Drug Delivery Devices

Abstract

A drug delivery device comprising: a first module (10) including a zinc-air battery (14) positioned at one end of the first module (10); a second module (12) including electrodes (16) for attachment to one end of the first module (10); and activation means (18) for activating the zinc-air battery (14), the activation means (18) being designed to puncture at least one hole in the hermetic seal of the zinc-air battery (14) when the second module (12) is attached to one end of the first module (10).

Description

[Technical field]

[0001] The present disclosure relates to drug delivery devices. [Background technology]

[0002] There are a variety of diseases that require regular treatment by delivery of drugs, particularly by injection of drugs. Such injections can be performed by using injection devices used either by medical professionals or by the patients themselves.

[0003] Drug injection devices, especially for self-use by patients, can be equipped with electronic circuits for user assistance. For example, US Pat. No. 5,999,333 discloses a pen-shaped drug delivery device, comprising a drug reservoir with an outlet, a removable cap applied to cover the outlet portion of the drug reservoir in a position attached to the device body, and a drug ejection means including a dose setting means enabling a user to set the dose of drug to be ejected, the set dose being indicated in a window printed on a rotatable scale drum. The device is provided with an electronic circuit, comprising sensor means adapted to capture characteristic values ​​relating to the dose of drug ejected from the reservoir by the ejection means during an ejection event, processor means adapted to determine the dose based on the captured characteristic values, storage means adapted to store at least one dose, display means adapted to display information relating to the dose, such as the determined dose and associated time values, and a power source. The power source is in the form of a zinc-air battery, which may be devoid of air and therefore inactive until first use. The zinc-air battery includes a number of air holes, which communicate with the outside through one or more passages formed between the battery and an opening formed in the outer surface of the pen body. The cap of the pen is provided with a sealing surface portion adapted to seal the opening when the cap is in a fully installed position. When the cap is fully or partially removed from the device body, the passage opening is exposed and communication is established between the battery's air holes and the outside, thereby allowing oxygen-rich air to enter the battery, which initiates the above-mentioned chemical process and generates a voltage, which activates the electronic circuit and allows the discharged dose to be registered, which can then be displayed on the display means. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] WO2016 / 193122A1 Summary of the Invention [Means for solving the problem]

[0005] In one aspect, the present disclosure provides a modularization of a drug delivery device having a first and / or second module, which when integrated together, is configured to construct an electronically controlled and / or electronically monitored pen-shaped injection device, thereby realizing the functionality of electronically controlled and / or monitored discharge of a liquid drug formulation to an external administration site, the modularization comprising: a first module including a liquid drug-filled reservoir, a first downstream portion of a liquid drug ejection mechanism configured to eject a portion of the liquid drug from the liquid drug reservoir upon actuation, and a self-contained energy source, in particular an electrochemical cell or battery; and / or a second module including a second upstream portion of the liquid drug ejection mechanism and electronic circuitry configured to control and / or monitor the status and / or operation of either the first or second portions of the liquid drug ejection mechanism; An electromechanical interface is provided on the first and / or second module, the electromechanical interface comprising: releasably coupling the first module and the second module, thereby forming a coupled mechanical structure, more particularly a fixedly coupled mechanical structure; operatively connecting an ejection mechanism portion of a first module to an ejection mechanism portion of a second module; The modularization is configured to provide an electrical path for supplying energy from an electrical energy source integrated in a first module to an electrical circuit included in a second module.

[0006] Certain embodiments of the present disclosure may provide a drug delivery device having a first and a second module. Furthermore, certain embodiments of the present disclosure may provide a drug delivery device having a first module configured to be coupled with a second module to construct a pen-shaped injection device. Further, certain embodiments of the present disclosure may provide a drug delivery device having a second module configured to be coupled with a first module to construct a pen-shaped injection device.

[0007] The above-mentioned "injection device" can be considered as a more detailed drug delivery device, as long as it includes an ejection mechanism as well as a liquid drug reservoir, from which a user can eject a liquid drug. When provided in a cannula, an injection of the ejected liquid drug into a human or animal body can be performed. The injection can be, for example, subcutaneous, intramuscular, or intravenous, according to the common understanding of these terms in the medical field. In some cases, the injection device can be a dose-controlled injection device for allowing a user to eject a predetermined amount of liquid drug from the reservoir. In some cases, the dose-controlled injection device can be a multiple-injection dose-controlled injection device, which allows a user to perform multiple dose-controlled ejection operations from the same drug container. Typical examples thereof can be found in various pen injection devices for diabetes.

[0008] The term "modularization" as used above and below is understood to apply to all individual modules as independent devices and to integration of two or more modules. In such "modularization", when the scope is semantically limited to an individual module or an incomplete integration of a module, references to the remaining modules or the remaining integration of a module are to be interpreted in the sense of the boundary connection requirements resulting from the individual module or the incomplete integration of a module.

[0009] The modifiers "upstream" and "downstream" used above with respect to the ejection mechanism are understood to be attached to the concept of a drive train implemented in the ejection mechanism, and the flow of mechanical force or power along that drive train. In particular, a member located "downstream" of the drive train is expected to follow the action, movement, or actuation of the "upstream" member during normal ejection operations. Clearly, "upstream" and "downstream" are relative modifiers. In the relationship between two drive train members, the member located "upstream" is closer to the source of the mechanical power that causes the ejection drive train to perform the ejection operation.

[0010] The disclosed modularization of electronically controlled and / or monitored injection devices is applicable to improve the consistency of component lifetimes, thereby reducing the amount of waste and costs. In particular, modularization can be implemented to collect multiple components with fairly short lifetimes or soon to reach their end of life into one of multiple modules. Preferably, the drug reservoir and the electrical energy source are assigned together in the same module, and the electrical circuitry can be assigned to another module, either completely or to a major extent. This assignment allows the module containing the drug container and the electrical energy source to be replaced at the same time, thereby keeping the major part of the electrical circuitry with the other module for subsequent reuse. The underlying idea is that a multi-dose liquid drug injection device has a shelf life of several weeks after first use, due to the potential risk of drug degradation, which roughly corresponds to the typical period of power delivery after activation of a standard zinc-air battery. On the other hand, for electronic circuits, a longer usage period is desirable, at least for cost reasons. On the other hand, it may be found preferable to have short-lived modules free of electronic components to avoid waste regulations other than those applicable to empty drug containers and sharps. Finally, proper allocation of components to modules may help improve quality of care by consolidating business requirements into one item. In the exemplary conventional situation of a reusable injection pen incorporating a dose capture and recording unit, to ensure a properly captured drug administration, the user must pay attention to the battery charge state at the time of dose capture and check whether there is sufficient remaining drug container for future administrations. Failure in either case will prevent the user from administering a properly recorded dose required for the treatment plan.

