Breathing assistance apparatuses and / or components thereof and / or uses thereof
The respiratory assistance device addresses the issue of unsafe operation by requiring user health verification through a touchscreen interface and controller, ensuring safe gas delivery and remote monitoring.
Patent Information
- Application Number
- JP2025106850
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-11-04
- Filing Date
- 2025-06-24
- Publication Date
- 2025-10-02
AI Technical Summary
Existing respiratory assistance devices lack a mechanism to ensure safe and effective operation by verifying user health inputs before delivering breathable gas, potentially leading to unsafe conditions if not properly initialized.
A respiratory assistance device equipped with a touchscreen interface that presents user health questions and requires a predetermined number of user inputs before enabling operation, including a controller to manage this process and potentially transmit data to a patient management platform.
Ensures safe operation by verifying user health status before initiating gas delivery, reducing the risk of unsafe conditions and allowing for remote monitoring and management of patient health parameters.
Smart Images

Figure 2025144566000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates to various respiratory assistance devices and / or components thereof and / or uses thereof. [Background technology]
[0002] Respiratory support devices are used in a variety of settings, such as hospitals, healthcare facilities, residential care or home environments, to deliver a flow of gas to a user or patient. Respiratory support devices come in a variety of forms, such as freestanding humidification devices, continuous positive airway pressure (CPAP) devices, ventilators or high-flow devices.
[0003] Respiratory aid devices typically have 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 the respiratory aid device housing to the patient. For example, the device may be placed on a floor or other support surface, and the patient may be in bed. 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, which delivers liquid to the humidifier liquid chamber via another tube. Alternatively, the liquid chamber can be removed and refilled as needed. The recess houses a heater plate, which heats the liquid chamber to humidify gas passing through the liquid chamber. The humidified gas is then delivered to the patient.
[0004] References herein to external sources, including patents and other publications, are generally for the purpose of providing a context for considering features of the present disclosure, and unless otherwise noted, reference to such external publications should not be construed as an admission that such sources are prior art or form part of the common general knowledge in the art in any jurisdiction. Summary of the Invention [Means for solving the problem]
[0005] In one aspect, the present disclosure provides a respiratory assistance device configured to deliver breathable gas to a patient, the respiratory assistance device comprising a user interface comprising a touch screen configured to present a plurality of user health questions and a plurality of user input elements through which user input is received; The respiratory assistance device relates to a respiratory assistance device, wherein the delivery of breathable gas from the respiratory assistance device to the patient is conditioned on the respiratory assistance device receiving a predetermined number of user inputs.
[0006] In a further aspect, the present disclosure relates to the delivery of ventilation to a patient through the use of a respiratory assistance apparatus configured to supply breathable gas to the patient, the respiratory assistance apparatus comprising: the respiratory assistance device comprises a user interface comprising a touch screen configured to present a plurality of user health questions and a plurality of user input elements through which user input is received; The respiratory assistance device disables or prevents operation of components of the respiratory assistance device until a predetermined number of user inputs are received.
[0007] In a further aspect, the present disclosure provides a respiratory assistance device comprising: a source of one or more breathable gases; a breathing conduit for delivering breathable gas to a patient via a patient interface; a touchscreen located on or in the respiratory assistance device; a controller for controlling operation of the respiratory assistance device, including actuation and operation of the respiratory assistance device; Equipped with The controller a) requesting a touchscreen to display a plurality of user health questions and a plurality of user input elements through which user input is received; b) disabling or preventing operation of a component of the device until a predetermined number of user inputs are received; The present invention relates to a respiratory assistance device configured as follows.
[0008] In a further aspect, the present disclosure provides a use of a respiratory assistance device for providing respiratory assistance to a patient, the use comprising: a) A respiratory assistance device comprising: Touch screen and a respiratory conduit for delivering breathable gas to the patient via a patient interface; a controller for controlling respiratory assistance device operation, including actuation and operation of the respiratory assistance device, the controller comprising an electronic processor and a memory in communication with the electronic processor; providing a respiratory assistance device comprising: b) instructions executable by an electronic processor that, when executed by the electronic processor, cause the controller to: requiring a touchscreen to display a plurality of user health questions and a plurality of user input elements through which user input is received; · Preventing or preventing operation of a device component until a predetermined number of user inputs are received; Providing instructions; Regarding use, including
[0009] The respiratory assistance device includes a network interface through which predetermined user inputs can be transmitted to a patient and device management platform (eg, a server).
[0010] The respiratory assistance device may include a housing, a flow generator within the housing for generating breathable gas, and an outlet in fluid communication with the breathing conduit.
[0011] In a further aspect, the present disclosure relates to a respiratory assistance apparatus for providing a flow of breathable gas to a user, the respiratory assistance apparatus comprising: Housing and a user interface located on a top surface of the housing so as to be visible and accessible, the user interface including a color touch screen and / or one or more buttons; a source of breathable gas; a controller adapted to control delivery of breathable gas to a user, the controller being in electronic communication with a user interface and controlling the user interface to sequentially present two or more questions in response to receiving a start-up input at the user interface, the two or more questions being presented as a combination of words and / or indicia and / or graphics and / or selectable buttons; Equipped with the user interface receives a response to each question, the response to each question being communicated to the controller; the controller is configured to process a response to each question and / or transmit the response to each question to a remote electronic device; The user interface is configured to present the user with two or more questions before presenting the user with an operating parameter selection screen, which allows the user to select one or more operating parameters.
[0012] In a further aspect, the present disclosure relates to a respiratory assistance apparatus for providing a flow of breathable gas to a user, the respiratory assistance apparatus comprising: Housing and a user interface located on a top surface of the housing so as to be visible and accessible, the user interface including a color touch screen and / or one or more buttons; a source of breathable gas; a controller adapted to control delivery of breathable gas to a user, the controller being in electronic communication with a user interface and controlling the user interface to sequentially present two or more questions in response to receiving a start-up input at the user interface, the two or more questions being presented as a combination of words and / or indicia and / or selectable buttons; Equipped with the user interface receives a response to each question, the response to each question being communicated to the controller; the controller is configured to process a response to each question and / or transmit the response to each question to an external or remote service or platform; The controller Locking access to any other mode or function until the controller receives a response to each question, or Restricting access to operational modes until the controller receives a response to each question, or Disables operation of the flow generator and humidifier until a response to each question is received It is configured as follows: The questions posed to the patient are: a first question relating to the user's physical condition and presenting a plurality of distinct selectable responses; a second question related to the user's throat condition, the second question being related to the user's throat condition, the user interface presenting a plurality of selectable indicia, each indicia representing (or corresponding to) a response; A third question related to the patient's breathing or respiratory rate; Includes.
[0013] In one example, the response is received by the controller through a user (ie, patient) interacting with a touch screen and / or one or more buttons.
[0014] The response may constitute an answer to the question.
[0015] Responses can be entered by performing gestures on the touchscreen and / or by touching or pressing specific buttons or interacting with predetermined portions of the touchscreen.
[0016] Responses can be entered by the user (ie, patient) by pressing or manipulating one or more buttons in a predetermined combination or in a predetermined sequence.
[0017] Responses to questions can be entered by the user interacting with the touchscreen (eg, performing gestures, etc.) and pressing or manipulating one or more buttons in predetermined combinations.
[0018] The source of breathable gas may be a flow generator that is part of the respiratory assistance device.
[0019] The flow generator may be controlled by a controller to control the delivery of breathable gas to a user.
[0020] The flow generator may be a pump or a blower or a compressor or any other suitable unit configured to generate a flow of pressurized gas.
[0021] The respiratory aid device may include a humidifier.
[0022] The humidifier may include at least a heater plate and a humidification chamber (eg, a humidification liquid chamber) configured to hold a humidification liquid.
[0023] The chamber can be configured to be removably positioned on a heater plate such that the heater plate can heat the contents of the chamber.
[0024] The controller may be configured to control the heater plate to heat the contents of the chamber.
[0025] The humidifier may be located downstream of the source of breathable gas, the flow of breathable gas being delivered to the humidifier for humidification.
[0026] In a further aspect, the present disclosure provides a respiratory assistance device comprising: a housing having a fluid inlet and a fluid outlet; a flow generator located within the housing downstream of and in fluid communication with the fluid inlet; a humidifier located within the housing downstream of and in fluid communication with the flow generator and upstream of the fluid outlet in fluid communication with the fluid outlet, the humidifier including a heater; a touchscreen located on the housing; a network interface located within the housing; a controller located within the housing and in electrical communication with the flow generator, the humidifier, the touch screen, and the network interface, the controller comprising an electronic processor and a memory in communication with the electronic processor, the controller controlling the actuation and operation of the flow generator, the humidifier, and the touch screen; Equipped with The memory includes instructions executable by the electronic processor, the instructions, when executed by the electronic processor, causing the controller to: - The heater is activated when the respiratory support device is activated, requiring a touchscreen to display a plurality of user health questions and a plurality of user input elements through which user input is received; Disabling or preventing operation of a component of the device (e.g., controlling the device or a flow generator) until a predetermined number of user inputs are received; A respiratory assistance device that causes a predetermined number of user inputs to be transmitted to a patient and device management platform via a network interface.
[0027] In a further aspect, the present disclosure provides a respiratory assistance device comprising: a housing having a fluid inlet and a fluid outlet; a flow generator located within the housing downstream of and in fluid communication with the fluid inlet; a humidifier located within the housing downstream of and in fluid communication with the flow generator and upstream of the fluid outlet in fluid communication with the fluid outlet, the humidifier including a heater; a touchscreen located on the housing; a controller located within the housing and in electrical communication with the flow generator, the humidifier, and the touch screen, the controller comprising an electronic processor and a memory in communication with the electronic processor, the controller controlling the actuation and operation of the flow generator, the humidifier, and the touch screen; Equipped with The memory includes instructions executable by the electronic processor, the instructions, when executed by the electronic processor, causing the controller to: a) requesting the touch screen to display a user interface presenting a plurality of requests for user health information and a plurality of user input elements at which the user information is received by the controller as user input; b) Relating to a respiratory assistance device that prevents or inhibits operation of a component of the device (e.g., controlling the device, a flow generator or a humidifier) until a predetermined number of user inputs are received from a user input element.
[0028] In a further aspect, the present disclosure provides a respiratory assistance device comprising: a housing having a fluid inlet and a fluid outlet; a flow generator located within the housing downstream of and in fluid communication with the fluid inlet; a humidifier located within the housing downstream of and in fluid communication with the flow generator and upstream of the fluid outlet in fluid communication with the fluid outlet, the humidifier including a heater; a touchscreen located on the housing; a controller located within the housing and in electrical communication with the flow generator, the humidifier, and the touch screen, the controller comprising an electronic processor and a memory in communication with the electronic processor, the controller controlling the actuation and operation of the flow generator, the humidifier, and the touch screen; Equipped with The memory includes instructions executable by an electronic processor that, when executed by the electronic processor, cause a controller to disable or prevent operation of a component of the device (e.g., a control of the device, a flow generator, or a humidifier) until a predetermined number of user inputs responsive to a plurality of displayed requests for user health information are received via a touchscreen unless the displayed requests for user health information are bypassed by the user.
[0029] Features from one or more embodiments or configurations may be combined with features from one or more other embodiments or configurations. Furthermore, two or more embodiments may be used together during the course of respiratory assistance for a patient.
[0030] The question is, a) general subjective medical questions, b) specific subjective medical questions; c) specific objective medical questions, and d) Any combination of (a) to (c) Any one or more of the following may be selected.
[0031] General subjective medical questions may relate to the patient's overall perception of the state of their health.
[0032] The specific subjective medical-related questions may be qualitative or quantitative questions.
[0033] Specific subjective medical questions may relate to the patient's perception of the state of a specific anatomical structure (eg, throat) or a specific physiological process (eg, breathing).
[0034] The specific subjective medical-related questions may be qualitative or quantitative questions.
[0035] Specific qualitative subjective medical questions may relate to the patient's perception of the state of a specific anatomical structure (eg, throat) or a specific physiological process (eg, breathing).
[0036] Specific quantitative subjective medical questions can relate to the patient's perception of the frequency of an action (eg, coughing).
[0037] Specific objective medical questions may relate to measurable health parameters (eg, sputum color, frequency or amount of medication use).
[0038] The one or more questions may be presented as textual questions, for example, the questions may include text that is presented in a user interface.
[0039] In one example, one or more questions are presented as a combination of a text question and multiple selectable answers, and the multiple selectable answers are presented as geometric shapes, pictures, icons, indicia, diagrams, or text, or a combination thereof.
[0040] In one example, the touchscreen may have a resolution of at least 300x150 pixels.
[0041] The touch screen may have a resolution of at least 400x250 pixels.
[0042] The touch screen has a resolution of at least 480x272 pixels.
[0043] The touch screen has a resolution of at least 600x400 pixels.
[0044] The touchscreen may be at least 3.5 inches in diagonal dimension.
[0045] The touchscreen may be at least 4 inches in diagonal dimension.
[0046] The touchscreen may be 4.2 inches diagonally.
[0047] The touchscreen can be up to 7 inches diagonally.
[0048] The touch screen can be an OLED or TFT LCD screen.
[0049] The touchscreen can have a resolution high enough to present icons, graphics, colors, indicia, diagrams, text, pictures, images, and photographs in a visual manner that is easy to see, read, and clear. The resolution is high enough to enhance the readability of content provided on the touchscreen.
[0050] The respiratory assistance device may include a controller configured to determine a change in the patient's physiological or medical condition based on the patient's answers (ie, responses) to the questions.
[0051] Patient data may be sent to an external or remote service or platform, for example, a remote patient and device management platform.
[0052] The patient and device management platform may be any one or combination of a remote device, a server, an application, a cloud service, or any other suitable hardware and software platform.
[0053] The external or remote service or remote platform may be a healthcare provider's computing system (e.g., a physician's server), or an equipment provider's system (e.g., a durable medical equipment provider's server), or an insurance company's system (e.g., an insurance company's server).
[0054] The external or remote service or platform may be configured to determine changes in the patient's physiological or medical condition based on the patient's responses to the interview.
[0055] The patient and device management platform may be configured to receive responses to the questions and determine changes in the patient's physiological or medical condition based on the responses.
[0056] The patient and device management platform can compare the received responses to previous stored responses to determine changes in the patient's physiological or medical condition.
[0057] The patient and device management platform may be configured to determine a change in the patient's physiological or medical condition based on a comparison of the patient's response to a patient criterion score (e.g., a criterion score associated with a question).
[0058] The determination of a change in the patient's physiological state or medical condition can be presented to the patient, a healthcare provider, or both the patient and the healthcare provider.
[0059] The controller may be configured to receive start-up input / requests via a touchscreen user interface.
[0060] The controller may be configured to communicate two or more questions sequentially to the touchscreen.
[0061] The controller Locking access to any other mode or function until the controller receives a response to each posed question, or Restricting access to operational modes until the controller receives a response to each question, or Disables operation of the flow generator and humidifier until a response to each question is received It can be configured as follows.
[0062] In a further aspect, the present disclosure provides a respiratory assistance device comprising: Housing and a source of one or more breathable gases; a respiratory conduit for delivering breathable gas to the patient via a patient interface; a touchscreen located on the housing; a controller located within the housing for controlling operation of the respiratory assistance device, including actuation and operation of the respiratory assistance device; Equipped with The controller requesting a touchscreen to display a plurality of user questions and a plurality of user input elements at which user input is received; Disable or prevent operation of a component of the device until a predetermined number of user inputs are received The present invention relates to a respiratory assistance device configured as follows.
[0063] The controller is in electrical communication with the touchscreen and includes an electronic processor and memory in communication with the electronic processor, the controller controlling the operation and behavior of the device.
[0064] The memory may include instructions executable by the electronic processor that, when executed by the electronic processor, cause the controller to: a) requesting the touchscreen to display a plurality of user questions and a plurality of user input elements at which user input is received; b) causing a component of the device to not operate or to be prevented from operating until a predetermined number of user inputs are received.
[0065] The apparatus may further include a flow generator and a humidifier located within the housing downstream of and in fluid communication with the flow generator and upstream of the fluid outlet, the humidifier including a heater plate, and a controller in electrical communication with the flow generator and the heater plate to control the actuation and operation of the flow generator and the heater plate.
[0066] The device may further comprise a network interface located within the housing and in electrical communication with the controller for transmitting the predetermined plurality of user inputs to an external or remote service or platform.
[0067] This device is a power switch coupled to the controller and configured to switch between an on mode and an off mode, wherein the respiratory assistance device is activated based on the power switch switching from the off mode to the on mode; The sensor may further include:
[0068] The power switch can be a button, knob, dial, rocker, toggle, or lever.
[0069] The instructions can cause the controller to request the network interface to transmit a predetermined plurality of user inputs to the server patient and device management platform one at a time after each of the user inputs is received via the controller.
[0070] The instructions can cause the controller to request the network interface to transmit a predetermined number of user inputs to the patient and device management platform after all of the user inputs have been received via the controller.
[0071] The instructions can cause the controller to request the network interface to transmit a predetermined plurality of user inputs to the patient and device management platform in groups after a group of user inputs is received via the controller.
[0072] At least one of the user input elements may be included in a group of user input elements that corresponds to at least one of the user questions.
[0073] The group of user input elements can include at least two user input elements that are visually distinct from one another.
[0074] The at least two user input elements may be visually distinguishable from one another based on color.
