User adjustment of treatment parameters

Abstract

The system (100) for respiratory therapy may include a pressure generator for a patient respiratory interface that delivers therapy to a user's airway, a user interface, and a controller coupled to the pressure generator configured to operate the generator for therapy. The controller may be configured to control the generator to deliver therapy for a therapy session in a therapy mode. The controller may be configured to receive input by a user on the user interface corresponding to adjustments to parameter(s) in a setup configuration mode. The controller may control generation of a user-perceivable sensory response in real time or near real time in response to the adjustments to the parameter(s) in the setup mode, where the control includes controlling the pressure generator to deliver therapy including a flow of pressurized breathable gas to the user's airway based on the received input and the corresponding adjustments.

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 417,803, filed October 20, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present technology relates generally to respiratory therapy devices and user adjustment of therapy parameters, such as comfort settings, via a user interface. More specifically, the technology relates to devices that enable therapy adjustment in a user feedback mode and that may employ a visual user interface. The user feedback mode and / or user interface may enhance the user's sensory awareness or understanding of therapy adjustments in real time or near real time when the user manually adjusts a therapy, which may provide pressure or flow therapy. The user interface may adjust therapy control parameters (such as pressure support parameters). For example, when or while the user is permitted to adjust parameters via the user interface, the user may perceive a sensory response (e.g., respiratory sensory response and / or facial tactile response) in the mask or other patient respiratory interface when changes to the therapy are delivered in response to the user's adjustments on the user interface in user feedback mode. Additional sensory feedback may include visual feedback, such as on a display of the user interface, that visually represents the effect of the user's adjustments. [Background technology]

[0003] Home respiratory therapy devices allow patients to receive respiratory therapy in the comfort of their own homes. However, due to the complexity of respiratory therapy devices, patients are not always granted access to reconfigure the respiratory therapy device, such as by changing some of the control parameters involved in delivering the therapy. Therefore, to configure the respiratory therapy device, patients typically bring the respiratory therapy device to a clinician's office, where the clinician must access its settings using, for example, clinician access rights enforced by authentication requirements (e.g., a password) and adjust the settings based on the clinician's expertise and the patient's comments. However, when the clinician adjusts the settings, the therapy change is typically experienced later in therapy mode, not in setup mode, preventing either the patient or the clinician from knowing how the adjustment feels. In this regard, existing respiratory therapy devices are not designed to provide patients with real-time or near-real-time sensory feedback regarding therapy changes, such as allowing the patient to experience / perceive a reaction reflected by the setting adjustment as the clinician makes the adjustment. For example, existing respiratory pressure therapy devices typically do not generate pressure, as the clinician adjusts the settings in setup mode, which also provides a display so that the patient receiving therapy is fully aware of the nature of the change. Typically, once the clinician has completed the setup process, they return the respiratory therapy device to the patient. The patient does not know the effect of the previous adjustments until they use it during a therapy session in therapy mode. In fact, this process makes it difficult for the patient to understand what has changed or what changes would be more desirable for them from a relatively intuitive perspective regarding multiple potential changes. Summary of the Invention

[0004] The present technology relates to improved therapy devices that can provide patients with a greater degree of parameter customization of control settings for therapy provided by the therapy device based on user perception. Such devices may generate one or more sensory feedback responses that the user can perceive in real time or near real time as the user adjusts parameters for controlling therapy, such as respiratory pressure or flow therapy, provided by a respiratory therapy device. Such improved therapy devices can provide a greater degree of user feedback and control regarding adjustments of therapy settings without relying on clinician support, enhancing patient awareness of therapy changes. Such user interfaces may provide feedback to the user that may include patient sensations (e.g., respiratory sensations) within a manual adjustment feedback loop in the device's active therapy user feedback adjustment mode. In such a mode, the device may provide sensory responses to the user's manual setting changes in real time or near real time, allowing the user to see and / or feel changes in therapy as they adjust therapy settings. Such device improvements may be implemented to provide a more intuitive process for educating or guiding the user to find more ideal or personalized setting(s) tailored to the user's needs and / or comfort level. Such ideal adjustments may also improve compliance with the therapy device, as a more comfortable treatment for a particular patient is more likely to result in continued use of the therapy device by that patient.

[0005] Some embodiments of the present technology may include a system for providing respiratory therapy to a user's airway. The system may include a pressure generator adapted to couple with a patient breathing interface to administer respiratory therapy to the user's airway. The system may include a controller coupled to the pressure generator and configured to operate the pressure generator to generate respiratory therapy, which may include a flow of pressurized breathable gas, based on at least one adjustable parameter. The system may include a user interface. The controller may include one or more processors. The controller may be configured to control the pressure generator to deliver respiratory therapy for a therapy session in a therapy mode. The controller may be configured to receive user input, which may be made on the user interface, in a setup configuration mode. The input may correspond to adjustment of the at least one adjustable parameter. In the setup configuration mode, the controller is configured to control generation of a user-perceivable sensory response in real time or near real time in response to adjustments to the at least one adjustable parameter, and the control may include controlling the pressure generator to deliver respiratory therapy, which may include a flow of pressurized breathable gas for delivery to the user's airway, based on the received input and the corresponding adjustment.

[0006] In some embodiments, the one or more processors may be configured to receive input corresponding to adjustment of at least one parameter during a first respiratory cycle of the user, and delivery of the adjusted flow of pressurized breathable gas occurs during a second respiratory cycle of the user following the first respiratory cycle. The at least one adjustable parameter may include one or more of an inspiratory pressure trigger threshold, an inspiratory pressure shape, a peak inspiratory pressure, an expiratory pressure trigger threshold, an expiratory pressure shape, and a peak expiratory pressure. The one or more processors may be configured to generate a user interface on a display coupled to the controller. The one or more processors may be configured to communicate with a wireless device to receive input corresponding to the adjustment to the at least one adjustable parameter. The user interface may include a graphical user interface displaying a target waveform including at least one visual feature corresponding to the at least one adjustable parameter. The adjustment to the at least one visual feature may correspond to the adjustment to the at least one adjustable parameter. The graphical user interface may be presented via a touchscreen, and the system may be configured to detect the adjustment corresponding to the at least one visual feature by a touch gesture on the touchscreen. The sensory response may include a visual response displayed on a graphical user interface. The visual response may include displaying on the graphical user interface a first execution waveform corresponding to the regulated pressurized breathable gas flow generated by the pressure generator. The visual response may further include displaying on the graphical user interface a second execution waveform corresponding to the user's respiratory airflow detected by the at least one sensor, the second execution waveform being displayed overlaid on the first execution waveform.

[0007] Some embodiments of the present technology may include a method of providing respiratory therapy to a user's airway. The method may include generating, by a pressure generator in each of a therapy mode and a setup configuration mode, a pressurized breathable gas flow delivered to the user's airway based on at least one adjustable parameter. The method may include receiving, by one or more processors in the setup configuration mode, input by a user on a user interface. The input may correspond to adjustment of the at least one adjustable parameter. The method may include generating a user-perceivable sensory response in real time or near real time in response to the adjustment to the at least one parameter, and the generating may include controlling delivery of the respiratory therapy to the user in the setup configuration mode based on the received input corresponding to the adjustment.

[0008] In some embodiments, receiving may occur during a first respiratory cycle of the user, and controlling delivery of respiratory therapy to the user in the setup configuration mode based on the received input and corresponding adjustments may occur during a second respiratory cycle of the user following the first respiratory cycle. The at least one parameter may include one or more of an inspiratory pressure trigger threshold, an inspiratory pressure shape, a peak inspiratory pressure, an expiratory pressure trigger threshold, an expiratory pressure shape, and a peak expiratory pressure. The one or more processors may generate a user interface on a display coupled to a controller of the pressure generator. The one or more processors may receive input from a wireless device that generates the user input. The user interface may include a graphical user interface, and the method may further include displaying a target waveform in the graphical user interface, the target waveform including at least one visual feature corresponding to the at least one adjustable parameter, and the adjustment to the at least one visual feature may correspond to the adjustment to the at least one adjustable parameter.

[0009] In some embodiments, the graphical user interface may be presented via a touchscreen, and the method may further include detecting an adjustment to at least one visual feature via a touch gesture on the touchscreen. The sensory response may include a visual response displayed on the graphical user interface. The visual response may include displaying, on the graphical user interface, a first execution waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator. The visual response may further include displaying, on the graphical user interface, a second execution waveform corresponding to the user's respiratory airflow detected by the at least one sensor, the second execution waveform being displayed overlaid on the first execution waveform.

[0010] Some embodiments of the present technology may include a user interface for inputting therapy settings in a setup configuration mode of a device for providing respiratory therapy to a user's airway. The user interface may include a display configured to present to a user visual features associated with a plurality of parameters that control operation of the device as the device delivers respiratory therapy. The user interface may include an input device configured to receive input from a user that may include iterative changes to the display of the visual features. The user interface may include a pressure generator configured to iteratively generate adjustments to the respiratory therapy provided by the device in a user feedback loop during operation in the setup configuration mode according to iterative adjustments to the plurality of parameters corresponding to the iterative changes to the visual features.

[0011] In some embodiments, the visual feature may include a feature icon displayed in association with at least a portion of a visual waveform representing the respiratory treatment over time. Activating the feature icon may select an associated parameter of the plurality of parameters for adjustment. The visual feature may further include a set of adjustment icons associated with the feature icon, which may be configured to adjust a portion of the visual waveform along with at least one associated waveform parameter of the plurality of parameters in response to user activation. The visual feature may be presented on a touchscreen and activated and / or modified by a user's touch. The input device may include one or more buttons or knobs, which may be configured to activate and / or modify the visual feature. The respiratory treatment may include a pressure treatment, and the plurality of parameters may include one or more pressure control parameters. The respiratory treatment may include a high-flow treatment, and the plurality of parameters may include one or more flow control parameters. The apparatus may include a controller and a pressure-generating device. Of course, some of these aspects may form sub-aspects of the present technology. Also, various of the sub-aspects and / or aspects may be combined in various ways and may form additional aspects or sub-aspects of the present technology.

[0012] Other features of the technology will become apparent upon consideration of the information contained in the following detailed description, summary, drawings, and claims.

[0013] The present technology is illustrated by way of example, and not limitation, in the drawings in which like reference numerals refer to like elements, including the following elements: [Brief explanation of the drawings]

[0014] [Figure 1A]An example of a therapy device for providing respiratory therapy (e.g., bi-level or variable level CPAP or pressure support) to a user's airway while allowing the user to manually adjust one or more therapy control parameters of the delivered therapy is shown, using an example of a user interface in accordance with the technology of the present invention, such as in a therapy-active user-adjusted feedback mode. [Figure 1B] 1 illustrates features of a therapy device with a wireless controller in some versions of the present technology. [Figure 1C] FIG. 1C is an illustration of a graphical user interface, such as on the display screen of a therapy device or wireless controller of FIG. 1A or FIG. 1B, showing manually adjustable visual features or feature icons on a target pressure waveform that may be adapted to implement therapy parameter adjustments, such as in a therapy active user-adjusted feedback mode of the present technology. [Figure 1D] FIG. 1C is another illustration of a graphical user interface, such as on the display screen of a therapy device or wireless control device of FIG. 1A or FIG. 1B, showing a user touching one visual feature or feature icon on the target pressure waveform on the display to select a therapy parameter adjustment associated with the visual feature or icon, such as in a therapy active user adjustment feedback mode of the present technology. [Figure 1E] FIG. 1D is an illustration of a graphical user interface presenting an adjustment icon or arrow icon, such as in response to the selection of FIG. 1D , which may be adapted to implement a parameter adjustment associated with a selected visual feature or feature icon, such as that selected in FIG. 1D , such as in a therapeutic active user adjustment feedback mode of the present technology. [Figure 1F] FIG. 1D is an illustration of another example of a graphical user interface presenting an adjustment icon or point control element, such as in response to the selection of FIG. 1D, which may be adapted to implement a parameter adjustment associated with a selected visual feature or feature icon, such as that selected in FIG. 1D, such as in a therapeutic active user adjustment feedback mode of the present technology. [Figure 2A]FIG. 1C is an illustration of an example transition of a graphical user interface, such as on a display screen or touch screen of a therapy device or wireless controller of FIG. 1A or FIG. 1B, showing a target pressure waveform that a user can visually manipulate or adjust to correspondingly achieve parameter adjustments, and the visual response to the user as the user manipulates or adjusts the target pressure waveform, thereby adjusting corresponding or related therapy control parameters, such as in a therapy active user-adjusted feedback mode of the present technology. [Figure 2B] FIG. 1C is an illustration of a graphical user interface that visually presents running waveforms overlaid, such as on the display screen of a therapy device or wireless controller of FIG. 1A or FIG. 1B, where the waveforms (e.g., pressure and flow) correspond to the pressure delivered by the respiratory apparatus and the patient's flow detected by the therapy device, as may be presented in a therapy-active user-adjusted feedback mode of the present technology. [Figure 2C] FIG. 1C is another illustration of a graphical user interface, such as on the display screen of a therapy device or wireless controller of FIG. 1A or FIG. 1B, visually presenting transitions in the shape of pressure waveforms that may be presented in the therapeutic active user-adjusted feedback mode of the present technology in response to manual changes in control parameters made by the user using, for example, the controls (buttons or icons) of the user interface described herein. [Figure 3] 10 illustrates the process of the control loop of the aforementioned therapy device for generating sensory feedback to the user while the user adjusts treatment parameters (e.g., target pressure waveform) in the therapeutic active user-adjusted feedback mode of the present technology. [Figure 4] 1 is a flow diagram illustrating an example process for generating sensory feedback to a user as the user adjusts a target pressure waveform. [Figure 5] 1 illustrates another example environment of a system for providing therapy to a user's airway, where the user may adjust therapy settings of the system through a user interface on a wireless device. [Figure 6]FIG. 10 is a schematic diagram of an example graphical user interface of a wireless device showing a target pressure waveform that a user can adjust and visual responses to the user as they make adjustments. [Figure 7] 1 shows an example of a control loop for generating a sensory response to a user as the user adjusts a setting (target pressure waveform). [Figure 8A] 1 shows an example of a system according to the present technology. A patient 1000 wearing a patient interface 3000 receives a supply of compressed air from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and sent to the patient 1000 through an air circuit 4170. A bed companion 1100 is also shown. [Figure 8B] The RPT device 4000 is shown in use on a patient 1000 wearing a nasal mask 3000. [Figure 8C] The RPT device 4000 is shown in use on a patient 1000 wearing a full face mask 3000. [Figure 9] An example of a non-invasive patient interface 3000 in the form of a nasal mask is shown. [Figure 10A] 4 shows an RPT device 4000 in accordance with one form of the present technology. [Figure 10B]

