Supplementary device for attachment to injection device

Abstract

To provide an Improved add-on devices capable of determining and communicating usage information associated with injection devices.SOLUTION: There is provided a supplementary device 200 configured to be releasably attached to an injection device 10. The supplementary device comprises: at least one wireless communication unit 241; and at least one sensor. Therein the supplementary device is configured: to activate the at least one sensor in response to receipt via the at least one wireless communication unit of a wireless communication from an external device; following activation, to use the at least one sensor to detect a start of an injection by the injection device; and to communicate via the at least one wireless communication unit the start of the injection to the external device.SELECTED DRAWING: Figure 3

Description

Technical Field

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

Background Art

[0002] There are various diseases that require regular treatment by injection of drugs. Such injections can be carried out by using an injection device, which can be performed by medical staff or by the patient themselves.

[0003] Injection devices (i.e., devices capable of delivering drugs from a pharmaceutical container) are intended to make it easier for patients to self-administer the treatment being injected. Current treatments delivered by self-administered injections include drugs for diabetes (both insulin and new GLP-1 class drugs), migraine, allergies, hormone therapy, drugs for anticoagulation, etc. Injection devices can be used to deliver a single dose of a particular life-saving drug. For example, they are often prescribed to people at risk of anaphylaxis. They are also often used in the military to protect personnel from chemical weapons. Alternatively, injection devices are used, for example, to administer drugs to people with multiple sclerosis, rheumatoid arthritis, or anemia according to a prescribed treatment schedule.

[0004] An injection device can be used only to deliver a single dose of a drug and can be a disposable or single-use device that needs to be disposed of after use. Other types of injection devices are reusable. They are typically arranged such that a user can detach a standard syringe. Reusable injection devices can be used to administer multiple parenteral drug deliveries, but the syringe is disposed of after being consumed and removed from the injection device. The syringe can be packaged using additional components to provide additional functionality. In a typical scenario, a disease can be treated by the patient themselves by injecting a drug dose using an injection device, for example, daily, weekly, bi-weekly, or monthly.

[0005] Injection devices are typically included in two categories: manual devices and auto-injection devices. In a manual device, the user must apply mechanical energy to push the liquid through the needle. This is usually done by some form of button / plunger that the user must continuously press during injection.

[0006] An auto-injection device is a device that fully or partially replaces the actions involved in parenteral drug delivery from a standard syringe. These actions can include insertion of the needle into the patient's skin, injection of the drug, removal of the needle, needle shielding, and prevention of reuse of the device. Auto-injection devices can reduce the force required by the user, problems related to gripping, and the possibility of delivering an incomplete dose. Triggering can be accomplished by a number of means, such as a trigger button or the action of the needle reaching its injection depth. In some devices, the energy to deliver the liquid is provided by a spring.

[0007] Needleless injection devices have been developed that deliver drugs using needleless injection techniques. Such systems deliver the drug through the skin using a mechanism that does not involve piercing the skin with a cannula.

[0008] To prevent misuse of the injection device or to track usage data over time, it is desirable to measure information regarding the state and / or usage of the injection device. Reusable, add-on devices are known that are suitable for use with a syringe and that monitor (and provide other information to the user) the dosage delivered by the syringe. An auxiliary device is described, for example, in Patent Document 1, which includes a fitting unit for releasably attaching the device to an injection device. The device includes a camera and performs optical character recognition (OCR) on a captured image visible through the dosage window of the injection pen, thereby determining the dosage of the drug set on the dial to the injection device.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0010] There is a need for an improved add-on device that can determine and transmit usage information associated with an injection device. There is a need for a method for minimizing the power consumption of such an add-on device.

Means for Solving the Problems

[0011] An auxiliary device 200 for attaching to an injection device 10 is provided that can determine usage amount information associated with the injection device 10 and transmit it to an external device 1000. The auxiliary device 200 can record and store data separately from the injection device that will be disposed of when used with a disposable injection device, and can combine usage data from multiple disposable devices for a single user, which is particularly advantageous.

[0012] According to an aspect of the present disclosure, an auxiliary device configured to be releasably attached to an injection device is provided, the auxiliary device including: at least one wireless communication unit; and at least one sensor; wherein the auxiliary device is configured to: activate at least one sensor in response to receiving wireless communication from an external device via the at least one wireless communication unit; subsequent to activation, use the at least one sensor to detect the start of an injection by the injection device; and transmit the start of the injection to the external device via the at least one wireless communication unit.

