Drug Delivery Device

Abstract

The present disclosure relates to a method of pairing an electronic data logging device of a drug delivery device with an external electronic device and to a respective drug delivery device. The drug delivery device comprises a housing configured to accommodate the medicament and to receive and/or mechanically engage with the electronic data logging device. The drug delivery device further comprises a first device component and a second device component. The first device component is movable relative to the second device component from a first positional state to a second positional state. The first device component comprises a first outer surface, and the second device component comprises a second outer surface. At least one of the first outer surface and the second outer surface comprises a first code portion of a pairing code for establishing a communication link between the electronic data logging device and an external electronic device.

Claims

1-15. (canceled)

16. A drug delivery device for administering of a dose of a medicament, the drug delivery device being operable to cooperate with an electronic data logging device, the drug delivery device comprising: a housing configured to accommodate the medicament and configured to receive and/or mechanically engage with the electronic data logging device; and a first device component and a second device component, wherein the first device component is movable relative to the second device component from a first positional state to a second positional state, wherein the first device component comprises a first outer surface, wherein the second device component comprises a second outer surface, wherein at least one of the first outer surface and the second outer surface comprises a first code portion of a pairing code for establishing a communication link between the electronic data logging device and an external electronic device, and wherein the pairing code is visually identifiable from outside the drug delivery device only when the first device component is in the second positional state relative to the second device component.

17. The drug delivery device according to claim 16, wherein the pairing code is non-discernible from outside of the drug delivery device when the first device component is in the first positional state.

18. The drug delivery device according to claim 16, wherein the first code portion or the pairing code is provided on the first outer surface, and wherein at least a part of the first code portion or the pairing code is concealed by the second device component when the first device component is outside the second positional state .

19. The drug delivery device according to claim 16, wherein the first outer surface is provided with one of the first code portion and the pairing code, wherein the first outer surface is further provided with a first concealing code portion that is indistinguishable from the first code portion or from the pairing code, wherein an indistinguishable composition of at least a portion of the first concealing code portion and at least one of the first code portion and the pairing code is discernible from outside the drug delivery device when the first device component is outside the second positional state.

20. The drug delivery device according to claim 19, wherein the first concealing code portion is concealed by the second device component when the first device component is in the second positional state.

21. The drug delivery device according to claim 16, wherein the pairing code comprises the first code portion and a second code portion, wherein the first code portion is provided on the first outer surface, and wherein the second code portion is provided on the second outer surface.

22. The drug delivery device according to claim 21, wherein the first code portion and the second code portion mutually recombine and constitute the pairing code when the first device component is in the second positional state.

23. The drug delivery device according to claim 16, wherein at least one of the pairing code and the first code portion extends along a first direction, and wherein the first device component is movable along the first direction relative to the second device component.

24. The drug delivery device according to claim 21, wherein the second outer surface is further provided with a second concealing code portion that is indistinguishable from the second code portion, and wherein the first code portion aligns with the second code portion when the first device component is in the second positional state.

25. The drug delivery device according to claim 24, wherein the first code portion or a fraction thereof aligns with the second concealing code portion when the first device component is outside the second positional state.

26. The drug delivery device according to claim 24, wherein at least one of the second concealing code portion and the second code portion extends along a second direction, and wherein the first device component is movable along the second direction relative to the second device component.

27. The drug delivery device according to claim 16, further comprising a first marker and a second marker, wherein the first marker is provided by or is connected to the first device component, wherein the second marker is provided by or is connected to the second device component, wherein the first marker is subject to a movement relative to the second marker when the first device component moves relative to the second device component, and wherein the first marker and the second marker visually align, visually overlap, or mechanically engage when the first device component reaches the second positional state relative to the second device component.

28. The drug delivery device according to claim 16, wherein the first device component is one of a dose dial, a dial extension, a number sleeve, and a protective cap of a pen-type injection device.

29. The drug delivery device according to claim 16, wherein the second device component is one of a housing, a body of the housing, and a cartridge holder of a pen-type injection device.

30. The drug delivery device according to claim 16, further comprising a cartridge filled with a medicament and arranged inside the housing.