[0033] Fig. 40 shows a schematic diagram of the pneumatic circuit of an RPT device 4000 in accordance with one form of the present technology, showing upstream and downstream directions. [Figure 10C] 40 shows a schematic diagram of the electrical components of an RPT device 4000 in accordance with an aspect of the present technology. [Figure 10D] 10D shows a schematic diagram of an algorithm 4300 implemented in an RPT device 4000 according to one aspect of the present technology. In Fig. 10D, solid arrows indicate the actual flow of information, e.g., via electronic signals. [Figure 10E] 10D, in accordance with an aspect of the present technology. [Figure 11] A humidifier 5000 is shown. DETAILED DESCRIPTION OF THE INVENTION

[0015] Before describing the present technology in further detail, it is to be understood that the present technology is not limited to particular examples described herein, as such may vary, and it is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples described herein, and is not intended to be limiting.

[0016] The following description is provided in conjunction with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or the other examples. Additionally, any single feature or combination of features in any example may constitute an additional example.

[0017] 1. Pressure Support System One aspect of the present technology relates to a system that delivers therapy, such as pressure therapy or flow therapy, to a user's airway, allows the user to adjust control parameters of the therapy, such as pressure or flow settings, and generates a sensory response (user feedback, such as in the form of visual and / or physical sensations) to the user in real time or near real time as the user adjusts the therapy. Implementations of such systems may be discussed in connection with the following text regarding pressure therapy devices.

[0018] FIG. 1A illustrates an example environment for a system 100 that may be configured to provide pressure therapy, such as pressure support, to the airway of a user 102. In one embodiment, the system 100 may include a respiratory therapy device that provides respiratory therapy to the user 102. For example, the system may include a respiratory pressure therapy (RPT) device. The system 100 may provide a flow of breathable gas to the user at controlled pressure(s) and / or controlled flow rate(s). A patient interface 104, such as a mask, may be used to connect the system 100 and the user 102. Depending on the therapy being applied, the interface 104 may form a seal with, for example, a facial region of the user 102 to facilitate delivery of gas at a pressure sufficiently different from ambient pressure to achieve a therapeutic effect.

[0019] As shown in FIG. 1B, the system 100 may include one or more processors 110 operably coupled to a pressure generator 112, a memory 114, a user interface 116, a network interface 118, and one or more sensors 124, etc.

[0020] The user interface 116 may include a display 120 for presenting a graphical user interface and one or more selectors 122, such as a menu selector, which may be a physical (e.g., knob) or virtual (e.g., icon) component. The selector(s) 122 may be in the form of, for example, a knob or button, which the user 102 may manipulate to operate the system 100. For example, the user 102 may manipulate the selector(s) 122 to navigate and / or select menus displayed on the display 120. Optionally, moving such selectors with a touch changes values ​​associated with parameters, which may be visualized by a change in a waveform on the display. Thus, the display 120 may have a touchscreen. The network interface 118 may have one or more transceivers, such as a Bluetooth® transceiver, a cellular transceiver, a Wi-Fi® communication transceiver, etc.

[0021] The sensor(s) 124, such as any of the sensors described in more detail herein, may be configured to generate an output signal that conveys information related to the treatment and / or respiration of the user 102. Information related to the user's respiration may include, but is not limited to, the flow rate of pressurized breathable gas and / or the pressure of breathable gas at the user's mouth. The processor(s) 110 may determine other parameters, such as the user's tidal volume and pulmonary air pressure, based on the information in the output signal.

[0022] 1.1 Adjustable parameters In this example, the pressure generator 112 may be configured, under the control of a controller, such as those described in more detail herein, to generate a pressurized flow of breathable gas for delivery to the airway of the user 102 according to a target pressure waveform. FIG. 1C shows an example of a target pressure waveform 130 from which the pressurized flow of breathable gas is generated. The target pressure waveform 130 may represent the varying pressure of the flow of breathable gas that the pressure generator attempts to generate. The target pressure waveform 130 may include an inspiratory pressure or positive inspiratory pressure (IPAP) to assist the user in breathing, indicated by "I" in FIG. 1C, and an expiratory pressure or positive expiratory pressure (EPAP) to assist the user in breathing, indicated by "E".

[0023] The user 102 may adjust control of the pressure generated by the pressure generator 102 through one or more adjustable parameters. For example, a parameter may be associated with an expiratory pressure reduction (EPR), which the user may set. In the example of FIG. 1C , the parameter may correspond to one or more visual features or points on or associated with the target pressure waveform 130, which may function as activatable icons for selecting and / or inputting adjustments to the associated parameter. The at least one parameter may include one or more of an inspiratory pressure trigger threshold, an inspiratory pressure shape, a peak inspiratory pressure, an expiratory pressure trigger threshold, an expiratory pressure shape, and a peak expiratory pressure. Each parameter is described in more detail below.

[0024] 1.1.1 Inspiratory Pressure Trigger Threshold The inspiratory pressure trigger threshold (IPTT) may be a parameter that indicates the point during a user's inspiratory cycle at which the pressure generator 112 generates inspiratory pressure to assist the user's inspiration. The IPTT may indicate the point at which the pressure generator 112 changes from generating expiratory pressure to generating inspiratory pressure. In one embodiment, the pressure generator 112 may not begin generating inspiratory pressure at the beginning of the user's inspiratory cycle. Rather, the pressure generator 112 may delay generating inspiratory pressure until later in the user's inspiratory cycle or begin generating inspiratory pressure just before the patient's inspiration begins.

[0025] The IPTT is a flow value defined relative to the user's inspiratory flow detected by the sensor(s) 124. In one example, the IPTT may be set to a value, such as a value in the range of approximately 2-5 L / min. In this example, the pressure generator 112 may begin generating inspiratory pressure when the user's inspiratory flow reaches the IPTT value. The IPTT may serve to delay or advance the onset of inspiratory pressure generation. For example, a larger IPTT value may delay the onset of inspiratory pressure generation, whereas a smaller IPTT value may advance the onset of inspiratory pressure generation.

[0026] Alternatively, the IPTT may be a pressure value defined relative to the user's inspiration pressure in the mask 104 detected by the sensor(s) 124. In one example, the IPTT may be a threshold value specifying a predetermined pressure in the mask 104, such as a decreasing pressure indicative of the patient inhaling. When the sensor(s) 124 detects the predetermined pressure in the mask 104, the pressure generator 112 may be triggered to begin generating inspiration pressure. In this example, an increase in the predetermined pressure is required; increasing the value of the IPTT may delay the onset of inspiration pressure generation, whereas a decrease in the value of the IPTT may accelerate the onset of inspiration pressure generation.

[0027] In some embodiments, the IPTT may be a learned value that may later be adjusted by the user. For example, the controller may be configured to learn the IPTT from the patient's breathing, and the learned value may be fine-tuned (e.g., decreased or increased) by the user so that the controller executes control of the inspiratory pressure earlier or later than the learned configuration. Learning may involve, for example, a phase index, such as through phase determination, as described in more detail herein. Such a process may associate (learn) flow characteristic(s) (e.g., any one or more of amplitude, rate of change, etc.) typically associated with a phase index (e.g., 1) that indicates the user's transition to inspiration, and then use any one or more of those flow characteristic(s) as threshold(s) tests for controlling the pressure transitions associated with inspiration.

[0028] 1.1.2 Intake pressure profile Inspiratory pressure shape may refer to parameters that determine the shape of the inspiratory pressure curve from the onset of inspiratory pressure to the peak inspiratory pressure. The pressure generator 112 may increase the pressurized breathable gas flow to the peak inspiratory pressure according to the inspiratory pressure shape. The inspiratory pressure shape may be correlated to the rise time of the inspiratory pressure from the onset of inspiratory pressure (e.g., end-expiratory pressure) to the peak inspiratory pressure. The inspiratory pressure shape may control the rate at which the inspiratory pressure rises to the peak inspiratory pressure.

[0029] The inspiration pressure shape may exhibit one or more of the following patterns: a straight line, a smooth curve (e.g., based on an exponential function), or a square-like curve. The inspiration pressure shape may include a parameter that determines the slope or smoothness of the inspiration pressure shape. In one example, by adjusting the inspiration pressure shape parameter, e.g., by adjusting a selector in the user interface, the inspiration pressure shape may be transformed from one shape to another, such as from a smooth curve to a square-like curve, or vice versa, and visualized on the user interface display as it is experienced at the patient interface.

[0030] 1.1.3 Peak inspiratory pressure The peak inspiratory pressure (PIP) may include a first parameter that controls the timing of when the peak inspiratory pressure occurs, which may be referred to as the time of occurrence of the peak inspiratory pressure or simply as the peak time. The peak time may represent the time when the peak delivery is stopped. For example, the peak time may indicate when to stop the inspiratory pressure delivery function and when to change from an inspiratory pressure delivery function (e.g., a pressure increase function) to an expiratory pressure delivery function (e.g., a pressure decrease function). The peak time may also indicate when the peak delivery is achieved within a specific point in the patient's detected respiratory cycle, such as relative to a predetermined phase of the patient's respiratory cycle, as described in more detail herein. The peak time may affect the inspiratory rise time. For example, increasing the peak time may slow the rise time of the inspiratory pressure, whereas decreasing the peak time may shorten the rise time of the inspiratory pressure. The pressure generator 112 may adjust the inspiratory pressure delivery function / equation based on the peak time so that the pressure rises to the peak point of the inspiratory cycle in a desired time.

[0031] The peak inspiratory pressure may include a second parameter that controls the amplitude of the peak inspiratory pressure and may represent the amount of pressure (e.g., IPAP pressure) delivered by the pressure generator 112 at the peak. This parameter may also be related to the pressure rise function as the inspiratory pressure delivery function approaches the peak inspiratory pressure. In some examples, the amplitude may be a positive pressure value or may be zero.

[0032] 1.1.4 Expiratory pressure trigger threshold The expiratory pressure trigger threshold (EPTT), or expiratory pressure cycle threshold, may be a parameter that controls when the pressure generator 112 begins to control the pressure drop during the user's expiratory cycle to assist the user's exhalation. The EPTT may indicate the time when the pressure generator 112 switches from generating inspiratory pressure to generating expiratory pressure.

[0033] The EPTT may be a flow value defined relative to the user's flow, such as the inspiratory flow or expiratory flow detected by the sensor(s) 124, or may be a phase index for phase determination from flow, as described in more detail herein. In one example, when the user's respiratory flow reaches an EPTT value (e.g., a fixed flow threshold or a calculated flow threshold, such as a percentage of peak inspiratory flow), the pressure generator 112 may begin to control pressure reduction. For example, a threshold may be assessed that is a percentage of peak inspiratory flow (e.g., approximately 30-50%, e.g., 45%), and when the patient's measured flow falls below this threshold, the pressure may change from inspiratory pressure to expiratory pressure. The EPTT may be useful for delaying or hastening the onset of decompression (e.g., a pressure reduction function). For example, increasing the EPTT value may delay the onset of decompression, whereas decreasing the EPTT value may hasten the onset of decompression.

[0034] Alternatively, the EPTT may be a pressure value defined relative to the user's exhalation pressure detected by the sensor(s) 124 in the mask. In one example, the EPTT may be a threshold value specifying a predetermined increase in pressure in the mask. When the sensor(s) 124 detects a predetermined increase in pressure in the mask, the pressure generator 112 may be cycled to begin reducing the pressure. In this example, an increase in the pressure increase by a predetermined amount is required, increasing the value of the EPTT may delay the onset of pressure reduction, whereas a decrease in the value of the IPTT may accelerate the onset of pressure reduction.

