Auxiliary device for attachment to an injection device

Abstract

An auxiliary device (200) configured to be releasably attached to an injection device (10), the auxiliary device comprising: at least one wireless communication unit (241); at least one sensor (250); wherein the auxiliary device is configured to: activate the at least one sensor in response to receiving a wireless communication from an external device (1000) via the at least one wireless communication unit; after activation, use the at least one sensor to detect a start of an injection of the injection device; and communicate the start of the injection to the external device via the at least one wireless communication unit.

Description

[0001] This application is a divisional application of a patent application filed on December 18, 2018, with application number 201880089347.4 and title "Auxiliary Device for Attachment to an Injection Device". Technical Field

[0002] This disclosure relates to an auxiliary device configured to be releasably attached to an injection device. Background Technology

[0003] Many diseases require regular treatment with injectable medications. These injections can be administered using an injection device, either by medical personnel or by the patient themselves.

[0004] Injection devices (i.e., devices capable of delivering medication from a drug container) are designed to make self-administered injection therapy easier for patients. Current therapies delivered via self-administered injection include medications for diabetes (both insulin and newer GLP-1 inhibitors), migraines, allergies, hormone therapy, anticoagulants, and more. Injection devices can also be used to deliver single doses of specific life-saving medications. For example, they are often prescribed to people at risk of allergic reactions. They are also frequently used in the military to protect personnel from chemical warfare agents. Alternatively, injection devices are used to administer medication according to a treatment plan prescribed for people with, for example, multiple sclerosis, rheumatoid arthritis, or anemia.

[0005] Injection devices can be disposable or single-use devices, intended for delivering only one dose of medication and requiring disposal after use. Other types of injection devices can be reusable. Typically, they are arranged to allow the user to load and unload a standard syringe. Reusable injection devices can be used to perform multiple parenteral drug deliveries; however, the syringe is disposed of after use and removal from the device. The syringe may be packaged with additional components to provide additional functionality. Typically, patients can self-treat their illnesses using injection devices, for example, based on daily, weekly, bi-weekly, or monthly doses of medication.

[0006] Injection devices are typically divided into two categories: manual devices and automatic injection devices.

[0007] In manual devices, the user must provide mechanical energy to drive fluid through the needle. This is typically accomplished by some form of button / plunger that must be continuously pressed by the user during injection.

[0008] An automated injection device is a complete or partial replacement for activities involving the parenteral delivery of medications from a standard syringe. These activities may include inserting a needle into the patient's skin, injecting the medication, removing the needle, shielding the needle, and preventing reuse. Automated injection devices can reduce: the force required by the user, hand tremors, and the possibility of incomplete dose delivery. Triggering can be performed by multiple devices, such as a trigger button or the action of the needle reaching its injection depth. In some devices, the energy for fluid delivery is provided by a spring.

[0009] Needle-free injection devices have been developed that use needle-free injection technology to deliver medications. These systems use mechanisms that do not involve penetrating the skin with a cannula to deliver medications through the skin.

[0010] To prevent misuse of the injection device or to track usage data, it is necessary to measure information related to the condition and / or use of the injection device. Reusable attachment devices suitable for use with syringes and for monitoring the dosage delivered by the syringe (and providing additional information to the user) are known. For example, WO 2011 / 117212 describes an auxiliary device including 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 the dosage window of the injection pen, thereby determining the dosage of the drug already dispensed into the injection device.

[0011] There is a need for improved add-on devices capable of identifying and communicating usage information associated with the injection device. There is also a need for methods to minimize the power consumption of such add-on devices. Summary of the Invention

[0012] An auxiliary device 200 is provided for attachment to an injection device 10, which is capable of determining usage information associated with the injection device 10 and transmitting it to an external device 1000. The auxiliary device 200 is particularly advantageous when used with disposable injection devices because it allows data to be recorded and stored separately from the injection device to be disposed of, and allows the combination of usage data from multiple disposable devices from a single user.

[0013] According to one aspect of this disclosure, an auxiliary device configured to be releasably attached to an injection device is provided, the auxiliary device comprising: at least one wireless communication unit; at least one sensor; wherein the auxiliary device is configured to: activate the at least one sensor in response to receiving wireless communication from an external device via the at least one wireless communication unit; after activation, use the at least one sensor to detect the start of injection by the injection device; and transmit the start of injection to the external device via the at least one wireless communication unit.

[0014] The auxiliary device may include an extension, and at least one sensor may be positioned on the extension. The extension may be a flexible printed circuit board.

[0015] The auxiliary device can be configured to indicate the start of injection when no injection has yet been detected by the injection device.

[0016] The auxiliary device can be configured to indicate that the start of injection by the injection device has been detected, and the end of injection by the injection device has not yet been detected.

[0017] The auxiliary device can be configured to indicate that the start of injection by the injection device has been detected, and that the end of injection by the injection device has not been detected within a predetermined time after the start of the injection.

[0018] The auxiliary device can be configured to indicate whether communication to the external device was successful.

[0019] The auxiliary device may also include a temperature sensor.

[0020] The auxiliary device can be configured to indicate whether the drug contained in the injection device meets a predetermined temperature parameter.

[0021] The auxiliary device can be configured to start a timer in response to determining that the agent included in the injection device does not meet a predetermined temperature parameter, and can provide an indication when the timer expires.

[0022] According to one aspect of this disclosure, a system is provided comprising: any of the auxiliary devices defined herein, and an injection device, wherein the auxiliary device is releasably attached to the injection device.

[0023] The injection device can be a disposable auto-injector.

[0024] The auxiliary device may include a housing that is shaped such that, when attached to the injection device, the housing of the auxiliary device is flush with the housing of the injection device.

[0025] The system may have a uniform width, but its longitudinal length is greater than that of the injection device.

[0026] The auxiliary device can be configured to attach to a groove located at the distal end of the injection device.

[0027] This invention includes:

[0028] 1. An auxiliary device configured to releasably attach to an injection device, the auxiliary device comprising:

[0029] At least one wireless communication unit;

[0030] At least one sensor;

[0031] An extension, wherein at least one sensor is positioned on the extension;

[0032] The auxiliary device is configured to:

[0033] The at least one sensor is activated in response to receiving wireless communication from an external device via the at least one wireless communication unit.

[0034] After activation, the at least one sensor is used to detect the start of injection by the injection device, and

[0035] The start of the injection is communicated to the external device via the at least one wireless communication unit.

[0036] 2. The auxiliary device according to item 1, wherein the extension is a flexible printed circuit board.

[0037] 3. The auxiliary device according to any of the preceding claims, wherein the auxiliary device is configured to indicate the start of injection by the injection device before it has been detected.

