Method and apparatus for constructing a medical device

Abstract

A method and device for determining and / or configuring the functionality of respiratory assistance devices, such as CPAP devices and high flow therapy devices, is provided. [Solution] A method for configuring a medical device for a patient, comprising steps of receiving information about the patient, the patient requiring a medical device; identifying and / or receiving a medical device configuration for the medical device, the medical device configuration being appropriate for the patient; and uploading the medical device configuration to a server, the medical device configuration on the server being for later download by the device when the patient receives and activates their medical device.

Description

[Technical Field]

[0001] The present invention relates to methods and devices for determining and / or configuring the functionality of medical devices, particularly respiratory assistance devices such as, but not limited to, CPAP devices and high flow therapy devices. [Background technology]

[0002] When a patient (user) needs a CPAP machine to help with obstructive sleep apnea, the patient visits a retailer who provides a consultation and selects a device with the appropriate features and prescription to treat the patient's breathing disorder. Summary of the Invention [Problem to be solved by the invention]

[0003] It is an object of the present invention to provide a method, system, and / or device for enabling configuration of a CPAP machine or other respiratory device (or more broadly, a "medical device"). [Means for solving the problem]

[0004] In one aspect, the invention includes a method of configuring a medical device for a patient, comprising receiving information about the patient, the patient requiring a medical device; identifying and / or receiving a medical device configuration for the medical device, the medical device configuration being appropriate for the patient; and uploading the medical device configuration to a server, the medical device configuration on the server for subsequent download by the device when the patient receives and activates their medical device.

[0005] In one embodiment, the configuration of the medical device is associated with at least a portion of the information about the patient on the server.

[0006] In one embodiment, the configuration of the medical device is associated with the medical device on the server.

[0007] In one embodiment, the configuration of a medical device is associated with the medical device by the medical device's identification information.

[0008] In one embodiment, the medical device is associated with at least a portion of the information about the patient on the server.

[0009] In one embodiment, the method further comprises providing the medical device to the patient in an unconfigured or default state.

[0010] In one embodiment, the method further includes the step of the medical device downloading a configuration of the device from the server upon activation of the medical device.

[0011] In one embodiment, the method further includes downloading the configuration to the medical device.

[0012] In one embodiment, the method further comprises providing the patient with a user input device for receiving patient input.

[0013] In one embodiment, the user input device provides a question regarding the likelihood that the user will use the medical device as prescribed.

[0014] In one embodiment, the medical device is a respiratory support device.

[0015] In one embodiment, the medical device is one of a CPAP machine, a bi-level machine, a high flow therapy machine, or other respiratory assistance machine.

[0016] In another aspect, the invention includes a medical device adapted to receive a configuration, the medical device including a communications interface for communicating with a server and receiving a configuration from the server, and a processor for receiving the configuration and configuring the medical device.

[0017] In one embodiment, the configuration is created as in any one of the method paragraphs above.

[0018] In one embodiment, the medical device is one of a CPAP machine, a bi-level machine, a high flow therapy machine, or other respiratory assistance machine.

[0019] In another aspect, the invention includes a system for configuring a medical device that includes a server having a communication interface for receiving a configuration of the medical device and providing the configuration to the medical device.

[0020] In one embodiment, the configuration is created as in any one of the method paragraphs above.

[0021] In one embodiment, the medical device is one of a CPAP machine, a bi-level machine, a high flow therapy machine, or other respiratory assistance machine.

[0022] In another aspect, the present invention includes a method of providing and / or configuring a medical device, comprising receiving information about a patient, the patient requiring a medical device; identifying and / or receiving a medical device configuration for the medical device, the medical device configuration being appropriate for the patient; uploading the medical device configuration to a server, the medical device configuration on the server being for transfer to the medical device; and providing the medical device to the patient.

[0023] In one embodiment, the method further includes configuring the medical device by downloading a configuration of the medical device from the server onto the medical device.

[0024] In one embodiment, the method further includes configuring the medical device by transferring a configuration of the medical device from the server onto the medical device using wireless data transfer technology such as NFC or RFID tags.

[0025] In one embodiment, after a patient receives and activates their medical device, the medical device downloads the medical device configuration from the server onto the medical device.

[0026] In one embodiment, a medical device provider configures the medical device by downloading the medical device configuration from a server onto the medical device before providing the medical device to the patient.

[0027] In one embodiment, the medical device provider configures the medical device when the device is off by transferring the medical device configuration from a server onto the medical device using wireless data transfer technology before providing the medical device to the patient.

[0028] In one embodiment, a provider provides a medical device to a patient by shipping the medical device to the patient in a configured or unconfigured state.

[0029] In one embodiment, the medical device implements a default configuration, such as Auto CPAP, before being configured by download or transfer, or if the configuration process fails.

[0030] In one embodiment, the medical device is a respiratory support device.

[0031] In one embodiment, the medical device is one of a CPAP machine, a bi-level machine, a high flow therapy machine, or other respiratory assistance machine.

[0032] In one embodiment, the medical device cannot provide therapy until the configuration of the medical device is determined to be complete.

[0033] In one embodiment, a message is sent to the medical device provider if the download is not confirmed within a predetermined time.

