User devices, systems, and methods for tracking the use of injection devices.

Abstract

A user device configured to track use of an injection device. The user device may include a processor, a memory, and a wireless transceiver. The user device may be configured to use the wireless transceiver to transmit and receive a first set of signals representing data associated with a particular injection device stored in a storage device configured to store a plurality of unused injection devices, and to transmit and receive a second set of signals representing data associated with a particular injection device discarded in the sharps collection container, the sharps collection container configured to store a plurality of used injection devices.

Description

Technical Field

[0001] The present disclosure relates to systems and tools that include user devices configured to track the use of injection devices and communicate with a plurality of other devices to effect disease tracking and improved patient compliance.

Background Art

[0002] Patients suffering from chronic diseases often require regular treatment with medications, for example, based on a predetermined schedule. Certain medications require refrigerated storage and are often stored in a household refrigerator or freezer for extended periods. In a home treatment environment, the patient stores the medication in the refrigerator and self-administers a predetermined dose as needed. Thus, medications are typically provided in secondary packaging for convenient placement and storage within a household refrigerator.

[0003] Medications can have a predetermined dosing schedule that requires dosing at relatively long intervals, for example, every two weeks or four weeks. The medication can be provided in secondary packaging that includes several doses that can be stored in a refrigerator for, for example, one to six months. It can be difficult for a patient to track each scheduled dosing time, which can lead to inadequate compliance with the prescribed dosing plan. Further, in the case of some medications with a long action, the user may generally be symptom-free at the time of the next prescribed injection, which can lead to a further risk of non-compliance with the prescribed dosing plan. In addition, during the course of such treatment, the scheduled dosing may need to be adjusted after consultation with a healthcare professional (HCP).

[0004] Patients may require training to use a particular type of injection device. Different types of injection devices may contain different doses of medication. Treatment may require the use of two or more types of injection devices. For example, a higher “initial dose” may be required, followed by a lower, more frequent “maintenance dose.” Certain medications may require injection at a specific temperature or within a specific temperature range. It may also be important that certain medications be taken at a specific time, before or after meals, or with or without other treatments. [Overview of the project] [Problems that the invention aims to solve]

[0005] Therefore, it may be useful to accurately track the use of specific injection devices to ensure that patients use them appropriately. These and other benefits are described in the systems and tools currently disclosed. [Means for solving the problem]

[0006] A first aspect disclosed herein is a user device configured to track the use of an injection device: Processor and; memory and; Wireless transceiver and Includes, Using a wireless transceiver, a first set of signals representing data associated with a particular injectable device stored in a storage device is transmitted and received between a storage device configured to hold multiple unused injectable devices, Using a wireless transceiver, a second set of signals representing data associated with a specific injection device discarded in a sharp object collection container is transmitted to and received from a sharp object collection container configured to hold multiple used injection devices. It requires a user device configured in such a way.

[0007] This makes it possible to use a user device, i.e., a device separate from any medical device, to monitor the use of the medical device, including the appropriateness of delivery and storage. In particular, a user device such as a smartphone or tablet can collect information on the delivery and use of an injectable device for the purpose of improving medication planning record-keeping and adherence, so that it can be easily adapted to the normal use of the injectable device by the patient. This is especially advantageous for injectable devices that are used infrequently and / or must be stored at low temperatures.

[0008] The user device may also include a camera, and the user device may: A camera is used to scan the injection device to determine at least the drugs contained within the injection device; Determine whether the drug contained in the injection device matches the prescribed drug; If the medication contained in the injection device matches the prescribed medication, a notification will be issued indicating that the storage of the injection device has been approved. It can be configured in this way.

[0009] The user device may be further configured to determine whether the dose of drug contained in the injection device matches the prescribed dose. The user device may also be further configured to determine whether the drug contained in the injection device has expired.

[0010] The user device may further include a display, which may be further configured to output reminders about using the injection device. The display may be a touch-sensitive display. The user device may: use a camera to scan the injection device to verify whether the drug contained within the injection device matches the prescribed drug; and if the drug contained within the injection device matches the prescribed drug, it may be configured to output a notification on the display indicating that the use of the injection device is authorized.

[0011] The user device can be further configured to track the number of injection devices stored in the storage device; and to send a notification to a third party that additional injection devices are needed when the number of injection devices stored in the storage device falls below a predetermined number. In some examples, the user device can automatically order additional injection devices.

[0012] The user device can be further configured to generate an injection device usage report based on a first set of signals and / or a second set of signals. The injection device usage report may include information about when each injection device was used. The injection device usage report may include information about how each injection device was used and disposed of. The injection device usage report may include a personal compliance score indicating the user's level of adherence to the prescribed medication plan. The injection device usage report may be sent to a healthcare professional or other healthcare support provider.

[0013] The injection device can be stored in a refrigerator, and the user device can be further configured to: calculate the time the injection device should remain outside the refrigerator before use; and provide notification of the time or time expiration. Notifications can be provided audibly and / or visually. The injection device can be configured as a pen, auto-injector, pre-filled syringe, or volumetric device (LVD). The injection device may have a drug volume of 1 ml. The injection device may have a drug volume of 2 ml.

[0014] A second aspect disclosed herein is a system for tracking the use of an injection device: User device with wireless transceiver; A storage device having a plurality of openings, each opening configured to store an unused injection device over a certain period of time, further comprising a storage device wireless transceiver; A sharps collection container having an opening and a reservoir configured to receive a plurality of used injection devices, further comprising a sharps collection container wireless transceiver, and the sharps collection container, including; The user device wireless transceiver is: Transmit and receive a first set of signals with the storage device wireless transceiver; Transmit and receive a second set of signals with the sharps collection container wireless transceiver, configured to; The first and second sets of signals represent data associated with a particular injection device that is stored in a storage device and then discarded in a sharps collection container, and require a system.

[0015] The storage device is: After the injection device is stored in one of the plurality of openings, scan the injection device; At least determine the ID of the injection device; Transmit the ID of the injection device to the user device as part of the first set of signals. It can be configured as follows.

[0016] The sharps collection container is: After the injection device is placed in the sharps collection container, scan the injection device; At least determine the ID of the injection device; Transmit the ID of the injection device to the user device as part of the second set of signals. It can be configured as follows.

[0017] The system can further include an injection device, and the injection device includes at least one of a safety system, a pen-type syringe, and an auto-injector.

[0018] The injection device can have a medicament. The medicament may be for treating a skin condition. The skin condition may be atopic dermatitis. The medicament can include an anti-IL-4 antibody or an antigen-binding fragment thereof, which can be a monoclonal antibody or an antigen-binding fragment thereof, or a polyclonal antibody or an antigen-binding fragment thereof in some cases. The anti-IL-4 monoclonal antibody can include dupilumab.

[0019] A third aspect disclosed herein is a method of tracking the use of an injection device in a system including a user device, a storage device configured to store an unused injection device over a period of time, and a sharp object collection container, comprising: using a wireless transceiver of the user device to transmit and receive a first set of signals between the storage device and the user device; using a wireless transceiver of the user device to transmit and receive a second set of signals between the sharp object collection container wireless transceiver, comprising, where the first and second sets of signals represent data associated with a specific injection device stored in the storage device and then discarded in the sharp object collection container, and a method is required.

[0020] A fourth aspect disclosed herein is a computer program comprising machine-readable instructions, which when executed by a processor, cause the processor to: control the wireless transceiver of the user device to transmit and receive a first set of signals representing data associated with a specific injection device stored in a storage device configured to store a plurality of unused injection devices; control the wireless transceiver of the user device to transmit and receive a second set of signals representing data associated with a specific injection device discarded in a sharp object collection container configured to store a plurality of used injection devices, and a computer program is required.

[0021] Computer programs can be stored in non-temporary computer-readable media.

[0022] A fifth aspect disclosed herein is a system for improving medication compliance in patients receiving treatment for chronic diseases: A user device (UD) having a UD processor, UD memory, UD wireless transceiver, and UD user interface; A storage device (SD) having multiple openings, each opening configured to store an unused injection device for a certain period of time, further comprising an SD processor, an SD memory, an SD wireless transceiver, and an SD user interface; A sharp object collection container (SB) having an opening and a storage container configured to receive a plurality of used injection devices, wherein the sharp object collection container further comprises an SB processor, an SB memory, and an SB wireless transceiver, Includes; A UD radio transceiver is configured to transmit and receive a first set of signals to and from an SD radio transceiver, and a UD radio transceiver is configured to transmit and receive a second set of signals to and from an SB radio transceiver; The system requires a first and second set of signals that represent data associated with a specific injection device, which is stored in a storage device and subsequently discarded in a sharp object collection container.

[0023] A sixth aspect disclosed herein is a method for storing, using, and disposing of a plurality of injection devices: Receiving multiple injection devices; Scanning multiple injection devices using a user device or storage device; Ensure that multiple injection devices are suitable for storage; To house multiple injection devices in a storage device; Receiving a reminder from a user device or storage device to use one or two of multiple injection devices; Taking one or two of multiple injection devices out of the storage device; To allow one or two of multiple injection devices to reach room temperature; Injecting a dose of medication contained within one or two of multiple injection devices; Scanning one or two of multiple injection devices using a user device or sharp object collection container; Dispose of one or two of the multiple injection devices in a sharp object collection container, This requires a method that includes [something]. [Brief explanation of the drawing]

[0024] [Figure 1] This is a schematic diagram of a digital system including a user device, an injection device, a waste disposal device, and a storage device, according to several embodiments. [Figure 2] Figure 3 shows the system including the user device and the storage device. [Figure 3] This is a schematic diagram of a user device according to several embodiments. [Figure 4] This indicates the user device displaying the overview screenshot. [Figure 5] Figure 3 shows screenshots of body parts that can be displayed on the user's device. [Figure 6] This flowchart shows exemplary operation of an application running on the user device shown in Figure 3, according to several embodiments. [Figure 7] This shows the storage device. [Figure 8A] This shows the storage device from the front, with the lid in the open position. [Figure 8B] This shows an internal view of the storage device from the front. [Figure 9]This flowchart shows an example of a user's use of an automatic syringe. [Figure 10] Figure 3 shows a screenshot of the second body part that can be displayed on the user device. [Modes for carrying out the invention]

[0025] Description of the entire digital system Referring to Figure 1, the device and digital system 600 are schematically shown. The system 600 may include various devices and digital subsystems. The various devices may include one or more injection devices 10, a storage device 100 configured to house one or more injection devices 10, and a sharp object collection container 3 configured to receive one or more used injection devices 10. The system 600 may also include a user device 400 configured to interact with one or more of the injection devices 10, the storage device 100, and the sharp object collection container 3. For example, the user device 400 may communicate wirelessly with one or more injection devices 10, the storage device 100, and the sharp object collection container 3. Communication between the user device 400 and the injection devices 10 may include the patient using the user device 400 to scan a label (not shown) on the injection device 10.

