Electronic Module and Modular System for a Drug Delivery Device

Abstract

An electronic module is configured for attachment to a proximal end of a drug delivery device in a predefined fastening configuration. The drug delivery device comprises an elongated housing extending in a longitudinal direction and comprising a distal end and the proximal end. The electronic module comprises a mechanical coding comprising a mechanical coding feature to engage with a mechanical counter coding feature of a mechanical counter coding provided at the proximal end of the drug delivery device, wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion extending in the longitudinal direction and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess, wherein, in some configurations, the mechanical coding and the mechanical counter coding are operable to prevent a fastening of the electronic module to the drug delivery device.

Claims

1-15. (canceled)

16. An electronic module configured for attachment to a proximal end of a drug delivery device in a predefined fastening configuration, the drug delivery device comprising an elongated housing extending in a longitudinal direction and comprising a distal end and the proximal end, the electronic module comprising: a mechanical coding comprising a mechanical coding feature to engage with a mechanical counter coding feature of a mechanical counter coding provided at the proximal end of the drug delivery device, wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion extending in the longitudinal direction, and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess, and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess, or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess, the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration.

17. The electronic module according to claim 16, further comprising a fastening element configured to mechanically engage with a complementary shaped counter fastening element of the drug delivery device in the predefined fastening configuration.

18. The electronic module according claim 17, wherein the mechanical coding is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the fastening element.

19. The electronic module according to claim 16, further comprising at least one longitudinal extension extending distally from a distal end of the electronic module and configured to extend into or through an aperture at the proximal end of the drug delivery device.

20. The electronic module according to claim 19, wherein the mechanical coding is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the longitudinal extension.

21. The electronic module according to claim 16, wherein the mechanical coding feature comprises the protrusion protruding in a longitudinal distal direction from a distally facing surface of the electronic module and configured to engage with a complementary shaped recess of the mechanical counter coding feature.

22. The electronic module according to claim 21, wherein the distally facing surface of the electronic module is in longitudinal abutment with a complementary shaped proximally facing surface of the drug delivery device.

23. The electronic module according to claim 16, wherein the mechanical coding comprises a coding section comprising a number of n discrete spatially non-overlapping coding feature positions and a number of k mechanical coding features each one of which located on one of the coding feature positions, wherein n and k are integer numbers and wherein k≤n.

24. A drug delivery device comprising: a housing comprising a distal end and a proximal end, wherein the proximal end is configured for attachment of an electronic module in a predefined fastening configuration, wherein the electronic module comprises: a mechanical coding comprising a mechanical coding feature to engage with a mechanical counter coding feature of a mechanical counter coding provided at the proximal end of the drug delivery device, wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion extending in the longitudinal direction, and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess, and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess, or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess, the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration, the drug delivery device comprising: a drive mechanism configured to set and/or to deliver a dose of a drug out of the distal end; and wherein the mechanical counter coding is provided at the proximal end and comprises the mechanical counter coding feature to engage with the mechanical coding feature of the mechanical coding of the electronic module.

25. The drug delivery device according to claim 24, further comprising a counter fastening element configured to mechanically engage with a complementary shaped fastening element of the electronic module in the predefined fastening configuration.

26. The drug delivery device according to claim 25, wherein the mechanical counter coding is defined by at least one of a position, an orientation, and a longitudinal extent of the mechanical counter coding feature relative to the counter fastening element.

27. The drug delivery device according to claim 24, wherein the mechanical counter coding feature comprises the recess configured to receive or to engage with a complementary shaped and distally extending protrusion of the coding feature of the mechanical coding when in the predefined fastening configuration.

28. The drug delivery device according to claim 27, wherein the recess is provided in at least one of a proximal facing surface of the drug delivery device, an outside surface of a sidewall of the drug delivery device and an inside surface of the sidewall of the drug delivery device.

29. The drug delivery device according to claim 28, further comprising a drug container filled with the drug.

30. A modular system comprising: an electronic module configured for attachment to a proximal end of a drug delivery device in a predefined fastening configuration, the drug delivery device comprising an elongated housing extending in a longitudinal direction and comprising a distal end and the proximal end, the electronic module comprising: a mechanical coding comprising a mechanical coding feature to engage with a mechanical counter coding feature of a mechanical counter coding provided at the proximal end of the drug delivery device, wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion extending in the longitudinal direction, and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess, and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess, or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess, the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration, and the drug delivery device; wherein the mechanical coding of the electronic module matches with the mechanical counter coding of the drug delivery device, and wherein the mechanical coding mechanically engages with the mechanical counter coding when the electronic module and the drug delivery device are in the predefined fastening configuration.

31. The modular system of claim 30, wherein the electronic module further comprises a fastening element configured to mechanically engage with a complementary shaped counter fastening element of the drug delivery device in the predefined fastening configuration.

32. The modular system of claim 31, wherein the mechanical coding is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the fastening element.