[0034] At least some of the described embodiments eliminate at least some of the manual input required to set up a patient for follow-up and monitoring, allowing the device to be provided to the patient without any configuration required before the patient receives it. This allows healthcare providers to give the device to the patient in an unopened box without the time expense of opening, powering on, configuring, and repackaging the device. Such an arrangement also enables novel distribution models where devices can be shipped directly to patients from a distant third-party or manufacturer warehouse without the healthcare provider having to touch the product before shipping.

[0035] At least some described embodiments provide a network-enabled pressure support device configured to communicate with a remote server configured to communicate with a database containing a record for each device provided to a patient, each device record including: -Device configuration settings (e.g., pressure setpoint, operating mode i.e., AUTO or CPAP, humidity setpoint) - Activation commands for therapeutic features (e.g., code to enable features that are already present on the device but are not active, such as Sensawake™, humidity, breath relief, etc.) -Software modules related to therapeutic functions (e.g., applications to provide functions not present on the device, such as Sensawake™ (vacuum reduction based on waking detection) and humidity) -Full or partial device firmware (e.g. new firmware versions including different pressure supply modes or alternative firmware versions) The device configuration profile may include an associated device configuration profile that includes one or more of the pieces of information:

[0036] When a device is powered on, if it has not previously received a configuration profile, it attempts to communicate with a remote server and provides its serial number and model. Upon accepting a connection from the device, the server attempts to retrieve the device's configuration profile from a database, indexed by the device's serial number. Upon receiving the configuration profile, the device applies the provided settings and / or downloads and installs any referenced software modules or firmware updates. The device then reconnects to the server to verify that the provided settings and updates have been applied.

[0037] In at least some embodiments, the patient's prescription must be applied before the device can be used therapeutically.

[0038] An embodiment will be described with reference to the drawings. [Brief explanation of the drawings]

[0039] [Figure 1A] 1 is a flow diagram illustrating actions of a patient, a provider, a medical device, and a cloud-based environment to enable configuration of a medical device according to a first exemplary embodiment. [Figure 1B] 10 is a flow diagram illustrating actions of a patient, a provider, a medical device, and a cloud-based environment to enable configuration of a medical device, according to another example embodiment. [Figure 1C] 10 is a flow diagram illustrating actions of a patient, a provider, a medical device, and a cloud-based environment to enable configuration of a medical device, according to another example embodiment. [Figure 2A] 1 shows a diagram of a system for configuring a medical device according to a first exemplary embodiment. [Figure 2B] 1 shows a diagram of a system for configuring a medical device according to another exemplary embodiment. [Figure 2C] 1 shows a diagram of a system for configuring a medical device according to another exemplary embodiment. [Figure 2D]1 shows a diagram of a system for configuring a medical device according to another exemplary embodiment. [Figure 2E] 1 shows a diagram of a system for configuring a medical device according to another exemplary embodiment. [Figure 3A] 1 illustrates a workflow of a patient, provider, medical device, and cloud-based environment to enable configuration of a medical device. [Figure 3B] 1 illustrates a workflow of a patient, provider, medical device, and cloud-based environment to enable configuration of a medical device. [Figure 3C] 1 illustrates a workflow of a patient, provider, medical device, and cloud-based environment to enable configuration of a medical device. [Figure 4] 10 shows screenshots of a user input device illustrating a high level workflow for obtaining information for the purpose of configuring a medical device. [Figure 5A] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5B] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5C] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5D] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5E] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5F] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5G] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5H] 10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5I]10 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 6A] 13 shows a provider screen to assist with a patient consultation. [Figure 6B] 13 shows a provider screen to assist with a patient consultation. [Figure 7] 1 shows identification marks on the device box used in constructing the medical device. DETAILED DESCRIPTION OF THE INVENTION

[0040] overview FIG. 1A illustrates a flow diagram of a method for configuring a medical device, and FIG. 2A illustrates an associated system for configuring a medical device. The medical device 20 may be a respiratory support device, such as a CPAP device, a bilevel device, a high-flow therapy device, or other similar respiratory support device. The described methods and devices may also relate to other types of respiratory support devices, and more broadly, to other types of medical devices. While the remaining description describes embodiments with respect to a CPAP respiratory support device 20, this is by way of example only and should not be considered limiting. The described methods include actions from the patient, the CPAP device provider, the computer system / cloud environment, and the CPAP device. It will be understood that this is provided for context and does not necessarily encompass all actions and the participants / hardware implementing those actions. The invention is defined by the claims.

[0041] A patient (user) needing a CPAP respiratory support device 20 (hereinafter referred to as a CPAP device or CPAP apparatus) to treat a breathing disorder visits a provider, such as a distributor of such CPAP devices (DME). The patient receives a user input device 21 from the provider (step 10) for use in inputting information that helps build a patient profile, helping the CPAP device provider determine what type of CPAP device is needed to treat the patient and how it should be configured. The user input device 21 also provides information to the distributor, helping the distributor advise and assist the user in using the CPAP device. The user input device 21 can be any suitable device, such as a computer, a tablet such as an iPad®, a mobile phone or other mobile device. The user input device can also be in a manual form that captures profile information, such as a paper questionnaire that is manually completed. The user input device presents the patient with a questionnaire, the responses to which help build the patient profile.