[0035] In some embodiments, the EPTT may be a learned value that may later be adjusted by the user. For example, the controller may be configured to learn the EPTT from the patient's breathing, and the learned value may be fine-tuned (e.g., decreased or increased) by the user so that the controller executes control of expiratory pressure earlier or later than the learned configuration. Learning may involve, for example, a phase index, such as through phase determination, as described in more detail herein. Such a process may, for example, associate (learn) flow characteristic(s) (e.g., any one or more of amplitude, rate of change, etc.) that are typically associated with a phase index (e.g., 0.5) that indicates the user's transition to exhalation, and then use any one or more of those flow characteristic(s) as threshold(s) tests for controlling pressure transitions associated with exhalation.

[0036] 1.1.5 Peak expiratory pressure The peak expiratory pressure (PEP) may include a first parameter representing the amplitude of the minimum expiratory pressure generated by the pressure generator 112 during a user's exhalation, or how much the pressure drops during a user's exhalation. This parameter may relate to a pressure drop function as the expiratory pressure supply function approaches the peak expiratory pressure, which may be ambient pressure or other pressure drop from the inspiratory peak pressure.

[0037] The peak expiratory pressure may include a second parameter indicating when to generate the peak expiratory pressure, which may be referred to as a peak expiratory pressure time. This peak time may indicate when to stop the expiratory pressure supply function. This peak time may also indicate when the peak expiratory pressure is achieved within the detected respiratory cycle, e.g., relative to the determined phase, as described in more detail herein. Based on this peak time, the pressure generator 112 may adjust the expiratory pressure supply function so that the pressure falls below the peak point of the expiratory cycle at a desired time. This peak time may affect the expiratory fall time. For example, a longer peak time may result in a slower expiratory pressure fall time, whereas a shorter peak time may result in a shorter expiratory pressure fall time.

[0038] 1.1.6 Expiratory pressure profile The expiratory pressure shape may refer to the shape of the expiratory pressure curve from the end of the inspiratory pressure to the peak expiratory pressure. The pressure generator 112 may reduce the pressurized breathable gas flow to the peak expiratory pressure according to the expiratory pressure shape. The expiratory pressure shape may be correlated to the expiratory pressure fall time from the end of the inspiratory pressure to the peak expiratory pressure. The expiratory pressure shape may control how fast or slow the expiratory pressure is during exhalation.

[0039] The expiratory pressure shape may exhibit one or more of the following patterns: a straight line, a smooth curve (e.g., based on an exponential function), or a square-like curve. The expiratory pressure shape may include a parameter that determines the slope or smoothness of the expiratory pressure shape. In one example, by adjusting this parameter, the expiratory pressure shape can change from one form to another, such as from a smooth curve to a square-like curve, or vice versa.

[0040] 1.1.7 Visual adjustment 1C , target pressure waveform 130 may include one or more visual features 132, 134, 136, 138, and 139 corresponding to different parameters. Each visual feature may be a dot or other visual icon displayed on or in association with the target pressure waveform. For example, visual feature 132 may correspond to one or more parameters related to IPTT. Visual feature 134 may correspond to one or more parameters related to inspiratory pressure shape. Visual feature 136 may correspond to one or more parameters related to peak inspiratory pressure shape and / or EPTT. Visual feature 138 may correspond to one or more parameters related to expiratory pressure shape. Visual feature 139 may correspond to one or more parameters related to peak expiratory pressure.

[0041] As previously mentioned, a user may activate one or more visual features, e.g., by manually adjusting them, to change the associated parameters. For example, an adjustment to a visual feature may correspond to an adjustment to an associated or corresponding therapy control parameter(s). Such a change may occur without the user having to be aware of or understand the value associated with the parameter change.

[0042] For example, in the case of a touchscreen, user 102 may activate a parameter change by touching a corresponding visual feature on the target pressure waveform 130. Accordingly, processor(s) 110 may detect such activation and / or adjustment to a visual feature via a touch gesture on the touchscreen. As an example, when a user touches a visual feature, such as visual feature 136 as shown in FIG. 1D, one or more optional icons or arrows 142-148 may appear on the graphical user interface, as shown in FIG. 1E. The user may adjust the visual feature (and its corresponding parameter(s)) by touching any one of the icons or arrows 142-148. The arrows 142-148 may increase or decrease one or more parameter values, which may be represented by a change in the visualization of the target pressure waveform (e.g., indicating a change in shape).

[0043] 1E, a user may change the position of visual feature 136 and / or its corresponding parameter value by touching any of arrows 142-148. A user may adjust the time of peak inspiratory pressure by touching arrows 144 and / or 148. Forward arrow 144 may move visual feature 136 toward the start of inspiration, potentially shortening the time of inspiratory pressure rise, while backward arrow 148 may move visual feature 136 toward exhalation, potentially slowing the time of inspiratory pressure rise.

[0044] By touching arrows 142 and / or 146, the user may adjust the amplitude of the peak inspiratory pressure, or the amount of pressure applied at the peak.

[0045] In another example, when the user 102 touches a visual feature, a menu may be displayed that provides one or more options for adjusting the visual feature or its corresponding parameters.

[0046] In yet another example, a user may adjust a visual feature and its corresponding parameters by dragging or moving the visual feature, such as visual feature 136, from an initial position to a new position 137 while the user is in contact with the visual feature on a touchscreen, as shown in FIG. 1E. The corresponding parameters may be adjusted proportionally based on the new position 137 relative to the initial position. For example, if the new position 137 is lower than the initial position, the corresponding parameters may be decreased proportionally. If the new position 137 is higher than the initial position, the corresponding parameters may be increased proportionally.

[0047] In another example, in the absence of or reliance on a touchscreen, user 102 may use selector(s) 122, which are menu selectors, to select any visual feature on target pressure waveform 130 to adjust its corresponding parameter. For example, user 102 may select visual feature 136 on target pressure waveform 130 to adjust the peak inspiratory pressure. Once visual feature 136 is selected, it may be represented in the graphical user interface by one or more icons or arrows 142-148. The user may adjust visual feature 136 or its corresponding parameter value by selecting one of arrows 142-148 using menu selector(s) 122.

[0048] 1E, changes to the visual feature or its corresponding parameters may change the visualized shape or configuration of the target pressure waveform 130. As the user adjusts the visual feature or its corresponding parameters via the touch screen or menu selector(s) 122, the graphical user interface may display such changes to the target pressure waveform. Optionally, the graphical user interface may simultaneously display the target pressure waveform 130 in its original configuration, shown by a solid line, and its adjusted shape or configuration, shown by a dashed line 150. As yet another option, additional boundary curves may be displayed to indicate limits on how far the manual adjustment may be made.

[0049] Another example user interface with similar functionality to that of FIG. 1E is the user interface of FIG. 1F. Visual parameter adjustment control 131 may be operated, such as when a visual element (e.g., visual feature 136) of target pressure waveform 130 is selected. The interface allows the user to drag the visual element (e.g., visual feature 133 shown as a dot or circle) over a grid or two-dimensional area defined by arrows configured as axes and labeled with descriptors (e.g., text labels) to identify the nature of the adjustment. Different labels may be used (the labels may reflect the language the user typically speaks). In some embodiments, axes (e.g., arrows) may be associated with different parameters. An axis may relate to one or more parameters (e.g., "strong" may relate to peak inspiratory pressure (PIP), peak expiratory pressure, and / or rise time). In embodiments, one version of visual parameter adjustment control 131 may be presented for inhalation-related adjustments and another version may be presented for exhalation-related adjustments. In some such embodiments, one may be presented for pressure and another for time. The following table shows some control embodiments for such a grid: [Table 1]

[0050] 2 System Mode The system 100 is configured to operate in various modes according to the programming of the controller, which may include an operating mode and a setup configuration mode, which may be a user feedback adjustment mode of active therapy.

[0051] 2.1 Operation Mode During the operational mode, system 100 may provide both to the user according to the parameters set from the configuration mode. Such an operational mode may be a typical therapy mode in which the patient receives both from system 100. For example, in the case of a sleep disordered breathing therapy device, the operational mode typically provides therapy while sleeping. In such a mode, the user typically does not have the option to manually adjust the device's therapy settings.

[0052] 2.2 Setup Configuration Mode However, during a settings configuration mode, which may be a user feedback adjustment mode of an active therapy, the user may adjust one or more parameters for setting up therapy operation, such as the parameters described above for controlling therapy, via the user interface 116. In this mode, the user interface 116 may provide the user with controls to change one or more parameters, as described above, within acceptable constraints, and may protect the user from improper adjustments that could harm the user or the system 100. In one example, referring to FIG. 2A , the display 120 may present a graphical user interface 160 illustrating a target pressure waveform 130 based on which a flow of pressurized breathable gas is generated in the configuration mode. Thus, the user may adjust one or more parameters for controlling pressure therapy by adjusting one or more visual features on the target pressure waveform 130 and perceive the therapy (e.g., before and after the change) so that the user understands the change in real time or near real time.

[0053] Thus, in this mode, system 100 may simulate therapy in real time or near real time based on the user's adjustments to a parameter(s). For example, each time the user adjusts a parameter, processor(s) 110 may detect the user's adjustment and generate a sensory response (user feedback) that the user can perceive. In one example, processor(s) 110 may detect the user's adjustment during the user's first respiratory cycle while therapy is being delivered and generate a sensory response based on the detected adjustment. The sensory response may include generating therapy during one or more additional respiratory cycles after the user's first respiratory cycle in response to the adjustment.

[0054] Thus, the sensory response may include the controller altering operation of the pressure generator 112 based on the user's adjustment to adjust the flow of pressurized breathable gas and deliver the adjusted pressurized breathable gas to a patient interface (e.g., a mask) worn by the user. Thus, the processor(s) 110 may detect the user's adjustment during the user's first breathing cycle and, while in the configuration mode, adjust and deliver the flow of pressurized breathable gas to the user based on the detected adjustment during at least one or more breathing cycle(s) of the user subsequent to the first breathing cycle. As a result, the user may immediately feel the effect of the therapy change (e.g., via the patient interface or mask) when the user changes one or more parameters controlling the therapy.

[0055] Additionally or alternatively, with continued reference to FIG. 2A , the processor(s) may generate a visual response via the graphical user interface 160. The visual response may provide a real-time view of one or more propagated or executed waveforms resulting from the user's parameter adjustments. The visual response may display a first executed waveform 162 in the graphical user interface corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator 112. The waveform 162 may begin at the start of inspiration and end at the end of expiration. The waveform 162 may be represented, for example, as a white curve on a black screen in the graphical user interface 160. By viewing it via the graphical user interface 160, the user can see how the waveform 162 changes in real time or near real time as the user adjusts the associated parameter(s).

[0056] In one example, the graphical user interface 160 may display a second execution waveform 164 corresponding to the user's respiratory airflow. The user's respiratory airflow, as indicated by the second execution waveform 164, represents what the user is currently inhaling and exhaling, which may change from breath to breath. The user's respiratory airflow may be detected by one or more sensors 124. The second execution waveform 138 may be displayed as a dashed line, and the first execution waveform 162 may be displayed as a solid line. The second execution waveform may be displayed in an overlay format against the first execution waveform, allowing the user to visualize the user's actual breathing against a simulated therapy waveform (when no therapy is being provided) or a visual version of the actual therapy being provided by the system 100.

[0057] FIG. 2B is another illustration of a graphical user interface 160 showing executed waveforms 162 and 164 comprising multiple respiratory cycles, which may move across the display screen as they are generated over time.

[0058] 2C is another schematic diagram of the graphical user interface 160 showing the change in shape of the pressure waveform 162, which changes from a curved shape to a square-like shape as a result of user adjustments in the setup mode. The graphical user interface 160 also shows a second waveform 164 representing the user's respiratory airflow relative to the pressure waveform (i.e., on the same time scale as the pressure waveform).

[0059] 2.3 Control Loop 3 illustrates a control loop implemented by processor(s) 110 that may generate a sensory response to the user when the user adjusts the therapy after entering configuration mode, thereby implementing an active therapy user feedback adjustment mode. In a first step, processor(s) 110 may detect a user adjustment transmitted via user interface 116. This adjustment may occur while the processor is controlling the pressure generator to deliver therapy according to the parameters set prior to the change. For example, processor(s) may detect that the user has adjusted one or more parameters 140 via menu selector(s) 122 and / or the touchscreen.

[0060] In a second step, the processor(s) 110 may instruct the pressure generator 112 to adjust the flow of pressurized breathable gas delivered to the user based on the detected adjustment.

[0061] In a third step, the adjusted pressurized breathable gas may be delivered to the user 102. As a result, the user 102 may feel a visible difference with each parameter change, such as in the user's respiratory system or at the patient interface (e.g., facial contact). As a result, the user can easily determine which parameter setting(s) feel most comfortable by simply iterating through each change as they feel it. Through this mechanism, the user 102 may find one or more personalized parameter settings that feel most comfortable to the user, since different users may prefer different parameter settings compared to other users. In other words, a parameter setting that feels comfortable to one user may not necessarily be comfortable to another user. Therefore, when providing user feedback as described herein, the configuration mode may more easily enable each user to customize parameter settings to suit their own needs and / or comfort level, without having to understand the technical nature of such parameters in detail and / or without requiring clinical assistance. This is particularly useful because many components of the system 100, such as the mask and the gas conduit that delivers breathable gas from the pressure generator to the mask, can affect the pressure a user feels in the mask. Allowing the user to customize parameter settings in this manner allows the user to easily find the optimum waveform despite variations in the user's particular system configuration.