33. The modular system of claim 30, wherein the electronic module further comprises at least one longitudinal extension extending distally from a distal end of the electronic module and configured to extend into or through an aperture at the proximal end of the drug delivery device.

34. The modular system of claim 33, wherein the mechanical coding is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the longitudinal extension.

35. The modular system of claim 30, wherein the mechanical coding feature comprises the protrusion protruding in a longitudinal distal direction from a distally facing surface of the electronic module and configured to engage with a complementary shaped recess of the mechanical counter coding feature.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0110] 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:

[0111] FIG. 1 shows an example of a drug delivery device provided with an electronic module,

[0112] FIG. 2 schematically shows numerous components of an example of an electronic module,

[0113] FIG. 3 shows one example of a mechanical coding of an electronic module and of a correspondingly-shaped mechanical counter coding at the proximal end of the drug delivery device,

[0114] FIG. 4 shows another example of a mechanical coding of the electronic module configured to engage with a complementary-shaped mechanical counter coding provided at the proximal end of the drug delivery device,

[0115] FIG. 5 schematically illustrates a logical structure of an electronic unit of the electronic module,

[0116] FIG. 6 shows another example of an electronic module as seen from its distal side,

[0117] FIG. 7 shows the electronic module or its housing connected to a component of the drug delivery device,

[0118] FIG. 8 shows a cross-section through the assembly of FIG. 7,

[0119] FIG. 9 shows a top view of the drug delivery device with a first mechanical counter coding,

[0120] FIG. 10 shows another example of a drug delivery device with a second mechanical counter coding,

[0121] FIG. 11 shows a further example of an electronic module provided with a mechanical coding,

[0122] FIG. 12 shows an enlarged section of the electronic module of FIG. 11,

[0123] FIG. 13 shows another example of an interface of an electronic module and a drug delivery device in accordance to FIGS. 11 and 12,

[0124] FIG. 14 shows another example of a coded interface compared to FIG. 13,

[0125] FIG. 15 shows another example of a coded interface between the electronic module and the drug delivery device,

[0126] FIG. 16 shows another example of a coded interface between the electronic module and the drug delivery device,

[0127] FIG. 17 shows another example of a coded interface between the electronic module and the drug delivery device,

[0128] FIG. 18 shows another example of a coded interface between the electronic module and the drug delivery device.

DETAILED DESCRIPTION

[0129] FIG. 1 illustrates a modular system 98 according to a first example. Modular system 98 may comprise a drug delivery device 100 that may comprise a container retaining member 101 and a main housing part 102. Container retaining member 101 may accommodate a drug container 103. The drug container 103 may comprise a cartridge sealed in proximal direction by a movable stopper 105 the drug container 103 may comprise a drug Dr. The main housing part 102 may house or surround the container retaining member 101 completely or partially and may comprise further parts of the drug delivery device 100. Alternatively, the main housing part 102 may be connected to the container retaining member 101 but may not surround it and even may not surround a part of the container retaining member 101, see dashed line in FIG. 1.

[0130] Within the main housing part 102 the following components may be arranged: [0131] a piston rod 104 that is adapted to move the piston that may be arranged within container retaining member 101, [0132] a driving mechanism 106 for the piston rod 104. The driving mechanism 106 may comprise an energy storing element, for instance a spring that is loaded manually before each use. Alternatively, the energy storing element may be loaded for instance during assembling of drug delivery device 100. Alternatively, a manually driven driving mechanism may be used, e.g. without an energy storing element that is used to drive piston rod 104.

[0133] With some examples and for instance at a proximal end P, an actuating element 108 is arranged that is used for the initiation of a movement of piston rod 104 into the container retaining member 101, whereby the driving mechanism 106 is used. Alternatively, an autoinjector device may be used that is actuated by an axial movement of a movable needle shroud (not shown). Actuating element may be used to dial the size of a dose of drug Dr in some embodiments.

[0134] Also, a cap 112 may be attached to main housing part 102 or to another part of drug delivery device 100. Cap 112 may be an outer cap that may include a smaller inner cap which protects a needle 110 directly.

[0135] If drug delivery device 100 is not an autoinjector, a dial sleeve may be screwed out of main housing 102 and may be pressed by a user in order to move plunger 104 distally and to inject drug Dr.

[0136] Drug delivery device 100 may be a single use or a multiple use device.

[0137] Drug Dr may be dispensed from the container through needle 110 or through a nozzle that is connectable and/or connected to the distal end D of drug delivery device 100. Needle 110 may be changed before each use or may be used several times.

[0138] Modular system 98 may comprise an electronic module 120 that is mechanically connected to a proximal end region P of drug delivery device 100, for instance to a proximal end region P of actuating element 108. Modular system 98 is described below in more detail, see FIG. 2 and corresponding description.

[0139] Electronic module 120 may be used not only for drug delivery device 100 but also for other drug delivery devices that are similar or identical to drug delivery device 100. Thus, electronic module 120 is used multiple times with different drug delivery devices in different modular systems 98, etc. Furthermore, the diameter of drug delivery device 100 is not increased by electronic module 120 promoting excellent handling of modular system 98, and especially of drug delivery device 100.