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

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

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

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

[0017] The auxiliary device can be configured to indicate whether transmission to the external device was successful. can be done.

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

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

[0020] The auxiliary device can be configured to start a timer in response to determining that the drug contained in the injection device does not meet a predetermined temperature parameter, and can provide an indication when the timer expires.

[0021] According to an aspect of the present disclosure, a system is provided that includes any of the auxiliary devices defined herein and an injection device, where the auxiliary device is removably attached to the injection device.

[0022] The injection device can be a disposable autoinjector.

[0023] The auxiliary device, when attached to the injection device, can include a housing formed such that the housing of the auxiliary device is in the same plane as the housing of the injection device.

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

[0025] The auxiliary device can be configured to be attached within a recess located at the distal end of the injection device.

Brief Description of the Drawings

[0026]

Figure 1A

Figure 1B

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[0027] In the following, embodiments are described with reference to a pen-type syringe. However, the present disclosure can be equally well implemented using other types of drug delivery devices such as syringes, pre-filled syringes, needleless injectors, and inhalers, without being limited to such applications.

[0028] An injection device 10 according to an embodiment (also referred to herein as a drug delivery device 10) is described with reference to FIGS. 1A and 1B below. 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 the direction of the patient's injection site during injection, while the distal end D faces away from the injection site.

[0029] The injection device 10 includes a body 9 and a cap 12 (also referred to herein as an outer needle cap 12 or ONC 12). The body 9 includes an outer housing 11. The outer housing 11 is an elongated tube. The outer housing 11 includes a cartridge holder or syringe holder (not shown) that supports a cartridge or syringe 18 containing a liquid medicament 16. In the following, the description shall refer to a cartridge 18 supported by a cartridge holder (not shown). The cartridge 18 is shown in FIG. 1B by a dashed line and can be positioned under a window 15 in the housing 11.

[0030] The outer housing 11 also houses a dosing mechanism (not shown) for dosing the drug 16 during injection.

[0031] The hollow needle 17 communicates with the internal volume of the cartridge 18 and serves as a conduit for the liquid drug 16 during injection. The needle 17 and the cartridge 18 are in fixed positions relative to each other and relative to the body 9. The stopper, plunger, piston, or plug 14 is movable within the cartridge 18 to discharge the drug contained within the cartridge 18 through the needle 17 under the operation of the dosing mechanism.

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

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

[0034] Figure 2a is a schematic view 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 injection devices and disposable injection devices. The auxiliary device 200 can also be suitable for use with manual syringes and auto-injectors. In certain embodiments, 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 means 210 for attaching to the injection device, or the injection device can include means for attaching to the auxiliary device 200. The auxiliary device 200 can include means 210 configured for attachment to a portion of the injection device that is 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 properly 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 can snap into a detent position and thus be configured to hold the auxiliary device 200 on the injection device. Other attachment means can include: adhesive surfaces, magnetic components, clips, threaded components, or any suitable means.

[0036] The injection device can include a cap 30 positioned at, on, or covering the attachment location of the auxiliary device 200. The cap 30 can include, for example, hooks similar to those of the auxiliary device 200 and can be attached in a similar manner. The cap 30 can be a removable cap that can be removed before attaching the auxiliary device 200.

[0037] The attachment means 210 can be such that when attached, the orientation, position, or alignment of the auxiliary device 200 relative to the injection device 10 is predetermined. The predetermined orientation, position, or alignment is to place any configuration, such as a sensor, in the correct location for its operation. For example, the auxiliary device 200 can include a hook 211 that engages a recess 31 on the injection device 10, and the hook 211 and the recess 31 are configured such that the auxiliary device 200 can be attached only in a manner that enables the correct functioning of the device, such as positioning any sensor in an optimal location for detection. The auxiliary device 200 can be attached to any part of the injection device 10 as 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 cover for at least a part of the auxiliary device 200.

