System and method for providing personalized pressure waveforms

Abstract

This technology includes a system, apparatus, and method that can generate positive airway pressure (PAP) according to an individualized pressure waveform, for example, using a respiratory pressure therapy device (4000), in order to provide individualized pressure waveforms and improve treatment comfort.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 496,054, filed on April 14, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] This technology generally relates to respiratory therapy systems and devices, as well as the adjustment of therapeutic parameters. More specifically, this technology relates to a system and method for providing individualized pressure waveforms and generating positive airway pressure (PAP) according to individualized pressure waveforms. [Background technology]

[0003] Home respiratory therapy devices allow patients to receive respiratory treatment comfortably at home. Some such devices can typically include automated algorithms that detect respiratory distress symptoms and, in response, adjust the therapeutic pressure to attempt to alleviate the respiratory distress events, and may even return to lower pressure after such events have subsided. While such therapeutic changes to therapeutic pressure are sufficient to treat all patients similarly and address detected respiratory / clinical events such as flow-limiting and obstructive apnea, these changes to therapeutic pressure generally do not address the comfort perceived by certain users in pressure therapy.

[0004] For many PAP users, the sensation of breathing with such therapeutic pressure can feel unnatural and uncomfortable, leading to decreased use of PAP therapy or even complete rejection. Patients may find the therapy they receive uncomfortable if they receive respiratory therapy with a pressure waveform that is significantly different from their own unique breathing pattern and / or preferences. Respiratory therapy devices may allow for some adjustment of control parameters regarding the delivery of the therapy. However, such access to such changes is usually limited to authorized users, such as clinicians. Furthermore, existing respiratory pressure therapy devices may not produce any arbitrary pressure therapy during such clinical setups when a clinician user adjusts the settings. Therefore, until use during a therapy session in therapy mode, the patient does not feel the effect of the adjustments made previously, and, considering isolation, typically does not even understand what changes have been made. In fact, in such a process, it is not easy for the patient to understand what has been changed from a comparative sensory perspective regarding multiple potential changes, or what changes are more desirable for the patient.

[0005] Furthermore, even after adjustments have been made to the treatment, patients may still experience discomfort when receiving respiratory therapy from a respiratory therapy device. For example, individual patients may have unique breathing patterns. In addition, patients may have different preferences regarding the aspects of the treatment they perceive as comfortable or uncomfortable.

[0006] Existing respiratory therapy devices do not readily allow for the individualization of therapy related to a patient's unique breathing pattern and preferences, such as control parameters for pressure waveforms. Therefore, respiratory therapy devices and systems that offer a higher degree of individualization may be needed to improve patient comfort when receiving PAP therapy. [Overview of the project]

[0007] This technology relates to an improved therapy system and device that can provide individualized pressure waveforms and generate positive airway pressure (PAP) according to the individualized pressure waveforms.

[0008] Some embodiments of this technology may include a system for providing respiratory therapy to a user's airway. The system may include one or more sensors configured to generate output signals that convey information related to one or more physiological parameters of the user, each of which indicates the user's level of comfort with respect to respiratory therapy. The system may include a pressure generator configured to be coupled to the patient's respiratory interface for providing respiratory therapy to the user's airway. The system may include a controller coupled to the pressure generator, which may include one or more processors. The controller may be configured to perform a waveform adjustment control loop. The controller may be configured to, during a waveform adjustment control loop, receive output signals from one or more sensors while delivering a pressurized flow of breathing gas to the user's airway according to a predetermined waveform; compare each of one or more physiological parameters with a corresponding baseline value; adjust at least one waveform parameter of the predetermined waveform based on the comparison, wherein the adjustment is selected to reduce the difference between the value of at least one of the one or more physiological parameters and the corresponding baseline value of at least one physiological parameter; and operate a pressure generator to produce a pressurized flow of breathing gas according to the adjusted predetermined waveform.

[0009] In some implementations, the controller may be configured to repeatedly execute a waveform adjustment control loop over a predetermined period of time.

[0010] In some embodiments, at least one waveform parameter may include the inspiratory shape of a given waveform. The controller may be configured to adjust the given waveform so that the inspiratory shape of the waveform is linear. The controller may be configured to adjust the given waveform so that the inspiratory shape is rounded. At least one waveform parameter may include the expiratory shape of a given waveform. The controller may be configured to adjust the given waveform so that the expiratory shape of the waveform is linear. The controller may be configured to adjust the given waveform so that the expiratory shape is rounded. At least one waveform parameter may include the rise time of the inspiratory phase of a given waveform. The controller may be configured to adjust the duration of the rise time. At least one waveform parameter may include the fall time of the expiratory phase of a given waveform. The controller may be configured to adjust the duration of the fall time. At least one waveform parameter may include the inspiratory pressure trigger threshold of a given waveform. At least one waveform parameter may include the expiratory pressure trigger threshold of a given waveform. At least one waveform parameter may include the peak expiratory pressure of a given waveform. At least one waveform parameter may include the peak intake pressure of a given waveform.

[0011] In some implementations, one or more physiological parameters may include one or more of the following: flow rate, pressure, carbon dioxide, tidal volume, respiratory rate, respiratory effort, heart rate, and exercise.

[0012] In some implementations, one or more physiological parameters may include two or more of the following: flow rate, pressure, carbon dioxide, tidal volume, respiratory rate, respiratory effort, heart rate, and exercise.

[0013] In some implementations, the controller may be configured to store a predetermined, adjusted waveform in memory.

[0014] Some embodiments of this technology may include a system for providing respiratory therapy to a user's airway. The system may include a pressure generator configured to be coupled to a patient's respiratory interface for providing respiratory therapy to the user's airway. The system may include a controller coupled to the pressure generator and comprising one or more processors. The controller may be configured to perform a waveform selection process. During the waveform selection process, the controller may be configured to provide the user with instructions to deliver a first waveform in relation to operating the pressure generator to generate a pressurized flow of respiratory gas according to a first waveform over a first period, and to provide the user with instructions to deliver a second waveform in relation to operating the pressure generator to generate a pressurized flow of respiratory gas according to a second waveform over a second period, and to prompt the user, using a user interface, for input selection between the instructions to deliver the first waveform and the instructions to deliver the second waveform.

[0015] In some embodiments, a first waveform may be generated according to a first set of one or more waveform parameters, and a second waveform may be generated according to a second set of one or more waveform parameters. At least one waveform parameter of the first set may differ from at least one waveform parameter of the second set. The differing at least one waveform parameter may include any one of the following: inspiratory shape, expiratory shape, inspiratory phase rise time, expiratory phase fall time, inspiratory pressure trigger threshold, expiratory pressure trigger threshold, peak inspiratory pressure, peak expiratory pressure, inspiratory pressure trigger threshold, and expiratory pressure trigger threshold. The controller may be configured to generate a third waveform based on user-entered input selections. During the waveform selection process, after generating the third waveform, the controller may be further configured to repeat the waveform selection process using (a) the waveform selected by the user between the first and second waveforms, and (b) the third waveform. The controller may be configured to iteratively execute the waveform selection control process over a predetermined period or a predetermined number of control selection cycles. The controller may be configured to prompt the user for an instruction that the first or second waveform is at an acceptable level of comfort. The controller may be configured to interrupt the waveform selection control process in response to the instruction. The controller may be configured to store the first or second waveform in memory based on the user's instruction.

[0016] Some embodiments of this technology may include a system for providing respiratory therapy to a user's airway. The system may include one or more sensors configured to generate output signals that transmit information relating to one or more physiological parameters of the user, each of which may include one or more sensors that represent at least one aspect of the user's respiration. The system may include a pressure generator configured to be coupled to the patient's respiratory interface for providing respiratory therapy to the user's airway. The system may include a controller coupled to the pressure generator and including one or more processors. The controller may be configured to monitor the output signals of one or more sensors over a period of time, approximate the user's breathing pattern based on the monitored output signals, generate a personalized pressure waveform based on the approximation of the user's breathing pattern, and operate the pressure generator to generate a pressurized flow of respiratory gas according to the generated personalized pressure waveform.

[0017] In some implementations, one or more sensors may include one or more of a pressure sensor, a flow sensor, a heart rate sensor, a carbon dioxide sensor, an accelerometer, and one or more EEG sensors. One or more physiological parameters may include one or more of pressure, flow rate, heart rate, carbon dioxide, chest body movement, and lung bioelectrical impedance. The controller may be configured to store one or more parameters of an individualized pressure waveform in memory.

[0018] Naturally, some aspects or modes of implementation may form sub-aspects of this technology. Furthermore, sub-aspects and / or various aspects may be combined in various ways to constitute additional aspects or sub-aspects of this technology.

[0019] Other features of this technology will become apparent when considering the information contained in the following detailed description, overview, drawings, and claims.

[0020] This technology is shown by way of example and not limitation in the drawings, and like reference numerals in the drawings refer to like elements including the following elements.

Brief Description of the Drawings

[0021] [Figure 1A] An example of a therapy device is shown that provides airway pressure (PAP) breathing therapy (e.g., two - level or variable - level CPAP or pressure support) to a user's airway using an example of a user interface according to the technology of the present invention in a therapy - active user - adjustment feedback mode, while allowing the user to manually adjust one or more therapy control parameters of the therapy being administered. [Figure 1B] shows the characteristics of such a therapy device having a wireless control device and one or more servers in some versions of the technology. [Figure 1C] It is an explanatory diagram of a target waveform and waveform parameters of the target waveform according to the technology. [Figure 1D] Another environmental example of a system for providing therapy to a user's airway is shown where the user may adjust the therapy settings of the system through the user interface of a wireless device. [Figure 2A] An explanatory diagram of a transition of an example of a graphical user interface, such as on a display screen or touch screen of a therapy device or wireless control device in FIG. 1A or FIG. 1B, showing a target pressure waveform that a user can visually operate or adjust to effect parameter adjustment, and a visual response to the user when the user operates or adjusts the target pressure waveform and thereby adjusts corresponding or related therapy control parameters in a therapy - active user - adjustment feedback mode, etc., of the present technology. [Figure 2B]This is an explanatory diagram of a graphical user interface that visually presents the waveforms (e.g., pressure and flow rate) overlaid on the display screen of a therapy device or wireless control device, such as in Figure 1A or Figure 1B, so that the waveforms (e.g., pressure and flow rate) correspond to the pressure delivered by the respiratory device and the patient's flow rate detected by the therapy device, and this may be presented in the therapy-active user-adjustable feedback mode of the technology. [Figure 2C] Figure 1A or Figure 1B illustrates another graphical user interface, such as the display screen of a therapy device or wireless control device, which visually presents the transition of the shape of the pressure waveform that may be presented in the therapy-active user-adjustable feedback mode of this technology in response to manual changes in control parameters made by the user using the user interface controls (buttons or icons) described herein. [Figure 3A] This demonstrates the adjustment of waveform shape parameters using this technology. [Figure 3B] This technology demonstrates the adjustment of waveform time parameters, such as the rise time and fall time of the pressure waveform. [Figure 3C] This technology demonstrates the adjustment of waveform timing parameters for pressure waveforms. [Figure 3D] This demonstrates the adjustment of the expiratory pressure release parameter (or multiple related parameters) of the pressure waveform using this technology. [Figure 3E] This shows three unique breathing patterns produced by this technology. [Figure 4A] Figure 1A or Figure 1B is an explanatory diagram of a graphical user interface, such as the display screen of a therapy device or wireless control device, which may be suitable for performing therapy parameter adjustments in the therapy-active user-adjusted feedback mode of this technology, by showing manually adjustable visual features or feature icons on the target pressure waveform. [Figure 4B]Figure 1A or Figure 1B illustrates another graphical user interface, such as the display screen of a therapy device or wireless control device, showing that the user touches a single visual feature or feature icon on the target pressure waveform on the display to select a therapy parameter adjustment associated with a visual feature or icon in the therapy-active user-adjusted feedback mode of this technology. [Figure 4C] This diagram illustrates a graphical user interface that presents adjustment icons or arrow icons in response to a selection, such as the one selected in Figure 4B, and which may be adapted to perform parameter adjustments associated with selected visual features or feature icons, such as those selected in Figure 4B, in the therapeutic active user adjustment feedback mode of this technology. [Figure 5] This is a flowchart of an exemplary waveform selection control loop that enables user selection between waveforms after experiencing two different waveforms, using this technology. [Figure 6A] This is an explanatory diagram illustrating an example waveform adjustment control loop using this technology. [Figure 6B] Figure 6A is a flowchart of an exemplary waveform adjustment control loop. [Figure 7A] This shows an example of the breathing pattern approximation and individualized waveform generation process using this technology. [Figure 7B] This shows an example of the breathing pattern approximation and individualized waveform generation process using this technology. [Figure 7C] This shows an example of the breathing pattern approximation and individualized waveform generation process using this technology. [Figure 7D] Figures 7A-7C show flowcharts of the breathing pattern approximation and individualized waveform generation processes. [Figure 8A] This figure shows an exemplary system using this technology. Patient 1000, wearing a patient interface 3000, receives pressurized air from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and sent to patient 1000 through an air circuit 4170. A roommate 1100 is also shown. [Figure 8B]This shows an RPT device 4000 in use on patient 1000 wearing a nasal mask 3000. [Figure 8C] The image shows an RPT device 4000 in use on patient 1000 wearing a full-face mask 3000. [Figure 9] An example of a non-invasive patient interface 3000 in the form of a nasal mask is shown. [Figure 10A] This shows an RPT device 4000 based on one embodiment of this technology. [Figure 10B] This diagram shows a schematic of the pneumatic circuit of the RPT device 4000, one embodiment of this technology. The upstream and downstream directions are indicated. [Figure 10C] A schematic diagram of the electrical components of the RPT device 4000 according to one aspect of this technology is shown. [Figure 10D] Figure 10D shows a schematic diagram of algorithm 4300 implemented in RPT device 4000 according to one aspect of this technology. In Figure 10D, solid arrows indicate the actual flow of information, for example, via electronic signals. [Figure 10E] This flowchart shows a method 4500 performed by the treatment engine module 4320 in Figure 10D, according to one aspect of this technology. [Figure 11] This indicates a humidifier 5000. [Modes for carrying out the invention]

[0022] Before describing this technology in further detail, please understand that this technology is not limited to the specific examples described herein and is subject to change. Furthermore, please understand that the terminology used in this disclosure is intended to illustrate only the specific examples described herein and is not intended to limit it.

[0023] The following explanation is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features in any one example may be combined with one or more features in another example or other examples. In addition, a single feature or combination of features in any example may constitute further examples. 1. Pressure support system

[0024] This technology relates to a system or device for providing therapy, such as pressure or flow therapy, to a user's airway. The system is configured to individualize (or facilitate such individualization) pressure waveforms for individual users, which typically target modifications that provide greater user comfort for a particular user, as opposed to modifications that provide therapeutic improvements. In this way, the pressurized flow provided to the user by the system according to the individualized pressure waveform can provide a level of personal customization that can improve patient comfort, which can lead the patient to higher therapeutic compliance. As will be discussed in more detail below, the system may be configured to individualize pressure waveforms for a user in several ways, including manual adjustment and / or automated methods according to this technology. As will be discussed in more detail herein, such a system may be configured, for example, according to any of the following:

[0025] Manual self-optimization: The user interacts directly with the device through the user interface (e.g., using an external control application) by changing the setting(s) and experiencing them until the most comfortable combination of settings is identified.

[0026] Manual optimization by a trained person: The user interacts with a trained person using a user interface that allows the trained person to operate the device, enabling the user to experience and select their preferences for different A or B tests (e.g., considering waveform A or waveform B). Additionally, the trained person can hear comments made by the user after each test. Based on the user's preferences and comments, one or more settings can be changed in any A-B test. The A-B tests may continue until the user's most comfortable combination of settings is identified and entered / selected.

[0027] Induced Self-Optimization: The user interacts directly with the therapy device through an automated user interface (such as an external control application), and a series of such A-B tests (e.g., considering waveform A or waveform B) are performed, with the user experiencing and selecting their preferences for A or B using the user interface. One or more settings are changed with each A-B test. The A-B tests can continue until the user's most comfortable combination of settings is identified and stored (e.g., in memory). Such A-B tests can be staged at different times, such as before or after different sessions, so that they can be completed or performed before the initial use of the therapy device and / or any subsequent use.

[0028] Automatic Optimization: The therapy device includes an automatic comfort determination control loop that does not require direct user input on the user interface. The system may make continuous or periodic changes based on comfort-related inputs from one or more sensors (e.g., flow, pressure, respiratory effort, heart rate, etc.) to determine which setting changes improve comfort. Such automatic optimization may be performed repeatedly or continuously.

[0029] The implementation of such a system may be considered in relation to the following pathways concerning pressure therapy devices.

[0030] Figure 1A shows an example environment of System 100, which may be configured to provide pressure therapy, such as pressure support, to the airway of User 102. In some embodiments, System 100 may include a respiratory therapy device that provides respiratory therapy to User 102. For example, System 100 may include an RPT device, such as one of the respiratory pressure therapy (RPT) devices described in more detail herein. System 100 may provide the user with a flow of respiratory gas at a controlled pressure(s) and / or controlled flow(s). System 100 may interface to User 102 using a patient interface 106, such as a respiratory interface or mask, and an airflow conduit 104. Depending on the treatment applied, the patient interface 106 may form a seal with, for example, the face area of ​​User 102 to facilitate the delivery of gas at a pressure sufficiently different from the ambient pressure to achieve the therapeutic effect.

[0031] As shown in Figure 1B, the system 100 may, among other things, have one or more of the following: a controller including one or more processors 110 operably coupled to a pressure generator 112, one or more memories 114, a user interface 116, a network interface 118, and one or more sensors 124.

[0032] The user interface 116 may include a display 120 for presenting a graphical user interface, and one or more selectors 122, such as a menu selector, which may be a physical (e.g., a knob, button, switch, etc.) or virtual (e.g., an icon) component. The user interface 116 is controlled by and can exchange information with the processor(s) 110. The graphical user interface may be generated by the processor(s) 110 (e.g., based on instructions in memory 114) and displayed to the user via the display 120. The processor(s) 110 may receive user input provided to the interface 116. The selectors(s) 122 may be in the form of knobs or buttons, for example, which the user 102 may operate to operate the system 100. For example, user 102 may operate selector(s) 122 to navigate and / or select from menus displayed on display 120, or make selections in response to prompts provided to the user by processor(s) 110 and displayed on display 120. Optionally, such selector(s) 112 may be moved by touch to change values ​​associated with parameters, which may be visualized by changes in waveforms on the display. Thus, display 120 may have a touchscreen. The network interface 118 may have one or more transceivers, such as Bluetooth transceivers, cellular transceivers, or Wi-Fi communication transceivers. The network interface 118 may also be configured to communicate via wired connections with other systems or devices.

[0033] Sensors 124, such as any one of the sensors described in more detail herein, may be configured to detect and generate output signals that transmit information relating to user 102's therapeutic and / or physiological parameters, such as the user's breathing pattern, or other physiological parameters indicating the user's comfort with the use of the therapy device. Information relating to the user's breathing includes, but is not limited to, the pressurized flow rate and / or pressure of the breathing gas at the user's mouth. Other physiological parameters that may be detected by sensors 124 may include, for example, carbon dioxide (CO2) concentration in the patient interface 106 and / or conduit 104, heart rate, respiratory rate, exercise (e.g., chest movement), and pulmonary bioelectrical impedance. Based on the information in the output signals, processors 110 may determine other physiological parameters, such as the user's tidal volume and transpulmonary pressure.

