponding to the time axis of the heatmap can be converted into a discrete respiration value representing the treatment session or time interval. In one example, the discrete respiration value can represent the patient's average respiration rate over the treatment session or other discrete time interval corresponding to the data cells of the color heatmap.

[0569] The discrete respiration values ​​may be plotted in the relevant data cells of the heatmap in raw format (e.g., numerical average respiration values) or may be converted or transformed into a score or ranking on a scale similar to the response data scales described above. By way of example, the average respiration values ​​may be classified or mapped into discrete respiration rate scores or rankings on a multi-level ranking scale of the type described above. In one configuration, a respiration ranking at one end of the scale may represent a good or healthy respiration rate and a ranking at the other end of the scale may represent an unhealthy respiration rate. For example, the average respiration values ​​over a treatment session or time interval may be mapped or transformed into a five-level scale (e.g., 0, 1, 2, 3, 4) or any other suitable ranking scale of the type described above in connection with patient health interview response data.

[0570] In some configurations, the respiration rate score or ranking data may be plotted in its respective data cell of the respiration rate data row in the color heat map 550. In some configurations, each respiration rate score or ranking may also be color coded for display based on a baseline color spectrum and one or more deviation color spectra in a manner similar to the patient health interview response data. For example, the stored baseline data for a patient may include baseline respiration rate data (e.g., the patient's average respiration rate over a treatment session or relevant time interval). Each respiration rate score may be color coded for display in the color heat map 550 as a function or based on any deviation of the respiration rate score from the patient's baseline respiration rate score data.

[0571] Additionally or alternatively, the respiration rate data may be plotted or displayed in any of a number of time series graphs (e.g., bar and / or line plots such as 570) with its respective bar or line or other plotted indicator or marker.

[0572] Oxygen saturation data (e.g., SpO 2 Data), FiO 2 Data, ROX data In one implementation, the color heat map 550 may further include data representative of the patient's oxygen saturation (e.g., SpO 2 data) can be configured to be plotted in the data rows of the heatmap. As previously mentioned above, SpO 2 Data may be provided to the controller by an external sensor, such as, but not limited to, a pulse oximeter or a wearable sensor. As with the example respiration rate data, raw SpO 2 The data can be processed, transformed, mapped, or converted into a format suitable for plotting in the data cells of the rows of the heatmap. In one configuration, the patient's SpO 2 The data is divided into discrete SpO 2In one example, the discrete SpO 2 Values ​​represent the patient's average SpO over a treatment session or other discrete time interval that corresponds to the data cells in the color heatmap. 2 can be represented as:

[0573] As with the respiratory rate data example, the discrete SpO 2 Values ​​are given in raw format (e.g., numerical mean SpO 2 The SpO2 value may be plotted in its associated data cell in a heat map or may be converted, transformed or mapped to a score or ranking on a scale. The scale may have good or healthy SpO2 at one end and good or healthy SpO3 at the other end. 2 and the other end of the scale represents unhealthy SpO 2 It may also be a multi-level ranking scale (e.g., a five-level scale of 0, 1, 2, 3, 4) representing:

[0574] In some configurations, SpO 2 The score or ranking data is the SpO 2 In another configuration, each SpO 2 The score or ranking can also be color coded for display based on the baseline color spectrum and one or more deviation color spectra in a manner similar to the patient health questionnaire response data. For example, the baseline data for a patient can be a baseline SpO 2 Data (e.g., the patient's average SpO over a treatment session or relevant time interval) 2 ). Each SpO 2 The scores are calculated based on the patient's baseline SpO for display in a color heat map 550. 2 SpO for score data 2 The colors can be coded as a function of or based on any deviation in the scores.

[0575] In another implementation, the color heat map 550 further includes a data line for each one or more rows of data in the heat map, the fraction of inspired oxygen, FiO 2and / or ROX index. In such a configuration, the plotted FiO in the heat map can be 2 and / or ROX index data is used by the device controller to measure SpO 2 or configured to maintain or keep constant SpO 2 This may be more useful in scenarios where a set point is being targeted. For example, the heat map may show FiO 2 Display data to set your target SpO 2 It can indicate how much oxygen the device must deliver during closed loop flow therapy to maintain the set point. Similarly, the FiO 2 To plot the ROX index data as the ROX index value as a function of . In particular, the ROX index data is calculated according to the following formula:

number

[0576] FiO 2 The data or ROX index data is the respiratory rate data and SpO 2 The data can be plotted in the same manner or format as described above for each row of data in the heat map. For example, FiO 2 The data or ROX index data is averaged over a treatment session or relevant time interval to obtain a discrete FiO 2 A discrete ROX index data value and / or a discrete FiO index data value may be generated. 2 The FiO or ROX index values ​​may be plotted in a heat map in their raw format, but may also be ranked according to an associated multi-level ranking scale of the type previously described. 2 The score or ranking may be classified, mapped, or converted to a ROX index score or ranking. 2 The FiO score and / or ROX index score are then calculated for each of the heat maps. 2In some configurations, the FiO 2 The score and / or ROX index score are calculated based on the reference color spectrum and the respective stored FiO 2 and / or may be color coded for display based on one or more deviation color spectrums based on any deviation of the scores relative to the ROX index reference data.