[0039] In some cases, when the housing 220 of the auxiliary device 200 is attached to the distal end of the injection device 10, the housing 220 of the auxiliary device 200 is formed to be 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 lateral width or diameter of the injection device 10. Alternatively, or in addition, when the housing 220 of the auxiliary device 200 is attached to the distal end of the injection device 10, the housing 220 of the auxiliary device can be configured to be parallel to and at the same height as the injection device housing 11. The housing 220 of the auxiliary device can have an edge configured such that at least a portion of the edge of the housing 220 of the auxiliary device contacts and aligns with at least a portion of the edge of the injection device housing 11 when the auxiliary device is attached to the injection device 10. In certain embodiments, the entire edge of the housing 220 of the auxiliary device is configured to contact and align 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 be at 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] When the auxiliary device 200 is attached to the injection device 10, at least a part of the auxiliary device 200 can be formed to extend into the injection device 10 (see Fig. 13A). Doing so enables, for example, positioning of sensors or components in a location that allows determination of information regarding the injection device 10. A part of the auxiliary device 200 that extends into the injection device 10 can be 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 positioned within 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 a removable cap 30 when the cap is attached to the injection device 10. The flexible or rigid extension 280 can have sensors such as those discussed herein, 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, and they are positioned on the extension 280 such that when the auxiliary device 200 is attached to the injection device 10, they can perform their roles (e.g., detecting movement of a part of 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 formed not to extend beyond the housing 11 of the injection device 10. In this situation, the injection device 10, for example, when attached, the auxiliary device 200 is It can have a recess located under a removable cap 30 disposed therein. Any component of the injection device 10 that needs to be exposed during use, such as a visual indicator 231, can be located on the surface of the auxiliary device 200 that remains exposed when attached, and thus this surface substantially forms the distal end of the injection device 10. In some embodiments, the auxiliary device 200 has a teardrop-shaped cross-section, and the teardrop-shaped cross-section can include a flexible or rigid extension 280 discussed herein (FIG. 13C). For example, the extension 280 is positioned relative to the auxiliary device 200 to form a teardrop shape when the device is not attached, and when preparing the auxiliary device 200 for attachment to the injection device 10, the extension 280 can be a flexible PCB that folds to a position such that it is disposed within a recess or cavity of the injection device 10 when attached.

[0043] FIG. 3 is a schematic view of an embodiment of an auxiliary device 200 showing some internal and external components. Internally, the auxiliary device 200 includes a main electronic circuit 24. The main electronic circuit 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). In some embodiments, the main electronic circuit 24 can be located on a flex PCB.

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

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

[0046] The auxiliary device 200 also includes a communication unit configured to transmit and / or receive information with another device. The communication unit 240 can be a wireless unit 241. Such transmission can be based on, for example, wireless 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 with another device while being connected, for example, by a cable or fiber connection. When data is transmitted, the unit (value) of the data being transferred can be defined explicitly or implicitly. The wireless unit 241 is coupled to and can be controlled thereby 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), and 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 can include a component 230 for providing feedback to the user. For example, the auxiliary device 200 can include one visual indicator 231, such as an LED 232, or a plurality of visual indicators 231. The visual indicator 231 can emit light to indicate a specific state to the user. If the device includes a plurality of visual indicators 231, a specific combination of the indicators that emit light can indicate different situations. Alternatively, or in addition, the individual visual indicators 231 can have different outputs or displays in response to the situation being indicated. For example, the visual indicator 231 can output light of different colors to indicate different situations. One or more visual indicators can be RGB LEDs 233.

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

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

[0050] As will be further discussed below, the component 230 for providing feedback to the user can be used to provide information regarding the start of the injection, such as a failure to detect the start of the injection, information regarding the end of the injection, such as a failure to detect the end of the injection, or information regarding the transmission status of the data, such as the success or failure of the data transmission.

[0051] The auxiliary device 200 can include a power source 212 such as a battery. The power source 212 can supply power to the electrical components of the auxiliary device 200, such as, for example, the main electronic circuit 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 shows an exemplary system and also shows the communication between the auxiliary device 200 and other devices.

