Methods and apparatus for medical device communication

Abstract

A method apparatus can include a server (130) that receives multiple transmissions of respiratory therapy data from a therapy device (150) over a network. The server can receive first summary data from a first wireless transmission from the device over at least a first communication channel. The server can receive second summary data from a second wireless transmission from the device over at least a second communication channel. The first summary data and the second summary data can each include a summary of therapy data. The server can access a first parameter from the received first data and can access a second parameter from the received second data. The server can compare the first parameter to the second parameter. The server can generate an output report based on a result of the comparison, the output report having data from the first data and / or the second data, and can transmit the output report from the server to a client device.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 552,883, filed February 13, 2024, the entire contents of which are incorporated herein by reference. Background Technology 1.1 Technical Field

[0004] This technology mainly involves the automatic transmission of therapeutic data between medical devices and remote server systems. 1.2 Background Technology

[0006] Home-use respiratory therapy devices allow patients to receive respiratory therapy in the comfort of their own homes. Supervision and review are beneficial for assessing patient adherence to and / or monitoring the use of such devices, as well as providing patients with feedback on their treatment. Such reviews may often involve evaluating the therapy data generated by the respiratory therapy device. Establishing communication with such devices (e.g., through automated transmission) allows for broader and more efficient access to data for reviewing therapy information, which in turn can improve patient experience and health.

[0007] Some existing respiratory therapy devices incorporate cellular modems to transmit therapy data to remote servers accessible to clinicians. However, due to communication limitations of such networks (such as quality or availability), cellular modems are not always reliable devices for efficient and timely data transmission.

[0008] In view of the above, there is a need for a cost-effective and time-saving communication method to transfer data from home therapy devices to remote server systems, such as for enabling automated transmission. Summary of the Invention

[0009] This technology relates to communication for sending data to medical devices, remote server systems (such as one or more servers), and / or client devices (such as smartphones or tablets).

[0010] Some specific implementations of this technology may include a method for one or more servers to receive multiple transmissions of respiratory therapy data from a respiratory therapy device via one or more networks. The method may include: receiving first summary data from a first wireless transmission from the respiratory therapy device via at least a first communication channel. The first summary data may include a summary of the respiratory therapy data. The method may include: receiving second summary data from a second wireless transmission from the respiratory therapy device via at least a second communication channel. The second summary data may also include a summary of the respiratory therapy data. The method may include: accessing one or more first parameters from the received first summary data. The method may include: accessing one or more second parameters from the received second summary data. The method may include: comparing one or more first parameters with one or more second parameters. The method may include: generating an output report based on the comparison result, the output report having data from one or more of the first and second summary data. The method may include: sending the output report from one or more servers to a client device.

[0011] In some implementations, the first communication channel may include transmission via a Wi-Fi communication network. Transmission via a Wi-Fi communication network may include communication from a client device to one or more servers, wherein the client device, after receiving first aggregated data from the respiratory therapy device, sends the first aggregated data to the one or more servers. The client device may include a smartphone or tablet computer configured by an application to communicate with the respiratory therapy device via a third communication channel. The third communication channel may include transmission via short-range wireless communication. Short-range wireless communication may include Bluetooth™ connectivity. The second communication channel may include transmission via a cellular communication network. Transmission via a cellular communication network may include transmitting second aggregated data from the respiratory therapy device to one or more servers.

[0012] In some specific implementations, the first and second summary data include one or more of the following: therapy duration; apnea index, hypopnea index; obstructive apnea index; central apnea index; undifferentiated apnea index; respiratory event-related arousal index; one or more leak measurements; one or more inspiratory pressure measurements; one or more expiratory pressure measurements; duration of Cheyne-Stokes breathing; one or more mask pressure measurements; one or more tidal volume measurements; one or more minute ventilation measurements; one or more respiratory rate measurements; ambient humidity measurement; humidifier temperature measurement; humidifier power measurement; heating element power measurement; one or more blower pressure measurements; one or more respiratory flow measurements; humidifier connection indicator; delivery tube connection indicator; blower flow measurement; and the number of usage periods. Optionally, one or more first parameters may include duration. Duration may be therapy duration. Comparisons may determine that a duration (such as therapy duration) is greater than one or more other durations (such as other therapy durations). The first summary data may consist of data that is redundant relative to a portion of the second summary data. One of the first and second summary data used to generate may be the second summary data.

[0013] In some implementations, the output report may include a treatment duration score. The treatment duration score in the output report can be derived from multiple parameters. These parameters may include several of the following: apnea-hypopnea index; leak measurement; number of mask removals; and duration of treatment use. The output report may include multiple scores. Each of these multiple scores can be derived from one of the multiple parameters.

[0014] Some specific embodiments of this technology may include a processor-readable medium having processor-executable instructions stored thereon, which, when executed by one or more processors, cause the one or more processors to perform a method for one or more servers to receive multiple transmissions of respiratory therapy data from a respiratory therapy device via one or more networks. This method may include any of the methods described herein.

[0015] Some specific implementations of this technology may include one or more servers, which may include one or more processors and may be configured to receive multiple transmissions of respiratory therapy data from a respiratory therapy device via one or more networks. One or more processors may be configured to receive first summary data from a first wireless transmission from the respiratory therapy device via at least a first communication channel. The first summary data may include a summary of respiratory therapy data. One or more processors may be configured to receive second summary data from a second wireless transmission from the respiratory therapy device via at least a second communication channel. The second summary data may include a summary of respiratory therapy data. One or more processors may be configured to access one or more first parameters from the received first summary data. One or more processors may be configured to access one or more second parameters from the received second summary data. One or more processors may be configured to compare one or more first parameters with one or more second parameters. One or more processors may be configured to generate an output report based on the comparison result, the output report having data from one or more of the first and second summary data. One or more processors may be configured to send the output report from one or more servers to a client device.

[0016] In some implementations, one or more servers are also configured to perform any of the methods described herein.

[0017] Some specific implementations of this technology may include a method for transmitting respiratory therapy data from a respiratory therapy device multiple times via one or more networks and a server system that may include one or more servers. The method may include: transmitting first aggregated data from the respiratory therapy device to one or more servers via a first wireless transmission through at least a first communication channel. The first aggregated data may include a summary of respiratory therapy data. The first communication channel may include cellular communication. The method may include: transmitting second aggregated data from the respiratory therapy device to a client device via a second wireless transmission through at least a second communication channel. The second aggregated data may include a summary of respiratory therapy data. The second communication channel may include short-range wireless communication. The method may include: transmitting second aggregated data received from the respiratory therapy device from the client device to one or more servers via at least a third communication channel. The method may include: receiving, at the client device, in a transmission from the server system, a generated output report having data from one of the first aggregated data and the second aggregated data and based on a result of a remote comparison by the server system of one or more first parameters from the first aggregated data and one or more second parameters from the second aggregated data, the second aggregated data being received by the server system from the client device.

[0018] In some specific implementations, the method may further include: a transmission of second aggregated data triggered by a client device via a second wireless transmission. Triggering may include: accessing a therapy data display application on the client device when the client device is communicatively paired with the respiratory therapy device.

[0019] In some implementations, the method may further include: a transmission of second aggregated data wirelessly triggered by the respiratory therapy device. The trigger may include: a transition from therapy mode to standby mode when the client device is communicatively paired with the respiratory therapy device. Optionally, this transition may occur in response to the respiratory therapy device detecting a mask removal event from signals from a pressure sensor and / or a flow sensor.

[0020] In some implementations, the method may further include: triggering the transmission of second aggregated data via a second wireless transmission by a client device. Triggering may include: establishing a communication pairing between the client device and the respiratory therapy device.

[0021] In some implementations, the method may further include: initiating a communication from a server system via accessing a therapy data display application on a client device to receive a generated output report at the client device. A second communication channel may include transmission over a Wi-Fi communication network. Transmission over a Wi-Fi communication network may include a communication from the client device to the server system, wherein the client device sends the second summary data to the server system after receiving it from the respiratory therapy device. The client device may include a smartphone or tablet configured by an application to communicate with the respiratory therapy device. Short-range wireless communication may include Bluetooth™ connectivity. Optionally, each of the first and second summary data includes one or more of the following: duration of therapy; apnea index, hypopnea index; obstructive apnea index; central apnea index; undifferentiated apnea index; respiratory event-related arousal index; one or more leak measurements; one or more inspiratory pressure measurements; one or more expiratory pressure measurements; duration of Cheyne-Stokes breathing; one or more mask pressure measurements; one or more tidal volume measurements; one or more minute ventilation measurements; one or more respiratory rate measurements; ambient humidity measurement; humidifier temperature measurement; humidifier power measurement; heating element power measurement; one or more blower pressure measurements; one or more respiratory flow measurements; humidifier connection indicator; delivery tube connection indicator; blower flow measurement; and the number of usage periods.

[0022] In some implementations, one or more first parameters may include duration. Duration may be the duration of treatment. Remote comparison may determine that the duration is greater than one or more other durations. The first summary data may consist of data that is redundant relative to a portion of the second summary data. One of the first and second summary data used to generate may be the second summary data. The output report may include a treatment duration score. The treatment duration score in the output report can be derived from multiple parameters. The multiple parameters may include several of the following: apnea-hypopnea index; leakage measurement; number of mask removals; and duration of treatment use. The output report may include multiple scores. Each of the multiple scores can be derived from one of the multiple parameters.

[0023] Some specific embodiments of this technology may include a processor-readable medium having processor-executable instructions stored thereon, which, when executed by one or more processors, cause the one or more processors to perform a method for transmitting respiratory therapy data from a respiratory therapy device via one or more networks and server systems in multiple transmissions. This method may be any of the methods described herein.

[0024] Some specific implementations of this technology may include a system that may include one or more respiratory therapy devices and a server system. The system may also include any processor-readable medium having processor-executable instructions as described herein.

[0025] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0026] This technology is illustrated by way of example and not limitation in the various figures of the accompanying drawings, in which the same reference numerals denote similar elements, including:

[0027] Figure 1 Example communication, including wireless communication, is illustrated between a server system (e.g., one or more remote servers 130), a medical device 120 (e.g., one or more respiratory therapy devices), and a client device 140 (such as a wireless communication device or smartphone of the present technology).

[0028] Figure 2 Example details of an example medical device illustrating this technology are shown.

[0029] Figure 3 Example details of an example server system illustrating this technology are provided.

[0030] Figure 4Example details of an example client device of the present technology are illustrated, which is a wireless communication device (e.g., wireless device 140), such as a smartphone or tablet.

[0031] Figures 5A to 5C An example user interface screen is depicted, illustrating the setup of an example client device (e.g., a wireless communication device) with a medical device 120 (such as a therapeutic device or respiratory therapy device of the present technology).

[0032] Figure 6A An example of communication between a medical device of this technology and a remote server of a server system is illustrated, including wireless cellular transmission.

[0033] Figure 6B Example communication between a medical device, a client device, and a remote server in a server system of the present technology is illustrated, including short-range wireless transmission.

[0034] Figure 6C An example process for transmitting data from a medical device 120 to a remote server 130 via a cellular data network is illustrated.

[0035] Figure 6D An example process for transmitting data from medical device 120 to remote server 130 via wireless device 140 is illustrated.

[0036] Figure 6E An example process is illustrated for transmitting data from a medical device 120 to a remote server 130 via different wireless channels with or without a wireless device 140, and for reporting the data based on at least partially repeated transmissions from the different channels.

[0037] Figure 6F A dashboard for displaying therapy data on a treatment data application (e.g., an application) is described, which is used to display treatment data to a patient on a client device (such as a wireless device 140).

[0038] Figure 7A An example respiratory therapy device according to the present technology, such as a respiratory pressure therapy (RPT) device, is shown. A patient 1000 wearing a patient interface 3000 receives a supply of pressurized air from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown.

[0039] Figure 7B The RPT device 4000 used by patient 1000 wearing a nasal mask 3000 is shown.

[0040] Figure 7CThe RPT device 4000 used by patient 1000 wearing a full-face mask 3000 is shown.

[0041] Figure 8 An example of a non-invasive patient interface 3000 in the form of a nasal mask is shown.

[0042] Figure 9A An RPT device 4000 in one form according to the present technology is shown.

[0043] Figure 9B A schematic diagram of the pneumatic circuit of one form of the RPT device 4000 according to the present technology is shown. The upstream and downstream directions are indicated.

[0044] Figure 9C A schematic diagram of the electrical components of an RPT device 4000 according to one aspect of the present technology is shown.

[0045] Figure 9D A schematic diagram of an algorithm 4300 implemented in an RPT device 4000 according to one aspect of the present technology is shown. Figure 9D In the image, solid arrows indicate the actual flow of information, for example, via electronic signals.

[0046] Figure 9E This is an example of... Figure 9D The flowchart of a method 4500 performed by the therapy engine module 4320 according to one aspect of the present technology.

[0047] Figure 10 The humidifier 5000 is shown. Detailed Implementation

[0048] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0049] The following description provides various examples of objects that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Furthermore, any single feature or combination of features from any of these examples can constitute yet another example.

[0050] 4.1 System Overview

[0051] Certain aspects of this technology relate to communication between medical device 120, a remote server system comprising one or more servers (such as remote server 130), and client devices (such as wireless device 140), such as... Figure 1As shown in the example.