[0011] In an embodiment, the entire mechanical discharge drive train is assigned to the first and second modules, respectively, so that not only the cartridge bung is assigned to the first module as the extreme end, but also one or more directly adjacent upstream members, i.e. the leg of the piston rod, and possibly the piston rod, can be included in the first module. This can be useful when there is high structural stability in the flow cycle of the supporting forces from the piston rod support along the piston rod to the bung, liquid, vial, and vial support and back to the piston again. This can be particularly useful when high concentration drug formulations need to be dispensed in small amounts with high accuracy.

[0012] In a more detailed embodiment, the first and / or second module are configured to be integrated into an axial arrangement having a liquid drug-filled reservoir, in particular a drug container, a liquid drug ejection mechanism, and an electrical energy source arranged along a longitudinal axis defined by the pen-shaped appearance of the integrated first and second modules.

[0013] In a more detailed embodiment, the first module may include a standard drug cartridge having a liquid drug formulation contained in a section of a glass vial separated from an exterior space by a rubber stopper seal that is movable along the cylindrical section of the glass vial as the extreme end of the liquid drug ejection mechanism of the first module to convert the mechanical driving force of the ejection mechanism into hydraulic pressure in the separated section of the glass vial.

[0014] In a more detailed embodiment, the power source may be a button cell battery positioned adjacent to the exterior-facing sealing surface of the rubber plug. In a more particular embodiment, the button cell battery may be configured to include a raised exterior structure suitable for transferring axial loads from an abutting drive train member to the rubber plug seal. In an even more particular embodiment, a flat cylindrical button cell battery may be arranged to contact the exterior-facing end of the rubber plug seal with one flat circular electrode and provide the opposite circular electrode surface as an input load plate for the adjacent upstream drive train element of the overall exhaust drive train. In that alternative, the outer edge surrounding the opposite electrode may be used as an input load support for the upstream drive train element to prevent mechanical loads from being transferred across the button cell seal or through its internal structure.

[0015] In an embodiment, the upstream drive train element abutting the button cell can be configured to include a portion of the electrical path to the electronic circuitry included in the second module. In a more detailed embodiment, the upstream drive train element abutting the button cell can be an elongated piston rod comprising a conductive material. In an even more detailed embodiment, the elongated piston rod can be provided as a component or integral part, the component or integral part comprising, in part, a conductive material and a non-conductive material.

[0016] In other embodiments, the entire ejection mechanism may be assigned to a module that includes the drug reservoir and the electrical energy source. This may be particularly useful for implementing the concept of reusable dose recording of a mechanical self-contained pre-filled pen injection device. In some cases, the first module may be a self-contained pre-filled mechanical pen injection device that mainly provides independent operation for setting and ejecting multiple desired doses from the drug reservoir. Only the functionality for electronically monitoring the dose setting and / or ejection operations to track or monitor drug administration may be provided by the second module. In such a situation, the electrical energy source may be included in the same module, preferably in the same external casing structure, together with the self-contained pre-filled mechanical pen injection device. An electromechanical connection or interface may provide power from the power source to the second module with the dose recording unit. A simplification may be achieved as long as the second module starts up directly after attachment to the first module. Furthermore, the life of the electrical energy source can be selected to safely extend over the maximum shelf life of the drug in the reservoir, so that the user can feel freed from the burden of paying attention to the charge status of the electrical energy source. As with conventional pen injection devices, the user can limit checking that there is sufficient content in the drug reservoir and that the shelf life has not expired, without affecting a fully compliant treatment. As long as these conditions are met, the user can count on the capacity of the energy source to provide sufficient power to properly operate the dose recording unit of the second module.

[0017] In another aspect, the present disclosure provides a modularized electronically controlled and / or monitored injection device, comprising a first module including a zinc-air battery located at one end of the first module, the zinc-air battery having a plurality of vent openings and a removable seal for covering the vent openings in a first configuration and exposing the vent openings in a second configuration, and a second module configured to be attached to one end of the first module and including electronic circuitry; the first module and / or the second module are provided with a plurality of mechanical interfaces for releasably connecting the first module and the second module to one another, thereby forming a mechanical structure, in particular a rigid mechanical structure; A modularization is provided in which one of the modules is provided with a seal remover operable to remove a seal from at least one of the vent openings of the zinc-air battery, and a mechanical interface between the first and second modules is configured to operate the seal remover when the first module is attached to the second module at any of the mechanical interfaces.

[0018] For some purposes, it may be advantageous for the zinc-air battery to be maintained in an inactive state prior to the first use of the injection device, in which the second part is attached to the first part of the drug delivery device. Another advantage may be seen as a more comfortable handling by the user, since the activation means activates the zinc-air battery when the second part is attached to the first part, so that the user does not have to manually remove the hermetic seal as an additional operation. If the first part is used as a drug cartridge holder, the first part can be easily disposed of when the cartridge and / or the zinc-air battery are empty, and the second part containing the electronic circuitry can be reused with another first part.

[0019] In an implementation, the first module may be a pen having a distal end and a proximal end and a dose button positioned at the distal end, with the zinc-air battery being positioned in the body in the dose button, particularly above the dose button.

[0020] In an alternative implementation, the first module may be a dosing mechanism of a drug delivery device, with the zinc-air battery located in a bearing of the dosing mechanism, which may include a cup-like shaped holder for the zinc-air battery and a cup-like shaped cover for clipping onto the holder, with the activation means integrated into the cover.

[0021] In yet another alternative implementation, the first module may be a pen having a distal end and a proximal end, and the zinc-air battery is located in a battery compartment of the first module. The battery compartment may be located outside the first module near one end of the first module.

[0022] The activation means may include at least one pin designed to be used as an electrode for electrically connecting a power supply connector of an electronic circuit to a power supply connector of the zinc-air battery.

[0023] In yet another aspect, the present disclosure provides an attachment module for a drug delivery device, comprising: A flexible body; a flexible display integrated into the flexible body; and electronic circuitry configured to communicate with electronic circuitry of the drug delivery device and to control the flexible display in response to communication between the electronic circuitry of the attachment device and the electronic circuitry of the drug delivery device.