31. A method of pairing an electronic data logging device of a drug delivery device with an external electronic device, wherein the drug delivery device comprises a first device component movable relative to a second device component, wherein the first device component comprises a first outer surface, wherein the second device component comprises a second outer surface, wherein at least one of the first outer surface and the second outer surface comprises a first code portion of a pairing code, the pairing code being visually identifiable from outside the drug delivery device only when the first device component is in a second positional state relative to the second device component, and wherein the method comprises: setting at least one of the external electronic device and the data logging device into a pairing mode; moving the first device component relative to the second device component from a first positional state, in which the pairing code is non-discernible, into the second positional state; visually identifying the pairing code from outside the drug delivery device; and using the pairing code to establish a communication link between the external electronic device and the data logging device.

32. The method according to claim 31, wherein the pairing code is non-discernible from outside of the drug delivery device when the first device component is in the first positional state.

33. The method according to claim 31, wherein the first code portion or the pairing code is provided on the first outer surface, and wherein at least a part of the first code portion or the pairing code is concealed by the second device component when the first device component is outside the second positional state.

34. The method according to claim 31, wherein the first outer surface is provided with one of the first code portion and the pairing code, wherein the first outer surface is further provided with a first concealing code portion that is indistinguishable from the first code portion or from the pairing code, wherein an indistinguishable composition of at least a portion of the first concealing code portion and at least one of the first code portion and the pairing code is discernible from outside the drug delivery device when the first device component is outside the second positional state.

35. The method according to claim 31, wherein the pairing code comprises the first code portion and a second code portion, wherein the first code portion is provided on the first outer surface, and wherein the second code portion is provided on the second outer surface.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0118] In the following, numerous examples of the injection device and the method of pairing a data logging device with an external electronic device will be described in greater detail by making reference to the drawings, in which:

[0119] FIG. 1 schematically illustrates an example of a drug delivery device implemented as an injection device,

[0120] FIG. 2 schematically illustrates numerous components of the drug delivery device of FIG. 1,

[0121] FIG. 3 is a schematic block diagram of an example of an electronic data logging device,

[0122] FIG. 4 schematically illustrates an electronic data logging device integrated into a drug delivery device,

[0123] FIG. 5 schematically illustrates a portion of the drug delivery device with first and second device components carrying a pairing code portion for setting of a communication link between the data logging device and the external electronic device, wherein first and second device components are in a first positional state,

[0124] FIG. 6 shows the example of FIG. 5, wherein first and second device components are in a second positional state,

[0125] FIG. 7 schematically illustrates another example of a drug delivery device provided with a pairing code, wherein first and second device components are in a first positional state,

[0126] FIG. 8 shows the example of FIG. 7, wherein the first and second device components are in a second positional state,

[0127] FIG. 9 shows first and second device components of FIGS. 7 and 8 in a third positional state, and

[0128] FIG. 10 shows a flowchart of executing a method of pairing an electronic data logging device with an external electronic device by using a pairing code as provided by the drug delivery device in accordance to any of the FIGS. 1-9.

DETAILED DESCRIPTION

[0129] One example of a drug delivery device 1 for administering of a dose of a medicament 27 is illustrated in FIGS. 1 and 2. The drug delivery device 1 is implemented as an injection device 30. The injection device 30 is a handheld pen-type injector. The injection device 30 may be implemented as a disposable injection device 30. It may comprise a pre-filled cartridge 6 arranged inside a cartridge holder 14. With a disposable injection device 30, the cartridge holder 14 may be non-detachably connected to a body 10 of a housing 32 of the injection device 30.

[0130] With other examples, the injection device 30 is a re-usable injection device, wherein the cartridge holder 14 is detachably connected to the body 10 for replacing an empty cartridge 6. At or near a distal end of the housing 32, hence at the distal end of the cartridge holder 14, there is provided a socket 28 configured to mount or to engage with an injection needle 15. The socket 28 may be implemented as a threaded socket and the injection needle 15 may comprise a needle hub begin correspondingly threaded to provide a threaded engagement with the socket 28.

[0131] Typically, the injection needle 15 is protected by an inner needle cap 16 and either by an outer needle cap 17 and/or a protective cap 18 that is configured to enclose and to protect a distal section of the housing 32 of the injection device 30. The body 10 may comprise and form a main housing part configured to accommodate a drive mechanism 34 as shown in FIG. 2. The cartridge holder 14 may be regarded as a distal housing component of the injection device 30. The cartridge holder 14 may be permanently or releasably connected to the body 10 or main housing.

