Assisting device to be attached to injection device

Abstract

To provide an assisting device configured to be releasably attached to an injection device.SOLUTION: An assisting device (200) is configured to be releasably attached to an injection device (10). The assisting device includes at least one radio communication unit (241) and at least one sensor (251). The assisting device starts at least one sensor (251) in response to a fact that the radio communication from an external device is received through at least one radio communication unit (241), detects start of the injection by the injection device (10) using at least one sensor (251) after starting it, and transmits the start of the injection to the external device through at least one radio communication unit (241).SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] This relates to an auxiliary device configured to be releasably attached to an injection device. [Background technology]

[0002] There are a variety of illnesses that require regular treatment by injection of medication. Such injections can be performed by the use of injection devices, which can be administered by medical personnel or by the patient themselves.

[0003] Injection devices (i.e. devices capable of delivering medication from a medicine container) aim to make it easier for patients to self-administer injected treatments. Current treatments delivered by self-administered injections include drugs for diabetes (both insulin and the new GLP-1 class of drugs), drugs for migraines, allergies, hormone therapy, blood thinners, etc. Injection devices can be used to deliver single doses of certain life-saving drugs. For example, they are often prescribed for people at risk of anaphylaxis. They are also often used by the military to protect personnel from chemical warfare agents. Alternatively, injection devices are used to administer medications according to a prescribed treatment schedule, for example to people with multiple sclerosis, rheumatoid arthritis, or anemia.

[0004] Injection devices can be disposable or single-use devices that can only be used to deliver a single dose of medication and need to be disposed of after use. Other types of injection devices are reusable. They are usually arranged so that the user can attach and detach a standard syringe. Reusable injection devices can be used to perform multiple parenteral drug deliveries, but the syringe is disposed of after it is consumed and removed from the injection device. The syringe can be packaged with additional parts to provide additional functionality. In a typical scenario, an illness can be self-treated by the patient by injecting a drug dose with the injection device, for example, daily, weekly, biweekly, or monthly.

[0005] Injection devices typically fall into two categories: manual devices and automatic injection devices. In manual devices, the user must provide mechanical energy to drive the fluid through the needle. This is usually accomplished by some form of button / plunger that the user must press continuously during the injection.

[0006] An automatic injection device is a device that completely or partially replaces the actions involved in parenteral drug delivery from a standard syringe. These actions include inserting a needle into the patient's skin, injecting the medication, removing the needle, shielding the needle, and preventing reuse of the device. Automatic injection devices can: reduce the user's required force, gripping problems, and the possibility of delivering an incomplete dose. Triggering can be accomplished by a number of means, such as, for example, a trigger button, or the action that the needle has reached its injection depth. In some devices, the energy to deliver the fluid is provided by a spring.

[0007] Needle-free injection devices have been developed that deliver medication using needle-free injection techniques. Such systems deliver medication through the skin using mechanisms that do not involve piercing the skin with a cannula.

[0008] It is desirable to measure information about the status and / or usage of the injection device in order to prevent mishandling of the injection device or to keep track of usage data. Reusable, add-on devices are known that are suitable for use with a syringe and monitor the dose delivered by the syringe (and provide other information to the user). It is described, for example, in US Pat. No. 5,399,363 to provide an auxiliary device that includes a mating unit for releasably attaching the device to the injection device. The device includes a camera and is configured to perform optical character recognition (OCR) on a captured image visible through a dose window of the injection pen, thereby determining the dose of medication that is dialed into the injection device. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] WO2011 / 117212 Summary of the Invention [Problem to be solved by the invention]

[0010] There is a need for improved add-on devices that can determine and communicate usage information associated with an injection device. There is a need for methods for minimizing power consumption of such add-on devices. [Means for solving the problem]

[0011] An auxiliary device 200 is provided for attachment to the injection device 10 that is capable of determining and communicating usage information associated with the injection device 10 to an external device 1000. The auxiliary device 200 is particularly advantageous when used with a disposable injection device because it can record and store data separately from an injection device that is to be disposed of, and can combine usage data from multiple disposable devices for one user.

[0012] According to aspects of the present disclosure, there is provided an auxiliary device configured to be releasably attached to an injection device, the auxiliary device including: at least one wireless communication unit; and at least one sensor; where the auxiliary device is configured to: activate the at least one sensor in response to receiving a wireless communication from an external device via the at least one wireless communication unit; following activation, detect the initiation of an injection by the injection device using the at least one sensor; and communicate the initiation of the injection to the external device via the at least one wireless communication unit.

[0013] The auxiliary device can include an extension and the at least one sensor can be located on the extension. The extension can be a flexible printed circuit board.

[0014] The auxiliary device may be configured to indicate that the start of an injection by the injection device has not been detected.

[0015] The auxiliary device may be configured to indicate that a start of an injection by the injection device has been detected, and that an end of an injection by the injection device has not been detected.

[0016] The auxiliary device may be configured to indicate that the start of an injection by the injection device has been detected, and that the end of an injection by the injection device has not been detected within a predetermined time of the start of the injection.

[0017] The auxiliary device may be configured to indicate whether or not communication to the external device was successful. can be done.

[0018] The auxiliary device may further include a temperature sensor.

[0019] The auxiliary device may be configured to indicate whether a medication contained in the injection device meets predetermined temperature parameters.

[0020] The auxiliary device may be configured to initiate a timer in response to determining that the medication contained in the injection device does not meet predetermined temperature parameters, and may provide an indication when the timer has expired.

[0021] According to an aspect of the present disclosure, there is provided a system including any auxiliary device as defined herein and an injection device, where the auxiliary device is releasably attached to the injection device.

[0022] The injection device may be a disposable auto-injector.

[0023] The auxiliary device may include a housing formed such that when attached to the injection device, the housing of the auxiliary device is flush with the housing of the injection device.

[0024] The system is of uniform width but has a longitudinal length greater than that of the injection device.

[0025] The auxiliary device may be configured to be mounted within a recess located at the distal end of the injection device. [Brief description of the drawings]