[0052] Medical device 120 may be a therapeutic device, such as a respiratory therapy device (which provides treatment to a user, such as respiratory therapy), and may be a respiratory therapy (RT) or respiratory pressure therapy (RPT) device as described in more detail herein. In some versions, medical device 120 may be an RPT device and / or a high-flow therapy device (HFT). Medical device 120 may provide a breathable gas flow to a user. An interface (such as a face mask) may be used to interface medical device 120 with the user. Depending on the therapy to be applied, the interface may, for example, form a seal with the user's facial area to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure to achieve the therapy. Although only one medical device 120 is illustrated in the figures, this technique is typically used for multiple such medical devices communicating with a server system. Furthermore, while the functionality described herein can be implemented using an RPT device, such functionality can also be similarly implemented using an HFT device or an RT device (such as in relation to the communication and / or therapy data display / reporting functionality described in more detail herein).

[0053] The server system (including one or more remote servers 130) can be a computing system located in a remote location that receives and stores therapeutic data (such as usage data, measured / determined health parameters, or events) from medical devices 120 (such as multiple such devices). The remote server can be implemented to monitor and / or assess a user's condition or treatment progress based on the therapeutic data generated by the medical devices 120, such as providing feedback to the patient. Therefore, the remote server 130 can be a cloud-based server system and can be implemented as one or more servers, such as by partitioning functionality among such servers. The remote server 130 can be accessible to clinicians. In some specific implementations, some servers in the remote server system may only receive and preprocess data, while other servers in the remote server system may receive or access such processed data and generate or provide insights (such as by providing clinicians or patients with access to such processed data, its summaries and reports, and insights based thereon).

[0054] The client device or wireless device 140 can be a computing system accessible to a user (and more typically, a patient using a medical device). Examples of wireless devices 140 may include mobile smartphones, tablets, netbooks, desktop computers, laptop computers, and wearable computing devices such as smartwatches, etc. While Figure 1Only one client device (e.g., wireless device 140) is illustrated, but it is understood that multiple such client devices can communicate with the server system. However, typically only one client device is paired with one medical device for short-range wireless communication between them. Such client devices are usually personal devices used by patients for home medical purposes (such as home medical therapies).

[0055] The medical device 120 may be controlled by a processor 150 (e.g., one or more processors), which may routinely generate data and write the data to the medical device's memory 156. Such data may include therapy data 126 related to one or more treatment procedures for the user. The therapy data 126 may include, but is not limited to, information or parameters determined by one or more sensor measurements of the user collected by the medical device 120 (such as those from the preprocessing module 4310 and / or the therapy engine module 4320, e.g., such as...). Figure 9D Therapeutic data may include any information or parameters of the medical device 120 (as shown), usage data of the medical device 120, and one or more device settings of the medical device 120 used in the user's treatment process. Therapeutic data may include sensor data and / or parameters determined (e.g., any data / parameters / measurements determined by the preprocessing module 4310 and the therapy engine module 430) such as respiratory measurements, which may include the number of respiratory events experienced by the user, such as the number of respiratory events per hour. Therapeutic data 126 may include usage data such as the duration for which the medical device has been used (e.g., usage hours), and the duration for which the user has worn the mask during one or more treatment sessions, the number of times the user has put on and taken off the mask, and the efficiency of the mask seal (e.g., mask leakage flow), etc. Therapeutic data may include device settings such as one or more parameters of the medical device: mode, maximum pressure, minimum pressure, and expiratory pressure release (EPR) settings, etc.

[0056] Given that the therapy data 126 can be stored in the memory 156 of the medical device 120, it may be useful to transmit the therapy data from the medical device 120 to a remote server 130 and / or a wireless device 140, for example, for analysis and / or display to a patient. To this end, to improve transmission efficiency, the medical device 120 may be configured to generate therapy summary data from the therapy data stored in memory for communication with the remote server and / or client device. For example, the wireless device 140 may include a therapy processing system 178 that provides the functionality of a therapy data display application (“Application”) configured to remotely retrieve information (e.g., from the server system) and display that information to the patient (e.g., in a “dashboard” on the client device). Thus, such information displayed on the dashboard may be generated by the server system. The generation of such displayed information may be based on summary data transmitted from the therapy device to the server system, either through communication with the client device or without communication with the client device (e.g., more directly to the server system).

[0057] As described in more detail herein, this technology provides a process and transmission for efficiently communicating therapeutic data between medical device 120, remote server 130, and wireless device 140.

[0058] 4.2 Medical Devices

[0059] like Figure 2 As illustrated in the example, medical device 120 may have one or more processors 150, a display 154, a memory 156, one or more network interfaces 158, and a selector 166 (such as an input device 4220 or a control element of a graphical user interface). The network interface 158 may have one or more transceivers 160, or operate as one or more transceivers, such as a short-range wireless (e.g., Bluetooth™) transceiver 162 and a long-range transceiver, such as a wireless transceiver 164 (e.g., a cellular and / or Wi-Fi transceiver). The selector 166 may, for example, take the form of a knob that can be manipulated by a user to navigate the menus shown on the display 154. As described in more detail herein, the medical device may be a therapeutic device, such as those shown in Figures 7 to 164. Figure 10 The RPT or RT device described herein. This medical device can generate data such as therapy data or aggregated therapy data, as previously described and as described in more detail herein. The medical device can also operate according to device settings (e.g., control parameters).

[0060] Therapeutic data may include, but is not limited to, one or more respiratory measurements of the user collected by the medical device 120, usage data of the medical device 120, and one or more device settings of the medical device 120 used during the user's treatment course. The respiratory measurements may include the number of respiratory events the user has experienced, such as the number of respiratory events per hour. Usage data may include the duration the medical device has been used (such as the number of hours used), the duration the user has worn a mask during one or more treatment courses, the number of times the user has put on and removed the mask, and the mask's sealing efficiency, etc.

[0061] The device settings may include one or more of the following parameters of the medical device: therapy mode, maximum pressure, minimum pressure, and expiratory pressure release (EPR) pressure, etc. For example, in a therapy setting, the maximum pressure may be 20 cmH2O. The minimum pressure may be 4 cmH2O. The therapy mode may be AutoSet™, indicating a pressure range, for example, from 4 cmH2O to 20 cmH2O (4 hPa to 20 hPa). In this AutoSet™ mode, the device can then modify the delivered therapy pressure within this range based on the detection of a respiratory event (e.g., a pressure increase in response to a detected flow restriction or obstructive apnea) or the absence of such an event (e.g., a pressure decrease). If EPR is enabled, EPR can be selected to provide one of three levels, where level 1 may indicate 1.0 cmH2O (1 hPa), level 2 may indicate 2.0 cmH2O (2 hPa), and level 3 may indicate 3.0 cmH2O (3 hPa). EPR can then be used to reduce the therapy pressure during exhalation by the amount set by the EPR. Such a reduction in the delivered pressure typically does not fall below a predetermined threshold (such as 4 cmH2O (4 hPa)).

[0062] In some implementations, aggregated therapy data may include any of the following: therapy start date and time, therapy end date and time, therapy duration and / or number of cycles. Medical devices may be configured to generate such aggregated therapy data, such as based on treatment data separately determined by their own sensors. Such aggregated therapy data may, for example, include one or more of the following: therapy duration; apnea index, hypopnea index; obstructive apnea index; central apnea index; undifferentiated apnea index; respiratory event-related arousal index; one or more leak measurements (such as different percentiles of leak volume); one or more inspiratory pressure measurements (such as different percentiles of inspiratory pressure); one or more expiratory pressure measurements (such as different percentiles of expiratory pressure); duration of Cheyne-Stokes breathing; one or more mask pressure measurements (such as different percentiles of mask pressure); one or more tidal volume measurements (such as tidal volume...). This data may include: different percentiles; one or more ventilation measurements (such as different percentiles of minute ventilation); one or more respiratory rate measurements; ambient humidity measurements (such as their average or percentiles); humidifier temperature measurements (such as their average or percentiles); humidifier power measurements (such as their average or percentiles); heating element power measurements (such as their average or percentiles); one or more blower pressure measurements (such as different percentiles of blower or flow generator pressure); one or more respiratory flow measurements (such as different percentiles of flow measurements); humidifier connection indicators; delivery tube connection indicators; blower flow measurements; and the number of usage periods. This aggregated data may be for a single treatment session with the medical device, such as a period of uninterrupted use, or a period encompassing multiple intermittent uses. This aggregated therapy data may be transmitted wirelessly from the therapy device using multiple different communication channels or protocols (e.g., cellular, Bluetooth™, or other short-range methods). Such different communication channel transmissions may transmit aggregated therapy data that is partially redundant with other transmitted aggregated therapy data. For example, aggregated therapy data transmitted from medical device 120 to server system via cellular network can be partially redundant relative to aggregated therapy data transmitted separately via wireless communication over different channels (e.g., short-range transmission to client device, and then transmission from client device to server system).

[0063] The memory 156 containing data from the medical device can be any type capable of storing information accessible to a processor, including computer-readable media. For example, the memory 156 of the medical device 120 can store instructions (e.g., processor control instructions) and data, such as those for implementing the data communication-related functions described herein, which can be executed by the processor 150 or otherwise used. The memory can be a non-transitory medium, such as a hard disk drive, memory card, optical disk, solid-state drive, etc. The memory can include different combinations of the foregoing, whereby different portions of the instructions and data are stored on different types of media. The instructions can be any set of instructions that are executed directly (e.g., machine code) or indirectly (e.g., scripts) by the processor. For example, the instructions can be stored as computer-readable code on a computer-readable medium. In that respect, the terms "instruction," "module," and "program" are used interchangeably herein. The instructions can be stored in an object code format that is directly processed by the processor, or in any other computer-readable language that includes scripts or sets of independent source code modules that are interpreted on demand or pre-compiled.

[0064] 4.3 Remote Server System

[0065] like Figure 3 As illustrated in the example, remote server 130 may include database 132 (e.g., one or more databases) for storing therapy data 126 related to treatment courses for multiple patients. Client devices and medical devices may be able to access the remote server system via one or more networks, such as cellular networks and / or the Internet. Each user or patient may be associated with an account on remote server 130. Each such account may store historical data, such as therapy data obtained from the user's treatment courses with the medical device, so that remote server 130 may store data that can be used to track the progress of each individual user. Each account may also store device information of the medical device used by the user.

[0066] Remote server 130 may be configured to provide support (such as therapy support) to patient users via therapy processing system 178 of wireless device 140. For example, remote server 130 may transmit therapy data or reports generated based on received therapy data (or received aggregated data) to therapy processing system 178 for display to a user (e.g., a patient). For example, one or more servers in the server system may be configured to receive multiple aggregated therapy data communications (such as communications from different communication channels as previously discussed) and generate output reports for communication to a client device (e.g., wireless device 14) and display on that client device. The output report may include a therapy duration score, such as the therapy duration score disclosed in U.S. Patent Application Publication No. 2017-0311879, the entire disclosure of which is incorporated herein by reference. The output report may, for example, include multiple parameters based on aggregated therapy data. These multiple parameters may include any number of the following: apnea-hypopnea index; leakage measurement; number of mask removals; and duration of therapy use.

[0067] In situations where multiple therapy summary data communications are received from different communication channels (as previously discussed), where different therapy summary data communications may be related to the same sleep therapy program (e.g., one night's sleep), a remote server system can generate an output report based on one of these therapy summary data communications, such as to ensure the use of the most applicable information. For example, the server system's server can be configured to compare one or more parameters from each of the multiple therapy summary data communications sent from different sources to select a therapy summary dataset to generate an output report for the patient. For example, one or more first parameters from a first summary data set (e.g., a document or dataset) can be compared with one or more second parameters from a second summary data set (e.g., a document or dataset). Such parameters being compared may include the duration of each therapy summary dataset from the therapy summary datasets. For example, the output report can be generated based on the therapy summary data set with the longest or longest duration (e.g., the duration of use of a medical device, e.g., therapy use or duration). However, in some versions, other parameters may be compared. For example, the comparison can consider multiple events (e.g., apnea index, hypopnea index, obstructive apnea index, central apnea index, undifferentiated apnea index, respiratory event-related arousal index, etc.). In such cases, an aggregate dataset with a larger number of such events compared to other aggregate datasets can be selected to generate the output report, such that the output report is based on data from the aggregate dataset selected according to the comparison.

[0068] For example, a patient may (intentionally or unintentionally) remove their mask during a sleep therapy session, and the mask may remain off the patient's face for a sufficient period of time for the medical device 120 to detect such a mask removal event and transmit therapy summary data (such as via...) Figure 6A The communication process (in the process of transmitting information) conveys the treatment regimen to a remote server. The patient can then put the mask back on and later (intentionally or unintentionally) remove it, allowing the medical device 120 to transmit treatment data (e.g., treatment summary data) again for another treatment regimen on the same date, but this time the treatment regimen may last longer than the previously reported one. Such additional communication can be achieved again via... Figure 6A The cellular communication process and / or this document (e.g., Figure 6B Other communication processes described herein may be performed. In some aspects of this technology, the remote server 130 may resolve conflicts among multiple such therapy datasets by selecting, for example, the most complete therapy summary data based on the comparisons described above. Thus, in some embodiments, the remote server may select one or more therapy summary datasets based on a comparison of therapy summary datasets received from different communication channels or parameter data therein. In some such embodiments, the remote server may be configured to compare such therapy summary datasets or data therein and extract therapy data from multiple such therapy summary datasets received from different communication channels to generate a report accordingly. Similarly, the remote server may be configured in other ways to combine at least two therapy summary datasets or data therein from a larger number of therapy summary datasets (e.g., three or more, at least partially received from different communication channels) based on one or more comparisons. Using the extracted data and / or the combined data, the remote server may then generate a therapy report based on the extracted and / or combined data.