[0038] 4. The auxiliary device according to any of the preceding claims, wherein the auxiliary device is configured to indicate that the start of injection by the injection device has been detected and the end of injection by the injection device has not yet been detected.

[0039] 5. The auxiliary device according to any of the preceding claims, wherein the auxiliary device is configured to indicate that the start of injection by the injection device has been detected, and the end of injection by the injection device has not been detected within a predetermined time period of the start of the injection.

[0040] 6. The auxiliary device according to any of the preceding claims, wherein the auxiliary device is configured to indicate whether the communication to the external device is successful.

[0041] 7. The auxiliary device according to any of the preceding claims further includes a temperature sensor.

[0042] 8. The auxiliary device according to item 7, wherein the auxiliary device is configured to indicate whether the agent included in the injection device meets a predetermined temperature parameter.

[0043] 9. The auxiliary device according to item 7, wherein the auxiliary device is configured to start a timer in response to determining that the agent included in the injection device does not meet a predetermined temperature parameter, and to provide an indication when the timer expires.

[0044] 10. A system comprising:

[0045] According to any of the foregoing auxiliary devices, and

[0046] Injection device

[0047] The auxiliary device is releasably attached to the injection device.

[0048] 11. The system according to item 10, wherein the injection device is a disposable auto-injector.

[0049] 12. The system according to claim 10 or 11, wherein the auxiliary device includes a housing shaped such that, when attached to the injection device, the housing of the auxiliary device is flush with the housing of the injection device.

[0050] 13. The system according to any one of claims 10 to 12, wherein the system has a uniform width but a longitudinal length greater than that of the injection device.

[0051] 14. The system according to any one of claims 10 to 13, wherein the auxiliary device is configured to be attached to a recess located at the distal end of the injection device. Attached Figure Description

[0052] Figure 1A A side view of the injection device is shown;

[0053] Figure 1B Show Figure 1A A side view of the injection device, with the cap removed;

[0054] Figure 2A An external view showing an embodiment of the auxiliary device;

[0055] Figure 2B The image shows an injection device with the cap removed, an injection device with an auxiliary device attached during the attachment process, and an injection device with the auxiliary device attached.

[0056] Figure 3 Internal components of an embodiment of an auxiliary device attached to an injection apparatus are shown;

[0057] Figure 4 This illustrates an implementation of the auxiliary device, and the communication between the injection device and external devices.

[0058] Figure 5A An embodiment of an auxiliary device including a conductive rubber pad is shown;

[0059] Figure 5B An embodiment of an auxiliary device is shown, which includes a conductive rubber pad to detect the start of the injection procedure when used with the injection device;

[0060] Figure 5C An embodiment is shown in which the auxiliary device includes a conductive rubber pad during use with the injection device after the injection procedure has begun;

[0061] Figure 6A An embodiment of an auxiliary device including a microswitch prior to the injection procedure is shown;

[0062] Figure 6B An embodiment of an auxiliary device including a microswitch during an injection procedure is shown;

[0063] Figure 6C An embodiment of an auxiliary device including a microswitch at the end of the injection procedure is shown;

[0064] Figure 7A An embodiment of an auxiliary device including an optical reflection sensor prior to the injection procedure is shown;

[0065] Figure 7B An embodiment of an auxiliary device including an optical reflection sensor during an injection procedure is shown;

[0066] Figure 7C An embodiment is shown that includes an auxiliary device with an optical reflection sensor at the end of the injection procedure;

[0067] Figure 8 A flowchart illustrating temperature determination-related operations that can be performed by an implementation of the auxiliary device is shown;

[0068] Figure 9 A flowchart illustrating temperature determination-related operations that can be performed by an implementation of the auxiliary device is shown;

[0069] Figure 10 A flowchart illustrating temperature determination-related operations that can be performed by an implementation of the auxiliary device is shown;

[0070] Figure 11 A flowchart illustrating operations that can be performed by an implementation of the auxiliary device is shown, which relate to determining the start and end of the injection procedure and transmitting data about this determination to an external device;

[0071] Figure 12 A flowchart illustrating operations related to determining drug-related information that can be performed by an implementation of the auxiliary device is shown; and

[0072] Figure 13 illustrates an embodiment of an auxiliary device including an extension configured such that when the auxiliary device is attached to an injection device, the extension is located within a recess or cavity of the injection device. Detailed Implementation

[0073] In the following description, embodiments will be referenced to pen injectors. However, this disclosure is not limited to such applications and can be equally applied to other types of drug delivery devices, such as syringes, pre-filled syringes, needle-free injectors, and inhalers.

[0074] Now refer to Figure 1A and Figure 1B The following describes an injection device 10 (also referred to herein as a drug delivery device 10) according to an embodiment. In some embodiments, the injection device 10 is a single-use injection device, 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 discarded after administering multiple doses. The injection device 10 has a proximal end P and a distal end D. The proximal end P faces the patient's injection site during injection, while the distal end D faces away from the injection site.

[0075] 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 medication 16. In the following description, it should be referred to as the cartridge 18 supported by the cartridge holder (not shown). The cartridge 18 is in… Figure 1B It is shown in dashed lines and can be positioned below window 15 in housing 11.

[0076] The outer housing 11 also houses a dispensing mechanism (not shown) for dispensing the drug 16 during injection.

[0077] The hollow needle 17 communicates with the internal volume of the cartridge 18 and acts as a conduit for the liquid medication 16 during injection. The needle 17 and the cartridge 18 are fixed relative to each other and to the body 9. A stop, plunger, piston, or stopper 14 is movable within the cartridge 18 to dispense the medication contained within the cartridge 18 through the needle 17 under the action of the dispensing mechanism.

[0078] The dispensing mechanism is mechanically coupled to the piston 14 of the cartridge 18. The dispensing mechanism is configured to move the piston axially in the proximal direction along the cartridge 18 to dispense the medication 16 through the needle 17. The dispensing mechanism includes components that cooperate in applying force to the piston 14 in response to an actuation input provided by the user. Here, the actuation input triggering the application of force to the piston 14 is received via a dose dispensing button 13 located at the distal end of the injection device 10. The dispensing mechanism is mechanically coupled to the dispensing button 13.

[0079] A label is provided on the housing 11. The label includes information 100 about the medication included in the injection device 10, including information for identifying the medication. The information for identifying the medication 100 may be in text form. The information for identifying the medication 100 may also be in color form. The information for identifying the medication 100 may also be encoded as a barcode, QR code, etc. The information for identifying the medication 100 may also be in the form of a black and white pattern, a color pattern, or a shaded pattern.

