Apparatus for user to adjust therapy parameters

Abstract

A system (100) for respiratory therapy may include a pressure generator for delivering therapy to a patient respiratory interface of an airway of a user; a user interface; and a controller coupled to the pressure generator and configured to operate the generator for the therapy. The controller may be configured to control the generator to deliver the therapy during a therapy period in a therapy mode. The controller may be configured to receive an input made by the user on the user interface in a setup configuration mode, the input corresponding to an adjustment to a parameter. In the setup mode, the controller may control, in real-time or near real-time, generation of a sensory response perceivable by a user in response to the adjustment of the parameter, including controlling the generator to deliver the therapy to the airway of the user, the therapy including pressurizing a flow of breathable gas, based on the received input and the corresponding adjustment.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 417,803, filed on October 20, 2022, the entire content of which is incorporated herein by reference. 1.1 Technical Field

[0003] The present technology generally relates to respiratory therapy devices and a user adjusting therapy parameters, such as comfort settings, via a user interface. More specifically, the present technology relates to devices that can provide for adjusting therapy in a user feedback mode and that can employ a visual user interface. The user feedback mode and / or the user interface can allow a user to enhance their sensory appreciation or understanding of therapy adjustments, such as in real - time or near - real - time when the user manually adjusts a therapy that can provide pressure therapy or flow therapy. The user interface can allow for adjusting therapy control parameters (e.g., pressure support parameters). For example, when a user is allowed to adjust a parameter via the user interface, when a change to the therapy is delivered in response to the user's adjustment on the user interface in the user feedback mode, the user can perceive a sensory response (user feedback) in a face mask or other patient breathing interface (e.g., a respiratory sensory response and / or a facial tactile response). Additional sensory feedback can include visual feedback (such as on a display of the user interface) that visually depicts the effect of the user's adjustment. 1.2 Background Art

[0004] Home respiratory therapy devices allow patients to receive respiratory therapy in the comfort of their homes. However, due to the complexity of the respiratory therapy devices, patients are typically denied access privileges to reconfigure the respiratory therapy devices (such as by changing some control parameters related to therapy delivery). Thus, to configure the respiratory therapy devices, patients typically need to bring the respiratory therapy devices to a clinician's office, where the clinician accesses the settings of the respiratory therapy devices, such as by using clinician access privileges enforced by authentication requirements (e.g., passwords), and adjusts the settings based on the clinician's expertise and the patient's input. However, when the clinician adjusts the settings, neither the patient nor the clinician perceives how the adjustment feels because changes to the therapy are typically felt later in the therapy mode rather than in the settings mode. In this regard, existing respiratory therapy devices are not designed to provide any real-time or near-real-time sensory feedback of therapy changes to the patient, such as when the clinician makes an adjustment, allowing the patient to feel / perceive the response reflected by the adjustment of the settings. For example, existing respiratory pressure therapy devices typically do not generate pressure when the clinician adjusts the settings in the settings mode and do not provide a display for the patient receiving the therapy to fully gain an understanding of the nature of the change. Typically, once the clinician has completed the configuration process, the clinician returns the respiratory therapy device to the patient. The patient does not know the effect of the previously made adjustments until they are used in the therapy mode during therapy. In fact, such a process does not even allow the patient to easily realize what changes have occurred or what might be a more desirable change for the patient (such as from a comparative sensory perspective regarding multiple potential changes). Summary of the Invention

[0005] The present technology relates to improved therapy devices that can provide a greater degree of appreciation of parameter customization of control settings for therapy delivered to a patient based on the user's perception. When a user adjusts parameters for controlling therapy, such as respiratory pressure or flow therapy provided by a respiratory therapy device, such devices can generate one or more sensory feedback responses that can be perceived by the user in real-time or near real-time. Such improved therapy devices can provide a greater degree of user feedback and control over adjustments to therapy settings, such as without relying on any clinician support, enabling the patient to better appreciate therapy changes. Such a user interface can provide feedback to the user that can include the patient's sensations (e.g., respiratory sensations) within a manual adjustment feedback loop of an active therapy user feedback adjustment mode of the device. Using such a mode, the device can provide a sensory response to the user for a manual setting change in real-time or near real-time, allowing the user to see and / or feel the changes in therapy as the user adjusts the therapy settings. Such device improvements can be implemented to provide a more intuitive process for the user to educate or guide the user to find more optimal or personalized settings that suit the user's needs and / or comfort level. Through such idealized adjustments, compliance with the therapy device can also be improved, as a therapy that is more comfortable for a particular patient is more likely to cause the patient to continue using the therapy device.

[0006] Some specific implementations of the present technology can include a system for providing respiratory therapy to a user's airway. The system can include a pressure generator adapted to be coupled to a patient breathing interface for delivering the respiratory therapy to the user's airway. The system can include a controller coupled to the pressure generator and configured to operate the pressure generator to generate the respiratory therapy based on at least one adjustable parameter, which can include a pressurized breathable gas flow. The system can include a user interface. The controller can include one or more processors. The controller can be configured to control the pressure generator to deliver the respiratory therapy during a therapy period in a therapy mode. The controller can be configured to receive an input that the user can make on the user interface in a settings configuration mode. The input can correspond to an adjustment to the at least one adjustable parameter. The controller can be configured to, in the settings configuration mode, in response to the adjustment to the at least one adjustable parameter, control the generation of a sensory response that can be perceived by the user in real-time or near real-time, including: controlling the pressure generator to deliver the respiratory therapy, which can include the pressurized breathable gas flow for delivery to the user's airway, based on the received input and the corresponding adjustment.

[0007] In some specific implementations, the one or more processors may be configured to receive the input corresponding to the adjustment of the at least one adjustable parameter during a first respiratory cycle of the user, and wherein the delivery of the adjusted pressurized breathable gas flow occurs during a second respiratory cycle of the user after the first respiratory cycle. The at least one adjustable parameter may include one or more of the following: 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 the 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 the input corresponding to the adjustment of the at least one adjustable parameter. The user interface may include a graphical user interface that displays a target waveform including at least one visual feature corresponding to the at least one adjustable parameter. The adjustment of the at least one visual feature may correspond to the adjustment of the at least one adjustable parameter. The graphical user interface may be presented via a touch screen, and wherein the system may be configured to detect the adjustment of the at least one visual feature by a touch gesture on the touch screen. The sensory response may include a visual response shown in the graphical user interface. The visual response may include displaying a first operating waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator in the graphical user interface. The visual response may further include displaying a second operating waveform corresponding to the respiratory gas flow of the user detected by at least one sensor in the graphical user interface, the second operating waveform being displayed in a superimposed manner relative to the first operating waveform.

[0008] Some specific implementations of the present technology may include a method for providing respiratory therapy to a user's airway. The method may include generating, by a pressure generator, the respiratory therapy in each of a therapy mode and a setting configuration mode based on at least one adjustable parameter, the respiratory therapy may include a pressurized breathable gas flow for delivery to the user's airway. The method may include receiving, by one or more processors, an input from the user on a user interface in the setting configuration mode. The input may correspond to an adjustment of the at least one adjustable parameter. The method may include generating, in response to the adjustment of the at least one parameter, a sensory response that can be perceived by the user in real time or near real time, including: controlling the delivery of the respiratory therapy to the user based on the received input corresponding to the adjustment in the setting configuration mode.

[0009] In some specific embodiments, the receiving can occur during the user's first respiratory cycle, and wherein the delivery of the respiratory therapy to the user based on the received input and corresponding adjustment control in the setup configuration mode can occur during the user's second respiratory cycle after the first respiratory cycle. The at least one parameter can include one or more of the following: 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 can generate the user interface on a display coupled to a controller of the pressure generator. The one or more processors can receive the input from a wireless device that generates the user input. The user interface can include a graphical user interface, and wherein the method can further include: displaying in the graphical user interface a target waveform including at least one visual feature corresponding to the at least one adjustable parameter, and wherein an adjustment to the at least one visual feature can correspond to an adjustment to the at least one adjustable parameter.

[0010] In some specific embodiments, the graphical user interface can be presented via a touch screen, and the method can further include: detecting, via a touch gesture on the touch screen, the adjustment to the at least one visual feature. The sensory response can include a visual response shown in the graphical user interface. The visual response can include displaying in the graphical user interface a first operational waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator. The visual response can further include displaying in the graphical user interface a second operational waveform corresponding to the user's respiratory airflow detected by at least one sensor, and the second operational waveform can be displayed in a superimposed manner relative to the first operational waveform.

[0011] Some specific embodiments of the present technology can 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 can include a display configured to present visual features associated with a plurality of parameters that control the operation of the device when the device generates the respiratory therapy. The user interface can include an input device configured to receive input from the user, and the input can include iterative modifications to the presentation of the visual features. The user interface can include a pressure generator configured to iteratively generate adjustments to the respiratory therapy provided by the device during operation of the setup configuration mode in a user feedback loop based on iterative adjustments to the plurality of parameters corresponding to the iterative modifications to the visual features.

[0012] In some specific embodiments, the visual feature may include a feature icon displayed in association with at least a portion of a visual waveform representing the time course of the respiratory therapy. Activation of the feature icon may select an associated parameter among the plurality of parameters for adjustment. The visual feature may further include a set of adjustment icons associated with the feature icon, wherein the set of adjustment icons may be configured to adjust the portion of the visual waveform and at least one associated waveform parameter among the plurality of parameters when activated by the user. The visual feature may be presented on a touch screen, wherein the visual feature is activated and / or modified by user touch. The input device may include one or more buttons or knobs, and wherein the one or more buttons or knobs may be configured to activate and / or modify the visual feature. The respiratory therapy may include pressure therapy, and the plurality of parameters may include one or more pressure control parameters. The respiratory therapy may include high-flow therapy, and the plurality of parameters may include one or more flow control parameters. The device may include a controller and a pressure generator. Of course, portions of these aspects may form sub-aspects of the present technology. In addition, each of these sub-aspects and / or aspects may be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

[0013] Other features of the present technology will become apparent by considering the following detailed description, the abstract of the specification, the drawings, and the claims included herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals refer to similar elements and include:

[0015] Figure 1A An example therapy device is shown 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 therapy being delivered, such as in an example user interface that utilizes the present technology in an active user adjustment feedback mode of the therapy.

[0016] Figure 1B Features of such a therapy device with a wireless control device in some versions of the present technology are illustrated.

[0017] Figure 1C is an illustration of Figure 1A or Figure 1B a graphical user interface on a display screen of a therapy device or a wireless control device, showing visual features or feature icons that are manually adjustable on a target pressure waveform and that are adapted to effect therapy parameter adjustment, such as in an active user adjustment feedback mode of the therapy of the present technology.

[0018] Figure 1Dis another illustration of a graphical user interface on a display screen of a therapy device or a wireless control device such as Figure 1A or Figure 1B showing a user touching a visual feature or feature icon on a target pressure waveform of a display to select a therapy parameter adjustment associated with the visual feature or icon, such as in the therapy active user adjustment feedback mode of the present technology.

[0019] Figure 1E is an illustration of a graphical user interface presenting adjustment icons or arrow icons in response to a selection such as Figure 1D The adjustment icons or arrow icons may be adapted to effect a parameter adjustment associated with the selected visual feature or feature icon (such as a visual feature or feature icon selected in 1D), such as in the therapy active user adjustment feedback mode of the present technology.

[0020] Figure 1F is another illustration of a graphical user interface presenting adjustment icons or point control elements in response to a selection such as Figure 1D The adjustment icons or point control elements may be adapted to effect a parameter adjustment associated with the selected visual feature or feature icon (such as a visual feature or feature icon selected in 1D), such as in the therapy active user adjustment feedback mode of the present technology.

[0021] Figure 2A is an illustration of a transition of an example graphical user interface on a display screen or touch screen of a therapy device or a wireless control device such as Figure 1A or Figure 1B showing a target pressure waveform that can be visually manipulated or adjusted by a user to effect a parameter adjustment accordingly, and its visual response to the user as the user manipulates or adjusts the target pressure waveform and thereby adjusts the corresponding or associated therapy control parameter, such as in the therapy active user adjustment feedback mode of the present technology.

[0022] Figure 2B is an illustration of a graphical user interface visually presenting an operating waveform in a superimposed manner on a display screen of a therapy device or a wireless control device such as Figure 1A or Figure 1B such that the waveform (e.g., pressure and flow) corresponds to the pressure delivered by a breathing device and the flow of a patient detected by the therapy device, which may be presented in the therapy active user adjustment feedback mode of the present technology.

[0023] Figure 2C is an illustration of a graphical user interface on a display screen of a therapy device or a wireless control device such as Figure 1A or Figure 1BAnother illustration of a graphical user interface on a display screen of a therapy device or a wireless control device visually presents a transformation in the shape of a pressure waveform, which can be presented in an active user adjustment feedback mode of therapy of the present technology in response to a manual change by the user to a control parameter (such as using a control (button or icon) of the user interface described herein).

[0024] Figure 3 Illustrates a process of a control loop of the above-described therapy device for generating sensory feedback to a user when the user adjusts a therapy parameter (e.g., a target pressure waveform) in an active user adjustment feedback mode of therapy of the present technology.

[0025] Figure 4 Is a flowchart of an example process for generating sensory feedback to a user when the user adjusts a target pressure waveform.

[0026] Figure 5 Illustrates another example environment of a system for providing therapy to a user's airway, where the user can adjust the therapy settings of the system through a user interface of a wireless device.