[0069] 4.4 Client Device

[0070] like Figure 4As illustrated in the example, a client device (e.g., a wireless communication device or wireless device 140) may include one or more processors 170, a display 172, a camera 174, a memory 176, a therapy processing system 178, and a network interface 180. The network interface 180 may have one or more wireless transceivers 182 (such as a short-range (e.g., Bluetooth™) transceiver 184) and one or more long-range transceivers (such as a cellular transceiver 186 and a Wi-Fi transceiver 188). The display 172 may be a monitor of any other electrical device having a screen or operable to display information (e.g., text, images, and / or other graphical elements). Additionally, the wireless device 140 may include all components typically used in conjunction with a computing device, such as a user interface subsystem. This user interface subsystem may include one or more user input devices (e.g., a mouse, keyboard, touchscreen, and / or microphone) for receiving input from a user and output devices (such as a screen and / or speakers).

[0071] Therapy processing system 178 (such as through programming of a therapy data display application) can generate prompts to the user individually or periodically. For example, therapy processing system 178 can remind the user daily (e.g., using short-range wireless (e.g., Bluetooth™) connection 190) to connect to medical device 120. In other cases, such as when a therapy data display application is launched on a client device and / or when medical device 120 transitions from therapy mode to standby mode, therapy processing system 178 can automatically connect to medical device 120. Optionally, therapy processing system 178 can also transmit one or more messages to medical device 120, such as via a wireless link with medical device, and / or receive therapy data (such as therapy summary data) via a wireless link with medical device.

[0072] The therapy processing system 178 can also receive the aforementioned output reports generated by the server system (such as therapy course scores and associated parameter data from the remote server 130). For example, the summary of course scores and associated data may include overall sleep scores, apnea-hypopnea index scores, leakage scores, mask compliance scores, and duration of use scores.

[0073] Therefore, the wireless device 140 can be configured to communicate with a remote server 130 or a medical device 120 via any of the following transceivers 182: a short-range transceiver 184, a cellular transceiver 186, and a Wi-Fi transceiver, as in accordance with the communications discussed previously and in more detail herein.

[0074] The memory 176 described herein may include one or more databases for storing information accessible to the processor 170. The memory 176 of the wireless device 140 may store instructions and data associated with the therapy processing system 178 (e.g., instructions and data associated with a therapy data display application), which may be executed by the processor 170 or otherwise used, including, for example, programming instructions for a therapy data display application. The memory 176 may be any type capable of storing information accessible to the processor, including computer-readable media. The memory may be a non-transitory medium, such as a hard disk drive, memory card, optical disk, solid-state drive, etc. The memory may include different combinations of the foregoing, whereby different portions of instructions and data are stored on different types of media. The instructions may be a collection of any instructions that are executed directly (e.g., machine code) or indirectly (e.g., scripts) by the processor. For example, the instructions may be stored as computer-readable code on a computer-readable medium. For that purpose, the terms “instruction,” “module,” and “program” are used interchangeably herein. The instructions can be stored in an object code format that is directly processed by the processor, or in any other computing device language that includes scripts or sets of independent source code modules that are interpreted on demand or pre-compiled.

[0075] The processors described herein (e.g., processors 150 and 170) can be any conventional processor, such as a commercially available GPU, CPU, TPU, etc. Alternatively, each processor can be a dedicated device, such as an ASIC or other hardware-based processor. Although the various figures illustrate processors and memory in the same box for functional purposes, such devices can actually include multiple processors, computing devices, or memories that may or may not be stored in the same physical housing. Similarly, memory can be a hard drive or other storage medium located in a different housing than the processor housing (e.g., in a cloud computing system). Therefore, references to processors or computing devices should be understood to include a collection of processors or computing devices or memories that may or may not operate in parallel. Processors 150 and 170 can access memories 156 and 176 via a network, respectively.

[0076] Example processes for implementing the above-described communication-related operations using system components (e.g., medical devices, server systems, and client devices) utilizing this technology can be considered in more detail in conjunction with Figures 5 and 6, as discussed in more detail herein.

[0077] 4.5 Settings

[0078] When a user first receives the medical device 120, the user can register the medical device 120 with a remote server. For example, the user can download and install a therapy data display application, including the therapy processing system 178, onto the user's wireless device 140, and create an account at a remote server system (e.g., server 130) via the therapy processing system 178. The therapy processing system 178 can then provide the functionality described herein, as well as a graphical user interface for such functionality.

[0079] For example, a short-range wireless (e.g., Bluetooth™) connection 190 can be established between medical device 120 and wireless device 140. Wireless device 140 can prompt the user to enter authentication information for connection 190. Figure 5A The authentication is shown as 124. Wireless device 140 may include an application prompting the user to enter authentication information. Alternatively, a browser on wireless device 140 may display a webpage prompting the user to enter authentication information. Once the user enters the authentication information into wireless device 140, wireless device 140 can transmit the authentication information to medical device 120 via connection 190. Medical device 120 can then write the authentication information to memory 156. The authentication information can be stored in memory 156 and can be used by medical device 120 to connect to wireless device 140. The authentication information can then be associated with a unique identifier of medical device 120. Authentication can be a password and / or other information variations that can be at least partially derived from such a password, such as a hash value generated by a hash function or other code transformations.

[0080] In one such example, such as Figure 5A As shown, the therapy processing system 178 (e.g., in...) Figure 5A The device (referred to as myAir™) can display an initial page 510 requesting the user to log in. This login information can be used as credentials to communicate with the remote server 130. Next, the therapy processing system 178 can connect to the medical device 120 (e.g., via a short-range wireless transceiver 184). Afterward, the user 200 can then use the selector 166 of the medical device 120 to select options or menus to confirm the connection between the wireless device 140 and the medical device 120. This connection may involve passing a unique identifier of the medical device (e.g., a serial number) to the server system to associate the user with the medical device.

[0081] like Figure 5B As shown, after completing the above settings, the therapy processing system 178 can display page 530, which indicates that the medical device 120 is ready and available. The therapy processing system 178 can then display a subsequent page 540 to obtain a baseline of the user's state, such as prompting the user to answer how sleepy they typically feel during the day. Figure 5CAs shown. Afterwards, the user can begin using the medical device, such as initiating therapeutic procedures using the device.

[0082] In some implementations, a user can register medical device 120 with a remote server without using a short-range wireless connection 190. For example, unique identifier device information, such as a serial number, of the medical device 120 can be obtained by capturing an image of a tag on the medical device 120. Alternatively, such device information can be input by the user into the therapy processing system 178 via, for example, keyboard input or audio input. Once the therapy processing system 178 obtains the device information, it can transmit it to the remote server 130 to complete the registration of the medical device 120.

[0083] 4.6 Sending data to the remote server

[0084] As discussed in more detail herein, medical device 120 will periodically store or write therapy data 126 to memory 156. In the case of therapy devices such as RT or RPT, such data may be generated during each treatment session using the therapy device, such as each night the therapy device is used. After medical device 120 generates therapy data 126 and writes it to memory 156, medical device 120 may then send such data (e.g., in the form of therapy summary data, such as name-value pair data objects or files in JSON format) to remote server 130 via one or more networks 110 (such as including cellular data networks) according to its programming instructions and processor 150. In this regard, memory 156 may store the address of remote server 130. The address of remote server 130 may be, for example, a domain name, a global Internet Protocol (IP) address, and / or a Media Access Control (MAC) address used for such access. Network interface 158 may wirelessly transmit the data stored in memory to the address of remote server 130. Optionally, in some versions, the medical device 120 may be pre-configured with a blocklist protocol that restricts the card's communication to only the desired server (i.e., remote server 130) to prevent it from connecting to or communicating with other servers that are not part of the system (e.g., uncertified servers). Such therapy summary data may be sent some time after the medical device detects the end of a therapy session (such as a mask removal event). In some cases, such events may occur multiple times during a single night of using the therapy device (referred to as a therapy session).

[0085] Remote server 130 may be a secure server with restricted access, requiring credential information to access it. The credential information may include, for example, a device identifier for medical device 120 or a device identifier for a card, such as a memory card or wireless memory card, or a combination of both. The device identifier may be unique (such as a non-sequential unique number) enabling remote server 130 to identify the medical device 120 that generated the data when it receives the data. The device identifier may include, but is not limited to, one or more of the following: a serial number or other unique number for medical device 120 and / or the type or model of medical device 120. In some implementations, medical device 120 may have credential information for accessing remote server 130.

[0086] In some specific implementations, such as Figure 6A In the example shown, medical device 120 may transmit credential information (shown as server credential 128) and therapy data 126 (e.g., therapy summary data) to remote server 130 via one or more networks 110, including at least partially using cellular wireless communication 110C with a cellular data network. Such access / communication may involve public-key encryption; for example, the medical device may be configured with a private key, and the remote server may possess a public key for that private key. The medical device may use the private key to sign its identity (e.g., serial number) and the transmitted data. Other methods for securing such communications may be implemented as described in U.S. Patent No. 11,596,754, the entire contents of which are incorporated herein by reference. After accessing remote server 130 using the credential information, medical device 120 may upload therapy data 126 to remote server 130. The credential information can then be used to identify the source of the uploaded therapy data 126. Optionally, the remote server 130 may transmit one or more device settings (e.g., therapy settings or parameters, such as treatment pressure, Autoset™ mode, humidity level, etc., or other settings or parameters described herein) to the medical device 120.

[0087] like Figure 6BAs shown, in another example, medical device 120 can use a short-range wireless (e.g., Bluetooth™) connection 190 to transmit credential information (e.g., server credential information) and treatment data 126 to wireless device 140 via short-range wireless communication. Wireless device 140 can then use the credential information to access remote server 130 via one or more networks 110 (such as via cellular wireless communication and / or Wi-Fi communication) and can upload treatment data 126 (e.g., treatment summary data) to remote server 130. Remote server 130 can send device settings (e.g., via push notifications) directly to medical device 120 without involving wireless device 140, but can also transmit such settings to medical device 120 via client devices (e.g., wireless device 140).

[0088] In some implementations, the wireless device 140 may have credential information for accessing the remote server 130. For example... Figure 6B As shown, in one example, when the wireless device 140 establishes a short-range wireless connection 190 with the medical device 120, it can also obtain credential information (e.g., server credential information) from the medical device 120, and then use the credential information (and / or some variant of the received credential information) to communicate with a remote server system (e.g., remote server 130).

[0089] 4.6.1 Cellular Data Transmission

[0090] Figure 6C A flowchart illustrating an example method for sending data from medical device 120 to a server system (e.g., remote server 130) is provided. At 302, processor 150 may instruct at least one wireless communication network interface 158 to join the wireless network using authentication information. In some embodiments, at 304, processor 150 may retrieve network authentication information from memory 156. In some embodiments, at 305, at least one wireless communication network interface 158 may wirelessly receive authentication information from wireless device 140, such as via connection 190.

[0091] At 306, processor 150 may instruct at least one wireless communication network interface 158 to send credential information to remote server 130. In some embodiments, at 308, the credential information may be retrieved from memory 156. In some embodiments, at 309, the credential information may be received wirelessly from wireless device 140. In some embodiments, the credential information may be retrieved from the firmware of medical device 120.

[0092] At 310, processor 150 may instruct at least one wireless communication network interface 158 to wirelessly transmit therapy data (e.g., therapy summary data) stored in memory 156, or data generated based on data stored in memory, to remote server 130 via a wireless network. In one embodiment, the wireless network may include a cellular data network using cellular wireless communication 110C. In such cases, the therapy data is transmitted directly to the server system in some sense through communication (which is at least partially wireless) (i.e., without communication via client devices (i.e., wireless device 140)).

[0093] 4.6.2 Short-range data transmission

[0094] In another specific implementation, such as Figure 6D As shown, wirelessly transmitting therapy data to a server system may involve a short-range wireless connection 190, allowing the wireless device 140 to act as an intermediary between the medical device 120 and the remote server 130. This short-range implementation can advantageously achieve higher data rates, for example, where the medical device 120 may be rate-limited and / or data-constrained, or where its connection to a cellular data network is otherwise inadequate. Therefore, the short-range implementation can reduce the latency between stopping therapy and uploading therapy data 126 to the remote server system (e.g., server 130). Additionally, by enabling the wireless device 140 to establish an interface with the remote server 130 (e.g., by calling an endpoint of the application programming interface (API) of the remote server), the remote server 130 can efficiently return feedback data (e.g., for displaying dashboard data) to the therapy processing system 178 of the wireless device 140 in response to the uploading of therapy data 126. The previously described credential information can be used to ensure the security of such communications, such as identifying the source of the uploaded therapy data and / or serving as a digital signature of the data. Therefore, securing such communications may also involve public-key encryption or any other method for securing such communications, such as those described in U.S. Patent No. 11,596,754, granted on March 7, 2023, the entire contents of which are incorporated herein by reference.

[0095] Although the above communication generally describes data transmission from medical device 120 to remote server 130, in some specific embodiments, medical device 120 may be configured to retrieve data from remote server 130 or an associated server of a server system (e.g., download or pull communication), or receive data from such server (e.g., push communication). Such data received or retrieved may be data useful for the operation of medical device 120. For example, medical device 120 may obtain from remote server 130 setting or control parameter data for controlling the operation of the medical device (e.g., any of flow settings, pressure settings, software updates, etc.). Similarly, medical device 120 may obtain message data (e.g., warnings, usage instructions, or other information) from remote server 130. Medical device 120 may then display the message data on its display. Optionally, in some specific embodiments, such communication to medical device 120 may be received, in whole or in part, via communication through a client device (e.g., wireless device 140), including short-range communication via connection 190.