[0577] Additionally or alternatively, SpO 2 Data, FiO 2 The data and / or ROX index data may be plotted or displayed on any of the time series graphs (e.g., bar and / or line plots such as 570) with a respective bar or line or other plotted indicator or marker.

[0578] Tidal volume data In some configurations, the respiratory assistance device may also be selectively operable in an NIV mode to provide a flow of gas for NIV therapy. In such configurations, the controller of the device may be configured to sense, measure, or determine tidal volume data representative or indicative of the patient's tidal volume during a treatment session.

[0579] In another configuration example, the color heat map 550 can be further configured to plot data representing the patient's tidal volume in the data rows of the heat map. As with any of the above examples, the tidal volume data can be converted into discrete tidal volume values ​​over each treatment session or related time interval (e.g., an average tidal volume per treatment session or related time interval can be determined). In one configuration, the discrete tidal volume values ​​can then be plotted as raw numerical values ​​in their respective data cells of the tidal volume data rows of the heat map. In another configuration, the discrete tidal volume values ​​may be classified, converted, or mapped to a corresponding tidal volume score or ranking according to an associated multi-stage ranking scale of the type described above. The tidal volume score or ranking can then be plotted in the respective data cells of the tidal volume data rows of the heat map. In some configurations, the tidal volume scores can be color coded for display based on a reference color spectrum and one or more deviation color spectra based on the deviation of the scores against the stored tidal volume reference data for the patient in a manner similar to other display data.

[0580] In some embodiments, when the respiratory assistance device is operating in an NIV mode to provide NIV therapy, the device's controller can be configured to determine respiratory rate data for the patient based on the detected inhalation and exhalation phases of the patient's respiratory cycle, and the respiratory rate data derived by the controller can be plotted in a respiratory rate data row of a color heat map or as bars or lines on a time series graph in a manner similar to that described in the previous respiratory rate data example above.

[0581] Additionally or alternatively, the patient's tidal volume data may be plotted or displayed in any of a number of time series graphs (e.g., bar and / or line plots such as 570) with respective bars or lines or other plotted indicators or markers.

[0582] Spirometry and / or pulmonary performance data In one example implementation, color heatmap 550 may be further configured to plot spirometry or spirometry-type data representative of a patient's pulmonary performance measurements or pulmonary function diagnostics.

[0583] In one embodiment, the respiratory aid apparatus and / or data server may be configured to operatively connect to an off-the-shelf or external spirometer device or system and receive spirometer data or other pulmonary function measurement data determined or sensed by the spirometer device or system. The respiratory aid apparatus and / or data server may be operatively connected to the spirometer device or system, for example, via a wired or wireless data connection.

[0584] In another embodiment, the respiratory assistance apparatus may be operable in a diagnostic or spirometry mode, or as a spirometry device. In one example, the respiratory assistance apparatus may be configured to operate in a spirometry mode through the use of a removable measurement device or accessory component that is attachable to the end of the respiratory conduit. The patient may perform an exhalation maneuver against the flow of gas in the measurement device. Spirometry and / or pulmonary performance measurement data may be extracted from sensor data generated by a device sensor that measures one or more characteristics of the gas flow during an exhalation maneuver.

[0585] Pulmonary performance measurement or spirometry data from any of the above configurations can be received, stored, and processed for display alongside other heat map data in heat map 550. Any one or more useful pulmonary performance measurement or spirometry data, values, or features can be processed and displayed. Such features or data can include, but are not limited to, peak flow and tidal volume, for example.

[0586] In some embodiments, the pulmonary performance or spirometry measurements may be performed before, during or after a patient health interview or questionnaire, or as part of the questionnaire process. In some embodiments, each set of questionnaire data for a questionnaire may include an associated set of pulmonary performance measurement or spirometry data, i.e., the pulmonary performance measurement or spirometry data may be captured at the same frequency as the questionnaire data. In other embodiments, the pulmonary performance measurement or spirometry data may be captured less frequently than the questionnaire data, such that only some questionnaires have associated pulmonary performance measurement or spirometry data, and such data is updated less frequently than the questionnaire data.