[0062] Also in a third step, the processor(s) 110 may generate a visual response to the user via the user interface 116. The user interface 116 may display a first execution waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator. The user interface 116 may also display a second execution waveform corresponding to the user's respiratory airflow. As a result, the user may visualize the effect(s) of the user's adjustments as the user adjusts one or more parameters.

[0063] In a fourth step, the user may iteratively make multiple different adjustments to one or more parameters, thereby facilitating a relative comparison until the user arrives at the parameter setting(s) that the user finds most comfortable. Accordingly, during this process, the pressure generator 112 may iteratively adjust the flow of pressurized breathable gas delivered to the user based on the user's adjustments. As the user adjusts the parameters, the user may iteratively feel the difference the adjustments make in the user's mask and / or respiratory system, while the resulting effect(s) of the adjustments may be visualized through one or more execution waveforms. This sense and visualization of changes, along with immediate iteration (near real-time), can result in significant synergistic improvements in respiratory therapy equipment setup when compared to traditional clinical equipment setups.

[0064] 2.4 Flow Diagram 4 shows an exemplary process for generating a sensory response to a user 102 when the user 102 adjusts the delivery of therapy. At 402, a pressure generator may generate a flow of pressurized breathable gas for delivery to the user's airway based on at least one adjustable parameter. At 404, a processor(s) may detect a user adjustment of the at least one parameter. At 406, the processor(s) may generate a user-perceivable sensory response in real time or near real time when the user adjusts the at least one parameter. The sensory response may include instructing the pressure generator to adjust the flow of pressurized breathable gas delivered to the user's airway based on the detected adjustment.

[0065] 3. Wireless Devices Referring to FIG. 5, system 100 may be wirelessly connected to wireless device 170 and may implement any of the operations described herein with respect to the configuration mode of operation, e.g., when wireless device 170 and a therapy device of system 100 communicate with each other to implement the configuration mode of operation. Thus, wireless device 170 may be a user-accessible computing system. Examples of wireless device 170 include mobile phones, tablets, netbooks, desktop computers, laptop computers, wearable computing devices such as smart watches, and the like. Referring to FIG. 1B, wireless device 170 may include one or more processors 172, memory 174, a user interface 176 including a display 178, and a network interface 180. Network interface 180 may include one or more transceivers, such as a Bluetooth transceiver, a cellular transceiver, and a Wi-Fi transceiver. Display 178 may be a monitor with a screen or other electrical device operable to display information (e.g., text, images, and / or other graphical elements). Additionally, wireless device 170 may include all components typically used in connection with a computing device, such as a user interface subsystem. User interface 176 may include one or more user input devices (e.g., a mouse, keyboard, touchscreen, and / or microphone) for receiving input from a user, and output devices such as speaker(s). Wireless device 170 may communicate with system 100, etc., via any of a Bluetooth transceiver, a cellular transceiver, and a Wi-Fi transceiver.

[0066] When the wireless device 170 is connected to the system 100, the wireless device 170 may bidirectionally communicate with the system 100. The wireless device 170 may transmit any user input, including any adjustments to one or more parameters, to the system 100. The system 100 may receive the user's input via the wireless device 170. A pressure generator of the system may adjust the therapy based on the user's input. The system 100 may transmit information regarding the adjusted therapy and / or the user's respiratory airflow to the wireless device 170 and may request the wireless device 170 to display any visual response to the user. The wireless device 170 may generate a visual response to the user based on the received information.

[0067] With reference to FIG. 6 , wireless device 170 may display a graphical user interface 180 shown on its display 178. Graphical user interface 180 may be similar to graphical user interface 160 shown in FIG. 2A . For example, graphical user interface 180 may display a target pressure waveform 130 for controlling the pressure support delivered by system 100. To adjust therapy, a user may adjust one or more visual features on the wireless device (e.g., target pressure waveform 130 on the screen of the wireless device), and in response, the wireless device communicates with the therapy device to provide any of the user responses or user feedback described above. Additionally, or alternatively, with continued reference to FIG. 6 , wireless device 170 may generate a visual response via graphical user interface 180. For example, wireless device 170 may receive data from system 100 related to the adjusted pressurized breathable gas flow generated by pressure generator 112 and / or the user's respiratory airflow and generate a visual response to the user based on the received information. The visual response may display a first execution waveform 162 corresponding to the regulated pressurized breathable gas flow generated by the pressure generator. In one example, the graphical user interface 180 may display a second execution waveform 164 corresponding to the user's respiratory airflow.

[0068] 7 illustrates an example of a control loop implemented by system 100 and wireless device 170. In a first step, processor(s) 172 of wireless device 170 may detect a user adjustment transmitted via a user interface 176 of wireless device 170. For example, processor(s) 172 may detect that a user has adjusted one or more parameters 140 via a touchscreen of wireless device 170.

[0069] In a second step, the processor(s) 172 of the wireless device 170 may transmit the adjusted parameter value(s) to the system 100, which may instruct the pressure generator 112 to adjust the flow of pressurized breathable gas delivered to the user based on the adjusted parameter value(s).

[0070] In a third step, the adjusted flow of pressurized breathable gas may be delivered to the user 102. As a result, the user 102 may feel a noticeable difference in the user's respiratory system with each adjustment.

[0071] Also in a third step, the processor(s) 110 of the system 100 may transmit information regarding the adjusted flow of pressurized breathable gas generated by the pressure generator and / or the user's respiratory airflow to the wireless device 170. The wireless device 170 may generate a visual response to the user via the user interface 176, which displays a first execution waveform corresponding to the adjusted flow of pressurized breathable gas generated by the pressure generator. The user interface 176 may also display a second execution waveform corresponding to the user's respiratory airflow. As a result, the user may visualize the effect(s) of the adjustment(s) through the wireless device 170 as the user adjusts one or more parameters.

[0072] In a fourth step, the user may iteratively adjust one or more parameters via the user interface 176 of the wireless device 170 until they reach a parameter setting that feels most comfortable. In this iterative process, the pressure generator 112 may iteratively adjust the flow of pressurized breathable gas based on the user's adjustments. As the user adjusts the parameter(s), the user may continually feel changes in pressure support in the user's respiratory system and visualize the effects of the adjustments through one or more execution waveforms displayed on the wireless device 170.

[0073] 4 Additional Exemplary Embodiments The above examples may be implemented to make many different and unique adjustments to therapy. For example, any of the user interfaces described above, such as the version in FIG. 1C , may be manipulated to control adjustments to the waveform, including changing the control algorithm to generate a modified waveform. For example, the waveform may be provided using any of the control algorithms described in more detail herein. However, for some modifications made using the user interface, the controller may adapt and provide therapy using a different pressure control algorithm for the modified waveform. For example, a user may manipulate the user interface to modify the visual waveform (e.g., see FIG. 1C ), thereby setting the positive inspiratory pressure (e.g., by adjusting one or more control elements, such as the point associated with visual feature 136) to a baseline (e.g., zero), such that such visual display becomes a flat line, causing the controller to generate no pressure at least during inspiration (and optionally during expiration). Similarly, a user may also manipulate the user interface, e.g., using one or more control elements, to cause the expiratory portion of the waveform to drop below the flat baseline of the inspiratory portion as a flat line or curve. This further decrease causes the controller to reduce the expiratory pressure below the inspiratory pressure, as indicated by the line. When the user reduces the expiratory pressure wave portion in this manner, the controller can change to a different control algorithm and generate a pressure waveform as a function of the measured patient flow rate (e.g., delivered pressure = alpha * flow rate). Alpha can be a multiplier value that may be determined from a value associated with the position of one or more of the user interface control elements (such as visual feature 139) or another point, such as visual feature 138. When such a control element is below zero pressure (i.e., ambient pressure), the function uses the flow rate and multiplier to control the pressure, causing it to go negative (or become negative) during exhalation and then return to zero during inhalation.

[0074] Additionally, in some embodiments, the user interface may display additional visual controls, such as a slider or other selector, that allow the user to adjust the alpha value. Pressure may be delivered as described with respect to negative pressure. However, in some cases, the alpha adjustment may simply be implemented as an addendum to the pressure control of a set waveform, whereby the alpha adjustment may provide additional pressure control to any of the other pressure control algorithms described herein. For example, an additive function (Pressure_extra=alpha*flow) may be added to the output pressure (P) of any additional control algorithm described herein, such as Equation (1) below: t ) or combine the delivered pressure with the function (i.e., Pressure_delivered=P t +Pressure_extra). Similarly, Pressure_extra may be added to the pressure output function defined by the parameters previously mentioned (IPTT, EPTT, PIP, PEP, etc.).

[0075] 5. Technical Effects The disclosed technology may have many technical advantages. First, the disclosed technology may put control of therapy in the hands of the user. The disclosed technology may enable the user to adjust therapy with complete ease and confidence. By using the disclosed technology, the user may independently find the ideal therapy parameter setting(s) tailored to the user's needs and / or comfort level without relying on any clinical assistance.

[0076] Second, the disclosed technology may provide the user with real-time or near-real-time sensory response(s) as they adjust one or more parameters related to their treatment. For example, the user may feel a tangible difference in their respiratory system with each parameter adjustment, e.g., by feeling pressure. By further example, a patient may feel a lack of air at low pressure (e.g., due to CO2), and by adjusting the waveform in the disclosed interface, the patient may perceive that their symptoms are being alleviated. As a result, the user can easily determine which parameter setting(s) make them feel most comfortable. The disclosed technology may also provide the user with a visual response via a display showing the effect of the user's adjustments.

[0077] Third, by allowing treatment-related visual features to be adjusted via a touchscreen, the technology significantly increases the degree of freedom to adjust parameters, allowing users to adjust parameters without requiring advanced technical knowledge.

[0078] 6 Memory and Processor Examples The memories 114 and 174 may be databases that store information accessible to the processor(s) 110 and 172, respectively. For example, the memory 114 of the system 100 may store instructions and data related to adjustable parameters for controlling the pressure support generated by the pressure generator 112. The memory 174 of the wireless device 170 may store instructions and data received from the system 100. The memories 114 and 174 may be of any type capable of storing information accessible to the processor(s), including a computing device-readable medium. The memory may be a non-transitory medium, such as a hard drive, memory card, optical disk, solid state, etc. The memory may include various combinations of the foregoing, whereby different portions of the instructions and data may be stored on different types of media. The instructions may be a set of instructions (e.g., machine code) that are executed directly by the processor(s) or a set of instructions (e.g., script) that are executed indirectly by the processor(s). For example, the instructions may be stored as computing device code on a computing device-readable medium. In this regard, the terms “instructions,” “modules,” and “programs” may be used interchangeably herein. The instructions may be stored in object code form for direct processing by a processor, or in other computing device languages, including scripts or collections of independent source code modules that are interpreted on demand or pre-compiled.

[0079] Processors 110 and 172 may be any common processor, such as a commercially available GPU, CPU, or TPU. Alternatively, each processor may be a dedicated device, such as an ASIC or other hardware-based processor. While FIG. 1B functionally depicts the processor and memory as being located within the same block, such devices may actually include multiple processors, computing devices, or memories, which may or may not be stored within the same physical housing. Similarly, memory may be a hard drive or other storage medium located within a different housing than the processor(s), for example, in a cloud computing system. Thus, references to a processor or computing device should be interpreted as including a collection of processors or computing devices or memories, whether or not operating in parallel. Processors 110 and 172 may access memories 114 and 174, respectively, over a network.

[0080] 7.1 Optional Processing System Examples Exemplary embodiments of system 100 are described in further detail below in Sections 7.1-7.5.

[0081] In one form, the system 100 may treat and / or monitor a respiratory disorder. The system 100 may be a respiratory therapy device (RT), such as an RPT device 4000, that supplies a pressurized airflow to the patient 1000 via an air circuit 4175 that connects to a patient interface 3000. The airflow may be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy, such as high flow therapy HFT). Thus, the RPT device may be configured to function as a flow therapy device, such as when using a patient interface that does not employ a seal that seals with the patient's respiratory system. In the following description, an RT or RPT device may be considered with reference to FIGS. 8A-11.

[0082] 7.2 Patient Interface 9 , a non-invasive patient interface 3000 in accordance with an aspect of the present technology may optionally comprise any of the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airways to facilitate the delivery of pressurized air to the airways.

[0083] 7.3 RPT Devices An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical and pneumatic components 4100, electrical components 4200, and is programmed to execute one or more algorithms 4300. The RPT device 4000 may have an outer housing 4010 formed as two parts, an upper portion 4012 and a lower portion 4014. Further, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 may include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0084] The air pressure path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying pressurized air, an outlet muffler 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow rate sensor 4274.

