Auxiliary device for monitoring use and / or storage of an injection device

Abstract

In one aspect the present disclosure relates to an electronic circuit (40) for monitoring use and / or storage of an injection device (1), wherein the injection device (1) comprises a body (11), which is configured to receive a medicament container (10) filled with an injectable medicament (8) or which is configured to contain the injectable medicament (8), the electronic circuit (40) comprising a clock (42), a temperature sensor (46) and a processor (44), - wherein the temperature sensor (46) is operable to measure a temperature of at least one of the medicament container (10) and the injectable medicament (8), and wherein the processor (44) is operable: i) to quantitatively determine a time interval during which the injection device (1) or the injectable medicament (8) is exposed to a non-refrigerated environment, ii) to compare the time interval with a predefined maximum time interval, and iii) to calculate or to estimate a residual time interval the injection device (1) is allowed to exposure to the non-refrigerated environment.

Description

[0001] Auxiliary Device for Monitoring Use and / or Storage of an Injection Device

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of monitoring use and / or storage of an injection device. Particularly, the present disclosure relates to the field of monitoring use and / or storage of injection devices and injectable medicaments in terms of exposure to varying thermal conditions. In further aspects the present disclosure relates to auxiliary device for monitoring use and / or storage of an injection device and / or of an injectable medicament. In further aspects the present disclosure relates to an electronic device for monitoring use and / or storage of an injection device as well as to a respective method and corresponding computer programs.

[0005] Background

[0006] Drug delivery devices allowing for multiple discrete or continuous dosing of a required dosage of a liquid medicinal product and further providing administration of such liquid drug to a patient, are as such well known in the prior art. Generally, such devices have substantially the same purpose as that of an ordinary syringe. Some medicaments require administration by way of infusion.

[0007] Drug delivery devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of equal or variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.

[0008] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and subsequent injecting of the dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.

[0009] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up. Disposable injection devices may be prefilled with the injectable medicament.

[0010] Medical devices, such as drug delivery devices or injection devices may have a limited lifetime. Due to regulatory provisions or for reasons of patient safety, medical devices or drug delivery devices may only be used for a rather limited number of times. Also, some medical devices, drug delivery devices or injection devices or parts thereof may be intended only for a one-time use. They may be designed or constructed as disposable devices or device components, which are intended to be discarded after use.

[0011] Injectable medicaments may require storage in a refrigerated environment, e.g. at a temperature between 2°C and 8°C. Prior to injection the medicament and / or an injection device prefilled with the medicament may be taken out of the refrigerated environment or refrigerated area before it is administered into biological tissue of a patient. Once a medicament has been taken out of a refrigerated area, such as a refrigerator, it has to be consumed within a predefined time interval, e.g. within 48 hours or 96 hours. The medicament may be stored at room temperature during such a predefined time interval. However, after lapse of such a predefined maximum time interval the medicament or injection device must not be used any longer.

[0012] Some medicaments may allow and support a repeated exposure to refrigerated and elevated temperatures and hence with respect to respective refrigerated or non-refrigerated environments. With some medicaments it may be admissible to store the medicament outside a refrigerated area for a certain period of time provided that the medicament is returned into the refrigerated environment therafter. The medicament may even tolerate a repeated exposure to refrigerated environment and non-refrigerated environment.

[0013] Nonetheless, a patient making use of an injection device for administering or injecting an injectable medicament, may become confused if a medicament located outside a nonrefrigerated area or environment can still be used or not. Such an uncertainty of a patient or user of the injection device may even increase if the patient or user of the injection device is traveling or is remote from his home and has no or only limited access to a refrigerated environment for the medicament or injection device.

[0014] Moreover, some patients may not even be precisely aware of the maximum time interval the medicament or injection device may be kept outside a refrigerated environment.

[0015] It is therefore desirable to provide improvements to administration and particularly to the selfadministration of injectable medicaments by way of which such uncertainties of a user or patients can be effectively set aside. It is a particular aim to improve patient safety as well as to improve a rather easy and straightforward operation and use of an injection device when outside a non-refrigerated area or environment.

[0016] Moreover, it is desirable to assist a patient or user of injection devices to control or to inspect a proper condition of the injection device and / or of the medicament located therein. In effect, usability of the injection device should be simplified and patient safety when using the injection device should be improved

[0017] Summary

[0018] In one aspect there is provided an electronic circuit for monitoring use and / or storage of an injection device. The injection device comprises a body. The body is configured to receive a medicament container filled with an injectable medicament. In some examples the body is configured to contain the injectable medicament. Here, the body of the injection device may form or constitute the medicament container.

[0019] The electronic circuit comprises a clock, a temperature sensor and a processor. The temperature sensor is operable to measure a temperature of at least one of the medicament container and the injectable medicament inside the medicament container when the electronic circuit , and / or the temperature sensor thereof is thermally coupled to at least one of the body of the injection device and the medicament container. The processor, the clock and the temperature sensor are mutually connected in a signal transmitting manner.

[0020] The processor is operable to quantitatively determine a time interval during which the injection device is exposed to a non-refrigerated environment. The processor is further operable or configured to compare the time interval and hence the determined time interval with a predefined maximum time interval. Based on this comparison the processor is operable to calculate, to estimate and / or to determine a time interval the injection device is allowed to exposure to the non-refrigerated environment.

[0021] In some examples the residual time interval may be obtained by subtracting the time interval during which the injection device is or has been exposed to the non-refrigerated environment from the predefined maximum time interval, which defines the maximum allowable time interval during which the injection device and / or the injectable medicament can be exposed to a nonrefrigerated environment or room temperature.

[0022] By calculating or estimating the residual time interval there may be directly provided a rather intuitive information to a user if and for how long the medicament contained inside the injection device can still be used. In this way, the user may precisely plan in advance the next or subsequent injection procedures to be conducted with the injection device.

[0023] Having knowledge of the residual time interval the injection device and / or the injectable medicament is allowed to exposure to the non-refrigerated environment increases patient safety and sets aside any doubts or uncertainties on the side of the user or patient if or how long an injection device or injectable medicament can still be used when kept exposed to the nonrefrigerated environment.

[0024] According to some examples the electronic circuit is integrated in the injection device. It may be integrated into an electronically and / or in an electromechanically implemented injection device. Hence, the electronic circuit may be implemented as an integral part of the injection device. It may be arranged inside the body or housing of the injection device. It may be also attached to the body of the injection device, e.g., to an outside surface of the body of the injection device.

[0025] According to other examples the electronic circuit is part of an auxiliary device or add-on device configured for fastening to the body of the injection device. Here, the electronic circuit may be arranged inside the housing of the add-on device. It may be also attached to an outside of the housing of the add-on device.

[0026] According to further examples, the processor is operable to quantitatively determine a thermal energy input into the injectable medicament. The thermal energy input may depend on the medicament's exposure to a temperature in the non-refrigerated environment and the time interval the medicament is exposed to the respective temperature. The thermal energy input is proportional to the temperature and is also proportional to the time interval at the respective temperature. The thermal energy input may represent the total amount of thermal energy to which the medicament a medicament container is exposed to. Here, the processor may be further operable to calculate or to estimate a residual time interval the injection device is allowed to exposure to a given or to a predefined temperature on the basis of the thermal energy input. For instance, a comparatively low thermal energy input may define a comparatively long future exposure to a non-refrigerated environment. A comparatively large thermal energy input may define a comparatively short future exposure to a nonrefrigerated environment. Likewise, and combinable with the above conditions, a comparatively low thermal energy input may define a future exposure to a comparatively high temperature and a comparatively large thermal energy input may define a comparatively low temperature, at which the medicament or medicament container could be further stored.

[0027] According to a further example the electronic circuit comprises at least one of an indicator and a display, which is or are operable to indicate or to display the residual time interval. The at least one of the indicator and the display may be controlled by the processor of the electronic circuit. The indicator may comprise a visual indicator, e.g. at least one or a sequence of discrete light sources or LEDs by way of which the residual or remaining time of use of the injection device or injectable medicament can be indicated.

[0028] In some examples the indicator may comprise an acoustic indicator. It may be implemented to provide a repetitive sound or a repetitive characteristic sound signal being indicative of a duration of the residual time interval. Here, the indicator may be implemented to generate discrete sounds, wherein each sound may represent a predetermined time intervals, such as one or several hours. By counting the number of discrete sounds the user may be provided with an acoustic signal comprising a sequence of acoustic signals on the basis of which the residual time interval can be acquired by a user or patient of the injection device.

[0029] When the electronic circuit comprises a display, which is controllable by the processor of the electronic circuit, the display may be configured to visually indicate the residual time interval on the display. Hence, when the residual time intervals is 12 hours during which the injection device and / or the injectable medicament can still be used, the display may visually indicate 12 hours.

[0030] By way of at least one of an indicator and a display the electronic circuit may operate in a standalone mode. Here, the electronic circuit itself may be configured to measure or to log a temperature of the medicament container, of the injectable medicament and / or of the injection device over time and to derive or to calculate the residual time interval on the basis of a predefined maximum time interval the medicament is allowed to be exposed in a non- refrigerated environment.

[0031] The at least one of the indicator and the display are then operable to audibly or to visually indicate the residual time interval to a user or patient making use of the injection device. In this way, the user obtains a rather direct and intuitive feedback if the medicament or injection device can still be used and for how long the medicament or injection device can still be used supposed that the injection device and / or the medicament are stored or kept in the nonrefrigerated environment.

[0032] According to a further example the electronic circuit comprises a transceiver to communicate with an external electronic device, typically with a communication unit of an external electronic device. The transceiver is configured or operable to transmit at least one of the time interval and the residual time interval to the external electronic device. In further examples the transceiver is also operable to communicate or to transmit a temperature signal as obtained from the temperature sensor to the external electronic device.