[0132] The cartridge 6 comprises a cylindrically-shaped or tubular-shaped barrel 25 sealed in proximal direction 3 by a bung 7 located inside the barrel 25. The cartridge six may be prefilled with a liquid medicament 27. The bung 7 is displaceable relative to the barrel 25 of the cartridge 6 in a distal direction 2 by means of a piston rod 20 of the drive mechanism 34. A distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum and being pierceable by a proximally directed tipped end of the injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge holder 14 the seal 26 of the cartridge 6 is penetrated thereby establishing a fluid transferring access to the interior of the cartridge 6.

[0133] When the injection device 1 is configured to administer e.g. human insulin, the dosage set by a dose dial 12 at a proximal end of the injection device 1 may be displayed in so-called international units (IU, wherein 1 IU is the biological equivalent of about 45.5 .Math.g of pure crystalline insulin (1/22 mg). The dose dial 12 may comprise a sleeve shaped knob at the proximal end of the housing 32 of the injection device 30.

[0134] As shown further in FIGS. 1 and 2, the body 10 comprises a dosage window 13 that may be in the form of an aperture in the body 10. The dosage window 13 permits a user to view a limited portion of a number sleeve 80 that is configured to move when the dose dial 12 is turned. The number sleeve 80 and the dosage window 13 provide a visual indication of a dose currently set. The dose dial 12 may be rotated on a helical path with respect to the body 10 when turned during setting and/or dispensing or expelling of a dose.

[0135] With some other type of injection device, the dose dial 12 may be locked in longitudinal direction to the body 10. It may be then limited to a rotational movement relative to the body 10 for setting of the dose.

[0136] The injection device 30 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. When the needle 15 is stuck into a skin portion of a patient, and when the trigger 11 or injection button is pushed, the insulin dose displayed in the dosage window 13 will be ejected from injection device 1. When the needle 15 of the injection device 1 remains for a certain time in the skin portion after the trigger 11 is pushed, a high percentage of the dose is actually injected into the patient’s body. Ejection of an insulin dose may also cause a mechanical click sound, which is however different from the sounds produced when using the dose dial 12.

[0137] In the illustrated embodiment, during delivery of the insulin dose, the dose dial 12 is turned to its initial position in an axial movement, that is to say without rotation, while the number sleeve 80 is rotated to return to its initial position, e.g. to display a dose of zero units.

[0138] The injection device 30 may be used for several injection processes until either the cartridge 6 is empty or the expiration date of the medicament in the injection device 1 (e.g. 28 days after the first use) is reached.

[0139] At least some components of an example of a drive mechanism 34 are illustrated in more detail in FIG. 2. The drive mechanism 34 comprises numerous mechanically interacting components. A flange like support of the housing 10 comprises a threaded axial through opening threadedly engaged with a thread 22 of the piston rod 20. The distal end of the piston rod 20 comprises a bearing 21 on which a pressure foot 23 is free to rotate with the longitudinal axis of the piston rod 20 as an axis of rotation. The pressure foot 23 is configured to axially abut against a proximally facing thrust receiving face of the bung 7 of the cartridge 6. During a dispensing action the piston rod 20 rotates relative to the housing 10 thereby experiencing a distally directed advancing motion relative to the housing 10 and hence relative to the barrel 25 of the cartridge 6. As a consequence, the bung 7 of the cartridge 6 is displaced in distal direction 2 by a well-defined distance due to the threaded engagement of the piston rod 20 with the housing 10.

[0140] Furthermore, there is provided a dose dial sleeve also denoted as number sleeve 80. The number sleeve 80 is located radially inward of the housing 10. A helical groove 81 is provided about an outer surface of the number sleeve 80. The body 10 is provided with the dosage window 13 through which a part of the outer surface of the number sleeve 80 can be seen. The body 10 is further provided with a helical rib at an inside sidewall portion of an insert piece 62, which helical rib is to be seated in the helical groove 81 of the number sleeve 80. The tubular shaped insert piece 62 is inserted into the proximal end of the tubular shaped body 10. Alternatively, such a helical rib may be also provided directly on an inside of the sidewall of the body 10. The helical rib as well as the insert piece 62 is rotationally and axially fixed to the body 10. There may be provided first and second stops on the body 10 to limit a dose setting procedure during which the number sleeve 80 is rotated in a helical motion relative to the housing 10.