[0085] One or more pneumatic path items may be arranged within a movable, unitary structure called a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0086] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 may include one or more PCBAs 4202.

[0087] 7.3.1 Mechanical and Pneumatic Components of RPT Devices The RPT device 4000 may include one or more of the following components in an integrated unit: In an alternative, one or more of the following components may be located as respective separate units.

[0088] 7.3.1.1 Air filter(s) An RPT device 4000 in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0089] In one form, the air inlet filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0090] In one form, an air outlet filter 4114, for example an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0091] 7.3.1.2 Muffler(s) An RPT device 4000 in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0092] In one form of the present technology, an inlet muffler 4122 is placed in the pneumatic path upstream of a pressure generator 4140 .

[0093] In one form of the present technology, an outlet muffler 4124 is placed in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0094] 7.3.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 for supplying compressed air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed within a volute. The pressure generator 4140 may be capable of producing, for example, a supply or flow of about 120 liters / minute of air at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or otherwise up to about 30 cmH2O.

[0095] The pressure generator 4140 is under the control of the therapy device controller 4240 .

[0096] In other forms, pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (such as a compressed air reservoir), or a bellows.

[0097] 7.3.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may be located on or form part of the air circuit, for example, a patient interface. An external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0098] In one form of the present technology, one or more sensors 4270 are positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 are constructed and positioned to generate data representative of a corresponding attribute of the airflow, such as flow rate, pressure, or temperature, at that point in the airflow.

[0099] In one form of the present technology, one or more sensors 4270 are placed proximate the patient interface 3000.

[0100] In one form, the signal from the transducer 4270 may be filtered, such as by low-pass, high-pass, or band-pass filtering.

[0101] 7.3.1.5 Anti-spillback valves In one form of the present technology, a non-return valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The non-return valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example towards the motor 4144.

[0102] 7.3.1.6 Air circuits The air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged to allow air flow to travel between two components, such as the pneumatic block 4020 and the patient interface 3000, in use.

[0103] 7.3.1.7 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 is delivered to the air circuit 4170 and / or patient interface 3000 at one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020.

[0104] 7.3.2 Electrical Components of RPT Devices 7.3.2.1 Power supply In one form of the present technology, the power supply 4210 is internal to the external housing 4010 of the RPT device 4000. In another form of the present technology, the power supply 4210 is located external to the external housing 4010 of the RPT device 4000.

[0105] In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0106] 7.3.2.2 Input Devices In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touchscreen. The buttons, switches, or turntables may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.

[0107] In one form, the input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options.

[0108] 7.3.2.3 Central Controller In one form of the present technology, the central controller 4230 is a processor adapted to control the RPT device 4000, for example an x86 INTEL® processor.

[0109] A central controller 4230 suitable for controlling an RPT device 4000 in accordance with another form of the present technology includes a processor based on an ARM Cortex™ M processor from ARM Holdings. For example, an STM32 series microcontroller from ST MICROELECTRONICS may be used.

[0110] In accordance with another alternative form of the present technology, another central controller 4230 adapted to control the RPT device 4000 includes a selected member of the ARM9-based 32-bit RISC CPU series. For example, an STM9 series microcontroller from ST MICROELECTRONICS may be used.

[0111] In certain alternative forms of the present technology, a 16-bit RISC CPU may be used as the central controller 4230 of the RPT device 4000. For example, a processor from the MSP430 series of microcontrollers manufactured by TEXAS INSTRUMENTS may be used.

[0112] In another form of the present technology, the central controller 4230 is a dedicated electronic circuit. In another form, the central controller 4230 is an application specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0113] The central controller 4230 is configured to receive input signal(s) from one or more sensors 4270, one or more input devices 4220, and the humidifier 5000.

[0114] The central controller 4230 is configured to provide output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0115] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, e.g., one or more algorithms 4300 represented as a computer program stored in a non-transitory computer-readable storage medium, such as the memory 4260 or other memory described herein. In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000, as described above. However, in some forms of the present technology, some methods may be performed by a remote device or server, such as the server described above. For example, the remote device or server may determine control settings to send to the ventilator or other RT device, e.g., by detecting respiratory-related events and identifying them by type by analyzing stored data, such as from any of the sensors described herein.

[0116] Although the central controller 4230 may include a single controller that interacts with the various sensors 4270, data communication interface 4280, memory 4260, and other devices, the functions of the controller 4230 may be distributed across multiple controllers. Thus, the term "central" as used herein is not meant to limit the architecture to a single controller or processor controlling other devices. For example, alternative architectures may include a distributed controller architecture including two or more controllers or processors, which may optionally communicate electronically (wired or wirelessly) directly or indirectly with the previously described finger sensors or a server that communicates with the finger sensors, such as to implement any of the methods described herein. This may include, for example, a separate local (i.e., within the RPT device 4000) or remote controller that executes several algorithms 4300, or two or more local or remote memories that store several algorithms. Furthermore, when expressed as a computer program, the algorithms may include high-level human-readable code (e.g., C++, Visual Basic, other object-oriented languages, etc.) or low-level / machine-level instructions (e.g., assembler, Verilog, etc.). Depending on the function of the algorithm(s), such code or instructions may be written into a controller, e.g., an ASIC or DSP, or ported to a DSP or general-purpose processor, which is then a run-time executable file that is specifically programmed to perform the tasks required by the algorithm(s).

[0117] 7.3.2.4 Clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230 .

[0118] 7.3.2.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0119] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the ONSEMI MC33035 brushless DC motor controller is used.

[0120] The RPT device 4000 according to the present technology includes one or more protection circuits 4250. 7.3.2.6 Protection Circuits It may include.

[0121] One form of protection circuit 4250 according to the present technology is an electrical protection circuit.

[0122] One form of protection circuit 4250 in accordance with the present technology is a temperature or pressure safety circuit.

[0123] 7.3.2.7 Memory In accordance with one form of the present technology, the RPT device 4000 includes memory 4260, such as non-volatile memory. In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0124] Memory 4260 may reside on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash memory.

[0125] Additionally or alternatively, the RPT device 4000 includes a removable form of memory 4260, such as a memory card made in accordance with the Secure Digital (SD) standard.

[0126] In one form of the present technology, memory 4260, such as any of the memories described above, functions as a non-transitory computer-readable storage medium on which are stored computer program instructions expressing one or more methodologies described herein, such as one or more algorithms 4300.

[0127] 7.3.2.8 Transducers The transducer may be internal to the RPT device 4000 or external to the RPT device 4000. The external transducer may be located, for example, on the air delivery circuit 4170, for example, at the patient interface 3000, or may form part of the air delivery circuit 4170. The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or forwards data to the RPT device 4000.

[0128] 7.3.2.8.1 Flow rate The flow transducer 4274 according to the present technology may be based on a differential pressure transducer, such as SENSIRION's SDP600 series differential pressure transducer. The differential pressure sensors are in fluid communication with the air circuit, with one of the pressure sensors connected to a corresponding first and second point of the flow restricting element.

[0129] In one example, a signal representing the total flow Qt from the flow transducer 4274 is received by the central controller 4230.

[0130] 7.3.2.8.2 Pressure A pressure transducer 4272 according to the present technology is placed in fluid communication with the pneumatic path. An example of a suitable pressure sensor 4272 is the HONEYWELL ASDX series sensor. Another suitable pressure sensor is the GE NPA series sensor.

[0131] In use, the signal from the pressure sensor 4272 is received by the central controller 4230. In one form, the signal from the pressure transducer 4272 is filtered before being received by the central controller 4230.

[0132] 7.3.2.8.3 Motor Speed In one form of the present technology, the motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or blower 4142. The motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be a speed sensor such as, for example, a Hall effect sensor.

[0133] 7.3.2.9 Data communication systems In one form of the present technology, a data communications interface 4280 is provided and connected to a central controller 4230. The data communications interface 4280 may be connected to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connected to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.

[0134] In one form, the data communication interface 4280 is part of the central controller 4230. In another form, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0135] In one form, the remote external communications network 4282 is the Internet. The data communications interface 4280 may be connected to the Internet using wired communications (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0136] In one form, the local external communications network 4284 utilizes one or more communications standards, such as Bluetooth or consumer infrared protocol, and may optionally communicate with any of the sensors described herein.

[0137] In one form, the remote external device 4286 is one or more computers, such as a cluster of computers and / or servers connected to a network, as described herein. In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be available to appropriately authorized personnel, such as a clinician.

[0138] The local external device 4288 may be a personal computer, a mobile phone, a tablet or a remote control.

[0139] 7.3.2.10 Output Devices (including optional displays and alerts) Output device 4290 according to the present technology may take the form of one or more of a visual, auditory and tactile unit. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0140] 7.3.2.10.1 Display Driver The display driver 4292 receives as input characters, symbols, or images intended to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0141] 7.3.2.10.2 Display Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, where display driver 4292 converts each character or symbol (), such as the digit "0", into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol.

[0142] 7.3.3 RPT Device Algorithm 7.3.3.1 Pre-processing module The pre-processing module 4310 according to the present technology receives as input raw data from a transducer 4270, e.g., a flow sensor 4274 or a pressure sensor 4272, and performs one or more processing steps to calculate one or more output values ​​that are used as input to another module, e.g., a therapy engine module 4320.

[0143] In one form of the present technology, the output values ​​include interface pressure Pm, respiratory flow Qr, and leak flow Ql.

[0144] In various forms of the present technology, the pre-processing module 4310 comprises one or more of the following algorithms: pressure compensation 4312, ventilation flow estimation 4314, leak flow estimation 4316, respiratory flow estimation 4317, ventilation determination 4311, target ventilation determination 4313, respiratory rate estimation 4318, and backup rate determination 4319.

[0145] 7.3.3.1.1 Pressure compensation In one form of the present technology, a pressure compensation algorithm 4312 receives as an input a signal indicative of the pressure in the pneumatic path near the outlet of the pneumatic block 4020. The pressure compensation algorithm 4312 estimates the pressure drop in the pneumatic circuit 4170 and provides as an output the estimated pressure Pm at the patient interface 3000.

[0146] 7.3.3.1.2 Ventilation flow estimation algorithm In one form of the present technology, a ventilation flow estimation algorithm 4314 takes as input an estimated pressure Pm at the patient interface 3000 and estimates the ventilation flow Qv of air out of the vent 3400 in the patient interface 3000.

[0147] 7.3.3.1.3 Leak flow rate estimation algorithm In one form of the present technology, a leak flow estimation algorithm 4316 takes as input the total flow Qt and the ventilation flow Qv and estimates the leak flow Ql. In one form, the leak flow estimation algorithm 4316 estimates the leak flow Ql by calculating the average value of the difference between the total flow and the ventilation flow Qv over a period of time long enough to include several respiratory cycles, for example 10 seconds.

[0148] In one form, the leak flow estimation algorithm 4316 receives as input the total flow Qt, ventilation flow Qv, and estimated pressure Pm within the patient interface 3000, estimates the leak flow Ql by calculating the leak conductance, and determines that the leak flow Ql is a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered unventilated flow, which is equal to the difference between the total flow Qt and the ventilation flow Qv, and the low-pass filtered square root of the pressure Pm, where the low-pass filter time constant has a value long enough to include several respiratory cycles, for example, about 10 seconds. The leak flow Ql may be estimated as the product of the leak conductance and the pressure function Pm.

[0149] 7.3.3.1.4 Respiratory flow estimation algorithm In one form of the present technology, the respiratory flow estimation algorithm 4317 takes as inputs the total flow Qt, the ventilation flow Qv, and the leak flow Ql, and estimates the air respiratory flow Qr for the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.

[0150] In another form of the present technology, the respiratory flow estimation algorithm 4317 provides a value as a surrogate for respiratory flow Qr. Possible surrogates for respiratory flow include: - 1000 respiratory movements of the patient's chest, - the current drawn by the pressure generator 4140; - motor speed of pressure generator 4140, -Patient transthoracic impedance 1000 is included.

[0151] The respiratory flow proxy value may be provided by a transducer 4270 within the RPT device 4000, for example a motor speed sensor 4276, or a sensor external to the RPT device 4000 such as a respiratory movement sensor or transthoracic impedance sensor.

[0152] 7.3.3.1.5 Ventilation Decision Algorithm In one form of the present technology, a ventilation determination algorithm 4311 takes as input the respiratory flow Qr and determines a measure Vent that is indicative of the current patient ventilation.

[0153] In some implementations, the ventilation determination algorithm 4311 determines a ventilation measurement that is an estimate of the actual patient ventilation, Vent.

[0154] In one such implementation, the measurement of ventilation volume Vent is half the absolute respiratory flow Qr, optionally filtered by a low-pass filter such as a second-order Bezier low-pass filter with a corner frequency of 0.11 Hz.

[0155] In one such implementation, the measurement of ventilation Vent is an estimate of total alveolar ventilation (i.e., non-anatomic dead space ventilation). This requires an estimation of anatomical dead space. Patient height (or arm span in cases of severe skeletal deformities) can be used as a good predictor of anatomical dead space. Total alveolar ventilation is equal to the measurement of actual patient ventilation, e.g., as determined above, minus the product of the estimated anatomical dead space and the estimated spontaneous breathing rate Rs.