[0033] By way of a transceiver a data processing as provided by the processor of the electronic circuit may be transferred at least in part to a device processor of the external electronic device. It may be then the device processor of the external electronic device that is operable to quantitatively determine a time interval during which the injection device is exposed to a non-refrigerator environment, to compare the time interval with a predefined maximum time interval and / or to calculate or to estimate the residual time interval the injection device is allowed to exposure to the non-refrigerated environment.

[0034] With this example the electronic circuit may be limited to derive or to acquire temperature signals as provided by the temperature sensor of the electronic circuit. A sequence of temperature signals may be then directly transmitted via the transceiver to the external electronic device and may be further processed by the external electronic device to finally calculate or to estimate the residual time interval the injection device is allowed to exposure to the non-refrigerated environment.

[0035] By way of the transceiver the electronic circuit may communicate with the external electronic device to audibly and / or visually indicate the residual time interval to a user. By way of the transceiver the temperature signals as generated and obtained from the temperature sensor as well as any further signals or intermediate signals derived therefrom can be transmitted to the external electronic device for further data processing and / or for indication or visualization to a user. In this way, the electronic circuit may be void of an own indicator or display. Rather, respective signals may be transmitted from the transceiver of the electronic circuit to the communication unit of the external electronic device, which may then be operable to indicate or to display respective information to a user. In this way, the overall size of the electronic circuit may be reduced and the electronic circuit may be provided with a rather compact geometric design, which is beneficial for integration into at least one of the injection device and an auxiliary device.

[0036] According to a further example the electronic circuit comprises a reading unit, which is operable to read an identifier of at least one of the injection device and the medicament container. In some examples the identifier may be indicative of the type of the medicament, of a pharmaceutical substance of the medicament and / or of a concentration of the medicament, of a manufacturing date, of a best before date and a LOT number of the medicament production.

[0037] The identifier may be further directly indicative of the predefined maximum time interval the medicament is allowed to be stored under non-refrigerated conditions.

[0038] The reading unit may be implemented as a wireless reading unit. It may be implemented as an optical reading unit, which may be configured to read an optical code provided on at least one of the injection device and the medicament container. In other examples the identifier may be implemented as an electronic identifier. It may provide wireless data or signal transmission between the reading unit and the identifier. The identifier may be implemented as a RFID chip or as a NFC chip. It may be electronically readable by the reading unit of the electronic circuit. In some examples the reading unit of the electronic circuit is implemented as a RFID reader or NFC reader.

[0039] In some examples the transceiver of the electronic circuit is implemented as a wireless transceiver. It may be implemented as a RF transceiver, as a Bluetooth transveiver, as a Bluetooth Low Energy (BLE) transceiver, as a RFID transceiver, as a Wi-Fi transceiver and the like wireless transceiver by way of which digital signals cane be wirelessly transferred.

[0040] In some examples the identifier is a wireless tag, such as a RFID tag and the reading unit is a wireless reader configured to read information stored in the identifier or tag.

[0041] According to a further example the processor of the electronic circuit is operable to define or to redefine the maximum time interval on the basis of medicament specific information obtainable via reading of the identifier. In some examples the data stored in the identifier may be directly indicative of the maximum time interval. Here, the processor of the electronic circuit may be operable to extract respective time information directly from the identifier as provided on one of the injection device and the medicament container.

[0042] With other examples the processor and / or the electronic circuit may be operable to define or to redefine the maximum time interval on the basis of reading the identifier and further by conducting a database query on the basis of the information read or obtained from the identifier. Here, the maximum time interval may not be directly stored in the identifier but the processor and / or the electronic circuit is or are operable to conduct a database query on the basis of the information obtained from the identifier and to receive the maximum time interval in return of the database query from the database.

[0043] In this way, the electronic circuit and / or the auxiliary device may provide an automated or semiautomated adjustment of the predefined maximum time interval the injection device and / or medicament is allowed to be exposed to non-refrigerated conditions. Here, the patient may no longer have to retrieve and / or to enter such information manually. Rather, the identifier as provided on one of the injection device and the medicament container has to be read by the reading unit of the electronic circuit. In this way there can be provided the necessary information for defining and redefining the predefined maximum time interval on the basis of which the processor is configured to calculate or to estimate the residual time interval the injection device and hence the injectable medicament is allowed to exposure to the non-refrigerated environment.

[0044] According to a further example the processor is operable to determine the time interval by counting a sequence of clock signals during which a temperature signal obtainable from the temperature sensor is indicative of a raised temperature, which raised temperature is larger than a predefined refrigeration temperature. In some examples the predefined refrigeration temperature may comprise a temperature interval between 2°C and 8°C. If the temperature sensor detects a temperature in the surrounding or environment of the injectable medicament that exceeds the upper limit of the refrigeration temperature interval the processor may start to count a sequence of clock signals, which may be regularly provided by the clock or clock generator of the electronic circuit.

[0045] By counting clock signals generated at a temporally regular pattern the processor obtains a time interval information during which the injection device and / or the injectable medicament is exposed to the raised temperature above the predefined refrigeration temperature.

[0046] In a further example the processor of the electronic circuit is operable to start counting the sequence of clock signals when the temperature signal obtainable from the temperature sensor is indicative of a temperature larger than the predefined refrigeration temperature. In this way, a rise of the temperature detectable by the temperature sensor may trigger counting of the sequence of clock signals. In this way, the electronic circuit may be automatically triggered to count and / or to measure the time interval during which the injection device and / or the injectable medicament is exposed to the non-refrigerated environment.

[0047] When the electronic circuit attached to or integrated into the injection device is taken out of the refrigerated environment and may be exposed to room temperature the user is in no way obliged to trigger the counting process but the electronic circuit is implemented to autonomously start determining or measuring the time interval during which the injection device is exposed to the non-refrigerated environment.

[0048] According to a further example the processor is also operable to stop or to interrupt counting the sequence of clock signals when the temperature signal is indicative of a cooling temperature, which is smaller than or equal the predefined refrigeration temperature. This may be of particular benefit when the injection device and / or the injectable medicament re-enters a refrigerated environment after being exposed to a non-refrigerated environment for a while.

[0049] Interruption or pausing of counting the sequence of clock signals may require that the injectable medicament is eligible or suitable for repeated exposure to non-refrigerated environment and refrigerated environments.

[0050] According to further examples, the processor may be operable to trigger a counting process and / or to stop a running counting process on the basis of a temperature measurement with a predefined latency and / or on the basis of a predefined temperature offset. The electronic circuit and hence the triggering of counting or counting interruption may be calibrated in accordance to a specific temperature sensor set up.

[0051] Here and with some examples the temperature sensor may be either in rather direct or indirect thermal coupling with the medicament container. When the injection device is then taken out of a refrigerated environment and when the medicament container may be somewhat encapsulated inside the injectable medicament to a larger degree compared to the temperature sensor, it may be provided that the temperature sensor measures an increase or decrease in temperature, which is not (yet) identical to the factual and / or momentary temperature of the medicament container and / or of the injectable medicament located therein. Here, the processor may be configured to calibrate the measurement signals as obtainable from the measurement sensor and / or to apply a latency time. In this way, the magnitude of a measurable temperature to be identified as exposure to a nonrefrigerated environment may be adjustable, either by the processor itself or by a user of the electronic circuit.

[0052] In addition or as an alternative the processor may be configured to trigger counting or determining of a time interval during which the injectable medicament is exposed to the nonrefrigerated environment after lapse of a latency time, which may likewise reflect the thermal inertia between a temperature measurable by the temperature sensor and a factual and / or momentary temperature of the medicament container or the medicament contained therein.

[0053] In the same way also interruption of the counting or determining of the time interval during which the injectable medicament is exposed to a non-refrigerated environment can be calibrated or executed after lapse of a predefined latency time.

[0054] In some examples the injectable medicament may be exposed to a non-refrigerated environment only once and may be then returned into a refrigerated environment only once before it is used again and constantly kept in a non-refrigerated environment thereafter.

[0055] The medicament may not tolerate or may not allow for a twofold or threefold alternating exposure to non-refrigerated and refrigerated environments.

[0056] Insofar, the processor may be operable to stop or to interrupt counting the sequence of clock signals depending on medicament specific information, which may be obtainable via reading of the identifier as provided on one of the injection device and the medicament container.

[0057] If the respective medicament specific information is indicative of a single or twofold storage in non-refrigerated and refrigerated environment the processor is configured to stop or to interrupt counting the sequence of clock signals when the temperature signal is indicative of a respective cooling temperature only when the respective medicament can be repeatedly exposed to such cooling temperatures without a necessity of being consumed or used within the predefined maximum time interval.

[0058] Insofar and according to some examples the processor may be operable to stop or to interrupt counting the sequence of clock signals when the temperature signal is indicative of a cooling temperature smaller than or equal the predefined refrigeration temperature only when the number of exposures of the injection device to the non-refrigerated environment does not exceed a maximum allowable exposure number.

[0059] For instance and with some examples, the injectable medicament is initially stored in the refrigerated environment. It may be exposed to a non-refrigerated environment for a first time interval and may then return into the refrigerated environment for another time interval. Thereafter, it may be exposed again to the non-refrigerated environment but may be then no longer returned into the refrigerated environment. Such an injectable medicament may be provided with a maximum allowable exposure number of two exposures to non-refrigerated temperatures or environments.

[0060] It may be then that the processor is operable to stop or to interrupt counting the sequence of clock signal and / or to interrupt determining the time interval during which the injection device is exposed to the non-refrigerated environment when the injection device and / or the injectable medicament returns from the norm-refrigerated environment into the reference generated environment. A second and subsequent exposure to the non-refrigerated environment and a further returning from the non-refrigerated environment into the refrigerated environment may then be recognized by the processor and may no longer lead to an interruption of counting of the sequence of clock signals.

