Display arrangement for an injection device

Abstract

The present invention relates to a display arrangement for an injection device for displaying the size of a dose of a medicament, the display arrangement comprising: a housing (60) providing a rotation axis (3) extending in an axial direction (4), a first display member (22) rotatably supported inside the housing (60) with regard to the rotation axis (3) and having at least one cam (32) radially offset from the rotation axis (3), a second display member (24) rotatably supported inside the housing (60) with regard to the rotation axis (3) and arranged axially adjacent to the first display member (24), a coupling member (26) rotatably engaged with the second display member (24), wherein the coupling member (26) is engaged with the at least one cam (32) of the first display member (22) when the first display member (22) is in a predefined angular position or angular range, wherein the coupling member (26) and the first display member (22) are mutually engaged via a retaining arrangement (48) when the cam (32) and the coupling member (26) are disengaged.

Claims

1. A display arrangement for an injection device for displaying a size of a dose of a medicament, the display arrangement comprising: a housing providing a rotation axis extending in an axial direction; a first display member rotatably supported inside the housing with regard to the rotation axis and comprising at least one cam radially offset from the rotation axis; a second display member rotatably supported inside the housing with regard to the rotation axis and arranged axially adjacent to the first display member; and a coupling member rotatably engaged with the second display member, wherein the at least one cam selectively engages with the coupling member, wherein the coupling member is engaged with the at least one cam of the first display member only when the first display member is in a predefined angular position or angular range, wherein a retaining arrangement is configured to engage the coupling member with the first display member when the at least one cam of the first display member and the coupling member are disengaged, and wherein the retaining arrangement comprises at least two retaining teeth separated in a circumferential direction on an outer circumference of the coupling member, wherein the at least two retaining teeth are in radial abutment with a retaining ring of the first display member when the first display member is outside the predefined angular position or angular range.

2. The display arrangement according to claim 1, wherein the retaining arrangement is configured to keep the coupling member in a fixed angular position while the first display member is rotatable between consecutive predefined angular positions or predefined angular ranges.

3. The display arrangement according to claim 1, wherein the coupling member is rotatably supported in the housing with regard to a coupling axis extending parallel but radially offset to the rotation axis and wherein the coupling member comprises a first geared section with a plurality of first teeth to mesh with the at least one cam when the first display member is in the predefined angular position or angular range.

4. The display arrangement according to claim 3, wherein the coupling member comprises a second geared section comprising a plurality of second teeth meshing with a geared section of the second display member.

5. The display arrangement according to claim 3, wherein the at least two retaining teeth are arranged axially offset to the plurality of first teeth of the coupling member.

6. The display arrangement according to claim 3, wherein the at least two retaining teeth are arranged axially adjacent to the plurality of first teeth of the coupling member.

7. The display arrangement according to claim 3, wherein a radial extension of the at least two retaining teeth is shorter than a radial extension of the plurality of first teeth.

8. The display arrangement according to claim 3, wherein the at least two retaining teeth are at least in sections axially flush with at least two of the plurality of first teeth.

9. The display arrangement according to claim 3, wherein the at least one cam radially overlaps with the retaining ring and axially protrudes from the retaining ring.

10. The display arrangement according to claim 3, wherein the retaining ring comprises a radially extending slit to receive one of the at least two retaining teeth when the first display member rotates through the predefined angular range or beyond the predefined angular position.

11. The display arrangement according claim 10, wherein the at least one cam comprises a first cam segment and a second cam segment separated in the circumferential direction by the slit of the retaining ring extending therebetween in the axial direction and a radial direction.

12. The display arrangement according to claim 3, wherein configurations of the retaining arrangement configured to engage the coupling member with the first display member when the at least one cam of the first display member and the coupling member are disengaged comprise configurations to engage a radially inward facing inner surface of the retaining ring.

13. The display arrangement according to claim 1, wherein at least one of the first display member and the second display member comprises a sleeve like shape and wherein at least one of the first display member and the second display member comprises a display surface with consecutive dose size indicating symbols on an outer circumference.

14. A display arrangement for an injection device for displaying a size of a dose of a medicament, the display arrangement comprising: a housing providing a rotation axis extending in an axial direction; a first display member rotatably supported inside the housing with regard to the rotation axis and comprising at least one cam radially offset from the rotation axis; a second display member rotatably supported inside the housing with regard to the rotation axis and arranged axially adjacent to the first display member; and a coupling member rotatably engaged with the second display member, wherein the at least one cam only selectively engages with the coupling member, wherein the coupling member is engaged with the at least one cam of the first display member only when the first display member is in a predefined angular position or angular range, wherein a retaining arrangement is configured to engage the coupling member with the first display member when the at least one cam of the first display member and the coupling member are disengaged, wherein the coupling member is rotatably supported in the housing with regard to a coupling axis extending parallel and radially offset to the rotation axis, and wherein the coupling member comprises a first geared section with a plurality of first teeth to mesh with the at least one cam when the first display member is in the predefined angular position or angular range.

