Systems and methods for assisting in the use of an injection device

Abstract

To provide a system and a method for supporting use of an injection device.SOLUTION: In a system for supporting use of an injection device, a smart phone 10 includes a display 12, and a processor which determines the injection device 16, obtains data on use of the determined injection device, and adds at least one overlay to the display. The at least one overlay is generated according to the obtained data on the determined use of the injection device. The processor adapts the at least one overlay according to contexts of an application on the injection device. The contexts of the application on the injection device include at least one of ambient light, time, date, temperature, history of use of the injection device, drug, the site of injection, and dosage.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a system and method for assisting the use of an injection device.

Background Art

[0002] In the art, injection devices such as auto-injectors are known for administering a drug to a patient's injection site. An injection by use of an injection device can be applied by a healthcare worker or the patient himself / herself. When applying an injection device, it may be helpful for a patient, in particular, to obtain assistance for the use of the injection device.

[0003] Patent Document 1 discloses a head-mounted display device for interfacing with a medical device configured to perform invasive procedures on a patient, such as operations for blood component collection, infusion, and supply.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0005] The first aspect provides a system for assisting in the use of an injection device. The system includes a display and a processor configured to determine the injection device and obtain data regarding the use of the determined injection device, and add at least one overlay to the display. The at least one overlay is generated according to the acquired data regarding the use of the determined injection device. The system can be implemented by, for example, a mobile computing device, particularly a handheld device such as a smartphone or a tablet computer, or a wearable device such as an optical head-mounted display. However, instead, a computer connected to a camera or a computer having a built-in camera such as a web camera can also be used. The display can be a transparent display on which at least one overlay is projected or displayed as used in an optical head-mounted display, a smartphone equipped with an active display such as an LCD or an OLED screen, a tablet computer, an opaque display on which at least one overlay is displayed together with an image display of the injection device captured using an image component as used in a head-mounted display, or a virtual display such as the retina of the viewer's eye. When using the injection device, the system can be used to provide augmented reality assistance to patients and medical staff.

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

[0007] The processor can be configured to process the captured image of the injection device to determine the injection device, and the image processing includes detecting the form, color, code, tag, and / or label on the injection device, and determining the injection device according to the detected form, color, code, tag, and label.

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

[0009] The system can include an image capture component for capturing an image of the injection device, and the processor is configured to display the captured image of the injection device on the display together with at least one overlay. For example, an image can be captured using a mobile computing device equipped with a built-in camera such as a smartphone, and the image can be displayed on its own screen together with one or more overlays.

[0010] The processor can be configured to apply at least one overlay according to environmental conditions, particularly according to ambient light, time, date, and temperature. For example, the overlay can be displayed in different colors according to time, date, and / or temperature, such as turning red when the injection time has passed or when the ambient temperature exceeds the range suitable for the pre-determined injection.

[0011] The processor can be configured to generate at least one overlay by loading data regarding the determined use of the injection device from an internal storage device and / or an external storage device via a data connection, particularly a wireless data connection. For example, if the system is implemented by a mobile computing device having a data connection, the information can be downloaded from a web server via a secure data connection. Alternatively, or in addition, some or all of the information can also be stored in an internal storage device of the system, such as the non-volatile memory of a mobile computing device.

[0012] The processor can be configured to detect a user's action and apply at least one overlay in response to the detected user's action. The user's action can include, for example, user input via a button, or a gesture, or a voice command. The user's action is processed by the processor and, for example, the display of at least one overlay can be controlled by sequentially displaying various instructions and / or hints for the use of the injection device in response to the processed user's action.

[0013] The processor can be configured to store data related to the usage history of the injection device. The usage history data can include, for example, a time and date stamp of the injection device utilization, the injection site, and the injection dosage.

[0014] Another aspect of the present specification provides a method for assisting in the use of an injection device, the method including determining the injection device, obtaining data regarding the determined use of the injection device, and adding at least one overlay to a display, the at least one overlay being generated in response to the obtained data regarding the determined use of the injection device.