[0140] FIG. 2 illustrates a modular system 200 of a second embodiment that may be the same as the first embodiment. However, more details are shown in FIG. 2. Modular system 200 may comprise for instance a housing part 102c that may correspond to housing part 102 described above. The actuating element 108c may correspond to actuating element 108 described above.

[0141] The modular system 200 may comprise: [0142] a clutch element 202 or other rotatable or moving element that may comprise radially protruding features 204, for instance teeth of a sprocket or of a sprocket sleeve, e.g. providing a rotary encoder, [0143] an essentially annular adapter element 210 that may encompass the side wall of actuating element 108, [0144] an electronic module 220 that may correspond to electronic module 120 and that may comprise an electronic unit 240. Electronic unit 240 is described below in more detail. [0145] an annular casing or housing 221 of electronic module 220, [0146] a chassis 222 within electronic module 220. Chassis 222 may comprise an annular wall 249 surrounding a compartment for electronic unit 240 and/or for several other parts. [0147] and a lid 224 of electronic module 220.

[0148] Fastening elements 226 may be used to connect housing 221 and adapter element 210. Alternatively, other connection means may be used or housing 221 and adapter element 210 may be formed integrally as one single part.

[0149] The following electronic components may be comprised within electronic module 220: [0150] a battery 230 or a rechargeable accumulator, and [0151] an electronic unit 240 that may form a PCBA (Printed Circuit Board Assembly).

[0152] Electronic unit 240 may comprise: [0153] a printed circuit board 242 (PCB) which may be named as substrate in the claims, [0154] at least one light source 264, e.g. an IR (Infra-Red) light source, or two light sources, [0155] at least one optical sensor 266 or at least two optical sensors, [0156] a transmitter unit 270, for instance a transmitter unit 270 that operates according to the Bluetooth (may be a registered trademark) protocol, for instance for communication with a smartphone or other computer device, [0157] a receiver unit 272, for instance a receiver unit 272 that operates according to the Bluetooth (may be a registered trademark) protocol, for instance for communication with a smartphone or other computer device, and [0158] an optional switch 274, for instance a micro switch.

[0159] FIG. 2 shows a longitudinal axis A of modular system 200. Electronic module 220 may be arranged proximally of actuating element 108c of the corresponding drug delivery device. Electronic module 220 and actuating element 108c are arranged symmetrically to axis A whereby electronic module 220 and actuating element 108c are in physical contact with each other, mainly via adapter element 210. Adapter element 210 may be plugged mechanically onto actuating element 108c.

[0160] The chassis 222 may comprise: [0161] three annular wall portions 244, 246 and 248 of an annular wall 249, [0162] a distal end 250 of chassis 222 and at the same time of annular wall portion 248, [0163] a wall 252 of chassis 222, and [0164] at least one optical guide 254 or at least two optical guides 254, 258.

[0165] A cup like structure may be formed by wall 252 and by a part of annular wall portion 248 around a proximal part or base part of optical guide 254. The cup like structure may comprise a laterally extending thinner portion 259 that may be regarded as a bottom portion of the cup like structure. Thinner portion 259 may be arranged near to but distally of a light source 264, e.g. IR, and of an optical sensor 266. A rib 260 may be arranged on thinner portion 259 and may extend proximally P up to printed circuit board 242. Rib 260 may be adjacent to light source 264, e.g. IR, and/or optical sensor 266. There may be a gap 262 between printed circuit board 242 and thinner portion 259 and/or a proximal or bottom portion of wall 252. Gap 262 may be filled with a potting compound/material 282. Rib 260 may protect light source 264, e.g. IR, and/or optical sensor 266 against potting compound/material 282 if it is in its melted state.

[0166] There may be a sequence of annular wall portions 244, 246 and 248 in this order from proximal P end to distal end of annular wall 249. Annular wall portion 244 may have a first diameter that corresponds to the diameter of the lid 224. The annular wall portion 246 may have a second diameter that is less than the first diameter. The second diameter may correspond to the diameter of printed circuit board 242. Furthermore, annular wall portion 248 may have a third diameter that is less than the second diameter.

[0167] A fill height 280 measured from PCB 242 may be in the range of 2 mm to 7 mm. The fill height 280 of the potting compound 282 or material may be selected appropriately, for instance to cover only a part of some of the electrical parts of electronic unit 240. The inner side of distal end 250 of annular wall portion 248 may not be covered by potting compound 282 or by another potting material. The potting compound 282 or potting material may be an electrical insulator. The wall 252 may protect the basis part of optical guide 254 against the potting compound/material 282 during potting.

