DRIVE MECHANISM FOR AN INJECTION DEVICE

Abstract

Disclosed is a drive mechanism for an injection device for setting and dispensing of a dose of a medicament, the drive mechanism including an inner body fixable inside a housing of the injection device, the inner body including an elongated shaft extending in an axial direction and having an outer thread, a tubular-shaped display member having an inner thread engaged with the outer thread, and a dose member axially displaceable between a dose setting position(S) and a dose dispensing position (D) relative to the display member. The display member includes at least one blocking member movable in axial direction (z) between a blocking position (B) and a release position and engageable with a blocking thread on the outer circumference of the inner body.

Claims

1.-15. (canceled)

16. A drive mechanism for an injection device for setting and dispensing of a dose of a medicament, the injection device comprising a housing, the drive mechanism comprising: an inner body fixable inside the housing and comprising an elongated shaft extending in an axial direction (z) and having an outer thread, a tubular-shaped display member having an inner thread engaged with the outer thread of the inner body, and a dose member axially displaceable between a dose setting position(S) and a dose dispensing position (D) relative to the display member, wherein the display member comprises at least one blocking member movable in axial direction (z) between a blocking position (B) and a release position (R) and engageable with a blocking thread axially extending on the elongated shaft of the inner body, wherein the blocking thread and the outer thread have the same pitch, and wherein the at least one blocking member of the display member is rotatable relative to the inner body a predetermined number of turns between a distal zero dose position (Z) on the inner body and a proximal maximum dose position (M) on the inner body, wherein, when in blocking position (B), the blocking member axially engages with the dose member and with the blocking thread to block an axial displacement of the dose member from the dose setting position(S) towards the dose dispensing position (D), and wherein the axial position of a distal end of the blocking thread on the inner body is located offset in the proximal direction (5) from the distal zero dose position (Z) by between 10% and 60% of the axial distance between the distal zero dose position (Z) and the proximal maximum dose position (M).

17. The drive mechanism according to claim 16, wherein the axial position of the distal end of the blocking thread on the inner body is located offset in the proximal direction (5) from the distal zero dose position (Z) by between 20% and 30% of the axial distance between the distal zero dose position (Z) and the proximal maximum dose position (M).

18. The drive mechanism according to claim 17, wherein the axial position of the distal end of the blocking thread on the inner body is located offset in the proximal direction (5) from the distal zero dose position (Z) by about 25% of the axial distance between the distal zero dose position (Z) and the proximal maximum dose position (M).

19. The drive mechanism according to claim 16, wherein the at least one blocking member of the display member is rotatable relative to the inner body between 1.080 and 2.160 between the distal zero dose position (Z) on the inner body and the proximal maximum dose position (M) on the inner body.

20. The drive mechanism according to claim 19, wherein the at least one blocking member of the display member is rotatable by 1.800 relative to the inner body between the distal zero dose position (Z) on the inner body and the proximal maximum dose position (M) on the inner body.

21. The drive mechanism according to claim 19, wherein the at least one blocking member of the display member is rotatable by 1.440 relative to the inner body between the distal zero dose position (Z) on the inner body and the proximal maximum dose position (M) on the inner body.

22. The drive mechanism according to claim 16, wherein the blocking thread comprises at least one recess having a size to receive the blocking member and/or radially inwardly extending protrusion thereof.

23. The drive mechanism according to claim 22, wherein the blocking thread comprises at least two recesses having a size to receive the blocking member and/or radially inwardly extending protrusion thereof, and wherein two adjacent recesses are spaced apart from each other by between 10% to 20% of the axial distance between the distal zero dose position (Z) and the proximal maximum dose position (M).

24. The drive mechanism according to claim 23, wherein the two adjacent recesses are spaced apart from each other by about 12.5% of the axial distance between the distal zero dose position (Z) and the proximal maximum dose position (M).

25. The drive mechanism according to claim 16, wherein the blocking member comprises a flexible arm extending in a tangential direction along the circumference of the display member.

26. The drive mechanism according to claim 16, wherein the blocking member comprises a radially inwardly extending protrusion at a free end section to engage with the blocking thread.

27. The drive mechanism according to claim 16, wherein the blocking member comprises an abutment at its free end section facing in axial direction (z) to axially abut with a corresponding abutment of the dose member.

28. The drive mechanism according to claim 16, wherein the axial position of a proximal end of the blocking thread on the inner body defines a minimum size of a therapeutic dose.

29. The drive mechanism according to claim 26, wherein a distal end of the blocking thread is chamfered, and wherein when rotating the display member in a dose incrementing direction the protrusion of the blocking member slides along the chamfer of the distal end of the blocking thread to flex the free end section of the blocking member from the release position (R) thereof in proximal direction (5) towards the blocking position (B), or to axially abut with the proximally facing edge of the blocking thread.

30. The drive mechanism according to claim 29, wherein, when rotating the display member in a dose dispensing direction with the blocking member in release position (R), the protrusion of the blocking member slides along a distal edge of the blocking thread as the blocking member passes the proximal end of the blocking thread when entering the blocking thread.

31. The drive mechanism according to claim 16, wherein the display member comprises a number sleeve and a dial sleeve and wherein the at least one blocking member is located on the dial sleeve or wherein the at least one blocking member is integrally formed with the dial sleeve.

32. The drive mechanism according to claim 16, wherein the inner body comprises at least a first maximum dose stop at its outer circumference to engage with first and second radially inwardly extending maximum dose stops of the display member, respectively, when the display member arrives in a maximum dose position.

33. The drive mechanism according to claim 16, further comprising a piston rod and a tubular-shaped driver extending in axial direction (z), wherein the piston rod comprises a first outer thread engaged with an inner thread of the inner body and comprises a second outer thread of opposite hand engaged with an inner thread of the driver, and wherein the dose member is permanently splined with the driver which is selectively rotationally lockable to the inner body by displacing the dose member into the dose dispensing position (D) and wherein the dose member and the display member are selectively rotationally lockable and releasable via a clutch (C) rotationally engaging the dose member and the display member when the dose member is in dose setting position(S) and rotationally releasing the dose member and the display member when the dose member is in dose dispending position (D).

34. An injection device for setting and dispensing of a dose of a medicament, comprising: a housing accommodating a drive mechanism, the drive mechanism comprising an inner body fixable inside the housing and comprising an elongated shaft extending in an axial direction (z) and having an outer thread, a tubular-shaped display member having an inner thread engaged with the outer thread of the inner body, and a dose member axially displaceable between a dose setting position(S) and a dose dispensing position (D) relative to the display member, wherein the display member comprises at least one blocking member movable in axial direction (z) between a blocking position (B) and a release position (R) and engageable with a blocking thread axially extending on the elongated shaft of the inner body, wherein the blocking thread and the outer thread have the same pitch, and wherein the at least one blocking member of the display member is rotatable relative to the inner body a predetermined number of turns between a distal zero dose position (Z) on the inner body and a proximal maximum dose position (M) on the inner body, wherein, when in blocking position (B), the blocking member axially engages with the dose member and with the blocking thread to block an axial displacement of the dose member from the dose setting position(S) towards the dose dispensing position (D), and wherein the axial position of a distal end of the blocking thread on the inner body is located offset in the proximal direction (5) from the distal zero dose position (Z) by between 10% and 60% of the axial distance between the distal zero dose position (Z) and the proximal maximum dose position (M); and a cartridge arranged inside the housing and filled with a liquid medicament.