[0042] The patient answers a questionnaire (step 11) by entering responses on a user input device 21, which elicits information from the user to help build a patient profile and assist the provider in determining the appropriate CPAP device 20 and its required configuration for the patient. A trained specialist at the provider receives the information and participates in a consultation with the patient to assess the patient's treatment requirements (step 12). The trained specialist selects an appropriate CPAP device and also determines the required configuration, which may include CPAP device capabilities, setup parameters, and the prescription (pressure prescription, in the case of a CPAP device) to be provided by the CPAP device. The CPAP configuration, or portions thereof, may also or alternatively be determined by a computer program and / or a physician. The trained specialist then registers the selected CPAP device and associates it with the patient (e.g., via patient-related information, i.e., the patient profile) preferably within a cloud computing environment 23 (server) (step 12A). This step may include, among other things, a configuration server 24. The trained professional also sets the configuration of the CPAP device (step 13), which is stored in the cloud computing environment 23 as a CPAP configuration profile on the server 24 (e.g., in the form of a record in a database of records for multiple CPAP devices). Alternatively or additionally, the CPAP device can be associated with the configuration of the medical device in the cloud computing environment (server), e.g., by means of a medical device identification. Alternatively or additionally, the configuration of the medical device can be associated with the patient (e.g., by means of information related to the patient, i.e., a patient profile).

[0043] The trained professional may assist the patient in enrolling in an instructional program, which may be an application-based program to assist the patient in using the CPAP device (Step 14). The provider gives the patient the selected CPAP device to take home for use (Step 15A). At that stage, the CPAP device has no configuration or a default configuration. Upon arriving home, the user activates the CPAP device (Step 15A). The CPAP device connects itself to a cloud computing environment and downloads the configuration used to configure itself and provide the functionality, setup configuration, and prescription determined by the provider (Step 16A). The patient can then use the CPAP device for therapy in the usual way.

[0044] 1B and 1C show a flow diagram of an alternative method for configuring a medical device, and FIGS. 2B through 2E show an associated system for configuring a medical device.

[0045] As an alternative, shown in Figures 1B and 2B, the provider's trained professionals do not supply the CPAP equipment, but rather the CPAP equipment is provided and registered by a third party provider.

[0046] As another alternative shown in Figures 1C, 2C, and 2D, the CPAP device can be registered and configured in a warehouse or other distribution center using cloud download or NFC and shipped directly to the user's location with that configuration, or the CPAP device can be shipped unconfigured or to be configured later by the user.

[0047] An exemplary embodiment will now be described.

[0048] First Exemplary Embodiment Exemplary embodiments will now be described in detail with respect to Figures 1A, 2A, and 3A-6B.

[0049] Figures 3A-3C show a storyboard step-by-step description of the method, Figure 4 shows the workflow for retrieving patient profile information and providing a configuration profile, and Figures 5a-6B show various screenshots of the user device and provider device for retrieving patient profile information and CPAP device configuration information.

[0050] 1A, 2A, and 3, a patient presents to a provider (step 10) and is given a user input device, such as a tablet 21, at the reception desk. The user input device has an application with a user interface that presents screens with a questionnaire that captures patient information from the patient (step 11) to build a patient profile (see FIGS. 5A-5I). The information captured includes personal details as well as responses to questions in the questionnaire that determine the patient's needs and characteristics. Information may be entered into the user input device 21 prior to a consultation with a trained professional, such as in a reception waiting area.

[0051] 4 and 5A-5I, a workflow 40 for entering user information using the application is described. The application begins and screens / tabs are provided requesting the user's login details such as username, password, creating a PIN, etc. (See screens 50 and 51 in Figures 5A and 5B). Screen 52 is then provided requesting the user's personal details such as name, gender, date of birth, contact details, etc. (See Figure 5C).

[0052] The application then provides screens (see FIGS. 5D-5I) presenting the patient with a questionnaire, which the patient is prompted to complete. By way of example, the patient is presented with a questionnaire page that asks questions eliciting information about the patient's perceptions, dispositions, and other psychological characteristics. The questionnaire may include, for example, 14 questions, and responses to the questions create a model that identifies key patient psychological factors related to the patient's use or non-use (adherence / non-adherence or compliance / non-compliance) of the CPAP device 20. The responses also build a personalized assistance program for the patient, which is delivered via text message or other communication means to assist the patient in the initiation of treatment, as described below. The questionnaire may include questions such as those described in PCT application WO 2013 / 187776, which is incorporated herein by reference in its entirety. As shown on screen 58 of FIG. 5I, the user can enter information and / or provide responses by touching buttons on a touchscreen.

[0053] As an example, the following questions / statements are asked / posed on the first screen / tab 53 as shown in FIG. 5D for the patient to respond to: · "About OSA, how much do you think OSA affects your sleep?" - responses on a 0-10 scale ranging from "does not affect my life at all" to "affects my life very much." "To what extent do you think CPAP can help your OSA?" - Responses on a 0-10 scale ranging from "not at all helpful" to "very helpful." "How worried are you about using a CPAP machine?" - Responses on a 0-10 scale ranging from "not at all worried" to "very worried." · "How confident are you that you will use your CPAP device as instructed?" - Responses on a 0-10 scale ranging from "not at all confident" to "very confident."