[0168] FIG. 5 illustrates schematically an electronic unit 500, for instance electronic unit 240. The electronic unit 500 may comprise: [0169] at least one processor Pr or another control unit, [0170] a memory Mem, for instance volatile and/or nonvolatile storing memory, [0171] a battery Bat or a rechargeable accumulator or any other electrical power source, [0172] an output device Out, for instance a sending unit, for instance for communication with a smartphone or other computer device, [0173] an optional input device In, for instance for communication with a smartphone or other computer device, [0174] a switch Sw, and [0175] at least one sensor S or at least two sensors, preferably optical sensor(s).

[0176] Further parts may be comprised in electronic unit 500 that are not shown, for instance a radiation source, especially a light source.

[0177] Processor Pr may be a microcontroller or microprocessor that performs instructions of a program which is stored in memory M. Alternatively, an FPGA (Field Programmable Gate Array), ASIC (Application Specific Integrated Circuit), PLA (Programmable Logic Array), PLD (Programmable Logic Device) or another appropriate circuitry may be used to implement a finite state machine that does not perform instructions of a program.

[0178] The electronic unit 500 may implement a quadrature encoder, e.g. an encoder that uses amplitude modulation 180 of two sensors having 180 degree phase shift between two sensor signals, for instance anti phase sensor signals. Alternatively, other sensing methods may be used.

[0179] There may be two alternative modes of operation of sensing in accordance with various embodiments. According to a first alternative, a first sensor and a second sensor, for instance optical sensors, may be provided having an angular offset that is half of the periodicity of encoded regions of the encoder ring, for instance on clutch element 202. In the embodiment according to the first alternative, the sensors may be operated to sample synchronously, i.e. at the same times (t1; t2, t3, . . . ). This may ease signal detection and/or signal processing.

[0180] According to a second alternative, a first sensor and a second sensor, for instance optical sensors, may be provided having an angular offset that differs from half of the feature periodicity of encoded regions of the encoder ring. Therefore, sensors I and II may operate in a staggered mode with an offset in time (delta t) between samplings. This may be used to achieve more balanced overall system power consumption than available in synchronous operation.

[0181] One of the following sensing modes may be used: [0182] 1) static thresholding, [0183] 2) dynamic thresholding, [0184] 3) not using a threshold to detect low-high transitions of the sensor signals. However, a threshold for a voltage difference of the two sensor signals may be used. Furthermore, scaling factors for mean and amplitude may be used. The scaling factors may be set during manufacturing, for instance during a calibration method. [0185] 4) same as 3) but differing in that the scaling factors may be calculated after each dose delivery. 5) peak-detect method that does preferably not use the setting of thresholds to detect low-high transitions of the sensor signal(s) and that does preferably not use scaling of signals to match mean and amplitude.

[0186] Spoken with other words one part of the disclosure relates to light pipe/guide 254 or optical pipe protection, preferably against loads. The optical pipe may be an optical fiber, a tube or other optical guiding means. An additional coating 256 on the outer surface of the light pipe may be used to prevent damage from loads coming from outside to the light pipe. One option would be a metal coating or a similar robust material coating to stiffen up the structure of the light pipe. A second option would be a soft coating to absorb impact loads resulting in less stresses of the light pipe. Another option would be reinforced coatings e.g. carbon fiber reinforced polymer (in German language: CFK) filled materials. A combination of two or of three of these options is possible as well.

[0187] FIG. 3 illustrates another example of a modular system 300. Generally, the modular system 300 is similar or almost identical to the modular system 98 or 200 as described above in connection with FIGS. 1 and 2. The modular system 300 comprises an electronic module 320. The electronic module 320 comprises a housing 321. The housing 321 may form or comprise a chassis 322. The chassis 322 is somewhat identical or equivalent to the chassis 222 as described above in connection with FIG. 2.

[0188] The electronic module 320 comprises a distal end 301 and a proximal end 302. Near or at the distal end 301 the electronic module 320 comprises a distally facing surface 360. At the distal surface 360 and/or at the distal end 301 there is further provided a mechanical coding 350. The mechanical coding 350 comprises a longitudinally extending protrusion 352 forming or constituting a mechanical coding feature 351. In the present example, the mechanical coding feature 351 comprises an annual shaped or tubular shaped hollow sleeve.

[0189] Along the circumference of the housing 321 there are provided numerous fastening elements 323, 324 and 325, 326. The fastening elements 323, 324, 325 may be arranged equidistantly along the circumference of the housing 321. Moreover, there are provided two separate optical guides, e.g. in form of light guides or light pipes 254, 258 also protruding distally from the distally facing surface 360 at the distal end 301. In FIG. 3 there is further illustrated a proximal end P of the drug delivery device 100. The proximal end P may comprise the actuating element 108. Thus, the movable, e.g. rotatable actuating element 108 may constitute or may form the proximal end P of the drug delivery device 100.

[0190] At the proximal end P there is provided a mechanical counter coding 370. The mechanical counter coding 370 comprises a mechanical counter coding feature 371. Here, the mechanical counter coding feature 371 comprises an annular recess 372 configured to engage and/or to receive the protrusion 352 and hence the mechanical coding feature 351 of the electronic module 320. The recess 372 may be located radially between a central cylindrical portion 312 and a surrounding sidewall portion featuring a proximally facing surface 380. The proximally facing surface of the cylindrical portion 312 and the surface 380 as well as a proximal end of the actuating element 108 may flush and may be located in a common transverse plane.

