Graphical user interface for flow therapy apparatus
Patent Information
- Application Number
- JP2024175948
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2017-12-08
- Filing Date
- 2024-10-07
- Publication Date
- 2025-10-22
AI Technical Summary
Existing respiratory devices lack an intuitive and adaptable graphical user interface for displaying and managing multiple parameters, including those from connected peripheral devices, which can hinder effective patient monitoring and device operation.
A graphical user interface for respiratory devices that dynamically adjusts display elements based on detected peripheral devices, prioritizes parameters, and includes automatic and manual modes for parameter control, with features like confidence value monitoring and ambient light adjustment.
Enhances user interaction and monitoring capabilities by providing a flexible and responsive interface that accommodates additional parameters and ensures reliable operation, improving patient care through enhanced parameter visibility and control.
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Abstract
Description
[Technical Field]
[0001] The present disclosure relates to a graphical user interface for controlling a flow therapy device. [Background technology]
[0002] Respiratory devices are used in a variety of settings, such as hospitals, medical facilities, home care, or home environments, to provide a flow of gas to a user or patient. The respiratory device, or flow therapy device, may include an oxygen inlet to allow for the delivery of supplemental oxygen along with the gas flow, and / or a humidifier to provide heated and humidified gas. A graphical user interface may be used to display characteristics of the gas flow, including flow rate, temperature, gas concentration such as oxygen concentration, humidity, pressure, etc. Summary of the Invention [Means for solving the problem]
[0003] According to certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a respiratory assistance device includes a housing; a display; and one or more processors configured with computer-readable instructions to generate a graphical user interface on the display including a parameter display portion including a first plurality of parameter display elements, each parameter display element configured to display a parameter value associated with a parameter of the respiratory assistance device, the first plurality of parameter display elements arranged in a first configuration to substantially fill the parameter display portion; receive input to include additional parameter display elements within the parameter display portion, the additional parameter display elements associated with the additional parameters; modify the parameter display portion to include the additional parameter display elements associated with the additional parameters, the modifying of the parameter display portion including generating the additional parameter display elements within the parameter display portion; modifying a shape of one or more of the first plurality of parameter display elements; and positioning the first plurality of parameter display elements and the additional parameter display elements within the parameter display portion to form a second plurality of parameter display elements, the second plurality of parameter display elements arranged in a second configuration within the parameter display portion.
[0004] In some configurations, the input is an indication that a peripheral device has been added to the respiratory assistance apparatus.
[0005] In some configurations, the display is generated automatically after the peripheral device is detected by the respiratory assistance apparatus.
[0006] In some configurations, the peripheral device is at least one of a pulse oximeter, a CO2 sensor, or a pressure sensor.
[0007] In some configurations, the peripheral device is a pulse oximeter.
[0008] In some configurations, the additional parameter is at least one of the patient's blood oxygen saturation, pulse rate, respiratory rate, perfusion index, CO2 concentration, or pressure.
[0009] In some configurations, the second plurality of parameter display elements substantially fills the parameter display portion.
[0010] In some configurations, the computer readable instructions further configure the processor to arrange the parameter display elements based on a priority value associated with each parameter.
[0011] In some configurations, the computer readable instructions further configure the processor to display a visual indication of the confidence values associated with the parameters of the parameter display elements of the second plurality of parameter display elements.
[0012] In some configurations, the visual indication changes the color of the displayed parameter value of the parameter display element.
[0013] In some configurations, once the confidence value falls below a threshold, the parameter value is no longer displayed.
[0014] In some configurations, the computer-readable instructions further configure the processor to transition from the first operating mode to the second operating mode when the parameter value exceeds or falls below a threshold associated with a parameter associated with one of the parameter display elements of the second plurality of parameter display elements, and to display a visual indication of the transition from the first operating mode to the second operating mode.
[0015] In some configurations, the computer-readable instructions further configure the processor to display a graphical user interface including input controls configured to receive input from a user to change the operating value of the parameter.
[0016] In some configurations, after the operating parameter value of a parameter is modified, the parameter display element for the parameter provides a graphical indication that the respiratory assistance device is adjusting the parameter until the parameter transitions to the modified value.
[0017] In some configurations, each parameter display element is associated with a different color.
[0018] In some configurations, each parameter display element displays the units of the parameter associated with the parameter display element.
[0019] In some configurations, the displayed value of the parameter is larger than the display of the units.
[0020] In some configurations, the device includes an ambient light sensor configured to sense ambient light, and the computer-readable instructions further configure the processor to automatically adjust the brightness of the display based on an output of the ambient light sensor.
[0021] In some configurations, the input is a user input, and the graphical user interface is configured to receive from a user a selection of parameters for addition to the parameter display portion.
[0022] In some configurations, for a first parameter display element of the first plurality of parameter display elements, the parameter value is a first parameter value, the parameter is a first parameter of the respiratory assistance device, and the first parameter display element is configured to display a second parameter value associated with a second parameter of the respiratory assistance device together with the first parameter value of the first parameter.
[0023] In some configurations, the representation of the first parameter value is larger than the representation of the second parameter value.
[0024] In some configurations, the first parameter is a primary parameter, the second parameter is a secondary parameter, and the secondary parameter is related to the primary parameter.
[0025] In some configurations, both the primary parameter and the secondary parameter are determined based on data received from the first patient sensor.
[0026] According to certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a method includes: generating a graphical user interface on a display of a respiratory assistance device, the graphical user interface including a parameter display portion including a first plurality of parameter display elements, each parameter display element configured to display a parameter value associated with a parameter of the respiratory assistance device, the first plurality of parameter display elements being arranged in a first configuration to substantially fill the parameter display portion; receiving input to include additional parameter display elements within the parameter display portion, the additional parameter display elements being associated with additional parameters; generating the additional parameter display elements within the parameter display portion; modifying a shape of one or more of the first plurality of parameter display elements; and positioning the first plurality of elements and the additional parameter display elements within the parameter display portion to form a second plurality of parameter display elements, the second plurality of parameter display elements being arranged in a second configuration within the parameter display portion.
[0027] In some configurations, the input is an indication that a peripheral device has been added to the respiratory assistance apparatus.
[0028] In some configurations, the display is generated automatically after the peripheral device is detected by the respiratory assistance apparatus.
[0029] In some configurations, the additional parameter is a patient parameter measured by a peripheral device.
[0030] In some configurations, the peripheral device is at least one of a pulse oximeter, a CO2 sensor, or a pressure sensor.
[0031] In some configurations, the additional parameter is at least one of the patient's blood oxygen saturation, pulse rate, respiratory rate, perfusion index, CO2 concentration, or pressure.
[0032] In some configurations, the second plurality of elements substantially fills the parameterized portion in the second configuration.
[0033] In some configurations, the method includes arranging the parameter display elements based on a priority value associated with each parameter.
[0034] In some configurations, the method includes displaying a visual representation of confidence values associated with parameters of parameter display elements of the second plurality of parameter display elements.
[0035] In some configurations, the visual indication changes color of the parameter value.
[0036] In some configurations, the method includes no longer displaying the parameter value when the parameter confidence value falls below a threshold.
[0037] In some configurations, the method includes transitioning from the automatic operating mode to the manual operating mode when the parameter value exceeds or falls below a threshold associated with a parameter associated with one of the parameter display elements of the second plurality of parameter display elements, and displaying a visual indication of the transition from the automatic operating mode to the manual operating mode.
[0038] In some configurations, the method includes displaying a graphical user interface including an input control configured to receive input from a user to change the operating value of the parameter.
[0039] In some configurations, after the operating parameter value of a parameter is modified based on input received from the user, the parameter display element for the parameter provides a graphical display indicating that the respiratory assistance device is adjusting the parameter until the parameter transitions to the modified value.
[0040] In some configurations, each parameter display element is associated with a different color.
[0041] In some configurations, each parameter display element displays the units of the parameter associated with the parameter display element.
[0042] In some configurations, the displayed value of the parameter is larger than the display of the units.
[0043] In some configurations, the method includes an ambient light sensor configured to sense ambient light, and the computer readable instructions further configure the processor to automatically adjust the brightness of the display based on an output of the ambient light sensor.
[0044] In some configurations, receiving the input includes receiving a selection of a parameter from a user for addition to the parameter display portion.
[0045] In some configurations, for a first parameter display element of the first plurality of parameter display elements, the parameter value is a first parameter value, the parameter is a first parameter of the respiratory assistance device, and the method further includes displaying, by the first parameter display element, a second parameter value associated with a second parameter of the respiratory assistance device together with the first parameter value of the first parameter.