[0034] The pressure generator 112 may be configured to generate a pressurized flow of breathing gas for delivery to the user 102's airway according to a target pressure waveform, under the control of a controller including one or more processors 110, such as a controller, which is described in more detail herein. The pressurized flow of breathing gas generated by the pressure generator 112 may be provided from the outlet of the pressure generator 112 through the airflow conduit 104 to the patient interface 106, thereby being delivered to the user 102's airway. The target pressure waveform, such as a pressure value and / or one or more parameters and / or a function for generating such a waveform, may be stored in memory 114. Figure 1C shows an example of a target pressure waveform 130, on which a pressurized flow of breathing gas is generated. The target pressure waveform 130 may represent the changing pressure of the breathing gas flow that the pressure generator 112 intends to generate. The target pressure waveform 130 may include an inspiratory pressure or positive inspiratory airway pressure (IPAP), indicated by "I" in Figure 1C, which may assist or be associated with the user's inspiration. The target pressure waveform 130 may also include an expiratory pressure or positive expiratory airway pressure (EPAP), indicated by "E," which may assist or be associated with the user's exhalation. Such pressures may or may not have a therapeutic effect, but the systems described herein are configured, in particular, to target pressures (e.g., pressure-time profile) selected for the comfort of a particular user.

[0035] It should be understood that system 100 may store additional target pressure waveforms in memory 114. For example, in addition to the target pressure waveform 130, system 100 may store a two-stage waveform (square waveform) that can be used. Memory 114 may store multiple different pressure waveforms, as will be described in more detail below.

[0036] It is understood that different users 102 may have their own natural breathing patterns, i.e., each user's breathing pattern which may be unique with respect to one or more breathing modes. For example, referring to Figure 3E, the unique breathing patterns 202, 204, and 206 of three different users are represented as airflow (flow rate) through each user's airway during the inspiratory and expiratory phases of breathing. Given the uniqueness of each person's natural breathing pattern, which is most likely to be a comfortable waveform for that person, a single pressure waveform 130 delivered from a respiratory therapy system such as system 100 may not be comfortable for each individual's breathing. In other words, the shape of the pressure waveform 130 may not match the unique shape and other modes of each user's airflow. Additionally, the pressure waveform 130 may not match the user's subjective comfort preferences.

[0037] Systems such as System 100 may also include several comfort-related parameters for adjusting such waveforms, such as ramp features and expiratory pressure release (EPR), which are intended to help the user adapt to PAP by reducing expiratory effort. For example, when a ramp feature is activated, the processor(s) 110 may control the pressure generator(s) 112 to begin delivering a pressurized stream of breathing gas at a pressure lower than the prescribed therapeutic pressure at the start of the therapy session (e.g., prescribed peak inspiratory pressure or IPAP) (e.g., relative to peak inspiratory pressure), with the delivered pressure gradually increasing to a prescribed pressure after the session. In this way, the user may gradually adjust to the sensation of pressure therapy. When an EPR feature is activated, the processor(s) 110 may also control the pressure generator(s) 112 to reduce the expiratory pressure (e.g., EPAP) by up to 3 cmH2O, which can improve the user's subjective comfort. The EPR feature may be used simultaneously with the ramp feature or separately after the ramp feature has been deactivated.

[0038] However, despite the use of such comfort-related features as EPR and ramp features, individual users 102 may still find PAP therapy uncomfortable. For example, the shape (e.g., profile) or other waveform parameters of the target waveform 130 may not adequately match or complement the user's natural breathing pattern. Furthermore, the 3 cmH2O maximum pressure release of the EPR feature may not provide sufficient relief for some users.

[0039] This technology provides a system 100 having several different features and processes for providing a personalized waveform to the user, which improves user comfort based on the user's unique breathing pattern and subjective preferences for the pressure waveform used. 1.1 Adjustable waveform parameters

[0040] Therefore, the controller may personalize or facilitate the personalization of the target waveform for user comfort and enable the selection of such a personalized target waveform. For example, a target pressure waveform, such as waveform 130, may be characterized by a plurality of waveform parameters that can be adjusted for the user's specific comfort. For example, to personalize the pressure waveform for a user, the processor(s) 110 of system 100 may be configured to selectively adjust these waveform parameters to generate a personalized pressure waveform that is more comfortable for the user based on the user's unique or natural breathing pattern and / or subjective preferences. As will be described in more detail below, system 100 may be configured to enable manual, expert induction, automatic self-induction, and / or automatic personalization of the target pressure waveform.

[0041] The waveform parameters adjustable by the processor(s) 110 can be classified into four groups: waveform shape parameters, waveform time parameters, waveform timing parameters, and pressure release parameters. It should be understood that there may be overlaps between parameters within each of these groups, and one or more parameters may belong to multiple groups. Grouping does not imply limitation. Waveform parameters may include, but are not limited to, one or more of the following: inspiratory pressure trigger threshold, inspiratory pressure shape, peak inspiratory pressure peak, expiratory pressure trigger threshold, expiratory pressure shape, peak expiratory pressure, inspiratory rise time, and expiratory fall time. Each of these waveform parameters may further include, or be characterized by, one or more (waveform) parameters that determine their adjustment. Furthermore, there may be overlaps between some of the waveform parameters. Some waveform parameters are described in detail below. 1.1.1 Waveform Shape Parameters

[0042] The waveform shape parameters, when adjusted, include parameters that modify the shape of the inspiratory or expiratory portion of the target waveform 130.

[0043] The inspiratory pressure shape 14 (shown in Figure 1C) may refer to waveform parameters that determine the shape of the inspiratory pressure curve from the start of inspiratory pressure to the peak inspiratory pressure. The processor(s) 110 may control the pressure generator 112 to increase the pressurized flow of breathing gas to the peak inspiratory pressure according to the inspiratory pressure shape 14. The inspiratory pressure shape 14 may correlate with the rise time of the inspiratory pressure from the start of inspiratory pressure (e.g., end of exhalation pressure) to the peak inspiratory pressure. The inspiratory pressure shape 14 may also control the rate at which the inspiratory pressure rises to the peak inspiratory pressure.

[0044] The intake pressure shape 14 may represent one or more of the following patterns: a linear line, a smooth curve (for example, based on an exponential function adjustable by the processor 110), or a rectangular curve. The intake pressure shape may include parameters for determining the slope or smoothness of the intake pressure shape. In one example, by adjusting the intake pressure shape parameter 14, for example by adjusting a selector in the user interface 116 or by automatic adjustment by the processor 110, the intake pressure shape 14 may be transformed from one form to another, for example, from a smooth curve to a rectangular curve. In some embodiments, the processor 110 may be configured to adjust the linearity of the intake pressure shape 14. For example, the processor 110 may adjust the shape to be more linear (i.e., to take a more linear / shorter path between the start of intake and the peak intake pressure), or to be less linear and more curved (i.e., to increase the convexity of the intake pressure shape 14).

[0045] The expiratory pressure shape 18 (shown in Figure 1C) may refer to the shape of the expiratory pressure curve from the end of the expiratory pressure to the peak expiratory pressure. The processor(s) 110 may control the pressure generator 112 to reduce the pressurized flow of breathing gas to the peak expiratory pressure according to the expiratory pressure waveform 18. The expiratory pressure shape 18 may correlate with the fall time of the expiratory pressure from the end of the inspiratory pressure to the peak expiratory pressure. The expiratory pressure shape 18 may control how fast or slow the expiratory force is during exhalation.

[0046] The expiratory pressure shape 18 may exhibit one or more of the following patterns: a linear line, a smooth curve (e.g., based on an exponential function adjustable by the processor 110), or a rectangular curve. The expiratory pressure shape 18 may include a parameter that determines the slope or smoothness of the expiratory pressure shape. In one example, by adjusting this parameter, the expiratory pressure shape 18 may change from one form to another, such as from a smooth curve to a rectangular curve, or vice versa. In some embodiments, the processor 110 may be configured to adjust the linearity of the expiratory pressure shape 18. For example, the processor 110 may adjust the shape to be more linear (i.e., to take a more linear / shorter path between the end of the inspiratory pressure and the peak expiratory pressure), or to be less linear and more curved (i.e., to increase the concavity of the expiratory pressure shape 18).

[0047] Referring to Figure 3A, the adjustments to both the inspiratory pressure shape 14 and the expiratory pressure shape 18 are shown ranging from a rectangular curve to a smooth "sawtooth" curve. It should be understood that the processor(s) 110 may be configured to adjust shapes 14 and 18 independently. In this regard, the user may prefer a smooth shape during inspiration and a linear shape during expiration, or vice versa. Alternatively or additionally, the processor(s) 110 may be configured to adjust shapes 14 and 18 together, that is, to perform the same type of adjustment for each of shapes 14 and 18 (for example, to make each of 14 and 18 a more rounded or more linear shape).

[0048] Additionally, please understand that adjustments to shapes 14 and 18 may also result in adjustments to other waveform parameters such as rise time and fall time. 1.1.2 Waveform Time Parameters

[0049] Waveform time parameters, when adjusted, include parameters that change the time it takes for pressure to increase during inspiration and the time it takes for pressure to decrease during expiration. Waveform time parameters may include the inspiratory rise time of inspiratory pressure from the start (e.g., end-expiratory pressure) to the peak inspiratory pressure, and the expiratory fall time of expiratory pressure from the end of inspiratory pressure to the peak expiratory pressure. Individual users may prefer a faster rise time during inspiration and a slower fall time during expiration, or vice versa. Waveform time parameters also include waveform parameters that are related to and / or affect the rise and fall times.

[0050] The intake rise time can be adjusted by the processor(s) 110 by adjusting one or more waveform parameters. For example, as described above, the intake pressure shape 14 can control how quickly or slowly the intake pressure rises to the peak intake pressure. Furthermore, the “peak time” parameter of the peak intake pressure 16 (shown in Figure 1C) can affect the intake rise time. The peak intake pressure 16 and peak time are described in more detail below. Therefore, any of these parameters can be adjusted by the processor(s) 110 to adjust the rise time.

[0051] The inspiratory fall time can be adjusted by the processor(s) 110 by adjusting one or more waveform parameters. For example, as described above, the expiratory pressure shape 18 can control how quickly or slowly the expiratory pressure decreases during exhalation. Furthermore, the “peak” time parameter of the peak expiratory pressure 20 (shown in Figure 1C) can affect the expiratory fall time. The peak expiratory pressure 20 and peak time will be described in more detail below. Therefore, any of these parameters can be adjusted by the processor(s) 110 to adjust the fall time.

[0052] The peak inspiratory pressure 16 may include a first parameter that controls when the peak inspiratory pressure 16 is generated, which may be called the time of the peak inspiratory pressure, or simply the peak time. The peak time may represent the time when the peak supply is stopped. For example, the peak time may indicate the timing of stopping the inspiratory pressure supply function and the timing of switching from the inspiratory pressure supply function (e.g., a pressure rise function) to the expiratory pressure supply function (e.g., a pressure drop function). The peak time may also indicate the timing at which the peak supply is achieved within a specific point in time within the patient's detected respiratory cycle, such as being related to a given phase of the patient's respiratory cycle, as will be described in more detail herein. The peak time may affect the inspiratory rise time. For example, a longer peak time may result in a slower inspiratory pressure rise time, and a shorter peak time may result in a shorter inspiratory pressure rise time. Based on the peak time, the processor(s) 110 may control the pressure generator 112 to adjust the function / equation of inspiratory pressure delivery so that the pressure rises to the peak point of the inspiratory cycle in a desired time.

[0053] The peak intake pressure 16 may include a second parameter that controls the amplitude of the peak intake pressure, which may represent the amount of pressure supplied by the pressure generator 112 at peak time (e.g., IPAP pressure). This parameter may also be related to the pressure rise function as the intake pressure supply function approaches the peak intake pressure 16.

[0054] The peak expiratory pressure 20 may include a first parameter representing the amplitude of the minimum expiratory pressure generated by the pressure generator 112 during the user's exhalation, or how much the pressure drops during the user's exhalation. This parameter may relate to the pressure drop function as the expiratory pressure supply function approaches the peak expiratory pressure 20, and the peak expiratory pressure 20 may be ambient pressure or other pressure drops from the peak inspiratory pressure 16.

[0055] The peak expiratory pressure 20 may include a second parameter indicating the timing of the generation of the peak expiratory pressure 20, which may be called the peak expiratory pressure time. This peak time may indicate the timing of the termination of the expiratory pressure supply function. This peak time may also indicate the timing at which the peak expiratory pressure 20 is achieved within the detected respiratory cycle, for example, in relation to the determined phase, as described in more detail herein. Based on this peak time, the pressure generator 112 may adjust the expiratory pressure supply function so that the pressure falls below the peak point of the expiratory cycle at a desired time. This peak time may affect the expiratory decline time. For example, a longer peak time may result in a slower expiratory pressure decline time, while a shorter peak time may result in a shorter expiratory pressure decline time.

[0056] Referring to Figure 3B, the adjustment of inspiratory rise time and expiratory fall time (by adjusting one or more of the parameters mentioned above) is shown. 1.1.3 Waveform Timing Parameters

[0057] Waveform timing parameters include parameters that define the time at which pressure begins to increase during inspiration and the time at which pressure begins to decrease during expiration. For example, individual users may prefer to start increasing the pressure earlier and decreasing or dropping it later, or vice versa. In one embodiment, the waveform timing parameters include an inspiratory pressure trigger threshold (IPTT) 12 and an expiratory pressure trigger threshold (EPTT) 17.

[0058] IPTT 12 may be a parameter indicating the point in time during the user's inspiratory cycle when the pressure generator 112 generates inspiratory pressure to assist the user's inspiration. IPTT 12 may indicate how quickly the pressure generator 112 switches from generating expiratory pressure to generating inspiratory pressure in relation to the user's respiratory cycle. In one embodiment, the pressure generator 112 may not begin generating inspiratory pressure at the start of the user's inspiratory cycle. Rather, the pressure generator 112 may delay generating inspiratory pressure until later in the user's inspiratory cycle, or it may begin just before the patient starts inhaling.

[0059] IPTT 12 may be a flow rate value defined based on the user's inspiratory airflow rate detected by the sensor(s) 124. In one example, IPTT 12 may be set to a value of approximately 4.5 L / min. In this example, when the user's inspiratory airflow rate reaches the IPTT 12 value, the pressure generator 112 may begin generating inspiratory pressure. IPTT 12 may play a role in delaying or accelerating the start of inspiratory pressure generation. For example, increasing the value of IPTT 12 may delay the start of inspiratory pressure generation, while decreasing the value of IPTT 12 may accelerate the start of inspiratory pressure generation.

[0060] Alternatively, IPTT 12 may be a pressure value defined relative to the user's inspiratory pressure in the mask 106 detected by sensor 124. In one example, IPTT 12 may be a threshold specifying a predetermined pressure in the mask 106, such as a downward pressure indicating patient inspiration. When sensor 124 detects a predetermined pressure in the mask 106, the pressure generator 112 may be triggered to begin generating inspiratory pressure. In this example, increasing the value of IPTT 12, which requires an increase in a predetermined pressure, may delay the start of inspiratory pressure generation, whereas decreasing the value of IPTT 12, which requires a reduction in a predetermined pressure drop, may accelerate the start of inspiratory pressure generation.

[0061] The EPTT 17, or expiratory pressure cycle threshold, may be a parameter that controls when the pressure generator 112 begins to assist the user's exhalation by controlling the pressure drop during the user's expiratory cycle. The EPTT 17 may indicate how quickly the pressure generator 112 switches from generating inspiratory pressure to generating expiratory pressure in relation to the user's breathing cycle.

[0062] EPTT 17 may be a flow rate value defined for the user's expiratory flow detected by sensor(s) 124, which may be related to a phase index, as described in more detail herein. In one example, once the user's expiratory flow reaches the value of EPTT 17, the pressure generator 112 may begin to control depressurization. EPTT 17 may play a role in delaying or accelerating the start of depressurization (e.g., a pressure drop function). For example, increasing the value of EPTT 17 may delay the start of depressurization, while decreasing the value of EPTT 17 may accelerate the start of depressurization.

[0063] Alternatively, EPTT 17 may be a pressure value defined relative to the user's breathing force detected by sensors 124 in the mask. In one example, EPTT 17 may be a threshold specifying a predetermined pressure increase within the mask. When sensors 124 detect a predetermined pressure increase within the mask, the pressure generator 112 may be circulated to begin reducing the pressure. In this example, increasing the value of EPTT 17 when a predetermined amount of pressure increase is required may delay the start of pressure reduction, while decreasing the value of EPTT 17 when a predetermined amount of pressure increase reduction is required may accelerate the start of pressure reduction.

[0064] Referring to Figure 3C, the adjustments for IPTT 12 and EPTT 17 are shown. 1.1.4 Expiratory Pressure Release (EPR)

[0065] The waveform parameters may further include expiratory pressure release (EPR) adjustment. As mentioned above, EPR adjustment may be limited to 3 cmH2O in existing respiratory therapy systems. System 100 of this technology may allow this parameter to be adjusted beyond this limit to a higher value (e.g., up to 6 cmH2O or more). In one embodiment, the minimum pressure at exhalation may remain at 4 cmH2O. Referring to Figure 3D, adjustments to the EPR parameter are shown. EPR may be set to the parameter that is most comfortable for the user. For example, as shown, the EPR parameter or setting may be set to different settings (e.g., settings 1, 2, and / or 3 shown) to adjust the level or degree of release. 1.2 Individualization of pressure waveforms

[0066] The processor(s) 110 is configured to personalize the pressure waveform for individual users by adjusting any one or more of the pressure waveform parameters described above to improve user comfort. The system 100 is configured to personalize the pressure waveform in several different ways. 1.2.1 Manual Optimization

[0067] In one embodiment, the system 100 is configured to allow the user to manually adjust the waveform parameters of the target pressure waveform 130, for example, those associated with its parameters / functions, which are stored in memory 114. The user interface 116 is configured to receive user input from the user and adjust any one or more of the waveform parameters of the target pressure waveform 130 described above. The user operates directly through the user interface 116, changing each waveform parameter until the most comfortable combination of waveform parameter settings (e.g., values ​​corresponding to each setting) is identified. As will be described in more detail below, the manual adjustment may be performed during the setup configuration mode of the system 100, and as the user adjusts one or more of the waveform parameters, the system 100 generates a sensory response perceived by the user (e.g., a breath-by-breath adjustment such that any changes made take effect on the next breath of the user) in real time or near real time. In this way, the user may adjust the waveform parameters as needed until the pressure waveform 130 is individualized and comfortable for the user. When the user is satisfied with the adjustment and the resulting waveform, the adjusted pressure waveform, including the corresponding waveform parameter values, may be stored, for example, in memory 114. The adjusted pressure waveform may later be used (for example, in the operating modes of system 100 described later) to provide the user with a pressurized flow of breathing gas according to the adjusted individualized pressure waveform stored in memory 114.

[0068] In one embodiment, the user interface 116 includes one or more menus through which the user can navigate via the selector 122 to select a setting and adjust the waveform parameters of the pressure waveform 130. In relation to one or more menus and settings, the user interface 116 may present the user with a description of each waveform parameter that informs the user which parameters the user can try to adjust first and what the user can expect when a particular parameter is adjusted. The following table includes illustrative information that may be included in one or more menus and settings or waveform parameters that can be adjusted by the user within the user interface 116. [Table 1] 1.2.1.1 Visual Adjustment

[0069] The system 100 may be configured, either additionally or alternatively, to provide enhanced visual adjustment capabilities for manually adjusting waveform parameters and personalizing pressure waveforms.

[0070] For example, referring to Figure 4A, the user interface 116 may display the target pressure waveform 130 to the user along with one or more visual features 132, 134, 136, 138, and 139 corresponding to different waveform parameters. Each visual feature may be a point or other visual icon displayed on or in relation to the target pressure waveform. For example, visual feature 132 may correspond to one or more parameters related to IPTT. Visual feature 134 may correspond to one or more parameters related to the inspiratory pressure shape. Visual feature 136 may correspond to one or more parameters related to the peak inspiratory pressure shape and / or EPTT. Visual feature 138 may correspond to one or more parameters related to the expiratory pressure shape. Visual feature 139 may correspond to one or more parameters related to the peak expiratory pressure.