[0080] Figure 2A This is a schematic diagram of an embodiment of an auxiliary device 200 for releasably attaching to the injection device 10 of FIG1. Figure 2B The illustration shows the injection device before, during, and after the embodiment attached to auxiliary device 200. Auxiliary device 200 is adapted to... Figure 1A and Figure 1B The injection device shown herein can be used in conjunction with other types of injection devices discussed above. The auxiliary device 200 can be used with injection devices, including reusable and disposable injection devices. The auxiliary device 200 can also be adapted for use with manual syringes and autoinjectors. In a particular embodiment, the auxiliary device 200 can be used with a disposable pen-type autoinjector.

[0081] The auxiliary device 200 may be attachable to the injection device 10. For example, the auxiliary device 200 may include a means 210 for attaching to the injection device, or the injection device may include a means for attaching to the auxiliary device 200. The auxiliary device 200 may include a means 210 configured to attach to a portion of the injection device, said portion being configured for attaching the auxiliary device 200. The injection device 10 and the auxiliary device 200 may optionally include cooperating alignment features to ensure that the auxiliary device 200 is correctly oriented and positioned relative to the injection device 10. In an illustrative embodiment, the auxiliary device 200 may include hooks 211, and the injection device may include recesses 31, wherein the hooks 211 of the auxiliary device 200 are configured to snap into place, and thus allow the auxiliary device 200 to remain on the injection device. Other attachment means may include: adhesive surfaces, magnetic components, clips, threaded components, or any suitable means.

[0082] The injection device may include a cap 30 located within, above, or over the attachment position of the auxiliary device 200. This cap 30 may, for example, include a hook similar to the hook of the auxiliary device 200 and be attached in a similar manner. The cap 30 may be a removable cap that can be removed before attaching the auxiliary device 200.

[0083] The attachment device 210 allows the orientation, position, or alignment of the auxiliary device 200 relative to the injection device 10 to be predetermined upon attachment. The predetermined orientation, position, or alignment can be positioning any feature (such as a sensor) 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, and the hook 211 and recess 31 may be configured such that the auxiliary device 200 can only be attached in a manner that allows the device to operate correctly, such as positioning any sensor in the optimal position for detection. The auxiliary device 200 can be attached to any part of the injection device 10, as long as the attachment does not interfere with the operation of the injection device 10. For example, the injection device 10 may be an autoinjector, and the auxiliary device 200 may be attached to the distal end of the autoinjector.

[0084] The auxiliary device 200 includes a housing 220. The housing 220 can provide an enclosure for at least a portion of the auxiliary device 200.

[0085] Optionally, the housing 220 of the auxiliary device 200 can be shaped 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, such as... Figure 2B As shown. Therefore, the attachment of the auxiliary device 200 to the injection device 10 results in an assembly with a uniform width, but longer than the length of the injection device 10 alone. To achieve this effect, the auxiliary device 200 can be shaped to have the same width or diameter as the injection device 10. Alternatively or additionally, 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 flush with the injection device housing 11. The auxiliary device housing 220 may have edges configured such that, when attached to the injection device 10, at least a portion of the edge of the auxiliary device housing 220 contacts and mates with at least a portion of the edge of the injection device housing 11. In a particular embodiment, when the auxiliary device 200 is attached to the injection device 10, 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.

[0086] Alternatively, the auxiliary device 200 may be configured to be attached to the distal end of the injection device 10 and be wider than the injection device 10, such that the resulting assembly is an injection device with a wider distal end.

[0087] The auxiliary device 200 can be shaped such that, when attached to the injection device 10, at least a portion of the auxiliary device 200 will extend into the injection device 10 (see [link]). Figure 13AThis can, for example, allow sensors or components to be positioned where information related to the injection device 10 can be determined. The portion of the auxiliary device 200 extending 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 located within a recess or cavity of the injection device 10. Figure 13B or Figure 13C This cavity or recess can be positioned such that when the removable cap 30 is attached to the injection device 10, the cavity or recess is covered by the cap. The flexible or rigid extension 280 may have sensors, such as the sensor 250 for detecting the start and end of injection discussed herein, a conductive rubber pad 260, a microswitch 261, an optical reflection sensor 263, an optical sensor 254, or a temperature sensor 255, positioned on the extension 280 in such a way that they can perform their function (e.g., detect movement of a portion of the injection device 10) when the auxiliary device 200 is attached to the injection device 10.

[0088] In some embodiments, the auxiliary device 200 is shaped such that it attaches to the distal end of the injection device 10 but does not extend beyond the housing 11 of the injection device 10. In this case, the injection device 10 may have, for example, a recess located below the removable cap 30, in which the auxiliary device 200 is located when attached. Any components of the injection device 10 that need to be exposed during use (such as the visual indicator 231) may be located on the surface of the auxiliary device 200, which remains exposed when attached, and thus this surface effectively 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 flexible or rigid extensions 280 as discussed herein. Figure 13C For example, the extension 280 may be a flexible PCB that, when the device is not attached, is positioned against the auxiliary device 200 to form a teardrop shape, and when the auxiliary device 200 is to be attached to the injection device 10, the flexible PCB may be folded such that the extension 280 is located within a groove or cavity of the injection device 10 when attached.

[0089] Figure 3This is a schematic diagram of an embodiment of the auxiliary device 200, showing some internal and external components. Internally, the auxiliary device 200 includes a main electronic component 24. The main electronic component 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), etc. The processor 25 executes program code (e.g., software or firmware). In some embodiments, the main electronic component 24 can be located on a flexible PCB.

[0090] The auxiliary device 200 may include memory. The main electronics 24 may include both program memory and main memory. The processor can execute program code stored in the program memory and use the main memory, for example, to store intermediate results. The program memory may be, for example, read-only memory (ROM), and the main memory may be, for example, random access memory (RAM). The device may include non-volatile memory for storing information, such as information derived from any sensors included within the auxiliary device 200.

[0091] The auxiliary device 200 also includes one or more sensors. The one or more sensors can be connected to and controlled by the main electronics 24.

[0092] The auxiliary device 200 also includes a communication unit configured to transmit and / or receive information to / from another device. The communication unit 240 may be a wireless unit 241. Such transmissions may be based on radio or optical transmissions, for example. In some embodiments, the wireless unit 241 is a Bluetooth transceiver. Alternatively, the wireless unit 241 may be replaced or supplemented by a wired unit (not shown) configured to transmit and / or receive information to / from another device in a wired manner (e.g., via cable or fiber optic connection). When transmitting data, the unit of the transmitted data (values) may be explicitly or implicitly defined. The wireless unit 241 may be coupled to and controlled by the main electronics 24. In a particular embodiment, an external device 1000 may activate the auxiliary device 200 via near-field communication (NFC), in which case the auxiliary device 200 will include a near-field communication antenna 242. In some embodiments, the auxiliary device 200 will include a communication unit 240 capable of Bluetooth communication and NFC.