[0054] The patient is prompted to answer / respond in an appropriate manner, for example, in this embodiment by indicating a number indicating how much they agree with the question / statement. This can be done by pressing a button on the touch screen of the user input device, as shown on screen 58 in Figure 5I. Once the information is entered, it is stored within the user input device 21 for later retrieval.

[0055] Additional pages / screens / tabs such as those shown in Figures 5E-5H can be presented to the patient to ask further questions that elicit responses on the patient's psychological and other characteristics. The user can navigate back and forth between pages to enter and modify answers / responses as needed.

[0056] Other questions posed that can be answered or responded to in a similar manner include: Figure 5E, Screen 54 "Do you have someone you can turn to for support?" - Yes / No "Which best describes your current relationship status?" - Married, Cohabiting, Widowed, Separated, Divorced, Unmarried, Other Figure 5F, Screen 55 "Do you have someone you can turn to for support?" - Yes / No "Do you think this person is supportive of you in managing your OSA?" Responses on a 0-10 scale ranging from "not at all supportive" to "very supportive" "What is the person's attitude toward using CPAP?" - Responses on a scale of 0-10 from "very negative" to "very positive" Figure 5G, Screen 56 "With which racial or ethnic group do you most identify?" - American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White or European American, Hispanic / T no, Other "What is your highest qualification?" - Less than high school diploma, High school diploma / GED, Associate's degree / vocational course, Bachelor's degree or higher "What is your occupation?" - Self-employed, Housewife, Student, Unable to work, Wage earner, Retired, Other "What is your household income?" - 0-$29,999, $30,000-$59,999, $100,000 or more, Do not answer Figure 5H, Screen 57 "How did you feel about your sleep testing experience?" - Responses on a 0-10 scale ranging from "very negative" to "very positive"

[0057] Examples of how a user may answer these questions by pressing answers on the touchscreen are shown on screen 58 in Figure 5I.

[0058] Once all questions have been answered, the user is ready to consult (step 12). The user brings their tablet or other user input device 21 to the trained specialist for the consultation. During the consultation, the patient hands the user input device to the trained specialist, who can enter a PIN or other authentication (see FIG. 6A, screen 60) to access a patient dashboard (see FIG. 6B, screen 61) that provides patient profile information based on the questionnaire responses, as well as the answers themselves. The application presents the trained specialist with topics that have been identified, selected, or otherwise determined based on the questionnaire responses. Topics provide meaningful areas of discussion, allowing the specialist to focus the conversation on areas that will be most helpful to the patient, saving time spent locating that information through the conversation. An example of such a topic is shown in FIG. 6B.

[0059] For example, referring to Figure 6B, for clients who indicate that OSA has a minimal impact on their life, professionals can be encouraged to discuss the following points: OSA is a serious health condition that can affect your ability to work and to perform at home. OSA can affect concentration, decision-making, and motivation. · OSA can be treated with CPAP.

[0060] Similarly, for patients who express uncertainty about their ability to use CPAP, professionals can encourage them to discuss the following: Good things take time. Learning how to use a CPAP takes time. Don't be discouraged if you don't get it right the first time. It may take time and practice before you feel confident using your CPAP every night. This is normal.

[0061] The professional can then select an appropriate configuration for the CPAP device (which may be a configuration appropriate for the patient) and train the patient on how to use the CPAP device, for example, using a demo unit on their desk. The configuration may be selected / defined by the professional, a physician, and / or a computer program. The professional does not need to unbox a new unit for the patient. Once the professional has completed the training, the boxed CPAP device 20 may be provided to the patient. The CPAP device 20 may have a default configuration or may be unconfigured.

[0062] Before the box is removed, the professional registers the CPAP device (step 12A). This registration can be via an "Assign Device" button on the user input device application, as shown in FIG. 6B. Pressing the "Assign Device" button turns on the user input device camera 22. The professional can point the camera at a label 25, such as a QR Code® barcode, serial number, or other identifying mark, on the CPAP device box (or on the device itself) to be given to the patient (see FIGS. 2 and 7). The application scans the identifying mark and assigns the patient to the CPAP device in a cloud-based database. The identifying mark may also be entered manually. The identifying mark on the CPAP device box preferably includes the device serial number and an on-device identification number for storage in the database. The identifying mark should be unique in format compared to other barcodes and identifying marks on the label to prevent other identifying marks from being accidentally scanned when the camera is pointed at the box. Preferably, if multiple identifying marks, such as barcodes, are on the box, the identifying mark for assigning and registering the device should be clearly identified as the identifying mark to be scanned or otherwise entered. This may involve demarcating and labeling the identification mark, or wrapping the identification mark near a corner of the box. The identification mark also needs to be in a format and size that allows it to be quickly and accurately scanned, such as by a mobile device, from a distance of 20 cm, presented at an angle that is comfortable for the person holding the user input device, if the box is on a tabletop.

[0063] The application then communicates with a cloud-based server to set up a record for the patient, which indicates the patient, the patient's device, and then the configuration.

[0064] At that point, the expert can provide the configuration (step 13).

[0065] The configuration profile is then uploaded and stored on a cloud server for later download by the CPAP device so that the CPAP device can self-configure.

[0066] Optionally, a trained professional can invite the patient to the application and associated patient-directed assistance programs to assist with treatment (step 14). If the professional decides to invite the patient, the patient will receive email instructions to their computer, user device, or mobile device telling them how to download the application onto their device and begin monitoring the progress of their own treatment.