[0071] The user may activate one or more visual features by, for example, manually adjusting them to change the associated waveform parameters (e.g., their values). For example, adjustments to a visual feature may correspond to adjustments to associated or corresponding therapeutic control parameters. Such changes may be made without the user needing to recognize or understand the values ​​associated with the changes to the waveform parameters.

[0072] For example, in the case of a touchscreen, user 102 may activate parameter changes by touching the corresponding visual feature on the target pressure waveform 130. Therefore, processor(s) 110 may detect such activations and / or adjustments to the visual features via touch gestures on the touchscreen. As an example, when a user touches a visual feature such as visual feature 136 as shown in Figure 4B, one or more optional icons or arrows 142-148 may be displayed on the graphical user interface, as shown in Figure 4C. The user may adjust the visual feature (and its corresponding parameter(s)) by touching any one of the icons or arrows 142-148. Arrows 142-148 may increase or decrease one or more parameter values, which may be indicated by a change in the visualization of the target pressure waveform (e.g., a change in shape).

[0073] Referring to the visual feature 136 shown in Figure 4C, the user may change the position of the visual feature 136 and / or its corresponding parameter value by touching any of the arrows 142-148. The user may adjust the time to peak inspiratory pressure by touching arrows 144 and / or 148. The forward arrow 144 may move the visual feature 136 toward the start of inspiration, which may result in a shorter time to rise in inspiratory pressure. On the other hand, the backward arrow 148 may move the visual feature 136 toward expiration, which may result in a slower time to rise in inspiratory pressure.

[0074] By touching arrows 142 and / or 146, the user may adjust the amplitude of the peak intake pressure, or the amount of pressure applied at peak time.

[0075] In another example, when user 102 touches a visual feature, a menu may appear offering one or more options for adjusting the visual feature or its corresponding parameters.

[0076] In yet another example, the user may adjust a visual feature and its corresponding parameters by dragging or moving the visual feature, such as visual feature 136, from its initial position to a new position 137 while the user is touching the visual feature on the touchscreen, as shown in Figure 4C. The corresponding parameters may be adjusted proportionally based on the new position 137 relative to the initial position. For example, if the new position 137 is lower than the initial position, the corresponding parameters may decrease proportionally. If the new position 137 is higher than the initial position, the corresponding parameters may increase proportionally.

[0077] In another embodiment, if there is no touchscreen, or if the user does not rely on a touchscreen, the user 102 may use a menu selector, selector(s) 122, to select any visual feature on the target pressure waveform 130 and adjust its corresponding parameter. For example, the user 102 may select a visual feature 136 on the target pressure waveform 130 to adjust the peak inspiratory pressure. When a visual feature 136 is selected, one or more icons or arrows 142-148 may be represented on the graphical user interface. The user may adjust the visual feature 136 or its corresponding parameter value by selecting one of the arrows 142-148 using the menu selector(s) 122.

[0078] In one embodiment, as shown in Figure 4C, the visualized shape or configuration of the target pressure waveform 130 may change due to changes in visual features or their corresponding parameters. When the user adjusts the visual features or their corresponding parameters via the touchscreen or menu selector(s) 122, the graphical user interface may display such changes to the target pressure waveform 130. Optionally, the graphical user interface may simultaneously display the target pressure waveform 130 in its original configuration, shown by a solid line, and the adjusted shape or configuration, shown by a dashed line 150. As yet another option, additional boundary curves may be displayed to indicate limitations associated with the extent of manual adjustment. 1.2.2 Manual optimization by trained personnel

[0079] System 100 may also be configured to allow a trained person, i.e., a person other than the user, to manually adjust the waveform parameters of the pressure waveform 130 to personalize the waveform for the user. The trained person may have greater knowledge than the user about how each waveform parameter may affect the user's comfort when adjusted, and to what extent each waveform parameter should be adjusted. The trained person may adjust the waveform parameters in the same manner as described above using the user interface 116. Alternatively, as will be described in more detail below, System 100 may be configured to receive one or more commands or inputs (e.g., in communication signals) from a radio or external device 170 used by a trained person (via the network interface 118). The received one or more commands or inputs are used by System 100 to adjust the waveform parameters of the target pressure waveform 130.

[0080] As part of waveform individualization, a trained person may administer a series of A-B tests to the user, in which the user selects their preference for either a first pressure waveform A or a second pressure waveform B at the end of each round of the test.

[0081] For example, a trained person may control the system 100 over a first period of time to provide a pressurized flow of breathing gas to the airway of user 102 according to a first waveform A having a first set of waveform parameters. The first waveform A may be a default waveform 130 stored in memory 114, or it may be a waveform having waveform parameters adjusted by the trained person. The trained person may then control the system 100 over a second period of time via a user interface to provide a pressurized flow of breathing gas to the airway of user 102 according to a second waveform B having a second set of waveform parameters. At least one waveform parameter from the second set of parameters is adjusted for the same parameter in the first set of parameters. For example, the inspiratory waveform shape in the first set of parameters may be linear, and the inspiratory waveform shape in the second set of parameters may be round or curved. Before providing the second waveform B to the user, the trained person may set the waveform parameters of the second waveform B using the user interface 116. The second waveform B may be generated by adjusting the first waveform A.

[0082] After the first round of the test in which the user breathes under the first waveform A and the second waveform B, the trained person asks the user which waveform they prefer. Additionally, the trained person may ask the user one or more specific questions about how the user felt during breathing when the first waveform A and the second waveform B were delivered. For example, the user may indicate whether they felt they received enough fresh air when each waveform was delivered (e.g., the pressure was too low) or whether they felt they were overinflated (e.g., the tidal volume was too high and / or the EPTT setting was too high (indicating slow timing)), or the trained person may ask the user for confirmation.

[0083] Based on the user's indicated preference for either the first waveform A or the second waveform B, and the user's comments / responses, the trained person conducts another test round offering the user the first waveform (i.e., either waveform A / B that the user indicated a preference for) and the second waveform. The second waveform may be a waveform that the trained person has further refined (by adjusting one or more waveform parameters). For example, the second waveform may be a refined version of waveform A / B. At least one waveform parameter of the second waveform may have a different value or be refined relative to the same at least one waveform parameter of the first waveform. The trained person again asks for the user's selection of which of the first or second waveforms they prefer, and for any additional comments from the user. Based on the user's preference and comments, the trained person may again refine one or more waveform parameter settings for the first or second waveform and conduct another A / B test round. This continuous A / B testing process, in which one of the two waveforms is replaced with the refined waveform after each test round, continues until a waveform with the most comfortable combination of waveform parameter values ​​is identified. Alternatively, the process may be continued for a predetermined period of time or until the user indicates that they have reached an acceptable level of comfort.

[0084] After the most (or acceptable) comfortable waveform is identified, the waveform and set of waveform parameters, as well as their values, are stored in memory 114. 1.2.3 System-Induced Self-Optimization

[0085] In another aspect of this technology, system 100 may be configured to further automate the aforementioned A / B waveform individualization so that system 100 automatically guides the user through the testing process using one or more waveform comparisons (e.g., A / B) or test queries to identify a comfortable pressure waveform. Thus, the controller may be configured to deliver two or more different waveforms (e.g., A / B waves) in which one or more parameters of each waveform differ. The user may identify which waveform is more comfortable than other waveforms by, for example, an input operation to the user interface of system 100, thereby allowing one or more parameters associated with the selected waveform to become part of a comfort waveform for further use by the user in the therapy device. In such a process, the selection of waveforms by comparison is substantially the selection of parameters, and since the selection is essentially based on the user's perception of the delivered waveform, the user does not even need to know or understand which parameters are changed. One or more such comparisons may be performed to further identify additional parameters, which may also be combined with the preceding parameters to be integrated into the user's individualized comfort waveform.

[0086] For example, in this embodiment, the system 100 may include selectable settings, for example, within a graphical user interface presented to the user, in order to activate the waveform selection control loop, and during the waveform selection control loop, the system 100 performs an automated induction waveform comparison test to identify a personalized pressure waveform that is comfortable for the user. The processor(s) 110 may be configured to automatically perform a series of A / B tests in which the user specifies a preference for waveform A or waveform B during each test run or loop. The settings or values ​​of one or more parameters may be changed by the processor(s) 110 in each A / B test. The A / B tests may continue in an automated manner until a comfortable (or most comfortable) combination of waveform parameter values ​​or settings is identified. Instructions for executing the waveform selection control loop may be stored in memory 114 and executed by the processor(s) 110.

[0087] Referring to Figure 5, a flowchart of the automatic waveform selection control loop is shown according to this technology.

[0088] In step 502, the processor(s) 110 provides the user with instructions for a first waveform. For example, in one embodiment, the processor(s) 110 may control the user interface 116 to display a message to the user indicating that a pressurized flow of breathing gas is being delivered to or will be delivered to the user's airway according to the first waveform. In connection with providing instructions to the user, the processor(s) 110 is also configured to operate the pressure generator 112 over a first period to generate a pressurized flow of breathing gas according to the first waveform. The first period is selected to allow the user to take several breaths and to understand different aspects of the first waveform and the user's comfort with respect to them.

[0089] After the first period, in step 504, the processor(s) 110 provides the user with instructions for a second waveform. For example, in one embodiment, the processor(s) 110 may control the user interface 116 to display a message to the user indicating that a pressurized flow of breathing gas is being delivered to the user's airway according to the second waveform. In connection with providing instructions to the user, the processor(s) 110 is also configured to operate the pressure generator 112 to generate a pressurized flow of breathing gas according to the second waveform over a second period occurring after the first period. The second period may have the same duration as the first period and is selected to allow the user to take several breaths and understand different aspects of the second waveform and the user's comfort with respect to them by feeling the delivered waveform.

[0090] The first and second waveforms are selected or generated by the processor(s) 110 such that at least one waveform parameter of the second waveform has a different value or setting for the same at least one parameter of the first waveform. For example, the first waveform may have a linear or square inspiratory or expiratory shape, and the second waveform may have a rounded inspiratory or expiratory shape. As another example, the first waveform may have a first peak inspiratory pressure, and the second waveform may have a second peak inspiratory pressure with a different value from the first peak inspiratory pressure. The processor(s) 110 may be configured to select the first and second waveforms from a plurality of waveforms stored in memory(s) 114 or a database accessible via the network interface(s) 118. Alternatively, the processor(s) 110 may generate the first and second waveforms by making adjustments to one or more waveform parameters of a predetermined waveform stored in memory(s) 114.

[0091] In step 506, the processor(s) 110 is configured to prompt the user (e.g., via user input to interface 116 or external device 170) to select a preference for a first or second waveform based on the user's perception of comfort during breathing. In some embodiments, the processor(s) 110 may further prompt the user for additional feedback regarding each of the first and second waveforms. Such feedback may relate, for example, to whether the user felt over-inflation, whether the user felt difficulty breathing, or whether the user felt that inhalation or exhalation was particularly difficult. In some embodiments, the processor(s) 110 provides the user with the option to repeat steps 502, 504 if the user feels that additional testing of the first and second waveforms is needed to form an opinion and provide feedback regarding the user's preference.

[0092] In step 510, the processor(s) 110 is configured to generate a third waveform based on the user's selection regarding the user's preference for at least one of the first or second waveforms, for comparison with another waveform (e.g., a first, second, or fourth waveform). The processor(s) 110 may further refine the generation of the third waveform based on other feedback, such as subjective input provided by the user in response to prompts from the processor (e.g., regarding whether the user felt overinflation or difficulty breathing), and / or the output of one or more sensors 124. The processor(s) 110 may generate the third waveform by adjusting at least one waveform parameter of the first or second waveform (whichever was selected by the user in step 506). In one embodiment, when performing step 510, the processor(s) 110 is configured to generate a third waveform having a set of parameters including at least one parameter having a different value or setting than the same parameter of the first and second waveforms. In other words, the third waveform has a different set of parameter values ​​or settings compared to the first and second waveforms.

[0093] In step 512, the processor(s) 110 is configured to prepare to re-execute the control loop by replacing the first waveform used in the control loop cycle with a waveform selected by the user between the first and second waveforms (if necessary), and replacing the second waveform with a generated third waveform. The processor(s) 110 is then configured to re-execute the loop, starting from step 502.

[0094] In one embodiment, method 500 may further include step 508 for terminating the control loop and selecting a waveform that is at an acceptable level of comfort for the user. Step 508 may be performed for a first loop or cycle of method 500, or for the first time for a second or subsequent loop or cycle of method 500. In step 508, processor(s) 110 prompts the user (e.g., via user interface 116 or external device 170) to indicate whether the first waveform (A) or the second waveform (B) is at an acceptable level of comfort and whether the user wishes to stop the A / B test process. If the user indicates that neither the first nor the second waveform is at an acceptable level of comfort for the user, processor(s) 110 may continue method 500 in step 510. Alternatively, if the user indicates that the first or second waveform is at an acceptable level of comfort for the user, the processor(s) 110 is configured to terminate the control loop, and method 500 terminates. The processor(s) 110 may then store the waveform that the user indicated as comfortable in step 508 in memory 114.

[0095] In one embodiment, the method 500 may be limited by a processor 110 to perform for a predetermined period or a predetermined number of control loop cycles, as described in more detail below. 1.2.4 Automatic Optimization

[0096] System 100 may be further configured to perform waveform individualization in a fully automated manner, for example, without requiring direct user input on a user interface. 1.2.4.1 Automatic waveform adjustment control loop

[0097] In one aspect of this technology, the processor(s) 110 of the system 100 may be configured to modify or adjust the pressure waveform in an automated manner (e.g., without user input entered on a user interface) based on the output of one or more sensors 124 in order to personalize the pressure waveform and improve user comfort. The adjustment may be performed as part of a control loop that is executed repeatedly, for example, continuously or at predetermined intervals, as will be described in more detail below.

[0098] For example, Figure 6A shows an example of a waveform adjustment control loop implemented using system 100 according to this technology.

[0099] In the first step, the processor(s) 110 may be configured to receive output signals from one or more sensors 124 while the pressurized flow of gas generated by the generator 112 is being delivered to the user 102 by the system 100. The pressurized flow of breathing gas is delivered according to a predetermined or target waveform, for example, the waveform 130 shown in Figure 1C or another default waveform. The predetermined or target waveform may be a waveform stored in memory 114 for providing therapy to the user 102.

[0100] In some such implementations, the sensor 124 is configured to generate an output signal that transmits information relating to one or more physiological parameters indicating user comfort in waveform form. One or more physiological parameters may be directly detected by the sensor 124 or determined by the processor(s) 110 based on information from the output signal of the sensor 124. User 102's physiological parameters may include, but are not limited to, flow rate, pressure, CO2, respiratory rate, respiratory effort, heart rate, tidal volume, respiratory volume, and / or user movement. The sensor 124 may include a flow sensor for detecting flow rate, a pressure sensor for measuring pressure, a CO2 sensor for detecting CO2 concentration (in the patient interface 106 or conduit 104), a heart rate sensor or monitor (e.g., a sensor for acquiring an electrocardiogram or a sensor for acquiring a photoplethysmogram), an accelerometer for measuring user movement (e.g., detecting the user's respiratory waveform or comfort level), or any other suitable sensor necessary to acquire information relating to the physiological parameters.

[0101] In the second step of the control loop in Figure 6A, the processor(s) 110 is configured to determine, based on one or more outputs of the sensor(s) 124, whether user comfort is at an acceptable level (e.g., below it). If the processor(s) 110 determines, based on the outputs of the sensor(s) 124, that user comfort is at an acceptable level (e.g., below it), then in the third step of Figure 6A, the processor(s) 110 may be configured to adjust at least one parameter(s) of a predetermined waveform currently being used to improve user comfort. In the fourth step of Figure 6A, the processor(s) 110 operates the pressure generator(s) 112 to generate a pressurized flow of breathing gas to be delivered to the user(s) 102 according to the adjusted predetermined waveform. Alternatively, if the processor(s) 110 determines in the second step that user comfort is at an acceptable level while the pressurized gas is being delivered to the user, the processor(s) 110 may then refrain from performing comfort adjustments in the third step, and the process proceeds to the fourth step.

[0102] The processor(s) 110 may repeatedly perform the first, second, third, and fourth steps of the control loop in Figure 6A, such as continuously (or iteratively) adjusting predetermined waveforms as needed based on the user's comfort level. Alternatively, the processor(s) 110 may periodically perform the first, second, third, and fourth steps as part of a staging process, as will be described in more detail below.

[0103] In one aspect, in order to determine the level of user comfort (or discomfort) and the adjustment(s) made to a predetermined waveform, in the second step of FIG. 6A, the processor(s) 110 is configured to compare the value of a physiological parameter (derived from the output of one or more of the sensors 124) with the corresponding baseline value of each physiological parameter (e.g., the respective baseline values of flow rate, pressure, respiratory effort, heart rate, etc.). The baseline value can be a value associated with each physiological parameter indicating that the user is comfortable. The determination of the baseline value will be described in more detail below.

[0104] In FIG. 6A, the values of the distinct physiological parameters are represented as A1, A2... A n , n , , n , n , n , n , n and the distinct baseline values corresponding to the physiological parameters are represented as B1, B2... B n For example, A1 is the first physiological parameter (e.g., respiratory rate) that is compared with the first baseline value B1 (e.g., the value of respiratory rate indicating that the user is comfortable), A2 is the second physiological parameter (e.g., tidal volume) that is compared with the second baseline value B2 (e.g., the value of tidal volume indicating that the user is comfortable), and so on. It should be understood that the control loop of FIG. 6A may employ any number of physiological parameters and any one of the physiological parameters may be compared with its corresponding unique baseline value.

[0105] In some embodiments, the comparison of each physiological parameter (A n ) is, for example, (a) the calculation of the difference between the value of the physiological parameter (A n ? B<00000​​​​​​​​​​​​​​This includes determining whether it is greater than (or less than) (represented as).

[0106] In one embodiment, to adjust a waveform, the processor(s) 110 may perform comparison and adjustment based on an evaluation of a single physiological parameter. In this embodiment, if the processor(s) 110 determines that the difference between the values ​​of the physiological parameter is greater than (or less than) a predetermined threshold associated with the physiological parameter, the processor(s) 110 may determine that user comfort is below an acceptable level and that comfort adjustment is necessary for the predetermined waveform. If this condition is not met, the processor(s) 110 determines that user comfort is acceptable and no adjustment is necessary.

[0107] In another embodiment, the processor(s) 110 may perform a comparison of each of several physiological parameters (e.g., two or more physiological parameters) with individual baseline values. This is shown in Figure 6A as (A1-B1)>C1, (A2-B2)>C2, ...(A n ?B n )>C n This is expressed as follows. In one example of this embodiment, if the processor(s) 110 determines, based on a comparison, that the difference between any physiological parameter and its baseline value is greater than a predetermined threshold, the processor(s) 110 determines that user comfort is below an acceptable level and that adjustment to the predetermined waveform is necessary. If this condition is not met, the processor(s) 110 determines that user comfort is acceptable and no adjustment is necessary. In another example of this embodiment, the processor(s) 110 may be configured to require a determination that some (or all) of a set of physiological parameters differ from their individual baseline values ​​by an amount greater than the individual predetermined threshold, so that user comfort is determined to be below an acceptable level.

[0108] In any of the above embodiments, it should be understood that, instead of calculating the difference between the physiological parameter and a predetermined baseline value, a ratio between the value of each physiological parameter and the baseline value of the physiological parameter may be calculated. Each ratio can be compared to a corresponding predetermined threshold to determine whether user comfort is at an acceptable level or whether adjustment to the predetermined threshold is necessary.

[0109] Baseline values ​​can be determined in one of several different ways. For example, in one embodiment, during the setup mode of system 100, with no treatment being provided to the user, values ​​from sensor 124 can be recorded (e.g., in memory 114) to identify individualized baseline values ​​indicating that the user is in a comfortable state. Alternatively or additionally, baseline values ​​can be determined empirically based on input attributes associated with the user, such as height, weight, age, sex, activity level, and medical status. For example, baseline values ​​for each physiological parameter indicating user comfort can be identified for a number of users with different heights, weights, ages, sexes, activity levels, medical statuses, etc., and stored in memory 114. Based on specific user attributes that can be entered on the user interface, a suitable baseline value can be determined or selected by a processor(s) 110, for example, by associating the value with such attributes in the device's memory.

