Methods and apparatus for medical device communications

Abstract

Methods and apparatus may include server(s) (130) receiving a plurality of transmissions of respiratory therapy data from a therapy device (150) over a network(s). The server(s) may receive first summary data from a first wireless transmission over at least a first communications channel from the device. The server(s) may receive second summary data from a second wireless transmission over at least a second communications channel from the device. The first and second summary data may each include a therapy data summary. The server(s) may access first parameter(s) from the received first data and may access second parameter(s) from the received second data. The server(s) may compare the first parameter(s) with the second parameter(s). The server(s) may generate an output report with data from the first data and / or the second data based on a result of the comparing and may transmit, from the server(s), the output report to a client device.

Description

METHODS AND APPARATUS FOR MEDICAL DEVICE COMMUNICATIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of United States Provisional Patent Application No. 63 / 552,883, filed February 13, 2024, the entire contents of which is incorporated herein by reference.1 BACKGROUND OF THE TECHNOLOGY1 1 FIELD OF THE TECHNOLOGY

[0002] The present technology generally relates to automated transmissions of therapy data between medical devices and remote server systems.1.2 DESCRIPTION OF RELATED ART

[0003] Home-based respiratory therapy devices allow patients to receive respiratory therapy in the comfort of the patients’ home. Supervised review is beneficial to evaluate compliance and / or to monitor conditions of the patients using such devices, as well as for providing feedback to patients regarding therapy. Such review may regularly involve assessment of therapy data generated by the respiratory therapy devices. Establishing communications, such as by automating transmissions, with such devices can pennit greater and more efficient access to data for such review of the therapy data which in turn can improve patient experience and health.

[0004] Some existing respiratory therapy devices implement a cellular modem to transfer therapy data to a remote server that is accessible by the clinician. However, due to communication limitations such as quality or availability of such networks, the cellular modem is not always a reliable device for efficient and timely transferring of data.

[0005] In view of the foregoing, there is a need for a cost effective, time-saving communications approach to data transfer from home therapy devices such as to automate transmissions to a remote server system.2 BRIEF SUMMARY OF THE TECHNOLOGY

[0006] The present technology concerns communications for transmitting data with medical devices, remote server systems such as one or more servers and / or client devices, such as smart phones or tablets.

[0007] Some implementations of the present technology may include a method of one or more servers receiving a plurality of transmissions of respiratory therapy data from a respiratory therapy device over one or more networks. The method may include receiving first summary data from a first wireless transmission over at least a first communications channel from the respiratory therapy device. The first summary data may include a summary of the respiratory therapy data. The method may include receiving secondsummary data from a second wireless transmission over at least a second communications channel from the respiratory therapy device. The second summary data may include a summary of the respiratory' therapy data. Hie 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 the one or more first parameters with the one or more second parameters. The method may include generating an output report with data from one, or at least one, of the first summary' data and the second summary data based on a result of the comparing. The method may include transmitting, from the one or more servers, the output report to a client device.

[0008] In some implementation, the first communications channel may include a transmission over a wireless fidelity (Wi-Fi) communications network. The transmission over the Wi-Fi communications network may include a communication from the client device to the one or more servers, wherein the client device transmits the first summary data to the one or more servers after receiving the first summary data from the respiratory' therapy device. The client device may' include a smart phone or tablet configured by an application to communicate with the respiratory therapy device via a third communications channel. The third communications channel may include a transmission via short-range wireless communications. The short-range wireless communications may include a Bluetooth™ connection. The second communications channel may include a transmission over on a cellular communications network. The transmission over the cellular communications network may include a communication of the second summary data from the respiratory' therapy device to the one or more servers.

[0009] In some implementations, the first summary data and second summary' data comprise one or more of: a therapy duration; an apnea index, an hypopnea index; an obstructive apnea index; a central apnea index; an undistinguished apnea index; a respiratory event related arousal index; one or more leak measures; one or more inspiratory pressure measures; one or more expiratory pressure measures; a duration of Cheyne-Stokes breathing; one or more mask pressure measures; one or more tidal volume measures; one or more minute ventilation measures; one or more respiratory rate measures; an ambient humidity measure; a humidifier temperature measure; a humidifier power measure; a heated tube power measure; one or more blower pressure measures; one or more respiratory flow measures; a humidifier connection indicator; a delivery tube connection indicator; a blower flow measure; and a number of use periods. Optionally, the one or more first parameters may include a duration. The duration may be a therapy duration. The comparing may determine that a duration, such as the 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 to a portion of the second summary’ data. The one of the first summary’ data and tire second summary data that is used for the generating may be the second summary data.

[0010] In some implementations, the output report may include a therapy session score. Tire therapy session score of the output report may be derived from a plurality of parameters. The plurality of parameters may include a plurality of: an apnea-hypopnea index; a leak measure; a mask removal count, and a therapy usage duration. The output report may include a plurality of scores. Each of tire plurality of scores may be derived from a parameter of the plurality of parameters.

[0011] Some implementations of the present technology may include a processor-readable medium, having stored thereon processor-executable instructions which, when executed by one or more processors, cause the one or more processors to perform a method of one or more servers receiving a plurality of transmissions of respiratory therapy data from a respiratory therapy device over one or more networks. The method may include any of the method described herein.

[0012] Some implementations ofthe present technology may include one ormore servers that may include one or more processors and that may be configured to receive a plurality of transmissions of respiratory therapy data from a respiratory therapy device over one or more networks. Tire one or more processors may be configured to receive first summary data from a first wireless transmission over at least a first communications channel from the respiratory therapy device. The first summary data may include a summary of the respiratory therapy data. The one or more processors may be configured to receive second summary data from a second wireless transmission over at least a second communications channel from the respiratory therapy device. The second summary data may include a summary of the respiratory therapy data. The one or more processors may be configured to access one or more first parameters from the received first summary' data. The one or more processors may be configured to access one or more second parameters from the received second summary data. Tire one or more processors may be configured to compare the one or more first parameters with the one or more second parameters. The one or more processors may be configured to generate an output report with data from one, or at least one, of the first summary data and the second summary data based on a result of the comparing. The one or more processors may be configured to transmit, from the one or more servers, the output report to a client device.

[0013] In some implementations, the one or more servers are further configured to perform any method described herein.

[0014] Some implementations of the present technology may include a method for communicating respiratory therapy data from a respiratory therapy device in a plurality of transmissions with a server system, that may include one or more servers, over one or more networks. The method may include sending first summary' data in a first wireless transmission over at least a first communications channel to the one or more servers from the respiratory therapy device. The first summary' data may include a summary of the respiratory therapy data. The first communication channel may include a cellular communication. Hiemethod may include sending second sum man data in a second wireless transmission over at least a second communications channel from the respiratory therapy device to a client device. The second summary data may include a summary of the respiratory therapy data. The second communication channel may include a short-range wireless communication. The method may include sending, from the client device, the second summary data received from tire respiratory therapy device to the one or more servers over at least a third communications channel. Tire method may include receiving, at the client device, in a communication from the server system, a generated output report with data from one of the first summary? data and the second summary? data based on a result of a remote comparison by the server system of one or more first parameters from the first summary data with one or more second parameters from the second summary data received by the server system from the client device.

[0015] In some implementations, the method may further include triggering, by the client device, the sending of the second summary data in the second wireless transmission. The triggering may include accessing, on the client device, a therapy data display application while the client device and the respiratory? therapy device are communicatively paired.

[0016] In some implementations, the method may further include triggering, by the respiratory therapy device, the sending of the second summary data in the second wireless transmission. The triggering may include transitioning from a therapy mode to a standby mode, while the client device and the respiratory? therapy device are communicatively paired. Optionally, the transitioning may occur in response to the respiratory? therapy device detecting, from a signal from a pressure sensor and / or flow sensor, a mask removal event.

[0017] In some implementations, tire method may further include triggering, by the client device, the sending of tire second summary data in the second wireless transmission. The triggering may include establishing a communications pairing between the client device and the respiratory therapy device.

[0018] In some implementations, the method may further include initiating the communication from the server system to receive at tire client device the generated output report, by accessing, on the client device, a therapy data display application. Tire second communications channel may include a transmission over a wireless fidelity (Wi-Fi) communications network. The transmission over the Wi-Fi communications network may include a communication from the client device to the server system, wherein the client device transmits the second summary data to the server system after receiving the second summary data from the respiratory? therapy device. The client device may include a smart phone or tablet configured by an application to communicate with the respiratory? therapy device. The short-range wireless communication may include a Bluetooth™ connection. Optionally, each of the first summary? data and the second summary? data comprise one or more of: a therapy duration; an apnea index, an hypopnea index; an obstructive apneaindex; a central apnea index; an undistinguished apnea index; a respiratory event related arousal index; one or more leak measures; one or more inspiratory pressure measures; one or more expiratory pressure measures; a duration of Cheyne-Stokes breathing; one or more mask pressure measures; one or more tidal volume measures; one or more minute ventilation measures; one or more respiratory rate measures; an ambient humidity measure; a humidifier temperature measure; a humidifier power measure; a heated tube power measure; one ormore blower pressure measures; one or more respiratory' flow measures; a humidifier connection indicator; a delivery tube connection indicator; a blower flow measure; and a number of use periods.

[0019] In some implementations, the one or more first parameters may include a duration. Tire duration may be a therapy duration. The remote comparison may determine that a duration that is greater than one or more other durations. The first summary data may consist of data that is redundant to a portion of the second sum man data. The one of the first summary data and the second summary data that is used for the generating, may be the second summary' data. The output report may include a therapy session score. The therapy session score of the output report may be derived from a plurality of parameters. The plurality of parameters may include a plurality of: an apnea-hypopnea index; a leak measure; a mask removal count, and a therapy usage duration. Hie output report may include a plurality of scores. Each of the plurality of scores may be derived from a parameter of the plurality of parameters.

[0020] Some implementations of the present technology may include a processor-readable medium, having stored thereon processor-executable instructions which, when executed by one or more processors, cause the one or more processors to perform a method for communicating respiratory therapy data from a respiratory therapy device in a plurality of transmissions with a server system over one or more networks. The method may be any of the methods described herein.

[0021] Some implementations of the present technology may include a system that may include one or more respiratory therapy devices and a server system. The system may further include any processor- readable medium, with processor-executable instructions, as described herein.

[0022] Other features of the technology will be apparent from consideration of tire information contained in the following detailed description, abstract, drawings and claims.3 BRIEF DESCRIPTION OF DRAWINGS

[0023] Tire present technology is illustrated by way of example, and not by way of limitation, in the figures of tlie accompanying drawings, in which like reference numerals refer to similar elements including:

[0024] Fig. 1 illustrates example communications, including wireless communications, between a server system (e.g.. one ormore remote server(s) 130), a medical device 120 (e.g., one ormore respiratory therapydevices), and a client device 140, such as a wireless communications device or smart phone of the present technology.

[0025] Fig. 2 illustrates example details of an example medical device of the present technology.

[0026] Fig. 3 illustrates example details of an example server system of the present technology.

[0027] Fig. 4 illustrates example details of an example client device that is a wireless communications device (e.g., wireless device 140) such as a smart phone or tablet of the present technology.

[0028] Figs. 5A-5C depict example user interface screens illustrating setup of an example client device (e.g., wireless communications device) with a medical device 120 such as a therapy device or respiratory therapy device of the present technology.

[0029] Fig. 6A illustrates example communications, such as including wireless cellular transmissions, between a medical device and a remote server of a server system of the present technology.

[0030] Fig. 6B illustrates example communications, such as including short-range wireless transmissions, between a medical device, a client device, and a remote server of a server system of the present technology.

[0031] Fig. 6C illustrates example processes for transmitting data from a medical device 120 over a cellular data network to a remote server 130.

[0032] Fig. 6D illustrates example processes for transmitting data from a medical device 120 via a wireless device 140 to a remote server 130.

[0033] Fig. 6E illustrates example processes for transmitting data from a medical device 120 without and with a wireless device 140 to a remote server 130 via different wireless channels and reporting data based on at least partially duplicated transmissions from the different channels.

[0034] Fig. 6F depicts a dashboard of a therapy data display application (e.g., app) for displaying therapy data to a patient on a client device, such as wireless device 140.

[0035] Fig. 7A shows an example respiratory therapy device, such as a respiratory pressure therapy (RPT) device, in accordance with the present technology. A patient 1000 wearing a patient interface 3000 receives a supply of pressurised air from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown.

[0036] Fig. 7B shows an RPT device 4000 in use on a patient 1000 with a nasal mask 3000.

[0037] Fig. 7C shows an RPT device 4000 in use on a patient 1000 with a full-face mask 3000.

[0038] Fig. 8 shows an example non-invasive patient interface 3000 in the form of a nasal mask.

[0039] Fig. 9A shows an RPT device 4000 in accordance with one form of the present technology.

[0040] Fig. 9B shows a schematic diagram of the pneumatic circuit of an RPT device 4000 in accordance with one form of the present technology. The directions of upstream and downstream arc indicated.

[0041] Fig. 9C shows a schematic diagram of the electrical components of an RPT device 4000 in accordance with one aspect of the present technology.

[0042] Fig. 9D shows a schematic diagram of the algorithms 4300 implemented in an RPT device 4000 in accordance with an aspect of the present technology. In Fig. 9D, arrows with solid lines indicate an actual flow of information, for example via an electronic signal.

[0043] Fig. 9E is a flow chart illustrating a method 4500 carried out by the therapy engine module 4320 of Fig. 9D in accordance with one aspect of the present technology.

[0044] Fig. 10 shows a humidifier 5000.4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

[0045] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0046] The following description is provided in relation to various examples which may share one or more common characteristics and / or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.4 1 SYSTEM OVERVIEW

[0047] Some aspects of the present technology relate to communications between a medical device 120, a remote server system of one or more servers such as remote server 130, and a client device such as wireless device 140, as shown in the example of Fig. 1.