[0075] The at least two user input elements may be visually distinguishable from one another based on color shading.
[0076] The at least two user input elements may be visually distinguishable from one another based on shape.
[0077] The at least two user input elements may be visually distinguishable from one another based on size.
[0078] The set of user input elements can range from 2 to 9.
[0079] The user input elements may include strings of text.
[0080] The user input elements may include graphics.
[0081] At least one component of the graphic group can have alphanumeric content extending therethrough and / or thereon.
[0082] At least one component of the graphic group may correspond to alphanumeric content other than a user health question, the alphanumeric content being positioned outside of the at least one component.
[0083] At least one of the user health questions may include an end-of-question mark.
[0084] The user interface can include multiple pages on which user questions and user input elements are located.
[0085] The user interface can include pages that present user health questions and user input elements.
[0086] The instructions may cause the controller to repeatedly request the touch screen to display the user health questions and user input elements for a period of at least two consecutive days.
[0087] The network interface can receive messages from the patient and device management platform, the messages being based on a predetermined number of user inputs sent to the patient and device management platform via the network interface.
[0088] The message may include video content that is output via the touchscreen.
[0089] The housing may contain a speaker, and the message includes audio content that is output through the speaker.
[0090] The network interface may be a first network interface, the message may be a first message, the housing may have a second network interface that sends a second message to the computing device in response to the first message, the second message being associated with a predetermined plurality of user inputs that are sent to the patient and device management platform via the first network interface, the second network interface being local to the computing device, and the computing device being other than the patient and device management platform.
[0091] The message may be indicative of a user health parameter that has deteriorated over a predetermined period of time as determined based on at least one of a predetermined plurality of user inputs.
[0092] The predetermined period of time may be at least two days.
[0093] The message may indicate that a user health parameter is deteriorating relative to a baseline value.
[0094] The message may be that two or more health parameters have deteriorated for at least two days and therefore the patient is deteriorating.
[0095] The questions may include health questions.
[0096] At least one of the user input elements may be included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including an odd number of user input elements, and the reference value is associated with a median user input element from the odd number of user input elements.
[0097] At least one of the user input elements may be included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including an odd number of user input elements, and the reference value is associated with a non-median user input element from the odd number of user input elements.
[0098] At least one of the user input elements may be included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including an even number of user input elements, and the reference value is associated with the user input element from the even numbered user input elements.
[0099] At least one of the user input elements may be included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including a first input element indicating a current position or a non-changing state of the health parameter, a second input element indicating an improvement in the health parameter, and a third user input element indicating a deterioration in the health parameter.
[0100] At least one of the user input elements may be a component of a pair of user input elements corresponding to at least one of the user health questions, the pair of user input elements corresponding to a pair of user inputs associated with a pair of data points that are mutually exclusive of each other, and the user input includes at least one component of the pair of user inputs.
[0101] The instructions may cause the controller to prevent or inhibit the skipping of a user health question before activating the flow generator.
[0102] The instructions may enable the controller to skip a user health question before activating the flow generator.
[0103] The instructions cause the controller to request the touch screen to display a page after the controller receives user input, the page presenting a menu for controlling or activating the flow generator or humidifier or for inputting operating parameters for the flow generator or humidifier.
[0104] The instructions can cause the controller to request the touch screen to display the user health questions and the user input elements such that at least one of the user health questions or at least one of the user input elements differs between at least two instances of the flow generator operating over a predetermined period of time.
[0105] The predetermined period of time may be at least two days.
[0106] The user health questions may include a first question and a second question, the first question preceding the second question, the user input may include a first user input and a second user input, the first user input preceding the second user input, the first user input corresponding to the first question, the second user input corresponding to the second question, and the second question depending on the content of the first user input.
[0107] The first user input and the second user input may be from the same user session.
[0108] The first user input may be from a first user session and the second user input may be from a second user session, the first user session preceding the second user session.
[0109] The controller may receive a predetermined number of user inputs before the heater reaches the predetermined temperature.
[0110] The user health questions and user input elements may be displayed upon startup of the controller.
[0111] The controller may disable the flow generator.
[0112] The controller may disable the flow generator upon start-up of the controller.
[0113] The controller may prevent operation of the flow generator.
[0114] The controller may prevent operation of the flow generator upon activation of the controller.
[0115] The predetermined plurality of user inputs may be all of the user inputs.
[0116] At least one of the user health questions may relate to a user disease progression or a user health state.
[0117] The instructions may enable the controller to skip user health questions before activating the flow generator, such that the skipped user health questions form multiple data points that are transmitted to the patient and device management platform via the network interface.
[0118] The controller may be configured to request the touchscreen to display a plurality of user questions and a plurality of user input elements through which user input is received when the device is in the warm-up and / or drying process.
[0119] In a further aspect, the present disclosure provides a respiratory assistance device comprising: a housing having a fluid inlet and a fluid outlet; a flow generator located within the housing downstream of and in fluid communication with the fluid inlet; a humidifier located within the housing downstream of and in fluid communication with the flow generator and upstream of the fluid outlet in fluid communication with the fluid outlet, the humidifier including a heater; a touchscreen located on the housing; a controller located within the housing and in electrical communication with the flow generator, the heater, and the touchscreen, the controller comprising an electronic processor and a memory in communication with the electronic processor, the controller controlling the actuation and operation of the flow generator, the humidifier, and the touchscreen, the memory including instructions executable by the electronic processor that, when executed by the electronic processor, cause the controller to (a) request the touchscreen to display a user interface presenting a plurality of requests for user health information and a plurality of user input elements through which the user information is received by the controller as user input, and (b) cause components of the device to be disabled or prevented from being operated until a predetermined plurality of user inputs are received from the user input elements; The present invention relates to a respiratory assistance device comprising:
[0120] The user health information and requests for user input elements may be displayed upon startup of the controller.
[0121] The controller may disable the flow generator or the heater.
[0122] The controller may disable the flow generator or heater upon start-up of the controller.
[0123] The controller may disable the flow generator.
[0124] The controller can disable the heater.
[0125] The controller may prevent activation of the flow generator or heater.
[0126] The controller may prevent activation of the flow generator or heater upon activation of the controller.
[0127] The controller may prevent operation of the flow generator.
[0128] The controller can prevent the heater from operating.
[0129] The predetermined plurality of user inputs may be all of the user inputs.
[0130] The controller may disable or prevent activation of the flow generator or heater until a predetermined number of user inputs from the user input element are received by the controller, unless the request for user health information and user input element is bypassed by the user.
[0131] 1. A respiratory assistance apparatus comprising: a housing having a fluid inlet and a fluid outlet; a flow generator located within the housing downstream of and in fluid communication with the fluid inlet; a humidifier located within the housing downstream of and in fluid communication with the flow generator and upstream of the fluid outlet in fluid communication with the fluid outlet, the humidifier including a heater; a touchscreen located on the housing; a controller located within the housing and in electrical communication with the flow generator, the humidifier, and the touch screen, the controller comprising an electronic processor and a memory in communication with the electronic processor, the controller controlling the actuation and operation of the flow generator, the humidifier, and the touch screen, the memory including instructions executable by the electronic processor that, when executed by the electronic processor, cause the controller to disable or prevent operation of components of the device until a predetermined plurality of user inputs responsive to a plurality of displayed requests for user health information are received via the touch screen unless the displayed requests for user health information are bypassed by the user; A respiratory assistance device comprising:
[0132] The displayed request for user health information may be displayed upon startup of the controller.
[0133] The controller may disable the flow generator or the heater.
[0134] The controller may disable the flow generator or heater upon start-up of the controller.
[0135] The controller may disable the flow generator.
[0136] The controller can disable the heater.
[0137] The controller may prevent activation of the flow generator or heater.
[0138] The controller may prevent activation of at least one of the flow generator or the heater upon activation of the controller.
[0139] The controller may prevent operation of the flow generator.
[0140] The controller can prevent the heater from operating.
[0141] The predetermined plurality of user inputs may be all of the user inputs.
[0142] In a further aspect, the present disclosure provides a respiratory assistance device comprising: a flow generator; a humidifier comprising a heater plate configured to heat the contents of a humidification chamber; a respiratory conduit for delivering breathable gas to the patient via the patient interface; A user I / O interface; a controller for controlling the flow generator and the humidifier; Equipped with The present invention relates to a respiratory assistance device, wherein the controller is configured to present a health questionnaire including one or more questions when the device is in a warm-up and / or drying process.
[0143] The health questions may be presented by displaying a number of user questions and a number of user input elements where user input is received.
[0144] This device goes through a warm-up process. a) Upon start-up of the Device, or b) when the user is prompted to input one or more operating parameters of the respiratory assistance device (optionally via a therapy control screen); or c) when the user begins to input one or more operating parameters of the respiratory assistance device (optionally via a therapy control screen); or d) When the user initiates a treatment (optionally via a treatment control screen), or e) When manually activated by the user; It may be configured to actuate.
[0145] The warm-up process may include controlling the heater plate to a particular temperature.
[0146] The particular temperature may be based on one or more temperature setpoints of the device (optionally, the temperature setpoints are one or more operating parameters of the device).
[0147] The specific temperature may be about 35°C.
[0148] The apparatus may include a heater plate temperature sensor, and the controller controls the temperature of the heater until the heater plate temperature sensor reaches a particular temperature.
[0149] The warm-up process may involve controlling the heater plate of the respiratory assistance device to control the chamber outlet temperature to a particular temperature.
[0150] The chamber outlet is the outlet of the humidification chamber and may optionally be measured at an elbow located after the chamber outlet of the humidification chamber.
[0151] Controlling the heater plate can include controlling the power provided to the heater plate.
[0152] The particular temperature may be based on one or more temperature setpoints of the device (optionally as one or more operating parameters of the device for the treatment).
[0153] The specified temperature may be about 5°C to about 15°C, or within about 10°C, or optionally about 5°C to about 15°C or about 10°C below one or more temperature set points.
[0154] The one or more temperature set points may be a desired dew point or a desired patient end temperature.
[0155] The one or more temperature 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%.
[0156] The warm-up process may include controlling a heater wire in a conduit attached to the device configured to provide gas to the patient to control the temperature at the end of the conduit to a conduit end-specific temperature.
[0157] The conduit end-specific temperature may be based on one or more temperature set points of the device (optionally as one or more operating parameters of the device for the treatment).
[0158] The conduit end specific temperature may be determined by the controller based on a selected temperature setpoint or sets of temperatures representative of the desired humidity.
[0159] The conduit end specific temperature may be a predetermined temperature.
[0160] The conduit-end specific temperature may be based on one or more temperature setpoints, the one or more temperature setpoints being desired patient-end temperatures.
[0161] The conduit end specific temperature may be within about 2°C to about 5°C, or about 2.5°C of the desired patient end temperature, optionally about 2°C to about 5°C, or about 2.5°C lower than the desired patient end temperature.
[0162] The one or more temperature set points may include a desired chamber outlet temperature, a desired dew point temperature (at the chamber outlet, or at the end of the breathing conduit), or a desired temperature at the end of the breathing conduit.
[0163] The warm-up process may include the controller shutting down the flow generator.
[0164] The warm-up process may include operating the flow generator at a predetermined flow rate or a predetermined flow generator output.
[0165] The predetermined flow rate may be lower than the therapeutic gas flow rate being delivered to the patient.
[0166] The predetermined flow generator output may be a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.
[0167] The controller a) at the end of a treatment session, or b) When manually activated by the user, or c) When the standby process has been active for a predetermined amount of time; It may be configured to activate a drying process.
[0168] The user can indicate when a therapy session has ended via the user I / O interface.
[0169] End of treatment may be determined by detecting that the user has removed the patient interface (and optionally a predetermined period of time has elapsed).
[0170] The drying process may involve controlling a heater wire in the breathing conduit while a flow generator provides gas at a set flow rate.
[0171] The drying process may involve controlling the heater plate of the humidifier to a predetermined value, or the heater plate may be turned off during the drying process.
[0172] The heater wire may be controlled by a controller to a predetermined temperature at the end of the patient breathing conduit, or to a predetermined duty cycle or to a predetermined power.
[0173] The predetermined duty cycle may be 100%.
[0174] The temperature may exceed 45°C.
[0175] The drying process may be configured to operate for about 20 minutes to about 40 minutes, or about 15 minutes.
[0176] The drying process can include controlling the flow generator to provide a predetermined flow generator output, the flow generator output being a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.
[0177] The drying process can include controlling the flow generator to provide a predetermined flow rate, the predetermined flow rate being between about 10 liters / minute and about 20 liters / minute.
[0178] The drying process may be configured to evaporate any remaining condensate within the device and / or the patient breathing conduit and / or patient interface.
[0179] The controller may be configured to disable or prevent operation of components of the device until a predetermined number of user inputs are received.
[0180] The controller may prevent the delivery of therapy until user input is received and / or the warm-up process is complete.
[0181] Based on the answers to the user questions related to the one or more health parameters and one or more past answers to the user questions related to the one or more health parameters, the controller can be configured to determine a deterioration in the patient's health, the deterioration in the patient's health being determined by: Deterioration of two or more health parameters (optionally from baseline) for at least two days Based on.
[0182] In a further aspect, the present disclosure provides a respiratory assistance device comprising: a flow generator; a respiratory conduit for delivering breathable gas to the patient via the patient interface; A user I / O interface; a controller for controlling the flow generator and the humidifier; Equipped with the controller is configured to display the health questionnaire at the user I / O interface, the health questionnaire including one or more user questions related to one or more health parameters, each question including a plurality of user input elements at which user input is received in response to the user question; the controller is configured to determine a deterioration in the patient's health based on answers to the user questions related to the one or more health parameters and one or more past answers to the user questions related to the one or more health parameters; The deterioration of the patient's health Deterioration of two or more health parameters (optionally from baseline) for at least two days This invention relates to a respiratory assistance device based on the above.
[0183] One or more past answers to user questions related to one or more health parameters are stored locally on the device and / or on the patient and device management platform.
[0184] The apparatus and / or patient and device management platform may be configured to notify the user if a deterioration in the patient's health is determined.
[0185] Deterioration in patient health may further be based on a deterioration (optionally from a baseline value) in one or more patient parameters.
[0186] The patient parameters may be one or more of patient oxygen saturation (optionally measured by at least one patient sensor) and / or patient respiratory rate (optionally determined from a flow signal from a flow sensor).
[0187] The patient parameter may be measured by at least one patient sensor.
[0188] The health interview may include one or more questions related to COPD status and / or one or more questions related to bronchiectasis status.
[0189] The health interview questions may be ordered so that questions related to COPD status are displayed first, followed by questions related to bronchiectasis.
[0190] General health questions may be presented before questions related to COPD status and questions related to bronchiectasis.
[0191] The apparatus may include a humidifier that includes a heater plate configured to heat the contents of the humidification chamber.
[0192] The user I / O may be a touchscreen, the touchscreen being at least 3.5 inches diagonal, or at least 4 inches diagonal, or 4.2 inches diagonal.
[0193] The health questionnaire may be displayed at the start of treatment and / or at the end of treatment.
[0194] The controller may be configured to display the health questionnaire when the device is in the warm-up and / or drying process.
[0195] This device goes through a warm-up process. a) Upon start-up of the Device, or b) when the user is prompted to input one or more operating parameters of the respiratory assistance device (optionally via a therapy control screen); or c) when the user begins to input one or more operating parameters of the respiratory assistance device (optionally via a therapy control screen); or d) When the user initiates a treatment (optionally via a treatment control screen), or e) When manually activated by the user; It may be configured to actuate.
[0196] The warm-up process may include controlling the heater plate to a particular temperature.
[0197] The particular temperature may be based on one or more temperature setpoints of the device (optionally, the temperature setpoints are one or more operating parameters of the device).
[0198] The specific temperature may be about 35°C.
[0199] The apparatus may include a heater plate temperature sensor, and the controller controls the temperature of the heater until the heater plate temperature sensor reaches a particular temperature.
[0200] The warm-up process may involve controlling the heater plate of the respiratory assistance device to control the chamber outlet temperature to a particular temperature.
[0201] The chamber outlet is the outlet of the humidification chamber and may optionally be measured at an elbow located after the chamber outlet of the humidification chamber.
[0202] Controlling the heater plate can include controlling the power provided to the heater plate.
[0203] The particular temperature may be based on one or more temperature setpoints of the device (optionally as one or more operating parameters of the device for the treatment).
[0204] The specified temperature may be about 5°C to about 15°C, or within about 10°C, or optionally about 5°C to about 15°C or about 10°C below one or more temperature set points.
[0205] The one or more temperature set points may be a desired dew point or a desired patient end temperature.
[0206] The one or more temperature 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%.
[0207] The warm-up process may include controlling a heater wire in a conduit attached to the device configured to provide gas to the patient to control the temperature at the end of the conduit to a conduit end-specific temperature.
[0208] The conduit end-specific temperature may be based on one or more temperature set points of the device (optionally as one or more operating parameters of the device for the treatment).
[0209] The conduit end specific temperature may be determined by the controller based on a selected temperature setpoint or sets of temperatures representative of the desired humidity.
[0210] The conduit end specific temperature may be a predetermined temperature.
[0211] The conduit-end specific temperature may be based on one or more temperature setpoints, the one or more temperature setpoints being desired patient-end temperatures.
[0212] The conduit end specific temperature may be within about 2°C to about 5°C, or about 2.5°C of the desired patient end temperature, optionally about 2°C to about 5°C, or about 2.5°C lower than the desired patient end temperature.