35. The injection device according to claim 34, wherein the axial position of a proximal end of the blocking thread on the inner body of the drive mechanism defines a minimum size of a therapeutic dose of the liquid medicament.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0093] In the following, embodiments of the drive mechanism and the injection device are described in detail by making reference to the drawings, in which:

[0094] FIG. 1 shows a perspective outer view of the injection device.

[0095] FIG. 2 shows an isolated and abstract illustration of display member and dose member.

[0096] FIG. 3a is an isolated perspective view of the inner body.

[0097] FIG. 3b is an isolated perspective view of an alternative embodiment of the inner body.

[0098] FIG. 4 shows the interaction of blocking member and blocking structure prior to engagement when setting a dose.

[0099] FIG. 5 shows the configuration according to FIG. 4 with the display member rotated further in the dose incrementing direction.

[0100] FIG. 6 shows the configuration according to FIG. 5 and the interaction of the blocking member with the dose member.

[0101] FIG. 7 is illustrative of a configuration wherein the blocking member disengages the blocking structure when a minimum size of a therapeutic dose has been set,

[0102] FIG. 8 shows the configuration of the device during dose dispensing.

[0103] FIG. 9 is illustrative of the maximum dose configuration of the display member.

[0104] FIG. 10 shows a cross section through display member and inner body.

[0105] FIG. 11 is a perspective cut view of the interior of the display member.

[0106] FIG. 12 shows a first embodiment of the drive mechanism in an initial configuration.

[0107] FIG. 13 shows the drive mechanism according to FIG. 12 in a maximum set dose configuration.

[0108] FIG. 14 is an exploded view of the components of the drive mechanism according to FIGS. 12 and 13.

[0109] FIG. 15 is a perspective and cut view of the interface between inner body and

[0110] piston rod.

[0111] FIG. 16 shows a cross section through the interface between driver and inner body.

[0112] FIG. 17 is a perspective view of the outer circumference of a shaft portion of the dose member.

[0113] FIG. 18 is illustrative of a ratchet-like protrusion of the driver coinciding with a correspondingly-shaped receptacle on the outer circumference of the dose member.

[0114] FIG. 19 is indicative of the configuration of FIG. 18 but with dose member and

[0115] driver axially shifted.

[0116] FIG. 20 shows an isolated perspective view of a last dose nut.

[0117] FIG. 21 is a cross section through the interface of last dose nut and inner body,

[0118] FIG. 22 shows the last dose nut threadedly engaged with a threaded portion of the driver.

[0119] FIG. 23 shows the clutch between display member and dose member in engagement.

[0120] FIG. 24 shows the clutch according to FIG. 23 in a released configuration.

[0121] FIG. 25 shows a flexible arm of the display member to engage with a toothed profile of the dose member.

[0122] FIG. 26 shows the mutual engagement of the flexible arm with the toothed profile.

[0123] FIG. 27 shows an exploded view of another embodiment of the injection device which is of reusable type.

[0124] FIG. 28 shows a dial sleeve of the display member according to FIG. 27.

[0125] FIG. 29 shows a proximal end of the display member according to FIG. 27.

[0126] FIG. 30 is an isolated view of a distal driver part according to FIG. 27.

[0127] FIG. 31 shows an isolated view of a coupler.

[0128] FIG. 32 shows an isolated view a last dose nut.

[0129] FIG. 33 shows a proximal driver part.

[0130] FIG. 34 shows a clutch of the dose member.

[0131] FIG. 35 is an isolated view of a proximal clicker part.

[0132] FIG. 36 is an isolated view of a distal clicker part.

[0133] FIG. 37 shows a proximal part of the dose member, and

[0134] FIG. 38 is a partially cut view through the drive mechanism when assembled in the injection device.

DETAILED DESCRIPTION

[0135] FIG. 1 shows a drug delivery device 1 in the form of an injection pen. The device has a distal end, shown as left end in FIG. 1 and a proximal end located at the right hand side FIG. 1. The components or parts of the drug delivery device 1 are shown in FIG. 14 in more detail but without showing the blocking member or blocking structure. The drug delivery device 1 includes an outer housing part 10, an inner body 20, a piston rod 30, a driver 40, a last dose nut 50, a display member 60, a dose member 70, a cartridge 80 and a cap 120, i.e. in total nine separate component parts. As shown in FIG. 14, a needle arrangement comprising a needle hub 2 and a needle cover 3 may be provided as additional components, which can be exchanged. The general concept and structure of the drive mechanism as shown in FIGS. 12 to 26 is similar to the mechanism disclosed in WO 2014/033197 A1, which is incorporated herein by reference.

[0136] The outer housing part 10 is a generally tubular element having a distal part, which forms a cartridge holder 11 for receiving the cartridge 80, and a proximal part, which forms an outer body 12. In one embodiment, the outer housing part 10 is transparent, with the outer body 12 being provided with an opaque layer 13. In FIG. 14, the opaque layer 13 covers most of the outer body 12 with the exception of a transparent window 14. Apertures 15 may be provided in the cartridge holder 11. Further, at its distal end the cartridge holder 11 has a thread 16 or the like for attaching the needle hub 2.

[0137] The inner body 20 is a generally tubular element having different diameter regions. The inner body 20 is received in the outer body 12 and permanently fixed therein to prevent any relative movement of the inner body 20 with respect to the outer body 12. An external thread 21 is provided on the outer surface of a shaft portion 20a of the inner body 20. Further, splines 22 are provided on the inner surface of the inner body 20 which are shown in FIG. 21. As can be taken from FIG. 15, the inner body 20 has near its distal end an inner thread 23.

[0138] The piston rod 30 is an elongated element having two external threads 31, 32 with opposite hand which overlap each other. One of these threads 31 engages the inner thread 23 of the inner body 20. A disk-like bearing 33 is provided at the distal end of the piston rod 30. As shown in FIG. 14, the bearing 33 may be attached to the piston rod 30 as a one-piece component via a predetermined breaking point. This allows that the bearing 33 is separated from the piston rod 30 such that the bearing 33 remains seated on the distal end of the piston rod 30 to allow relative rotation between the bearing 33 and the piston rod 30.

[0139] The driver 40 is a generally tubular element having different diameter regions. A distal region of the driver 40 has an external thread 41. An inner surface of the driver 40 has an inner thread 42 as shown in FIG. 22 engaging one of the external threads 32 of the piston rod 30. The driver 40 surrounds the piston rod 30 and is at least partly located within inner body 20. The driver 40 has at least one proximal opening 43 or slit which will be explained in more detail below. Further, a resilient finger 44 is provided on the driver 40 by a U-shaped cut in the skirt of the driver 40 as shown in FIGS. 12 and 13. The finger 44 is allowed to flex in the axial direction and engages the dose member 70. In addition, a flexibly hinged protrusion 45 as shown in FIGS. 18 and 19, is provided on the driver 40 by a similar cut out in the skirt of the driver 40. The protrusion 45 is allowed to flex radially inwardly and is provided with lateral flaps 46. The protrusion 45 engages splines 22 of the inner body 20.