[0061] According to a further example the processor of the electronic circuit is operable to generate an alert signal, when at least one of the following four conditions is met. According to a first condition the residual time interval approaches or equals zero. According to a second condition, the temperature of at least one of the medicament container and the injectable medicament as measured by the temperature sensor exceeds a predefined maximum allowable temperature. According to a third condition the exposure of the injection device to the non-refrigerated environment exceeds a predefined maximum thermal energy input into the injectable medicament. According to a fourth condition, a number of exposures of the injection device to the non-refrigerated environment exceeds a maximum allowable exposure number.

[0062] When the residual time interval approaches or equals zero the time interval during which the injection device is exposed to a non-refrigerated environment may be substantially equal to, it may be equal to or may even exceed the predefined maximum time interval during which the injection device and / or the injectable medicament is allowed to exposure to the non-refrigerated environment.

[0063] Moreover, and depending on the specifics or properties of the respective injectable medicament, it may not tolerate an exposure to an overly high temperature. Hence, as soon as a medicament should be exposed to a temperature exceeding a predefined maximum temperature, e.g. 30°C, the medicament should be no longer used. Accordingly, the processor may then immediately generate an alert signal on the basis of which the indicator of the electronic circuit may generate a respective user perceivable alert.

[0064] According to the third condition the exposure of the injection device to the non-refrigerated environment exceeds a predefined maximum thermal energy input into the injectable medicament. The maximum thermal energy input may depend on the temperature in the nonrefrigerated environment and the time interval the medicament is exposed to the respective temperature. In some examples the thermal energy input depends on both, the duration and temperature at which the injectable medicament is exposed to the non-refrigerated environment.

[0065] In some examples a maximum thermal energy input may be reached after a comparatively long time interval provided that the temperature in the non-refrigerated environment is comparatively low. Hence, with some examples the injectable medicament and / or the injection device may be stored slightly above the predefined refrigerated temperature. At comparatively low temperatures in a non-refrigerated environment and hence above the upper limit of the cooling temperature of the refrigerated environment the maximum allowable time interval of exposure to the non-refrigerated environment may be comparatively large or long.

[0066] Vice versa, when the injection device or the injectable medicament is exposed to a comparatively high temperature, slightly below the predefined maximum allowable temperature for the medicament, the time interval the injection device and / or the injectable medicament is allowed to exposure to the non-refrigerated environment may be comparatively short.

[0067] By the third condition, namely by using the maximum thermal energy input into the injectable medicament as a control parameter to calculate or to estimate a residual time interval the maximum thermal energy input into the injectable medicament can be used as a control parameter and the residual time interval the injection device is allowed to exposure to the nonrefrigerated environment can be prolonged, e.g. in the case of comparatively low environmental temperatures, or, the residual time interval can be reduced, e.g. in case of comparatively high environmental temperatures the injection device and / or the injectable medicament is exposed to.

[0068] In this way, individual characteristics of the third condition can be taken into account in order to maximize the residual time interval by simultaneously maintaining a high standard in terms of patient safety.

[0069] According to the fourth condition an alert signal may be generated when the number of exposures of the injection device to the non-refrigerated environment exceeds a maximum allowable exposure number. Here, the processor may be operable to detect or to log repeated storage in alternating refrigerated and non-refrigerated environments. If the medicament should not tolerate such repeated storage at different or varying temperatures the processor is operable to generate a respective alert signal in case that an unsuitable number of exposures to varying temperature conditions should be detected.

[0070] According to another example the electronic circuit is further equipped with a light source to illuminate at least one of the body and the medicament container when the housing is attached to the body of the injection device. By way of the light source there can be improved a visual inspection of the medicament contained inside the medicament container and hence inside the body of the injection device. Use of a light source may provide standardized visual inspection conditions for a user to determine or to visually inspect the quality and / or constitution of the injectable medicament.

[0071] For this, at least a portion, several portions or even the entirety of the medicament container may be transparent in order to allow a visual inspection of its content. Also, at least a portion of the body of the injection device may be provided with a window that is allowing to visually inspect the content and hence the injectable medicament contained inside the medicament container.

[0072] By way of the light source visual inspection of the injectable medicament located inside the medicament container and further located inside the body of the injection device can be improved and facilitated.

[0073] According to another aspect the present disclosure relates to an auxiliary device for monitoring use and / or storage of an injection device, wherein the injection device comprises a body, which is configured to receive a medicament container containing an injectable medicament or which is configured to contain the injectable medicament. The auxiliary device comprises a housing for fastening to the body of the injection device and further comprises an electronic circuit as described above. Insofar, all features, effects and benefits as described above in connection with the electronic circuit equally apply to the auxiliary device; and vice versa. The housing of the auxiliary device is particularly configured for fastening to the injection device in a well-defined configuration or orientation, such that the temperature sensor of the electronic circuit is in a well-defined position or relative position to the medicament container or to the injectable medicament.

[0074] According to a further example the housing of the auxiliary device comprises a sidewall confining a receptacle, which receptacle is sized to receive at least a portion of the body of the injection device. In some examples the sidewall of the housing comprises a sleeve or an annular ring-like geometry, which allows to arrange the housing of the auxiliary device on an outside surface of the body of the injection device. Typically and with some examples the housing of the auxiliary device can be attached to the body of the injection device in a well- defined position, orientation or configuration.

[0075] When in the well-defined or predefined position, orientation or configuration the light source may be aligned with a recess or window of the body of the injection device so as to provide an effective illumination of the medicament container and the liquid medicament contained therein in.

[0076] According to a further example the sidewall of the auxiliary device comprises a first sidewall portion provided with the light source. The light source may be provided at an inside surface of the sidewall to direct an inspection light into the body and / or through the body of the injection device.

[0077] According to a further example the sidewall of the auxiliary device further comprises a second sidewall portion, that is opposite to the first sidewall portion. The second sidewall portion is provided with an optical element. The optical element may comprise a lens, by way of which there may be provided an enlarged view of the medicament container and / or of the medicament located between the first sidewall portion and the second sidewall portion of the auxiliary device when the auxiliary device is duly attached and / or fixed to the body of the injection device.

[0078] In some examples the optical element comprises one of an aspherical or cylindrical lens and may provide a homogeneous illuminated area of the injection device and / or of the injectable medicament when the auxiliary device is duly attached to the injection device and when the light source is aligned with a transparent portion of the medicament container.

[0079] According to a further example the sidewall of the housing comprises an inwardly protruding projection, which is configured to mechanically engage with a window or recessed portion in the body of the injection device. In this way the inwardly protruding projection as provided on an inside surface of the sidewall of the housing of the auxiliary device may provide a kind of a snap fastening to a recessed portion and / or to a window in the body of the injection device. The inwardly protruding projection may provide or may constitute a fastening feature complementary shaped to a counter fastening feature as provided by the window in the body of the injection device.

[0080] In some examples there may be provided a first window and a second window in the body of the injection device. With an elongated body of the injection device extending in an axial direction the first window and the second window may be located at substantially identical axial or longitudinal positions. They may be provided diametrically opposite in a tubularly or sleevelike shaped sidewall of the body of the injection device. Likewise, also first and second sidewall portions of the sidewall of the auxiliary device may be located diametrically opposite to each other.

[0081] The first sidewall portion may align with a first window of the body of the injection device. The second sidewall portion may align with the second window of the body of the injection device. In some examples the first sidewall portion may be provided with the inwardly protruding projection. Likewise, the second sidewall portion may be provided with a second radially inwardly protruding projection. In this way, the first and the second sidewall portions of the sidewall of the auxiliary device may provide a kind of a snap-fastener or clip-like fastening between the auxiliary device and the body of the injection device.

[0082] According to a further example at least one of the temperature sensor and the light source is located on the inwardly protruding projection of the housing of the sidewall of the auxiliary device. In this way, the temperature sensor may be arranged in close vicinity or in direct mechanical and hence thermal contact with the medicament container located inside the body of the injection device. In this way, a rather direct temperature measurement of the medicament container and / or or of the medicament contained therein can be provided.

[0083] Also, and when the auxiliary device is equipped with a light source, providing of the light source on the inwardly protruding projection of the sidewall of the housing of the auxiliary device may provide a rather direct illumination of the medicament container inside the body of the injection device thereby improving visual inspection and / or illumination of the medicament container and the injectable medicament located therein.

[0084] In some examples the injection device is implemented as a syringe comprising a barrel and a movable stopper sealingly engaged with an inside surface of the barrel of the syringe. By moving the stopper or plunger of the syringe towards a distal injecting end the liquid medicament contained inside the barrel of the syringe can be expelled through an injection needle fluidically connected to a distally located outlet end of the barrel of the syringe. Here, the body of the injection device may form or constitute the medicament container and may coincide with the barrel of the syringe.

[0085] In other examples the injection device comprises a single dose and single use injection device. It may comprise a so-called auto injector comprising a needle and a medicament container readily assembled inside the body of the injection device. Here, the injection device comprises a drive mechanism or dispensing mechanism by way of which the injection needle in fluid communication with the medicament container may be displaced relative to the body of the injection device to puncture biological tissue of a patient. The drive mechanism or injection mechanism may be further operable to move a stopper of the medicament container towards a distal dispensing end to expel the injectable medicament through the injection needle into the biological tissue.

[0086] With further examples the injection device may comprise a pen-injector allowing to set and / or to inject multiple doses of the medicament of equal or of different size. Here, the injection device may comprise a dose dial or dose setter by way of which a user of the device is allowed to individually set a dose of different or individual size. The injection device may further comprise a trigger by way of which the patient or user may control or trigger a process of dose injection. In some examples the injection device is a disposable device. It may be prefilled with the medicament container and the injectable medicament contained therein. In other examples the injection device is implemented as a reusable injection device. It may provide replacement of an empty medicament container by another medicament container.