[0026] The user device 400 can further communicate with one or more digital subsystems to receive or transmit information relating to one or more injection devices 10, storage devices 100, and sharp object collection containers 3. This could include, for example, tracking one or more steps from when a patient receives the injection device 10 and successfully administers the drug contained within the injection device 10, until the injection device 10 is disposed of.

[0027] Upon receiving the injection device 10, the patient can place the device inside the storage device 100. As described below, the storage device 100 can be configured to receive and store one or more unused injection devices 10. Many medications for the treatment of chronic diseases require storage below room temperature. As a result, the storage device 100 is often placed in the patient's refrigerator.

[0028] For the effective treatment of chronic conditions, a physician or HCP may need to monitor the progress of use of the injection device 10 when it is used by a patient. This may include determining when the injection device 10 has been taken out of the refrigerator, allowed to reach room temperature (or any other temperature that may be considered the operating temperature of the injection device 10), operated by a patient, confirmed to have been successfully injected, and safely disposed of.

[0029] The patient can retrieve a specific injection device 10 from the storage device 100 because they need to self-inject. The storage device 100 and / or the injection device 10 can communicate with the user device 400 to provide one or more timestamps or other indications of when the patient retrieves the injection device 10 from the storage device 100.

[0030] For a single patient, multiple data points received from multiple sources can provide the physician or HCP with more accurate and consistent information. Similarly, multiple data inputs from the user device 400, storage device 100, and / or sharp object collection container 3 can verify that a particular injection device 10 was used and disposed of properly.

[0031] These and other advantages of System 600 are described below. In some embodiments, the injection device 10 can contain a drug for the long-term treatment of atopic dermatitis. The system diagram in Figure 1 shows the flow of information and the interactions between the different elements of System 600.

[0032] Training kit The context of the interaction is shown on the left side of Figure 1. For example, a physician or healthcare professional (HCP) may provide a patient with an injection training kit 1. The training kit may include a training injection device and instructions on how to operate the injection device. The physician / HCP may also access a website targeted at HCPs for further information and training and enter patient-specific information.

[0033] Any patient-specific information entered by the HCP on the HCP website can be transmitted to the patient website, and the patient can access this information through their personal profile. The patient website may include resources to assist the user in safely using the injection device 10 and storage device 100, including training videos.

[0034] Patients can receive ongoing support in the form of a Patient Support Program (PSP). Failure to adhere to the prescribed injection plan is a major challenge in providing patients with effective treatment, especially when the intervals between injections are long (e.g., 1 week, 2 weeks, 4 weeks, 6 weeks, or 8 weeks or longer). In one example of a Patient Support Program, the patient receives an introductory call before or at the same time as receiving the first injection device 10 or set of injection devices. The purpose of the introductory call is to explain the program, discuss predictions, allow the patient and / or caregiver to select program components, complete questionnaires and patient participation measurements (estimation of non-compliance risk), address any immediate concerns or worries of the patient and / or caregiver, confirm the date and time of the first follow-up call, and, together with the patient and / or caregiver, confirm the level of support the patient and / or caregiver will receive.

[0035] Next, patients may receive nurse visits and injection training. This may include a single visit by a nurse or up to three visits. In some examples of patient support programs, nurse visits may take place before the introductory phone call. Patient participation measurement (PAM) may have one of four different level indications, representing different risk levels of non-compliance with the prescribed medication plan. All levels may include phone calls for review with the patient four times a year. For patients with the lowest non-compliance risk (PAM level 4), phone calls may be made after each injection for a predetermined period, for example, the first four weeks, and then discontinued. For patients with a low non-compliance risk (PAM level 3), after phone calls after each injection for a predetermined period, patients may receive support phone calls every eight weeks. For patients with a high non-compliance risk (PAM level 2), support phone calls after each injection may continue for a longer period, for example, eight weeks, and then monthly. PAM level 2 may also include two motivational interviews per year. For patients with a very high risk of non-compliance (PAM Bell 1), support calls can be provided after each injection, for example, 5 days after each injection. Multiple motivational calls can be provided annually, for example, 3 or 4 times a year.

[0036] One of the advantages of the patient support program, training kit, and other configurations of the system described herein is that they increase patient adherence to prescribed medication plans. In one trial of 3,633 patients, 90% were enrolled in the home healthcare support program, and 70% were enrolled in a home healthcare support program that included delivery of injection devices. The overall adherence rate for this patient group was 91%, showing a significant increase in adherence compared to the case without the support program.

[0037] Starter kit The patient may be provided with an injection device 10 and a starter kit 2. Along with printed materials, the starter kit 2 may include a microsite containing key information on the operation of the injection device 10 and the storage device 100, and a link to download an application associated with the storage device 100. The starter kit may contain only the storage device 100, with the injection device 10 provided separately. Alternatively, the starter kit 2 may include the supply of the injection device 10 in addition to the storage device 100.

[0038] Patients can access the microsite using their user device 400 (which may be a smartphone, tablet, or similar device), for example, by scanning a QR code. The microsite may include a video instructing the user on how to self-inject using the injection device 10, a virtual reality program that can show the user a virtual version of the injection device 10 in operation, digital FAQs and answers, a link to the patient website, and a link to download the application. The microsite may request the patient to enter certain personal information, such as an email address. The microsite may then send an email to the patient's email address containing a link to download the application to one or more user devices 400.

[0039] Along with the starter kit, a single card that can be folded and placed in a phone holder can be provided. Users can select a virtual reality program from a microsite and place their phone in the provided phone holder. The virtual reality program may include virtual consultations with nurses and / or counselors, skin animations to demonstrate the causes and biological roles of certain skin conditions, 3D injection technology animations including 3D models of syringes, a series of infographics and virtual objects to assist with maintenance, FAQs and further resources.

[0040] As shown, patients can obtain support through the patient website, call centers, text reminders, and / or through home healthcare.

[0041] User devices In some embodiments, the user device 400 is a smartphone or tablet. However, the user device 400 can also be embodied as a laptop, a smart display such as a Nest Hub, a smart speaker (e.g., Amazon Echo or a similar voice-activated device), a smart TV, a smartwatch, or other wearable devices such as a headset or glasses, or a connected refrigerator. The user device 400 can download applications from a digital store or be pre-programmed using applications. There may be various versions of the application for use with the various devices mentioned above. A user can download applications to multiple user devices, and a single digital profile can ensure that information entered or updated on one device is synchronized with other devices.

[0042] As will be explained in more detail below, after downloading the application, the user can set or override certain information on the storage device 100. The storage device 100 can communicate operational information to the user device 400, such as the number of injection devices 10 stored in the storage device 100, the number of days remaining until the next scheduled injection, temperature (for example, local temperature, which, depending on the context, may mean the temperature of the storage device 100, the injection devices 10, the medication, or any combination thereof), humidity, and battery level. When the user needs to order additional injection devices 10, this can be achieved using the application, and a new supply of injection devices 10 will be delivered to the patient's home. In this case, the application can provide notifications of when the injection devices 10 have been shipped and when they are scheduled to be delivered. Such notifications are particularly useful when the medication contained in the injection devices 10 must be kept below a certain temperature, for example, refrigerated.

[0043] The user device 400 can also be connected to one or more storage devices 100 and / or the digital sharp object collection container 3. The user device 400 is configured to communicate wirelessly using wireless communication protocols. For example, the first external device can communicate wirelessly using Wi-Fi, Bluetooth, ZigBee, IrDA, etc. The user device 400 can communicate with each of the other connected parts of the system 1000 in various ways. For example, the user device 400 can communicate directly (peer-to-peer) with the storage device 100 using Bluetooth. Alternatively, or in addition, the user device 400 can communicate with the storage device 100 via a wireless access point using WiFi. The user device 400 can communicate with the injection device 10 using NFC. For example, the user device 400 can act as a reader and the injection device 10 can act as a target. Alternatively, the injection device 10 can be read optically or magnetically by the user device 400 using infrared light.

[0044] The user device 400 can communicate directly with the digital sharp object collection container 3, for example, using Bluetooth. Alternatively, or in addition, the user device 400 can communicate with the digital sharp object collection container 3 via a wireless access point using Wi-Fi.

[0045] Injection device The injection device 10 described herein can be configured to inject a drug into a patient. For example, delivery may be subcutaneous, intramuscular, or intravenous. Such a device can be operated by the patient or a caregiver such as a nurse or physician and may include various types of pre-filled syringes, safety systems, pen-type injectors, or auto-injectors. The device may include a cartridge-based system that requires puncturing a sealed ampoule before use. The amount of drug delivered by these various devices can range from about 0.5 ml to about 2 ml. Yet another device may include a high-volume device ("LVD") or patch pump configured to adhere to the patient's skin for a certain period (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a "large" volume of drug (typically about 2 ml to about 5 ml or more).

[0046] By combining them with specific medications, the aforementioned devices can also be customized to operate within the required specifications. For example, a device can be customized to inject medication within a specific time frame (e.g., approximately 3 to 20 seconds for auto-injectors, and approximately 10 to 60 minutes for LVDs). Other specifications may include shelf life, expiration date, biocompatibility, and environmental considerations, as well as several conditions related to low or minimal discomfort or human factors. Such differences can arise from various factors, such as the viscosity of the medication (e.g., approximately 3 cP to 50 cP). As a result, injection devices often include hollow needles of approximately 25 to 31 gauge. Common sizes are 27 and 29 gauge.

[0047] The injection device 10 described herein may also include one or more automated functions. For example, one or more of needle insertion, drug injection, and needle retraction may be automated. Energy for one or more automated steps may be supplied by one or more energy sources. Energy sources may include, for example, mechanical energy, pneumatic energy, chemical energy, or electrical energy. For example, a mechanical energy source may include a spring, lever, elastomer, or other mechanical mechanism for storing or releasing energy. One or more energy sources may be combined within a single device. The device may further include gears, valves, or other mechanisms for converting energy into the movement of one or more components of the device.

