Electronic System for a Drug Delivery Device

Abstract

An electronic system for a drug delivery device including a dose setting and drive mechanism, a communication unit, an electronic control unit, and an electrical use detection. The dose setting and drive mechanism includes a first member and a second member that move relative to each other at least in the dose delivery operation and/or in the dose setting operation of the drug delivery device. The electronic system has a first state in which the communication unit is not activated and a second state in which the communication unit is activated. The electrical use detection unit is configured to generate a first signal indicative that the user has commenced or finished the relative movement between the first member and the second member. The electronic control unit is configured to switch the electronic system from the first state into the second state in response to the first signal.

Claims

1-15. (canceled)

16. An electronic system for a drug delivery device, the electronic system comprising: a dose setting and drive mechanism which is configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose, the dose setting and drive mechanism comprising a first member and a second member, wherein the dose setting and drive mechanism is configured such that, during at least one of the dose delivery operation or the dose setting operation, the first member moves relative to the second member; a communication unit for communicating with an external device; an electronic control unit configured to control an operation of the electronic system; and an electrical use detection unit operatively connected to the electronic control unit, and configured to generate a first signal indicative that a user has commenced or finished the relative movement between the first member and the second member, wherein the electronic system is configured to be switched from a first state in which the communication unit is not activated, into a second state in which the communication unit is activated, thereby inducing the communication unit to establish a communication with the external device, wherein the switching is in response to the first signal.

17. The electronic system according to claim 16, wherein the communication unit comprises a wireless communication interface for communicating with the external device, wherein the electronic system is configured to switch from the first state into the second state by the electronic control unit, thereby inducing the communication unit to initiate a manual synchronization and/or a pairing with the external device.

18. The electronic system according to claim 16, wherein the electrical use detection unit is further configured to generate a second signal indicative that the user has commenced the dose setting operation or the dose delivery operation, wherein the electronic system is configured to be switched from the first state or the second state into a third state by the electronic control unit in response to the second signal, wherein dose data is collected in the third state.

19. The electronic system according to claim 18, wherein the electrical use detection unit is configured to generate the second signal in response to a relative movement of two members of the dose setting and drive mechanism.

20. The electronic system according to claim 18, wherein the electrical use detection unit is configured to generate the second signal in response to a relative rotational movement between a third member of the dose setting and drive mechanism, and one of the first member and the second member during the dose delivery operation.

21. The electronic system according to claim 16, further comprising a movable switching feature that is operatively coupled to one or both of the first member and the second member such that an axial displacement of the first member relative to the second member causes a movement of the switching feature relative to the first member and/or the second member, and wherein the electronic system is configured such that an axial movement of the switching feature is used to trigger generation of the first signal.

22. The electronic system according to claim 21, wherein the movable switching feature is linearly guided.

23. The electronic system according to claim 21, wherein the movable switching feature is resiliently biased into engagement with a block feature before the first member is moved axially a predefined distance relative to the second member, and wherein, when the first member is moved relative to the second member, the block feature is removed from the switching feature such to form a biasing force that drives the movement of the switching feature to cause the generation of the first signal.

24. The electronic system according to claim 16, further comprising a movable switching feature that is operatively coupled to the first member and/or the second member such that a predefined axial displacement of the first member relative to the second member is converted into a movement of the switching feature, the movement being perpendicular to the predefined axial displacement of the first member relative to the second member, and causing generation of the first signal.

25. The electronic system according to claim 24, wherein the predefined axial displacement is converted into the movement of the switching feature when the dose setting or dose delivery operation is finished.

26. The electronic system according to claim 16, wherein the electrical use detection unit comprises at least one electrically conductive spring arm deflectable in response to the relative movement between the first member and the second member to establish or break an electrical connection with at least one electrical contact, and wherein the electrical use detection unit is configured to generate the first signal in response to establishing or breaking an electrical connection between the at least one electrically conductive spring arm and the at least one electrical contact.

27. The electronic system according to claim 16, wherein the first member is a dial sleeve or is a member axially and/or rotationally locked to the dial sleeve such that the first member is rotatable relative to a housing of the dose setting and drive mechanism at least in the dose setting operation, and wherein the second member is a dose and/or injection button or a member axially and/or rotationally locked to the dose and/or injection button such that the second member is axially displaceable relative to the first member and rotationally constrained to the housing at least in the dose setting operation.

28. The electronic system according to claim 16, wherein the first member comprises an encoder ring having a first portion with a first inner diameter and a second portion with a second inner diameter different from the first inner diameter, wherein the first portion and the second portion are located at axially different positions of the encoder ring.