[0110] It should be understood that in any of the embodiments described above, a range of baseline values ​​may be used instead of a baseline value. For example, for each physiological parameter, the processor(s) 110 may be configured to determine whether the value of the physiological parameter falls within a range of baseline values ​​for that physiological parameter that indicate an acceptable level of user comfort. If one or more of the evaluated physiological parameter values ​​are not within the corresponding range, the processor(s) 110 may determine that user comfort is below an acceptable level and that adjustments to a given waveform are necessary. The range of baseline values ​​for each physiological parameter may be determined in the same manner as described above, i.e., by recording sensor outputs when the user is in a comfortable state and / or by using physical attributes associated with the user.

[0111] The techniques for identifying baseline values ​​or ranges described herein are not intended to be limiting, and it should be understood that other methods for identifying baseline values ​​or ranges for use in conjunction with these techniques are intended to be within the scope of this disclosure.

[0112] After the processor(s) 110 determines that adjustment is needed for a given waveform based on a comparison of physiological parameters with baseline values ​​or ranges of baseline values, the processor(s) 110 is configured to adjust at least one waveform parameter of the given waveform (e.g., any of the waveform parameters described above) to improve user comfort. The control loop shown in Figure 6A may be executed iteratively. If the processor(s) 110 determines that user comfort is at an acceptable level based on a comparison of physiological parameters with baseline values ​​or ranges, the processor(s) 110 makes no adjustments to the waveform or loop and returns to the start of the loop to receive and monitor data again from the sensor(s) 124.

[0113] In one embodiment, as will be described in more detail below, the control loop may be executed by the processor 110 as part of a staging process for a predetermined amount of time or for a predetermined number of control loops.

[0114] Adjustments to at least one waveform parameter of a given waveform are selected by the processor(s) 110 to reduce the difference between at least one value of the physiological parameter and the baseline value corresponding to that physiological parameter. It should be understood that the processor(s) 110 may be configured to adjust a single waveform parameter or multiple waveform parameters in each operation of the control loop. Additionally, the processor(s) 110 may prioritize the adjustment of certain waveform parameters that are considered to have a greater relative impact on user comfort than other waveform parameters that are considered to have a smaller relative impact on user comfort. The preferred waveform parameter is adjusted first.

[0115] In some implementations, the processor(s) 110 may be configured to select an amount or degree of adjustment (e.g., a relatively small adjustment or a large adjustment) for one or more waveform parameters based on the amount of difference calculated by the processor(s) 110 between one or more physiological parameters and their individual baseline values ​​during the comparison. The processor(s) 110 may be configured to make a larger adjustment to the waveform parameters when a larger difference is calculated, or a smaller adjustment to the waveform parameters when a smaller difference is calculated.

[0116] Referring to Figure 6B, a flowchart of Method 600 of the automatic waveform adjustment control loop according to the present technology is shown. In step 602, the processor(s) 110 receives output signals from one or more sensors that detect information related to one or more physiological parameters indicating user comfort. The output signals are received while delivering a pressurized flow of breathing gas to the user's airway according to a predetermined waveform. In step 604, the processor(s) 110 compares each of the one or more physiological parameters with a corresponding baseline value. In step 606, the processor(s) 110 determines, based on the comparison, whether adjustment is needed for at least one waveform parameter of the predetermined waveform to improve user comfort. If the processor(s) 110 determines that no adjustment is needed, Method 600 returns to step 602. Alternatively, if the processor(s) 110 determines that an adjustment is needed, the processor(s) 110 is configured to adjust the value or setting of at least one waveform parameter of the predetermined waveform. The adjustment is made to reduce the difference between at least one value of one or more physiological parameters and the corresponding baseline value of at least one physiological parameter. For example, as described above, the processor(s) 110 may adjust any one of the following: inspiratory shape, expiratory shape, inspiratory phase rise time, expiratory phase fall time, inspiratory pressure trigger threshold, expiratory pressure trigger threshold, peak inspiratory pressure, peak expiratory pressure, inspiratory pressure trigger threshold, and expiratory pressure trigger threshold of a given waveform. In step 610, the processor(s) 110 operates a pressure generator to produce a pressurized flow of breathing gas according to the given waveform adjusted in step 608, and then the method returns to step 602.

[0117] Method 600 and the functions described above can be activated by user input to the user interface 116, or by one or more commands received by the system 100 from an external device such as the device 170. 1.2.4.2 Automatic individualized waveform approximation

[0118] In another aspect of this technology, the processor(s) 110 of system 100 may be configured to approximate the user's breathing pattern using sensor outputs from or calculated therefrom of sensors(s) 124. The processor(s) 110 may then generate individualized pressure waveforms based on the approximation. In this way, the individualized waveforms approximate the user's natural breathing pattern so as to maximize the user's comfort while delivering a pressurized flow of breathing gas according to the individualized waveforms.

[0119] For example, Figures 7A to 7C illustrate exemplary waveform personalization based on approximation of the user's breathing pattern according to an embodiment of the present technology. A processor(s) 110 receives output signals from one or more sensors(s) 124 that detect information related to one or more physiological parameters indicating the user's breathing pattern, for example, when the user is not receiving respiratory pressure therapy or is not wearing a respiratory interface (e.g., a mask). Physiological parameters are parameters that can be used to approximate the user's breathing pattern. For example, physiological parameters may include, but are not limited to, one or more of flow rate, pressure, CO2, lung movement, and / or pulmonary bioelectrical impedance. In one embodiment, the sensor(s) 124: (a) Flow sensor for detecting flow rate, (b) Pressure sensor for measuring pressure, (c) CO2 sensors for measuring the concentration of CO2, for example, in the patient interface 106, the conduit 104, or another part of the air delivery pathway or airway pathway, (d) An accelerometer to measure the user's lung movement (for example, attached to the user's chest with a chest band or in the form of a non-contact sensor), (e) One or more EEG patch sensors, for example, that can be attached to the user's chest, for detecting the bioelectrical impedance of the user's lungs, which may change in response to different respiratory volumes, or (f) may include one or more of any other suitable sensors necessary for obtaining information relating to physiological parameters.

[0120] The processor(s) 110 may monitor the sensor signal output of the sensor(s) 124 over a period of time and store the output in memory 114. Figure 7A shows a portion of the data points 701 from the flow sensor plotted over time. The data points 701 may be the direct output from the flow sensor (of the sensor(s) 124) or data points derived from it by the processor(s) 110. Some of the data points 701 shown in Figure 7A are points corresponding to the user's breathing cycle (including inhalation and exhalation). In one embodiment, the processor(s) 110 is configured to divide the monitored output data into breathing cycles and use the divided data belonging to at least one of the breathing cycles in the waveform personalization process of this technology.

[0121] The plotted data points 701 roughly correspond to the user's natural breathing pattern. As shown in Figure 7B, the processor(s) 110 is configured to approximate the user's breathing pattern based on the data points 701. The approximated breathing pattern is represented by a curve 702. In one embodiment, the processor(s) 110 generates or determines the curve 702 by processing the data points 701 and determining the best-fitting curve that fits the data points 701, for example, within an acceptable level of precision. In identifying the best-fitting curve 702, the processor(s) 110 may determine that some of the data points 701 are outliers and may exclude these data points from the analysis and curve 702.

[0122] In one embodiment, the processor(s) 110 may be configured to approximate the user's breathing pattern by averaging data from multiple breathing cycles. For example, the processor(s) 110 may divide data points 701 into a series of breathing cycles and determine the curve 702 of data points 701 in each of the series of breathing cycles (e.g., by identifying each best-fit curve or line). The processor(s) 110 may then generate a curve 702 which is the average of all the determined curves 702 for the series of breathing cycles over a monitored period. The average curve 702 is an approximation of the user's breathing pattern. This approach can smooth out any irregularities in the data that may exist in individual breathing cycles but not across the average of the breathing cycles.

[0123] In any of these embodiments for generating an approximation of the user's breathing pattern 702, the processor(s) 110 is configured to generate a personalized pressure waveform 703 based on the approximation of the user's breathing pattern 702, as shown in Figure 7C. For example, the processor(s) 110 may extract breathing parameters from the approximated breathing waveform 702. Based on the extracted breathing parameters, the processor(s) 110 may determine pressure waveform parameters. From the calculated pressure waveform parameters, the processor(s) 110 may generate a personalized pressure waveform 703. The processor(s) 110 may then store the personalized pressure waveform 703 in memory 114 and / or operate the pressure generator 112 to generate a pressurized flow of breathing gas according to the personalized pressure waveform 703.

[0124] Referring to Figure 7D, a flowchart of Method 750 of this technology is shown, which generates a personalized pressure waveform for a user based on an approximation of the user's breathing pattern.

[0125] In step 752, the processor(s) 110 receives output signals from one or more sensors that detect information related to one or more physiological parameters that indicate the user's breathing pattern. The one or more physiological parameters may be any of the physiological parameters described above. The physiological parameters may be detected directly by one or more sensors(s) 124 or calculated by the processor(s) 110 based on the output of the sensors(s) 124. In step 754, the processor(s) 110 monitors the sensor outputs over a period of time. The period may be selected to capture data related to one or more breathing cycles of the user. In step 756, the processor(s) 110 approximates the user's breathing pattern based on the monitored outputs. In step 758, the processor(s) 110 generates an individualized pressure waveform based on the approximation of the user's breathing pattern. In step 760, the processor(s) 110 operates the pressure generator(s) 112 to generate a pressurized flow of breathing gas according to the generated individualized pressure waveform.

[0126] Method 750 and the functions described above can be activated by user input to the user interface 116, or by one or more commands received by the system 100 from an external device such as the device 170.

[0127] In any embodiment described herein, it should be understood that the processor(s) 110 may use physiological parameters detected or calculated from the sensor(s) 124 to personalize the user's experience in a manner other than waveform parameters of the pressure waveform. For example, CO2 determined or detected from the output of the sensor(s) 124 may be used by the processor(s) 110 to control (and optimize) the airflow(s) of the gas flow through one or more vents of the system 100. For example, the system 100 may include one or more vents in the patient interface 106 and / or conduit 104 to allow gas in the airflow delivery path (including the conduit 104 and patient interface 106) to escape into the atmosphere or be discharged into the atmosphere. The CO2 concentration in the patient interface 106 and / or conduit 104 may indicate whether a sufficient level of flushing has been achieved within the patient interface 106 so that the user 102 does not rebreathe exhaled CO2 remaining in the patient interface 106 and / or conduit 104, or whether the airflow needs to be increased (for example, by opening the vent or increasing the opening size of the vent). 1.2.5 Stage Optimization

[0128] In any of the waveform personalization embodiments described herein, personalization may occur in one or more stages over a predetermined period of time. In this regard, optimizing the pressure waveform for user comfort can be time-consuming and / or computationally intensive for the processor(s) 110 (e.g., due to extensive experimentation and adjustment). However, user comfort can be significantly improved by performing stepwise waveform personalization without finding the "optimal" waveform in a single session. For example, instead of achieving the most comfortable setting of the pressure waveform or combination of waveform parameters in a single session, a short optimization session may be performed first over a predetermined period (e.g., 5 minutes, 10 minutes, 30 minutes, 45 minutes, 1 hour, etc.). The user may then continue using the system 100 as usual to receive therapy.

[0129] In one embodiment, the processor(s) 110 is configured to prompt the user when an optimization session is complete and to further prompt the user later (e.g., several days later) to perform a further optimization session to make additional adjustments to the pressure waveform to improve comfort. The processor(s) 110 may prompt the user by outputting a notification (e.g., a display message or other visual or audio prompt) to the user interface 116 indicating that an optimization session is complete or to perform a further optimization session. Alternatively or additionally, the processor(s) 110 may send prompts to an external device or application (e.g., device 170) via the network interface 118.

[0130] In some embodiments, the processor(s) 110 is configured to limit the optimization session to a predetermined period (e.g., 5 minutes, 10 minutes, 30 minutes, 45 minutes, 1 hour, etc.) or a predetermined number of control loops (e.g., 5 control loops, 10 control loops, 100 control loops, etc.). For example, the processor(s) 110 may be configured to impose these limitations with respect to any of the waveform individualization processes described in sections 1.2.3 and 1.2.4.

[0131] Furthermore, the processor(s) 110 may be configured to prioritize the adjustment of one or more waveform parameters at an earlier stage or session that have a greater impact on user comfort. This can help limit the optimization time at each stage and reduce the time required to identify a waveform that is comfortable for the user. For example, the processor(s) 110 may be configured to first adjust (or prompt the user to adjust) the waveform shape (inhalation shape and / or exhalation shape) in a first stage before attempting to adjust other waveform parameters. The waveform shape may be the only parameter(s) adjusted in the first stage. The waveform shape (e.g., linear vs. curve) may have the greatest impact on user comfort. After the waveform shape has been sufficiently adjusted to user comfort, the processor(s) 110 may be configured to assign descending priority to other waveform parameters based on their likely impact on user comfort. For example, the processor(s) 110 may be configured to adjust (or prompt the user to adjust) the waveform's expiratory pressure release (EPR level) in a second stage (or after waveform shape adjustment has been attempted or completed), since the amount of expiratory pressure release may have the second greatest impact on user comfort. 1.2.6 Optimization efficiency based on additional data

[0132] Further efficiency may be achieved in any of the waveform personalization embodiments described herein by using additional user data to improve the personalization process. For example, user data (e.g., gender, weight, height, age, fitness level, etc.) may be input to the system 100 (e.g., by user input or by data received via the network interface 118) and used by the processor(s) 110 to narrow down the presented settings or waveform parameters or limit the number of options used by the user or in any of the control loops described above.

[0133] In one example, based on user data, processor(s) 110 may select one or more waveforms from a set of waveforms stored in memory 114 or an external database accessible to processor(s) 110 via network interface 118. Each of the waveforms has a set of preset waveform parameters, and each waveform has different combinations of parameter values ​​or settings of those sets of waveform parameters. The waveforms may be previously tested or determined from a large group of users to determine the type of user who has found each waveform most comfortable and to associate it with the waveform. It should be understood that any of the waveforms stored in memory 114 with preset combinations of settings may be selectable by user(s) 102 via interface 116 for use with system(s) 100 for delivering a pressurized stream of breathing gas according to the selected waveform. Additionally, user(s) 102 may save one or more custom waveforms with preset settings or waveform parameters (e.g., using any of the individualization embodiments described herein) that can be selected directly by the user or used by processor(s) 110.

[0134] Based on user data, the processor(s) 110 may select one or more waveforms from a plurality of waveforms that are likely to be most comfortable for the user based on a specific set of user data. The selected waveforms may then be further individualized, for example, using one of the individualization implementations described earlier, to select adjustments to the parameters of such waveforms. Waveform selection based on user data can significantly reduce optimization time because the initially selected waveforms may have waveform parameter relationships closer to the waveforms that the user ultimately identifies as most comfortable using the individualization implementations described above. Therefore, fewer waveform parameter adjustments may be required to identify a comfortable and individualized waveform for the user.

[0135] The selected waveform may be used in any of the individualization modes described above. For example, if a user (or trained professional) manually adjusts the parameters of the pressure waveform, the processor(s) 110 may select a waveform from the aforementioned multiple waveforms that is likely to be comfortable for the user as a starting point. The user (or trained professional) then adjusts the selected waveform, which may result in fewer adjustments.

[0136] In another example, if the user selects the comparative test (e.g., A / B test) control loop described in Section 1.2.3, the processor(s) 110 may first select a first waveform A and a second waveform B from a set of stored relevant waveforms based on user data. The processor(s) 110 may then use the selected waveforms A and B in the automated A / B test process described in Section 1.2.3. This can reduce the number of A / B tests required to identify the waveforms using waveform parameter settings that are convenient for the user.

[0137] In another example, if the user selects the control loop described above in Section 1.2.4.1, the processor(s) 110 may select a predetermined waveform from a set of stored waveforms based on user data to be adjusted in the control loop. The processor(s) 110 may then use the selected waveform in the control loop to perform iterative adjustments based on physiological parameters as described above. This can reduce the number of control loop iterations required to adjust the waveform to a user-acceptable level of comfort.

[0138] In another example, if the user chooses the process described above in Section 1.2.4.2 to personalize the waveform based on an approximation of the user's breathing pattern, the processor(s) 110 may incorporate into the generation step 758 a waveform selected from a plurality of stored waveforms based on user data. The processor(s) 110 may select a waveform that is both (i) found to be comfortable by a user with similar user data (height, weight, age, etc.) to user 102, and (ii) matches user 102's approximate breathing pattern. This may lead to a pressure waveform that is more likely to be personalized and comfortable for user 102. 1.2.7 Optimization Constraints

[0139] In any of the waveform personalization embodiments described herein, the processor(s) 110 may be configured to impose constraints or limitations on adjustments made to waveform parameters, either by manual adjustments by the user or a trained professional, or by automatic adjustments by the processor(s) 110. For example, the processor(s) 110 may limit adjustments to one or more of the waveform parameters to a specific range that is safe for the user or within the prescribed therapeutic requirements for a particular waveform parameter. These limitations may also be applied to the process described in step 758 of Figure 7. In this way, the personalized pressure waveforms obtained from any of the personalization embodiments described herein are safe and compliant with therapeutic prescriptions. 2. System Mode

[0140] System 100 is configured to operate in various modes according to the programming of the controller (for example, including a processor(s) 110). Such modes may include operating modes and setup configuration modes. The setup configuration mode may be a user feedback adjustment mode for active treatment. 2.1 Operating Modes

[0141] During operation mode, system 100 may provide the user with both according to the parameters set from configuration mode. Such operation mode may be a typical treatment mode in which the patient receives both from system 100. For example, in the case of a sleep-disordered breathing therapy device, the operation mode typically provides treatment during sleep. In such a mode, the user is usually not provided with the option to manually adjust the therapy settings of the device.

[0142] In one embodiment, the automatic waveform adjustment control loop described above in relation to Figures 6A-6B and in Section 1.2.4.1 may be executed during the operating mode of the system 100. In this embodiment, the system 100 continuously and automatically adjusts the waveform 130 while providing therapy to improve user comfort.

[0143] In some implementations, the processor(s) 110 may be configured to determine the user's sleep state while the therapy is provided to the user using the system 100. The processor(s) 110 may be configured to activate (or enable activation of) the automatic waveform adjustment control loop described above in relation to Figures 6A-6B and in Section 1.2.4.1 when the user is in a particular sleep state, and to prevent activation of the waveform adjustment control loop when the user is in another sleep state. For example, if the user is determined to be awake or in a light sleep state, the processor(s) 110 may activate the automatic waveform adjustment control loop described above in relation to Figures 6A-6B and in Section 1.2.4.1. If the user is determined to be in a sleep state, the processor(s) 110 may deactivate the automatic waveform adjustment control loop and return the waveform 130 to its default therapeutic parameter. The processor(s) 110 may be configured to determine the user's sleep state based on the output from the sensor(s) 124.