[0087] The auxiliary device may be detachably connectable or detachably mountable to or onto the injection device in order to monitor use and / or storage of the injection device. Typically, the injection device with the injectable medicament readily stored or contained therein is to be kept in a refrigerated area or refrigerated environment. The auxiliary device may be attached to the injection device when in the refrigerated environment. Taking the injection device with the auxiliary device attached thereto out of the refrigerated environment into a non-refrigerated environment may trigger the processor of the auxiliary device to quantitatively determine or to quantitatively measure a time interval during which the injection device and / or the injectable medicament is exposed to the non-refrigerated environment. According to another aspect the present disclosure also relates to an injection device for injecting at least a dose of a medicament into biological tissue. The injection device comprises a body, which is configured to receive a medicament container, which is filled or which contains an injectable medicament or which is configured to contain the injectable medicament.

[0088] The injection device further comprises an electronic circuit as described above. Here, the temperature sensor of the electronic circuit is operable to measure a temperature of at least one of the medicament container and the injectable medicament. The electronic circuit may be integrated into the injection device. It may be arranged inside the body of the injection device or may be attached to the body of the injection device. In some examples, the electronic circuit and / or in the temperature sensor thereof may be attached to or may be attachable to the medicament container.

[0089] In some examples, the electronic circuit and / or the temperature sensor thereof may be in direct thermal contact with the medicament container when the medicament container is arranged inside the body of the injection device.

[0090] Since the injector device comprises an electronic circuit as described above, all features, effects and benefits as described above in connection with the electronic circuit equally apply to the injection device; and vice versa.

[0091] In some examples the injection device comprises a drive mechanism. The drive mechanism may comprise a piston rod or a plunger operable to urge or move a piston or stopper of the medicament container in a distal direction. The medicament container may comprise a distally located outlet through which the medicament can be expelled out of the medicament container.

[0092] The medicament container may comprise a barrel. The medicament container may comprise a pre-filled syringe. The medicament container may comprise a cartridge filled with the medicament and sealed towards a longitudinal proximal direction by the stopper, which is displaceable by the drive mechanism in order to expel a dose of the medicament through the distally located outlet of the medicament container. In some examples, the medicament container is readily attached with an injection needle at its outlet. In other examples the distal outlet of the medicament container is sealed by a pierceable septum, which can be pierced by a double-tipped injection needle.

[0093] In some examples the injection device comprises a pen-type injector. It may comprise one of an auto injector, a single-dose injection pen, a multidose injection pen. In some examples the injection device comprises a multiple dose injection pen, which provides individual setting and dispensing or injection of multiple doses of equal size or of different sizes, e.g. user-settable sizes.

[0094] According to another aspect the present disclosure also relates to an electronic device for monitoring use and / or storage of an injection device. The electronic device comprises a device housing, a device processor located inside the device housing, a device display controllable by the device processor, a communication unit operably connected to the device processor and configured to receive and to process signals from the electronic circuit or auxiliary device as described above.

[0095] The electronic device may act as an external electronic device, which is external to the electronic circuit or auxiliary device as described above. The electronic device may be implemented as a portable or wearable electronic device. In some examples the electronic device may comprise a smartphone, a smartwatch or a tablet computer operable to communicate with the electronic circuit, which is integrated into, attached to or which is attachable to the injection device.

[0096] According to a further example the communication unit of the electronic device is operable to wirelessly communicate with a transceiver of the electronic circuit and / or of the auxiliary device. The communication unit may be implemented as a wireless transmitter or wireless transceiver. The communication unit may be operable to wirelessly exchange data or signals with the transceiver of the electronic circuit. The communication unit may be operable to communicate with the transceiver of the electronic circuit by way of RF communication-based protocols, such as RFID, NFC, Bluetooth, Bluetooth low energy (BLE) and the like standardized communication protocols.

[0097] The communication unit may be configured to synchronize and / or to pair with the transceiver of the electronic circuit.

[0098] According to a further example the communication unit of the electronic device is operable to receive temperature signals generated by the temperature sensor of the electronic circuit. Here, the device processor of the electronic device may be operable to quantitatively determine a time interval during which the injection device is exposed to a non-refrigerated environment. It may be further operable to compare the time interval with a predefined maximum time interval, and to calculate or to estimate a residual time interval the injection device is allowed to exposure to the non-refrigerated environment. In some examples at least portions or the entirety of the data processing as provided by the processor of the electronic circuit and as described above in connection with the processor of the electronic circuit may be provided by the device processor of the electronic device. It is hence conceivable that the auxiliary device or the electronic circuit as described above comprises a processor, which is limited in its functionality to simply receive temperature signals from the temperature sensor and to transmit such temperature signals via the transceiver to the electronic device.

[0099] A quantitative determination of the time interval during which the injection device is exposed to the non-refrigerated environment, a comparison of the time interval with the predefined maximum time interval and / or a calculation or estimation of the residual time interval the injection device is allowed to exposure to the non-refrigerated environment may be then entirely or at least partially conducted by the device processor of the electronic device. In this way, the complexity of the processor of the electronic circuit and / or of the auxiliary device can be reduced at the benefit of the device processor of the electronic device, which may be rather easily operable to conduct a data processing as described above.

[0100] It is even conceivable that the electronic circuit is void of an own clock provided that the temperature sensor and the processor of the electronic circuit are in permanent communication or permanent broadcasting range with the communication unit of the electronic device.

[0101] In some examples it is conceivable that the electronic circuit comprises the temperature sensor, the processor, the clock and a memory as well as a transceiver. In situations, in which the transceiver is disconnected from the communication unit of the electronic device it may be then that the processor simply acquires and stores temperature signals in the memory concurrently with respective clock signals or timing signals. The so-stored data may be then regularly or frequently transmitted to the communication unit of the electronic device upon a pairing between the electronic circuit and the external electronic device.

[0102] Here, the further processing of the data stored in the memory of the electronic circuit and transmitted to the electronic device may be entirely or at least partially conducted by the device processor of the electronic device. In this way, computational power required for the calculation or estimation of the residual time interval may be then entirely or at least partially provided by the external electronic device, e.g., by a respective smartphone, tablet computer or smart watch. According to a further example the electronic device comprises a device reading unit operable to read an identifier of at least one of the injection device and the medicament container. Here, the device reading unit may provide the same or like functionality as the reading unit as described above in connection with the electronic circuit or auxiliary device. The device reading unit may be operable to read information from an electronic identifier or to capture a visual or optical code of the identifier provided on one of the injection device and the medicament container. In this way, also the electronic device may be equipped or provided with a reading unit on the basis of which medicament specific information obtainable via reading of the identifier can be obtained and provided to the device processor for the purpose of calculating or estimating a residual time interval the injection device is allowed to exposure to the nonrefrigerated environment.

[0103] According to a further example the device processor of the electronic device is operable to define or to redefine the maximum time interval on the basis of medicament specific information obtainable via reading of the identifier as provided on one of the injection device and the medicament container. In this way and depending on the specifics or properties of the medicament the predefined maximum time interval the medicament may be exposed to a nonrefrigerated environment can be adapted in accordance to the medicament contained in the medicament container currently in use with the injection device.

[0104] According to a further example the device processor of the electronic device is operable to control at least one of an operation and a color adjustment of a light source of the electronic circuit and / or of the auxiliary device via control signals transmitted between the transceiver of the electronic circuit or auxiliary device and the communication unit of the electronic device. Here, and through the pairing or signal transmission between the communication unit of the electronic device and the transceiver of the electronic circuit or auxiliary device the external electronic device can be used as a kind of a remote control for controlling operation and / or functions of the electronic circuit or auxiliary device. As an example, the intensity and / or color adjustment of the light source of the electronic circuit or of the auxiliary device may be controlled by the external electronic device.

[0105] Moreover, and according to another example the device processor and the device display of the electronic device is or are configured to visually indicate at least one of an indication, a notification, a user input and a reference illustration to a user of the electronic device. The indication, notification, user input or reference illustration can be of particular use in order to allow user interaction with the electronic circuit via the remote control as provided by the electronic device paired or coupled to the electronic circuit. Hence, the device display may be operable to visually indicate the residual time interval the injection device is allowed to exposure to the non-refrigerated environment. The device display and the device processor controlling the device display may be further operable to graphically or visually illustrate a temporal evolution of temperature exposure of the injection device or injectable medicament to varying environmental conditions or temperatures.

[0106] Hence, the device display may be operable to visually illustrate a temperature history the injection device and / or the injectable medicament has been exposed to.

[0107] Moreover, the device display may be operable to emulate a user input. Hence, certain portions of the device display may emulate a depressible or touchable surface area, which when touched by a finger of a user may be used for interpretation of a respective user input or user command.

[0108] Moreover, the device processor and the device display may be configured to provide a reference illustration of a visual inspection of the medicament container contained or located inside the body of the injection device. A user, which is manually inspecting the quality or constitution of the injectable medicament, e.g. with the help of an illumination by activating the light source of the electronic circuit, is provided with one or a series of reference illustrations that allow to make a decision if the visual impression of the medicament or medicament container as obtained or provided to the user matches with a normal visual impression that arises from a medicament or medicament container comprising a good or acceptable quality or constitution.

[0109] Moreover, the reference illustration may also reflect examples of medicament containers and medicaments that comprise a poor or non-acceptable quality or constitution and which should not be used by the patient. In this way and by providing a reference illustration on the device display of the external electronic device the user or patient is intuitively assisted to make a decision if a medicament should be used or not.