[0046] In some configurations, the representation of the first parameter value is larger than the representation of the second parameter value.
[0047] In some configurations, the first parameter is a primary parameter, the second parameter is a secondary parameter, and the secondary parameter is related to the primary parameter.
[0048] In some configurations, both the primary parameter and the secondary parameter are determined based on data received from the first patient sensor.
[0049] According to certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a respiratory assistance device includes a housing, a display, and one or more processors configured with computer-readable instructions to generate a graphical user interface on the display including a parameter display portion including a first plurality of parameter display elements, each parameter display element associated with a parameter of the respiratory assistance device, and wherein during a first operating mode, the first plurality of parameter display elements are arranged in a first configuration; receive an indication that the respiratory assistance device has entered a second operating mode; and during the second operating mode, provide a link indicator that visually links two or more parameter display elements to form linked parameter display elements.
[0050] In some configurations, the computer readable instructions further configure the processor to display operational limits for each linked parameter display element associated with the second mode of operation.
[0051] In some configurations, the computer readable instructions further configure the processor to display a visual indicator that provides an indication of the current value of the parameter relative to the operating limit.
[0052] In some configurations, visually linking two or more parameter display elements includes changing the shape of at least one of the linked parameter display elements.
[0053] In some configurations, visually connecting two or more parameter display elements includes removing gaps between the two or more parameter display elements.
[0054] In some configurations, the link indicator is a frame surrounding the linked parameter display elements.
[0055] In some configurations, during the second operating mode, the operating limits of at least one of the parameters associated with the linked parameter display element are displayed.
[0056] In some configurations, the device includes an ambient light sensor configured to sense ambient light, and the computer-readable instructions further configure the processor to automatically adjust the brightness of the display based on an output of the ambient light sensor.
[0057] In some configurations, for a first parameter display element of the first plurality of parameter display elements, the parameter value is a first parameter value, the parameter is a first parameter of the respiratory assistance device, and the first parameter display element is configured to display a second parameter value associated with a second parameter of the respiratory assistance device together with the first parameter value of the first parameter.
[0058] In some configurations, the representation of the first parameter value is larger than the representation of the second parameter value.
[0059] In some configurations, both the first parameter and the second parameter are determined based on data received from the first patient sensor.
[0060] In some configurations, a first parameter display element of the linked parameter display elements is blood oxygen saturation and a second parameter display element of the linked parameter display elements is oxygen concentration.
[0061] According to certain features, aspects, and advantages of at least one of the embodiments disclosed herein, a method includes generating a graphical user interface on a display of a respiratory assistance device, the graphical user interface including a parameter display portion including a first plurality of parameter display elements, each parameter display element associated with a parameter of the respiratory assistance device, and during a first operating mode, the first plurality of parameter display elements are arranged in a first configuration; receiving an indication that the respiratory assistance device has entered a second operating mode; and during the second operating mode, providing a link indicator that visually links two or more parameter display elements to form a linked parameter display element.
[0062] In some configurations, a first parameter display element of the linked parameter display elements is blood oxygen saturation and a second parameter display element of the linked parameter display elements is oxygen concentration.
[0063] In some configurations, the method includes displaying operational limits for each linked parameter display element associated with the second mode of operation.
[0064] In some configurations, the method further includes displaying a visual indicator that provides an indication of the current value of the parameter relative to the operating limit.
[0065] In some configurations, the method includes changing a shape of at least one of the linked parameter display elements when providing the linkage indicator.
[0066] In some configurations, the link indicator is a frame surrounding the linked parameter display elements.
[0067] In some configurations, the method includes displaying an operational limit associated with at least one of the linked parameter display elements during the second operational mode.
[0068] In some configurations, visually connecting two or more parameter display elements includes removing gaps between the two or more parameter display elements.
[0069] In some configurations, the method includes sensing ambient light with an ambient light sensor and automatically adjusting brightness of the display based on an output of the ambient light sensor.
[0070] In some configurations, for a first parameter display element of the first plurality of parameter display elements, the parameter value is a first parameter value, the parameter is a first parameter of the respiratory assistance device, and the method further includes displaying, by the first parameter display element, a second parameter value associated with a second parameter of the respiratory assistance device together with the first parameter value of the first parameter.
[0071] In some configurations, the representation of the first parameter value is larger than the representation of the second parameter value.
[0072] In some configurations, both the first parameter and the second parameter are determined based on data received from the first patient sensor.
[0073] Features of one or more embodiments or configurations may be combined with features of one or more other embodiments or configurations. Additionally, more than one embodiment may be used together during the process of assisting a patient's breathing.
[0074] As used herein, the term "comprising" means "consisting at least in part of." When interpreting each statement herein that includes the term "comprising," features other than those preceding the term may also be present. Related terms such as "comprise" and "comprises" should be interpreted similarly.
[0075] 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) and also to any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7); therefore, every subrange of every range explicitly disclosed herein is hereby expressly disclosed. These are merely examples of what is specifically intended, and all possible combinations of numerical values between the minimum and maximum values recited are likewise considered to be expressly set forth in this application.
[0076] It should be understood that alternative embodiments or configurations may include any or all combinations of two or more of the parts, elements, or features shown, described, or referenced herein.
[0077] The present invention may also be broadly considered to consist of any or all of the parts, elements, and features individually or collectively referenced or indicated in the specification of this application, and any combination of any two or more of said parts, elements, or features.
[0078] Numerous modifications in structure and widely different embodiments and applications of the present invention will suggest themselves to those skilled in the art to which this invention pertains without departing from the scope of the present invention as defined in the appended claims. The present disclosure and descriptions herein are purely illustrative and are not intended to be limiting in any sense. Where reference is made herein to specific integers that have known equivalents in the art to which this invention pertains, such known equivalents are deemed to be incorporated herein as if individually set forth. [Brief explanation of the drawings]
[0079] [Figure 1] 1 shows in schematic form a flow therapy device. [Figure 2A-2B] 1 illustrates a graphical user interface for a flow therapy device. [Figure 3A-3C]1 illustrates a graphical user interface of a flow therapy device including multiple parameter display elements. [Figures 4A-4D] 1 illustrates a graphical user interface of a flow therapy device including parameter display elements associated with patient sensors. [Figures 5A-5H] 1 illustrates a graphical user interface for a flow therapy device relating to configuring flow parameters for the flow therapy device. [Figures 6A-6F] 1 illustrates a graphical user interface of a flow therapy device associated with an automatic mode of operation of the flow therapy device. [Figure 7A-7C] 10 illustrates a graphical user interface of a flow therapy device in an alarm state. [Figures 8A-8F] 1 illustrates a graphical user interface of a flow therapy device showing trend data. DETAILED DESCRIPTION OF THE INVENTION
[0080] Flow Therapy Device A flow therapy device 10 is shown in FIG. 1. A flow therapy device may refer to any type of respiratory assistance or artificial respiration device that can be used to deliver a flow of gas to a user or patient. For example, a flow therapy device may include, but is not limited to, devices configured to provide high-flow therapy, non-invasive ventilation (NIV), continuous positive airway pressure (CPAP), bilevel positive airway pressure, minimally invasive ventilation (MIV), and / or other types of respiratory assistance treatment. Device 10 may include a main housing 1 that houses a flow generator 11 in the form of a motor / impeller arrangement (e.g., a blower), an optional humidifier 12, a controller 13, and a user interface 14 (e.g., including a display and input devices such as buttons, a touchscreen, etc.). Controller 13 may be configured or programmed to control the operation of the device. For example, the controller may control device components, including, but not limited to, operating the flow generator 11 to create a flow of gas (gas stream) for delivery to the patient, operating the humidifier 12 (if present) to humidify and / or heat the generated gas stream, controlling the flow of oxygen to the flow generator blower, receiving user input from the user interface 14 for reconfiguration and / or user-defined operation of the device 10, and outputting information to a user (e.g., on a display). In some configurations, the oxygen stream may be delivered into a flow therapy device downstream of the blower. The user may be a patient, medical personnel, or others involved in the use of the device. As used herein, "gas stream" may refer to any gas stream that may be used in a respiratory assistance or artificial ventilation device, such as a flow of ambient air, a flow containing substantially 100% oxygen, a flow containing some combination of ambient air and oxygen, etc.