[0048] Each of the automated functions of an automatic syringe can be activated via an activation mechanism. Such an activation mechanism may include one or more buttons, levers, needle sleeves, or other activation components. Activating an automated function can be a one-step or multi-step process. That is, the user may need to activate one or more activation components in order to perform the automated function. For example, the user may place the needle sleeve against their body and press it down to inject medication. In other devices, the user may need to press down a button and retract the needle shield to inject.

[0049] In addition, such activation may trigger one or more functions. For example, an activation sequence may trigger at least two of the following: needle insertion, drug injection, and needle retraction. Some devices may also require a specific sequence of steps to perform one or more automated functions. Other devices may operate through steps that are not sequence-dependent.

[0050] Some injection devices 10 may include one or more functions of a safety system, a pen injector, or an autoinjector. For example, injection device 10 may include a mechanical energy source (typically found in autoinjectors) configured to automatically inject a drug and a dose setting mechanism (typically found in pen injectors).

[0051] According to some embodiments, the injection device 10 typically includes a housing that includes a container (e.g., a syringe) containing the drug to be injected, and components necessary to facilitate one or more steps of the delivery process. The injection device 10 may also include a cap assembly that can be detachably attached to the housing. Typically, the user must remove the cap from the housing before operating the device 10.

[0052] The housing of the injection device 10 has a distal region and a proximal region. The term "distal" refers to a location relatively close to the needle or injection site, and the term "proximal" refers to a location relatively far from the needle or injection site.

[0053] Device 10 may also include a needle sleeve connected to the housing so that the sleeve can move relative to the housing. For example, the sleeve can move longitudinally parallel to the longitudinal axis. In particular, movement of the sleeve in the proximal direction can allow the needle to extend from the distal region of the housing.

[0054] The injection device 10 may include a label that can be read by another device and may contain encoded information. The label may be externally or internally placed on the injection device 10. For example, the label on the injection device 10 may be read by the user device 400 using NFC. The label may include a barcode, QR code, or other optically encoded information that can be optically read by the user device 400. Alternatively, or in addition, the injection device 10 may have magnetically encoded information. The injection device 10 may be scanned or otherwise read by the user device 400 before the injection is administered, after the injection is administered, or before each injection device 10 is placed in the storage device 100. These and various other methods of tagging the injection device 10 with information are considered. Various types of information may be included on the label. These may include the type of drug or injection device, manufacturer, expiration date, dosage, country of origin, etc.

[0055] In some embodiments, the injection device 10 may include a wireless communication module. This allows the injection device 10 to connect to and communicate directly with the user device 400. The injection device can also communicate directly with the storage device 100 and / or the digital sharp object collection container 3.

[0056] Digital sharp object collection container The digital system 600 may also include a digital sharp object collection container 3 that can determine when a used injection device 10 has been placed inside. The digital sharp object collection container 3 may include one or more sensors located around or near the opening through which the used injection device 10 is placed. The sensors may be configured to read information provided on the tag of each injection device when it is placed inside the bottle. The digital sharp object collection container 3 may create a timestamp indicating the time of disposal of the injection device 10 and the contents of the injection device. The digital sharp object collection container 3 may transmit this information to the user device 400 quickly or periodically. The digital sharp object collection container 3 may store an injection plan for the user. This plan can be updated using an application on the user device 400. If the digital sharp object collection container 3 determines that the injection device 10 has been placed inside the bottle on a day or time when no injection is scheduled according to the plan, it may send an alarm to the user device 400. The application on the user device 400 can also provide connectivity with the digital sharp object collection container 3 to act as a primary record or double-check of the user's injection history. The digital sharp object collection container 3 can also be configured to send reminders via the application on the user device 400 when the next injection is scheduled and to locally store data regarding the user's adherence to the injection schedule.

[0057] The digital sharp object collection container may also include a display such as an LCD and / or one or more LEDs. The LCD may be a touch-sensitive display. In addition to the touch-sensitive display, the digital sharp object collection container 3 may also include a speaker and one or more user inputs. The display can be activated whenever an injection device is placed in the digital sharp object collection container 3. The display may show the patient's recent injection history and / or future injection plan. The digital sharp object collection container 3 may receive information about the number of injection devices 10 remaining in the storage device 100, either directly from the storage device 100 or via an application on the user device 400. This information, and, where appropriate, a reminder to order more injection devices, may also be displayed. Any alarms regarding the unexpected placement of injection devices may also be displayed on the display and / or communicated audibly using the speaker.

[0058] Storage devices The storage device 100 can be configured to detect when the injection device 10 is inserted or removed via a label provided on the injection device 10. The storage device 100 can be configured to synchronize this information with an application on the user device 400.

[0059] Referring to Figure 7, an exemplary embodiment of the storage device 100 is shown. The storage device 100 includes a case 110 having a lid 120. The case 110 may include a bottom surface 131, a top surface 141, and two side walls 142. The bottom surface 131 is curved to meet the top surface 141 at the rear of the device. At the front end of the case 110, an opening is formed between the bottom surface 131, the top surface 141, and the two side walls 142.

[0060] The lid 120 may include a latching mechanism for holding the lid 120 in the closed position. The lid 120 may further include a locking mechanism configured to prevent the lid 120 from moving to the open position. The locking mechanism may be electronically controlled. The case 110 is configured to hold and house a plurality of injection devices 10. The length of the case 110, measured between the rear of the case and the lid 120, is sufficient to accommodate the length of each injection device 10. Other lid configurations may also be considered. A portion of the lid 120 may be transparent and translucent to form an observation window 121 through the lid 120.

[0061] The case 110 further includes a panel 150 positioned within the opening. The panel 150 includes a plurality of openings 151. The openings 151 are configured to hold a plurality of corresponding injection devices 10. The openings 151 within the panel 150 are circular in shape. The openings 151 can be square or rectangular in shape to accommodate other sizes of injection devices 10. The width of each opening is sufficient to accommodate the width of each injection device 10. The panel 150 includes a row of six openings to hold six injection devices 10 arranged in a row along the width of the case 110.

[0062] The storage device 100 may be configured to hold more than six or fewer than six injection devices 10 within the case 110. The retention mechanism can store multiple injection devices 10 in place within the opening 151. The retention mechanism may include a mechanical catch configured to engage with each injection device 10, for example, a spring-loaded push-catch push-release mechanism.

[0063] The user can receive the storage device 100 empty. When the user is supplied with multiple injection devices 10, they can be loaded into the storage device 100. The lid 120 is moved to the open position, and each injection device 10 is inserted into one of the corresponding openings 151. The lid 120 is moved to the closed position. The storage device 100 is placed in the refrigerator until the first scheduled administration time is set. The storage device 100 can be placed in the refrigerator before and after the initial insertion of the injection devices 10.

[0064] For example, the dosing time for one type of injection device 10 can be scheduled every 14 days or every 28 days, according to the prescription and / or product leaflet of the drug provided with the injection device 10. For some injection devices 10, the period between scheduled dosing times can be from 2 to 60 days, according to the drug requirements. The storage device 100 can be configured to contain and store multiple types of injection devices 10 simultaneously or at different times. The storage device 100 can contain multiple injection devices 10 providing one or more different drugs with one or more different dosing intervals.

[0065] The storage device may include a processor configuration (not shown) operably coupled to a wireless communication module (not shown). The wireless communication module may be configured to broadcast a connection request signal when it determines that the refrigerator door has been opened. When a response signal is received from the user device 400, the wireless communication module is configured to establish communication with the user device 400. The processor configuration controls the communication with the user device 400.

[0066] The processor configuration can control the wireless communication module to transmit information about the storage device 100 and the multiple injection devices 10 to the user device 400. The wireless communication module can transmit the status of the injection devices 10; for example, it can transmit the remaining time until the next scheduled medication time. The wireless communication module can transmit device information received from the sensor array 240; for example, it can transmit the number and type of injection devices 10 stored in the storage device 100. If one of the injection devices 10 has expired, the wireless communication module can send an alarm to the user device 400.

[0067] The wireless communication module can transmit status information of the storage device 100 to the user device 400. For example, the wireless communication module can transmit environmental information provided by a temperature sensor or a humidity sensor.

[0068] The user device 400 can also initiate communication with the storage device 100 even when the refrigerator door is closed. This allows applications running on the user device 400 to overwrite and update information on the storage device 100 at any given time. The application can also request that certain information be sent or resent by the storage device 100 at any given time.

[0069] The storage device 100 is configured to establish communication with one or more user devices 400 and wireless terminals 300. In some embodiments, the storage device 100 is configured to determine whether the refrigerator door is open and to establish communication on the condition that the refrigerator door is open. The storage device 100 is further configured to transmit information about a plurality of injection devices 10 to the wireless terminals 300. The storage device 100 can be configured to request information about a plurality of injection devices from the wireless terminals 300.

[0070] In some embodiments, the storage device 100 is further configured to provide a visual and / or audio reminder to the user when a scheduled medication time is due. The storage device 100 may be further configured to provide a reminder conditionally on the refrigerator door being open. The storage device 100 may be further configured to determine whether the lid 120 is in the open or closed position, and to deactivate the audio reminder when it detects that the lid 120 has been moved to the open position.

[0071] Figure 8A shows the storage device 100 from the front with the lid 120 in the open position. The panel 150 and opening 151 are visible. The shown storage device 100 includes a plurality of injection devices 10, each of which may be of a different device type. Different types of injection devices 10 can deliver different drugs. Alternatively, different types of injection devices 10 may have different doses or concentrations of the same drug, or different drug delivery methods. Different types of injection devices 10 may have different dosing intervals.

[0072] The storage device 100 includes an electronic system 200. The electronic system 200 includes a number of components connected together to provide a specific set of functions described below. The components of the electronic system 200 are mounted on a printed circuit board (PCB), but may instead be interconnected through some other medium.

[0073] Some of the electronic components of the electronic system 200 are user interface hardware components, and together they provide a user interface 210 for the storage device 100.

[0074] The electronic system 200 includes a display 211. The display 211 is an example of an optical transducer. The display 211 includes two 7-segment light-emitting diode (LED) arrays. The display 211 is visible to the user through a transmissive observation window 121 in the lid 120 when the lid 20 is in the closed position. The electronic system 200 includes an LED array 220. The LED array 220 is an example of an optical transducer. The electronic system 200 includes a reset button 164. The reset button 164 is an example of an input device. The reset button 164 is a spring-loaded plunger button that can be pressed by the user. The electronic system 200 includes a speaker. The speaker is an example of an audio transducer.