[0067] If the provider decides to start an assistance program, the patient will receive a welcome text, email, message, or other communication asking if they would like to participate in the program. If the patient participates in the program, the patient will begin receiving feedback and encouraging messages.

[0068] Patients are provided with a CPAP machine in a box and sent home.

[0069] Further setup may be required by the provider to establish patient monitoring. No access to a cloud-based server is required to complete the setup.

[0070] When the patient gets home, they can unpack and turn on their CPAP device (step 15A). The CPAP device includes a communications interface 26, such as an internal or external modem, that connects the CPAP device to a cloud-based server. The CPAP device downloads a patient-specific configuration profile from the cloud-based server.

[0071] The CPAP device then self-configures itself according to the configuration profile (step 16A).

[0072] In one example, a network-enabled pressure support device is provided that is configured to communicate with a remote server that is configured to communicate with a database that contains a record for each device provided to a patient. -Device configuration settings (e.g., pressure setpoint, operating mode i.e., AUTO or CPAP, humidity setpoint) - Activation commands for therapeutic functions (e.g., code to enable functions that are already present on the device but are not active, such as Sensawake™ or humidity) -Software modules related to therapeutic functions (e.g., applications to provide functions not present on the device (e.g., Sensawake™, humidity, etc.)) -Full or partial device firmware (e.g. new firmware versions including different pressure supply modes or alternative firmware versions) The device configuration profile may include an associated device configuration profile that includes one or more of the pieces of information:

[0073] When a device is powered on, if it has not previously received a configuration profile, it attempts to communicate with a remote server and provides its serial number and model (step 16A). Upon accepting a connection from the device, the server attempts to retrieve the device's configuration profile from a database, indexed by the device's serial number. Upon receiving the configuration profile, the device applies the provided settings and / or downloads and installs any referenced software modules or firmware updates (step 16A). The device then reconnects to the server to verify that the provided settings and updates have been applied.

[0074] If the user does not activate the device, the configuration will not be downloaded. Alternatively, if the user activates the CPAP device but does not properly connect to the cloud-based server, the CPAP device will not download the configuration. Failure to download the configuration can cause difficulties and may result in no or suboptimal therapy being delivered. In this case, if the configuration has not been downloaded for a period of time, e.g., two days, an alert is sent to the provider so that the provider can contact the patient and resolve the issue. Similarly, or alternatively, the CPAP device may have a default configuration that provides at least some therapy and is not harmful. The default may be an autotitration CPAP, in which the pressure delivered to the patient is automatically adjusted based on feedback. However, this default configuration may not provide optimal therapy, which may be harmful to the patient. To prevent the use of a default or other incorrect configuration for an extended period of time, the CPAP device may be locked out after a certain period of time, such as two days, without setting a personalized configuration. The medical device cannot deliver therapy until it is determined that the medical device configuration is complete. For example, if the download is not confirmed within a predetermined period of time, a message may be sent to the patient telling them to contact their provider.

[0075] Further exemplary embodiments Another exemplary embodiment will now be described with respect to Figures 1B and 2B. The description provided herein is intended to highlight the differences between this exemplary embodiment and other exemplary embodiments.

[0076] This embodiment applies when the retailer does not supply the particular CPAP device 20 being recommended, but rather the CPAP device 20 is provided by a competitor. The process (steps 10, 11, 12, 13, and 14) proceeds as usual, but the patient is not provided with the CPAP device 20 by the provider; rather, the patient receives the CPAP device 20 from another provider. However, even if the actual CPAP device 20 is provided by another provider, the configuration is still uploaded to the cloud-based servers 23, 24 by a trained professional. Similarly, the CPAP device 20 is also registered by the other provider, but the registration process is similar to the registration process described in the first exemplary embodiment.

[0077] The registration process will now be described in more detail. A trained professional uploads an order number that is linked to the patient's configuration profile, allowing other providers to register the CPAP device 20 with the patient. When the patient visits another provider, the other provider can register the CPAP device 20 by linking the CPAP device 20's serial number to the correct configuration profile (step 15B). The other provider uses their own input device 21B to capture the label 25 on the CPAP device 20 using camera 22B or manually enter the CPAP device 20's serial number into input device 21B.

[0078] When the patient receives the CPAP device 20 from another provider and takes it home, the patient turns it on in the normal manner (step 16B), has the configuration downloaded, and the device is configured in the normal manner (step 17B).

[0079] This being the case, the provider will conduct a consultation and select a device with the appropriate features and prescription to treat the patient's breathing disorder.

[0080] Further exemplary embodiments Another exemplary embodiment will now be described with respect to Figures 1C, 2C, 2D, and 2E. The description provided herein is intended to highlight the differences between this exemplary embodiment and other exemplary embodiments.

[0081] This embodiment applies when a CPAP device 20 is ordered and shipped directly to the patient's home. The process (steps 10, 11, 12, 13, and 14) proceeds as usual, except that the patient is not provided with a CPAP device by a provider; instead, the CPAP device 20 is shipped from a warehouse, distribution center, or some other remote location. In this case, the warehouse is responsible for registering and configuring the CPAP device 20, but the registration process is similar to the registration process described in the exemplary embodiment described above.