[0156] In other embodiments, the ventilation determination algorithm 4311 determines a measurement of ventilation vent that is substantially proportional to the actual patient ventilation. In such an embodiment, the peak respiratory flow rate Qpeak of the estimated cycle inspiration interval is realized. Many other programs, including this program and the sampling of the respiratory flow rate Qr, generate measurements that are approximately proportional to the ventilation volume on the premise that the shape of the flow rate waveform does not change much (here, when the respiratory flow rate waveforms normalized temporally and amplitude-wise are similar, the shapes of both respirations are considered similar). Simple examples include the median of the positive respiratory flow rate, the median of the absolute value of the respiratory flow rate, and the standard deviation of the flow rate. Any linear combination of any order statistics of the statistics of the absolute value of the respiratory flow rate using positive coefficients, and even those using both positive and negative coefficients, are approximately proportional to the ventilation volume. Another example is the average value of the respiratory flow velocity at the intermediate KK ratio (time) of the inspiration part, where 0 < K < 1. If the shape of the flow velocity waveform does not change, there can be any number of measurements that are exactly proportional to the ventilation volume.

[0157] In other forms, the ventilation determination algorithm 4311 determines a ventilation index Vent that is not based on the respiratory flow rate Qr. This index is a surrogate indicator of the current patient ventilation, such as the oxygen saturation (SaO2) or partial pressure of carbon dioxide (PCO2) obtained from a suitable sensor worn by the patient 1000.

[0158] 7.3.3.1.6 Target Ventilation Volume Determination Algorithm In one form of the present technology, the central controller 4230 receives the current measured value of ventilation volume Vent as an input and executes one or more target ventilation volume determination algorithms 4313 for determining the target value Vtgt of the measured value of ventilation volume.

[0159] In some forms of the present technology, the target ventilation volume determination algorithm 4313 does not exist, and the target value Vtgt is predetermined, for example, by hard-coding it in the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0160] In other forms of the present technology, for example adaptive servo ventilation (ASV) therapy (described below), the target ventilation determination algorithm 4313 calculates the target ventilation Vtgt from a value Vtyp indicative of the patient's 1000 typical recent ventilation.

[0161] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a high percentage of the typical recent ventilation Vtgt, but less than the typical recent ventilation Vtyp. Such a high percentage may be in the range of (80%, 100%), (85%, 95%), (87%, 92%).

[0162] In other forms of adaptive servo-ventilation, the target ventilation, Vtgt, is calculated as a unit multiple slightly greater than the typical current ventilation, Vtyp.

[0163] Typical recent ventilation Vtyp is the value to which the distribution of current ventilation (Vent) at multiple time instants over a given time scale tends to converge, i.e., it is a measure of the convergence trend of current ventilation in the recent past. In one implementation of the target ventilation determination algorithm 4313, the recent history is on the order of several minutes, but in any case must be longer than the time scale of a Cheyne-Stokes rise-fall cycle. The target ventilation determination algorithm 4313 can use any of a variety of known convergence trend measures to determine typical recent ventilation Vtyp from the measured current ventilation (Vent). One such measure is the output of a low-pass filter on the current ventilation (Vent) measurement, with a time constant equal to 100 seconds.

[0164] 7.3.3.1.7 Respiratory flow estimation In one form of the present technology, a respiratory flow estimation algorithm 4318 takes as input the patient's 1000 respiratory flow Qr and generates an estimate of the patient's spontaneous breathing flow Rs.

[0165] The respiratory rate estimation algorithm 4318 can estimate the spontaneous breathing rate Rs during spontaneous breathing by the patient 1000, i.e., when the RPT device 4000 is not delivering "pre-breaths" (described below). In some forms of the present technology, the respiratory flow estimation algorithm 4318 estimates respiratory flow during periods of low servo assist (defined as pressure support minus minimum pressure support) at a value less than 4 cmH2O in one implementation, as this is more likely to reflect spontaneous respiratory effort.

[0166] In some forms of the present technology, the respiratory flow estimation algorithm 4318 estimates respiratory flow during sleep breathing, since respiratory flow during these periods can be substantially different from respiratory flow during wakefulness. Anxiety typically causes a higher respiratory rate than during sleep. While a patient is concentrating on their breathing process, the respiratory rate typically is lower than normal awake or sleep breathing rates. Patent application number PCT / AU2010 / 000894, disclosed as WO2011 / 006199, is incorporated herein by reference and can be used to identify periods of wakefulness breathing from respiratory flow Qr.

[0167] In some forms of the present technology, the respiratory flow estimation algorithm 4318 estimates the spontaneous breathing flow rate Rs as the reciprocal of one of various well-known statistical measures of the concentration tendency of breath duration Ttot over the period of interest. It is desirable for such measures to reject, or at least be robust to, outliers. A metric that trims the mean value by discarding a percentage of the lowest and highest K ranked breath durations and then calculates the mean value from the remaining breath durations is robust to outliers. For example, if K is 0.25, this corresponds to discarding the upper and lower quartiles of breath duration Ttot. The median is another reliable measure of central tendency, but may not produce satisfactory results when the distribution is strongly bimodal. The simple average is susceptible to outliers and can also be used as a measure of central tendency. An initial interval filtering phase may be used in which consecutive time intervals corresponding to impossible breath rates (e.g., greater than 45 breaths / min or less than 6 breaths / min) are excluded from the mean calculation as outliers. Another filtering mechanism that can be used alone or in combination with interval filtering is to eliminate any breaths that do not belong to a sequence of N consecutive spontaneous breaths, where N is a small integer (e.g., 3), and to eliminate the early and late breaths of a sequence of four consecutive spontaneous breaths, such as the first and last breaths of a four-breath sequence. The underlying principle of this latter mechanism is that the first and last breaths of a series of spontaneous breaths, as well as the typical early and late breaths, may be atypical. For example, the first spontaneous breath may be the result of arousal, while the last spontaneous breath may be longer due to reduced respiratory drive and a preparatory breath terminating the spontaneous breath sequence.

[0168] In some forms of the present technology, the respiratory flow estimation algorithm 4318 makes an initial estimate of the spontaneous breathing flow Rs using an initial estimation period to allow subsequent processing in the therapy engine module 4320 to begin, and then continuously updates the estimate of the spontaneous breathing flow Rs using a longer estimation period to improve statistical robustness. For example, the estimated initial period may be 20 minutes of adequate spontaneous breathing, but the estimated period may then be gradually increased to some maximum duration, such as 8 hours. This estimate can use a low-pass filter on the breath duration, instead of using a low-pass filter on the breath duration, which has gradually longer response times (or more accurately, gradually lower angular frequencies) as the session progresses.

[0169] In some forms, suitably processed short-term (e.g., 10 minute) measurements of concentration trends, such as trimmed averages, may be input into a suitable low-pass filter to give an estimated Rs that varies over the hourly or longer time scale. The advantage is that it is not necessary to store and process large amounts of breath duration data, which may result if a trimmed average needs to be calculated over a moving window of breath duration data spanning hours or days.

[0170] In some forms of the present technology, respiratory rate measured for a short period of time, particularly within a single breath, may be used in place of respiratory duration in the concentration tendency measurements described above, and may give substantially similar but different results.

[0171] 7.3.3.2 Treatment Engine Module In one form of the present technology, the therapy engine module 4320 receives as input one or more of the pressure in the patient interface 3000 Pm, the patient's air respiratory flow Qr, and an estimate of the intrinsic breathing rate Rs, and provides as output one or more therapy parameters. In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring detection 4326, airway patency determination 4327, and therapy parameter determination 4329.

[0172] 7.3.3.2.1 Phase Determination Algorithm In one form of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow Qr and provides as an output the phase Φ of the patient's 1000 current respiratory cycle.

[0173] In some forms known as discrete phase determination, the phase output Φ is a discrete variable. One implementation of discrete phase determination provides a binary phase output Φ having values ​​for inspiration or expiration, e.g., values ​​represented by 0 and 0.5 revolutions, upon detecting the onset of spontaneous inspiration and expiration, respectively. The "trigger" and "loop" RPT device 4000 can efficiently perform discrete phase determination because the trigger and loop points are the moments when the phase changes from expiration to inspiration and inspiration to expiration, respectively. In one embodiment of binary phase determination, the phase output Φ is resolved to a discrete value of 0 (thus "triggers" the RPT device 4000) when respiratory flow Qr has a value greater than a positive threshold, and is resolved to a discrete value of 0.5 revolutions (thus "cycles" the RPT device 4000) when respiratory flow Qr has a value more negative than a negative threshold.

[0174] Another implementation of discrete phase determination provides a ternary phase output Φ having one of the following values: inspiration, inspiration pause, expiration.

[0175] In another form, called continuous phase determination, the phase output Φ is a continuous variable, such as a change from 0 to 1 revolution or 0 to 2π radians. An RPT device 4000 with continuous phase determination can trigger and loop when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one implementation of continuous phase determination, fuzzy logic analysis of respiratory flow Qr is used to determine continuous values ​​of phase Φ. The continuous phase values ​​determined in this implementation are commonly referred to as "fuzzy phases." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to respiratory flow Qr:

[0176] 1. If respiratory flow is zero and increases suddenly, the phase will be 0 rotations.

[0177] 2. If respiratory flow is stable at a constant value, the phase should be 0.25 rotations.

[0178] 3. If respiratory flow is zero and falls rapidly, the phase is 0.5 rotations.

[0179] 4. If respiratory flow is large and stable, the phase should be 0.75 rpm.

[0180] 5. When respiratory flow is stable at zero and the 5-second low-pass filtered absolute value of respiratory flow is large, the phase is 0.9 rpm.

[0181] 6. If respiratory flow is positive and the phase is exhalation, the phase is 0 rotations.

[0182] 7. If respiratory flow is negative and the phase is inspiration, the phase is 0.5 revolutions.

[0183] 8. If the 5-second low-pass filtered absolute value of respiratory flow is large, the phase increases at a steady rate equal to the patient's respiratory flow, low-pass filtered with a 20-second time constant.

[0184] The output of each rule can be represented as a vector with a phase, which is the result of that rule, and a magnitude, which is the degree of ambiguity that the rule is true. Respiratory flow is a ambiguity, such as "large" or "stable," determined by appropriate membership functions. Rule results are represented as vectors and combined by some function, such as centroid. In this combination, rules may have equal or different weights.

[0185] In another implementation of sequential phase determination, the inspiration time Ti and expiration time Te are first estimated from the respiratory flow Qr, and the phase Φ is determined to be half the percentage of the inspiration time Ti that has elapsed since the previous trigger time, or half the percentage of the expiration time Te that has elapsed since the previous cycle time in 0.5 revolutions (whichever is closer).

[0186] In some forms of the present technology suitable for pressure support ventilation therapy (described below), the phase determination algorithm 4321 is configured to be triggered even when respiratory flow Qr is not significant, such as during apnea. As a result, the RPT device 4000 provides a "backup breath" when the patient 1000 is not making a spontaneous respiratory effort. In this form, known as the spontaneous / timed (S / T) pattern, the phase determination algorithm 4321 can utilize the backup rate Rb provided by the backup rate determination algorithm 4319.

[0187] The phase determination algorithm 4321 using "fuzzy phase" can achieve an S / T pattern by including a "momentum" rule in the fuzzy phase rule using a backup rate Rb. The momentum rule acts to advance the successive phases from expiration to inspiration at the backup rate Rb when the characteristics of respiratory flow Qr do not advance the successive phases by other rules. In one implementation, the further the measured ventilation Vent (described below) is below the target ventilation Vtgt, the higher the weight of the momentum rule in the combination. However, a sudden increase in pressure support in response to mild to moderate hypoventilation (compared to the target ventilation) can cause ventilation to be very close to the target ventilation. When ventilation is close to the target, the desired momentum rule is given a lower weight, and at other times (when the patient is not centrally apneic), the patient is allowed to breathe at a rate significantly lower than the respiratory flow without being unnecessarily prompted by the ventilator to breathe at a higher rate. However, if the momentum rule is given low weighting when ventilation is below but close to the target ventilation, adequate ventilation may be easily achieved with relatively high-pressure support at a rate significantly below the backup rate. Because spare breaths allow the target breath to be delivered with lower-pressure support, delivering them at a higher rate is desirable. This is ideal for many reasons, one important of which is the reduction of mask leak.

[0188] In summary, in the fuzzy phase determination algorithm 4321 that implements the S / T pattern, there is a dilemma when selecting weights for momentum rules, including the backup rate Rb. If the weights are too high, the patient may feel like they are being "pushed" by the backup rate. If the weights are too low, the pressure support may be too great. Therefore, it is desirable to provide a method for realizing an S / T pattern that does not rely on the momentum rules described above.