29. The electronic system according to claim 28, wherein a transition ramp is provided axially interposed between the first portion and the second portion.

30. The electronic system according to claim 28, wherein one of the first portion and the second portion is provided with a radially inwardly directed ratchet teeth and/or with ratchet pockets.

31. The electronic system according to claim 16, wherein the first member is a dial sleeve or is a member axially and/or rotationally locked to the dial sleeve such that first member is axially displaceable relative to a housing of the dose setting and drive mechanism at least in the dose delivery operation, and wherein the second member is a member axially displaceable relative to the first member upon abutment with the housing or a member axially locked to the first member at least in the dose delivery operation.

32. The electronic system according to claim 31, wherein the second member is guided in a dose and/or injection button or a member axially and/or rotationally locked to the dose and/or injection button such that the second member abuts the housing.

33. The electronic system according to claim 31, wherein the second member is a member axially locked to the dose and/or injection button only if the dose and/or injection button is axially displaced against a bias of a spring.

34. The electronic system according claim 16, wherein the first member is a dose and/or injection button, and the second member is a chassis or skirt of a dosage knob, wherein the dose and/or injection button is axially displaceable and/or axially elastically deformable relative to the second member, and wherein the electrical use detection unit comprises an axial switch such that an axial displacement of at least a portion of the dose and/or injection button relative to the second member actuates the axial switch.

35. A drug delivery device comprising: a cartridge containing a medicament; and an electronic system comprising a dose setting and drive mechanism which is configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose, the dose setting and drive mechanism comprising a first member and a second member, wherein the dose setting and drive mechanism is configured such that, during at least one of the dose delivery operation the dose setting operation, the first member moves relative to the second member, a communication unit for communicating with an external device, an electronic control unit configured to control an operation of the electronic system, an electrical use detection unit operatively connected to the electronic control unit, and configured to generate a first signal indicative that a user has commenced or finished the relative movement between the first member and the second member, wherein the electronic control unit is configured to be switched from a first state in which the communication unit is not activated, into a second state in which the communication unit is activated, thereby inducing the communication unit to establish a communication with the external device, wherein the switching is in response to the first signal.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0073] Non-limiting, exemplary embodiments of the disclosure will now be described with reference to the accompanying drawings, in which:

[0074] FIG. 1 shows an embodiment of a drug delivery device;

[0075] FIG. 2 shows a perspective view of an encoder of a system of a first embodiment;

[0076] FIG. 3 shows a cut-away view on a portion of the system of the first embodiment;

[0077] FIGS. 4a-c show a cut-away view on a portion of the system of a second embodiment in different states;

[0078] FIG. 5 shows a sectional view on a portion of the system of the second embodiment;

[0079] FIG. 6 shows a sketch of the system of a third embodiment;

[0080] FIGS. 7a-c show a portion of the system of a third embodiment in different states;

[0081] FIG. 8 shows an encoder ring of the third embodiment;

[0082] FIGS. 9a-b show a cut-away view on a portion of the system of a fourth embodiment in different states;

[0083] FIGS. 10a-b show a cut-away view on a portion of the system of the fourth embodiment in different states;

[0084] FIG. 11 shows a perspective view of a portion of the system of the fourth embodiment;

[0085] FIG. 12 shows a sectional view on a portion of the system of the fourth embodiment;

[0086] FIG. 13 shows a top view on a portion of the system of the fourth embodiment;

[0087] FIG. 14 shows a perspective view of a portion of the system of a fifth embodiment with removed cap;

[0088] FIG. 15 shows a perspective view of the system of FIG. 14 with a partially cut away cap;

[0089] FIG. 16 shows a perspective view of the cap of the system of FIG. 15;

[0090] FIG. 17 shows a sectional view of a portion of the system of the fifth embodiment; and

[0091] FIG. 18 illustrates schematically an embodiment of an electronic system for a drug delivery device.

[0092] In the figures, identical elements, identically acting elements or elements of the same kind may be provided with the same reference numerals.

DETAILED DESCRIPTION

[0093] In the following, some embodiments will be described with reference to an insulin injection device. The present disclosure is however not limited to such application and may equally well be deployed with injection devices that are configured to eject other medicaments or drug delivery devices in general, preferably pen-type devices and/or injection devices.

[0094] Embodiments are provided in relation to injection devices, in particular to variable dose injection devices, which record and/or track data on doses delivered thereby. These data may include the size of the selected dose and/or the size of the actually delivered dose, the time and date of administration, the duration of the administration and the like. Features described herein include the arrangement of sensing elements and power management techniques (e.g. to facilitate small batteries and/or to enable efficient power usage).

