Systems and methods for supporting use of an injection device

Abstract

A system for supporting use of an injection device includes a display and a processor configured to determine the injection device, obtain data regarding the determined use of the injection device, and add at least one overlay on the display, wherein the at least one overlay is generated as a function of the obtained data relating to the determined use of the injection device. And a processor configured to adapt the at least one overlay in accordance with an application environment of the injection device, the application environment of the injection device comprising at least one of: ambient light; time; date; temperature; a history of use of the injection device; a drug; an injection site; and dosage.

Description

[0001] This invention application is a divisional application based on an invention patent application with an application date of November 15, 2018, application number 201880086356.8 (international application number PCT / EP2018 / 081302) and name “System and method for supporting the use of injection devices”. Technical Field

[0002] The present invention relates to a system and method for supporting the use of an injection device. Background Art

[0003] Injection devices (such as automatic injectors) are known in the art for dispensing a medicament to an injection site of a patient. Injections performed using an injection device can be administered by medical personnel or the patient himself. For the use of an injection device, it may be helpful, especially for a patient, to obtain support for the use of the injection device.

[0004] EP 3 200 109 A1 discloses a head mounted display device for interfacing with a medical device, wherein the medical device is configured to perform invasive procedures on a patient, such as blood component collection, infusion, feeding operations, etc. Summary of the invention

[0005] A first aspect provides a system for supporting the use of an injection device, the system comprising a display and a processor, the processor being configured to determine the injection device, obtain data about the use of the determined injection device, and add at least one overlay on the display, wherein the at least one overlay is generated according to the obtained data about the use of the determined injection device. The system can be implemented, for example, by a mobile computing device, in particular a handheld device such as a smartphone or a tablet computer, or a wearable device such as an optical head-mounted display. However, a computer (e.g. a webcam) coupled to a camera or having a built-in camera can also be used instead. The display can be: a transparent display on which at least one overlay is projected or displayed, such as an overlay utilized in an optical head-mounted display; a non-transparent display on which at least one overlay is displayed with a representation of an image of the injection device captured by an image component, such as an image component utilized in a smartphone, a tablet computer, a head-mounted display with an active display (e.g. an LCD or OLED screen), or a virtual display (e.g. the retina of an observer's eye). The system can be used to implement augmented reality support for patients and medical staff when using an injection device.

[0006] The at least one overlay may include text information, a video, and / or one or more images. For example, the text information may include tips on the use of the injection device, the video may be a training video showing the correct use of the injection device, and the image may show different aspects of the use of the injection device.

[0007] The processor may be configured to determine the injection device by performing image processing on a captured image of the injection device, wherein the image processing includes detecting a morphology, a color, a code, a label and / or a marking on the injection device, and determining the injection device based on the detected morphology, color, code, label, marking.

[0008] The processor may be configured to determine the injection device by receiving injection device identification data. For example, the injection device identification data may be electronically stored in an internal storage device of the injection device. The internal storage device may be implemented, for example, by an RFID or NFC chip or tag. The system may, for example, include a wireless receiver for receiving the injection device identification data, wherein the wireless receiver particularly includes at least one of the following: an RFID reader; an NFC reader; Receiver.

[0009] The system may include an image capture component to capture an image of the injection device, wherein the processor is configured to display the captured image of the injection device and the at least one overlay on the display. For example, a mobile computing device (such as a smartphone) with a built-in camera may be used to capture the image and compare the image to one or more overlays. Figure 1 The two are displayed together on their own screen.

[0010] The processor may be configured to adapt the at least one overlay according to environmental conditions, in particular according to the following conditions: ambient light, time, date, temperature. For example, the overlay may be displayed in different colors according to time, date and / or temperature, such as displaying the overlay in red when the injection is too late or the ambient temperature at the time of injection is outside a predetermined temperature range.