[0140] The last dose nut 50 is provided between the inner body 20 and the driver 40. External ribs 51 of the nut 50 engage splines 22 of the inner body 20. An internal thread 52 of the nut as shown in FIG. 20 engages the external thread 41 of the driver 40. As an alternative, splines and ribs could be provided on the interface between the nut 50 and the driver 40 and threads could be provided on the interface between the nut 50 and the inner body 20. As a further alternative, the nut 50 may be designed as e.g. a half nut. Further, in the embodiment of FIG. 20, four rotational hard stops 53 are provided on nut 50 for interaction with corresponding stops 47 on the driver 40 at the proximal end of the thread 41

[0141] The display member 60 is a generally tubular element with an internal thread 61 engaging the external thread 21 of the inner body 20. Thus, the display member 60 is interposed between the inner body 20 and the outer body 12. A series of numbers is provided, e.g. printed, on the outer surface of the display member 60. The numbers are arranged on a helical line such that only one number or only a few numbers are visible in through window 14 of the outer body 12. As will be explained in more detail below, the display member 60 is attached to the driver 40 preventing relative axial movement but allowing relative rotation.

[0142] A zero unit rotational hard stop formed by a stop wall 62 of the display member 60 and a corresponding stop face 24 on the inner body 20 as shown in FIGS. 3 and 11. This stop defines the distal zero dose position Z of the display member 60 with respect to the inner body 20. FIGS. 3 and 11 show also a maximum dose (e.g. a 80 units) rotational hard stop formed by a stops 63a and 63b at the distal end and proximal ends of the display member 60 and a corresponding stops 25a, 25b on the outer circumference or in thread 21 of the inner body 20. This stop defines the proximal maximum dose position M of the display member 60 relative to the inner body 20. Thus, a user is prevented from dialing below zero units and above e.g. 80 units.

[0143] The dose member 70 has a proximal end with an, e.g. serrated, flange or dose button 71 or outer skirt allowing a user to easily grip and dial the dose member 70. A sleeve-like part 72 of the dose member 70 with a reduced diameter extends in the distal direction 4 and is inserted into the driver 40 such that a limited relative axial movement is allowed but relative rotation is prevented. This is achieved by a rib 73 on the sleeve-like part 72 which is guided in a proximal opening 43 of the driver 40 as shown in FIG. 13. A recess 73a which generally has the outline of the protrusion 45 and its lateral flaps 46 is provided in the sleeve-like part 72 of dose member 70.

[0144] A clutch C is provided between the display member 60 and the dose member 70 by corresponding teeth 64 and 74 as shown in FIGS. 23 and 24. If the teeth 74 of the dose member 70 engage teeth 64 of the display member 60, these components will be rotationally locked. The resilient finger 44 of the driver 40 biases the dose member 70 in the proximal direction 5 of the device 1, i.e. in a direction engaging the clutch teeth 64, 74. The clutch C can be released allowing relative rotation by shifting the dose member 70 axially with respect to the display member 60 against the bias of finger 44.

[0145] Further, a dispense clicker is provided by flexible arms 65 on the display member 60 and a toothed profile 75 on the inner side of the dose button 71 of the dose member 70. This clicker is shown in FIGS. 25 and 26.

[0146] The cartridge 80 includes a pre-filled, necked-down cartridge reservoir 81, which may be typically made of glass. A rubber type bung 82 or stopper is located at the proximal end of the cartridge reservoir 81, and a pierceable rubber seal (not shown) is located at the other, distal, end. A crimped annular metal cap 83 is used to hold the rubber seal in place. The cartridge 80 is provided within the cartridge holder 11 with bearing 33 of piston rod 30 abutting bung 82.

[0147] FIG. 14 shows the cap 120 attached to the distal end of the device 1, thus covering the cartridge holder 11. The cap 120 may be releasable snapped onto the outer housing 10 and can be taken off for use of the device 1.

[0148] In the following, the function of the disposable drug delivery device 1 and its components will be explained in more detail.

[0149] To use the device, a user has to select a dose. In the start (at rest) condition as shown in FIGS. 1 and 12 the display member 60 indicates the number of doses dialed to the user. The number of dialed units can be viewed through the dose window 14 in the outer body 12. Due to the threaded engagement between the display member 60 and the inner body 20 rotation of the dose member 70 in a clockwise fashion causes the display member 60 to wind out of the device and incrementally display the number of units to be delivered.

[0150] During dose setting dose member 70, driver 40 and display member 60 are rotationally locked together via clutch teeth 64, 74. Further, dose member 70, driver 40 and display member 60 are axially coupled. Thus, these three components wind out of the outer housing 10 during dose setting.

[0151] Clockwise rotation of the dose member 70 causes the driver 40 to rotate and in doing so it advances along the piston rod 30 which remains fixed throughout dialing. The protrusion 45 and splines 22 form a clicker arrangement that provides tactile and audible feedback to the user when dialing doses. This clicker arrangement has the further functions of defining discrete positions for the display member 60 when dialing and of providing a method of locking the rotation of the driver 40 and the dose member 70 when dosing. During dialing hence, during dose setting the dose member 70 is in an axial position relative to the driver 40 such that the pocket or recess 73a is located radially inwards of the protrusion 45. Thus, the protrusion 45 is allowed to flex radially inwards to overcome splines 22 thereby providing a tactile and audible feedback to the user. FIG. 16 shows the flexible protrusion arm 45 located between splines 22 which are e.g. 15 apart.

[0152] At the maximum settable dose of 80 units, the stop features 63a, 63b and 25a, 25b shown in FIGS. 3 and 11 engage to prevent further dialing. The last dose nut 50 provides the function of logging the total number of dispensed units. The nut 50 locks the device 1 at the end of life and as such no more drug can be dialed or dispensed by the user. The last dose nut 50 and the driver 40 are connected via a threaded interface 41, 52 as explained above. Further, the last dose nut 50 is assembled into splines 22 as shown in FIG. 21 such that the nut 50 and the inner body 20 are permanently rotationally locked together. Rotation of the driver 40 during dialing causes the nut 50 to advance along the driver 40 thread 41. The nut 50 is free to slide axially within the inner body 20 at all times which allows advancement of the nut 50. The change in pitch shown in FIG. 22 towards the final doses axially accelerates the advancement of the nut 50 towards the end of life lockout condition.

[0153] At the end of life condition, the stop features 53 of the last dose nut 50 contact the corresponding features 47 on the driver 40. The splined contact with inner body 20 reacts any torque transmitted by these stop features 47.

[0154] With the desired dose is dialed, the device 1 is ready for dose dispensing. This basically requires pushing the dose member 70 which will result in a disengagement of the clutch teeth 64, 74. As mentioned above, when dialing a dose the dose member 70 is biased out and the clutch features 64, 74 which rotationally lock the driver 40, dose member 70 and display member 60 together are engaged as shown in FIG. 23. Upon pressing the proximal button portion of the dose member 70 the clutch features 64, 74 disengage as shown in FIG. 24 and a relative rotation between the display member 60 and the dose member 70 is possible. In all conditions the driver 40 and the dose member 70 are rotationally locked together by the engagement of the rib 73 and the opening 43. Thus, with the clutch 64, 74 disengaged, i.e. dose member 70 depressed or pushed in distal direction the dose member 70 and the driver 40 are rotationally locked together with the dose member 70, the driver 40 and the display member 60 still being axially coupled.

[0155] At the same time the relative axial movement of the dose member 70 with respect to the driver 40 results in the pocket or recess 73 being shifted relative to the protrusion 45. Thus, the protrusion 45 is prevented from flexing inwards because flaps 46 rest on a non-recessed area of the sleeve portion 70a of the dose member 70. A comparison of FIGS. 18 and 19 shows this activation of the lockout feature preventing the flexible protrusion arm 45 from overcoming splines 22 if the dose member 70 is pressed. In this condition, the driver 40 and the dose member 70 are rotationally constrained to the inner body 20 thus preventing any rotation relative to the outer housing 10 if the splines 22 are axially aligned with the device as shown in FIG. 16. There is also conceivable an alternative embodiment with twisted splines 22. There, the twisted splines serve to induce a rotation of the driver as it is subject to a distally directed displacement during dose dispensing.