[0024] As an advantage, the attachment module can be seen as enabling a variety of uses, for example, the attachment module can be attached to various positions on the drug delivery device to better accommodate the habits of the user holding the drug delivery device, such as attachment in a position that does not cover the display of the attachment device. Another advantage is that the attachment device can be easily detached from the drug delivery device and is formed in such a way that it can be held by the user in a way that allows comfortable reading of the information shown on the flexible display. Yet another advantage is that the attachment module, due to its flexibility, can be attached to a variety of drug delivery devices.

[0025] The electronic circuitry of the attachment module may be further configured to, in response to the communication, unlock use of the drug delivery device.

[0026] The electronic circuitry of the attachment module may be configured to control the flexible display to display information arising from the operation of the drug delivery device, in particular information about one or more delivered injection doses, time, retention time, battery status, and one or more alarms.

[0027] The attachment module may further include a user input means, the electronic circuitry being configured to process signals generated by the user input means and control communication with the flexible display and / or the drug delivery device in response to the processed signals.

[0028] The attachment module may further include an interface for communicating with a computing device, in particular for transmitting data relating to the drug delivery device and its use to the computing device for further processing.

[0029] In yet another aspect, the present disclosure provides a method for operating a supplemental device for a drug delivery device, the supplemental device including an electronic circuit having at least one processor and at least one storage, the processor performing the following steps of the method: detecting attachment of a supplemental device to a drug delivery device; detecting drug delivery by the drug delivery device; recording the detected drug delivery in storage; and generating at least one signal in response to the recording.

[0030] An advantage is that the signal can alert the user when, for example, the drug cartridge of the drug delivery device is empty and should be disposed of. Thus, the signal can remind the user to detach the capture device from the drug delivery device when the supplemental device and the drug delivery device are coupled to each other, and not to dispose of the supplemental device as it can be reused with a new disposable drug delivery device.

[0031] Producing at least one signal in response to the recording includes: generating a signal after a final drug delivery by the drug delivery device; The method may include one or more of the steps of generating a signal prior to reaching a final location of the drug delivered by the drug delivery device.

[0032] At least one signal is an auditory signal generated by a sound generator of the supplemental device; a visual signal generated by a visual signal indicator of the supplemental device; It may include one or more of the haptic signals generated by a haptic signal generator of the supplemental device. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a cross-sectional view of a first embodiment of an injection device. [Figure 2A] FIG. 2 is a cross-sectional view of a second embodiment of an injection device. [Figure 2B] FIG. 2 is a cross-sectional view of a second embodiment of an injection device. [Figure 2C] FIG. 13 is a cross-sectional view showing an embodiment of a zinc-air battery for use with an embodiment of an injection device. [Figure 3A] FIG. 13 is a cross-sectional view of a third embodiment of an injection device. [Figure 3B] FIG. 13 is a cross-sectional view of a third embodiment of an injection device. [Figure 4A] FIG. 13 is a cross-sectional view of a fourth embodiment of an injection device. [Figure 4B] FIG. 13 is a cross-sectional view of a fourth embodiment of an injection device. [Figure 5A] FIG. 13 is a cross-sectional view of a fifth embodiment of an injection device. [Figure 5B] FIG. 13 is a cross-sectional view of a fifth embodiment of an injection device. [Figure 6A] FIG. 13 is a cross-sectional view of a sixth embodiment of an injection device. [Figure 6B] FIG. 13 is a cross-sectional view of a sixth embodiment of an injection device. [Figure 7A] 1A-1C show an embodiment of an attachment device for an injection device. [Figure 7B] 1A-1C show an embodiment of an attachment device for an injection device. [Figure 8A] 1 is a flow chart of an embodiment of a method for operating a supplemental device for a drug delivery device. [Figure 8B] 1A-1C are schematic diagrams illustrating an embodiment of a supplemental device for an injection device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] In the following, embodiments of the present disclosure are described with reference to an injection device, in particular a two-part disposable injection device in the form of a pen, but the present disclosure is not limited to such applications and can equally be implemented in other types of drug delivery devices, in particular in shapes other than pens.

[0035] The embodiments described below relate to a modularized pen-shaped injection device comprising two modules which, when integrated, constitute an electronically controlled and / or monitored injection device, which provides functionality for electronically controlling and / or monitoring the ejection of a liquid drug formulation to an external administration site.

[0036] A first embodiment of an injection device will now be described with reference to Figure 1. The injection device is a two-part device comprising a disposable syringe having a body 10'' in the form of a pen having a proximal end P and a distal end D, and a supplementary device 12'' attached to the distal end D of the body 10''. The proximal end P of the body 10'' is directed towards the injection site of the patient during injection, and the distal end D is directed away from the injection site.

[0037] The body 10'' includes an outer housing 11''. The outer housing 11'' is an elongated tube. The outer housing 11'' includes a cartridge or syringe holder (not shown) that supports a cartridge or syringe (not shown) containing a liquid medication, and has a mechanical interface to a supplemental device 12'' that contains an electrical drive train for causing dispensing of the medication during injection by the body 10''. A battery compartment 24 is located outside the outer housing 11''. The battery compartment 24 is provided to house a zinc-air battery 14''.

[0038] The body 10'' with the zinc-air battery 14'' forms a disposable part of the injection device, which can be disposed of when the battery and / or the cartridge containing the liquid medicament are empty.

[0039] The supplemental device 12'' is designed as an attachment to the distal end D of the body 10''. The supplemental device 12'' includes an electric drive train having a mechanical interface for interfacing with a mechanical interface of the body 10''. The electric drive train includes an electric motor 26a, a gear 26b, and a drive screw 26c. The motor 26a is controlled by an electronic circuit 16'' for implementing the control and / or measurement functions of the injection device, which also senses the drive train to ensure reliability of the drive train. The electronic circuit 16'' can also store and / or receive and / or transmit data regarding the use of the injection device. The electronic circuit 16'' may further control the display of the supplemental device 12''. The electronic circuit 16'' can include a microcontroller having firmware configured to measure and record the use of the injection device, such as, for example, time, hold time, battery status, one or more alarms, one or more delivered injection doses, etc.

[0040] An activation means in the form of a pin 18'' is located on the mounting side of the supplemental device 12'' opposite the battery compartment 24 containing the zinc-air battery 18''. In this embodiment, the pin 18'' is part of the supplemental device 12'' and is integrated into the device 12''.