[0015] Another aspect of the present specification provides a device including a processor, a memory, a display, a camera, and software stored in a non-volatile member of the memory, and the software configures the processor of the device to capture one or more images of an injection device using the camera, display the captured images of the injection device on the display, determine the injection device, and obtain data regarding the use of the determined injection device, and configure to add at least one overlay to the display, and the at least one overlay is generated according to the acquired data regarding the use of the determined injection device.

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

[0017] Applying at least one overlay according to the context of the application of the injection device can include at least one of: displaying the overlay in a different color according to at least one of ambient light; time; date; temperature; usage history of the injection device; drug; injection site; dosage; changing the display content of the overlay according to at least one of ambient light; time; date; temperature; usage history of the injection device; drug; injection site; dosage; changing the size of the overlay according to at least one of ambient light; time; date; temperature; usage history of the injection device; drug; injection site; dosage; selecting the position of the overlay on the display according to at least one of ambient light; time; date; temperature; usage history of the injection device; drug; injection site; dosage.

Brief Description of the Drawings

[0018]

Figure 1

Figure 2

Figure 3

DETAILED DESCRIPTION OF THE INVENTION

[0019] The systems and methods described herein can advantageously be used for the training and assistance of patients or users of injection devices, particularly auto-injection devices, by augmented reality. The system and method utilize, for example, an augmented reality application incorporated into a smartphone to display one or more overlays on a display such as the screen of the smartphone or the lens of an optical head-mounted display, and the (one or more) overlays are generated by a processor according to data related to the use of the injection device.

[0020] The overlay can include information such as training videos for the correct use of the injection device, usage history of the injection device, safety information for the user, step-by-step guidance information for correctly using the injection device, warnings, and feedback on usage. Therefore, the system and method can provide assistance for the use of the injection device, particularly providing further training and safety for the user.

[0021] The system according to an embodiment can be implemented by a display for displaying the (one or more) overlays and a processor configured to determine the injection device (for which assistance is required), obtain data related to the use of the determined injection device, and generate one or more overlays according to the obtained data and the context of the injection device application, where the context of the application can include at least one of ambient light; time; date; temperature; usage history of the injection device; drug; injection site; dosage.

[0022] As hardware, a smartphone or a head-mounted display equipped with software for implementing the "augmented reality" system according to the embodiment can be used. The hardware can also be configured to determine an injection device for which a display by augmented reality is to be generated. The determination can be made by scanning the injection device or by receiving other data. This can be carried out by receiving other data.

[0023] After the determination of the injection device, data regarding the use of the injection device, such as a training video explaining the correct use of the injection device, an instruction manual, and / or a usage history of the injection device, can be loaded.

[0024] FIG. 1 shows an implementation form of the system of the present invention by a smartphone 10, which includes an LCD, a TFT (thin film transistor), an OLED (organic light emitting diode), or an electronic paper screen as a display 12, and a camera module incorporated as an image capturing component 14. The smartphone 10 is configured to implement the system of the present invention by software such as an "app" downloaded and installed on the smartphone.

[0025] Figure 2 is a schematic diagram of the smartphone 10 of FIG. 1, showing the internal components of the smartphone 10. The smartphone 10 includes a memory 102, i.e., a working or volatile memory such as a random access memory (RAM), and a non-volatile memory. The non-volatile memory stores not only data files and associated metadata, but also an operating system and software 104 (advantageously as a separate application) to assist in the use of the injection device. The software 104 can be provided to the smartphone 10 at the time of manufacture, or downloaded to the smartphone 10 from, for example, an application marketplace or an application store, or sideloaded onto the smartphone 10. The display 12 of the smartphone 10 can be a touch display having a display member 106 and a tactile interface member 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 further includes an ambient light sensor for detecting ambient light at the location of the smartphone 10. Additionally, the smartphone 10 can include a temperature sensor for measuring the ambient temperature, such as room temperature. The smartphone 10 also houses a battery 105 for supplying power to the smartphone 10 by a power source 103. The camera 14 of the smartphone 10 can be of the digital type and includes an imaging sensor for capturing images in a digital manner, and the images can be stored in the RAM or the non-volatile memory. The processor 101 of the smartphone 10 is configured to transmit and receive signals with 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 as a result of user input from the tactile interface 107. The display 106 can be any type of resistive touch screen or capacitive touch screen. Alternatively, the display may not be a touch screen.For example, the display can be a liquid crystal display (LCD).