[0095] Certain embodiments in this document are illustrated with respect to Sanofi's AMSTAR® injection device where an injection button and grip (dose setting member or dose setter) are combined. The injection button may provide the user interface member for initiating and/or performing a dose delivery operation of the drug delivery device. The grip or knob may provide the user interface member for initiating and/or performing a dose setting operation. Both devices are of the dial extension type, i.e. their length increases during dose setting. Other injection devices with the same kinematical behaviour of the dial extension and button during dose setting and dose expelling operational mode are known as, for example, the Kwikpen® device marketed by Eli Lilly and the Novopen® 4 device marketed by Novo Nordisk. An application of the general principles to these devices therefore appears straightforward and further explanations will be omitted. However, the general principles of the present disclosure are not limited to that kinematical behaviour. Certain other embodiments may be conceived for application to Sanofi's SoloSTAR® injection device where there are separate injection button and grip components/dose setting members. Thus, there may be two separate user interface members, one for the dose setting operation and one for the dose delivery operation.

[0096] “Distal” is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the drug delivery device or components thereof and/or point away from, are to be arranged to face away from or face away from the proximal end. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and/or from the distal end of the drug delivery device or components thereof. The distal end may be the end closest to the dispensing and/or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and/or towards the proximal end. A distal surface may face towards the distal end and/or away from the proximal end. The dispensing end may be the needle end where a needle unit is or is to be mounted to the device, for example.

[0097] FIG. 1 is an exploded view of a medicament delivery device or drug delivery device. In this example, the medicament delivery device is an injection device 1, e.g. a pen-type injector, such as Sanofi's AllSTAR® injection pen.

[0098] The injection device 1 of FIG. 1 is an injection pen that comprises a housing 10 and contains a container 14, e.g. an insulin container, or a receptacle for such a container. The container may contain a drug. A needle 15 can be affixed to the container or the receptacle. The container may be a cartridge and the receptacle may be a cartridge holder. The needle is protected by an inner needle cap 16 and either an outer needle cap 17 or another cap 18. An insulin dose to be ejected from injection device 1 can be set, programmed, or ‘dialed in’ by turning a dosage knob 12, and a currently programmed or set dose is then displayed via dosage window 13, for instance in multiples of units. The indicia displayed in the window may be provided on a number sleeve or dial sleeve. For example, where the injection device 1 is configured to administer human insulin, the dosage may be displayed in so-called International Units (IU), wherein one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1/22 mg). Other units may be employed in injection devices for delivering analogue insulin or other medicaments. It should be noted that the selected dose may equally well be displayed differently than as shown in the dosage window 13 in FIG. 1.

[0099] The dosage window 13 may be in the form of an aperture in the housing 10, which permits a user to view a limited portion of a dial sleeve 20 that is configured to move when the dosage knob 12 is turned, to provide a visual indication of a currently set dose. The dosage knob 12 is rotated on a helical path with respect to the housing 10 when setting a dose.

[0100] In this example, the dosage knob 12 includes one or more formations to facilitate attachment of a data collection device.

[0101] The injection device 1 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustic feedback to a user. In this embodiment, the dosage knob or dose button 12 also acts as an injection button 11. When needle 15 is stuck into a skin portion of a patient, and then dosage knob 12/injection button 11 is pushed in an axial direction, the insulin dose displayed in display window 13 will be ejected from injection device 1. When the needle 15 of injection device 1 remains for a certain time in the skin portion after the dosage knob 12 is pushed, the dose is injected into the patient's body. Ejection of the insulin dose may also cause a mechanical click sound, which may be different from the sounds produced when rotating the dosage knob 12 during dialing of the dose.

[0102] In this embodiment, during delivery of the insulin dose, the dosage knob 12 is returned to its initial position in an axial movement, without rotation, while the dial sleeve 20 is rotated to return to its initial position, e.g. to display a dose of zero units. As noted already, the disclosure is not restricted to insulin but should encompass all drugs in the drug container 14, especially liquid drugs or drug formulations.

[0103] Injection device 1 may be used for several injection processes until either the insulin container 14 is empty or the expiration date of the medicament in the injection device 1 (e.g. 28 days after the first use) is reached. In the case of a resuable device, it is possible to replace the insulin container.

[0104] Furthermore, before using injection device 1 for the first time, it may be necessary to perform a so-called “prime shot” to remove air from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing dosage knob 12 while holding injection device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be assumed that the selected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament selected from the injection device 1 is equal to the dose received by the user.