[0026] [Figure 1A] FIG. 2 is a side view of the injection device. [Figure 1B] FIG. 1B is a side view of the injection device of FIG. 1A with the cap removed. [Figure 2A] 1 is a schematic diagram of an embodiment of an auxiliary device. [Figure 2B] 1 shows an injection device with the cap removed, an injection device in the process of attaching an auxiliary device, and an injection device with the auxiliary device attached. FIG. [Diagram 3] FIG. 13 shows the internal components of an embodiment of an auxiliary device that is attached to an injection device. [Figure 4]1 illustrates communication between an auxiliary device, an injection device, and an embodiment of an external device. [Figure 5A] 13A-13C show an embodiment of an auxiliary device including a conductive rubber pad. [Figure 5B] 13A-13C show an embodiment of an auxiliary device including a conductive rubber pad in use with an injection device to detect the start of an injection procedure. [Figure 5C] 13A-13C show an embodiment of an auxiliary device including a conductive rubber pad in use with an injection device to detect the start of an injection procedure. [Figure 6A] 13A-13C show an embodiment of an auxiliary device including a microswitch prior to an injection procedure. [Figure 6B] 13A-13D show an embodiment of an auxiliary device including a microswitch during an injection procedure. [Figure 6C] 13A-13D show an embodiment of an auxiliary device including a microswitch at the end of an injection procedure. [Figure 7A] 13A-13D show an embodiment of an auxiliary device including an optical reflective sensor prior to an injection procedure. [Figure 7B] 13A-13D show an embodiment of an auxiliary device including an optical reflective sensor during an injection procedure. [Figure 7C] 13A-13D show an embodiment of an auxiliary device including an optical reflective sensor at the end of an injection procedure. [Figure 8] 4 is a flow diagram illustrating operations performed by an embodiment of an auxiliary device with respect to temperature measurement. [Figure 9] 4 is a flow diagram illustrating operations performed by an embodiment of an auxiliary device with respect to temperature measurement. [Figure 10] 4 is a flow diagram illustrating operations performed by an embodiment of an auxiliary device with respect to temperature measurement. [Figure 11] 11 is a flow diagram illustrating operations performed by an embodiment of an auxiliary device with respect to determining the start and end of an injection procedure and transferring data related to this determination to an external device. [Figure 12]11 is a flow diagram illustrating operations performed by an embodiment of an auxiliary device with respect to determining medication-related information. [Figure 13] 13A-13C show embodiments of an auxiliary device that include an extension configured to sit within a recess or cavity of an injection device when the auxiliary device is attached to the injection device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] In the following, embodiments are described with reference to a pen injector, however, the present disclosure is not limited to such applications and can be equally well deployed with other types of drug delivery devices, such as syringes, prefilled syringes, needleless injectors, and inhalers.

[0028] An injection device 10 (also referred to herein as drug delivery device 10) according to embodiments will now be described with reference to FIGS. 1A and 1B. In some embodiments, the injection device 10 is a single-use injection device 10, such as an auto-injector. In some other embodiments, the injection device 10 is a reusable injection device, or an injection device that can be used to inject several doses before being discarded. The injection device 10 has a proximal end P and a distal end D. The proximal end P faces towards the injection site of the patient during injection, while the distal end D faces away from the injection site.

[0029] Injection device 10 includes a body 9 and a cap 12 (also referred to herein as an outer needle cap 12 or ONC 12). Body 9 includes an outer housing 11. Outer housing 11 is an elongated tube. Outer housing 11 includes a cartridge or syringe holder (not shown) that supports a cartridge or syringe 18 containing a liquid medicament 16. Hereinafter, the description will refer to cartridge 18 being supported by the cartridge holder (not shown). Cartridge 18 is shown in dashed lines in FIG. 1B and can be located below a window 15 in housing 11.

[0030] The outer housing 11 also houses a dispensing mechanism (not shown) that causes the medication 16 to be dispensed during injection.

[0031] A hollow needle 17 communicates with the interior volume of the cartridge 18 and acts as a conduit for the liquid medicament 16 during injection. The needle 17 and cartridge 18 are in fixed positions relative to each other and to the body 9. A stopper, plunger, piston or bung 14 is movable within the cartridge 18 to expel the medicament contained within the cartridge 18 through the needle 17 under operation of a dispensing mechanism.

[0032] The dispensing mechanism is mechanically coupled to the piston 14 of the cartridge 18. The dispensing mechanism is configured to move the piston axially proximally along the cartridge 18 to dispense the medicament 16 through the needle 17. The dispensing mechanism includes components that cooperate to apply a force to the piston 14 in response to an actuation input provided by a user, where the actuation input that triggers the application of the force to the piston 14 is received by a dose dispensing button 13 located at the distal end of the injection device 10. The dispensing mechanism is mechanically coupled to the dose dispensing button 13.

[0033] A label is provided on the housing 11. The label includes information 100 about the medication contained in the injection device 10, including information identifying the medication. The information 100 identifying the medication can be in the form of text. The information 100 identifying the medication can also be in the form of color. The information 100 identifying the medication can also be coded into a bar code, a QR code, or the like. The information 100 identifying the medication can also be in the form of a black and white pattern, a color pattern, or shading.

[0034] FIG. 2a is a schematic diagram of an embodiment of an auxiliary device 200 for releasably attaching to the injection device 10 of FIG. 1. FIG. 2b shows the injection device before, during and after attachment to an embodiment of the auxiliary device 200. The auxiliary device 200 is suitable for use with the injection devices shown in FIGS. 1A and 1B, as well as other types of injection devices discussed above. The auxiliary device 200 can be for use with injection devices, including both reusable and disposable injection devices. The auxiliary device 200 can also be suitable for use with manual injectors and auto-injectors. In a particular embodiment, the auxiliary device 200 can be for use with a disposable pen-type auto-injector.

[0035] The auxiliary device 200 can be attached to the injection device 10. For example, the auxiliary device 200 can include a means 210 for attachment to the injection device, or the injection device can include a means for attachment to the auxiliary device 200. The auxiliary device 200 can include a means 210 configured for attachment to a part of the injection device configured for attachment of the auxiliary device 200. The injection device 10 and the auxiliary device 200 can optionally include cooperating alignment features to ensure that the auxiliary device 200 is correctly oriented and positioned with respect to the injection device 10. In an illustrative example, the auxiliary device 200 can include a hook 211 and the injection device can include a recess 31, where the hook 211 of the auxiliary device 200 is configured to be able to snap into position and thus hold the auxiliary device 200 on the injection device. Other attachment means can include: an adhesive surface, a magnetic component, a clip, a threaded component, or any suitable means.

[0036] The injection device may include a cap 30 that sits at, on, or over the attachment location of the auxiliary device 200. The cap 30 may, for example, include hooks similar to those of the auxiliary device 200 and may be attached in a similar manner. The cap 30 may be a removable cap that may be removed prior to attachment of the auxiliary device 200.

[0037] The attachment means 210 may provide a predetermined orientation, position or alignment of the auxiliary device 200 relative to the injection device 10 when attached. The predetermined orientation, position or alignment is such that any structure, such as a sensor, is located in the correct location for its operation. For example, the auxiliary device 200 may include a hook 211 that engages with a recess 31 on the injection device 10, the hook 211 and the recess 31 being , the auxiliary device 200 can be configured such that it can only be attached so as to enable correct functioning of the device, e.g., to allow any sensors to be positioned in an optimal location for detection. The auxiliary device 200 can be attached to any part of the injection device 10, so long as its attachment does not interfere with the operation of the injection device 10. For example, the injection device 10 can be an auto-injector and the auxiliary device 200 can be attached to the distal end of the auto-injector.

[0038] The auxiliary device 200 includes a housing 220. The housing 220 can provide an outer covering for at least a portion of the auxiliary device 200.