[0027] Figure 6 Is a schematic illustration of an example graphical user interface of a wireless device, showing a target pressure waveform that can be adjusted by the user and a visual response to the user when the user makes an adjustment.

[0028] Figure 7 Illustrates an example control loop for generating a sensory response to a user when the user adjusts a setting (e.g., a target pressure waveform).

[0029] Figure 8A Illustrates an example system according to the present technology. Patient 1000 wearing patient interface 3000 receives a supply of pressurized air from RPT device 4000. The air from RPT device 4000 is humidified in humidifier 5000 and transmitted along air circuit 4170 to patient 1000. Bed partner 1100 is also shown.

[0030] Figure 8B Illustrates RPT device 4000 used by patient 1000 wearing nasal mask 3000.

[0031] Figure 8C Illustrates RPT device 4000 used by patient 1000 wearing full-face mask 3000.

[0032] Figure 9 Illustrates an example non-invasive patient interface 3000 in the form of a nasal mask.

[0033] Figure 10A Illustrates RPT device 4000 according to one form of the present technology.

[0034] Figure 10B FIG. 2 shows a schematic diagram of a pneumatic circuit of an RPT device 4000 according to one form of the present technology. The upstream and downstream directions are indicated.

[0035] Figure 10C FIG. 3 shows a schematic diagram of electrical components of an RPT device 4000 according to one aspect of the present technology.

[0036] Figure 10D FIG. 4 shows a schematic diagram of an algorithm 4300 implemented in an RPT device 4000 according to one aspect of the present technology. In Figure 10D , the solid arrows indicate the actual information flow, for example, via electronic signals.

[0037] Figure 10E FIG. 5 is a flowchart of a method 4500 according to one aspect of the present technology, which is illustrated by Figure 10D the therapy engine module 4320.

[0038] Figure 11 FIG. 6 shows a humidifier 5000. DETAILED DESCRIPTION

[0039] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, and the specific examples described herein may vary. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific examples described herein only and are not intended to be limiting.

[0040] The following description is provided with respect to various examples that may share one or more common features and / or characteristics. 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 other examples. Additionally, any single feature or combination of features in any one of the examples may constitute another example.

[0041] 1. Pressure Support System

[0042] One aspect of the present technology relates to a system for providing therapy (such as pressure therapy or flow therapy) to a user's airway, enabling the user to adjust control parameters of the therapy (such as pressure or flow settings), and generating 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 when the user adjusts the therapy. Specific implementations of such systems may be considered in conjunction with the following paragraphs regarding pressure therapy devices.

[0043] Figure 1AAn example environment of system 100 is shown, which can be configured to provide pressure therapy, such as pressure support, to the airway of user 102. In one embodiment, system 100 can include a respiratory therapy device that provides respiratory therapy to user 102. For example, the system can include a Respiratory Pressure Therapy (RPT) device. System 100 can provide a breathable gas flow to the user at a controlled pressure and / or a controlled flow rate. A patient interface 104, such as a face mask, can be used to interface system 100 with user 102. Depending on the therapy to be applied, interface 104 can, for example, form a seal with the facial area of user 102 to facilitate delivery of gas at a pressure with a sufficient difference from the ambient pressure to achieve the therapy.

[0044] As Figure 1B shown, system 100 can have one or more of the following: 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.

[0045] User interface 116 can include one or more of the following: a display 120 for presenting a graphical user interface; and one or more selectors 122, such as menu selectors, which can be physical components (e.g., knobs) or virtual components (e.g., icons). Selector 122 can, for example, take the form of a knob or a button that user 102 can manipulate to operate system 100. For example, user 102 can manipulate selector 122 to navigate and / or select a menu displayed on display 120. Optionally, such selectors can be moved by touch to change values associated with parameters, and these values can be visualized by changing the waveforms on the display. Thus, display 120 can have a touch screen. Network interface 118 can have one or more transceivers, such as a Bluetooth transceiver, a cellular transceiver, and a Wi-Fi communication transceiver.

[0046] Sensor 124 (such as any sensor described in more detail herein) can be configured to generate an output signal that conveys information related to the therapy and / or respiration of user 102. Information related to the user's respiration can include, but is not limited to, the flow rate of the pressurized breathable gas flow and / or the pressure of the breathable gas at the user's mouth. Processor 110 can determine other parameters, such as the user's tidal volume and transpulmonary pressure, based on the information in these output signals.

[0047] 1.1 Adjustable Parameters

[0048] In this example, pressure generator 112 can be configured to generate a pressurized breathable gas flow for delivery to the airway of user 102 according to a target pressure waveform under the control of a controller (such as the controller described in more detail herein). Figure 1CAn exemplary target pressure waveform 130 is illustrated, and a pressurized breathable gas flow is generated based on the target pressure waveform. The target pressure waveform 130 may represent the varying pressure of the breathable gas flow that the pressure generator is intended to generate. The target pressure waveform 130 may include: an inspiratory pressure or inspiratory positive airway pressure (IPAP), indicated by the "I" in Figure 1C , for assisting the user's inspiration; and an expiratory pressure or expiratory positive airway pressure (EPAP), indicated by the "E", for assisting the user's expiration.

[0049] The user 102 may adjust control of the pressure generated by the pressure generator 102 through one or more adjustable parameters. For example, these parameters may be associated with an expiratory pressure reduction (EPR) that may be set by the user. In the example of Figure 1C , these parameters may correspond to one or more visual features or points on or associated with the target pressure waveform 130, and the one or more visual features or points may act as activatable icons for selecting and / or inputting adjustments to the relevant parameters. These parameters may include, but are not limited to, any one or more of the following: an inspiratory pressure trigger threshold, an inspiratory pressure shape, a peak inspiratory pressure peak, an expiratory pressure trigger threshold, an expiratory pressure shape, and a peak expiratory pressure. Each parameter will be discussed in detail below.

[0050] 1.1.1 Inspiratory Pressure Trigger Threshold

[0051] The inspiratory pressure trigger threshold (IPTT) may be a parameter that indicates when the pressure generator 112 begins to generate an inspiratory pressure to assist the user's inspiration during the user's inspiratory cycle. The IPTT may indicate when the pressure generator 112 changes from generating an expiratory pressure to generating an inspiratory pressure. In one embodiment, the pressure generator 112 may not begin generating an inspiratory pressure at the start of the user's inspiratory cycle. Instead, the pressure generator 112 may delay the generation of the inspiratory pressure until a later time point in the user's inspiratory cycle, or begin at a time shortly before the start of the patient's inspiration.

[0052] The IPTT may be a flow value defined relative to the user's inspiratory flow rate detected by the sensor 124. In one example, the IPTT may be set to a value in a range such as, for example, from about 2 to 5 L / min. In this example, once the user's inspiratory flow rate reaches the IPTT value, the pressure generator 112 may begin generating an inspiratory pressure. The IPTT may be used to delay or accelerate the start of inspiratory pressure generation. For example, increasing the value of the IPTT may delay the start of inspiratory pressure generation, while decreasing the value of the IPTT may accelerate the start of inspiratory pressure generation.

[0053] Alternatively, the IPTT can be a pressure value defined relative to the inspiratory pressure of the user at the mask 104 detected by the sensor 124. In one example, the IPTT can be a threshold that specifies a predetermined pressure in the mask 104 (such as a dropping pressure indicative of the patient's inspiration). When the sensor 124 detects the predetermined pressure in the mask 104, the pressure generator 112 can be triggered to start generating the inspiratory pressure. In this example, increasing the value of the IPTT (which requires increasing the predetermined pressure) can delay the start of the inspiratory pressure generation, while decreasing the value of the IPTT (which requires decreasing the amount of the predetermined pressure drop) can accelerate the start of the inspiratory pressure generation.

[0054] In some specific implementations, the IPTT can be a learned value that can be adjusted by the user later. For example, the controller can be configured to learn the IPTT from the patient's breathing, and then this learned value can be fine-tuned (e.g., decreased or increased) by the user, such that the controller can achieve the control of the inspiratory pressure earlier or later than the learned configuration. For example, the learning can involve a phase index such as determined by phase determination described in more detail herein. Such a process can correlate (learn) flow characteristics (such as any one or more of amplitude, rate of change, etc.) typically associated with a phase index (e.g., 1) indicative of the user's transition to inspiration, and then use any one or more of these flow characteristics as a threshold test for controlling the inspiratory-related pressure transition. 1.1.2 Inspiratory Pressure Shape

[0055] The inspiratory pressure shape can refer to a parameter that determines the shape of the inspiratory pressure curve from the start of the inspiratory pressure to the peak inspiratory pressure. The pressure generator 112 can increase the pressurized breathable gas flow to the peak inspiratory pressure according to the inspiratory pressure shape. The inspiratory pressure shape can be related to the rise time of the inspiratory pressure from the start (e.g., end-expiratory pressure) to the peak inspiratory pressure. The inspiratory pressure shape can control how fast the inspiratory pressure rises to the peak inspiratory pressure.

[0056] The inspiratory pressure shape can 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 inspiratory pressure shape can include parameters that determine the slope or smoothness of the inspiratory pressure shape. In one example, by adjusting the inspiratory pressure shape parameters, such as by adjusting a selector of the user interface, the inspiratory pressure shape can be transformed from one form to another form, such as from a smooth curve to a square-like curve, or vice versa, and when this transformation is felt in the patient interface, the transformation can be visualized on the user interface display.

[0057] 1.1.3 Peak Inspiratory Pressure

[0058] Peak inspiratory pressure (PIP) may include a first parameter that controls when the peak inspiratory pressure is generated, and this time may be referred to as the time of the peak inspiratory pressure, or simply the peak time. The peak time may represent the time when the peak supply stops. For example, the peak time may indicate when to stop the inspiratory pressure delivery function and when to change from the inspiratory pressure delivery function (e.g., the pressure rise function) to the expiratory pressure delivery function (e.g., the pressure fall function). The peak time may also indicate when the peak supply is reached within a specific time point in the detected patient respiratory cycle, such as being related to a determined 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 down the inspiratory pressure rise time, while decreasing the peak time may shorten the inspiratory pressure rise time. Based on the peak time, the pressure generator 112 may adjust the function / equation of the inspiratory pressure delivery such that the pressure rises to the peak point of the inspiratory cycle within the desired time.

[0059] Peak inspiratory pressure may include a second parameter that controls the amplitude of the peak inspiratory pressure, and this amplitude may represent the amount of pressure (e.g., IPAP pressure) supplied by the pressure generator 112 at the peak time. This parameter may also relate to the pressure rise function when 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.

[0060] 1.1.4 Expiratory pressure trigger threshold

[0061] 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 reduction to assist the user in exhaling during the user's expiratory cycle. The EPTT may indicate when the pressure generator 112 changes from generating inspiratory pressure to generating expiratory pressure.

[0062] 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 124), or it may be a phase index determined based on the flow-based phase, as described in more detail herein. In one example, once the user's respiratory flow reaches the EPTT value (which may be, for example, a fixed flow threshold or a calculated flow threshold, such as a percentage of the peak inspiratory flow), the pressure generator 112 may begin to control the pressure reduction. For example, a threshold that may be evaluated as a percentage of the peak inspiratory flow (e.g., a percentage in the range of about 30% to 50%, such as 45%) may be used, and if the measured value of the patient's flow is below this threshold, the pressure will change from the inspiratory pressure to the expiratory pressure. The EPTT can be used to delay or accelerate the start of the pressure reduction (e.g., the pressure fall function). For example, increasing the value of the EPTT may delay the start of the pressure reduction, while decreasing the value of the EPTT may accelerate the start of the pressure reduction.

[0063] Alternatively, the EPTT can be a pressure value defined relative to the user's exhalation pressure detected by the sensor 124 at the mask. In one example, the EPTT can be a threshold that specifies a predetermined pressure increase in the mask. When the sensor 124 detects a predetermined pressure increase in the mask, the pressure generator 112 can cycle to begin pressure reduction. In this example, increasing the value of the EPTT (which requires increasing the predetermined pressure increase) can delay the start of pressure reduction, while decreasing the value of the IPTT (which requires decreasing the predetermined pressure increase) can accelerate the start of pressure reduction.

[0064] In some embodiments, the EPTT can be a learned value that can be adjusted by the user later. For example, the controller can be configured to learn the EPTT from the patient's breathing, and this learned value can then be fine-tuned (e.g., decreased or increased) by the user such that the controller achieves control of the exhalation pressure earlier or later than the learned configuration. For example, the learning can involve a phase index such as determined by phase determination described in more detail herein. Such a process can, for example, correlate (learn) flow characteristics (e.g., any one or more of amplitude, rate of change, etc.) typically associated with a phase index (e.g., 0.5) indicating the user's transition to exhalation, and then use one or more of these flow characteristics as a threshold test for controlling the exhalation-related pressure transition. 1.1.5 Peak Expiratory Pressure

[0065] The peak expiratory pressure (PEP) can include a first parameter that represents the amplitude of the minimum expiratory pressure generated by the pressure generator 112 during the user's exhalation, or represents the degree of pressure drop during the user's exhalation. When the expiratory pressure delivery function approaches the peak expiratory pressure, this parameter can relate to the pressure drop function, and the peak expiratory pressure can be the ambient pressure or some other pressure reduced from the inspiratory peak pressure.