[0041] The use of the injection device is described below. At first use, the supplementary device 12'' needs to be attached to the body 10'', as shown in Fig. 1. Once the supplementary device 12'' is attached to the body 10'', thereby connecting the mechanical interfaces and allowing the drive screw 26c to apply force to the bung of the body 10'' to cause dispensing of the drug, the pin 18'' of the activation means has pierced the airtight seal of the zinc-air battery 14'', so that air can pass through the pierced air hole in the airtight seal and activate the power supply from the now activated zinc-air battery 14'' via the pin 18''.

[0042] A second embodiment of an injection device will now be described with reference to Figures 2A, 2B and 2C. The injection device is a two-part device comprising a disposable syringe having a body 10 in the form of a pen with a proximal end P and a distal end D, and a supplementary device 12 attached to the distal end D of the body part 10. The proximal end P of the body 10 is directed towards the injection site of the patient during injection and the distal end D is directed away from the injection site.

[0043] The body 10 includes an outer housing 11. The outer housing 11 is an elongated tube. The outer housing 11 includes a cartridge holder or syringe holder (not shown) that supports a cartridge or syringe (not shown) that contains a liquid medicament.

[0044] The outer housing 11 also houses a dispensing mechanism for triggering dispensing of the medicament during injection. The dispensing mechanism includes a dose button 20, which can be pressed against the outer housing 11. The dose button 20 is mechanically coupled to a piston 13 of a cartridge (not shown). The dispensing mechanism is configured to move the piston axially proximally along the cartridge to dispense the medicament through, for example, a needle (not shown) at the proximal end. The dose button 20 may apply a force to the piston 13 in response to an actuation input provided by a user. Here, the actuation input that triggers the application of a force against the piston 13 is received by a dose dispensing button or dose button 20 located at the distal end D of the body 10 of the injection device.

[0045] A zinc-air (Zn / O2) battery 14 having an airtight seal is positioned above the dose button 20. Because it is hermetically sealed, the zinc-air battery is inactive until first use, at which time one or more air holes are punctured in the airtight seal to activate the zinc-air battery 14.

[0046] 2C shows a cross-sectional view of a zinc-air battery 14 in which zinc powder 14a is contained in an anode can 14b and electrically isolated from an outer cathode can 14g by an insulating gasket 14c. The outer can 14g has an opening 14i. A sealing layer 14h is provided on the outside of the outer can 14g to provide an airtight seal for the opening 14i. When an air hole is drilled in the sealing layer 14h, air can pass through the opening 14i and through the Teflon membrane 14f to enter the air electrode 14e, which is separated from the zinc powder anode 14a by a separator 14d. The sealing layer 14h can be implemented, for example, by hermetically embedding the zinc-air battery 14 in the dosage button 20, for example by injection molding, where the molding material should be a soft material, for example TPE (thermoplastic elastomer), and / or a thin material that can be perforated to activate the zinc-air battery 14. The perforation allows air to enter the air electrode 14e through the opening 14i and the Teflon membrane 14f, initiating a chemical reaction to generate electricity.

[0047] The body 10 with the zinc-air battery 14 forms a disposable part of the injection device, which can be disposed of when the battery and / or the cartridge containing the liquid medicament are empty.

[0048] A further part of the injection device is formed by a supplementary device 12, which is designed as a clip-on attachment to the distal end D of the main body 10, in particular to the dose button 20. The supplementary device 12 comprises an electronic circuit 16 for implementing the control and / or measurement functions of the injection device. The electronic circuit 16 may comprise a microcontroller with firmware configured to measure and record the use of the injection device, such as for example time, hold time, battery status, one or more alarms, one or more delivered injection doses, etc.

[0049] Activation means in the form of a pin 18 having a tip 18a is located on the underside of the electronic circuitry 16. In this embodiment, the pin 18 is part of and integrated into the supplemental device 12.

[0050] The use of the injection device is described below. At the first use, the supplementary device 12 needs to be clipped to the main body 10, i.e., to the dose button 20, as shown in Fig. 2A and Fig. 2B. In Fig. 2A, the supplementary device 12 is not yet fully clipped to the dose button 20, and Fig. 2B shows that the supplementary device 12 is fully clipped to the dose button 20. As shown in Fig. 2B, when the supplementary device 12 completely covers the dose button 20, the tip 18a of the pin 18 of the activation means on the underside of the electronic circuit 16 pierces the airtight seal of the zinc-air battery 14, so that air can pass through the perforated air hole of the airtight seal, through the opening 14i and the Teflon membrane 14f, and into the air electrode 14e.

[0051] A third embodiment of the injection device will now be described with reference to Figures 3A and 3B. The injection device comprises a first part 10' and a second part 12' for attachment to one end of the first part 10'.

[0052] The first part 10' is a dispensing mechanism of the drug delivery device for triggering dispensing of the medicament during injection. The dispensing mechanism comprises a bearing 22 for the zinc-air battery 14' and the activation means 18'. The bearing 22 comprises a cup-like shaped holder 22a for the zinc-air battery 14', which is mechanically coupled to the piston 13' (not shown) of the cartridge. The dispensing mechanism is configured to move the piston 13' axially along the cartridge in a proximal direction to dispense the medicament through, for example, a needle (not shown) at the proximal end. The bearing 22 further comprises a cup-like shaped cover 22b for clipping over the holder 22a. The bearing 22 forms a button by means of which a force can be applied to the piston 13' in response to an actuation input applied by the user. Here, the actuation input triggering the application of a force to the piston 13' is received by the bearing 22 located at the distal end D of the body 10' of the injection device.

[0053] A zinc-air (Zn / O2) battery 14' having an airtight seal is positioned in a holder 22a and covered by a cover 22b. The zinc-air battery 14' can be assembled into the holder 22a, for example, by injection molding. Being airtight sealed, the zinc-air battery is inactive until it is first used, at which time one or more air holes are drilled in the airtight seal to activate the zinc-air battery 14'. The zinc-air battery 14' can be similar to or even identical to the battery shown in FIG. 2C.

[0054] The first part 10' having the zinc-air battery 14' may belong to a disposable part of the drug delivery device, which can be disposed of when the battery and / or the cartridge containing the liquid medicament are empty.

[0055] The second part 12' is designed as a plug for mounting to the cover 22b and includes an electronic circuit 16' for implementing the control and / or measurement functions of the injection device. The electronic circuit 16' may include a microcontroller with firmware configured to measure and record the use of the injection device, such as, for example, time, hold time, battery status, one or more alarms, one or more delivered injection doses, etc.