[0039] Optionally, the housing 220 of the auxiliary device 200 is formed such that when attached to the distal end of the injection device 10, the housing 220 of the auxiliary device 200 is flush with the housing of the injection device 10, as shown in FIG. 2b. Attaching the auxiliary device 200 to the injection device 10 thus results in an assembly of uniform width, but longer in length than the injection device 10 alone. To achieve this effect, the auxiliary device 200 can be formed to have the same width or diameter as the transverse width or diameter of the injection device 10. Alternatively, or in addition, the housing 220 of the auxiliary device 200 can be configured such that when attached to the distal end of the injection device 10, the auxiliary device housing 220 is parallel to and at the same height as the injection device housing 11. The auxiliary device housing 220 can have edges configured such that at least a portion of the edge of the auxiliary device housing 220 contacts and matches at least a portion of the edge of the injection device housing 11 when attached to the injection device 10. In certain embodiments, the entire edge of the auxiliary device housing 220 is configured to contact and mate with the entire edge of the injection device housing 11 when the auxiliary device 200 is attached to the injection device 10.

[0040] Alternatively, the auxiliary device 200 can be attached to the distal end of the injection device 10 and configured to be wider than the injection device 10, such that the resulting assembly is an injection device with a wider distal end.

[0041] The auxiliary device 200 can be formed such that when attached to the injection device 10, at least a portion of the auxiliary device 200 extends into the injection device 10 (see FIG. 13A). This allows, for example, the positioning of a sensor or component in a location that allows the determination of information for the injection device 10. The portion of the auxiliary device 200 that extends into the injection device 10 can be, for example, a flexible or rigid extension 280, such as a flexible printed circuit board (PCB) extension. The flexible or rigid extension 280 can be configured such that when the auxiliary device 200 is attached to the injection device 10, the flexible or rigid extension 280 is located in a recess or cavity of the injection device 10 (FIG. 13B or FIG. 13C). This cavity or recess can be arranged to be covered by the removable cap 30 when said cap is attached to the injection device 10. The flexible or rigid extension 280 may have sensors, such as, for example, a sensor 250 for detecting the start and end of an injection, a conductive rubber pad 260, a microswitch 261, a light reflection sensor 263, a light sensor 254, or a temperature sensor 255, as discussed herein, located on the extension 280 so as to perform their role (e.g., detecting movement of a part of the injection device 10) when the auxiliary device 200 is attached to the injection device 10.

[0042] In some embodiments, the auxiliary device 200 is attached to the distal end of the injection device 10 but is configured so that it does not extend beyond the housing 11 of the injection device 10. In this situation, the injection device 10 is configured so that, for example, when attached, the auxiliary device 200 The auxiliary device 200 may have a recess located under the removable cap 30 that is disposed within the auxiliary device 200. Any components of the injection device 10 that need to be exposed during use, such as the visual indicator 231, may be located on a surface of the auxiliary device 200 that is still exposed when attached, and thus this surface essentially forms the distal end of the injection device 10. In some embodiments, the auxiliary device 200 has a teardrop-shaped cross-section, which may include a flexible or rigid extension 280 as discussed herein (FIG. 13C). For example, the extension 280 may be a flexible PCB that is positioned relative to the auxiliary device 200 to form a teardrop shape when the device is not attached, and that can be folded when preparing the auxiliary device 200 for attachment to the injection device 10 into a position such that the extension 280 is disposed within a recess or cavity of the injection device 10 when attached.

[0043] 3 is a schematic diagram of an embodiment of an auxiliary device 200 showing some internal and external components. Internally, the auxiliary device 200 includes main electronics 24. The main electronics 24 includes at least a processor 25. The processor 25 can be, for example, a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or the like. The processor 25 executes program code (e.g., software, or firmware). The main electronics 24 can be located on a flexible PCB in some embodiments.

[0044] The auxiliary device 200 may include memory. The primary electronics 24 may include both program memory and main memory. The processor may execute program code stored in the program memory and may use the main memory, for example, to store intermediate results. The program memory may be, for example, a read-only memory (ROM), and the main memory may be, for example, a random access memory (RAM). The device may include non-volatile memory for storing information, such as, for example, information derived from any sensors included within the auxiliary device 200.

[0045] The auxiliary device 200 also includes one or more sensors that are coupled to and controlled by the main electronics 24.

[0046] The auxiliary device 200 also includes a communication unit configured to transmit and / or receive information to and from another device. The communication unit 240 can be a wireless unit 241. Such transmission can be based on, for example, radio transmission or optical transmission. In some embodiments, the wireless unit 241 is a Bluetooth transceiver. Alternatively, the wireless unit 241 can be replaced or supplemented by a wired unit (not shown) configured to transmit and / or receive information to and from another device in a wired state, for example by a cable or fiber connection. When data is transmitted, the unit (value) of data to be transferred can be explicitly or implicitly defined. The wireless unit 241 can be coupled to and controlled by the main electronic circuit 24. In a particular example, the external device 1000 can activate the auxiliary device 200 by near field communication (NFC), in this example, the auxiliary device 200 will include a near field communication antenna 242. In some examples, the auxiliary device 200 will include a communication unit 240 capable of both Bluetooth communication and NFC.

[0047] The auxiliary device 200 may include a component 230 for providing feedback to the user. For example, the auxiliary device 200 may include a visual indicator 231, such as an LED 232, or multiple visual indicators 231. The indicators 231 may emit light to indicate a particular condition to a user. If a device includes multiple visual indicators 231, a particular combination of the light emitting indicators may indicate different conditions. Alternatively, or in addition, each visual indicator 231 may have a different output or display in response to the indicated condition. For example, the visual indicators 231 may output different colors of light to indicate different conditions. One or more of the visual indicators may be RGB LEDs 233.

[0048] The auxiliary device 200 may also include one or more audible indicators 234, such as an audio module 104 configured to provide audible feedback to a user of the auxiliary device 200. The one or more audible indicators 234 may be, for example, a speaker, a buzzer, a piezoelectric buzzer, or any suitable audible indicator. This may be an alternative to the visual indicator 231 or may be in addition to the visual indicator 231. Both the one or more visual indicators 231 and the one or more audible indicators 234 may be coupled to and controlled by the main electronics 24.

[0049] The auxiliary device 200 may optionally include a locking sensor 106 configured to sense whether the attachment mechanism is in a locked or unlocked position.

[0050] As discussed further below, component 230 for providing feedback to the user can be used to provide information regarding the start of an injection, e.g., a failure to detect the start of an injection, information regarding the end of an injection, e.g., a failure to detect the end of an injection, or information regarding the status of data transmission, e.g., successful or unsuccessful data transmission.

[0051] The auxiliary device 200 may include a power source 212, such as a battery, which may provide power to electrical components of the auxiliary device 200, such as, for example, the main electronics 24, the memory 34, the wireless unit 241, one or more sensors, the visual indicator 231, and / or the audible indicator 234.

[0052] FIG. 4 illustrates an exemplary system and shows communication between the auxiliary device 200 and other devices.

[0053] The auxiliary device 200 has a hibernate state in which the electronic components are in a low power mode and all non-essential electrical processes are powered down. For example, if the auxiliary device 200 includes sensors, audible indicators 234, or visual indicators 231, in the hibernate state these components are not active or powered. This has the advantage of minimizing the power consumption of the auxiliary device 200.