[0081] The patient breathing conduit 16 is coupled at one end to a gas outlet 21 of the housing 1 of the flow therapy device 10. The patient breathing conduit 16 is coupled at the other end to a patient interface 17, such as a non-sealing nasal cannula having a manifold 19 and nasal prongs 18. Additionally or alternatively, the patient breathing conduit 16 may be coupled to a face mask, nasal mask, nasal pillow mask, endotracheal tube, tracheostomy interface, or the like. The gas flow generated by the flow therapy device 10 may be humidified and delivered to the patient via the patient conduit 16 through the cannula 17. The patient conduit 16 may include a heater wire 16a for heating the gas flow passing to the patient. The heater wire 16a may be under the control of the controller 13. The patient conduit 16 and / or the patient interface 17 may be considered part of the flow therapy device 10 or its peripheral devices. The flow therapy device 10, the breathing conduit 16, and the patient interface 17 together may form a flow therapy system.
[0082] The controller 13 can control the flow generator 11 to generate a gas flow at a desired rate. The controller 13 can also control a supplemental oxygen inlet valve to enable the delivery of supplemental oxygen, a humidifier 12 (if present) can humidify and / or heat the gas flow to an appropriate level, etc. The gas flow is directed to the patient through a patient conduit 16 and a cannula 17. The controller 13 can also control a heating element in the humidifier 12 and / or a heating element 16a in the patient conduit 16 to heat the gas to a desired temperature for a desired level of therapy and / or patient comfort. The controller 13 can be programmed with or can determine an appropriate target temperature for the gas flow.
[0083] The oxygen inlet port 28 can include a valve through which pressurized gas can enter the flow generator or blower. The valve can control the flow of oxygen to the flow generator blower. The valve can be any type of valve, including a proportional valve or a binary valve. The oxygen source can be an oxygen cylinder or a hospital oxygen supply. Medical-grade oxygen is typically 95% to 100% pure. Lower purity oxygen sources can also be used. Examples of valve modules and filters are disclosed in U.S. Provisional Patent Application No. 62 / 409,543, entitled "Valve Modules and Filter," filed October 18, 2016, and U.S. Provisional Patent Application No. 62 / 488,841, entitled "Valve Modules and Filter," filed April 23, 2017, both of which are incorporated herein by reference in their entireties.
[0084] The flow therapy device 10 can measure and control the oxygen content of the gas delivered to the patient, and therefore the oxygen content of the gas inhaled by the patient. In configurations where high-flow therapy is used, the high flow rate of gas delivered meets or exceeds the patient's maximum inspiratory demand. This means that the amount of gas delivered by the device to the patient during inspiration meets or exceeds the amount of gas inhaled by the patient during inspiration. Thus, high-flow therapy not only helps prevent entrainment of ambient air as the patient breathes in, but also flushes exhaled gases from the patient's airway. As long as the flow rate of delivered gas meets or exceeds the patient's maximum inspiratory demand, entrainment of ambient air is prevented, and the gas delivered by the device is substantially the same as the gas inhaled by the patient. Therefore, because the oxygen concentration measured by the device (fraction of oxygen delivered (FdO2)) is substantially the same as the oxygen concentration inhaled by the user (fraction of oxygen inspired (FiO2)), these terms may be interpreted as equivalent.
[0085] Operational sensors 3a, 3b, 3c, such as flow, temperature, and / or pressure sensors, may be located at various locations within the flow therapy device 10. Additional sensors (e.g., sensors 20, 25) may be located at various locations on the patient conduit 16 and / or cannula 17 (e.g., temperature sensor 29 may be present at or near the end of the inspiratory tube). Output from the sensors may be received by the controller 13 to assist the controller in operating the flow therapy device 10 to provide appropriate therapy. In some configurations where high-flow therapy is used, providing appropriate therapy includes meeting the patient's maximum inspiratory demand. The device 10 may include a transmitter and / or receiver 15 to enable the controller 13 to receive signals 8 from the sensors and / or control various components of the flow therapy device 10, including, but not limited to, the flow generator 11, humidifier 12, and heater wire 16a, or accessories or peripherals associated with the flow therapy device 10. Additionally or alternatively, the transmitter and / or receiver 15 may provide data to a remote server or allow remote control of the device 10 .
[0086] Oxygen may be measured by placing one or more gas composition sensors (such as an ultrasound transducer system) after mixing of the oxygen with ambient air is complete. Measurements can be made in the device, the supply conduit, the patient interface, or any other suitable location.
[0087] The oxygen concentration may also be measured by using flow sensors in at least two of the ambient air inlet conduit, the oxygen inlet conduit, and the final supply conduit to determine the flow rates of at least two gases. By determining the flow rates of both inlet gases or one inlet gas and one total flow rate, along with the assumed or measured oxygen concentration of the inlet gases (approximately 20.9% for ambient air and approximately 100% for oxygen), the oxygen concentration of the final gas composition can be calculated. Alternatively, flow sensors can be located in all three of the ambient air inlet conduit, the oxygen inlet conduit, and the final supply conduit to allow for redundancy and testing of each sensor for proper operation by checking the consistency of readings. Other methods of measuring the oxygen concentration delivered by the flow therapy device 10 may also be used.
[0088] The flow therapy device 10 may include an ambient light sensor 30. The ambient light sensor 30 may be located near the user interface 14. The ambient light sensor 30 may enable the flow therapy device 10 to automatically change the brightness of the screen based on the level of ambient light. This may be particularly beneficial because the device may be used at home or in a hospital room where people are sleeping.
[0089] The flow therapy device 10 may include a patient sensor 26, such as a pulse oximeter, that measures one or more physiological parameters of the patient, such as the patient's blood oxygen saturation (SpO2), heart rate, respiratory rate, perfusion index, etc., and provides a signal quality measurement. The patient sensor 26 may be referred to as a peripheral device. The sensor 26 may communicate with the controller 13 via a wired connection or by communication via a wireless transmitter on the sensor 26. The sensor 26 may be a disposable adhesive sensor designed to be connected to the patient's finger. The sensor 26 may also be a non-disposable sensor. Sensors designed for various age groups and that can be connected to various patient locations and used with the flow therapy device are available. The pulse oximeter is typically attached to the user's finger, although other locations, such as the earlobe, are also optional. The pulse oximeter is connected to a processor within the device and continuously provides a signal indicative of the patient's blood oxygen saturation. In some configurations, the patient sensor 26 may be a carbon dioxide (CO2) sensor or pressure sensor. The CO2 sensor can measure the concentration of exhaled CO2. The pressure sensor may measure ambient pressure, pressure at the patient interface, or pressure within the fluid line.
[0090] Several types of flow therapy devices can provide high-flow therapy, which can be administered nasally and / or orally or via a tracheostomy interface. High-flow therapy can deliver gas to a user at a flow rate that meets or exceeds the intended user's maximum inspiratory flow requirements. High-flow therapy can create a washout effect in the nasopharynx, such that the high input gas flow flushes out the anatomical dead space in the upper airway. This creates a reservoir of fresh gas available for each breath while minimizing nitrogen and carbon dioxide rebreathing. Meeting inspiratory demand and airway washout are even more important when attempting to control a patient's FdO2. High-flow therapy can be delivered using a non-sealing patient interface, such as a nasal cannula. A nasal cannula may be configured to deliver respiratory gas to the user's nose at a flow rate that exceeds the intended user's maximum inspiratory flow requirements.
[0091] The flow generator or blower 11 may include an ambient air inlet port 27 for entraining ambient room air through the blower. The flow therapy device 10 may also include an oxygen inlet port 28 leading to a valve through which pressurized gas can enter the flow generator or blower 11. The valve can control the flow of oxygen to the flow generator or blower 11. The valve can be any type of valve, including a proportional valve or a binary valve.
[0092] The blower can operate at a motor speed greater than about 1,000 RPM and less than about 30,000 RPM, greater than about 2,000 RPM and less than about 21,000 RPM, or between any of the aforementioned values. Operation of the blower can mix gases entering the blower through the inlet port. Using the blower as a mixer can reduce pressure losses that would otherwise occur in systems with separate mixers, such as static mixers that include baffles, due to the energy required for mixing. In some configurations, oxygen can be entrained in the flow therapy device downstream of the blower.
[0093] Flow therapy devices can use closed-loop control, allowing the patient or clinician to set a target SpO2 instead of a target FdO2. The flow therapy device can automatically change the FdO2 of the flow therapy device to achieve the target SpO2 based on the target SpO2, the current SpO2, and the current FdO2 value. Automatic control of FdO2 can help quickly and accurately adjust the FdO2 until the target SpO2 is achieved. The system can generate a patient-specific model for each patient at the start of a treatment session. In some configurations, the system may continuously update the patient model throughout the treatment session. The flow therapy device can adjust the FdO2 as needed without constant clinician monitoring, allowing for greater accuracy in achieving the target SpO2 to remain within the target SpO2 range. The target value may also be referred to as an operating value.
