Method and apparatus for configuring medical device

Abstract

To provide a method, system and / or apparatus to allow configuration of a CPAP apparatus or other breathing apparatus.SOLUTION: A method of configuring a medical device for a patient comprises: receiving information on a patient, the patient requiring a medical device; clarifying and / or receiving a medical device configuration for the medical device, the medical device configuration being suitable for the patient; and uploading the medical device configuration to a server, where the medical device configuration on the server is for later download by the device when the patient has received their medical device and activated the medical device.SELECTED DRAWING: Figure 2A

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 apparatus (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 the steps of receiving information about a patient, where the patient requires a medical device, identifying and / or receiving a medical device configuration for the medical device, where the medical device configuration is appropriate for the patient, and uploading the medical device configuration to a server, where the medical device configuration on the server is for later 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 a server.

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

[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 machine.

[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 support 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 arrangement 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 support 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 arrangement 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 support machine.

[0022] In another aspect, the present invention includes a method of providing and / or configuring a medical device, comprising the steps of receiving information about a patient, where the patient requires a medical device; identifying and / or receiving a medical device configuration for the medical device, where the medical device configuration is suitable for the patient; uploading the medical device configuration to a server, where the medical device configuration on the server is 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 prior to providing the medical device to a patient.

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

[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 support machine.

[0032] In one embodiment, the medical device cannot provide therapy until 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 on the device before the patient receives it. This allows a healthcare provider to give the device to the patient in an unopened box without the time expense of opening, powering, configuring, and repackaging the device. Such an arrangement also enables new distribution models where devices can be shipped directly to patients from a distant third party or manufacturer warehouse without the healthcare provider needing to touch the product prior to 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 that includes 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 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™ (reduced pressure based on waking detection) and humidity) -Complete or partial device firmware (e.g. new firmware versions including different pressure supply modes or alternative firmware versions) The information 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 device cannot be used therapeutically unless a patient prescription is applied.

[0038] An embodiment will be described with reference to the drawings. [Brief description 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] 11 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] 11 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, a provider, a medical device, and a cloud-based environment to enable configuration of a medical device. [Figure 3B] 1 illustrates a workflow of a patient, a provider, a medical device, and a cloud-based environment to enable configuration of a medical device. [Figure 3C] 1 illustrates a workflow of a patient, a provider, a medical device, and a cloud-based environment to enable configuration of a medical device. [Figure 4] 1 shows screenshots of a user input device illustrating a high level workflow for obtaining information for the purposes of configuring a medical device. [Figure 5A] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5B] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5C] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5D] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5E] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5F] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5G] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5H] 13 shows a screen of a user input device for obtaining patient responses to build a patient profile. [Figure 5I]13 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 markings on the device box used in constructing a medical device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] overview FIG. 1A shows a flow diagram of a method for configuring a medical device, and FIG. 2A shows an associated system for configuring a medical device. The medical device 20 may be a respiratory support device, such as a CPAP device, a biphasic device, a high-flow therapy device, or other similar respiratory support devices. The described methods and devices may relate to other types of respiratory support devices, and more broadly, to other types of medical devices. In the remaining description, the embodiments are described in relation to a CPAP respiratory support device 20, which 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 that the invention does not necessarily encompass all actions and the participants / hardware that implement those actions. The invention is defined by the claims.

[0041] A patient (user) who needs a CPAP respiratory support device 20 (hereinafter CPAP device or CPAP machine) to treat a breathing disorder visits a provider such as a distributor (DME) of such devices. The patient receives from the provider (step 10) a user input device 21 for use in inputting information that helps to build a patient profile, helping the CPAP device provider to 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 to help 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 may be in the form of a manual form that captures profile information, such as a paper questionnaire that is filled out manually or otherwise. The user input device provides the patient with a questionnaire, the responses to which help to build the patient profile.

[0042] The patient answers the questionnaire (step 11) by inputting 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 expert of the provider receives the information and participates in a consultation with the patient to evaluate the patient's treatment requirements (step 12). The trained expert selects a suitable CPAP device and also determines the required configuration, which may include the CPAP device's capabilities, set-up parameters, the prescription the CPAP device will provide (pressure prescription in the case of a CPAP device), etc. The CPAP configuration or parts thereof may also or instead be determined by a computer program and / or a physician. The trained expert then registers the selected CPAP device and associates it with the patient (e.g. by information related to the patient, i.e. the patient profile) preferably in 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 an identification of the medical device. Alternatively or additionally, the configuration of the medical device can be associated with the patient (e.g., by information related to the patient, i.e., a patient profile).

[0043] The trained professional may assist the patient to enroll in an instructional program, which may be an application-based program to assist the patient in the use of 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 has a default configuration. Upon arriving at home, the user activates the CPAP device (step 15A). The CPAP device connects itself to a cloud computing environment and downloads the configuration that it uses to configure itself to provide the functionality, set-up 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 with the configuration to the customer's location of use, or the CPAP device can be shipped unconfigured or to be configured later by the customer.