[0096] 4.6.2 Example of multi-channel transmission

[0097] As previously described, in some specific implementations, wireless communication can be used, for example, via different channels with a server system, to transmit aggregated data (such as therapy aggregated data (e.g., multiple aggregated datasets)) multiple times, where each communication relates to the use of the medical device during the same treatment session (e.g., the same night), although such use may include periods of interrupted use, such as... Figure 6E As described. Such communication may include information about Figure 6A and Figure 6B The described communication combination. For example, at 602, medical device 120 can upload therapy data to remote server 130, such as uploaded summary data for the first part of the night due to the detection of an event (such as a mask removal event). At 604, the therapy data can be uploaded to the remote server for storage in a database of the server system. Such communication can occur at multiple times; for example, if the medical device detects multiple events (such as mask removal events), it can use methods such as reference... Figure 6AThe cellular communication described herein. Subsequently, after further use of the medical device 120, the wireless device 140 may be triggered by a patient accessing a therapy data display application of the therapy processing system 178. Such triggering may or may not initiate a request for additional therapy summary data and the transmission of additional therapy summary data from the medical device to the wireless device 140 via a short-range connection (such as connection 190) at 606 and 608, respectively. Upon receiving summary data (if any), the wireless device 140 may upload the summary data to a remote server 130 via network 110 (e.g., Wi-Fi and / or cellular), such as for storage in a database of the server system. Then, at 614, the wireless device 140 may request a report from the remote server 130. In response to the request and / or receipt of summary data, at 616, the remote server 130 of the server system may generate an output report based on the selected summary data (such as based on access to and comparison of parameters of multiple summary data communications), as previously described. At 618, the remote server system can then (e.g., via Wi-Fi and / or cellular) transmit the output report to the wireless device 618 for display on the wireless device 140 using the therapy processing system 178.

[0098] 4.6.3 Periodic processes

[0099] Once the medical device 120 is registered with the remote server 130, the medical device 120 can routinely or periodically upload treatment data 126 to the remote server 130 after each treatment session, such as events related to mask removal as previously discussed. Such communication can be conducted via [unclear - likely a continuation of the previous sentence]. Figure 6A The cellular wireless communication process is transmitted, and / or may be transmitted via... Figure 6B It transmits short-range wireless related processes.

[0100] In some implementations, the therapy processing system 178 of the client device may periodically or periodically prompt the user to connect to the medical device 120, and / or may automatically connect to the medical device to trigger therapy data communication, as previously described. Such “trigger conditions” can be programmed into the therapy processing system 178 through its therapy data display application and / or medical device. Example trigger conditions may include, but are not limited to, any one or more of the following:

[0101] • When a user launches the application and a valid short-range wireless pairing exists between the wireless device 140 and the medical device 120, the therapy processing system 178 (“application”) can establish a connection with the medical device 120. Through this connection, the client device can request and obtain available therapy data (e.g., therapy summary data) from the medical device 120 and then transmit the therapy data to the server system. In some cases, the therapy summary data may be encoded differently before being transmitted to the server system than it was received from the medical device.

[0102] • When medical device 120 transitions from therapy mode to standby mode (e.g., due to the detection of a mask removal event as previously described), medical device 120 can assess its connection to therapy processing system 178 and, if a valid short-range wireless communication pairing exists between wireless device 140 and medical device 120, can initiate a transfer. Through such a connection, a client device can receive therapy data (e.g., therapy summary data) from medical device 120, and then the client device can transfer the therapy data to the server system. In some cases, the encoded form of the therapy summary data may differ from the form received from the medical device before being transferred to the server system.

[0103] • When wireless device 140 establishes a short-range wireless pairing with medical device 120, therapy processing system 178 can connect to the medical device. Through this connection, the client device can request and obtain available therapy data (e.g., therapy summary data) from medical device 120 and then transmit the therapy data to the server system. In some cases, the therapy summary data may be encoded differently before being transmitted to the server system than it was received from the medical device.

[0104] Other events can also be used to initiate this type of transmission.

[0105] 4.6.4 Dashboard

[0106] The therapy processing system 178 (“Application”) can display page 680 (“Dashboard”) which displays therapy data from remote server 130 or medical device 120, such as Figure 6EAs shown. In one example, the therapy processing system 178 may display one or more of the following based on such data: usage hours 682, mask seal efficiency 684, number of breathing events per hour 686, number of times the user puts on and takes off the mask 688, and total sleep score 690 or therapy quality indicators. In some aspects of this technology, the application may display a dashboard each time a triggering event occurs or when the user / patient accesses the application. Such access may initiate a request to the server system to download generated output reports, which may be based on the aforementioned therapy summary data, such as a comparison of parameters communicated by the server system across multiple therapy summary data sets.

[0107] For example, the application can display a dashboard each time a patient opens it. Such an opening (such as when the short-range communication connection 190 transceiver (e.g., Bluetooth™) is enabled) will allow the medical device to transmit therapy summary data to the client device, and then to the server system, after a suitable data transfer pairing (e.g., Bluetooth™ pairing) has been established between the wireless device 140 and the medical device 120. The client device can then request and download a report generated by the server system based on the selected therapy summary data. Thus, a report generated based on the patient's previous night's therapy data 126 may be visible in the application, allowing, for example, viewing a sleep score 690 or other therapy quality indicators along with one or more of its sleep summary items 682, 684, 686, 688. In some implementations, the patient can view multiple sleep therapy data, such as a report generated based on their therapy summary data from the most recent two or more nights.

[0108] 4.6.5 Encryption / Compression

[0109] In some implementations, the medical device 120 and the client device (e.g., the wireless device 140) can transmit therapy data as encrypted data to the remote server 130 in order to communicate securely with the remote server 130.

[0110] In one example, medical device 120 and / or wireless device 140 may have stored encryption information (e.g., a key) in their memory to encrypt any data to be transmitted to remote server 130. Their processors can use the encryption key to encrypt the provided data and instruct network interface 158 to wirelessly transmit the encrypted data to remote server 130.

[0111] In some embodiments, the transmitted data may or may not be compressed. Any known compression method may be used. For example, in some embodiments, compression may be achieved by any compression method described in PCT / EP2023 / 077274, filed October 2, 2023, the entire contents of which are incorporated herein by reference.

[0112] 4.7 Optional Example Treatment System

[0113] Sections 4.8 and 4.9 discuss example implementations of the medical device 120.

[0114] In one embodiment, the medical device 120 can treat and / or monitor respiratory disturbances. The medical device 120 can be a respiratory therapy (RT) device, such as an RPT device 4000, for supplying a pressurized airflow to a patient 1000 via an air circuit 4170 leading to a patient interface 3000. This airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as high-flow therapy, HFT). Therefore, the RPT device can also be configured as a flow therapy device, such as when using a patient interface that does not utilize a seal forming a seal with the patient's respiratory system. Reference may be made to the following description. Figures 7A to 10 Consider RT or RPT devices.

[0115] 4.8 Patient Interface

[0116] As shown in Figure 7, the non-invasive patient interface 3000 according to one aspect of the present technology may optionally include any of the following functional aspects: a sealing formation structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing formation structure 3100 is arranged around an inlet to the patient's airway to facilitate the supply of pressurized air to the airway.

[0117] 4.9 RPT device

[0118] refer to Figure 9A , Figure 9B , Figure 9C , Figure 9D and Figure 9EAccording to one aspect of the present technology, the RPT device 4000 includes mechanical and pneumatic components 4100, electrical components 4200, and is programmed to execute one or more algorithms 4300. The RPT device 4000 may have an outer housing 4010 formed in two parts: an upper portion 4012 and a lower portion 4014. In one form, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 may include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0119] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying pressurized air, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0120] One or more of the air path components may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of a chassis 4016.

[0121] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RPT device 4000 may include more than one PCBA 4202.

[0122] 4.9.1 Mechanical and pneumatic components of the RPT device

[0123] The RPT device 4000 may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be positioned as respective independent units.

[0124] 4.9.1.1 Air Filter

[0125] One form of RPT device 4000 according to the present technology may include one or more air filters 4110.

[0126] In one configuration, the air inlet filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0127] In one configuration, an air outlet filter 4114 (e.g., an antibacterial filter) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0128] 4.9.1.2 Muffler

[0129] One form of RPT device 4000 according to the present technology may include one or more mufflers 4120.

[0130] In one embodiment of this technology, the inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0131] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0132] 4.9.1.3 Pressure Generator

[0133] In one form of this technology, the pressure generator 4140 for supplying pressurized 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 volute. The pressure generator 4140 may be able to generate an air supply or airflow, for example, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, at about 120 liters per minute.

[0134] The pressure generator 4140 is controlled by the therapeutic device controller 4240.

[0135] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0136] 4.9.1.4 Transducer

[0137] The transducer can be inside or outside the RPT device. An external transducer can be located on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that sends or transmits data to or from the RPT device.

[0138] In one form of this technology, one or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. The one or more transducers 4270 are configured and arranged to generate data representing corresponding characteristics of the airflow, such as flow rate, pressure, or temperature at that point in the aerodynamic path.

[0139] In one form of this technology, one or more transducers 4270 are located near the patient interface 3000.

[0140] In one embodiment, the signal from transducer 4270 can be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0141] 4.9.1.5 Anti-overflow valve

[0142] In one embodiment of this technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0143] 4.9.1.6 Air Circuit

[0144] According to one aspect of the technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow to travel between two components, such as the pneumatic block 4020 and the patient interface 3000.

[0145] 4.9.1.7 Oxygen delivery

[0146] In one form of this technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path (such as upstream of pneumatic block 4020), air circuit 4170 and / or patient interface 3000.

[0147] 4.9.2 Electrical components of RPT device

[0148] 4.9.2.1 Power Supply

[0149] In one embodiment of this technology, the power supply 4210 is located inside the outer housing 4010 of the RPT device 4000. In another embodiment of this technology, the power supply 4210 is located outside the outer housing 4010 of the RPT device 4000.

[0150] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0151] 4.9.2.2 Input Device

[0152] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touchscreen. The buttons, switches, or dials can be physically connected to an external housing 4010 in one form, or wirelessly communicate with a receiver electrically connected to a central controller 4230 in another form.

[0153] In one form, the input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options.

[0154] 4.9.2.3 Central Controller

[0155] In one form of this technology, the central controller 4230 is a processor suitable for controlling the RPT device 4000, such as an x86 Intel processor.

[0156] According to another form of the present technology, a central controller 4230 suitable for controlling an RPT device 4000 includes a processor based on an ARM Cortex-M processor from ARM Holdings. For example, an STM32 series microcontroller from STMICROELECTRONICS can be used.

[0157] According to another alternative form of the present technology, a central controller 4230 suitable for controlling the RPT device 4000 includes a member selected from the ARM9-based 32-bit RISC CPU family. For example, a STR9 series microcontroller from ST Microelectronics can be used.

[0158] In some alternative forms of this technology, a 16-bit RISC CPU can be used as the central controller 4230 of the RPT device 4000. For example, a processor from the MSP430 series microcontrollers manufactured by Texas Instruments can be used.

[0159] In another form of this technology, the central controller 4230 is a dedicated electronic circuit. In another form, the central controller 4230 is an application-specific integrated circuit (ASIC). In yet another form, the central controller 4230 includes discrete electronic components.

[0160] The central controller 4230 is configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and humidifier 5000.

[0161] The central controller 4230 is configured to provide output signals to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0162] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium (such as memory 4260 or other memories described herein). In some forms of this technology, as previously discussed, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device or server (such as the previously mentioned server). For example, the remote positioning device or server may determine control settings for transmission to a ventilator or other RT device, such as by detecting respiratory-related events and by classifying them by type through analysis of stored data such as from any sensors described herein.

[0163] While the central controller 4230 may include a single controller that interacts with various sensors 4270, data communication interface 4280, memory 4260, and other devices, the functionality of controller 4230 may be distributed across more than one controller. Therefore, the term "central" as used herein does not imply limiting the architecture to a single controller or processor that controls other devices. For example, alternative architectures may include a distributed controller architecture involving more than one controller or processor, which may optionally communicate electronically (wired or wirelessly) directly or indirectly with the previously described finger sensors or a server communicating with the finger sensors, such as for implementing any of the methods described herein. This may include, for example, a separate local (i.e., within the RPT device 4000) or remote positioning controller that executes some algorithms 4300, or even more than one local or remote memory that stores some algorithms. Furthermore, when represented as a computer program, the algorithms may include high-level human-readable code (e.g., C++, Visual Basic, other object-oriented languages, etc.) or low-level / machine-level instructions (Assembler, Verilog, etc.). Depending on the functionality of the algorithm, such code or instructions can be programmed into a controller (e.g., an ASIC or DSP), or it can be a runtime executable ported to a DSP or general-purpose processor, which is then specifically programmed to perform the tasks required by the algorithm.

[0164] 4.9.2.4 Clock

[0165] RPT device 4000 may include a clock 4232 connected to central controller 4230.

[0166] 4.9.2.5 Therapeutic device controller

[0167] In one form of this technology, the therapy device controller 4240 is a therapy control module 4330, which forms part of an algorithm 4300 executed by the central controller 4230.

[0168] In one embodiment of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0169] 4.9.2.6 Protection Circuit

[0170] The RPT device 4000 according to the present technology may include one or more protection circuits 4250.

[0171] One form of the protection circuit 4250 according to this technology is an electrical protection circuit.

[0172] One form of the protection circuit 4250 according to this technology is a temperature or pressure safety circuit.

[0173] 4.9.2.7 Memory

[0174] According to one embodiment of the present 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.

[0175] The memory 4260 can be located on PCBA 4202. The memory 4260 can be in the form of EEPROM or NAND flash memory.

[0176] Additionally or alternatively, the RPT device 4000 includes a removable form of memory 4260, such as a memory card made according to the Secure Digital (SD) standard.

[0177] In one form of the present technology, memory 4260 (such as one of the memories previously described) acts as a non-transitory computer-readable storage medium storing computer program instructions, such as one or more algorithms 4300, representing one or more methods described herein.