[0056] An activation means in the form of a pin 18' having a tip 18a' is incorporated into the cover 22b of the first part 10'. Thus, when the cover 22b is clipped onto the holder 22a, the tip 18a' of the pin 18' pierces the hermetic seal of the zinc-air battery 14' and activates the zinc-air battery 14'. In this embodiment, the pin 18' is incorporated into the first part 10', i.e. into the cover 22b.

[0057] The use of the injection device is described below. At first use, the plug 12' must be attached to the cover 22b, pressed down and the cover 22b clipped to the holder 22a, as shown in Figures 3A and 3B. In Figure 3A, the plug 12' is not yet attached to the cover 22b, while Figure 3B shows the plug 12' attached to the cover 22b, pressed down and the cover 22b clipped to the holder 22a. As shown in Figure 3B, when the plug 12' is attached to the cover 22b and the cover 22b is clipped to the holder 22a, the tip 18'a of the pin 18' of the activation means integrated in the cover 22b pierces the airtight seal of the air-zinc battery 14, so that air can pass through the air hole pierced in the airtight seal, through the opening 14i and the Teflon membrane 14f, and into the air electrode 14e. The other side of the pin 18' may pierce the plug 12' and make contact with the electronic circuitry 16'.

[0058] In the embodiment described above, the pins 18, 18' can also be designed to be usable as electrodes for powering the electronic circuits 16, 16'.

[0059] A fourth embodiment of an injection device will now be described with reference to Figures 4A and 4B. The injection device is a two-part device comprising a disposable syringe having a body 10''' in the form of a pen having a proximal end P and a distal end D, and a supplementary device 12''' attached to the distal end D of the body part 10''. The proximal end P of the body 10 is directed towards the injection site of the patient during injection and the distal end D is directed away from the injection site.

[0060] The body 10''' includes a drug cartridge 11''' containing a liquid drug formulation, the drug cartridge 11''' being contained in a section 100 of a glass vial. The section 100 is separated from the exterior space by a rubber stopper seal 102, which is movable along the cylindrical section of the glass vial. On the side of the rubber stopper seal 102 exposed to the exterior space, a first part 110 of the electromechanical interface of the body 10''' and a supplementary device 12''' are attached. The first part 110 includes the zinc-air battery 14, two passages 112 extending from one side of the part 110 to the zinc-air battery 14 to allow air to pass from the external space to the zinc-air battery 14, electrical contacts 18a''' for connecting the contacts of the zinc-air battery with electrical contacts 18''' of the supplemental device 12''', and a recess 108 for mechanically coupling the first part 110 to the second part 104 of the electromechanical interface of the supplemental device 12'''. The seal 114 hermetically covers the open end of the cartridge 11''' to prevent activation of the zinc-air battery 14. The outer housing 11''' is an elongated tube. The first part 110 is held in the cartridge 11''' by a protrusion provided at the distal end D of the cartridge 11''' to prevent it from falling out.

[0061] The supplemental device 12''' includes an electro-mechanical interface second portion 104 having a mating side with electrical contacts 18''' and a protrusion 106 configured to fit into a recess 108 in the first portion 110. The contacts 18''' are electrically connected to an electronic circuit 16 that is housed in the second portion 104 and adapted to be powered by the zinc-air battery 14 via the electrical contacts 18'' and 18a'''.

[0062] To use the injection device, the modules 10''' and 12''' need to be coupled. This is done by manually removing the seal 114, thereby allowing air to flow from the exterior space and the passageway 112 into the zinc-air battery 14, thus activating the battery 14. Furthermore, the second part 104 of the electromechanical interface of the supplemental device 12''' needs to be coupled to the first part 110 by attaching the side of the second part 104 that includes the electrical contacts 18''' and the protrusion 106 to the side of the first part 110 that has the recess 108 and the electrical contacts 18a''', as shown in FIG. 4B.

[0063] To expel a portion of the liquid drug formulation, axial pressure of the first and second portions 110, 104 can be applied downwardly on section 116 of second portion 104 to move first portion 110 and rubber stopper 102 downward.

[0064] The electronic circuit 16, powered by the activated zinc-air battery 14 via the electrical contacts 18''', 18a''', can be configured to electronically control and / or monitor the discharge of the liquid drug formulation. For example, the electronic circuit 16 can be configured to measure the distance of the downward movement of the second portion 104, the first portion 110, and the rubber stopper 102, and calculate the discharge amount of the liquid drug formulation from the measured distance. The electronic circuit 16 can also be configured to control a liquid drug discharge mechanism (not shown), for example, for moving the second portion 104, the first portion 110, and the rubber stopper 102 downward. The mechanism can include, for example, an electric motor and a gear with a drive screw (e.g., similar to mechanisms 26a, 26b, 26c of the embodiment shown in FIG. 1) for driving the second portion 104 downward.

[0065] A fifth embodiment of the injection device will now be described with reference to Figures 5A and 5B. The fifth embodiment is similar to the fourth embodiment, but differs only in the implementation of the hermetic seal of the zinc-air battery 14. This seal includes two seals 114', each of which covers one of the inlets of two passages 112 extending from the side of the part 110 towards the zinc-air battery 14 and through which air can pass from the external space to the zinc-air battery 14. The seals 114' may extend beyond the edge of the drug cartridge 11''' and may be fixed to the edge, for example attached to the edge. The other end of the seal 114' may be removably attached to cover the inlets of the two passages 112, so that when the first part 110 moves downwards, the seal 114' is pulled away from the inlets of the two passages 112, thus removing the hermetic seal of the passages 112. Thus, upon first use of the injection device, i.e. when modules 10''' and 12''' are connected to each other and the second part 104, the first part 110 and the rubber stopper 102 are moved downwards to expel a dose of liquid drug formulation, the seal 114' is pulled out from the entrances of the two passages 112, thereby allowing air to pass from the exterior space and the passages 112 to the zinc-air battery 14, thus activating the battery 14.