[0048] Tire medical device 120 may be a therapy device, such as a respiratory therapy device that provides treatment to a user, such as respiratory treatment and may be a respiratory therapy (RT) or respiratory pressure therapy (RPT) device described in more detail herein. In some versions, the medical device 120 may be an RPT device and / or a high flow therapy device (HFT). The medical device 120 may provide a flow of breathable gas to the user. An interface, such as a mask, may be used to interface the medical device 120 to the user. Depending upon the therapy to be applied, the interface may form a seal, e.g., with a face region of the user, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy. Although only one medical device 120 is illustrated, technology will typically be applied to multiple such medical devices that communicate with the server system. Moreover, although the functionality described herein may be implemented with an RPT device, such functionality may be similarlyimplemented with an HFT device or RT device, such as in relation to the communications and / or therapy data display / reporting functionalities described in more detail herein.

[0049] Tire server system, including one or more remote scrvcr(s) 130, may be a remotely located computing system that receives and stores therapy data, such as usage data, measured / determined health parameters or events, of the medical device 120 such as a plurality of such devices. The remote server(s) may be implemented to monitor and / or evaluate conditions or treatment progress of the user based on therapy data generated by the medical device 120, such as to provide feedback to the patient. Thus, the remote server(s) 130 may be a cloud-based server system, and may be implemented as one or more servers such as to divide functionality amongst such servers. The remote server 130 may be accessible to a clinician(s). In some implementations, some servers of the remote server system may merely receive and pre-process data, and other servers of the remote server system may receive or access such processed data and generate or provide insights such as by providing clinician or patient access to such processed data, summaries or reports thereof and insights based thereon.

[0050] Tire client device or wireless device 140 may be a computing system accessible by a user, and more typically, a patient using the medical device. Examples of the wireless device 140 may include mobile smart phone, tablet, netbook, desktop computer, laptop computer, and wearable computing device such as a smartwatch, among other possibilities. Although only one client device (e.g., wireless device 140) is illustrated in Fig. 1, it will be understood that multiple such client devices may communicate with the server system. However, it is typical that only one client device is paired with one medical device for short-range wireless communications between them. Such a client device is typically a personal device of the patient who uses tire medical device for a home medical use such as a home medical therapy.

[0051] 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 into a memory’ 156 of the medical device. Such data may include therapy data 126 related to one or more treatment sessions of the user. Therapy data 126 may include, but not limited to, one or more sensor measurements or determined information or parameters, such as any from the pre-processing module 4310 and / or the therapy engine module 4320 (as shown, for example, in Fig. 9D), of the user as collected by the medical device 120, usage data of tire medical device 120. and one or more device settings of the medical device 120 used in the user’s treatment session(s). The therapy data may include sensor data and / or determined parameters such as with the modules described in more detail here (e g., any data / parameters / measurements determined by the pre-processing 4310 and therapy engine 430 modules) such as respiratory’ measurements that may include the number of respiratory' events a user has experienced, such as a number of respiratory events per hour. Therapy data 126 may include usage data such as the duration of time the medical device has been used such as usage hours, andthe duration of time a mask has been worn by the user during one or more treatment sessions, number of times that the mask is taken on and off the user’s face, and efficiency of mask seal such as flow rate of mask leak, among others. The therapy data may include device settings such as one or more of the following parameters of the medical device: mode, maximum pressure, minimum pressure, and expiratory pressure relief (EPR) settings, among other possibilities.

[0052] Given that therapy data 126 may be stored in the memory 156 of the medical device 120, it may be usefid to communicate that therapy data from the medical device 120 to the remote server(s) 130 and / or to the wireless device 140, e.g., for analysis and / or for display to a patient. To this end, for transmission efficiency purposes, tire medical device 120 may be configured to generate therapy summary data from therapy data stored in the memory for communication to the remote server(s) and / or client device. For example, the wireless device 140 may include a therapy processing system 178 that provides functionality of a therapy data display application (an "app") that is configured to remotely retrieve (e.g., from the server system) and display information such as in a "dashboard" of the client device to a patient. Thus, such information that is displayed in the dashboard may be generated by the server system. Such a generation of display information may be based on summary data that is transmitted to the server system from therapy device, which transmissions may be both with communications through the client device and transmission not through the client device, e.g.. transmission more directly to the server system.

[0053] As described in more detail herein, the present technology provides processes and transmissions for efficiently communicating therapy data between the medical device 120, the remote server 130, and the wireless device 140.4.2 Medical Device

[0054] As shown in the example of Fig. 2, the medical device 120 may have one or more processor(s) 150, a display 154, memory 156, one or more network interface(s) 158, and a selector 166, such as an input device 4220 or control element of a graphic user interface. Tire network interface 158 may have, or operated as. one or more transceivers 160, such as a short-range wireless (e.g.. Bluetooth™) transceiver 162 and a longer-range transceiver such as a wireless transceiver 164 (e.g., cellular and / or Wifi transceiver(s)). The selector 166 may, for example, take the form of a knob, which may be manipulated by the user to navigate menus shown in the display 154. As described in more detail herein, the medical device may be a therapy device, such as an RPT or RT device described in relation to Figs. 7-10. The medical device may generate data such as therapy data or the summan' therapy data as previously described and described in more detail herein. The medical device may also operate in accordance with device settings (e.g., control parameters).

[0055] Therapy data may include, but not limited to, one or more respiratory measurements of the user as 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 in the user’s treatment session(s). Tire respiratory measurements may include the number of respiratory events a user has experienced, such as number of respiratory events per hour. The usage data may include the duration of time the medical device has been used such as usage hours, and the duration of time a mask has been worn by the user during one or more treatment sessions, number of times that the mask is taken on and off tire user’s face, and efficiency of mask seal, among others.

[0056] Tire device settings may include one or more of the following parameters of the medical device: therapy mode, maximum pressure, minimum pressure, and expiratory pressure relief (EPR) pressure, among other possibilities. By way of example, in one treatment setting, the maximum pressure may be 20 cmH20. The minimum pressure may be 4 cmH20. The therapy mode may be AutoSet™ (an auto-adjusting mode), indicating, for example, a pressure range of 4 cmfCO to 20 cm ICO (4-20 hPa). In such an AutoSet™ mode, the device may then modify the delivered therapy pressure, within tire range, depending on detection of respiratory events (e.g., a pressure increase in response to a detected flow limitation or obstructive apnea) or an absence of detection of such events (e.g., a pressure decrease). Tire EPR, if enabled, may be selected to provide one of three levels, where level 1 may indicate 1.0 cmH20 (1 hPa), level 2 may indicate 2.0 cmH20 (2 hPa), and level 3 may indicate 3.0 cmH20 (3 hPa). The EPR may then operate the device to provide a reduction of the therapy pressure during expiration by the amount of the EPR setting. Such a reduction in pressure delivered will not typically drop below a predetermined threshold, such as 4 cmH20 (4 hPa).

[0057] In some implementations, the summary therapy data may include, for example, any of: therapy start date and time, therapy end date and time, therapy duration, and / or number of periods of use. The medical device may be configured to generate such summary therapy data, such as from therapy data it otherwise has determined with its sensors. Such summary therapy data may, for example, include any one for more of: a therapy duration; an apnea index, an hypopnea index; an obstructive apnea index; a central apnea index; an undistinguished apnea index; a respiratory event related arousal index; one or more leak measures (such as different percentiles of leak amount); one or more inspiratory pressure measures (such as different percentiles of inspiratory pressure); one or more expiratory pressure measures (such as different percentiles of expiratory pressure); a duration of Cheyne-Stokes breathing; one or more mask pressure measures (such as different percentiles of mask pressure); one or more tidal volume measures (such as different percentiles of tidal volume); one or more ventilation measures (such as different percentiles of minute ventilation); one or more respiratory rate measures; an ambient humidity measure (such as an average or ccntilc thereof); a humidifier temperature measure (such as an average or centile thereof); a humidifier power measure (suchas an average or centile thereof); a heated tube power measure (such as an average or centile thereof); one or more blower pressure measures (such as different percentiles of blower or flow generator pressure); one or more respiratory flow measures (such as different percentiles of flow rate measures); a humidifier connection indicator; a delivery tube connection indicator; a blower flow measure; and a number of use periods. Such summary data may be for a session of use with the medical device such as a period of time of uninterrupted use or a period of time covering several interrupted uses. Such summary therapy data may be communicated from the therapy device by a plurality of wireless transmissions using a plurality of different communications channels or protocols (e.g., cellular, Bluetooth™ or other short-range means, etc.). Such different communications channel transmissions may transmit summary therapy data that is partially redundant to other transmitted summary therapy data. For example, summary therapy data that is transmitted by cellular network from the medical device 120 to the server system may be partially redundant to summary therapy data that is separately transmitted by a different channel wireless communication (e.g., short-range transmission to client device) and then by the client device to the server system).

[0058] Tire memory 156, with tire data of the medical device, may be of any type capable of storing information accessible by the processor(s), including a computing device-readable medium. For example, the memory 156 of the medical device 120 may store instructions (e.g., processor control instructions) and data, such as to implement the data communications related functions described herein that may be executed or otherwise used by the processor(s) 150. The memory' may be a non-transitory medium such as a harddrive, memory' card, optical disk, solid-state, etc. Tire memory may include different combinations of the foregoing, whereby different portions of the instructions and data are stored on different types of media. The instructions may be any set of instructions to be executed directly (such as machine code) or indirectly (such as scripts) by tire processor(s). For example, the instructions may be stored as computing device code on the computing device-readable medium. In that regard, the terms “instructions7’, “modules” and “programs” may be used interchangeably herein. The instructions may be stored in object code format for direct processing by the processor, or in any other computing device language including scripts or collections of independent source code modules that are interpreted on demand or compiled in advance.4.3 Remote Server System

[0059] The remote server(s) 130, as illustrated in the example of Fig. 3, may include a database 132 (e.g., one or more databases) for storing therapy data 126 that concerns the treatment sessions of a plurality' of patients. The remote server system may be accessible to the client device and the medical device over one or more networks such as a cellular network and / or an internet. Each user or patient may be associated with an account with the remote server(s) 130. Each such account may store historical data, such as therapy-l idata, obtained from the user’s sessions with the medical device, so that the remote server 130 can store data from which the progress of each individual user can be tracked. Each account may also store device infomiation of the medical device used by tire user.

[0060] The remote server(s) 130 may be configured to provide support (such as therapy support) to the patient user through the therapy processing system 178 ofthe wireless device 140. For example, the remote server 130 may send therapy data or a generated report based on received therapy data (or received summary data) to the therapy processing system 178 for display to tire user (e.g., patient). For example, one or more servers of the server system may be configured to receive multiple summary therapy data communications, such as from different communications channels as previously discussed, and generate an output report for communication to, and display on, the client device (e.g., wireless device 14). The output report may include a therapy session score, such as a therapy session score disclosed in U.S. Patent Application Publication No. US 2017-0311879, the entire disclosure ofwhich is incorporated herein by reference. The output report may include, for example, a plurality of parameters that are based on the sum maty therapy data. The plurality of parameters may include any plurality of: an apnea-hypopnea index; a leak measure; a mask removal count, and a therapy usage duration.

[0061] In instances of receiving multiple therapy summary data communications, such as from different communication channels as previously discussed such as where different therapy summary data communications may relate to the same sleep session (e.g., a night of sleep), the remote server system may generate the output report based on one of them, such as to ensure use of the most applicable information. For example, a server of the server system may be configured to compare one or more parameters from each of a plurality of the summary therapy data communications from different transmissions to select one summary therapy data set for generating the output report to a patient. For example, one or more first parameters from a first summary data (e.g.. file or data set) may be compared with one or more second parameters from a second summary data (e.g., file or data set). Such compared parameter(s) may include a duration from each of the therapy summary data sets. For example, the output report may be generated from the summary therapy data with a longer or longest duration, such as a longer or longest duration of use of the medical device (e.g., therapy usage or duration time). However, in some versions other parameters may be compared. For example, the comparison may consider a number of events (e.g.. anyone or more of an apnea index, an hypopnea index; an obstructive apnea index; a central apnea index; an undistinguished apnea index; a respiratory event related arousal index, etc.). In such case(s), a summary data set having a greater number of such events than other summary data sets may be selected for generation of the output report such that the output report is based on the data of the selected summary set from the comparison(s).

[0062] For example, it may occurthat apatient removes (either intentionally or unintentionally) their mask during a sleep session, with the mask remaining off the patient's face for long enough that the medical device 120 will detect such a mask removal event and communicate a therapy session to the remote server by sending therapy summary data, such as via the communications processes of Fig. 6A. The patient then may replace the mask, and later remove it (either intentionally or unintentionally), so that the medical device 120 may again send therapy data (e.g., therapy summary data) for another therapy session on the same date but which may be with a longer duration than the previous report. Such additional communications may be again by the cellular communications process of Fig. 6A and / or other communications processes described herein (e.g., Fig. 6B). In some aspects of tire technology, tire remote server 130 may deconflict such multiple communicated therapy data sets by selecting for example, a most complete therapy summary data according to the aforementioned comparison(s). Thus, in some implementations, the remote server may choose one, or at least one, therapy summary data set based on comparing therapy summary data sets, or parameter data therefrom, received from different communications channels. In some such implementations, the remote server may be configured to compare such therapy summary data sets, or data therefrom, and extract therapy data from multiple of such therapy summary data sets received from different communications channels for generating a report therefrom. Similarly, the remote server may be configured to otherwise, based on one or more comparisons, combine at least two therapy summary data sets, or data therefrom, from a larger plurality of therapy summary data sets (e.g., three or more) which at least are in part received from different communications channels. With the extracted data and / or combined data, the remote server may then generate a therapy report from the extracted and / or combined data.4.4 Client device

[0063] The client device (e.g., wireless communications device or wireless device 140), as shown in the example of Fig. 4, may include one or more processors 170, a display 172, a camera 174, memory 176, a therapy processing system 178, and a network interface 180. Tire 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 longer range transceivers, such as a cellular transceiver 186. and a Wi-Fi transceiver 188. Tire display 172 may be a monitor having a screen or any other electrical device that is operable to display information (e.g., text, imagery and / or other graphical elements). In addition, the wireless device 140 may include all of the components normally used in connection with a computing device such as a user interface subsystem. The user interface subsystem may include one or more user input devices (e.g., a mouse, keyboard, touch screen and / or microphone) for receiving input from the user, and output devices such as a screen and / or speaker(s).