[0082] The registration process will now be described in more detail. A trained professional uploads an order number that is tied to the patient's configuration profile, allowing registration of the CPAP device to be completed in the warehouse. Once the warehouse receives the order number, the serial number of the CPAP device can be properly matched to the configuration profile (step 15C). A warehouse employee uses input device 21C to capture the label 25 on the CPAP device 20 using camera 22C or manually enter the serial number of the CPAP device 20 into input device 21C. Once the registration process is complete, the CPAP device 20 can be shipped directly to the patient ready to use (step 16C). The patient powers on the CPAP device 20 as normal for configuration (step 17C).

[0083] Alternatively, the CPAP device can be unpackaged, powered on, and configured before being shipped directly to the patient, as shown in Figure 2D. As previously described, the CPAP device 20 includes a communications interface 26, such as an internal or external modem, that connects it to the cloud-based servers 23, 24. The CPAP device downloads a patient-specific configuration profile from the cloud-based servers 23, 24. The CPAP device 20 is then configured in the usual manner (step 16C) and can be shipped directly to the patient ready for use (step 17C).

[0084] Alternatively, the CPAP device 20 can be registered (step 15C) and configured (step 16C) in a warehouse or distribution center while it is powered off and / or still packaged using wireless data transfer techniques as described with respect to FIG. 2E.

[0085] Configuration of the CPAP device 20 (step 16C) can be accomplished when the CPAP device 20 includes an embedded, smart, near-field communication (NFC) chip 27 (or "tag") with local memory configurable by an NFC-enabled computing device 21D, such as a smartphone or tablet. To initiate the CPAP configuration process, the NFC-enabled computing device 21D is brought into proximity with the NFC tag 27 to create an NFC connection. This allows the NFC computing device 21D to obtain identification-related information from the CPAP device 20, such as its serial number and model. The NFC computing device 21D then connects to a remote cloud-based server 23, 24. Upon accepting the connection from the NFC computing device 21D, the server 24 attempts to retrieve a configuration profile for the CPAP device 20 from a database, indexed by the CPAP device's serial number. Once the correct configuration profile is obtained, the provided settings and / or referenced software modules and / or firmware updates are downloaded from the cloud-based server 23, 24 to the NFC computing device 21D (step 16C). Once the NFC connection is made between the NFC computing device 21D and the NFC tag 27, the CPAP device 20 can apply the provided settings and / or download and install the referenced software module or firmware update. The CPAP device 20 then reconnects to the NFC computing device 21D to confirm that the provided settings and updates have been applied. Confirmation that the provided settings and updates have been applied can also be relayed from the NFC computing device 21D to the remote cloud-based servers 23, 24. At this point, the CPAP device 20 is properly configured and can be shipped directly to the patient ready for use (step 17C).

[0086] The NFC computing device 21D can also be used to complete the CPAP registration (step 15C) in place of the input device 21C by using the camera 22D to capture the label 25 on the CPAP device 20 or by manually entering the serial number of the CPAP device 20 into the NFC computing device 21D.

[0087] It may also be possible that other wireless data transfer standards and / or technologies can be used instead of NFC, such as RFID.

[0088] Further exemplary embodiments One embodiment includes a device that is fitted with an internal property [RxSet] that determines whether a configuration has been applied to the device. Each time the device is powered on, the RxSet property is checked; if the RxSet property is false, the device immediately contacts a remote server to query for a configuration profile. During this process, which can take several minutes, an animation is displayed on the unit's display indicating that the device is self-configuring. Any buttons or controls on the device are locked out during this process, so the patient must wait for the process to complete, and the device cannot provide therapy until the process is complete. Once the downloaded configuration profile is verified with the server, a completion message is displayed to the user before the device returns to its normal standby mode. At this point, the RxSet property is set to true, meaning that any subsequent time the device is powered on, the device will immediately enter normal standby mode.

[0089] If the device cannot communicate with the remote server or cannot identify a configuration profile for its serial number, the device may retry the connection several times before displaying an error message such as "Prescription not available. Please contact your healthcare provider." In this case, the RxSet property keeps its default false value, meaning that any time the device is powered on, the device will again attempt to connect and download a configuration profile.

[0090] While a prescription is being downloaded, it may be desirable for the patient to be able to explore their device and learn its features, rather than being completely locked out of the device until it is configured. Another embodiment consists of a similar device as described above, adapted with an internal property [RxSet] that determines whether a configuration has been applied to the device. The RxSet property is checked each time the device is powered on. If the RxSet property is false, the device communicates with the remote server to query the configuration profile. In this case, however, the device continues to start normally and enters standby mode while communication with the remote server continues in the background. The device displays a crossed-out Rx indicator symbol on the display, indicating that the device's settings have not yet been configured. The patient can enter all of the device's menus and explore the device normally, but if they attempt to start therapy while communication is still ongoing, an animation appears on the unit's display indicating that the device is self-configuring and therapy cannot be started. The patient can continue to explore the device's other features, but will not be able to start therapy. Once the configuration process is complete, the crossed-out Rx symbol disappears from the display, and therapy can be started normally. At this point the RxSet property is set to true, which means that any time after the device is powered on, the device will enter normal standby mode and be able to provide therapy.