[0093] The auxiliary device 200 may include components 230 for providing feedback to the user. For example, the auxiliary device 200 may include one visual indicator 231 (such as an LED 232) or multiple visual indicators 231. The visual indicator 231 may emit light to indicate a specific state to the user. If the device includes multiple visual indicators 231, specific combinations of the emitting indicators may indicate different states. Alternatively or additionally, depending on the indicated state, individual visual indicators 231 may have different outputs or displays. For example, visual indicators 231 may output different colors of light to indicate different states. One or more visual indicators may be RGB LEDs 233.

[0094] The assistive device 200 may also include one or more auditory indicators 234, such as an audio module 104 configured to provide audio feedback to a user of the assistive device 200. The one or more auditory indicators 234 may be, for example, a speaker, a buzzer, a piezoelectric buzzer, or any suitable auditory indicator. This may be an alternative to or a supplement to the visual indicator 231. Both the one or more visual indicators 231 and the one or more auditory indicators 234 may be coupled to and controlled by the main electronics 24.

[0095] The auxiliary device 200 may optionally include a locking sensor 106, which is configured to sense whether the attachment mechanism is in a locked or unlocked position.

[0096] As will be discussed further below, the component 230 for providing feedback to the user can be used to provide information about the start of injection (e.g., failure to detect the start of injection), the end of injection (e.g., failure to detect the end of injection), or the status of data transmission (e.g., successful or unsuccessful data transmission).

[0097] The auxiliary device 200 may include a power source 212, such as a battery. The power source 212 may supply power to the electrical components of the auxiliary device 200, such as the main electronics 24, memory 34, wireless unit 241, one or more sensors, visual indicator 231 and / or auditory indicator 234.

[0098] Figure 4 An exemplary system is shown, and communication between the auxiliary device 200 and other devices is illustrated.

[0099] The auxiliary device 200 has a static state in which the electronic components can be in a low-power mode, in which all non-essential electrical processes are powered off. For example, if the auxiliary device 200 includes sensors, auditory indicators 234, or visual indicators 231, these components will not be activated or powered in the static state. This has the advantage of minimizing the power consumption of the auxiliary device 200.

[0100] The auxiliary device 200 can be activated, i.e., transition from a static state to an active state, via a signal 1001 received from the external device 1000. The signal 1001 may include a wake-up signal. The external device 1000 can activate the auxiliary device 200 via a signal transmitted through any suitable means (including wired or wireless connections) and communicated to the communication unit 240 of the auxiliary device 200. The communication unit 240 of the auxiliary device 200 is configured to receive the signal even when the auxiliary device 200 is in a low-power mode, for example, by not requiring a separate power supply or by maintaining access to power to the auxiliary device 200 in a low-power mode. In a particular embodiment, the external device can activate the auxiliary device 200 via near-field communication, in which case the auxiliary device 200 will include a near-field communication antenna 242.

[0101] Once activated, the auxiliary device 200 can be in an active state. In this state, for example, any sensor can be able to perform detection. In this state, the auxiliary device 200 can be able to transmit data to the external device 1000.

[0102] The injection device 10 is capable of delivering an injection regardless of the state of the auxiliary device 200. For example, the injection device 10 may be an autoinjector capable of delivering an injection whether the auxiliary device 200 is attached or not, or when the auxiliary device 200 is in a stationary or active state.

[0103] External device 1000 can be any device capable of communicating with auxiliary device 200 and of storing, processing, displaying, or transmitting data received from auxiliary device 200. For example, external device 1000 can be a tablet computer, smartphone, smartwatch, computer, or any suitable device.

[0104] The auxiliary device 200 and / or the injection device 10 may include at least one sensor 251 capable of detecting the start of injection 271 via 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 be capable of detecting movement of a portion of the injection device 10 associated with the injection itself; for example, the sensor 251 may detect movement of the plunger 14 or a component connected to or associated with the plunger. To detect the start of injection, the sensor 251 may detect the start of movement of the aforementioned component.

[0105] For example, sensor 251 may be a conductive rubber pad 260 included within auxiliary device 200, which can be configured to detect movement of components of injection device 10 related to the injection procedure when auxiliary device 200 is attached to injection device 10. Thus, conductive rubber pad 260 can detect the start of the injection procedure via injection device 10. Rubber pad 260 can be positioned such that when auxiliary device 200 is attached to injection device 10, a protrusion from the plunger or associated component is pressed against the conductive rubber pad. This protrusion is configured to retract into injection device 10 as the plunger advances, so that once injection has begun, the protrusion is no longer pressed into the rubber pad. Alternatively or additionally, conductive rubber pad 260 may be positioned on a rigid or flexible extension 280 (e.g., a flexible PCB) as described herein to allow the conductive rubber pad 260 to be positioned where information related to injection device 10 can be determined when auxiliary device 200 is attached to injection device 10.

[0106] Conductive rubber pad 260 can be like Figure 5A As depicted in the image. The rubber pad includes protrusions that are positioned so as to be pressed into the pad and placed under stress when the auxiliary device 200 is attached to the injection device 10. Figure 5B The protrusion is forced into this position through a portion of the plunger 14 (such as a protrusion of the plunger 14), or a component attached to or associated with the plunger. When the plunger moves ( Figure 5C The portion of the protrusion pressing against the rubber pad moves away from the rubber pad, thus releasing the protrusion and allowing it to relax away from the rubber pad. This movement can therefore be detected, allowing the initiation of the injection to be determined.

[0107] Alternatively or additionally, the sensor may be a switch configured to detect movement of a component of the injection device 10 involved in the injection procedure. The switch may be a microswitch 261. The switch may be included within the auxiliary device itself. Alternatively, the switch or microswitch 261 may be located within the injection device 10 and may communicate the start of the injection procedure to the auxiliary device 200. This communication may be via any suitable means, such as a wired connection. Alternatively or additionally, the switch or microswitch 261 may be positioned on a rigid or flexible extension 280 (e.g., a flexible PCB) as described herein to allow the switch or microswitch 261 to be positioned where information related to the injection device 10 can be determined when the auxiliary device 200 is attached to the injection device 10.