[0054] The auxiliary device 200 may be woken up, i.e., moved from a dormant state to an active state, by a signal 1001 received from the external device 1000. The signal 1001 may comprise a wake-up signal. The external device 1000 may wake up the auxiliary device 200 by a signal sent via any suitable means, including a wired or wireless connection, and communicated to the communication unit 240 of the auxiliary device 200. The communication unit 240 of the auxiliary device 200 may be capable of receiving the signal while the auxiliary device 200 is in a low power mode, for example by not requiring a separate power source while in the low power mode, or by maintaining access to a power source of the auxiliary device 200. In a particular example, the external device can wake up the auxiliary device 200 via near-field communication, in this example, the auxiliary device 200 would include a near-field communication antenna 242.

[0055] When activated, the auxiliary device 200 can be in an active state, in which, for example, one or more of the sensors can detect, and in which the auxiliary device 200 can transfer data to the external device 1000.

[0056] The injection device 10 can administer an injection regardless of the status of the auxiliary device 200. For example, the injection device 10 can be an auto-injector that can deliver an injection without or with the auxiliary device 200 attached, or when the auxiliary device 200 is in a dormant or active state.

[0057] External device 1000 can be any device capable of communicating with auxiliary device 200 and capable of storing, processing, displaying, or transmitting data received from auxiliary device 200. For example, external device 1000 can be a tablet, a smartphone, a smartwatch, a computer, or any suitable device.

[0058] The auxiliary device 200 and / or the injection device 10 may include at least one sensor 251 capable of detecting the initiation 271 of an injection by the injection device 10. The sensor 251 may include a switch, a conductive rubber pad, a Hall effect sensor, a piezoelectric sensor, an optical sensor, or any suitable sensor. The sensor 251 may detect the movement of a part of the injection device 10 associated with the injection itself, for example, the sensor 251 may detect the movement of the plunger 14 or the movement of a component linked or associated with the plunger. To detect the initiation of an injection, the sensor 251 may detect the initiation of the movement of the aforementioned component.

[0059] For example, the sensor 251 can be a conductive rubber pad 260 included in the auxiliary device 200, which can be configured to detect the movement of a component of the injection device 10 involved in the injection procedure when the auxiliary device 200 is attached to the injection device 10. The conductive rubber pad 260 can thus detect the start of an injection procedure by the injection device 10. The rubber pad 260 can be arranged such that a protrusion from the plunger, or an associated component, is pressed against the conductive rubber pad when the auxiliary device 200 is attached to the injection device 10. This protrusion is configured to retract into the injection device 10 as the plunger advances, so that when the injection starts, the protrusion is no longer pressed into the rubber pad. Alternatively or in addition, the conductive rubber pad 260 can be located on a rigid or flexible extension 280 as described herein, such as, for example, a flexible PCB, allowing the conductive rubber pad 260 to be positioned in a position that allows information to be determined for the injection device 10 when the auxiliary device 200 is attached to the injection device 10.

[0060] The conductive rubber pad 260 may be as shown in Figure 5A. The rubber pad includes a protrusion that is positioned to be pressed into the pad and under pressure when the auxiliary device 200 is attached to the injection device 10 (Figure 5B). The protrusion is forced into this position by a part of the plunger 14, such as a protrusion from the plunger 14, or a component attached to or associated with the plunger. When the plunger is moved (Figure 5C), the part of the rubber pad pressing on the protrusion moves away from the rubber pad, releasing the protrusion and allowing it to relax away from the rubber pad. However, This movement can then be detected and the start of the injection can be determined.

[0061] Alternatively or in addition, the sensor can be a switch configured to detect the movement of a component of the injection device 10 involved in the injection procedure. The switch can be a microswitch 261. The switch is included in the auxiliary device itself. Alternatively, the switch or microswitch 261 can be located in the injection device 10 and can communicate the start of the injection procedure to the auxiliary device 200. This communication can be by any suitable means, such as, for example, a wired connection. Alternatively or in addition, the switch or microswitch 261 can be located on a rigid or flexible extension 280 as described herein, such as, for example, a flexible PCB, allowing the switch or microswitch 261 to be positioned in a location that allows the determination of information about the injection device 10 when the auxiliary device 200 is attached to the injection device 10.

[0062] In an embodiment, the microswitch 261 can be as shown in FIG. 6. The microswitch is located in the auxiliary device 200, but can detect the movement of a lever 32 located in the injection device 10. The lever 32 can be located in a slot or gap 33 in the plunger (FIG. 6A) and is biased towards the slot or gap 33 before the start of the injection procedure. Alternatively, the lever 32 is located in and biased towards a slot or gap 33 of a component attached to the plunger to move with the plunger. When the plunger, or a component associated with the plunger, moves, the lever 32 is pushed out of the slot or gap 33 and the microswitch can detect this movement to determine the start of the injection (FIG. 6B).

[0063] Alternatively or in addition, the sensor can be an optical reflection sensor 263. This sensor 263 can sense the movement of a component of the injection device 10 involved in the injection procedure. For example, the optical reflection sensor 263 can continuously sense the movement of the plunger 14. To facilitate this detection, the plunger of the injection device 10 can be patterned or coded so that a specific part of the plunger 14 can be identified. The optical reflection sensor 263 can be included within the auxiliary device 200 itself. Alternatively, the optical reflection sensor 263 can be located within the injection device 10 and can communicate the start of the injection procedure to the auxiliary device 200. This communication can be by any suitable means, such as, for example, a wired connection. Alternatively or in addition, the optical reflection sensor 263 can be located on a rigid or flexible extension 280 as described herein, such as, for example, a flexible PCB, allowing the optical reflection sensor 263 to be positioned in a position that allows the measurement of information about the injection device 10 when the auxiliary device 200 is attached to the injection device 10.

[0064] 7A shows an exemplary auxiliary device 200 including an optical reflection sensor 263 attached to an injection device 10 prior to starting an injection procedure. In this example, once the injection procedure is started (FIG. 7B), the optical reflection sensor 263 can continuously detect the progress of the injection as the plunger passes the sensor, since the plunger includes alternating sections with unique optical characteristics that can be detected by the sensor. Once the injection is finished (FIG. 7C), the sensor can detect the end of the injection, since the alternating sections no longer pass the sensor, or the last section of the plunger positioned to be detected by the sensor has a unique optical characteristic that allows its identification.

[0065] If the auxiliary device 200 does not detect the start of an injection within a predetermined time after being activated by the external device 1000, the auxiliary device 200 may initiate any of the functions disclosed herein. The user can be notified via feedback means.

[0066] At least one sensor capable of detecting the start of an injection may communicate this information to a processor 25 or controller contained within the auxiliary device 200 .

[0067] The auxiliary device 200 and / or the injection device 10 may include at least one sensor 250 capable of detecting the end 272 of an injection by the injection device 10. This sensor 250 may also sense the start 271 of an injection, as discussed above. Alternatively, there may be multiple sensors, e.g., a sensor 251 for detecting the start 271 of an injection procedure, and a separate sensor 252 for detecting the end 272 of an injection procedure. The sensor 250 may detect a movement of a part of the injection device 10 associated with the injection itself, e.g., the sensor may detect the movement of the plunger 14, or the movement of a component linked or associated with the plunger. To detect the end 272 of an injection, the sensor 250 may detect the end of the movement of the aforementioned component, or may detect the movement of a component to a position associated with the end of the injection. For example, the sensor 250 may detect when the plunger has moved the entire length required for the injection.