[0141] The dose dial 12 in form of a dose dial grip is disposed about an outer surface of the proximal end of the number sleeve 80. An outer diameter of the dose dial 12 typically corresponds to and matches with the outer diameter of a proximal end of the body 10. The dose dial 12 is secured to the number sleeve 80 to prevent relative movement there between. The dose dial 12 is provided with a central opening.

[0142] A trigger 11, also denoted as dose button is substantially T-shaped. It is provided at a proximal end of the injection device 10. A stem 64 of the trigger 11 extends through the opening in the dose dial 12. The stem 64 and hence the trigger 11 is retained for limited axial movement relative to the number sleeve 80. A head of the trigger 11 is generally circular. The trigger side wall or skirt extends from a periphery of the head and is further adapted to be seated in a proximally accessible annular recess of the dose dial 12.

[0143] To dial a dose a user rotates the dose dial 12, along a dose incrementing direction 4, e.g clockwise. Dialing of a dose may be accompanied by a clicking sound. In this way, audible and/or tactile feedback of the dose being dialed is provided. Dialing of a dose is further accompanied by a rotation of the number sleeve 80, which starts to extend from the body 10 towards the proximal direction 3 when dialed along a dose incrementing direction 4, e.g in a clockwise sense.

[0144] The number sleeve 80, the dose dial 12 and the trigger may form part of a dial extension 70, hence and assembly of components of the drive mechanism 34 that starts to extend or to displace from the proximal end of the body 10 as a dose is dialed. During dispensing of a dose, hence when a user depresses the trigger 11 in distal direction 2, the dial extension 70 is subject to a distally directed movement relative to the body 10, hence along the distal direction 2. During such a dispensing motion, the number sleeve 80 is subject to a rotation along a dose decrementing direction 5, e.g. counter-clockwise.

[0145] The expelling mechanism or drive mechanism 34 as described above is only exemplary for one of a plurality of differently configured drive mechanisms that are generally implementable in a disposable or re-usable pen-injector. The drive mechanism as described above is explained in more detail e.g. in WO2004/078239A1, WO 2004/078240A1 or WO 2004/078241A1 the entirety of which being incorporated herein by reference.

[0146] The drug delivery device 1, hence the injection device 30 may be further equipped with a data logging device 100 as indicated in FIGS. 3 or 4. The data logging device 100 may be integrated into the injection device 30. It may be positioned in a hollow receptacle provided by at least one of the trigger 11 and the dose dial 12. With other examples, the data logging device 100 is a separate component detachably connectable to the body 10 or to some other portion of the housing 32 of the injection device 30.

[0147] FIG. 2 is thus illustrative of a medicament injection system 102. The medicament injection system 102 comprises the injection device 30 and at least the data logging device 100. The data logging device 100 may be attachable to the injection device 30. It may be detachably connectable or detachably fixable to the housing 32 of the injection device 30. Alternatively, the data logging device 100 is integrated into the injection device 30. The medicament injection system 102 may further comprise the external electronic device 65. The external electronic device 65 may be implemented as a portable electronic device. It may comprise a smart watch, a smart phone, a tablet computer or a personal computer. The external electronic device 65 and the data logging device 100 are configured to establish a communication link 66, e.g. a wireless communication link, in order to transfer data therebetween.

[0148] The data logging device 100 as schematically indicated in FIG. 3 typically comprises a sensor, e.g. in form of rotation sensing arrangement 200, by way of which a relative rotation of at least one component of the drug delivery device 1 relative to another component of the drug delivery device 1 can be determined or quantitatively measured, e.g. during at least one of setting of the dose and dispensing of the dose.

[0149] The data logging device 100 may be either integrated into the drug delivery device 1 or may be provided as a separate add-on device. When provided as a separate add-on device the data logging device 100 may be provided with an own housing 101 attachable to the housing 32 of the drug delivery device 1 or injection device 30.