15. A drive mechanism for an injection device for dispensing a dose of a medicament, the drive mechanism comprising: an elongated housing extending in an axial direction and providing a rotation axis extending in the axial direction; a piston rod configured to operably engage with a piston of a cartridge and further configured to displace the piston in an axial distal direction; a dose setting member rotatably supported on the housing; a drive sleeve rotatably or threadedly engaged with the piston rod; and a display arrangement comprising: a first display member rotatably supported inside the housing with regard to the rotation axis and comprising at least one cam radially offset from the rotation axis; a second display member rotatably supported inside the housing with regard to the rotation axis and arranged axially adjacent to the first display member; and a coupling member rotatably engaged with the second display member, wherein the at least one cam selectively engages with the coupling member, wherein the coupling member is engaged with the at least one cam of the first display member only when the first display member is in a predefined angular position or angular range, wherein a retaining arrangement is configured to engage the coupling member with the first display member when the at least one cam of the first display member and the coupling member are disengaged, wherein the display arrangement is alternately engageable with the drive sleeve and with the dose setting member for dispensing or setting of the dose of the medicament, and wherein the retaining arrangement comprises at least two retaining teeth separated in a circumferential direction on an outer circumference of the coupling member, wherein the at least two retaining teeth are in radial abutment with a retaining ring of the first display member when the first display member is outside the predefined angular position or angular range.

16. The drive mechanism according to claim 15, further comprising an arc-shaped clicking member configured to audibly engage with a toothed structure of the housing or of an insert attached to the housing, wherein the clicking member is elastically and radially deformable by engagement with an axially displaceable last dose limiting member.

17. An injection device for dispensing a dose of a medicament, comprising: an elongated housing extending in an axial direction and providing a rotation axis extending in the axial direction; a piston rod configured to operably engage with a piston of a cartridge and further configured to displace the piston in an axial distal direction; a dose setting member rotatably supported on the housing; a drive sleeve rotatably or threadedly engaged with the piston rod; a display arrangement comprising: a first display member rotatably supported inside the housing with regard to the rotation axis and comprising at least one cam radially offset from the rotation axis; a second display member rotatably supported inside the housing with regard to the rotation axis and arranged axially adjacent to the first display member; and a coupling member rotatably engaged with the second display member, wherein the at least one cam selectively engages with the coupling member, wherein the coupling member is engaged with the at least one cam of the first display member only when the first display member is in a predefined angular position or angular range, wherein a retaining arrangement is configured to engage the coupling member with the first display member when the at least one cam of the first display member and the coupling member are disengaged, wherein the display arrangement is alternately engageable with the drive sleeve and with the dose setting member for dispensing or setting of the dose of the medicament, and wherein the retaining arrangement comprises at least two retaining teeth separated in a circumferential direction on an outer circumference of the coupling member, wherein the at least two retaining teeth are in radial abutment with a retaining ring of the first display member when the first display member is outside the predefined angular position or angular range; and a cartridge at least partially filled with the medicament and being arranged to operably engage the piston rod.

18. The injection device according to claim 17, wherein the cartridge is arranged in the housing.

19. The injection device according to claim 17, wherein the cartridge is arranged in a cartridge holder connected or connectable to the housing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In the following, an embodiment of the display arrangement, the drive mechanism and the injection device is described in detail by making reference to the drawings, in which:

(2) FIG. 1 shows a longitudinal cross-section through the injection device,

(3) FIG. 2 shows an exploded and perspective view of the various components of the injection device,

(4) FIG. 3 shows another longitudinal cross-section through the drive mechanism in an initial configuration,

(5) FIG. 4 is an enlarged cross-section of a dose limiting mechanism,

(6) FIG. 5 shows an enlarged longitudinal cross-section of the display arrangement,

(7) FIG. 6a is a perspective view of the first display member and the coupling member prior to an engagement of cam and coupling member,

(8) FIG. 6b shows a corresponding cross-section through the first display member as seen in distal direction,

(9) FIG. 7a shows the first display member and the coupling member according to FIG. 6a but with the cam in engagement with the coupling member,

(10) FIG. 7b is a cross-section through the first display member according to FIG. 7a,

(11) FIG. 8a shows a perspective view of the first display member and the coupling member after the cam has passed the coupling member and

(12) FIG. 8b shows a cross-section corresponding to the configuration according to FIG. 8a,

(13) FIG. 9 shows an isolated perspective view of the distal end of the coupling member,

(14) FIG. 10 shows an opposite perspective view of a proximal end of the coupling member,

(15) FIG. 11 shows the drive mechanism in longitudinal cross-section with the dose button partially depressed,

(16) FIG. 12 is indicative of the drive mechanism according to FIG. 11 with the dose button completely depressed to trigger the dispensing procedure,

(17) FIG. 13 is illustrative of the drive mechanism according to FIGS. 11 and 12 with the dose button released prior to a termination of the dose dispensing,

(18) FIG. 14 perspectively illustrates a distal end of the drive sleeve threadedly engaged with a last dose member,

(19) FIG. 15 shows an isolated perspective view of a proximal end of the drive sleeve,

(20) FIG. 16 shows a perspective and partially cut view of a dial sleeve to engage with the crown wheel portion of the drive sleeve according to FIG. 15,

(21) FIG. 17 is a perspective cross-sectional view of the interface of dial sleeve and drive sleeve,

(22) FIG. 18 is a perspective illustration of a dispense clicking mechanism during dose setting,

(23) FIG. 19 shows the dispense clicking mechanism according to FIG. 18 during dose dispensing and

(24) FIG. 20 shows a cross-section through the dispense clicking mechanism according to FIGS. 18 and 19.