[0026] The software 104 configures the processor 101 of the smartphone 10 to capture an image of the injection device 16 using the camera module 14 and display the captured image on the display 12 of the smartphone 10. As a result, a realistic injection device 16 is displayed on the display 12.

[0027] Thereafter, the software configures the processor to determine the injection device 16, that is, the type and model of the injection device, by identifying the injection device 16. Depending on the available hardware resources of the smartphone, various options for identifying the injection device 16 can be implemented: 1. The software can include image processing capabilities, thereby processing the captured image showing the injection device 16. During the processing, the overall form of the injection device 16 or each member of the device 16, particularly the form of the housing 160 of the device, the form of the needle 161 (particularly the length), the form of the drug container 162 (particularly the dimensions), and / or the color of the entire injection device 16 or members 160, 161, 162 of the device, and / or tags such as codes 163, QR tags, labels printed on another member such as the housing 160 or the drug container 162, etc., can be detected for the characteristic configuration of the injection device. The code 163, tag, label can be detected by OCR (Optical Character Recognition) technology. 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. Therefore, it is not necessary for the software and the smartphone itself to provide image processing capabilities, but it may require computing resources beyond the capabilities of the smartphone. 3. If the smartphone 10 is equipped with a wireless receiver such as, for example, a Bluetooth (registered trademark) receiver, an NFC (Near Field Communication) reader, and / or an RFID (Radio Frequency Identification) reader, and the injection device 16 includes a Bluetooth (registered trademark) transmitter, an NFC tag, and / or an RFID tag, the processor of the smartphone 10 can obtain the identification data of the injection device via the wireless data connection 164 between the smartphone 10 and the injection device 16. The identification data can be stored in the internal memory of the injection device 16, and / or 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 a wired data connection including, for example, a USB (Universal Serial Bus) data connection.

[0028] Once the injection device 16 is identified by one of the above methods, the software continues to obtain data regarding the use of the identified injection device 16 (use support data). The use support data can be part of the application or streamed / downloaded from a server (which requires a high-speed internet connection), and can include training information regarding the use of the identified injection device such as video, text, audio, image information, for example, training videos (step-by-step training for the user), device usage history, or safety information for the user. The use support data can also include information regarding accessories shown in the captured image of the injection device.

[0029] The use support data can be received from various information sources as listed below: 1. The use support data can be stored in the internal storage device of the smartphone, for example, as part of the software, and thus can be loaded into the main memory of the smartphone by the processor for subsequent processing. 2. The usage support data can also be stored in an external storage device such as a server or a web server. In such a case, the software can configure the processor of the smartphone to connect to the external storage device via a data connection such as a wireless data connection, and download and / or stream the necessary usage support data to the main memory of the smartphone for subsequent processing. 3. The usage support data can also be obtained from an internal storage device of the injection device, such as the non-volatile memory of an electronic device incorporated in the injection device. For example, the injection device can include an electronic device including a controller, a wireless transceiver, and a non-volatile memory. The usage support data can be stored in the non-volatile memory. The software executed by the processor of the smartphone can configure the processor to establish a wireless data connection with the wireless transceiver of the electronic device incorporated in the injection device according to the identified injection device. When the wireless data connection is established, the software can request the stored usage support data and receive the requested data via the established wireless data connection.

[0030] After obtaining usage support data for the identified injection device 16, the software continues to configure the processor to generate one or more overlays on the display 12. The overlays can be generated to provide support regarding the use of the injection device 16 to the user of the injection device 16 by, in particular, boxes 120, 121 containing text information regarding the use of a specific member of the injection device 16 and text information 122 having the identification code of the injection device 16. The text information boxes 120, 121 can be displayed near, at the position of, or on each member of the captured image of the injection device on the display 12, so that as a result, the user can quickly obtain hints on using the injection device by looking at the text information boxes 120, 121. Not only that, but video and / or (one or more) images can be displayed by one or more overlays. The video and / or image can be displayed, for example, in a transparent mode so that it overlaps the captured image of the injection device on the display 12 and can explain the correct use of the injection device.