[0108] In this embodiment, the microswitch 261 may be depicted as shown in Figure 6. The microswitch is located within the auxiliary device 200, but can detect movement of the lever 32 located within the injection device 10. The lever 32 may be located within a slot or gap 33 in the plunger before the injection procedure begins. Figure 6A The lever 32 can be biased toward the slot or gap 33. Alternatively, the lever 32 can be located within and biased toward the slot or gap 33 of the component attached to the plunger so as to move with the plunger. When the plunger or the plunger-associated component moves, the lever 32 can be expelled from the slot or gap 33, and a microswitch can detect this movement to determine the start of injection. Figure 6B ).

[0109] Alternatively or additionally, the sensor may be an optical reflection sensor 263. This sensor 263 may be able to sense movement of components of the injection device 10 involved in the injection procedure. For example, the optical reflection sensor 263 may be able to continuously sense movement of the plunger 14. To facilitate this detection, the plunger of the injection device 10 may be patterned or encoded to allow identification of specific portions of the plunger 14. The optical reflection sensor 263 may be included within the auxiliary device 200 itself. Alternatively, the optical reflection sensor 263 may be located within the injection device 10 and may communicate the start of the injection procedure to the auxiliary device 200. This communication may be via any suitable means, such as a wired connection. Alternatively or additionally, the optical reflection sensor 263 may be positioned on a rigid or flexible extension 280 (e.g., a flexible PCB) as described herein to allow the optical reflection sensor 263 to be positioned where information related to the injection device 10 can be determined when the auxiliary device 200 is attached to the injection device 10.

[0110] Figure 7A An example auxiliary device 200, including an optical reflection sensor 263, is shown attached to the injection device 10 before the injection procedure is initiated. In this embodiment, once the injection procedure has been initiated ( Figure 7B As the plunger moves past the sensor, the optical reflection sensor 263 can continuously detect the progress of the injection because the plunger comprises alternating segments with different optical properties that can be detected by the sensor. Once the injection has ended ( Figure 7C The sensor can detect the end of the injection, either because the alternating section no longer passes through the sensor, or because the last section of the plunger, positioned for detection by the sensor, has unique optical properties that allow it to be identified.

[0111] If the auxiliary device 200 does not detect the start of injection within a predetermined time after the auxiliary device 200 has been activated by the external device 1000, the auxiliary device 200 may notify the user via any feedback method disclosed herein.

[0112] At least one sensor capable of detecting the start of injection can transmit this information to a processor 25 or controller included within the auxiliary device 200.

[0113] The auxiliary device 200 and / or the injection device 10 may include at least one sensor 250 capable of detecting the end of injection 272 via the injection device 10. This sensor 250 may also be capable of sensing the start of injection 271, as discussed above. Alternatively, multiple sensors may be present, such as a sensor 251 for detecting the start of the injection procedure 271 and a separate sensor 252 for detecting the end of the injection procedure 272. The sensor 250 may be capable of detecting movement of a portion of the injection device 10 associated with the injection itself; for example, the sensor may detect movement of the plunger 14 or a component connected to or associated with the plunger. To detect the end of injection 272, the sensor 250 may detect the end of movement of the aforementioned component, or it may detect that the component has moved to a position associated with the end of injection. For example, the sensor 250 may detect when the plunger has moved the full length required for the injection.

[0114] Sensor 250 may include a switch, a conductive rubber pad, a Hall effect sensor, a piezoelectric sensor, an optical sensor, or any suitable sensor.

[0115] Sensor 250 may 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 may detect that the component (e.g., a plunger or a component associated with the plunger) has moved to a position associated with the end of the injection. For example, the switch may detect when the plunger has moved the full length required for the injection. The switch may be a microswitch 261. The switch may be included within the auxiliary device 200 itself. Alternatively, the switch or microswitch 261 may be located within the injection device 10 and may communicate the start of the injection procedure to the auxiliary device 200. This communication may be via any suitable means, such as a wired connection. The switch or microswitch 261 may be positioned on a rigid or flexible extension 280 as described herein, such as a flexible PCB.

[0116] In the implementation scheme, the microswitch 261 can be as depicted in Figure 6. During the injection procedure, the microswitch 261 can be operated by, for example... Figure 6B The lever 32 shown is activated, having been pushed into the activated position by the plunger 14, in which the lever 32 is biased against the plunger 14. At the end of the injection procedure, the plunger 14 will move to a position where the lever 32 can move to the relaxed position, thus deactivating the microswitch 261. Figure 6C And allows determination of the end of the injection procedure 272.

[0117] At least one sensor 250 capable of detecting the end of injection 272 via the injection device 10 may be a conductive rubber pad 260, which is positioned such that the detected component moves to a position associated with the end of injection. The conductive rubber pad 260 may be positioned on a rigid or flexible extension 280 as described herein, such as a flexible PCB.

[0118] Alternatively or additionally, sensor 250 may be an optical reflection sensor 263. This sensor 263 may be able to sense the movement of components of the injection device 10 involved in the injection procedure. For example, the optical reflection sensor may be able to continuously sense the movement of a component (e.g., a plunger) associated with the injection and detect when this movement ends 272. Alternatively, the optical reflection sensor may be able to sense when a portion of the aforementioned component reaches a predetermined position associated with the end of the injection ( Figure 7C For example, an optical reflection sensor can be able to detect when a portion of the plunger has moved to a position indicating that the plunger has moved the full length required for injection. To facilitate these detections, the plunger of the injection device 10 can be patterned or encoded to allow identification of specific portions of the plunger. The optical reflection sensor can be included within the auxiliary device 200 itself. Alternatively, the optical reflection sensor 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 via any suitable means, such as a wired connection. The optical reflection sensor 263 can be positioned on a rigid or flexible extension 280 (e.g., a flexible PCB) as described herein to allow the optical reflection sensor 263 to be positioned where information related to the injection device 10 can be determined when the auxiliary device 200 is attached to the injection device 10.

[0119] If the auxiliary device 200 does not detect the end of injection 272 within a predetermined time after the auxiliary device 200 has been activated by the external device 1000, the auxiliary device 200 may notify the user.

[0120] At least one sensor 250 capable of detecting the end of injection can transmit this information to a processor 25 or controller included within the auxiliary device 200.

[0121] The auxiliary device 200 may include a sensor 251 for detecting the start of injection and a separate sensor 252 for detecting the end of injection. Alternatively, the auxiliary device 200 may include a single sensor 250 capable of determining both the start and end of injection. As a third alternative, the auxiliary device 200 may include a sensor 263 capable of continuously detecting the progress of the injection procedure.