[0178] 4.9.2.8 Transducer

[0179] The transducer can be inside the device 4000 or outside the RPT device 4000. An external transducer can be located, for example, on the air delivery circuit 4170 (e.g., at the patient interface 3000) or form part of the air delivery circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that sends or transmits data to the RPT device 4000.

[0180] 4.3.2.8.1 Traffic Flow

[0181] The flow transducer 4274 according to this technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION. The differential pressure transducer is in fluid communication with the pneumatic circuit, and one of each pressure transducer is connected to the corresponding first and second points in the flow-limiting element.

[0182] In one example, the central controller 4230 receives a signal representing the total flow rate Qt from the flow transducer 4274.

[0183] 4.3.2.8.2 Pressure

[0184] According to this technology, the pressure transducer 4272 is positioned in fluid communication with the pneumatic path. An example of a suitable pressure transducer 4272 is a sensor from the HONEYWELL ASDX series. Alternatively, a suitable pressure transducer is a sensor from the GENERAL ELECTRIC NPA series.

[0185] In use, the central controller 4230 receives signals from the pressure transducer 4272. In one embodiment, the signals from the pressure transducer 4272 are filtered before being received by the central controller 4230.

[0186] 4.3.2.8.3 Motor Speed

[0187] In one embodiment of this technology, a motor speed transducer 4276 is used to determine the rotational speed of a motor 4144 and / or a blower 4142. The motor speed signal from the motor speed transducer 4276 can be provided to a therapy device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0188] 4.9.2.9 Data Communication System

[0189] In one embodiment of this technology, a data communication interface 4280 is provided, and this data communication interface is connected to a central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0190] 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 a processor.

[0191] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0192] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols, and may optionally communicate with any sensor described herein.

[0193] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers and / or a server as described herein. In another form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible to a properly authorized person, such as a clinician.

[0194] The local external device 4288 can be a personal computer, mobile phone, tablet computer, or remote control device.

[0195] 4.9.2.10 Includes output devices for optional displays and alarms.

[0196] The output device 4290 according to this technology can take the form of one or more of a visual, audio, and tactile unit. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0197] 4.9.2.10.1 Display Driver

[0198] Display driver 4292 receives characters, symbols, or images to be displayed on monitor 4294 as input and converts them into commands that cause monitor 4294 to display those characters, symbols, or images.

[0199] 4.9.2.10.2 Monitor

[0200] Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0201] 4.9.3 RPT device algorithm

[0202] 4.9.3.1 Preprocessing Module

[0203] According to the present technology, the preprocessing module 4310 receives raw data from the transducer 4270 (e.g., flow sensor 4274 or pressure sensor 4272) as input and performs one or more processing steps to calculate one or more output values ​​that will be used as input to another module (e.g., therapy engine module 4320).

[0204] In one form of this technology, the output values ​​include the interface or mask pressure Pm, the breathing flow rate Qr, and the leakage flow rate Ql.

[0205] In various forms of this technology, the preprocessing module 4310 includes one or more of the following algorithms: pressure compensation 4312, ventilation flow estimation 4314, leakage flow estimation 4316, respiratory flow estimation 4317, ventilation volume determination 4311, target ventilation volume determination 4313, respiratory rate estimation 4318, and backup rate determination 4319.

[0206] 4.9.3.1.1 Pressure Compensation

[0207] 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. The pressure compensation algorithm 4312 estimates the pressure drop in the air circuit 4170 and provides an estimated pressure Pm in the patient interface 3000 as output.

[0208] 4.9.3.1.2 Ventilation flow rate estimation

[0209] In one form of this technology, the ventilation flow estimation algorithm 4314 receives the estimated pressure Pm in the patient interface 3000 as input and estimates the ventilation flow Qv of the air from the vent 3400 in the patient interface 3000.

[0210] 4.9.3.1.3 Leakage Flow Estimation

[0211] In one form of this technology, the leakage flow 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 another form, the leakage flow estimation algorithm 4316 estimates the leakage flow rate Ql by calculating the average of the difference between the total flow rate and the ventilation flow rate Qv over a sufficiently long period of time that includes several respiratory cycles (e.g., about 10 seconds).

[0212] In one form, the leakage flow estimation algorithm 4316 receives the total flow rate Qt, ventilation flow rate Qv, and estimated pressure Pm from the patient interface 3000 as input, and estimates the leakage flow rate Ql by calculating the leakage conductance and determining the leakage flow rate Ql as a function of the leakage conductance and pressure Pm. The leakage conductance can be calculated as the low-pass filtered non-ventilation flow rate equal to the quotient of 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, where the low-pass filtered time constant has a sufficiently long time to include the value of several respiratory cycles (e.g., approximately 10 seconds). The leakage flow rate Ql can be estimated as the product of the leakage conductance and the pressure Pm.

[0213] 4.9.3.1.4 Respiratory Flow Estimation

[0214] In one form of this technology, the respiratory flow estimation algorithm 4317 receives total flow Qt, ventilation flow Qv, and leakage flow Ql as inputs, and estimates the patient's air respiratory flow Qr by subtracting ventilation flow Qv and leakage flow Ql from the total flow Qt.

[0215] In other forms of this technology, the respiratory flow estimation algorithm 4317 provides a value that serves as a substitute for the respiratory flow rate Qr. Possible substitutes for respiratory flow rate include:

[0216] • Patient's chest respiratory movements 1000

[0217] • The pressure generator consumes 4140 kWh of current.

[0218] • Pressure generator motor speed 4140

[0219] • Patient's transthoracic impedance is 1000.

[0220] The respiratory flow rate surrogate value can be provided by the transducer 4270 (e.g., motor speed sensor 4276) in the RPT device 4000 or by a sensor external to the RPT device 4000 (such as a respiratory motion sensor or a transthoracic impedance sensor).

[0221] 4.9.3.1.5 Determining Ventilation Rate

[0222] In one form of this technology, the ventilation determination algorithm 4311 receives input of respiratory flow Qr and determines a measurement value Vent indicating the current patient ventilation.

[0223] In some specific implementations, the ventilation determination algorithm 4311 determines the measured value of ventilation, Vent, which is an estimate of the actual patient ventilation.

[0224] In one such implementation, the measured ventilation value Vent is half the absolute value of the respiratory flow Qr, which is optionally filtered by a low-pass filter, such as a second-order Bessel low-pass filter with an angular frequency of 0.11 Hz.

[0225] In one such implementation, the measured ventilation value, Vent, is an estimate of the total alveolar ventilation (i.e., non-anatomical dead space ventilation). This requires an estimate of the anatomical dead space. The patient's height (or arm span in the case of severe skeletal deformities) can be used as a good predictor of the anatomical dead space. The total alveolar ventilation is then equal to the actual patient ventilation measurement (e.g., as determined above) minus the product of the estimated anatomical dead space and the estimated spontaneous breathing rate, Rs.

[0226] In other implementations, the ventilation determination algorithm 4311 determines a measurement of ventilation (Vent) that is approximately proportional to the actual patient ventilation. One such implementation estimates the peak respiratory flow (Q-peak) of the inspiratory portion of the cycle. If the flow waveform shape does not vary significantly (here, the shapes of two breaths are considered similar when the flow waveforms of breaths normalized in time and amplitude are similar), this procedure involving sampling the respiratory flow (Qr) and many other procedures produce measurements that are approximately proportional to the ventilation. Some simple examples include the median of the positive respiratory flow, the median of the absolute values ​​of the respiratory flow, and the standard deviation of the flow. Any linear combination of statistics of any order of absolute values ​​of respiratory flow with positive coefficients, and even some linear combinations of statistics of any order of absolute values ​​of respiratory flow with both positive and negative coefficients, are approximately proportional to the ventilation. Another example is the average of the respiratory flow in the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. If the flow waveform shape is constant, there are arbitrarily large numbers of measurements that are precisely proportional to the ventilation.

[0227] In other forms, the ventilation determination algorithm 4311 determines a measurement of ventilation, Vent, which is not based on respiratory flow Qr, but rather on a substitute for the current patient ventilation, such as oxygen saturation (SaO2) or partial pressure of carbon dioxide (PCO2) obtained from a suitable sensor attached to the patient 1000.

[0228] 4.9.3.1.6 Determining the target ventilation rate

[0229] In one form of this technology, the central controller 4230 takes the current ventilation measurement value Vent as input and executes one or more target ventilation determination algorithms 4313 to determine the target value Vtgt of the ventilation measurement.

[0230] In some forms of this technology, there is no target ventilation rate determination algorithm 4313, and the target ventilation rate Vtgt is predetermined, for example, by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0231] In other forms of this technology, such as adaptive servo ventilation (ASV) therapy (described below), the target ventilation determination algorithm 4313 calculates the target ventilation Vtgt based on the value Vtyp indicating the patient's typical recent ventilation of 1000.

[0232] In some forms of adaptive servo ventilation therapy, the target ventilation volume Vtgt is calculated as a high proportion of the typical recent ventilation volume Vtyp, but less than that typical recent ventilation volume. This high proportion can range from (80%, 100%) to (85%, 95%) to (87%, 92%).

[0233] In other forms of adaptive servo ventilation therapy, the target ventilation volume Vtgt is calculated as an integer multiple slightly larger than the typical recent ventilation volume Vtyp.

[0234] A typical recent ventilation volume (Vtyp) is the value at which the distribution of the current ventilation volume (Vent) measurement tends to cluster over several moments on some predetermined time scales; that is, a measure of the central tendency of the current ventilation volume measurement over its recent history. In one specific implementation of the target ventilation volume determination algorithm 4313, the recent history is on the order of minutes, but in any case should be longer than the Cheyne-Stokes rise-fall period. The target ventilation volume determination algorithm 4313 can use any of a variety of well-known measures of central tendency to determine the typical recent ventilation volume (Vtyp) based on the current ventilation volume measurement (Vent). One such measure is the output of a low-pass filter to the current ventilation volume measurement (Vent), where the time constant is equal to one hundred seconds.

[0235] 4.9.3.1.7 Respiratory Rate Estimation

[0236] In one form of this technology, the respiratory rate estimation algorithm 4318 receives the patient's respiratory flow Qr as input and generates an estimate of the patient's spontaneous respiratory rate Rs.

[0237] The respiratory rate estimation algorithm 4318 can estimate the spontaneous respiratory rate Rs during a period of 1000 spontaneous breaths by the patient, i.e., when the RPT device 4000 is not delivering "backup breaths" (as described below). In some forms of this technology, the respiratory rate estimation algorithm 4318 estimates the respiratory rate during periods of low servo-assisted breathing (defined as pressure support minus minimum pressure support) (less than 4 cmH2O in one specific implementation), because such periods are more likely to reflect spontaneous breathing effort.

[0238] In some forms of this technology, the respiratory rate estimation algorithm 4318 estimates the respiratory rate during periods of sleep breathing, because the respiratory rate during these periods may differ significantly from the respiratory rate during wakefulness. Anxiety typically leads to a higher respiratory rate than during sleep. When patients are focused on their own breathing process, their respiratory rate is typically lower than during normal wakefulness or sleep. Techniques such as those described in patent application PCT / AU2010 / 000894, published as WO 2011 / 006199 (the entire disclosure of which is incorporated herein by reference), can be used to identify periods of wakefulness breathing from the respiratory flow Qr.

[0239] In some forms of this technique, the respiratory rate estimation algorithm 4318 estimates the spontaneous respiratory rate Rs as the reciprocal of one of several known statistical measures of the central tendency of the respiratory duration Ttot during the period of interest. In such measures, it is desirable to reject outliers, or at least be robust to outliers. One such measure, the trimmed mean, in which the lower and higher proportions K of the ordered respiratory durations are discarded, and the mean is calculated based on the remaining respiratory durations, is robust to outliers. For example, when K is 0.25, this corresponds to discarding the upper and lower quartiles of the respiratory duration Ttot. The median is another robust measure of central tendency, although this can occasionally give unsatisfactory results when the distribution is strongly bimodal. A simple mean can also be used as a measure of central tendency, although it is sensitive to outliers. An initial interval filtering stage can be employed, in which consecutive time intervals corresponding to unreliable respiratory rates (e.g., greater than 45 breaths / min or less than 6 breaths / min) are excluded as outliers from the mean calculation. Other filtering mechanisms that can be used alone or in combination with interval filtering include excluding any breaths that are not part of a sequence of N consecutive spontaneous breaths, where N is some small integer (e.g., 3), and excluding the early and late breaths of a consecutive spontaneous breath sequence, such as excluding the first and last breaths of a four-breath sequence. The basic principle of the latter mechanism is that the first and last breaths of a spontaneous breath sequence (in particular, and generally the early and late breaths) may be atypical; for example, the first spontaneous breath may occur due to arousal, and the last spontaneous breath may be longer due to reduced respiratory drive, resulting in a backup breath that ends the spontaneous breath sequence.

[0240] In some forms of this technique, the respiratory rate estimation algorithm 4318 uses an initial estimation period to make an initial estimate of the spontaneous respiratory rate Rs, enabling subsequent processing in the therapy engine module 4320 to begin. The estimated spontaneous respiratory rate Rs is then continuously updated using estimation periods longer than the initial estimation period to improve statistical robustness. For example, the initial estimation period could be 20 minutes of appropriate spontaneous breathing, but the estimation period can then be gradually increased up to a maximum duration, such as 8 hours. Instead of using a rolling window of this duration for the estimation, a low-pass filter of the respiratory duration can be used, with the response time gradually increasing (more precisely, the angular frequency gradually decreasing) as the treatment progresses.