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

[0050] 1A, 2A and 3, a patient visits a provider (step 10) and is given a user input device such as a tablet 21 at reception. The user input device has an application with a user interface providing screens with a questionnaire that captures patient information from the patient (step 11) to build a patient profile (see FIGS. 5A to 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] With reference to Figures 4 and 5A to 5I, a workflow 40 for entering user information using the application is described. The application starts and a screen / tab is 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). A 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 FIG. 5D-FIG. 5I) that present the patient with a questionnaire, which the patient is prompted to complete. In one example, the patient is presented with a questionnaire page that asks questions that elicit information about the patient's perceptions, dispositions, and other psychological characteristics. The questionnaire may include, for example, 14 questions, and responses to those questions create a model that identifies important patient psychological factors related to the use or non-use (adherence / non-adherence or compliance / non-compliance) of the CPAP device 20. Those responses also build a personalized assistance program for the patient, which is delivered by text message or other communication means to assist the patient at the beginning of treatment, as described below. The questionnaire may include questions such as those described in the PCT application published as WO 2013 / 187776, which is incorporated herein by reference in its entirety. As shown on screen 58 of FIG. 5I, the user may enter information and / or provide responses by touching buttons on a touch screen.

[0053] As an example, the following questions / statements are asked / posed on the first screen / tab 53 as shown in FIG. 5D, and responded to by the patient: · “About OSA, how much do you think OSA affects your sleep” – responses on a 0–10 scale ranging from “It doesn’t affect my life at all” to “It affects my life a lot.” · “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 machine 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 the extent to which he / she agrees 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] The patient can be presented with additional pages / screens / tabs such as those shown in Figures 5E-5H 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 input and amend answers / responses as required.

[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 your management of OSA?" Responses were on a 0-10 scale ranging from "not at all supportive" to "very supportive" "What is the person's attitude towards using a CPAP?" - Responses on a scale of 0 to 10 ranging from "very negative" to "very positive" Figure 5G, Screen 56 "With which racial or ethnic group do you most commonly categorize yourself?" - 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 degree, Bachelor's degree or higher "What is your occupation?" - Self-employed, Housewife, Student, Disabled, 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 touch screen are shown on screen 58 in FIG. 5I.

[0058] Once all questions have been answered, the user is ready to consult (step 12). When conducting a consultation, the user takes his tablet or other user input device 21 to the trained specialist. 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 answers, 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 answers. Topics provide areas of meaningful discussion and allow the specialist to focus the conversation on areas that will be most helpful to the patient, saving time in trying to track down that information through a conversation. An example of such a topic is shown in FIG. 6B.

[0059] For example, referring to Figure 6B, for a client who indicates that OSA has a minimal impact on their life, the professional may be prompted to discuss the following points: OSA is a serious health condition that can affect your ability to work and live 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 a suitable configuration for the CPAP device (which is a suitable configuration for the patient) and train the patient on how to use the CPAP device, for example using a demo unit on his desk. The configuration can be selected / defined by the professional, a doctor, 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 patient can be provided with a boxed CPAP device 20, which may have a default configuration or may be unconfigured.

[0062] The professional registers the CPAP device before the box is taken away (step 12A). This registration can be by an "assign device" button on the application of the user input device as shown in FIG. 6B. Pressing the assign device button turns on the camera 22 of the user input device. The professional can aim the camera at a label 25, such as a QR code barcode, serial number, other identification mark, etc., on the box of the CPAP device (or on the device itself) that is to be given to the patient (see FIGS. 2 and 7). The application scans the identification mark and assigns the patient to the CPAP device in the cloud-based database. The identification mark may be entered manually. The identification mark on the CPAP device box preferably includes the serial number of the device and an identification number on the device for storage in the database. The identification mark should be unique in terms of its format compared to other barcodes and identification marks on the label, so that other identification marks are not accidentally scanned when the camera is aimed at the box. Preferably, if there are multiple identification marks, e.g. barcodes, on the box, the identification mark for assigning and registering the device should be clearly identified as the identification 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 by a mobile device or the like from a distance of, for example, 20 cm, delivered at an angle that is comfortable for the person holding the user input device when 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 an 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 the treatment (step 14). If the professional decides to invite the patient, the patient receives email instructions to their computer, user device, or mobile device informing 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 monitoring of the patient. There is no need to access the cloud-based server to complete the setup.