DETAILED DESCRIPTION

(25) In FIGS. 1 and 2, the complete injection device 10 is illustrated in a longitudinal cross section and in an exploded view with its various components. The injection device 10 is of pen-injector type and comprises a substantially cylindrical and axially elongated shape. Throughout the Figures the axial distal direction is denoted with reference number 1 and the opposite proximal direction is denoted with reference number 2. The injection device 10 comprises a drive mechanism 18 and further has a proximal housing 60, also denoted as body in which the drive mechanism 18 is accommodated. The housing 60 defines a longitudinal or axial direction 4 and further has at its centre a rotation axis 3, with regard to which various components of the injection device 10 are rotatable.

(26) In distal direction 1 the housing 60 is connected with a cartridge holder 13 which is adapted to accommodate and to receive a cartridge 12 containing the medicament 11 to be dispensed by the injection device 10 by way of its drive mechanism 18. The cartridge 12 typically comprises a vitreous barrel of cylindrical or tubular shape and is sealed in distal direction 1 by a pierceable sealing member, such like a septum.

(27) In proximal direction 2, the cartridge 12 is sealed by means of a piston 14 slidably arranged in the barrel of the cartridge 12. The piston 14 typically comprises an elastomeric material, by way of which the proximal end of the cartridge 12 can be effectively sealed in a fluid- and gas-tight manner. The piston 14 of the cartridge 12 is to be operably engaged with a distal end of a piston rod 90 of the injection device's 10 drive mechanism 18. A distally directed displacement of the piston 14 typically induced and governed by the piston rod 90 leads to a respective build up of a fluid pressure inside the cartridge 12. When the distal outlet of the cartridge 12 is connected with e.g. a needle assembly, which is not illustrated here, a predefined amount of the liquid medicament, which equals a previously set dose, can be expelled from the cartridge 12 and can be dispensed via the injection needle. At its distal end the injection device 10, hence the cartridge holder 13 thereof comprises a threaded socket 16 to releasably engage with the needle assembly.

(28) The cartridge holder 13 and hence the cartridge 12 assembled therein is to be protected and covered by a removable protective cap, which is not further illustrated. Prior to setting and/or dispensing of a dose, the protective cap 19 of the injection device 10 as well as an inner needle cap of the needle assembly have to be removed. After dispensing or injecting of the medicament, e.g. into biological tissue, the needle assembly is typically to be disconnected from the cartridge holder 13 and is to be discarded.

(29) The drive mechanism 18 as illustrated in the various FIGS. 1 to 20 comprises numerous functional and mechanically inter-engaging components by way of which a dose of variable size can be set and subsequently dispensed. The drive mechanism 18 is of semi-automated type. It comprises a means for storing mechanical energy during a dose setting procedure. Said mechanical energy is then usable for driving the piston rod in distal direction 1 during a dose dispensing procedure. Consequently, it is the device 10 and the drive mechanism 18 that provide mechanical energy and a driving force or driving torque to conduct an injection procedure. Consequently, an injection force does not have to be provided by the user during the dose dispensing process.

(30) Dose dispensing requires distally directed advancing of the piston rod 90 relative to the cartridge 12, hence relative to the cartridge holder 13 and relative to the housing 60. The drive mechanism 18 is operable to set a dose of arbitrary size. The size of a dose actually set is visually displayed to a user via a display arrangement 20 located in a proximal portion of the housing 60. The housing 60 comprises a substantially cylindrical hollow shape. As shown in FIG. 2 it comprises a window 62 near its proximal end covered by an inlay 70.

(31) The inlay 70 has a transparent cover 63 that overlaps with the window of the housing 60. The cover can include a magnifying lens so that numbers or symbols of display surfaces 28 of the display arrangement 20 appear enlarged to a user. In the instance illustrated in FIG. 3, the housing 60 near its distal end comprises a centrally-located threaded support 64 that receives the threaded piston rod 90. The axially elongated piston rod 90 comprises an outer thread 91 that is threadedly engaged with an inner thread 65 of the support 64. In this way, a rotation of the piston rod 90 relative to the housing 60 leads to a distally-directed advancing motion of the piston rod 90 relative to the housing 60 and relative to the barrel of the cartridge 12.

(32) At its distal end the piston rod is rotatably connected with a radially widened pressure piece 92, which almost completely abuts with a proximal thrust-receiving surface of the cartridge's 12 piston 14. Due to the rotatable bearing of the pressure piece 92 on the piston rod 90, the pressure piece may rest on the piston 14 while the piston rod 90 rotates during dose dispensing.

(33) The piston rod 90 further comprises at least one, typically at least two diametrically oppositely located longitudinal grooves 94 by way of which the piston rod 90 is in permanent rotational engagement with a drive sleeve 110. As shown in FIG. 17 the drive sleeve 110 comprises two radially inwardly extending protrusions 111 extending in longitudinal or axial direction from its radially inwardly-facing sidewall portion. These protrusions 111 engage with the longitudinally extending grooves 94 of the piston rod 90, that are indicated on FIG. 2.