[0156] With the desired dose dialed the dose member 70 can be depressed and the piston rod 30 driven forward to dispense drug from the cartridge 80. The interaction of mating threads between the piston rod 30, driver 40 and inner body 20 delivers a mechanical advantage, for example of 2:1 in the illustrated example. The initial and new device in a zero dose configuration is depicted in FIG. 12 while FIG. 13 shows the device 1 with 80 units dialed prior to pushing the dose member 70.

[0157] During dose dispensing, a dispense clicker is active which involves dose member 70 and display member 60. The dispense clicker provides primarily audible feedback to the user that drug is being dispensed. As shown in FIGS. 25 and 26 the interaction between the flexible arms 65 on the display member 60 and the toothed profile 75 on the button flange 71 provide this dispense click. Relative rotation is only allowed in one direction. This occurs when the components are decoupled during dispense and a click is produced for every unit.

[0158] In FIGS. 2-11, the minimum dose mechanism or the minimum dose function of the drive mechanism is explained in general. As it is apparent from a comparison of FIGS. 2 and 12, the shape of the dose member 70 as illustrated in FIG. 2 slightly varies from the overall shape of the dose member 70 as shown in the embodiment of FIGS. 12-26. However, the overall functionality of the dose member 70 and its interaction with all other components in particular with the display member 60 and the driver 40 is at least similar or even identical to the interaction as explained above in connection with FIGS. 12-26. In the illustrations according to FIGS. 2-11 the piston rod 30, the driver 40 as well as the last dose nut 50 are omitted for reasons of clarity.

[0159] The inner body 20 includes an elongated shaft 20a as shown in FIG. 3. Along the outer circumference of the elongated shaft there is provided the outer thread 21 that is threadedly engaged with a radially inwardly extending thread feature or inner thread 61 of the display member 60 as shown in FIG. 11. In addition, the elongated shaft 20a includes a blocking structure 26. In the present embodiment the blocking structure 26 includes a blocking thread 27 extending axially between convolutions of the outer thread 21. The blocking structure 26, hence the blocking thread 27 terminates in distal direction 4 with a distal ends 26a, 27a. The blocking structure 26 terminates in proximal direction 5 with proximal ends 26b, 27b. Hence, the blocking thread 27 terminates in proximal terminal direction 5 with a proximal end 27b. As illustrated in FIG. 3a the distal and proximal ends 27a, 27b of the blocking thread 27 are located within the axial extension of the outer thread 21. The axial offset between the blocking thread 27 and the outer thread 21 is about half the pitch of the outer thread 21. The lead of the blocking thread 27 is substantially equal or absolutely identical to the lead of the outer thread 21.

[0160] As shown in FIG. 2 the display member 60 includes a stepped down portion at its proximal part 60b which is received in the sleeve-shaped dose member 70 having a tubular shaft 70a extending from the dose dial or dose button 71 in distal direction 4. The proximal part 60b and the dose member 70 are selectively rotationally engageable by means of the clutch C as it is described in connection with FIGS. 23 and 24. The proximal part 60b of the display member 60 is not further illustrated in FIGS. 4-11 for reasons of simplicity.

[0161] The display member 60 includes at least one blocking member 66 as shown in FIG. 4. The blocking member 66 includes a flexible arm extending in a tangential direction and coincides with the sidewall 60a of the display member 60 as seen in an axial projection. The blocking member 66 includes a base portion 66c by way of which the blocking member 66 is joined with the sidewall 60a of the display member 60. Between the blocking member 66 and an axially adjacent sidewall portion 60a there is provided a tangential slit 66a or a respective gap by way of which the blocking member 66, in particular its free end 66b is free to flex or to deform in axial direction (z). Hence, the sidewall 60a of the display member 60 includes a recess that is large enough to support and to allow distally or proximally directed flexing or displacing of the blocking member 66.

[0162] As shown in FIG. 11 the free end 66b of the blocking member 66 includes a radially inwardly extending protrusion 67. The protrusion 67 has a rib-like shape and extends substantially parallel to the inner thread 61. The protrusion 67 is particularly adapted to mate or to engage with the blocking thread 27 on the outer circumference of the inner body 20. As can be seen from FIGS. 4 and 5 the blocking member 66 comprises an L-shaped structure with a long side extending tangentially and with a short side extending axially, in proximal direction. At the proximal end of the free end 66b of the blocking member 66 there are provided two fork-like abutment portions 68 that are adapted to axially engage with a distally facing abutment 76 of the dose member 70 as shown in FIG. 6. The abutments 68 are arranged radially outwardly of a support face 69 which extends proximally from the proximal end of the abutment portion 68. As shown in the various configurations of FIGS. 2 and 6 the support face 69 is constrained by an inside facing sidewall of the dose member 70 so as to provide an effective axial guiding between the mutually corresponding axial abutments 68, 76 of blocking member 66 and dose member 70.

[0163] The distal ends 26a, 27a are axially spaced from the stops 24 at the distal end of the outer thread 21 by the length of the display member 60 from its distal end to the at least one blocking member 66 and by an additional axial space which defines the size of the variable or titration dose range, i.e. the distal end 27a of the blocking thread 27 defines the maximum size of a variable titration dose while the axial location of the proximal end 27b of the blocking thread 27 defines the minimum value of a fixed dose that can be set and subsequently dispensed by the injection device 1.

[0164] Generally, the blocking member 66 may assume different axial positions on the inner body 20 depending on the amount of relative rotation of the display member 60 with respect to the inner body 20. In an initial configuration, prior to setting a dose or when the drive mechanism is in a zero dose configuration the display member 60 is in its most distal position on the inner body 20. This position is referred to as the distal zero dose position Z. On the other hand, the most proximal position which the display member 60 assumes on the inner body 20, i.e. the position of a maximum dose being selected, is referred to as the proximal maximum dose position M.

[0165] In the depicted embodiments, the axial position of a distal end 27a of the blocking thread 27 on the inner body 20, i.e. the position defining the maximum size of a variable titration dose, is located offset in the proximal direction 5 from the distal zero dose position Z by between 20% and 30%, for example up to 25% of the axial distance between the distal zero dose position Z and the proximal maximum dose position M. However, this position may be located nearer to the distal zero dose position Z or nearer to the proximal maximum dose position M, for example between 10% and 60% of the axial distance between the distal zero dose position Z and the proximal maximum dose position M. Typically, the display member 60 is rotatable relative to the inner body 20 a predetermined number of turns, e.g. four or five full turns corresponding to a relative rotation of 1.440 or 1.800 between the distal zero dose position Z on the inner body 20 and the proximal maximum dose position M on the inner body 20.

[0166] In an initial configuration, prior to setting a dose or when the drive mechanism is in a zero dose configuration Z the blocking member 66, in particular its protrusion 67 is not yet engaged with the blocking thread 27 as shown in FIG. 4. In this initial configuration the blocking member 66, in particular its protrusion 67 is located distally from the distal end 27a of the blocking thread 27. Hence, the dose member 70 is displaceable in distal direction to disengage the clutch C and to initiate a dispensing procedure as described above.