[0011] The processor may be configured to load said data regarding the determined use of the injection device from an internal storage device and / or from an external storage device via a data connection, in particular a wireless data connection, to generate the at least one overlay. For example, if the system is implemented by a mobile computing device with a data connection, the information may be downloaded from a network server via a secure data connection. Alternatively or additionally, some or all of the information may also be stored in an internal storage device of the system, for example in a non-volatile memory of a mobile computing device.

[0012] The processor may be configured to detect user actions and adapt the at least one overlay in dependence on the detected user actions. The user actions may include user input, for example, via a button, a gesture, or a voice command. The user actions may, for example, be processed by the processor to control the presentation of the at least one overlay, for example by sequentially displaying various instructions and / or prompts for use of the injection device in dependence on the processed user actions.

[0013] The processor may be configured to store data regarding a usage history of the injection device. The usage history data may, for example, include a time and date stamp of use of the injection device, an injection site, and an injected dose.

[0014] Another aspect of the present specification provides a method for supporting the use of an injection device, the method comprising determining the injection device, obtaining data regarding the use of the determined injection device, and adding at least one overlay on a display, wherein the at least one overlay is generated based on the data obtained regarding the use of the determined injection device.

[0015] Another aspect of the present specification provides a device comprising a processor, a memory, a display, a camera, and software stored in a non-volatile portion of the memory, wherein the software configures the processor of the device to capture one or more images of an injection device through the camera, to show the captured images of the injection device on the display, to determine the injection device, to obtain data regarding the use of the determined injection device, and to add at least one overlay on the display, wherein the at least one overlay is generated based on the data obtained regarding the use of the determined injection device.

[0016] The device may be, for example, a smartphone, a personal digital assistant, a tablet or laptop computer, or a head mounted display device.

[0017] Adapting the at least one overlay according to the application environment of the injection device may include at least one of the following: displaying the overlay in different colors according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dose; changing the displayed content of the overlay according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dose; changing the size of the overlay according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dose; selecting the position of the overlay on the display according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dose.

[0018] Specifically, the present invention includes but is not limited to the following:

[0019] 1. A system for supporting the use of an injection device, the system comprising a display and a processor, the processor being configured to determine the injection device, obtain data regarding the use of the determined injection device, and add at least one overlay on the display, wherein the at least one overlay is generated based on the obtained data regarding the use of the determined injection device, and wherein the processor is configured to adapt the at least one overlay based on an application environment of the injection device, the application environment of the injection device comprising at least one of the following: ambient light; time; date; temperature; use history of the injection device; medication; injection site; dose.

[0020] 2. A system according to claim 1, wherein the at least one overlay includes text information, video and / or one or more images.

[0021] 3. A system according to item 1 or 2, wherein the processor is configured to determine the injection device by performing image processing on a captured image of the injection device, wherein the image processing includes detecting the morphology, color, code, label and / or marking on the injection device, and determining the injection device based on the detected morphology, color, code, label, marking.

[0022] 4. A system according to item 1, 2 or 3, wherein the processor is configured to determine the injection device by receiving injection device identification data.

[0023] 5. A system according to any of the preceding clauses, comprising an image capture component to capture an image of the injection device, wherein the processor is configured to display the captured image of the injection device and the at least one overlay on the display.

[0024] 6. A system according to any of the preceding items, wherein the processor is configured to generate the at least one overlay by loading the data regarding the determined use of the injection device from an internal storage device and / or from an external storage device via a data connection, in particular a wireless data connection.

[0025] 7. A system according to any of the preceding items, wherein the processor is configured to detect user actions and adapt the overlay according to the detected user actions.

[0026] 8. A system according to any of the preceding clauses, wherein the processor is configured to store data regarding a usage history of the injection device.

[0027] 9. A method for supporting the use of an injection device, the method comprising

[0028] determining the injection device,

[0029] obtaining data regarding usage of the determined injection device, and

[0030] Adding at least one overlay on the display, wherein the at least one overlay is generated based on the data obtained about the determined use of the injection device and adapted based on the application environment of the injection device, the application environment of the injection device comprising at least one of the following: ambient light; time; date; temperature; use history of the injection device; medication; injection site; dosage.