[0191] The surface 380 is provided on an inner annular shaped sidewall 381 or annular ring 311. Between the inner sidewall 381 and an outer side wall 382 of the actuating element 108 there is provided an annular groove 310. Radially between the inner sidewall 381 and the outer sidewall 382 there is provided an outer annular groove 310 to receive the optical guides 254, 258. The outer annular groove 310 is separated by the annular ring 311 and hence by the inner sidewall 381 from the annular recess 372.

[0192] The optical guides 254, 258 extend into the annular groove 310 when the electronic module 320 and hence it chassis 322 is mounted or assembled to the drug delivery device 100 in at least one of two available predefined fastening configurations. The optical guides 254, 258 may extend the same length as the keying feature 316 or coding feature 351 measured for instance from a circuit board within the chassis 322. Alternatively, the optical guides 254, 258 may be slightly shorter than the mechanical coding feature 351. With some examples, only one of the optical guides 254 or 258 may be used.

[0193] The recess 372, hence the annular groove forming or constituting the keying feature 318 is complementary shaped to the keying feature 316. In effect, only a drug delivery device 100 equipped with the mechanical counter coding feature 371 can be connected with the presently illustrated electronic module 320 provided with the complementary shaped coding feature 351. Insofar, the keying feature 318 and hence the mechanical counter coding feature 371 is inverse shaped compared to the keying feature 316 or mechanical coding feature 351. The counter coding feature 371 comprises an inner diameter sized and configured to receive the outer dimensions of the mechanical coding feature 351.

[0194] The longitudinal extent of the mechanical counter coding feature 371 is larger than or equal to the longitudinal extent of the complementary shaped coding feature 351. This allows and supports a complete insertion of the coding feature 351, e.g. of the protrusion 352, into the complementary-shaped counter coding feature 371, e.g. into the recess 372.

[0195] With other, non-matching examples, the longitudinal extent of the coding feature 351 may be larger than a corresponding longitudinal extent of the counter coding feature 371. In this way, and when the coding feature 351 enters or engages the counter coding feature 371 the entirety of the coding feature 351 cannot be received in the counter coding feature 371 thereby preventing a mutual engagement of the fastening elements 326 with the complementary-shaped counter fastening elements 327. Here, an insert motion of the coding feature 351 into the counter coding feature 371 is effectively blocked, e.g. by a blocking feature or an end wall of the counter coding feature 371. Accordingly, and when reaching such a blocking configuration the fastening elements 326 will be located at a longitudinal offset from the counter fastening elements 327. Here, a fastening of the electronic module 320 to the drug delivery device 100 will be effectively prevented.

[0196] The same applies when the geometric shape of the protrusion 352 of the coding feature 351 does not match with the geometric shape of the recess 372 of the counter coding feature 371 or when a position of the protrusion 352 in the plane transverse to the longitudinal direction is not matching with the respective position of the recess 372 in the transverse plane.

[0197] The outer sidewall 382 of the actuating or adjusting element 108 comprises numerous counter fastening elements 327 on its inside facing sidewall portion and hence towards the annular groove 310. The counter fastening elements 327 are configured to engage with correspondingly shaped fastening elements 326 of the electronic module 320. The fastening elements 326 protrude distally from the distal face 360 of the housing 321. The fastening elements 326 and/or the counter fastening elements 327 are configured as snap elements or clip elements and they are hence configured to form a snap fit or clipped connection between the electronic module 320 and the drug delivery device 100.

[0198] The further fastening elements 323, 324, 325 may comprise or may form a hook, each of which being configured to engage with a longitudinal groove 330 on the outside surface of the actuating/adjusting element 108.

[0199] The hooks or fastening elements 323, 324, 325 serve to block a relative rotation between the electronic module 320 and the actuating/adjusting element 108. The hooks or fastening elements 323, 324, 325 cooperate with the grooves 330. Alternatively, an adapter element may be used that corresponds to the adapter element 210 as illustrated in FIG. 2. The hooks or fastening element 323, 324, 325 may provide or contribute to an axial fixing of the electronic module 322 to the drug delivery device 100, e.g. by a clamping or friction fit to the actuating/adjusting element 108.

[0200] In an alternative but not illustrated example, the mechanical coding feature 351 and hence the keying feature 316 may be arranged at the actuating/adjusting element 108, whereas the annular ring 311 is located on the chassis 322 or housing 321 of the electronic module 320.

[0201] The fastening elements 326 and the counter fastening elements 327 may form or constitute a clip connection and may provide a detachable fastening of the electronic module 322 from the drug delivery device 100.

[0202] The further example of a modular system 400 as illustrated in FIG. 4 comprises a similar structure but distinguishes from the electronic module 320 as shown in FIG. 3 by the specific implementation of the mechanical coding 450 and the mechanical coding feature 451. Accordingly, also the mechanical counter coding 470 and the respective mechanical counter coding feature 471 of the drug delivery device 100 distinguish from the example of FIG. 3.