[0167] When the display member 70 is turned further in a dose incrementing direction relative to the inner body 20 the protrusion 67 of the blocking member 66 engages the chamfered distal end 27a of the blocking thread 27. Thanks to the chamfer 27c the protrusion 67 experiences a slight displacement in proximal direction 5, thereby pivoting the blocking member 66 with its free end in proximal direction 5. In this way, the axial size of the gap 66a at least in the region of the free end section 66b enlarges and the abutment 68 of the free end section 66b approaches the corresponding abutment 76 of the dose member 70. As the protrusion 67 has passed the chamfer 27c it is urged in proximal direction 5 by the proximally facing edge 27e of the blocking thread 27.

[0168] In this configuration the abutment 68 of the free end 66b of the blocking member 66 axially abuts with, or is in very close proximity to the abutment 76 of the dose member 70, thereby inhibiting and blocking a distally directed displacement of the dose member 70 relative to the inner body 20 as well as relative to the display member 60. In this way the clutch C remains locked and the device 1 cannot be switched into a dispensing mode. As long as the blocking member 66 is engaged with the blocking thread 27 or with the blocking structure 26 this axial abutment and blocking configuration between the blocking member 66 and the dose member 70 is maintained. Hence, the blocking member cannot flex because it is engaged with the blocking thread. Because the dose member is in abutment with the blocking member also the dose member cannot be displaced distally to initiate dispense.

[0169] When the flexible blocking member 66 is axially engaged with the proximally facing edge 27e of the blocking thread 27 any axially directed force transferred via the dose member 70 is directly transferred via the blocking member 66 to the inner body 20. Due to this comparatively short and rather direct load path between the dose member 70 and the inner body 20 a robust and strong blocking action can be provided. In this blocking configuration there is inherently only very little flexibility that could otherwise confuse a user. With the blocking member being in axial proximal abutment with the blocking thread 27 and being further in axial distal abutment or close proximity with the dose member 70, the blocking member is axially sandwiched between the dose member 70 and the inner body 20. In this way axial blocking of the dose member 70 is relatively free of play or slack that may confuse a user.

[0170] It is only when dialing the display member 60 further in the dose incrementing direction that the blocking member 66 disengages the blocking structure 26, i.e. the blocking thread 27, so that the blocking member 66 relaxes and returns to its unbiased and initial state as indicated in FIG. 7. There, the protrusion 67 has just passed the proximal end 27b of the blocking thread 27. Consequently, the blocking member 66, in particular its free end section 66b is displaceable or flexible in distal direction 4 either under the effect of a distally advancing dose member 70 or just by a relaxation into its natural unbiased state.

[0171] In FIG. 8 a configuration is shown wherein the drive mechanism has dispensed a few units so that the residual amount of medicament to be dispensed is less than the intended minimum dose size. As the drive mechanism conducts a dose dispensing procedure the blocking member 66 is in its release position R and it is flexed in the distal direction due to the distally directed displacement of the dose member 70 being then in dose dispensing position D. As the display member 60 rotates in the dose decrementing direction during dose dispensing the blocking member 66 passes along the distal side of the blocking thread 27d as shown in FIG. 8.

[0172] When entering the blocking thread 27 from the proximal side during dose dispensing the protrusion 67 is located near a distally facing edge 27d of the blocking thread 27. Even in the event that in such a configuration as shown in FIG. 8 the dispensing procedure should be interrupted the blocking member 66 is effectively prevented from pivoting or flexing in the proximal direction 5. Therefore, in the event that the dose dispensing procedure should be continued the dose member 70 is not prevented by the blocking member from being displaced into its dose dispensing position D. Even if the blocking member 66 and the dose member come into in axial abutment prior to the dose member 70 reaching the dose dispensing position D the blocking member 66 is free to be at least slightly displaced in axial distal direction 4 and thus dispensing can be re-initiated.

[0173] In this condition, the clutch C between the dose member 70 and the display member 60 is opened or released and the dispensing can continue. In other words, the blocking member 66, in particular its free end section 66b remains trapped on the distal side of the blocking thread 27. The user is then able to resume dispensing a dose, even when the display member 60 should be in a position below the predefined minimum dose value.

[0174] Even though in FIGS. 2-11 there is only illustrated a single blocking member 66 it is generally conceivable to provide two or even more blocking members 66 around the circumference of the display member 60. If two or more blocking members are provided, an equivalent number of blocking threads will be needed.

[0175] In FIG. 9, a maximum dose configuration is illustrated, wherein a maximum dose stop 63b located on a tangentially facing sidewall of the blocking member 66 tangentially abuts with a correspondingly-shaped stop 25b of the inner body.

[0176] The arrangement of inner body 20 and display member 60 includes two pairs of mutually corresponding stops. As shown in FIG. 3, the inner body 20 includes a distally located maximum stop 25a and a proximally located maximum stop 25b. Both stops extend radially outward from the circumference of the inner body's 20 elongated shaft 28 and comprise an abutment surface facing in tangential direction. The respective abutment surface coincides with the radial and axial plane. The display member 60 also includes at least one proximal maximum dose stop 63b and at least one distal maximum dose stop 63a as shown in FIG. 11. In the embodiment shown in FIG. 11 two distal maximum dose stops 63a are provided that mate and engage with correspondingly-shaped dose stops 25a on the inner body 20. The mutually corresponding stops 25a, 25b, 63a, 63b simultaneously engage as the display member 60 has reached a maximum dose configuration, i.e. the display member 60 is in the proximal maximum dose position M. The mutually engaging stops 25a, 25b, 63a, 63b then prevent any further dose incrementing rotation of the display member 60 relative to the inner body 20.

[0177] It is generally sufficient to provide only one pair of maximum dose stops, e.g. 25a, 63a. The two pairs of mutually corresponding maximum dose stops 25a, 25b, 63a, 63b reinforce each other. Consequently, the load to be expected on the respective blocking member when reaching the block configuration is lower than it would be when only one pair of mutually corresponding stops, e.g. pair 25a, 63a would be implemented. This has the advantage, that the stop features can be designed rather smaller than might otherwise be the case. This does not only save space, but also facilitates the device assembly, namely when the display member 60 is threaded onto the inner body 20. Comparatively small stops 25a, 25b, 63a, 63b are less prone to fracture or damage during assembly.

[0178] Since the minimum as well as the maximum deliverable dose volume only depends on the geometry and the overall design of the inner body 20, its blocking thread 27 and the location of maximum dose stops 25a, 25b different device types can be easily configured for various applications. Also different dose sizes can be easily implemented by changing only one component. Since the minimum and maximum dose features do not protrude beyond a basic envelope of the inner body it is even straight forward to implement the minimum and maximum dose function with a wide range of different device configurations using common automated assembly equipment.

[0179] In FIG. 3b, an alternative embodiment of an inner body 220 is shown having a blocking structure 26 with a blocking thread 227 that slightly differs from the blocking thread 27 as shown in FIG. 3a. The blocking thread 227 has several recesses 227a, 227b, 227c, 227d or interrupts that define discrete dose sizes to be exclusively dispensed by means of the respective drive mechanism. The blocking thread 227 extends almost all along the axial extension of the shaft 20a. Only when the position of the blocking member 66 axially and/or tangentially overlaps with a position of one of the recesses 227a, 227b, 227c, 227d, the dose member 70 and hence the blocking member 66 is displaceable in distal direction 4 to initiate a dispensing action.