[0075] The LED array 220 includes an array of 18 light-emitting diodes (LEDs). The LEDs of the LED array 220 are positioned on the panel 150 in close proximity to the openings 151. The LED array 220 includes three LEDs 221, 222, and 223 for each of the six openings 151. Each of the three LEDs 221, 222, and 223 can illuminate in a different color. For example, the LED array 220 may include a blue LED 221, a white LED 222, and a red LED 223 for each opening 151.

[0076] Figure 8B shows an internal view of the housing device 100 from the front. The rear view of PCB 201 is shown.

[0077] The electronic system 200 includes a sensor array 240. The sensor array 240 is mounted on the rear surface of the PCB 201. The sensor array 240 includes a plurality of device sensors 241. The number of device sensors 241 corresponds to the number of injection devices 10 that can be housed by the housing device 100. Each device sensor 241 is mounted adjacent to one of a plurality of openings 151.

[0078] The device sensor 241 is configured to output a signal when the injection device 10 is positioned within the opening or during insertion into the opening 151. The device sensor 241 is a radio frequency identification (RFID) reader including a radio frequency antenna. Each device sensor 241 takes the form of a loop corresponding to each of the openings 151. The device sensor 241 is positioned to detect a device tag placed on the injection device 10. The device tag is a passive RFID tag including a radio frequency antenna. The device sensor 241 generates an electromagnetic field to activate the device tag and detects a response signal transmitted by the device tag. The device sensor 241 can be configured to read device information stored on the device tag. The processor configuration 230 can store the device information received from the injection device 10.

[0079] The sensor array 240, while separate from the device sensors 241, may include electronic components that form part of the sensor array 240 itself. The device sensors 241 can provide signals transmitted by the device tag, and the electronic components perform signal analysis and communication to the processor arrangement 230. Alternatively, each device sensor 241 may include electronic components for performing analysis of detected signals. Further alternatively, the analysis of incoming signals may be performed by the processor arrangement 230.

[0080] System Description Referring to Figure 2, various embodiments of System 1000 are shown. System 1 includes a storage device 100. The storage device 100 is shown to be placed in a refrigerator according to an exemplary operating mode. The storage device 100 can be placed in a refrigerator by the user, and multiple injection devices 10 can be placed inside the storage device 100.

[0081] The system includes a user device 400 as described above, one or more injection devices 10 as described above, a digital sharp object collection container 3, and a wireless terminal 300.

[0082] In some embodiments, the user device 400 may be a mobile phone. The user device 400 is an example of a wireless communication device. The user device may also be referred to as a communication device, computing device, or mobile device, and is not necessarily associated with a single user. The user device 400 is configured to communicate wirelessly using a wireless communication protocol. For example, the first external device may communicate wirelessly using Wi-Fi, Bluetooth, ZigBee, IrDA, etc.

[0083] The user device 400 can be operated, for example, by a patient. According to an exemplary mode of operation, the user device 400 can be placed in close proximity to the storage device 100. For example, the user device 400 can be carried or held by a patient.

[0084] The wireless terminal 300 can be a wireless access point such as a wireless router. The wireless terminal 300 is configured to broadcast Wi-Fi signals. Alternatively, the wireless terminal 300 can be configured to broadcast signals using Li-Fi or any alternative wireless protocol. The wireless terminal 300 provides access to the wireless LAN to compatible devices within range. The wireless terminal 300 can be further configured to provide access to the Internet through the wireless LAN. The wireless terminal 300 connects to the Internet wirelessly via Ethernet connection, PLC connection, or using Wi-Fi, Li-Fi, or mobile communication protocols such as GSM, CDMA, EDGE, GPRS, HSPA, WiMAX, LTE, etc.

[0085] As shown, the user device 400 can communicate directly with the storage device 100, the injection device 10, and the digital sharp object collection container 3 using Bluetooth, Zigbee, or another suitable peer-to-peer protocol. Alternatively, the user device 400 may communicate only with the storage device 100. The injection device 10 can exchange information with the storage device 100, which is then pushed or otherwise synchronized with an application on the user device 400. In some other embodiments, the user device 400 communicates with the storage device 100 only via the wireless terminal 300. The digital sharp object collection container 3 can communicate only via the wireless terminal 300, thereby exchanging information received by reading the injection device 10.

[0086] In some other embodiments, the injection device 10 may have a similar level of functionality to the storage device 100. For example, each injection device 10 may be programmed with a countdown indicating the number of days remaining before it is used for injection. Each injection device 10 may also monitor its temperature and report it to the user device 400. The injection device 10 may also be configured to report when it was used.

[0087] As described above, the user device 400 can run applications that enable it to read information from the storage device 100, the digital sharp object collection container 3, and the injection device 10, and to exchange information with them. For example, the user device 400 can transmit and receive a first set of signals to and from the storage device representing data associated with a particular injection device stored (or to be stored) in the storage device, and a second set of signals to and from the digital sharp object collection container representing data associated with a particular injection device to be discarded in the sharp object collection container. Many of the calibrations of the storage device 100 described above can be performed by applications on the user device 400 so that the user device functions as a primary control and alarm means for the system 600.

[0088] For example, the storage device 100 may have a sensor that determines whether an injection device is present in each of the openings, but may not have any further information about the injection devices 10. Instead, a user device 400 is used to scan each injection device 10 before it is placed inside the storage device. This can be done by scanning or photographing a label provided on the body of the injection device 10. In some other embodiments, the information is stored in an RFID tag or the like, which is queried by the user device 400. The user device 400 determines at least the type and amount of medication in the injection device 10, as well as any expiration date. The information contained in the label or RFID tag may also include the device ID, device type, dosing period, and warm-up period of the injection device 10.

[0089] Once information is obtained from the injection device 10, the user device 400 then monitors the time until the next scheduled injection. At a specific, customizable time interval until the next scheduled injection, the user device 400 can remind the user using visual and / or audible alarms. If the injection device 10 has reached its expiration date, this can also be communicated to the user via the user device 400.

[0090] The user device 400 can also be used to scan each injection device 10 as it is taken out of the storage device 100 for use. This allows the user device 400 to remind the user if the injection device 10 must be left at room temperature for a minimum amount of time to warm up before use, and to alert the user when that time has elapsed. The minimum time can be based, for example, on local temperature (e.g., storage device 100 temperature or injection device 10 temperature) and the operating temperature of the injection device 10 or the medication (e.g., room temperature). Scanning the injection device 10 as it is taken out of the storage device 100 can also serve as a determination that the injection device 10 has been used, allowing the user device 400 to track the user's medication history and monitor compliance with the medication plan. The user device 400 can display an interface that prompts the user to confirm that the scanned injection device 10 has been used.

[0091] The storage device 100 has openings for multiple injection devices 10. If the user device 400 is used to scan each injection device before it is stored and when it is in use, the user device can also be used to track the number and type of injection devices to be stored, and thus the user's current supply of injection devices. The user device 400 can display a reminder when the user needs more injection devices 10, for example when only one injection device remains, or a certain time before the last injection device is scheduled to be used.

[0092] In some other embodiments, the storage device 100 is capable of determining the ID of at least each opening of the injection device 10. This allows the user device 400 to communicate to the storage device 100 which of the stored injection devices 10 should be used at any given time. For example, if the storage device 100 stores several identical injection devices 10, at the time of injection, the user device 400 can indicate that the injection device 10 with the nearest expiration date should be used. If properly equipped, the storage device 100 can indicate which injection device 10 the user should use by illuminating the opening containing the injection device 10. Alternatively, or in addition, the user device 400 can visually indicate which opening contains the injection device 10 to be used, using text or audio cues, or using a representation on the storage device 100. In some situations, the user must use two injection devices 10 for administration, for example, at the start of a treatment program. In other cases, the storage device 100 can be used to store two different types of medications that the user will inoculate. In these cases, it is important that the stored injection devices 10 can be distinguished and individually shown to the user by the user device 400 and / or storage device 100.

[0093] In some embodiments, the user device 400 is configured to determine where the injection device 10 should be placed within the storage device 100 and to show this information to the user. The user device 400 is configured to scan the first injection device 10 using a camera, RFID reader, or other appropriate hardware to determine at least one of the drug dose contained in the injection device and the device's expiration date. The user device 400 then determines which of the openings in the storage device 100 should be used to store this injection device. By default, the user device may select the leftmost empty opening, but in some situations, for example, where the user is prescribed two different medications or two different doses of the same medication, the user device may determine that the rightmost empty opening should be used. The user device 400 may also attempt to have the injection devices stored from left to right in order of expiration date. This process can then be repeated until all the injection devices received by the user are stored.

[0094] The user device can display a representation of the storage device, particularly the openings of the storage device. After scanning an injection device, the user device can display this representation and indicate which opening the injection device should be placed in. This can be done by illuminating each opening on the representation, displaying text with appropriate commands and arrows pointing to each opening, or a combination of these. The user device can also emit an audible tone or command regarding the placement of the injection device. When the injection device is placed in the correct opening (i.e., the opening where a particular injection device should be located), the user device can display a confirmation message. If the injection device is placed in the wrong opening, the user device can display a message indicating this and prompt the user to move the injection device to the correct opening. However, if all openings are identical and the user does not follow this prompt for correct placement, the user device can update the information it holds regarding the location where each injection device is stored accordingly.

[0095] Next, at the time when the injection is scheduled, the user device 400 may again indicate to the user which opening contains the injection device 10 from which the injection should be used, by indicating this on the representation of the storage device and / or using an audible command. If the storage device is configured to receive and interpret such a command, the user device may also send a signal to the storage device to indicate, for example, by illuminating the opening, which opening the injection device should be taken from.