[0122] The auxiliary device 200 may be able to determine information about the medication within the injection device 10, for example, via sensor 253. For instance, the auxiliary device 200 may be able to determine the type of medication, its identity, ID number, batch number, expiration date, elapsed time, or similar information. The auxiliary device 200 may include sensor 254, which is capable of determining the optical properties of a portion of the injection device 10 or a component associated with or attached to the injection device (such as a medication cartridge) to determine medication-related information. Alternatively or additionally, sensor 253 may be able to detect codes from which medication-related information can be derived.

[0123] The auxiliary device 200 may include an optical sensor 254 capable of determining information about the medication within the injection device 10. For example, the information 100 identifying the medication may be the color of the housing 11 of the injection device 10, or the color of an area of ​​the housing or a label attached to the housing. In these embodiments, the optical sensor 254 may be a simple photometer configured to detect color. In some other embodiments, the information 100 identifying the medication may be a QR code or other similar encoded information, and the optical 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 optical sensor 254. The light source may provide light of a specific wavelength or spectrum to improve color detection by the optical sensor 254. The light source may be arranged in such a way that undue reflection, for example, due to bending of the housing 11, is avoided or reduced. In an example embodiment, the optical sensor 254 is a camera unit configured to detect a code 100 (e.g., a barcode, which may be, for example, a one-dimensional or two-dimensional barcode) associated with the injection device 10 and / or the medication contained therein. This code 100 may be located, for example, on the housing 11 or on the medication container included in the injection device 10, to name just a few examples. This code 100 may, for example, indicate the type of injection device 10 and / or the medication, and / or other attributes (e.g., expiration date). The sensor 100 may be a QR code 100. QR codes are typically black and white, and therefore color detection is not required on portions of the optical sensor 254. This makes the optical sensor 254 simple and inexpensive to manufacture. In other embodiments, the auxiliary device 200 may include a sensor (not shown) capable of determining information about the medication within the injection device 10 via other means, such as RFID detection.

[0124] Processor 25 can be configured to check the information 100 read by sensor 253 against pre-stored information, for example, to verify that the user is injecting the correct medication. If processor 25 fails to identify information 100 or identifies information 100 indicating that the injection procedure may be inappropriate, for example if the information indicates that the user should be receiving a different medication at that time, then assistive device 200 can generate an alarm signal. The alarm signal may include the use of any feedback method disclosed herein, including an indicator 230 associated with assistive device 200 or communication with an external device 1000 that can display information to the user.

[0125] Optionally, the auxiliary device 200 may 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. Figure 8 The diagram shows a flowchart illustrating operations that can be performed by an auxiliary device 200 including a temperature sensor 255.

[0126] Temperature sensor 255 can be positioned on rigid or flexible extension 280 (e.g., flexible PCB) as described herein to allow temperature sensor 255 to be positioned in a location suitable for estimating the temperature of the agent present in injection device 10.

[0127] Temperature sensor 255 can begin detection after auxiliary device 200 has been activated 601, and therefore temperature sensor 255 can be activated while auxiliary device 200 is active. After activation, temperature sensor 255 can determine temperature 602.

[0128] It is preferable to deliver the medication at a specific temperature (e.g., room temperature) because injecting medication that is too cold or too hot may cause discomfort to the user. However, some medications are stored at low temperatures. Therefore, when it is determined that the temperature is below a predetermined temperature 603 (e.g., room temperature), the auxiliary device 200 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 of those disclosed herein, including an indicator 230 associated with the auxiliary device 200 or communication with an external device 1000 that can display information to the user.

[0129] Alternatively or additionally, the auxiliary device 200 may activate the timer 606 upon detecting ambient temperature or an incorrect temperature, such as... Figure 9As shown. The timer can run for a period of time required for the agent to reach the desired temperature. This time period can be adjusted depending on the type or identity of the agent or other properties (such as the volume of the agent). Once the time has elapsed 607, the user 605 can be notified via an indicator 230 associated with the auxiliary device 200 or via communication with an external device 1000 that can display information to the user.

[0130] In other embodiments, the auxiliary device 200 may include the ability to determine temperature 612 (see Figure 10 A temperature-sensitive patch. The temperature-sensitive patch can be configured to indicate when the temperature is unsuitable for injection 614 and / or suitable for injection 615 based on whether the ambient temperature matches a predetermined temperature 613. For example, when the temperature is unsuitable, the temperature-sensitive patch may be a specific color, such as red. In other embodiments, when the temperature is suitable, the temperature-sensitive patch may be a different color, such as green. This allows the user to determine whether the temperature of the medication is suitable for initiating the injection procedure.

[0131] Temperature sensor 255 can provide information to processor 25 of auxiliary device 200. Processor 25 can process the received information and transmit it to external device 1000, for example, via communication unit 240. Alternatively or additionally, processor 25 of auxiliary device 200 may be able to use specific algorithms to determine the temperature of the drug within injection device 10 based on the provided information. This information can be transmitted to external device 1000, for example, via communication unit 240. In other embodiments, the information received by processor 25 will be processed and transmitted to external device 1000, and any calculations (including estimations of the drug temperature within injection device 10) will be performed by external device 1000.

[0132] Communication of information from temperature sensor 255 to external device 1000 can be performed by any method or simultaneously with any transmission, as disclosed herein.

[0133] Communication unit 240 is capable of transmitting data 1002 to external device 1000; the transmission can be via any suitable means, such as wired or wireless communication. External device 1000 may be the same external device used to activate auxiliary device 200. The transmission can be activated via near-field communication (NFC), and / or the transmission can be performed via NFC. In some embodiments, the data transmission will be performed via Bluetooth. In other embodiments, NFC will be used to activate auxiliary device 200, and Bluetooth will be used to transmit the collected information. Auxiliary device 200 may be able to sense whether the data transmission was successful or completed, and if not, auxiliary device 200 may retry the transmission and / or notify the user of the data transmission failure.

[0134] The transmitted data may include information about the start of injection, the end of injection, temperature, and / or drug-related information.

[0135] In some implementations, data is transmitted after the start of injection is detected; in other implementations, data is transmitted after the end of injection is detected. The user may be notified by any means or method disclosed herein.

[0136] Optionally, the auxiliary device 200 may include a memory 34 suitable for storing information determined by the sensors. This information may include information about the start of injection, the end of injection, the medication, temperature, or any other derived information. Data to be transmitted to the external device 1000 may be data stored in the memory 34.

[0137] External device 1000 can process and display the received information. External device 1000 can also transmit data to third-party devices, such as cloud services.

[0138] Before injection begins, the external device 1000 may display warnings or alerts to the user, such as those related to the drug's identity as discussed herein. The external device 1000 may also, or alternatively, display instructions for recommended treatment.

[0139] After injection, the external device 1000 can display information or instructions based on the received information, such as history logs, next dose date, treatment instructions, etc.