[0203] As already described in connection with FIG. 3, the electronic module 420 comprises two diametrically oppositely located fastening elements 426 to engage with correspondingly shaped counter fastening elements 427 on an inside of the outer sidewall 482 of the actuating/adjusting element 108. The housing 421 and/or the chassis 422 of the electronic module 420 further comprises a number of supplemental fastening element 423, 424, 425. These fastening elements 423, 424, 425 may be implemented as a hook to engage with longitudinal grooves 430 on the outside surface of the actuating/adjusting element 180 when the electronic module 420 is assembled and/or attached to the proximal end P of the drug delivery device 100 in the predefined fastening configuration.

[0204] The housing 421 or the chassis 422 comprises a distally facing surface 460. The optical guides 254, 258 as well as the numerous fastening elements 423, 424, 425, 426 may protrude distally from this distally facing surface 460. The distal end 401 of the chassis 422 is provided with a mechanical coding 450. The mechanical coding 450 comprises a mechanical coding feature 451. The mechanical coding feature 451 comprises a geometric structure with cross-shaped cross section protruding distally from the distally facing surface 460. It may provide a keying feature 416. The proximal end P of the drug delivery device 100, hence the proximal surface 480 of the actuating/adjusting member element 108 comprises a complementary-shaped counter coding feature 471. The counter coding feature 471 forms a mechanical counter coding 470 matching with the mechanical coding 450 when the electronic module 420 is assembled and attached to the drug delivery device 100 in the predefined fastening configuration.

[0205] The counter coding feature 471 comprises a recess 472. The recess is shaped in a cross wise manner. The recess 472 is provided in the central cylindrical portion 412 of the actuating/adjusting element 108. The recess 472 comprises two elongated mutually crossing slits 411, 413. Here, the slit 411 may be shaped to receive a slab—of plate-like element 438 of the coding feature 451. The slit 413 may be shaped and arranged to engage and/or to receive the further slab—or a plate-like element 436 of the mechanical coding feature 451.

[0206] Between the central cylindrical portion 412 and the outside or outer sidewall 482 there is also provided an annular groove 410 to receive the light guides 254, 258.

[0207] It should be noted, that the light guides 254, 258 are an example of a longitudinal extension 255 that may be provided on the chassis 322, 422 of the electronic modules 320, 420 as a symmetry breaking feature.

[0208] Generally, the codings 350, 450 may be defined by the shape of the mechanical coding features 351, 451 as well as by the position of the mechanical coding features 351, 451 relative to at least one of the extension 255 and/or relative to at least one of the fastening elements 326, 426.

[0209] When the electronic module 320, 420 is in the predefined fastening configuration on the drug delivery device 100, the distally facing surface surface 360, 460 of the electronic module 320. 420 may be in abutment with the proximally facing surface 380, 480 provided at the proximal end P of the drug delivery device 100. In this way a rather tilt-free mechanical fastening of the electronic module 320, 420 to the drug delivery device 100 can be provided.

[0210] The cross-like and non-rotationally symmetric structure of the coding feature 451 and the respective counter coding feature 471 is further beneficial to provide a torque proof engagement between the electronic module 420 and the actuating/adjusting element 108. The adjusting element 108 may be rotatable, e.g. for adjusting or setting of a dose of the drug. Here, the user may use the electronic module 420 as a kind of a dial extension. The user may use or may grip the chassis 422 or the housing 421 of the electronic module 420 to induce a respective torque onto the actuating/adjusting element 108.

[0211] In the sequence of FIGS. 6 to 10 there is shown another example of an electronic module 520 suitable for attachment to a proximal end P of a drug delivery device 100. Again, the electronic module 520 is configured for attachment to an actuating/adjusting element 108 as shown in FIG. 2. The electronic module 520 comprises a housing 521 with a chassis 522. The housing 521 comprises a distal end 501 and a proximal end 502. The housing 521 or the chassis 522 may comprise a somewhat tubular shaped structure. Here, a distally facing surface 560 is provided on a circumferential rim of the housing facing in distal direction and being located at or near a distal end 501 of the housing 521.

[0212] As described before in connection with FIGS. 3 and 4, also with the example of FIGS. 6 to 10 there are provided numerous fastening elements 523, 524, 525, 526 around the outer circumference of the housing 521. The fastening elements 523, 524, 525, 526 may protrude from the distal end 501 of the housing 521. They may protrude at least from the distally facing surface 560. As it is apparent from FIGS. 8 and 9 at least two of the fastening elements, namely the fastening elements 524 and 526 serve to provide a mechanical coding 550.

[0213] The mechanical coding 550 comprises at least one coding feature 551, 552. Here, the coding feature 551 coincides with the fastening element 526. In other words, the mechanical coding feature 552 is formed by the fastening element 526. The other coding feature 551 is provided and/or formed by the fastening element 524.