[0096] The storage device 100 detects when an injection device is placed in or removed from an opening. The storage device 100 may also have a wireless transceiver and be configured to send a signal to the user device 400 indicating which of the multiple openings the injection device was placed in and from which it was removed. If the storage device's sensors can determine a particular type of injection device, this information is also transmitted as a signal. The user device receives this signal and checks whether the injection device was placed in or removed from the correct opening. If the injection device was removed from the correct opening, the user device may output a confirmation message. If the injection device was removed from the wrong opening, the user device may output an alarm. For example, if there are several stored injection devices, all containing the same dose of medication, it may not matter which injection device is used. In such situations, the user device may output an alarm, but if the alarm is ignored, no further action is taken. If the user repositions the injection device to the opening from which it was removed and then removes the injection device from the correct opening, the alarm is canceled. If the user does not replace the incorrect injection device, the user device may continue to output an alarm, for example, on the display or audibly. If the user continues to ignore the alarm, the user device may determine that the wrong drug or incorrect dosage has been administered and may send an alarm message to the user's healthcare professional or the user's patient support program. In this way, the risk of misadministration can be reduced.

[0097] If a storage device contains several injection devices that are identical in that they contain the same dose of the same medication, the user device can be configured to select the injection device with the earliest expiration date and to indicate the opening containing this injection device on the storage device's representation and / or by sending an indication to the storage device. In this way, the possibility of medication expiring and going to waste is reduced.

[0098] In some situations, for example, when a user is administering a first dose of a prescribed medication, or when different doses of medication must be administered, the user may be required to use two or more injection devices. In this situation, the user may not be familiar with the procedure, and therefore it may be important to guide the user. A user device can be configured to indicate two or more openings of a storage device containing different injection devices. The user device can distinguish between two or more openings using a representation of the storage device and / or by signaling to the storage device. The storage device can then illuminate the openings accordingly, for example, by illuminating only the opening containing the first injection device to be used, or by illuminating two or more openings in different colors and / or by flashing the opening of the first injection device to be used. Similar illumination can be used on the representation displayed on the user device using descriptive text and / or audible instructions.

[0099] In addition, the user device 400 can remind or prompt the user to confirm that the appropriate injection device 10 has been selected from one or more openings. For example, the user device 400 can remind the user to confirm the expiration date, dosage, drug type, etc. For example, treatment may require a high priming dose of the drug followed by a regular, lower maintenance dose. Such treatment can be achieved using two or more injection devices: one for the priming dose and a smaller injection device for the maintenance dose. In particular, two injection devices can be used for a priming dose that is twice the maintenance dose, thereby achieving the maintenance dose with a single injection device. Alternatively, a single injection device may contain twice the dose of the drug required for the maintenance dose. Here, the user device 400 can instruct the user to use this single injection device for the priming dose, and then use the other, lower-dose injection device for the regular maintenance dose. As described above, storing or using injection devices containing different doses of the drug may require additional verification steps to ensure that the user is using the appropriate injection device. Such information may also be stored and / or transmitted to third parties to improve patient compliance with specific medication schedules.

[0100] In some embodiments, the user device 400 can request the user to scan the injection device 10 after it has been used. This enables improved user compliance monitoring and medication plan tracking. The user device 400 can also communicate with the digital sharps collection container 3. In some embodiments, the digital sharps collection container 3 can be configured to detect when the injection device 10 is placed inside, but not to detect further details of the injection device. The digital sharps collection container 3 can communicate the detection to the user device 400. The user device 400 can then check whether any injection device has been recently scanned after being removed from the storage device and link the discard in the digital sharps collection container 3 to the scanned injection device. Alternatively, the user device 400 can request the user to verify that the injection device recently discarded in the digital sharps collection container 3 is the recently scanned injection device 10.

[0101] In some other embodiments, the digital sharp object collection container 3 is capable of scanning a placed injection device 10 to determine at least its ID and communicating this ID to the user device 400. The digital sharp object collection container 3 can scan a placed injection device by querying an RFID tag on the injection device or by obtaining an image of a label on the injection device. This allows the user device 400 to link disposal in the digital sharp object collection container 3 with the scanned injection device 10 without requiring user confirmation. The user device 400 can be configured to indicate that the scanned injection device 10 has been used, even if it is scanned only after the injection device 10 has been removed from the storage device 100 and not after use.

[0102] The user device 400 may also be further configured to calculate the user's personal compliance score based on the scan of the injection device 10 and / or data received from the digital sharp object collection container 3. This personal compliance score can be displayed to the user periodically or as needed. The user device 400 may also indicate whether the user is on schedule with respect to the medication. If the user is not on schedule, the user device may display an alarm. The user device may also be configured to generate an injection device usage report based on signals exchanged between the user device and the storage device and / or signals exchanged between the user device and the digital sharp object collection container. The injection device usage report may include information on when and how each injection device was used and discarded, as well as the personal compliance score described above.

[0103] When used herein, the term “user device 400 identifies (determines)” includes the user device scanning and recording information from the injection device 10, or receiving information from the storage device 100, the digital sharp object collection container 3, or other system components. Where it is stated that user device 400 “verifies” certain information or statements (such as whether the injection device 10 is suitable for storage in the storage device 100), this includes the user providing user device 400 with some confirmation that the relevant information is correct. For example, user device 400 may display information that has been scanned or otherwise received and ask the user to check it against what the user knows or can see. If the user responds affirmatively, user device 400 “verifies” the accuracy of the information. In some other situations, user device 400 may “verify” the accuracy of information it scans or receives by checking it against information it already holds. For example, after reminding the user to use a particular injection device, the user device may be used to scan the injection device. Next, the user device can verify that it is the correct injection device by checking the ID of the scanned injection device against the stored information (in this case, the identity of the injection device that the user was reminded to use).

[0104] User device configuration and functionality Figure 3 schematically shows user device 400 according to several embodiments. User device 400 can be a mobile phone. User device 400 is an example of a wireless communication device. User device may also be referred to as a communication device, computing device or mobile device, and is not necessarily associated with a single user. User device 400 is configured to communicate wirelessly using a wireless communication protocol. For example, the first external device can communicate wirelessly using Wi-Fi, Bluetooth, ZigBee, IrDA, etc.

[0105] The user device 400 can be operated, for example, by a patient. According to an exemplary mode of operation, the user device 400 can be placed in close proximity to the storage device 100. For example, the user device 400 can be carried or held by a patient.

[0106] The user device 400 includes a processor 402, memory 404, a wireless transceiver 406, a user input 408, a display 412, a camera 410, a microphone 416, an RFID reader 418, and a speaker 414. In some embodiments, the user device 400 is a smartphone or a tablet computer. The processor 402 can be, for example, a microprocessor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), etc. The display can be a touch-sensitive display and can be based on dose-sensitive or resistive-sensitive technology.

[0107] Memory 404 may include both program memory for storing program code (e.g., software or firmware) and main memory for storing data. The processor 402 is configured to execute the program code stored in program memory and to read, write, and delete data from main memory. In some embodiments, the program code may be an application that can be downloaded and installed on a user device 400. The application provides connectivity with the storage device 100. The application may also be a disease management and tracking tool for patient use. The program memory may be, for example, read-only memory (ROM), and the main memory may be, for example, random access memory (RAM).

[0108] The user device 400 can communicate via the wireless transceiver 406 by using WLAN, Bluetooth, or any other suitable wireless protocol. The user device 400 may include multiple network interfaces, any of which can be used to exchange data with the storage device 100, the injection device 10, the digital sharp object collection container 3, or any combination thereof.

[0109] The user device 400 includes one or more user inputs 408, such as a touchscreen, keypad or keyboard, accelerator or gyroscope, mouse, or microphone 416 for receiving voice commands. The user device 400 may also include a camera 410 configured to capture images of the user, visible labels, codes, etc., on the injection device 10. The user device may be configured to scan the injection device using a scanning device. The scanning device may refer to the camera 410 or an RFID reader 418. When used in relation to the user device 400, the term “scan” may refer to the use of any of these components to read information provided to the injection device 10.

[0110] During operation, the user device 400 connects to the storage device 100, the injection device 10, the digital sharp object collection container 3, or any combination thereof, via the storage device's wireless communication module 260 using a wireless transceiver 406. In some embodiments, this connection uses the Bluetooth protocol to form direct pairing between the two devices. Pairing can be initiated by the user device 400 at any time. In addition, the storage device 100 may attempt to initiate Bluetooth pairing when it detects that the refrigerator door is open or when a dedicated button on the storage device 100 is pressed. In some other embodiments, the connection between the user device 400 and the storage device 100, the injection device 10, the digital sharp object collection container 3, or any combination thereof, uses a WiFi connection via a wireless terminal 300.

[0111] The connection between the user device 400 and the storage device 100 allows operational information to be set on the storage device 100 or via an application on the user device 400 and synchronized between the two devices.

[0112] When connected, the storage device 100 can be configured to periodically transmit information to the user device 400, and the user device can push certain information to the storage device 100. The storage device 100 transmits countdown information indicating the number of days remaining until the next scheduled injection. The storage device 100 also transmits temperature information and battery level information. If equipped with appropriate sensors, the storage device 100 can also transmit information indicating the number of drug injection devices remaining in the storage device 100. The user device 400 receives this information and stores it in memory 404. The user device 400 can transmit certain information to overwrite the information stored in the storage device 100, such as the current time and date, the number of days remaining until the next scheduled injection, the injection interval, and the number of drug injection devices stored in the storage device 100. The operational information described above, when enabled, can be pushed to or from the injection device 10 and / or the digital sharp object collection container 3 so that all connected devices have the latest information.

[0113] When a user opens an application on the user device 400, a homepage is displayed on the display 412. The homepage can display the number of days remaining until the next scheduled injection. If the user determines that the displayed number of days remaining until the next scheduled injection is inaccurate, they can enter a countdown reset command using user input 408. Even if the displayed number of days remaining until the next scheduled injection is correct, the user can reset the counter on the storage device using the application instead of the reset switch 215. In response to receiving a countdown reset command, the user device 400 sends the countdown reset command to the storage device 100. Upon receiving the countdown reset command, the storage device 100 overwrites the information it stores indicating the number of days remaining until the next scheduled injection, resetting the value to a predetermined initial value.

[0114] The user device can also receive a reset notification from the storage device 100 when the user presses the reset switch. In response, the user device 400 resets the number of days remaining until the next injection is scheduled to a predetermined initial value on the user device. In this way, the user can continue to use the reset switch 215 on the storage device 100 if desired, but an application on the user device can overwrite the information on the storage device 100 if it determines that the information is incorrect. Whenever the user device 400 receives a reset notification from the storage device 100 or a countdown reset command is received via user input 408, a reset timestamp is created and stored in memory 404. The timestamp includes the exact date and time the reset occurred.