[0031] To more appropriately assist the user or patient when using the injection device, the generation of one or more overlays on the display 12 includes the application of an overlay according to the context of the application of the injection device 16.

[0032] The application of the overlay can include displaying the overlay in different colors, changing the display context of the overlay, changing the size of the overlay, and selecting the position of the overlay. The context of the application of the injection device 16 can include one or more environmental conditions such as ambient light, temperature, time, and / or date, as well as one or more injection-related conditions such as the usage history of the injection device, drugs, injection site, dosage, etc. Examples of the application of the overlay according to the context of the application of the injection device are given below: - When the ambient light is lower than a certain threshold, in order to make it easier for the patient to recognize the overlay even under poor lighting conditions, the color and / or size of the overlay can be changed; - When the temperature exceeds the range recommended or required for injection, change the content of the overlay to display a warning message, and / or change the color of the overlay to a color such as red or yellow to warn the patient that the environmental conditions are inappropriate for injection, and / or increase the size of the overlay so that the patient will not miss it; - When the time and / or date is different from the prescribed medication plan, change the content, color, size, and / or position of the overlay so that the patient can easily recognize the overlay and be reminded that the injection is actually not required and not prescribed; - When the usage history of the injection device indicates that an injection is actually necessary (unnecessary) and / or prescribed (not prescribed), change the content, color, size, and / or position of the overlay so that the patient can easily recognize the overlay, be aware that an injection is actually necessary (unnecessary) and prescribed (not prescribed), and also know when the last injection was given; - The drug can be displayed by the overlay applied respectively. For example, an overlay with a large red color and content located in the center of the display and emphasizing the importance can be used to arouse the patient's attention about important insulin injections. The size, position, color, and / or content of the overlay can be changed to inform the patient about the type of drug and the drug itself; - The injection site can be indicated by an overlay with a color and position on the display to be emphasized. In that case, the injection site is shown to assist the patient during injection; - By selecting an overlay representing the required dosage, for example, by showing an icon representing the dosage in a color and / or size that allows the patient to easily recognize the required dosage, the dosage of the scheduled injection can be indicated.

[0033] Figure 3 shows a flowchart of software executed by a smartphone's processor. After the software is launched on the smartphone (start step), the software activates the built-in smartphone camera 14 at step 200 and captures an image of the injection device 16 in the subsequent step 202. The captured image is displayed on the smartphone screen at step 204, thus showing a realistic representation of the injection device, i.e., "reality". In step 206, the software checks whether it has received identification data from the injection device 16 wirelessly or wired. If it has received the identification data, the software continues at step 208 to load text information, (one or more) videos, and / or (one or more) images regarding the use of the injection device 16 by using the identification data received from one or more of the information sources described above. If it has not received the identification data, the software proceeds to step 212 instead of step 208 and starts image processing of the captured image of the injection device 16 to detect the form, color, and / or code on the injection device. In step 214, the software checks whether a code has been detected by the image processing. If detected, it proceeds to step 216 and loads text information, (one or more) videos, and / or (one or more) images regarding the use of the injection device 16 by using the code detected from one or more of the information sources described above. If no code has been detected by the image processing, the software searches for the injection device by the detected form and / or color at step 218 and then loads text information, (one or more) videos, and / or (one or more) images regarding the use of the searched injection device 16 in the next step 220. Then, in step 222 following steps 208, 216, and 220, the software generates one or more overlays including the loaded information and adds the overlay to the smartphone display or screen to overlap the "realistic" display of the injection device 16 in the subsequent step 224, creating augmented reality for the user.In step 226, the software checks whether an end command has been received, and if so, stops execution. Until an end command is detected in step 226, the software repeats steps 222 and 224, generating one or more overlays to add to the smartphone screen, where the content of the overlay may be different each time it is repeated. For example, a step-by-step guide can be presented to the user.