[0110] Generally, the electronic device for monitoring use and / or storage of the injection device is configured to be used with an electronic circuit and / or with an auxiliary device for monitoring use and / or storage of an injection device as described above. Insofar, all features, effects and benefits as described above in connection with the electronic circuit and / or in connection with the auxiliary device equally apply to the electronic device; and vice versa. According to another aspect the present disclosure also relates to a monitoring system for monitoring use and / or storage of an injection device. The monitoring system comprises an electronic circuit and / or an auxiliary device as described above and further comprises an electronic device as described above. Typically, the electronic device is configured to communicate with the electronic circuit or auxiliary device. Insofar, all features, effects and benefits as described above in connection with the electronic circuit or auxiliary device and as described above in connection with the electronic device equally apply to the monitoring system.

[0111] In still another aspect the present disclosure relates to a method of monitoring use and / or storage of an injection device. The injection device comprises a body. The method may comprise the steps of attaching an auxiliary device configured for monitoring use and / or storage of the injection device to the body of the injection device. The body is configured to receive a medicament container filled with an injectable medicament, or the body is configured to contain the injectable medicament.

[0112] Alternative, the method comprises the step of using an electronic circuit as described above, which is already integrated in or implemented with the injection device.

[0113] The method further comprises the step of measuring a temperature of at least one of the medicament container and the injectable medicament. The method further comprises the step of quantitatively determining a time interval during which the injection device is exposed to a non-refrigerated environment. The method further comprises the step of comparing the determined time interval with a predefined maximum time interval and further comprises the step of calculating or estimating a residual time interval the injection device is allowed to exposure to the non-refrigerated environment.

[0114] According to some examples the method of monitoring use and / or storage of an injection device is to be implemented or conducted with one of an electronic circuit and an auxiliary device as described above, with an electronic device as described above and / or with a monitoring system as described above. Insofar, all features, effects and benefits as described above in connection with any one of the electronic circuit, the auxiliary device, the electronic device and the monitoring system as well as any interactions between these devices and the system equally apply to the method of monitoring use and / or storage of the injection device.

[0115] According to a further aspect the present disclosure further relates to a computer program comprising computer readable instructions, which when executed by a processor of an electronic circuit and / or of an auxiliary device cause the processor to execute the steps of processing of temperature signals obtainable from a temperature sensor of the auxiliary device, e.g., when the auxiliary device is attached or fastened to a body of an injection device containing an injectable medicament. The computer readable instructions further cause the processor to quantitatively determine a time interval during which the injection device is exposed to a non-refrigerated environment.

[0116] The computer readable instructions further cause the processor to compare the time interval with a predefined maximum time interval and to calculate or to estimate a residual time interval the injection device is allowed to exposure to the non-refrigerated environment. In further examples the computer program may be further configured to provide or to indicate or to illustrates the residual time interval the injection device is allowed to exposure to the nonrefrigerated environment, e.g. via at least one of an indicator and a display.

[0117] In some examples the computer program is executable by a processor of an electronic circuit as described above. Insofar, all features, effects and benefits as described above in connection with the electronic circuit or auxiliary device and the method of monitoring use and / or storage of an injection device by making use of an electronic circuit and / or of an auxiliary device equally apply to the computer program; and vice versa.

[0118] According to another aspect the present disclosure also relates to another computer program comprising computer readable instructions, which when executed by a device processor of an electronic device cause the device processor to execute the steps of transmitting control signals from a communication unit of the electronic device to an electronic circuit of an injection device or of an auxiliary device for monitoring use and / or for monitoring storage of the injection device.

[0119] In addition or alternative, the computer readable instructions cause the device processor to receive the signals from a transceiver of the electronic circuit and / or of the auxiliary device, wherein the signals received from the transceiver are indicative of at least one of a temperature of at least one of a medicament container and an injectable medicament inside a body of an injection device, and to cause the device processor to calculate or to estimate a time interval during which the injection device is exposed to a non-refrigerated environment and to determine or to calculate a residual time interval the injection device is allowed to exposure to the nonrefrigerated environment.

[0120] Optionally, the computer readable instructions further may cause the device processor to execute the step of indicating or displaying the residual time interval by a display of the electronic device.

[0121] In some examples the further computer program is to be executed by the device processor of an electronic device as described above. Insofar, all features, effects and benefits as described above in connection with the electronic device, its operation and the method of using such an electronic device, e.g., in combination with an electronic circuit or with an auxiliary device as described above equally apply to the further computer program; and vice versa.

[0122] Generally, the scope of the present disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

[0123] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0124] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API 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, double 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 contemplated.

[0125] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0126] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0127] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0128] Examples of insulin analogues are 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, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0129] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(co-carboxyheptadecanoyl) human insulin.

[0130] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, GRMD-0901, NN-9423, NN-9709, 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, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0131] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0132] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0133] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0134] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0135] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0136] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0137] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0138] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0139] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0140] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0141] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0142] Brief description of the drawings

[0143] In the following, some examples of an electronic circuit and of an auxiliary device for monitoring use and / or storage of an injection device will be described in greater detail by making reference to the drawings, in which:

[0144] Fig. 1 shows an example of an injection device and a monitoring device configured for monitoring use and / or / for storage of the injection device,

[0145] Fig. 2 shows a further example of an injection device,

[0146] Fig. 3 shows a further example of an injection device,

[0147] Fig. 4 shows the auxiliary device attached to the injection device,

[0148] Fig. 5 shows a diagram of exposure of the injection device to varying temperature over time,

[0149] Fig. 6 shows an external electronic device configured to communicate with the auxiliary device,

[0150] Fig. 7 shows a further example of an external electronic device,

[0151] Fig. 8 shows a further example of an auxiliary device,

[0152] Fig. 9 shows a cross section through the configuration of Fig. 4, in which the auxiliary device is duly attached to the body of the injection device,

[0153] Fig. 10 is illustrative of a first display configuration of the external electronic device, Fig. 11 shows another display configuration of the electronic device,

[0154] Fig. 12 shows another display configuration of the electronic device,

[0155] Fig. 13 shows a further display configuration of the electronic device,

[0156] Fig. 14 is a flowchart of a method of monitoring use and / or storage of an injection device making use of the auxiliary device, and Fig. 15 is a block diagram of the auxiliary device and the electronic device forming or constituting a monitoring system.

[0157] Detailed description

[0158] In Figs. 1-3 there are illustrated numerous examples of injection devices 1. The injection devices 1 are of elongated shape. They extend along a longitudinal axis. Towards or near a distal longitudinal end and hence towards a distal direction 2 there is provided and outlet 14 for expelling an injectable medicament. In some examples, the outlet 14 is provided with an injection needle 15, which is configured to pierce or to puncture biological tissue of a patient for injecting a dose of the liquid medicament into the biological tissue.

[0159] In the opposite proximal direction 3 and hence at the proximal end some of the injection devices 1 may comprise one of a trigger 23 and a plunger flange 21 , which is depressible or operable and hence actuatable by a user of the injection device 1. For injecting of a dose of the medicament a user may have to apply a distally directed pressure onto the trigger 23 or plunger flange 21 in order to induce or to trigger a dispensing or injecting operation to be conducted with the injection device 1.

[0160] For executing or triggering a process of dose injection a user may hold the injection device 1 in his hand 4. He may apply a distally directed pressure onto the proximal end of the injection device 1 , e.g. by making use of a thumb 5 of the respective hand 4 while one or several fingers 6 of the same hand grip or firmly hold a housing 11 of the injection device. The injection device 1 may be implemented as an injection pen as shown in the examples of Figs. 1 and 2.

[0161] The injection device 1 according to Fig. 2 may comprises a dial extension, which is configured to move in proximal direction 3 relative to a body 11 or housing in the course of setting of a dose. Here, a user may set a dose of individual or fixed size by rotating a dose dial 24, by way of which a proximally directed helical motion of the dose dial 24 and / or of the entire dial extension is induced relative to the housing 11.

[0162] The process of dose injecting may require applying an actuation force in distal direction 2 onto the trigger 23, which is located at the proximal end of the injection device 1. The dial extension may then return into an initial position in distal direction. The force applied by user may transition into a driving motion of a stopper 9 relative to a barrel of a medicament container 10 , which may be implemented as a cartridge. In another example the injection device 1 according to Figs. 1 and 2 may be implemented as a so-called auto-injector. This injection device 1 may also comprise a body 11 , which is to be firmly held or gripped by numerous fingers 6 of a hand 4 of a user. Also here, a user may optionally apply a distally directed pressure onto the body 11 either by his thumb 5 or with any one or several of his fingers 6.

[0163] The injection device 1 further comprises a shield 12, e.g. in form of a tubular sleeve that sheaths an injection needle 15 pointing with its tipped end in distal direction 2. In an initial or idle configuration of the injection device 1 the injection needle 15 way be completely enclosed by the shield 12. For injecting of a dose, the distal end of the shield 12 may be placed against the skin of a patient. A user may then apply a distally directed force effect or movement of the housing 11 relative to the shield 12, by way of which expelling of a dose of the medicament may be triggered. Here, a trigger of the injection mechanism 22 may be located inside the housing 11 and may be actuated by inducing a distally directed displacement of the housing 11 relative to the shield 12.

[0164] In the further example of an injection device 1 as shown in Figs. 3 and 4 the injection device 1 may comprise a syringe or safety syringe. The injection device 1 may comprises the syringe carrier (not shown), which is configured to house or to fix an ordinary syringe as shown in Fig. 3 therein. The syringe as shown in Fig. 3 comprises a tubularly-shaped barrel with an outlet 14 at its distal end. The outlet 14 is provided with an injection needle 15. Inside the barrel there is provided a movable stopper 9. Between the outlet 14 and the stopper 9 there is located an injectable medicament 8. By moving the stopper 9 relative to the barrel in distal direction 2, a dose of the medicament 8 can be expelled through the outlet 14 and hence through the injection needle 15 into biological tissue.