[0094] The present disclosure provides a flow therapy device that can implement a closed-loop oxygen control system, the features of which may be combined with the features of one or more of the configurations disclosed herein.
[0095] The flow therapy device may be operated in an automatic mode or a manual mode. In the automatic mode, the controller can automatically control the FdO2 based on a target FdO2 determined based on the target SpO2. In the manual mode, the controller can receive a target FdO2 from a clinician or patient, such as via a user interface. In the automatic or manual mode, the valve at the oxygen inlet may be connected to a controller that can control the oxygen concentration in the gas flow based on the target FdO2. The controller can execute a control algorithm that can continuously measure the FdO2 output by the flow therapy device. The controller can continue to adjust the valve at the oxygen inlet until the measured FdO2 reaches the target FdO2. The measured FdO2 may be determined by a gas composition sensor.
[0096] The flow therapy device may be configured to change from automatic mode to manual mode if the patient's SpO2 is not within the acceptable patient range. In some cases, the flow therapy device automatically returns to manual mode if the patient's SpO2 is outside (above or below) the patient limits or if the patient's SpO2 does not transition within the limits within a specified time after the start of a therapy session. The flow therapy device may return to manual mode if the patient sensor signal quality falls below a threshold level for a specified time. In some configurations, the flow therapy device may activate an alarm when it switches from automatic mode to manual mode. In some configurations, the flow therapy device may activate an alarm, but the flow therapy device does not automatically switch from automatic mode to manual mode. An activated alarm may generate an option that the user can select to override automatic mode and return to manual mode. In such configurations, the alarm may be minimized, and the flow therapy device may continue to operate in automatic mode until the user manually switches the flow therapy device from automatic mode to manual mode. The alarm mode interface is discussed further herein with respect to at least Figures 7A-7C.
[0097] The closed-loop oxygen control system may employ two control loops. The first control loop may be implemented by an SpO2 controller. The SpO2 controller may determine a target FdO2 based in part on the target SpO2. As described above, the target SpO2 value may be a single value or a range of acceptable values. This value may be preset, selected by a clinician, or automatically determined based on patient background. Typically, the target SpO2 value is received or determined before or at the beginning of a treatment session, but the target SpO2 value may be received at any time during the treatment session. During a treatment session, the SpO2 controller may also receive as inputs a measured FdO2 reading from the gas composition sensor, as well as a measured SpO2 reading and a signal quality reading from the patient sensor. Based at least in part on this input, the SpO2 controller may output a target FdO2 to the second control loop.
[0098] The second control loop may be implemented by an FdO2 controller. The FdO2 controller may receive inputs of a measured FdO2 and a target FdO2. The FdO2 controller may then output an oxygen inlet valve control signal for controlling operation of the oxygen valve based on the difference between the measured and target FdO2 values. The FdO2 controller may also receive the target FdO2 value output from the first control loop when the flow therapy device is operating in automatic mode. The FdO2 controller may also receive additional parameters, such as a flow rate value, gas properties, and / or measured FdO2. The FdO2 controller may determine the oxygen flow rate required to achieve the target FdO2 from at least some of the inputs. The FdO2 controller may use the flow rate input to modify the valve control signal. If the flow rate changes, the FdO2 controller can automatically calculate the new required oxygen flow rate required to maintain the target FdO2 at the new flow rate without having to wait for feedback from a gas concentration sensor, such as a measured FdO2 value. The FdO2 controller can then output a modified valve control signal to control the valve based on the new flow rate. In some configurations, the FdO2 controller's control signal may set the oxygen valve's current to control the operation of the oxygen valve. Additionally or alternatively, the FdO2 controller can sense changes in the measured FdO2 and change the valve position accordingly. During manual mode, the second control loop can operate independently without receiving a target FdO2 from the first control loop. Rather, the target FdO2 can be received from a user input or an initial value.
[0099] During automatic mode, the flow therapy device may enter a learning phase in which the controller generates a patient-specific model. After the learning phase, the flow therapy device operates in a control phase using the patient-specific model until the end of the treatment session or until the flow therapy device enters manual mode. The flow therapy device may continuously update the patient-specific model throughout the treatment session. In such a configuration, the flow therapy device may eliminate the learning phase entirely. Further examples of closed-loop control systems are disclosed in International Application No. PCT / NZ2018 / 050137, filed October 4, 2018, entitled "Closed Loop Oxygen Control," which is incorporated herein by reference in its entirety.
[0100] User Interface 2A-8F illustrate an example of a graphical user interface 100 of the user interface 14 of the flow therapy device 10. The graphical user interface 100 can provide a display of flow therapy treatment information and indicators of patient health. The flow therapy device 10 can be configured to display patient-related information on one or more user interface screens. Each screen of the user interface 100 can be configured to display one or more indicators related to the flow therapy session and the patient.
[0101] The graphical user interface 100 allows an operator to control the operation of the flow therapy device 100. The graphical user interface 100 may include a touch screen, which allows a user to directly interact with elements of the graphical user interface 100. The graphical user interface 100 may include a number of buttons for interacting with the flow therapy device. Other types of user input devices, such as a mouse, keyboard, stylus, and / or other devices, may also be used to interact with the user interface screen.
[0102] 2A and 2B, the graphical user interface 100 may include one or more buttons along the bottom of the display, which may include a back button 102, a trends button 103, a power button 104, and / or a menu button 106. In the configuration shown in FIG. 2B, the back button 102 has been replaced with the trends button 103. In such a configuration, the back button 102 may be provided in a different location within the graphical user interface 100, if appropriate. One or more of the buttons 102, 103, 104, and 106 may be graphical elements within the graphical user interface 100. One or more of the buttons 102, 103, 104, and 106 may be separate from the screen and the graphical user interface 100. The buttons may be capacitive. The buttons 102, 103, 104, and 106 may be sealed to prevent any gaps or crevices, thereby preventing the ingress of water and other particles.
[0103] One or more of the buttons located beneath the displays 102, 103, 104, and 106 may be configured to include a physical distinguishing feature so that a user can identify and / or distinguish the button by touch. The button may be recessed, protruding, and / or have a different texture on its surface. This allows a user to identify and / or distinguish the button when its visual distinguishing feature is not visible, such as when the device is being used in the dark. In some configurations, only a subset of the buttons include a physical distinguishing feature. For example, the power button may be the only button that includes a physical distinguishing feature. This may allow a user to easily locate the power button in the dark to power up the device and turn on the screen. In some configurations, one or more of the buttons may be backlit and / or glow in the dark.
[0104] The physical distinguishing features may be used to identify the location of the buttons. Additionally, the physical distinguishing features may be different for each button so that a user can use the physical distinguishing features to distinguish between the buttons. The physical distinguishing features may be shaped to resemble the visual symbols of each button.
[0105] The physical distinguishing feature can be located on the button itself, allowing the physical distinguishing feature to indicate the exact location of the button. Alternatively, the physical distinguishing feature may be located adjacent to the button (such as above or below or on the housing), allowing a user to identify and / or distinguish between the buttons without accidentally pressing them, especially if the buttons are capacitive.
[0106] The graphical user interface 100 may include a top display portion 108, such as a bar. The top display portion 108 may be divided into one or more subsections. The top display portion 108 may display an operating mode element 110 that displays the current operating mode. A mode selection element 112 may be configured to display available operating modes and allow a user to switch between available modes. The top display portion 108 may include a display of a battery level 114, as shown in FIG. 2A . The top bar portion 108 may also include additional elements, such as a device settings element. The device settings may be accessible via a menu button. The device settings may be used to configure the device and may be configured to be generally inaccessible to the user so that they cannot be subsequently changed. For example, the device settings may be password protected.
[0107] The graphical user interface 100 may include a lower display portion 116 along the bottom of the screen. The lower display portion 116 may display notifications to the user. The notifications may relate to the current status of the device, such as confirmation that a command is being executed. The lower display portion 116 may display warnings to the user. These warnings may initially be full-screen warnings and then minimize to the lower display portion 116 (as shown in FIGS. 7A-7C). The lower display portion 116 may then have an additional indicator that the warning still exists. In one configuration, the lower display portion 116 may flash yellow until the warning is dismissed. In some configurations, the warning screen may automatically maximize after a set amount of time after the warning screen minimizes or after the user last interacts with the flow therapy device. The lower display portion 116 may have an indication of whether the flow therapy device is in standby mode or operational mode. For example, the lower display portion 116 may be yellow when the device is standby, with an accompanying statement or indicator. The lower display portion 116 may include an indication of the battery level 114, as shown in Figure 2B. In some configurations, the lower display portion may include an indication that the flow therapy device is communicatively connected to another device, such as via USB, WiFi, GSM, Bluetooth, and / or other wired or wireless communication interface.