[0241] In some forms, short-term (e.g., 10-minute) measurements with appropriate processing of central tendency (such as trimmed averages) can be fed into a suitable low-pass filter to give an estimate of the variation over timescales of hours or longer. This has the advantage of not requiring the storage and processing of potentially large amounts of respiratory duration data, which could be necessary to calculate a trimmed average based on a moving window of respiratory duration data lasting hours or days.

[0242] In some forms of this technique, the respiratory rate measured over a short period of time, particularly within a single breath, can be used instead of the respiratory duration in the above-mentioned central tendency measurements, thus giving roughly similar but not identical results.

[0243] 4.9.3.1.8 Backup Rate Determination

[0244] In one form of this technology, the backup rate determination algorithm 4319 receives an estimate of the spontaneous breathing rate Rs provided by the breathing rate estimation algorithm 4318 as input and returns a "backup rate" Rb. The backup rate Rb is the rate at which the RPT device 4000 will deliver backup breaths (i.e., continue to provide ventilatory support) to the patient 1000 without significant spontaneous breathing effort.

[0245] In one form of the preprocessing module 4310, there is no backup rate determination algorithm 4319. Instead, the backup rate Rb is manually provided to the RPT device 4000, for example, via the input device 4220, or hard-coded when configuring the RPT device 4000.

[0246] In a form called adaptive backup rate, backup rate determination algorithm 4319 determines a backup rate Rb as a function of the spontaneous breathing rate Rs. In one implementation, this function determines the backup rate Rb as the spontaneous breathing rate Rs minus a constant such as 2 breaths per minute. In another implementation, this function determines the backup rate Rb as the spontaneous breathing rate Rs multiplied by a constant slightly less than 1.

[0247] In a form called variable backup rate, backup rate determination algorithm 4319 determines the backup rate Rb as a function of time. The backup rate Rb is initialized to a value called the autonomous backup rate (SBR), which is a fraction of the final target backup rate called the sustained timed backup rate (STBR). This fraction can be two-thirds, three-quarters, or other positive values ​​less than one. The SBR is the reciprocal of the timeout period compared to the backup breath when the most recent inspiratory breath was voluntary (i.e., patency-triggered). The STBR can be predetermined (e.g., by manual input or hard-coding as described above) or set to a typical respiratory rate, such as 15 bpm. From the previous voluntary breath, the backup rate Rb increases from the SBR to the STBR over time. This increase can be based on a predetermined curve, such as a series of steps or a continuous linear curve. The curve is chosen such that the backup rate Rb reaches the STBR after predetermined intervals. This interval can be measured in units of time, such as 30 seconds, or relative to the patient’s breathing, such as 5 breaths.

[0248] In some forms of variable backup rates, the predetermined interval at which the backup rate Rb increases from the SBR to the STBR can be a function of the adequacy of the current ventilation volume. In a specific implementation suitable for servo ventilation, where there is a target value Vtgt for the measured ventilation volume, the backup rate approaches the STBR more quickly, to the point that the current measured ventilation volume Vent is less than the target ventilation volume Vtgt.

[0249] In one form of variable backup rate, known as adaptive variable backup rate, backup rate determination algorithm 4319 determines the backup rate Rb as a function of the currently estimated spontaneous breathing rate Rs provided by respiratory rate estimation algorithm 4318, and a function of time. Similar to variable backup rate determination, adaptive variable backup rate determination increases the backup rate Rb from SBR to STBR at predetermined intervals, which may be a function of current ventilation adequacy. STBR can be initialized to a standard respiratory rate, such as 15 bpm. Once a reliable estimate of the spontaneous breathing rate Rs is available from respiratory rate estimation algorithm 4318, STBR can be set to the currently estimated spontaneous breathing rate Rs multiplied by a constant. SBR can be set to a fraction of STBR, as in variable backup rate. In one form, for example, a two-thirds fraction can be set to a lower value, such as 0.55, during the initial estimation period of spontaneous breathing rate Rs to accommodate occasional long breathing durations in patients with relatively low respiratory rates (such as 12 breaths per minute).

[0250] In some forms, the constant multiplied by the currently estimated spontaneous breathing rate Rs to obtain the STBR can be slightly higher than 1, such as 1.1, to provide more aggressive ventilation during apnea, which may be desirable in short-term apnea. This constant can be slightly lower than 1, such as 0.8, especially if difficulty in resynchronizing with the patient when they attempt to return is a problem in that particular patient. A lower backup rate makes resynchronization easier by prolonging the apnea, which typically occurs during apnea.

[0251] 4.9.3.2 Therapy Engine Module

[0252] In one form of this technology, the therapy engine module 4320 receives one or more of the following as inputs: pressure Pm from the patient interface 3000, respiratory flow rate Qr to the patient, and an estimated spontaneous breathing rate Rs; and provides one or more therapy parameters as outputs. In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, inspiratory flow rate limitation determination 4324, apnea / insufficiency determination 4325, snoring detection 4326, airway patency determination 4327, and therapy parameter determination 4329.

[0253] 4.9.3.2.1 Phase Determination

[0254] In one form of this technology, the phase determination algorithm 4321 receives a signal indicating respiratory flow Qr as input and provides the phase F of the patient's current respiratory cycle as output.

[0255] In some forms known as discrete phase determination, the phase output F is a discrete variable. One specific implementation of discrete phase determination provides a dual-value phase output F with either an inspiratory or expiratory value, for example, values ​​represented as 0 revolutions and 0.5 revolutions respectively when spontaneous inspiration and the start of expiration are detected. The RPT device 4000, which performs "triggering" and "switching," effectively performs discrete phase determination because the trigger point and the switching point are the moments when the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one specific implementation of dual-value phase determination, the phase output F is determined to have a discrete value of 0 when the respiratory flow Qr has a value exceeding a positive threshold (thus "triggering" the RPT device 4000), and is determined to have a discrete value of 0.5 revolutions when the respiratory flow Qr has a value more negative than a negative threshold (thus "switching" the RPT device 4000).

[0256] Another specific implementation of discrete phase determination provides a three-valued phase output F with values ​​for one of inhalation, intermediate inhalation pause, and exhalation.

[0257] In other forms known as continuous phase determination, the phase output F is a continuous value, such as varying from 0 to 1 revolution or from 0 to 2 p radians. The RPT device 4000 performing continuous phase determination can be triggered and switched when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one specific implementation of continuous phase determination, fuzzy logic analysis of the respiratory flow Qr is used to determine the continuous value of phase F. The continuous value of the phase determined in this specific implementation is often referred to as the "fuzzy phase." In one specific implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow Qr:

[0258] 1. If the respiratory flow is zero and increases rapidly, the phase is 0 revolutions.

[0259] 2. If the respiratory flow rate is a large positive value and stable, the phase is 0.25 revolutions.

[0260] 3. If the respiratory flow is zero and decreases rapidly, the phase is 0.5 revolutions.

[0261] 4. If the respiratory flow rate is a large negative value and stable, the phase is 0.75 revolutions.

[0262] 5. If the respiratory flow is zero and stable, and the absolute value of the 5-second low-pass filter for the respiratory flow is large, then the phase is 0.9 revolutions.

[0263] 6. If the respiratory flow is positive and the phase is expiration, then the phase is 0 revolutions.

[0264] 7. If the respiratory flow is negative and the phase is inspiration, then the phase is 0.5 revolutions.

[0265] 8. If the absolute value of the 5-second low-pass filter for respiratory flow is large, the phase increases at a steady rate equal to the patient’s respiratory rate, and the time constant of the low-pass filter is 20 seconds.

[0266] The output of each rule can be represented as a vector, with phase representing the result of the rule and amplitude representing the degree of ambiguity of the rule being true. Appropriate membership functions are used to determine the degree of ambiguity for terms such as "larger" or "stable" respiratory flow. The results of the rules are represented as vectors and then combined using a function such as centroid. In this combination, the rules can be weighted equally or differently.

[0267] In another specific implementation of continuous phase determination, the inhalation time Ti and exhalation time Te are first estimated based on the respiratory flow rate Qr. Then, the phase F is determined as half of the inhalation time Ti that has elapsed since the previous trigger moment, or 0.5 turns plus half of the exhalation time Te that has elapsed since the previous switching moment (whichever is more recent).

[0268] In some forms of this technique suitable for pressure support ventilation therapy (described below), the phase determination algorithm 4321 is configured to trigger even when the respiratory flow Qr is not significant, such as during apnea. As a result, the RPT device 4000 delivers "backup breathing" in the absence of spontaneous breathing effort from the patient 1000. For such forms, known as spontaneous / timed (S / T) mode, the phase determination algorithm 4321 may utilize the backup rate Rb provided by the backup rate determination algorithm 4319.

[0269] The phase determination algorithm 4321 using "fuzzy phase" can achieve S / T mode using a backup rate Rb by including a "momentum" rule in the fuzzy phase rule. The effect of the momentum rule is that if the characteristic of the respiratory flow Qr is not present, the backup rate Rb will advance the continuous phase from expiration to inspiration; otherwise, the respiratory flow will advance the continuous phase through other rules. In one specific implementation, the greater the measurement of ventilation Vent (described below) is below the target value of ventilation Vtgt (also described below), the higher the momentum rule is weighted in the combination. However, due to the rapid increase in pressure support in response to mild to moderate hypoventilation (relative to the target ventilation), the ventilation may be very close to the target ventilation. It is desirable to give the momentum rule a lower weight when the ventilation is close to the target to allow the patient to breathe at a rate significantly lower than at other times (when the patient is not in central apnea) without being unnecessarily pushed by the ventilator to breathe at a higher rate. However, when the momentum rule is given a lower weight when the ventilation rate is below but close to the target ventilation rate, sufficient ventilation can be easily achieved at a relatively high pressure support at a rate much lower than the backup rate. It is desirable to deliver backup breathing at a higher rate because this will make it possible to deliver the target ventilation rate at a lower pressure support. This is desired for several reasons, one key reason being to reduce mask leakage.

[0270] In summary, the fuzzy phase determination algorithm 4321 for implementing S / T mode presents a dilemma in selecting weights for the momentum rule, which includes the backup rate Rb: if the weights are too high, the patient may feel "pushed" by the backup rate; if they are too low, the stress support may be excessive. Therefore, it is desirable to provide a method for implementing S / T mode that does not rely on the momentum rule described above.

[0271] The phase determination algorithm 4321 (discrete or continuous, without momentum rules) can implement the S / T mode using a backup rate Rb in a manner called timing backup. Timing backup can be implemented as follows: The phase determination algorithm 4321 attempts to detect the onset of inhalation due to spontaneous breathing effort, for example, by monitoring the respiratory flow rate Qr as described above. If no onset of inhalation due to spontaneous breathing effort is detected within a time period (called the interval of the backup timing threshold) after the last trigger moment whose duration is equal to the reciprocal of the backup rate Rb, the phase determination algorithm 4321 sets the phase output F to the inspiratory value (thus triggering the RPT device 4000). Once the RPT device 4000 is triggered and a backup breathing start is delivered, the phase determination algorithm 4321 attempts to detect the onset of spontaneous exhalation, for example, by monitoring the respiratory flow rate Qr, and sets the phase output F to the expiratory value at the onset of spontaneous exhalation (thus switching the RPT device 4000).

[0272] If the backup rate Rb increases from SBR to STBR over time, as in the variable backup rate system described above, the backup timing threshold begins to lengthen and then gradually shortens. That is, the RPT device 4000 starts less alert and gradually becomes more alert to the point of lack of spontaneous breathing effort as more backup breaths are delivered. If the patient prefers to breathe at a substandard rate, this RPT device 4000 is unlikely to make the patient feel “pushed” while still delivering backup breaths when needed.

[0273] If the STBR in a variable backup rate system adapts to the patient’s estimated spontaneous breathing rate Rs, as described above in an adaptive variable backup rate system, then backup breathing will be delivered at a rate that adapts to the patient’s recent spontaneous breathing effort.

[0274] 4.9.3.2.2 Waveform Determination

[0275] In one form of this technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapeutic pressure Pt that varies as a function of the phase F of the patient's respiratory cycle, based on a waveform template P(F).

[0276] In one form of this technology, waveform determination algorithm 4322 provides a waveform template P(F) with values ​​in the range [0, 1] over the domain of phase value F provided by phase determination algorithm 4321, for use by therapy parameter determination algorithm 4329.

[0277] In one form suitable for discrete or continuous phase values, the waveform template P(F) is a square wave template with a value of 1 for phase values ​​up to and including 0.5 revolutions and a value of 0 for phase values ​​greater than 0.5 revolutions. In another form, the waveform template P(F) suitable for continuous phase values ​​includes two smooth curve portions: for phase values ​​up to 0.5 revolutions, the smooth curve portion (e.g., raised cosine) rises from 0 to 1, and for phase values ​​greater than 0.5 revolutions, the smooth curve portion (e.g., in exponential form) decays from 1 to 0. An example of such a "smooth and comfortable" waveform template is the "shark fin" waveform template, where the rise is raised cosine and the smooth decay is quasi-exponential (making the limit of P exactly zero when F approaches one revolution).

[0278] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template P(F) from a waveform template library according to the settings of the RPT device 4000. Each waveform template P(F) in the library can be provided as a lookup table of values ​​P relative to the phase value F. In other forms, the waveform determination algorithm 4322 calculates the waveform template P(F) "on the fly" using a predetermined functional form that may be parameterized by one or more parameters, such as the time constant of the exponentially curved portion. The parameters of the functional form can be predetermined or depend on the current state of the patient 1000.