[0213] The one or more temperature set points may include a desired chamber outlet temperature, a desired dew point temperature (at the chamber outlet, or at the end of the breathing conduit), or a desired temperature at the end of the breathing conduit.
[0214] The warm-up process may include the controller shutting down the flow generator.
[0215] The warm-up process may include operating the flow generator at a predetermined flow rate or a predetermined flow generator output.
[0216] The predetermined flow rate may be lower than the therapeutic gas flow being provided to the patient.
[0217] The predetermined flow generator output may be a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.
[0218] The controller a) at the end of a treatment session, or b) When manually activated by the user, or c) When the standby process has been active for a predetermined amount of time; It may be configured to activate a drying process.
[0219] The user can indicate when a therapy session has ended via the user I / O interface.
[0220] End of treatment may be determined by detecting that the user has removed the patient interface (and optionally a predetermined period of time has elapsed).
[0221] The drying process may involve controlling a heater wire in the breathing conduit while a flow generator provides gas at a set flow rate.
[0222] The drying process may involve controlling the heater plate of the humidifier to a predetermined value, or the heater plate may be turned off during the drying process.
[0223] The heater wire may be controlled by a controller to a predetermined temperature at the end of the patient breathing conduit, or to a predetermined duty cycle or to a predetermined power.
[0224] The predetermined duty cycle may be 100%.
[0225] The temperature may exceed 45°C.
[0226] The drying process may be configured to operate for about 20 minutes to about 40 minutes, or about 15 minutes.
[0227] The drying process can include controlling the flow generator to provide a predetermined flow generator output, the flow generator output being a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.
[0228] The drying process can include controlling the flow generator to provide a predetermined flow rate, the predetermined flow rate being between about 10 liters / minute and about 20 liters / minute.
[0229] The drying process may be configured to evaporate any remaining condensate within the device and / or the patient breathing conduit and / or patient interface.
[0230] The controller may be configured to disable or prevent operation of components of the device until a predetermined number of user inputs are received.
[0231] The controller may prevent the delivery of therapy until user input is received and / or the warm-up process is complete.
[0232] Reference to a range of numbers disclosed herein (e.g., 1 to 10) also incorporates reference to every rational number within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as every range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and thus is intended to explicitly disclose all subranges of all ranges explicitly disclosed herein. These are merely examples of what is specifically intended, and all possible combinations of numerical values between the minimum and maximum values recited should be considered to be equally explicitly stated in this application.
[0233] It is to be understood that alternative embodiments or configurations may include any or all combinations of two or more of the parts, elements or features illustrated, described or referred to herein.
[0234] Some embodiments of the present disclosure may be broadly described as consisting in or including any or all combinations of the parts, elements and features, and any two or more of said parts, elements or features, individually or collectively, referred to or shown in the specification of this application, and where specific wholes having known equivalents in the art to which this disclosure pertains are referred to herein, such known equivalents are deemed to be incorporated herein as if individually set forth.
[0235] The term "comprising" as used herein means "including." When interpreting each sentence containing the term "comprising" herein, the feature or features preceding the term may also be present. Related terms such as "comprise" and "comprises" should be interpreted similarly.
[0236] The term "request" when used in reference to a controller may refer to a controller sending a signal to a component instructing the component to perform one or more actions.
[0237] As used herein, the term "(s)" following a noun refers to the plural and / or singular form of that noun.
[0238] As used herein, the term "and / or" means "and" or "or," or both where the context allows.
[0239] The present disclosure contemplates the structures disclosed above and those described below by way of example only.
[0240] Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein and with reference to the following figures. [Brief explanation of the drawings]
[0241] [Figure 1]1 illustrates, in schematic form, a respiratory assistance device; [Figure 2] FIG. 1 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. [Figure 3] [Figure 4] FIG. 10 is a right side view of the elbow, showing the location of the temperature sensor in dashed lines. [Figure 5] 1 is a schematic diagram of a respiratory assistance device. [Figure 6] 10 is a flowchart of the operation of the controller. [Figure 6A] 10 is a flowchart of the operation of the controller. [Figure 6B] 10 is a flowchart of the operation of the controller. [Figure 7] 1 is a flowchart of a process for determining deviations for personal health questionnaire responses based on preset baseline values. [Figure 8] 1 is a flowchart of a process for conditionally presenting a personal health questionnaire to a respiratory assistance device patient. [Figure 9] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 10] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 11] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 12] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 13] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 14] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 15] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 16] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 17]1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 18] 1 illustrates a user interface for presenting a personal health questionnaire to a respiratory assistance device. [Figure 19] 1 illustrates a patient and device management platform-based dashboard presenting a plot generated based on multiple responses to multiple questions in a personal health questionnaire. [Figure 20] The plots in Figure 19 track responses over time based on multiple symptom criteria and multiple medication criteria. [Figure 21] Responses are shown for time based on multiple symptom criteria and multiple medication criteria. [Figure 22] 1 shows a deterioration overview for healthcare providers. [Figure 23] Shows an overview of efficacy. [Figure 24] FIG. 1 is a flow diagram illustrating a system for providing respiratory assistance or providing respiratory therapy to a patient. DETAILED DESCRIPTION OF THE INVENTION
[0242] Patients suffering from COPD, 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 primary care physician (i.e., doctor) may want the patient to continue regular high-flow therapy at home, including at a retirement village or hospice, or at a location outside the hospital. In such cases, the patient's primary care 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 home nasal high-flow therapy. The patient may contact an equipment provider who can provide the patient with a medical device based on the prescription.
[0243] A prescription may be a flow rate set by a clinician for a given patient.
[0244] 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 device's memory, or may be stored in the device.
[0245] 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.
[0246] As used herein, the term "healthcare provider" includes any party that provides healthcare, such as a hospital system, a physician, a medical consultant, or any other healthcare professional.
[0247] Because home nasal high-flow therapy can provide respiratory support to patients, thereby eliminating the need for patients to remain in the hospital and / or reducing the likelihood of exacerbations and therefore costly readmissions, healthcare providers often find it prudent (e.g., financially and / or clinically) to compensate discharged COPD patients for the cost of providing home nasal high-flow devices.
[0248] Unfortunately, some patients receiving home therapy, such as nasal high flow therapy, may still experience COPD exacerbations (i.e., a return or worsening of COPD symptoms) or other deteriorations in health conditions that could lead to hospitalization. Therefore, being able to predict (e.g., by monitoring the patient's condition) whether a patient's condition has worsened to the point where hospitalization is required would be beneficial to the patient and the caregiver. That is, a physician could intervene and treat a patient before they experience a COPD exacerbation (e.g., worsening symptoms) that requires hospitalization, or more generally, before they reach a point where they require costly hospitalization.
[0249] 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 (e.g., prior to an exacerbation).
[0250] One way to gather the necessary information (to predict conditions requiring hospitalization) is to have patients periodically answer questions about their current health status. However, this presents a problem because patients receiving home care may be too unwell, elderly, or frail to regularly complete questionnaires on paper or using an additional device (e.g., mobile phone, tablet, desktop, laptop). Furthermore, even if a patient is physically well enough, they may self-diagnose, or the task may become tedious, discouraging the patient and causing them to stop completing the questionnaire, especially if the questionnaire is not user-friendly (e.g., a paper form or a poorly laid-out digital questionnaire). Completing the questionnaire (completely) on paper or an additional user device (e.g., mobile phone, tablet, desktop, laptop) can be cumbersome for patients because it requires them to use another device, and for this reason, patients often do not complete questionnaires provided on paper or other devices.
[0251] In some embodiments, each time a patient activates the respiratory assistance device, the device may present a series of questions on one or more touchscreens.
[0252] The questions form part of a medical interview (i.e., a medical interview 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.
[0253] As used herein, the term "health parameter" refers to a measurable factor related to a patient's mental and / or physical state. In some embodiments, a health parameter may be a subjective factor related to a patient's perception of their own health. For example, it may be the patient's general physical condition.
[0254] In some embodiments, the health parameters may be based on patient parameters (eg, parameters ie, the patient's respiratory rate, oxygen saturation, measured by a device, as described in more detail below).
[0255] Health parameters may be subjective qualitative factors based on the patient's perception of their own health, such as sore throat, degree of dyspnea, and severity and / or type and / or frequency of cough, etc. Health parameters may be objective quantitative factors that are directly measurable, such as sputum color (based on a color chart), medication use (e.g., frequency and amount of medication, e.g., antibiotics, steroids or inhalers), etc.
[0256] 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.
[0257] At least some of the health parameters are indicative of COPD symptoms that COPD patients may frequently suffer from. 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 be indicative of dyspnea and / or respiratory distress and / or bronchiectasis.
[0258] The respiratory assistance device may include one or more touchscreens that display after the device is powered on (e.g., started up). In some embodiments, the or each touchscreen displays a question. Alternatively, the questions may be implemented as multiple pages that can be scrolled. Alternatively, the questions may be presented as a single sentence that is scrolled to respond to the question. Alternatively, each screen displays a separate question, and each time the patient answers a question, the next question is presented on the screen.
[0259] In some embodiments, the questions are displayed in a user I / O interface (as described in more detail below).
[0260] In some embodiments, the respiratory assistance device may include an internal clock that may maintain the 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.
[0261] The questions can be presented based on the current date and time, for example, the questions can be presented once a day based on information from an internal clock.
[0262] In one example implementation, the question is presented once when the device is turned on.
[0263] The questions may be presented on first use every day (eg, each day of the week) or each predetermined period.
[0264] In some embodiments, the internal clock is a real-time clock (RTC).
[0265] In some embodiments, after the patient answers the final question in the questionnaire, the respiratory assistance device displays a therapy control screen that the patient can use to start therapy.
[0266] In some embodiments, the patient can skip the questionnaire, for example, if they are too unwell to complete it. If the patient skips the questionnaire, the device allows treatment to begin without the patient having to complete the questionnaire. For example, the touchscreen displays a treatment control screen that the patient can use to begin treatment.
[0267] 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 provided to the patient (ie, patient end temperature), O2 concentration, or other such operating parameters.
[0268] The patient may be required to complete a questionnaire (e.g., including multiple questions) and respond to each question in the questionnaire presented on the screen of the respiratory support device. The patient may be able to skip the questionnaire if they have completed the questionnaire at least once a day.
[0269] In some embodiments, the controller may track responses from the patient to the questions. After all questions in the interview have been answered, the controller may determine that the interview is complete.
[0270] As mentioned above, after the patient has answered the final question in the interview, the controller may determine that the interview is complete.
[0271] In some embodiments, the questionnaire is presented on a touch screen while the respiratory assistance device is being set up.
[0272] In some embodiments, the questionnaire is presented to the user during a warm-up process 5611, for example, on a touch screen, as shown in FIG. 6A.
[0273] The warm-up process allows the humidity in the breathing circuit to reach the desired level as quickly as possible while minimizing condensation and / or thermal overshoot.
[0274] The warm-up process involves activating the heater plate of the respiratory assistance device to warm the contents of the humidification chamber.
[0275] 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 the operating temperature of the heater plate when the humidifier is providing humidification. The specific temperature may be approximately 35°C.
[0276] Controlling the heater plate includes controlling the power provided to the heater plate.
[0277] 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 example, for the warm-up process.
[0278] In some embodiments, the warm-up process may involve heating a heater plate of the respiratory assistance device to reach a particular temperature.
[0279] In some embodiments, the warm-up process includes heating a heater plate of the respiratory assistance device to control the chamber outlet temperature to a particular temperature.
[0280] 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.
[0281] 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). Setpoints, such as the chamber outlet temperature, the desired dew point temperature (at the chamber outlet or end of the breathing conduit), or the 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.
[0282] The specified temperature may be about 5°C to about 15°C, or within about 10°C, or optionally about 5°C to about 15°C, or about 10°C below one or more temperature set points.
[0283] The one or more temperature 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%.
[0284] In some embodiments, the warm-up process may include heating a heater plate of the respiratory aid device to achieve humidity of the gas (e.g., at the chamber outlet or at the end of the breathing conduit).
[0285] The warm-up process may also or alternatively include controlling a heater wire 16a in a conduit attached to the device configured to provide gas to the patient to control the temperature at the end of the conduit to a conduit end-specific temperature.
[0286] The conduit end-specific temperature may be based on one or more temperature set points of the device (optionally as one or more operating parameters of the device for treatment) (eg, as described above).
[0287] The conduit end specific temperature may be determined by the controller based on a selected temperature setpoint or sets of temperatures representative of a desired humidity.
[0288] The conduit end specific temperature may be a predetermined temperature (eg, 35°C).
[0289] The temperature setpoint or sets may be a desired patient-end temperature.
[0290] The conduit end specific temperature may be within about 2°C to about 5°C, or about 2.5°C of the desired patient end temperature, optionally about 2°C to about 5°C, or about 2.5°C below the desired patient end temperature.
[0291] Once a certain temperature is reached, the warm-up process can be completed.
[0292] The device may provide an audible or visual indication, such as a visual cue, when the warm-up process is complete.
[0293] 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 delivered to the patient.
[0294] The predetermined flow rate may be low enough to ensure that hot and / or humid gas does not collect within the humidification chamber.
[0295] The predetermined flow rate can be lower than the therapeutic gas flow being delivered to the patient. The predetermined flow generator output can be a predetermined motor speed that can be between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.
[0296] An activation signal can be provided to the heater plate by the controller to heat the heater plate. The interview and the questions that make up the interview are presented on the touchscreen (or other user I / O interface) of the respiratory assistance device during the warm-up process (e.g., as shown in FIG. 6A). This is advantageous because the patient will often be waiting until the warm-up process is complete.
[0297] The warm-up process may last for several minutes, e.g., 5 to 25 minutes, to provide a suitable period 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 touchscreen).
[0298] By presenting the questions to the user during the warm-up process, the patient can 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 patient is more likely to answer the questions because they are engaging with and using the respiratory assistance device.
[0299] In some embodiments, the therapy control screen may be presented upon device startup.
[0300] In some embodiments, the warm-up process may be run at device start-up.
[0301] In some embodiments, the warm-up process may be activated when the user is prompted (optionally via a therapy control screen) to enter one or more operating parameters of the respiratory assistance device.
[0302] In some embodiments, the warm-up process may be activated when a user begins inputting one or more operating parameters of the respiratory assistance device (optionally via a therapy control screen).
[0303] In some embodiments, the warm-up process can be manually activated by a user.
[0304] In some embodiments, the warm-up process is activated when the user starts a treatment (eg, via a treatment control screen).
[0305] In some embodiments, the respiratory assistance device displays a therapy control screen upon 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 enters a warm-up process and may optionally display a questionnaire (e.g., as described above).
[0306] 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.
[0307] The drying process may be configured to evaporate any condensed water remaining in the device and / or the patient breathing conduit and / or patient interface.
[0308] The drying process may be as described in WO 2006 / 126900, the contents of which are incorporated herein by reference in their entirety.
[0309] The drying process can include activating a heater wire 16a in the patient breathing conduit 16 while the flow generator provides gas at a set flow rate or a predetermined motor speed. The set flow rate can be lower than the therapeutic gas flow being provided to the patient. The predetermined motor speed can be between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.
[0310] Additionally or alternatively, the drying process can include controlling the heater plate of the humidifier to a predetermined value, which may be low enough to prevent the humidifier from generating humidity. Alternatively, the heater plate can be turned off during the drying process.
[0311] 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.
[0312] The predetermined duty cycle may be 100%.
[0313] The predetermined temperature may be greater than 45°C.
[0314] The drying process may be configured to operate for about 20 minutes to about 40 minutes, or about 15 minutes.
[0315] During the drying process, the flow generator can optionally be set to a predetermined flow rate sufficient to ensure gas flow through the patient breathing circuit to remove evaporated condensate, which can be between about 10 liters / minute and about 20 liters / minute.
[0316] The drying process can occur at the end of a treatment session. The patient (or other healthcare professional) can indicate when the 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.
[0317] The drying process can be manually activated by the patient or a healthcare provider.
[0318] In some embodiments, the end of therapy 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 a flow sensor. Optionally, the end of therapy may be determined by detecting that the user has removed the patient interface and a predetermined period of time has elapsed.
[0319] In some embodiments, the device can detect when the user removes the patient interface when no breath is detected. Breathing can be detected based on a flow signal measured from a flow sensor.
[0320] In some embodiments, the drying process can be activated when a standby process has been active for a predetermined amount of time. The standby process can include operating a flow generator (e.g., a blower) at a predetermined flow rate (or, e.g., a predetermined motor speed) when a therapeutic gas flow is not being delivered to the patient. The predetermined flow rate can be lower than the therapeutic gas flow being delivered to the patient. The predetermined motor speed can be between about 1000 RPM and 3000 RPM, or about 2000 RPM.
[0321] The standby process can be manually activated by the patient or a healthcare provider.
[0322] The point at which to stop the drying mode can be determined in several ways. The first of these is to measure the temperature of the gas at the chamber outlet (e.g., at elbow 30 / 171). When the temperature of the gas at the chamber outlet drops below or equals the ambient temperature (preferably measured by an additional temperature sensor located, for example, on the flow generator or elsewhere in the device housing), the flow generator and heater wire 16a are turned off by the controller. In this way, as the gas flows through the humidification chamber and the heater plate cools, the humidity of the gas flowing through the conduit decreases and the conduit 3 becomes drier.