[0144] In any of the waveform personalization embodiments described herein, a personalization waveform process (as described in sections 1.2.1 to 1.2.4) is performed, and if a personalization waveform that is comfortable for the user is identified, the personalization waveform may be stored in memory 114 and used during the operating mode of system 100 to deliver a pressurized flow of breathing gas to the user according to the personalized comfortable waveform. In some embodiments, a plurality of such personalization waveforms (as described in sections 1.2.1 to 1.2.4) identified as comfortable for the user from the personalization waveform process may be stored in memory 114, selected by the user for use in the operating mode, or automatically selected by processor 110 for use in the operating mode based on the detection of different conditions (e.g., based on data from sensor 124 or evaluation of other detected conditions). However, such waveforms may not be preferably therapeutic, for example, to meet a prescribed pressure or even to avoid a respiratory distress event. Therefore, the processor(s) 110 may be configured to change the comfort waveform to a more therapeutic waveform or to transform the comfort waveform into a more therapeutic version of the comfort waveform (and vice versa) after an initial period of use in a sleep session or at a specific time, such as when a specific event such as sleep or sleep-disordered breathing is detected. For example, the processor(s) 110 may be configured to operate the generator(s) 112 to provide an individualized waveform initially, or when it is determined that the user is awake or in a light sleep state, and to transition to a default therapeutic waveform (before adjustment) when it is determined that the user is in a deep sleep state. The processor(s) 110 may use sensors(s) 124 to determine the sleep state or use sleep history time to transition between the default therapeutic waveform and the individualized waveform.

[0145] The processor(s) 110 may be configured to control the generator(s) 112 to transition (or switch) between using different waveforms stored in memory (e.g., previously learned waveforms), such as a first waveform and a second waveform, which may be based on one or more detected states (e.g., detected based on data from sensors(s) 124) and / or user input. In some embodiments, the first waveform may be a default therapeutic waveform, and the second waveform may be an individualized waveform (obtained using the waveform individualization process described herein). In other embodiments, the first waveform is a first individualized waveform, and the second waveform is a second individualized waveform having at least one waveform parameter value different from the corresponding waveform parameter of the first waveform. In any of these embodiments, the processor(s) 110 may be configured to control the generator(s) 112 to transition or switch between the first waveform and the second waveform, for example, based on the detected sleep state of the patient, as described above. Similarly, the processor(s) 110 may also be configured to present a user interface that allows the user to select between different waveforms by user input, thereby causing the generator 112 to transition from delivering a first waveform to delivering a second waveform, and the user can select between different labeled features of different waveforms (for example, one suitable when the patient has congestion, a cold or influenza (flu) or seasonal allergies (e.g., pollen), and another suitable when the patient is normal (e.g., no congestion)).

[0146] The processor(s) 110 may also be configured to control the generator(s) 112 to transition or switch between a first waveform and a second waveform based on detecting, in addition to or instead of, the user's sleep state, one or more of the user's states. For example, the processor(s) 110 may be configured to transition or switch between a first waveform or a second waveform based on detecting whether the user is congested. In one embodiment, if the processor(s) 110 detects that the user is in a congestive state, the processor(s) 110 may be configured to control the generator(s) 112 to transition or switch to a first waveform, and if the processor(s) 110 detects that the user is not in a congestive state, the processor(s) 110 may be configured to control the generator(s) 112 to transition or switch to a second waveform. In this embodiment, the first waveform may be a default therapeutic waveform or an individualized waveform appropriate for a user experiencing congestion. If the first waveform is an individualized waveform, the first waveform may be a waveform previously identified and stored in memory by using one of the waveform individualization modes described herein while the user is experiencing congestion. The second waveform may be a waveform previously identified and stored in memory by using one of the waveform individualization modes described herein while the user is in a non-congestive state. In some embodiments, the second waveform is identified using one of the waveform individualization modes described herein while the user is in a non-congestive state and is awake.

[0147] In one embodiment, the processor(s) 110 may be configured to detect whether the user is congested or not based on data from (or derived from) the sensor(s) 124, and the detection may be further based on the detection that the user is awake. In one example, the processor(s) 110 uses the sensor(s) 124 to monitor one or more of the physiological parameters described herein. The processor(s) 110 determines whether the current value or the mean of a set of values ​​for the current window or period of the monitored physiological parameter (e.g., spanning one or more breaths from the current moment to a previous moment) differs from a predetermined baseline value associated with the monitored physiological parameter. Alternatively, the processor(s) 110 determines whether the current value or mean is outside (above or below) a predetermined baseline range of values ​​for the monitored physiological parameter. In one embodiment, the predetermined baseline value or range of values ​​may be a known value or range that is expected from the user when the user is not experiencing congestion. In one embodiment, a predetermined baseline value or range includes a historical set of values ​​for a physiological parameter, or is determined by the processor(s) 110 based on such a set. In either of these embodiments, the processor(s) 110 is configured to determine that the user is congested if it determines that the monitored physiological parameter is currently different from a predetermined baseline value by a predetermined amount, or is outside a predetermined range (e.g., historical set of values) (e.g., above or below). In some embodiments, the processor(s) 110 may periodically determine whether the user is congested (e.g., every 5 minutes, every hour, etc.). In some embodiments, the monitored physiological parameter may be shape volume and / or respiratory rate that can represent the user's flow profile, and the difference from the user's baseline may be considered congestion.In some embodiments, the processor(s) 110 may be configured to monitor multiple physiological parameters and require the user to determine that they are congested if two or more physiological parameters indicate that the user is congested (based on a comparison with the corresponding baseline value or range of each physiological parameter). In some embodiments, congestion may be detected by detecting flow limitation, for example by detecting the shape of the flow signal, such as flow flattening or inspiratory flow flattening of the flow signal, but if the patient is also in a detected awake or non-sleep state, flow limitation is considered to be congestion.

[0148] In some embodiments, instead of directly and automatically transitioning or switching between the first and second waveforms, if the processor(s) 110 detects that the user is in a state of congestion, the processor(s) 110 may be configured to warn or notify the user (e.g., via the user interface 116) that congestion has been detected, and then prompt the user on the user interface with a query asking whether the user wants to switch from the first waveform to the second waveform (e.g., a waveform suitable for congestion). The processor(s) 110 may then proceed with the transition based on user input allowing or confirming the switch.

[0149] In some embodiments, the processor(s) 110 is configured to switch or transition between a first waveform and a second waveform (or prompt the user to identify whether they wish to switch or transition between waveforms) based on whether the user is in a congestive or non-congestive state, only when the processor(s) 110 detects that the user is awake. In other embodiments, the processor(s) 110 is configured to switch or transition between a first waveform and a second waveform (or prompt the user) based on whether the user is in a congestive or non-congestive state, regardless of whether the user is asleep or awake.

[0150] In one embodiment, the transition between a first waveform and a second waveform (or any number of waveforms) includes gradually adjusting the waveform parameter values ​​or settings of the delivery waveform during (to or from) the first waveform (e.g., a therapeutic waveform) and the waveform parameter values ​​or settings of the second waveform (e.g., a personalized waveform), and vice versa.

[0151] Furthermore, the processor(s) 110 may be configured to implement the waveform personalization configuration described herein using EPR and ramp features. For example, if it is determined that the user is awake and the ramp feature is activated, the processor(s) 110 uses a personalized waveform but gradually increases the pressure level using the protocol of the ramp feature until the full range of pressure defined by the parameters of the personalized waveform is reached. The EPR feature may be activated while the personalized waveform is in use, but the pressure release level may be modified based on the sleep state. 2.2 Setup Configuration Mode

[0152] During a setup configuration mode, which may be an active therapy user feedback adjustment mode, a user or trained professional may identify a comfortable waveform by switching between previously stored waveforms (e.g., default waveforms or previously identified individualized waveforms) (e.g., via user interfaces 116 or 176). The previously stored waveforms may include waveforms with different shapes and waveform parameters, as described above. When a user selects a waveform from the stored waveforms, the processor(s) 110 may operate the pressure generator(s) 112 to deliver pressure according to the selected waveform. The user may identify a waveform that is comfortable to them by repeating this process several times, selecting different waveforms for pressure delivery. As described in more detail herein, the selection of a waveform from the stored waveforms and other adjustments to the waveform parameters may be made by the user on the user interface(s) 176 of a wireless device(s) 170 (e.g., a smartphone). In this way, the wireless device(s) 170 may function as a user interface and as a remote control of the system 100 by transmitting waveform selection control signals to the system's processor(s) 110 to operate the pressure generator(s) 112. The wireless device 170 may also be configured to display descriptors or visual representations of each different waveform in order to distinguish each waveform that can be selected by the user.

[0153] Furthermore, during the setup configuration mode, the user or a trained professional may manually adjust one or more parameters to set up the therapy operation, for example, the waveform parameters described above to control the therapy via the user interface 116 (for example, as described in sections 1.2.1 and 1.2.2). Additionally, during the active therapy user feedback adjustment mode, one of the automated individualization processes described in sections 1.2.3 and 1.2.4 may be activated to adjust one or more waveform parameters of the target waveform 130 to achieve a comfortable individualized waveform. In any case, during the setup mode, the processor(s) 110 is configured to simulate the therapy by operating the generator(s) 112 to provide a pressurized flow of respiratory gas to the user's airway according to the target waveform 130. During this mode, the waveform parameters of the waveform 130 may be adjusted manually or automatically, which may be within certain or acceptable constraints, and the processor(s) 110 may operate the pressure generator(s) 112 so that the adjustments are implemented in real time or near real time and sensory feedback is provided to the user of the adjustments. In this way, the user can perceive the adjustments, make further manual changes, instruct trained professionals to make further manual changes, and / or respond to user prompts regarding the user's perceived comfort in consideration of waveform adjustments (e.g., in assisted and automated A / B testing embodiments).

[0154] The user interface 116 may provide the user with control to modify one or more parameters as described above, within permissible constraints, and may protect the user from inappropriate adjustments that could harm the user or the system 100. In one example, referring to Figure 2A, the display 120 may display a graphical user interface 160 showing a target pressure waveform 130 that serves as a reference for the generation of a pressurized flow of breathing gas in configuration mode. Thus, the user may adjust one or more parameters for controlling pressure therapy by adjusting one or more visual features on the target pressure waveform 130, and recognize the therapy (e.g., before and after the change), allowing the user to understand the change in real time or near real time.

[0155] Therefore, in this mode, the system 100 may simulate treatment in real time or near real time based on the user's adjustments to the parameters(s). For example, each time the user adjusts a parameter, the processor(s) 110 may detect the user's adjustment and generate a sensory response (user feedback) that the user can perceive. In one example, the processor(s) 110 may detect the user's adjustment during the user's first respiratory cycle while the treatment is being provided and generate a sensory response based on the detected adjustment. The sensory response may include generating treatment during one or more additional respiratory cycles after the user's first respiratory cycle, depending on the adjustment.

[0156] Therefore, sensory responses may include the controller modifying the operation of the pressure generator 112 based on user adjustments to adjust the pressurized breathable gas flow and delivering the adjusted pressurized breathable gas to the patient interface (e.g., mask) worn by the user. Thus, the processor(s) 110 may detect user adjustments during the user's first breathing cycle and, while in configuration mode, adjust and supply the pressurized breathable gas flow to the user based on adjustments detected during at least one or more breathing cycles (or more) of the user following the first breathing cycle. As a result, the user may immediately feel the effect of the change in treatment (e.g., via the patient interface or mask) when the user changes one or more parameters for controlling the treatment.

[0157] Additionally, or alternatively, continuing to refer to Figure 2A, the processor(s) 110 may generate a visual response via a graphical user interface 160. The visual response may provide a real-time view of one or more propagating or running waveforms resulting from the user's parameter adjustments. The visual response may also display a first running waveform 162 in the graphical user interface corresponding to the adjusted pressurized breathable gas flow generated by the pressure generator 112. The waveform 162 may begin at the start of inspiration and end at the end of expiration. The waveform 162 may be represented, for example, as a white curve on a black screen of the graphical user interface 160. By displaying this via the graphical user interface 160, the user can recognize how the waveform 162 changes in real time or near real time as the user adjusts the relevant parameter(s).

[0158] In one example, the graphical user interface 160 may display a second execution waveform 164 corresponding to the user's respiratory airflow. The user's respiratory airflow, shown by the second execution waveform 164, represents what the user is currently inhaling and exhaling, which may change with each breath. The user's respiratory airflow may be detected by one or more sensors 124. The second execution waveform 138 may be displayed as a dashed line, and the first execution waveform 162 may be displayed as a solid line. The second execution waveform may be displayed as an overlay on the first execution waveform, which may be preferable, allowing the user to visualize their actual breathing against a simulated treatment waveform (if no treatment is provided) or a visual version of the actual treatment provided by the system 100.

[0159] Figure 2B is another explanatory diagram of the graphical user interface 160, showing execution waveforms 162 and 164, which include multiple respiratory cycles, and these waveforms may move across the display screen as they are generated over time.

[0160] Figure 2C is another schematic diagram of the graphical user interface 160 showing the change in the shape of the pressure waveform 162, which changes from a curved shape to a rectangular shape as a result of adjustments made by the user in setting mode. The graphical user interface 160 also shows a second waveform 164 representing the user's breathing airflow relative to the pressure waveform (i.e., on the same time scale as the pressure waveform). 3. Further technical features and advantages 3.1 Distributed communications, computation, and data synchronization 3.1.1 Radio equipment

[0161] Referring to Figure 1D, System 100 may be wirelessly connected to the wireless device 170, for example, by implementing one of the aforementioned user interface functions with the wireless device 170, in order to achieve any operation and / or setup configuration mode described herein with respect to waveform individualization as described in Section 1.2, when the wireless device 170 and the therapeutic devices of System 100 communicate with each other. Thus, the wireless device 170 may be a user-accessible computing system, and the aforementioned processes and / or selections may be activated using a graphical user interface on the wireless device. Examples of the wireless device 170 include mobile phones, tablets, netbooks, desktop computers, laptop computers, and wearable computing devices such as smartwatches. Referring to Figure 1B, the wireless device 170 may include one or more processors 172, memory 174, a user interface 176 including a display 178, and a network interface 180. The network interface 180 may have one or more transceivers, such as Bluetooth transceivers, cellular transceivers, and Wi-Fi transceivers. The display 178 may be a monitor with a screen, or other electrical device capable of displaying information (e.g., text, images, and / or other graphic elements). Furthermore, the wireless device 170 may include all components typically used for connecting to 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, keyboard, touchscreen, and / or microphone) for receiving input from the user, and output devices such as speakers. The wireless device 170 may communicate with system 100, etc., via a Bluetooth transceiver, a cellular transceiver, or a Wi-Fi transceiver.

[0162] Once the wireless device 170 is communicatively connected to the system 100, the wireless device 170 may communicate bidirectionally with the system 100. The wireless device 170 may transmit any user input to the system 100, including any selection of waveforms, responses to prompts, and / or adjustments to one or more waveform parameters. The system 100 may receive user input via the wireless device 170. The pressure generator 112 of the system 100 may adjust the therapy based on user input to the device 170. The system 100 may transmit information to the wireless device 170 relating to the adjusted therapy, the user's respiratory airflow, user prompts, and any other information separately available via the user interface 116, and may request the wireless device 170 to display any visual or other response to the user. Based on the received information, the wireless device 170 may generate a visual or audio response to the user.

[0163] The wireless device 170 may be used in any of the waveform individualization embodiments described above in Section 1.2 and elsewhere in this specification. Furthermore, the wireless device 170 may be configured to perform any of the features of the processor(s) 110 described herein.

[0164] Although device 170 is described as a wireless device, it should be understood that in other embodiments, device 170 may be a device (e.g., a laptop computer or a desktop computer) configured to communicate with system 100 via a wired connection and using any preferred wired communication protocol. 3.1.2 Server(s) and Cloud Connection

[0165] As shown in Figure 1B, the system 100 and / or wireless device 170 may further be communicably connected to one or more servers 190 (for example, via the Internet, a cellular network, or any other network). The server 190 may include one or more processors 192, one or more memories 194, a user interface 196 (including a display 198), and a network interface 199. The processor 192 may include and be configured to perform any of the features of the processors 110, 172 described herein. The memory 194 may include any of the features and may store any of the data described herein in relation to the memories 114, 174. The user interface 196 may include any of the features of the user interfaces 116, 176. The network interface 199 may include any of the features of the network interfaces 118, 180.

[0166] In some embodiments, the server(s) 190, system 100, and wireless device 170 are configured to communicate and exchange data. In one embodiment, the server(s) 190 is configured to receive data from system 100 and / or wireless device 170 (via network interface 199). The data may include any of the following: (i) input to user interfaces 116, 176, (ii) generated by processor(s) 110, 172, (iii) stored in memory 114, 174, and / or (iii) output by sensor(s) 124. The data may be stored in memory 194, and processor(s) 192 may process the data to generate processed data. The processed data generated by processor(s) 192 is transmitted to system 100 and / or wireless device 170. In some embodiments, processor(s) 192 may be configured to process data received from system 100 and / or radio device 170, thereby replacing some or all of the functions of processor(s) 110 and / or processor(s) 172. For example, processor(s) 192 of server(s) 190 may receive data input to user interfaces 116 and / or 176 and data from sensor(s) 124, and may perform any of the personalized waveform processes described herein, such as determining waveform parameters for personalized waveforms or adjusting a target waveform to personalize a target waveform. Processor(s) 192 may transmit the generated or adjusted personalized waveforms (i.e., waveform parameters associated with each) to radio device 170 and / or system 100, thereby enabling system 100 to then deliver a pressurized flow of breathing gas to the user using the personalized waveforms according to the personalized waveforms determined or identified by processor(s) 192. Please understand that server(s) 190 may communicate with multiple systems 100 (and / or wireless devices 170) and process data for multiple systems 100 (and / or wireless devices 170).The advantage of using server(s) 190 to process the data is that the computational and processing loads related to the waveform individualization techniques described herein can be offloaded to the processor(s) of server(s) 190, rather than being placed on user equipment (e.g., system 100 and wireless device 170) which may have relatively less computing power than server(s) 190.

[0167] In one embodiment, a user's personalized waveform (and any other associated data) may be stored in system memory 114, radio device memory 174, and / or server memory 194 and shared among them. In this regard, if a user identifies a personalized waveform using any of the waveform personalization embodiments described herein, the personalized waveform may be stored in any one of system memory 114, radio device memory 174, and / or server memory 194. The system 100, radio device 170, and / or server(s) 190 are then configured to share and synchronize data (e.g., waveform parameter values) associated with each of the personalized waveforms stored in each of the system 100, radio device 170, and / or server(s) 190. Personalized waveform data (as well as any other data associated with the user, such as user credentials, device settings, and preferences) may be associated with a user profile. In this way, when a user replaces their system 100, when the user logs into their user profile (for example, on their radio device 170 and / or system 100), the user's personalized waveform data (and any other data associated with the user) can be transferred from the memory 194 of the server(s) 190 or the memory 174 of the radio device 170, and thus can then be used on the new system 100. The data transfer process may occur automatically, for example, when system 100 is first set up and attempts to synchronize the user data, settings, and / or preferences stored in memory 114 with the user data, settings, and / or preferences of the same user stored in memory 174 and / or memory 194. Alternatively, the data transfer process may occur in response to a request from the user (for example, via user interface 176 or input to user interface 116). 3.2 System Control

[0168] It should be understood that System 100 can be configured to be controlled in many different ways. For example, as described above, System 100 can be controlled via user input to any one of the user interfaces 116, 176, or 196 (e.g., using buttons, a touchscreen, etc.) and can interact with user input. In some embodiments, System 100, the radio device 170, and / or the server(s) 190 may be configured to interact with System 100 and receive audio (i.e., verbal) commands or inputs from the user as a means of controlling System 100. In one example, System 100 and / or the radio device 170 may include a microphone, and the processor(s) 110, 172 may be configured to translate the audio information received by the microphone into commands or user inputs. System 100 and / or the radio device 170 may also include a speaker, which is used to respond to voice commands and inputs received from the user via audio output from the speaker, or to output audio prompts, queries, or notifications. In this manner, audio and audio equipment (e.g., microphone and / or speaker) may be used as a medium that can be part of a user interface for interaction between (i) system 100 and / or wireless device 170 and (ii) the user. In this embodiment, processors 110, 172 are configured to perform any of the waveform personalization embodiments described herein by communicating with the user via audio or voice commands and responses (i.e., receiving audio commands from the user to the microphone and outputting audio responses, queries, prompts, etc., using the speaker). For example, a voice command may be received by system 100 or wireless device 170 to initiate or select any one of the waveform personalization processes described herein. Furthermore, system 100 or wireless device 170 may wait to prompt and listen for input from the user regarding whether to find a personalized waveform that is comfortable, or which embodiments of the personalized waveform are comfortable or uncomfortable.The audio user input can then be used to perform the waveform individualization process described above (such as performing A / B waveform testing). 3.3 Technical Effects

[0169] The disclosed technology may have several technological benefits. Firstly, the disclosed technology may allow the user to control the treatment. The disclosed technology may enable the user to adjust the treatment completely easily and confidently. By using the disclosed technology, the user may independently find the ideal treatment parameter setting(s) that suits their needs and / or comfort level, without relying on any clinical assistance.