[0034] Some additional possible applications and implementations are briefly described below:

[0035] It is also possible to audit and record the use of the injection device 16 using the augmented reality generated by the software. For example, a step-by-step training can visualize each step of the user. The steps taken by the user can be verified later (via a (photo) camera), which means that the user mimics the presented visualization and the software verifies the user's actions to provide feedback. If the user's steps are correct, the training continues with the next step; if the user's steps are incorrect, a warning is given, for example, and the training does not proceed until the user can perform each step correctly. The user can thus confirm that they are using the device correctly. The software can also give a warning and suggest a solution if an error or misuse is detected. The feedback can be visual (text, image, or light), auditory (sound), or tactile (vibration warning). This will increase reliability and user understanding.

[0036] The smartphone 10 can be left in use without interruption (e.g., an interruption is recognized to perform steps handled with both hands). Thereby, it may be possible to save the user from information transmission, or there may be a procedure to detect the state of the injection device 16 depending on a significant change in the geometry of the injection device (e.g., whether the cap is attached or not).

[0037] The user can manually record the injection site, time, and dose in the software, or record it when the camera 14 takes a picture of it. The application can also give a notification such as a warning at a determined time when the user has to inject the drug. It is also possible to check whether the correct drug is being used according to the user's information. The warning can be programmed as a reminder, for example, of when to take the injection device out of the refrigerator or when to inject after reaching the determined acclimatizing temperature. An electronic device incorporated in the injection device 16, such as an RFID chip, can further report the state of the injection and confirm a successful injection; it is possible to record the information directly in a log as a track record of the injection.

[0038] The terms "drug" or "medication" are used synonymously herein and refer to a pharmaceutical preparation containing one or more pharmaceutical active ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally, a pharmaceutically acceptable carrier. A pharmaceutical active ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medication is used for the treatment, therapy, prevention, or diagnosis of a disease, or alternatively, for improving physical or mental health. A drug or medication is used for a limited duration or, in the case of chronic diseases, regularly.

[0039] As described below, a drug or agent can include at least one API of one or more types of formulations, or a combination thereof, for treating one or more diseases. Examples of APIs include small molecules with a molecular weight of 500 Da or less; polypeptides, peptides, and proteins (such as hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0040] The drug or agent is contained within a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other solid or flexible container configured to provide a chamber suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chamber is designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chamber is designed to store the drug for about 1 month to about 2 years. Storage can be carried out 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 a dual-chamber cartridge configured to store separately two or more components of a pharmaceutical formulation scheduled for administration (e.g., an API and a diluent, or two different types of drugs), one in each chamber, or can include such a dual-chamber cartridge. In such cases, the two chambers of the dual-chamber cartridge are configured to allow mixing between the two or more components before and / or during dosing into a human or animal body. For example, the two chambers can be such that they (e.g., 2 They are in fluid communication with each other through a conduit between two chambers and are configured to allow the two components to be mixed by the user before dosing, if desired. Alternatively, or in addition thereto, the two chambers are configured to allow mixing when the components are being dosed into the human or animal body.

[0041] The drugs or agents contained within the drug delivery devices described herein are used in the treatment and / or prevention of numerous different types of medical disorders. Examples of disorders include, for example, diabetes, or complications associated with diabetes such as diabetic retinopathy, thromboembolism such as deep vein thrombosis or pulmonary embolism. Another example of a disorder is acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs include, for example, but not limited to, those described in the Handbook Rote Liste 2014, main group 12 (antidiabetic drugs) or main group 86 (antineoplastic drugs), and the Merck Index, 15th edition, etc.

[0042] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes, or complications associated with type 1 or type 2 diabetes, include insulin, such as 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 "analog" and "derivative" refer to a polypeptide having a molecular structure obtained formally from the structure of a natural peptide, such as the structure of human insulin, by deleting and / or exchanging at least one amino acid residue found in the natural peptide and / or by adding at least one amino acid residue. The amino acid residues added and / or exchanged can be codable amino acid residues, or other natural residues or fully 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 obtained formally from the structure of a natural peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more amino acids. Optionally, one or more amino acids found in the natural peptide may be deleted and / or substituted by other amino acids containing non-codable amino acids, or amino acids containing non-codable amino acids may be added to the natural peptide.