[0105] As explained above, the dosage knob 12 also functions as an injection button 11 so that the same component is used for dialling/setting the dose and dispensing/delivering the dose.

[0106] In the following, an electronic system 100 according to the disclosure will be described with respect to several different exemplary embodiments. The electronic system 100 comprises a dose setting and drive mechanism which may be part of an injection device 1 as depicted in FIG. 1 and an electrical power supply 150, e.g. a rechargeable or non-rechargeable battery, as shown in FIG. 18. The electronic system further comprises an electronic control unit 110 configured to control an operation of the electronic system which has a first state and a second state, wherein the electronic system has an increased electrical power consumption in the second state as compared to the first state. The electronic system further comprises an electrical use detector unit 130 which is operatively connected to the electronic control unit 110 and which is configured to generate at least a first signal which is indicative that the user performs an operation. An example of such an operation is that the user of the injection device and/or the electronic system enters a manual synchronization or pairing mode of the electronic system. The electronic system is configured such that it is switched from the first state into the second state by the electronic control unit 110 in response to said first signal. The electronic system further comprises a communication unit 140 for communicating with another device. When the communication unit is active to perform the manual synchronization or pairing mode, the electronic system is in its second state.

[0107] The present disclosure comprises several alternatives for generating the first signal by means of an electrical use detector unit 130. In more detail, the embodiments are based on detecting an axial movement of a first member of the dose setting and drive mechanism with respect to a second member of the dose setting and drive mechanism.

[0108] A first embodiment is depicted in FIGS. 2 to 4. In this embodiment relative axial movement of the button 11 with respect to the dose dial sleeve 20 causes generation of the first signal. FIG. 2 shows the proximal end of the dose dial sleeve 20 which is provided with an encoder ring 30 which may be a unitary component part with the dose dial sleeve 20 or which may be a separate component part rigidly constrained to the dose dial sleeve 20. In other words, the dose dial sleeve 20 and the encoder ring 30 behave as a single component part. As can be seen in FIG. 2, the encoder ring 30 is provided with a series of radially oriented ratchet teeth 31 arranged between ratchet pockets 32. Towards its distal end, the encoder ring 30 is provided with a transition ramp 33 which ends in a cylindrical portion 34 with a continuous cylindrical inner surface. The inner diameter of the cylindrical portion 34 substantially corresponds to the inner diameter of the tips of the ratchet teeth 31. This inner diameter of the cylindrical portion 34 is smaller compared to the inner diameter defined by the ratchet pockets 32.

[0109] FIG. 3 shows the encoder ring 30 and the dose dial sleeve 20 in a sectional view through a plane in the transition ramp 33. Further, FIG. 3 shows a chassis 40 arranged within the space defined by the encoder ring 30 and the dose dial sleeve 20. The chassis 40 may be retained in or may be part of button 11 or a driver of the dose setting and drive mechanism.

[0110] The chassis 40 has a substantially circular outer shape and is provided with a guiding groove 41 running in a direction perpendicular to the axis of rotation of the dose dial sleeve 20. Further, the chassis 40 is provided with two electrical contacts 42, 43 in the form of metal pressings fixed within the chassis 40. The electrical contacts 42, 43 form a switch which is open in a condition with no forces acting on the electrical contacts 42, 43. The switch may be closed by elastically deflecting the electrical contact 42 towards the electrical contact 43.

[0111] A switching feature in the form of a shuttle 50 is guided in the guiding groove 41 of the chassis 40 such that the shuttle 50 is allowed to be axially displaced within the guiding groove 41. A radially outwards facing tip of the shuttle 50 is formed as a ratchet tooth 51 mating with the ratchet teeth 31 and the ratchet pockets 32 of the encoder ring 30. The length of the shuttle 50 is chosen such that the electrical contact 42 biases the shuttle 50 into one of the ratchet pockets 32 depending on the relative rotational position of the chassis 40 with respect to the encoder ring 30. However, upon relative rotation between the encoder ring 30 and the chassis 40, for example during dose delivery, the shuttle 50 is pushed inwards by engagement with the respective ratchet tooth 31 against the bias of the electrical contact 42 which is deflected to close the switch by contacting the electrical contact 43 as shown in FIG. 3.