[0115] In some other embodiments, the user can adjust the number of days remaining until the next scheduled injection. The updated value can then be stored on the user device 400 and communicated to the storage device 100. The range over which the user can adjust the number of days remaining until the next scheduled injection can be limited by the injection interval, for example, ±14 days.

[0116] The application's homepage can, in some cases, also display the number of drug injection devices remaining in storage device 100. Using user input 408, the user can manually enter the number of drug injection devices remaining in storage device 100. This information is, in some cases, sent to storage device 100. The application can also decrease the recorded number of drug injection devices remaining in storage device 100 by one.

[0117] The application's homepage can display the local temperature, for example, the current temperature of the storage device 100, based on temperature information transmitted by the storage device. The user can use the application to set upper and / or lower threshold temperatures that the storage device 100 should not exceed. If the temperature reported to the user device by the storage device 100 exceeds the threshold, the application is configured to sound an alarm. The alarm can be visually displayed on the display 412 and / or audibly emitted via the speaker 414.

[0118] The injection interval (scheduled time between injections) can be predetermined as 14 days. The storage device 100 can be pre-programmed with this interval. However, the user may be prescribed a different interval, such as 21 days or 28 days. The application allows the user to manually adjust the injection interval. Upon receiving a manual adjustment of the injection interval, the user device 400 pushes the updated injection interval to the storage device 100, which is then stored as a new predetermined initial value. When the application determines that only one day remains until the next scheduled injection, a reminder is displayed on the display 412. On the scheduled injection date, a further reminder is displayed, and an audible alarm can also be emitted by the speaker 414. The user can set the date on which the reminders / alarms are activated.

[0119] When the application determines that only one drug injection device remains in the storage device 100 after a countdown reset, the application displays a reorder reminder on the display 412. The reminder can also be displayed when only two drug injection devices remain. When the battery level of the storage device 100, reported to the user device 400 by the storage device 100, drops below a predetermined threshold, the application causes the user device 400 to emit a visual and / or audible alert.

[0120] In addition to connectivity and data exchange with storage device 100, the application can also function as a disease management and tracking tool. The application can enable users to track the progression and symptoms of skin conditions such as atopic dermatitis. The application can enable users to record the occurrence and severity of symptoms such as skin flare-ups, itching, insomnia, and stress. Users can use the application to input information about symptom flare-ups and / or record the severity of symptoms regularly, for example, once a week. The application provides feedback on anonymized usage information, enabling the evaluation of key performance indicators (KPIs) of the application. By correlating information from multiple user devices running the application, the application developer or provider can determine one or more of the following: download count, number of initiated registrations, number of completed registrations, average session length, average session frequency, average session interval, number of screens / journeys per session, most used features, number of active users per week, number of active users per month, and measures of compliance improvement compared to baseline levels.

[0121] In addition to providing connectivity with the storage device 100, the application on the user device 400 allows the user to monitor the progression of their disease as described in more detail with respect to Figure 3. The application also allows the generation of patient summary reports to be shared with the patient's HCP.

[0122] Referring to Figure 4, a user device 400 is shown displaying an overview screenshot 500. The overview page 500 can be accessed via a soft button from the application's homepage. The overview 500 includes several quick-link soft buttons 502. By selecting any of these buttons, the user can either open a web browser and navigate to a web page containing information, or open a phone application with pre-filled phone numbers on the user device 400.

[0123] Overview page 500 also includes an activity graph 504 that shows the user the reported level of symptoms of atopic dermatitis (or a similar skin condition) over a recent period. The activity graph can be switched between severity, itching, and insomnia. Overview page 500 also displays certain statistics 506 regarding user-reported symptoms, such as the total number of entries recorded, the number of reported flare-ups, the median level of reported flare severity, the median level of reported insomnia, and the median level of reported itching.

[0124] The overview page 500 also displays several icons 508 that can be selected to navigate to various pages of the application. These may include an overview page icon, an injection history page icon, a photo page icon, a new entry page icon (the central icon in Figure 3), and a resource icon. The icon corresponding to the currently viewed page can be highlighted.

[0125] The selection of the history icon can display a more detailed version of the graph shown in activity graph 504. The time period can be adjusted to show entries from, for example, last week, last month, or last year. The history can toggle the display between severity, itching, insomnia, or stress, or it can show traces of two or more of these variables.

[0126] Selecting a new entry icon opens a short questionnaire about flare-ups. For example, the user may be asked to select potential triggers for flare-ups (such as humidity or heat), as well as the level of symptoms such as itching, insomnia, and stress. Each symptom can be recorded as low, medium, or high. The user can then be prompted to take a picture of the flare-up. Alternatively, the application may allow the user to add the image as the first step in recording the flare-up. The application can then ask the user to enter other information about the flare-up, although this information may be optional.

[0127] When a user commands the application to record an image, the application accesses the camera 410 of the user device 400. Once the user takes a photograph, the application presents a body part screen 800, as shown in Figure 5. The body part screen shows a person with defined body area boundaries. The user can then select the body area corresponding to the photograph they just took. The user saves the new entry. The application creates a patient photojournal from the images and other information entered by the user. Each image is stored with its associated timestamp, associated body part, and any entered triggers, symptoms, and severity information.

[0128] The photo icon selection can display an album of all photos taken by the user using the application. The user can filter and sort these photos by body area or by associated symptoms and / or severity. For example, the user can filter photos in a patient's photojournal by showing only photos of the left palm. The application can then display only these images and, if applicable, a timeline showing when the images were taken and / or charts showing when the user entered trigger, symptom, and / or severity data. Alternatively, the patient's photojournal can be automatically grouped according to body parts. The patient's photojournal can also be viewed through a mannequin, as shown in Figure 5. Each body area associated with a photo can be highlighted or colored. The user can then select one of the body part areas on the mannequin and open the associated photo album.

[0129] In another embodiment, the location or associated image of the injection site can be recorded using a body part screen 800 or a similar representation of the whole or partial body, as shown in Figure 5. For example, the patient can record where and when the injection was administered on their body. Such injection location and date information can be stored by the user device 400. This allows for the recording of a history of injection site information.

[0130] In addition to the location of the injection site, the user device 400 can be configured to request and store information related to the injection experience from the patient. This could include, for example, the patient's mood that day, whether the injection was painful, whether the injection device worked properly, and whether the total dose of the medication was delivered.

[0131] The user device 400 can be further configured to acquire and store relevant images of the injection before and after the injection. Such image data can be recorded to track where the injection was administered or any adverse reactions at the injection site. Such tracking of the injection site may be necessary for patients with skin conditions, as the location of existing skin lesions at the desired injection site may not make the site suitable for injection.

[0132] Furthermore, patient compliance can be improved by tracking where the patient injects themselves. For example, if a certain body part is overused for injections, the user device 400 can recommend that a different body part be used. Conversely, if a certain body part is underused for injections, the user device 400 can recommend that the patient use that body part for injections. Such recommendations can help the patient select an appropriate injection site when injections are infrequent. Patients may simply forget where they injected themselves if injections are given once every one, two, or four weeks. In this regard, the application can present a second body part screen 1010, as shown in Figure 10. The second body part screen 1010 shows different potential injection areas on the displayed body. For example, some of these areas on the upper arm may only be shown for injections administered by a caregiver. The most common areas for self-injection are the upper leg and abdomen. The application may indicate which of these areas should be used for the next injection by, for example, highlighting the area, flashing the area, an arrow or leader line appearing with an indication that the area can be used, or any other appropriate method of drawing attention to the suggested body area.

[0133] Images of the injection site or related images of the injection site (including video, with or without audio), or any data relating to which body part was injected, can also be provided to healthcare providers or third parties via the user device 400. Such information can enable healthcare providers to provide better advice to patients. For example, patients with a low body mass index ("BMI") may experience less pain when injected into the abdomen rather than the leg. However, patients with a high BMI may find it easier to operate the injection device on their leg. Furthermore, patients with flare-ups of skin lesions on the abdomen may be advised to operate the injection device on their leg, or to have a caregiver inject the medication into their arm. With the assistance of the user device 400, such customized injection protocols can be developed for each patient, improving the patient experience.

[0134] The application can also prompt the user to complete an assessment of a specific disease activity and its impact on quality of life. Depending on the type of assessment, prompts may appear when each new entry is recorded, or periodically, for example, weekly. These assessments can be optional. For example, the application may prompt the user to complete the PO-SCORAD and / or POEM questionnaires to assess disease activity and the DLQI questionnaire to assess its impact on quality of life. Each of these assessments can generate a score as an output.

[0135] The application can also be used to generate reports. A "Generate Report" button can be placed on the overview screen or on the patient photo journal screen. The report can be viewed by the user and shown to or sent to the user's physician. When the user selects the Generate Report button, a screen can be displayed that allows the user to select what data to include in the report. The application can be configured to generate a historical graph of symptoms (severity, itching, insomnia, etc.), and the user can select one or more of these. By default, the report may have a time range for the current month, but this can be adjusted upon request. Other data that can be included in the report includes the number of recorded entries, the number of reported flare-ups, the most reported inflammation severity, the most reported insomnia level, the most reported stress level, the most reported triggers, and photos from the patient photo journal.

[0136] If the user has completed an assessment of disease activity and / or its impact on quality of life, the report may also include these results. For example, PO-SCORAD or POEM scores can be shown in the report for each week represented in the report, or for each entry within the report, for the selected period as a whole. If the score is calculated for each week represented in the report or for each entry within the report, the score can be shown as a graph of the assessed score against time. Any DLQI scores stored for the reporting period can be displayed in the same way as disease activity scores.

[0137] The selection of resource icons can lead to pages and training modules containing further information about atopic dermatitis. In particular, modules on understanding atopic dermatitis, managing atopic dermatitis, and communicating with the user's healthcare provider can be provided in this section. Each of these modules may consist of several items. Additional educational content can be delivered through the application in the form of short hints displayed on the overview screen and / or regularly provided quizzes. The application enables users to better track the progression of their disease and more easily determine potential triggers for flare-ups. The combination of information collected within the application regarding the timing, severity, and symptoms of flare-ups can also lead to better clinical outcomes when viewed by HCPs, because it provides a much more complete representation than is typically obtained from conversations with patients.

[0138] Figure 6 is a flowchart illustrating the exemplary operation of an application running on a user device according to several embodiments. The process begins in step 50 when the user device 400 receives countdown information from the storage device 100. The countdown information indicates the number of days remaining until the next injection is scheduled. This information can be automatically pushed to the user device 400 by the storage device 100 when the two devices are first connected and / or periodically thereafter. The countdown information is stored in the application.