[0189] The phase determination algorithm 4321 (discrete or continuous without momentum regulation) can implement the S / T pattern using the backup rate Rb in a manner called scheduled backup. Scheduled backup can be achieved by the phase determination algorithm 4321 attempting to detect the onset of inspiration due to a spontaneous breathing effort, for example, by monitoring the respiratory flow Qr, as described above. The phase determination algorithm 4321 sets the phase output Φ to an inspiration value (thus triggering the RPT device 4000) if the onset of inspiration due to a spontaneous breathing effort is not detected within a period of time since the last trigger time whose duration is equal to the inverse of the backup rate Rb (an interval called the backup timing threshold). When the RPT device 4000 is triggered to begin delivery of a spare breath, the phase determination algorithm 4321 attempts to detect the onset of spontaneous expiration, such as by monitoring the respiratory flow Qr, and based on this, sets the phase output Φ to an expiration value (thus cycling the RPT device 4000).

[0190] As in the variable backup rate method described above, as the backup rate Rb increases over time from SBR to STBR, the backup timing threshold begins to lengthen and gradually shortens. That is, the RPT device 4000 is initially less vigilant and then becomes increasingly vigilant to the lack of spontaneous breathing effort as more reserve breaths are delivered. Such an RPT device 4000 is less likely to make the patient feel like they are being "pushed" while still providing reserve breaths as needed if the patient prefers to breathe at a slower rate than normal.

[0191] Like the adaptive variable backup rate system described above, if the STBR of the variable backup rate system matches the patient's estimated spontaneous breathing rate Rs, spare breaths are delivered at a rate that matches the patient's own recent spontaneous breathing effort.

[0192] 7.3.3.2.2 Waveform determination algorithm In one form of the present technology, a therapy control module 4330 controls a pressure generator 4140 to provide a therapy pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ).

[0193] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having values ​​in the range [0, 1] over the domain of phase values ​​Φ provided by the phase determination algorithm 4321 which are used by the treatment parameter determination algorithm 4329.

[0194] In one form, applied to discrete or continuous-valued phases, the waveform template Π(Φ) is a square wave template with a value of 1 for phase values ​​less than 0.5 revolutions and a value of 0 for phase values ​​equal to or greater than 0.5 revolutions. In a form suitable for continuous-valued phases, the waveform template Π(Φ) has two smoothly curved sections: a smoothly curved section (e.g., a rising cosine) that rises from 0 to 1 for phase values ​​up to 0.5 revolutions, and a smooth bend (e.g., exponentially for phase values ​​greater than 0.5 revolutions) that decays from 1 to 0. An example of this "smooth and comfortable" waveform template is the "shark fin" waveform template, where the rise is a rising cosine and the smooth decay is subexponential (so that the limit of Π is just zero as Φ approaches 1 revolution).

[0195] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a waveform template library according to the settings of the RPT device 4000. Each waveform template Π(Φ) in the library may be provided as a look-up table of values ​​Φ versus phase values ​​Π. In other forms, the waveform determination algorithm 4322 uses a predetermined functional form (which may be parameterized by one or more parameters (e.g., a time constant of an exponential curve portion)) to "dynamically" calculate the waveform template Π(Φ). The parameters of the functional form may be predetermined or may depend on the current state of the patient 1000.

[0196] In some forms of the present technology, applied to a discrete binary phase of inspiration (Φ=0 revolutions) or expiration (Φ=0.5 revolutions), the waveform determination algorithm 4322 calculates a waveform template Π "dynamic" as a function of the discrete phase Φ and time t measured since the most recent trigger instant. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) as two parts (inspiration and expiration) as follows:

[0197]

number

[0198] 7.3.3.3 Treatment Control Module A therapy control module 4330 in accordance with one aspect of the present technology receives therapy parameters as input from a therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver airflow in accordance with the therapy parameters.

[0199] In one form of the present technology, the treatment parameter is a treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow such that the interface pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt.

[0200] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0201] In one form of the present technology, the therapy parameter is the instantaneous therapy pressure Pt. In one implementation of this form, the therapy parameter determination algorithm 4329 determines the therapy pressure Pt using the formula:

[0202]

number

[0203] If the waveform determination algorithm 4322 provides the waveform template Π(Φ,t) as a lookup table of values ​​Π indexed by the phase Φ, the treatment parameter determination algorithm 4329 applies equation (1) by finding the lookup table entry closest to the current value Φ of the phase returned by the phase determination algorithm 4321, or by interpolating between two entries that straddle the current value Φ of the phase.

[0204] The values ​​of amplitude A and base pressure P0 may be set by treatment parameter determination algorithm 4329 in a manner described below depending on the respiratory pressure treatment mode selected.

[0205] 7.5 Terminology For purposes of this disclosure, in some aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, alternative definitions may apply.

[0206] 7.5.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, and in other forms of the present technology, air may refer to a combination of other breathable gases, for example, oxygen-rich atmospheric air.

[0207] Respiratory pressure therapy (RPT): Air is delivered to the entrance of the airways at a positive therapeutic pressure, usually relative to the atmosphere.

[0208] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to the detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0209] Patient: A person, whether or not suffering from a respiratory condition.

[0210] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting the therapy pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0211] 7.5.2 Aspects of the Respiratory Cycle Apnea: According to some definitions, apnea is said to occur when the flow rate falls below a predetermined threshold for a period of time, e.g., 10 seconds. Obstructive apnea is said to occur when some form of airway obstruction does not allow airflow despite the patient's efforts. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway.

[0212] Respiratory rate: The patient's rate of spontaneous breathing, usually measured in breaths per minute.

[0213] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0214] Effort (breathing): The effort made by a spontaneous breather to breathe.

[0215] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0216] Flow limitation: Flow limitation is considered to be a condition in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0217] Hypopnea: Flow is reduced but not stopped. In one form, hypopnea is said to occur when flow is reduced below a threshold rate for a sustained period of time. In one form, adults may be considered hypopneas if any of the following occur:

[0218] (i) A 30% decrease in patient breathing for at least 10 seconds plus an associated 4% desaturation, or (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds and associated desaturation or agitation of at least 3%.

[0219] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0220] Patency (Airway): The degree to which the airway is open, or the extent to which the airway is open. The patient's airway is open. Airway patency may be quantified, for example, as a value of one (1) for an open state or a value of zero (0) for a closed (occluded) state.

[0221] Positive end-expiratory pressure (PEEP): The pressure in the lungs above atmosphere that exists at the end of expiration.

[0222] Peak flow (Q peak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0223] Respiratory flow, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the estimate of respiratory flow by an RPT device, as distinct from "true respiratory flow" or "true respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0224] Tidal Volume (Vt): The volume of air inhaled or exhaled during normal breathing when no extra effort is exerted.

[0225] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0226] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0227] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0228] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. This can be associated with a state of flow limitation in which flow increases slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistance behavior).

[0229] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inspiratory and expiratory flow per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute.

[0230] 7.5.3 RPT Device Parameters Flow rate: The instantaneous volume (or mass) of air delivered per unit time. Flow rate and ventilation have the same volumetric or mass dimension per unit time, but flow rate is measured over a shorter period of time. In the example of patient breathing, flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion of the patient's respiratory cycle. In some cases, reference to flow rate refers to a scalar quantity (i.e., a quantity with magnitude only). In other cases, reference to flow rate refers to a vector quantity (i.e., a quantity with both magnitude and direction). The symbol Q is followed by the flow rate. "Flow rate" is sometimes simply referred to as "flow." Total flow rate Qt is the flow rate of air exiting the RPT device. Ventilation flow rate Qv is the flow rate of air exiting the exhaust port to expel exhaled gases. Leak flow rate Ql is the flow rate of leaks from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air entering the patient's respiratory system.

[0231] Leak: The term "leak" refers to an unintended flow of air. In one example, a leak can occur as a result of an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the elbow relative to the circumference.

[0232] Pressure: Force per unit area. Pressure is measured in cmH2O or gf / cm 2 , and a series of units including hectopascals. 1 cmH2O is 1 g-f / cm 2 , which is approximately 0.98 hectopascals. Unless otherwise stated, pressures are given in units of cmH2O herein. Pressures at the patient interface are labeled Pm and treatment pressures, which indicate the target value that the mask pressure Pm should currently achieve, are labeled Pt.

[0233] 7.5.4 Ventilator terminology Adaptive Servo Ventilator (ASV): A servo ventilator that has a variable, rather than fixed, target ventilation that can be learned from some characteristics of the patient, such as the patient's breathing characteristics.

[0234] Backup Rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator will deliver to the patient unless triggered by spontaneous breathing effort.

[0235] Cycled: The end of the inspiratory phase of the ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to be cycled to cease delivering breaths.

[0236] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are applied within a breath to produce the desired interface pressure the ventilator attempts to achieve at a given time.

[0237] End-Expiratory Pressure (EEP): The desired interface pressure the ventilator attempts to achieve at the end of the expiratory portion of exhalation. If Φ = 1, then when the pressure waveform template Π(Φ) is forced to zero at the end of exhalation, i.e., Π(Φ) = 0, then EEP is equal to EPAP.

[0238] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0239] Pressure Support: A numerical value indicating the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, generally referring to the difference in pressure between peak and base pressure during inspiration (e.g., PS = IPAP - EPAP). In some situations, pressure support refers to the difference the ventilator attempts to achieve, rather than the difference it actually achieves.

[0240] Servo-ventilator: A ventilator that measures patient ventilation, has a target ventilation, and adjusts the level of pressure support to move patient ventilation toward the target ventilation.

[0241] Servo Assist: Pressure Support minus Minimum Pressure Support.

[0242] Spontaneous / Timed (S / T): A pattern in which a ventilator or other device attempts to detect the onset of a breath in a spontaneously breathing patient. If the device does not detect a breath within a predetermined period, the device automatically begins delivering a breath.

[0243] Swing: A term equivalent to pressure support.

[0244] Triggered: When a ventilator delivers breathing air to a spontaneously breathing patient, it is said to do so by being triggered at the start of the respiratory portion of the breathing cycle by the patient's effort.

[0245] Typical Recent Ventilation: Typical recent ventilation Vtyp is the value around which recent ventilation measurements over a given timescale tend to cluster, i.e., a measure of the central tendency of ventilation measurements over recent history.

[0246] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0247] 4.6 Other Notes A portion of the disclosure of this patent document contains copyrighted material. The copyright owner has no objection to anyone copying this patent document or this patent disclosure for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0248] Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of the range, and for any other stated or intervening value in the stated range, is encompassed by the technology. The upper and lower limits of these intervening ranges, independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0249] Furthermore, when one or more values ​​are described herein as being implemented as part of the technology, it should be understood that these values ​​may be approximated unless otherwise stated and may utilize any suitable significant figures to the extent that actual technical implementation may permit or require.

[0250] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0251] Although particular materials are described as being suitable for use in the construction of a component, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0252] It should be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0253] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of such publications. The publications mentioned herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Additionally, the publication dates provided may differ from the actual publication dates, which may need to be independently confirmed.

[0254] Moreover, in interpreting this disclosure, all terms should be interpreted in the broadest reasonable manner consistent with the context. The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps not specifically recited.

[0255] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.

[0256] Although the technology herein has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details unnecessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects can be performed simultaneously or even synchronously.

[0257] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0258] While the present invention has been described with reference to specific implementations, it will be apparent to those skilled in the art that the present invention is not limited to the details of the illustrative implementations set forth above, and that various changes and modifications can be made to the present invention without departing from its scope. Therefore, the present implementations are considered in all respects to be illustrative and not restrictive, and the scope of the present invention is indicated by the appended claims, rather than by the foregoing description. Accordingly, all changes that come within the meaning and range of equivalency of the claims are intended to be embraced by the present invention. In other words, any modifications, variations, or equivalents that fall within the scope of the basic underlying principles and whose essential attributes are claimed in this patent application are intended to be covered. Furthermore, readers of this patent application will understand that the terms "comprising" or "comprise" do not exclude other elements or steps, and that the terms "a" or "an" do not exclude a plurality, and that a single element, such as a computer system, processor, or another integrated unit, may fulfill the functions of several means recited in the claims. Any reference signs in the claims should not be construed as limiting the respective associated claims. When used in the specification or claims, terms such as "first," "second," "third," "a," "b," "c," and the like are introduced to distinguish between similar elements or steps and do not necessarily describe an order or chronology. Similarly, terms such as "top," "bottom," "above," and "below" are introduced for descriptive purposes and do not necessarily denote relative locations. It should be understood that terms so used are interchangeable under appropriate circumstances, and that implementations of the invention are capable of operating in accordance with the invention in other sequences or with orientation(s) other than those described or illustrated above.

[0259] 7.7 Other examples of this technology The following paragraphs provide further examples of the techniques described herein.

[0260] Example 1 1. A method of providing respiratory therapy to an airway of a user, comprising: a pressure generator adapted to be coupled to a patient respiratory interface to deliver the respiratory treatment to the airway of the user; a controller coupled to the pressure generator and configured to operate the pressure generator to generate a respiratory treatment including a pressurized flow of breathable gas based on at least one adjustable parameter; a user interface; the controller includes one or more processors and is configured to control the pressure generator in a therapy mode to deliver the respiratory therapy during a therapy session; The controller, in a setup configuration mode, configured to receive input by the user made on the user interface, the input corresponding to an adjustment to the at least one adjustable parameter; configured to control generation of a sensory response perceptible to the user in real time or near real time in response to adjustments to the at least one adjustable parameter; The system, wherein the controlling includes controlling the pressure generator to administer the respiratory therapy including the pressurized flow of breathable gas delivered to the airway of the user based on the received input and corresponding adjustments.