(34) In this way the drive sleeve 110 is permanently rotatably coupled with the piston rod 90. The drive sleeve 110, which is slidably displaceable relative to the housing 60 as well as relative to the piston rod 90 is biased relative to the housing 60 in axial direction 4 by way of a dispensing spring 130. The dispensing spring 130 is received in an annular recess 112 provided at the distal front face of the drive sleeve 110. The annular recess 112 is adapted to receive a proximal end of the dispensing spring 130 while a distal end of the dispensing spring 130 axially abuts with the support 64 centrally located inside the housing 60. The dispensing spring 130 serves to displace the drive sleeve 110 into the proximal direction 2. Hence, the drive sleeve 110 is displaceable in distal direction 1 against the action of the dispensing spring 130.

(35) As shown in FIGS. 14 and 17 the drive sleeve 110 further comprises a geared section 113 at its distal end featuring numerous detents 114 extending radially outwardly from the outer circumference of the drive sleeve 110. At an axial distance from the geared section 113 there is provided a gear structure 116 extending around the outer circumference of the drive sleeve 110. Even further separated from the distal end the drive sleeve 110 comprises a threaded section 117 which in distal direction 2 is terminated by a radially outwardly and axially extending stop member 124.

(36) On the threaded section 117 there is located a last dose limiting member 122 forming a last dose limiting mechanism 120. The last dose limiting member 122 may comprise an annular or ring-like shape and has a radially inwardly-facing thread engaging with the outer threaded section 117 of the drive sleeve 110. The last dose limiting member 122 comprises two or even more radially outwardly extending protrusions 125 that extend in axial direction 4. The protrusions 125 engage with a longitudinal recess or groove 142 of a dial sleeve 140.

(37) The dial sleeve 140 comprises a radially widened distal portion 143, a neck portion 144 proximally adjacent thereto and a proximal portion 145 extending all the way through and towards the proximal end of the housing 60. The distal portion 143 of the dial sleeve 140 receives the drive sleeve 110 through which the piston rod 90 completely extends. A proximal portion of the piston rod 90 extending in proximal direction 2 from the proximal end of the drive sleeve 110 extends into or even through the neck portion 144 of the dial sleeve 140 as illustrated in FIG. 3.

(38) In the neck portion 144 the dial sleeve 140 comprises a threaded section 146 which is threadedly engaged with a single dose limiting member 150. The single dose limiting member 150 as shown in FIGS. 3 and 4 comprises a radially inwardly-facing threaded section 152 threadedly engaged with the threaded section 146 of the dial sleeve 140. Radially outwardly the single dose limiting member 150 comprises a radially outwardly extending protrusion 154 that is rotatably constrained but axially guided in a groove 81 of an insert 80 that is permanently fixed and received in the housing 60. The groove 81 extends in axial direction 4 so that a rotation of the dial sleeve 140 relative to the housing 60 leads to an axial displacement of the single dose limiting member 150.

(39) The drive mechanism 18 further comprises a dose setting member 100 located at a proximal end of the housing 60. The dose setting member 100 has the form of a user-actuatable dial grip and is rotatably supported on the housing 60. As illustrated in FIG. 5 the dose setting member 100 may even serve as a proximal extension of the housing 60. Near its distal end the dose setting member comprises a radially inwardly extending protrusion 102 engaging with a correspondingly-shaped recess at the housing's 60 proximal end. In this way, the dose setting member is axially constrained and axially secured to the housing 60.

(40) At the very proximal end of the injection device 10 there is provided a dose button 105. The dose button 105 is rotatably fixed to the dose setting member, e.g. by way of a splined interface, providing a rotational coupling of dose setting member 100 and dose button 105 but allows for an axial displacement of the dose button 105 relative to the dose setting member 100 and hence relative to the housing 60. In a central portion of an end face 106 the dose button 105 comprises a distally-extending bulged portion 107 which is in permanent and direct abutment with a proximal end face of a ring gear 160. The ring gear 160 comprises a cup-shaped central receptacle to receive a proximal end of the dial sleeve 140. The ring gear 160 is permanently rotatably and axially connected to the dial sleeve 140. A rotation of the ring gear 160 as well as any axial displacement of the ring gear 160 equally transfers to the dial sleeve 140.

(41) The ring gear 160 is selectively rotatably engageable with the dose setting member 100. As indicated in FIG. 5, the ring gear 160 comprises a geared section 162 at its outer circumference that engages with a radially inwardly extending detent structure or with a correspondingly geared or toothed structure 101 of the dose setting member 100. In this way, any rotation of the dose setting member 100 relative to the housing 60 can be equally transferred to a respective rotation of the ring gear 160. The ring gear 160 further comprises a radially-widened portion 163 at its distal end that comprises an annular geared structure 164 at an inside-facing sidewall portion.

(42) The radially widened portion 163 the geared structure 164 meshes with a planet gear 170 that is rotatably arranged on a bearing 72 of the inlay 70. Hence, the planet gear 170 is fixed to the inlay 70 and hence fixed to the housing 60 but is rotatable with respect to the bearing 72 extending in axial direction 4. The planet gear 170 further meshes with a geared section 38 of an axially-extending shaft 37 of a first display member 22 of a display arrangement 20. The display arrangement 20 comprises a first sleeve-like or annular-shaped display member 22 as well as a second sleeve shaped and annular display member 24. The second display member 24 is arranged axially adjacent to the first display member 22. First and second display members 22, 24 comprise a display surface 28 that is provided with various consecutive symbols 29 by way of which a two or three digit number representing the size of the dose can be illustrated in the window 62 of the housing 60.