[0043] Examples of insulin analogs include 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 proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and Lys at position B29 is replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0044] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir (registered trademark)), B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 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-carboxyheptadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)), 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.

[0045] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, liraglutide (Lyxumia®, exenatide (exendin-4, Dyetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-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.

[0046] Examples of oligonucleotides include, for example: mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0047] Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0048] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists such as gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0049] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as poly-sulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0050] 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 that retain the ability to bind an antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immune or humanized, fully human, non-human (e.g., murine), or single-chain antibodies. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the anti- body has a low or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or variant that does not support binding to Fc receptors, e.g., having a mutated or deleted Fc receptor-binding region. The term antibody also includes antibody-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins (CODVs) with an orientation of the cross-linking region.

[0051] 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) that does not include the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide that is capable of binding to an antigen. An antibody fragment can include a cleaved portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific antibody fragments, or multispecific antibody fragments such as bispecific, trispecific, tetra-specific, and multi-specific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent antibody fragments, or multivalent antibody fragments such as divalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelate recombinant antibodies, tribodies or biobodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Further examples of antigen-binding antibody fragments are known in the art.

[0052] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in maintaining the correct positioning of the CDR sequences and enabling antigen binding, rather than being the CDR sequences themselves. The framework region itself is not usually directly involved in antigen binding, as is known in the art, but specific residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0053] Examples of antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0054] Pharmaceutically acceptable salts of any API described herein are also contemplated for use of the drug or agent in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0055] It will be understood by those skilled in the art that changes (additions and / or deletions) to the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the concepts of this disclosure, which include such changes and all equivalents thereof.

Claims

1. A system for assisting in the use of an injection device, a display, and a processor configured to determine an injection device, obtain data regarding the use of the determined injection device, and add at least one overlay to the display, wherein at least one overlay is generated according to the acquired data regarding the use of the determined injection device, and the processor is configured to apply at least one overlay according to the context of the application of the injection device, and the context of the application of the injection device includes at least one of ambient light; time; date; temperature; usage history of the injection device; administered dose, Applying at least one overlay according to the context of the application of the injection device includes at least one of displaying the overlay in a different color so as to make it easier to recognize the displayed overlay and / or reducing the risk of overlooking the displayed overlay; changing the size of the overlay; selecting the position of the overlay on the display, and the processor is further configured to detect a user's action and apply at least one overlay according to the detected user's action, the system.

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

3. The processor is configured to perform image processing on a captured image of the injection device to determine the injection device, and the image processing includes detecting the form, color, code, tag, and / or label on the injection device, and determining the injection device according to the detected form, color, code, tag, label, the system according to claim 1 or 2.

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

5. The system according to any one of claims 1 to 4, comprising an image capture component for capturing an image of the injection device, wherein the processor is configured to display the captured image of the injection device on a display together with at least one overlay.

6. The system according to any one of claims 1 to 5, wherein the processor is configured to generate at least one overlay by loading data regarding the use of the determined injection device from an internal storage device and / or an external storage device via a data connection, particularly a wireless data connection.

7. The system according to any one of claims 1 to 6, wherein the processor is configured to store data related to the usage history of the injection device.

8. A device comprising a processor, a memory, a display, a camera, and software stored in a non-volatile member of the memory, wherein the software configures the processor of the device to capture one or more images of an injection device using the camera, display the captured image of the injection device on the display, determine the injection device, obtain data regarding the use of the determined injection device, and add at least one overlay to the display, wherein the at least one overlay is generated according to the acquired data regarding the use of the determined injection device and applied according to the context of the application of the injection device, and the context of the application of the injection device includes at least one of ambient light; time; date; temperature; usage history of the injection device; and administered dose. Applying at least one overlay according to the context of the application of the injection device includes at least one of: displaying the overlay in a different color so that it is easier to recognize the displayed overlay and / or reducing the risk of overlooking the displayed overlay; changing the size of the overlay; selecting the position of the overlay on the display, and The device, wherein the processor is further configured to detect a user action and apply at least one overlay in response to the detected user action. **Claim 9** The device according to claim 8, wherein the device is a smartphone, a personal digital assistant, a tablet or laptop computer, or a head-mounted display device.

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