[0214] On or near the distal end 501 of the housing 521 there is further provided at least one supplemental fastening element 526. The fastening element 526 is configured to engage with a correspondingly or complementary-shaped counter fastening element 527 provided at an inside surface of a sidewall 534 of the actuating/adjusting element 108.

[0215] On the outside surface 532 of the sidewall 534 of the actuating/adjusting element 108 there are provided numerous slots or grooves 530. In the present example, there is provided at least one coding groove 536, 538 featuring a radial depth that is larger than a radial depth of other grooves 530 provided on the outside surface 532. The coding grooves 536, 538 are configured to exclusively engage with the mechanical coding features 551, 552 of the mechanical coding 550 of the electronic module 520. The radial depth as well as the circumferential or tangential size of the coding grooves 536, 538 matches with the respective geometric shape of the protrusions 552, forming the mechanical coding feature. The protrusions 552 may comprise a radially inwardly extending engaging structure complementary shaped to the geometry and dimensions of the coding grooves 536, 538.

[0216] As it is further apparent from FIG. 8, the actuating/adjusting element 108 further comprises two apertures 542, 544 that are diametrically opposite to each other adjacent to the inside 533 of the sidewall 534. The apertures 542, 544 are shaped and configured to receive the optical guides 254, 258 and hence the longitudinal extension 255 protruding from the distal end 501 of the electronic module 520. The position of the mechanical coding features 551 relative to the longitudinal extension 255 defines the mechanical coding 550 of the electronic module 520.

[0217] Accordingly, and as it becomes apparent from a comparison of FIGS. 9 and 10, the position of the coding grooves 536, 538 relative to the apertures 542, 544 and/or relative to the counter fastening features 527 defines a respective counter coding 570. A mutual assembly of the electronic module 520 and the drug delivery device 100 is only possible when the longitudinal extension 255 is in alignment with one of the apertures 542, 544. Moreover, a mutual assembly is only possible and when the fastening elements 526 are longitudinally aligned with the counter fastening elements 527. As such, the mutual orientation and the alignment of the fastening elements 526 with the counter fastening elements 527 and/or the alignment of the longitudinal extension 255 with the aperture 542, 544 define two specific predefined fastening configurations mutually distinguish by a relative rotation of the 180°.

[0218] In FIG. 9 there is illustrated a virtual L1 extending through the middle of the oppositely located counter fastening elements 527. There is further shown another virtual line L2 extending through the diametrically oppositely located mechanical counter coding features 571.

[0219] In the example of FIG. 10 there is shown a mechanical counter coding 570 that distinguishes from the mechanical counter coding 570 as illustrated in FIG. 9. With the example of FIG. 10, the angle between the respective L1 and L2 distinguishes from the respective angle of the example of FIG. 9. In the example of FIG. 9, the angular position or the tangential or circumferential position of the counter coding features 571 relative to the counter fastening elements 527 and/or relative to the apertures 542, 544 has changed compared to the configuration of FIG. 9. Accordingly, the proximal end of the drug delivery device 100 as illustrated in FIG. 10 comprises a mechanical counter coding that distinguishes from a mechanical counter coding at a proximal end of a drug delivery device 100 as illustrated in FIG. 9.

[0220] The coding grooves 536, 538 are presently configured at a radial recess 572 in the outside surface 532 of a sidewall 534 of the actuating/adjusting element 108. By varying the angular position of the mechanical counter coding features 571 relative to the fixed position of the counter fastening element 527 and/or relative to the position of the apertures 542, 544 numerous different mechanical counter codings 570 can be provided for generally equal or similar types of drug delivery devices 110. In the same way, also the position of the coding features 551, and in particular of the fastening elements 524, 526 may be subject to variations to provide different mechanical codings for numerous electronic modules 520.

[0221] In case that an electronic module 520 comprising a mechanical coding 550 non-matching with the mechanical counter coding 570 of the drug delivery device 100, the coding features 551 will be located circumferentially offset and hence outside the coding grooves 536, 538. In the predefined fastening configuration, in which the fastening elements 526 engages with the correspondingly shaped counter fastening element 527, the coding features 551, hence the protrusions 552 may have no suitable channel to run in. They may thus block and impede a proper arrangement and assembly of the electronic module 522 the drug delivery device 100.

[0222] As seen in FIGS. 9 and 10, the coding grooves 536 may end in a radially outwardly extending flange provided at the very proximal end P of the actuating/adjusting element 108. In this way, the coding grooves 536, 538 and hence the respective counter coding features 571 may provide a snap fit engagement with the correspondingly-shaped protrusions 552 of the respective coding features 551 of the mechanical coding 550 of the electronic module 520.

[0223] The mechanical coding features 551 may each comprise a resiliently deformable snap feature to form a snap fit connection with the correspondingly shaped counter coding features 571 provided at the proximal end P of the drug delivery device 100. The snap fit engagement may further provide a longitudinal fastening and/or fixing between the electronic module 320 and the drug delivery device 100.