(43) As will be explained later first and second display members 22, 24 are mutually coupled by means of a coupling member 26. The coupling member 26 comprises an axially-extending shaft 40 that is rotatably supported in a corresponding bearing of the insert 80. In this way, the coupling member 26 is free to rotate with regard to the insert 80 and hence with regard to the housing 60 but is fixed in axial direction 4. As it is apparent from FIG. 5, the proximal end of the coupling member 26 is axially constrained by a flange-like and radially outwardly extending body 23 of the first display member 22, which body 23 radially extends between the annular display surface 28 and the radially inwardly located shaft 37 of the first display member 22.

(44) The first display member 22 is permanently rotatably engaged with the dial sleeve 140. When the dial sleeve 140 during dose setting is dialed in a dose incrementing direction 5 the first display member 22 and, depending on the size of dose and depending on the number of revolutions of the dose setting member 100, also the second display member 24 starts to rotate in order to visualize consecutive rising numbers in the window 62 that represent the size of the dose actually set. During a dose dispensing procedure, which is to be triggered by a distally-directed depression of the dose button 105 the dial sleeve 140 is disconnected or disengaged from the dose setting member 100. During dose dispensing the dial sleeve 140 together with the drive sleeve 110 rotates in an opposite dose decrementing direction 6 according to which the display arrangement 20 with its first and second display members 22, 24 returns into an initial configuration.

(45) In the following setting of a dose will be described.

(46) In an initial configuration as illustrated in FIG. 3 the dispensing spring 130 applies proximally-directed pressure to the drive sleeve 110 and further onto the dial sleeve 140. Since the proximal end of the dial sleeve 140 is received in a receptacle of the ring gear 160 also the ring gear 160 is located in a proximal end position. Due to the axial abutment of the ring gear 160 with the dose button 105 also the dose button 105 is in an inactive and proximal initial position.

(47) In this configuration as it is shown in an enlarged view in FIG. 5 the toothed structure 101 of the dose setting member 100 is engaged with the geared section 162 of the ring gear 160. A rotation of the dose setting member 100 in a dose incrementing direction 5 therefore leads to a respective rotation of the dial sleeve 140. As a consequence, the single dose limiting member 150 travels in axial, presently in distal direction 1 as it becomes apparent from a comparison of FIGS. 3 and 4. The dial sleeve 140 comprises a distal stop 147 as well as a proximal stop 148 to engage with a respective stop 156 of the single dose limiting member 150. Hence, when a maximum allowable dose is set, the single dose limiting member 150 has traveled all the way in distal direction 1 until it engages with its stop 156 with a corresponding distal stop 147 of the dial sleeve 140. Mutually corresponding stops 147, 148, 156 of the dial sleeve 140 and of the single dose limiting member 150 typically extend in axial and radial direction so that a well-defined and directly acting stop can be provided as soon as a predefined angular position of the dial sleeve 140 has been reached.

(48) In the initial configuration of the drive mechanism 18 as shown in FIG. 3, the single dose limiting member 150 is in engagement with the zero dose stop 148. In this stop configuration a rotation of the dial sleeve 140 in dose decrementing direction 6 is interrupted and prevented. So in the initial configuration of the drive mechanism 18 a dialing of the dose setting member 100 in a dose decrementing direction 6, that would lead to a negative dose size is effectively prevented. Moreover, the zero dose stop configuration also limits the dispensing procedure and serves to terminate the dispensing procedure of a dose previously set.

(49) As the dial sleeve 140 is rotated in dose incrementing direction 5 it serves to rotate a collar 180. The collar 180 comprises numerous proximally-extending wings that are received in correspondingly-shaped axially extending recesses 149 provided at a distal end of the dial sleeve 140. The collar 180 is axially fixed but rotatable to the housing 60. Due to the mutual engagement of the wings 181 with the recesses 149 the collar 180 is permanently rotatably coupled with the dial sleeve 140. Since the recesses 149 and the wings 181 extend in axial direction 4, the dial sleeve 140 is axially displaceable relative to the collar 180 and remains rotatably coupled therewith.

(50) The collar 180 is connected with a distal end of a helical drive spring 136 extending around the outer circumference of the dial sleeve 140. A proximal end of the helical drive spring 136 is fixed to the insert 80. Typically, in an initial configuration as shown in FIG. 3 the drive spring 136 is already pre-loaded. Upon rotation of the dial sleeve 140 in dose incrementing direction 5 the drive spring 136 is biased and wound-up further so as to increase the mechanical energy stored in the drive spring 136. In the initial or dose setting configuration the drive sleeve 110 is engaged via its distally-located geared section 113 with a correspondingly-shaped geared section 67 of the housing 60.

(51) Hence, in the initial or dose setting configuration the drive sleeve 110 is rotatably fixed to the housing 60. The collar 180 comprises a central through opening with a radially inwardly facing geared structure 182. In the dose setting configuration the geared structure 182 facing towards the outer circumference of the drive sleeve 110 is axially-located between the geared section 113 and the geared structure 116 of the distal portion of the drive sleeve 110. In this way, the collar 180 together with the dial sleeve 140 is allowed to rotate while the drive sleeve 110 is rotatably fixed to the housing 60.