[0150] The data logging device 100 comprises one or more processors 240, such as a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like, together with a memory 114. The memory may 114 include a program memory and main memory, which can store software for execution by the processor 240 and data generated or captured during use of the data logging device 100 such as counted pulses, derived dose size, time stamp, etc. An optional switch 122 connects a power source 120 to the electronic components of the data logging device 100, including the rotation sensing arrangement 200. A display 118 may or may not be present. The rotation sensing arrangement 200 may be coupled to a first member 201 and a second member 202. It comprises at least one sensor 220 connected or attached to the second member 202 and further comprises at least one signal generator 210 connected or attached to the first member 201.

[0151] With the present implementation of the rotation sensing arrangement 200 in a data logging device 100 one of the first member 201 and the second member 202 can be connected or fastened to the housing 32 of the injection device 30 and the other one of the first member 201 and the second member 202 is for instance connectable or fastenable to the rotatable dose dial 12 of the injection device 30.

[0152] The data logging device 100 typically comprises an interface 124 connected to the processor 240. The interface 124 may be a wireless communications interface for communicating with another external electronic device 65, e.g. in form of a portable electronic device, via a wireless communication protocol or network such as Wi-Fi or Bluetooth®, RFID or NFC (near field communication). The wireless communication interface may be operable in the radio frequency range. For instance, the wireless communication interface may be based on radio-frequency identification technology (known as RFID) which allows compatible hardware to both supply power to and communicate with an otherwise unpowered and passive electronic tag using radio waves. It may be hence used for identification, authentication and tracking.

[0153] With other examples, the interface 124 is implemented as a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro-USB connector. For this, the interface 124 comprises a transceiver 126 configured for transmitting and receiving data. FIG. 3 depicts an example of an injection system in which the add-on device 100 is connected to an external electronic device 65, via a communication link 66 for data transfer. The data connection 66 may be of wired or wireless type.

[0154] For example, the processor 240 may store determined delivered medicament amounts and time stamps for the injections as they are administered by the user and subsequently, transfer that stored data to the external electronic device 65. The device 65 maintains a treatment log and/or forwards treatment history information to a remote location, for instance, for review by a medical professional.

[0155] The add-on device 100 or data collection device may be configured to store data such as delivered medicament amounts and time stamps of numerous injection events, such as 35 or more injection events. According to a once-daily injection therapy this would be sufficient to store a treatment history of about one month. The data memory 114 may be organized in a first-in first-out manner ensuring that most recent injection events are always present in the memory of the data collection device 100. Once transferred to an external electronic device 65 the injection event history in the add-on device 100 might be deleted. Alternatively, the data remains in the add-on device 100 and the oldest data is deleted automatically once new data is stored. This way the log in the data collection device is built up over time during usage and will always comprise the most recent injection events. Alternatively, other configuration could comprise a storage capacity of 70 (twice daily), 100 (three months) or any other suitable number of injection events depending on the therapy requirements and/or the preferences of the user.

[0156] In another embodiment, the interface 124 may be configured to transmit information using a wireless communications link and/or the processor 240 may be configured to transmit such information to the external electronic device 65 periodically.

[0157] The processor 240 may control the optional display 118 to show the determined medicament dose information, and/or to show an elapsed time since a last medicament dose was delivered. For example, the processor 240 may cause the display 118 to switch periodically between displaying the most recent determined medicament dosage information and the elapsed time.

[0158] The power source 120 may be a battery. The power source 120 may be a coin cell, or multiple coin cells arranged in series or parallel. A timer 115 may be also provided. In addition to, or instead of, switching the add-on device 100 on and off, the switch 122 may be arranged to trigger the timer 115 when engaged and/or disengaged. For example, if the timer 115 is triggered on both engagement or disengagement of the first and second electrical contacts of the switch or both operation and ceasing of operation of the switch 122, then the processor 240 may use the output from the timer 115 to determine a length of time during which the trigger 11 was pressed, for example to determine the duration of an injection.