[0064] The therapy processing system 178, such as with the programming of the therapy data display application, may generate prompts to the user on an individual or regular basis. For instance, the therapy processing system 178 may remind the user on a daily basis to connect with the medical device 120, e.g., using a short-range wireless (e.g., Bluetooth™) connection 190. In other instances, the therapy processing system 178 may connect automatically with the medical device 120. such as when the therapy data displayapplication is launched on the client device and / or when the medical device 120 transitions from a therapy mode to a standby mode. Optionally, the therapy processing system 178 may also communicate one or more messages to the medical device 120, such as via a wireless link with the medical device, and / or receive therapy data, such as therapy summary data, via the wireless link with the medical device.

[0065] The therapy processing system 178 may also receive the aforementioned output report generated by the server system such as a therapy session score and associated parameter data from the remote server(s) 130. For example, the summary session score and associated data may include an overall sleep score, an apnea hypopnea index score, a leak score, a mask compliance score, and a usage duration score.

[0066] Tirus, the wireless device 140 may be configured to communicate, such as with tire remote server(s) 130 or medical device 120, via any of the following transceivers 182: the short-range transceiver 184, the cellular transceiver 186 and the Wi-Fi transceiver, such as according to the communications previously discussed and as discussed in more detail herein.

[0067] The memory 176 described herein may comprise one or more database(s) that stores information accessible by the processor(s) 170. The memory 176 of the wireless device 140 may store instructions and data associated with the therapy processing system 178 (with, for example, the therapy data display application) that may be executed or otherwise used by tire processor(s) 170, including, for example, programming instructions of the therapy data display application. The memory 176 may be of any type capable of storing information accessible by the processor(s), including a computing device -readable medium. The memory may be a non-transitory medium such as a hard-drive, memory card, optical disk, solid-state, etc. The memory may include different combinations of the foregoing, whereby different portions of the instructions and data are stored on different ty pes of media. The instructions may be any set of instructions to be executed directly (such as machine code) or indirectly (such as scripts) by the processor(s). For example, the instructions may be stored as computing device code on the computing device-readable medium. In that regard, the terms “instructions”, “modules” and “programs” may be used interchangeably herein. The instructions may be stored in object code format for direct processing by the processor, or in any other computing device language including scripts or collections of independent source code modules that arc interpreted on demand or compiled in advance.

[0068] The processors described herein (e.g., processor(s) 150 and 170) may be any conventional processors, such as commercially available GPUs, CPUs, TPUs, etc. Alternatively, each processor may be a dedicated device such as an ASIC or other hardware-based processor. Although various drawing figures functionally illustrate the processors, memory as being within the same block, such devices may actually include multiple processors, computing devices, or memories that may or may not be stored within the same physical housing. Similarly, the memory may be a hard drive or other storage media located in a housing different from that of the processor(s), for instance in a cloud computing system. Accordingly, references to a processor or computing device will be understood to include references to a collection of processors or computing devices or memories that may or may not operate in parallel. Tire processors 150 and 170 may respectively access the memory 156 and 176 via a network.

[0069] Example processes for implementing the aforementioned communications-related operations with the components of a system of the present technology (e.g., medical device, server system and client device) may be considered in more detail in relation to Figs. 5-6 as discussed in more detail herein.4.5 Setup

[0070] When the user receives the medical device 120 for the first time, the user may register the medical device 120 with the remote server. For example, the user may download and install a therapy data display application comprising the therapy processing system 178 onto the user’s wireless device 140, and create an account at the remote server system (e.g., servcr(s) 130) through the therapy processing system 178. The therapy processing system 178 may then provide the functionality described herein as well as a graphic user interface for such functionality.

[0071] For example, a short-range wireless (e.g.. Bluetooth™) connection 190 may be set up between the medical device 120 and the wireless device 140. The wireless device 140 may prompt a user to enter the authentication information of the connection 190, shown as authentication 124 in Fig. 5A. The wireless device 140 may include an application that prompts the user to enter the authentication infonnation. Alternatively, a browser on the wireless device 140 may display a web page that prompts the user to enter the authentication information. Once the user enters the authentication information into the wireless device 140, the wireless device 140 may transmit the authentication information to the medical device 120 via the connection 190. The medical device 120 may then write the authentication information onto the memory 156. The authentication information may be stored in the memory 156, and be used by the medical device 120 for connecting to the wireless device 140. The authentication infonnation may then be associated with a unique identifier of the medical device 120. The authentication may be a password and / or otherinformation variant that may be derived at least in part from such a password, such as a hash from a hash function or other code transformation.

[0072] In one such example, as shown in Fig. 5A, the therapy processing system 178 (e.g., referred to as my Air™ in Fig. 5A) may display an initial page 510, requesting the user to sign in. Such sign in information may serve as credentials for communicating with the remote server 130. Next, the therapy processing system 178 may connect with the medical device 120, e.g., via short-range wireless transceiver 184. Thereafter, the user 200 may then use the selector 166 of the medical device 120 to select an option or menu to confirm a connection of the wireless device 140 w ith the medical device 120. Such a connection may involve a transfer of tire unique identifier of the medical device (e.g., serial number) to the server system, so as to associate the user with the medical device.

[0073] As shown in Fig. 5B. after completing the above setup, the therapy processing system 178 may display a page 530 showing that the medical device 120 is ready to use. The therapy processing system 178 may then display a subsequent page 540 to get a baseline of the user’s status, such as prompting the user to answ er how sleepy the user usually feels during the day as shown in Fig. 5C. Thereafter, a user may begin use of the medical device, such as to begin a therapy session with the device.

[0074] In some implementations, tire user may register the medical device 120 with the remote server without using the short-range wireless connection 190. For example, unique identifier device information of the medical device 120, such as the serial number, may be acquired by capturing an image of a label on the medical device 120. Alternatively, such device information may be entered by the user into the therapy processing system 178, through keyboard input or audio input, for example. Once the therapy processing system 178 obtains the device information, it may send tire device information to the remote server 130 to complete registration of the medical device 120.4.6 Data Transmission to Remote Server

[0075] As discussed in more detail herein, periodically, the medical device 120 will store or w rite therapy data 126 into tire memory 156. In the case of a therapy device, such as an RT or RPT, such data may be generated each session with the therapy device, such as during each night of use with the therapy device. After the medical device 120 generates and writes therapy data 126 to the memory 156, the medical device 120, according to its programming instructions and processor(s) 150, then may transmit such data, such as in the form of therapy summary data (e.g., by a JSON formatted name-value pair data object or file) to the remote server 130 via one or more networks 110, such as including a cellular data network. In this regard, the memory 156 may store an address of the remote sewer 130. Hie address of the remote server 130 may be, for example, a domain name, a global Internet protocol (IP) and / or a media access control (MAC)address for such access. The network interface 158 may wirelessly transmit data stored in the memory to the address of the remote server 130. Optionally, in some versions, the medical device 120 may be preconfigured with a block listing protocol that limits the card’s communications to only a desired server(s) (i.e.. remote server 130) so as to preclude it from connecting with or communicating with other servers (e.g., non-authentic servers) that are not part of the system. Such a transmission of therapy summary data may be made after a period of time following when the medical device detects an end of therapy, such as a mask removal event. In some cases, such event may occur multiple times during one night of use of the therapy device, otherwise referred to as a therapy session.

[0076] Tire remote server 130 may be a secure server having restricted access, requiring credential information to access the remote server 130. Credential information may, for example, include a device identifier of the medical device 120 or a device identifier of a card, such as a memory card or wireless memory card, or a combination of both. The device identifier(s) may be unique, such as a non-sequential unique number, enabling the remote server 130 to determine the medical device 120 that generates the data when the remote server 130 receives the data. The device identifier(s) may include, but not limited to, one or more of the following: a serial or other unique number of the medical device 120, and / or a type or device model of tire medical device 120. In some implementations, the medical device 120 may have tire credential information for accessing the remote server 130.

[0077] In some implementations, such as the example as shown in FIG. 6A, the medical device 120 may send credential information (shown as server credential 128) and therapy data 126 (e.g., therapy summary data) to the remote server 130 via the one or more networks 110, including at least in part using cellular wireless communications HOC with a cellular data network. Such access / communications may involve public-key cryptography such as, for example, where the medical device may be configured with a private key for which the remote server has the public key. Tire medical device may use the private key to sign its identity (e.g. serial number) and the data transferred. Other methods for securing such communications may be implemented as described in U.S. Patent No. 11,596,754, the entire disclosure of which is incorporated herein by reference. After accessing the remote server 130 with the credential information, tire medical device 120 may upload tire therapy data 126 to the remote server 130. The credential information may then serve to identify source of tire uploaded therapy data 126. Optionally, tire remote serve r(s) 130 may send one or more device settings (e.g., therapy setting or parameter such as a treatment pressure, Autoset™ mode, humidity level, etc. or other described herein) to the medical device 120.

[0078] In another example as shown in FIG. 6B, the medical device 120 may send credential information (e.g., server credential infomration) and therapy data 126 to the wireless device 140 with short-range wireless communications using a short-range wireless (e.g., Bluetooth™) connection 190. The wirelessdevice 140 then may use the credential information to access the remote server 130 via the one or more network(s) 110, such as via cellular wireless communications and / or wireless fidelity (Wi-Fi) communications, and may upload the therapy data 126 (e.g., therapy summary data) to tire remote server 130. Tire remote server 130 may transmit device settings (e.g., by push notification) directly to the medical device 120, without involving the wireless device 140 but may also transfer such settings to the medical device 120 via the client device (e.g., wireless device 140).

[0079] In some implementations, the wireless device 140 may have the credential information for accessing the remote server 130. In one example as shown in FIG. 6B, when the wireless device 140 establishes the short-range wireless connection 190 with the medical device 120, it also may retrieve the 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) for communicating with the remote server system (e.g., remote server 130).4.6.1 Cellular Data Transmissions

[0080] Fig. 6C illustrates a flow diagram with an example method for transmitting data from the medical device 120 to the server system (e.g., remote server 130). At 302, the processor(s) 150 may instruct at least one wireless communication network interface 158 to join a wireless network using authentication information. In some implementations, at 304, the processor(s) 150 may retrieve network authentication infomiation from the memory 156. In some implementations, at 305, the authentication infomiation may be wirelessly received by tire at least one wireless communication network interface 158 from the wireless device 140, such a via connection 190.

[0081] At 306, the processor(s) 150 may instruct the at least one wireless communication network interface 158 to transmit credential information to the remote server 130. In some implementations, the credential information may be retrieved at 308 from the memory' 156. In some implementations, the credential infomiation may be wirelessly received at 309 from the wireless device 140. In some implementations, the credential information may be retrieved from a firmware of the medical device 120.

[0082] At 310, the processor(s) 150 may instruct the at least one wireless communication network interface 158 to wirelessly transmit the therapy data (e.g., therapy summary data) stored in the memory 156, or generated from data stored therein, to the remote server 130 via the wireless network. In one implementation, the wireless network may include the cellular data network using cellular wireless communications 110C. In such an event, the therapy data is sent by communications, which are at least in part wireless, in a sense, directly to the server system (i.e., without communicating through the client device (i.e.. wireless device 140)).4.6.2 Short-Range Data Transmissions

[0083] In another implementation, as shown in Fig. 6D, the wireless communications of therapy data to the server system may involve the short-range wireless connection 190, such that the wireless device 140 may be an intermediary between the medical device 120 and the remote server 130. A short-range implementation advantageously may enable a higher data rate, e.g., if tire medical device 120 may be ratelimited and / or data-limited or otherwise lacking in its connection with a cellular data network. Thus, a short- range implementation may enable lower latency between cessation of therapy and upload of therapy data 126 to the remote server system (e.g., server 130). Additionally, by having the wireless device 140 establish the interface with the remote server 130 (e.g., by invoking an endpoint of an application programming interface (API) with the remote server), it may be possible for the remote server 130 to efficiently respond with feedback data (e.g., to display dashboard data) back to the therapy processing system 178 of the wireless device 140 in response to an upload of therapy data 126. Credential information as previously described may be utilized to secure such communications, such as to identify source of the uploaded therapy data and / or to serve as a digital signature of the data. Thus, securing such communications may also involve public-key cry ptography or any other methods for securing such communications such as those described in U.S. Patent No. 11,596,754, issued on March 7, 2023, the entire disclosure of which is incorporated herein by reference.