[0066] The peak expiratory pressure can include a second parameter that indicates when the peak expiratory pressure is generated, and this time can be referred to as the time of the peak expiratory pressure. This peak time can indicate when to stop the expiratory pressure delivery function. The peak time can also indicate when the peak expiratory pressure is reached within the detected respiratory cycle, such as in relation to a determined phase as described in more detail herein. Based on this peak time, the pressure generator 112 can adjust the expiratory pressure delivery function such that the pressure drops to the peak point in the expiratory cycle within the desired time. The peak time can affect the expiratory descent time. For example, increasing the peak time can slow down the expiratory pressure descent time, while decreasing the peak time can shorten the expiratory pressure descent time.

[0067] 1.1.6 Expiratory Pressure Shape

[0068] The expiratory pressure profile can 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 can reduce the pressurized breathable gas flow to the peak expiratory pressure according to the expiratory pressure profile. The expiratory pressure profile can be related to the time it takes for the expiratory pressure to drop from the end of the inspiratory pressure to the peak expiratory pressure. The expiratory pressure profile can control how fast or slow the expiratory pressure drops during exhalation.

[0069] The expiratory pressure profile can assume 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 profile can include parameters that determine the slope or smoothness of the expiratory pressure profile. In one example, by adjusting the parameter, the expiratory pressure profile can be transformed from one form to another, such as from a smooth curve to a square-like curve, or vice versa.

[0070] 1.1.7 Visual Adjustment

[0071] Reference Figure 1C As previously mentioned, the user can activate one or more visual features, such as by manual adjustment, to change the relevant parameters. For example, the adjustment of a visual feature can correspond to the adjustment of a relevant or corresponding therapy control parameter. Such changes can be made without the user having to perceive or understand the values associated with the parameter changes.

[0072] For example, in the case of a touchscreen, the user 102 can activate a change in the parameter by touching the corresponding visual feature on the target pressure waveform 130. Thus, the processor 110 can detect such activation and / or adjustment of the visual feature through touch gestures on the touchscreen. In one example, once the user touches a visual feature, such as the visual feature 136 as

[0073] shown, one or more optional icons or arrows 142 to 148 can appear on the graphical user interface, as Figure 1D shown. Figure 1EAs shown, the user can adjust the visual feature (and thus its corresponding parameter) by touching any one of the icons or arrows 142 to 148. Arrows 142 to 148 can increase or decrease one or more parameter values, which can be presented by a visual change in the target pressure waveform (e.g., a change in the displayed shape).

[0074] Reference Figure 1E Referring to the visual feature 136 shown, the user can change the position and / or its corresponding parameter value of the visual feature 136 by touching any one of the arrows 142 to 148. The user can adjust the time of the peak inspiratory pressure by touching arrow 144 and / or 148. The forward arrow 144 can move the visual feature 136 towards the start of inspiration, which in turn can shorten the inspiratory pressure rise time. On the other hand, the backward arrow 148 can move the visual feature 136 towards expiration, which in turn can slow down the inspiratory pressure rise time.

[0075] By touching arrow 142 and / or 146, the user can adjust the amplitude of the peak inspiratory pressure, or the amount of pressure applied at the peak time.

[0076] In another example, when the user 102 touches the visual feature, a menu can be displayed that provides one or more options for adjusting the visual feature or its corresponding parameter.

[0077] In yet another example, the user can drag or move the visual feature from its initial position to a new position 137 (as Figure 1E shown) by utilizing the user's contact with the visual feature (such as visual feature 136) on the touch screen to adjust the visual feature and its corresponding parameter. The corresponding parameter can 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 parameter can be proportionally decreased. If the new position 137 is higher than the initial position, the corresponding parameter can be proportionally increased.

[0078] In another example, in the absence of a touch screen or independent of a touch screen, the user 102 can use a selector 122 as a menu selector to select any visual feature on the target pressure waveform 130 in order to adjust its corresponding parameter. For example, the user 102 can select the visual feature 136 of the target pressure waveform 130 to adjust the peak inspiratory pressure. When the visual feature 136 is selected, one or more icons or arrows 142 to 148 can appear on the graphical user interface. The user can adjust the visual feature 136 or its corresponding parameter value by using the menu selector 122 to select any one of the arrows 142 to 148.

[0079] In some examples, as Figure 1EAs shown, a change in a visual feature or its corresponding parameter can result in a change in the visual shape or configuration of the target pressure waveform 130. When the user adjusts a visual feature or its corresponding parameter via a touchscreen or menu selector 122, the graphical user interface can display any such change to the target pressure waveform. Optionally, the graphical user interface can simultaneously display the target pressure waveform 130 in its original configuration as shown by the solid line curve, and its adjusted shape or configuration as shown by the dashed curve 150. In a further option, additional boundary curves can be displayed to indicate the limits associated with how much such manual adjustment can be made.

[0080] Another example of a user interface having a function similar to Figure 1E is the user interface of Figure 1F . When a visual element of the target pressure waveform 130 (e.g., visual feature 136) is selected, for example, the visual parameter adjustment control 131 can be operated. This interface enables the user to drag a visual element (e.g., visual feature 133 illustrated as a point or a circle) on a grid or two-dimensional area bounded by arrows configured as axes and labeled with descriptors (e.g., text labels) for identifying the nature of the adjustment. Different labels can be used (the labels can reflect any language commonly used by the user). In some specific implementations, these axes (e.g., arrows) can be associated with different parameters. These axes can be associated with one or more parameters (e.g., "strength" can be related to peak inspiratory pressure PIP, peak expiratory pressure, and / or rise time). In some specific implementations, one version of the visual parameter adjustment control 131 can be presented for inspiration-related adjustments, and another version can be presented for expiration-related adjustments. In some such specific implementations, one version can be presented for pressure, and another version can be presented for timing. The following table describes several control specific implementations of such grids:

[0081]

[0082] 2. System Modes

[0083] System 100 is configured to operate in various modes according to the programming of its controller. Such modes can include an operation mode and a settings configuration mode. The settings configuration mode can be an active therapy user feedback adjustment mode.

[0084] 2.1 Operation Mode

[0085] During an operation mode, system 100 may provide therapy to a user based on parameters set from a configuration mode. Such operation modes may be typical therapy modes during which a patient receives therapy from system 100. For example, in the case of a sleep apnea therapy device, the operation mode typically provides therapy during a sleep period. Such modes generally do not provide the user with an option to manually adjust the therapy settings of the device.

[0086] 2.2. Set Configuration Mode

[0087] However, during a set configuration mode, which may be an active therapy user feedback adjustment mode, the user may adjust one or more parameters used to set therapy operation, such as the parameters previously described for controlling therapy via user interface 116. In this mode, user interface 116 may give the user control over modifying one or more parameters (as described above) within allowed constraints and may prevent the user from making inappropriate adjustments that are harmful to the user or system 100. In one example, referring Figure 2A , display 120 may display graphical user interface 160, which illustrates target pressure waveform 130, based on which a pressurized breathable gas flow 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 target pressure waveform 130 and perceive the therapy (e.g., before and after the change), thereby providing the user with a real-time or near real-time understanding of the change.

[0088] Thus, in this mode, when the user adjusts a parameter, system 100 may simulate the therapy in real-time or near real-time based on the user's adjustment. For example, whenever the user adjusts a parameter, processor 110 may detect the user's adjustment and generate a sensory response (user feedback) that can be perceived by the user. In one example, processor 110 may detect the user's adjustment during the user's first respiratory cycle while providing therapy and generate a sensory response based on the detected adjustment. The sensory response may include generating therapy according to the adjustment during one or more additional respiratory cycles of the user after the first respiratory cycle.

[0089] Accordingly, the sensory response can include the controller: changing the operation of the pressure generator 112 to adjust the pressurized breathable gas flow based on the user's adjustment, and delivering the adjusted pressurized breathable gas flow to a patient interface (e.g., a mask) worn by the user. Thus, in the configuration mode, the processor 110 can detect the user's adjustment during the user's first respiratory cycle and adjust and deliver the pressurized breathable gas flow to the user during at least one or more respiratory cycles of the user after the first respiratory cycle based on the detected adjustment. As a result, when the user changes one or more parameters for controlling the therapy, the user can immediately feel (e.g., via the patient interface or mask) the effect of the therapy change.

[0090] Additionally or alternatively, continuing to refer to Figure 2A , the processor can generate a visual response via the graphical user interface 160. The visual response can provide a real-time view of one or more propagated waveforms or running waveforms generated by the user's parameter adjustment. The visual response can display a first running waveform 162 corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator 112. The waveform 162 can start at the beginning of inspiration and end at the end of expiration. For example, the waveform 162 can be presented as a white curve on a black screen in the graphical user interface 160. The user can perceive how the waveform 162 changes in real time or near real time when the user adjusts the relevant parameters by viewing via the graphical user interface 160.

[0091] In one example, the graphical user interface 160 can display a second running waveform 164 corresponding to the user's respiratory airflow. The user's respiratory airflow shown by the second running waveform 164 can represent the user's current inhalation and exhalation volumes, which can vary with each breath. The user's respiratory airflow can be detected by one or more sensors 124. The second running waveform 138 can be presented as a dashed curve, while the first running waveform 162 can be presented as a solid curve. The second running waveform can be displayed in a superimposed manner relative to the first running waveform, such that the user can visualize the user's actual breathing relative to the simulated therapy waveform (when no therapy is provided) or a visual version of the actual therapy provided by the system 100.

[0092] Figure 2B Another illustration of the graphical user interface 160 is provided, which shows running waveforms 162 and 164 including several respiratory cycles, and as these running waveforms are generated over time, they can advance on the display screen.

[0093] Figure 2Cis another illustrative example of the graphical user interface 160, which shows the shape transformation of the pressure waveform 162, where the pressure waveform 162 changes from a curved shape to a square-like shape due to user adjustments in the configuration mode. The graphical user interface 160 also illustrates a second waveform 164, which represents the user's respiratory airflow relative to the pressure waveform (i.e., on a common time scale).

[0094] 2.3. Control Loop

[0095] Figure 3 Illustrates a control loop implemented by the processor 110, where the processor 110 can generate a sensory response to the user when the user adjusts the therapy after entering the configuration mode, which can be used to implement an active therapy user feedback adjustment mode. In a first step, the processor 110 can detect a user adjustment submitted via the user interface 116, which can be made while the processor controls the pressure generator to deliver therapy according to the parameters set before the change. For example, the processor can detect that the user adjusts one or more parameters 140 via the menu selector 122 and / or the touch screen.

[0096] In a second step, the processor 110 can instruct the pressure generator 112 to adjust the pressurized breathable gas flow to be delivered to the user based on the detected adjustment.

[0097] In a third step, the adjusted pressurized breathable gas flow can be delivered to the user 102. As a result, the user 102 can perceive a difference in each parameter change, such as in the user's respiratory system or at the patient interface (e.g., the facial contact area). As a result, the user can easily decide what parameter settings make the user feel most comfortable, such as by simply iterating through the changes while feeling each change. Through this mechanism, the user 102 can find one or more personalized parameter settings that make the user feel most comfortable, because different users may prefer different parameter settings compared to other users. That is, a parameter setting that makes one user feel comfortable may not necessarily make another user feel comfortable. Therefore, when providing the user feedback described herein, the configuration mode can more easily allow each user to customize the parameter settings according to the user's own needs and / or comfort level, without the user having to understand in detail the technical nature of such parameters and / or even without clinical assistance. This is particularly helpful because many components of the system 100 (such as the mask and the gas conduit for delivering the breathable gas from the pressure generator to the mask) may affect the pressure felt by the user at the mask. By allowing the user to personalize the parameter settings in such a way, the user can more easily find the user's optimal waveform, regardless of the differences in the user's specific system components.

[0098] Also in the third step, the processor 110 can generate a visual response to the user via the user interface 116. The user interface 116 can display a first operating waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator. The user interface 116 can also display a second operating waveform corresponding to the user's respiratory gas flow. As a result, when the user adjusts one or more parameters, the user can visualize the effects generated by the user's adjustment.

[0099] In the fourth step, the user can iteratively make various adjustments to one or more parameters and thus easily experience them until the user reaches the parameter settings that make the user feel most comfortable through relative comparison. Thus, during this process, the pressure generator 112 can repeatedly adjust the pressurized breathable gas flow for delivery to the user based on the user's adjustments. When the user adjusts the parameters, the user can repeatedly feel the differences in the adjustments at the user's mask and / or in the user's respiratory system, while also visualizing the effects of the adjustments through one or more operating waveforms. Such a sense of change and visualization, combined with the current (e.g., near real-time) iteration, can provide a significant synergistic improvement in the respiratory therapy machine settings compared to typical clinical equipment settings.

[0100] 2.4. Flowchart

[0101] Figure 4 An example process for generating a sensory response to the user 102 when the user 102 adjusts therapy delivery is shown. At 402, a pressure generator can generate a pressurized breathable gas flow for delivery to the user's airway based on at least one adjustable parameter. At 404, the processor can detect the user's adjustment of the at least one parameter. At 406, when the user adjusts the at least one parameter, the processor can generate a sensory response that can be perceived by the user in real time or near real time. The sensory response can include an indication that the pressure generator adjusts the pressurized breathable gas flow for delivery to the user's airway based on the detected adjustment.