[0031] 10. A device comprising a processor, a memory, a display, a camera, and software stored in a non-volatile portion of the memory, wherein the software configures the processor of the device to capture one or more images of an injection device through the camera, to show the captured images of the injection device on the display, to determine the injection device, to obtain data regarding the use of the determined injection device, and to add at least one overlay on the display, wherein the at least one overlay is generated based on the obtained data regarding the use of the determined injection device and is adapted based on an application environment of the injection device, the application environment of the injection device comprising at least one of: ambient light; time; date; temperature; use history of the injection device; medication; injection site; dosage.

[0032] 11. A device according to item 11, the device being a smart phone, a personal digital assistant, a tablet or laptop computer, or a head mounted display device.

[0033] 12. A system according to any one of items 1 to 8, a method according to item 9, or a device according to item 10 or 11, wherein adapting the at least one overlay according to the application environment of the injection device includes at least one of the following: displaying the overlay in different colors according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage; changing the displayed content of the overlay according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage; changing the size of the overlay according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage; selecting the position of the overlay on the display according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In the attached picture:

[0035] Figure 1 A system according to an embodiment is shown;

[0036] Figure 2 A schematic diagram showing an arrangement of a system according to an embodiment; and

[0037] Figure 3 A flow chart of a method according to an embodiment is shown. DETAILED DESCRIPTION

[0038] The systems and methods described herein can be advantageously used to train and assist patients or users of injection devices, particularly auto-injector devices, via augmented reality. The systems and methods utilize an augmented reality application, for example embedded in a smartphone, to display one or more overlays on a display such as a smartphone screen or a lens of an optical head mounted display, wherein the one or more overlays are generated by a processor based on data regarding the use of the injection device.

[0039] The overlay may include information such as a training video on the correct use of the injection device, a history of the use of the injection device, safety information for the user, step-by-step guide information on the correct use of the injection device, warnings, usage feedback, etc. Thus, the system and method may provide support for the use of the injection device, in particular, additional training and safety for the user.

[0040] The system according to the embodiment can be implemented by a display for displaying one or more overlays and a processor, wherein the processor is configured to determine an injection device that needs to be supported, obtain data about the use of the determined injection device, and generate one or more overlays based on the obtained data and the application environment of the injection device, wherein the application environment may include at least one of the following: ambient light; time; date; temperature; use history of the injection device; drug; injection site; dosage.

[0041] A smartphone or head mounted display with software implementing an "augmented reality" system according to an embodiment may be used as the hardware. The hardware may also be configured to determine the injection device for which the augmented reality representation should be generated. The determination may be implemented by scanning the injection device or by receiving identification data of the injection device.

[0042] Once the injection device is identified, data regarding the use of the injection device may be loaded, such as a training video demonstrating the proper use of the injection device, an instructional manual, and / or a history of use of the injection device.

[0043] Figure 1The inventive system is shown implemented with the aid of a smartphone 10 that includes an LCD, TFT (Thin Film Transistor), OLED (Organic Light Emitting Diode), or ePaper screen as display 12 and an integrated camera module as image capture component 14. The smartphone 10 consists of software such as an “app” that is downloaded to and installed on the smartphone to implement the inventive system.

[0044] Figure 2 yes Figure 1 Schematic diagram of a smartphone 10, showing the internal components of the smartphone 10. The smartphone 10 includes memory 102, i.e., working or volatile memory, such as random access memory (RAM), and non-volatile memory. The non-volatile memory stores an operating system and software 104 for supporting the use of the injection device (which is advantageously a unique application) and storing data files and associated metadata. The software 104 can be set in the smartphone 10 at the time of manufacture, or it can be downloaded to the smartphone 10, for example from an application market or application store, or it can be side-loaded into the smartphone 10. The display 12 of the smartphone 10 can be a touch-sensitive display having a display portion 106 and a tactile interface portion 107. The smartphone 10 also includes a communication interface 108, such as a Bluetooth, cellular radio and / or WLAN (wireless local area network) interface. The smartphone 10 is further equipped with an ambient light sensor to detect ambient light at the location of the smartphone 10. In addition, the smartphone 10 can be equipped with a temperature sensor to measure the ambient temperature (e.g., room temperature). The smartphone 10 also houses a battery 105 to power the smartphone 10 via a power source 103. The camera 14 of the smartphone 10 may be of a digital type and may include an imaging sensor for digitally capturing images that may be stored in RAM or non-volatile memory. The processor 101 of the smartphone 10 is configured to send and receive signals to and from other components in order to control the operation of the other components. For example, the processor 101 controls the display of content on the display 106 and receives signals due to user input from the tactile interface 107. The display 106 may be any type of resistive touch screen or capacitive touch screen. The display may also not be a touch screen. For example, it may be a liquid crystal display (LCD).