[0112] During a dose setting operation of the injection device 1 the relative axial position of the chassis 40 with respect to the encoder ring 30 is such that the shuttle 50 is aligned with the proximal portion of the encoder ring 30 allowing interaction between the shuttle 50 and the ratchet teeth 31 and the ratchet pockets 32. However, upon actuation of the button 11 the chassis 40 may be axially displaced axially with respect to the encoder ring 30 such that the shuttle 50 is guided along the transition ramp 33 to engage the cylindrical portion 34. This relative axial movement between the chassis 40 and to the encoder ring 30 may occur only at the end of dose delivery. As shown in FIG. 3, the shuttle 50 is pushed radially inwards when engaging the cylindrical portion 34, thereby closing the switch formed by the electrical contacts 42, 43. In contrast to the dose setting or dose delivery operation, when the shuttle 50 oscillates upon rotation of the dose dial sleeve 20 with the encoder ring 30 relative to the chassis 40, thereby repeatedly opening and closing the switch formed by electrical contacts 42, 43, the switch is permanently closed when the shuttle 40 has been moved axially with respect to the encoder ring 30 such that the shuttle 50 engages the cylindrical portion 34. The electrical system 100, more specifically the use detection unit 130, detects the permanent closing of the switch and generates a first signal which may activate a manual synchronization or pairing mode.

[0113] As is apparent from FIG. 3, the first signal may not only be generated at the end of dose delivery but may also be generated with the injection device being in the home state or position, i.e. prior to dose setting. In such a home state the button 11 simply has to be pressed to activate a manual synchronization or pairing mode of the electrical system.

[0114] The switch formed by electrical contacts 42, 43 may further be part of a motion sensing unit 120 of the electrical system 100 detecting relative rotation between the dose dial sleeve 20 and the chassis 40 during dose delivery as the shuttle 50 is repeatedly closing the second switch formed by the electrical contacts 42 and 43. This condition may generate a second use signal which may turn on encoder functions of the electrical system.

[0115] A second embodiment is depicted in FIGS. 4a to 5 which is similar to the first embodiment. Again, the dose dial sleeve 20 is provided with an encoder ring 30 having ratchet teeth 31 and ratchet pockets 32. Further, a chassis 40 is provided with a guiding groove 41 guiding shuttle 50, suitable for engaging ratchet teeth 31 and ratchet pockets 32.

[0116] In contrast to the first embodiment, the second embodiment comprises two switches formed by electrical contacts 42, 43 and 44. Further, the axial position between the chassis 40 and the encoder ring 30 is such that in the home state or position of the injection device 1, i.e.

[0117] prior to dose setting, the shuttle 50 is located proximally spaced from the encoder ring 30 as shown in FIG. 5. This position is further depicted in FIG. 4a where it is shown that the shuttle 50 is pushed radially outwards by the electrical contact 44. In this condition, i.e. prior to the button 11 being pressed, neither switch is closed as the electrical contacts 42, 43 and 44 are not deflected by the shuttle 50.

[0118] FIG. 4b shows a condition when the button 11 is pressed, thereby axially displacing the chassis 40 with respect to the encoder ring 30. This results in pushing the shuttle 50 radially inwards to the major diameter of the ratchet, i.e. the diameter defined by the ratchet pockets 32. Due to this displacement of the shuttle 50 the first switch between the electrical contact 44 and the electrical contact 42 is closed. By closing this first switch the first signal is generated, thereby turning on the manual synchronization and pairing function of the electrical system.

[0119] FIG. 4c shows a condition when the dose dial sleeve 20 with the encoder ring 30 starts to rotate with respect to the chassis 40, for example during dose delivery. Due to this rotation, of the shuttle 50 is repeatedly pushed radially inwards to the minor diameter of the ratchet, i.e. the inner diameter defined by the tips of the ratchet teeth 31, thereby repeatedly closing the second switch formed by the electrical contacts 42 and 43 as described above with respect to the first embodiment. This condition may generate a second use signal which may turn on encoder functions of the electrical system.

[0120] The third embodiment is depicted in FIGS. 6 to 8 which is similar to the first embodiment. Again, the dose dial sleeve 20 (not shown) is provided with an encoder ring 30 having ratchet teeth 31 and ratchet pockets 32. Further, a chassis 40 (not shown) is provided with a guiding groove 41 guiding shuttle 50 suitable for engaging ratchet teeth 31 and ratchet pockets 32.

[0121] In contrast to the first embodiment, the third embodiment comprises a cylindrical portion 34 of the encoder ring 30 located at the proximal end of the encoder ring 30. Thus, the ratchet formed by ratchet teeth 31 and ratchet pockets 32 is located distally of the cylindrical portion 34. In addition, the design of the electrical contacts 42, 43 is amended such that the switch formed by the electrical contacts 42, 43 is open when the shuttle 50 abuts the cylindrical portion 34 or is pushed radially inwards by the contact with the ratchet teeth 31. On the other hand, the switch formed by the electrical contacts 42, 43 is closed as the shuttle 50 is allowed to enter into the ratchet pockets 32 due to the bias of the electrical contact 42 acting on the shuttle 50. In other words, the third embodiment operates substantially inverse compared to the first embodiment.