[0159] Alternatively, or additionally, the processor 240 may use the timer 115 to monitor a length of time that has elapsed since an injection was completed, as indicated by a time of disengagement of respective switch components or ceasing of operation of the switch 122. Optionally, the elapsed time may be shown on the display 118. Also optionally, when the switch 122 is next operated, the processor 240 may compare the elapsed time with a predetermined threshold, to determine whether a user may be attempting to administer another injection too soon after a previous injection and, if so, generate an alert such as an audible signal and/or a warning message on the display 118 or via the output 116. The output 160 may be configured to generate an audible sound or to induce a vibration hence to produce a tactile signal, e.g. for alerting the user.

[0160] The sensing arrangement 200 as shown in FIG. 3 might be implemented as a rotation sensing arrangement. It may comprise a first member 201 and a second member 202. The first member 201 is rotatable relative to the second member 202 with regards to an axis of rotation 203. Typically, the first member 201 and the second member 202 are arranged coaxial with regards to the axis of rotation 203. With some examples, the first member 201 and the second member 202 are arranged axially adjacent with regard to the axis of rotation 203. The first member 201 and the second member 202 may be directly mechanically engaged. With other examples, the first member 201 and the second member 202 are mechanically disengaged from each other. Here, the first member 201 and the second member 202 may be separately arranged or rotationally supported in or at a housing 32 of the injection device 30 or in or at a respective housing 101 of a separate add-on device 100.

[0161] At least one of the first member 201 and the second member 202 is typically rotationally supported in or on the housing 10 of the injection device 1. With some examples, both, the first member 201 and the second member 202 can be rotationally supported on or with regard to the housing 32. Typically, and depending on the specific implementation or integration of the rotation sensing arrangement 200 in the injection device 30 one of the first member 201 and the second member 202 is rotationally locked to the housing 32 whereas the other one of the first member 201 and the second member 202 is rotationally movable relative to the housing 10. Typically, one of the first member 201 and the second member 202 is rotatable relative to the housing 32 with regard to the axis of rotation 203. The second member 202 may be represented by the dose dial 12. The first member 201 may be represented by the trigger 11. During at least one of setting and dispensing of the dose, the second member 202 is subject to a rotation relative to the first member 201. A degree of relative rotation between the first member 201 and the second member 202 is directly indicative of the size of the dose actually set and/or dispensed.

[0162] The rotation sensing arrangement 200 may comprise a printed circuit board 260 as illustrated in FIG. 4. On the printed circuit board 260 there may be provided the processor 240 together with the at least one sensor 220. The printed circuit board 260 may be further provided with a power source 120. The power source 120 may be located on one side of the printed circuit board 260. On the same side or on the opposite side of the printed circuit board 260 there may be provided the processor 240 and/or the at least one sensor 220.

[0163] In order to provide sufficient data security establishing of a communication link 66 between the data logging device 100 and an external electronic device 65 requires use of a pairing code 320. Due to regulatory requirements the pairing code 320 may have to be visible or discernible from outside the drug delivery device 1. However, it should not be directly visible to any person gaining access to the drug delivery device 1. In order to prevent unauthorized pairing of the electronic data logging device 100 with the external electronic device 65 the pairing code 320 is either concealed by a component of the drug delivery device 1 and has to be revealed by an action of a user. According to other options, the pairing code 320 is split or distributed on at least two device components 301, 302. For recombining of the pairing code 320, the first and second device components 301, 302 will have to be moved into a predefined positional state.

[0164] In the example of FIGS. 5 and 6, at least one of a dial extension 70 and a number sleeve 80 provides a first device component 301 movable relative to a second device component 302. The second device component 302 may be provided by the body 10 of the housing 32 of the injection device 30. The first device component 301 is at least partially contained or received inside a hollow section of the second device component 302. As it is apparent from a comparison of FIGS. 5 and 6, the first device component 301 is displaceable or movable relative to the second device component 302 along a longitudinal direction, hence towards a proximal direction 3. Optionally, the first device component 301 may be also rotatable relative to the second device component 302.

[0165] Mutual engagement of the first and second device components 301, 302 may only allow and support a helical motion of the first device component 301 relative to the second device component 302. The first device component 301 is provided with a first outer surface 311. On the first outer surface 311 there is provided at least a first code portion again 321 of a pairing code 320. Typically, the entirety of the pairing code is required for establishing or for setting up of the communication link 66 between the data logging device 100 and the external electronic device 65.