[0070] When the patient gets home, they can unpack the CPAP device and turn it on (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 configuration profile for the patient 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 includes a record for each device that has been 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.) -Complete or partial device firmware (e.g. new firmware versions including different pressure supply modes or alternative firmware versions) The information 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 the 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 is not downloaded. Alternatively, if the user activates the CPAP device but does not properly connect to the cloud-based server, the CPAP device does not download the configuration. Not downloading the configuration can cause difficulties and may result in no therapy being provided or suboptimal therapy being provided. In this case, if the configuration has not been downloaded for a period of time, e.g., two days, an alert is provided to the provider so that the patient can be contacted and the problem can be resolved. Similarly or alternatively, the CPAP device may have a default configuration that provides at least some therapy and is not detrimental. The default may be an autotitration CPAP, where the pressure provided to the patient is automatically adjusted based on feedback. However, this default configuration may not provide optimal therapy, which may be detrimental to the patient. To stop a default or other incorrect configuration from being used for an extended period of time, such as two days without setting a personalized configuration, the CPAP device may be locked out after a period of time, such as two days, without setting a personalized configuration. The medical device cannot provide therapy until it is determined that the configuration of the medical device is complete. For example, if the download is not confirmed within a predetermined period of time, a message may be provided to the patient to contact the 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 particular CPAP device 20 being recommended is not supplied by the retailer, but rather is provided by a competitor. The process (steps 10, 11, 12, 13, and 14) proceeds as normal, but the patient is not provided with the CPAP device 20 by the provider, but 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 registration of the CPAP device 20 is also performed 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 ties to the patient's configuration profile. This allows other providers to register the CPAP device 20 with the patient. If the patient visits another provider, the other provider can register the CPAP device 20 by linking the serial number of the CPAP device 20 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 the camera 22B or manually enters the serial number of the CPAP device 20 into the 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 normal, except that the patient is not provided with a CPAP device by a provider, but 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 the registration of the CPAP device to be completed in the warehouse. Once the warehouse accepts 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 enters 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 for use (step 16C). The patient powers up the CPAP device 20 as normal for configuration (step 17C).

[0083] Alternatively, the CPAP device can be unpacked, powered on, configured and 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 a cloud-based server 23, 24. The CPAP device downloads a patient-specific configuration profile from the cloud-based server 23, 24. The CPAP device 20 is then configured in the normal 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 packed 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 close proximity with the NFC tag 27 to create an NFC connection. This allows the NFC computing device 21D to obtain information related to its identification from the CPAP device 20, such as its serial number and model. The NFC computing device 21D 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 serial number of the CPAP device. 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 an 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 verify that the provided settings and updates have been applied. Verification that the provided settings and updates have been applied may 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 CPAP registration (step 15C) instead 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 the case 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 if a configuration has been applied to the device. Each time the device is powered on, the RxSet property is checked, and if it is false, the device immediately communicates with the remote server to query for a configuration profile. During this process, which can take several minutes, an animation is shown 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 has been checked by 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. Contact your healthcare provider." In this case, the RxSet property keeps its default false value, which means that the device will attempt to connect and download a configuration profile again any time after the device is powered on.

[0090] While the prescription is being downloaded, it may be desirable for the patient to be able to explore their device and learn its capabilities, rather than being completely locked out of the device until it is configured. Another embodiment consists of a similar device as above adapted with an internal property [RxSet] that determines if a configuration has been applied to the device. The RxSet property is checked each time the device is powered on. If it is false, the device will communicate with the remote server to query the configuration profile. In this case, however, the device will continue to start up normally and enter standby mode while communication with the remote server continues in the background. The device will display a crossed out Rx indicator symbol on the display indicating that the settings on the device have not yet been configured. The patient will be able to 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 will be displayed on the unit's display indicating that the device is self-configuring and therapy cannot be started. The patient will simply not be able to start therapy and can continue to explore the other features of the device. Once the configuration process is complete, the crossed out Rx symbol will disappear from the display and therapy can be started normally. At this point the RxSet property is set to true, which means that any time thereafter the device is powered on the device will go into 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 may retry connecting several times. If it still cannot obtain a profile after retrying, attempting to start therapy on the device may result in the device displaying an error message such as "Prescription not available. Contact your healthcare provider" and therapy cannot be started, but the patient may continue to explore other features of the device, only unable to start therapy. The RxSet property keeps its default false value, which means that the device will attempt to connect again and download a configuration profile any time after the device is powered on.

[0092] Another embodiment consists of a device that includes a default AUTO CPAP mode, where the device automatically adjusts its output pressure for therapy pressure based on the occurrence of an event. As before, the device is fitted with an internal property [RxSet] that determines if a configuration has been applied to the device. Each time the device is powered on, the RxSet property is checked, and if it is false, the device will communicate with a remote server to query for a configuration profile. During this process, which may take several minutes, the device will function normally and be able to provide therapy in this default AUTO CPAP mode. The device will continue 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, which means that the device will not continue to connect and search for a profile any time after 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 configure 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 that contains 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 may take several minutes, an animation is displayed on the unit's display indicating that the device is self-configuring. The downloaded configuration profile instructs the device to download a complete firmware image that contains the operating firmware for the type of device that is prescribed for the patient, for example 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 the manufacture of a single model of device that contains this base firmware. When first powered on, the device can adapt itself to one of many possible models to provide the specific therapy modes and features that the patient requires.