[0323] A second method for determining when the drying mode should be terminated by the controller is to cut off power to the humidification chamber, maintain gas flow through the conduit at a constant rate or pulses, and maintain power to the heater wire 16a to evaporate any condensate from the conduit walls. After a predetermined time, preferably greater than one minute, the heater wire 16a and flow generator are turned off. Yet another method for controlling conduit drying is to turn off the flow generator and power to the heater plate power. The controller then compares the heater plate temperature to the ambient temperature measured inside or outside the device (as described above). When this temperature difference or comparison is within predetermined limits, typically near zero, the gas flow is initiated in a manner similar to that described above.
[0324] It may take longer to dry the condensate in the conduit than to cool the chamber, in which case it may be necessary to extend the dry mode for some time, for example up to 30 minutes, depending on the ambient temperature of the water remaining in the chamber.
[0325] FIG. 1 illustrates a respiratory assistance device as a high-flow device that delivers a flow of gas (which may include one or more gases) to a patient.
[0326] Alternatively, the device may be, for example, a CPAP device and / or a bi-level device (or any combination thereof). The device may provide, for example, CPAP therapy and / or bi-level pressure therapy (or any combination thereof).
[0327] 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 .
[0328] An exemplary device is described in WO 2011 / 056080, the contents of which are incorporated herein by reference in their entirety.
[0329] The respiratory assistance device comprises a gas supply and optionally a gas humidifier. 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.
[0330] When used with a humidifier, a respiratory assistance device typically has a structure in which gas at the required pressure 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.
[0331] 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.
[0332] CPAP devices can be used to deliver continuous positive airway pressure or CPAP therapy to a patient (as described in more detail below).
[0333] The bilevel device can be used to deliver bilevel pressure to a patient or bilevel therapy to a patient (as described in more detail below).
[0334] Respiratory assistance devices typically have 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 the housing of the respiratory assistance device to the patient. For example, the device may be placed on the floor or other support surface, and the patient may be in bed.
[0335] The respiratory assistance device can 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 can 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.
[0336] 1 illustrates an example respiratory assistance device 10. Respiratory assistance device 10 is configured to provide high-flow therapy and function as a high-flow device.
[0337] Respiratory assistance device 10 is further configured to provide pressure therapy and can function as a pressure therapy device.
[0338] The respiratory support device 10 can be configured to provide a high flow rate of gas when in 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 bilevel positive pressure therapy or continuous positive pressure therapy. For example, in bilevel pressure therapy, the device 10 is configured to provide a gas flow such that the patient experiences inspiratory and expiratory pressure, both of which are positive. In continuous pressure therapy, the device 10 is configured to deliver gas at a constant pressure that can be set by the 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, such as a nasal cannula or tracheal interface, is used. Conversely, to deliver pressure therapy, a sealing patient interface (e.g., a nasal mask, full-face mask, or nasal pillows) is used.
[0339] Generally, the device 10 comprises a main housing 100 that houses a flow generator 11, a humidifier 12, a controller 13, and a user I / O interface 14 (including, for example, a display and input devices such as buttons, a touch screen, etc.).
[0340] In some embodiments, the user I / O interface may be part of an auxiliary device. The auxiliary device 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 through one or more servers.
[0341] In some embodiments, medical questions may be presented to the user I / O interface of the auxiliary device, and the user may answer the questions on the auxiliary device.
[0342] 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.
[0343] The auxiliary device can upload the answers to the questions (optionally along with other information from the device, such as patient parameters) to a patient and device management platform.
[0344] In some embodiments, a touch screen may be provided as or as part of the user I / O interface 14.
[0345] In some embodiments, the controller may consist of multiple controllers for controlling different components of the device 10 .
[0346] 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 inputs.
[0347] 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).
[0348] The multiple controllers may include multiple controllers that receive sensor input, each controller that receives sensor input being associated with a particular sensor or set of sensors.
[0349] The multiple controllers may be configured to communicate with each other (eg, via a bus) and / or with a master controller.
[0350] 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.
[0351] 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 the user via the user interface 14 (e.g., on a display).
[0352] 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 the user.
[0353] The user may be a patient, a healthcare 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 device 10 is a patient. The patient uses the device to receive high-flow or pressure therapy as prescribed by a healthcare provider (e.g., a physician).
[0354] In connection with answering questions (as described elsewhere), it will be appreciated that the user is preferably the patient, as the questions relate to health parameters of the patient.
[0355] A patient breathing conduit 16 is 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, 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).
[0356] Additionally or alternatively, the patient breathing conduit 16 may be connected to a face mask (eg, an airtight mask if pressure therapy such as CPAP or bilevel pressure therapy is provided).
[0357] 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.
[0358] The gas flow generated by the respiratory assistance device 10, which may be humidified, 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 that heats the gas flow to the patient. The heater wire 16a is controlled by the controller 13. Alternatively, the patient assistance device includes a separate heater wire controller (e.g., one of the controllers described above) that controls the output (e.g., power or current or voltage) to the heater wire.
[0359] 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, as shown in FIG. 1, that provides high-flow respiratory assistance, i.e., high-flow respiratory therapy, to a patient.
[0360] The controller 13 controls the flow generator 11 to generate a gas flow at a desired rate.
[0361] In some embodiments, the controller controls one or more valves to control the mixture of air and oxygen or other alternative gases.
[0362] In some embodiments, the controller controls the humidifier 12 to humidify and / or heat the gas stream to an appropriate level.
[0363] The gas flow is directed to the patient through a patient breathing conduit 16 and a patient interface 17. 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 patient comfort.
[0364] 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.
[0365] 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.
[0366] 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.
[0367] In some embodiments, at least one of the motion sensors 3 a, 3 b, 3 c, 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.
[0368] 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.
[0369] In some embodiments, the device can measure one or more patient parameters. The patient parameters can be, for example, one or more of the patient's respiratory rate and oxygen saturation. The patient parameters can be or related to one or more physiological parameters of the patient. The patient parameters can be measured by patient sensors (as described below) or can be determined based on sensors from the device.
[0370] In some embodiments, the respiratory rate can be determined based on a flow signal from a flow sensor. The respiratory rate can be determined, for example, as disclosed in WO 2019 / 102384, the contents of which are incorporated herein by reference in their entirety.
[0371] 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 can help the controller 13 operate the respiratory assistance device 10 to provide optimal therapy.
[0372] 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 allows the controller 13 to receive signals 8 from sensors and / or control various components of the respiratory assistance 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 assistance device 10.
[0373] Additionally or alternatively, the transmitter and / or receiver 15 may transmit data to an external or remote service or platform, such as a remote patient and device management platform. The patient and device management platform may be any one or combination of a remote device, a server, an application, a cloud service (e.g., a distributed computer system resource), 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.
[0374] The respiratory assistance device 10 can be any suitable type of device, but in some configurations can 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. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from about 15 liters per minute (LPM) to about 70 liters per minute (LPM), or more. Typical flow rates for pediatric patients (e.g., neonates, infants, children) 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 the administration of a gas mixture composition containing 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.
[0375] 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 a patient at a flow rate greater than 1 LPM, such as from about 1 LPM to about 25 LPM, or from about 2 LPM to about 25 LPM, or from about 2 LPM to about 5 LPM, or from about 5 LPM to about 25 LPM, or from about 5 LPM to about 10 LPM, or from about 10 LPM to about 25 LPM, or from about 10 LPM to about 20 LPM, or from about 10 LPM to 15 LPM, or from about 20 LPM to 25 LPM. High flow therapy devices for adult, neonatal, infant, or pediatric patients can, in some configurations, deliver gas to a patient at a flow rate of from 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 about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.
[0376] High-flow therapy has been shown to be effective in meeting or exceeding a patient's inspiratory flow, increasing patient oxygenation and / or reducing patient 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 each breath while reducing rebreathing of carbon dioxide, nitrogen, etc.
[0377] In one example for high-flow therapy, a non-sealing or non-sealing user interface, such as a nasal cannula, is used. For CPAP or other pressure therapies, a sealing interface, such as a nasal mask, full face mask, or nasal pillows, is typically used.
[0378] 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.
[0379] As will be described below, respiratory assistance apparatus 10 includes various features that aid in the function, use and / or configuration of respiratory assistance apparatus 10.
[0380] 2 and 3, 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.
[0381] 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.
[0382] The base unit 50 of the device 10 can have a movable finger guard 140 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 141 a is in the cover position as shown in Figure 2. The barrier 141 a is movable between the cover position and a lowered access position in which the recess 108 is less or not covered by the barrier 141 a.
[0383] 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-and-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 liquid chamber bay.
[0384] The floor of the recess 108 has a receiving portion 108a that receives 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 a circular shape. The heater plate 140 is resiliently mounted, for example, to a biasing device such as a spring. The resiliently mounted heater plate allows the heater plate to move downward to accommodate the liquid chamber 151 within 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.
[0385] 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 with each other.
[0386] The lower chassis 104 has a motor recess that receives 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 121. The base can 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 that forms a blower to provide gas flow and can include one or more sensors that sense characteristics of the gas passing through the motor module. The motor module can include sensors that sense parameters of the gas passing through the motor module. In one example, the motor module can 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 sensors are arranged in electronic communication with the controller so that the controller can receive sensor outputs for use by the controller in controlling the device and its components.
[0387] 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.
[0388] The housing may include two gas inlets 27, 28. The first inlet may be an ambient air inlet, and the second inlet may be for an auxiliary gas, such as oxygen or heliox, or another auxiliary gas. In the example shown, the auxiliary gas is oxygen. The auxiliary gas source may include 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.
[0389] The motor recess 122 comprises a recess opening in the housing bottom wall 115. Alternatively, the recess opening can be in a different portion of the housing, such as the side, front or top of the housing.
[0390] 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 the battery. The battery in the battery module 125 may be replaceable.
[0391] The battery module 125 can provide power in the event of a utility power loss. In some embodiments, the controller is configured to detect a utility power loss and automatically switch to drawing power from the battery module 125 to provide the functionality of the respiratory assistance device.
[0392] When the battery module 125 is utilized to power the device, the device can operate for a predetermined amount of time, for example, 30 minutes to 1 hour.
[0393] 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 device components, especially when the battery is being charged. In an alternative configuration, the battery may be mounted inside the main housing.
[0394] The housing may be provided with a battery cover 126 that covers 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 housing's bottom wall 115. Alternatively, the battery cover 126 may extend beyond the housing's bottom wall 115 to accommodate longer, larger batteries.
[0395] As shown in FIG. 3, the base unit 50 of the device 10 includes a mounting mechanism 127 for mounting the device to a support device.
[0396] 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 alternatively be integrally formed with any of the other walls of the housing, such as the back wall, right side wall, or other wall.
[0397] 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.
[0398] The integral attachment mechanism 127 has higher impact strength compared to additional threaded parts. The attachment mechanism 127 can also be reinforced, for example, by modifying the wall thickness, adding ribs, or modifying the internal geometry.
[0399] 3 shows a humidifier liquid chamber 151 (i.e., reservoir) for use with respiratory aid apparatus 10. Chamber 151 is a removable liquid chamber that is filled with a liquid, such as water, for humidifying the respiratory gas. Liquid chamber 151 is removable from base unit 50 of respiratory aid apparatus 10 for easier refilling or disposal.
[0400] The liquid chamber 151 has a body 152 with a peripheral wall 153, 20 and a roof 156. The body defines an interior chamber for receiving liquid. A base 154 is provided at the lower end of the peripheral wall, and the base 154 has a base flange 155 that protrudes outward 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 interior chamber of the liquid chamber 151. The respiratory assistance apparatus base unit 50 has complementary chamber connection ports, including a gas outlet port 161 and a humidified gas inlet port 163. When the liquid chamber is received in 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.
[0401] 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 needed.
[0402] In the illustrated form, the liquid chamber 151 has a substantially cylindrical shape.
[0403] 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.
[0404] 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 position 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.
[0405] 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 could have aligned inlet and outlet ports, for example.
[0406] The gas outlet port 161, the humidified gas inlet port 163 and the patient outlet port 30 each include a soft seal such as a wiper seal, an L-seal, a T-seal, an X-ring or an O-ring to provide a sealed gas passage between the device 10, the liquid chamber 151, the patient breathing conduit 16 and, optionally, one or more accessories.
[0407] The gas outlet port 161 and the gas inlet port 163 include multiple sealing elements. The sealing elements can be wiper seals, T-seals, L-seals, X-rings, or O-rings. The wiper seals can have a T-shaped cross-section. The gas outlet port 161 and the gas inlet port 163 can each include two, three, or more sealing elements. In one configuration, the gas inlet port 163 and the gas outlet port 161 each include a pair of wiper seals. In this configuration, the gas inlet port 163 has two wiper seals positioned adjacent to each other at the gas inlet port 163. Similarly, the gas outlet port 161 includes a pair of wiper seals positioned adjacent to each other at the gas outlet port 161. The pair of wiper seals (or other types of sealing elements) at each port 161, 163 improves the seal with the corresponding base unit connection port 157, 159, improving protection against liquid ingress into the interior of the housing of the base unit 50 of the device in which the electronics are located. When the liquid chamber 151 is coupled to the gas inlet port 163 and gas outlet port 161 of the base unit 50, one wiper seal can be positioned inside each base unit connection port 157, 159 and one wiper seal can be located outside each base unit connection port 157, 159 when the liquid chamber is assembled with the base unit 50. Alternatively, when the liquid chamber 151 is assembled on the heater plate 140 in the recess 108, both wiper seals are positioned inside each base unit connection port 157, 159. An arrangement using two wiper seals per port 161, 163 provides redundancy against liquid ingress. A similar arrangement can be used for L-seals, X-seals, or O-rings. The gas outlet port 161 and the gas inlet port 163 of the base unit 50 are structured to have elongated portions, i.e., the length of the ports 161, 163 is such that a wiper seal, L-seal, X-ring or O-ring can be retained on the ports 161, 163.
[0408] 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 in a substantially linear motion to form a gas connection between the ports.
[0409] The chamber connection ports 161, 163 are parallel cylindrical features extending from the housing of the respiratory assistance apparatus base unit 50. The ports 161, 163 typically have equal contours and lengths, and axes that lie in the same horizontal plane. The ports 161, 163 typically terminate at their tips in the same vertical plane. The ports 161, 163 have a port separation distance or pitch, which is the horizontal distance between the centers or axes of each port 161, 163. This is substantially equal to the horizontal distance between the centers of the liquid chamber base unit connection ports 157, 159.
[0410] In some embodiments, the base unit connection ports 157, 159 of the humidification chamber (e.g., liquid chamber) are chamber connection ports 161, 163 that are pneumatically connected to the device 50 when the humidification chamber is provided in the liquid chamber bay (e.g., as described in more detail above).
[0411] The chamber connection ports 161, 163 (which are male connection members in the illustrated form) of the respiratory assistance apparatus base unit 50 are inserted concentrically into the base unit connection ports 157, 159 (which are female connection members in the illustrated form) of the liquid chambers. The inner diameters of the base unit connection ports 157, 159 are larger than the outer diameters of the chamber connection ports 161, 163.
[0412] The liquid chamber 151 may be initially inserted at an angle into the recess 108 and then tilted to be substantially horizontal so that the rear of the travel of the liquid chamber 151 is substantially linear. The recess 108 may include one or more rails that help hold the liquid chamber in place within the recess 108.
[0413] Respiratory assistance apparatus 10 may have any one or more of the features and / or functions of respiratory assistance apparatus described and shown in WO 2016 / 207838, the contents of which are incorporated herein by reference in their entirety.
[0414] To prevent gas from leaking 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 sealing element or elements may be on the outer surface of the male port and seal against the inner surface of the female port. In one configuration, liquid chamber gas inlet port 157 and 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, liquid chamber ports 157, 159 may be male ports, and ports 161, 163 of respiratory assistance apparatus base unit 50 may be female ports.
[0415] The screen 212 (see FIGS. 2 and 3) is located on the housing (e.g., on the top or side) and has a fixed position, however, the screen 212 may have an adjustable position (e.g., hinged).
[0416] 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 the visibility of the screen to the patient. Additionally, the location of the screen 212 on the top surface of the housing makes the screen and its contents more easily viewable by the patient, for example, in a home environment.
[0417] In some embodiments, the screen 212 is a color screen, preferably a color touchscreen (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, for example, 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, making the interview more engaging because it is easier to see. A large touchscreen 212 also improves the readability of the presented content, which further helps make the content more engaging.
[0418] The high-resolution color touch screen 212 allows for the presentation of a variety of questions that may require the presentation of colors or shades of colors (e.g., sputum color). The screen 212 being a touch screen also allows for easier patient interaction because it is simpler and more intuitive to use, as it requires the user to touch the screen 212 and make gestures on the screen to input information. The touch screen eliminates the need for buttons or dials that may require complex sequences of pressing to input data, such as respond to a medical questionnaire.
[0419] 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.
[0420] In one example, the touchscreen has a resolution of at least 300 x 150 pixels. In one example, the touchscreen has a resolution of 400 x 250 pixels. More preferably, the screen has a resolution of 480 x 272 pixels.
[0421] The touch screen may have a resolution of at least 600x400 pixels.
[0422] The touchscreen may be at least 3.5 inches in diagonal dimension.
[0423] The touchscreen may be at least 4 inches in diagonal dimension.
[0424] The touchscreen may be 4.2 inches diagonally.
[0425] The touchscreen can be up to 7 inches diagonally.
[0426] The touch screen can be an OLED or TFT LCD screen.