[0170] Secondly, the disclosed technology may provide the user with real-time or near-real-time sensory responses when the user adjusts one or more treatment-related parameters. For example, the user may perceive a specific difference in their respiratory system with each parameter adjustment. As a result, the user can easily determine which parameter setting makes them feel most comfortable. The disclosed technology may also provide the user with visual responses via a display indicating the effect of the user's adjustments.

[0171] Thirdly, by enabling adjustment of treatment-related visual features via a touchscreen, this technology significantly increases the degree of freedom in adjusting parameters, allowing users to adjust parameters without requiring advanced technical knowledge.

[0172] Fourth, the automatic adjustment and control of the waveform parameters described above enables advanced personalization of the waveforms provided to the user in a high-speed (real-time or near real-time) manner, so that the waveforms can be personalized to the user's unique breathing patterns and preferences.

[0173] Fifth, the use of sensor-based feedback loops, such as those used in sections 1.2.4.1 and 1.2.4.2, can overcome potential problems for the user that cannot identify or characterize which particular aspect of the user's breathing or waveform is uncomfortable. 3.4 Examples of memory and processors

[0174] Memories 114, 174, and 194 may be databases that store information accessible by processors 110, 172, and 192, respectively. For example, memories 114, 174, and 194 may store instructions and data associated with adjustable waveforms, as well as other parameters for controlling pressure support generated by pressure generator 112, for example, to generate user interfaces for such waveform customization as described herein. Memory 174 of wireless device 170 and memory 194 of server 190 may store instructions and data received from system 100. Memories 114, 174, and 194 may be any type of computing device-readable medium that can store information accessible by processors. Memories may be non-temporary media such as hard drives, memory cards, optical discs, and solid-state media. Memories may include various combinations of the above, thereby storing different parts of instructions and data on different types of media. Instructions may be a set of instructions (such as machine code) executed directly by the processor(s) or a set of instructions (such as a script) executed indirectly. For example, instructions may be stored as computing device code on a computing device-readable medium. In this regard, the terms “instruction,” “module,” and “program” may be used interchangeably herein. Instructions may also be stored in object code format to be processed directly by the processor, or in other computing device languages, including scripts or collections of independent source code modules that are interpreted on demand or pre-compiled.

[0175] Processors 110, 172, and 192 can be any common processor, such as a commercially available GPU, CPU, or TPU. Alternatively, each processor could be a dedicated device, such as an ASIC or other hardware-based processor. Although Figure 1B functionally shows processors and memory located in the same block, such a device actually includes multiple processors, computing devices, or memory, which may or may not be stored in the same physical housing. Similarly, memory may be a hard drive or other storage media located in a different housing from the processor(s) in, for example, a cloud computing system. Thus, references to processors or computing devices are interpreted as including a collection of processors or computing devices or memory, whether they operate in parallel or not. Processors 110, 172, and 192 can access memory 114, 174, and 194, respectively, via a network. 4.1 Examples of treatment systems

[0176] Exemplary embodiments of System 100 are described in further detail in the following sections 4.1 to 4.5.

[0177] In one embodiment, system 100 may treat and / or monitor a respiratory disease. System 100 may also be a respiratory therapy device (RT), such as an RPT device 4000 that supplies a pressurized airflow to patient 1000 via an air circuit 4170 connected to a patient interface 3000. The airflow may be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as high-flow therapy (HFT). Thus, the RPT device may be configured to function as a flow therapy device, for example, when using a patient interface that does not use seals to seal the patient's respiratory system. In the following description, RT or RPT devices may be considered with reference to Figures 8A-811. 4.2 Patient Interface

[0178] As shown in Figure 9, a non-invasive patient interface 3000 according to one aspect of the present technology may optionally include any of the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some embodiments, the functional aspects may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional aspects. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway in order to facilitate the supply of pressurized air to the airway. 4.3 RPT Devices

[0179] An RPT device 4000 according to one aspect of this technology comprises mechanical and pneumatic components 4100 and electrical components 4200, and is programmed to execute one or more algorithms 4300. The RPT device 4000 may have an external housing 4010 formed as two parts, an upper part 4012 and a lower part 4014. In one embodiment, the external housing 4010 may include one or more panels 4015. The RPT device 4000 may include a chassis 4016 supporting one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0180] The pneumatic path of the RPT device 4000 may include one or more air path articles, for example, an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying pressurized air, an outlet muffler 4124, and one or more transducers 4270 such as a pressure sensor 4272 and a flow sensor 4274.

[0181] One or more air passage articles can be housed within a movable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be located within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0182] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, 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 configuration, the RPT device 4000 may include two or more PCBAs 4202. 4.3.1 Mechanical and pneumatic components of RPT devices

[0183] The RPT device 4000 may include one or more of the following components in its overall unit. In another configuration, one or more of the following components may be arranged as independent units. 4.3.1.1 Air filters (multiple filters allowed)

[0184] An RPT device 4000 according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0185] In one configuration, the air inlet filter 4112 is located upstream of the pressure generator 4140 and at the starting point of the pneumatic path.

[0186] In one configuration, an air outlet filter 4114, such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000. 4.3.1.2 Muffler (multiple mufflers are possible)

[0187] An RPT device 4000 according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0188] In one embodiment of this technology, the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0189] In one embodiment of this technology, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000. 4.3.1.3 Pressure Generator

[0190] In one embodiment of this technology, the pressure generator 4140 for supplying compressed air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed in a helical structure. The pressure generator 4140 can generate, for example, a supply or flow of air of about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O.

[0191] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0192] In other configurations, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air container), or a bellows. 4.3.1.4 Transducers (multiple can be used)

[0193] The transducer may be located inside or outside the RPT device. External transducers may be positioned on or form part of an air circuit, such as a patient interface. External transducers may also be in the form of non-contact sensors, such as Doppler radar motion sensors, that transmit or transfer data to the RPT device.

[0194] In one embodiment of this technology, one or more sensors 4270 are positioned upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 are configured and positioned at the relevant points in the airflow to generate data representing corresponding attributes of the airflow, such as flow rate, pressure, or temperature.

[0195] In one embodiment of this technology, one or more sensors 4270 are placed near the patient interface 3000.

[0196] In one configuration, the signal from transducer 4270 may be filtered, for example, by low-pass, high-pass, or band-pass filtering. 4.3.1.5 Check valve

[0197] In one embodiment of this technology, a check valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The check valve is positioned and configured to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144. 4.3.1.6 Air Circuit

[0198] An air circuit 4170 according to one aspect of this technology is a conduit or tube configured and arranged to allow airflow to move between two components, such as a pneumatic block 4020 and a patient interface 3000, during use. 4.3.1.7 Oxygen delivery

[0199] In one embodiment of this technology, supplemental oxygen 4180 is delivered to the air circuit 4170 and / or patient interface 3000 at one or more points in the pneumatic path, such as upstream of the pneumatic block 4020. 4.3.2 Electrical Components of the RPT Device 4.3.2.1 Power supply

[0200] In one embodiment of this technology, the power supply 4210 is located inside the external housing 4010 of the RPT device 4000. In another embodiment of this technology, the power supply 4210 is located outside the external housing 4010 of the RPT device 4000.

[0201] In one embodiment of this technology, the power supply 4210 supplies power only to the RPT device 4000. In another embodiment of this technology, the power supply 4210 supplies power to both the RPT device 4000 and the humidifier 5000. 4.3.2.2 Input Devices

[0202] In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that enable a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touchscreen. The buttons, switches, or dials may, in one embodiment, be physically connected to an external housing 4010, or in another embodiment, be able to communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0203] In one embodiment, the input device 4220 may be configured and positioned to allow a human to select a value and / or a menu option. 4.3.2.3 Central Controller

[0204] In one embodiment of this technology, the central control unit 4230 is a processor suitable for controlling the RPT device 4000, such as an x86 Intel processor.

[0205] A central controller 4230 suitable for controlling the RPT device 4000 according to another form of this technology includes a processor based on an ARM Cortex™ M processor from ARM Holdings. For example, an STM32 series microcontroller from ST MICROELECTRONICS may be used.

[0206] According to another alternative form of this technology, a different central controller 4230 suitable for controlling the RPT device 4000 includes components selected from an ARM9-based 32-bit RISC CPU series. For example, an STR9 series microcontroller from ST MICROELECTRONICS may be used.

[0207] In certain alternative forms of this technology, a 16-bit RISC CPU may be used as the central controller 4230 of the RPT device 4000. For example, a processor from Texas Instruments' MSP430 series microcontrollers may be used.

[0208] In another embodiment of this technology, the central controller 4230 is a dedicated electronic circuit. In another embodiment, the central controller 4230 is an application-specific integrated circuit (ASIC). In yet another embodiment, the central controller 4230 includes separate electronic components.

[0209] The central controller 4230 is configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and humidifiers 5000.

[0210] The central controller 4230 is configured to supply output signals to one or more of the output devices 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0211] In some embodiments of this technology, the central controller 4230 is configured to implement one or more algorithms 4300, which are represented as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260 or other memory described herein, one or more methodologies described herein. In some embodiments of this technology, as stated above, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methods may be performed by a remote device or server, such as the server described herein. For example, a remotely located device or server may determine control settings to be transmitted to a ventilator or other RT device by detecting respiratory-related events and identifying them by type by analyzing stored data from one of the sensors described herein, for example.

[0212] The central controller 4230 may include a single controller that interacts with various sensors 4270, a data communication interface 4280, memory 4260, and other devices, but the functions of controller 4230 may be distributed across multiple controllers. Therefore, the term “central” as used herein does not mean that the architecture is limited to a single controller or processor controlling other devices. For example, an alternative architecture may include a distributed controller architecture with two or more controllers or processors, which may communicate electronically (wired or wirelessly) directly or indirectly with the previously described finger sensors or servers communicating with the finger sensors, such as to implement any of the methods described herein. This may include, for example, separate local (i.e., within the RPT device 4000) or remote controllers that execute several algorithms 4300, or two or more local or remote memories that store several algorithms. Furthermore, when expressed as a computer program, the algorithms may include human-readable advanced code (e.g., C++, Visual Basic, or other object-oriented languages) or low-level / machine-level instructions (e.g., assembler, Verilog). Depending on the function of the algorithm(s), such code or instructions may be written to a controller such as an ASIC or DSP, or they may be a runtime executable file ported to a DSP or general-purpose processor, and may be specifically programmed to perform the tasks required by the algorithm(s). 4.3.2.4 Clock

[0213] The RPT device 4000 may include a clock 4232 connected to the central controller 4230. 4.3.2.5 Therapy device controller

[0214] In one embodiment of this technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0215] In one embodiment of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an ONSEMI MC33035 brushless DC motor controller is used. 4.3.2.6 Protection circuit

[0216] The RPT device 4000 according to this technology may include one or more protection circuits 4250.

[0217] One form of the protection circuit 4250 relating to this technology is an electrical protection circuit.

[0218] One form of the protection circuit 4250 relating to this technology is a temperature or pressure safety circuit. 4.3.2.7 Memory

[0219] According to one embodiment of this technology, the RPT device 4000 includes a memory 4260 such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0220] Memory 4260 can reside on PCBA 4202. Memory 4260 can be in the form of EEPROM or NAND flash memory.

[0221] Additionally, or alternatively, the RPT device 4000 includes a removable form of memory 4260, such as a memory card manufactured in accordance with the Secure Digital (SD) standard.

[0222] In one embodiment of this technology, memory 4260, such as one of the aforementioned memories, functions as a non-temporary computer-readable storage medium that stores computer program instructions representing one or more methodologies described herein, such as one or more algorithms 4300. 4.3.2.8 Transducer

[0223] The transducer may be located inside the RPT device 4000 or outside the RPT device 4000. The external transducer may be located, for example, on the patient interface 3000, for example, on the air delivery circuit 4170, or may form part of the air delivery circuit 4170. The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device 4000. 4.3.2.8.1 Flow rate

[0224] The flow transducer 4274 in this technology can be based on a differential pressure transducer, such as the SENSIRION SDP600 series differential pressure transducer. The differential pressure transducer is in fluid communication with the pneumatic circuit, and one of each pressure transducer is connected to the first and second points of the flow limiting element, respectively.

[0225] In one example, the central controller 4230 receives a signal from the flow sensor 4274 representing the total flow rate Qt. 4.3.2.8.2 Pressure

[0226] The pressure transducer 4272 in this technology is positioned to communicate with both the pneumatic path and the fluid. An example of a suitable pressure transducer 4272 is the HONEYWELL ASDX series sensor. An alternative suitable pressure transducer is the GE NPA series sensor.

[0227] During use, the signal from the pressure transducer 4272 is received by the central controller 4230. In one configuration, the signal from the pressure transducer 4272 is filtered before being received by the central controller 4230. 4.3.2.8.3 Motor Speed

[0228] In one embodiment of this technology, the motor speed sensor 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 may be supplied to the therapy device controller 4240. The motor speed transducer 4276 may be a speed sensor such as a Hall effect sensor. 4.3.2.9 Data Communication System

[0229] In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 can connect to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can connect to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0230] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0231] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may be connected to the Internet using wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0232] In one embodiment, the local external communication network 4284 can communicate with any sensor described herein, as needed, using one or more communication standards such as Bluetooth or the Consumer Infrared Protocol.

[0233] In one embodiment, the remote external device 4286 is one or more computers, such as a cluster of computers and / or servers connected to a network, as described herein. In one embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be available to a properly authorized person, such as a clinician.

[0234] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote controller. 4.3.2.10 Output devices (including displays and alarms, as appropriate)

[0235] The output device 4290 in this technology can take the form of one or more visual, auditory, and tactile units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display. 4.3.2.10.1 Display Driver

[0236] The display driver 4292 receives characters, symbols, or images intended to be displayed on the display 4294 as input and converts them into commands to display them on the display 4294. 4.3.2.10.2 Display

[0237] 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 may be an 8-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logical signals that indicate whether each of the eight segments is activated to display a particular character or symbol. 4.3.3 RPT Device Algorithm 4.3.3.1 Preprocessing Module

[0238] The preprocessing module 4310 in this technology receives raw data as input from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272), performs one or more processing steps, and calculates one or more output values ​​to be used as input to other modules (e.g., a therapy engine module 4320).

[0239] In one embodiment of this technology, the output values ​​include interface or mask pressure Pm, breathing flow rate Qr, and leakage flow rate Ql.

[0240] In various forms of this technology, the preprocessing module 4310 comprises one or more algorithms for pressure compensation 4312, ventilation flow rate estimation 4314, leakage flow rate estimation 4316, respiratory flow rate estimation 4317, tidal volume determination 4311, target tidal volume determination 4313, respiratory rate estimation 4318, and backup rate determination 4319. 4.3.3.1.1 Pressure Compensation

[0241] In one embodiment of this 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. Next, the pressure compensation algorithm 4312 estimates the pressure drop in the air circuit 4170 at the patient interface 3000 and provides the estimated pressure Pm as output. 4.3.3.1.2 Estimation of ventilation flow rate

[0242] In one embodiment of this technology, the ventilation flow rate estimation algorithm 4314 receives an estimated pressure Pm in the patient interface 3000 as input and estimates the ventilation flow rate Qv of air from the ventilation port 3400 in the patient interface 3000. 4.3.3.1.3 Leakage Flow Rate Estimation

[0243] In one embodiment of the present technology, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt and the ventilation flow rate Qv as inputs and estimates the leakage flow rate Ql. In one embodiment, the leakage flow rate estimation algorithm 4316 estimates the leakage flow rate Ql by calculating the average value of the difference between the total flow rate and the ventilation flow rate Qv over a length of time sufficient to include several respiratory cycles, for example, 10 seconds.

[0244] In one embodiment, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm within the patient interface 3000 as inputs, calculates the leakage conductance, and determines the leakage flow rate Ql as a function of the leakage conductance and the pressure Pm, thereby estimating the leakage flow rate Ql. The leakage conductance is calculated as the quotient of the low-pass filtered non-ventilation flow rate equal to the difference between the total flow rate Qt and the ventilation flow rate Qv, and the square root of the low-pass filtered pressure Pm, and the low-pass filter time constant has a value long enough to include several respiratory cycles, for example, about 10 seconds. The leakage flow rate Ql can be estimated as a function of the product of the leakage conductance and the pressure, Pm. 4.3.3.1.4 Respiratory Flow Rate Estimation Algorithm

[0245] In one embodiment of the present technology, the respiratory flow rate estimation algorithm 4317 receives the total flow rate Qt, the ventilation flow rate Qv, and the leakage flow rate Ql as inputs, and estimates the respiratory flow rate Qr of air for the patient by subtracting the ventilation flow rate Qv and the leakage flow rate Ql from the total flow rate Qt.

[0246] In other embodiments of the present technology, the respiratory flow rate estimation algorithm 4317 provides a value as a proxy for the respiratory flow rate Qr. Things that can be considered as alternatives to the respiratory flow rate include - the respiratory movement 1000 of the patient's chest, - the current drawn by the pressure generator 4140, - the motor speed of the pressure generator 4140, - the trans-chest impedance 1000 of the patient.

[0247] A surrogate value for respiratory flow may be provided by a transducer 4270 within the RPT device 4000, such as a motor speed sensor 4276, or by a sensor outside the RPT device 4000, such as a respiratory motion sensor or a transthoracic impedance sensor. 4.3.3.1.5 Ventilation Volume Determination Algorithm

[0248] In one embodiment of this technology, the ventilation volume determination algorithm 4311 receives the respiratory flow rate Qr as input and determines the measured Vent which indicates the current patient's ventilation volume.

[0249] In some implementations, the ventilation volume determination algorithm 4311 determines an actual value of the ventilation volume Vent, which is an estimate of the actual patient's ventilation volume.

[0250] In this implementation, the measured value of the ventilation volume Vent is half the absolute value of the respiratory flow rate Qr, and is filtered as appropriate by a low-pass filter, such as a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz.

[0251] In one such implementation, the measurement of tidal volume (Vent) is an estimate of the total alveolar ventilation (i.e., non-anatomical dead space ventilation). This requires the estimation of anatomical dead space. A good predictor of anatomical dead space can be the patient's height (or arm span in cases of severe skeletal deformities). Total alveolar ventilation is equal to the measured actual patient ventilation, determined as described above, minus the product of the estimated anatomical dead space and the estimated spontaneous respiratory rate (Rs).

[0252] In other implementation forms, the ventilation volume determination algorithm 4311 determines a measured value of the ventilation volume vent that is approximately proportional to the actual patient ventilation. In such an implementation form, the peak respiratory flow rate Qpeak is estimated over the intake portion of the cycle. This procedure, along with many other procedures involving sampling of the respiratory flow rate Qr, results in a measured value that is approximately proportional to the ventilation, provided that the shape of the flow rate waveform does not change much (here, two breaths are considered to have similar shapes if the respiratory flow rate waveforms, normalized by time and amplitude, are similar). Simple examples include the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow rates. Any linear combination of any order statistics of the absolute values of the respiratory flow rates using positive coefficients, and in some cases, those using both positive and negative coefficients, is approximately proportional to the ventilation volume. Another example is the average value of the respiratory flow velocity at the intermediate KK ratio (time) of the intake portion, where 0 < K < 1. If the shape of the flow velocity waveform does not change, there are an arbitrary number of measured values that are exactly proportional to the ventilation volume.