[0102] 3. Wireless Device

[0103] Reference Figure 5 , the system 100 can be wirelessly connected to the wireless device 170 so as to implement any of the operations described herein regarding the operation of the configuration mode when the wireless device 170 and the therapy device of the system 100 communicate with each other to implement the operation of the configuration mode. Thus, the wireless device 170 can be a computing system accessible by the user. Examples of the wireless device 170 can include mobile phones, tablets, netbooks, desktop computers, laptop computers, and wearable computing devices (such as smart watches), and so on. Reference Figure 1B, the wireless device 170 may include one or more processors 172, a memory 174, a user interface 176 including a display 178, and a network interface 180. The network interface 180 may have one or more wireless transceivers, such as a Bluetooth transceiver, a cellular transceiver, and a Wi-Fi transceiver. The display 178 may be a monitor having a screen or any other electrical device operable to display information (e.g., text, images, and / or other graphical elements). Additionally, the wireless device 170 may include all components typically associated with a computing device, such as a user interface subsystem. The user interface 176 may include one or more user input devices (e.g., a mouse, a keyboard, a touch screen, and / or a microphone) for receiving input from a user and output devices (such as speakers). The wireless device 170 may communicate with, such as the system 100, via any of the following transceivers: a Bluetooth transceiver, a cellular transceiver, and a Wi-Fi transceiver.

[0104] When the wireless device 170 is connected to the system 100, the wireless device 170 may communicate bidirectionally with the system 100. The wireless device 170 may send any user input to the system 100, including any adjustment to one or more parameters. The system 100 may receive the user's input via the wireless device 170. The pressure generator of the system may adjust the therapy based on the user's input. The system 100 may transmit information related to 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.

[0105] Reference Figure 6 , the wireless device 170 may display a graphical user interface 180 shown in its display 178. The graphical user interface 180 may be similar to Figure 2A the graphical user interface 160 illustrated. For example, the graphical user interface 180 may display a target pressure waveform 130 for controlling the pressure support delivered by the system 100. To adjust the therapy, the user may adjust one or more visual features on the wireless device (e.g., the target pressure waveform 130 on the screen of the wireless device), and in response to the adjustment, the wireless device communicates with the therapy device to provide any one of the above user responses or user feedback. Additionally or alternatively, continuing to refer to Figure 6, the wireless device 170 can generate a visual response via the graphical user interface 180. For example, the wireless device 170 can receive data related to the adjusted pressurized breathable gas flow generated by the pressure generator 112 and / or the user's respiratory airflow from the system 100, and generate a visual response to the user based on the received information. The visual response can display a first operating waveform 162 corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator. In one example, the graphical user interface 180 can display a second operating waveform 164 corresponding to the user's respiratory airflow.

[0106] Figure 7 Illustrates an example control loop implemented by the system 100 and the wireless device 170. In a first step, the processor 172 of the wireless device 170 can detect a user adjustment submitted via the user interface 176 of the wireless device 170. For example, the processor 172 can detect that the user adjusts one or more parameters 140 via the touch screen of the wireless device 170.

[0107] In a second step, the processor 172 of the wireless device 170 can transmit the adjusted parameter values to the system 100, which can instruct the pressure generator 112 to adjust the pressurized breathable gas flow delivered to the user based on the adjusted parameter values.

[0108] In a third step, the adjusted pressurized breathable gas flow can be delivered to the user 102. As a result, the user 102 can feel a perceivable difference in the user's respiratory system due to each adjustment.

[0109] Also in the third step, the processor 110 of the system 100 can transmit information related to the adjusted pressurized breathable gas flow generated by the pressure generator and / or the user's respiratory airflow to the wireless device 170. The wireless device 170 can generate a visual response to the user via the user interface 176, displaying a first operating waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator. The user interface 176 can also display a second operating waveform corresponding to the user's respiratory airflow. As a result, when the user adjusts one or more parameters, the user can visualize the effect of the adjustment through the wireless device 170.

[0110] In a fourth step, the user can repeatedly adjust one or more parameters via the user interface 176 of the wireless device 170 until a parameter setting that makes the user feel most comfortable is reached. During this iterative process, the pressure generator 112 can repeatedly adjust the pressurized breathable gas flow based on the user's adjustments. When the user adjusts the parameters, the user can continuously feel the change in pressure support in the user's respiratory system and visualize the effect of the adjustment through one or more operating waveforms displayed in the wireless device 170.

[0111] 4. Additional Example Specific Implementations

[0112] The above examples can be implemented to make many different and unique adjustments to the therapy. For example, any of the user interfaces in the above user interface (such as Figure 1C versions) can be manipulated to control the adjustment of the waveform, including, for example, changing the control algorithm used to generate the modified waveform. For example, any of the control algorithms described in more detail herein can be provided for the waveform. However, some changes made using the user interface can adapt the controller to provide therapy using different pressure control algorithms for the modified waveform. For example, the user can operate the user interface to modify the visual waveform (e.g., see Figure 1C ), such that the positive inspiratory pressure (e.g., by adjusting one or more control elements, such as the points associated with the visual feature 136) reaches a baseline (e.g., zero), such that the visual display becomes a flat line, such that the controller does not generate pressure at least during inspiration (and optionally expiration). Similarly, the user can further manipulate the user interface, such as using one or more of its control elements, such that the expiratory portion of the waveform portion drops below the flat baseline of the inspiratory portion in the form of a flat line or a curve. This further drop causes the controller to reduce the expiratory pressure below the inspiratory pressure, as shown by the line. When the user reduces the expiratory pressure wave portion in such a manner, the controller can change to another control algorithm, in which the pressure waveform can be generated based on the measured patient flow (e.g., delivered pressure = α * flow). α can be a multiplier value that can be determined based on a value associated with the position of one or more of the control elements in the user interface (e.g., 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 and the multiplier to control the pressure such that the pressure is negative (or results in a negative pressure) during expiration and then rises back to zero pressure during inspiration.

[0113] Additionally, in some specific implementations, the user interface can display another visual control that allows the user to adjust the value of α, such as a slider or other value selector. The pressure can be delivered as described with respect to the negative pressure. However, in some such cases, the α adjustment can simply be implemented as an additive function to the pressure control of the set waveform, such that the α adjustment provides additional pressure control to any of the other pressure control algorithms described herein. For example, the additive function (pressure_extra = α * flow) can be added to the output pressure (P t ) of any of the further control algorithms described herein, such as the following equation (1), such that the delivered pressure is a combination of the functions. (i.e., pressure_delivered = P t+Pressure_Extra). Similarly, Pressure_Extra can be added to the pressure output function defined by the above parameters (e.g., IPTT, EPTT, PIP, PEP).

[0114] 5. Technical Advantages

[0115] The disclosed technology can have many technical advantages. First, the disclosed technology can give the user control over the therapy. The disclosed technology can enable the user to adjust the therapy completely easily and confidently. By using the disclosed technology, the user can independently find the ideal therapy parameter settings that suit the user's needs and / or comfort level without relying on any clinical support.

[0116] Second, when the user adjusts one or more parameters related to the therapy, the disclosed technology can provide a sensory response to the user in real time or near real time. For example, for each parameter adjustment, the user can feel a perceivable difference in the user's respiratory system, such as by feeling pressure. As a further example, a patient may feel short of breath at low pressure (such as due to CO2), and by adjusting the waveform using the disclosed interface, the patient can perceive that the condition has been alleviated. As a result, the user can easily decide what parameter settings make the user feel most comfortable. The disclosed technology can also provide a visual response to the user via a display that shows the effect of the user's adjustment.

[0117] Third, by enabling the adjustment of visual features associated with the therapy via a touch screen, the disclosed technology provides greater freedom in adjusting parameters and allows the user to adjust the parameters without a high level of technical understanding.

[0118] 6. Example Memory and Processor

[0119] Memories 114 and 174 can be databases that store information that can be accessed by processors 110 and 172, respectively. For example, the memory 114 of system 100 can store instructions and data associated with adjustable parameters for controlling the pressure support generated by the pressure generator 112. The memory 174 of the wireless device 170 can store associated instructions and data received from system 100. Memories 114 and 174 can be any type capable of storing information that can be accessed by a processor, including computer-readable media. The memory can be a non-transitory medium, such as a hard disk drive, memory card, optical disc, solid-state drive, etc. The memory can include different combinations of the foregoing, whereby different portions of the instructions and data are stored on different types of media. The instructions can be any set of instructions that are executed directly (such as machine code) or indirectly (such as a script) by the processor. For example, the instructions can be stored as computer device code on a computer-readable medium. In that regard, the terms "instructions", "modules", and "programs" can be used interchangeably herein. The instructions can be stored in an object code format that is directly processed by the processor, or in any other computer device language that includes a script or collection of independent source code modules that are interpreted on demand or pre-compiled.

[0120] Processors 110 and 172 can be any conventional processor, such as a commercially available GPU, CPU, TPU, etc. Alternatively, each processor can be a dedicated device, such as an ASIC or other hardware-based processor. Although Figure 1B the processors and memories are illustrated functionally within the same box, such devices can actually include multiple processors, computing devices, or memories that may or may not be stored within the same physical housing. Similarly, the memory can be a hard disk drive or other storage medium located in a housing different from the processor (such as in a cloud computing system). Accordingly, references to a processor or computing device should be understood to include references to a collection of processors or computing devices or memories that may or may not operate in parallel. Processors 110 and 172 can access memories 114 and 174 via a network, respectively.

[0121] 7.1 Optional Example Treatment System

[0122] Example embodiments of system 100 are discussed in more detail in Sections 7.1 through 7.5 below.

[0123] In one form, system 100 can treat and / or monitor respiratory disorders. System 100 can be a respiratory therapy (RT) device such as RPT device 4000 for supplying a pressurized air stream to patient 1000 via air circuit 4170 leading to patient interface 3000. This air stream can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as high flow therapy HFT). Thus, an RPT device can also be configured to function as a flow therapy device, such as when using a patient interface that does not use a seal that seals with the patient's respiratory system. In the following description, the RT or RPT device can be considered with reference to Figures 8A to 11 for purposes of discussion.

[0124] 7.2 Patient Interface

[0125] As Figure 9 shown, the non-invasive patient interface 3000 according to one aspect of the present technology can optionally include any of the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to air circuit 4170, and a forehead support 3700. In some forms, the functional aspects can be provided by one or more physical components. In some forms, one physical component can provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of pressurized air to the airway.

[0126] 7.3 RPT Device

[0127] The RPT device 4000 according to one aspect of the present technology includes mechanical and pneumatic components 4100, electrical components 4200, and is programmed to execute one or more algorithms 4300. The RPT device 4000 can have an external housing 4010 that is formed in two parts: an upper part 4012 and a lower part 4014. In one form, the external housing 4010 can include one or more panels 4015. The RPT device 4000 can include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0128] The pneumatic path of the RPT device 4000 can include one or more air path components, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., 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 sensor 4274.

[0129] One or more of the air path components may be located within a removable monolithic structure, which will be referred to as the pneumatic block 4020. The pneumatic block 4020 may be located within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0130] The RPT device 4000 may have 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 form, the RPT device 4000 may include more than one PCBA 4202.

[0131] 7.3.1 RPT Device Mechanical and Pneumatic Components

[0132] The RPT device 4000 may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective standalone units.

[0133] 7.3.1.1 Air Filter

[0134] The RPT device 4000 according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0135] In one form, the air inlet filter 4112 is located at the start of the pneumatic path upstream of the pressure generator 4140.

[0136] In one form, the air outlet filter 4114 (e.g., an antibacterial filter) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0137] 7.3.1.2 Silencer

[0138] The RPT device 4000 according to one form of the present technology may include a silencer 4120 or a plurality of silencers 4120.

[0139] In one form of the present technology, the inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0140] In one form of the present technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0141] 7.3.1.3 Pressure Generator

[0142] In one form of the present technology, the pressure generator 4140 for supplying pressurized air is a controllable blower 4142. For example, the blower 4142 can include a brushless DC motor 4144 having one or more impellers housed in a volute. The pressure generator 4140 can be capable of generating an air supply or an air flow, for example, at about 120 liters per minute, at a positive pressure in the range from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O.

[0143] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0144] In other forms, the pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0145] 7.3.1.4 Transducer

[0146] The transducer can be inside or outside the RPT device. An external transducer can be located, for example, on an air circuit (e.g., the patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor (such as a Doppler radar motion sensor that sends or transmits data to the RPT device).

[0147] In one form of the present technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 are constructed and arranged to generate data representative of corresponding characteristics of the air flow, such as the flow rate, pressure, or temperature at that point in the pneumatic path.

[0148] In one form of the present technology, one or more transducers 4270 are located at a position close to the patient interface 3000.

[0149] In one form, the signal from the transducer 4270 can be filtered, such as by low-pass filtering, high-pass filtering, or band-pass filtering.

[0150] 7.3.1.5 Anti-backflow valve

[0151] In one form of the present technology, the anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0152] 7.3.1.6 Air circuit

[0153] An air circuit 4170 according to one aspect of the present technology is a conduit or tube which in use is configured and arranged to allow an air flow to travel between two components such as a pneumatic block 4020 and a patient interface 3000.

[0154] 7.3.1.7 Oxygen delivery

[0155] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path (such as upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0156] 7.3.2 RPT device electrical components

[0157] 7.3.2.1 Power supply

[0158] In one form of the present technology, the power supply 4210 is inside the outer housing 4010 of the RPT device 4000. In another form of the present technology, the power supply 4210 is outside the outer housing 4010 of the RPT device 4000.

[0159] In one form of the present technology, the power supply 4210 supplies power only to the RPT device 4000. In another form of the present technology, the power supply 4210 supplies power to both the RPT device 4000 and the humidifier 5000.