[0427] In the alternative, the display may include a color touchscreen that includes a plurality of buttons or mechanical switches that allow the patient to input information using a combination of buttons or switches or dials and the touchscreen.
[0428] As shown in FIG. 3 , the device 100 includes a shroud 190 that supports the screen 212 and fits around the elbow 30. The shroud 190 is designed so that it will not be removed during normal use. The shroud has a mechanism that allows it to clip onto a screen carrier, which is in turn fastened to the upper chassis 102 so as to become part of the housing 100. The screen carrier can connect to and support the display 212. In an alternative configuration, no screen carrier may be provided, and the shroud 190 can clip directly onto a portion of the housing 100, such as the top surface of the housing or the upper chassis 102.
[0429] The shroud 190 is configured such that the removable elbow 171 cannot be removed from the screen carrier of the housing by simply pulling the removable elbow 171 in the second forward direction relative to the housing 100. The removable elbow 171 is removable from the housing 100 when the shroud 100 is attached to the housing. The respiratory assistance device 10 may include features of a respiratory assistance device, particularly a high flow device, such as those described in U.S. Patent Application No. 62 / 925,971, the contents of which are incorporated herein by reference in their entirety.
[0430] The apparatus may include a valve that allows auxiliary gas to be introduced into the blower.
[0431] 5 is a schematic diagram of a respiratory assistance apparatus. In particular, the respiratory assistance apparatus (which may be respiratory assistance apparatus 10 as described above) may be similar to other respiratory apparatuses described above. The respiratory assistance apparatus 5700 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 touch-enabled screen 212, a network interface 5714, and a humidifier 5716 (e.g., humidifier 12).
[0432] 1-3, 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, the humidifier 5716, whether mains powered or battery powered, may include a heater (e.g., a heating plate, a heating element).
[0433] The controller is in electronic communication with the flow generator, the display, the network interface, and the heater plate. The controller includes an electronic processor (e.g., a logic controller, a 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, the heater plate, and the screen 212.
[0434] 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 electrically and / or mechanically coupled to the controller 5704 that toggles between an on mode and an off mode, which may be based on a manual input (e.g., user input, patient input). The respiratory apparatus 5700 may be activated based on the switch 5706 switching from an off mode to an on mode, and deactivated based on the switch 5706 switching from an on mode to an 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.
[0435] 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 powered or battery powered. In some embodiments, the speaker 5708 is not present.
[0436] 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 touchscreen (e.g., resistive, capacitive). The screen 212 is rectangular, but can be a different shape (e.g., square, circular). The screen 212 may be mains powered or battery powered.
[0437] 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 platform, e.g., a server for patient and device management.
[0438] In some embodiments, the device includes a network interface. The network interface is located within the housing, but can also be located external to the housing. The network interface includes a wireless signal receiver, a wireless signal transmitter, or a wireless signal transceiver, each of which has a wireless signal radio antenna or an optical signal modulator depending on the signal modality (e.g., radio, optical), although wired communication (e.g., a 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 (e.g., web, application, database, virtual server, cloud service) that may or may not be a patient and device management platform, or a computing device (e.g., smartphone, tablet, wearable, medical monitor) that is local or remote to the network interface. It should be noted that the network interface can 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 can include a cellular modem (3G, 4G, 5G, 6G), a Wi-Fi card, and a Bluetooth chip. In some embodiments, there is no network interface.
[0439] 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.
[0440] 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 plurality of user health questions (e.g., related to the patient's disease progression or health status) and a plurality of user input elements through which user input is received, (c) disable or prevent activation of flow generation until the predetermined plurality of user inputs are received, and (d) transmit the predetermined plurality 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 plurality of user inputs before the heater plate of the humidifier reaches a predetermined temperature (e.g., a gas temperature of approximately 37 degrees). The user health questions and user input elements may be displayed upon startup of the controller.
[0441] 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 through which the user health information is received by the controller as user input, and (b) disable or prevent (e.g., hardware, software) operation of a flow generator of a heater plate, which may occur during operation of the controller, until a predetermined plurality of user inputs are received from the user input elements. 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. The controller may disable or prevent operation of the flow generator and / or heater until a predetermined plurality of user inputs are received from the user input elements, unless the requests for user health information and the user input elements are user bypassed (e.g., hardware, software). The predetermined plurality of user inputs may be all of the user inputs. The controller can disable or prevent (e.g., hardware, software) operation of the flow generator or heater plate based on the controller employing or electrically communicating with a valve (e.g., solenoid valve) or gate of the respiratory assistance device to be in an off position, a flow-closed position, or a flow-restricted position. The controller can enable bypass / override for a predetermined period of time (e.g., once a day for tracking purposes over 30 or 60 days).
[0442] For example, the instructions can cause the controller to disable or prevent operation of the flow generator or heater plate (e.g., hardware, software) until a predetermined number of user inputs responsive to a plurality of displayed requests for user health information are received via the display, which may occur upon startup of the controller, unless the displayed requests for user health information are user-bypassed (hardware, software). The requests for user health information and user input elements can be displayed upon startup of the controller. The predetermined number of user inputs can be all of the user inputs. The controller can disable or prevent operation of the flow generator and / or heater until a predetermined number of user inputs are received from the user input elements, unless the requests for user health information and user input elements are user-bypassed (e.g., hardware, software). The predetermined number of user inputs can be all of the user inputs. The controller can disable or prevent (e.g., hardware, software) operation of the flow generator or heater plate based on the controller employing or electrically communicating with a valve (e.g., solenoid valve) or gate of the respiratory assistance device to be in an off position, a flow-closed position, or a flow-restricted position. The controller can enable bypass / override for a predetermined period of time (e.g., once a day for tracking purposes over 30 or 60 days).
[0443] The controller may 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.
[0444] The controller may also be configured to lock access to any other mode or function 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, i.e., patient, responds to the questionnaire at least once per day.
[0445] 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 on the screen 212. In some embodiments, when power is provided to the device, the screen is configured to activate 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).
[0446] Startup may include activation of the respiratory assistance device or activation of the respiratory assistance device. As indicated by block 5604, startup / activation activates the device to begin interrogating the user, which results 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).
[0447] In some embodiments, the device begins to operate and query the user by entering a warm-up mode and / or a drying mode.
[0448] In some embodiments, as described in more detail above, start-up can include the presentation of a treatment control screen that the patient can use to begin treatment.
[0449] The questions can include 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, regardless of whether the first and second potential questions are from the same user session, the second question can depend 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 a second user session, where the first user session precedes the second 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 expression, regardless of whether the second question is obtained or generated from the respiratory assistance device 5700 (which can be the respiratory assistance device 10 as described above) or from a patient and device management platform, e.g., a server in communication with the respiratory assistance device 5700.
[0450] 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.
[0451] In some embodiments, after a question (e.g., a first question) is answered, the health parameters may be updated, and the content of a subsequent question (e.g., a second question) may be determined based on the health parameters (e.g., the updated health parameters).
[0452] A healthcare provider (eg, a physician) may be able to generate a health questionnaire for a patient by selecting one or more predetermined questions from a database of questions.
[0453] 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.
[0454] The database of questions can be located on the patient and device management platform and / or the device.
[0455] In some embodiments, the database of questions can be customized based on 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.
[0456] If a healthcare provider (e.g., a physician) selects one or more predetermined questions remotely (i.e., not on the device) from a database of questions, once the healthcare provider selects the questions, the selected questions can be transmitted to the device and stored on the device.
[0457] 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.
[0458] In some embodiments, questions (as part of the health questionnaire) may be based on the patient's condition (e.g., COPD, bronchiectasis, etc.). Questions may be added to or removed from the health questionnaire based on the patient's condition. For example, if the patient has bronchiectasis, the health questionnaire may include questions related to sputum color and whether the patient is taking antibiotics.
[0459] A healthcare provider (e.g., a physician) can select questions from a list related to the patient's condition to add to the health questionnaire. Alternatively, or in addition, the healthcare provider (e.g., a physician) can select a patient's condition, and the health questionnaire 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.
[0460] In some embodiments, the questions in the health interview are ordered so that questions related to COPD status are displayed first, followed by questions related to bronchiectasis status.
[0461] In some embodiments, a general health questionnaire is presented before the questions related to COPD status and the questions related to bronchiectasis status.
[0462] For example, questions related to COPD may include daily sputum volume, sputum color and / or cough status.
[0463] For example, questions related to bronchiectasis may include whether the patient is taking steroids and / or using an inhaler.
[0464] In some embodiments, a patient's predetermined condition (e.g., COPD or bronchiectasis) can be determined based on answers to questions related to the predetermined condition. For example, if answers to questions related to bronchiectasis are below baseline and / or worsening, this may indicate that the patient has bronchiectasis.
[0465] 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.
[0466] Healthcare providers (eg, physicians) may be able to add custom questions to a database of questions.
[0467] A healthcare provider can generate the health questionnaire directly on the device or from an ancillary device (such as a mobile device connected to the patient and device management platform).
[0468] The patient then enters their response to each question via the touchscreen (see block 5608). The patient's responses are then processed (5910). This processing may include plotting the set of responses, as shown in Figures 19 and 20, or sending the dataset of responses to the patient and device management platform, external storage, a mobile device, or an insurance company, equipment provider, or healthcare provider. Analysis or processing of the dataset may be performed at any stage, for example, by the patient and device management platform. In some embodiments, after the patient has answered the final question in the questionnaire, the respiratory assistance device displays a therapy control screen that the patient can use to initiate therapy.
[0469] In some embodiments, the patient and device management platform may store a patient profile including one or more of the patient's details, baseline data for the patient's health parameters, the patient's Airvo device serial number, and / or prescription settings.
[0470] 8 is a flow chart of a process for conditionally presenting a personal health questionnaire to a respiratory assistance device patient. In particular, process 5800 is performed via respiratory assistance device 5700 and the patient and device management platform, as described above. Respiratory assistance device 5700 may be respiratory assistance device 10, as described above.
[0471] The term block herein may refer to one or more steps performed by the apparatus 5700 (eg, by a controller).
[0472] In block 5802, respiratory assistance apparatus 5700 (which may be respiratory assistance apparatus 10 as described above) (e.g., controller 5704) displays a number of health questions as a personal health interview to the patient (or, if the patient is incapacitated, to a caregiver or physician) on display 5712 (same as display 212) via controller 5704 (same as controller 13) during start-up of respiratory assistance apparatus 5700, as shown in FIGS. 9-18 . This start-up may include booting up respiratory assistance apparatus 5700 (e.g., controller 5704) or, if respiratory assistance apparatus 5700 (e.g., controller 5704) is already up and running, operating respiratory assistance apparatus 5700 (e.g., flow generator 5710, humidifier 5716) before use. In some embodiments, start-up may include a warm-up process (as described above).
[0473] 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 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.
[0474] 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 mandatory question presentation. 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 is different between at least two instances of the flow generator 5710 being activated over a predetermined period of time (e.g., at least two days).
[0475] At block 5806, the respiratory assistance device 5700 (e.g., controller 5704) determines (e.g., controller 5704) whether the 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-interview basis (e.g., skipping the entire questionnaire if the patient is too ill to complete it) or on a question-by-question basis (e.g., skipping particular or any questions).
[0476] The skip information can be tracked and itself can be a data point that is later identified by the patient and device management platform, e.g., a server.
[0477] Additionally, 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 activated during a calendar day, the controller 5704 allows 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.
[0478] 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 time intervals (e.g., every two or three days), or may be set by a physician or defined by clinical practice.
[0479] At block 5808, the respiratory assistance device 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 device 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 of the questionnaire before activating the flow generator 5710.
[0480] In 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) to start the respiratory assistance device, change the respiratory assistance device, or turn off the respiratory assistance device.
[0481] At block 5812, the respiratory assistance device 5700 (e.g., controller 5704) receives a set of responses or answers to the personal health questionnaire from the patient. Such reception 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.
[0482] In block 5814, the respiratory assistance device 5700 (e.g., controller 5704) transmits the set of answers (e.g., wired, wireless, waveguide, encrypted, decrypted, unencrypted) to the patient and device management platform via the network interface 5714. The patient and device management platform may be any suitable platform, for example, a server web application, a database, a cloud service, a virtual server. 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 may 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., one answer transmission followed by another answer transmission). The controller 5704 can request the network interface 5714 to transmit a 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) have been 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 a set of answers (e.g., a predetermined plurality of user touch inputs) to the server in groups after a group of answers has been received via the controller (e.g., transmit after each 2nd, 3rd, 4th, 5th, 6th, 7th, etc. answer). Note that the controller 5704 can request the network interface 5714 to transmit a set of answers along with a patient or machine identifier to enable valid patient and device management platform-based identification and subsequent processing of the set of answers.
[0483] In some embodiments, the answer set is stored in the memory of the device. Optionally, the answer set can be provided to a patient and device management platform.
[0484] 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 per day), potentially lowering data transmission costs by requiring less frequent data transfers to create a connection between the device and the patient and device management platform versus more frequent transmissions.
[0485] In some embodiments, the device can be configured to store the answer and send the answer to the patient and device management platform when the drying process is activated (automatically or by the user).
[0486] In block 5816, the patient and device management platform takes action based on the set of responses being processed. For example, such action 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 platform, locating a patient or machine profile (e.g., a 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 analysis on the patient or machine profile (e.g., plotting the patient's responses over time, predicting no change or a 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 platform may merge or fuse interview data (e.g., data provided from responses to the interview) with sensor data (e.g., provided by the respiratory assistance 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 actionable.
[0487] In some embodiments, the sensor data may be one or more patient parameters (eg, the patient's respiratory rate, oxygen saturation, as described in more detail elsewhere herein).
[0488] As used herein, a patient's "health status" is a collective determination of the patient's health based on the patient's health parameters.
[0489] At block 5818, the correspondence may include the server plotting the set of answers, as shown in Figures 19 and 20. The plot may provide a graphical representation of the patient's health parameters and changes in the patient's health parameters. The plot may also indicate the patient's health status.
[0490] The plot may be part of a report that is presented to a user (eg, a patient, a caregiver, or a healthcare provider).
[0491] In some embodiments, a set of answers to multiple questions in a personal health questionnaire (including, for example, past health questionnaires that may be stored in memory of the device and / or patient and device management platform), optionally multiple answers or sets of answers, may be plotted and / or form part of a report.
[0492] In some embodiments, the device is configured to generate and / or display a report on a screen.
[0493] 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.
[0494] 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.
[0495] In block 5820, the response may include the patient and device management platform, e.g., a 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., the 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 form of software. As described further below, the notification may be prompted or generated based on a set of answers that meet or fail to meet a predetermined threshold. For example, the threshold may be a baseline value custom-set by the patient's physician, and the threshold may be met based on a predetermined deviation from that baseline value.
[0496] In some embodiments, the baseline value may be set by a physician (or other healthcare provider) based on an initial set of patient tests.
[0497] In block 5822, the response may include the patient and device management platform, e.g., a server, notifying the patient (or a caregiver providing close care 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 server, or via a respiratory assistance device 5700 in signal communication with the server via a network interface 5714. Such a notification may be generated based on a 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 form of software. For example, such a notification may be output via speaker 5708 or display 5712. A notification may be prompted or generated based on a set of answers that meet or do not meet a predetermined threshold, as described further below. For example, the threshold may be a baseline value custom-set by the patient's physician, and the threshold may be met based on a predetermined deviation from that baseline value. In some embodiments, notification may be provided on the device or to a healthcare provider.
[0498] After the questionnaire is completed, the controller 5704 can control the display 5712 to present a screen (e.g., page) after the controller 5704 receives the set of answers, whether before, during, or after transmission to the patient and device management platform, e.g., a server. The screen presents a menu for controlling or activating the flow generator 5710 or humidifier 5716 or for entering operating parameters for the flow generator 5710 or humidifier 5716. Note that while process 5800 is performed via the respiratory assistance device 5700 and the patient and device management platform, in some circumstances, process 5700 can be performed locally. For example, instead of transmitting the set of answers to the patient and device management platform, the respiratory assistance device 5700 (i.e., respiratory assistance device 10) can be programmed to perform similar processing locally and then take action as described herein. For example, the respiratory assistance device 5700 can perform block 5820 or 5822.
[0499] 7 is a flow chart of a process for determining deviations for responses to a personal health questionnaire based on pre-established baseline values. In particular, process 5900 is performed via respiratory assistance device 5700 and a server, as described above.
[0500] 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 establishes multiple reference values for multiple questions of a personal health questionnaire associated with the patient or machine identifier. For example, the patient and device platform, e.g., a server, can present a browser-based user interface on the computing device operated by the user, where the user interface is programmed to receive multiple 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 answers to the questions can later be measured against the reference values as established by the user.
[0501] At block 5904, the respiratory assistance device 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 device 5700, as shown in Figures 9-18. This start-up may include activation of the respiratory assistance device 5700 (e.g., controller 5704) or activation of the respiratory assistance device 5700 (e.g., flow generator 5710, humidifier 5716) prior to use if the respiratory assistance device 5700 (e.g., controller 5704) is already up and running. The questionnaire includes one or more questions that are presented on the screen 212, i.e., the display 5712.
[0502] At block 5906, the respiratory assistance device 5700 (e.g., controller 5704) receives a plurality 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.