(52) As illustrated in FIGS. 15-17 the drive sleeve 110 comprises a crown wheel portion 118 at its distal end that meshes with a correspondingly-shaped crown wheel portion 141 of the dial sleeve 140 facing in distal direction. The teeth of the crown wheel portions 118, 141 are adapted to provide a rather smooth dose incrementing rotation of the dial sleeve 140 relative to the drive sleeve 110. The engagement of crown wheel portion 141 and 118 is designed and configured such, that the restoring torque of the biased drive spring 136 is less than a force required to rotate the dial sleeve 140 in the opposite dose decrementing direction 6 relative to the drive sleeve 110.

(53) Since the drive sleeve 110 is axially biased by the dispensing spring 130 the drive sleeve 110 shuttles back and forth due to the axial extension of the mutually engaging crown wheel portions 118, 141 as the dial sleeve 140 is rotated in the dose incrementing direction 5 or dose decrementing direction 6. The mutual engagement of the crown wheel portions 141, 118 does not only keep the drive spring 136 biased and does not only prevent a self-actuated release of the drive spring 136 but also provides an audible as well as a tactile feedback to the user of the device during actuation, hence during dialing of the dose setting member 100. The shape and geometry of the mutually engaging crown wheel portions 118, 141 is selected such, that the dial sleeve 140 can be also rotated in a dose decrementing direction 6 in case that a selected dose should be too large.

(54) During setting of a dose and during rotation of the dial sleeve 140 relative to the drive sleeve 110 also the last dose limiting member 122 advances from its initial proximally-located position in distal direction 1 as it is apparent from a comparison of the configurations according to FIGS. 3 and 12. Since the dial sleeve 140 and the drive sleeve 110 rotate in unison during a dose dispensing procedure the last dose limiting member 122 will not be subject to any further axial displacement. During a consecutive dose setting procedure the last dose limiting member 122 will be displaced further in distal direction 1 until it engages with a radial and/or axial stop 124 provided at a distal end of the drive sleeve 110. This mutual abutment serves to prevent to dial and to select a dose that would exceed the amount of medicament left in the cartridge.

(55) During a dose setting procedure but also during dose dispensing the ring gear 160 is permanently engaged with the dial sleeve 140 as well as with the planet gear 170. A rotation in dose incrementing direction 5, typically during dose dispensing and induced via a user dialing the dose setting member 100 relative to the housing 60 transfers into a rotation of the first display member 22 as shown in the sequence of FIG. 6a-8b. On the outer circumference of the disc- or sleeve-shaped first display member 22 there is provided a display surface 28 on which consecutive numbers ranging from 0-9 are equidistantly located.

(56) The first display member 22 comprises an axially extending shaft 37 in a central portion. The rather smooth and even-shaped shaft 37 is intersected by the proximal portion 145 of the dial sleeve 140. In this way, the first display member 22 is rotatably supported on the dial sleeve 140. Axially adjacent to the first display member 22 there is located the second display member 24, which comprises also numerous digits ranging from 0-12. While the first display member 22 represents the ones of a two or three digit number the second display member 24 represents the tenth or decades of a two or three digit number. In this way, every discrete dose size between 0-120 IU can be illustrated by the display arrangement 20. The display arrangement 20 is by no way limited to the illustration of dose sizes between 0 and 120 but may be used also for other scales and other medicaments.

(57) The display surfaces 28 of first and second display members 22, 24 are axially flush. First and second display members 22, 24 that constitute an odometer-like display arrangement 20 are coupled by means of a coupling member 26 featuring various geared sections 42, 44 and a retaining section 46 as it becomes apparent from FIGS. 9 and 10. The coupling member 26 is located radially offset and is hence rotatable relative to a coupling axis 7 extending parallel but radially offset from the centrally-located rotation axis 3.

(58) The first display member 22 comprises an axially extending cam 32 near its outer edge or outer circumference. Hence, the cam 32 is located eccentric with regard to the rotation axis 3 or with regard to the center or shaft 37 of the first display member 22. The cam 32 is configured to mesh with a first geared section 42 of the coupling member 26. As illustrated in FIG. 10, the first geared section 42 comprises numerous equidistantly arranged radially outwardly extending first teeth 43. Every time the cam 32 reaches and passes by the coupling member 26, the cam 32 circumferentially or tangentially abuts and engages with one of the first teeth 43 of the first geared section 42, thereby inducing a well-defined and limited rotation onto the coupling member 26.

(59) The coupling member 26 further comprises a second geared section 44 with a number of second teeth 45. The second geared section 44 is located axially offset and at an axial distance from the first geared section 42. As illustrated in FIG. 5, the second geared section 44 meshes with a radially inwardly-facing geared section 25 of the second display member 24, which is configured as a sleeve and which is rotatably supported by the insert 80. In this way any rotation of the coupling member 26 induced by the cam 32 of the first display member 22 is transferred into a respective rotation of the second display member 24 for each direction of rotation.

(60) The cam 32 of the first display member 22 axially extends from a retaining ring 30 extending around the entire circumference of the first display member 22. As illustrated in FIGS. 6a, 7a and 8a the retaining ring 30 is radially inwardly stepped down compared to the display surface 28.