[0165] For inducing a distally directed dispensing motion the stopper 9 is mechanically connected to a plunger 20, which protrudes in proximal direction 3 from a proximal end of the barrel 10. The plunger 20 is provided with a radially widened plunger flange 21 at or near the proximal end, which allows to induce a respective dispensing or actuation force onto the plunger 20 and hence onto the stopper 9 for urging the stopper 9 in distal direction 2.

[0166] In some examples the needle 15 may be initially covered by a protective cap 16 as shown in Fig. 1. The autoinjector as shown in Fig. 1 may comprise a medicament container 10, which may be implemented as a tubularly-shaped barrel filled with the injectable medicament 8. The medicament container 10 may be movably disposed inside the body 11 and may be urged in distal direction together with the needle 15 to puncture an injection site of a patient. At least one of the medicament container 10 and the body 11 may be optionally provided with an identifier 26. The identifier 26 may comprise an optical or visual code by way of which the injection device 1 and / or answers or the injectable medicament 8 can be unequivocally identified. The identifier 26 may comprise an electronic identifier. It may provide digitally stored information being indicative of at least one of a medicament type, a medicament name, a date of manufacturing, a best before date, a LOT number and the like information by way of which the injectable medicament 8 can be unequivocally identified. The identifier 26 may be implemented as a machine-readable identifier.

[0167] The identifier 26 may comprise one of a visual code, an optical code, a magnetic code. Alternatively or additionally, the identifier 26 may comprise a machine-readable code. It may be implemented as a RFID tag or NFC tag with a non-erasable or with a programmable digital memory capable to store and to provide information being indicative of the medicament and / or of the injection device.

[0168] In some examples the medicament container 10 filled with the injectable medicament 8 is readily installed inside the body 11 of the injection device 1 . Hence, the injection device 1 may be implemented as a prefilled injection device.

[0169] The injectable medicament 8 may require refrigerated storage. With the prefilled injection device 1 the entirety of the injection device and hence the injection device 1 with the injectable medicament 8 as provided in the medicament container 10 and located inside the body 11 of the injection device may have to be kept in a refrigerated environment. Taking the injection device 1 out of the refrigerated area may be intended immediately before injection of the injectable medicament 8.

[0170] The medicament 8 may be allowed for a storage at room temperature or at an elevated temperature, e g. between 20°C and 30° only for a limited period of time, hence a predefined maximum time interval.

[0171] The medicament 8 may be returned into a refrigerated environment to prolong its lifetime and overall time of use. In some examples, the medicament 8 may not tolerate a return into a refrigerated environment once it has been taken out of the refrigerated environment and once the medicament 8 has been subject to a rise in temperature above a refrigeration temperature.

[0172] In Fig. 5 there is shown a diagram 60 illustrating an example of temporal evolution of a temperature of the injection device 1 and / or of the injectable medicament 8 over time. During a first time interval 61 the medicament and / or the injection device 1 is kept in a refrigerated environment. Here, the temperature is between the refrigerated temperature of 2°C - 8°C. When the temperature of the injectable medicament rises above the upper refrigerating temperature, and e.g. exceeds 8°C there will be determined or measured a time interval of 32 hours until the injectable medicament 8 returns into a refrigerated environment and until the injectable medicament has been cooled down to the upper limit of the refrigerated temperature of 8°C.

[0173] In a subsequent time interval 62 the injectable medicament 8 is kept again in a refrigerated environment. During or after lapse of the second time interval 62 the injectable medicament is taken out of the refrigerated environment and the time interval during which the injection device or the injectable medicament 8 is exposed to the non-refrigerated environment will be subject to a further increase until a maximum time interval of e.g. 48 hours or 96 hours has been reached.

[0174] As particularly illustrated in Figs. 1 , 4 and 8 there is provided an auxiliary device 30 comprising a housing 31 , which is configured for detachable fastening to the body 11 of the injection device 1. The auxiliary device 30, the details of which are schematically illustrated in the block diagram of Fig. 15, comprises an electronic circuit 40 comprising a clock 42, a temperature sensor 46 and a processor 44. By way of the temperature sensor 46 the auxiliary device 30 is configured to measure or to determine a temperature of the medicament container 10 and / or of the injectable medicament 8 when the auxiliary device 30 is duly attached to the body 11 of the injection device 1.

[0175] The housing 31 of the auxiliary device 30 may comprise a tubular or in sections annular shape. The housing 31 comprises a sidewall 33, which is sized to form or to constitute a receptacle 32 that allows for insertion of at least a portion of the body 11 into the receptacle 32 or even through the receptacle 32. The sidewall 33 comprises an outside surface 34 and an inside surface 35. The housing 31 and hence the sidewall 33 may comprise a sleeve-like shape, which is open in a longitudinal distal direction 2 and in a longitudinal proximal direction 3. This allows to slip or to slide the housing 31 of the auxiliary device 30 onto the outside surface of the body 11 of the injection device 1 as indicated in Fig. 4.

[0176] The housing 31 comprises an annular shaped ring portion 38, which is sized to receive the body 11 of the injection device 1 in longitudinal direction there through. The sidewall 33 comprises an inside surface 35 facing towards an outside surface of the body 11 of the injection device 1 when duly attached to the body 11. On the inside surface 35 there may be provided one or two radially inwardly protruding projections 36, 36', details of which will be further apparent from the cross-section of Fig. 9.

[0177] On the projection 36 there may be provided the temperature sensor 46. There may be optionally provided also a light source 52 in order to illuminate the medicament container 10. The projection 36, 36' may be particularly suitable for insertion into a recessed portion or window 18, 18' of a sidewall of the body 11 of the injection device 1. Hence, a longitudinal and / or circumferential extent of the projection 36, 36' may be complementary shaped to a cross-section of the window 18, 18'. In this way, the projections 36 36' may provide a fastening of the auxiliary device 30 to the body 11 of the injection device 1.

[0178] By arranging the temperature sensor 46 on the projection 36 a lateral or radial distance between the temperature sensor 46 and the medicament container 10 can be reduced to a minimum when the auxiliary device 30 is attached to the body 11. In some examples it may be even provided that the temperature sensor 46 gets in direct mechanical and hence thermal contact with the medicament container 10. This allows for a rather precise and direct temperature measurement of the medicament container 10 and / or of the injectable medicament 8 contained therein.

[0179] Optionally, the auxiliary device 30 comprises a light source 52, which is configured to illuminate the medicament container 10.

[0180] The body 11 of the injection device 1 may comprise a first window 18 and a second window 18'. The first and the second windows 18, 18' may align with respective first and second sidewall portions 39, 39' of the sidewall 33 of the housing 31 of the auxiliary device 30 as illustrated in Fig. 1 . The windows 18, 18' of the body 11 may be located diametrically opposite to each other. Accordingly, also the sidewall portions 39, 39' may be located diametrically opposite to each other. The first sidewall portion 39 may be provided with the light source 52, e.g., implemented as a LED, which is tunable in brightness and / or color.

[0181] A second sidewall portion 39' of the sidewall 33 of the housing 31 may be provided with an optical element 37. The optical element 37 may be implemented as a lens, e.g. as an aspheric lens or as a cylindrical lens. The lens 37 may be located diametrically opposite to the light source 52 and may provide a rather homogeneous illumination area of the medicament container 10 inside the body 11 of the injection device 1. The second sidewall portion 39', which is provided with the optical element 37, may comprise a through recess or through opening 56, in which the optical element 37 is located. This allows for a direct visual inspection of the medicament container 10 through the optical element 37. By illuminating the medicament container 10 with the help of the light source 52 the illumination and hence visual inspection of the medicament container 10 and / or of the injectable medicament 8 contained therein can be improved. The through opening 56 as provided with the optical element 37 is also visible in the illustration of Figs. 1 and 8 of the auxiliary device 30.

[0182] In some examples the first and second sidewall portions 39, 39' may protrude in longitudinal direction from the annular shaped rim portion 38 of the sidewall 33 of the housing 31 of the auxiliary device 30. The longitudinally protruding sidewall portions 39, 39' may provide at least a slight resilient deformation in radial direction so as to facilitate a mechanical engagement and disengagement between the projection 36, 36' and the windows 18, 18' or through recesses in the sidewall of the body 11 of the injection device 1.

[0183] When duly mounted to the injection device 1 the optical element 37 is clearly visible from outside the auxiliary device 30. It may provide an improved visual inspection of the medicament container 10 located inside the body 11 of the injection device 1. The auxiliary device 30 may be optionally provided with at least one of an indicator 48 and a display 49. By way of the indicator 48 or display 49 there may be indicated or illustrated a residual time interval the injection device 1 or injectable medicament 8 may be allowed to exposure to the non-refrigerated environment.

[0184] The auxiliary device 30 may be provided with an acoustic indicator by way of which e.g. a number of hours corresponding to the residual time may be audibly indicated to the user of the auxiliary device 1. In further examples the display 49 may be implemented as a two-dimensional spatially resolving display by way of which numbers or symbols may be visually indicated to a user, which numbers or symbols might be indicative of the residual time interval the injection device is allowed to exposure to the non-refrigerated environment.

[0185] The auxiliary device 30 comprises an electronic circuit 40 as shown in Fig. 15. The electronic circuit 40 comprises a printed circuit board 41, which is equipped with numerous electronic components, such as a clock 42, a digital memory 43, a processor 44 or controller, a transceiver 45, a temperature sensor 46, an indicator 48 or display 49.

[0186] The electronic circuit 40 may be further connected to an energy source 50, such as a battery via a switch 51. The auxiliary device 30 may be further provided with the light source 52 and with a reading unit 54, the latter of which being also indicated in the schematic illustration of Fig. 8.

[0187] By way of the reading unit 54 and the auxiliary device 30 is operable to read the identifier 26 as provided on the body 11 or medicament container 10. By way of the reading unit 54 there can be automatically obtained injection device related or medicament related information through readout of the identifier 26.