[0587] In one embodiment, one or more pulmonary performance measurement or spirometry data features may be plotted and / or represented in each pulmonary performance or spirometry data row of the heat map 550. Similar to any of the above examples, the pulmonary performance measurement or spirometry data may be converted into discrete pulmonary performance measurement or spirometry values ​​over each relevant time interval (e.g., discrete peak flow or tidal volume values ​​over or representing a particular time interval, e.g., a particular day or week represented in the heat map).

[0588] In one configuration, the discrete pulmonary performance measurement or spirometry data values ​​may then be plotted as raw numerical values ​​in their respective data cells of the pulmonary performance measurement or spirometry data rows of the heat map. In another configuration, the discrete pulmonary performance measurement or spirometry data values ​​may be categorized, converted, or mapped to a corresponding pulmonary performance measurement or spirometry score or ranking (e.g., peak flow score and / or tidal volume score) according to an associated multi-stage ranking scale of the type described above. One or more pulmonary performance measurement or spirometry scores or rankings may then be plotted (according to the time period or interval during which they were captured) in the respective data cells of their respective pulmonary performance measurement or spirometry data rows of the heat map. In some configurations, one or more pulmonary performance measurement or spirometry scores may be color coded for display based on a reference color spectrum and one or more deviation color spectrums based on the deviation of the score relative to the stored pulmonary performance measurement or spirometry reference data for the patient in a manner similar to other display data.

[0589] Additionally or alternatively, one or more of the pulmonary performance measurements or spirometry data may be plotted or displayed in any of a number of time series graphs (e.g., bar and / or line plots such as 570) with a respective bar or line or other plotted indicator or marker.

[0590] Medication prompts Patients are often given or prescribed antibiotics or other medications when they are discharged or sent home from the hospital, or after a medical visit, however, they may choose or be instructed to use them only if they begin to feel unwell.

[0591] In some configurations, the respiratory assistance device and / or data server may process the interview data to determine (based on one or more thresholds, criteria and / or trend analysis) whether the patient's health condition is deteriorating. If a deteriorating condition is detected or determined based on the interview data, the controller of the respiratory assistance device may trigger a prompt to the patient to begin using their prescribed medication via a notification or message on the device's display or a message or notification sent or pushed to the patient's smartphone, tablet, wearable, computer or other electronic device.

[0592] Additionally or alternatively, detection of a worsening condition may trigger a message, notification, or alert to the patient's healthcare provider to encourage the patient to start taking medication or to consider contacting the patient to prescribe the necessary or suggested medication. The alert or notification to the healthcare provider may be displayed on a dashboard or notification panel of the healthcare provider's interface to the patient and device management platform, or may be otherwise pushed or sent directly to the healthcare provider's electronic device (e.g., computer, smartphone, tablet, wearable, etc.).

[0593] Time stamps (e.g., time intervals, times of day and / or days) associated with triggered patient and / or healthcare provider medication prompts may also be marked or displayed or highlighted as features or graphical elements within data cells of a heat map, such as 550, or as indicators or markers in a time series graph, such as 570, or plotted in other manners as data points or markers or indications against the time axis of the heat map and / or time series graph.

[0594] Encourage contact with medical institution In some configurations, the respiratory support device may prompt the patient to contact a healthcare provider in response to certain changes in the interview data and / or time series charts (e.g., heat maps such as 550 and / or time series graphs such as 570). For example, the prompts may be visual and / or audible. The prompts may be in the form of notifications, alerts or messages and / or audible notifications, alerts or messages that may be displayed on the respiratory support device and / or pushed to the patient's personal electronic device (e.g., smartphone, tablet, wearable, computer).

[0595] In one example embodiment, the interview data and / or time series charts (e.g., heat maps and / or time series graphs) are processed by the respiratory assistance device and / or a data server (e.g., a patient and device management platform) and can trigger a prompt to contact one's healthcare provider if the data meets one or more predefined or configurable trigger criteria or thresholds. In some scenarios, the trigger criteria may specify an overall deterioration of the patient's condition (e.g., deterioration of three or more health parameters), or the trigger criteria may relate to a specified degree of deterioration of one or more selected health ...