[0122] In a similar manner as in the first embodiment, the encoder ring 30 of the third embodiment may be provided with a transition ramp 33 between the cylindrical portion 34 and the ratchet portion 31, 32. In addition or as an alternative, the shuttle 50 may be provided with a respective ramp at the ratchet tooth 51.

[0123] In the third embodiment, the shuttle 50 is held on the cylindrical portion 34 of the encoder ring 30 in the home position or state, i.e. prior to dose setting. In this condition the switch 42, 43 is open. The switch 42, 43 remains open during dose setting when the user rotates the dose dial sleeve 20 by means of the dosage knob 12. As soon as the user presses the button 11, i.e. causes a relative axial movement of the button 11 (with chassis 40) with respect to the dose dial sleeve 20 (with encoder ring 30), the shuttle 50 falls into the ratchet pocket 32 biased by the electrical contact 42, thereby closing the switch 42, 43. This closing of the switch is detected and causes generation of the first signal, thereby turning on the manual synchronization and pairing function of the electrical system.

[0124] During the dose delivery operation, the shuttle 50 is repeatedly pushed radially inwards against the bias of the electrical contact 42 by interaction of the ratchet tooth 51 with the ratchet teeth 31. Thus, the switch 42, 43 is repeatedly opened and closed (as the ratchet tooth 51 falls back into one of the ratchet pockets 32). This may be detected and may cause generation of a second use signal, thereby turning on an encoder function of the electrical system.

[0125] A fourth embodiment is depicted in FIGS. 9a to 13. Again, the dose dial sleeve 20 is provided with an encoder ring 30 having ratchet teeth 31 and ratchet pockets 32. Further, a chassis 40 is provided with a guiding groove 41 guiding shuttle 50 suitable for engaging ratchet teeth 31 and ratchet pockets 32. In addition, electrical contacts 42, 43 are provided in a similar configuration as in the first embodiment, i.e. a switch formed by of the contacts 42, 43 is open if the ratchet tooth 51 of the shuttle 50 engages the ratchet pocket 32 and the switch is closed as the ratchet tooth 51 passes over one of the ratchet teeth 31 and is pushed radially inwards against the bias of electrical contact 42.

[0126] In contrast to the first to third embodiments, the encoder ring 30 is not provided with a cylindrical portion intended for engagement with the shuttle 50. Thus, the encoder ring 30 may be shorter in the axial direction compared to the first to third embodiments. The dose setting and drive mechanism of the fourth embodiment further comprises a clutch sleeve 60 and an inner housing 70. The clutch sleeve 60 may be provided with a ring of clutch teeth 61 (FIG. 12) provided on a flange-like portion 62 for engagement with a corresponding ring of clutch teeth 21 provided on the dose dial sleeve 20. A clutch spring (not shown) may be provided acting on the clutch sleeve 60 to push the clutch teeth 21 into engagement with the clutch teeth 61. The clutch teeth 21, 61 may be disengaged against the bias of the clutch spring when the user pushes the button 11, e.g. for the dose delivery operation, thereby displacing the clutch sleeve 60 axially with respect to the dose dial sleeve 20. The dose dial sleeve 20 may be in threaded engagement with the inner housing 70 such that the dose dial sleeve 20 is guided along a helical path during dose setting operation and dose delivery operation. Further, the inner housing 70 is provided with a proximal end face 71 for abutment with the flange-like portion 62 of the clutch sleeve 60. The distal side of the flange-like portion 62 abuts the proximal end face 71 at the end of dose delivery when the button 11 is pressed. After a user releases the button 11, the clutch spring lifts the flange-like portion 62 away from the proximal end face 71, thereby re-engaging clutch teeth 21, 61.

[0127] The dose setting and drive mechanism of the fourth embodiment further comprises a pin 80 which is guided in the chassis 40 such that a relative axial movement of the pin 80 relative to the chassis 40 is permitted. The pin 80 comprises a finger 81 which passes through a cut out in the flange-like portion 62 of the clutch sleeve 60 and protrudes distally through the flange-like portion 62 as shown in FIGS. 9a and 10a. Further, the pin 80 comprises a ramp 82 on the proximal side of the pin 80. This ramp 82 passes through a cut out in the guiding groove 41 of the chassis 44 engagement with a corresponding ramp 52 of the shuttle 50.