[0045] The software 104 configures the processor 101 of the smartphone 10 to capture an image of the injection device 16 through the camera module 14 and display the captured image on the display 12 of the smartphone 10 , such that the real injection device 16 is displayed on the display 12 .

[0046] Thereafter, the software configures the processor to determine the injection device 16, i.e. the kind and type of the injection device, by identifying the injection device 16. Various options for identifying the injection device 16 may be implemented depending on the available hardware resources of the smartphone:

[0047] 1. The software may include image processing capabilities, with which a captured image showing the injection device 16 may be processed and characteristic features of the injection device may be detected during the processing, such as the morphology of the entire injection device 16 or parts of the device 16, in particular the morphology of the device housing 160, the morphology of the needle 161, in particular the length, the morphology of the drug container 162, in particular the size, and / or the color of the entire device 16 or parts 160, 161, 162 of the device 16, and / or a code 163, a label such as a QR label, a mark printed on the housing 160 or another part such as the drug container 162. The code 163, label, mark may be detected by OCR (Optical Character Recognition) technology.

[0048] 2. The software can upload the captured image showing the injection device 16 via a data connection to an image processing service provider such as a web service or an image processing program executed by a computer connected to the smartphone 10. Thus, the software and smartphone itself do not need to provide image processing functionality, which sometimes requires computing resources beyond the capabilities of a smartphone.

[0049] 3. If the smartphone 10 is equipped with a wireless receiver, e.g. receiver, an NFC (Near Field Communication) reader and / or an RFID (Radio Frequency Identification) reader, and the injection device 16 includes In the case of a smart phone 10 that uses a transmitter, an NFC tag and / or an RFID tag, the processor of the smart phone 10 can obtain the injection device identification data via the wireless data connection 164 between the smart phone 10 and the injection device 16. The identification data can be stored in an internal storage device of the injection device 16 and / or in the NFC tag and / or the RFID tag. The identification data can also be transmitted via an IR (infrared) or optical data connection or by means of a wired data connection, such as a USB (Universal Serial Bus) data connection.

[0050] When an injection device 16 is identified by one of the above processes, the software proceeds to obtain data (usage support data) regarding the use of the identified injection device 16. The usage support data may be part of the application or streamed / downloaded from a server, which requires a high-speed Internet connection, and may include training information regarding the use of the identified injection device, such as video, text, audio, image information, such as training videos (user steps / step-by-step training), device usage history, or safety information for the user. The usage support data may also include information regarding accessories shown in a captured image of the injection device.

[0051] Usage support data may be received from various sources as listed below:

[0052] 1. Usage support data may be stored in an internal storage device of the smartphone, for example may be part of the software and thus may be loaded by the processor into the main memory of the smartphone for further processing.

[0053] 2. The usage support data may also be stored in an external storage device such as a server, network server, etc. In this case, the software may configure the processor of the smartphone to contact the external storage device via a data connection (e.g., a wireless data connection) and download and / or stream the required usage support data to the smartphone's main memory for further processing.