[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 accomplished by an online management system that is configured to communicate with the database.

[0097] In one embodiment, a patient can be set up within this management system by a healthcare provider 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 a barcode on the device or on the device's 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 configuration profile for the patient may then be created by the provider by selecting the patient's prescribed settings or modes via 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 that references 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. The device may be provisioned with a header that includes the serial number, model, and family of the device along with any or all of the following:

[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 a configuration profile has been applied to a device and verified to be correct. Possible status values ​​are: PENDING - A configuration profile has been created but not claimed by the device. APPLIED - A 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 patient can again be set up in the management system by the healthcare provider 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 in 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 since a serial number has not yet been assigned. A unique patient ID is added to the order that allows 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 a remote server, perhaps when it is first powered on at the patient's home, it sends a data structure containing its serial number back to the remote server, which does a lookup in a database of configuration profiles to see if a configuration profile exists for that serial number.

[0108] If the profile is found, the data for that profile 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 what is in the received profile, the received profile is ignored. Ignoring such old profiles prevents older profiles from being applied after the profile is created, when the device's configuration is 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 the 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's path provided in the module element. This path references the module file that 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 the configuration profile for that module, 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 has been applied, the device reconnects to the remote server and returns updated values ​​for any settings that have been changed by the profile, and the version of any modules or firmware that have been installed. The server compares these values ​​with those in the original profile that was 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 predefined 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 period of time. This notification can be by an alert that is displayed within the patient management system interface the next time the provider logs on, or it can be a text message, call, or email that is automatically generated by the server.

Claims

1. A method of providing or configuring a medical device, A step of receiving information about patients who require medical devices, The steps include: determining and / or receiving a medical device configuration of the medical device suitable for the patient; A step of uploading the medical device configuration to a server, wherein the medical device configuration on the server is configured to be transferred to the medical device, The steps include providing the medical device to the patient, A method that includes this.

2. The method according to claim 1, further comprising the step of configuring the medical device by downloading the medical device configuration from the server onto the medical device.

3. The method according to claim 1, further comprising the step of configuring the medical device by transferring the medical device configuration from the server to the medical device using wireless data transfer technology.

4. The method according to claim 3, wherein the wireless data transfer technology is NFC.

5. The method according to claim 3, wherein the wireless data transfer technology is cellular.

6. The method according to claim 1, wherein the medical device configuration includes a patient prescription.

7. The method according to claim 6, wherein the formulation includes at least one humidity setpoint.

8. The method according to claim 1, wherein the medical device downloads the medical device configuration from the server onto the medical device after the patient receives the medical device and activates the medical device.

9. The method according to claim 1, wherein the provider of the medical device configures the medical device by downloading the medical device configuration from the server onto the medical device before providing the medical device to the patient.

10. The method according to claim 1, wherein the provider of the medical device configures the medical device by transferring the medical device configuration from the server to the medical device using wireless data transfer technology before providing the medical device to the patient when the medical device is off.

11. The method according to claim 1, wherein the medical device is provided to the patient by shipping the medical device to the patient, and the medical device is in an configured or unconfigured state.

12. The method according to claim 1, wherein the medical device implements a default configuration before it is configured by download or transfer, or if the proper configuration of the medical device fails.

13. The method according to claim 1, wherein the medical device is a biphasic device or a high-flow therapy device.

14. The method according to claim 1, wherein the medical device cannot provide treatment until it is determined that the configuration of the medical device is complete.

15. The method according to claim 1, wherein if the download of the medical device configuration is not confirmed within a predetermined time, a message is sent to the provider of the medical device.

16. The method according to claim 1, wherein the medical device cannot be used therapeutically unless the medical device configuration related to the patient is applied to it.

17. A method of providing and / or configuring a medical device, A step of receiving information about a patient requiring the medical device, wherein the medical device includes a biphasic device or a high-flow therapy device. A step of determining and / or receiving the medical device configuration of the medical device, wherein the medical device configuration is suitable for the patient, the medical device configuration includes a prescription, and the prescription includes at least one humidity setting point. A step of uploading the medical device configuration to a server, wherein the medical device configuration uploaded to the server is for transfer to the medical device, The steps include providing the medical device to the patient, The step includes storing the aforementioned medical device configuration in relation to the medical device, A method wherein the prescription is linked to the serial number of the medical device.

18. The method according to claim 17, further comprising the step of configuring the medical device by downloading the medical device configuration from the server onto the medical device.

19. The method according to claim 17, further comprising the step of configuring the medical device by transferring the medical device configuration from the server to the medical device using wireless data transfer technology.

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