[0066] 6A and 6B show a sixth embodiment of the injection device, which will now be described with reference to these figures. The sixth embodiment is also similar to the fourth and fifth embodiments, but differs in the implementation of the first part 110' and the hermetic seal of the zinc-air battery 14 located in the first part 110'. As can be seen from FIGS. 6A and 6B, the first part 110' includes one passage 112' extending from the left side to the right side of the part 110'. The zinc-air battery 14 is located in the part 110', with one side exposed to the passage 112'. Thus, when air enters the passage 112', it can pass through the passage to the exposed side of the zinc-air battery 14 and activate the battery 14. The exposed side of the battery 14 is in an unused state covered by a seal 114'', which may, for example, be removably attached to the exposed side and extend through the passage 112' past an edge of the drug cartridge 11''', and secured to the edge, for example, be attached to the edge. When the first portion 110' is moved downward, the seal 114' is pulled away from the exposed side of the zinc-air battery 14, thereby allowing air passing through the passage 112' to activate the zinc-air battery 14. Thus, upon first use of the injection device, i.e. when modules 10''' and 12''' are connected to each other and the second part 104, the first part 110 and the rubber stopper 102 are moved downwards to expel a dose of liquid drug formulation, the seal 114' is pulled out from the exposed side of the zinc-air battery 14, thereby allowing air to pass from the exterior space and the passageway 112' to the zinc-air battery 14, thus activating the battery 14.

[0067] In the following, an embodiment of an attachment device 30 for a drug delivery device 40 will be described with reference to Figures 7A and 7B.

[0068] The drug delivery device 40 may be a pen-shaped injection device having an elongated body 40 having a distal end D and a proximal end P. The proximal end P may be provided with a syringe for injecting a medication from a cartridge inside the body 40 into the patient's body. The distal end D may be provided with a dose button 46 and a dose selector 48. The dose to be injected may be selected with the dose selector 48 and dosing may be initiated by the patient by pressing the dose button 46. Pressing the dose button 46 may then trigger an internal mechanism to inject the selected dose into the patient's body via the syringe.

[0069] The drug delivery device 40 may further contain an electronic circuit 42 adapted to perform tasks such as, for example, measuring the delivered injection dose, time, retention time, battery status, and / or outputting one or more alarms, for example when the drug cartridge and / or the battery is empty. The electronic circuit 42 may further be adapted to communicate and exchange data with another electronic circuit, in particular via wireless transmission, for example according to the Bluetooth® standard or the Near Field Communication (NFC) standard.

[0070] The attachment device 30 for the drug delivery device 40 includes a flexible body 32 incorporating a flexible display 34, in particular a flexible OLED (organic light emitting diode) display. The attachment device 30 is bendable, so that it can be twisted around the body 40 of the drug delivery device and positioned at a patient's preferred position. For example, a user can position the attachment device 30 on the body 40 such that the display 34 is not covered by the user's hand when using the drug delivery device.

[0071] FIG. 7B shows the attachment device 30 bent in a flat, handheld mode, detached from the body 40 of the drug delivery device, in which the attachment device 30 can be held by a user, for example, or placed on a table.

[0072] As shown in Fig. 7B, the attachment device 30 may also include a user input means 38 in the form of a button and / or the flexible display 34 may include touch screen functionality for receiving user input. An electronic circuit 36 ​​is incorporated into the flexible body 32 and configured to control the display 34, process signals generated by the user input means 38, and / or communicate with the electronic circuit 42 of the drug delivery device 40 and / or a computing device 50, e.g., a mobile computing device such as a smartphone, a laptop computer, and / or a tablet computer. The communication 44 with the electronic circuit 42 of the drug delivery device may be wired or wireless. For wired communication, electrical contacts may be incorporated into the flexible body and electrical contacts may also be incorporated into the body 40 of the drug delivery device, e.g., multiple contacts may be incorporated at different locations on the body 40 to allow the attachment device 30 to be positioned at different locations on the body 40. Electrical contacts, for example a micro USB (Universal Serial Bus) connector, for connecting the attachment device 30 to the computing device 50 may also be provided on the flexible body 32. Wireless communication 44 with the electronic circuit 42 may be effected in particular via short-range wireless communication, such as according to the Bluetooth® standard or the Near Field Communication (NFC) standard. Wireless communication 52 with the computing device 50 may be effected via short-range wireless communication, such as according to the Bluetooth® standard or the Near Field Communication (NFC) standard, or via longer-range wireless communication, such as according to the IEEE 802.11 standard.

[0073] The communication 44 between the electronic circuitry 36 of the attachment device 30 and the electronic circuitry 42 of the drug delivery device 40 may be established upon user input via the user input means 38 and / or via touchscreen input if the display 34 has touchscreen functionality, and / or may be established automatically when the attachment device 30 is twisted about the body 40. For example, a switch incorporated in the flexible body 32 may be activated upon bending of the body 32, causing the electronic circuitry 36 to switch to a mode in which the communication 44 with the electronic circuitry 42 of the drug delivery device 40 can be established.

[0074] The electronic circuitry 36 of the attachment device 30 can receive data from and transmit data to the electronic circuitry 42 of the drug delivery device 40 via the established communication 44. For example, the electronic circuitry 36 may receive data regarding the use of the drug delivery device 40, such as the delivered injection dose, time, hold time, battery status of the device 40, one or more alarms, and / or transmit data for controlling the use of the drug delivery device 40, such as an unlock code that allows a user to operate the drug delivery device 40.

[0075] The electronic circuitry 36 is configured to control the display 34 such that information received from the drug delivery device 40 via the communication 44 is displayed. The electronic circuitry 36 can be further configured to process signals generated by the user input means 38 and / or the touch screen. The electronic circuitry 36 can also be configured to control the communication 44 in response to the processed signals generated by the user input means 38 and / or the touch screen. For example, after attaching the device 30 to the drug delivery device 40, the user may press one of the user input means 38 to establish the communication 44, and after the communication 44 is established, an unlock code may be transmitted via the communication 44 to the electronic circuitry 42 of the drug delivery device 40 to enable the patient to perform an injection. The electronic circuitry 36 can further be configured to enable customization of the information displayed on the display 34, such as customization of the arrangement and / or type of displayed information.

[0076] Additionally, the attachment device 30 can be configured to be assigned to a particular user with user identification information stored by the electronic circuitry 36 so that the attachment device 30 can only be used by that user and not by other users. To identify the user, the electronic circuitry 36 can be configured to require a code that the user must enter via the user input means 38 or touch screen before the attachment device 30 can be used.

[0077] The electronic circuitry 36 of the attachment device 30 can be further configured to store the data received from the electronic circuitry 42 of the drug delivery device 40. The stored data can then be transmitted to the computing device 50 via communication 52 for further processing, e.g. evaluation and / or storage in a patient's treatment ID card. The communication 52 can also be configured to customize the attachment device 30, e.g. to adapt the attachment device 30 to the user's requirements, e.g. assigning the attachment device 30 to a specific user, customizing the information displayed on the display 34, etc. For convenient customization, the computing device 50 can be configured with dedicated software, such as an app for programming the attachment device 30 and / or for evaluating the data received from the electronic circuitry 36.