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

[0054] The auxiliary device 200 can be activated, i.e., transitioned from an inactive state to an active state, by a signal 1001 received from an external device 1000. The signal 1001 can include a wake-up signal. The external device 1000 can activate the auxiliary device 200 by a signal sent via any suitable means including a wired or wireless connection and transmitted to the communication unit 240 of the auxiliary device 200. The communication unit 240 of the auxiliary device 200 can receive signals while the auxiliary device 200 is in a low-power mode, for example, by not requiring another power source or by maintaining access to the power source of the auxiliary device 200. This can be achieved. In a specific example, the external device can activate the auxiliary device 200 by short-range communication. In this example, the auxiliary device 200 will include a short-range communication antenna 242.

[0055] When activated, the auxiliary device 200 can enter an active state. In this state, for example, one or more arbitrary sensors can detect. The auxiliary device 200 can transfer data to the external device 1000 in this state.

[0056] The injection device 10 can administer an injection regardless of the situation of the auxiliary device 200. For example, the injection device 10 can be an auto-injector, which can deliver an injection when the auxiliary device 200 is not attached, or when attached, or when the auxiliary device 200 is in an inactive or active state.

[0057] The external device 1000 can be any device that can communicate with the auxiliary device 200 and can store, process, display, or transmit data received from the auxiliary device 200. For example, the external device 1000 can be a tablet, smartphone, smartwatch, computer, or any suitable device.

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

[0059] For example, the sensor 251 can be a conductive rubber pad 260 included within the auxiliary device 200, which can be configured to detect the movement of the components of the injection device 10 included in the injection procedure when the auxiliary device 200 is attached to the injection device 10. Thus, the conductive rubber pad 260 can detect the start of the injection procedure by the injection device 10. The rubber pad 260 can be arranged such that when the auxiliary device 200 is attached to the injection device 10, a protrusion from the plunger or a related component is pushed against the conductive rubber pad. This protrusion is configured to retract into the injection device 10 as the plunger advances, and thus, when the injection starts, the protrusion is no longer pushed into the rubber pad. Alternatively, or in addition, the conductive rubber pad 260 can be located on a rigid or flexible extension 280 described herein, such as a flexible PCB, and can be positioned such that when the auxiliary device 200 is attached to the injection device 10, it enables the determination of information about the injection device 10.

[0060] The conductive rubber pad 260 can be as shown in Fig. 5A. The rubber pad includes protrusions that are arranged to be pushed into the pad and be under pressure when the auxiliary device 200 is attached to the injection device 10 (Fig. 5B). The protrusions are 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 moves (Fig. 5C), the part that presses on the protrusions of the rubber pad moves away from the rubber pad, releasing the protrusions and allowing the protrusions to relax away from the rubber pad. Thus this movement can 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 components of the injection device 10 included in the injection procedure. The switch can be a microswitch 261. The switch is included within the auxiliary device itself. Alternatively, the switch or the 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 a wired connection for example. Alternatively, or in addition, the switch or the microswitch 261 can be located on a rigid or flexible extension 280 described herein, such as a flexible PCB for example, and can be positioned at a location that enables determination of information regarding 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 within the auxiliary device 200, but can detect the movement of the lever 32 located within the injection device 10. The lever 32 can be located within a slot or gap 33 within the plunger (FIG. 6A) and biased in the direction of the slot or gap 33 before the start of the injection procedure. Alternatively, the lever 32 can be located within and biased in the direction of a slot or gap 33 of a component attached to the plunger so as 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 components of the injection device 10 included 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 as to be able to identify a particular portion of the plunger 14. The optical reflection sensor 263 can be included inside 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 a wired connection, for example. Alternatively, or in addition, the optical reflection sensor 263 can be located on a rigid or flexible extension 280 described herein, such as a flexible PCB, for example, and positioned such that when the auxiliary device 200 is attached to the injection device 10, the optical reflection sensor 263 can be positioned at a location that enables measurement of information regarding the injection device 10.

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

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

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

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

[0068] The sensor 250 can 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 components of the injection device 10 included in the injection procedure. The switch can detect the movement of a component, such as a 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 entire length required for the injection. The switch can be a microswitch 261. The switch can be included inside the auxiliary device 200 itself. Alternatively, the switch or microswitch 261 can be located inside 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 a wired connection. The switch or microswitch 261 can be located on a rigid or flexible extension 280 described herein, such as a flexible PCB.