[0068] The sensor 250 may include a switch, a conductive rubber pad, a Hall Effect sensor, a piezoelectric sensor, an optical sensor, or any suitable sensor.

[0069] The sensor 250 can be a switch configured to detect the position or movement of a component of the injection device 10 involved in the injection procedure. The switch can detect the movement of a component, such as, for example, the plunger, or a component associated with the plunger, to a position associated with the end of the injection. For example, the switch can detect when the plunger has moved the full length required for the injection. The switch can be a microswitch 261. The switch can be included within the auxiliary device 200 itself. Alternatively, the switch or microswitch 261 can be located within the injection device 10 and can communicate the start of the injection procedure to the auxiliary device 200. This communication can be by any suitable means, such as, for example, a wired connection. The switch or microswitch 261 can be located on a rigid or flexible extension 280 as described herein, such as, for example, a flexible PCB.

[0070] In an embodiment, the microswitch 261 may be as shown in Figure 6. During an injection procedure, the microswitch 261 is activated by the lever 32, as shown in Figure 6B, which is forced into an activated position by the plunger 14, which biases the lever 32 against the plunger 14. At the end of the injection procedure, the plunger 14 moves to a position where it can move the lever 32 to a relaxed position and therefore no longer activates the microswitch 261 (Figure 6C), allowing the end 272 of the injection procedure to be determined.

[0071] The at least one sensor 250 capable of detecting the end of injection 272 by the injection device 10 can be a conductive rubber pad 260, which is positioned such that movement of the component to a position associated with the end of injection is detected. The conductive rubber pad 260 can be located on a rigid or flexible extension 280 as described herein, such as, for example, a flexible PCB.

[0072] Alternatively, or in addition, the sensor 250 may be an optical reflective sensor 263. This sensor 263 may sense the movement of a component of the injection device 10 involved in the injection procedure. For example, an optical reflective sensor may sense the movement of a component associated with the injection, such as a plunger. The optical reflective sensor can continuously sense the movement of the components that have been moved and detect when this movement has ended 272. Alternatively, the optical reflective sensor can sense when a portion of the aforementioned components has reached a predetermined position associated with the end of the injection (FIG. 7C). For example, the optical reflective sensor can detect when a portion of the plunger has moved to a position that indicates that the plunger has moved the entire length required for the injection. To facilitate these detections, the plunger of the injection device 10 is patterned or coded so that a particular portion of the plunger can be identified. The optical reflective sensor can be included within the auxiliary device 200 itself. Alternatively, the optical reflective sensor can be located within the injection device 10 and communicate the start of the injection procedure to the auxiliary device 200. This communication can be by any suitable means, such as, for example, a wired connection. The optical reflective sensor 263 can be located on a rigid or flexible extension 280 as described herein, such as, for example, a flexible PCB, such that when the auxiliary device 200 is attached to the injection device 10, the optical reflective sensor 263 can be positioned in a position that allows the determination of information for the injection device 10.

[0073] If the auxiliary device 200 does not detect 272 the end of the injection within a predetermined time after being activated by the external device 1000, the auxiliary device 200 may notify the user.

[0074] At least one sensor 250 capable of detecting the end of an injection can communicate this information to a processor 25 or controller contained within the auxiliary device 200 .

[0075] The auxiliary device 200 can include a sensor 251 for detecting the start of an injection and a separate sensor 252 for detecting the end of an injection. Alternatively, the auxiliary device 200 can include a single sensor 250 that can determine both the start and end of an injection. As a third alternative, the auxiliary device 200 can include a sensor 263 that can continuously detect the progress of the injection procedure.

[0076] The auxiliary device 200 can determine information about the medication in the injection device 10, for example, by means of the sensor 253. For example, the auxiliary device 200 can determine the type of medication, the medication's identification, ID number, batch number, expiration date, age, or similar information. The auxiliary device 200 can include a sensor 254 that can determine optical characteristics of a portion of the injection device 10 or a component associated with or attached to the injection device 10, such as a medication cartridge, to determine information related to the medication. Alternatively or in addition, the sensor 253 can detect a code from which information related to the medication can be derived.

[0077] The auxiliary device 200 may include a light sensor 254 capable of determining information regarding the medication in the injection device 10. For example, the medication identifying information 100 may be the color of the housing 11 of the injection device 10, or the color of an area of ​​the housing or of a label affixed to the housing. In these embodiments, the light sensor 254 may be a simple photometer configured to detect color. In some other embodiments, the medication identifying information 100 may be a QR code, or other similar coded information, and the light sensor 254 may be a camera or a QR code reader. Additionally, one or more light sources may be provided to improve the reading of the light sensor 254. The light source may provide light of a certain wavelength or spectrum to improve color detection by the light sensor 254. The light source may be positioned such that undesirable reflections, for example due to curvature of the housing 11, are avoided or reduced. In an exemplary embodiment, the light sensor 254 detects a code 100 (e.g., a one-dimensional or two-dimensional bar code and / or a code associated with the injection device 10 and / or the medication contained therein). The auxiliary device 200 is a camera unit configured to detect a code 100, such as a bar code that can be used to identify a specific drug in the injection device 10. The code 100 can be located, for example, on the housing 11 or on a drug container included in the injection device 10, just to name a few. The code 100 can indicate, for example, the type of injection device 10 and / or the drug, and / or other characteristics (e.g., expiration date). The code 100 can be a QR code 100. QR codes are generally black and white, and therefore no color detection is required on the part of the optical sensor 254. This can make the optical sensor 254 simpler and cheaper to manufacture. In other embodiments, the auxiliary device 200 can include a sensor (not shown) that can determine information about the drug in the injection device 10 by other means, such as detecting an RFID.

[0078] The processor 25 can be configured to check the information 100 read by the sensor 253 against pre-stored information, for example, to verify that the user is injecting the correct medication. If the processor 25 does not recognize the information 100 or recognizes that the information 100 indicates a possible improper injection procedure, such as, for example, if the information indicates a different medication than the user should receive at that time, the auxiliary device 200 can generate an alarm signal. The alarm signal can include the use of any of the feedback methods disclosed herein, including an indicator 230 associated with the auxiliary device 200 or communication to an external device 1000 that can display the information to the user.

[0079] Optionally, the auxiliary device 200 may include a temperature sensor 255. The temperature sensor 255 may detect the temperature of the auxiliary device 200 itself, and this information may be used to estimate the temperature of the medication present in the injection device 10. A flow diagram illustrating operations that may be performed by an auxiliary device 200 including a temperature sensor 255 is shown in FIG.

[0080] The temperature sensor 255 may be located on a rigid or flexible extension 280 as described herein, such as, for example, a flexible PCB, to allow the temperature sensor 255 to be positioned in a suitable location to estimate the temperature of the medication present in the injection device 10.