[0503] At block 5908, the respiratory assistance device 5700 (e.g., controller 5704) transmits the responses (e.g., wired, wireless, waveguide, encrypted, decrypted, unencrypted) via the network interface 5714 from the respiratory assistance device 5700 to a remote patient and device management platform (e.g., a server) so that the patient and device management platform can receive and process the responses, as described below. The controller 5704 can request the network interface 5714 to transmit the responses (e.g., a predetermined plurality of user touch inputs) to the server one by one after each of the responses is received via the controller 5704 (e.g., one response transmission followed by another response transmission). The controller 5704 can request the network interface 5714 to transmit the responses (e.g., a predetermined 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 the 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.
[0504] 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 to the server, locates a patient or machine profile (e.g., a 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 reference values, reads the patient or machine profile containing the patient's response, performs a comparison of the response to the reference values (e.g., reference value against the response, or the response against the reference value), and determines multiple deviations (e.g., binary, Boolean, alphanumeric) of the response from the reference value (if such deviations exist), some of which may include a degree of deviation (e.g., a 5-point increase relative to the reference value or a 10% decrease relative to the reference value).
[0505] Alternatively, the process of determining multiple deviations of the response to the baseline may be implemented and executed by the controller of the respiratory assistance device instead of the patient and device management platform.
[0506] 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.
[0507] If the patient's health parameters are not stable, the patient may be considered unstable.
[0508] A deterioration in a patient's health may indicate that the patient is at risk of developing or is at risk of an exacerbation.
[0509] The exacerbation may be a COPD exacerbation.
[0510] A patient's deterioration in health may indicate another health problem, such as a cold, hay fever, or an allergic reaction.
[0511] By indicating a deterioration in the patient's health, the healthcare provider may be able to implement further measures.
[0512] The patient and device management platform and / or the apparatus may determine instability in the patient's health based on the answer to the user question and one or more previous answers to the user question, and determine deterioration.
[0513] 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).
[0514] A patient may be deemed to be deteriorating if there is a deterioration in two or more health parameters (optionally relative to baseline values) for at least two days.
[0515] 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.
[0516] 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).
[0517] For example, if SpO2 worsens or falls below a threshold of, say, 85%, the patient may be deemed to be deteriorating.
[0518] For example, if the respiratory rate increases by a threshold of, say, 25%, the patient may be deemed to be deteriorating.
[0519] In some embodiments, a patient may be considered to be deteriorating if, for at least two days, both of the following are present: A deterioration (optionally from a baseline value) of one or more health parameters. A deterioration (optionally from a baseline value) of one or more patient parameters, and / or one or more patient parameters falling below a threshold, and / or one or more patient parameters changing above a threshold.
[0520] For example, in the SpO2 and respiratory rate example above, a further deterioration of at least one health parameter may be required for the patient to be deemed to be deteriorating.
[0521] At block 5912, the patient and device platform, e.g., a server, takes action based on the deviations (or lack thereof) being processed. For example, the patient and device platform can perform analytics on the patient or machine profile (e.g., plotting patient responses against time, predicting no change or positive or negative changes to the patient's health status based on the patient responses), as further described below.
[0522] In block 5914, responding may include the server plotting the set of answers so that deviations are visually identifiable or visually clear, as shown in FIGS.
[0523] In block 5916, the response can include the patient and device management platform, e.g., a 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 server. Such notification 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 notification can be manifested via a mobile app, a dedicated software application, a browser-navigable portal, or other form of software.
[0524] 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 assistance device 5700 in signal communication with the server via 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.
[0525] In some embodiments, the response may include notifying the patient and / or notifying non-patients (e.g., family, physicians, caregivers) based on a determination that the patient is deteriorating.
[0526] 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 a 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 output via the display 5712. If the housing 100 contains a speaker 5708, the message can include audio content output via the speaker 5708.
[0527] In situations where the respiratory assistance apparatus 5700 has multiple network interfaces 5714 (e.g., Wi-Fi, Bluetooth), the respiratory assistance apparatus 5700 can 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 can 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) can be local to the computing device, where the computing device is other than the server.
[0528] 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, 3, 4, 5, 6, 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, where the computing device is in communication with a server but is remote from the patient and device management platform, e.g., the server.
[0529] The message from the patient and device management platform may be a notification that the patient is deteriorating.
[0530] 7 have been described in relation to the respiratory assistance device's interaction with the patient and the device management platform. However, in alternative embodiments, the steps set forth 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 at block 5910 may be performed by a controller of the respiratory assistance device, and the selection at 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.
[0531] In a further alternative embodiment, a response to the question can be received at the device's controller (5906). The question can be sent to a user device, e.g., a 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, e.g., 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 notify the non-patient about the patient's health condition.
[0532] FIGS. 9-18 illustrate 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 may include a single screen presenting a question and potential answers. While FIGS. 9-18 illustrate a user interface including multiple screens (e.g., pages) presented in sequence as shown in FIGS. 9-18, this order is exemplary and may be changed. For example, the screen shown in FIG. 15 (or any other FIG. 11-18) may be presented before the screen shown in FIG. 16 (or any other FIG. 11-18) or after the screen shown in FIG. 18 (or any other FIG. 11-18). Display 5712 displays a user interface including the screens shown in FIGS. 9-18 included in the personal health questionnaire, as described herein. Furthermore, FIGS. 9-18 may be embodied as a single screen that is vertically or horizontally touch-scrollable (e.g., in the manner of a web page). Additionally, the respiratory assistance device 5700 (e.g., controller 5704) can be programmed to repeatedly request the display 5712 to display the questions and potential answers over a period of at least two consecutive days. Alternatively, each question may be presented as a separate scrollable page.
[0533] FIG. 9 illustrates a startup screen having a graph user touch element, a power user touch element, and a menu user touch element. For example, the startup screen may be the first screen a patient sees when powering on the respiratory assistance device as described herein. The graph user touch element, when selected, may enable the presentation of data graphs for various device parameters or patient health parameters, whether the presentation occurs on the same page or a different page of the user interface, as described herein. The power user touch element, when selected, may be used to power on, power off, or restart the respiratory assistance device, as described herein. For example, in response to the power user touch element being selected when the respiratory assistance device is already powered on, the power user touch element may enable the display of a power-off graphic or a restart graphic on the display 5712. The menu user touch element, when selected, may enable the presentation of a menu for various usage options, whether the presentation occurs on the same page or a different page of the user interface, as described herein. The launch screen also shows a set of manufacturer and device identification information (e.g., text, graphics) above the graph, power, and menu user touch elements. Note that the graph, power, and menu user touch elements visually remain throughout the pages of the user interface shown in Figures 14-18, but may disappear (all as a group or only some may disappear) for some pages of the user interface while others may remain.
[0534] 10 shows an introduction screen after the start-up screen. The introduction screen displays a greeting message (or other introductory or welcoming message) above the graph user touch elements, power user touch elements, and menu user touch elements that visually remain from the start-up screen (e.g., the same graph user touch elements, the same power user touch elements, a new screen containing the same user power elements, or updating the content above the remaining graph user touch elements, power user touch elements, and menu user touch elements). The greeting message indicates that the 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., not in the middle, on the right vertical plane, spanning between the left and right vertical planes, in the top horizontal plane, in the center of the display).
[0535] FIG. 11 illustrates a general health screen presenting questions (e.g., Request for User Health Information, Health Questions) asking about a patient's general health at a given time. The questions are alphanumeric but may additionally or alternatively include pictorial content. The questions include an end-of-question marker, but this can be omitted (e.g., select one from the following options). The day of the given day is dynamic and changes based on when this question is displayed. This change can occur based on the time / date tracked via controller 5704 (e.g., internal clock). For example, a first set time period can correspond to morning (e.g., from 4:00 AM to 11:59:00 AM local time), a second set time period can correspond to afternoon (e.g., from 12:00 PM to 5:59:00 PM local time), and a third set time period can correspond to evening (e.g., from 6:00 PM to 3:59:00 AM local time). This time dynamics feature can be omitted (e.g., "how are you feeling now"). Nevertheless, this inquiry relates to a general health parameter as described herein, and a response of "poor" indicates a deterioration in the patient's health, regardless of whether the inquiry relates to a baseline value.
[0536] The general health screen presents 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 in circumstances where multiple answers may be entered non-exclusively). As shown, a first input element indicates the current position or unchanged state of the health parameter (e.g., fair), a second input element indicates an improvement (e.g., good) in the health parameter, and a third user input element indicates a deterioration (e.g., poor) in the health parameter. The user input elements range from two to nine, although fewer or more user input elements are possible. The user input elements are text strings and graphics, whether they define a single content group (e.g., text integrally embedded within a graphic) or multiple content groups (the text strings extend (e.g., overlay) over at least one of the graphics or over the graphics). These user input elements are nevertheless visually identical to one another, but in terms of the content of potential answers, at least two user input elements in the group of user input elements may be visually distinct from one another, for example, such visual distinction may exist based on graphic background or foreground color, shade of graphic background or foreground color, graphic shape, graphic size, font type, font size, font color, shade of font color, font placement, or other graphic or font characteristics.
[0537] The message of FIG. 10 and the question and user input elements (potential answers) of FIG. 11 are presented in an electronic conversation-like manner (e.g., chat-style, email-style, text message-style) such that the question is positioned between the greeting message and the potential answers. However, the electronic conversation-like manner can be omitted or presented in a different style (e.g., an up-down or left-right swipe carousel). The question is presented so as to be visually distinct from the user input elements, although this presentation can be varied, and such visual distinction can be changed or eliminated. The user interface can present the question and potential answers based on the user scrolling via a touchscreen and submitting an answer when the questionnaire is completed.
[0538] FIG. 12 shows a sore throat screen presenting a question similar to that of 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 relative to the patient's condition associated with the answer and (as described in more detail below) have facial expressions associated with the patient's condition associated with the answer. 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 answer) indicates a deterioration in the patient's health, regardless of whether the question relates to the baseline. Note that baseline potential answers are visually distinguished (e.g., green) from other potential answers (although this may not be the case). For example, such visual distinction can occur by overlaying an associated user input element on a graphic (e.g., green). The user input elements include odd user input elements, where the reference value is associated with the median user input element from the odd user input elements, but it should be noted that non-median user input elements or even elements are possible as well, in any combination.
[0539] 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 absent), and that alphanumeric content is positioned (e.g., vertically or horizontally oriented) outside of the at least one user input element (e.g., a graphical tooltip, a graphical label). Note further that the user input elements are first graphical groups (e.g., squares that are visually distinct from one another) within which are included second graphical groups (e.g., faces with different expressions), regardless of whether the second graphical groups are embedded or overlaid on top of the first graphical groups. Note also that the first graphical groups are visually distinct from one another based on the color of the graphical background, but this can vary based on various characteristics (e.g., graphic shading, graphic hatching, graphic size, graphic shape), or are not visually distinct. Additionally, the second graphic group is visually distinct from one another based on the display of the face, which may vary based on various characteristics (e.g., face size, face shape, face color, face color shading) or may not be visually distinct from one another.
[0540] 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 expression can also have a neutral face (corresponding to a neutral response to the question).
[0541] Figure 13 shows a respiration screen presenting similar questions to those in Figures 11 and 12. However, unlike the questions and potential answers in Figures 11 and 12, the questions and potential answers in Figure 13 relate to the patient's respiratory parameters. If the patient's physician has set a baseline of, for example, medium (a middle answer), then any answer to the left of that question will suggest a deterioration in the patient's health, regardless of whether the question relates to the baseline.
[0542] FIG. 14 shows a cough screen posing similar questions to those in FIGS. 11-13. However, unlike the questions and potential answers in FIGS. 11-13, the questions and potential answers in FIG. 14 relate to the patient's cough parameters. If the patient's physician has established a baseline, such as most of the time, then any answer to the left of the question, whether or not it relates to the baseline, indicates a decline in the patient's health.
[0543] FIG. 15 shows a sputum color screen presenting similar questions to those in FIGS. 11-14. However, unlike the questions and potential answers in FIGS. 11-14, the questions and potential answers in FIG. 15 relate to questions related to the patient's sputum color parameters. If the patient's physician has established a baseline, for example, the second color from the right, then any answer to the left of that baseline, whether or not the question relates to the baseline, suggests a decline in the patient's health.
[0544] FIG. 16 illustrates an antibiotics screen presenting a similar question to those in FIGS. 11-15. However, unlike the questions and potential answers in FIGS. 11-15, the questions and potential answers in FIG. 16 relate to a question related to a patient's antibiotic use parameters. If the patient was not taking antibiotics, selecting the answer "taking" suggests a decline in the patient's health, regardless of whether the question is related to a baseline. Furthermore, note that while the potential answers are binary, this can be changed as needed. For example, FIG. 16 illustrates a pair of user input elements corresponding to a question related to a patient's antibiotic use parameters. Input from these user input elements is associated with a pair of mutually exclusive data points (e.g., taking or not taking).
[0545] FIG. 17 shows a steroid screen presenting similar questions to those 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 "yes" would suggest a decline in the patient's health, regardless of whether the question is related to baseline values.
[0546] FIG. 18 shows an inhaler use screen presenting similar questions to those 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 use parameters. If the patient's physician has established a baseline of, for example, 1-3 times per day, then any answer to the left of that question, whether or not it relates to the baseline, suggests a decline in the patient's health.
[0547] FIG. 21 also shows a number of questions related to, for example, the patient's breathing, the patient's fatigue, the patient's throat and muscles, if the patient has a fever and / or shivers, and the patient's infection.
[0548] FIG. 19 illustrates a patient and device management platform-based (e.g., server-based) dashboard presenting a plot generated based on multiple responses to multiple questions in a personal health questionnaire.
[0549] Figure 20 shows the plot of Figure 19 tracking responses over time based on multiple symptom criteria and multiple medication criteria. The patient's physician (e.g., another health care provider or healthcare provider) operates the computing device as described above, thereby accessing data related to the patient's responses through the application as described above.
[0550] 20 may show a response to each question related to a given health parameter, or may show a general status of a health parameter based on multiple questions. It will be understood that where reference is made herein to showing a response, it may also show a status of a health parameter (e.g., based on multiple responses and / or one or more patient parameters).
[0551] For each of his or her patients (e.g., based on a patient or machine identifier), the physician operates a computing device that allows the physician to view a server-based dashboard. In this web page, the physician can view a chart (Detail A) that tracks the patient's responses to the interview.
[0552] Information related to the patient's responses to the interview over time and / or any information regarding patient parameters over time can be presented as a report (e.g., a patient diary). The report can include one or more charts (as described below) and information regarding patient and device parameters. The report can also include, for example, any alert, compliance, usage, or prescription information for the patient.
[0553] The report may also indicate the time the prescription was changed, allowing the healthcare provider to see the effect of that prescription on one or more health parameters.
[0554] The reports allow the healthcare provider to assess whether the prescription is effective. For example, the clinician can reduce the flow rate required if the patient is improving. Alternatively, for example, the healthcare provider can increase the flow rate or O2 concentration if the condition is worsening.
[0555] In some embodiments, based on the reports, the clinician may also increase humidity if there is a decrease in compliance.
[0556] The report may be a daily report, ie, the report is generated every day, or the responses to the questions may be plotted daily.
[0557] The report can show responses to the questionnaire for each day (e.g., as shown in Figures 20 and 21). If the patient completes the questionnaire multiple times in a day, the worst decision for each health parameter or response may be displayed, or the responses may be averaged.
[0558] The report can also provide an indication to the clinician if the patient did not complete the questionnaire for a particular day or days. The days on which the questionnaire was not completed are presented in the report and can include blank cells, for example, as shown in FIG. 21. An indication that the questionnaire was not completed on a particular day can also provide an alert to the clinician that the patient needs assistance or can prompt the clinician to investigate. For example, if there are several days on which the questionnaire was not completed, this can indicate that the patient may be hospitalized.
[0559] A report may group one or more health parameters (eg, as shown in FIG. 21).
[0560] In some embodiments, if the questionnaire is not completed for a predetermined number of consecutive days or a predetermined number of days in a period of time (e.g., four times in a week), one or more notifications may be generated.
[0561] This chart (Figure 19) allows a physician to (among other things) track aspects of a patient's health, consider whether the patient's condition is likely to deteriorate to the point of hospitalization, and monitor the nasal high flow device's prediction of whether the patient's condition will deteriorate to the point of hospitalization.
[0562] Figure 21 shows an alternative plot to Figure 20 that tracks responses over time based on multiple symptom criteria and multiple medication criteria. In Figure 21, each patient response can be shown with an associated numerical score (as described below) to indicate that response relative to other responses. For example, more negative responses can be numbered higher than more positive responses. The relative numerical scores allow a medical professional (e.g., a physician) to more easily track aspects of a patient's health, consider whether a patient's condition is likely to worsen to the point of hospitalization, and monitor a nasal high flow device's prediction of whether a patient's condition will worsen to the point of hospitalization.
[0563] Numerical scores may be provided in addition to or as an alternative to color coding (as shown in FIG. 21).
[0564] As shown in Figures 20 and 21, color coding can indicate a deterioration in the associated health parameter. The color coding can range from a first color (e.g., gray or blue) associated with no or minimal change in response to a second color (dark red) associated with a substantial deterioration in response. It will be appreciated that there can be multiple intermediate colors between the first and second colors associated with varying levels of deterioration (e.g., blue indicating mild deterioration and orange indicating severe deterioration, as shown in the figures).
[0565] In some embodiments, the color coding may include several colors that indicate an improvement in the health parameter, for example, if the response indicates that the health parameter is improving, a green color may indicate that the associated health parameter is improving.