(61) As shown in FIG. 5, a proximal portion of the sleeve-shaped second display member 24 can be radially supported by the retaining ring 30. In this way, the first display member 22 provides a kind of bearing for the second display member 24. The retaining ring from which the cam 32 extends in distal direction 1 comprises a radially inward-facing inner surface 36 that engages and/or abuts with a retaining section 46 of the coupling member 26. The retaining ring 30 of the first display member 22 and the retaining section 46 of the coupling member 26 constitute and form a retaining arrangement 48 that serves to prevent a rotation of the coupling member 26 and hence of the second display member 24 when the cam 32 is disengaged from the coupling member 26.

(62) Hence, the cam 32 is in engagement with the coupling member 26 only when located in a predefined angular position or when located in a predefined angular range. When located outside the predefined angular position or angular range, hence when the cam 32 is decoupled and contactless with regard to the coupling member 26 the retaining arrangement 48 serves to prevent a self-actuated or otherwise unintentional rotation of the coupling member 26 and of the second display member 24. Hence the predefined angular position or angular range is defined by the operable engagement between cam 32 and coupling member 26.

(63) The retaining section 46 of the coupling member 26 comprises three equidistantly separated retaining teeth 47. As shown in FIG. 10, there are provided three retaining teeth while the first geared section 42 comprises six first teeth 43. As shown in FIG. 10, every second tooth of the first teeth 43 is axially adjacent with a retaining tooth 47. The retaining teeth 47 however comprise a shorter extension in radial direction compared to the first teeth 43. In addition and as illustrated in the sequence of FIGS. 6b, 7b and 8b the retaining teeth 47 comprise beveled side flanks 47a, 47b. The side flanks 47a, 47b are oriented and configured such, that the side flank 47b of a selected retaining tooth 47 as well as a side flank 47a of a neighboring retaining tooth 47 are simultaneously in radial abutment with the radially inward-facing inner surface 36 of the retaining ring 30. Due to the simultaneously abutment of two retaining teeth 47 with the retaining ring 30 the coupling member 26 is hindered from rotating while the retaining ring 30 and the first display member 22 are still free to rotate in such a way that the inner surface 36 of the retaining ring 30 slides along the side flanks 47a, 47b of neighboring retaining teeth 47.

(64) As it is particularly apparent from FIG. 6b the retaining ring 30 comprises a radial recess 31 that is adapted to radially receive the retaining tooth 47. Apparently, the recess 31 coincides with the cam 32. Hence, when the cam 32 passes or engages with one of the first teeth 43 the retaining tooth 47 axially adjacent to the particular one of the first teeth 43 is allowed to enter the recess 31 as illustrated in FIG. 7b. As the retaining ring 30 with the cam 32 and with the first display member 22 rotates further the retaining tooth 47 leaves the recess 31 so that it engages with its side flank 47b with the retaining ring 30.

(65) As it is further apparent from the perspective illustration of the first display member 22 according to FIGS. 6a, 7a and 8a the recess 31 extends into the cam 32 and divides the cam 32 into two cam segments 33, 34. The cam segments 33, 34 are designed and configured to fit into the intermediate space provided between two consecutive first teeth 43 of the first geared section.

(66) In this way, the driving torque to rotate the coupling member 26 can be divided among several first teeth 43 of the first geared section. The recess 32 of the retaining ring 30 extends in axial direction 4 and extends between and separates the cam segments 32. In the region between the cam segments 33, 34 the recess 31 may comprise or form a cam slit 35 as shown in FIG. 8a.

(67) As it is further apparent from FIGS. 9 and 10 the coupling member 26 comprises a separating disc portion 49 extending between first and second geared section 42, 44. In general since the teeth 43, 45 of first and second geared section 42, 44 are flush in axial direction 4 such a separating disc portion is substantially ineffective in regard to a coupling between first and second display members 22, 24. The separating disc portion 49 may be beneficial to provide axial abutment e.g. for the second display member's 24 geared section 25.

(68) Since the first display member 22 is permanently rotatably engaged with the dial sleeve 140 and since the cam 32 has a symmetrical shape with regard to a dose incrementing direction 5 and in regard to a dose decrementing direction 6 the odometer-like display arrangement 20 is equally operable during dose setting as well as during dose dispensing. Typically, during dose setting a sequence of increasing numbers shows up in the window 62 while during dose dispensing the numbers decrement.

(69) In the following dispensing of a dose will be described.

(70) For dispensing of a dose the user simply depresses the dose button 105 in distal direction 1. In this way and due to the axial abutment between the dose button 105, the ring gear 160 and the dial sleeve 140, the dial sleeve 140 is displaced in distal direction 1 in unison with the drive sleeve 110, which axially abuts with the dial sleeve 140. As the ring gear 160 is displaced in distal direction 1 its geared section 162 disengages from the toothed structure 101 of the dose setting member 100 as it is illustrated in FIG. 11. There, the drive mechanism 18 is illustrated with the dose button 105 partially depressed.

(71) As a consequence, the ring gear 160 and hence the display arrangement 20 with its first display member 22 is decoupled from the dose setting member 100. Any further rotation of the dose setting member 100 therefore no longer has an influence on the angular position of the dial sleeve 140. With the dose button 105 at least partially depressed as illustrated in FIG. 11 a further manipulation of the dose size is prevented. Moreover, the display arrangement 20 which remains engaged with the ring gear 160 is decoupled from the dose setting member 100. In the partially depressed configuration the drive sleeve 110 is displaced in distal direction to such an extent that the radially inwardly-facing geared structure 182 of the collar 180 engages with the geared structure 116 of the drive sleeve 110.