[0081] The temperature sensor 255 can start detecting 601 after the auxiliary device 200 is powered up, so the temperature sensor 255 is powered up in the active state of the auxiliary device 200. After powering up, the temperature sensor 255 can measure 602 the temperature.

[0082] Since injection of a medication that is too cold or too hot can be uncomfortable for the user, it is preferable to deliver the medication at a particular temperature, e.g., room temperature. However, some medications are stored at lower temperatures. Thus, when the auxiliary device 200 determines 603 that the temperature is below a predetermined temperature, such as room temperature, it can notify the user that the medication is not at the correct temperature 604. When the correct temperature is reached, the auxiliary device 200 can notify the user 605. The feedback method can be any disclosed herein, including an indicator 230 associated with the auxiliary device 200, or communication to an external device 1000 that can display the information to the user.

[0083] Alternatively, or in addition, when the auxiliary device 200 detects an ambient or incorrect temperature, it may start a timer 606 as shown in FIG. 9. The timer may run for the length of time required for the medication to reach the required temperature. This length of time may be adjusted in response to the type or identity of the medication, or in response to other characteristics such as the volume of the medication. After the time has elapsed 607, a timer associated with the auxiliary device 200 may be started. The user may be notified 605 by a marked indicator 230 or by communication to an external device 1000 which may display the information to the user.

[0084] In other embodiments, the auxiliary device 200 can include a temperature sensitive patch capable of measuring 612 temperature (see FIG. 10). The temperature sensitive patch can be configured to indicate when the temperature is not suitable 614 for injection and / or suitable 615 for injection based on whether the ambient temperature matches a predetermined temperature 613. For example, the temperature sensitive patch can be a particular color, such as red, when the temperature is not suitable. In other examples, the temperature sensitive patch can be a different color, such as green, when the temperature is suitable. This allows the user to determine whether the temperature of the medication is suitable to begin the injection procedure.

[0085] The temperature sensor 255 can provide information to the processor 25 of the auxiliary device 200. The processor 25 can process the received information and transmit the received information to the external device 1000, for example, via the communication unit 240. Alternatively or additionally, the processor 25 of the auxiliary device 200 can use a certain algorithm to ascertain the temperature of the drug in the injection device 10, based on the provided information. This information can be transmitted to the external device 1000, for example, via the communication unit 240. In other embodiments, the information received by the processor 25 is processed and transmitted to the external device 1000, and any calculations, including the estimation of the temperature of the drug in the injection device 10, are performed by the external device 1000.

[0086] The communication of the temperature sensor 255 information to the external device 1000 can be by any method, or simultaneously with any transmission, as disclosed herein.

[0087] The communication unit 240 can transmit the data 1002 to the external device 1000; the transmission can be by any suitable means, such as wired or wireless communication. The external device 1000 can be the same external device used to wake up the auxiliary device 200. The transfer can be initiated and / or proceeded by near-field communication. In some embodiments, the data transfer will be via Bluetooth. In other embodiments, near-field communication will be used to wake up the auxiliary device 200 and Bluetooth will be used to transmit the collected information. The auxiliary device 200 can sense whether the data transfer is successful or complete, and if not, the auxiliary device 200 can retry the transmission and / or inform the user that the data transmission failed.

[0088] The data transmitted may include information regarding the start of the injection, the end of the injection, temperature, and / or medication-related information.

[0089] In some embodiments, the data is transmitted after the start of the injection is detected, and in other embodiments, the data is transmitted after the end of the injection is detected. The user may be notified by any means or method disclosed herein.

[0090] Optionally, the auxiliary device 200 may include a memory 34 suitable for storing information measured by the sensors. This information may include information regarding the start of the injection, the end of the injection, the drug, the temperature, or any other derived information. The data transmitted to the external device 1000 may be the data stored in the memory 34.

[0091] The external device 1000 can process and display the received data. The external device 1000 can also transmit the data to a third party device, such as a cloud service. It is possible.

[0092] The external device 1000 may display a warning or alert to the user prior to the start of an injection, such as those discussed herein with respect to medication identification. The external device 1000 may also, or alternatively, display instructions for a recommended treatment.

[0093] After the injection, the external device 1000 may display information or instructions based on the received information, such as a history record, the date of the next dose, indications for treatment, and the like.

[0094] 11 shows a flow diagram illustrating operations that may be performed by an exemplary embodiment of an auxiliary device 200. This embodiment is an auxiliary device 200 that includes a short-range communication antenna 242, a sensor 251 for detecting the start of an injection procedure with a disposable auto-injector, and optionally a separate sensor 252 for detecting the end of the injection procedure, a processor 25, and a hook 211 configured to attach the auxiliary device 200 to a predetermined location on the disposable auto-injector.

[0095] The sensor in this embodiment is configured to detect the start of injection and the end of injection with separate components. The start of injection is detected by conductive rubber pad 260 as shown in Figure 5 and described herein. The end of injection can be detected by any means or sensor disclosed herein.

[0096] The auxiliary device 200 of this embodiment works as follows: The auxiliary device 200 is connected to a disposable pen-type auto-injector via a hook 211 that snaps into a recess 31 contained by the auto-injector, thus mounting the auxiliary device 200, and the sensors, in place. The auxiliary device 200 is mounted such that the resulting assembly is of extended length compared to the injection device 10 alone. After mounting, the electronic circuitry of the auxiliary device 200 is then activated by an external device 1000, such as a smartphone, by short-range communication (step 501). This activates the sensors, including both the start of injection sensor 251 and the end of injection sensor 252.

[0097] The auxiliary device 200 of this embodiment also includes a temperature sensitive label as described herein. The temperature sensitive label will indicate to the user whether the medication is at the proper temperature for injection, as shown in FIG. 10 and described herein. If the temperature is not at the proper temperature, the user will wait until the patch indicates that the temperature is correct before beginning the injection procedure.

[0098] After activation, if the start of injection sensor 251 does not detect the start of injection within a predefined time 502, the user is notified 504. If in step 502 the sensor detects the start of injection, this is communicated to the processor 25. If thereafter the end of injection sensor 252 does not detect the end of injection within a predefined time, the user is notified 504. If the end of injection sensor 252 detects the end of injection 503, this is communicated to the processor 25. When the processor 25 receives the start and end of injection information, it can then transmit 505 the information to the external device 1000 by the communication unit 240 via short-range communication. This transmission is triggered by a communication 1001 received from the external device 1000 by short-range communication or Bluetooth low energy. If the information transmission fails or is incomplete, the auxiliary device 200 will retransmit 506 the information.

[0099] Based on the data received, the external device 1000 displays instructions and information to the user based on the device's usage history. The auto-injector can then be disposed of 507.

[0100] The auxiliary device 200 of this embodiment may not detect the end of an injection, in which case it would only include a sensor 251 for detecting the start of an injection. In this situation, the method of operation would be as described herein, but would lack the steps relating to detecting the end of an injection.