[0180] The tangential and axial positions of the recesses 227a, 227b, 227c, 227d define discrete dose sizes for which the dispensing of a dose is exclusively possible. Simply by modifying or replacing the inner body 20 with a blocking thread 27 by another inner body 220 with a different blocking thread 227 the injection device can be transformed from a device that allows individual setting of doses of variable size to a fixed dose device, or vice versa.

[0181] The recesses 227a, 227a, 227c, 227d are positioned such that two adjacent recesses are spaced apart from each other by between 10% to 20%, for example by 12.5%, of the axial distance between the distal zero dose position Z and the proximal maximum dose position M. This corresponds for example to 10 units.

[0182] While the embodiment as shown in FIGS. 12 to 26 relates to a disposable injection device the alternative embodiment according to FIGS. 27 to 38 relates to a reusable injection device. The minimum dose function as described with reference to FIGS. 1 to 11 is not further illustrated in FIGS. 12 to 38 just for reasons of simplicity.

[0183] Components of the reusable embodiment according to FIGS. 27 to 38 that are identical or similar compared to the embodiment of FIGS. 12 to 26 are denoted with identical or like reference numerals unless stated otherwise. Where components have changes in comparison to the disposable embodiment similar components have been assigned with reference numerals increased by 100. The general concept and structure of the drive mechanism as shown in FIGS. 27 to 38 is similar to the mechanism disclosed in WO 2014/033195 A1, which is incorporated herein by reference. Implementation and adaptation of the minimum dose function as described above in connection with FIGS. 1 to 11 equally applies to the embodiment of FIGS. 27 to 38.

[0184] In this embodiment, the driver 140 is a generally tubular element having in the embodiment shown in the Figures three components 141, 142, 143 which are depicted in FIGS. 27, 30, 31, and 33 in more detail. The driver 140 includes a distal drive sleeve 141, a proximal drive sleeve 142 and a coupler 143. The distal drive sleeve 141 engages with the piston rod thread 32 to drive the piston rod 30 through the inner body 20 during dose delivery. The distal drive sleeve 141 is also permanently connected to the coupler 143 which in turn is releasably engaged through reset clutch features to the proximal drive sleeve 142. The two halves of the drive sleeve 141, 142 are rotationally and axially connected during dialing and dispense, but are decoupled rotationally during device reset so that they can rotate relative to each other.

[0185] The proximal drive sleeve 142 shown in FIG. 33 supports components of a clicker 100 and sleeve shaped clutch 90 and transfers rotational movement from the dose member 70 to the coupler 142 and distal drive sleeve 141. Teeth features 147 located at the distal end of proximal drive sleeve 142 engage with the reset clutch features on the coupler 143 to connect both halves of the drive sleeve during dialing and dispense. During reset these teeth 147 disengage.

[0186] Several splines are provided on the outer surface of proximal drive sleeve 142 engaging with a distal clicker part 101, preventing relative rotation during dialing and dispense. Further splines, which are located in the middle region of proximal drive sleeve 142, engage with the clutch 90 component. They may be arranged to be non-rotationally symmetric so that the various clicker components cannot be assembled accidentally upside down.

[0187] The proximal portion of proximal drive sleeve 142 has four arms or fingers 148. A hook-like bearing surface 149 exists on the underside of flange segments on the end of the flexible fingers 148 as seen in FIG. 33. The flexible fingers 148 are separated with gaps or slots that make space for the dose member 70 to snap to the clutch 90 and also enable these fingers to flex inwards during assembly of the proximal drive sleeve 142 to a dial sleeve 162. After assembly the hooks 149 retain the proximal drive sleeve 142 relative to the dial sleeve 162 under the reaction force from the spring 103.

[0188] During dispense, the dose member 70 depresses the spring 103 via the clutch 90 and the clicker components and this spring 103 is reacted through the coupler 143 to the proximal drive sleeve 142 which then through bearing surfaces 149 applies axial load to the dial sleeve 162. This axial load drives the dial sleeve 162 and hence a number sleeve 161 along the helical thread of the inner body 20, back into the body of the device, until the zero dose stop faces 62 on the number sleeve 161 contact the inner body 20.

[0189] The coupler 143 shown in FIG. 31 rotationally couples the two halves of the drive sleeve 140 together during dialing and dispense, whilst allowing them to de-couple during reset. The coupler 143 also transfers the last dose stop load from the proximal drive sleeve 142 to the distal drive sleeve 141. Two sets of teeth are provided in the coupler 143 for engaging teeth 146 and teeth 147, respectively. The coupler 143 is snapped onto distal drive sleeve 141 allowing limited relative axial movement with respect to the proximal drive sleeve 142.

[0190] The display member 160 is a generally tubular element which is composed of a number sleeve 161 and dial sleeve 162 which are snapped together during assembly to axially and rotationally constrain these two components, which thus act as a single part. The dial sleeve 162 is assembled to the number sleeve 161 such that once assembled, no relative movement is allowed. The parts are made as separate components to enable both molding and assembly. Also, whereas the number sleeve 161 is preferably white to give contrast for the e.g. black dose numbers, the dial sleeve 162 color can be chosen to suit the aesthetics or perhaps to distinguish the drug type.

[0191] At the proximal end, the dial sleeve 162 has internal clutch features 165 that engage with the clutch component 90 during dialing and disengage from the clutch during dispense. These clutch features 165 rotationally lock the dial sleeve 162 to the clutch 90 during dialing and when the zero and maximum dose stops are engaged. When the dose member 70 is depressed, these clutch features disengage to allow the clutch 90 to move axially whilst the dial sleeve 162 and number sleeve 161 spin back to the zero unit start position.

[0192] The dial sleeve 162 rotates out during dialing through its engagement with the clutch 90 and number sleeve 161 and rotates back in during dispense under the axial force applied by the proximal drive sleeve 142 to a flange-like bearing face 166 on the proximal end of the dial sleeve as shown in FIG. 29. This bearing face 166 engages with the flexible arms 148 of the proximal drive sleeve 142 during dispense. Two diametrically opposite faces 167 may engage with the outer body 10 when the maximum dose has been dialed, forming the maximum dose stop faces.

[0193] A central sleeve-like portion of the dose member 70 is provided with four arms 173 having hook-like snap features 174 at their respective distal ends. The arms 173 form splined surfaces engaging with the clutch 90 to transfer torque from the dose member 70 through the clutch to the dial sleeve 162 and proximal drive sleeve 142. The snap features 174 engage apertures in the clutch 90 and are designed with angled undercut faces to maintain engagement when an axial load is applied to pull the dose member 70 out of the pen body 10. The space between arms 173 defines pockets giving clearance for the flexible arms 148 of proximal drive sleeve 142 to slide freely relative to the dose member 70 and clutch 90 when the dose member 70 is depressed and released during dose dispense.

[0194] The tubular clutch 90 is provided between the display member 160 and the dose member 70. The clutch is fixed relative to and retains the dose member 70 and together they travel axially relative to the proximal drive sleeve 142 when the dose member 70 is depressed during dispense, disengaging the clutch teeth 95 from the dial sleeve clutch teeth 165. It also transfers torque from the dose member 70 to the proximal drive sleeve 142, and the dialing and zero and maximum dose stop loads from the dose member 70 via the clutch teeth to the dial sleeve 162 and number sleeve 161.