[0261] Example 2 The system of Example 1, wherein the one or more processors are configured to receive the input corresponding to the adjustment of the at least one parameter during a first respiratory cycle of the user, and the delivery of the adjusted flow of pressurized breathable gas occurs during a second respiratory cycle of the user following the first respiratory cycle.

[0262] Example 3 The at least one adjustable parameter may include: Inspiratory pressure trigger threshold, Intake pressure shape, Peak intake pressure, Inspiratory pressure trigger threshold, Expiratory pressure shape, The system of any one of Examples 1-2, wherein one or more of: peak expiratory pressure.

[0263] Example 4 4. The system of any one of Examples 1-3, wherein the one or more processors are configured to generate the user interface on a display coupled to the controller.

[0264] Example 5 The system of any one of Examples 1-4, wherein the one or more processors are configured to communicate with a wireless device to receive the input corresponding to the adjustment to the at least one adjustable parameter.

[0265] Example 6 The system of any one of Examples 1-5, wherein the user interface comprises a graphical user interface displaying a target waveform including at least one visual feature corresponding to the at least one adjustable parameter, and wherein adjustments to the at least one visual feature correspond to adjustments to the at least one adjustable parameter.

[0266] Example 7 7. The system of Example 6, wherein the graphical user interface is presented via a touchscreen, and the system is configured to detect adjustments to the at least one visual feature through touch gestures on the touchscreen.

[0267] Example 8 The sensory response includes a visual response displayed on a graphical user interface, the visual response including: The system of any one of Examples 6-7, further comprising displaying on a graphical user interface a first execution waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator.

[0268] Example 9 The visual response may further comprise: 9. The system of Example 8, further comprising displaying, on the graphical user interface, a second execution waveform corresponding to the user's respiratory airflow detected by at least one sensor, the second execution waveform being overlaid on the first execution waveform.

[0269] Example 10 1. A method of providing respiratory therapy to an airway of a user, comprising: generating, by a pressure generator in each of a therapy mode and a setup configuration mode, the respiratory therapy including a flow of pressurized breathable gas delivered to the airway of the user based on at least one adjustable parameter; receiving, by one or more processors in the setup configuration mode, an input by the user on a user interface corresponding to an adjustment to the at least one adjustable parameter; generating a sensory response perceptible to the user in real time or near real time in response to the adjustment to the at least one parameter; The method, wherein the generating includes controlling delivery of the respiratory therapy to the user in the setup configuration mode based on the received input corresponding to the adjustment.

[0270] Example 11 The method of Example 10, wherein the receiving occurs during a first respiratory cycle of the user, and controlling the delivery of the respiratory therapy to the user in the setup configuration mode based on the received input and corresponding adjustment occurs during a second respiratory cycle of the user following the first respiratory cycle.

[0271] Example 12 The at least one parameter may include: Inspiratory pressure trigger threshold, Intake pressure shape, Peak intake pressure, Inspiratory pressure trigger threshold, Expiratory pressure shape, 12. The system of any one of Examples 10-11, wherein one or more of: peak expiratory pressure.

[0272] Example 13 13. The method of any one of Examples 10-12, wherein the one or more processors generate the user interface on a display coupled to a controller of the pressure generator. Example 14 13. The method of any one of Examples 10-12, wherein the one or more processors receive the user input from a wireless device that generates the input.

[0273] Example 15 the user interface comprising a graphical user interface, the method further comprising: 15. The method of any one of Examples 10-14, comprising displaying a target waveform in the graphical user interface, the target waveform including at least one visual feature corresponding to the at least one adjustable parameter, wherein an adjustment to the at least one visual feature corresponds to an adjustment to the at least one adjustable parameter.

[0274] Example 16 The graphical user interface is presented via a touch screen, and the method further comprises: 16. The method of example 15, comprising detecting an adjustment to the at least one visual feature by a touch gesture on the touchscreen.

[0275] Example 17 The sensory response includes a visual response shown on the graphical user interface, the visual response comprising: The method of any one of Examples 15-16, further comprising displaying on the graphical user interface a first execution waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator.

[0276] Example 18 The visual response is 18. The system of Example 17, further comprising displaying, on the graphical user interface, a second execution waveform corresponding to the user's respiratory airflow detected by at least one sensor, the second execution waveform being overlaid on the first execution waveform.

[0277] Example 19 a user interface for inputting therapy settings in a setup configuration mode of a device for providing respiratory therapy to a user's airway, the user interface comprising: a display configured to present to the user visual features associated with a plurality of parameters that control operation of the device as the device delivers the respiratory treatment; an input device configured to receive input from the user including iterative modifications to the presentation of the visual features; a pressure generator configured to iteratively generate adjustments to the respiratory therapy provided by the device in a user feedback loop during operation in the setup configuration mode in accordance with iterative adjustments to the plurality of parameters corresponding to the iterative modifications to the visual features.

[0278] Example 20 20. The user interface of Example 19, wherein the visual feature comprises a feature icon displayed in association with at least a portion of a visual waveform representing a time course of the respiratory treatment.

[0279] Example 21 21. The user interface of example 20, wherein activating the characteristic icon selects an associated parameter of the plurality of parameters for adjustment.

[0280] Example 22 The user interface of any one of Examples 20-21, wherein the visual feature further includes a set of adjustment icons associated with the feature icon, the set of adjustment icons configured to adjust portions of the visual waveform along with at least one associated waveform parameter of the plurality of parameters in response to activation by the user.

[0281] Example 23 23. The user interface of any one of Examples 19 to 22, wherein the visual features are presented on a touch screen, and the visual features are activated and / or changed by a user's touch.

[0282] Example 24 The user interface of any one of Examples 19 to 22, wherein the input device comprises one or more buttons or knobs, the one or more buttons or knobs configured to activate and / or modify the visual features.

[0283] Example 25 25. The user interface of any one of Examples 19-24, wherein the respiratory therapy includes a pressure therapy and the plurality of parameters includes one or more pressure control parameters.

[0284] Example 26 26. The user interface of any one of Examples 19-25, wherein the respiratory therapy includes a high-flow therapy and the plurality of parameters includes one or more flow control parameters.

[0285] Example 27 27. The user interface of any one of Examples 19 to 26, wherein the device comprises a controller and a pressure generator.

Claims

1. 1. A system for providing respiratory therapy to an airway of a user, comprising: a pressure generator adapted to be coupled to a patient respiratory interface to deliver the respiratory treatment to the airway of the user; a controller coupled to the pressure generator and configured to operate the pressure generator to generate a respiratory treatment comprising a pressurized flow of breathable gas based on at least one adjustable parameter; a user interface; the controller includes one or more processors and is configured to control the pressure generator in a therapy mode to deliver the respiratory therapy during a therapy session; The controller, in a setup configuration mode, configured to receive input by the user made on the user interface, the input corresponding to an adjustment to the at least one adjustable parameter; configured to control generation of a sensory response perceptible to the user in real time or near real time in response to adjustments to the at least one adjustable parameter; The system, wherein the controlling includes controlling the pressure generator to administer the respiratory therapy including the pressurized flow of breathable gas delivered to the airway of the user based on the received input and corresponding adjustments.

2. 2. The system of claim 1, wherein the one or more processors are configured to receive the input corresponding to the adjustment of the at least one parameter during a first respiratory cycle of the user, and wherein the delivery of the adjusted flow of pressurized breathable gas occurs during a second respiratory cycle of the user following the first respiratory cycle.

3. The at least one adjustable parameter may include: Inspiratory pressure trigger threshold, Intake pressure shape, Peak intake pressure, Inspiratory pressure trigger threshold, Expiratory pressure shape, and Peak expiratory pressure The system according to any one of claims 1 to 2, comprising one or more of:

4. The system of any one of claims 1 to 3, wherein the one or more processors are configured to generate the user interface on a display coupled to the controller.

5. 5. The system of claim 1, wherein the one or more processors are configured to communicate with a wireless device to receive the input corresponding to the adjustment to the at least one adjustable parameter.

6. 6. The system of claim 1, wherein the user interface comprises a graphical user interface displaying a target waveform including at least one visual feature corresponding to the at least one adjustable parameter, and wherein adjustments to the at least one visual feature correspond to adjustments to the at least one adjustable parameter.

7. The system of claim 6 , wherein the graphical user interface is presented via a touchscreen, and the system is configured to detect adjustments to the at least one visual feature through touch gestures on the touchscreen.

8. The sensory response includes a visual response displayed on a graphical user interface, the visual response including:

8. The system of claim 6, further comprising displaying, on a graphical user interface, a first execution waveform corresponding to the regulated flow of pressurized breathable gas produced by the pressure generator.

9. The visual response may further comprise:

9. The system of claim 8, further comprising displaying a second execution waveform on the graphical user interface corresponding to the user's respiratory airflow detected by at least one sensor, the second execution waveform being overlaid on the first execution waveform.

10. 1. A method of providing respiratory therapy to an airway of a user, comprising: generating, by a pressure generator in each of a therapy mode and a setup configuration mode, the respiratory therapy including a flow of pressurized breathable gas delivered to the airway of the user based on at least one adjustable parameter; receiving, by one or more processors in the setup configuration mode, an input by the user on a user interface corresponding to an adjustment to the at least one adjustable parameter; generating a sensory response perceptible to the user in real time or near real time in response to the adjustment to the at least one parameter; The method, wherein the generating includes controlling delivery of the respiratory therapy to the user in the setup configuration mode based on the received input corresponding to the adjustment.

11. 11. The method of claim 10, wherein the receiving occurs during a first respiratory cycle of the user, and controlling the delivery of the respiratory therapy to the user in the setup configuration mode based on the received input and corresponding adjustments occurs during a second respiratory cycle of the user following the first respiratory cycle.

12. The at least one parameter may include: Inspiratory pressure trigger threshold, Intake pressure shape, Peak intake pressure, Inspiratory pressure trigger threshold, Expiratory pressure shape, and Peak expiratory pressure The system according to any one of claims 10 to 11, comprising one or more of:

13. The method of any one of claims 10 to 12, wherein the one or more processors generate the user interface on a display coupled to a controller of the pressure generator.

14. The method of any one of claims 10 to 12, wherein the one or more processors receive the user input from a wireless device that generates the input.

15. the user interface comprising a graphical user interface, the method further comprising:

15. The method of claim 10, comprising displaying a target waveform in the graphical user interface, the target waveform including at least one visual feature corresponding to the at least one adjustable parameter, wherein adjustments to the at least one visual feature correspond to adjustments to the at least one adjustable parameter.

16. The graphical user interface is presented via a touch screen, and the method further comprises: The method of claim 15 , comprising detecting an adjustment to the at least one visual feature by a touch gesture on the touchscreen.

17. The sensory response includes a visual response shown on the graphical user interface, the visual response comprising:

17. The method of any one of claims 15 to 16, comprising displaying on the graphical user interface a first execution waveform corresponding to the regulated flow of pressurized breathable gas produced by the pressure generator.

18. The visual response is 18. The method of claim 17, further comprising displaying, on the graphical user interface, a second execution waveform corresponding to the user's respiratory airflow detected by at least one sensor, the second execution waveform being overlaid on the first execution waveform.

19. a user interface for inputting therapy settings in a setup configuration mode of a device for providing respiratory therapy to a user's airway, the user interface comprising: a display configured to present to the user visual features associated with a plurality of parameters that control operation of the device as the device delivers the respiratory treatment; an input device configured to receive input from the user including iterative modifications to the presentation of the visual features; a pressure generator configured to iteratively generate adjustments to the respiratory therapy provided by the device in a user feedback loop during operation in the setup configuration mode in accordance with iterative adjustments to the plurality of parameters corresponding to the iterative modifications to the visual features.

20. 20. The user interface of claim 19, wherein the visual feature comprises a feature icon displayed in association with at least a portion of a visual waveform representing the time course of the respiratory treatment.

21. The user interface of claim 20 , wherein activating the characteristic icon selects an associated parameter of the plurality of parameters for adjustment.

22. 22. The user interface of claim 20, wherein the visual feature further includes a set of adjustment icons associated with the feature icon, the set of adjustment icons configured to adjust portions of the visual waveform along with at least one associated waveform parameter of the plurality of parameters upon activation by the user.

23. A user interface according to any one of claims 19 to 22, wherein the visual features are presented on a touch screen, the visual features being activated and / or modified by a user's touch.

24. 23. A user interface according to any one of claims 19 to 22, wherein the input device comprises one or more buttons or knobs, the one or more buttons or knobs configured to activate and / or modify the visual features.

25. The user interface of any one of claims 19 to 24, wherein the respiratory therapy comprises a pressure therapy and the plurality of parameters comprises one or more pressure control parameters.

26. The user interface of any one of claims 19 to 25, wherein the respiratory therapy comprises a high-flow therapy and the plurality of parameters comprises one or more flow control parameters.

27. A user interface according to any one of claims 19 to 26, wherein the device comprises a controller and a pressure generator.

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