[0139] The application provides a function that allows the user to overwrite the countdown information received from the storage device 100. In step 52, the application receives a countdown reset command via one or more user inputs from the user device 400. In step 54, the number of days remaining until the next injection is scheduled is reset in the application to a predetermined initial value. This predetermined value can be 14 days, but this itself can be changed via the application. The application also creates a reset timestamp indicating the exact date and time of the reset. This information is stored in the reset history and can be viewed in a chart from the application.

[0140] In step 56, the application sends a countdown reset command, or information derived from the command, to the storage device 100. The application can be configured to automatically send this information in response to the receipt of a countdown reset command.

[0141] In step 58, the storage device 100 receives a countdown reset command and updates the number of days remaining until the next injection is scheduled in memory to a predetermined initial value. [Industrial applicability]

[0142] Figure 9 is a flowchart illustrating an example of user use of an auto-injector. In addition to the functions and configurations described above, various aspects of the system 600 can enable the following uses of the injection device 10 by a patient. The example shown in Figure 9 refers to an auto-injector (AI), but it is understood that one type of injection device 10 can be used. The auto-injector can also be called a “pre-filled pen”.

[0143] First, in step 900, the patient may receive an injection device 10. The injection device 10 may include an auto-injector (AI). The injection device 10 (e.g., an auto-injector) may be received by mail order, delivery service, or pickup from a pharmacy. The package received by the patient may include one or more auto-injectors / injection devices 10. For example, the package may include six injection devices 10 representing a three or six-month supply. A single package of injection devices 10 may also include one or more auto-injectors containing different doses of medication.

[0144] Upon receipt, the patient can scan one or more auto-injectors / injection devices 10 using the user device 400 in step 901. It is also possible that a storage device 100 may have a similar function (step 902). For example, the patient can scan the auto-injector label before loading the auto-injector into the storage device 100. As described above, the injection device 10 may include a QR code, NFC, or a similar label containing various medications, devices, or other information. If the injection device is a visible code, barcode, QR code, etc., it can be captured by the camera 410 of the user device 400. Instead of or in addition to a visible code, the injection device may include an RFID tag that can be read by the RFID reader 418 of the user device 400.

[0145] By scanning with either the user device 400 (step 901) or the storage device 100 (step 902), confirmation can be provided that the correct injection device 10 has been received and properly placed for long-term in-home storage. The user device 400 or the storage device 100 can provide confirmation that is sent to a third party to verify that it has been received and stored correctly. Such signaling from two separate sources can provide further assurance that the patient is complying with the proper receiving and storage instructions.

[0146] In step 903, the user device 400 and / or storage device 100 can determine whether the auto-injector is OK to store or suitable for storage. If the auto-injector is OK to store, in step 904, the user device 400 or storage device 100 can then communicate this information to the database to confirm that the auto-injector is OK to store. This may include, for example, confirming that the patient has received an auto-injector containing medication appropriately prescribed for this particular patient, that the auto-injector contains the correct dose of medication, that the medication is not expired (or will not expire by the time the patient uses the auto-injector), that neither the medication nor the auto-injector has been recalled, that the patient has not been prescribed another medication that may cause adverse reactions to the medication contained in the auto-injector, that the patient's physician has not changed the patient's treatment, or for other reasons. If it is determined in step 903 that the auto-injector is OK to store, the patient can be instructed to place the auto-injector into the storage device 100. If, in step 903, it is determined that the auto-syringe is not suitable for storage, in step 905, the patient may be instructed to dispose of the auto-syringe in the sharp object collection container 3. In step 906, the sharp object collection container detects that it has received a rejected auto-syringe.

[0147] In step 906a, the user device 400 and / or the sharp object collection container 3 can communicate one or more signals individually or cumulatively to confirm and / or reconfirm that the auto-syringe has been properly disposed of. In this step, upon receiving confirmation from the sharp object collection container 3 that the auto-syringe has been properly disposed of, the user device 400 can update the information it stores to reflect that the rejected auto-syringe has been properly disposed of. In addition, the user device 400 can send confirmation messages to the sharp object collection container 3, the storage device 100, or both. The information in the storage device 100 can then be updated to reflect that the rejected auto-syringe has been properly disposed of.

[0148] Next, the system 600 can order a replacement auto-injector for the patient. Then, the user device 400 can provide confirmation to a specific patient. The physician or HCP can also provide further information to a specific patient based on specific details associated with the injection device 10.

[0149] After placing an auto-syringe in the storage device 100 (step 904), the patient may need to place another auto-syringe in the storage device 100. For example, if all of the multiple injection devices 10 in the package require storage, the user can scan for another injection device 10 using either the user device 400 (step 901) or the storage device 100 (step 902).

[0150] After placing one or more auto-injectors in the storage device 100 (step 904), the patient may need to administer the injection themselves after a long waiting period. Typically, administration for chronic diseases can be done weekly, every two weeks, or once a month. Some may be less frequent, and some medication schedules may vary. For example, initially, the patient may need to take the medication every two weeks. Then, after some time, the same patient may need to take the medication every four weeks.

[0151] In long-term treatment, it should be considered that patients may not need to take their medication on a highly regular schedule. For certain chronic diseases, patients may be able to shift their medication forward or backward by one or more days without adverse consequences. For example, a patient may prefer to self-administer their medication over the weekend rather than over the following week. Shifting medication forward by one or more days may not have a significant impact on the patient's treatment. Such changes to the medication schedule may require prior approval from the patient's physician.

[0152] The user device 400 may, in step 907, provide the patient with a reminder to use the auto-injector / injection device 10. For example, the notification may automatically appear on the display 412 of the user device 400 when the reminder time arises. Alternatively, or in addition, the storage device 100 may, in step 908, provide the patient with a reminder to use the auto-injector / injection device 10. This reminder may take the form of an audible alarm emitted by the storage device. This may be accompanied by a visual alarm, such as some or all of the segments of the display 211, or the flashing of some or all of the LED array 220. In some embodiments, the reminder to use the auto-injector / injection device 10 (or an instruction to display the reminder) is generated by the storage device 100 and then transmitted to the user device 400. As described above, the reminder may include audible or visual indicators from one or both devices. Providing multiple reminders from multiple sources can help with compliance, particularly for chronic diseases requiring long-term administration.

[0153] While the injection device 10 is housed in the storage device 100, other information can be transmitted between the user device 400 and the storage device 100. One or both devices 400, 100 can update information associated with the injection device 10. For example, the storage device 100 may be configured to monitor local temperature. If the local temperature falls outside the range for an extended period, the storage device 100 can provide an alarm to the user device 400. The user device 400 can determine that the injection device 10 is still suitable for use if the cold chain of the injection device 10 has failed for a short period. However, if the cold chain has failed for an extended period, the user device 400 can signal the user to discard the injection device 10, as described above. These and other signals associated with the events in step 903 can also be performed while the injection device 10 is housed in the storage device 100.

[0154] Following such reminders provided by steps 907 and / or 908, in step 909, the patient may remove the auto-syringe from the storage device 100. In step 910, the patient may then scan the auto-syringe using the user device 400 as described above. Alternatively, in step 911, the storage device 100 may scan the auto-syringe as it is removed from the refrigeration compartment. In step 912, the user device 400 and / or the storage device 100 may determine whether the auto-syringe is OK to use. These may include the events described above for step 903. If the injection device is OK to use, in step 913, either or both of the devices 100 and 400 may provide a signal to a remote server or database to confirm that the removed auto-syringe is suitable for use. For the same reasons described above, it may not be appropriate for the patient to use the auto-syringe. If inappropriate (step 914), the patient can then discard the rejected auto-syringe in the sharp object collection container 3 in steps 906 and 906a, as described above. Typically, the signals exchanged between the user device and the storage device for a particular injector can be referred to as the first set of signals, and the signals exchanged between the user device and the digital sharp object collection container for a particular injector can be referred to as the second set of signals.

[0155] If a particular auto-injector / injection device 10 is determined to be suitable for use, in step 915, the user device 400 may determine how long the auto-injector should be kept outside the refrigerator until its temperature rises to an acceptable level. The user device 400 may calculate the time based at least in part on the type of auto-injector / injection device 10, the type and volume of medication in the auto-injector, the room temperature, the expected temperature of the auto-injector's location, or other factors. As part of step 915, the time may be provided to the patient through a timing interface. The timing interface may provide an audible signal when the time is up. The user device 400 may also provide the patient with instructions on how to use and / or dispose of the auto-injector. This may include, if necessary, how to remove the cap, how to perform a priming shot, how to attach the needle, how to inject, how to ensure that a complete dose has been injected, and how to safely dispose of the auto-injector.

[0156] In some situations, the patient may decide not to administer the day's dose after the auto-injector has been removed from the refrigerated compartment. For various reasons, the patient may decide to wait for more than one day. Instead of returning the auto-injector to the storage device 100, the patient may leave the auto-injector at room temperature. Such administration may be permitted with the patient's prior approval from their physician, who may be notified before and after.

[0157] If it is determined that the patient wishes to delay the injection, in step 916, the user device 400 may allow the patient to set a separate timer. The second timer may have one or more time limits that restrict the number of days the patient may delay the medication. The desired time delay, physician approval, location of the auto-injector, and other information may be entered or received via the user device 400. If applicable, in step 917, the desired injection delay time may be communicated to the physician for approval.

[0158] In step 918, the patient prepares the auto-syringe for use. After deciding to administer the medication themselves, the patient may use the user device 400 to perform one or more actions (not shown). For example, the patient may use the user device 400 to scan the auto-syringe to indicate one or more events, which may include an approximate injection start time.

[0159] As described above, in step 921, the patient may self-inject a dose of the drug using an auto-injector / injection device 10. In the case of an auto-injector, this may include removing the cap from the auto-injector, positioning the correct end of the auto-injector against the patient's skin at a specific location (for example, often the abdomen or upper thigh), administering the dose of the drug, and then removing the auto-injector once the injection process is complete.

[0160] Once the injection is complete (step 922), the patient may or may not recap the auto-syringe. The patient may also perform another step using the user device 400, for example, scanning the auto-syringe.

[0161] Following the injection in step 922, the patient or a person assisting the patient with the process can input various information into the user device 400. For example, an image of the injection site can be taken, and indications of the injection process, pain ratings, etc., can be recorded. Such information can be associated with timestamps for later analysis.