[0091] If the device cannot communicate with the remote server or identify a configuration profile for its serial number, the device can retry connecting several times. If it still cannot obtain a profile after retrying, attempting to start a therapy on the device will result in the device displaying an error message such as "Prescription not available. Please contact your healthcare provider," and therapy cannot be started; however, the patient can continue to explore other features of the device; the RxSet property remains its default false value, meaning that the device will attempt to connect and download a configuration profile again any time the device is powered on.

[0092] Another embodiment consists of a device that includes a default AUTO CPAP mode, in which the device automatically adjusts its output pressure to a therapy pressure based on the occurrence of an event. As before, the device is configured with an internal property [RxSet] that determines whether a configuration is applied to the device. Each time the device is powered on, the RxSet property is checked, and if the RxSet property is false, the device communicates with a remote server to query a configuration profile. During this process, which can take several minutes, the device functions normally and can provide therapy in this default AUTO CPAP mode. The device continues to operate in this mode until it successfully connects to the remote server and receives a configuration profile with updated therapy settings. At this point, the RxSet property is set to true, meaning that the device will not continue to connect and search for a profile any time the device is powered on.

[0093] In all of these embodiments, at any time before a configuration profile is applied to the device, the provider can enter a secret "clinician mode" by entering a specific combination of keys on the device. Clinician mode allows the provider to manually set prescription settings on the device. Manually configuring the device sets the RxSet property in the device to true, allowing the device to enter normal standby mode and unlock from delivering therapy.

[0094] Another embodiment consists of a device containing only a base firmware image that connects to a remote server and retrieves a configuration profile that instructs the device on which complete firmware image to download and install. When powered on in this base firmware state, the device communicates with the remote server to query the configuration profile. During this process, which can take several minutes, an animation appears on the unit's display indicating the device is self-configuring. The downloaded configuration profile instructs the device to download a complete firmware image containing the operating firmware for the type of device prescribed for the patient, such as an AUTO CPAP image or a Bi-Level image. The device then downloads and installs that image and restarts to a therapeutically operational state. This embodiment allows for the manufacture of a single model of device containing this base firmware. When initially powered on, the device can adapt itself to one of many possible models to provide the specific therapy modes and features required by the patient.

[0095] The ability of a device to connect and obtain a configuration profile relies on configuration profiles for the patient and device being provisioned on a remote server.

[0096] This is done by an online management system configured to communicate with the database.

[0097] In one embodiment, a healthcare provider can set up a patient in this management system via a website, tablet, or mobile application before the device is given or shipped to the patient. Adding a patient creates a patient object in the database that consists of:

number

[0098] Each patient is given a unique ID that identifies them within the data structure.

[0099] Once a patient is created, a device can be assigned to the patient by its serial number. A device can be assigned via a website, tablet, or mobile application by entering the device serial number via the application interface, or by using the camera on the tablet or mobile device to scan the barcode on the device or device packaging and extract the device serial number. Assigning a device to a patient results in a device record being created in the database, which is related to the patient by the patient Id. A device record consists of:

number

[0100] A patient configuration profile can then be created by the provider by selecting the patient's prescribed settings or modes through this website, tablet, or mobile interface. -Device configuration settings (e.g., pressure setpoint, operating mode i.e., AUTO or CPAP, humidity setpoint) - Activation commands for therapeutic features (e.g., code to enable features that are already present on the device but are not active, such as SensAwake™ or humidity) - Header data referencing the path of the software module that the device should download to install the additional functionality - Header data referencing the path of the firmware image that the device should download to upgrade its operating software along with a header containing the serial number, model, and family of the device it is provisioned for.

[0101] for example, Device configuration settings:

number

number

number

number

[0102] Once a configuration profile is created, it is stored in a database that is indexed by the device serial number. The configuration profile also has an associated state value so that it can be tracked throughout its lifecycle. For example:

number

[0103] The status value allows the system to evaluate whether the configuration profile has been applied to the device and is verified as correct. Possible status values ​​are: PENDING - A configuration profile has been created but not claimed by the device APPLIED - The configuration profile is required by the device CONFIRMED - The configuration profile has been applied on the device and has been confirmed to be accurate

[0104] In another embodiment, before the device is shipped to the patient, the healthcare provider can again set up the patient in this management system via a website, tablet, or mobile application. Each patient is given a unique ID that identifies them within the data structure.

[0105] In this embodiment, instead of the device serial number being entered or scanned by the healthcare provider, an order for the device is created within the system. This order can be transmitted to a remote fulfillment center. To create this order, the healthcare provider is prompted to select the device model, enter a delivery address, and create a patient configuration profile as before. This configuration profile is temporarily associated with the order because a serial number has not yet been assigned. A unique patient ID is added to the order, allowing the order to be referenced back to the patient.

[0106] The order is transmitted to a fulfillment center running software adapted to communicate with the patient management server. Upon picking the order, the fulfillment center scans or enters the provided order number and device serial number into the software, which transmits the information back to the remote server. Upon receiving this fulfillment information, the server retrieves the configuration profile associated with the order and updates the configuration profile with the provided serial number.

[0107] When the device connects to the remote server, perhaps when it is first powered on at the patient's home, it sends back a data structure containing its serial number to the remote server, which then performs a lookup in its database of configuration profiles to see if a configuration profile exists for that serial number.