[0253] In other forms, the ventilation volume determination algorithm 4311 does not rely on the ventilation flow rate Qr, but instead determines a measured value Vent of the current patient ventilation, which serves as a proxy for the ventilation, obtained from a suitable sensor attached to the patient 1000, such as the oxygen saturation (SaO2) or the partial pressure of carbon dioxide (PCO2). 4.3.3.1.6 Target Ventilation Volume Determination

[0254] In one form of the present technology, the central controller 4230 takes the measured value vent of the current ventilation as an input and executes one or more target ventilation volume determination algorithms 4313 to determine the target value Vtgt of the ventilation measurement.

[0255] In some forms of the present technology, there is no target ventilation volume determination algorithm 4313, and the target ventilation volume Vtgt is predetermined, for example, by hard - coding it into the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0256] In other forms of this technology, such as adaptive servo ventilation (ASV) therapy (described later), the target tidal volume determination algorithm 4313 calculates the target tidal volume Vtgt from a value Vtyp that indicates a typical recent tidal volume for patient 1000.

[0257] In some forms of adaptive servo ventilation therapy, the target tidal volume Vtgt is calculated as a higher percentage of the typical recent tidal volume Vtyp, but less than or equal to it. Such higher percentages may range from (80%, 100%), (85%, 95%), or (87%, 92%).

[0258] In other forms of adaptive servo ventilation, the target tidal volume Vtgt is calculated as a unit multiple that is slightly larger than the typical recent tidal volume Vtyp.

[0259] A typical recent ventilation volume Vtyp is the value at which the distribution of measured current ventilation volume Vent over multiple time moments on a given time scale tends to converge; in other words, it is the measured central trend of measured current ventilation volume over recent history. In one implementation of the target ventilation volume determination algorithm 4313, the recent history is several minutes, but in any case, it must be longer than the time scale of the Cheyne-Stokes rise-fall cycle. The target ventilation volume determination algorithm 4313 can use any of various known central trend measurements to determine a typical recent ventilation volume Vtyp from measured current ventilation volume vent. One such measurement is the output of a low-pass filter to the current ventilation volume vent measurement, with a time constant equal to 100 seconds. 4.3.3.1.7 Respiratory rate estimation

[0260] In one embodiment of this technology, the respiratory rate estimation algorithm 4318 receives the respiratory flow rate Qr of patient 1000 as input and generates an estimate of the patient's spontaneous respiratory flow rate Rs.

[0261] The respiratory rate estimation algorithm 4318 can estimate the spontaneous respiratory rate Rs of patient 1000 during spontaneous breathing, i.e., when the RPT device 4000 does not deliver “reserve breaths” (described later). In some embodiments of this technology, when servo assist (defined as pressure support minus minimum pressure support) is low, the respiratory rate estimation algorithm 4318 estimates the respiratory rate over periods of less than 4 cmH2O, because such periods are more likely to reflect spontaneous respiratory effort.

[0262] In some forms of this technology, the respiratory rate estimation algorithm 4318 estimates the respiratory flow rate during sleep breathing because the respiratory rate during these periods can be substantially different from that during wakefulness. Anxiety typically causes a higher respiratory rate than during sleep. While a patient is focused on their breathing process, their respiratory rate is usually lower than that of normal wakeful or sleep. Patent application number PCT / AU2010 / 000894, disclosed as WO2011 / 006199, is incorporated herein by reference and may be used to identify the cycle of wakeful breathing from the respiratory flow rate Qr.

[0263] In some forms of this technique, the respiratory rate estimation algorithm 4318 estimates the spontaneous respiratory rate Rs as the reciprocal of one of various well-known statistically observed values ​​of the central trend of respiratory duration Ttot over a period of interest. Such measurements are desirable to reject or at least be robust to outliers. One such measure, the trimmed mean, is robust to outliers by discarding the K proportions of the lower and upper limits of the sorted respiratory durations and calculating the mean over the remaining respiratory durations. For example, if K is 0.25, this is equivalent to discarding the upper and lower quartiles of the respiratory duration Ttot. The median is another reliable measure of central trend, but may not yield satisfactory results if the distribution is strongly bimodal. The simple mean can also be used as a measure of central trend, although it is susceptible to outliers. An initial interval filtering phase may be used, in which consecutive time intervals corresponding to impossible respiratory rates (e.g., greater than 45 breaths / min or less than 6 breaths / min) are excluded as outliers from the mean calculation. Another filtering mechanism, which can be used alone or in combination with interval filtering, is to exclude any breaths that do not belong to a sequence of N consecutive spontaneous breaths, where N is a small integer (e.g., 3), and to exclude the initial and late breaths of a sequence of consecutive spontaneous breaths, for example, the first and last breaths of a sequence of four breaths. The rationale for the latter mechanism is that, of a sequence of spontaneous breaths, the first and last breaths in particular, generally the initial and late breaths, may be abnormal. For example, the first spontaneous breath may be a result of awakening, and the last spontaneous breath may be longer because respiratory drive has decreased and preparatory breaths terminate the spontaneous breath sequence.

[0264] 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, enabling the start of subsequent processing in the therapy engine module 4320. Thereafter, to improve statistical robustness, an estimation of the spontaneous respiratory rate Rs is continuously updated using an estimation period longer than the initial estimation period. For example, the estimated initial period may be a suitable spontaneous respiration of 20 minutes, but the estimated period may then gradually increase up to a maximum duration, such as 8 hours. Instead of using a rolling window of this duration for this estimation, a low-pass filter of the respiratory duration may be used, where the response time gradually increases (more precisely, the corner frequency gradually decreases) as the session progresses.

[0265] In some forms, appropriately processed short-term (e.g., 10 minutes) measured values of the central tendency, such as a trimmed mean, may be input into a suitable low-pass filter to give an estimated Rs that varies on a time scale or more than one time scale. The advantage is that there is no need to store and process a huge amount of respiratory duration data that may occur when it is necessary to calculate a trimmed mean over a moving window of respiratory duration data over several hours or days.

[0266] In some forms of the present technology, the respiratory rate measured over a short period, particularly within a single breath, may be used instead of the respiratory duration in the above-described central tendency measurement, and may give substantially similar but different results. 4.3.3.2 Therapy Engine Module

[0267] In one embodiment of this technology, the therapy engine module 4320 receives one or more inputs from the patient interface 3000, such as pressure Pm, patient air-breathing flow rate Qr, and estimated spontaneous respiratory rate Rs, and provides one or more therapy parameters as outputs. In various embodiments, the therapy engine module 4320 includes one or more algorithms, such as phase determination 4321, waveform determination 4322, inspiratory flow limit determination 4324, apnea / hypopnea determination 4325, snoring detection 4326, airway patency determination 4327, and therapy parameter determination 4329. 4.3.3.2.1 Phase determination

[0268] In one embodiment of this technology, the phase determination algorithm 4321 receives a signal indicating the respiratory flow rate Qr as input and provides the phase ¹ of the current respiratory cycle of patient 1000 as output.

[0269] In some forms known as discrete phase determination, the phase output is a discrete variable. One implementation of discrete phase determination provides a binary phase output having values ​​for inhalation or exhalation, for example, 0 and 0.5 rotations, respectively, when the start of spontaneous inhalation and exhalation is detected, respectively. The “trigger” and “loop” RPT device 4000 can efficiently perform discrete phase determination because the trigger and loop points are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one embodiment of binary phase determination, the phase output is determined to a discrete value of 0 (thus “triggering” the RPT device 4000) if the respiratory flow rate Qr is above a positive threshold, and to a discrete value of 0.5 rotations (thus “cycled” the RPT device 4000) if the respiratory flow rate Qr is below a negative threshold.

[0270] Another implementation of discrete phase determination provides a tri-phase output having one of the following values: inhalation, pause during inhalation, or exhalation.

[0271] In another form called continuous phase determination, the phase output is a continuous variable such as a change from 0 to 1 revolution or from 0 to 2 radians. The RPT device 4000, which performs continuous phase determination, can be triggered and looped when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one implementation of continuous phase determination, the continuous value of phase is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous phase value determined in this implementation is generally called the "fuzzy phase". In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr.

[0272] 1. If the respiratory flow rate is zero and then rapidly increases, the phase will rotate 0 times.

[0273] 2. If the respiratory flow rate is stable at the same rate, the phase should be set to 0.25 rotations.

[0274] 3. If the respiratory flow rate is zero and rapidly decreases, the phase should be set to 0.5 rotations.

[0275] 4. If the respiratory flow rate is large and stable, the phase should be set to 0.75 rpm.

[0276] 5. When the respiratory flow rate is stable at zero and the absolute value of the respiratory flow rate after 5 seconds of low-pass filtering is large, the phase is 0.9 rpm.

[0277] 6. When the respiratory flow rate is positive and the phase is expiratory, the phase is 0 rotations.

[0278] 7. When the respiratory flow rate is negative and the phase is inspiratory, the phase is 0.5 rotations.

[0279] 8. If the absolute value of the respiratory flow rate after 5 seconds of low-pass filtering is large, the phase increases at a steady rate equal to the patient's respiratory flow rate and is low-pass filtered with a time constant of 20 seconds.

[0280] The output of each rule can be represented as a vector having a phase, which is the result of the rule, and a magnitude, which is the degree of ambiguity to which the rule is true. The respiratory flow rate is the degree of ambiguity, such as "high" or "stable," and is determined by an appropriate membership function. The results of the rules are represented as vectors and are joined by several functions, such as the centroid. In this combination, the weights of the rules may be equal or different.

[0281] In another implementation of continuous phase determination, the inspiratory time Ti and expiratory time Te are initially estimated from the respiratory flow rate Qr. Then, the phase is determined to be half the proportion of the inspiratory time Ti elapsed since the previous trigger time, or half the proportion of the expiratory time Te elapsed since the previous cycle time (whichever is closer) for every 0.5 cycles.

[0282] In some forms of this technology suitable for pressure-assisted ventilation (described later), 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 provides “preparatory breaths” when patient 1000 is not making spontaneous respiratory efforts. In this form, called the spontaneous / timing (S / T) pattern, the phase determination algorithm 4321 can utilize the backup rate Rb provided by the backup rate determination algorithm 4319.

[0283] The phase determination algorithm 4321, which uses "fuzzy phase," can achieve an S / T pattern by incorporating a "momentum" rule into the fuzzy phase rule using a backup rate Rb. The momentum rule acts to advance the continuous phase from expiratory to inspiratory by the backup rate Rb when the respiratory flow Qr feature does not advance the continuous phase by other rules. In one implementation, the lower the measured ventilation Vent (described below) is compared to the target ventilation Vtgt (described below), the greater the weight of the momentum rule in the combination. However, a rapid increase in pressure support in response to mild to moderate ventilatory deficits (compared to target ventilation) can bring ventilation very close to target ventilation. As ventilation approaches the target, the desired momentum rule is given a lower weight, allowing the patient to breathe at a rate significantly lower than the respiratory flow rate at other times (when the patient is not experiencing central apnea) and not unnecessarily prompted by the ventilator to breathe at a higher rate. However, when the tidal volume is lower than the target tidal volume but still close to it, if the exercise rule is given a low weighting, adequate ventilation can easily be achieved with relatively high pressure support at a rate significantly below the backup rate. Since the reserve breath allows the target breath to be delivered with lower pressure support, it is desirable to deliver it at a higher rate. This is ideal for several reasons, one of which is the reduction of mask leak.

[0284] In summary, the fuzzy phase determination algorithm 4321 that implements the S / T pattern presents a dilemma when selecting the weights for the momentum rule, including the backup rate Rb: if the weight is too high, the patient may feel "pushed" by the backup rate; if it is too low, the pressure support may be too great. Therefore, it is desirable to provide a method for achieving an S / T pattern that is independent of the aforementioned momentum rule.

[0285] The phase determination algorithm 4321 (discrete or continuous without momentum rules) can implement an S / T pattern using a backup rate Rb in a method called scheduled backup. Scheduled backup can be achieved by the phase determination algorithm 4321 attempting to detect the onset of inspiration by spontaneous respiratory effort, for example, by monitoring the respiratory flow rate Qr, as described above. If the phase determination algorithm 4321 does not detect the onset of inspiration by spontaneous respiratory effort within a period since the last trigger time, the duration of which is equal to the reciprocal of the backup rate Rb (an interval called the backup timing threshold), it sets the phase output ? to the inspiration value (thus triggering the RPT device 4000). Once the RPT device 4000 is triggered and pre-breathing begins, the phase determination algorithm 4321 attempts to detect the onset of spontaneous exhalation, for example by monitoring the respiratory flow rate Qr, and based on this, sets the phase output ? to the exhalation value (thus cycling the RPT device 4000).

[0286] As in the variable backup rate scheme described above, as the backup rate Rb from SBR to STBR increases over time, the backup timing threshold begins to lengthen and gradually shortens. That is, the RPT device 4000 is initially less alert and becomes increasingly alert to a lack of spontaneous breathing effort as more reserve breaths are transmitted. Such an RPT device 4000 is less likely to make the patient feel "pushed along" while providing reserve breaths as needed, if the patient prefers to breathe at a lower-than-normal rate.

[0287] As with the adaptive variable backup rate system described above, if the STBR of the variable backup rate system matches the patient's estimated spontaneous breathing rate Rs, then reserve breathing is performed at a rate that matches the patient's own recent spontaneous breathing effort. 4.3.3.2.2 Waveform Determination Algorithm

[0288] In one embodiment of this technology, the treatment control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that changes as a function of the phase of the patient's respiratory cycle according to a waveform template(?). The waveform template(?) can be adjusted, for example, using any of the embodiments described herein in sections 1.1 to 1.2.

[0289] In one embodiment of this technology, the waveform determination algorithm 4322 provides a waveform template(?) having values ​​in the range [0, 1] on the domain of phase values(?) provided by the phase determination algorithm 4321 used by the therapy parameter determination algorithm 4329.

[0290] In one form, applicable to discrete or continuous phases, the waveform template (?) is a square wave template where the value is 1 for phase values ​​less than 0.5 turns and 0 for phase values ​​greater than or equal to 0.5 turns. In the form suitable for continuous phases, the waveform template (?) has two smoothly curved portions: a smoothly curved portion (e.g., rising cosine) where the phase value rises from 0 to 1 up to 0.5 turns, and a smooth bend (e.g., exponentially for phase values ​​greater than 0.5 turns) where the smooth bend decays from 1 to 0. An example of this "smooth and comfortable" waveform template is the "shark fin" waveform template, where the rise is the cosine of the rise and the smooth decay is quasi-exponential (thus, as ? approaches 1 turn, the limit of ? becomes just zero).

[0291] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template (?) from a waveform template library according to the settings of the RPT device 4000. Each waveform template (?) in the library can be provided as a lookup table of values ​​for phase values ​​(?). In other forms, the waveform determination algorithm 4322 uses a predetermined functional form (which may be parameterized by one or more parameters (e.g., time constants for the exponential curve portion)) to calculate the waveform template (?) "dynamically". The parameters of the functional form may be predetermined or may depend on the current state of patient 1000.

[0292] In some forms of this technology, it is applied to discrete binary phases of inhalation (?=0 rotations) or exhalation (?=0.5 rotations), and the waveform determination algorithm 4322 calculates the waveform template "dynamic" as a function of discrete phases measured since the most recent trigger moment and time t. In one such form, the waveform determination algorithm 4322 calculates the waveform template (?, t) as two parts (inhalation and exhalation) as follows:

[0293]

number

[0294] According to one aspect of this technology, the therapy control module 4330 receives therapy parameters as input from the therapy parameter determination algorithm 4329 of the therapy engine module 4320, and controls the pressure generator 4140 to deliver an airflow according to the therapy parameters.

[0295] In one embodiment of this technology, the therapeutic parameter is the therapeutic pressure Pt, and the therapeutic control module 4330 controls the pressure generator 4140 to supply a gas flow at the patient interface 3000 where the mask pressure Pm is equal to the therapeutic pressure Pt. 4.5 Terminology

[0296] For the purposes of this disclosure, one or more of the following definitions may be applied in some forms of the Art. Alternative definitions may be applied in other forms of the Art. 4.5.1 General

[0297] Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen-rich atmosphere).

[0298] Respiratory pressure therapy (RPT): Air is supplied to the airway entrance, usually at a positive therapeutic pressure relative to atmospheric pressure.

[0299] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increases in response to the detection of signs of partial upper airway obstruction and decreases when there are no signs of partial upper airway obstruction).

[0300] Patient: A person (regardless of whether or not they have a respiratory illness) Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset. 4.5.2 Characteristics of the respiratory cycle

[0301] Apnea: According to some definitions, apnea occurs when airflow falls below a predetermined threshold for a certain period, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea refers to a condition in which apnea is detected despite the airway being open, due to decreased or absent respiratory effort.

[0302] Respiratory rate or respiratory rate (Rs): This is the number of spontaneous breaths a patient takes, usually measured as respiratory rate per minute.

[0303] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0304] Labor (breathing): This is the act of breathing, which is a spontaneous activity performed by a person.

[0305] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0306] Flow restriction: This is considered a situation in a patient's respiration where an increase in the patient's exertion does not result in a corresponding increase in flow rate. If flow restriction occurs in the inspiratory portion of the respiratory cycle, it may be called inspiratory flow restriction. If flow restriction occurs in the expiratory portion of the respiratory cycle, it may be called expiratory flow restriction.

[0307] Hypopnea: Flow decreases, but does not stop. In one morphology, if the flow rate drops below the threshold velocity for an extended period, it is said that hypopnea has occurred. In one morphology of an adult, hypopnea may be considered if any of the following occurs:

[0308] (i) A 30% decrease in patient respiration lasting at least 10 seconds, and an associated 4% decrease in saturation, or (ii) A decrease in patient respiration for at least 10 seconds (but less than 50%), and associated desaturation or awakening of at least 3%.

[0309] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0310] Airway patency: The degree to which the airway is open, or the extent to which the airway is open. The patient's airway is open. Airway patency can be quantified, for example, as a value of 1 if it is patent, and as a value of zero (0) if it is closed (obstructed).

[0311] Positive end-expiratory pressure (PEEP): This is the pressure in the lungs at the end of exhalation that is greater than the atmospheric pressure.

[0312] Peak flow rate (Q peak): This is the maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0313] Respiratory flow / airflow, patient airflow / airflow (Qr): These synonyms should be understood as referring to the estimated respiratory flow rate by an RPT device, distinct from "true respiratory flow" or "true respiratory airflow." These represent the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0314] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no extra exertion is applied.

[0315] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0316] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0317] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0318] Upper airway obstruction (UAO): This includes both partial and total upper airway obstruction. This can be associated with a flow-limiting condition in which flow may increase slightly or even decrease as the pressure difference across the upper airway increases (behavior of Stirling resistance).

[0319] Ventilation: The measured total volume of gas exchange performed by a patient's respiratory system. Ventilation measurements may include either or both inspiratory and expiratory airflow per unit time. When expressed as volume per minute, this volume is often called "minute ventilation." Minute ventilation is sometimes simply expressed as volume and is understood as volume per minute. 4.5.3 RPT Device Parameters

[0320] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate and ventilation have the same volume or mass dimension per unit time, but flow rate is measured over a shorter time. Flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore may be negative for the expiratory portion. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate is assigned to the symbol Q. "Flow rate" is sometimes simply called "flow". Total flow rate Qt is the flow rate of air leaving the RPT device. Ventilation flow rate Qv is the flow rate of air leaving the ventilator and expelling exhaled gas. Leakage flow rate Ql is the flow rate of accidental leakage from the patient interface system. Respiratory flow rate Qr is the flow rate of air entering the patient's respiratory system.

[0321] Leakage: The term "leakage" is taken to mean an unintended airflow. In one embodiment, leakage may occur as a result of an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur at the circumferential elbow relative to the surroundings.