[0108] The graphical user interface 100 may include a central or main display portion 118 disposed between the upper display portion 108 and the lower display portion 116. The main display portion 118 may include multiple parameter display elements 120. The parameter display elements 120 may also be referred to as parameter elements or parameter tiles. Each parameter display element 120 may correspond to a device or patient parameter. Each type of patient or device parameter may be associated with a specific color (e.g., flow rate may be blue, FiO2 may be green, etc.). Associating a specific color with each parameter allows a user to quickly recognize the type of parameter being displayed by the graphical user interface 100. The graphical user interface 100 may include a start / stop tile 125 (as shown in FIG. 2B). The start / stop tile 125 may be used to switch between therapy mode and standby mode. The start / stop tile 125 may additionally include a graphical indication of whether the device is in therapy mode or standby mode. In the configuration of FIG. 2B, the tile 125 includes a fan icon. In standby mode, the fan icon may be gray and stationary. In therapy mode, the fan icon may be white and spinning. The start / stop tile 125 may include text to indicate whether the device is in therapy mode or standby mode.
[0109] The parameter display element 120 may include a parameter value 122 and a parameter label 124. The parameter value 122 may be a number representing the value of the parameter, and the parameter label 124 may display the parameter's units. The parameter's units are constant. The units may provide an indication of what the parameter display element represents. For example, L / min indicates that the parameter is a flow rate. The label may be configured to display a name or abbreviation associated with the parameter in addition to or instead of the parameter's units. For example, the parameter label 124 may alternate between units and an abbreviation. The label 124 may be smaller than the parameter value 122. In some configurations, the parameter display element may include a second device or patient parameter 123. The second parameter 123 may include a corresponding parameter value and label (which may include the parameter's units and / or an icon). In the configuration shown in FIG. 2B, the second parameter 123 is a respiratory rate and is incorporated into the flow rate tile. In the illustrated configuration, the respiratory rate is accompanied by an icon (such as a pair of lungs) to indicate what the number represents. If the second parameter cannot be measured, this section of the parameter display element can be left blank. For example, as shown in FIG. 2A , no second parameter value or label may be displayed. If the second parameter can be measured, the second parameter can be automatically displayed within the parameter display element without modifying the configuration of the parameter display element on the main display portion 118. This can be advantageous because alternatives can be to have occasionally blank parameter display elements or to have constantly changing parameter display element layouts based on whether a second parameter (such as respiratory rate or another parameter) can be measured.
[0110] A larger parameter within a parameter display element 120 may be referred to as a primary parameter. A primary parameter of a parameter display element may be displayed at all times, even if there is sometimes no current parameter value to display (such as the parameter display element of FIG. 4A). A secondary parameter may be referred to as a secondary parameter if the secondary parameter is related to or dependent on the primary parameter. Primary and secondary parameters may be grouped, combined, or otherwise related based on the relationship between the parameters and / or the sensors used to measure the parameters. For example, SpO2 and pulse rate may be grouped because both parameters may be measured using the same patient sensor, such as a pulse oximeter.
[0111] The parameter display element may have different units of measurement associated with each parameter. For example, some non-limiting examples of units for various parameters are as follows: Oxygen concentration: FiO2, FdO2, O2 (including % symbol, decimal value, or use oxygen partial pressure) Oxygen saturation: SpO2, SaO2 Flow rate: L / min, LPM, L.min-1, liters per minute Breathing rate: RR, BPM, breaths / min temperature: °C, °F pressure: cmH2O, mmHg, Pa, psi CO2 concentration: CO2 (CO2 ratio or CO2 partial pressure)
[0112] As shown in FIG. 2A, the parameter values 122 may be significantly larger than the parameter labels 124. The parameter values 122 may be updated at a predetermined rate based on the parameter. For example, the flow rate may be updated periodically (e.g., every second, every two seconds, etc.), aperiodically, event-based (e.g., when the value changes), or other configuration setting-based. In FIG. 2A, the three parameter display elements 120 are the same size and shape. The parameter display elements 120 may have different sizes and shapes.
[0113] The graphical user interface 100 may include a default set of parameter display elements 120 that are displayed when the flow therapy device is powered on. The default parameter display elements 120 may be the parameter display elements 120 displayed in FIG. 2A . The flow therapy device may be configured to allow a user to determine the default parameter display elements 120 displayed by the graphical user interface 100. The flow therapy device may allow a user to change the position or order of the parameter display elements 120 within the graphical user interface 100. Each of the displayed parameter display elements may be user-selectable. The parameter display elements 120 may have a predetermined number of settings that can be modified by the user. For example, the user may be able to set the operating value of the parameter or modify various display characteristics, such as color, abbreviation, or other display characteristics associated with the parameter. The user may be able to select two or more parameters that can be displayed on a single parameter display element. In some configurations, the user can select a primary parameter to display and a secondary parameter to display. In such configurations, the secondary parameters available for display may be limited to parameters related to the primary parameter (e.g., parameters measured using the same patient sensor).
[0114] 2A, the graphical user interface 100 is in a landscape or horizontal orientation, but the same design characteristics may apply to a portrait or vertical orientation of the graphical user interface 100. For example, the illustrated layout may be rotated 90 degrees, in which case the top and bottom portions may be located at the top and bottom of the screen, or alternatively, the top and bottom portions may extend to the sides. In a vertical orientation, the parameter display elements 120 may be stacked vertically. Each parameter display element 120 may have the same width and height.
[0115] 3A and 3B, the graphical user interface 100 may be configured so that additional parameter display elements 120 are added to the main display portion 118. The shape of the existing parameter display elements 120 may be automatically adjusted to accommodate the additional parameter display elements 120 within the main display portion 118. The shape of each parameter display element 120 may be configured to use substantially all of the available space within the main display portion 118.
[0116] Generally, modifying the shape of a parameter display element involves modifying the shape characteristics of the parameter display element. Some examples of shape characteristics that can be modified may include the type of shape (e.g., rectangular, circular, octagonal, rhomboid, specially designed shape, or any other type of shape), the dimensions of the shape (e.g., the height and width of a rectangle), the aspect ratio, and / or other characteristics that affect the shape of the parameter display element. Other visual characteristics of the parameter display element may be modified based on changes in the shape of the parameter display element. For example, the format of icons and / or text within the parameter display element may depend on the shape of the parameter display element and may be automatically modified to accommodate changes in shape (e.g., font size is reduced as the shape becomes smaller). A change in shape may refer to a change in size and / or aspect ratio while maintaining the same general shape of the parameter display element. In the configuration shown in FIG. 3A , the respiration rate parameter “RR” has been added to the main display portion 118.
[0117] Advantages of automatically adjusting the shape to fill the entire area may include the display of larger parameter display elements that are easier to read, especially when viewed from a distance. When fewer parameter display elements are present, it is preferable to utilize all available space by changing the shape of the icons. When additional parameter display elements are added, it is preferable to change the shape of the parameter display elements so that all parameter display elements fit on the screen. An alternative to this is that not all display elements are visible at once, and thus the user must interact with the screen to see them. This leads to the user being unable to see parameters from a distance if the corresponding display element is not already displayed on the screen. Additionally, the relative size of parameter display elements on the display can help indicate the importance of the parameters. More important parameters can have a larger size relative to other parameters, which can help the user focus on the more important parameters and relegate less important parameters to the background.
[0118] Additional parameter display elements 120, such as parameter display elements 120 related to different patient parameters, may optionally be displayed. These parameter display elements 120 may be added by a user selecting additional parameters to display through configuration. Additionally or alternatively, different embodiments of the flow therapy device may be configured to display specific parameters according to the flow therapy device's specifications or specific user requirements. Additionally or alternatively, certain parameters may be displayed only when appropriate hardware is connected (e.g., SpO2 may be displayed only when a pulse oximeter is connected). Additional parameters may include respiratory rate, oxygen saturation, pulse rate, CO2 concentration, pressure, and / or other parameters. In some configurations, the flow therapy device may automatically add parameters associated with a peripheral device when the peripheral device is connected to the flow therapy device. For example, the flow therapy device may automatically generate a display after detecting that a peripheral device has been connected and then add parameters measured by the peripheral device to the parameter display portion.