[0279] In some forms of this technique suitable for discrete two-valued phases of inhalation (F = 0 rpm) or exhalation (F = 0.5 rpm), the waveform determination algorithm 4322 calculates the waveform template P "on demand, instantly," as a function of the discrete phase F and the time t measured from the most recent trigger moment (the transition from exhalation to inhalation). In one such form, the waveform determination algorithm 4322 calculates the waveform template P(F, t) in both parts (inhalation and exhalation) as follows:

[0280] Where Pi(t) and Pe(t) are the inspiratory and expiratory portions of the waveform template P(F, t), and Ti is the inhalation time. In one such form, the inspiratory portion Pi(t) of the waveform template smoothly rises from 0 to 1 parameterized by the rise time, and the expiratory portion Pe(t) of the waveform template smoothly falls from 1 to 0 parameterized by the fall time.

[0281] 4.9.3.2.3 Determination of Inspiratory Flow Limit

[0282] In one form of this technology, the processor executes one or more algorithms 4324 for detecting inhalation flow limitation (partial obstruction).

[0283] In one form, algorithm 4324 receives the respiratory flow signal Qr as input and provides a measure of the degree to which the inspiratory portion of the breath exhibits inspiratory flow restriction as output.

[0284] In one form of this technique, the inspiratory portion of each breath is identified based on the estimated phase F at each moment. For example, the inspiratory portion of a breath is a value of respiratory flow rate where phase F is less than or equal to 0.5. An interpolator interpolates along the inspiratory flow rate-time curve for each breath at multiple uniformly spaced points (e.g., sixty-five) representing time points. The curve described by the points is then scalar-scaled to have a uniform length (duration / period) and uniform area to eliminate the effects of variations in respiratory rate and depth. The scaled breaths are then compared in a comparator to a pre-stored template representing normal, unobstructed breathing. At any time during the inspiratory period from this template, breaths deviating beyond a specified threshold (typically 1 scaling unit) are rejected, such as those caused by coughing, sighing, swallowing, and hiccups as determined by the test element. For non-rejected data, a moving average of the first such scaled point from the preceding few inspiratory events is calculated by the central controller 4230. This is repeated for the second such point on the same inspiratory event, and so on. Therefore, for example, sixty-five scaled data points are generated by the central controller 4230 and represent the moving average of the preceding few intake events (e.g., three events). The moving average of the continuously updated values ​​of the sixty-five points is referred to below as the "scaled flow" and denoted as Qs(t). Alternatively, a single intake event may be used instead of a moving average.

[0285] Based on the scaled flow, two shape factors can be calculated and used to determine the partial blockage.

[0286] The shape factor 1 is the ratio of the average of the intermediate (e.g., thirty-two) scaled flow points to the average of the total (e.g., sixty-five) scaled flow points. When this ratio is greater than 1, breathing is considered normal. When the ratio is 1 or less, breathing is considered obstructed. A ratio of approximately 1.17 is considered the threshold between partially obstructed and unobstructed breathing, and is equivalent to the degree of obstruction that allows for adequate oxygenation in a typical user.

[0287] The shape factor 2 is calculated as the RMS deviation from a unit scaled flow rate at intermediate (e.g., thirty-two) points. An RMS deviation of approximately 0.2 units is considered normal. Zero RMS deviation is considered a fully flow-restricted breath. The closer the RMS deviation is to zero, the more flow-restricted the breath will be considered.

[0288] Shape factors 1 and 2 can be used as alternatives, or in combination. In other forms of this technique, the number of sampling points, breaths, and intermediate points can differ from those described above. Furthermore, the threshold can differ from the thresholds described.

[0289] 4.9.3.2.4 Determination of Apnea and Insufficient Respiration

[0290] In one form of this technology, the central controller 4230 executes one or more algorithms 4325 for detecting apnea and / or insufficiency of breathing.

[0291] In one form, one or more apnea / insufficiency detection algorithms 4325 receive respiratory flow Qr as input and provide a flag indicating that apnea or insufficiency has been detected as output.

[0292] In one form, apnea is considered detected when a function of respiratory flow Qr falls below a flow threshold within a predetermined time period. This function can be determined by peak flow, relatively short-term average flow, or an intermediate flow between relatively short-term average and peak flow, such as RMS flow. The flow threshold can be a relatively long-term measurement of flow.

[0293] In one form, insufficiency is considered detected when a function of respiratory flow Qr falls below a second flow threshold within a predetermined time period. This function can be a peak flow, a relatively short-term average flow, or an intermediate flow between the relatively short-term average and peak flows, such as RMS flow. The second flow threshold can be a relatively long-term measurement of the flow. The second flow threshold is greater than the flow threshold used to detect apnea.

[0294] In one form, such respiratory events can be characterized as central or obstructive based at least in part on the aforementioned type detection based on finger sensor PPG.

[0295] 4.9.3.2.5 Detection of snoring

[0296] In one form of this technology, the central controller 4230 executes one or more snoring detection algorithms 4326 for detecting snoring.

[0297] In one form, the snoring detection algorithm 4326 receives the respiratory flow signal Qr as input and provides a measure of the degree of snoring presence as output.

[0298] The snoring detection algorithm 4326 may include a step of determining the intensity of the flow signal in the range of 30 Hz to 300 Hz. Furthermore, the snoring detection algorithm 4326 may also include a step of filtering the respiratory flow signal Qr to reduce background noise (e.g., the sound of airflow from the blower 4142 in the system).

[0299] 4.9.3.2.6 Determining airway patency

[0300] In one form of this technology, the central controller 4230 executes one or more algorithms 4327 for determining airway patency.

[0301] In one form, the airway patency algorithm 4327 receives a respiratory flow signal Qr as input and determines the power of the signal in a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak within this frequency range is considered an indication of an open airway. The absence of a peak is considered an indication of a closed airway.

[0302] In one form, the frequency range within which the peak is sought is the frequency of small forced oscillations in the therapeutic pressure Pt. In one specific implementation, the forced oscillation frequency is 2 Hz, and the amplitude is approximately 1 cmH2O.

[0303] In one form, the airway patency algorithm 4327 receives the respiratory flow signal Qr as input and determines whether a cardiac signal is present. The absence of a cardiac signal is considered an indication of a closed airway.

[0304] 4.9.3.2.7 Determination of Therapeutic Parameters

[0305] In some forms of this technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 to determine one or more therapy parameters using values ​​returned by one or more other algorithms in the therapy engine module 4320.

[0306] In one form of this technology, the therapeutic parameter is the instantaneous therapeutic pressure Pt. In a specific implementation of this form, the therapeutic parameter determination algorithm 4329 uses the following equation to determine the therapeutic pressure Pt: (1)

[0308] in:

[0309] •A is the amplitude.

[0310] • F is the current value of the phase;

[0311] • P(F) is the waveform template value (in the range of 0 to 1) at the current value of the phase, and

[0312] • _P_0 is the base pressure.

[0313] If waveform determination algorithm 4322 provides waveform template P(F) as a lookup table of values ​​indexed by phase F, then therapeutic parameter determination algorithm 4329 applies equation (1) by locating the nearest lookup table entry to the current phase value F returned by phase determination algorithm 4321 or by interpolating between two entries spanning the current phase value F.

[0314] The values ​​of amplitude A and base pressure P0 can be determined by the therapy parameter algorithm 4329, which sets them according to the selected pressure therapy mode as described below.

[0315] 4.9.3.3 Therapy Control Module

[0316] According to one aspect of the present technology, the therapy control module 4330 receives therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 as input, and controls the pressure generator 4140 to deliver an airflow according to the therapy parameters.

[0317] In one form of this technology, the therapy parameter is the treatment pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver an airflow at the patient interface 3000 with a mask pressure Pm equal to the treatment pressure Pt. Based on the therapy parameters determined by the central controller 4230 and the therapy parameter determination algorithm 4329, such treatment pressures can provide, for example, pressure support (PS) therapy, continuous positive airway pressure (CPAP) therapy, automated positive airway pressure (APAP) therapy, and / or bilevel therapy, such as a therapy where the inspiratory treatment pressure (IPAP) is higher than the expiratory pressure (EPAP). In some forms of bilevel therapy, IPAP is a treatment pressure that serves the same purpose as the treatment pressure in a CPAP therapy mode, and EPAP is IPAP minus an amplitude A with a “small” value (a few cmH2O), sometimes referred to as expiratory pressure release (EPR). This form is sometimes referred to as CPAP therapy using EPR, which is generally considered more comfortable than direct CPAP therapy. In CPAP therapy using EPR, one or both of IPAP and EPAP can be hard-coded or manually entered as constant values ​​into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 can repeatedly calculate IPAP and / or EPAP during CPAP using EPR. In this alternative, the therapy parameter determination algorithm 4329 repeatedly calculates EPAP and / or IPAP based on indicators or measurements of sleep apnea returned by the corresponding algorithm in the therapy engine module 4320, in a manner similar to that described above for calculating the basal pressure P0 in APAP therapy.

[0318] 4.9.3.4 Fault Detection

[0319] In one form of this technology, the processor executes one or more methods 4340 for detecting fault conditions. The fault conditions detected by the one or more methods may include at least one of the following:

[0320] • Power failure (no power or insufficient power)

[0321] • Transducer fault detection

[0322] • The presence of the component cannot be detected.

[0323] • Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2).

[0324] • Test alarms cannot generate detectable alarm signals.

[0325] When a fault condition is detected, the corresponding algorithm notifies the existence of the fault by signaling one or more of the following:

[0326] • Activate auditory, visual, and / or dynamic (e.g., vibration) alarms.

[0327] • Send messages to external devices

[0328] • Event Log

[0329] 4.10 Humidifier

[0330] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 10 As shown), it alters the absolute humidity of the air or gas delivered to the patient relative to ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity of the airflow and raise its temperature (relative to ambient air) before it is delivered to the patient's airway.

[0331] 4.11 Glossary

[0332] For the purposes of this disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0333] 4.11.1 Routine

[0334] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0335] Respiratory pressure therapy (RPT): Delivering an air supply to the airway at a therapeutic pressure that is normally positive relative to the atmosphere.

[0336] Continuous positive airway pressure (CPAP) therapy: a respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.

[0337] Patient: A person, regardless of whether they have a respiratory illness.

[0338] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure can be automatically adjusted between a minimum and a maximum limit, for example, varying with each breath, depending on whether there is an indication for an SDB event.

[0339] 4.11.2 Aspects of the respiratory cycle

[0340] Apnea: According to some definitions, apnea is considered to have occurred when respiratory flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to have occurred when some form of airway obstruction prevents airflow despite the patient's efforts. Central apnea is considered to have occurred when apnea is detected due to reduced or absent respiratory effort.

[0341] Respiratory rate (Rs): The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0342] Duty cycle: The ratio of inhalation time Ti to total respiratory duration Ttot.

[0343] Effort (breathing): The work that a person who breathes spontaneously tries to do while breathing.

[0344] The expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0345] Flow restriction: A state of breathing in which increased effort by the patient does not result in a corresponding increase in flow rate. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0346] Hypoventricular hypopnea: Reduced flow, but not complete cessation of flow. In one form, hypoventricular hypopnea is considered to have occurred when the flow rate decreases below a threshold for an extended period. In one form in adults, any of the following can be considered hypoventricular hypopnea:

[0347] (i) The patient’s breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0348] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.

[0349] The inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow rate to the start of expiratory flow rate is considered the inspiratory portion of the respiratory cycle.

[0350] Patentity (airway): The degree to which the airway is open or the extent to which the airway is open. A patent airway is open. Airway patentness can be quantified, for example, a value (1) for patent and a value of zero (0) for closed.

[0351] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure present in the lungs at the end of expiration.

[0352] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0353] Respiratory flow / airflow, patient flow / airflow (Qr): These synonyms can be understood as the RPT device’s estimate of respiratory airflow, as opposed to “true respiratory flow” or “true respiratory airflow,” which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0354] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort.

[0355] (Inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0356] Expiratory time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0357] Total time or respiratory duration (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the next respiratory flow waveform.

[0358] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or may even decrease as the pressure differential across the upper airway increases (Starling resistance behavior).

[0359] Ventilation: A measurement of the total amount of gas exchanged by a patient's respiratory system. A measurement of ventilation can include one or both inspiratory flow rate and expiratory flow rate (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.

[0360] 4.11.3 RPT Device Parameters

[0361] Flow rate: The instantaneous volume (or mass) of air delivered per unit time. While flow rate and ventilation have the same volume or mass per unit time, flow rate is measured over a much shorter period of time. Flow rate can be nominally positive for the inspiratory portion of a patient's respiratory cycle and therefore negative for the expiratory portion. In some cases, the reference to flow rate will be a scalar, i.e., a quantity with only magnitude. In other cases, the reference to flow rate will be a vector, i.e., a quantity with both magnitude and direction. Flow rate will be given by the symbol Q. "Flow rate" is sometimes simply abbreviated to "flow". Total flow rate Qt is the flow rate of air leaving the RPT device. Tidal flow rate Qv is the flow rate of air leaving the vent to allow flushing of exhaled gas. Leakage flow rate Ql is the flow rate of air unintentionally leaked from the patient interface system. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0362] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak might occur in the swivel bend leading to the environment.

[0363] Pressure: Force per unit area. Pressure can be measured in a range of units, including cmH2O, gf / cm2, and hectopascals. 1 cmH2O equals 1 g-f / cm2, approximately 0.98 hectopascals. In this instruction manual, unless otherwise stated, pressure is given in cmH2O. Pressure at the patient interface (mask pressure) is given by the symbol Pm, while treatment pressure is given by the symbol Pt, which represents the target value to be achieved at the current moment through mask pressure Pm.

[0364] 4.11.4 Terminology used for ventilators

[0365] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined from some characteristics of the patient, such as the patient's respiratory characteristics.

[0366] Backup rate: A parameter of the ventilator that determines the rate of breathing delivered to the patient by the ventilator if not triggered by spontaneous breathing effort (usually in breaths per minute).