[0566] For example, if for a particular day the response is worse than the previous day (or the average of the preceding few days), the color may be a darker red.
[0567] Plots such as those shown in Figures 19, 20, and 21 may also show one or more patient parameters, such as SpO2 and respiratory rate, as described in more detail above. The one or more patient parameters may be plotted against time.
[0568] Additionally or alternatively, plots such as those shown in Figures 19, 20 and 21 may also show compliance information indicating patient compliance with treatment (which may include, for example, time of use).
[0569] Compliance information can be determined based on breath detection in a nasal high flow system. Compliance can be determined by detecting patient breaths based on a flow signal, for example, as described in PCT / IB2020 / 051816, the contents of which are incorporated herein by reference in their entirety.
[0570] Figure 22 shows the provider deterioration overview.
[0571] The deterioration overview may display the number of patients where some health parameter exceeds a threshold that may indicate patient deterioration (eg dark green sputum).
[0572] The deterioration overview can also display the number of patients who are deteriorating.
[0573] The deterioration overview may also display the number of patients and the length of time that they have been deteriorating.
[0574] Figure 23 shows the efficacy overview. The efficacy overview displays various patient parameters (e.g., SpO2, respiratory rate) and can also group patients based on thresholds.
[0575] The efficacy overview can also display other warnings from the device (eg, low water or low oxygen warnings).
[0576] FIG. 24 shows an architecture diagram illustrating a system for providing respiratory assistance or respiratory therapy to a patient. Briefly, the respiratory assistance device generates data in the form of the patient's answers to one or more questions in a medical interview. In one embodiment, the respiratory assistance device can further generate data in the form of dashboards and / or plots, as shown in FIGS. 19 and 20, respectively. The data (answers and / or dashboards and / or plots) can then be provided to a USB, a patient and device management platform, an external storage device such as a mobile device (e.g., smartphone, laptop, tablet, wearable), an insurance company, or an equipment provider. If the data is provided to a USB, it can later be downloaded to a computer, which can then provide the data to the patient and device management platform or insurance company. In some embodiments, the mobile device or patient and device management platform may be able to provide data (e.g., information to the patient regarding changes in their physiological or medical condition) back to the respiratory assistance device.
[0577] A healthcare provider can receive data about the patient (i.e., patient responses to questions and / or dashboards and / or plots) via a mobile device (e.g., smartphone, laptop, tablet, wearable), or directly from the respiratory assistance device, the patient and device management platform, or from the equipment provider. The healthcare provider can then feed the data (e.g., information to the patient regarding changes in their physiological or medical condition) back to the respiratory assistance device (e.g., via the patient and device management platform) or proactively modify the respiratory assistance device's treatment prescription.
[0578] As described above, a user of a respiratory assistance device is provided with a questionnaire formed of one or more questions on an integrated touchscreen of the respiratory assistance device ("respiratory assistance device") that provides the therapy. The questionnaire is received on one or more touchscreens through which the user also provides their responses. The responses are plotted in a graphical format that visually represents health parameters recorded by the patient.
[0579] As shown in FIG. 7 , in some embodiments, baseline values 5902 of the patient's health status are 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 in a medical interview from the device. In such embodiments in which baseline status of the patient's health parameters is established, the healthcare provider (and / or the patient) may be able to determine changes from the baseline, whether that be an improvement in one or more health parameters or a deterioration in one or more health parameters. In one embodiment, the predetermined baseline values 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).
[0580] Each health parameter may have an associated reference value.
[0581] The reference values for the health parameters may be dynamically adjusted (eg, by the device and / or by a patient and device management system).
[0582] The baseline value may be updated based on answers to one or more questions as part of a health interview over a period of time.
[0583] In some embodiments, the baseline value for a health parameter may be updated based on a period of consistent responses to questions or interviews by the patient. For example, the baseline value for 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.
[0584] 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 predetermined time (e.g., number of days) or number of responses to the health interview.
[0585] In some embodiments, the reference value may be cycled towards different reference values.
[0586] For example, if a patient's consistency indicates that the patient responds that they cough occasionally (i.e., Figure 14) 10 times in a row, the criteria associated with this patient parameter can be updated to cough occasionally.
[0587] The baseline values can be updated based on the season, for example, if it is winter, the patient's symptoms are expected to worsen, and the worsening symptoms are reflected in the answers to the questions (e.g., the answers become more negative).
[0588] The reference value may be updated to be lower or more negative in cold seasons (e.g., winter). The reference value may be updated to be higher or more positive in warm seasons (e.g., ).
[0589] The reference value may be updated based on the weather or weather forecast.
[0590] The reference value may be updated to be higher or more positive as the weather becomes warmer or more humid, and may be updated to be lower or more negative as the weather becomes colder or less humid.
[0591] The baseline can be updated based on the location of the device.
[0592] The weather and / or season and / or device location can be entered by the patient (or other user when setting up the device), or can be determined by the point of sale or by the device's positioning system (e.g., GPS, GNSS, or cell tower triangulation).
[0593] In some embodiments, before the baseline is updated, the patient may be prompted as to whether or not they want the baseline to be updated.
[0594] In some embodiments, before the metrics are updated, the healthcare provider (eg, physician) may be prompted as to whether or not they want the metrics updated.
[0595] The reference values may be updated periodically (e.g., every six months).
[0596] When the respiratory assistance device is activated, a questionnaire is displayed on the touch screen for the patient to answer (5904). As explained above, the questionnaire may include one or more questions and may be displayed on one or more screens. The device then receives answers to each of the questions from the patient (5906).
[0597] As shown in Figures 19 and 20, the responses can be plotted in a graphical format that visually depicts the health parameters recorded by the patient. In one embodiment, the plotted health parameters allow a healthcare provider to more easily review the health status of the user (patient). Thus, the plotted data (i.e., a visual presentation of the responses to the questionnaire) allows a healthcare provider to track changes in the health parameters and determine the patient's health status or changes in health status.
[0598] In some embodiments, a determination of an exacerbation or onset of an exacerbation (as described above) may be provided to the user.
[0599] As shown in Figure 23, a healthcare provider can access data related to a patient's responses. This access can be via providing the data directly to the healthcare provider, or via an equipment provider, patient and device management platform, or server-based application. Additionally, access can be via mobile, such as by phone.
[0600] In some embodiments, the patient may be able to skip the interview, for example if they are too unwell to complete it. In some embodiments, the respiratory assistance device may require the patient to provide answers to each of the interview questions before allowing them to access a therapy control screen where they can begin therapy.
[0601] The responses provided by the patient to the interview can be used by a healthcare provider (e.g., remotely, locally) to determine changes (e.g., worsening, the same, improving) in the patient's health parameters. For example, the responses provided by the patient to the interview can be used to ascertain input related to a given health or physiological parameter.
[0602] The questionnaire may present questions along with selectable graphics that correspond to answers to those questions. The patient may touch the selectable graphics to complete the questionnaire.
[0603] In some embodiments, the respiratory assistance device transmits the patient's responses to the questionnaire to a server for plotting the responses.
[0604] Alternatively, the respiratory assistance device may be configured to plot the patient's responses.
[0605] In some embodiments, based on answers provided by one or more interviews, the server may issue an alert to a computing device (e.g., smartphone, tablet, wearable, workstation) operated by the healthcare provider.
[0606] In some embodiments, a healthcare provider has access to the patient's responses to the interview and can use those responses, whether from a single session or multiple sessions of interview responses, to do any one or more of the following: · Modifying a patient's treatment regimen delivered by a respiratory support device. · Customize the medical history presented to patients. Prescribe pharmacological interventions.
[0607] In some embodiments, based on the patient's responses to the medical interview, from a single session or multiple sessions of responses to the medical interview, the apparatus and / or patient and device management platform is configured to contact a healthcare provider (e.g., a physician) or alert emergency services (e.g., an ambulance service).
[0608] In some embodiments, based on a determination that the patient is having an exacerbation episode, the apparatus and / or patient and device management platform is configured to contact a healthcare provider (e.g., a physician) or alert emergency services (e.g., an ambulance service).
[0609] Preferably, the healthcare provider takes action based on the plotted results of the patient's health status.
[0610] In connection with changing a patient's treatment prescription, a healthcare provider may receive answers to questions provided by the patient and, upon reviewing those answers, remotely change one or more treatment settings (prescription) of the respiratory assistance device, such as flow rate, O2 percentage, treatment pressure and / or duration of treatment.
[0611] A healthcare provider can customize the questions provided to a patient. For example, the questions can be customized to more effectively provide the patient with medical parameters targeted to the patient's health needs, or the questions can be modified to maintain the patient's interest (as custom questions, as described above).
[0612] Based on the answers provided by the patient to the questions, the healthcare provider may prescribe pharmacological interventions, such as prescribing antibiotics, steroids and / or inhaler use.
[0613] In some embodiments, the questions may vary, as the questions asked may depend on answers previously given (in the same session or in previous sessions). For example, the controller may be configured to selectively present particular questions based on the patient's previous responses, or based on changes in one or more health parameters over time or changes in the patient's health status over time.
[0614] A healthcare provider can determine whether the patient's health condition is deteriorating based on the plotted results of the patient's condition. Alternatively, the change in the patient's health condition can be presented on the device's screen, or an alarm can be generated by the respiratory assistance device to indicate to the user that the patient needs to see a doctor or hospital.
[0615] In one embodiment, mandatory completion of the questionnaire ensures that health information about the patient is collected. For example, the respiratory assistance device can be configured to require mandatory patient responses to the questionnaire. Use of the respiratory assistance device can be locked (e.g., flow rate or humidity levels can be locked until the patient provides their response to the questionnaire). Preventing use of the respiratory assistance device ensures that the user of the respiratory assistance device completes the questionnaire and that the healthcare provider (e.g., the patient's physician) and / or the patient can respond in a timely manner.
[0616] In some embodiments, the mandatory completion of the questionnaire can be relaxed or adjusted. For example, the questionnaire only needs to be completed once at a predetermined interval (e.g., once a day, etc.). There may be other situations that justify bypassing the enforcement of the mandatory completion of the questionnaire. For example, if the patient's answers to the questionnaire indicate a need to begin treatment immediately. Furthermore, the mandatory completion of the questionnaire can be adjusted if the answers provided by the user indicate that the user is providing incorrect or inconsistent answers to the questionnaire. For example, this can be determined if inconsistent answers are provided to the relevant questionnaire. In some embodiments, this information is also represented graphically.
[0617] Mandatory completion of the questionnaire can be implemented by preventing effective operation of the respiratory assistance device until responses to a predetermined set of questionnaires are received. Requiring the patient to complete the questionnaire before every treatment session can improve the likelihood that the patient will regularly complete the questionnaire.
[0618] As described above, the interview can include a wide range of questions. The questions can be general questions directed to the patient's physical or mental health. For example, as shown in FIG. 11 , a general question asks, "How are you feeling this morning?" with three options: "good," "average," and "bad." The patient can freely select one of these options on the touchscreen. This type of question is subjective and qualitative; that is, different patients may answer this question differently, even if they are in the same physical condition. When compared to a baseline, the answer to this question provides a comparative reference point for the patient's overall physical condition.
[0619] As shown in Figures 12 and 13, further questions ask, "Do you have a sore throat?" and "How is your breathing?" with five different options for response, ranging from "extremely" to "not at all," and "difficult" to "easy," respectively. Again, self-reported levels of pain and / or discomfort are subjective, but provide a useful comparison when compared to baseline values. The scoring system is made easy to use by using colorful graphics, as in Figures 11 and 12, and by representing scores pictorially (in this case, with faces indicating degrees of happiness or discomfort).
[0620] Figure 14 shows the question, "Are you still coughing?" with five different options ranging from "always" to "never." This question reports the frequency of something, but is a subjective quantitative question in that it depends on the patient's subjective analysis of the severity of the cough.
[0621] Figure 15 shows the question, "What color is your sputum?" followed by a five-color color chart to which the patient can compare their sputum. The use of color charts to analyze sputum is known (see Stockley RA, Bayley D, Hill SL, Hill AT, Crooks S, Campbell EJ. Assessment of airway neutrophils by sputum color: correlation with airways inflammation. Thorax 2001;56:366-372). Thus, this type of question provides an objective, qualitative assessment of health parameters.
[0622] Figures 16 and 17 show quantitative questions, i.e., patients provide objective quantitative answers. Questions include "Are you taking antibiotics?" or "Are you taking steroids?", to which patients can select "Yes" or "No." Figure 17 shows "Are you using an inhaler?", which provides four qualitative answers.
[0623] The screen 212 can be configured to present the user with a first question, the first question relating to how the user is feeling and presenting a plurality of distinct selectable responses. The screen 212 can then be configured to present the user with a second question, the second question relating to, for example, the condition of the user's throat, and the screen 212 presents a plurality of selectable indicia, each representing (or corresponding to) a response. The screen 212 can be configured to present a third question relating to the patient's respiration or respiratory rate.
[0624] In some embodiments, the questions are asked sequentially.
[0625] Alternatively, in some embodiments, the question asked depends on the answer given to a previous question, whether in the same session or a previous session.
[0626] For example, if a question asks about sputum color and the answer given indicates mucopurulent sputum, subsequent questions may target the amount, timing and duration of antibiotic use.
[0627] Similarly, some questions may be skipped if the answers to the questions indicate that the patient's health parameters are trending in a positive direction.
[0628] In one embodiment, each answer provided by the patient to a question is represented by a numerical score, and the cumulative total is used to initiate an event, which can be selected from sending data to a healthcare provider, marking the sent data as urgent or non-urgent, and sending data to a specific device.
[0629] For example, a "positive" response may be given a score of 1 or 2, while a higher score of 4 or 5 represents a negative response (where positive and negative are relative to health status). Thus, a series of low scores may not trigger a threshold event, such as sending data to a healthcare provider. However, if the patient is moderately unwell, a first threshold for sending data to a healthcare provider may be met. If the patient is particularly unwell, as indicated by a high score, the data may be sent with an alert and / or sent to the healthcare provider's mobile device for immediate attention.
[0630] The present disclosure enables an attractive, easy-to-use questionnaire to be displayed on the touch screen of a respiratory assistance device.
[0631] In order to enable timely and informed use of the responses to the questionnaire, it is useful for the responses to be processed locally or remotely at the respiratory assistance device and then made available in a usable format. For example, the questionnaire could be presented on an integrated touchscreen at start-up of the respiratory assistance device, before any other selectable options are presented to the user.
[0632] The presented questionnaire can be intuitive to attract and capture the user's attention. Patients are more likely to complete the answers to the questionnaire questions because they are already familiar with using respiratory assistance devices to receive treatment. Furthermore, making the questionnaire intuitive and engaging encourages patients to interact with it regularly and ensures that the questionnaire is not overly tedious to complete.
[0633] The questionnaire is also more accessible because the questions are presented on the device's integrated touchscreen, eliminating the need for the user to activate or handle a second device (e.g., a phone), which increases the likelihood that the user will complete the questionnaire due to ease of use (i.e., a single device for treatment and completing the questionnaire).
[0634] Reference to any prior art in this specification is not, and should not be construed as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in the field of endeavor in any country in the world.
[0635] When reference is made herein to directional terms such as "upper," "lower," "front," "rear," "horizontal," "vertical," etc., these terms refer to the device when in a typical in-use position and / or are used to indicate and / or describe a relative direction or orientation with respect to a particular orientation shown in the figures.
Claims
1. 1. A respiratory assistance apparatus comprising: Housing and a source of one or more breathable gases; a respiratory conduit for delivering the breathable gas to a patient via a patient interface; a touchscreen located on the housing; and a controller located within the housing for controlling respiratory assistance device operation, including actuation and operation of the respiratory assistance device; Equipped with The controller: - requesting the touchscreen to display a plurality of user questions and a plurality of user input elements through which user input is received; Disabling or preventing operation of a component of the device until a predetermined number of the user inputs are received The respiratory assistance device is configured to:
2. The device of claim 1 , wherein the controller is in electrical communication with the touchscreen and comprises an electronic processor and memory in communication with the electronic processor, the controller controlling the operation and behavior of the device.
3. The memory includes instructions executable by the electronic processor, the instructions, when executed by the electronic processor, causing the controller to: a) requesting the touchscreen to display a plurality of user questions and a plurality of user input elements at which user input is received; b) causing a component of said device to be inoperative or prevented from operating until a predetermined number of said user inputs are received; 3. The apparatus of claim 2.
4. 4. The apparatus of claim 1, comprising: a flow generator; and a humidifier located within the housing downstream of and in fluid communication with the flow generator and upstream of and in fluid communication with the fluid outlet, the humidifier including a heater plate; and the controller in electrical communication with the flow generator and the heater plate to control activation and operation of the flow generator and the heater plate.
5. 5. The apparatus of claim 1, further comprising a network interface located within the housing and in electrical communication with the controller for transmitting the predetermined plurality of user inputs to an external or remote service or platform.
6. a power switch coupled to the controller and configured to switch between an on mode and an off mode, the respiratory assistance device operating based on the power switch switching from the off mode to the on mode; The apparatus of any one of claims 1 to 5, further comprising:
7. The device of claim 6 , wherein the power switch is a button, a knob, a dial, a rocker, a toggle, or a lever.
8. 8. The apparatus of claim 5, wherein the instructions cause the controller to request the network interface to transmit the predetermined plurality of user inputs one-by-one to a server patient and device management platform after each of the user inputs is received via the controller.