[0108] If a profile is found, the profile's data is extracted from the database, encrypted, and returned to the device, and the status value in the database for that configuration profile is set to APPLIED.

[0109] When a profile is received, the device decodes it and first verifies the serial number, model, and family contained in the header to ensure that the profile is for that particular device. The device then reads the creation date and time and compares it to the last time a configuration change was made to the device. If the previous configuration change is more recent than that in the received profile, the received profile is ignored. Ignoring such an older profile prevents an older profile from being applied after the profile is created if the device's settings are changed, for example, through the device's user interface.

[0110] If the received profile includes a firmware element, the device reconnects to the server using the path provided in the firmware element. This path references a firmware file that is incrementally downloaded to the device. Once the file is completely downloaded, a checksum of the downloaded file is calculated. If the checksum of the downloaded file matches the checksum provided in the configuration profile, the device installs the new firmware and restarts.

[0111] If the received profile contains an install module element, for each referenced module, the device reconnects to the server using the module path provided in the module element. This path references the module file, which is incrementally downloaded to the device. Once the module file is completely downloaded, a checksum of the downloaded file is calculated. If the checksum of the downloaded file matches the checksum provided in that module's configuration profile, the device installs the new module, and its functionality becomes available to the device.

[0112] If the received profile includes a feature activation element, each of the features referenced in the list is enabled and made available to the device.

[0113] If the received profile contains a settings element, each referenced setting is updated on the device.

[0114] Once a profile is applied, the device reconnects to the remote server and returns updated values ​​for any settings changed by the profile, as well as the version of any modules or firmware installed. The server compares these values ​​with those in the original profile returned to the device. If the values ​​match, the status characteristic in the database for that configuration profile is set to CONFIRMED.

[0115] The remote server is configured to check the status of the new configuration profile a predetermined period of time (e.g., 24 hours) after its creation. If the profile's status is not CONFIRMED upon checking, the healthcare provider is notified that the device was unable to obtain its configuration within the allowed time period. This notification can be via an alert that appears within the patient management system interface the next time the provider logs on, or it can be a text message, call, or email automatically generated by the server.

Claims

1. 1. A system comprising: a respiratory assistance device having a communications interface and device data including an identification of the respiratory assistance device; a remote server capable of communicating with the database; a first user input device of a first party associated with providing respiratory therapy, the first party being a trained professional; a second user input device of a second party associated with providing respiratory therapy, the second party being a respiratory assistance device provider; the first user input device is configured to transmit data to the database for storage; The data is Patient data and configuration data including a configuration profile of the respiratory assistance device; the second user input device is configured to transmit data including device registration information corresponding to the device data to the database for storage; the patient data and the configuration data are associated with stored device registration information, the device registration information associating the respiratory assistance device with a patient associated with the patient data; the first party associates an order number with the patient data and the configuration data, and the second party associates the device registration information with the patient data and the configuration data using the order number; wherein said respiratory assistance device is adapted to configure itself by communicating directly or indirectly with said remote server via a communications interface to: Establishing a direct or indirect connection with said remote server; transmitting said device data directly or indirectly to said remote server; and receiving, directly or indirectly, said configuration data from a remote server; the respiratory assistance device is further configured to apply the configuration data to provide a prescription according to a customized configuration profile; A system in which the second party configures the respiratory assistance device without powering on the respiratory assistance device, the communication interface includes an NFC-enabled chip or tag, the second user input device includes an NFC-enabled computing device, and the communication interface communicates with the remote server via the NFC-enabled computing device to configure the respiratory assistance device.

2. 10. The system of claim 1, wherein the respiratory assistance device configures itself immediately when first powered on in the patient's home.

3. A system as described in any one of claims 1 to 2, wherein the respiratory assistance device is provided with a predetermined configuration profile and is configured to provide a prescription in accordance with the predetermined configuration profile if the respiratory assistance device fails to communicate with the remote server.

4. The system of any one of claims 1 to 3, wherein the remote server is configured to search a database for the device registration information corresponding to the device data and obtain associated configuration data for transmission.

5. A system according to any one of claims 1 to 4, wherein the device data is stored in an internal memory of the respiratory assistance device.

6. The system of any preceding claim, wherein the device data includes a device serial number.

7. The system of any preceding claim, wherein the device registration information includes a device serial number.

8. The system of any one of claims 1 to 7, wherein the communication interface comprises an internal modem or an external modem.

9. A system according to any preceding claim, wherein the device registration information is or is inferred from an identifying mark on the respiratory assistance device or on packaging associated with the respiratory assistance device.

10. The system of claim 9 , wherein the identification mark is a bar code.

11. The configuration data is - Device configuration settings, - Activation command, - software modules, and / or The system of any one of claims 1 to 10, being all or part of the device firmware.

12. The system of claim 11 , wherein the device configuration settings include a pressure setpoint, an operating mode, and / or a humidity setpoint.

13. 13. A system according to claim 11 or 12, wherein the respiratory assistance device has a therapy function disabled and the activation command includes an instruction to enable the therapy function.

14. A system according to any one of claims 11 to 13, wherein the software modules comprise applications that enable the respiratory assistance device to provide additional therapy functions.

15. The system of any preceding claim, wherein the first user input device comprises a personal computer or a tablet.

16. A system according to any preceding claim, wherein the respiratory assistance device is a CPAP device.

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