[0119] As additional parameters are added, the parameter display elements 120 may be adjusted to accommodate the additional parameter display elements 120. The system may generate the additional parameter display elements within the parameter display portion. The shape of existing parameter display elements may be modified to accommodate the additional parameter display elements. One or more of the existing parameter display elements may be repositioned to accommodate the additional parameter display elements. The new configuration of parameter display elements may include substantially all of the main display portion 118. This layout may be similar to that described above, with the parameter display elements 120 arranged side-by-side. Alternatively, to maintain a desired aspect ratio of the parameter display elements 120, the parameter display elements 120 may be arranged such that some parameter display elements 120 are stacked on top of each other and the remaining parameter display elements 120 are arranged side-by-side. Exemplary layouts are shown in FIGS. 3a and 3b.
[0120] FIG. 3A shows a sample layout of four parameter display elements 120, with the larger parameter display elements 120 dominating and displayed side-by-side, while the remaining smaller parameter display elements 120 are smaller and stacked on top of each other. Alternatively, the smaller parameter display elements 120 can be to the right or midway between the larger parameter display elements 120. The larger parameter display elements 120 may be wider than the smaller parameter display elements 120, with the larger parameter display elements 120 in FIGS. 3A and 3B shown as approximately twice the width of the smaller parameter display elements 120. In a four-tile arrangement (FIG. 3A), the larger and smaller parameter display elements 120 each have approximately the same aspect ratio. In a five-tile arrangement (FIG. 3B), the smaller parameter display elements 120 have an altered aspect ratio, and the units of each smaller parameter display element 120 may be positioned next to the parameter value rather than below it. The larger parameter display elements 120 may be automatically determined based on a priority value associated with each parameter, user configuration settings, and / or system configuration settings. Each parameter may have a defined priority value. The priority value may be used to determine the parameter's position within the display. For example, higher priority parameters may be larger blocks, while lower priority parameters may be smaller blocks. In FIG. 3A, FiO2 and flow rate are displayed as larger parameter display elements 120.
[0121] In Figure 3B, an additional parameter display element 120, SpO2, has been added to the main display portion 118. This layout, with five parameter display elements 120, is similar to the configuration of Figure 3A, with two parameter display elements 120 occupying a larger amount of space and the remaining three parameter display elements 120 stacked on top of each other to the side.
[0122] 3C shows four parameter display elements 120 with a start / stop tile. The SpO2 parameter display element 120 has pulse rate as a secondary parameter 123. The flow parameter display element 120 has respiratory rate as a secondary parameter 123. Thus, this layout corresponds to the display of six parameters, two of which are secondary parameters.
[0123] 4A-4D provide an example of a graphical user interface 100 after a patient sensor, such as a pulse oximeter measuring SpO2, is connected to a flow therapy device. The flow therapy device receives an indication that a sensor is connected and can automatically detect the type of patient sensor. The patient sensor may provide multiple patient parameters to the flow therapy device. The layout of the graphical user interface 100 can be modified to accommodate one or more parameter display elements associated with the patient sensor. For example, a pulse oximeter can provide SpO2 data and pulse rate data, among other patient parameters. The flow therapy device may automatically add one or more parameter display elements associated with the patient sensor to the graphical user interface, or a user may manually add the parameters to the graphical user interface.
[0124] If a patient sensor parameter is unavailable (e.g., connected to the flow therapy device but not to the patient), the flow therapy device may provide an indication that the parameter value cannot be displayed. For example, as shown in FIG. 4A, the value may be indicated with two dashed lines in place of the parameter value. If the patient sensor provides the parameter value, the parameter value may be displayed on the graphical user interface 100.
[0125] After a patient parameter signal is received by a patient sensor, the display of the parameter value may be delayed until a confidence value (e.g., signal quality value) associated with the parameter meets a threshold. The graphical user interface 100 may be configured to provide an indication that patient parameter data has been received but is not yet ready for display. The indication may include changing the color of the parameter value (e.g., graying out the parameter value), providing an auxiliary indicator 129 (e.g., a spinning disk icon), and / or providing another indication on the graphical user interface 100. When the confidence value (e.g., signal quality) of the patient monitor falls below a specified threshold, the display of the parameter value may be altered (e.g., replacing the parameter value with a dashed line or changing the color of the parameter value).
[0126] The screens shown in Figures 4A-4C provide exemplary displays illustrating various steps associated with using a patient sensor with a flow therapy device. The screen shown in Figure 4A may be displayed when a patient sensor is connected to the flow therapy device but the patient is not wearing the patient sensor (or the patient is wearing the patient sensor but the patient cannot be detected).
[0127] 4B may be displayed when patient sensors are connected to the device and the patient is wearing the patient sensors, but patient parameters (such as SpO2) cannot be measured or have not yet been measured, which may be because the patient has only recently worn the patient sensors.
[0128] The screen shown in Figure 4C may be displayed when a patient sensor is connected to the device, the patient is wearing the patient sensor, and a patient parameter (such as SpO2) can be measured, but the signal quality is below a threshold. The screen shown in Figure 4D may be displayed when a patient sensor is connected to the device, the patient is wearing the patient sensor, and a patient parameter (such as SpO2) can be measured, and the signal quality is above a threshold.
[0129] 5A-5H, a user can change a parameter (also referred to as the parameter's operating value) in a parameter display element 120 by selecting the parameter element, such as by touching the element on a touchscreen. The parameter may also be modifiable via settings. Once a parameter is selected, the upper portion 108 may change to provide information about the parameter being changed. The upper portion may also include a confirmation element 132 or a cancel element 134. The parameter change screen may allow a user to set the parameter's operating value for the flow therapy device. The graphical user interface 100 may display input elements 136 configured to provide user manipulation of the parameter. For example, the parameter may be increased or decreased. The input elements allow a user to easily decrease or increase the parameter's value. The graphical user interface may also include a range 138 or value indicating the range of operating limits for the parameter, as shown in FIGS. 5A-5C. In some configurations, such as those shown in FIGS. 5E-5F, the range may be indicated by a bar extending between upper and lower limits, with an icon 137 on the bar indicating where the current value is relative to the limits.
[0130] Once input from the user is received and confirmed, the lower portion 116 may provide notification that a change to the parameter is being implemented by the flow therapy device, as shown in FIGURE 5D. The parameter display element 120 of the parameter being changed may provide a visual indicator that it is changing, such as flashing between a first and a second brightness, changing color, changing shade, or making another visual change to the display characteristics of the parameter display element. For example, the first brightness may be a normal level and the second brightness may be dimmer or brighter than the first brightness.
[0131] The FiO2 interface may include input controls 136 for modifying the target FiO2 as shown in Figures 5C and 5G. Once the FiO2 target is selected, the user can confirm this value and the device will begin adjusting the FiO2 to this level.
[0132] Additionally or alternatively, when a pulse oximeter is connected to a flow therapy device or to a flow therapy device and a patient, the FiO2 interface may include an input 140 for initiating automatic closed-loop control of the FiO2 value to maintain a target SpO2. This auto mode input 140 may be unavailable if the SpO2 signal is too weak. The auto mode input 140 may be unavailable based on other conditions, such as an SpO2 measurement that is too low, a flow rate that is too low, flow restriction, a general fault condition (e.g., water outage, disconnected tubing, etc.), and / or other conditions that prevent the flow therapy device from executing the auto mode input. If auto mode is unavailable, the option may be removed entirely from the graphical user interface, as shown in FIG. 5G. Additionally, the bottom display portion may display an indication of why auto mode is unavailable.
[0133] The FiO2 graphical user interface may include high and low buttons 139 (as shown in FIG. 5G) that can be used to indicate whether a high-pressure or low-pressure oxygen source is connected to the flow therapy device. The high-pressure oxygen source is supplied through an oxygen control valve, which the device can control to titrate the FiO2 to a desired level. The low-pressure oxygen source is supplied through a low-pressure oxygen inlet, and the flow rate of this oxygen is not controlled by the device.
[0134] If the user selects low pressure, the screen shown in Figure 5H can be displayed and the user is instructed to titrate the oxygen concentration using the flow rotameter. Also, when a low pressure source is connected, the automatic mode is not available.
[0135] 6C and 6D , a display of a particular value may include a scale or range 126 indicating the current range limits 128 of a parameter, such as an acceptable range for a patient's SpO2 value. A value indicator 130 may indicate the value of the parameter on the scale 126 relative to the parameter limits 128. In some configurations, the value indicator may provide an indication of the trend of the parameter being measured. For example, the indicator 130 may be a neutral icon (e.g., a circle) or a directional icon, such as an up or down arrow, indicating whether the parameter value is increasing or decreasing. The display may change between different icon types based on the situation. The limit 128 may be selected based on a particular limit associated with the patient. For example, for SpO2, the limit may be determined based on the patient's health range. Additionally, the flow therapy device may be configured to provide a visual indication to indicate that an element is outside of acceptable limits, such as a change in color of the limit value 128 and / or indicator 130, and the parameter display element may provide a visual effect (e.g., flashing) and / or provide another indication. 6C and 6D, the indicator 130 and the number showing the lower limit of the scale change color to indicate that the value is outside the acceptable range. The parameter value 122 may also change color to indicate that the value is outside the acceptable range.