[0188] The processor 44 is operably connected to the clock 42 and is configured to count a sequence of clock signals generated by the clock 42 when the temperature as measured by the temperature sensor 46 is above a predefined refrigeration temperature or above a refrigeration temperature interval. It may be provided that the processor 44 and the temperature sensor 46 regularly measure the temperature in direct vicinity of the medicament container 10. As long as the temperature is within a predefined refrigeration temperature interval, e.g. between 2°C and 8°C the processor 44 may be somewhat in an idle or sleep mode.

[0189] It may be only upon a rise of the temperature above the refrigeration temperature or temperature interval and upon generation of respective temperature signals by the temperature sensor 46 that the processor 44 autonomously triggers counting of clock signals as provided by the clock 42. Counting of clock signals is equivalent to a quantitative determination of a time interval during which the injection device and / or the injectable medicament 8 is exposed to a non-refrigerated environment.

[0190] The processor 44 may start counting as soon as the temperature rises above the predefined refrigeration temperature, e.g. above 8°C. In some examples and if allowable or tolerable by the medicament the counting may automatically stop or interrupted when the temperature falls below the predefined refrigeration temperature as indicated with the prime interval 62 as shown in Fig. 5. After lapse of such a time interval 62 and when the injection device 1 and / or the injectable medicament 8 should be again subject to exposure to non-refrigerated conditions or temperature the measured temperature will rise again and the processor 44 may resume counting of the sequence of clock signals to quantitatively determine the time interval and hence the total time interval during which the injection device is or has been exposed to the nonrefrigerated environment.

[0191] The processor 44 is further operable and configured to compare and / or to quantitatively determine the time interval with a predefined maximum time interval that the injection device 1 and / or the injectable medicament 8 is allowed to be exposed to a non-refrigerated environment. If such maximum time interval should be reached the processor 44 may be operable to generate an alert, e.g. via the indicator 48 and / or via the display 49. In addition, or alternatively the processor 44 may be configured to generate an alert via a signal transmission between the transceiver 45 and the communication 106 of an external electronic device 100, e.g. implemented as a smart phone. It may be then that the external electronic device 100 generates a respective audible, tactile and / or visual alert thus informing the user that the injection device 1 and / or the injectable medicament 8 have been exposed unduly or overlong to non-refrigerated conditions.

[0192] By way of the switch 51 the auxiliary device may be switched on. The switch 51 may be integrated into the inside surface 35 of the sidewall 36 and may be automatically switch on upon attachment or fastening of the housing 31 of the auxiliary device 30 to the body 11 of the injection device 1. The external electronic device 100 may be paired with the transceiver 45 of the auxiliary device 30 by a wired connection or wirelessly.

[0193] For a wireless connection the transceiver 45 may be configured to communicate with the communication unit 106 on the basis of RF transmission signals and / or by making use of standardized communication protocols, such as RFID, Bluetooth, Bluetooth low energy (BLE) or NFC. The electronic device comprises a device housing 101 and a device processor 102. The electronic device 100 may further comprise a manually operable actuating element 103, which may slightly protrude from the device housing 101.

[0194] The electronic device 100 further comprises a device display 104. The device display 104 may occupy a major portion of a front side of the housing 101. The device display 104 may be implemented as a touch-sensitive display. The display 104 may provide visual information content to the user and may further emulate control patches or control or actuating elements on the display that may be operated by a finger of a user through touching-, sliding or tapping movements.

[0195] Alternative to the implementation as a smartphone the external electronic device 100 may be also implemented as a smartwatch as shown in Fig. 7. Here, the external electronic device one 100 also comprises a device housing 101 with at least one actuating element 103 and a touch- sensitive display 104. The housing 101 of the electronic device 100 may be detachably fastenable to a wrist 7 of a user via a wristband 109 or strap.

[0196] The electronic device 100 may permanently or frequently communicate with the auxiliary device 30 and there may be established a pairing or communication link between the communication unit 106 and the transceiver 45. In some examples the electronic device 100 may be configured as a kind of a remote control for the auxiliary device 30. Hence, some or all functions of the electronic circuit 40 may be controlled or adjusted by the electronic device 100. For instance, the light source 52 of the auxiliary device 30 may be controlled by the external electronic device 100. The graphical user interface and hence the device display 104 of the electronic device 100 may provide a rather intuitive and straightforward control and operation of various functions of the auxiliary device 30. The auxiliary device 30 may be thus void of a manually operable actuating element 103. It may only comprise a switch 51, which may be switched on through interaction with the body 11 of the injection device 1 , e.g. upon mounting the auxiliary device 30 to the body 11.

[0197] The electronic circuit 40 of the auxiliary device 30 may be then in a permanent or frequent and non-permanent pairing mode with the external electronic device 100. The processor 44 of the electronic circuit 40 of the auxiliary device 30 may be operable to calculate or to determine a residual time interval the injection device is allowed to exposure to the non-refrigerated environment.

[0198] On the basis of device specific or injectable medicament specific information as obtainable via the reading unit 54 from the identifier 26 the predefined maximum time interval may be kept or redefined by the processor 44. The maximum time interval the injection device and / or the injectable medicament 8 may be exposed to the non-refrigerated environment may be stored in the memory 43. The processor 44, which is operable to count a sequence of clock signasl and hence to determine the time interval during which the injection device and / or the injectable medicament 8 is exposed to the non-refrigerated environment, is operable to permanently compare the momentary determined time interval with the predefined maximum time interval.

[0199] On the basis of the momentary time interval and the predefined maximum time interval the processor 44 is operable to derive or to calculate the residual time interval the injection device is allowed to exposure to the non-refrigerated environment. This information is either directly provided to a user via the indicator 48 or via the display 49. Alternative or additionally, respective information may be provided by the device display 104 and hence through the communication link between the transceiver 45 and the communication unit 106.

[0200] In some examples the functionality of the processor 44 and / or of the entire electronic circuit 40 may be reduced to a minimum, e.g. to the measurement of a temperature 46 and to the transmission of respective temperature signals to the communication unit 106 of the external electronic device 100. It may be then, that the device processor 102 is configured to quantitatively determine the time interval during which the injection device is actually exposed to the non-refrigerated environment and to compare the time interval with the predefined maximum time interval. The device processor 102 may be further operable to calculate or to estimate the residual time interval the injection device is allowed to exposure to the non-refrigerated environment. In this way, at least parts of or almost the entirety of the functionality of the processor 44 of the auxiliary device 30 may be transferred or shifted to the functionality of the device processor 102, which allows to reduce costs and implementing expenditure for the electronic components of the electronic circuit 40 in principle.

[0201] The auxiliary device 30 as well as the external electronic device 100 may be equipped or deployed with a software or computer program by way of which the auxiliary device 30 and the external electronic device 100 may either operate stand alone or by way of which the devices 30, 100 communicate with each other and mutually complement with regard to their functionality.

[0202] Generally, the electronic circuit 40 may be also provided in a standalone configuration, i.e. without integration into the auxiliary device 30. Here, the electronic circuit 40 may be integrated into the injection device 1 , e.g., in the body 11 of the injection device 1. Here, the electronic circuit 40 may be identically or almost identical equipped or configured with regard to its hardware component compared to the auxiliary device 30. By integrating the electronic circuit 40 in the body 11 of the injection device 1, all features, effects and benefits as described above in connection with the auxiliary device 30 may be likewise provided by the electronic circuit 40.

[0203] The electronic circuit 40 may communicate with the external electronic device 100 and may transfer or exchange data with the external electronic device 100, specifically with the communication unit 106 of the external electronic device 100.

[0204] The method of monitoring use and / or storage of the injection device 1 is schematically illustrated by the flowchart according to Fig. 14. The method is generally implementable with the auxiliary device 30 in a standalone mode and / or with a monitoring system 150 comprising the auxiliary device 30 and the external electronic device 100.

[0205] In a first step of the method of monitoring use and / or storage of the injection device 1 the auxiliary device 30 is attached to the body 11 of the injection device 1. In the course of attaching the auxiliary device 30 to the body 11 of the injection device 1 the processor 44 of the electronic circuit 40 may be provided or supplied with electrical energy by an inherent actuation of the switch 51. In a subsequent step 202 the temperature of at least one of the medicament container 10 and the injectable medicament 8 is measured by the temperature sensor 46. In step 204 there is quantitatively determined a time interval during which the injection device 1 is exposed to a non-refrigerated environment. For this, and as soon as the measured temperature rises above a predefined refrigeration temperature, e.g. above 8°C the processor 44 starts counting of a repetitive sequence of clock signals as provided by the clock 42or clock generator.

[0206] In step 206 the so-determined time interval, which is indicative of the total duration the injection device and / or the injectable medicament 8 is or has been exposed to non-refrigerated environment, is compared with a predefined maximum allowable time interval the injectable medicament may be exposed to such a non-refrigerated environment. In step 208 there is finally calculated or estimated a residual time interval the injection device 1 and / or the injectable medicament 8 is allowed to exposure to the non-refrigerated environment.

[0207] In a further optional step (not illustrated) the residual time interval is provided to a user via at least one of an indicator 48 and a display 49 of the auxiliary device 30 and / or via a speaker or display 104 of the external electronic device 100, which can be in a permanent or transient data exchanging mode with the electronic circuit 40 via the transceiver 45 and the communication unit 106.

[0208] In the sequence of Figs. 10-13 numerous display configurations of the touch sensitive display 104 of the external electronic device 100 are illustrated that may assist a user in using the auxiliary device 30 for monitoring use or storage of the injection device 1.

[0209] In an initial configuration as shown in Fig. 10 there is provided an indication 110 on the display 104 together with a notification 111 by way of which a user is prompted to manually check the expiry date on a label as provided on the body 11 of the injection device 1. On the display configuration there are provided two alternative user inputs 112, 113 that may be tapped by a user in response. The user input 112 indicates that the expiry date is not O.K. This user input 112 should be tapped by the user when the expiry date of the medicament 8 has lapsed. The alternative user input 113 should be tapped by a user when the expiry date as indicated or provided on the body 11 of the injection device 1 is still O.K. thus indicating that the medicament and / or injection device can be used in principle.