Claims

1. 1. A system comprising: A plurality of respiratory therapy devices configured to deliver a flow of gas to a respective plurality of users for respiratory therapy, each respiratory therapy device comprising: a flow generator for generating a flow of the gas; a humidifier for heating and humidifying the gas stream; a controller operable to control the flow generator and the humidifier; a user interface including a display that allows user interaction with the controller; a plurality of respiratory therapy devices, each comprising: a data server in data communication with the respiratory therapy device; a display device in data communication with the data server; Equipped with the controller of the respiratory therapy device is configured to receive response data, including symptom data and / or medication data, based on user input to the user interface in response to a set of questions presented on the display related to one or more health parameters from at least one of a symptom category and a medication category, and to transmit the response data to the data server; the data server is configured to receive the response data from the plurality of respiratory therapy devices for the plurality of users, process the response data against reference data associated with each respective user, and generate a graphical dashboard accessible or rendered for display by the display device; the graphical dashboard plots, for each user, a summary time series chart of the user's processed response data against the user's baseline data by category, each summary time series chart plotting or representing deviations of symptom data and / or medication data against their respective baseline data over a period of time; the generated graphical dashboard is displayed or rendered on the display device; The system wherein the summary time series chart for each user includes a time series graph plotting both symptom data deviation and medication data deviation.

2. 10. The system of claim 1, wherein the plots of symptom data deviation and medication data deviation are visually distinguishable from one another within the same time series graph or are visually represented as separate data sets.

3. 10. The system of claim 1, wherein the plots of symptom data deviations and the plots of medication data deviations are represented by the same or different types of plots.

4. 10. The system of claim 1, wherein the plots of symptom data deviation and medication data deviation are represented as separate plots within the same time series graph or as combined plots within the same time series graph.

5. 2. The system of claim 1, wherein the plots representing the symptom data deviations and the medication data deviations are selected from any one or more of the following types of plots: dot plot, line chart or line graph, bar chart, lollipop chart, stacked bar chart, and grouped bar chart.

6. 2. The system of claim 1, wherein the summary time series graph for each user includes the symptom data deviations plotted as time series bar charts and the medication data deviations plotted as time series line charts, or vice versa, within the same time series graph.

7. 7. The system of claim 6, wherein the bar charts and the line charts representing the symptom data deviations and the medication data deviations are visually distinguished from one another by color, pattern, or shading.

8. 8. The system of claim 1, wherein the data server is configured to process the response data to extract or generate symptom data deviations and medication data deviations in the form of category deviation parameters for plotting, the category deviation parameters representing, for a user, a total number of health parameters within each respective category that deviate from their respective reference data for each time interval associated with the time axis of the time series graph.

9. The data server, a symptom category deviation parameter that represents or is a function of the total number of health parameters that deviate from their reference values ​​for each time interval, and a medication category deviation parameter that represents or is a function of the total number of health parameters that deviate from their reference values ​​for each time interval, wherein each deviation parameter is plotted on the time series graph; or a worsening deviation parameter for each category that represents or is a function of the total number of health parameters within the category that have a worsening deviation from their baseline value for each time interval, and an improving deviation parameter for each category that represents or is a function of the total number of health parameters within the category that have a better deviation from their baseline value for each time interval, wherein each deviation parameter is plotted on the time series graph; The system of claim 8 configured to generate:

10. 10. The system of claim 9, wherein the data server is configured to generate the symptom category deviation parameters and the medication category deviation parameters for each time interval based on a data set representing associated color-coded time series plots of the user's response data for the one or more health parameters over a period of time, wherein each plotted response of the response data is selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, and the color spectrum selected for each response is a function of or based on any deviation of the response data from the reference data.

11. 11. The system of claim 10, wherein the category deviation parameter over each time interval is based on or is a function of the number of answers within each respective category that are color-coded in each of the deviation color spectrums.

12. 8. The system of claim 1, wherein the summary time series chart for each user includes a color-coded time series plot of the user's response data for the one or more health parameters over a period of time, each plotted response of the response data being selectively color-coded for display according to a reference color spectrum or one or more deviation color spectrums, the color spectrum selected for each response being a function of or based on any deviation of the response data from the reference data.

13. 13. The system of claim 12, wherein the plotted responses, when plotted against the time axis of the color-coded time series plot, are grouped into rows or otherwise aligned with their associated health parameters, and / or the plotted responses are presented in defined category groups based on the categories associated with the health parameters to which the plotted responses relate.

14. 8. The system of claim 1, wherein the data server is further configured to process the response data of the plurality of users to determine priorities among the users, and wherein the generated graphical dashboard is configured to display or present the summary time series chart of the plurality of users based at least in part on the determined priorities of the users.

15. 15. The system of claim 14, wherein the priority of each user represents the user's overall health status relative to other users based on the response data, and the graphical dashboard is configured such that the summary time series graph is presented in an order or arrangement that prioritizes the users with worse health status according to the user's priority.

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