[0166] The second device component 302 comprises a second outer surface 312. On the second outer surface 312 there is provided a second code portion 322. A recombination of the second code portion 322, hence the character “B” and the sequence of numbers and characters “123ABC” of the first code portion 321 complement or constitute the pairing code 320. The pairing code 320 is only complemented and recombined from the first code portion 321 and the second code portion 322 when the first device component 301 is in a predefined second positional state 352 relative to the second device component 302.

[0167] This particular positional state is characterized by a relative position of first and second device component 301, 302 and/or by a predefined rotational orientation of the first and second device components 301, 302 relative to each other. The second positional state 352 may be characterized and may be identified by a first marker 303 of the first device component 303 configured to coincide, to align or to spatially overlapping with a second marker 304 provided by the second device component 302. Here, the second marker 304 is an aperture in the sidewall of the first device component 302. The aperture 304 may coincide with the above-mentioned the dosage window 13. The first marker 303 may be a selected or predefined number or symbol of numerous available numbers or symbols as provided on the outer surface 311 of the first device component 301, e.g. implemented as a number sleeve 80. In the presently illustrated example, the first marker 303 is number 25, also indicating that a dose of 25 units has been actually set in the present configuration of first and second device components 301, 302.

[0168] In the presently illustrated example also the second device component 302 is provided with a second code portion 322. The second code portion 322 and the first code portion 321 have to be aligned along a straight line or along a helical line so as to reconstitute the pairing code 320 required for establishing or for setting up the communication link 66.

[0169] With the presently illustrated example, the second code portion 322 is provided on the second outer surface 312 in combination with a second concealing code portion 336. The second concealing code portion 336 provides some further or supplemental code portion that is generally indistinguishable from the second code portion 322. The second concealing code portion 336 may comprise numerous characters, symbols or numbers aligned with the second code portion 322. When not being appropriately informed, e.g. by a user manual of the drug delivery device, it is not known to authorized user of the drug delivery device 1, which one of the second concealing code portions 336, e.g. letters “A” or “C” and the second code portion 322, character “B” should align with the first code portion 321 in order to recombine and to constitute the pairing code 320.

[0170] In the example of FIGS. 5 and 6, the second concealing code portion 336 extends along a second direction 4. The second direction may extend at a predefined angle relative to a first direction 3. The first code portion extends along the first direction 3 and the second concealing code portion 336 extends along or parallel to the second direction 4. When the first device component 301 is subject to both, a movement along the first direction 3 and along the second direction 4 relative to the second device component 302 for arriving at the second positional state 352 an intersection of a longitudinal extension of the first code portion 321 with the second concealing code portion 336 may point to or indicate the second code portion 322.

[0171] In the presently illustrated example and when for instance a dose of the medicament should be dialed that does not match with the first marker 303, there will be an alignment mismatch between the first code portion 321 and the second code portion 322 and thus the pairing code 320 will not show up appropriately.

[0172] In another example as illustrated in the sequence of FIGS. 7-9, the second device component 302 is void of a second code portion 322 or a second concealing code portion 336. There, the second device component 302 is opaque and receives at least a portion of the first device component 301 in its hollow interior. In the first positional state 351 as illustrated in FIG. 7, the first outer surface 311 of the first device component 301 is hardly visible from outside the injection device 30. It is upon a movement of the first device component 301 relative to the second device component 302, that a portion of the first outer surface 311 is revealed from the second device component 302.

[0173] The movement of the first device component 301 relative to the second device component 302 from the first positional state 351 as shown in FIG. 7 towards and into the second positional state 352 as shown in FIG. 8 may be conducted in the course of setting of a dose of the medicament. Hence, the user manual for pairing of the electronic data logging device 100 and the external electronic device 65 may instruct the user of the injection device 30 to dial a number of 25 standard units. This dialing or dose setting motion, e.g. conducted by the movement of the first device component 301 relative to the second device component 302, leads to a combined rotational and longitudinal displacement of the first device component 301 relative to the second device component 302.

[0174] As illustrated in FIG. 8, the first device component 301 protrudes in longitudinal direction from a longitudinal end, hence from the proximal end of the first device component 302. As a consequence, a respective portion of the first outer surface 311 appears. When arriving at the second positional state 352 as illustrated in FIG. 8, it is only the entirety of the pairing code 320 that is visually identifiable from outside the drug delivery device 30. Here, it is only and exclusively the pairing code 320 that is revealed.