[0367] Switching: Termination of the inspiratory phase of the ventilator. When a ventilator is delivering breaths to a spontaneously breathing patient, the ventilator is considered switched to stop delivering breaths at the end of the inspiratory portion of the respiratory cycle.

[0368] Positive expiratory airway pressure (EPAP): The baseline pressure to which the ventilator will attempt to achieve the desired mask pressure at a given time, by adding pressure changes within the respiratory tract.

[0369] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory phase of breathing. If the pressure waveform template P(F) is zero at the end of expiration, i.e., when F = 1, P(F) = 0, then EEP equals EPAP.

[0370] IPAP: The desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of breathing.

[0371] Pressure support (PS): Indicates a numerical value in a ventilator therapy where the pressure increase during inspiratory breathing exceeds the pressure during expiratory breathing, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0372] Servo ventilator: A ventilator that measures a patient’s ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0373] Servo Assist: Pressure Support minus Minimum Pressure Support.

[0374] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0375] Oscillation: A term equivalent to pressure support.

[0376] Triggered: When a ventilator delivers a breath of air to a patient who is breathing spontaneously, it is considered to be triggered by the patient's effort at the beginning of the inspiratory portion of the respiratory cycle.

[0377] Typical recent ventilation: Typical recent ventilation (Vtyp) is a recent measurement of ventilation over a predetermined time scale that tends to cluster around it, i.e., a measurement of the central tendency of recent historical ventilation measurements.

[0378] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0379] 4.11.5 Anatomical Structure of the Respiratory System

[0380] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0381] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0382] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0383] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. The nasal cavity is divided into two parts by vertical wings called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal turbinates. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0384] Pharynx: The part of the pharynx located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0385] 4.12 Other Remarks

[0386] This patent document contains a portion of copyrighted material. The copyright holder does not object to any fax copying of the patent document or patent disclosure appearing in the Patent and Trademark Office's patent documents or records, but otherwise reserves all copyright rights.

[0387] Unless the context clearly indicates otherwise and where a range of values ​​is provided, it should be understood that every intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range, as well as any other stated or intermediate values ​​within the range, are covered by this technique. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also covered by this technique, but are subject to any explicit exclusions within the stated range. Where the stated range includes one or both of these limitations, the range excluding any one or both of those included limitations is also included in this technique.

[0388] Furthermore, where one or more values ​​described herein are implemented as part of this technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used for any suitable significant number to the extent that the actual technical implementation may allow or require.

[0389] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. Although any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0390] When a particular material is identified for use in constructing a component, clearly alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein should be understood as capable of being manufactured, and therefore can be manufactured together or separately.

[0391] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0392] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided only for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0393] Furthermore, in interpreting this disclosure, all terms should be interpreted in the broadest and most reasonable manner consistent with the context. In particular, the terms “comprising” and “including” should be interpreted as referring to an element, component, or step in a non-exclusive manner, indicating that the referenced element, component, or step may be present, used, or combined with other elements, components, or steps not expressly referenced.

[0394] The headings used in the detailed embodiments are for convenience of the reader only and should not be used to limit the subject matter found throughout this disclosure or the claims. The headings should not be used to interpret the claims or to limit the scope of the claims.

[0395] Although the techniques described herein have been illustrated with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details not required for practicing the technology. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects thereof can be performed simultaneously or even concurrently.

[0396] Therefore, it should be understood that various modifications can be made to the exemplary embodiments and other arrangements can be designed without departing from the spirit and scope of this technology.

[0397] Although the invention has been illustrated with reference to specific embodiments, it will be apparent to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the technology can be practiced with various changes and modifications without departing from the scope of the invention. Therefore, the embodiments are to be considered illustrative rather than restrictive in all respects, and the scope of the technology is indicated by the appended claims rather than by the foregoing description; and thus, all variations within the meaning and scope of equivalents of the claims are intended to be included therein. In other words, the invention is intended to cover any and all modifications, variations, or equivalents that fall within the scope of the basic principles and whose essential properties are claimed in this patent application. The reader of this patent application will also understand that the words “comprising” or “including” do not exclude other elements or steps, the words “a” or “an” do not exclude a plurality, and a single element such as a computer system, processor, or other integrated unit may perform the function of several components listed in the claims. Any reference numerals in the claims should not be construed as limiting the respective claims. When used in the specification or claims, the terms “first,” “second,” “third,” “a,” “b,” “c,” etc., are introduced to distinguish similar elements or steps and do not necessarily describe a sequence or chronological order. Similarly, the terms “top,” “bottom,” “above,” “below,” etc., are introduced for descriptive purposes and do not necessarily indicate relative positions. It should be understood that such terms are interchangeable where appropriate, and embodiments of the present technology can operate in other orders or orientations different from those described or illustrated above, according to the present technology.

Claims

1. A method for receiving multiple transmissions of respiratory therapy data from a respiratory therapy device via one or more servers through one or more networks, the method comprising: The first summary data, which includes a summary of the respiratory therapy data, is received from the respiratory therapy device via at least a first communication channel from a first wireless transmission. Receive second summary data from a second wireless transmission via at least a second communication channel, the second summary data including a summary of the respiratory therapy data; Access one or more first parameters from the first summary data received; Access one or more second parameters from the received second summary data; Compare the one or more first parameters with the one or more second parameters; An output report is generated based on the results of the comparison, the output report having data from one of the first summary data and the second summary data; as well as The output report is sent from one or more servers to the client device.

2. The method of claim 1, wherein the first communication channel comprises transmission via a Wi-Fi communication network.

3. The method of claim 2, wherein the transmission via the Wi-Fi communication network comprises: Communication from the client device to the one or more servers, wherein the client device sends the first summary data to the one or more servers after receiving the first summary data from the respiratory therapy device.

4. The method according to any one of claims 1 to 3, wherein the client device comprises a smartphone or tablet computer, the smartphone or tablet computer being configured by an application to communicate with the respiratory therapy device via a third communication channel.

5. The method of claim 4, wherein the third communication channel comprises transmission via short-range wireless communication.

6. The method of claim 5, wherein the short-range wireless communication includes a Bluetooth™ connection.

7. The method according to any one of claims 1 to 6, wherein the second communication channel comprises transmission via a cellular communication network.

8. The method of claim 7, wherein the transmission via the cellular communication network comprises transmitting the second aggregated data from the respiratory therapy device to the one or more servers.

9. The method according to any one of claims 1 to 8, wherein the first summary data and the second summary data include one or more of the following: treatment duration; Apnea index, hypopnea index; obstructive apnea index; central apnea index; Apnea index not distinguished; Respiratory event-related arousal index; One or more leak measurements; one or more inspiratory pressure measurements; one or more expiratory pressure measurements; duration of Cheyne-Stokes breathing; One or more mask pressure measurements; One or more tidal volume measurements; One or more minute ventilation measurements; one or more respiratory rate measurements; Ambient humidity measurement; Humidifier temperature measurement; Humidifier power measurement value; Heating element power measurement; pressure measurement of one or more blowers; One or more respiratory flow measurements; Humidifier connection indicator; Delivery pipe connection indicator; Blower flow rate measurement; And the number of time periods used.

10. The method according to any one of claims 1 to 9, wherein the one or more first parameters include duration.

11. The method of claim 10, wherein the duration is the duration of therapy.

12. The method according to any one of claims 1 to 11, wherein the comparison determines that the duration is greater than one or more other durations.

13. The method according to any one of claims 1 to 12, wherein the first summary data consists of a portion of redundant data relative to the second summary data.

14. The method of claim 13, wherein one of the first summary data and the second summary data is the second summary data.

15. The method according to any one of claims 1 to 14, wherein the output report includes a treatment duration score.

16. The method of claim 15, wherein the treatment course score in the output report is derived based on a plurality of parameters, the plurality of parameters including multiple of the following: apnea-hypopnea index; leakage measurement; number of mask removals; and duration of treatment use.

17. The method of claim 16, wherein the output report comprises a plurality of scores, wherein each of the plurality of scores is derived based on one of the plurality of parameters.

18. A processor-readable medium having processor-executable instructions stored thereon, the processor-executable instructions, when executed by one or more processors, causing the one or more processors to perform a method for one or more servers to receive multiple transmissions of respiratory therapy data from a respiratory therapy device via one or more networks, the method comprising the method according to any one of claims 1 to 17.

19. One or more servers, said one or more servers including one or more processors, and configured to receive multiple transmissions of respiratory therapy data from a respiratory therapy device via one or more networks, said one or more processors being configured to: The first summary data, which includes a summary of the respiratory therapy data, is received from the respiratory therapy device via at least a first communication channel from a first wireless transmission. Receive second summary data from a second wireless transmission via at least a second communication channel, the second summary data including a summary of the respiratory therapy data; Access one or more first parameters from the first summary data received; Access one or more second parameters from the received second summary data; Compare the one or more first parameters with the one or more second parameters; An output report is generated based on the results of the comparison, the output report having data from one of the first summary data and the second summary data; as well as The output report is sent from one or more servers to the client device.

20. One or more servers according to claim 19, wherein the one or more servers are further configured to perform the method according to any one of claims 2 to 17.

21. A method for transmitting respiratory therapy data from a respiratory therapy device multiple times via one or more networks and a server system including one or more servers, the method comprising: First aggregated data is transmitted from the respiratory therapy device to one or more servers via at least a first communication channel using a first wireless transmission method. The first aggregated data includes a summary of the respiratory therapy data. The first communication channel includes cellular communication. Second summary data is transmitted from the respiratory therapy device to the client device via at least a second communication channel using a second wireless transmission method. The second summary data includes a summary of the respiratory therapy data. The second communication channel includes short-range wireless communication. The second summary data received from the respiratory therapy device is transmitted from the client device to the one or more servers via at least a third communication channel; as well as At the client device, a generated output report is received in a communication from the server system. The generated output report contains data from one of the first summary data and the second summary data and is based on the result of a remote comparison by the server system of one or more first parameters from the first summary data and one or more second parameters from the second summary data, which is received by the server system from the client device.

22. The method according to claim 21, further comprising: The transmission of the second aggregated data is triggered by the client device via the second wireless transmission, wherein the triggering includes: When the client device is paired with the respiratory therapy device in a communicative manner, the therapy data display application is accessed on the client device.

23. The method according to claim 21, further comprising: The transmission of the second aggregated data is triggered by the respiratory therapy device via the second wireless transmission, wherein the triggering includes: When the client device and the respiratory therapy device are paired in a communication manner, the device switches from therapy mode to standby mode.

24. The method of claim 23, wherein the transition occurs in response to the respiratory therapy device detecting a mask removal event from signals from a pressure sensor and / or a flow sensor.

25. The method according to claim 21, further comprising: The transmission of the second aggregated data is triggered by the client device via the second wireless transmission, wherein the triggering includes: A communication pairing is established between the client device and the respiratory therapy device.

26. The method according to any one of claims 21 to 25, further comprising: The communication is initiated from the server system by accessing the therapy data display application on the client device to receive the generated output report at the client device.

27. The method according to any one of claims 21 to 26, wherein the second communication channel comprises transmission via a Wi-Fi communication network.

28. The method of claim 27, wherein the transmission via the Wi-Fi communication network includes a communication from the client device to the server system, wherein the client device sends the second summary data to the server system after receiving the second summary data from the respiratory therapy device.

29. The method according to any one of claims 21 to 28, wherein the client device comprises a smartphone or tablet computer configured by an application to communicate with the respiratory therapy device.

30. The method of claim 29, wherein the short-range wireless communication includes a Bluetooth™ connection.

31. The method according to any one of claims 21 to 30, wherein each of the first summary data and the second summary data includes one or more of the following: duration of treatment; Apnea index, hypopnea index; obstructive apnea index; central apnea index; Apnea index not distinguished; Respiratory event-related arousal index; One or more leak measurements; one or more inspiratory pressure measurements; one or more expiratory pressure measurements; duration of Cheyne-Stokes breathing; One or more mask pressure measurements; One or more tidal volume measurements; One or more minute ventilation measurements; one or more respiratory rate measurements; Ambient humidity measurement; Humidifier temperature measurement; Humidifier power measurement value; Heating element power measurement; pressure measurement of one or more blowers; One or more respiratory flow measurements; Humidifier connection indicator; Delivery pipe connection indicator; Blower flow rate measurement; And the number of time periods used.

32. The method according to any one of claims 21 to 31, wherein the one or more first parameters include duration.

33. The method of claim 32, wherein the duration is the duration of therapy.

34. The method of any one of claims 21 to 33, wherein the remote comparison determines a duration greater than one or more other durations.

35. The method according to any one of claims 21 to 34, wherein the first summary data consists of a portion of redundant data relative to the second summary data.

36. The method of claim 35, wherein one of the first summary data and the second summary data is the second summary data.

37. The method according to any one of claims 21 to 36, wherein the output report includes a treatment duration score.

38. The method of claim 37, wherein the treatment duration score in the output report is derived based on a plurality of parameters, the plurality of parameters including multiple of the following: apnea-hypopnea index; leakage measurement; number of mask removals; and duration of treatment use.

39. The method of claim 38, wherein the output report comprises a plurality of scores, wherein each of the plurality of scores is derived based on one of the plurality of parameters.

40. A processor-readable medium having processor-executable instructions stored thereon, the processor-executable instructions, when executed by one or more processors, causing the one or more processors to perform a method for transmitting respiratory therapy data from a respiratory therapy device via one or more networks and server systems in multiple transmissions, the method comprising the method according to any one of claims 21 to 39.

41. A system comprising one or more respiratory therapy devices and a server system, the system further comprising a processor-readable medium according to claim 40.

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