[0084] Although the aforementioned communications generally describe transmissions of data from the medical device 120 to the remote server 130. in some implementations, the medical device 120 may be configured to retrieve data (e.g., download or pull communication) from the remote server 130 or a related server of the server system, or receive data from such a server (e.g., a push communication). Such received or retrieved data may be data useful for operation of tire medical device 120. For example, the medical device 120 may obtain settings or control parameter data (e.g., any of flow rate settings, pressure settings, a software update, etc.) from the remote server 130 for controlling operation of the medical device. Similarly, the medical device 120 may obtain message data (e.g.. a warning, use instructions or other information) from the remote server 130. The medical device 120 then may display the message data on a display of the medical device 120. Optionally, in some implementations, such communications to the medical device 120 may be received, in whole or in part, via communications through the client device (e.g., wireless device 140) including short-range communications via the connection 190.4.6.2 Example Multiple Communications Channels Transmissions

[0085] As previously mentioned, in some implementations, multiple wireless communications of summary data, such as therapy summary data, (e.g., multiple summary data sets) that each concern use of the medicaldevice during a same session (e.g., the same night) albeit with interrupted periods of use, may be made with the server system as described in Fig. 6E such as over different channels. Such communications may include a combination of communications as described in relation to Figs. 6A and 6B. For example, at 602, the medical device 120 may upload therapy data to a remote server 130, such as summary data from a first portion of a night due to a detection of an event, such as a mask removal event. At 604, the therapy data may be uploaded to the remote server for storage in the database(s) of the server system. Such communications may happen at multiple times, such as if the medical device detects multiple events such as the mask removal events and may use cellular communication such as described in Fig. 6A. Thereafter, the wireless device 140 may be triggered by a patient accessing the therapy data display application of the therapy processing system 178 after further use of the medical device 120. Such triggering may, or might not, initiate a request and transfer of further therapy summary data to the wireless device 140 from the medical device at 606 and 608 respectively over a short-range connection, such as connection 190. With the received summary data (if at all), the wireless device 140 may then upload the summary data to the remote server 130 such as for storage in a database of the sever system via a network 110 (e.g., Wi-fi and / or cellular). The wireless device 140 may then request a report from the remote server 130 at 614. In response to the request and / or receipt of the summary data, the remote serve r(s) 130 of the server system at 616 may then generate an output report based on selected summary data, such as based on access and comparison of parameter(s) of multiple summary data communications as previously described. At 618, the remote server system may then communicate (e.g., via Wi-fi and / or cellular) the output report to the wireless device 618 for display on the wireless device 140 with the therapy processing system 178.4.6.3 Periodic Processes

[0086] Once the medical device 120 is registered at the remote server 130, the medical device 120 may routinely or periodically upload the therapy data 126 to the remote server 130 after each treatment session period of use such as detected in relation to mask removal cvcnt(s) as previously discussed. Such communications may be transmitted via the cellular wireless related communications processes of Fig. 6A and / or may be transmitted via the short-range wireless related processes of Fig. 6B, depending on connection availability and / or any predetermined priority.

[0087] In some implementations, the therapy processing system 178 of the client device may regularly or periodically prompt the user to connect with the medical device 120, and / or may automatically connect with the medical device to trigger the therapy data communications as previously described. Such a "trigger" may be programmed into the therapy processing system 178 by its therapy data display application and / or the medical device. Example triggers may include, but not limited to, any one or more of:• The therapy processing system 178 ("app") may initiate a connection with the medical device 120 when the application is launched by a user and there is a valid short-range wireless pairing between the wireless device 140 and the medical device 120. With such a connection, the client device may then request and obtain available therapy data (e.g., therapy summan’ data) from the medical device 120 and then transfer the therapy data to the server system. In some cases, the therapy summary data may be encoded into a different form from that received from the medical device before transfer to the server system.• The medical device 120 may evaluate a connection with the therapy processing system 178 when the medical device 120 transitions from a therapy mode to standby mode (e.g., as a result of detection of a mask removal event as previously described) and if there is a valid short-range wireless communications pairing between tire wireless device 140 and the medical device 120, it may initiate a transfer. With such a connection, the client device may then receive therapy data (e.g., therapy summary data) from the medical device 120 and then the client device may transfer the therapy data to the server system. In some cases, the therapy summary data may be encoded into a different form from that received from the medical device before transfer to the server system.• Tire therapy processing system 178 may connect with the medical device when the wireless device 140 establishes a short-range wireless pairing with the medical device 120. With such a connection, the client device may then request and obtain available therapy data (e.g., therapy summary data) from the medical device 120 and then transfer the therapy data to the server system. In some cases, the therapy summary data may be encoded into a different form from that received from the medical device before transfer to the server system.Other events may also be implemented for initiating such transfers.4.6.4 Dashboard

[0088] The therapy processing system 178 ("app") may display a page 680 ("dashboard") showing the therapy data from the remote server 130 or from the medical device 120, as shown in Fig. 6E. In one example, the therapy processing system 178 may display one or more of usage hours 682, efficiency of mask seal 684, respiratory events per hour 686, number of times that the mask is on and off the user 688 and a total sleep score 690 or a therapy quality indicator based on such data. In some aspects of the technology, the app may display the dashboard each time that a trigger occurs or when the app is accessed by the user / patient. Such access may initiate a request to the server system to download a generated outputreport, which may be based on the aforementioned therapy summary data, such as based on the server system's comparison of parameter(s) of multiple therapy sum maty data communications.

[0089] For example, the app may display the dashboard each time a patient opens the app. Such an opening, such as when a short-range communication connection 190 transceiver (e.g., Bluetooth™) is turned on, after they have established a suitable data transfer pairing (e.g., Bluetooth™ pairing) between the wireless device 140 and the medical device 120, will cause the medical device to transfer the therapy summary data to the client device and then to the server system. The client device may then request and download the generated report created by the server system based on the selected therapy summary data. As such, a report based on their previous night's therapy data 126 may be visible in the app, so that, for example, a sleep score 690 or other therapy quality indicator along with one or more of their sleep summary items 682, 684. 686, 688 may be viewed. In some implementations, the patient may view a plurality of sleep session data such as generated reports based their last two or more nights of therapy summary data.4.6.5 Encryption / Compression

[0090] In some implementations, the medical device 120 and client device (e.g., wireless device 140) may send the therapy data as encrypted data to the remote server 130. so as to have secure communications with the remote server 130.

[0091] In one example, the medical device 120 and / or wireless device 140 may have stored an encryption infomiation (e.g., key(s)) in their memory for encrypting any data for sending to the remote server 130. Their processor(s) may encrypt data provided using an encryption key, and instruct the network interface 158 to wirelessly transmit the encrypted data to the remote server 130.

[0092] In some implementations, the sent data may. or may also, be compressed. Any known compression method may be employed. In some implementations, compression may, for example, be implemented by any of the compression methodologies described in PCT / EP2023 / 077274, filed on 2 October 2023, the entire disclosure of which is incorporated herein by reference.4.7 OPTIONAL EXAMPLE TREATMENT SYSTEMS

[0093] An example embodiment of the medical device 120 is discussed in sections 4.8 to 4.9.

[0094] In one form, the medical device 120 may treat and / or monitor a respiratory disorder. Tire medical device 120 may be a respiratory therapy device (RT) such as an RPT device 4000 for supplying a flow of pressurised air to the patient 1000 via an air circuit 4170 leading to a patient interface 3000. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as high flow therapy HFT). Thus, RPT devices may also be configured to act as flow therapy devices, suchas when using a patient interface that does not use a seal that seals with the patient’s respiratory system. In the following description, the RT or RPT device may be considered in reference to Figs. 7A-10.4.8 PATIENT INTERFACE

[0095] As shown in Fig. 7, a non-invasive patient interface 3000 in accordance with one aspect of the present technology may optionally comprise any of the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, a connection port 3600 for connection to air circuit 4170, and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal -forming structure 3100 is arranged to surround an entrance to an airway of the patient so as to facilitate the supply of pressurised air to the airway.4 9 RPT DEVICE

[0096] Referring to Fig. 9A, 9B, 9C, 9D, 9E, an RPT device 4000 in accordance with one aspect of the present technology comprises mechanical and pneumatic components 4100, electrical components 4200 and is programmed to execute one or more algorithms 4300. Tire RPT device 4000 may have an external housing 4010 fomred in two parts, an upper portion 4012 and a lower portion 4014. In one form, the external housing 4010 may include one or more panel(s) 4015. Tire RPT device 4000 may comprise a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0097] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g. , an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying pressurised air (e.g., a blower 4142), an outlet muffler 4124, and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.

[0098] One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.

[0099] Tire RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250. memory 4260, transducers 4270, 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. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.4.9.1 RPT device mechanical & pneumatic components

[0100] An RPT device 4000 may comprise one or more of the following components in an integral unit. In an alternative fonn. one or more of the following components may be located as respective separate units.4.9.1.1 Air filter(s)

[0101] An RPT device 4000 in accordance with one form of the present technology may include an air filter 4110, or a plurality of air filters 4110.

[0102] In one form, an air inlet filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.

[0103] In one form, an air outlet filter 4114. for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000.4.9.1.2 Muffler (s)

[0104] An RPT device 4000 in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0105] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.

[0106] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000.4.9.1.3 Pressure generator

[0107] In one fonn of the present technology, a pressure generator 4140 for supplying pressurised air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers housed in a volute. Tire pressure generator 4140 may be capable of generating a supply or flow of air, for example at about 120 litres / minute, at a positive pressure in a range from about 4 cmH20 to about 20 cmH20, or in other fonns up to about 30 cmH20.

[0108] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0109] In other forms, a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g., compressed air reservoir), or a bellows.4.9.1.4 Transducer (s)

[0110] Transducers may be internal of the RPT device, or external of the RPT device. External transducers may be located for example on or form part of the air circuit, e.g., the patient interface. External transducersmay be in the form of non-contact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.[OHl] In one form of the present technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 are constructed and arranged to generate data representing respective properties of the air flow, such as a flow rate, a pressure or a temperature, at that point in the pneumatic path.

[0112] In one form of the present technology, one or more transducers 4270 are located proximate to the patient interface 3000.

[0113] In one fomr, a signal from a transducer 4270 may be filtered, such as by low-pass, high-pass or band-pass filtering.4.9.1.5 Anti-spill back valve

[0114] In one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from tire humidifier 5000, for example to the motor 4144.4.9.1.6 Air circuit

[0115] An air circuit 4170 in accordance with one aspect of the present technology is a conduit or tube constructed and arranged to allow, in use, a flow of air to travel between two components such as the pneumatic block 4020 and tire patient interface 3000.4.9.1.7 Oxygen delivery

[0116] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020, to the air circuit 4170 and / or to the patient interface 3000.4.9.2 RPT device electrical components4.9.2.1 Power supply

[0117] In one form of the present technology power supply 4210 is internal of the external housing 4010 of the RPT device 4000. In another form of the present technology, power supply 4210 is external of the external housing 4010 of the RPT device 4000.

[0118] In one fomr of the present technology power supply 4210 provides electrical power to the RPT device 4000 only. In another fonn of the present technology, power supply 4210 provides electrical power to both RPT device 4000 and humidifier 5000.4.9.2.2 Input devices

[0119] In one form of the present technology, an RPT device 4000 includes one or more input devices 4220 in tire form of buttons, switches or dials to allow a person to interact with the device. Tire buttons, switches or dials may be physical devices, or software devices accessible via a touch screen. The buttons, switches or dials may, in one form, be physically connected to the external housing 4010. or may. in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 4230.

[0120] In one form tire input device 4220 may be constructed and arranged to allow a person to select a value and / or a menu option.4.9.2.3 Central controller

[0121] In one fonn of the present technology, the central controller 4230 is a processor suitable to control an RPT device 4000 such as an x86 INTEL processor.

[0122] A central controller 4230 suitable to control an RPT device 4000 in accordance with another form of tire present technology includes a processor based on ARM Cortex-M processor from ARM Holdings. For example, an STM32 series microcontroller from ST MICROELECTRONICS may be used.

[0123] Another central controller 4230 suitable to control an RPT device 4000 in accordance with a further alternative fonn of the present technology includes a member selected from the family ARM9-based 32-bit RISC CPUs. For example, an STR9 series microcontroller from ST MICROELECTRONICS may be used.

[0124] In certain alternative forms of the present technology, a 16-bit RISC CPU may be used as the central controller 4230 for the RPT device 4000. For example, a processor from tire MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS, may be used.

[0125] In another form of the present technology, tire central controller 4230 is a dedicated electronic circuit. In another form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 comprises discrete electronic components.

[0126] Tire central controller 4230 is configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220. and the humidifier 5000.

[0127] The central controller 4230 is configured to provide output signal(s) to one or more of an output device 4290, a therapy device controller 4240, a data communication interface 4280, and the humidifier 5000.

[0128] In some forms of the present technology, the central controller 4230 is configured to implement the one or more methodologies described herein, such as the one or more algorithms 4300, expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260 orother memory described herein. In some forms of the present technology, as previously discussed, the central controller 4230 may be integrated with an RPT device 4000. However, in some forms of the present technology, some methodologies may be performed by a remotely located device or server such as the server previously mentioned. For example, the remotely located device or server may determine control settings for transfer to a ventilator or other RT device such as by detecting respiratory related events and distinguishing them by type by an analysis of stored data such as from any of the sensors described herein.

[0129] While the central controller 4230 may comprise a single controller interacting with various sensors 4270, data communications interface 4280, memory 4260, as well as other devices, the functions of controller 4230 may be distributed among more than one controller. Tirus, the temr "central" as used herein is not meant to limit the architecture to a single controller or processor that controls the other devices. For example, alternative architectures may include a distributed controller architecture involving more than one controller or processor, which may optionally be directly or indirectly in electronic (wired or wireless) communications with the previously described finger sensor or a server in communication with tire finger sensor, such as for implementing any of the methodologies described herein. This may include, for example, a separate local (i.e., within RPT device 4000) or remotely located controller that perform some of the algorithms 4300, or even more than one local or remote memory that stores some of the algorithms. In addition, the algorithms when expressed as computer programs may comprise high level human readable code (e.g., C++, Visual Basic, other object oriented languages, etc.) or low / machine level instructions (Assembler, Verilog, etc.). Depending on the functionality of an algorithm(s), such code or instructions may be burnt in the controller, e.g., an ASIC or DSP, or be a run time executable ported to a DSP or general purpose processor that then becomes specifically programmed to perfonn tire tasks required by the algorithm(s).4.9.2.4 Clock

[0130] The RPT device 4000 may include a clock 4232 that is connected to the central controller 4230.4.9.2.5 Therapy device controller

[0131] In one fonn of the present technology, therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithms 4300 executed by the central controller 4230.