[0070] In an embodiment, the microswitch 261 can be as shown in FIG. 6. During the injection procedure, the microswitch 261 is actuated by the lever 32 as shown in FIG. 6B, which is forced to the actuated position by the plunger 14, and the lever 32 is biased against the plunger 14. At the end of the injection procedure, the plunger 14 moves to a position where the lever 32 relaxes, and thus no longer actuates the microswitch 261 (FIG. 6C), allowing the end 272 of the injection procedure to be determined.

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

[0072] Alternatively, or in addition, sensor 250 can be a light reflection sensor 263. This sensor 263 can sense the movement of the components of the injection device 10 included in the injection procedure. For example, the light reflection sensor can continuously sense the movement of a component associated with injection, such as a plunger, and detect 272 when this movement ends. Alternatively, the light reflection sensor can sense when a part of the aforementioned components reaches a predetermined position associated with the end of injection (Figure 7C). For example, the light reflection sensor can detect when a part of the plunger moves to a position indicating that the plunger has moved the entire length required for injection. To facilitate these detections, the plunger of the injection device 10 is patterned or coded so that a specific part of the plunger can be identified. The light reflection sensor can be included inside the auxiliary device 200 itself. Alternatively, the light reflection sensor can be arranged within the injection device 10 and can transmit the start of the injection procedure to the auxiliary device 200. This transmission can be by any suitable means, such as a wired connection. The light reflection sensor 263 can be located on a rigid or flexible extension 280 described herein, such as a flexible PCB, so that when the auxiliary device 200 is attached to the injection device 10, the light reflection sensor 263 can be positioned at a location that enables determination of information regarding the injection device 10. Instead, the light reflection sensor can sense when a part of the aforementioned components reaches a predetermined position associated with the end of injection (Figure 7C). For example, the light reflection sensor can detect when a part of the plunger moves to a position indicating that the plunger has moved the entire length required for injection. To facilitate these detections, the plunger of the injection device 10 is patterned or coded so that a specific part of the plunger can be identified. The light reflection sensor can be included inside the auxiliary device 200 itself. Alternatively, the light reflection sensor can be arranged within the injection device 10 and can transmit the start of the injection procedure to the auxiliary device 200. This transmission can be by any suitable means, such as a wired connection. The light reflection sensor 263 can be located on a rigid or flexible extension 280 described herein, such as a flexible PCB, so that when the auxiliary device 200 is attached to the injection device 10, the light reflection sensor 263 can be positioned at a location that enables determination of information regarding the injection device 10.

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

[0074] At least one sensor 250 capable of detecting the end of injection can transmit this information to the processor 25 or controller included 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 the injection. Alternatively, the auxiliary device 200 can include a single sensor 250 that can determine both the start and the end of the 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 medicament within the injection device 10, for example, by means of the sensor 253. For example, the auxiliary device 200 can determine the type of medicament, the identification of the medicament, an ID number, a batch number, an expiration date, an elapsed time, or similar information. The auxiliary device 200 can include a sensor 254 that can determine the optical properties of a component associated with or attached to the injection device 10, such as a part of the injection device 10 or a medicament cartridge, in order to determine information related to the medicament. Alternatively, or in addition, the sensor 253 can detect a code from which information related to the medicament can be derived.

[0077] The auxiliary device 200 can include an optical sensor 254 capable of determining information about the drug within the injection device 10. For example, the information 100 for identifying the drug can be the color of the housing 11 of the injection device 10, or the color of an area of the housing, or the color of a label attached to the housing. In these embodiments, the optical sensor 254 can be a simple photometer configured to detect color. In some other embodiments, the information 100 for identifying the drug can be a QR code or other similar coded information, and the optical sensor 254 can be a camera or a QR code reader. Additionally, one or more light sources can be provided to improve the reading by the optical sensor 254. The light source can provide light of a certain wavelength or spectrum to improve color detection by the optical sensor 254. The light source can be arranged, for example, so that unwanted reflections caused by the curvature of the housing 11 are avoided or reduced. In an exemplary embodiment, the optical sensor 254 is a camera unit configured to detect a code 100 (e.g., a one-dimensional or two-dimensional barcode as a barcode that can be) related to the injection device 10 and / or the drug contained therein. This code 100 can be located, for example, on the housing 11 or on the drug container contained in the injection device 10. This code 100 can indicate, for example, the type of the injection device 10 and / or the drug, and / or other characteristics (e.g., expiration date). This code 100 can be a QR code 100. The QR code is generally black and white, and thus, on the side of the optical sensor 254, there is no need to detect color. Doing so can simplify and reduce the cost of manufacturing the optical sensor 254. In other embodiments, the auxiliary device 200 can include a sensor (not shown) capable of determining information about the drug within the injection device 10 by other means, such as RFID detection.