[0195] Drive sleeve splines 91 provided on an inner surface of the clutch engage with the proximal drive sleeve 142. At the distal end face, clutch biasing teeth 92 are provided which mate with similar teeth 109 on the proximal clicker part 102 to ensure that in the unrestrained button out position (dialed dose) the clutch is biased in rotation to the proximal clicker part 102 under the biasing action of the clutch spring 103 thus ensuring that the dose number shown on the display member is correctly and unambiguously displayed to the user. The teeth 92 are shallow in height to prevent the proximal clicker part 102 from engaging with splines on the proximal drive sleeve 142 during dialing. Four snap apertures 93 serve to retain the snap features 174 of the dose member 70. Near its proximal end, the clutch has splines 94 which at the end of dispense with the dose member 70 depressed lock to the inner body 20 to prevent the user from rotating the dose member 70 below the zero-dose position.

[0196] Clutch teeth 95 engage with clutch teeth 165 of the dial sleeve 162 to rotationally couple the dose member 70 via the clutch to the number sleeve 161. During dispense the clutch 90 is moved axially so as to disengage these clutch teeth 95 releasing the dial sleeve 162 to rotate back into the device whilst the clutch 90 and hence driver 140 move axially to dispense the dose.

[0197] The clicker 100 includes a distal clicker part 101, a proximal clicker part 102 and a spring 103. The spring 103 serves to bias the dose member 70 out so that at the end of a dose the dose member 70, in particular its proximal button portion pops out, re-engaging the clutch 90 with the dial sleeve 162 ready for dialing. Further, it provides the spring force for the clicker components to provide audible and tactile feedback to the user and also provides detent positions for the number sleeve 161. In addition, it holds the two halves of the drive sleeves 141, 142 in rotational engagement during dialing and dispense, whilst allowing them to disengage during device reset.

[0198] The distal clicker part 101 is permanently splined to the proximal drive sleeve 142 and engages with the proximal clicker part 102 which in turn is splined to the inner body 20. During dialing when the drive sleeve is rotated relative to the inner body 20, the two clickers 101, 102, rotate relative to each other under the compression force of the clutch spring 103. This force combined with the clicker teeth formed on the end face of each clicker provides the clicks and also the detent dialing positions.

[0199] During dispense, the two clickers 101, 102 are pressed together under the axial dispense load applied by the user to the dose member 70 and this prevents relative rotation between the proximal drive sleeve 142 and inner body 20, driving the piston rod 30 forwards to deliver the dose. The splines 104 on the inner bore rotationally couple the distal clicker part 101 to the proximal drive sleeve 142, but allow free axial movement when the dose member 70 is depressed during dispense and when the two clickers ride over each other during dialing. The profile of the clicker teeth 105, 106 on both distal clicker part 101 and proximal clicker part 102 are identical and ride over each other under the compressive load from the spring 103 during dialing.

[0200] The proximal clicker part 102 is permanently splined to the inner body 20 by external splines 107 which prevent relative rotation with the inner body 20 during both dialing and dispense, providing clicks during dialing and locking the proximal drive sleeve 142 in rotation during dispense. Additional cylindrically shaped splines 108 also couple the proximal clicker part 102 rotationally to the proximal drive sleeve 142 when the dose member 70 is depressed, thus preventing the user from dialing past 80 units with the dose member 70 depressed. Proximal clicker part 102, in addition to the primary clicker teeth 106, has clutch biasing teeth 109 on the opposite end face. These teeth mate with similar teeth 92 on the clutch 90 to ensure that in the unrestrained button out position (dialed dose) the clutch is biased in rotation by the proximal clicker part 102 under the biasing action of clutch spring 103.

[0201] The cartridge bias spring 110 is assembled as two components one after the other, the lower first and the upper second. The spring combination serves to apply an end load to the cartridge 80 at extremes of tolerance so as to bias it forwards onto the end face of the ferrule in the cartridge holder 11. This ensures that when the user removes and attaches a needle, the friction between the needle cannula and septum of the cartridge 80 does not move the cartridge 80 axially relative to the cartridge holder 11. The bias spring 110 also acts to provide a force against which the user has to connect the cartridge holder 11 and this may add to the tactile feedback of a bayonet joint between cartridge holder 11 and inner body 20. The spring 100 also serves to eject the cartridge holder 11 if the cartridge holder is not correctly attached in a secure position, highlighting this error to the user.

[0202] During dose setting, the dose member 70, driver 140 and display member 160 are rotationally locked together via clutch 90. Further, dose member 70, driver 140 and display member 160 are axially coupled. Thus, these three components wind out of the outer body 12 during dose setting. Clockwise rotation of the button dose member 70 causes the driver 140 to rotate on a helical path and in doing so it advances along the piston rod 30 which remains fixed throughout dialing. The clicker arrangement 100 provides tactile and audible feedback to the user when dialing doses. At the maximum settable dose of 80 units, the stop features 12 and 67 engage to prevent further dialing.

[0203] With the desired dose dialed, the device 1 is ready for dose dispensing. This requires pushing the proximal button portion of the dose member 70 which will result in a disengagement of the clutch 90 from dial sleeve 162 thus allowing relative rotation between the display member 160 and the dose member 70. In all conditions the driver 140 and the dose member 70 are rotationally locked together by engagement of arms 173 and fingers 148 and by splines 91 engaging corresponding splines on proximal drive sleeve 142. Thus, with the clutch 90 disengaged dose member 70 and driver 140 is rotationally locked together with the dose member 70, the driver 140 and the display member 160 still being axially coupled.

[0204] When dispensing a dose, the dose member 70 and clutch 90 are moved axially relative to the mechanism compressing the clutch spring 103. Because the proximal clicker part 102 is splined to the inner body 20 and the axial load passing through the clicker teeth 105, 106 locks the distal clicker part 101 in rotation to the proximal clicker part 102, the drive sleeve 140 and clutch 90 parts of the mechanism are forced to move axially whilst the dial sleeve 162 and number sleeve 161 are free to spin back into the outer housing 10. The interaction of mating threads between the piston rod 30, driver 140 and inner body 20 delivers a mechanical advantage of, for example 2:1.

[0205] In other words, axially advancing driver 40 causes the piston rod 30 to rotate which due to the threaded engagement of piston rod 30 with the inner body 20 advances the piston rod 30. During dose dispensing dispense clicker 168, 71 is active which involves dose member 70 and display member 160. The dispense clicker provides primarily audible feedback to the user that the medicament is being dispensed.

[0206] When dispensing of a dose is complete and when the user removes the force from the end of the dose member 70, the clutch spring 103 pushes this dose member 70 proximally, re-engaging the teeth 165 and 95 between the clutch and the dial sleeve.

[0207] Resetting the device starts with removal of the cartridge holder 11 and replacing an empty cartridge with a full cartridge 80. As the cartridge holder 11 is re-attached, the bung of the new cartridge 80 contacts bearing 33, thus pushing piston rod 30 back into the housing. Initially, the piston rod 30 screws into the inner body 20, thereby axially disengaging the coupler 143 from the proximal drive sleeve 142 against the biasing force of spring 103. Once disengaged the coupler 143 is free to start rotating together with distal drive sleeve 141 and continues to do so as the cartridge holder 11 is moved axially into engagement with the inner body 20. Thus, the distal drive sleeve 141 rotates with respect to the proximal drive sleeve 142 which is still rotationally constrained in inner body 20 as clicker parts 101 and 102 are pressed together by compressed spring 103.