[0160] 7.3.2.2 Input device

[0161] 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 to allow a person to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touch screen. The buttons, switches, or dials can be physically connected to the outer housing 4010 in one form, or can wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.

[0162] In one form, the input device 4220 can be configured and arranged to allow a person to select values and / or menu options.

[0163] 7.3.2.3 Central controller

[0164] In one form of the present technology, the central controller 4230 is a processor adapted to control the RPT device 4000, such as an x86 INTEL processor.

[0165] According to another form of the present technology, a central controller 4230 adapted to control the RPT device 4000 includes a processor based on an ARM Cortex-M processor from ARM Holdings. For example, a microcontroller from the STM32 series from STMICROELECTRONICS can be used.

[0166] According to another alternative form of the present technology, another central controller 4230 adapted to control the RPT device 4000 includes a member selected from the family of ARM9-based 32-bit RISC CPUs. For example, a microcontroller from the STR9 series from ST MICROELECTRONICS can be used.

[0167] In certain alternative forms of the present technology, a 16-bit RISC CPU can 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 can be used.

[0168] 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.

[0169] The central controller 4230 is configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and the humidifier 5000.

[0170] The central controller 4230 is configured to provide output signals to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0171] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as a computer program stored on a non-transitory computer-readable storage medium (such as the memory 4260 or other memories described herein). In some forms of the present technology, as previously discussed, the central controller 4230 can be integrated with the RPT device 4000. However, in some forms of the present technology, some methods can be performed by a remotely located device or server (such as the previously mentioned server). For example, the remotely located device or server can determine control settings for delivery to a ventilator or other RT device, such as by detecting respiratory-related events and differentiating them by type by analyzing stored data from any of the sensors described herein.

[0172] Although the central controller 4230 can include a single controller that interacts with various sensors 4270, data communication interfaces 4280, memories 4260, and other devices, the functionality of controller 4230 can be distributed among more than one controller. Thus, the term "central" as used herein does not mean that the architecture is limited to a single controller or processor that controls other devices. For example, an alternative architecture can include a distributed controller architecture involving more than one controller or processor, which can 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 for implementing any of the methods described herein. This can include, for example, a separate local (i.e., within the RPT device 4000) or remotely located controller that executes some algorithms 4300, or even more than one local or remote memories that store some algorithms. Additionally, when represented as a computer program, an algorithm can include high-level human-readable code (e.g., C++, Visual Basic, other object-oriented languages, etc.) or low-level / machine-level instructions (Assembler, Verilog, etc.). Depending on the functionality of the algorithm, such code or instructions can be burned into a controller (e.g., an ASIC or DSP), or can be a runtime executable program that is ported to a DSP or a general-purpose processor, which is then specifically programmed to perform the tasks required by the algorithm.

[0173] 7.3.2.4 Clock

[0174] The RPT device 4000 can include a clock 4232 connected to the central controller 4230.

[0175] 7.3.2.5 Therapy Device Controller

[0176] In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330, which forms part of an algorithm 4300 executed by the central controller 4230.

[0177] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0178] 7.3.2.6 Protection Circuit

[0179] The RPT device 4000 according to the present technology can include one or more protection circuits 4250.

[0180] One form of the protection circuit 4250 according to the present technology is an electrical protection circuit.

[0181] One form of the protection circuit 4250 according to the present technology is a temperature or pressure safety circuit.

[0182] 7.3.2.7 Memory

[0183] In one form according to the present technology, the RPT device 4000 includes a memory 4260, such as a non-volatile memory. In some forms, the memory 4260 may include a static RAM powered by a battery. In some forms, the memory 4260 may include a volatile RAM.

[0184] The memory 4260 may be located on the PCBA 4202. The memory 4260 may be in the form of an EEPROM or a NAND flash memory.

[0185] Additionally or alternatively, the RPT device 4000 includes a memory 4260 in a removable form, such as a memory card made according to the Secure Digital (SD) standard.

[0186] In one form of the present technology, the memory 4260 (such as one of the memories described previously) serves as a non-transitory computer-readable storage medium on which computer program instructions representing one or more methods described herein, such as one or more algorithms 4300, are stored.

[0187] 7.3.2.8 Transducer

[0188] The transducer may be inside the device 4000 or outside the RPT device 4000. The external transducer may be located, for example, on the air delivery circuit 4170 (e.g., at the patient interface 3000) or form part of the air delivery circuit. The external transducer may be in the form of a non-contact sensor (such as a Doppler radar motion sensor that sends or transmits data to the RPT device 4000).

[0189] 7.3.2.8.1 Flow

[0190] The flow transducer 4274 according to the present technology may be based on a differential pressure transducer, such as the SDP600 series differential pressure transducers from SENSIRION. The differential pressure transducer is in fluid communication with the pneumatic circuit, and one of each pressure transducer is connected to a corresponding first point and a second point in the flow-limiting element.

[0191] In one example, the central controller 4230 receives a signal from the flow transducer 4274 representing the total flow Qt.

[0192] 7.3.2.8.2 Pressure

[0193] The pressure transducer 4272 according to the present technology is positioned in fluid communication with the pneumatic path. Examples of suitable pressure transducers 4272 are sensors from the HONEYWELL ASDX series. Another suitable alternative pressure transducer is a sensor from the NPA series of GENERAL ELECTRIC.

[0194] In use, the central controller 4230 receives a signal from the pressure transducer 4272. In one form, the signal from the pressure transducer 4272 is filtered before being received by the central controller 4230.

[0195] 7.3.2.8.3 Motor speed

[0196] In one form of the present technology, a motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 can be provided to the therapy device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor such as a Hall effect sensor.

[0197] 7.3.2.9 Data communication system

[0198] In one form of the present technology, a data communication interface 4280 is provided and the data communication interface is connected to the central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0199] 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 can include an integrated circuit or a processor.

[0200] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can use wired communication (e.g., via Ethernet or fiber optic) or a wireless protocol (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0201] In one form, the local external communication network 4284 utilizes one or more communication standards such as Bluetooth or the consumer infrared protocol and can optionally communicate with any of the sensors described herein.

[0202] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers and / or a server as described herein. In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 can be accessible by a duly authorized person, such as a clinician.

[0203] The local external device 4288 can be a personal computer, a mobile phone, a tablet computer, or a remote control device.

[0204] 7.3.2.10 Output devices including an optional display, an alarm

[0205] The output device 4290 according to the present technology can take the form of one or more of a visual, an audio, and a tactile unit. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0206] 7.3.2.10.1 Display driver

[0207] The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input and converts them into commands that cause the display 4294 to display these characters, symbols, or images.

[0208] 7.3.2.10.2 Display

[0209] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an eight-segment display, in which case the display driver 4292 converts each character or symbol (such as the digit "0") into eight logic signals that indicate whether the eight corresponding segments are to be activated to display a particular character or symbol.

[0210] 7.3.3 RPT device algorithm

[0211] 7.3.3.1 Preprocessing module

[0212] The preprocessing module 4310 according to the present technology receives raw data from the transducer 4270 (such as the flow sensor 4274 or the pressure sensor 4272) as input and performs one or more processing steps to calculate one or more output values that will be used as input to another module, such as the therapy engine module 4320.

[0213] In one form of the present technology, the output values include the interface or mask pressure Pm, the respiratory flow Qr, and the leak flow Ql.

[0214] In various forms of the present technology, the preprocessing module 4310 includes one or more of the following algorithms: pressure compensation 4312, ventilation flow estimation 4314, leak flow estimation 4316, respiratory flow estimation 4317, ventilation volume determination 4311, target ventilation volume determination 4313, respiratory rate estimation 4318, and backup rate determination 4319.

[0215] 7.3.3.1.1 Pressure compensation

[0216] In one form of the present technology, the pressure compensation algorithm 4312 receives as input a signal indicating 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 air circuit 4170 and provides as output the estimated pressure Pm in the patient interface 3000.

[0217] 7.3.3.1.2 Ventilation flow estimation

[0218] In one form of the present technology, the ventilation flow estimation algorithm 4314 receives as input the estimated pressure Pm in the patient interface 3000 and estimates the ventilation flow Qv of air from the ventilation port 3400 in the patient interface 3000.

[0219] 7.3.3.1.3 Leak flow estimation

[0220] In one form of the present technology, the leak flow estimation algorithm 4316 receives the total flow Qt and the ventilation flow Qv as inputs and estimates the leak flow Ql. In one form, the leak flow estimation algorithm 4316 estimates the leak flow Ql by calculating the average of the difference between the total flow and the ventilation flow Qv over a period of time (e.g., about 10 seconds) long enough to include several respiratory cycles.

[0221] In one form, the leak flow estimation algorithm 4316 receives the total flow Qt, the ventilation flow Qv, and the estimated pressure Pm in the patient interface 3000 as inputs and estimates the leak flow Ql by calculating the leak conductance and determining the leak flow Ql as a function of the leak conductance and the pressure Pm. The leak conductance can be calculated as the quotient of the low-pass filtered non-ventilation flow equal to the difference between the total flow Qt and the ventilation flow Qv and the square root of the low-pass filtered pressure Pm, where the low-pass filter time constant has a value long enough to include several respiratory cycles (e.g., about 10 seconds). The leak flow Ql can be estimated as the product of the leak conductance and the pressure function Pm.

[0222] 7.3.3.1.4 Respiratory flow estimation

[0223] In one form of the technology, the respiratory flow estimation algorithm 4317 receives the total flow Qt, the ventilation flow Qv, and the leakage flow Ql as inputs, and estimates the respiratory flow Qr of the air to the patient by subtracting the ventilation flow Qv and the leakage flow Ql from the total flow Qt.

[0224] In other forms of the technology, the respiratory flow estimation algorithm 4317 provides a value that serves as a surrogate for the respiratory flow Qr. Possible surrogates for the respiratory flow include:

[0225] - The respiratory movement 1000 of the patient's chest

[0226] - The current 4140 consumed by the pressure generator

[0227] - The motor speed 4140 of the pressure generator

[0228] - The transthoracic impedance 1000 of the patient

[0229] The respiratory flow surrogate value can be provided by a transducer 4270 in the RPT device 4000 (e.g., the motor speed sensor 4276) or a sensor external to the RPT device 4000 (such as a respiratory movement sensor or a transthoracic impedance sensor).

[0230] 7.3.3.1.5 Ventilation determination

[0231] In one form of the technology, the ventilation volume determination algorithm 4311 receives an input of the respiratory flow Qr and determines a measured value Vent that indicates the current patient ventilation volume.

[0232] In some specific implementations, the ventilation volume determination algorithm 4311 determines a measured value Vent of the ventilation volume, which is an estimated value of the actual patient ventilation volume.

[0233] In one such specific implementation, the measured value Vent of the ventilation volume is half of the absolute value of the respiratory flow Qr, which is optionally filtered by a low-pass filter such as a second-order Bessel low-pass filter having an angular frequency of 0.11 Hz.

[0234] In one such specific implementation, the measured value Vent of the ventilation volume is an estimated value of the total alveolar ventilation volume (i.e., the non-anatomical dead space ventilation volume). This requires an estimate of the anatomical dead space. The patient's height (or the arm span in the case of severe skeletal deformities) can be used as a good predictor of the anatomical dead space. Then, the total alveolar ventilation volume is equal to the measured value of the actual patient ventilation volume (e.g., as determined above) minus the product of the estimated anatomical dead space and the estimated spontaneous respiratory rate Rs.

[0235] In other specific implementations, the ventilation volume determination algorithm 4311 determines a measured value Vent of the ventilation volume that is approximately proportional to the actual patient ventilation volume. One such specific implementation estimates the peak respiratory flow Qpeak during the inspiratory portion of the estimation cycle. If the flow waveform shape does not vary much (here, when the flow waveforms of breaths are similar when normalized in time and amplitude, the shapes of two breaths are considered similar), then this procedure of sampling the respiratory flow Qr and many other procedures result in measured values that are approximately proportional to the ventilation volume. Some simple examples include the median of the positive respiratory flow, the median of the absolute value of the respiratory flow, and the standard deviation of the flow. Any linear combination of any order statistics of the absolute value of the respiratory flow using positive coefficients, and even any linear combination of any order statistics of the absolute value of the respiratory flow using both positive and negative coefficients, is approximately proportional to the ventilation volume. Another example is the average of the respiratory flow in the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. If the flow waveform shape is constant, there are any large number of measured values that are exactly proportional to the ventilation volume.

[0236] In other forms, the ventilation volume determination algorithm 4311 determines a measured value Vent of the ventilation volume that is not based on the respiratory flow Qr, but rather a surrogate for the current patient ventilation volume, such as the oxygen saturation (SaO2) or partial pressure of carbon dioxide (PCO2) obtained from a suitable sensor attached to the patient 1000.

[0237] 7.3.3.1.6 Target ventilation volume determination

[0238] In one form of the present technology, the central controller 4230 takes the measured value Vent of the current ventilation volume as an input and executes one or more target ventilation volume determination algorithms 4313 for determining a target value Vtgt of the ventilation volume measurement.

[0239] In some forms of the present technology, there is no target ventilation volume determination algorithm 4313, and the target ventilation volume Vtgt is pre - determined, for example, by hard - coding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0240] In other forms of the present technology, such as adaptive servo - ventilation (ASV) therapy (described below), the target ventilation volume determination algorithm 4313 calculates the target ventilation volume Vtgt based on a value Vtyp indicating the typical recent ventilation volume of the patient 1000.