[0078] The processor 25 can be configured to examine the information 100 read by the sensor 253 against pre-stored information, for example, to verify that the user is injecting the correct drug. If the processor 25 does not recognize the information 100, or if the information 100 indicates that the injection procedure may be inappropriate, such as when the information indicates a drug different from what 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 can include a temperature sensor 255. The temperature sensor 255 can detect the temperature of the auxiliary device 200 itself, and this information can be used to estimate the temperature of the drug present in the injection device 10. A flowchart showing the operations that can be performed by the auxiliary device 200 including the temperature sensor 255 is shown in FIG. 8.

[0080] The temperature sensor 255 can be located on a rigid or flexible extension 280 described herein, such as a flexible PCB, to enable the temperature sensor 255 to be placed in a location suitable for estimating the temperature of the drug present in the injection device 10.

[0081] At 601, the temperature sensor 255 can start detection after the auxiliary device 200 is activated. Thus, the temperature sensor 255 is activated in the active state of the auxiliary device 200. After activation, the temperature sensor 255 can measure the temperature at 602.

[0082] Injecting a drug that is too cold or too hot can be uncomfortable for the user, so it is preferable to deliver the drug at a specific temperature, such as room temperature. However, some drugs are stored at low temperatures. Therefore, when the auxiliary device 200 determines that the temperature is lower than a predetermined temperature, such as room temperature 603, the auxiliary device 200 can notify the user that the drug 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 of those disclosed herein, including an indicator 230 associated with the auxiliary device 200 or communication to an external device 1000 that can display information to the user.

[0083] Alternatively, or in addition, the auxiliary device 200 can start a timer 606 when it detects the ambient temperature or an incorrect temperature, as shown in FIG. 9. The timer can operate over the length of time required for the drug to reach the required temperature. This length of time can be adjusted in response to the type or identification of the drug or in response to other characteristics such as the volume of the drug. After the time has elapsed 607, the auxiliary device 200 can notify the user by means of an indicator 230 associated with it or by communication to an external device 1000 that can display information to the user 605.

[0084] In other embodiments, the auxiliary device 200 can include a temperature-sensitive patch 612 that can measure temperature (see FIG. 10). The temperature-sensitive patch can be configured to indicate when the temperature is not suitable for injection 614 and / or suitable for injection 615 based on whether the ambient temperature matches a predetermined temperature 613. For example, the temperature-sensitive patch can be a specific 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 drug is suitable for starting 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 an external device 1000, for example, via the communication unit 240. Alternatively or in addition, the processor 25 of the auxiliary device 200 can use a specific algorithm to confirm the temperature of the drug within 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 within 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 performed by any method or simultaneously with any transmission, as disclosed herein.

[0087] The communication unit 240 can transmit 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 activate the auxiliary device 200. The transfer can be initiated by short-range communication and / or the transfer can be advanced by short-range communication. In some embodiments, the data transfer will be via Bluetooth. In other embodiments, short-range communication is used to activate the auxiliary device 200 and Bluetooth is used to transmit the collected information. The auxiliary device 200 can sense whether the data transfer was successful or completed, and if not, the auxiliary device 200 can retry the transmission and / or notify the user that the data transmission has failed.

[0088] The data to be transmitted can include information regarding the start of injection, the end of injection, temperature, and / or drug-related information.

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

[0090] Optionally, the auxiliary device 200 can include a memory 34 suitable for storing the information measured by the sensor. This information can include information regarding the start of injection, the end of injection, the drug, temperature, or any other derived information. The data transmitted to the external device 1000 can 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 transmit the data to a third-party device, such as a cloud service. can do.

[0092] Before the start of injection, the external device 1000 can display a warning or alert to the user, such as those discussed herein regarding the identification of the drug. The external device 1000 can further or alternatively display instructions for the recommended treatment.