[0132] In one form of the present technology, therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form a MC33035 brushless DC motor controller, manufactured by ONSEMI is used.4.9.2.6 Protection circuits

[0133] An RPT device 4000 in accordance with the present technology may comprise one or more protection circuits 4250.

[0134] One form of protection circuit 4250 in accordance with the present technology is an electrical protection circuit.

[0135] One form of protection circuit 4250 in accordance with the present technology is a temperature or pressure safety circuit.4.9.2.7 Memory

[0136] In accordance with one form of the present technology the RPT device 4000 includes memory 4260, for example non-volatile memory. In some forms, memory 4260 may include battery powered static RAM. In some forms, memory 4260 may include volatile RAM.

[0137] Memory' 4260 may be located on PCBA 4202. Memory' 4260 may be in the form of EEPROM, or NAND flash.

[0138] Additionally or alternatively, RPT device 4000 includes a removable form of memory 4260, for example a memory card made in accordance with the Secure Digital (SD) standard.

[0139] In one form of tire present technology, the memory 4260. such as any of the memories previously described, acts as a non-transitory computer readable storage medium on which is stored computer program instructions expressing the one or more methodologies described herein, such as the one or more algorithms 4300.4.9.2.8 Transducers

[0140] Transducers may be internal of tire device 4000, or external of the RPT device 4000. External transducers may be located for example on or form part of the air delivery circuit 4170, e.g., at the patient interface 3000. External transducers may be in the form of non-contact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device 4000.4.3.2.8.1 Flow rate

[0141] A flow rate transducer 4274 in accordance with the present technology may be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION. The differential pressure transducer is in fluid communication with the pneumatic circuit, with one of each of the pressure transducers connected to respective first and second points in a flow restricting element.

[0142] In one example, a signal representing total flow rate Qt from the flow transducer 4274 is received by the central controller 4230.4.3.2.8.2 Pressure

[0143] A pressure transducer 4272 in accordance with the present technology is located in fluid communication with the pneumatic path. An example of a suitable pressure transducer 4272 is a sensor from the HONEYWELL ASDX series. An alternative suitable pressure transducer is a sensor from the NPA Series from GENERAL ELECTRIC.

[0144] In use, a signal from the pressure transducer 4272 is received by tire central controller 4230. In one form, tire signal from the pressure transducer 4272 is filtered prior to being received by the central controller 4230.4.3.2.8.3 Motor speed

[0145] In one form of the present technology a motor speed transducer 4276 is used to determine a rotational velocity of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. Hie motor speed transducer 4276 may, for example, be a speed sensor, such as a Hall effect sensor.4.9.2.9 Data communication systems

[0146] In one form of the present technology, a data communication interface 4280 is provided, and is connected to the central controller 4230. Data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. Hie remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0147] In one form, data communication interface 4280 is part of the central controller 4230. In another form, data communication interface 4280 is separate from the central controller 4230, and may comprise an integrated circuit or a processor.

[0148] In one form, remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet, or optical fibre) or a wireless protocol (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0149] In one form, local external communication network 4284 utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol and may optionally communicate with any of die sensors described herein.

[0150] In one form, remote external device 4286 is one or more computers, for example a cluster of networked computers and / or server as described herein. In one form, remote external device 4286 may be virtual computers, rather than physical computers. In either case, such a remote external device 4286 may be accessible to an appropriately authorised person such as a clinician.

[0151] The local external device 4288 may be a personal computer, mobile phone, tablet or remote control.4.9.2.10 Output devices including optional display, alarms

[0152] An output device 4290 in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display.4.9.2.10.1 Display driver

[0153] A display driver 4292 receives as an input the characters, symbols, or images intended for display on the display 4294, and converts them to commands that cause the display 4294 to display those characters, symbols, or images.4.9.2.10.2 Display

[0154] A display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol, such as the figure "0". to eight logical signals indicating whether the eight respective segments are to be activated to display a particular character or symbol.4.9.3 RPT device algorithms4.9.3.1 Pre-processing module

[0155] A pre-processing module 4310 in accordance with tire present technology receives, as an input, raw data from a transducer 4270, for example a flow rate sensor 4274 or a pressure sensor 4272, and performs one or more process steps to calculate one or more output values that will be used as an input to another module, for example a therapy engine module 4320.

[0156] In one form of the present technology, the output values include the interface or mask pressure Pm, the respiratory flow rate Qr, and the leak flow7rate QI.

[0157] In various fonns of the present technology, the pre-processing module 4310 comprises one or more of the following algorithms: pressure compensation 4312, vent flow rate estimation 4314, leak flow rateestimation 4316, respiratory flow rate estimation 4317, ventilation determination 4311, target ventilation determination 4313, respiratory rate estimation 4318, and backup rate determination 4319.4.9.3.1.1 Pressure compensation

[0158] In one form of the present technology, a pressure compensation algorithm 4312 receives as an input a signal indicative of the pressure in the pneumatic path proximal to an outlet of the pneumatic block 4020. The pressure compensation algorithm 4312 estimates the pressure drop in the air circuit 4170 and provides as an output an estimated pressure, Pm, in the patient interface 3000.4.9.3.1.2 Vent flow rate estimation

[0159] In one fonn of the present technology, a vent flow rate estimation algorithm 4314 receives as an input an estimated pressure. Pm, in tire patient interface 3000 and estimates a vent flow rate of air, Qv, from a vent 3400 in a patient interface 3000.4.9.3.1.3 Leak flow rate estimation

[0160] In one fonn of the present technology, a leak flow rate estimation algorithm 4316 receives as an input a total flow rate Qt and a vent flow rate Qv. and estimates a leak flow rate QI. In one form, the leak flow rate estimation algorithm 4316 estimates the leak flow rate QI by calculating an average of the difference between the total flow rate and the vent flow rate Qv over a period sufficiently long to include several breathing cycles, e.g., about 10 seconds.

[0161] In one form, the leak flow estimation algorithm 4316 receives as an input a total flow rate Qt, a vent flow rate Qv, and an estimated pressure, Pm. in the patient interface 3000. and estimates a leak flow rate QI by calculating a leak conductance, and determining a leak flow rate QI to be a function of leak conductance and tire pressure Pm. Leak conductance may be calculated as the quotient of low-pass filtered non-vent flow rate equal to the difference between total flow rate Qt and vent flow rate Qv, and low-pass filtered square root of pressure Pm, where the low-pass filter time constant has a value sufficiently long to include several breathing cycles, e.g., about 10 seconds. The leak flow rate QI may be estimated as the product of leak conductance and a function of pressure, Pm.4.9.3.1.4 Respiratory flow rate estimation

[0162] In one form of the present technology, a respiratory flow rate estimation algorithm 4317 receives as an input a total flow rate, Qt, a vent flow rate, Qv, and a leak flow rate, QI, and estimates a respiratory flow rate of air, Qr, to the patient, by subtracting the vent flow rate Qv and the leak flow rate QI from the total flow rate Qt.

[0163] In other forms of the present technology, the respiratory flow estimation algorithm 4317 provides a value that acts as a proxy for the respiratory flow rate Qr. Possible proxies for respiratory flow rate include:• Respiratory movement of the chest of the patient 1000• Current drawn by the pressure generator 4140• Motor speed of the pressure generator 4140• Trans-thoracic impedance of the patient 1000

[0164] Tire respiratory flow rate proxy value may be provided by a transducer 4270 in the RPT device 4000, e.g., the motor speed sensor 4276, or a sensor external to the RPT device 4000, such a respiratory movement sensor or a trans-thoracic impedance sensor.4.9.3.1.5 Ventilation determination

[0165] In one form of the present technology, a ventilation determination algorithm 4311 receives an input a respiratory flow rate Qr, and determines a measure Vent indicative of current patient ventilation.

[0166] In some implementations, the ventilation detennination algorithm 4311 determines a measure of ventilation Vent that is an estimate of actual patient ventilation.

[0167] In one such implementation, the measure of ventilation Vent is half the absolute value of respiratory flow, Qr, optionally filtered by low-pass filter such as a second order Bessel low-pass filter with a comer frequency of 0. 11 Hz.

[0168] In one such implementation, the measure of ventilation Vent is an estimate of gross alveolar ventilation (i.e. non-anatomical-deadspace ventilation). This requires an estimate of anatomical deadspace. One can use the patient's height (or arm-span in cases of severe skeletal deformity) as a good predictor of anatomical deadspace. Gross alveolar ventilation is then equal to a measure of actual patient ventilation, e.g., determined as above, less the product of the estimated anatomical deadspace and the estimated spontaneous respiratory rate Rs.

[0169] In other implementations, the ventilation detennination algorithm 4311 determines a measure of ventilation Vent that is broadly proportional to actual patient ventilation. One such implementation estimates peak respiratory flow rate Qpeak over the inspiratory portion of the cycle. This and many other procedures involving sampling the respiratory flow rate Qr produce measures which are broadly proportional to ventilation, provided the flow rate waveform shape does not vary very much (here, the shape of two breaths is taken to be similar when the flow rate waveforms of the breaths normalised in time and amplitude are similar). Some simple examples include the median positive respiratory flow rate, the median of the absolute value of respiratory flow rate, and the standard deviation of flow rate. Arbitrary linearcombinations of arbitrary order statistics of the absolute value of respiratory flow rate using positive coefficients, and even some using both positive and negative coefficients, are approximately proportional to ventilation. Another example is the mean of tire respiratory flow rate in the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. There is an arbitrarily large number of measures that are exactly proportional to ventilation if the flow rate waveform shape is constant.

[0170] In other forms, the ventilation determination algorithm 4311 determines a measure Vent of ventilation that is not based on respiratory flow rate Qr, but is a proxy for the current patient ventilation, such as oxygen saturation (SaO2), or partial pressure of carbon dioxide (PCO2), obtained from suitable sensors attached to the patient 1000.4.9.3.1.6 Target ventilation determination

[0171] In one form of the present technology, a central controller 4230 takes as input the measure of current ventilation, Vent, and executes one or more target ventilation determination algorithms 4313 for the determination of a target value Vtgt for the measure of ventilation.

[0172] In some forms of the present technology, there is no target ventilation determination algorithm 4313, and the target ventilation Vtgt is predetermined, for example by hard-coding during configuration of the RPT device 4000 or by manual entry through the input device 4220.

[0173] In other forms of the present technology, such as adaptive servo-ventilation (ASV) therapy (described below), the target ventilation determination algorithm 4313 computes the target ventilation Vtgt from a value Vtyp indicative of the typical recent ventilation of the patient 1000.

[0174] In some forms of adaptive servo-ventilation therapy, the target ventilation Vtgt is computed as a high proportion of, but less than, the typical recent ventilation Vtyp. The high proportion in such forms may be in the range (80%, 100%), or (85%, 95%), or (87%, 92%).

[0175] In other forms of adaptive servo-ventilation therapy, the target ventilation Vtgt is computed as a slightly greater than unity multiple of the typical recent ventilation Vtyp.

[0176] Tire typical recent ventilation Vtyp is tire value around which the distribution of the measure of current ventilation Vent over multiple time instants over some predetermined timescale tends to cluster, that is, a measure of the central tendency of the measure of current ventilation over recent history. In one implementation of the target ventilation determination algorithm 4313, the recent history is of the order of several minutes, but in any case should be longer than the timescale of Cheyne-Stokes waxing and waning cycles. The target ventilation determination algorithm 4313 may use any of the variety of well-known measures of central tendency to determine the typical recent ventilation Vtyp from the measure of currentventilation, Vent. One such measure is the output of a low-pass filter on the measure of current ventilation Vent, with time constant equal to one hundred seconds.4.9.3.1.7 Respiratory rate estimation

[0177] In one fonn of the present technology, a respiratory rate estimation algorithm 4318 receives as an input a respiratory flow rate, Qr, to the patient 1000, and produces an estimate of the spontaneous respiratory rate Rs of the patient.

[0178] Tire respiratory rate estimation algorithm 4318 may estimate the spontaneous respiratory rate Rs over periods when the patient 1000 is breathing spontaneously, i.e.. when the RPT device 4000 is not delivering “backup breaths” (described below). In some forms of the present technology, the respiratory rate estimation algorithm 4318 estimates the respiratory rate over periods when servo-assistance (defined as pressure support minus minimum pressure support) is low, in one implementation less than 4 cmH20, as such periods are more likely to reflect spontaneous respiratory effort.

[0179] In some forms of the present technology, the respirator) rate estimation algorithm 4318 estimates the respiratory rate over periods of asleep breathing, since the respiratory rate during these periods may be substantially different from tire respiratory rate during wake . Anxiety typically results in a higher respiratory rate than that prevailing during sleep. When patients focus on their own breathing process, their respiratory rates are typically lower than those during normal wakefulness or during sleep. Techniques such as described in Patent Application no. PCT / AU2010 / 000894, published as WO 2011 / 006199, the entire disclosure of which is hereby incorporated herein by reference, may be used to identify periods of awake breathing from the respiratory flow rate, Qr.

[0180] In some forms of the present technology, the respiratory rate estimation algorithm 4318 estimates the spontaneous respiratory rate Rs as the reciprocal of one of a variety of well-known statistical measures of central tendency of breath duration Ttot during the period of interest. In such measures it is desirable to reject, or at least be robust to, outliers. One such measure, trimmed mean, in which the lower and upper K proportions of tire sorted breath durations are discarded and the mean calculated on the remaining breath durations, is robust to outliers. For example, when K is 0.25, this amounts to discarding the upper and lower quartiles of breath duration Ttot. Tire median is another robust measure of central tendency, though this can occasionally give unsatisfactory results when the distribution is strongly bimodal. A simple mean may also be employed as a measure of central tendency, though it is sensitive to outliers. An initial interval filtering stage, in which contiguous time intervals corresponding to implausible respiratory rates (e.g., greater than 45 breaths / minute or less than 6 breaths / minute) are excluded as outliers from the mean calculation, may be employed. Other filtering mechanisms which may be used alone or in combination with interval filteringare to exclude any breaths that are not part of a sequence of N successive spontaneous breaths, where N is some small integer (e.g., 3), and to exclude the early and late breaths of a sequence of successive spontaneous breaths, e.g., to exclude the first and last breaths of a sequence of four breaths. The rationale for the latter mechanism is that the first and the last breaths in particular, and the early and late breaths in general, of a sequence of spontaneous breaths may be atypical; for example, the first spontaneous breath may occur as a result of an arousal, and the last spontaneous breath may be longer because of the decreasing respiratory drive which results in the backup breath which ends the sequence of spontaneous breaths.