[0162] In step 923, the patient can then dispose of the auto-syringe / injection device 10. Such disposal may include, in step 925, placing the used auto-syringe in the sharp object collection container 3, which can detect that it has received the used auto-syringe. In step 925a, upon receiving confirmation from the sharp object collection container 3 that the auto-syringe has been properly disposed of, the user device 400 can update its stored information to reflect that the used auto-syringe has been properly disposed of. In addition, the user device 400 can send a confirmation signal to one or more sources within the system 600. Alternatively, in step 924, the user can use the user device 400 to scan the used AI. This information can then be provided by the user device 400 to other sources within the system 600 without the use of the sharp object collection container 3.

[0163] Various parts of the system 600 can be notified when the disposal of the injection device 10 is successful. As described above, compliance is improved and the safe disposal of the auto-injector / injection device 10 is improved by having multiple data provided by multiple devices. In addition, as provided in steps 906a and 925a, the user device 400 can provide confirmation that the disposal of the injection device 10 has been successful.

[0164] In some embodiments, the storage device 100, user device 400, and / or sharp object collection container 3 can provide a signal indicating that another auto-syringe / injection device 10 should be delivered to the patient. Such signaling or ordering can be done each time an injection device 10 is discarded, or after a predetermined number of devices have been discarded. For example, if packages of two, four, or six injection devices 10 are available, the system 600 can reorder only that number of devices after two, four, or six injection devices 10 have been discarded. Various numbers of injection devices 10 are possible in one or more packages.

[0165] The terms “drug” or “pharmaceutical” are used synonymously herein to describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical is used to treat, cure, prevent or diagnose a disease, or otherwise improve physical or mental well-being. Drugs or pharmaceuticals may be used for a limited duration or, in the case of chronic disorders, regularly.

[0166] As described below, drugs or pharmaceuticals may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules, polypeptides, peptides, and proteins with molecular weights of 500 Da or less (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (e.g., 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 intended.

[0167] The drug or pharmaceutical can be contained in a primary package or “drug container” adapted for use with the injection device 10. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide chambers suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chambers may be designed to store drugs for at least one day (e.g., one day to at least 30 days). In some cases, the chambers may be designed to store drugs for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs) one in each chamber individually. In such cases, the two chambers of a dual-chamber cartridge can be configured to allow mixing of two or more components before and / or during administration to a human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and, optionally, to allow mixing of the two components by the user before administration. Alternatively or additionally, the two chambers can be configured to allow mixing of the components at the time of administration to a human or animal body.

[0168] The drugs or agents contained in the injection device 10 described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), anguina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are listed in handbooks such as Rote Liste 2014 (for example, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0169] 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, e.g., human insulin, or human insulin analogs or derivatives; glucagon-like peptides (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors; or pharmaceutically acceptable salts or solvates thereof; or mixtures thereof. As used herein, the terms “analog” and “derivative” refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as the structure of human insulin, by the deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or the addition of at least one amino acid residue. The added and / or replaced amino acid residue may be any of the coding amino acid residues, other naturally occurring residues, or purely synthetic amino acid residues. Insulin analogs are also called “insulin receptor ligands.” In particular, the term “derivative” refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as a polypeptide having the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. In some cases, one or more amino acids present in a naturally occurring peptide are deleted and / or replaced by other amino acids, including non-coding amino acids, or amino acids are added to a naturally occurring peptide, including non-coding ones.

[0170] 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 may be replaced with Asp, Lys, Leu, Val or Ala and Lys at position B29 may be replaced with Pro; Ala(B26) human insulin; Des(B28~B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0171] 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-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB29LysB30 human insulin. These are B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)); B29-N-(N-litocoryl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0172] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of Hiramonster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), and r-exendin -4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexene, Biador-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.

[0173] An example of an oligonucleotide is mipomersen sodium (Kynamro®), a cholesterol-lowering antisense agent used to treat familial hypercholesterolemia.

[0174] Examples of DPP4 inhibitors include vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0175] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0176] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or their derivatives, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0177] As used herein, the term “antibody” refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind to antigens. Antibodies may be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies may have effector function and be complement-immobilized. In some embodiments, antibodies may have reduced or no ability to bind to Fc receptors. For example, antibodies may be isotypes or subtypes, antibody fragments, or mutants that do not support binding to Fc receptors, for example, having mutations or deletions in the Fc receptor-binding region. The term “antibody” also includes antigen-binding molecules based on quadrivalent bispecific tandem immunoglobulins (TBTIs) and / or bivariable-region antibody-like binding proteins (CODVs) with crossover binding region orientation.

[0178] The terms “fragment” or “antibody fragment” refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy chain and / or light chain polypeptides) that do not contain the full-length antibody polypeptide but still contain at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleavage portions of the full-length antibody polypeptide, but the term is not limited to such cleavage fragments. Examples of antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-stranded Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, quadrispecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, quadrivalent and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small module immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0179] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides that primarily mediates specific antigen recognition. The term "framework region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides that is not a CDR sequence and primarily maintains the proper arrangement of the CDR sequence to enable antigen binding. While the framework region itself is typically not directly involved in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody may directly participate in antigen binding or influence the interaction ability of one or more amino acids in the CDR with the antigen.

[0180] Examples of antibodies include anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0181] Any pharmaceutically acceptable salt of any API described herein is intended for use with a drug or pharmaceutical in the injection device 10. Examples of pharmaceutically acceptable salts include acid addition salts and basic salts.

[0182] Those skilled in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the invention, which encompasses such modifications and all their equivalents.

Claims

1. A user device (400) configured to track the use of an injection device (10): Camera (410) and; Processor (402) and; Memory (404) and; Wireless transceiver (406) and; Includes, A camera is used to scan the injection device to determine at least the drugs contained within the injection device; Determine whether the drug contained in the injection device matches the prescribed drug; If the medication contained in the injection device matches the prescribed medication, a notification will be issued indicating that the storage of the injection device has been approved; A wireless transceiver is used to transmit and receive a first set of signals representing data associated with a particular injectable device stored in a storage device (100) configured to house a plurality of unused injectable devices (10); The user device is configured to use a wireless transceiver to transmit and receive a second set of signals representing data associated with a particular injection device discarded in a sharp object collection container (3) which is configured to hold a plurality of used injection devices (10).

2. The user device (400) according to claim 1, further configured to determine whether the dose of drug contained in the injection device matches a prescribed dose.

3. The user device (400) according to claim 1 or 2, further configured to determine whether the drug contained in the injection device has expired.

4. Further including a display (412), where the user device is: Use the display to output a reminder to use the injection device. A user device (400) configured according to any one of claims 1 to 3.

5. The camera is used to scan the injection device and verify whether the medication contained within the device matches the prescribed medication; If the medication contained in the injection device matches the prescribed medication, a notification will be displayed on the screen indicating that the use of the injection device has been approved. The user device (400) according to claim 4, configured as described above.

6. Track the number of injection devices stored in the storage device; When the number of injection devices stored in the storage device falls below a predetermined number, a notification is sent to a third party indicating that additional injection devices are needed. A user device (400) according to any one of claims 1 to 5, further configured as follows.

7. A user device (400) according to any one of claims 1 to 6, further configured to generate an injection device usage report based on a first set of signals and / or a second set of signals.

8. A user device (400) configured to track the use of an injection device (10): Processor (402) and; Memory (404) and; Wireless transceiver (406) and; Includes, A wireless transceiver is used to transmit and receive a first set of signals representing data associated with a particular injectable device stored in a storage device (100) configured to house a plurality of unused injectable devices (10); A wireless transceiver is configured to transmit and receive a second set of signals representing data associated with a particular injection device discarded in a sharp object collection container (3) which is configured to hold a plurality of used injection devices (10), The injection device is stored in the refrigerator, and the user device is: Calculate the time the injection device should remain outside the refrigerator before use; Provide notice of time or expiration date. The user device (400) is further configured as follows.

9. A system (600) for tracking the use of an injection device (10): A user device (400) according to any one of claims 1 to 8; A storage device (100) having a plurality of openings, each opening configured to store an unused injection device over a certain period of time, further comprising a storage device wireless transceiver; A sharp object collection container (3) having an opening and a storage container configured to receive a plurality of used injection devices, further comprising a sharp object collection container wireless transceiver, Including; User device wireless transceiver: The storage device transmits and receives a first set of signals to and from the wireless transceiver; It is configured to transmit and receive a second set of signals to and from a sharp object collection container wireless transceiver; The first and second sets of signals are stored in a storage device and then in a sharp object collection container. The system represents data associated with a specific injection device that is to be discarded.

10. Storage devices: After the injection device is placed in one of several openings, the injection device is scanned; At the very least, determine the ID of the injection device; The system (600) according to claim 9, configured to transmit the ID of an injection device to a user device as part of a first set of signals.

11. The container for collecting sharp objects is After the injection device is placed in the sharp object collection container, the injection device is scanned; At the very least, determine the ID of the injection device; The system (600) according to claim 9 or 10, configured to transmit the ID of an injection device to a user device as part of a second set of signals.

12. The system (600) according to any one of claims 9 to 11, further comprising an injection device, wherein the injection device comprises at least one of a safety system, a pen-type syringe, and an auto-injector.

13. The system (600) according to claim 12, wherein the injection device comprises a drug, the drug comprising an anti-IL-4 antibody or an antigen-binding fragment thereof, which may optionally be a monoclonal antibody or an antigen-binding fragment thereof, or a polyclonal antibody or an antigen-binding fragment thereof.

14. A method for tracking the use of an injection device in a system including a user device (400), a storage device (100) configured to store unused injection devices over a period of time, and a sharp object collection container: A camera is used to scan the injection device to determine at least the drugs contained within the injection device; Determine whether the drug contained in the injection device matches the prescribed drug; If the medication contained in the injection device matches the prescribed medication, a notification will be issued indicating that the storage of the injection device has been approved; Using the user device's wireless transceiver, a first set of signals is transmitted and received between the storage device and the user device; Using the user device's wireless transceiver, a second set of signals is transmitted and received between the user device and the sharp object collection container's wireless transceiver. Includes, The method wherein the first and second sets of signals represent data associated with a particular injection device that is stored in a storage device and subsequently discarded in a sharp object collection container.

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