[0136] 6A-6D, after a user selects the automatic mode, such as by selecting the automatic mode input 140 on the FiO2 configuration interface screen, the graphical user interface 100 may display a next screen (as shown in FIG. 6A or 6E) in which the user is prompted to enter a patient type. The graphical user interface includes multiple inputs 142 that identify a patient type, such as normocapnic, hypercapnic, etc., or any patient type. The patient type may include one or more parameters, such as the patient's condition, weight, height, age, and / or gender. Upon selecting an SpO2 limit, selectable options may be labeled without reference to the patient type. For example, the options may be labeled with an SpO2 range or as a number (e.g., 1, 2, 3, etc.). Additionally or alternatively, the options may be labeled as high, medium, or low.
[0137] The patient type can determine the control limits for SpO2. Control limits 144 corresponding to the patient type may be displayed next to each patient type. Additionally or alternatively, the patient type can affect one or more control parameters, particularly the default control algorithm used in situations where patient characterization fails, such as when the flow therapy device fails to generate a patient-specific model.
[0138] Referring to FIG. 6B, a graphical user interface can provide defined operating limits for the flow therapy device's FiO2 and the patient's SpO2. The user can be prompted to confirm the patient's control limits. The FiO2 control limits can be a percentage range from a starting point, such as 10% above and below the starting point. The limits can be further restricted by the physical limits of the flow therapy device, such as a minimum 21% FiO2. Alternatively, the user can be prompted to input a selected FiO2 limit.
[0139] FIG. 6E shows a screen configuration that allows a user to adjust the FiO2 control range and SpO2 target range on the same screen. The left portion of the screen displays the FiO2 control range next to plus and minus inputs. The plus and minus inputs can be used to adjust the FiO2 control range 141. The FiO2 limits can be controlled simultaneously, such that the upper and lower limits change simultaneously when the user presses the plus or minus input. In some situations, the FiO2 control range can be truncated by a physical limit of the system, such as the maximum or minimum FiO2 the system can deliver. In these situations, pressing the plus or minus input can result in only one of the upper and lower limits changing. In some configurations, the upper and lower limits are separate and can be changed individually.
[0140] The right side of the screen is used to display SpO2 target ranges next to various patient type inputs 142. When the user presses one of these inputs 142, the selected patient type is highlighted and the corresponding SpO2 control range 144 may be displayed. Figure 6F shows a configuration where the user can use the plus and minus inputs to cycle through the possible SpO2 target ranges.
[0141] Selecting an input may involve changing the color, shading, or brightness of the input. Additionally or alternatively, selecting an input may involve adding one or more visual indicators, such as arrows, to indicate the selected patient type.
[0142] The SpO2 target range can be displayed by showing the upper and lower limits of the target range, thereby indicating to the user the range within which the device will attempt to maintain SpO2. Additionally or alternatively, the SpO2 target range display can include a target value, thereby indicating to the user what the target SpO2 value within the SpO2 target range is.
[0143] By displaying both the FiO2 control range and the SpO2 target range on the same screen, a user can adjust both ranges while still being able to see them. This allows a user, such as a clinician, to more easily determine the FiO2 control range based on the SpO2 target range. If the FiO2 control range and the SpO2 target range were set on different screens, the user may need to repeatedly switch between the two screens to make this determination.
[0144] After user confirmation, the flow therapy device may enter a learning phase, a feedforward phase, or another type of configuration phase before entering automatic mode. During the learning phase, measured FiO2 and SpO2 values may be displayed. The device may have an additional feature to indicate that it is in the learning phase or automatic mode configuration.
[0145] The FiO2 set point can be used for subsequent FiO2 increments during the learning phase. Additionally, this value can be used to define the FiO2 control limits. Additionally, the user can be prompted to enter the learning phase increments, but the flow therapy device can use the FiO2 selected in the previous stage.
[0146] Additionally or alternatively, the device may display FiO2 limits 128 and / or SpO2 limits 128 next to the value of each parameter. An indicator 146, such as a spinning disk, may appear in the center of each range, signifying that the limits have not yet been applied due to the learning or configuration phase.
[0147] Additionally or alternatively, the FiO2 and SpO2 parameter display elements 120 may be linked and / or have a link indicator 148, such as a box around them, to indicate that the values are linked due to being in automatic control mode. The link indicator may also change the shape of the parameter display element 120 to provide a visual indication to the user that the parameters are no longer separate. For example, in FIGS. 6C, 6D, and 6G, the gap between the FiO2 parameter display element and the SpO2 parameter display element has been eliminated. Additionally, the link indicator 148 is a box surrounding both elements. Additionally, the screen of FIG. 6G presents the user with two additional options: an auto-exit input 143 that returns the device to manual mode; and a limit adjustment input 145 that allows the user to return to the previous closed-loop control initiation screen where the user could adjust the FiO2 control range and SpO2 target range. This screen may be configured to appear when the user presses the FiO2 parameter display element.
[0148] Once the learning or configuration phase is complete, indicators 130 display the current measurement's location within those control limits. Indicators 130 provide an indication of how close each target value is to its respective limit. If the SpO2 is too high or too low, indicators 130 indicate that something may be wrong with the patient and serve to notify the patient or caregiver that attention is needed. Additionally, if the FiO2 indicator is too high or too low (e.g., near the upper or lower limit) on range 126, this may help indicate that the FiO2 has deviated too far from the original set point or center of the control range for maintaining therapy. Having the indicators next to each other also allows for a visual comparison of the two values. Because a low FiO2 results from a low SpO2 reading, a low FiO2 is less of a concern if the SpO2 is also low; if both are at the same level, there may be no need for concern regarding the patient's response. However, if the FiO2 is significantly higher than the SpO2, it may indicate that the flow therapy device is delivering significantly more FiO2 than intended in an attempt to achieve the target SpO2 and that the patient is not responding.
[0149] The control system of the flow therapy device may attempt to vary the FiO2 within its control limits in an effort to maintain the SpO2 in the center of its target range. However, even if the flow therapy device is unable to maintain the SpO2 at the control limits, the flow therapy device may be configured not to vary the target FiO2 to a value outside of its control range.
[0150] 7A-7C illustrate interfaces related to alarms. The alarm interface may indicate that the flow therapy device is no longer operating in automatic mode. If the flow therapy device is unable to maintain SpO2 within the target range using the allowable FiO2 input, the flow therapy device may issue an alarm and return to manual mode. The upper portion 108 may display the reason for the alarm (e.g., SpO2 falling below a limit). The flow therapy device may include a user input control 150 that may activate the alarm and request the user's acknowledgement that the flow therapy device has returned to manual mode. Additionally, the graphical user interface may include a display element portion 152 that displays one or more parameters related to the alarm, such as FiO2 and SpO2. In some configurations, the interface may display one or more parameters not related to the alarm but that may still provide useful information to the user. For example, if a water shortage alarm related to the humidifier is activated, FiO2, SpO2, pulse rate, and / or other values may be displayed.
[0151] In some configurations, the alarm does not automatically return the flow therapy device to manual mode. After the alarm is activated, the user can use input control 150 to return the flow therapy device to manual mode. Alternatively, the user can minimize the alarm using control 151 (shown in FIG. 7B) to continue operating the flow therapy device in automatic mode. When minimized, the warning moves to the lower display portion. The lower display portion may further include input 153 and / or a visual effect (e.g., a flashing yellow light) to indicate that the alarm has not been cleared. Pressing input 153 and / or the lower display portion can raise the full-screen alarm again ( FIG. 7B ). This can be advantageous to allow the user to exit automatic mode and attempt to resolve the error without having to re-enter automatic mode.
[0152] 8A-8F provide examples of graphical user interfaces showing trend data. The trend display can be accessed by selecting the menu button 106 or the trends button 103. The trend menu can have one or more parameters that can be viewed, such as FiO2, SpO2, flow rate, and respiratory rate. Two or more trends, such as FiO2 and SpO2, can be displayed within the same screen. Having multiple parameters on the same screen can be useful in determining correlations between parameters, such as FiO2 and SpO2, which can aid in assessing a patient's condition.