9. 8. The apparatus of claim 5, wherein the instructions cause the controller to request the network interface to transmit the predetermined plurality of user inputs to the patient and device management platform after all of the user inputs have been received via the controller.
10. 10. The apparatus of claim 5, wherein the instructions cause the controller to request the network interface to transmit the predetermined plurality of user inputs to the patient and device management platform in groups after a group of the user inputs is received via the controller.
11. The device according to any one of claims 1 to 10, wherein at least one of the user input elements is included in a group of user input elements corresponding to at least one of the user questions.
12. The device of any one of claims 1 to 11, wherein the group of user input elements comprises at least two user input elements that are visually distinct from one another.
13. The device of claim 12 , wherein the at least two user input elements are visually distinguished from one another based on color.
14. The device of claim 12 , wherein the at least two user input elements are visually distinguishable from one another based on color shading.
15. The device of any one of claims 12 to 14, wherein the at least two user input elements are visually distinguishable from one another based on shape.
16. The device of any one of claims 12 to 15, wherein the at least two user input elements are visually distinguished from one another based on size.
17. The apparatus of any one of claims 12 to 16, wherein the set of user input elements ranges from 2 to 9.
18. The apparatus of any one of claims 12 to 17, wherein the user input elements comprise strings of text.
19. The apparatus of any one of claims 12 to 18, wherein the user input elements comprise graphics.
20. 20. The apparatus of claim 19, wherein at least one component of the graphical group has alphanumeric content extending therethrough or thereon.
21. 21. The device of claim 19 or 20, wherein at least one component of the graphic group corresponds to alphanumeric content other than the user health question, the alphanumeric content being positioned outside the at least one component.
22. The device of any one of claims 1 to 21, wherein at least one of the user health questions includes an end-of-question mark.
23. An apparatus according to any preceding claim, wherein the user interface comprises a plurality of pages on which the user questions and the user input elements are arranged.
24. The apparatus of any preceding claim, wherein the user interface comprises a page presenting the user health questionnaire and the user input elements.
25. 25. The device of any one of claims 1 to 24, wherein the instructions cause the controller to repeatedly request the touch screen to display the user health questionnaire and the user input elements for a period of at least two consecutive days.
26. 26. The apparatus of any one of claims 1 to 25, wherein the network interface receives messages from the patient and device management platform, the messages being based on the predetermined plurality of user inputs sent to the patient and device management platform via the network interface.
27. 27. The device of claim 26, wherein the message comprises video content output via the touchscreen.
28. 27. The device of claim 26, wherein the housing contains a speaker and the message includes audio content output through the speaker.
29. 27. The apparatus of claim 26, wherein the network interface is a first network interface, the message is a first message, the housing has a second network interface that sends a second message to a computing device in response to the first message, the second message being related to the predetermined plurality of user inputs that are sent to the patient and device management platform via the first network interface, the second network interface being local to the computing device, and the computing device being other than the patient and device management platform.
30. 27. The device of claim 26, wherein the message advises of a user health parameter that has deteriorated over a predetermined period of time as determined based on at least one of the predetermined plurality of user inputs.
31. 31. The apparatus of claim 30, wherein the predetermined period of time is at least two days.
32. 31. The device of claim 30, wherein the message indicates that the user health parameter is deteriorating relative to a baseline value.
33. 31. The device of claim 30, wherein the message indicates that two or more health parameters have deteriorated for at least two days and therefore the patient is deteriorating.
34. The apparatus of any preceding claim, wherein the questions include health questions.
35. 35. The apparatus of claim 32, wherein at least one of the user input elements is included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including an odd number of user input elements, and the reference value is associated with a median user input element from the odd number of user input elements.
36. 34. The apparatus of claim 33, wherein at least one of the user input elements is included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including an odd number of user input elements, and the reference value is associated with a non-median user input element from the odd number of user input elements.
37. 34. The device of claim 33, wherein at least one of the user input elements is included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including an even number of user input elements, and the reference value is associated with a user input element from the even number of user input elements.
38. 38. The device of claim 1, wherein at least one of the user input elements is included in a group of user input elements corresponding to at least one of the user health questions, the group of user input elements including a first input element indicating a current position or a non-changing state of the health parameter, a second input element indicating an improvement in the health parameter, and a third user input element indicating a deterioration in the health parameter.
39. 39. The apparatus of claim 1, wherein at least one of the user input elements is a component of a pair of user input elements corresponding to at least one of the user health questions, the pair of user input elements corresponding to a pair of user inputs associated with a pair of mutually exclusive data points, and the user input includes a component of at least one of the pair of user inputs.
40. 40. The apparatus of any one of claims 1 to 39, wherein the instructions cause the controller to prevent or inhibit skipping of the user health question before activating the flow generator.
41. 41. The apparatus of any one of claims 1 to 40, wherein the instructions enable the controller to skip the user health question before activating the flow generator.
42. 42. The device of any one of claims 1 to 41, wherein the instructions cause the controller to request the touch screen to display a page after the controller receives the user input, the page presenting a menu for controlling or operating the flow generator or the humidifier or for inputting operating parameters of the flow generator or the humidifier.
43. 43. The apparatus of any one of claims 1 to 42, wherein the instructions cause the controller to request the touch screen to display the user health questions and the user input elements such that at least one of the user health questions or at least one of the user input elements is different between at least two instances of the flow generator being operational over a predetermined period of time.
44. 44. The apparatus of claim 43, wherein the predetermined period of time is at least two days.
45. 45. The device of claim 1, wherein the user health questions include a first question and a second question, the first question precedes the second question, the user input includes a first user input and a second user input, the first user input precedes the second user input, the first user input corresponds to the first question, the second user input corresponds to the second question, and the second question depends on content of the first user input.
46. 46. The apparatus of claim 45, wherein the first user input and the second user input are from the same user session.
47. 46. The apparatus of claim 45, wherein the first user input is from a first user session and the second user input is from a second user session, the first user session preceding the second user session.
48. An apparatus according to any preceding claim, wherein the controller receives the predetermined plurality of user inputs before the heater reaches a predetermined temperature.
49. An apparatus according to any preceding claim, wherein the user health questions and the user input elements are displayed on start-up of the controller.
50. 50. Apparatus according to any preceding claim, wherein the controller prevents the flow generator from operating.
51. 51. The apparatus of claim 50, wherein the controller prevents the flow generator from operating upon activation of the controller.
52. 52. Apparatus according to any preceding claim, wherein the controller prevents operation of the flow generator.
53. 53. The apparatus of claim 52, wherein the controller prevents operation of the flow generator upon activation of the controller.
54. Apparatus according to any preceding claim, wherein the predetermined plurality of user inputs is all of the user inputs.
55. 55. The apparatus of any preceding claim, wherein at least one of the user health questions relates to a user disease progression or a user health state.
56. 56. The apparatus of any one of claims 1 to 55, wherein the instructions enable the controller to skip the user health questions before activating the flow generator, such that the skipped user health questions form multiple data points that are transmitted to the patient and device management platform via the network interface.
57. 57. An apparatus according to any preceding claim, wherein the controller is configured to request the touchscreen to display a plurality of user questions and a plurality of user input elements through which user input is received when the apparatus is in a warm-up process and / or a drying process.
58. 1. A respiratory assistance apparatus comprising: a flow generator; a humidifier comprising a heater plate configured to heat the contents of a humidification chamber; a respiratory conduit for delivering breathable gas to the patient via the patient interface; a user I / O interface; a controller for controlling the flow generator and the humidifier; Equipped with A respiratory assistance device, wherein the controller is configured to present a health questionnaire including one or more questions when the device is in a warm-up and / or drying process.
59. 59. A respiratory assistance device according to claim 58, wherein the health questionnaire is presented by displaying a plurality of user questions and a plurality of user input elements through which user input is received.
60. The warm-up process a) at start-up of the device, or b) when the user is prompted to input one or more operating parameters of the respiratory assistance device (optionally via a therapy control screen); or c) when the user begins to input one or more operating parameters of the respiratory assistance device (optionally via a therapy control screen); or d) when the user initiates a treatment (optionally via a treatment control screen); or e) When manually activated by the user; 60. A respiratory aid apparatus as claimed in claim 58 or 59, configured to be actuated.
61. 61. A respiratory aid apparatus as claimed in claim 59 or 60, wherein the warm-up process comprises controlling the heater plate to a particular temperature.
62. 62. A respiratory assistance device according to claim 61, wherein the particular temperature is based on one or more temperature set points of the device (optionally, the temperature set points are one or more operating parameters of the device).
63. 63. A respiratory assistance apparatus as claimed in claim 61 or 62, wherein the specified temperature is about 35°C.
64. A respiratory assistance device according to any one of claims 59 to 63, wherein the device comprises a heater plate temperature sensor, and wherein the controller controls the temperature of the heater until the heater plate temperature sensor reaches the specified temperature.
65. A respiratory aid apparatus according to any one of claims 59 to 64, wherein the warm-up process comprises controlling the heater plate of the respiratory aid apparatus to control a chamber outlet temperature to a particular temperature.
66. 66. A respiratory assistance apparatus according to claim 65, wherein the chamber outlet is an outlet of a humidification chamber, optionally measured at an elbow located after the chamber outlet of the humidification chamber.
67. A respiratory aid apparatus according to any one of claims 64 to 66, wherein controlling the heater plate comprises controlling power provided to the heater plate.
68. A respiratory assistance device as described in any one of claims 64 to 66, wherein the particular temperature is based on one or more temperature set points of the device (optionally as one or more operating parameters of the device for the therapy).
69. 69. A respiratory assistance apparatus as described in claim 68, wherein the particular temperature is about 5°C to about 15°C, or within about 10°C, or optionally about 5°C to about 15°C or about 10°C below one or more set points.
70. 70. A respiratory aid apparatus as claimed in claim 68 or 69, wherein the one or more temperature set points are a desired dew point or a desired patient end temperature.
71. A respiratory assistance device as described in any one of claims 68 to 70, wherein one or more temperature set points correspond to a required relative humidity or a required absolute humidity, optionally wherein the relative humidity is between about 90% and about 100%, or about 100%.
72. A respiratory assistance device as described in any one of claims 59 to 71, wherein the warm-up process includes controlling a heater wire in a conduit attached to the device configured to provide gas to a patient to control the temperature at the end of the conduit to a conduit end specific temperature.
73. 73. A respiratory assistance device as claimed in claim 72, wherein the conduit end-specific temperature is based on one or more temperature set points of the device (optionally as one or more operating parameters of the device for therapy).
74. 74. A respiratory aid apparatus as claimed in claim 73, wherein the one or more temperature set points are a desired dew point or a desired patient end temperature.
75. 75. A respiratory aid apparatus as claimed in claim 73 or 74, wherein the conduit end-specific temperature is determined by a controller based on one or more selected temperature set points representative of a desired humidity.
76. A respiratory assistance apparatus as claimed in any one of claims 72 to 75, wherein the conduit end specific temperature is based on one or more temperature set points, the one or more temperature set points being desired patient end temperatures.
77. 77. A respiratory assistance apparatus as described in claim 76, wherein the conduit end specific temperature is within about 2°C to about 5°C, or about 2.5°C of the desired patient end temperature, optionally about 2°C to about 5°C, or about 2.5°C lower than the desired patient end temperature.
78. 78. A respiratory assistance apparatus as claimed in claim 77, wherein the conduit end specific temperature is a predetermined temperature.
79. A respiratory aid apparatus according to any one of claims 59 to 78, wherein the warm-up process includes the controller shutting down the flow generator.
80. A respiratory aid apparatus according to any one of claims 59 to 79, wherein the warm-up process comprises operating the flow generator at a predetermined flow rate or a predetermined flow generator output.
81. 81. A respiratory assistance apparatus as claimed in claim 80, wherein the predetermined flow rate is lower than the therapeutic gas flow being provided to the patient.
82. 81. A respiratory assistance apparatus according to claim 80, wherein the predetermined flow generator output is a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.
83. The controller: a) at the end of a treatment session, or b) When manually activated by the user, or c) when the standby process has been active for a predetermined amount of time; A respiratory aid apparatus as claimed in any one of claims 59 to 82 configured to activate the drying process.
84. 84. A respiratory assistance device according to claim 83, wherein a user indicates when the therapy session has ended via the user I / O interface.
85. 85. A respiratory assistance device as claimed in claim 83 or 84, wherein the end of therapy is determined by detecting that the user has removed the patient interface (and optionally a predetermined period of time has elapsed).
86. A respiratory assistance apparatus as described in any one of claims 59 to 85, wherein the drying process comprises controlling a heater wire in the breathing conduit while the flow generator provides gas at a set flow rate.
87. A respiratory assistance device as described in any one of claims 59 to 86, wherein the drying process includes controlling a heater plate of the humidifier to a predetermined value, or the heater plate can be turned off during the drying process.
88. A respiratory assistance device as claimed in any one of claims 59 to 87, wherein the heater wire is controlled by the controller to a predetermined temperature at the end of the patient breathing conduit or to a predetermined duty cycle or to a predetermined power.
89. 89. A respiratory assistance apparatus as claimed in claim 88, wherein the predetermined duty cycle is 100%.
90. 90. A respiratory assistance apparatus as claimed in claim 88 or 89, wherein the predetermined temperature is greater than 45°C.
91. A respiratory aid apparatus according to any one of claims 59 to 90, wherein the drying process is configured to operate for between about 20 minutes and about 40 minutes, or about 15 minutes.
92. 92. A respiratory assistance device as claimed in any one of claims 59 to 91, wherein the drying process comprises controlling the flow generator to provide a predetermined flow generator output, the flow generator output being a motor speed of between about 1000 RPM and about 3000 RPM or less than about 2000 RPM.
93. 93. A respiratory assistance apparatus as claimed in any one of claims 59 to 92, wherein the drying process comprises controlling the flow generator to provide a predetermined flow rate, the predetermined flow rate being between about 10 litres / minute and about 20 litres / minute.
94. A respiratory assistance device according to any one of claims 59 to 94, wherein the drying process is configured to evaporate any remaining condensate in the device and / or the patient breathing conduit and / or the patient interface.
95. A respiratory assistance device as claimed in any one of claims 59 to 94, wherein the controller is configured to disable or prevent operation of components of the device until a predetermined number of the user inputs are received.
96. A respiratory assistance apparatus according to any one of claims 57 to 95, wherein the controller prevents the delivery of therapy until the user input has been received and / or the warm-up process has been completed.
97. The controller is configured to determine a deterioration in patient health based on the answers to the user questions related to one or more health parameters and one or more past answers to the user questions related to one or more health parameters, and the deterioration in patient health is determined by: A deterioration in two or more health parameters (optionally from baseline) for at least two days A respiratory assistance device according to any one of claims 57 to 95, based on
98. a flow generator; a respiratory conduit for delivering breathable gas to the patient via the patient interface; a user I / O interface; a controller for controlling the flow generator and the humidifier; Equipped with the controller is configured to display a health questionnaire on the user I / O interface, the health questionnaire including one or more user questions related to one or more health parameters, each question including a plurality of user input elements for receiving user input in response to the user question; the controller is configured to determine a deterioration in patient health based on the answers to the user questions related to one or more health parameters and one or more previous answers to the user questions related to one or more health parameters; said deterioration in the patient's health; A deterioration in two or more health parameters (optionally from baseline) for at least two days Respiratory support device based on.
99. 99. A respiratory assistance device as described in claim 98, wherein the one or more previous answers to the user questions related to one or more health parameters are stored locally on the device and / or on a patient and device management platform.
100. 100. A respiratory assistance device as described in claim 98 or 99, wherein the device and / or patient and device management platform or the patient and device management platform is configured to notify a user if a deterioration in the patient's health is determined.
101. A respiratory assistance apparatus according to any one of claims 98 to 100, wherein the deterioration in patient health is further based on a deterioration (optionally from a baseline) in one or more patient parameters.
102. 102. A respiratory assistance apparatus as described in claim 101, wherein the patient parameters are one or more of patient oxygen saturation (optionally measured by at least one patient sensor) and / or patient respiratory rate (optionally determined from a flow signal from a flow sensor).
103. 103. A respiratory assistance apparatus according to claim 101 or 102, wherein the patient parameter is measured by at least one patient sensor.
104. A respiratory assistance device as claimed in any one of claims 98 to 103, wherein the health questionnaire includes one or more questions relating to a COPD condition and / or one or more questions relating to a bronchiectasis condition.
105. 105. A respiratory assistance apparatus according to claim 104, wherein the questions of the health interview are ordered so that questions relating to COPD status are presented first, followed by questions relating to bronchiectasis.
106. 106. A respiratory assistance apparatus as claimed in claim 104 or 105, wherein general health questions are presented before questions relating to COPD status and questions relating to bronchiectasis.
107. A respiratory aid apparatus as claimed in any one of claims 98 to 106, comprising a humidifier comprising a heater plate configured to heat the contents of a humidification chamber.
108. A respiratory assistance device as described in any one of claims 98 to 107, wherein the user I / O is a touchscreen, and the touchscreen is at least 3.5 inches in diagonal dimension, or at least 4 inches in diagonal dimension, or 4.2 inches in diagonal dimension.
109. A respiratory assistance apparatus as claimed in any one of claims 98 to 108, wherein the health questionnaire is displayed at the start of treatment and / or at the end of treatment.
110. A respiratory assistance device according to any one of claims 98 to 109, wherein the controller is configured to display the health questionnaire when the device is in a warm-up and / or drying process.