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

[0094] FIG. 11 shows a flowchart illustrating operations that can be implemented by an exemplary embodiment of the auxiliary device 200. This embodiment includes a short-range communication antenna 242, a sensor 251 for detecting the start of an injection procedure by a disposable auto-injector, 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 position on the disposable auto-injector.

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

[0096] The auxiliary device 200 of this embodiment operates 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 included in the auto-injector, and thus the auxiliary device 200 and the sensors are attached to a predetermined position. The auxiliary device 200 is attached such that the resulting assembly has an extended length compared to the injection device 10 alone. After attachment, the electronic circuit of the auxiliary device 200 is then activated by an external device 1000, such as a smartphone, via short-range communication (step 501). This activates the sensors including both the injection start sensor 251 and the injection end sensor 252.

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

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

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

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

[0101] FIG. 11 is a flowchart showing operations that can be implemented by an exemplary embodiment of the auxiliary device 200. This embodiment includes a communication unit 240 capable of communicating in the BLE whisper mode, a sensor 250 for detecting the start and end of an injection procedure by a disposable auto-injector, a processor 25, and a hook 211 configured to attach the auxiliary device 200 to a predetermined position on the disposable auto-injector. The auxiliary device 200 also includes an extension 280 which is a flexible PCB that can extend outwardly from the body of the auxiliary device 200. When attached to the injection device, this flexible PCB is positioned within the housing of the injection device and extends along the injection device in a direction forming a right angle (as shown by FIG. 13B). The auxiliary device 200 further includes a multicolor LED 233 that enables feedback to the user.

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

[0103] The auxiliary device 200 of this embodiment operates 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 included by the auto-injector, attaching the auxiliary device 200, and thus the sensor, to a predetermined position. The electronic circuitry of the auxiliary device 200 is then activated by an external device 1000 such as a smartphone via short-range communication, which 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, as shown in FIG. 10 and described herein, will indicate to the user whether the drug is at a temperature suitable for injection. If the temperature is not at the appropriate temperature, the user will wait until the patch indicates that the temperature is correct before starting the injection procedure.

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

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

[0107] FIG. 11 shows a flowchart illustrating operations that can be implemented by an exemplary embodiment of the auxiliary device 200. This embodiment is an auxiliary device 200 that can communicate with an external device via both NFC and Bluetooth. The auxiliary device 200 also includes a temperature sensor 255, a sensor 253 for identifying a drug, a plurality 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 (shown by FIG. 13C). The auxiliary device 200 also includes an extension 280 that is a flexible PCB that can extend outwardly from the body of the auxiliary device 200. When attached to the injection device, this flexible PCB will be positioned within the housing of the injection device and will extend along the injection device in a perpendicular direction.

[0108] The auxiliary device 200 includes a light reflection sensor 263 that can continuously detect the progress of the injection procedure, as shown in FIG. 7 and described herein. The light reflection sensor 263 is disposed on the flexible PCB such that when attached to the injection device, the light reflection sensor 263 is in the position shown in FIG. 7. The auxiliary device 200 is designed to be used with an auto-injector having a plunger 14 or a component associated with the plunger, where at least some optical characteristics of the plunger are such that the position of the plunger can 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 with 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 position. The electronic circuit of the auxiliary device 200 is then activated 501 by an external device 1000, such as a smartphone, via short-range communication. Doing so activates the sensors included by the auxiliary device 200.

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

[0111] The auxiliary device 200 also measures the ambient temperature with the temperature sensor 255 and calculates the estimated temperature of the drug within the auto-injector. If the temperature does not match a predetermined temperature, the auxiliary device 200 will alert the user, for example, by illuminating a specific pattern of LEDs or by displaying a specific color with one or more LEDs. Thereafter, the auxiliary device 200 will indicate to the user that the predetermined temperature has been detected and thus the injection can proceed, or the auxiliary device 200 has activated a timer when an incorrect temperature is detected and will wait until the timer expires before indicating to the user that the injection can proceed. These processes are shown in FIGS. 8 and 9 and are described herein.

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

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

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

[0115] The terms "drug" or "medication" are used synonymously herein and refer to a pharmaceutical formulation comprising one or more pharmaceutical active ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. A pharmaceutical active ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medication is used for the treatment, cure, prevention, or diagnosis of a disease, or alternatively, to improve physical or mental health. A drug or medication is used for a limited duration or, in the case of chronic diseases, periodically.