[0128] As the finger 81 of the pin 80 protrudes distally through the flange-like portion 62, the distal end of finger 81 abuts the proximal end face 71 of the inner housing 70 at the end of dose delivery, i.e. when the dose dial sleeve 20 and the clutch sleeve 60 are moved distally with respect to the inner housing 70. This results in an axial displacement of the pin 80 with respect to the chassis 40 such that the ramp 82 engages the ramp 52 of the shuttle 50 and pushes the shuttle 50 radially inwards against the bias of electrical contact 42, thereby closing the switch formed by electrical contacts 42, 43. By closing this switch the first signal is generated, thereby turning on the manual synchronization and pairing function of the electrical system.

[0129] During the dose delivery operation, the shuttle 50 is repeatedly pushed radially inwards against the bias of the electrical contact 42 by interaction of the ratchet tooth 51 with the ratchet teeth 31 as explained above with respect to the first embodiment. Thus, the switch 42, 43 is repeatedly opened and closed (as the ratchet tooth 51 falls back into one of the ratchet pockets 32). This may be detected and may cause generation of a second use signal, thereby turning on an encoder function of the electrical system.

[0130] A fifth embodiment is depicted in FIGS. 14 to 17. In this fifth embodiment, the electrical use detection unit 130 for detecting the first signal which causes turning on the manual synchronization and pairing function of the electrical system is located in the dosage knob 12 below the button 11. In contrast to other embodiments in which the dosage knob 12 and the button 11 may be a single unitary component part, the button 11 is formed as a separate cap which is attached to the skirt of the dosage knob 12 during assembly of the system or device. A printed circuit board (PCB) 90 is located within the dosage knob 12 below the button 11 with an axial switch 91 provided, e.g. centrally, on the PCB 90. The PCB 90 may further comprise other electronic components, like LEDs 92.

[0131] In the fifth embodiment, the cap-like button 11 is elastically deformable, for example by means of a skeleton as depicted in FIG. 16. This skeleton is preferably covered by the skin of a softer material such that the skin may form a seal by means of a circumferential bead engaging a respective groove in the skirt of the dosage knob 12 as shown in FIG. 17. The skin may further comprise a translucent portion such that a back-lit logo or the like may be provided on the button 11 which may be indicative of an operation of the electronic system, for example the manual synchronization and pairing function of the electrical system.

[0132] The force required for actuation of the axial switch 91 may be selected depending on the intended function. Thus, it is possible to actuate the axial switch 91 by the relatively low force such that the axial switch 91 is activated prior to disengagement of a clutch, for example the clutch formed by clutch teeth 21, 61 of the dose dial sleeve 20 and the clutch sleeve 60. As an alternative, a relatively high force, e.g. exceeding the force of a clutch spring acting on clutch sleeve 60, may be required to actuate the axial switch 91. This results in actuation of the axial switch 91 during dose delivery operation or at the end of dose delivery.

[0133] Although not depicted in FIGS. 14 to 17, a second use signal may be generated during dose delivery, thereby turning on an encoder function of the electrical system. The generation of the second use signal may be identical or similar to the generation of the second use signal in the first to fourth embodiments, i.e. by interaction of a shuttle 50 with a ratchet 31, 32 of an encoder ring 30.

[0134] The electronic system 100 comprises an electronic control unit 110. The control unit may comprise a controller. Specifically, the control unit may comprise a processor arrangement.

[0135] Also, the control unit 110 may comprise one, or a plurality of memory units, such as a program memory and a main memory. The control unit 110 is expediently designed to control operation of the electronic system 100. The control unit 110 may communicate via wired interfaces or wireless interfaces with further units of the electronic system 100. It may transmit signals containing commands and/or data to the units and/or receive signals and/or data from the respective unit. The connections between the units and the electronic control unit are symbolized by the lines in FIG. 18. However, there also may be connections between the units which are not illustrated explicitly. The control unit may be arranged on a conductor carrier, e.g. a (printed) circuit board, like the PCB 90 shown in FIGS. 14, 15 and 17. The other unit(s) of the electronic system may comprise one or more components which are arranged on the conductor carrier as well.