[0241] In some forms of the adaptive servo - ventilation therapy, the target ventilation volume Vtgt is calculated as a high proportion of the typical recent ventilation volume Vtyp, but less than that typical recent ventilation volume. Such high proportions for such forms can be in the range of (80%, 100%) or (85%, 95%) or (87%, 92%).

[0242] In other forms of adaptive servo-ventilation therapy, the target ventilation volume Vtgt is calculated as an integer multiple slightly greater than the typical recent ventilation volume Vtyp.

[0243] The typical recent ventilation volume Vtyp is the value to which the distribution of the measured current ventilation volume Vent over multiple moments tends to cluster on some predetermined time scale, i.e., a measure of the central tendency of the measured current ventilation volume in the recent history. In a specific implementation of the target ventilation volume determination algorithm 4313, the recent history is on the order of a few minutes, but in any case should be longer than the time scale of the Cheyne-Stokes cycle. The target ventilation volume determination algorithm 4313 can use any one of a variety of well-known measures of central tendency to determine the typical recent ventilation volume Vtyp based on the measured current ventilation volume Vent. One such measure is the output of a low-pass filter on the measured current ventilation volume Vent, where the time constant is equal to one hundred seconds.

[0244] 7.3.3.1.7 Respiratory Rate Estimation

[0245] In one form of the present technique, the respiratory rate estimation algorithm 4318 receives the respiratory flow Qr of the patient 1000 as an input and produces an estimate of the patient's spontaneous respiratory rate Rs.

[0246] The respiratory rate estimation algorithm 4318 can estimate the spontaneous respiratory rate Rs during periods when the patient 1000 is breathing spontaneously, i.e., when the RPT device 4000 is not delivering a "backup breath" (as described below). In some forms of the present technique, the respiratory rate estimation algorithm 4318 estimates the respiratory rate during periods when the servo-assist (defined as the pressure support minus the minimum pressure support) is low (less than 4 cmH2O in one specific implementation), because such periods are more likely to reflect the spontaneous breathing effort.

[0247] In some forms of the present technique, the respiratory rate estimation algorithm 4318 estimates the respiratory rate during periods of sleep breathing, because the respiratory rate during these periods may be significantly different from the respiratory rate during wakefulness. Anxiety typically results in a higher respiratory rate than during sleep. When patients focus on their own breathing process, their respiratory rate is typically lower than during normal wakefulness or sleep. Techniques such as those described in the patent application PCT / AU2010 / 000894, published as WO 2011 / 006199 (the entire disclosure of which is incorporated herein by reference) can be used to identify periods of wakeful breathing from the respiratory flow rate Qr.

[0248] In some forms of the present technology, the respiratory rate estimation algorithm 4318 estimates the spontaneous respiratory rate Rs as the reciprocal of one of a variety of well-known statistical measures of the central tendency of the respiratory duration Ttot during a period of interest. Among such measures, it is desirable to reject outliers or at least be robust to outliers. One such measure, the trimmed mean, in which the lower and higher K proportions of the sorted respiratory durations are discarded and the mean is calculated from the remaining respiratory durations, is robust to outliers. For example, when K is 0.25, this is equivalent to discarding the upper and lower quartiles of the respiratory duration Ttot. The median is another robust measure of central tendency, although this occasionally gives unsatisfactory results when the distribution is strongly bimodal. The simple mean can also be used as a measure of central tendency, although it is sensitive to outliers. An initial interval filtering stage can be employed in which consecutive time intervals corresponding to implausible respiratory rates (e.g., greater than 45 breaths per minute or less than 6 breaths per minute) are excluded from the mean calculation as outliers. Other filtering mechanisms that can be used alone or in combination with interval filtering are to exclude any breaths that are not part of an N consecutive sequence of spontaneous breaths, where N is some small integer (e.g., 3), and to exclude the early and late breaths of a consecutive sequence of spontaneous breaths, e.g., excluding the first and last breaths of a four-breath sequence. The rationale for the latter mechanism is that the first and last breaths of a sequence of spontaneous breaths (in particular, and early and late breaths in general) may be atypical; for example, the first spontaneous breath may occur due to arousal and the last spontaneous breath may be longer due to a decreased respiratory drive, which results in a backup breath that ends the sequence of spontaneous breaths.

[0249] In some forms of the present technology, the respiratory rate estimation algorithm 4318 makes an initial estimate of the spontaneous respiratory rate Rs using an initial estimation period so that subsequent processing in the therapy engine module 4320 can begin, and then uses an estimation period that is longer than the initial estimation period to continuously update the estimate of the spontaneous respiratory rate Rs to improve statistical robustness. For example, the initial estimation period can be 20 minutes of suitable spontaneous breaths, but the estimation period can then gradually increase up to some maximum duration, e.g., 8 hours. Instead of using a rolling window of that duration for the estimation, a low-pass filter of the respiratory duration can be used, with the response time gradually getting longer (more precisely, the angular frequency gradually decreasing) as the treatment session progresses.

[0250] In some forms, a short-term (e.g., 10-minute) measurement of a suitable measure of central tendency, such as a trimmed mean, can be input into a suitable low-pass filter to give an estimate Rs that varies on a time scale of hours or longer. This has the advantage that it is not necessary to store and process potentially large amounts of breath duration data, which can occur if a trimmed mean is to be calculated based on a moving window of breath duration data spanning hours or days.

[0251] In some forms of the present technology, the respiratory rate measured over a short period, particularly within a single breath, can also be used in place of the breath duration in the above-described measure of central tendency, thereby giving generally similar but not identical results.

[0252] 7.3.3.2 Therapy Engine Module

[0253] In one form of the present technology, the therapy engine module 4320 receives as input one or more of the pressure Pm in the patient interface 3000, the respiratory flow Qr of air to the patient, and the estimated value Rs of the spontaneous respiratory rate, and provides one or more therapy parameters as output. In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, inspiratory flow limit determination 4324, apnea / hypopnea determination 4325, snore detection 4326, airway patency determination 4327, and therapy parameter determination 4329.

[0254] 7.3.3.2.1 Phase Determination

[0255] In one form of the present technology, the phase determination algorithm 4321 receives as input a signal indicative of the respiratory flow Qr and provides as output the phase Φ of the current respiratory cycle of the patient 1000.

[0256] In some forms referred to as discrete phase determination, the phase output Φ is a discrete variable. A particular implementation of discrete phase determination provides a binary-valued phase output Φ with inhalation or exhalation values, such as values of 0 turns and 0.5 turns respectively when the onset of spontaneous inhalation and exhalation are detected. The RPT device 4000 of "trigger" and "cycle" effectively performs discrete phase determination because the trigger point and the cycle point are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation respectively. In a particular implementation of binary-valued phase determination, the phase output is determined to have the discrete value 0 (thereby "triggering" the RPT device 4000) when the respiratory flow Qr has a value exceeding a positive threshold, and is determined to have the discrete value 0.5 turns (thereby "cycling" the RPT device 4000) when the respiratory flow Qr has a value more negative than a negative threshold.

[0257] Another specific implementation of discrete phase determination provides a three-valued phase output Φ having a value in one of inhalation, mid-inspiratory pause, and exhalation.

[0258] In other forms, known as continuous phase determination, the phase output Φ is a continuous value, e.g., varying from 0 to 1 revolution, or 0 to 2π radians. The RPT device 4000 performing continuous phase determination can trigger and cycle when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one specific implementation of continuous phase determination, a fuzzy logic analysis of the respiratory flow Qr is used to determine the continuous value of the phase Φ. The continuous value of the phase determined in this specific implementation is commonly referred to as the "fuzzy phase". In one specific implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow Qr:

[0259] 1. If the respiratory flow is zero and rapidly increasing, the phase is 0 revolutions.

[0260] 2. If the respiratory flow is a large positive value and stable, the phase is 0.25 revolutions.

[0261] 3. If the respiratory flow is zero and rapidly decreasing, the phase is 0.5 revolutions.

[0262] 4. If the respiratory flow is a large negative value and stable, the phase is 0.75 revolutions.

[0263] 5. If the respiratory flow is zero and stable, and the absolute value of the 5-second low-pass filtered respiratory flow is large, the phase is 0.9 revolutions.

[0264] 6. If the respiratory flow is positive and the phase is exhalation, the phase is 0 revolutions.

[0265] 7. If the respiratory flow is negative and the phase is inhalation, the phase is 0.5 revolutions.

[0266] 8. If the absolute value of the 5-second low-pass filtered respiratory flow is large, the phase increases at a steady rate equal to the patient's respiratory rate, with a low-pass filtering time constant of 20 seconds.

[0267] The output of each rule can be represented as a vector, whose phase is the result of the rule, and whose magnitude is the degree of fuzziness that the rule is true. Appropriate membership functions are used to determine the degree of fuzziness of "large", "stable", etc. for the respiratory flow. The results of the rules are represented as vectors and then combined by some function such as taking the centroid. In this combination, the rules can be weighted equally or differently.

[0268] In another specific implementation of continuous phase determination, the inhalation time Ti and the exhalation time Te are first estimated based on the respiratory flow rate Qr. Then the phase Φ is determined as half the proportion of the inhalation time Ti that has elapsed since the previous trigger moment, or 0.5 turns plus half the proportion of the exhalation time Te that has elapsed since the previous cycle moment (whichever is closer).

[0269] In some forms of the present technology suitable for pressure support ventilation therapy (described below), the phase determination algorithm 4321 is configured to trigger even when the respiratory flow rate Qr is not significant, such as during apnea. As a result, the RPT device 4000 delivers "backup breaths" without the patient 1000's spontaneous breathing effort. For such forms referred to as the spontaneous / timed (S / T) mode, the phase determination algorithm 4321 can utilize the backup rate Rb provided by the backup rate determination algorithm 4319.

[0270] The phase determination algorithm 4321 using "fuzzy phase" can implement the S / T mode by including a "momentum" rule in the fuzzy phase rule. The effect of the momentum rule is that if there is no characteristic of the respiratory flow rate Qr, the continuous phase is forwarded from exhalation to inhalation at the backup rate Rb, otherwise the respiratory flow rate will forward the continuous phase through other rules. In a specific implementation, the further the measured value of the ventilation volume Vent (described below) is below the target value of the ventilation volume Vtgt (also described below), the higher the momentum rule is weighted in the combination. However, due to the rapid increase in pressure support in response to mild to moderate hypoventilation (relative to the target ventilation volume), the ventilation volume may be very close to the target ventilation volume. It is desirable that when the ventilation volume approaches the target, a lower weight is given to the momentum rule to allow the patient to breathe at a rate significantly lower than the respiratory rate at other times (when the patient is not in central apnea) without being unnecessarily pushed by the ventilator to breathe at a higher rate. However, when a lower weight is given to the momentum rule when the ventilation volume is above a value that is below but close to the target ventilation volume, sufficient ventilation volume can be easily achieved at a relatively high pressure support at a rate far lower than the backup rate. It is desirable to deliver backup breaths at a higher rate because this will enable the delivery of the target ventilation volume at a lower pressure support. This is desirable for various reasons, one key reason being to reduce mask leakage.

[0271] Generally speaking, in the fuzzy phase determination algorithm 4321 implementing the S / T mode, there is a dilemma in selecting the weighting for the momentum rule that includes the backup rate Rb: if too high, the patient may feel "pushed" by the backup rate. If too low, the pressure support may be too high. Therefore, it is desirable to provide a method for implementing the S / T mode that does not rely on the momentum rule described above.

[0272] The phase determination algorithm 4321 (discrete or continuous, without momentum rules) can implement the S / T mode using the backup rate Rb in a manner called timing backup. The timing backup can be implemented as follows: The phase determination algorithm 4321 attempts to detect the start of inhalation due to spontaneous breathing efforts, for example, by monitoring the respiratory flow Qr as described above. If the start of inhalation due to spontaneous breathing efforts is not detected within a time period (an interval called the backup timing threshold) after the last trigger moment whose duration is equal to the reciprocal of the backup rate Rb, then the phase determination algorithm 4321 sets the phase output Φ to the inhalation value (thus triggering the RPT device 4000). Once the RPT device 4000 is triggered and the backup breath starts to be delivered, the phase determination algorithm 4321 attempts to detect the start of spontaneous exhalation, for example, by monitoring the respiratory flow Qr. At the start of spontaneous exhalation, the phase output Φ is set to the exhalation value (thus cycling the RPT device 4000).

[0273] If the backup rate Rb increases from SBR to STBR over time, as in the variable backup rate system described above, then the backup timing threshold starts to lengthen and then gradually shorten. That is, the RPT device 4000 starts to be less vigilant and gradually becomes more vigilant for the lack of spontaneous breathing efforts as more backup breaths are delivered. If the patient prefers to breathe at a rate below the standard, then this RPT device 4000 is less likely to make the patient feel "pushed", while still delivering backup breaths when needed.

[0274] If the STBR in the variable backup rate system adapts to the estimated spontaneous breathing rate Rs of the patient, as in the adaptive variable backup rate system described above, then the backup breaths will be delivered at a rate that adapts to the patient's own recent spontaneous breathing efforts.

[0275] 7.3.3.2.2 Waveform determination

[0276] In one form of the present technology, the therapy control module 4330 controls the 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 the waveform template Π(Φ).

[0277] In one form of the present technology, the waveform determination algorithm 4322 provides the waveform template Π(Φ), where values in the range [0, 1] in the phase value Φ domain provided by the phase determination algorithm 4321 will be used by the therapy parameter determination algorithm 4329.