[0210] In the further display configuration of Fig. 11 the display 104 provides another indication 110 in form of a graphical illustration of a portion of the injection device 1 and a portion of the auxiliary device 30 attached to the injection device 1 . There is further provided a notification 111 prompting the user to check the display 49 of the auxiliary device 30 if the residual time interval the injection device 1 is allowed to exposure to a non-refrigerated environment is still larger than zero. Also here, there are provided two alternative user inputs 112, 113 by way of which the user may provide a feedback if the so-called "time out of refrigeration" (TooR) is O.K. or is not O.K.

[0211] In a further display configuration as shown in Fig. 12 the display 104 provides another indication 110 together with a notification 111 prompting the user to conduct a visual inspection of the medicament 8 located inside the medicament container 10. For this, the display 104 provides a control element 115 by way of which a user may control and activate or adjust the light source 52 of the auxiliary device 30. A respective control command as entered by the user, e.g. by shifting the control element up and down or along a predefined control movement direction, is transferred to the auxiliary device 30 and hence to the processor 44 of the auxiliary device 30.

[0212] In response, a color setting and / or brightness of the tunable light source 52 may be adjusted accordingly.

[0213] The display 104 may further provide a test section 116 that may reflect or show the selected color in accordance to the color settings or intensity settings as defined by the control element 115. The test section 116 may have or form a kind of a reference illustration 114, which the user may visually compare with the impression gained through the optical element 37 of the auxiliary device 30.

[0214] In a further display configuration according to Fig. 13 the user may be provided with alternative reference illustrations 114, 114' illustrating typical illustrations or impressions of the optical element 37 when the medicament 8 and / or the medicament container are in a proper condition as in the example of the reference illustration 114. In another comparative reference illustration 114' the display 104 shows configurations or conditions of the medicament container 10 and 30 or of the injectable medicament 8, in which at least one of the medicament container 10 and the injectable medicament 8 are not in a condition of use.

[0215] Providing of reference illustrations 114 is a rather easy and straightforward way to assist a user to make a decision if the medicament 8 or medicament container 10 can still be used or should no longer be used. In this way patient safety when using the injection device 1 can be improved. Reference Numbers

[0216] 1 injection device

[0217] 2 distal direction

[0218] 3 proximal direction

[0219] 4 hand

[0220] 5 thumb

[0221] 6 finger

[0222] 7 wrist

[0223] 8 medicament

[0224] 9 stopper

[0225] 10 medicament container

[0226] 11 body

[0227] 12 shield

[0228] 13 syringe carrier

[0229] 14 outlet

[0230] 15 needle

[0231] 16 protective cap

[0232] 17 flange portion

[0233] 18 window

[0234] 20 plunger

[0235] 21 plunger flange

[0236] 22 injection mechanism

[0237] 23 trigger

[0238] 24 dose dial

[0239] 26 identifier

[0240] 30 monitoring device

[0241] 31 housing

[0242] 32 receptacle

[0243] 33 sidewall

[0244] 34 outside surface

[0245] 35 inside surface

[0246] 36 projection

[0247] 37 optical element

[0248] 38 rim portion

[0249] 39 extension

[0250] 40 electronic circuit 41 printed circuit board

[0251] 42 clock

[0252] 43 memory

[0253] 44 processor

[0254] 45 transceiver

[0255] 46 sensor

[0256] 48 indicator

[0257] 49 display

[0258] 50 energy source

[0259] 51 switch

[0260] 52 light source

[0261] 54 reading unit

[0262] 56 through opening

[0263] 60 diagram

[0264] 61 time interval

[0265] 62 time interval

[0266] 100 electronic device

[0267] 101 device housing

[0268] 102 device processor

[0269] 103 actuating element

[0270] 104 device display

[0271] 106 communication unit

[0272] 107 device reading unit

[0273] 108 device memory

[0274] 109 wristband

[0275] 110 indication

[0276] 111 notification

[0277] 112 user input

[0278] 113 user input

[0279] 114 reference illustration

[0280] 150 monitoring system

Claims

Claims1. An electronic circuit (40) for monitoring use and / or storage of an injection device (1), wherein the injection device (1) comprises a body (11), which is configured to receive a medicament container (10) filled with an injectable medicament (8) or which is configured to contain the injectable medicament (8), the electronic circuit (40) comprising a clock (42), a temperature sensor (46) and a processor (44), wherein the temperature sensor (46) is operable to measure a temperature of at least one of the medicament container (10) and the injectable medicament (8), and wherein the processor (44) is operable: i) to quantitatively determine a time interval during which the injection device (1) or the injectable medicament (8) is exposed to a non-refrigerated environment, ii) to compare the time interval with a predefined maximum time interval, and iii) to calculate or to estimate a residual time interval the injection device (1) is allowed to exposure to the non-refrigerated environment.

2. The electronic circuit (40) according to claim 1 , wherein the electronic circuit (40) comprises at least one of an indicator (48) and a display (49) operable to indicate or to display the residual time interval.

3. The electronic circuit (40) according to claim 2, wherein the indicator (48) comprises an acoustic indicator.

4. The electronic circuit (40) according to any one of the preceding claims, wherein the electronic circuit (40) comprises a transceiver (45) to communicate with an external electronic device (100) and to transmit at least one of the time interval and the residual time interval to the external electronic device (100).

5. The electronic circuit (40) according to any one of the preceding claims, wherein the electronic circuit (40) comprises a reading unit (54) operable to read an identifier (26) of at least one of the injection device (1) and the medicament container (10).

6. The electronic circuit (40) according to claim 5, wherein the processor (44) is operable to define or to redefine the maximum time interval on the basis of medicament specific information obtainable via reading of the identifier (26).

7. The electronic circuit (40) according to any one of the preceding claims, wherein the processor (44) is operable to determine the time interval by counting a sequence of clock signals during which a temperature signal obtainable from the temperature sensor (46) is indicative of a raised temperature, which is larger than a predefined refrigeration temperature.

8. The electronic circuit (40) according to claim 7, wherein the processor (44) is operable to stop or to interrupt counting the sequence of clock signals when the temperature signal is indicative of a cooling temperature, which is smaller than or equal the predefined refrigeration temperature.

9. The electronic circuit (40) according to any one of the preceding claims, wherein the processor (44) is operable to generate an alert signal, when at least one of the following conditions is met: the residual time interval approaches or equals zero; a temperature of at least one of the medicament container (10) and the injectable medicament (8) exceeds a predefined maximum temperature, the exposure of the injection device (1) to the non-refrigerated environment exceeds a predefined maximum thermal energy input into the injectable medicament (8), a number of exposures of the injection device (1) to the non-refrigerated environment exceeds a maximum allowable exposure number.

10. The electronic circuit (40) according to any one of the preceding claims, wherein the electronic circuit (40) further comprises a light source (52) to illuminate at least one of the body (11) and the medicament container (10).

11. An auxiliary device (30) for monitoring use and / or storage of an injection device (1), wherein the injection device (1) comprises a body (11), which is configured to receive a medicament container (10) filled with an injectable medicament (8) or which is configured to contain the injectable medicament (8), the auxiliary device comprising: a housing (31) for fastening to the body (11) of the injection device (1), and an electronic circuit (40) according to any one of the preceding claims.

12. The auxiliary device (30) according to claim 11 , wherein the housing (31) comprises a sidewall (33) confining a receptacle (32) sized to receive at least a portion of the body (11) of the injection device (1).

13. The auxiliary device (30) according to claim 11 or 12, wherein the sidewall (33) comprises an inwardly protruding projection (36), which is configured to mechanically engage with a window (18) or recessed portion in the body (11) of the injection device (1).

14. The auxiliary device (30) according to claim 13, wherein the temperature sensor (46) is located on the inwardly protruding projection (36).

15. The auxiliary device (30) according to claim 12 and comprising an electronic circuit (40) according to claim 10, wherein the sidewall (33) comprises a first sidewall portion (39) provided with the light source (52) and wherein the sidewall (33) comprises a second sidewall portion (39') opposite to the first sidewall portion (39) and provided with an optical element (37).

16. An injection device (1) for injecting a dose of an injectable medicament, the injection device comprising: a body (11), which is configured to receive a medicament container (10) filled with an injectable medicament (8) or which is configured to contain the injectable medicament (8), an electronic circuit (40) according to any one of the preceding claims 1-10.

17. An electronic device (100) for monitoring use and / or storage of an injection device (1), the electronic device (100) comprising: a device housing (101), a device processor (102) located inside the device housing (101), a device display (104) controllable by the device processor (102), a communication unit (106) operably connected to the device processor (102) and configured to receive and to process signals from an auxiliary device (30) according to any one of the preceding claims 10 - 15.

18. A monitoring system (150) for monitoring use and / or storage of an injection device (1), the monitoring system (150) comprising an electronic circuit (40) according to any one of the preceding claims 1-10 and an electronic device (100) according to claim 13.

19. A method of monitoring use and / or storage of an injection device (1), the method comprising the steps of: using an electronic circuit (40) for monitoring use and / or storage of an injection device (1) comprising a body (11), wherein the body (11) is configured to receive a medicament container (10) filled with an injectable medicament (8) or is configured to contain the injectable medicament (8),measuring a temperature of at least one of the medicament container (10) and the injectable medicament (8), quantitatively determining a time interval during which the injection device (1) is exposed to a non-refrigerated environment, - comparing the time interval with a predefined maximum time interval, and calculating or estimating a residual time interval the injection device is allowed to exposure to the non-refrigerated environment.

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