[0224] The proximal end P of the drug delivery device 100 may also comprise a proximally facing surface 580, which is indicated in FIG. 7. In the predefined fastening configuration as shown in FIG. 7, the distally facing surface 560 of the electronic module 520 is in abutment with the proximally facing surface 580 of the actuating/adjusting element 108. In this way, a tilt-free mutual fastening between the electronic module 520 and the drug delivery device 100 can be provided.

[0225] In the further example as illustrated in FIGS. 11-18 the electronic module 620 comprises a housing 621 with a chassis 622. The electronic module 620 comprises a distal end 601 and an oppositely located proximal end 602. The electronic module 620 may be somewhat equivalent or even identical to the electronic module 220, 320, 420 or 520 as described above in connection with FIG. 2, 3, 4 or 6, respectively. The electronic module 620 distinguishes from the further examples by a particular type of a mechanical coding 650. The housing 621 comprises numerous wall portions 644, 646, 648 that are somewhat equivalent or identical to the wall portions 244, 246, 248 as described above.

[0226] A distal end of the wall portion 648 is provided with a distally facing surface 660. On this surface 660 there is provided a mechanical coding section 659. Apart from that, the housing 621 comprises a fastening element 626 implemented as a snap feature or as a clip feature to engage with a correspondingly shaped counter fastening element 627 provided on the proximal end P of the drug delivery device 100. The proximal end P of the drug delivery device 100 is provided with a proximally facing surface 680. When the electronic module 620 is in the predefined fastening configuration the proximally facing surface 680 may abut with the distally facing surface 660.

[0227] With the examples of FIGS. 11-18, the mechanical counter coding 670 may be provided on a portion of an actuating/adjusting element 108. It may be provided on a radial inner part of the actuating/adjusting element 108. Hence, the actuating/adjusting element 108 may comprise such an inner part and an outer, e.g. sleeve-shaped part surrounding the inner part. The outer part may comprise an outside wall 534 as for instance illustrated in the example of FIG. 7.

[0228] In the present example the coding section 659 comprises four discrete spatially non-overlapping coding feature positions 655, 656, 657, 658 as illustrated in greater detail in FIG. 12. The coding feature positions 655, 656, 657, 658 may be individually provided with a coding feature 651, 653. In the presently illustrated example, there are provided two individual coding features 651, 653. The coding feature 651 is provided on the first coding feature position 655. The second coding feature 653 is provided on a fourth coding feature position 658. The coding feature positions 656, 657 are void of a coding feature. The coding features 651, 653 each comprise a protrusion 652, 654 protruding in distal direction from the distally facing surface 660. The protrusion 652, 654 of the coding features 651, 653 comprise a tab-like geometry. The coding features 651, 653 are complementary shaped and/or complementary positioned to counter coding features 671, 673 provided on the proximal end P of the drug delivery device 100 as illustrated for instance in FIG. 15.

[0229] There, the counter coding 670 comprises a complementary-shaped counter coding section 679. The counter coding section 679 comprises a number of discrete spatially non-overlapping counter coding feature position 675, 676, 677, 678. In the example of FIG. 14, a counter coding feature 671 in the form of a recess 672 is provided on a first counter coding feature position 675 and another coding feature 673 in form of another recess 674 is provided on a third counter coding feature position 677.

[0230] As it is apparent with all examples of FIGS. 13 and 18, the mechanical coding 650 is complementary shaped to a respective mechanical counter coding 670. The mechanical counter coding 670 is of inverse shape compared to the respective mechanical coding 650.

[0231] In the present examples, the coding section 659 comprises four discrete spatially non-overlapping coding feature positions for two mechanical coding features, each one of which located on one of the coding feature positions. Likewise, the mechanical counter coding section 679 comprises four discrete spatially non-overlapping counter coding feature positions 675, 676, 677, 678 and two mechanical counter coding features 671, 673 each one of which located on one of the counter coding feature positions.

[0232] For the examples as shown in FIGS. 13-18 the number of coding feature positions of the coding section 659 equals the number of counter coding feature positions of the counter coding section 679. Moreover, the number of coding features equals the number of counter coding features. So with the presently illustrated example with four coding feature positions and with two mechanical coding features there can be provided six different mechanical codes or codings 650 and respective mechanical counter codes or codings 670. Generally, if the total number of discrete spatially non-overlapping coding feature positions is n, there are 2.sup.n possible configurations and arrangements. But not all of these arrangements may guarantee a unique and dedicated pairing. The condition to ensure that that all but one of the electronic modules 620 is hindered to engage with a drug delivery device is that every mechanical coding 650 comprises the same number of mechanical coding features 651, 653. The number of unique permutations of k coding features in n coding feature positions is equal to the binomial coefficient according to the following equation:

[00002]$\left(\begin{array}{c}n\\ k\end{array}\right)=\frac{n!}{k!\left(n-k\right)!}$

[0233] The maximum number of available combinations is obtained when k=n/2.