[0136] Electronic system 100 may further comprise a motion sensing unit 120. The motion sensing unit 120 may comprise one or a plurality of sensors, e.g. the sensor switches 42, 43, 44 described further above. In case optoelectronic sensors which detect electromagnetic radiation, such as IR sensors, are used, the motion sensing unit may additionally comprise a radiation emitter which emits the radiation to be detected by the sensor. However, it should be noted that other sensor systems, e.g. magnetic sensors could be employed as well. A motion sensing unit which has an electrically operated sensor and an electrically operated source for stimulating the sensor—such as a radiation emitter and an associated sensor—the power consumption may be particularly high and, hence, power management may have particular impact. Each sensor may have an associated radiation emitter. Motion sensing unit 120 may be designed to detect and preferably measure relative movement of two movable members of a dose setting and drive mechanism of or for the drug delivery device during a dose setting operation and/or during a dose dispensing operation. For example, the motion sensing unit may measure or detect relative rotational movement of two movable members of the dose setting and drive mechanism with respect to one another. Based on movement data received from or calculated from the signals of the unit 120, the control unit may calculate the dose data.

[0137] Electronic system 100 may further comprise a use detection unit 130. The use detection unit may be associated with the user interface member, e.g. button 11, or members such that manipulation of the member for setting and/or delivering a dose thereof may be detected. When the manipulation is detected, the use detection unit generates or triggers generation of a use signal. The use signal can be transmitted to the electronic control unit 110. The electronic control unit may, in response to the signal, issue a command or signal to one of, an arbitrarily selected plurality of, or all of the other electrically operated units of the system. For example, the control unit may cause that the respective unit is switched from a first state, e.g. a sleeping state or idle state with a lower power consumption or an off state with no power consumption, to a second state with an increased power consumption. The switching may be done by an according switching command or signal issued by the electronic control unit to the respective unit. In response to the use signal all units may be switched to the second state or just selected units. If only selected units are switched to the second state with higher power consumption, it is expedient that these units are intended to be used during the operation which is intended to be commenced by the user or which has been commenced.

[0138] The electronic system 100 may further comprise a communication unit 140, e.g. an RF, WiFi and/or Bluetooth unit. The communication unit may be provided as a communication interface between the system or the drug delivery device and the exterior, such as other electronic devices, e.g. mobile phones, personal computers, laptops and so on. For example, dose data may be transmitted by the communication unit to the external device. The dose data may be used for a dose log or dose history established in the external device. The communication unit may be provided for wireless or wired communication.

[0139] Electronic system may further comprise an electrical power supply 150, such as a rechargeable or non-rechargeable battery. The power supply 150 may provide electrical power to the respective units of the electronic system.

[0140] Although not explicitly depicted, the electronic system may comprise a, preferably permanent and/or non-volatile, storage or memory unit, which may store data related to the operation of the drug delivery device such as dose history data, for example.

[0141] Still further, in an embodiment the electrical use detection unit 130 may comprise a capacitive sensor instead of the axial switch 91.

[0142] Summarizing, according to the present disclosure the electrical use detection unit 130 may be able to detect contact to a face of the electronic system, e.g. the top face of an electronic module, meaning this system can be used to induce dose synchronisation with an app of a further electronic device, e.g. mobile phones, personal computers, laptops and so on, or to put the electronic module into a Bluetooth advertising mode. In the event that the dose button 11 was pressed (but no dose selected) for a time greater than t.sub.1 (e.g. 1 second) but less than t.sub.2 (e.g. 5 seconds) only one channel of the two IR-LEDs 92 would be observed to go to a “high” state. This characteristic signal could be used to initiate a dose synchronisation sequence with the app.

[0143] Similarly, if the dose button 11 was pressed (but no dose selected) for a time greater than t.sub.2 (e.g. 5 seconds) the characteristic optical signal could be used to initiate a Bluetooth advertising sequence.

[0144] Thus, dose synchronisation and Bluetooth pairing may be achieved with the top-mounted switch 91 or other alternatives of the electrical use detection unit 130 as described above, if the switch is held closed for a specified period of time, e.g. 3-5 seconds to induce synchronization and/or more than 5 seconds to induce Bluetooth pairing.

TABLE-US-00001 Reference Numerals 1 device 10 housing 11 injection button 12 dosage knob 13 dosage window 14 container/container receptacle 15 needle 16 inner needle cap 17 outer needle cap 18 cap 20 dose dial sleeve 21 clutch teeth 30 encoder ring 31 ratchet teeth 32 ratchet pockets 33 transition ramp 34 cylindrical portion 40 chassis 41 guiding groove 42 electrical contact 43 electrical contact 44 electrical contact 50 shuttle (switching feature) 51 ratchet tooth 52 ramp 60 clutch sleeve 61 clutch teeth 62 flange-like protrusion 70 inner housing 71 proximal end face 80 pin 81 finger 82 ramp 90 PCB 91 axial switch 92 LED 100 electrical system 110 control unit 120 motion sensing unit 130 use detection unit 140 communication unit 150 electrical power supply