[0181] In some forms of the present technology, the respiratory rate estimation algorithm 4318 makes an initial estimate of the spontaneous respiratory rate Rs using an initial period of estimation, to enable the subsequent processing in the therapy engine module 4320 to begin, and then continuously updates the estimate of the spontaneous respiratory rate Rs using a period of estimation that is longer than the initial period of estimation, to improve statistical robustness. For example, the initial period of estimation may be 20 minutes of suitable spontaneous breaths, but tire period of estimation may then progressively increase up to some maximum duration, for example 8 hours. Rather than a rolling window of this duration being used for this estimation, low -pass filters on breath duration may be used, with progressively longer response times (more precisely, progressively lower comer frequencies) as the session proceeds.

[0182] In some forms, a suitably processed short-term (e.g.. 10-minute) measure of central tendency, such as trimmed mean, may be input to a suitable low-pass filter to give an estimate Rs which changes on the time scale of hours or longer. This has the advantage that potentially large amounts of breath duration data do not need to be stored and processed, as might occur if a trimmed mean needs to be calculated on a moving window of breath duration data lasting hours or days.

[0183] In some forms of the present technology, respiratory rates measured over short periods of time, and in particular over one breath, may also be used instead of breath duration in the above-described measures of central tendency, giving generally similar but not identical results.4.9.3.1.8 Backup rate determination

[0184] In one form of the present technology, a backup rate determination algorithm 4319 receives as input a spontaneous respiratory rate estimate Rs provided by the respiratory rate estimation algorithm 4318 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 a patient 1000 in the absence of significant spontaneous respiratory effort.

[0185] In one form of the pre-processing module 4310, there is no backup rate determination algorithm 4319, and the backup rate Rb is instead provided manually to the RPT device 4000, e.g. , via tire input device 4220, or hard-coded at the time of configuration of the RPT device 4000.

[0186] In one form, known as adaptive backup rate, the backup rate determination algorithm 4319 determines the backup rate Rb as a function of the spontaneous respiratory rate Rs. In one implementation, the function determines the backup rate Rb as the spontaneous respiratory rate Rs minus a constant such as 2 breaths per minute. In another implementation, the function determines the backup rate Rb as the spontaneous respiratory rate Rs multiplied by a constant that is slightly less than unity.

[0187] In one form, known as variable backup rate, the backup rate determination algorithm 4319 determines the backup rate Rb as a function of time. The backup rate Rb is initialised to a value known as the spontaneous backup rate (SBR) that is some fraction of a final target backup rate, known as the sustained timed backup rate (STBR). The fraction may be two thirds, or three quarters, or other positive values less than one. The SBR is the reciprocal of the timeout period to a backup breath when the most recent inspiration was a spontaneous (z.e., patent-triggered) breath. The STBR may be predetermined e.g., by manual entry or hard-coding as described above) or set to some typical respiratory rate such as 15 bpm. Over time elapsed since tire previous spontaneous breath, the backup rate Rb is increased from the SBR towards the STBR. The increase may be according to a predetermined profile, such as a series of steps, or a continuous linear profile. The profile is chosen such that the backup rate Rb reaches the STBR after a predetermined interval. Tire interval may be measured in units of time, such as 30 seconds, or relative to the patient’s respiration, such as 5 breaths.

[0188] In some forms of variable backup rate, the predetennined interval over which the backup rate Rb increases from the SBR towards the STBR may be a function of the adequacy of current ventilation. In one implementation, suitable for servo-ventilation in which a target value Vtgt exists for the measure of ventilation, the backup rate approaches the STBR faster to the extent that current measure of ventilation Vent is less than the target ventilation Vtgt.

[0189] In one fomr of variable backup rate, known as adaptive variable backup rate, tire backup rate determination algorithm 4319 determines the backup rate Rb as a function of the current estimated spontaneous respiratory rate Rs provided by the respiratory rate estimation algorithm 4318, as well as a function of time. As in variable backup rate determination, adaptive variable backup rate determination increases the backup rate Rb from the SBR towards the STBR over a predetermined interval that may be a function of the adequacy of current ventilation. The STBR may be initialised to a standard respiratory rate, such as 15 bpm. Once a reliable estimate of spontaneous respiratory rate Rs is available from the respiratory rate estimation algorithm 4318, the STBR may be set to the current estimated spontaneous respiratory rateRs multiplied by some constant. The SBR may be set to some fraction of the STBR, as in variable backup rate. In one form, the fraction, for example two thirds, can be set to a lower value, such as 0.55, during the initial period of estimation of the spontaneous respiratory rate Rs, to accommodate occasional long breath durations in patients with relatively low respiratory rates, such as 12 breaths per minute.

[0190] In some forms, the constant by which the current estimated spontaneous respiratory rate Rs is multiplied to obtain the STBR may be slightly higher than 1, e.g., 1.1, to provide more aggressive ventilation during apneas, which may be desirable in short apneas. Tire constant may be somewhat lower than 1, e.g., 0.8, particularly if difficulty in resynchronisation with the patient on tire return of patient effort turns out to be a problem in a particular patient. Lower backup rates make resynchronisation easier, by lengthening the expiratory pause, during which resynchronisation commonly occurs.4.9.3.2 Therapy Engine Module

[0191] In one form of the present technology, a therapy engine module 4320 receives as inputs one or more of a pressure, Pm, in a patient interface 3000, a respiratory flow rate of air to a patient, Qr, and an estimate Rs of the spontaneous respiratory rate, and provides as an output one or more therapy parameters. In various forms, the therapy engine module 4320 comprises one or more of the following algorithms: phase determination 4321. waveform determination 4322. inspiratory flow limitation determination 4324. apnea / hypopnea determination 4325, snore detection 4326, airway patency determination 4327, and therapy parameter determination 4329.4.9.3.2.1 Phase determination

[0192] In one fonn of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow. Qr. and provides as an output a phase F of a current breathing cycle of a patient 1000.

[0193] In some forms, known as discrete phase determination, the phase output F is a discrete variable. One implementation of discrete phase determination provides a bi-valued phase output F with values of either inhalation or exhalation, for example represented as values of 0 and 0.5 revolutions respectively, upon detecting the start of spontaneous inhalation and exhalation respectively. RPT devices 4000 that ‘"trigger” and “cycle” effectively perform discrete phase determination, since the trigger and cycle points are the instants at which the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one implementation of bi-valued phase determination, the phase output F is determined to have a discrete value of 0 (thereby “triggering” the RPT device 4000) when the respiratory' flow rate Qr has a value that exceeds a positive threshold, and a discrete value of 0.5 revolutions (thereby “cycling” theRPT device 4000) when a respiratory flow rate Qr has a value that is more negative than a negative threshold.

[0194] Another implementation of discrete phase determination provides a tri -valued phase output F with a value of one of inhalation, mid-inspiratory pause, and exhalation.

[0195] In other forms, known as continuous phase determination, the phase output F is a continuous value, for example varying from 0 to 1 revolutions, or 0 to 2p radians. RPT devices 4000 that perform continuous phase determination may trigger and cycle when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one implementation of continuous phase determination, a continuous value of phase F is determined using a fuzzy logic analysis of the respiratory flow rate Qr. A continuous value of phase determined in this implementation is often referred to as “fuzzy phase”. In one implementation of a fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr.1 . If the respiratory flow rate is zero and increasing fast then the phase is 0 revolutions.2. If the respiratory flow rate is large positive and steady then the phase is 0.25 revolutions.3. If the respirator}' flow rate is zero and falling fast, then the phase is 0.5 revolutions.4. If the respiratory’ flow rate is large negative and steady then the phase is 0.75 revolutions.5. If the respiratory flow rate is zero and steady and the 5-second low-pass filtered absolute value of the respiratory- flow rate is large then the phase is 0.9 revolutions.6. If the respiratory flow rate is positive and the phase is expiratory, then the phase is 0 revolutions.7. If the respiratory' flow rate is negative and the phase is inspiratory, then the phase is 0.5 revolutions.8. If the 5-second loyv-pass filtered absolute value of the respiratory' flow rate is large, tire phase is increasing at a steady rate equal to tire patient’s respiratory rate, low-pass filtered with a time constant of 20 seconds.

[0196] The output of each rule may be represented as a vector whose phase is the result of the rule and whose magnitude is the fuzzy extent to which the rule is true. The fuzzy extent to which the respiratory' flow rate is “large”, “steady”, etc. is determined with suitable membership functions. The results of the rules, represented as vectors, are then combined by some function such as taking the centroid. In such a combination, the rules may be equally weighted, or differently weighted.

[0197] In another implementation of continuous phase detennination, the inhalation time 77 and the exhalation time Te are first estimated from the respiratory flo v rate Qr. The phase F is then determined as the half the proportion of the inhalation time Ti that has elapsed since the previous trigger instant, or 0.5 revolutions plus half the proportion of the exhalation time Te that has elapsed since the previous cycle instant (yvhichcvcr was more recent).

[0198] In some forms of the present technology, suitable for pressure support ventilation therapy (described below), the phase determination algorithm 4321 is configured to trigger even when the respiratory flow rate Qr is insignificant, such as during an apnea. As a result, the RPT device 4000 delivers "‘backup breaths” in the absence of spontaneous respiratory effort from the patient 1000. For such forms, known as spontaneous / timed (S / T) modes, the phase determination algorithm 4321 may make use of the backup rate Rb provided by the backup rate determination algorithm 4319.

[0199] A phase determination algorithm 4321 that uses ‘'fuzzy phase” may implement S / T mode using the backup rate Rb by including a “momentum” rule in the fuzzy phase rules. Tire effect of the momentum rule is to carry the continuous phase forw ard from exhalation to inhalation at tire backup rate Rb if there are no features of respiratory flow rate Qr that would otherwise carry the continuous phase forward through the other rules. In one implementation, the more it is true that the measure of ventilation Vent (described below) is well below a target value Vtgt for ventilation (also described below), the more highly the momentum rule is weighted in the combination. However, as a result of the rapid increase in pressure support in response to mild to moderate hypoventilation (with respect to the target ventilation), the ventilation may be quite close to the target ventilation. It is desirable that the momentum rule is given a low weighting when the ventilation is close to target, to allow the patient to breathe at rates significantly lower than the respiratory rate at other times (when the patient is not in a central apnea) without being unnecessarily pushed to breathe at a higher rate by the ventilator. However, when the momentum rule is given a low weighting when ventilation is above a value which is below but close to the target ventilation, adequate ventilation may easily be achieved at a relatively high pressure support at a rate well below the backup rate. It would be desirable for the backup breaths to be delivered at a higher rate, because this would enable the target ventilation to be delivered at a lower pressure support. This is desirable for a number of reasons, a key one of which is to diminish mask leak.

[0200] To summarise, in a fuzzy phase determination algorithm 4321 that implements S / T mode, there is a dilemma in choosing the weighting for tire momentum rule incorporating the backup rate Rb '. if it is too high, the patient may feel “pushed along” by the backup rate. If it is too low, the pressure support may be excessive. Hence it is desirable to provide methods of implementing S / T mode which do not rely on the momentum rule described above.

[0201] A phase determination algorithm 4321 (either discrete, or continuous without a momentum rule) may implement S / T mode using the backup rate Rb in a manner known as timed backup. Timed backup may be implemented as follows: the phase determination algorithm 4321 attempts to detect the start of inhalation due to spontaneous respiratory effort, for example by monitoring the respirator) flow rate Qr as described above. If the start of inhalation due to spontaneous respiratory effort is not detected within aperiod of time after the last trigger instant whose duration is equal to the reciprocal of the backup rate Rb (an interval known as the backup timing threshold), the phase determination algorithm 4321 sets the phase output F to a value of inhalation (thereby triggering tire RPT device 4000). Once the RPT device 4000 is triggered, and a backup breath begins to be delivered, the phase determination algorithm 4321 attempts to detect the start of spontaneous exhalation, for example by monitoring the respiratory flow rate Qr, upon which the phase output F is set to a value of exhalation (thereby cycling the RPT device 4000).

[0202] If the backup rate Rb is increased over time from the SBR to the STBR, as in a variable backup rate system described above, the backup timing threshold starts out longer and gradually becomes shorter. That is, the RPT device 4000 starts out less vigilant and gradually becomes more vigilant to lack of spontaneous respiratory effort as more backup breaths are delivered. Such an RPT device 4000 is less likely to make a patient feel “pushed along” if they would prefer to breathe at a lower than standard rate, while still delivering backup breaths when they are needed.

[0203] If the STBR in a variable backup rate system adapts to the patient’s estimated spontaneous respiratory rate Rs, as in an adaptive variable backup rate system described above, the backup breaths will be delivered at a rate that adapts to the patient’s own recent spontaneous respiratory efforts.4.9.3.2.2 Waveform determination

[0204] In one form of the present technology, the therapy control module 4330 controls a pressure generator 4140 to provide a treatment pressure Pt that varies as a function of phase F of a breathing cycle of a patient according to a waveform template P(F).

[0205] In one form of the present technology, a waveform determination algorithm 4322 provides a wavefonn template P(F) with values in the range [0, 1] on the domain of phase values F provided by the phase determination algorithm 4321 to be used by the therapy parameter determination algorithm 4329.