[0054] 3. The usage support data may also be obtained from an internal storage device of the injection device (e.g., a non-volatile memory of an electronic device integrated in the injection device). For example, the injection device may be equipped with an electronic device including a controller, a wireless transceiver, and a non-volatile memory. The usage support data may be stored in the non-volatile memory. Software executed by a processor of the smartphone may configure the processor to establish a wireless data connection with a wireless transceiver of the integrated electronics of the injection device according to the identified injection device. After the wireless data connection is established, the software may request the stored usage support data and receive the requested data via the established wireless data connection.

[0055] After obtaining the use support data for the identified injection device 16, the software proceeds to configure the processor to generate one or more overlays on the display 12. The overlays may be generated such that the overlays may provide support for the use of the injection device to the user of the injection device 16, in particular by means of text boxes 120, 121 containing text information about the use of certain parts of the injection device 16 and text information 122 with the identification code of the injection device 16. The text information boxes 120, 121 may be displayed on the display 12 near, at or above the respective parts of the captured image of the injection device, so that the user may immediately get tips about the use of the injection device by viewing the text information boxes 120, 121. Moreover, a video and / or one or more images may be displayed by the one or more overlays. The video and / or image may be displayed, for example, in a transparent mode so that it overlays the captured image of the injection device on the display 12 and may demonstrate the correct use of the injection device.

[0056] Generating one or more overlays on the display 12 includes adapting the overlays according to the application environment of the injection device 16 to better assist a user or patient in using the injection device.

[0057] Adapting the overlay may include displaying the overlay in a different color, changing the display content of the overlay, changing the size of the overlay, selecting the location of the overlay. The application environment of the injection device 16 may include one or more environmental conditions, such as ambient light, temperature, time and / or date, and one or more injection-related conditions, such as the use history of the injection device, the drug, the injection site, and the dosage. The following lists examples of adapting the overlay according to the application environment of the injection device:

[0058] - When the ambient light is below a certain threshold, the color and / or size of the overlay may be changed to make it easier for the patient to identify the overlay even in poor lighting conditions;

[0059] - When the temperature is outside the recommended or required injection range, the content of the overlay may be changed to display a warning message, and / or the color of the overlay may be changed to a color such as red or yellow to warn the patient that environmental conditions are not suitable for injection, and / or the size of the overlay may be increased so that the patient cannot ignore it;

[0060] -When the time and / or date differs from the prescribed dosing schedule, the overlay content, color, size and / or location may be changed so that the patient can easily identify the overlay and be aware that the injection is not actually what was requested and prescribed;

[0061] - when the usage history of the injection device indicates that an injection is not actually necessary and / or is not prescribed, the content, color, size and / or position of the overlay may be changed so that the patient can easily identify the overlay and notice that an injection is not actually necessary and prescribed, and also see when the last injection occurred;

[0062] - The medication may be displayed via a respectively adapted overlay (e.g., the size, position, color and / or content of the overlay may be changed to inform the patient about the type of medication and the medication itself, such as using a large red overlay positioned in the middle of the display to emphasize the importance of the content to warn the patient that an important insulin injection is to be performed);

[0063] - the injection site may be shown on the display by an overlay with highlighted color and position, wherein the injection site is shown so as to help the patient perform the injection;

[0064] - The dose to be injected may be displayed by selecting an overlay representing the required dose (eg by showing an icon representing the dose in colour and / or size), which allows the patient to easily identify the required dose.