[0140] Figure 11 A flowchart illustrating operations that can be performed by an illustrative embodiment of the auxiliary device 200 is shown. This embodiment is the auxiliary device 200, which includes a near-field communication antenna 242, a sensor 251 for detecting the start of an injection procedure for a disposable autoinjector, a separate sensor 252 optionally for detecting the end of an injection procedure, a processor 25, and a hook 211 configured to attach the auxiliary device 200 to a predetermined position on the disposable autoinjector.

[0141] In this embodiment, the sensor is configured to detect the start and end of injection via a separate component. The start of injection is detected by the 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.

[0142] The auxiliary device 200 of this embodiment operates as follows. The auxiliary device 200 is connected to a disposable pen-type autoinjector via a hook 211, which engages in a recess 31 included in the autoinjector, thereby attaching the auxiliary device 200 and thus the sensors to a predetermined position. The auxiliary device 200 is attached in such a way that the resulting assembly has an extended length compared to the standalone injection device 10. After attachment, the electronics of the auxiliary device 200 are then activated by an external device 1000 (such as a smartphone) via near-field communication (step 501). This activates both the injection start sensor 251 and the injection end sensor 252.

[0143] The auxiliary device 200 in 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 appropriate temperature for injection, such as... Figure 10 As shown and described in this article. If the temperature is not appropriate, the user will wait until the patch indicates the temperature is correct before starting the injection procedure.

[0144] After activation, if the injection start sensor 251 does not detect injection start 502 within a predetermined time, the user 504 is notified. If the sensor detects injection start step 502, this is transmitted to the processor 25. Subsequently, if the injection end sensor 252 does not detect injection end 503 within a predetermined time, the user 504 is notified. If the injection end sensor 252 does detect injection end 503, this is transmitted to the processor 25. Upon receiving injection start and end information, the processor 25 is then able to transmit the information 505 to the external device 1000 via near-field communication through the communication unit 240. This transmission is activated by communication 1001 received from the external device 1000 via near-field communication or Bluetooth Low Energy. If the information transmission fails or is incomplete, the auxiliary device 200 will retransmit the information 506.

[0145] Based on the received data, the external device 1000 displays instructions and information to the user based on the device's usage history. The autoinjector 507 can now be disposed of.

[0146] The auxiliary device 200 in this embodiment may not detect the end of the injection, and in this case, it will only include a sensor 251 for detecting the start of the injection. In this case, the operation method will be as described herein, but the steps related to detecting the end of the injection are missing.

[0147] Figure 11A flowchart illustrating operations that can be performed by an illustrative embodiment of the auxiliary device 200 is shown. This embodiment is the auxiliary device 200, which includes a communication unit 240 capable of communication via BLE whisper mode, a sensor 250 for detecting the start and end of the injection procedure of 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 extending outward 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 vertically along the injection device. Figure 13B (As shown). The auxiliary device 200 also includes a multi-color LED 233, which allows for feedback to the user.

[0148] In this embodiment, sensor 250 is configured to detect the start and end of injection via a single microswitch 261 moving the plunger of injection device 10. Sensor 250 is located on a flexible PCB such that, when attached to the injection device, microswitch 261 is positioned as shown in FIG. 6. The sensor is configured to transmit this information to processor 25 included within auxiliary device 200.

[0149] The auxiliary device 200 of this embodiment operates as follows. The auxiliary device 200 is connected to a disposable pen-type autoinjector via a hook 211, which engages in a recess 31 included in the autoinjector, thereby attaching the auxiliary device 200 and thus the sensor to a predetermined position. The electronics of the auxiliary device 200 are then activated by an external device 1000 (such as a smartphone) via near-field communication, as in step 501. This activates the sensor 250 for detecting the start and end of the injection procedure.

[0150] The auxiliary device 200 in 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 appropriate temperature for injection, such as... Figure 10 As shown and described in this article. If the temperature is not appropriate, the user will wait until the patch indicates the temperature is correct before starting the injection procedure.

[0151] After activation, if sensor 250 does not detect injection start 502 within a predetermined time, it notifies user 504 via multi-color LED 233. If sensor 250 detects injection start 502, it transmits this to processor 25. Subsequently, if sensor 250 does not detect injection end 503 within a predetermined time, it notifies user 504 via multi-color LED 233. If sensor 250 does detect injection end 503, it transmits this to processor 25. Upon receiving injection start and end information, processor 25 can then transmit the information 505 to external device 1000 via near-field communication through communication unit 240. This transmission is activated by communication received from external device 1000 via near-field communication. If information transmission fails or is incomplete, auxiliary device 200 will retransmit the information 506.

[0152] Based on the received data, the external device 1000 displays instructions and information to the user based on the device's usage history. The autoinjector 507 can now be disposed of.

[0153] Figure 11 A flowchart illustrating operations that can be performed by an illustrative embodiment of the assistive device 200 is shown. This embodiment is an assistive device 200 capable of communicating with external devices via both NFC and Bluetooth. The assistive device 200 also includes a temperature sensor 255, a sensor 253 for identifying the drug, multiple LEDs 232 for indicating the device status to the user, and a processor 25. The assistive device 200 itself has a teardrop-shaped cross-section and is configured to attach to the distal end of a disposable autoinjector. Figure 13C (As shown). The auxiliary device 200 also includes an extension 280, which is a flexible PCB that extends outward from the main 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 vertically along the injection device.

[0154] The auxiliary device 200 includes an optical reflection sensor 263 capable of continuously detecting the progress of the injection procedure, as depicted in FIG7 and as described herein. The optical reflection sensor 263 is located on a flexible PCB such that, when attached to the injection device, the optical reflection sensor 263 is positioned as shown in FIG7. The auxiliary device 200 is designed for use with an autoinjector having a plunger 14 or components associated with a plunger, wherein the optical properties of at least a portion of the plunger enable determination of the plunger's position. In this embodiment, the sensor 263 is capable of monitoring movement of the plunger of the injection device 10, and the plunger of the injection device 10 has an alternating pattern to aid in monitoring.

[0155] 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. This activates the sensors included in the auxiliary device 200.

[0156] The auxiliary device 200 can then determine the identity of the medication within the disposable autoinjector by any of the methods disclosed herein. If the medication identity does not match the predetermined medication identity, the auxiliary device 200 will alert the user, for example, by illuminating a specific pattern of LEDs or displaying a specific color via one or more LEDs. This is achieved by... Figure 12 The description describes an auxiliary device 200 being activated 551, which activates a drug information determination sensor 253, thereby allowing the determination of drug-related information 552. The auxiliary device 200 can then determine whether the information matches a predetermined drug identity 553 and notify the user of a mismatch 554.