[0101] Fig. 11 is a flow diagram illustrating operations that can be performed by an exemplary embodiment of the auxiliary device 200. This embodiment is an auxiliary device 200 including a communication unit 240 capable of communicating by BLE whisper mode, a sensor 250 for detecting the start and end of an injection procedure with a disposable auto-injector, a processor 25, and a hook 211 configured to attach the auxiliary device 200 to a predetermined position on a disposable auto-injector. The auxiliary device 200 also includes an extension 280 that is a flexible PCB that can extend outward from the main body of the auxiliary device 200. When attached to the injection device, this flexible PCB is located within the housing of the injection device and extends along the injection device in a direction perpendicular to it (as shown by Fig. 13B). The auxiliary device 200 further includes a multi-colored LED 233 that allows feedback to the user.

[0102] The sensor 250 in this embodiment is configured to detect both the start and end of an injection by movement of the plunger of the injection device 10 via a single microswitch 261. The sensor 250 is positioned on a flexible PCB such that, when mounted on the injection device, the microswitch 261 is positioned as shown in Figure 6. The sensor is configured to communicate this information to a processor 25 included within the auxiliary device 200.

[0103] The auxiliary device 200 of this embodiment works as follows: The auxiliary device 200 is connected to a disposable pen-type auto-injector by a hook 211 that snaps into a recess 31 contained by the auto-injector, mounting the auxiliary device 200, and therefore the sensor, in place. The electronic circuitry of the auxiliary device 200 is then activated by an external device 1000, such as a smartphone, via short-range communication, this is step 501. Doing so activates the sensor 250 for detecting the start and end of the injection procedure.

[0104] The auxiliary device 200 of this embodiment also includes a temperature sensitive label as described herein. The temperature sensor label will indicate to the user whether the medication is at the proper temperature for injection, as shown in FIG. 10 and described herein. If the temperature is not at the proper temperature, the user will wait until the patch indicates that the temperature is correct before beginning the injection procedure.

[0105] After activation, if the sensor 250 does not detect the start of injection within a predefined time 502, the user is notified 504 via the multicolor LED 233. If the sensor 250 detects the start of injection within a predefined time 502, this is communicated to the processor 25. Then, if the sensor 250 does not detect the end of injection within a predefined time 503, the user is notified 504 via the multicolor LED 233. If the sensor 250 detects the end of injection within a predefined time 503, this is communicated to the processor 25. When the processor 25 receives the start and end of injection information, it can then transmit the information 505 via short-range communication to the external device 1000 by the communication unit 240. This transmission is triggered by a communication received from the external device 1000 by short-range communication. If the information transmission fails or is incomplete, the auxiliary device 200 will retransmit the information 506.

[0106] Based on the data received, the external device 1000 displays instructions and information to the user based on the device's usage history. The auto-injector can then be disposed of 507.

[0107] FIG. 11 shows a flow diagram illustrating operations that can be performed by an exemplary embodiment of the auxiliary device 200. This embodiment is an auxiliary device 200 that can communicate with external devices by both NFC and Bluetooth. The auxiliary device 200 also includes a temperature sensor 255, a sensor 253 for determining the identity of the medication, a number of LEDs 232 for indicating the device status to the user, and a processor 25. The auxiliary device 200 itself has a teardrop cross-section and is configured to be attached to the distal end of a disposable auto-injector (as shown by FIG. 13C). The auxiliary device 200 also includes an extension 280, which is a flexible PCB that can extend outwardly from the main body of the auxiliary device 200. When attached to the injection device, this flexible PCB will be located within the housing of the injection device and will extend perpendicularly along the injection device.

[0108] The auxiliary device 200 includes an optical reflective sensor 263 capable of continuously detecting the progress of an injection procedure as shown in FIG. 7 and described herein. The optical reflective sensor 263 is positioned on a flexible PCB such that when attached to an injection device, the optical reflective sensor 263 is in the position shown in FIG. 7. The auxiliary device 200 is designed for use with an auto-injector having a plunger 14, or a component associated with the plunger, where optical properties of at least a portion of the plunger allow the position of the plunger to be determined. In this example, the sensor 263 can monitor the movement of the plunger of the injection device 10, and the plunger of the injection device 10 has an alternating pattern to assist in the monitoring.

[0109] The auxiliary device 200 of this embodiment operates as follows: The auxiliary device 200 is connected to a disposable pen-type auto-injector at a predetermined location. The electronics of the auxiliary device 200 are then activated 501 by an external device 1000, such as a smartphone, via near-field communication. Doing so activates sensors included by the auxiliary device 200.

[0110] The auxiliary device 200 can then determine the identity of the medication in the disposable auto-injector by any means disclosed herein. If the medication identity does not match the predetermined medication identity, the auxiliary device 200 will alert the user, for example, by flashing a particular pattern of LEDs or displaying a particular color with one or more LEDs. This is illustrated by FIG. 12, where the auxiliary device 200 is activated 551 to activate the medication information measurement sensor 253 and can determine information related to the medication 552. The auxiliary device 200 can then check 553 whether the information matches the predetermined medication identity and notify 554 the user of the mismatch.

[0111] The auxiliary device 200 also measures the ambient temperature with a temperature sensor 255 and calculates an estimated temperature of the medication in the auto-injector. If the temperature does not match the predetermined temperature, the auxiliary device 200 will alert the user, for example, by flashing a particular pattern of LEDs or displaying a particular color with one or more LEDs. The auxiliary device 200 will then indicate to the user that a predetermined temperature has been detected and therefore the injection can proceed, or the auxiliary device 200 will have started a timer when it detected the incorrect temperature and will wait until the timer has elapsed before indicating to the user that the injection can proceed. These processes are shown in Figures 8 and 9 and described herein.

[0112] After the start of the injection is detected by the optical reflection sensor 263, the injection is continuously monitored by the sensor so that both the start 502 and end 503 of the injection procedure can be determined. The sensor 263 continues to monitor the injection until the end of the injection is detected 503, as shown in FIG. 7 and described herein.

[0113] When the processor 25 receives the start and end of injection information, it may then transmit 505 the information via Bluetooth communication to the external device 1000. If the information transmission fails or is incomplete, the auxiliary device 200 will retransmit 506 the information.

[0114] Based on the data received, the external device 1000 displays instructions and information to the user based on the device's usage history. The auto-injector can then be disposed of 507.

[0115] The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest terms, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease, or otherwise improve physical or mental health. Drugs or agents are used for a limited duration, or periodically for chronic diseases.

[0116] As described below, the drug or agent may include at least one API, or a combination thereof, in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules with a molecular weight of 500 Da or less; polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. The nucleic acid is incorporated into a molecular delivery system such as a vector, a plasmid, or a liposome. Mixtures of one or more drugs are also contemplated.

[0117] The drug or agent is contained within a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir, or other solid or flexible container configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber is designed to accommodate the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber is designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some cases, the drug container can be or include a dual-chamber cartridge configured to store two or more components of a pharmaceutical formulation to be administered separately, one in each chamber (e.g., an API and a diluent, or two different types of drugs). In such cases, the two chambers of the dual-chamber cartridge are configured to allow mixing between the two or more components before and / or during administration into the human or animal body. For example, the two chambers are configured such that they are in fluid communication with each other (e.g., by a conduit between the two chambers) to allow mixing of the two components by a user prior to administration, if desired. Alternatively, or in addition, the two chambers are configured to allow mixing of the components as they are being administered into the human or animal body.