[0116] As described below, a drug or medication can comprise at least one API of various types of formulations, or a combination thereof, for treating one or more diseases. Examples of APIs include small molecules with a molecular weight of 500 Da or less; polypeptides, peptides, and proteins (such as hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids are incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

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

[0118] The drugs or agents contained within the drug delivery devices described herein are used for the treatment and / or prevention of numerous different types of medical disorders. Examples of disorders include, for example, diabetes, or complications associated with diabetes such as diabetic retinopathy, and thromboembolisms such as deep vein thrombosis or pulmonary embolism. Another example of a disorder is acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs include, for example, but not limited to, those described in the Handbook Rote Liste 2014, main group 12 (antidiabetic drugs) or main group 86 (antineoplastic drugs), and the Merck Index, 15th edition, etc.

[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, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to a polypeptide having a molecular structure obtained formally from the structure of a natural peptide, such as the structure of human insulin, by deleting and / or exchanging at least one amino acid residue found in the natural peptide and / or by adding at least one amino acid residue. The amino acid residues added and / or exchanged can be codable amino acid residues, or other natural residues or fully synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide having a molecular structure obtained formally from the structure of a natural peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more amino acids. Optionally, one or more amino acids found in the natural peptide may be deleted and / or replaced by other amino acids containing non-codable amino acids, or amino acids containing non-codable amino acids may be added to the natural peptide.

[0120] Examples of insulin analogs include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and Lys at position B29 is replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[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 (registered trademark)), B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-ω-carboxyheptadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)), B29-N-(N-lithocholyl -γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin, and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[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®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

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

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

[0127] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab’)2 fragments that retain the ability to bind an antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immune or humanized, fully human, non-human (e.g., murine), or single-chain antibodies. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has low or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, antibody fragment or variant that does not support binding to Fc receptors, e.g., having a mutated or deleted Fc receptor binding region. The term antibody also includes antibody-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins (CODV).

[0128] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide) that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide that is capable of binding to an antigen. An antibody fragment can include a cleaved portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific antibody fragments, or multispecific antibody fragments such as bispecific, trispecific, tetra-specific, and multi-specific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent antibody fragments, or multivalent antibody fragments such as divalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelate recombinant antibodies, tribodies or diabodies, 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 "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in maintaining the correct positioning of the CDR sequences and enabling antigen binding, rather than being the CDR sequences themselves. The framework region itself usually does not directly participate in antigen binding, as is known in the art, but specific residues within the framework region of a particular antibody can directly participate in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

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

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

[0132] Those skilled in the art will recognize that modifications (additions and / or removals) of the various components, formulations, devices, methods, systems, and embodiments of the API described herein can be made without departing from the full scope and spirit of the disclosure, and it is understood that such modifications, and any and all equivalent forms thereof, are included.

Claims

1. 1. An auxiliary device configured for releasable attachment to an injection device, comprising: At least one wireless communication unit; At least one sensor; an extension, the at least one sensor being located on the extension; Here, the auxiliary device is activating 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, detecting the initiation of an injection by the injection device using at least one sensor; The auxiliary device is configured to communicate the initiation of an injection to an external device via at least one wireless communication unit.

2. The auxiliary device of claim 1 , wherein the extension is 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. An auxiliary device according to any preceding claim, configured to indicate whether communication to the external device was successful.

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

8. 8. The auxiliary device of claim 7, configured to indicate whether a medication contained in the injection device meets predetermined temperature parameters.

9. 8. The auxiliary device of claim 7, 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 has expired.

10. 13. A system comprising: An auxiliary device according to any one of claims 1 to 9; Injection device and Including, The system, wherein the auxiliary device is releasably attached to the injection device.

11. The system of claim 10 , wherein the injection device is a disposable auto-injector.

12. 12. The system of claim 10 or 11, 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.

13. A system according to any one of claims 10 to 12, having a uniform width but a longitudinal length greater than that of the injection device.

14. The system according to any one of claims 10 to 13, wherein the auxiliary device is configured to be mounted within a recess located at the distal end of the injection device.

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