[0278] In one form suitable for discrete or continuous-valued phase, the waveform template Π(Φ) is a square wave template that has a value of 1 for phase values up to and including 0.5 revolutions and a value of 0 for phase values above 0.5 revolutions. In one form suitable for continuous-valued phase, the waveform template Π(Φ) includes two smoothly curved portions, i.e., for phase values up to 0.5 revolutions, the smoothly curved portion (e.g., a raised cosine) rises from 0 to 1, and for phase values above 0.5 revolutions, the smoothly curved portion (e.g., an exponential) decays from 1 to 0. An example of such a "smooth and comfortable" waveform template is the "shark fin" waveform template, where the rise is a raised cosine and the smooth decay is quasi-exponential (such that the limit of Π is precisely zero as Φ approaches one revolution).

[0279] In some forms of the present technology, the waveform determination algorithm 4322 selects the 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 can be provided as a look-up table of values of Π with respect to the phase value Φ. In other forms, the waveform determination algorithm 4322 "on the fly" computes the waveform template Π(Φ) using a predetermined functional form that may be parameterized by one or more parameters (e.g., the time constant of the exponentially curved portion). The parameters of the functional form can be predetermined or depend on the current state of the patient 1000.

[0280] In some forms of the present technology suitable for discrete binary phase for inhalation (Φ = 0 revolutions) or exhalation (Φ = 0.5 revolutions), the waveform determination algorithm 4322 "on the fly" computes the waveform template Π as a function of the discrete phase Φ and the time t measured from the most recent trigger moment. In one such form, the waveform determination algorithm 4322 computes the waveform template Π(Φ, t) in two parts (inhalation and exhalation) as follows:

[0281]

[0282] where Π i (t) and Π e (t) are the inhalation and exhalation parts of the waveform template Π(Φ, t), and Ti is the inhalation time. In one such form, the inhalation part Π i (t) of the waveform template is a smooth rise from 0 to 1 parameterized by a rise time, and the exhalation part Π e (t) of the waveform template is a smooth decay from 1 to 0 parameterized by a fall time.

[0283] 7.3.3.3 Therapy Control Module

[0284] The therapy control module 4330, according to one aspect of the present technology, receives as input the therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver an air flow according to the therapy parameters.

[0285] In one form of the present technology, the therapy parameter is the treatment pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver an air flow such that the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt.

[0286] In some forms of the present technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 for determining one or more therapy parameters using values returned by one or more other algorithms in the therapy engine module 4320.

[0287] In one form of the present technology, the therapy parameter is the instantaneous treatment pressure Pt. In a specific implementation of this form, the therapy parameter determination algorithm 4329 uses the following equation to determine the treatment pressure Pt:

[0288] Pt = AΠ(Φ,t) + P0 (1)

[0289] Where:

[0290] A is the amplitude,

[0291] Π(Φ,t) is the waveform template value at the current value Φ of the phase and time t (in the range of 0 to 1), and

[0292] P0 is the base pressure.

[0293] If the waveform determination algorithm 4322 provides the waveform template Π(Φ,t) as a look-up table of values Π indexed by the phase Φ, the therapy parameter determination algorithm 4329 applies equation (1) by locating the nearest look-up table entry to the current value Φ of the phase returned by the phase determination algorithm 4321, or by interpolating between two entries straddling the current value Φ of the phase.

[0294] The values of the amplitude A and the base pressure P0 can be set by the therapy parameter determination algorithm 4329 in the following manner according to the selected respiratory pressure therapy mode.

[0295] 7.5 Glossary

[0296] For the purposes of this disclosure, in certain forms of the present technology, one or more of the following definitions may be applied. In other forms of the present technology, alternative definitions may be applied.

[0297] 7.5.1 Conventional

[0298] Air: In some forms of the present technology, air can be considered to mean atmospheric air, and in other forms of the present technology, air can be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0299] Respiratory pressure therapy (RPT): Delivery of an air supply to the airways at a therapeutic pressure that is typically positive relative to the atmosphere.

[0300] Continuous positive airway pressure (CPAP) therapy: A respiratory pressure therapy in which the therapeutic pressure is generally constant throughout the patient's respiratory cycle. In some forms, the pressure at the inlet of the airway is slightly higher during exhalation and slightly lower during inhalation. In some forms, this pressure will vary between different respiratory cycles of the patient, e.g., increase in response to detection of an indication of partial upper airway obstruction and decrease in the absence of an indication of partial upper airway obstruction.

[0301] Patient: A person, whether or not they have a respiratory disease.

[0302] Auto positive airway pressure (APAP) therapy: A CPAP therapy in which the therapeutic pressure is automatically adjustable between a minimum and a maximum, e.g., different with each breath, depending on whether there is an indication of an SDB event.

[0303] 7.5.2 Aspects of the respiratory cycle

[0304] Apnea: By some definitions, apnea is considered to occur when the respiratory flow drops below a pre-determined threshold for a period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to a decrease or absence of respiratory effort.

[0305] Respiratory rate (Rs): The rate of a patient's spontaneous breathing, typically measured as the number of breaths per minute.

[0306] Duty cycle: The ratio of the inhalation time Ti to the total respiratory duration Ttot.

[0307] Effort (respiratory): The work done by a person breathing spontaneously in an attempt to breathe.

[0308] The expiratory part of the respiratory cycle: The period from the start of expiratory flow to the start of inspiratory flow.

[0309] Flow limitation: A condition in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow limitation.

[0310] Hypopnea: A decrease in flow, but not a cessation of flow. In one form, hypopnea can be considered to occur when the flow decreases below a threshold for a period of time. In one form in adults, any of the following can be considered hypopnea:

[0311] (i) A 30% decrease in the patient's breathing for at least 10 seconds plus a related 4% desaturation; or

[0312] (ii) A decrease (but less than 50%) in the patient's breathing for at least 10 seconds, accompanied by at least a 3% associated desaturation or arousal.

[0313] Inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0314] Patency (airway): The degree or extent to which the airway is open. A patent airway is open. Airway patency can be quantified, for example, with a value of (1) being patent and a value of zero (0) being closed.

[0315] Positive end-expiratory pressure (PEEP): The pressure in the lungs at the end of expiration that is above atmospheric pressure.

[0316] Peak flow (Qpeak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0317] Respiratory flow / gas flow, patient flow / gas flow (Qr): These synonymous terms can be understood to refer to the RPT device's estimate of the respiratory gas flow, as opposed to the "true respiratory flow" or "true respiratory gas flow", which is the actual respiratory flow experienced by the patient, typically expressed in liters per minute.

[0318] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is applied.

[0319] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0320] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0321] (Total) time or breath duration (Ttot): The total duration between the start of the inspiratory portion of one breath flow waveform and the start of the inspiratory portion of the next breath flow waveform.

[0322] Upper airway obstruction (UAO): Includes partial and complete upper airway obstruction. This may be associated with a state of flow limitation, where flow increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling impedance behavior).

[0323] Ventilation volume (Vent): A measure of the total amount of gas exchanged by the patient's respiratory system. The measure of ventilation volume can include one or both of inspiratory flow and expiratory flow (per unit time). When expressed as a volume per minute, this quantity is commonly referred to as "minute ventilation". Minute ventilation is sometimes simply given as a volume, understood to be a volume per minute.

[0324] 7.5.3 RPT device parameters

[0325] Flow: The instantaneous volume (or mass) of air delivered per unit time. Although flow and ventilation volume have the same volume or mass magnitude per unit time, flow is measured over a much shorter time period. Flow can be nominally positive for the inspiratory portion of the patient's respiratory cycle and thus negative for the expiratory portion of the patient's respiratory cycle. In some cases, the reference to flow will be a reference to a scalar, i.e., a quantity having only magnitude. In other cases, the reference to flow will be a reference to a vector, i.e., a quantity having both magnitude and direction. Flow will be given the symbol Q. "Flow" is sometimes simply abbreviated to "flow rate". Total flow Qt is the flow of air leaving the RPT device. Ventilation flow Qv is the flow of air leaving the vent to allow flushing of the exhaled gas. Leakage flow Ql is the flow that unintentionally leaks from the patient interface system. Respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0326] Leakage: The term leakage will be considered an unintended air flow. In one example, leakage may occur due to an imperfect seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow leading to the environment.

[0327] Pressure: Force per unit area. Pressure can be measured in a range of units including cmH2O, g-f / cm 2 and hectopascals. 1 cmH2O is equal to 1 g-f / cm 2 , approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in units of cmH2O. The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved through the mask pressure Pm at the current moment.

[0328] 7.5.4 Terms for ventilators

[0329] Adaptive servo-ventilator (ASV): A servo-ventilator with a variable rather than a fixed target ventilation volume. The variable target ventilation volume can be derived from some characteristics of the patient (such as the patient's respiratory characteristics).

[0330] Backup rate: A parameter of a ventilator that establishes the respiratory rate (usually in breaths per minute) that the ventilator will deliver to the patient if not triggered by an effort of spontaneous breathing.

[0331] Cycled: The termination of the inspiratory phase of a ventilator. When a ventilator delivers a breath to a spontaneously breathing patient, at the end of the inspiratory part of the respiratory cycle, the ventilator is considered to cycle to stop delivering the breath.

[0332] Expiratory positive airway pressure (EPAP): The base pressure to which a varying pressure within a breath is added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0333] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory part. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ)=0 when Φ = 1, then EEP is equal to EPAP.

[0334] IPAP: The desired mask pressure that the ventilator attempts to achieve during the inspiratory part of a breath.

[0335] Pressure support: A figure indicating that the pressure increases during inspiration of a ventilator by more than the pressure during expiration of the ventilator, and generally means the pressure difference between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator aims to achieve rather than the difference actually achieved.

[0336] Servo-ventilator: A ventilator that measures the patient's ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to bring the patient's ventilation volume to the target ventilation volume.

[0337] Servo-assist: Pressure support minus minimum pressure support.

[0338] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath of a spontaneously breathing patient. However, if the device does not detect a breath within a pre-determined time period, the device will automatically initiate the delivery of a breath.

[0339] Swing: A term equivalent to pressure support.

[0340] Triggered: When the ventilator delivers a breath of air to a patient breathing spontaneously, it is considered to be triggered by the patient's effort at the start of the inspiratory part of the respiratory cycle.

[0341] Typical recent ventilation volume: The typical recent ventilation volume Vtyp is the value around which the recent measurements of the ventilation volume tend to cluster within a certain pre-determined time scale, that is, the measurement of the central tendency of the measured values of the ventilation volume in the recent history.

[0342] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0343] 4.6 Other remarks

[0344] Part of the disclosure of this patent document contains copyrighted material. The copyright owner does not oppose anyone making a facsimile reproduction of the patent document or patent disclosure as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights otherwise.

[0345] Unless the context clearly indicates otherwise and in the case of providing a range of values, it should be understood that each intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range, and any other stated or intermediate value within the said range, is covered by this technology. The upper and lower limits of these intermediate ranges (which may independently be included in the intermediate range) are also covered by this technology, subject to any specific excluded limitations in the said range. In the case where the range includes one or both of the limits, ranges excluding either or both of the included limits are also included in this technology.

[0346] Furthermore, in the case where one or more values are stated herein as being achieved as part of this technology, it should be understood that, unless otherwise stated, such values may be approximate and such values may be used to any suitable number of significant figures to the extent that the actual technical implementation permits or requires them.

[0347] 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 to which this technology belongs. Although any methods and materials similar or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0348] When a particular material is identified for constructing a component, an obvious alternative material with similar properties can be used as a substitute. Furthermore, unless otherwise specified, any and all components described herein should be understood to be capable of being manufactured and can therefore be manufactured together or separately.

[0349] It should be noted that, as used in this specification and the appended claims, the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0350] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials as the subject matter of those publications. The publications discussed 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 is not entitled to antedate such disclosure by virtue of prior invention. Additionally, the dates of publication provided may be different from the actual publication dates, which may require independent verification.

[0351] Furthermore, in interpreting this disclosure, all terms should be construed in the broadest reasonable manner consistent with the context. In particular, the terms "comprising" and "including" should be construed to refer to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0352] The section headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subject matter found throughout this disclosure or the claims. Section headings should not be used to interpret the scope of the claims or claim limitations.

[0353] Although the techniques herein have been described with reference to specific embodiments, it should be understood that these embodiments merely illustrate the principles and applications of the present technology. In some cases, the terms and symbols may imply specific details not necessary for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise stated, they are not intended to indicate any order but may be used to distinguish different elements. Additionally, although the process steps in a method may be described or illustrated in sequence, such sequence is not required. Those skilled in the art will recognize that such sequence may be modified and / or aspects thereof may be performed simultaneously or even synchronously.

[0354] Accordingly, it should be understood that various modifications can be made to the exemplary embodiments without departing from the spirit and scope of the present technology, and other arrangements can be designed.