[0322] Pressure: Force per unit area. Pressure is expressed as cmH2O, g·f / cm². 2 It can be expressed in a series of units, including hectopascals. 1 cmH2O is equal to 1 g·f / cm³. 2 This is approximately 0.98 hectopascals. Unless otherwise specified, pressure is given in cmH2O units. Pressure in the patient interface is denoted by Pm, where the mask pressure Pm indicates the target value to be achieved at that moment, and therapeutic pressure is denoted by Pt. 4.5.4 Terminology related to mechanical ventilation

[0323] Adaptive servoventilator (ASV): A servoventilator with a variable target ventilation rather than a fixed one. The variable target ventilation can be learned from certain patient characteristics, such as the patient's respiratory characteristics.

[0324] Backup rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous respiratory exertion.

[0325] Cycled: This marks the end of the inspiratory phase of a ventilator. When a ventilator is delivering breath to a patient who is breathing spontaneously, the ventilator stops delivering breath at the end of the inspiratory portion of the respiratory cycle, and this is called cycled.

[0326] Positive expiratory airway pressure (EPAP): This is the base pressure that generates the desired interface pressure that a ventilator attempts to achieve in a given time, through the application of varying pressures during respiration.

[0327] End-Expiratory Pressure (EEP): This is the desired interface pressure that the ventilator attempts to achieve at the end of the exhalation portion. When ?=1, and the pressure waveform template ?(?) is set to zero, i.e., ?(?)=0, EEP is equal to EPAP.

[0328] Positive Inspiratory Airway Pressure (IPAP): This is the maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of breathing.

[0329] Pressure support is a numerical value indicating that the inspiratory pressure of a ventilator has risen above the expiratory pressure of the ventilator, and generally represents the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some situations, pressure support refers to the difference that the ventilator is trying to achieve, rather than the difference it actually achieves.

[0330] A servoventilator is a ventilator that measures patient ventilation, has a target ventilation level, and adjusts the level of pressure support to direct patient ventilation toward the target ventilation.

[0331] Servo assist: Subtracts minimum pressure support from pressure support.

[0332] Spontaneous / Timed (S / T): This is a pattern of ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. However, if the device cannot detect breathing within a predetermined period, the device automatically starts delivering air.

[0333] Swing: This term is equivalent to pressure support.

[0334] Triggered: When a ventilator delivers breathing air to a patient who is breathing spontaneously, it is called triggered by the patient's exertion at the start of the respiratory portion of the respiratory cycle.

[0335] Typical recent ventilation: Typical recent ventilation (Vtyp) is the measured value of the central trend of recent ventilation measurements over a given time scale, where recent ventilation measurements tend to cluster around it.

[0336] Ventilator: A mechanical device that provides pressure assistance to a patient when they are performing some or all of the breathing motion. 4.6 Other Notes

[0337] Some of the disclosures in this patent document include copyrighted material. The copyright holder reserves all copyrights to any other purpose for which any person may copy this patent document or patent disclosure, provided that such copies are intended to be included in the patent files or records of the Japan Patent Office.

[0338] Unless otherwise clearly indicated by the context or provided for a range of values, it is understood that 1 / 10 of the lower limit, the interval between the upper and lower limits of the range, and each intervention value for any other stated value or intervention value within the stated range are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits within the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding one or both of these stated limits is also included in this technique.

[0339] In addition, where one or more values ​​are described herein as being implemented as part of the technology, it should be understood that these values ​​can be approximated unless otherwise stated and may be used for any appropriate valid number to the extent that the actual technical implementation may be permissible or required.

[0340] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0341] While certain materials are described as suitably used for constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or individually.

[0342] Note that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents unless the context clearly indicates otherwise.

[0343] All published documents cited herein are used for disclosure and description and reference to the methods and / or materials covered by those documents. The published documents cited herein are provided solely for their disclosures prior to the filing date of this application. Nothing in this specification should be construed as acknowledging or acknowledging that this technology is not prior to such published documents for the purpose of prior patents. Furthermore, the publication dates provided may differ from the actual publication dates and may require individual verification.

[0344] Furthermore, in interpreting this disclosure, all terms should be interpreted in the broadest and most reasonable way in the context. The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the described elements, components, or steps may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0345] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings shall not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0346] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, the terms “first” and “second” are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish distinct elements. Furthermore, while the descriptions or examples of process steps in the methods may be given in order, such order is not required. Those skilled in the art will recognize that such order is changeable and / or that such actions can be performed simultaneously or even synchronously.

[0347] Therefore, it should be understood that numerous modifications are possible in the exemplary embodiments, and other configurations may be devised, without departing from the intent and scope of this technology.

[0348] While the present invention has been described with reference to specific implementations, it will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary implementations described above, and that the present invention can be embodied with various changes and modifications without departing from its scope. Therefore, these embodiments are considered illustrative and non-limiting in all respects, and the scope of the present invention is indicated not by the foregoing description but by the appended claims, and therefore all changes that fall within the meaning and equivalence of the claims are intended to be encompassed within the present invention. In other words, all changes, modifications, or equivalents that fall within the scope of the basic principles and whose essential attributes are asserted in this patent application are intended to be covered. Furthermore, readers of this patent application should understand that the terms “comprising” or “comprise” do not exclude other elements or steps, and the terms “a” or “an” do not exclude plurals, and that a single element, such as a computer system, processor, or another integrated unit, can realize the functions of several means enumerated in the claims. No reference numeral in the claims should be construed as limiting the respective claims to which they relate. Terms such as “first,” “second,” “third,” “a,” “b,” and “c,” when used in the specification or claims, are introduced to distinguish similar elements or steps and do not necessarily describe a sequence or chronological order. Similarly, terms such as “upper,” “lower,” “top,” and “bottom” are introduced for descriptive purposes and do not necessarily indicate a relative position. It should be understood that these terms are interchangeable under appropriate circumstances and that embodiments of the Art can operate in other sequences or in orientations different from those described or illustrated above. 5. Other examples of technology

[0349] The following paragraphs provide further examples of the techniques described herein. Example 1.

[0350] A system for providing respiratory therapy to the user's airway, One or more sensors configured to generate output signals that transmit information relating to one or more physiological parameters of a user, each of which one or more physiological parameters indicates the user's comfort level with respect to the respiratory therapy, A pressure generator configured to be coupled to a patient breathing interface in order to administer the respiratory therapy to the user's airway, The pressure generator is coupled to a controller which includes one or more processors, The controller is configured to execute a waveform adjustment control loop, The controller, during the waveform adjustment control loop, Receiving output signals from one or more sensors while delivering a pressurized flow of breathing gas to the user's airway according to a predetermined waveform, Comparing each of the one or more physiological parameters with the corresponding baseline value, Adjusting at least one waveform parameter of the predetermined waveform based on the comparison, wherein the adjustment is selected to reduce the difference between at least one value of the one or more physiological parameters and the corresponding baseline value of the at least one physiological parameter. A system configured to operate the pressure generator to generate a pressurized flow of breathing gas according to the adjusted predetermined waveform.

[0351] Example 2. The system according to Example 1, wherein the controller is configured to repeatedly execute the waveform adjustment control loop over a predetermined period of time.

[0352] Example 3. The system according to Example 1 or 2, wherein the at least one waveform parameter includes the intake shape of the predetermined waveform.

[0353] Example 4. The system according to Example 3, wherein the controller is configured to adjust the predetermined waveform such that the intake shape of the waveform is linear.

[0354] Example 5. The system according to Example 3, wherein the controller is configured to adjust the predetermined waveform so that the intake shape is rounded.

[0355] Example 6. The system according to Example 1 or 2, wherein the at least one waveform parameter includes the exhalation shape of the predetermined waveform.

[0356] Example 7. The system according to Example 6, wherein the controller is configured to adjust the predetermined waveform such that the exhalation shape of the waveform is linear.

[0357] Example 8. The system according to Example 6, wherein the controller is configured to adjust the predetermined waveform so that the exhalation shape of the waveform is rounded.

[0358] Example 9. The system according to Example 1, wherein the at least one waveform parameter includes the rise time of the intake phase of the predetermined waveform.

[0359] 10. The system according to Example 9, wherein the controller is configured to adjust the duration of the rise time.

[0360] Example 11. The system according to Example 1, wherein the at least one waveform parameter includes the fall time of the expiratory phase of the predetermined waveform.

[0361] Example 12. The system according to Example 11, wherein the controller is configured to adjust the duration of the fall time.

[0362] Example 13. The system according to Example 1, wherein the at least one waveform parameter includes an intake pressure trigger threshold for the predetermined waveform.

[0363] Example 14. The system according to Example 1, wherein the at least one waveform parameter includes a breath pressure trigger threshold for the predetermined waveform.

[0364] Example 15. The system according to Example 1, wherein the at least one waveform parameter includes the peak expiratory pressure of the predetermined waveform.

[0365] Example 16. The system according to Example 1, wherein the at least one waveform parameter includes the peak intake pressure of the predetermined waveform.

[0366] Example 17. The system according to any one of Examples 1 to 16, wherein the one or more physiological parameters include one or more of flow rate, pressure, carbon dioxide, tidal volume, respiratory rate, respiratory effort, heart rate, and exercise.

[0367] Example 18. The system according to any one of Examples 1 to 16, wherein one or more physiological parameters include two or more of flow rate, pressure, carbon dioxide, tidal volume, respiratory rate, respiratory effort, heart rate, and exercise.

[0368] Example 19. The system according to any one of Examples 1 to 18, wherein the controller is configured to store the adjusted predetermined waveform in memory.

[0369] Example 20. A system for providing respiratory therapy to a user's airway, A pressure generator configured to be coupled to a patient breathing interface in order to administer the respiratory therapy to the user's airway, The pressure generator is coupled to a controller which includes one or more processors, The controller is configured to perform a waveform selection process, The controller, during the waveform selection process, Providing the user with a notification that a first waveform has been delivered in connection with operating the pressure generator to generate a pressurized flow of breathing gas according to the first waveform over a first period of time, Providing the user with a notification that a second waveform has been delivered in connection with operating the pressure generator to generate a pressurized flow of breathing gas according to the second waveform over a second period, A system configured to prompt the user for input of an input selection between an instruction to deliver a first waveform and an instruction to deliver a second waveform, using a user interface.

[0370] Example 21. The system according to Example 20, wherein the first waveform is generated according to a first set of one or more waveform parameters, and the second waveform is generated according to a second set of one or more waveform parameters, wherein at least one waveform parameter of the first set is different from at least one waveform parameter of the second set.

[0371] Example 22. The at least one different waveform parameter is: Intake shape, Exhalation shape, Intake phase rise time, Exhalation phase fall time, Inspiratory pressure trigger threshold, Exhalation pressure trigger threshold, Peak intake pressure, Peak expiratory pressure, Inspiratory pressure trigger threshold, and The system described in Example 21, which includes one of the following: a respiratory pressure trigger threshold.

[0372] Example 23. The system according to any one of Examples 20 to 22, wherein the controller is further configured to generate a third waveform based on the user's input selection.

[0373] Example 24. The system according to Example 23, wherein the controller is configured to generate the third waveform according to at least one parameter resulting from the selected waveform associated with the input input selection.

[0374] Example 25. The system according to any one of Examples 23 to 24, wherein, after generating the third waveform during the waveform selection process, the controller is further configured to repeat the waveform selection process using (a) the waveform selected by the user between the first and second waveforms, and (b) the third waveform.

[0375] Example 26. The system according to Example 24, wherein the controller is configured to iteratively perform the waveform selection control process over a predetermined period or a predetermined number of control selection cycles.

[0376] Example 27. The system according to any one of Examples 20 to 26, wherein the controller is configured to prompt the user for an instruction that the first waveform or the second waveform is at an acceptable comfort level, and the controller is configured to interrupt the waveform selection control process in response to the instruction.

[0377] Example 28. The system according to Example 27, wherein, based on the instructions from the user, the controller is configured to store the first waveform or the second waveform in memory.

[0378] Example 29. A system for providing respiratory therapy to a user's airway, One or more sensors configured to generate output signals that transmit information relating to one or more physiological parameters of a user, each of which one or more physiological parameters represents at least one aspect of the user's respiration, A pressure generator configured to be coupled to a patient breathing interface in order to administer the respiratory therapy to the user's airway, The pressure generator is coupled to a controller which includes one or more processors, The aforementioned controller, The output signals of one or more of the aforementioned sensors are monitored over a certain period of time. Approximating the user's breathing pattern based on the monitored output signal, To generate an individualized pressure waveform based on the approximation of the user's breathing pattern, A system configured to operate the pressure generator to generate a pressurized flow of breathing gas according to the generated individualized pressure waveform.

[0379] Example 30. The system according to Example 29, wherein the one or more sensors include one or more of a pressure sensor, a flow sensor, a heart rate sensor, a carbon dioxide sensor, an accelerometer, and one or more EEG sensors.

[0380] Example 31. The system according to any one of Examples 29-30, wherein the one or more physiological parameters include one or more of pressure, flow rate, heart rate, carbon dioxide, chest body movement, and lung bioelectrical impedance.

[0381] Example 32. The system according to any one of Examples 30 to 31, wherein the controller is configured to store one or more parameters of the individualized pressure waveform in memory.

Claims

1. A system for providing respiratory therapy to the user's airway, One or more sensors configured to generate output signals that transmit information relating to one or more physiological parameters of a user, wherein each of the one or more physiological parameters indicates the user's comfort level with respect to the respiratory therapy, A pressure generator configured to be coupled to a patient breathing interface in order to administer the respiratory therapy to the user's airway, The pressure generator is coupled to a controller which includes one or more processors, The controller is configured to execute a waveform adjustment control loop, The controller, during the waveform adjustment control loop, Receiving output signals from one or more sensors while delivering a pressurized flow of breathing gas to the user's airway according to a predetermined waveform, Comparing each of the one or more physiological parameters with the corresponding baseline value, Adjusting at least one waveform parameter of the predetermined waveform based on the comparison, wherein the adjustment is selected to reduce the difference between at least one value of the one or more physiological parameters and the corresponding baseline value of the at least one physiological parameter. A system configured to operate the pressure generator to generate a pressurized flow of breathing gas according to the adjusted predetermined waveform.

2. The system according to claim 1, wherein the controller is configured to repeatedly execute the waveform adjustment control loop over a predetermined period of time.

3. The system according to claim 1 or 2, wherein the at least one waveform parameter includes the intake shape of the predetermined waveform.

4. The system according to claim 3, wherein the controller is configured to adjust the predetermined waveform such that the intake shape of the waveform is linear.

5. The system according to claim 3, wherein the controller is configured to adjust the predetermined waveform so that the intake shape is rounded.

6. The system according to claim 1 or 2, wherein the at least one waveform parameter includes the exhalation shape of the predetermined waveform.

7. The system according to claim 6, wherein the controller is configured to adjust the predetermined waveform such that the exhalation shape of the waveform is linear.

8. The system according to claim 6, wherein the controller is configured to adjust the predetermined waveform such that the exhalation shape of the waveform is rounded.

9. The system according to claim 1, wherein the at least one waveform parameter includes the rise time of the intake phase of the predetermined waveform.

10. The system according to claim 9, wherein the controller is configured to adjust the duration of the rise time.

11. The system according to claim 1, wherein the at least one waveform parameter includes the fall time of the expiratory phase of the predetermined waveform.

12. The system according to claim 11, wherein the controller is configured to adjust the duration of the fall time.

13. The system according to claim 1, wherein the at least one waveform parameter includes an intake pressure trigger threshold for the predetermined waveform.

14. The system according to claim 1, wherein the at least one waveform parameter includes a breath pressure trigger threshold for the predetermined waveform.

15. The system according to claim 1, wherein the at least one waveform parameter includes the peak expiratory pressure of the predetermined waveform.

16. The system according to claim 1, wherein the at least one waveform parameter includes the peak intake pressure of the predetermined waveform.

17. The system according to any one of claims 1 to 16, wherein the one or more physiological parameters include one or more of flow rate, pressure, carbon dioxide, tidal volume, respiratory rate, respiratory effort, heart rate, and exercise.

18. The system according to any one of claims 1 to 16, wherein the one or more physiological parameters include two or more of the following: flow rate, pressure, carbon dioxide, tidal volume, respiratory rate, respiratory effort, heart rate, and exercise.

19. The system according to any one of claims 1 to 18, wherein the controller is configured to store the adjusted predetermined waveform in memory.

20. A system for providing respiratory therapy to the user's airway, A pressure generator configured to be coupled to a patient breathing interface in order to administer the respiratory therapy to the user's airway, The pressure generator is coupled to a controller which includes one or more processors, The controller is configured to perform a waveform selection process, The controller, during the waveform selection process, Providing the user with a notification that a first waveform has been delivered in connection with operating the pressure generator to generate a pressurized flow of breathing gas according to the first waveform over a first period of time, Providing the user with a notification that a second waveform has been delivered in connection with operating the pressure generator to generate a pressurized flow of breathing gas according to the second waveform over a second period, A system configured to prompt the user for input selection between an instruction to deliver a first waveform and an instruction to deliver a second waveform, using a user interface.

21. The system according to claim 20, wherein the first waveform is generated according to a first set of one or more waveform parameters, and the second waveform is generated according to a second set of one or more waveform parameters, wherein at least one waveform parameter of the first set is different from at least one waveform parameter of the second set.

22. The aforementioned at least one different waveform parameter is Intake shape, Exhalation shape, Intake phase rise time, Exhalation phase fall time, Inspiratory pressure trigger threshold, Exhalation pressure trigger threshold, Peak intake pressure, Peak expiratory pressure, Inspiratory pressure trigger threshold, and The system according to claim 21, comprising any one of the following: a respiratory pressure trigger threshold.

23. The system according to any one of claims 20 to 22, wherein the controller is further configured to generate a third waveform based on the input selection of the user.

24. The system according to claim 23, wherein the controller is configured to generate the third waveform according to at least one parameter resulting from the selected waveform associated with the input input selection.

25. The system according to any one of Embodiments 23 to 24, wherein, after generating the third waveform during the waveform selection process, the controller is further configured to repeat the waveform selection process using (a) the waveform selected by the user between the first waveform and the second waveform, and (b) the third waveform.

26. The system according to claim 24, wherein the controller is configured to iteratively execute the waveform selection control process over a predetermined period or a predetermined number of control selection cycles.

27. The system according to any one of claims 20 to 26, wherein the controller is configured to prompt the user for an instruction that the first waveform or the second waveform is at an acceptable comfort level, and the controller is configured to interrupt the waveform selection control process in response to the instruction.

28. The system according to claim 27, wherein the controller is configured to store the first waveform or the second waveform in memory based on the instruction from the user.

29. A system for providing respiratory therapy to the user's airway, One or more sensors configured to generate output signals that transmit information relating to one or more physiological parameters of a user, wherein each of the one or more physiological parameters represents at least one aspect of the user's respiration, A pressure generator configured to be coupled to a patient breathing interface in order to administer the respiratory therapy to the user's airway, The pressure generator is coupled to a controller which includes one or more processors, The aforementioned controller, The output signals of one or more of the aforementioned sensors are monitored over a certain period of time. Approximating the user's breathing pattern based on the monitored output signal, To generate an individualized pressure waveform based on the approximation of the user's breathing pattern, A system configured to operate the pressure generator to generate a pressurized flow of breathing gas according to the generated individualized pressure waveform.

30. The system according to claim 29, wherein the one or more sensors include one or more of a pressure sensor, a flow sensor, a heart rate sensor, a carbon dioxide sensor, an accelerometer, and one or more EEG sensors.

31. The system according to any one of claims 29 to 30, wherein the one or more physiological parameters include one or more of pressure, flow rate, heart rate, carbon dioxide, chest body movement, and lung bioelectrical impedance.

32. The system according to any one of claims 30 to 31, wherein the controller is configured to store one or more parameters of the individualized pressure waveform in memory.

Images