[0078] An embodiment of a method for operating a supplementary device 60 for a drug delivery device 70 will now be described with reference to Figures 8A and 8B. The supplementary device 60 is a reusable add-on device for a disposable drug delivery device 70. Typically, the supplementary device 60 may include some electronic circuitry for controlling and monitoring the use of the drug delivery device 60. For example, the supplementary device 60 may include control electronic circuitry for assisting a user of the drug delivery device 70 in the correct use, in particular in the injection of a medication. The supplementary device 60 may also include monitoring electronic circuitry for determining the number of uses of the drug delivery device 70, for example for recording the injected dose of medication, the time and date of each injection.

[0079] The method functions to output at least one signal in response to recording drug delivery by the drug delivery device 70. The output of the signal may assist a user of the disposable drug delivery device 70 in preventing disposal of the reusable supplemental device 60, or in other words, in warning the user to remove the supplemental device 60 from the drug delivery device 70 when disposing of the drug delivery device 70.

[0080] The method is implemented as an algorithm executed by the supplemental device 60. The algorithm may signal a record of detected drug delivery to a user of the disposable drug delivery device 70, and in particular may signal when the disposable drug delivery device 70 is empty.

[0081] An embodiment of the algorithm will be described in detail with reference to the flow chart shown in FIG. 8A and a schematic diagram of a supplemental device 60 attached to the distal end D of a drug delivery device 70 shown in FIG. 8B.

[0082] The algorithms are implemented as firmware stored in memory 64 of the supplemental device 60 and executed by a processor 62. The supplemental device 60 may include a number of signalling means, in particular an audio generator 66a such as a speaker, a visual signal indicator 66b such as an LED (light emitting diode), and a tactile signal generator 66c such as a vibration alert motor.

[0083] A sensor (not shown) may be provided to detect attachment of the supplemental device 60 to the drug delivery device 70. The sensor may be implemented as a contact 68 capable of contacting a mating contact 74 of the drug delivery device 70, or may be implemented as a non-contact sensor, e.g., a Hall sensor, capable of detecting a magnetic field generated by a magnet in the drug delivery device 70.

[0084] The drug delivery device 70 may include electronic circuitry 72 for measuring drug delivery, such as an electronic counter for simply counting the doses delivered, and mating contacts 74 for the contacts 68. Data exchange between the processor 62 and the electronic circuitry 72 may be wireless or wired, as shown in Figure 8B by contacts 68, 74, through which a wired data link may be established between the processor 62 and the electronic circuitry 72 when the supplemental device 60 is attached to the drug delivery device 70.

[0085] After starting, in a first step S10, the algorithm checks whether the supplementary device 60 is attached to the drug delivery device 70 by a sensor. For example, the processor 62 receives a signal from the electronic circuit 72 by a wired data link established via the contacts 68 and 74. If a wireless sensor is used, the processor 62 may receive a signal from the sensor signaling the attachment of the supplementary device 60 to the drug delivery device 70, for example a signal from a Hall sensor detecting a nearby magnetic field. If the attachment of the supplementary device 60 to the drug delivery device 70 is detected in step S10, the algorithm continues to a second step S12.

[0086] In step S12, the algorithm detects whether a drug is / has been delivered by the drug delivery device 70. In particular, the processor 62 can request information about the drug delivery from the electronic circuitry 72 of the drug delivery device 70 via a data link established, for example, via the contacts 68 and 74. It is also conceivable that the processor 62 detects the drug delivery by a sensor (not shown) provided for detecting the drug delivery, integrated in the supplementary device 60 or the drug delivery device 70. Such a sensor can be used in cases where only the supplementary device 60 contains the electronic circuitry and the disposable drug delivery device 70 contains only a mechanism for dispensing the medicament from the cartridge. The detected drug delivery can be a count of each dispensed dose, for example x dispensed doses, a count of the total dispensed doses, for example y total dispensed doses, or a last dose counter, for example x dispensed doses. It is conceivable that a counter starts at the maximum number of doses contained in the cartridge and counts down for each dispensed dose, with the detected drug delivery being the actual counter value read out.

[0087] The detected drug delivery is recorded in a third step S14 by the processor 62 in the storage 64. To enable the record to be assigned to a drug delivery device 70, the record may include a date and / or time stamp and a unique identifier of the drug delivery device 70 or of the drug cartridge contained in the device 70. The unique identifier allows the supplemental device to be used with a variety of drug delivery devices 70.

[0088] After the recording step S14, the algorithm continues to a fourth step S16, generating at least one signal depending on the recording performed in the previous step S14. In particular, the processor may check in step S16 whether the recording performed in step S14 achieves one or more predetermined criteria.

[0089] One criterion may be that the last dose has been delivered by the drug delivery device 70. Another criterion may include a position before reaching a final position within the drug delivery device, for example when the drug cartridge contains only remaining doses.

[0090] The processor may confirm achievement of the criterion, for example by comparing the detected drug delivery recorded in step S14 with the maximum number of doses possible, or may check whether a countdown counter is below a predetermined threshold such as 1 or 2 (for the number of doses remaining), or may check whether a dose counter exceeds a predetermined threshold such as the maximum number of doses.

[0091] When the processor 62 detects that one or more predetermined criteria have been achieved, the processor 62 may generate a control signal to one or more of the signaling means. For example, the processor 62 may control the sound generator 66a to generate an audio signal, the visual signal indicator 66b to generate a visual signal, and / or the tactile signal generator 66c to generate a tactile feedback signal, such as a vibration of the supplemental device 60. In this way, the user can be aware that the last dose contained in the cartridge of the drug delivery device 70 has been dispensed or that only one dose remains for injection, and that the drug delivery device 70 must soon be replaced with a new one, and that the supplemental device 60, which contains the electronic circuitry for controlling drug dispensing by the drug delivery device 70, should be removed from the drug delivery device 70 and not disposed of.