[0065] Figure 32 shows a flow chart of the software executed by the processor of the smartphone. After the software is started on the smartphone (step start), the software starts the built-in smartphone camera 14 in step 200 to capture an image of the injection device 16 in a subsequent step 202. In step 204, the captured image is displayed on the smartphone screen, thus showing a true representation of the injection device, i.e. "reality". In step 206, the software checks whether identification data is received from the injection device 16 wirelessly or by wire. If identification data is received, the software proceeds in step 208 to load text information, one or more videos and / or one or more images about the use of the injection device 16 by using the identification data received from one or more sources as explained before. If no identification data is received, the software proceeds to step 212 instead of continuing in step 208 and starts image processing of the captured image of the injection device 16 to detect the morphology, color and / or code on the injection device. In step 214, the software checks if the image processing detected a code, and if so, proceeds to step 216, at which time text information, one or more videos and / or one or more images about the use of the injection device 16 are loaded by using the code detected from one or more sources as explained previously. If the image processing does not detect a code, the software retrieves the injection device in the detected morphology and / or color in step 218, and loads text information, one or more videos and / or one or more images about the use of the retrieved injection device 16 in a subsequent step 220. In step 222, following steps 208, 216 and 220, the software then generates one or more overlays containing the loaded information, and in a subsequent step 224 adds them on the smartphone display or screen to overlay a representation of the "real" injection device 16 to create an augmented reality for the user. In step 226, the software checks if a termination command has been received, and if so, stops execution. Before the termination command is detected in step 226, the software loops through steps 222 and 224 to generate and add one or more overlays on the smart phone screen, wherein the content of the overlays may change in each loop, for example, a step-by-step guide may be displayed to the user.

[0066] In the following, some other possible applications and implementations of the embodiments will be briefly described:

[0067] The augmented reality created by the software can also be used to review and record the use of the injection device 16. Step-by-step training can, for example, visualize the user steps. There may be subsequent controls (via a (photo) camera) for the user steps performed, which means that the user imitates the visualization shown, and the software controls the user actions and issues feedback. In the case of a correct user step, the training will continue to show the next step, in the case of an incorrect user step, the training will, for example, issue a warning, and the training will not continue until the user can correctly perform the corresponding step. The user gets a confirmation that they are using the device correctly. If an error or misuse is detected, the software may also issue a warning and propose a solution. The feedback can be visible (text, image or light), audible (sound) or tactile (vibration warning). This will enhance confidence and user understanding.

[0068] The smartphone 10 can be put down while using the app without interruption (a pause can be identified, such as performing a two-hand step). Thus, the user can skip information, or there can be a process to detect the condition of the injection device 16 by means of a significantly changed geometry on the injector device (e.g., cap attached vs. not attached).

[0069] The user can record the injection site, time and dose manually in the software, or can record the injection site, time and dose when the camera 14 takes a picture. The application can also issue a notification, such as a warning, at a defined time when the user should inject the drug. It can also verify whether the correct drug is used based on the user information. The warning can be programmed as a reminder, such as when to take the injection device out of the refrigerator or when to inject after reaching a defined adaptation temperature. The electronic device (e.g., an RFID chip) integrated in the injection device 16 can additionally report the injection status and confirm the success of the injection; the information can be directly recorded in the injection tracking record.

[0070] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation containing one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0071] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, i.e., double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into a molecular delivery system (e.g., a vector, a plasmid, or a liposome). Mixtures of one or more drugs are also contemplated.

[0072] The drug or medicament can be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20 ° C) or refrigerated temperature (e.g., from about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (e.g., API and diluent, or two different drugs) of a drug preparation to be administered separately, one of which is stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., by means of a conduit between the two chambers), and allow the user to mix the two components if desired prior to dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are dispensed into a human or animal body.

[0073] The medicine or medicament contained in the drug delivery device as described herein can be used to treat and / or prevent many different types of medical disorders. The example of obstacle includes, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Another example of obstacle is acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. The example of API and medicine is those as described in the following manual: such as Rote Liste 2014 (for example, but not limited to, main group (main group) 12 (antidiabetic drugs) or 86 (tumor drugs)) and Merck Index, the 15th edition.

[0074] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other natural residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0075] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0076] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulindegludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0077] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exendin-4 Liraglutide (a 39-amino acid peptide produced by the salivary glands of the Gila monster) Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-Xten.

[0078] Examples of oligonucleotides are e.g. Mipomersen sodium It is a cholesterol-reducing antisense therapeutic used to treat familial hypercholesterolemia.

[0079] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0080] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0081] Examples of polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 It is a sodium hyaluronate.

[0082] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind to antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody, or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment or a mutant, and the antibody does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor binding region. The term antibody also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0083] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide), which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, tetravalent and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Additional examples of antigen-binding antibody fragments are known in the art.