[0355] Although the present invention has been illustrated by reference to specific embodiments, it will be apparent to those skilled in the art that the present invention is not limited to the details of the foregoing illustrative embodiments, and that the technology can be implemented with various changes and modifications without departing from the scope of the present invention. Accordingly, this embodiment is to be considered in all respects as illustrative and not restrictive, the scope of the technology being indicated by the appended claims rather than by the foregoing description, and all changes within the meaning and range of equivalents of the claims are therefore intended to be embraced therein. In other words, the present invention is intended to cover any and all modifications, variations or equivalents that fall within the scope of the basic principles and whose basic properties are claimed in this patent application. The reader of this patent application will also understand that the words "comprising" or "including" do not exclude other elements or steps, the word "a" or "an" does not exclude a plurality, and a single element such as a computer system, a processor or another integrated unit can implement the functions of several components recited in the claims. Any reference signs in the claims should not be construed as limiting the respective claims. When used in the specification or claims, the terms "first", "second", "third", "a", "b", "c", etc. are introduced to distinguish similar elements or steps and do not necessarily describe an order of sequence or a temporal order. Similarly, the terms "top", "bottom", "above", "below", etc. are introduced for purposes of description and do not necessarily denote a relative position. It should be understood that such terms are interchangeable where appropriate, and that the embodiments of the technology can be operated in other sequences or in orientations different from those described or illustrated above.

[0356] 7.7 Further embodiments of the technology

[0357] The following paragraphs further illustrate embodiments of the technology described herein.

[0358] Example 1. A system for providing respiratory therapy to a user's airway, the system comprising:

[0359] A pressure generator adapted to be coupled to a patient breathing interface for delivering the respiratory therapy to the user's airway;

[0360] A controller coupled to the pressure generator and configured to operate the pressure generator to generate the respiratory therapy based on at least one adjustable parameter, the respiratory therapy comprising a pressurized breathable gas flow; and

[0361] A user interface,

[0362] wherein the controller includes one or more processors and is configured to control the pressure generator to deliver the respiratory therapy during a therapy period in a therapy mode; and

[0363] wherein the controller is configured to, in a setup configuration mode:

[0364] receive an input made by the user on the user interface, the input corresponding to an adjustment to the at least one adjustable parameter; and

[0365] in response to the adjustment to the at least one adjustable parameter, control the generation of a sensory response perceivable by the user in real time or near real time, including:

[0366] based on the received input and the corresponding adjustment, control the pressure generator to deliver the respiratory therapy, the respiratory therapy including a pressurized breathable gas flow for delivery to the airways of the user.

[0367] Example 2. The system according to Example 1, wherein the one or more processors are configured to receive the input corresponding to the adjustment to the at least one adjustable parameter during a first respiratory cycle of the user, and wherein the delivery of the adjusted pressurized breathable gas flow occurs during a second respiratory cycle of the user after the first respiratory cycle.

[0368] Example 3. The system according to any one of Examples 1 to 2, wherein the at least one adjustable parameter includes one or more of the following:

[0369] inspiratory pressure trigger threshold;

[0370] inspiratory pressure shape;

[0371] peak inspiratory pressure;

[0372] expiratory pressure trigger threshold;

[0373] expiratory pressure shape; and

[0374] peak expiratory pressure.

[0375] Example 4. The system according to any one of Examples 1 to 3, wherein the one or more processors are configured to generate the user interface on a display coupled to the controller.

[0376] Example 5. The system according to any one of Examples 1 to 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.

[0377] Example 6. The system according to any one of Examples 1 to 5, wherein the user interface includes a graphical user interface that displays a target waveform including at least one visual feature corresponding to the at least one adjustable parameter, and wherein an adjustment to the at least one visual feature corresponds to an adjustment to the at least one adjustable parameter.

[0378] Example 7. The system according to Example 6, wherein the graphical user interface is presented via a touch screen, and wherein the system is configured to detect an adjustment to the at least one visual feature by a touch gesture on the touch screen.

[0379] Example 8. The system according to any one of Examples 6 to 7, wherein the sensory response includes a visual response shown in the graphical user interface, the visual response including:

[0380] Displaying in the graphical user interface a first operating waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator.

[0381] Example 9. The system according to Example 8, wherein the visual response further includes:

[0382] Displaying in the graphical user interface a second operating waveform corresponding to the user's respiratory airflow detected by at least one sensor, the second operating waveform being displayed in a superimposed manner relative to the first operating waveform.

[0383] Example 10. A method for providing respiratory therapy to a user's airway, the method comprising:

[0384] Generating, by a pressure generator, the respiratory therapy in each of a therapy mode and a setting configuration mode based on at least one adjustable parameter, the respiratory therapy including a pressurized breathable gas flow for delivery to the user's airway;

[0385] Receiving, by one or more processors in the setting configuration mode, an input from the user on a user interface, the input corresponding to an adjustment to the at least one adjustable parameter; and

[0386] Generating, in response to the adjustment to the at least one parameter, a sensory response perceptible by the user in real time or near real time, including:

[0387] Controlling, in the setting configuration mode, the delivery of the respiratory therapy to the user based on the received input corresponding to the adjustment.

[0388] Example 11. The method according to Example 10, wherein the receiving occurs during a first respiratory cycle of the user, and wherein the delivering of the respiratory therapy to the user based on the received input and the corresponding adjustment control in the setup configuration mode occurs during a second respiratory cycle of the user after the first respiratory cycle.

[0389] Example 12. The method according to any one of Examples 10 to 11, wherein the at least one parameter includes one or more of the following:

[0390] Inspiratory pressure trigger threshold;

[0391] Inspiratory pressure shape;

[0392] Peak inspiratory pressure;

[0393] Expiratory pressure trigger threshold;

[0394] Expiratory pressure shape; and

[0395] Peak expiratory pressure.

[0396] Example 13. The method according to any one of Examples 10 to 12, wherein the one or more processors generate the user interface on a display of a controller coupled to the pressure generator.

[0397] Example 14. The method according to any one of Examples 10 to 12, wherein the one or more processors receive the input from a wireless device that generates the user input.

[0398] Example 15. The method according to any one of Examples 10 to 14, wherein the user interface includes a graphical user interface, and wherein the method further includes:

[0399] Displaying a target waveform in the graphical user interface that includes at least one visual feature corresponding to the at least one adjustable parameter, and wherein an adjustment to the at least one visual feature corresponds to an adjustment to the at least one adjustable parameter.

[0400] Example 16. The method according to Example 15, wherein the graphical user interface is presented via a touch screen, and wherein the method further includes:

[0401] Detecting the adjustment to the at least one visual feature by a touch gesture on the touch screen.

[0402] Example 17. The method according to any one of Examples 15 to 16, wherein the sensory response includes a visual response shown in the graphical user interface, the visual response including:

[0403] Display a first operating waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator in the graphical user interface.

[0404] Example 18. The method according to Example 17, wherein the visual response further comprises:

[0405] Display a second operating waveform corresponding to the user's respiratory airflow detected by at least one sensor in the graphical user interface, the second operating waveform being displayed in a superimposed manner relative to the first operating waveform.

[0406] 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:

[0407] A display configured to present visual features associated with a plurality of parameters to the user, the plurality of parameters controlling the operation of the device when the device generates the respiratory therapy;

[0408] An input device configured to receive input from the user, the input including iterative modification of the presentation of the visual features; and

[0409] A pressure generator configured to iteratively generate an adjustment to the respiratory therapy provided by the device during operation of the setup configuration mode in a user feedback loop based on an iterative adjustment of the plurality of parameters corresponding to the iterative modification of the visual features.

[0410] Example 20. The user interface according to Example 19, wherein the visual features include feature icons displayed in association with at least a portion of a visual waveform representing the time course of the respiratory therapy.

[0411] Example 21. The user interface according to Example 20, wherein activation of the feature icon selects an associated parameter among the plurality of parameters for adjustment.

[0412] Example 22. The user interface according to any one of Examples 20 to 21, wherein the visual features further include a set of adjustment icons associated with the feature icons, wherein the set of adjustment icons is configured to adjust at least one associated waveform parameter of the visual waveform and the plurality of parameters when activated by the user.

[0413] Example 23. The user interface according to any one of Examples 19 to 22, wherein the visual features are presented on a touch screen, wherein the visual features are activated and / or modified by user touch.

[0414] Example 24. The user interface according to any one of Examples 19 to 22, wherein the input device comprises one or more buttons or knobs, and wherein the one or more buttons or knobs are configured to activate and / or modify the visual feature.

[0415] Example 25. The user interface according to any one of Examples 19 to 24, wherein the respiratory therapy comprises pressure therapy, and the plurality of parameters comprises one or more pressure control parameters.

[0416] Example 26. The user interface according to any one of Examples 19 to 25, wherein the respiratory therapy comprises high flow therapy, and the plurality of parameters comprises one or more flow control parameters.

[0417] Example 27. The user interface according to any one of Examples 19 to 26, wherein the device comprises a controller and a pressure generator.

Claims

1. A system for providing respiratory therapy to a user's airway, the system comprising: A pressure generator adapted to be coupled to a patient breathing interface for delivering the respiratory therapy to the user's airway; A controller coupled to the pressure generator and configured to operate the pressure generator to generate the respiratory therapy based on at least one adjustable parameter, the respiratory therapy including a pressurized breathable gas flow; And A user interface, Wherein the controller includes one or more processors and is configured to control the pressure generator to deliver the respiratory therapy during a therapy period in a therapy mode; and Wherein the controller is configured to, in a setup configuration mode: Receive an input made by the user on the user interface, the input corresponding to an adjustment to the at least one adjustable parameter; And In response to the adjustment to the at least one adjustable parameter, control the generation of a sensory response perceivable by the user in real time or near real time, including: Based on the received input and the corresponding adjustment, control the pressure generator to deliver the respiratory therapy, the respiratory therapy including the pressurized breathable gas flow for delivery to the user's airway.

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

3. The system according to any one of claims 1 to 2, wherein the at least one adjustable parameter includes one or more of the following: 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.

4. The system according to 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. The system according to any one of claims 1 to 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.

6. The system according to any one of claims 1 to 5, wherein the user interface includes a graphical user interface that displays a target waveform including at least one visual feature corresponding to the at least one adjustable parameter, and wherein an adjustment to the at least one visual feature corresponds to an adjustment to the at least one adjustable parameter.

7. The system according to claim 6, wherein the graphical user interface is presented via a touch screen, and wherein the system is configured to detect an adjustment to the at least one visual feature by a touch gesture on the touch screen.

8. The system according to any one of claims 6 to 7, wherein the sensory response includes a visual response shown in the graphical user interface, the visual response including: Display a first operating waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator in the graphical user interface.

9. The system according to claim 8, wherein the visual response further comprises: Display a second operating waveform corresponding to the user's respiratory gas flow detected by at least one sensor in the graphical user interface, the second operating waveform being displayed in a superimposed manner relative to the first operating waveform.

10. A method for providing respiratory therapy to a user's airway, the method comprising: Generating the respiratory therapy by a pressure generator in each of a therapy mode and a setting configuration mode based on at least one adjustable parameter, the respiratory therapy comprising a pressurized breathable gas flow for delivery to the user's airway; Receiving, by one or more processors, an input from the user on a user interface in the setting configuration mode, the input corresponding to an adjustment to the at least one adjustable parameter; And In response to the adjustment of the at least one parameter, generating a sensory response that can be perceived by the user in real time or near real time, comprising: Controlling the delivery of the respiratory therapy to the user based on the received input corresponding to the adjustment in the setting configuration mode.

11. The method according to claim 10, wherein the receiving occurs during the user's first respiratory cycle, and wherein controlling the delivery of the respiratory therapy to the user based on the received input and the corresponding adjustment in the setting configuration mode occurs during the user's second respiratory cycle after the first respiratory cycle.

12. The method according to any one of claims 10 to 11, wherein the at least one parameter comprises one or more of the following: Inspiratory pressure trigger threshold; Inspiratory pressure shape; Peak inspiratory pressure; Expiratory pressure trigger threshold; Expiratory pressure shape; and Peak expiratory pressure.

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

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

15. The method according to any one of claims 10 to 14, wherein the user interface comprises a graphical user interface, and wherein the method further comprises: Displaying a target waveform in the graphical user interface that includes at least one visual feature corresponding to the at least one adjustable parameter, and wherein an adjustment to the at least one visual feature corresponds to an adjustment to the at least one adjustable parameter.

16. The method according to claim 15, wherein the graphical user interface is presented via a touch screen, and the method further comprises: Detecting the adjustment to the at least one visual feature by a touch gesture on the touch screen.

17. The method according to any one of claims 15 to 16, wherein the sensory response comprises a visual response shown in the graphical user interface, the visual response comprising: Display a first operating waveform corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator in the graphical user interface.

18. The method according to claim 17, wherein the visual response further comprises: Display a second operating waveform corresponding to the user's respiratory gas flow detected by at least one sensor in the graphical user interface, the second operating waveform being displayed in a manner superimposed relative to the first operating 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 visual features associated with a plurality of parameters to the user, the plurality of parameters controlling the operation of the device when the device generates the respiratory therapy; An input device configured to receive input from the user, the input including iterative modification of the presentation of the visual features; And A pressure generator configured to iteratively generate an adjustment to the respiratory therapy provided by the device during operation of the setup configuration mode in a user feedback loop based on an iterative adjustment of the plurality of parameters corresponding to the iterative modification of the visual features.

20. The user interface according to claim 19, wherein the visual features include feature icons displayed in association with at least a portion of a visual waveform representing the time course of the respiratory therapy.

21. The user interface according to claim 20, wherein activation of the feature icon selects an associated parameter among the plurality of parameters for adjustment.

22. The user interface according to any one of claims 20 to 21, wherein the visual features further include a set of adjustment icons associated with the feature icon, wherein the set of adjustment icons is configured to adjust the portion of the visual waveform and at least one associated waveform parameter among the plurality of parameters when activated by the user.

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

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

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

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

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

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