[0208] As the distal drive sleeve 141 rotates, last dose nut 50 is reset to its (distal) start position. The last dose nut 50 is threadedly engaged with an outer thread 144 of the distal drive sleeve 141. Coupling the cartridge holder 11 to inner body 20 backs off the mechanism due to the bayonet structure allowing re-engagement of the proximal drive sleeve 142 with coupler 143 and thus the distal drive sleeve 141.

[0209] It is to be noted here, that the minimum dose function as described in connection with FIGS. 1 to 11 is equally implementable or is actually implemented with the reusable device as described in connection with FIGS. 27 to 38.

[0210] The display member 160 as it is implemented with the injection device device 1 and with the drive mechanism according to FIGS. 27-38 includes a number sleeve 161 and a dial sleeve 162. The dial sleeve 162 is provided with the ratchet arm 168 near a proximal end and further has the bearing face 166 and the clutch feature 165 to selectively engage with the teeth 95 of the clutch 90 The number sleeve 161 and the dose sleeve 162 are permanently and mutually engaged. A distal section of the dial sleeve 162 is located inside a proximal section of the number sleeve 161. Hence, the sidewall 181 of the number sleeve 161 encloses at least a distal portion of the sidewall 182 of the dial sleeve 162.

[0211] There are provided mutually corresponding recesses 184 and protrusions 185 on the radially overlapping portions of the number sleeve 161 and the dial sleeve 162. In an embodiment there are provided at least two recesses near a proximal end of the number sleeve 161 that engage with and receive radially outwardly extending protrusions on a distal section of sidewall of the dial sleeve 162. In this way a snap-fit engagement between number sleeve 161 and dial sleeve 162 is obtained. The dial sleeve 162 is therefore permanently rotationally and axially locked to the number sleeve 161 and vice versa.

[0212] In one embodiment, there are provided two blocking members 66 at a proximal end of the number sleeve 161. The radially inwardly extending protrusions 67 of the blocking members 66 each extend through an aperture of the sidewall of the dial sleeve 162. In this way the protrusions 67 and hence the blocking members 66 extends radially through the sidewall of the dial sleeve 162 in order to directly engage with the blocking structure 26 on the outer circumference of the inner body 20. The longitudinal or axial extension of the aperture is large enough so as to allow and to support an axial displacement of the blocking member 66 with regard to the dial sleeve 162 and with regard to the number sleeve 161 when in a release configuration R.

[0213] In the release configuration R the protrusion 67 of the blocking member 66 is located distally from the blocking structure 26 and hence distally from the blocking thread 27. In other words, the blocking member 66 may be in alignment with an intersection or gap of the blocking thread 27. In the release position or release configuration R the dose member 70 is displaceable in distal direction 4 thereby urging the flexible blocking member 66 in distal direction.

[0214] In a blocking position B, the protrusion 67 of the blocking member 66 is located on a proximal side of the blocking structure 26. Here, a distal edge 67d of the protrusion 67 faces a proximal edge 27e of the blocking thread 27. In this blocking position B the blocking member 66 is in axial abutment with the blocking structure 26. The blocking member 66 cannot be displaced in distal direction 4. A distally directed dispensing force acting on the dose member 70 transfers via the abutment 76 and 68 into the blocking member 66. Said force is reacted through the mutual axial abutment of the correspondingly-shaped proximal and distal edges 27e, 67d thereby preventing and impeding a distally directed displacement of the blocking member 66.

[0215] With a further embodiment of the display member there is implemented the same interaction and positive engagement between the number sleeve and the dial sleeve and between the dose member 70, the blocking members 66 and the inner body 20. There is only one exception in that the blocking members 66 are located on the dial sleeve rather than on the number sleeve 161. Here, the dial sleeve and/or the number sleeve includes an aperture of a recess like the aperture of the dial sleeve 162 to support and to provide a direct mechanical interaction between the blocking member 66 and the blocking structure 26.

[0216] With this embodiment the number sleeve and the elastic blocking members 66 can be made from different materials. Since the number sleeve is typically provided with numbers or symbols on its outer circumference to indicate a size of a dose in the window 14 of the outer body 12 a material can be selected and used for the number sleeve that is particularly suitable for printing or coating. For the blocking members 66 and for the dial sleeve integrally formed with the blocking members 66 a different plastic material can be chosen that provides desirable or optimized mechanical properties for the elastic deflection of the blocking members 66. For instance, the dial sleeve and the blocking members 66 can be made from POM.

LIST OF REFERENCE NUMBERS

[0217] 1 injection device [0218] 2 hub [0219] 3 cover [0220] 4 distal direction [0221] 5 proximal direction [0222] 10 housing [0223] 11 cartridge holder [0224] 12 outer body [0225] 13 layer [0226] 14 window [0227] 15 aperture [0228] 16 thread [0229] 20 inner body [0230] 20a shaft [0231] 21 outer thread [0232] 22 spline [0233] 23 inner thread [0234] 24 stop [0235] 25a, b stop [0236] 26 blocking structure [0237] 26a distal end [0238] 26b proximal end [0239] 27 blocking thread [0240] 27a distal end [0241] 27b proximal end [0242] 27c chamfer [0243] 27d distal edge [0244] 27e proximal edge [0245] 30 piston rod [0246] 31 outer thread [0247] 32 outer thread [0248] 33 bearing [0249] 40 driver [0250] 41 thread [0251] 42 inner thread [0252] 43 opening [0253] 44 finger [0254] 45 protrusion [0255] 46 flap [0256] 47 stop [0257] 50 last dose nut [0258] 51 external rib [0259] 52 inner thread [0260] 53 stop [0261] 60 display member [0262] 60a sidewall [0263] 60b proximal part [0264] 61 inner thread [0265] 62 stop [0266] 63a stop [0267] 63b stop [0268] 64 teeth [0269] 65 flexible arm [0270] 66 blocking member [0271] 66a slit [0272] 66b free end [0273] 66c base portion [0274] 67 protrusion [0275] 67d distal edge [0276] 68 abutment [0277] 69 support face [0278] 70 dose member [0279] 70a sleeve portion [0280] 71 dose dial/dose button [0281] 72 sleeve-like part [0282] 73 rib [0283] 73a recess [0284] 74 teeth [0285] 75 toothed profile [0286] 76 abutment [0287] 80 cartridge [0288] 81 reservoir [0289] 82 bung [0290] 83 crimped metal cap [0291] 90 clutch [0292] 91 splines [0293] 92 teeth [0294] 93 aperture [0295] 94 splines [0296] 95 teeth [0297] 100 clicker [0298] 101 distal clicker [0299] 102 proximal clicker [0300] 103 clutch spring [0301] 104 splines [0302] 105 clicker teeth [0303] 106 clicker teeth [0304] 107 splines [0305] 108 splines [0306] 109 teeth [0307] 110 cartridge bias spring [0308] 120 cap [0309] 140 driver [0310] 141 distal drive sleeve [0311] 142 proximal drive sleeve [0312] 143 coupler [0313] 144 thread [0314] 145 stop [0315] 146 teeth [0316] 147 teeth [0317] 148 flexible finger [0318] 149 hook [0319] 160 display member [0320] 161 number sleeve [0321] 162 dial sleeve [0322] 165 clutch feature [0323] 166 bearing face [0324] 167 stop [0325] 168 ratchet arm [0326] 173 arm [0327] 174 snap feature [0328] 220 inner body [0329] 227 blocking thread [0330] 227a recess [0331] 227b recess [0332] 227c recess [0333] 227d recess [0334] Z distal zero dose position [0335] M proximal maximum dose position