Claims

1. A drug delivery device having first and second modules (10''', 12''') which, when integrated, are configured to construct an electronically controlled and / or electronically monitored pen-shaped injection device, thereby providing electronically controlled and / or monitored ejection of a liquid drug formulation to an external administration site, the drug delivery device comprising: a first module (10''') including a liquid drug-filled reservoir (100), a first downstream portion (102, 110) of a liquid drug ejection mechanism configured to eject a portion of the liquid drug from the liquid drug reservoir when actuated, and a self-contained electrical energy source (14), in particular as an electrochemical cell or battery; a second module (12''') including a second upstream portion (104) of the liquid medication ejection mechanism, and an electronic circuit (16), the electronic circuit configured to control and / or monitor the status and / or operation of either the first or second portions of the liquid medication ejection mechanism; Including, The first and second modules are provided with an electromechanical interface (18''', 106, 108), the electromechanical interface comprising: releasably coupling the first module and the second module, thereby forming a coupled mechanical structure, more particularly a fixedly coupled mechanical structure; operatively connecting an ejection mechanism portion of a first module to an ejection mechanism portion of a second module; Providing an electrical path for supplying energy from an electrical energy source integrated into the first module to electrical circuitry contained in the second module. The drug delivery device is configured as follows.

2. 2. The device of claim 1, wherein the first and second modules (10'', 12'') are configured to be integrated into an axial arrangement, the axial arrangement having a liquid drug-filled reservoir (100), a liquid drug ejection mechanism (102, 104, 110), and an electrical energy source (14) arranged along a longitudinal axis defined by the pen-shaped appearance of the integrated first and second modules.

3. 3. The device of claim 1 or 2, wherein the first module (10''') comprises a standard drug cartridge (11''') having a liquid drug formulation contained in a section of a glass vial separated from an external space by a rubber stopper seal (102), the rubber stopper seal being movable along the cylindrical section of the glass vial as an extreme end of the liquid drug ejection mechanism part of the first module for converting a mechanical driving force of the ejection mechanism into a hydraulic pressure in the separated section of the glass vial.

4. 4. The device of claim 3, wherein the power source is a button cell battery (14) positioned adjacent to the exterior-facing sealing surface of the rubber plug (102).

5. 5. The device of claim 4, wherein the button cell is configured to include a raised exterior structure adapted to transfer axial loads from an abutting drive train member to the rubber plug seal.

6. 6. The device of claim 4 or 5, wherein the button cell is a flat cylindrical button cell arranged to contact the outwardly facing end of the rubber plug seal with one flat circular electrode and to provide the opposite circular electrode surface as an input load plate for the adjacent upstream drive train element of the overall exhaust drive train.

7. 6. The device of claim 4 or 5, wherein the button cell is a flat, cylindrical button cell, the outer edge surrounding the opposing electrode of the button cell being used as an input load support for upstream drive train elements to prevent mechanical loads from being transmitted across the seal of the button cell or through its internal structure.

8. The upstream drive train element abutting the button cell is configured to include a portion of the electrical path to the electronic circuitry contained in the second module. A device according to claim 6 or 7.

9. A device as claimed in any one of claims 6 to 8, wherein the upstream drive train element which abuts the button cell is an elongated piston rod comprising a conductive material.

10. 10. The device of claim 9, wherein the elongated piston rod is provided as a component or integral part, the component or integral part comprising, in part, conductive and non-conductive materials.

11. An electronically controlled and / or monitored pen-shaped injection device, comprising: a first module (10) including a zinc-air battery (14), the zinc-air battery having a plurality of vent openings and a removable seal for covering the vent openings in a first configuration and exposing the vent openings in a second configuration; a second module (12) configured to be attached to one end of the first module (10) and including electronic circuitry (16); the first module and the second module are provided with a plurality of mechanical interfaces for releasably coupling the first module and the second module to one another thereby forming a mechanical structure; The injection device, wherein one of the modules is provided with a seal remover operable to remove a seal from at least one of the vent openings of the zinc-air battery, and the mechanical interface between the first and second modules is configured to operate the seal remover when the first module is attached to the second module at any of the mechanical interfaces.

12. The zinc-air battery is located at one end of the first module (10). Item 12. The device according to item 11.

13. The device of claim 11, wherein the first module is a pen (10) having a distal end and a proximal end, a dose button (20) is positioned at the distal end, and a zinc-air battery (14) is positioned in the dose button (20), in particular above the dose button (20).

14. 12. The device according to claim 11, wherein the first module (10') is a dispensing mechanism of an injection device and the zinc-air battery (14') is located in a bearing (22) of the dispensing mechanism.

15. 15. The device according to claim 14, wherein the support (22) comprises a cup-like shaped holder (22a) for the zinc-air battery (14') and a cup-like shaped cover (22b) for being placed and clipped onto the holder (22a), the cover (22b) incorporating the activation means (18).

16. 12. The device of claim 11, wherein the first module is a pen (10'') having a distal end and a proximal end, and the zinc-air battery (14'') is positioned in a battery compartment (24) of the first module (10'').

17. 17. The device of claim 16, wherein the battery compartment (24) is located outside the first module (10'') near one end of the first module (10'').

18. 16. The device according to claim 15, wherein the activation means (18) comprises at least one pin designed to be used as an electrode for electrically connecting a power supply connector of the electronic circuit (16) to a power supply connector of the zinc-air battery (14).

19. A pen-shaped drug delivery device (40) according to any one of claims 1 to 18, comprising an attachment module (30) for a pen-shaped drug delivery device (40), The attachment module (30) comprises: A flexible body (32); A display (34) integrated into the flexible body; and an electronic circuit (36) configured to communicate with the electronic circuit (42) of the pen-shaped drug delivery device (40) and to control the display (34) in response to communication (44) between the electronic circuit (36) of the attachment device (30) and the electronic circuit (42) of the pen-shaped drug delivery device (40).

20. 20. The device of claim 19, wherein the electronic circuit (36) is further configured to unlock use of the pen-shaped drug delivery device (40) in response to the communication (44).

21. A device as claimed in claim 19 or 20, wherein the electronic circuit (36) is configured to control the display (34) so ​​as to be able to display information resulting from the operation of the pen-shaped drug delivery device (40), in particular information about one or more delivered injection doses, time, retention time, battery status, one or more alarms.

22. A device according to any one of claims 19 to 21, further comprising user input means (38), wherein the electronic circuit (36) is configured to process signals generated by the user input means (38) and to control communication (44) with the display (34) and / or the electronic circuit (42) of the pen-shaped drug delivery device (40) depending on the processed signals.

23. The device according to any one of claims 19 to 22, further comprising an interface for communicating with a computing device (50), in particular for transmitting data relating to the pen-shaped drug delivery device (40) and its use to the computing device (50) for further processing.

Images