[0157] The auxiliary device 200 also determines the ambient temperature via a temperature sensor 255 and calculates the estimated temperature of the medication inside the auto-injector. If the temperature does not match the predetermined temperature, the auxiliary device 200 will alert the user, for example, by illuminating a specific pattern of LEDs or displaying a specific color via one or more LEDs. Subsequently, the auxiliary device 200 will either indicate to the user that the predetermined temperature has been detected and injection can therefore proceed, or the auxiliary device 200 will activate a timer when an incorrect temperature is detected and will wait until the timer has elapsed before instructing the user that injection can proceed. These processes are... Figure 8 and Figure 9 It is described in the text and as presented herein.

[0158] Once the optical reflection sensor 263 detects the start of injection, the sensor continuously monitors the injection, thereby allowing the determination of the start 502 and end 503 of the injection procedure. The sensor 263 continues to monitor the injection until the end 503 of the injection is detected, as depicted in Figure 7 and as described herein.

[0159] Upon receiving injection start and end information, the processor 25 can then transmit the information 505 to the external device 1000 via Bluetooth communication. If the information transmission fails or is incomplete, the auxiliary device 200 will retransmit the information 506.

[0160] Based on the received data, the external device 1000 displays instructions and information to the user based on the device's usage history. The autoinjector 507 can now be disposed of.

[0161] The terms "drug" or "pharmaceutical preparation" are used synonymously herein and describe pharmaceutical preparations containing one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. A drug or pharmaceutical preparation may be used for a limited duration or periodically for a chronic condition.

[0162] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, namely double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also covered.

[0163] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" adapted for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one in each chamber. In this case, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers) and allow the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing to occur while the components are being dispensed into a human or animal.

[0164] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical conditions. Examples of conditions include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic conditions (such as deep vein or pulmonary thromboembolism). Other examples of conditions are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0165] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (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 mixtures thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been deleted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0166] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (lisgu insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0167] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, 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-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin) ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0168] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include lixinaside. Exenatide (Exendin-4, Liraglutide is a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langnatide / HM-11260C, CM-3, GLP-1Eligen, 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.

[0169] Examples of oligonucleotides include, for instance, sodium mipronil. It is an antisense agent used to lower cholesterol in the treatment of familial hypercholesterolemia.

[0170] Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0171] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0172] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20. It is a type of sodium hyaluronate.

[0173] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. The antibody may be a polyclonal antibody, monoclonal antibody, recombinant antibody, chimeric antibody, deimmunized or humanized antibody, fully human antibody, non-human (e.g., murine) antibody, or single-chain antibody. In some embodiments, the antibody has effector function and may fix complement. In some embodiments, the antibody has reduced or no ability to bind to the Fc receptor. For example, the antibody may be an isotype or subtype, antibody fragment, or mutant that does not support binding to the Fc receptor, for example, it has a mutagenic or missing Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or antibody-like binding proteins with a dual variable region having a cross-binding region orientation (CODV).

[0174] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0175] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the frame region of some antibodies can directly participate in antigen binding or influence the ability of one or more amino acids in the CDR to interact with the antigen.

[0176] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0177] This also covers pharmaceutically acceptable salts of any API described herein for use in drug delivery devices for drugs or pharmaceutical preparations. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0178] Those skilled in the art will understand that various components / components of the APIs, formulations, devices, methods, systems, and implementations described herein may be modified (added and / or removed) without departing from the full scope and spirit of this disclosure, which covers such modifications and any and all equivalents thereof.

Claims

1. An auxiliary device configured to be releasably attached to an injection device, the auxiliary device comprising: at least one wireless communication unit; at least one optical sensor; an extension coupled to the optical sensor, wherein the extension extends into the injection device when the auxiliary device is attached to the injection device; wherein the auxiliary device is configured to: use the at least one optical sensor to detect at least one of a start of an injection or an end of an injection of the injection device; and communicate at least one of the start of the injection or the end of the injection to an external device via the at least one wireless communication unit, wherein the extension and the optical sensor are arranged such that, when the auxiliary device is attached to the injection device, the optical sensor is configured to detect at least one of the start of the injection or the end of the injection by detecting movement of a component within the injection device.

2. The auxiliary device of claim 1, wherein the optical sensor is arranged to continuously detect progress of the injection.

3. The auxiliary device of claim 1 or 2, wherein the component comprises alternating segments having different optical properties that are detectable by the optical sensor.

4. The auxiliary device of claim 3, wherein the auxiliary device is configured to detect an end of injection at least in part by detecting that the alternating segments no longer pass the optical sensor.

5. The auxiliary device of claim 1 or 2, wherein the auxiliary device is configured to activate the at least one sensor in response to receiving a signal.

6. The auxiliary device of claim 1 or 2, wherein the auxiliary device is configured to indicate that a start of an injection of the injection device has not been detected.

7. The auxiliary device of claim 1 or 2, wherein the auxiliary device is configured to indicate that a start of an injection of the injection device has been detected and that an end of the injection of the injection device has not been detected.

8. The auxiliary device of claim 1 or 2, wherein the auxiliary device is configured to indicate whether communication with the external device was successful.

9. The auxiliary device of claim 1 or 2, further comprising a separate sensor for determining an end of the injection.

10. The auxiliary device of claim 9, wherein the separate sensor is a switch.

11. The auxiliary device of claim 1 or 2, wherein, after an end of the injection has been detected, the auxiliary device is configured to communicate at least one of the start of the injection or the end of the injection to an external device via the at least one wireless communication unit.

12. The auxiliary device of claim 1 or 2, wherein the auxiliary device is configured to be attached to a distal end of the injection device.

13. The auxiliary device of claim 1 or 2, wherein the component within the injection device is a component associated with a plunger of the injection device.

14. The supplementary device of claim 1 or 2, wherein the supplementary device comprises a hook configured to couple with a corresponding groove in the injection device to attach the supplementary device to the injection device.

15. A system for an injection device, comprising: a supplementary device according to any preceding claim, and the injection device, wherein the supplementary device is releasably attached to the injection device.

16. The system of claim 15, wherein the injection device is a disposable auto-injector.

17. The system of claim 15 or 16, wherein the supplementary device comprises a housing shaped such that, when attached to the injection device, the housing of the supplementary device is flush with the housing of the injection device.

18. The system of claim 15 or 16, wherein the system has a uniform width, but a longitudinal length greater than the injection device.

19. The system of claim 15 or 16, wherein the supplementary device is configured to attach within a groove located at a distal end of the injection device.

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