[0206] In one form, suitable for either discrete or continuously-valued phase, the waveform template P(F) is a square-wave template, having a value of 1 for values of phase up to and including 0.5 revolutions, and a value of 0 for values of phase above 0.5 revolutions. In one form, suitable for continuously-valued phase, the wavefonn template P(F) comprises two smoothly curved portions, namely a smoothly curved (e.g.. raised cosine) rise from 0 to 1 for values of phase up to 0.5 revolutions, and a smoothly curved (e.g., exponential) decay from 1 to 0 for values of phase above 0.5 revolutions. One example of such a “smooth and comfortable” waveform template is the “shark fin” waveform template, in which the rise is a raised cosine, and the smooth decay is quasi-exponential (so that the limit of P as F approaches one revolution is precisely zero).

[0207] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template P(F) from a library of waveform templates, dependent on a setting of tire RPT device 4000. Each waveform template P(F) in the library may be provided as a lookup table of values P against phase values F. In other forms, the waveform detennination algorithm 4322 computes a waveform template P(F) ‘"on the fly” using a predetermined functional fonn, possibly parametrised by one or more parameters (e.g., time constant of an exponentially curved portion). The parameters of the functional form may be predetermined or dependent on a current state of the patient 1000.

[0208] In some forms of the present technology, suitable for discrete bi-valued phase of either inhalation (F = 0 revolutions) or exhalation (F = 0.5 revolutions), the waveform determination algorithm 4322 computes a wavefonn template P “on the fly” as a function of both discrete phase F and time t measured since the most recent trigger instant (transition from exhalation to inhalation). In one such fonn, the waveform determination algorithm 4322 computes the waveform template P(F, t) in two portions (inspiratory and expiratory ) as follows:

[0209]

[0210] where Pz(t) and Pc(Z) are inspiratory and expiratory portions of the waveform template P(F, t), and Tl is the inhalation time. In one such form, the inspiratory portion Pz(t) of the wavefonn template is a smooth rise from 0 to 1 parametrised by a rise time, and the expiratory' portion Pe(t) of the waveform template is a smooth fall from 1 to 0 parametrised by a fall time.4.9.3.2.3 Determination of inspiratory flow limitation

[0211] In one fonn of tire present technology, a processor executes one or more algorithms 4324 for the detection of inspiratory flow limitation (partial obstruction).

[0212] In one fonn the algorithm 4324 receives as an input a respiratory flow rate signal Qr and provides as an output a metric of the extent to which the inspiratory portion of the breath exhibits inspiratory flow limitation.

[0213] In one form of the present technology, the inspiratory portion of each breath is identified based on the phase F estimated at each instant. For example, the inspiratory portion of tire breath is the values of respiratory flow for which the phase F is less than or equal to 0.5. A number of evenly spaced points (for example, sixty-five), representing points in time, are interpolated by an interpolator along the inspiratory flow-time curve for each breath. The curve described by the points is then scaled by a scaler to have unity length (duration / period) and unity' area to remove the effects of changing respiratory' rate and depth. The scaled breaths are then compared in a comparator with a pre-stored template representing a normal unobstructed breath. Breaths deviating by more than a specified threshold (typically 1 scaled unit) at anytime during the inspiration from this template, such as those due to coughs, sighs, swallows and hiccups, as determined by a test element, are rejected. For non-rejected data, a moving average of the first such scaled point is calculated by central controller 4230 for the preceding several inspiratory events. This is repeated over the same inspiratory events for the second such point, and so on. Thus, for example, sixty five scaled data points are generated by central controller 4230, and represent a moving average of the preceding several inspiratory events, e.g.. three events. The moving average of continuously updated values of the (e.g., sixty five) points are hereinafter called the "scaled flow", designated as Qs(t). Alternatively, a single inspiratory event can be utilised rather than a moving average.

[0214] From the scaled flow, two shape factors relating to the determination of partial obstruction may be calculated.

[0215] Shape factor 1 is the ratio of the mean of the middle (e.g.. thirty-two) scaled flow points to the mean overall (e.g., sixty-five) scaled flow points. Where this ratio is in excess of unity, the breath will be taken to be normal. Where the ratio is unity or less, the breath will be taken to be obstructed. A ratio of about 1.17 is taken as a threshold between partially obstructed and unobstructed breathing, and equates to a degree of obstruction that would pennit maintenance of adequate oxygenation in a typical user.

[0216] Shape factor 2 is calculated as the RMS deviation from unit scaled flow, taken over the middle (e.g., thirty two) points. An RMS deviation of about 0.2 units is taken to be nonnal. An RMS deviation of zero is taken to be a totally flow-limited breath. The closer the RMS deviation to zero, the breath will be taken to be more flow limited.

[0217] Shape factors 1 and 2 may be used as alternatives, or in combination. In other fonns of the present technology, the number of sampled points, breaths and middle points may differ from those described above. Furthermore, the threshold values can other than those described.4.9.3.2.4 Determination of apneas and hypopneas

[0218] In one form of the present technology, a central controller 4230 executes one or more algorithms 4325 for the detection of apneas and / or hypopneas.

[0219] In one fonn, the one or more apnea / hypopnea detection algorithms 4325 receive as an input a respiratory flow rate Qr and provide as an output a flag that indicates that an apnea or a hypopnea has been detected.

[0220] In one form, an apnea will be said to have been detected when a function of respiratory flow rate Qr falls below a flow threshold for a predetermined period of time. Tire function may determine a peak flow, a relatively short-term mean flow, or a flow intermediate of relatively short-term mean and peak flow, for example an RMS flow. Tire flow threshold may be a relatively long-term measure of flow.

[0221] In one form, ahypopnea will be said to have been detected when a function of respiratory flow rate Qr falls below a second flow threshold for a predetermined period of time. Tire function may determine a peak flow, a relatively short-term mean flow, or a flow intermediate of relatively short-tenn mean and peak flow, for example an RMS flow. Tire second flow threshold may be a relatively long-term measure of flow. The second flow threshold is greater than the flow threshold used to detect apneas.

[0222] In one form, such respiratory events may be characterized as central or obstructive based at least in part on the aforementioned finger sensor PPG based type detection.4.9.3.2.5 Detection of snore

[0223] In one form of the present technology, a central controller 4230 executes one or more snore detection algorithms 4326 for the detection of snore.

[0224] In one form, the snore detection algorithm 4326 receives as an input a respiratory' flow rate signal Qr and provides as an output a metric of the extent to which snoring is present.

[0225] Tire snore detection algorithm 4326 may comprise a step of determining the intensity of the flow rate signal in the range of 30-300 Hz. Tire snore detection algorithm 4326 may further comprises a step of filtering the respiratory flow rate signal Qr to reduce background noise, e.g., tire sound of airflow in the system from the blower 4142.4.9.3.2.6 Determination of airway patency

[0226] In one form of the present technology, a central controller 4230 executes one or more algorithms 4327 for the determination of airway patency.

[0227] In one fonn, airway patency algorithm 4327 receives as an input a respiratory flow rate signal Qr, and determines the power of the signal in the frequency range of about 0.75Hz and about 3Hz. The presence of a peak in this frequency range is taken to indicate an open airway . The absence of a peak is taken to be an indication of a closed airway.

[0228] In one fonn, the frequency range within which the peak is sought is the frequency of a small forced oscillation in the treatment pressure Pt. In one implementation, the forced oscillation is of frequency 2 Hz with amplitude about 1 cmH20.

[0229] In one fonn, airway patency algorithm 4327 receives as an input a respiratory flow rate signal Qr, and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is taken to be an indication of a closed airway.4.9.3.2. 7 Determination of therapy parameters

[0230] In some forms of the present technology, the central controller 4230 executes one or more therapy parameter detennination algorithms 4329 for the detennination of one or more therapy parameters using the values returned by one or more of the other algorithms in the therapy engine module 4320.

[0231] In one form of the present technology, the therapy parameter is an instantaneous treatment pressure Pt. In one implementation of this form, the therapy parameter determination algorithm 4329 determines the treatment pressure Pt using the equation

[0232] (1)

[0233] where:• A is an amplitude,• F is the current value of phase;• P(F) is the waveform template value (in the range 0 to 1) at the current value of phase, and• _P_0 is a base pressure.

[0234] If the waveform determination algorithm 4322 provides the waveform template P(F) as a lookup table of values indexed by phase F, the therapy parameter detennination algorithm 4329 applies equation (1) by locating the nearest lookup table entry to the current value F of phase returned by the phase determination algorithm 4321. or by interpolation between tire two entries straddling the current value F of phase.

[0235] The values of the amplitude A and the base pressure _P_0 may be set by the therapy parameter determination algorithm 4329 depending on the chosen pressure therapy mode in the manner described below.4.9.3.3 Therapy control module

[0236] The therapy control module 4330 in accordance with one aspect of the present technology receives as inputs the therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320, and controls the pressure generator 4140 to deliver a flow of air in accordance with the therapy parameters.

[0237] In one fonn of the present technology, the therapy parameter is a treatment pressure Pt. and the therapy control module 4330 controls the pressure generator 4140 to deliver a flow of gas whose mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt. In accordance with the therapy parameters determined by the central controller 4230 and the therapy parameter detennination algorithms 4329, such treatment pressure may provide, for example, a Pressure Support (PS) therapy, a Continuous Positive Airway Pressure (CPAP) therapy, an Automatic Positive Airway Pressure (APAP)therapy and / or a Bi-level therapy such as a therapy with a treatment pressure during inspiration (IPAP) that is higher than a pressure during expiration (EPAP), etc. In some forms of bi-level therapy, the IPAP is a treatment pressure that has the same purpose as the treatment pressure in CPAP therapy modes, and the EPAP is the IPAP minus the amplitude A, which has a “small” value (a few cmH20) sometimes referred to as tire Expiratory Pressure Relief (EPR). Such forms are sometimes referred to as CPAP therapy with EPR, which is generally thought to be more comfortable than straight CPAP therapy. In CPAP therapy with EPR, either or both of the IPAP and the EPAP may be constant values that are hard-coded or manually entered to the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may repeatedly compute the IPAP and / or the EPAP during CPAP with EPR. In this alternative, the therapy parameter determination algorithm 4329 repeatedly computes the EPAP and / or the IPAP as a function of indices or measures of sleep disordered breathing returned by tire respective algorithms in the therapy engine module 4320 in analogous fashion to the computation of the base pressure P0 in APAP therapy described above.4.9.3.4 Detection of fault conditions

[0238] In one form of the present technology, a processor executes one or more methods 4340 for the detection of fault conditions. The fault conditions detected by the one or more methods may include at least one of the following:• Power failure (no power, or insufficient power)• Transducer fault detection• Failure to detect the presence of a component• Operating parameters outside recommended ranges (e.g., pressure, flow, temperature. PaO2)• Failure of a test alarm to generate a detectable alarm signal.

[0239] Upon detection of the fault condition, the corresponding algorithm signals the presence of the fault by one or more of the following:• Initiation of an audible, visual & / or kinetic (e.g. , vibrating) alarm• Sending a message to an external device• Logging of the incident4.10 HUMIDIFIER

[0240] In one form of the present technology there is provided a humidifier 5000 (e.g., as shown in Fig. 10) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delive ry to the patient’s airways.4.11 GLOSSARY

[0241] For the purposes of the present disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.4.11.1 General

[0242] Air: In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g., atmospheric air enriched witir oxygen.

[0243] Respiratory Pressure Therapy (RPT) : Tire delivery of a supply of air to the airways at a treatment pressure that is typically positive with respect to atmosphere.

[0244] Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressure therapy in which the treatment pressure is approximately constant through a breathing cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some fonns, the pressure will vary between different breathing cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

[0245] Patient: A person, whether or not they are suffering from a respiratory disease.

[0246] Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in which tire treatment pressure is automatically adjustable, e.g., from breath to breath, between minimum and maximum limits, depending on tire presence or absence of indications of SDB events.4.11.2 Aspects of the breathing cycle

[0247] Apnea: According to some definitions, an apnea is said to have occurred when respiratory flow rate falls below a predetermined threshold for a duration, e.g., 10 seconds. An obstructive apnea will be said to have occurred when, despite patient effort, some obstruction of the airway does not allow air to flow. A central apnea will be said to have occurred when an apnea is detected that is due to a reduction in breathing effort, or the absence of breathing effort.

[0248] Breathing rate, or respiratory rate (Rs): The rate of spontaneous respiration of a patient, usually measured in breaths per minute.

[0249] Duty> cycle: The ratio of inhalation time, Ti to total breath duration, Ttot.

[0250] Effort (breathing): The work done by a spontaneously breathing person attempting to breathe.

[0251] Expiratory portion of a breathing cycle: Hie period from the start of expiratory flow to the start of inspiratory flow.

[0252] Flow limitation'. The state of affairs in a patient's respiration where an increase in effort by the patient does not give rise to a corresponding increase in flow. Where flow limitation occurs during an inspiratory portion of the breathing cycle it may be described as inspiratory flow limitation. Where flow limitation occurs during an expiratory portion of the breathing cycle it may be described as expiratory flow limitation.

[0253] Hypopnea-. A reduction in flow, but not a cessation of flow. In one form, a hypopnca may be said to have occurred when there is a reduction in flow below a threshold for a duration. In one form in adults, the following either of the following may be regarded as being hypopneas:

[0254] (i) a 30% reduction in patient breathing for at least 10 seconds plus an associated 4% desaturation; or

[0255] (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds, with an associated desaturation of at least 3% or an arousal.

[0256] Inspiratory portion of a breathing cycle'. The period from the start of inspiratory flow to the start of expiratory flow will be taken to be the inspiratory portion of a breathing cycle.

[0257] Patency (airway)'. Tire degree of the airway being open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example with a value of one (1) being patent, and a value of zero (0). being closed.

[0258] Positive End-Expiratory Pressure (PEEP)'. The pressure above atmosphere in the lungs that exists at the end of expiration.

[0259] Peak flow rate (Qpeak)'. The maximum value of flow during the inspiratory' portion of the respiratory flow rate waveform.