[0153] The y-axis for each variable can automatically adjust to the range of the data set. For example, in FIG. 8A, FiO2 above is shown on a scale of 20% to 40%. However, if the FiO2 exceeds this scale, the graphical user interface can adjust to a new scale, such as 20% to 60%, so that the data is displayed. The x-axis can be a function of time. The scale can be any defined time frame (e.g., 45 minutes). In the illustrated display, the most recent data is at the far right, and the graph moves to the left as new data is introduced. The x-axis can be configured to change to include all data for the session.
[0154] 8D-8F show trend graph configurations that include two inputs for manipulating the display of data on the trend graph. These inputs indicate the time scale 160 of the trend and the parameter 158 being displayed. When the parameter input 158 is pressed, the flow therapy device displays a list of parameters for which trend data is available, such as SpO2, FiO2, flow, and respiratory rate. In some configurations, multiple parameters, such as FiO2 and SpO2, can be displayed simultaneously.
[0155] The time scale input 160, when selected, provides a list of time scale options. The currently selected time scale may be highlighted. Time scale options may include including any defined time period, such as 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, or any other defined time scale. The selected time scale controls the time window over which trend data is displayed. For example, if 1 hour is selected, the trend screen will include data from that hour. If the user wants to see how a parameter has changed over a longer period of time, the user may want to select a longer time scale. Alternatively, if only more recent data is needed, such as if treatment has recently begun, the user may want to select a shorter time scale. Decreasing the time scale may allow for a more detailed view of the data, as the data for that period may be stretched to fit across the entire graph.
[0156] Trend data may also be available for additional parameters and parameter combinations, particularly those with clinical significance. For example, a measure of a patient's oxygen efficiency may be calculated by the device, which then displays this data as a trend over time. Oxygen efficiency is based on the relationship between the patient's oxygen saturation and the oxygen concentration of the delivered gas. For example, oxygen efficiency may be calculated by dividing SpO2 by FiO2. Additionally or alternatively, the device may display a trend of SpO2 divided by FiO2 and then further divided by the patient's respiratory rate.
[0157] A trend graph may include a limit region 154 (e.g., a shaded region or top / bottom lines) that indicates the control limits (also called operating thresholds) of a parameter, such as the control limits of SpO2. The limit region may be visually distinct from the background and other display elements of the trend graph. The limit region may vary along the x-axis. For example, an FiO2 graph may display a series of limits in a portion of the x-axis representing the time when auto mode was used, then no limit during a period of manual mode, and then a new, different limit for the next period when auto mode was used with a different FiO2 limit. Trend graphs may have gaps during times when data is unavailable. For example, SpO2 may have gaps in its trend to indicate periods when the signal quality of SpO2 data was too low or unavailable. Additionally or alternatively, a graph may have a line to indicate a target value for a parameter, such as a target SpO2.
[0158] Unless the context indicates otherwise, throughout the specification and claims, the words "comprise", "comprising", and the like are to be interpreted in an inclusive sense, i.e., "including, but not limited to", rather than an exclusive or exhaustive sense.
[0159] The terms "approximately," "about," and "substantially," as used herein, refer to an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, in some embodiments, where the context permits, the terms "approximately," "about," and "substantially" can mean an amount that is 10% or less of the stated amount, 5% or less of the stated amount, and 1% or less of the stated amount.
[0160] The reference to any prior art in this specification is not, and should not be construed as, an acknowledgment or any form of suggestion that this prior art forms part of the common general knowledge within the scope of the invention in any country in the world.
[0161] The disclosed apparatus and systems may also be broadly considered to consist of any or all of the parts, elements, and features individually or collectively referenced or shown in the specification of this application, or any combination of two or more of said parts, elements, or features.
[0162] Where in the foregoing description reference is made to whole entities or components that have known equivalents thereof, these whole entities are incorporated herein as if individually set forth.
[0163] Depending on the embodiment, certain acts, events, or functions of any algorithm, method, or process described herein may be performed in a different order, added, combined, or omitted entirely (e.g., not all acts or events described are necessary for the execution of an algorithm). Furthermore, in some embodiments, acts or events may be performed not sequentially but simultaneously, for example, via multithreading, interrupt processing, or multiple processors or processor cores, or other parallel architectures.
[0164] It should be noted that various changes and modifications to the preferred embodiments of the present invention described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the disclosed apparatus and system and without diminishing its attendant advantages. For example, various components can be rearranged as desired. Accordingly, such changes and modifications are intended to be included within the scope of the disclosed apparatus and system. Moreover, not all features, aspects, and advantages are necessarily required to implement the disclosed apparatus and system. Therefore, the scope of the disclosed apparatus and system is intended to be defined only by the following claims.
Claims
1. 1. A respiratory assistance apparatus comprising: Housing and The display and one or more processors, generating a graphical user interface on the display including a parameter display portion including a plurality of parameter display elements, at least one parameter display element being associated with a first parameter of the respiratory assistance device, the plurality of parameter display elements being arranged to substantially fill the parameter display portion; automatically adjusting a shape of at least one of the plurality of parameter display elements to accommodate additional parameter display elements associated with additional parameters and to substantially fill the parameter display portion; one or more processors configured with computer readable instructions, 10. A respiratory assistance device, comprising:
2. 2. A respiratory assistance device as claimed in claim 1, wherein adjusting the shape of the at least one parameter display element comprises modifying a shape characteristic of the at least one parameter display element.
3. 3. The respiratory assistance device of claim 2, wherein the shape characteristics include shape type including rectangular, circular, octagonal, diamond, specially designed shapes, shape dimensions, aspect ratio, and / or other characteristics that affect the shape of the at least one parameter display element.
4. 4. A respiratory assistance device as described in any one of claims 1 to 3, wherein the computer readable instructions further configure the one or more processors to modify visual characteristics of the at least one parameter display element based on adjusting the shape of the at least one parameter display element.
5. 5. A respiratory assistance device according to claim 4, wherein the visual characteristics include icon and / or text formatting within the at least one parameter display element.
6. 4. A respiratory assistance device as described in any one of claims 1 to 3, wherein the computer readable instructions further configure the one or more processors to adjust the size and / or aspect ratio of the at least one parameter display element while maintaining the same general shape of the at least one parameter display element.
7. 4. A respiratory assistance device as described in any one of claims 1 to 3, wherein the computer readable instructions further configure the one or more processors to adjust the relative size of at least two of the plurality of parameter display elements within the parameter display portion based on the importance of the associated parameter.
8. 4. A respiratory assistance device according to any preceding claim, wherein the additional parameters include at least one of respiratory rate, oxygen saturation, pulse rate, CO2 concentration, or pressure.
9. A respiratory assistance device according to any one of claims 1 to 3, wherein the additional parameter display elements are added by a setting in which a user selects the additional parameters they wish to display.
10. A respiratory assistance apparatus according to any preceding claim, wherein the additional parameter display elements are added when a peripheral device is added to the respiratory assistance apparatus.
11. A respiratory assistance device as described in any of claims 1 to 3, wherein the computer readable instructions further configure the one or more processors to adjust the shape of at least one of the plurality of parameter display elements so that some parameter display elements are arranged stacked on top of each other and remaining parameter display elements are arranged next to each other.
12. 12. A respiratory assistance device as claimed in claim 11, wherein each of the plurality of parameter display elements has approximately the same aspect ratio.
13. 12. A respiratory assistance device as described in claim 11, wherein at least one of the number of parameter display elements is configured to be smaller than at least one of the remaining parameter display elements, and wherein the at least one smaller parameter display element has a different aspect ratio than the larger parameter display element.
14. 4. A respiratory assistance device according to any preceding claim, wherein the computer readable instructions further configure the processor to arrange the plurality of parameter display elements based on a priority value associated with each parameter.
15. A respiratory assistance device according to any preceding claim, wherein the graphical user interface is in landscape or portrait orientation.
16. A respiratory assistance device according to any preceding claim, wherein the at least one parameter display element further relates to a second parameter of the respiratory assistance device.
17. 17. A respiratory assistance apparatus as claimed in claim 16, wherein the second parameter is related to the first parameter.
18. 4. A respiratory assistance device according to any preceding claim, wherein the first parameter comprises oxygen concentration, oxygen saturation, flow rate, respiratory rate, temperature, pressure, or CO2 concentration.
19. 8. A respiratory assistance device as claimed in claim 7, wherein smaller parameter display elements have a different aspect ratio than larger parameter display elements.
20. 11. A respiratory assistance apparatus according to claim 10, wherein the additional parameter display element relates to the additional parameter added by a user and is provideable by the peripheral device.