[0175] As it is apparent from the further illustration of FIG. 9, and hence when the first device component 301 is moved further and beyond the second positional state, e.g. along the proximal direction 3 relative to the first device component 302 a further portion of the first outer surface 311 reveals. The further portion of the first outer surface 311 is provided with a first concealing code portion 335. The first concealing code portion 335 is indistinguishable from the first code portion 321 or from the pairing code 320. Hence, in the configuration as shown in FIG. 9, a user of the device will be unable to visually identify which part of the indistinguishable combination of the pairing code 320 and the first concealing code portion 335 should be used or which part thereof is relevant for initiating or approving the pairing between the data logging device 100 and the external electronic device 65.

[0176] With typical implementations of the drug delivery device 30, the first device component 301 is movable relative to the second device component 302 from the first positional state 351, such as illustrated in FIGS. 5 and 7 to the second positional state 352 as illustrated in FIGS. 6 and 8 and vice versa from the second positional state 352 towards and into the first positional state 351 without the necessity to dispense a dose of the medicament 27.

[0177] In FIG. 10, a flowchart of a method of pairing of the data logging device 100 with the external electronic device 65 is illustrated. Typically, the method of pairing can be conducted with a drug delivery device 1 or with an injection device 30 as described above in connection with an external electronic device 65 and a data logging device 100, either provided as a separate data logging device 100 or integrated into the drug delivery device 1.

[0178] For setting up a communication link 66 between the data logging device 100 and the external electronic device 65 in a first step 400, at least one of the external electronic device 65 and the data logging device 100 is set into a pairing mode. Typically, the external electronic device 65 and the data logging device 100 are configured to set up a wireless communication link, e.g. using a standardized RF connection protocol, such as Bluetooth. In a subsequent step 402 the first device component 301 is moved relative to the second device component 302 from a first positional state 351, in which the pairing code 320 is non-discernible, into the second positional state 352. In a subsequent step 404, the pairing code 320 is visually identified by a user of the drug delivery device. In a further step 406, the pairing code 320 as identified by the user in step 404 is used to establish or to approve the communication link 66 between the external electronic device 65 and the data logging device 100.

[0179] List of reference numbers [0180] 1 drug delivery device [0181] 2 distal direction [0182] 3 first direction [0183] 4 second direction [0184] 5 dose decrementing direction [0185] 6 cartridge [0186] 7 bung [0187] 8 drive mechanism [0188] 9 dose setting mechanism [0189] 10 body [0190] 11 trigger [0191] 12 dose dial [0192] 13 dosage window [0193] 14 cartridge holder [0194] 15 injection needle [0195] 16 inner needle cap [0196] 17 outer needle cap [0197] 18 protective cap [0198] 19 protrusion [0199] 20 piston rod [0200] 21 bearing [0201] 22 threaded section [0202] 23 pressure foot [0203] 25 barrel [0204] 26 seal [0205] 27 medicament [0206] 28 socket [0207] 30 injection device [0208] 32 housing [0209] 34 drive mechanism [0210] 62 insert piece [0211] 64 stem [0212] 65 external electronic device [0213] 66 communication link [0214] 70 dial extension [0215] 80 number sleeve [0216] 81 groove [0217] 100 data logging device [0218] 101 housing [0219] 102 medicament injection system [0220] 114 memory [0221] 115 timer [0222] 116 output [0223] 118 display [0224] 120 power source [0225] 122 switch [0226] 124 interface [0227] 126 transceiver [0228] 200 sensing arrangement [0229] 201 first member [0230] 202 second member [0231] 203 axis of rotation [0232] 210 signal generator [0233] 220 sensor [0234] 240 processor [0235] 260 printed circuit board [0236] 301 device component [0237] 302 device component [0238] 303 marker [0239] 304 marker [0240] 311 outer surface [0241] 312 outer surface [0242] 320 pairing code [0243] 321 code portion [0244] 322 code portion [0245] 335 code portion [0246] 336 code portion [0247] 351 positional state [0248] 352 positional state [0249] 353 positional state