[0260] Respiratory flow / airflow rate, patient flow / airflow rate (Qr) These synonymous terms may be understood to refer to the RPT device’s estimate of respiratory- airflow rate, as opposed to "true respiratory' flow rate” or "true respiratory' airflow rate”, which is the actual respiratory' flow rate experienced by the patient, usually expressed in litres per minute.

[0261] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing, when extra effort is not applied.

[0262] Inhalation Time (Ti) The duration of the inspiratory portion of the respiratory flow rate wavefonn.

[0263] Exhalation Time (Te) The duration of the expiratory' portion of the respiratory flow rate waveform.

[0264] (total) Time, or breath duration (Ttot)'. The total duration between the start of the inspiratory' portion of one respiratory' flow rate waveform and the start of the inspiratory' portion of the following respiratory’ flow rate wavefonn.

[0265] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, in which the flow rate increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behaviour).

[0266] Ventilation (Vent)-. A measure of the total amount of gas being exchanged by the patient’s respiratory system. Measures of ventilation may include one or both of inspiratory and expiratory flow, per unit time. When expressed as a volume per minute, this quantity is often referred to as ‘'minute ventilation”. Minute ventilation is sometimes given simply as a volume, understood to be the volume per minute.4.11.3 RPT device parameters

[0267] Flow rate-. The instantaneous volume (or mass) of air delivered per unit time. While flow rate and ventilation have the same dimensions of volume or mass per unit time, flow rate is measured over a much shorter period of time. Flow may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow' rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate will be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow ’. Total flow rate. Qt. is the flow of air leaving the RPT device. Vent flow rate, Qv, is the flow of air leaving a vent to allow' washout of exhaled gases. Leak flow rate, QI, is the flow rate of unintentional leak from a patient interface system. Respiratory flow rate, Qr, is the flow of air that is received into the patient's respiratory' system.

[0268] Leak'. The word leak w ill be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient's face. In another example leak may occur in a swivel elbow to the ambient.

[0269] Pressure: Force per unit area. Pressure may be measured in a range of units, including cmH20, g- f / cm2, hectopascal. 1 cmH20 is equal to 1 g-f / cm2 and is approximately 0.98 hectopascal. In this specification, unless otherwise stated, pressure is given in units of cmH20. The pressure in the patient interface (mask pressure) is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the mask pressure Pm at the current instant of time, is given the symbol Pt.4.11.4 Terms for ventilators

[0270] Adaptive Servo- Ventilator (ASV) : A servo-ventilator that has a changeable rather than a fixed target ventilation. Hie changeable target ventilation may be learned from some characteristic of the patient, for example, a respiratory characteristic of the patient.

[0271] Backup rate: A parameter of a ventilator that establishes the respiratory rate (typically in number of breaths per minute) that the ventilator will deliver to the patient, if not triggered by spontaneous respiratory effort.

[0272] Cycled: The termination of a ventilator's inspiratory phase. When a ventilator delivers a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering the breath.

[0273] Expiratory positive airway pressure (EPAP): a base pressure, to which a pressure varying within the breath is added to produce the desired mask pressure which tire ventilator will attempt to achieve at a given time.

[0274] End expiratory pressure (EEP) : Desired mask pressure which the ventilator will attempt to achieve at the end of the expiratory portion of the breath. If the pressure waveform template P(F) is zero-valued at the end of expiration, i.e., P(F) = 0 when F = 1, the EEP is equal to the EPAP.

[0275] IPAP: desired mask pressure which the ventilator will attempt to achieve during the inspiratory' portion of the breath.

[0276] Pressure support (PS) : A number that is indicative of a ventilator therapy where there is an increase in pressure during ventilator inspiration over that during ventilator expiration, and generally means the difference in pressure between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some contexts pressure support means the difference which the ventilator aims to achieve, rather than what it actually achieves.

[0277] Servo-ventilator: A ventilator that measures patient ventilation, has a target ventilation, and which adjusts the level of pressure support to bring the patient ventilation towards the target ventilation.

[0278] Servo-assistance: Pressure support minus minimum pressure support.

[0279] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the initiation of a breath of a spontaneously breathing patient. If however, the device is unable to detect a breath within a predetermined period of time, the device will automatically initiate delivery of the breath.

[0280] Swing: Equivalent term to pressure support.

[0281] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be triggered to do so at the initiation of the inspiratory portion of the breathing cycle by the patient's efforts.

[0282] Typical recent ventilation: The typical recent ventilation Vtyp is the value around which recent measures of ventilation over some predetermined timescale tend to cluster, that is, a measure of the central tendency of the measures of ventilation over recent history'.

[0283] Ventilator. A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.4.11.5 Anatomy of the respiratory system

[0284] Diaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, containing 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.

[0285] Larynx: The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.

[0286] Lungs'. The organs of respiration in humans. Hie conducting zone of the lungs contains the trachea, the bronchi, the bronchioles, and the terminal bronchioles. The respiratory zone contains the respiratory bronchioles, the alveolar ducts, and the alveoli.

[0287] Nasal cavityr The nasal cavity (or nasal fossa) is a large air filled space above and behind the nose in the middle of the face. The nasal cavity is divided in two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal outgrowths called nasal conchae (singular "concha") or turbinates. To the front of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.

[0288] Pharynx: Tire part of the throat situated immediately inferior to (below) the nasal cavity, and superior to the oesophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the phary nx), the oropharynx (mesopharynx) (the oral part of the phar nx), and the laryngopharynx (hypopharynx).4.12 OTHER REMARKS

[0289] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in tire Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0290] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0291] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0292] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of tire exemplary methods and materials are described herein.

[0293] When a particular material is identified as being preferably used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0294] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents, unless the context clearly dictates otherwise.

[0295] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0296] Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest reasonable manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0297] The subject headings used in tire detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0298] Although the technology herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that arc not required to practice the technology. For example, although the terms "first" and "second" may be used, unlessotherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in tire methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and / or aspects thereof may be conducted concurrently or even synchronously.

[0299] It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the technology.

[0300] Although the present invention has been illustrated by 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 tire present technology may be embodied with various changes and modifications without departing from tire scope thereof. The present examples are therefore to be considered in all respects as illustrative and not restrictive, the scope of the technology being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. In other words, it is contemplated to cover any and all modifications, variations or equivalents that fall within the scope of the basic underlying principles and whose essential attributes are claimed in this patent application. It will furthermore be understood by the reader of this patent application that the words "comprising" or "comprise" do not exclude other elements or steps, that the words "a" or "an" do not exclude a plurality, and that a single element, such as a computer system, a processor, or another integrated unit may fulfil the functions of several means recited in the claims. Any reference signs in the claims shall not be construed as limiting the respective claims concerned. The terms "first", "second", third", "a", "b", "c", and the like, when used in the description or in the claims are introduced to distinguish between similar elements or steps and are not necessarily describing a sequential or chronological order. Similarly, the terms "top", "bottom", "over", "under", and the like are introduced for descriptive purposes and not necessarily to denote relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and embodiments of the technology are capable of operating according to the present technology in other sequences, or in orientations different from the one(s) described or illustrated above.

Claims

CLAIMS1. A method of one or more servers receiving a plurality of transmissions of respiratory therapy data from a respiratory therapy device over one or more networks, the method comprising: receiving first summary data from a first wireless transmission over at least a first communications channel from the respiratory therapy device, the first summary data comprising a summary of the respiratory therapy data; receiving second summary data from a second wireless transmission over at least a second communications channel from the respiratory therapy device, the second summary data comprising a summary of the respiratory therapy data; accessing one or more first parameters from the received first summary data; accessing one or more second parameters from the received second summary data; comparing the one or more first parameters with the one or more second parameters; generating an output report with data from one of the first summary data and the second summaij' data based on a result of the comparing; and transmitting, from the one or more servers, the output report to a client device.

2. The method of claim 1, wherein the first communications channel comprises a transmission over a wireless fidelity (Wi-Fi) communications network.

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

4. The method of any one of claims 1 to 3, wherein the client device comprises a smart phone or tablet configured by an application to communicate with the respiratory therapy device via a third communications channel.

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

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

7. The method of any one of claims 1 to 6. wherein the second communications channel comprises a transmission over on a cellular communications network.

8. Tire method of claim 7, wherein the transmission over the cellular communications network comprises a communication of the second summary data from the respiratory therapy device to the one or more servers.

9. The method of any one of claims 1 to 8, wherein the first summary data and second summary data comprise one or more of: a therapy duration; an apnea index, an hypopnea index; an obstructive apnea index; a central apnea index; an undistinguished apnea index; a respiratory' event related arousal index; one or more leak measures; one or more inspiratory pressure measures; one or more expiratory pressure measures; a duration of Cheyne-Stokes breathing; one or more mask pressure measures; one or more tidal volume measures; one or more minute ventilation measures; one or more respiratory rate measures; an ambient humidity measure; a humidifier temperature measure; a humidifier power measure; a heated tube power measure; one or more blower pressure measures; one or more respiratory flow measures; a humidifier connection indicator; a delivery' tube connection indicator; a blower flow measure: and a number of use periods.

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

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

12. Tire method of any one of claims 1 to 11, wherein the comparing determines that a duration is greater than one or more other durations.

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

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

15. The method of any one of claims 1 to 14, wherein the output report comprises a therapy session score.

16. The method of claim 15, wherein the therapy session score of the output report is derived from a plurality of parameters, the plurality of parameters comprising a plurality of: an apnea-hypopnea index; a leak measure; a mask removal count, and a therapy usage duration.

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

18. A processor-readable medium, having stored thereon processor-executable instructions which, when executed by one or more processors, cause the one or more processors to perform a method of one or more servers receiving a plurality of transmissions of respiratory therapy data from a respiratory therapy device over one or more networks, the method comprising the method of any one of claims 1 to 17.

19. One or more servers comprising one or more processors and configured to receive a plurality of transmissions of respiratory therapy data from a respiratory therapy device over one or more networks, wherein the one or more processors are configured to: receive first summary data from a first wireless transmission over at least a first communications channel from the respiratory therapy device, the first summary data comprising a summary of the respiratory therapy data; receive second summary data from a second wireless transmission over at least a second communications channel from the respiratory therapy device, the second summary data comprising a summary of the respiratory therapy data; access one or more first parameters from the received first summary data; 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; generate an output report with data from one of the first summary data and the second summary data based on a result of the comparing; and transmit, from the one or more servers, the output report to a client device.

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

21. A method for communicating respiratory therapy data from a respiratory therapy device in a plurality of transmissions with a server system, comprising one or more servers, over one or more networks, the method comprising: sending first summary data in a first wireless transmission over at least a first communications channel to the one or more servers from the respiratory therapy device, the first summary data comprising a summary of the respiratory therapy data, the first communication channel comprising a cellular communication; sending second summary data in a second wireless transmission over at least a second communications channel from the respiratory therapy device to a client device, the second summary data comprising a summary of the respiratory therapy data, the second communication channel comprising a short-range wireless communication; sending, from the client device, the second summary data received from the respiratory therapy device to the one or more servers over at least a third communications channel; and receiving, at the client device, in a communication from the server system, a generated output report with data from one of the first summary data and the second summary data based on a result of a remote comparison by the server system of one or more first parameters from the first summary data with one or more second parameters from the second summary data received by the server system from the client device.

22. Tire method of claim 21, further comprising: triggering, by the client device, the sending of the second summary data in the second wireless transmission, wherein the triggering comprises: accessing, on the client device, a therapy data display application while the client device and the respiratory therapy device are communicatively paired.

23. Tire method of claim 21, further comprising: triggering, by the respiratory therapy device, the sending of tire second summary data in the second wireless transmission, wherein tire triggering comprises: transitioning from a therapy mode to a standby mode, while the client device and the respiratory' therapy device are communicatively paired.

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

25. The method of claim 21, further comprising: triggering, by the client device, the sending of the second summary data in the second wireless transmission, wherein the triggering comprises: establishing a communications pairing between the client device and the respiratory therapy device.

26. Tire method of any one of claims 21 to 25, further comprising, initiating the communication from the server system to receive at tire client device the generated output report, by accessing, on the client device, a therapy data display application.

27. Tire method of any one of claims 21 to 26, wherein the second communications channel comprises a transmission over a wireless fidelity (Wi-Fi) communications network.

28. The method of claim 27. wherein tire transmission over the Wi-Fi communications network comprises a communication from the client device to the server system, wherein the client device transmits the second summary data to the server system after receiving the second summary data from the respiratory therapy device.

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

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

31. The method of any one of claims 21 to 30, wherein each of the first summary data and the second summary data comprise one or more of: a therapy duration; an apnea index, an hypopnea index; an obstructive apnea index; a central apnea index; an undistinguished apnea index; a respiratory event related arousal index: one or more leak measures; one or more inspiratory pressure measures: one or more expiratory pressure measures; a duration of Cheyne-Stokes breathing: one or more mask pressure measures: one or more tidal volume measures; one or more minute ventilation measures; one or more respiratory rate measures; an ambient humidity measure; a humidifier temperature measure; a humidifier power measure; a heated tube power measure; one or more blower pressure measures; one or more respiratory flowmeasures; a humidifier connection indicator; a delivery tube connection indicator; a blower flow measure; and a number of use periods.

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

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

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

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

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

37. The method of any one of claims 21 to 36, wherein the output report comprises a therapy session score.

38. Tire method of claim 37, wherein the therapy session score of the output report is derived from a plurality of parameters, the plurality of parameters comprising a plurality of; an apnea-hypopnea index; a leak measure; a mask removal count, and a therapy usage duration.

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

40. A processor-readable medium, having stored thereon processor-executable instructions which, when executed by one or more processors, cause the one or more processors to perform a method for communicating respiratory therapy data from a respiratory therapy device in a plurality of transmissions with a server system over one or more networks, the method comprising the method of 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 the processor-readable medium of claim 40.

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