[0118] The drugs or agents contained in the drug delivery device described herein are 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, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Other examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs include, for example, but are not limited to, those listed in the Handbook of Rote Liste 2014, Main Group 12 (antidiabetic drugs) or Main Group 86 (tumor drugs), and Merck Index, 15th Edition.

[0119] 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 a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. The terms "analog" and "derivative" as used herein refer to a polypeptide having a molecular structure that is derived from the structure of a natural peptide, e.g., the structure of human insulin, by deleting and / or replacing at least one amino acid residue found in the natural peptide, and / or by adding at least one amino acid residue. The added and / or replaced amino acid residue can be a codable amino acid residue, or another natural residue, or a completely synthetic amino acid residue. Insulin analogs are also called "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that is derived formally from that of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more amino acids. Optionally, one or more amino acids found in the naturally occurring peptide may be deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0120] Examples of insulin analogues 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 the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and in position B29, Lys is replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0121] 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®), B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-ω-carboxyheptadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®), B29-N-(N-lithoyl -γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0122] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Dyetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, laxative, cefotaxime ... These include ngrenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-Xten.

[0123] Examples of oligonucleotides include, for example: mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0124] Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0125] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0126] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof.An example of the pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of hyaluronic acid derivatives is Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0127] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immunoglobulin or humanized, fully human, non-human (e.g., murine), or single chain antibodies. In some embodiments, antibodies have effector functions and can fix complement. In some embodiments, antibodies have reduced ability to bind or cannot bind Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments or variants that do not support binding to Fc receptors, e.g., have mutated or deleted Fc receptor binding regions. The term antibody also refers to tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins with cross-linking region orientation. (CODV)-based antibody binding molecules.

[0128] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., antibody heavy and / or light chain polypeptides) that does not include the full-length antibody polypeptide, but still includes at least a portion of the full-length antibody polypeptide that can bind to an antigen. An antibody fragment can include a truncated portion of the full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific antibody fragments, or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent antibody fragments, or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Further examples of antigen-binding antibody fragments are known in the art.

[0129] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences, but are primarily responsible for maintaining the correct positioning of CDR sequences to allow antigen binding. Although framework regions themselves are usually not directly involved in antigen binding, as is known in the art, certain residues in the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDRs to interact with the antigen.

[0130] Exemplary antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0131] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use in the drug delivery device or agent. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0132] Those skilled in the art will understand that modifications (additions and / or removals) of the various components, formulations, devices, methods, systems, and embodiments of the API described herein may be made without departing from the full scope and spirit of the present disclosure, which encompasses such modifications and any and all equivalent forms thereof.

Claims

1. 1. An auxiliary device configured for releasable attachment to an injection device, comprising: at least one pair of elongated attachment means for releasably attaching the auxiliary device to the injection device; a sensor arrangement including an extension extending through a distal end of the injection device and into a cavity of the injection device along a first axis substantially parallel to a longitudinal axis of the injection device such that when the auxiliary device is attached to the injection device, the optical sensor arrangement can be used to detect the start of an injection by detecting movement of a portion within the injection device, the extension being configured to extend a greater distance along the first axis within the cavity than any distance perpendicular to the first axis; Including, The auxiliary device is configured to use an optical sensor arrangement to detect the initiation of an injection by the injection device.

2. The auxiliary device of claim 1 , wherein the optical sensor arrangement comprises a flexible printed circuit board.

3. 3. An auxiliary device as claimed in claim 1 or 2, configured to indicate that the start of an injection by an injection device has not been detected.

4. 4. The auxiliary device according to any one of claims 1 to 3, configured to indicate that a start of an injection by the injection device has been detected and that an end of an injection by the injection device has not been detected.

5. 5. The auxiliary device of claim 1 , configured to indicate that the start of an injection by the injection device has been detected and that the end of an injection by the injection device has not been detected within a predetermined time of the start of the injection.

6. The auxiliary device according to any one of claims 1 to 5, further comprising a wireless communication unit.

7. The auxiliary device of claim 6 , further configured to communicate the initiation of the injection to an external device via at least one wireless communication unit.

8. 8. An auxiliary device as claimed in claim 6 or 7, configured to indicate whether wireless communication to an external device was successful.

9. An auxiliary device according to any preceding claim, further comprising a temperature sensor.

10. 10. The auxiliary device of claim 9, configured to indicate whether a medication contained in the injection device meets predetermined temperature parameters.

11. 10. The auxiliary device of claim 9, configured to initiate a timer in response to determining that a medication contained in the injection device does not meet a predetermined temperature parameter, and to provide an indication when the timer has expired.

12. 13. A system comprising: An injection device; 1. An auxiliary device configured for releasable attachment to an injection device, comprising: at least one pair of attachment means for releasably attaching the auxiliary device to the injection device; a sensor arrangement including an extension extending through a distal end of the injection device and into a cavity of the injection device along a first axis substantially parallel to a longitudinal axis of the injection device such that when the auxiliary device is attached to the injection device, the optical sensor arrangement can be used to detect the start of an injection by detecting movement of a portion within the injection device, the extension being configured to extend a greater distance along the first axis within the cavity than any distance perpendicular to the first axis; the auxiliary device being configured to use an optical sensor arrangement to detect initiation of an injection by the injection device; The system comprising:

13. The system of claim 12 , wherein the injection device is a disposable auto-injector.

14. 14. The system of claim 12 or 13, wherein the auxiliary device includes a housing that is formed such that when attached to the injection device, the housing of the auxiliary device is flush with the housing of the injection device.

15. A system according to any one of claims 12 to 14, having a uniform width but a longitudinal length greater than that of the injection device.

16. The system according to any one of claims 12 to 15, wherein the auxiliary device is configured to be mounted within a recess located at the distal end of the injection device.

17. The system of any one of claims 12 to 17, wherein the injection device contains a medicament.

18. The system of any one of claims 12 to 17, wherein the auxiliary device further comprises a temperature sensor.

19. 20. The system of claim 18, wherein the auxiliary device is configured to indicate whether a medication contained in the injection device meets predetermined temperature parameters.

20. 20. The system of claim 19, wherein the auxiliary device is configured to initiate a timer in response to determining that the medication contained in the injection device does not meet predetermined temperature parameters, and to provide an indication when the timer expires.

21. A system according to any one of claims 12 to 20, wherein the auxiliary device is configured to indicate that start of an injection by the injection device has not been detected.

22. A system according to any one of claims 12 to 21, wherein the auxiliary device is configured to indicate that a start of an injection by the injection device has been detected and that an end of an injection by the injection device has not been detected.

23. The system according to any one of claims 12 to 22, wherein the auxiliary device further comprises a wireless communication unit.

24. 24. The system of claim 23, wherein the auxiliary device is further configured to communicate the initiation of the injection to an external device via the at least one wireless communication unit.

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