[0084] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is typically not directly involved in antigen binding, as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0085] Examples of antibodies are anti-PCSK-9 mAb (eg, Alirocumab), anti-IL-6 mAb (eg, Sarilumab), and anti-IL-4 mAb (eg, Dupilumab).

[0086] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0087] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components / components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein without departing from the full scope and spirit of the present disclosure, and that the present invention encompasses such modifications and any and all equivalents thereof.

Claims

1. A system for supporting the use of an injection device, the system comprising a display and a processor, the processor being configured to determine the injection device, obtain data regarding the use of the determined injection device, and add at least one overlay on the display, wherein the at least one overlay is generated based on the obtained data regarding the use of the determined injection device, and wherein the processor is configured to adapt the at least one overlay based on an application environment of the injection device, the application environment of the injection device comprising at least one of the following: ambient light; time; date; temperature; a history of use of the injection device; a drug; an injection site; a dose; and wherein the adaptation of the at least one overlay depending on the application environment of the injection device comprises at least one of the following: displaying the overlay in a different color, changing the displayed content of the overlay, changing the size of the overlay, and selecting a position of the overlay on the display.

2. The system of claim 1, wherein the at least one overlay comprises textual information, a video and / or one or more images.

3. The system according to claim 1 or 2, wherein the processor is configured to determine the injection device by performing image processing on a captured image of the injection device, wherein the image processing includes detecting a morphology, color, a code, a label and / or a marking on the injection device, and determining the injection device based on the detected morphology, color, code, label, marking.

4. The system of claim 1, 2 or 3, wherein the processor is configured to determine the injection device by receiving injection device identification data.

5. The system of any one of the preceding claims, comprising an image capture component to capture an image of the injection device, wherein the processor is configured to display the captured image of the injection device and the at least one overlay on the display.

6. System according to any of the preceding claims, wherein the processor is configured to generate the at least one overlay by loading the data regarding the determined use of the injection device from an internal storage device and / or from an external storage device via a data connection, in particular a wireless data connection.

7. A system according to any one of the preceding claims, wherein the processor is configured to detect user actions and to adapt the overlay according to the detected user actions.

8. A system according to any preceding claim, wherein the processor is configured to store data relating to a usage history of the injection device.

9. A method for supporting the use of an injection device, the method comprising determining the injection device, obtaining data regarding usage of the determined injection device, and Adding at least one overlay on the display, wherein the at least one overlay is generated based on the data obtained about the determined use of the injection device and adapted based on the application environment of the injection device, the application environment of the injection device comprising at least one of the following: ambient light; time; date; temperature; use history of the injection device; medication; injection site; dosage.

10. A device comprising a processor, a memory, a display, a camera, and software stored in a non-volatile portion of the memory, wherein the software configures the processor of the device to capture one or more images of an injection device through the camera, to show the captured images of the injection device on the display, to determine the injection device, to obtain data about the use of the determined injection device, and to add at least one overlay on the display, wherein the at least one overlay is generated based on the obtained data about the use of the determined injection device and is adapted based on an application environment of the injection device, the application environment of the injection device comprising at least one of the following: ambient light; time; date; temperature; history of use of the injection device; medication; injection site; dosage; and wherein the adaptation of the at least one overlay depending on the application environment of the injection device comprises at least one of the following: displaying the overlay in a different color, changing the displayed content of the overlay, changing the size of the overlay, and selecting a position of the overlay on the display.

11. The device of claim 11, the device being a smart phone, a personal digital assistant, a tablet or laptop computer, or a head mounted display device.

12. A system according to any one of claims 1 to 8, a method according to claim 9, or a device according to claim 10 or 11, wherein adapting the at least one overlay according to the application environment of the injection device includes at least one of the following: displaying the overlay in different colors according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage; changing the displayed content of the overlay according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage; changing the size of the overlay according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage; selecting the position of the overlay on the display according to at least one of the following: ambient light; time; date; temperature; usage history of the injection device; medication; injection site; dosage.

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