(72) In the partially depressed configuration the drive sleeve 110, in particular its distally-located geared section 113 is still engaged and coupled with the geared section 67 of the housing 60. The drive sleeve 110 is still hindered from rotating relative to the housing 60 but is already rotatably engaged with the collar 180 that is drivable by the wound-up drive spring 136. In the course of depressing the dose button 105 in distal direction 1 a rotational coupling between the collar 180 and the drive sleeve 110 is established and activated before the drive sleeve 110 is liberated or decoupled from the housing 60. In this way uncontrolled slip of the drive sleeve 110 can be effectively prevented.

(73) As the dose button 105 is completely depressed in distal direction the geared section 113 with its various detents 114 of the drive sleeve 110 disengage from the geared section 67 of the housing 60 so the drive sleeve 110 is no longer rotationally constrained. Torque and mechanical energy stored in the drive spring 136 is then transmitted through the collar 180 to the drive sleeve 110 causing it to rotate. A rotating drive sleeve 110 leads to a respective rotation of the piston rod 90, which due to its threaded engagement with the housing 60 advances in distal direction so as to expel a predefined amount of the medicament 11 from the cartridge 12.

(74) During the dispensing procedure the dial sleeve 140 also rotates in the dose decrementing direction 6. The single dose limiting member 150 returns into its initial configuration as shown in FIG. 3 until it engages with a corresponding stop 148 of the dial sleeve. Simultaneously, the rotation of the ring gear 160 causes the first display member 22 to rotate back towards a zero unit position.

(75) Alternatively, a dispensing procedure may be abruptly stopped when the user releases the dose button 105 as it is illustrated in FIG. 13. Then, under the action of the dispensing spring 130 the drive sleeve 110 will first re-engage with the housing's 60 geared section 67 and will then disengage and release from the collar 180.

(76) When the drive sleeve 110 returns into its initial position under the action of the dispensing spring 130, the chamfers or beveled portions 115 provided on a proximal end of the detents 114 of the drive sleeve's 110 geared section 113 serve to induce a slight counter-directed rotation of the drive sleeve 110. Due to this small but distinct counter-rotation the piston rod 90 will be retracted by a predefined distance. This backs the pressure piece 92 away from the piston 14 of the cartridge 12 so that the piston 14 may elastically relax into an initial configuration in proximal direction 2 so that inevitable relaxing of the elastic piston 14 has no or at least a reduced pressure increasing effect on the medicament 11 contained in the cartridge 12. In this way, post dispensing droplet generation to be observed at the distal tip of the needle can be effectively reduced.

(77) In order to provide an audible feedback during dose dispensing and in order to indicate to a user that a dispensing procedure is in progress the drive mechanism 18 and the injection device 10 comprise a clicking member 190 that is audibly engaged with a toothed structure 82 of the insert 80 during dose dispensing but which is disengaged and decoupled from the toothed structure 82 when the drive mechanism 18 is in dose setting configuration. The clicking member 190 comprises an arched shape and is provided at a proximal end of a cup-shaped and radially widened receptacle 139 on the proximal portion 145 of the dial sleeve 140. The receptacle 139, radially confined by a rim shaped side wall portion 138, opens towards the proximal end is adapted to receive a circumferential or ring-shape toothed structure 82 of the insert 80, which is fixed to the housing 60.

(78) As shown in FIGS. 3 and 18 the clicking member 190 and the toothed structure 82 are axially offset. It is due to the distally-directed displacement of the dial sleeve 140 during a dose dispensing procedure that the clicking member 190 engages and meshes with the toothed structure 82 as it is apparent from FIGS. 12 and 19. As the dial sleeve 140 rotates in dose decrementing direction 6 the clicking member 190 repeatedly meshes and slides along consecutive teeth of the insert's 80 toothed structure 82. With every tooth an audible click sound is generated indicating to the user, that dose dispensing is still in progress.

(79) The clicking member 190 comprises a radially inwardly extending nose portion 194 matching in shape and geometry with the shape of the saw tooth-like shaped toothed structure 82.

(80) At a predefined tangential or circumferential distance from the free end of the clicking member 190, where the nose portion 194 is provided the clicking member 190 comprises a radially outwardly extending bulged portion 196. The bulged portion 196 extends slightly radially outwardly compared to tangentially adjacent and rather smooth and arc-shaped portions of the clicking member 190. As the end of the dispensing procedure approaches, which coincides with a returning of the single dose limiting member 150 into its proximal end position as indicated in FIG. 3, the single dose limiting member 150 engages with the bulged portion 196 and applies a radially inwardly-directed tension or pre-tension onto the clicking member 190.

(81) In this way, the flexible length of the clicking member 190 is effectively shortened and the clicking member, hence its arc-shaped clicking arm is stiffened. As a zero dose configuration is finally reached that coincides with a termination of the dispensing procedure a more energetic click sound is generated, thereby audibly indicating to a user, that the end of the dispensing procedure has been reached.

(82) Release of the dose button 105 and the corresponding proximally-directed displacement of the dial sleeve 140 disengages the clicking member 190 from the toothed structure. In order to allow elastic relaxation of the clicking member the single dose limiting member 150 comprises an annular recess 158 providing a radially outwardly located relaxing space for the clicking member 190. In this way, a permanent deformation of the clicking member 190 can be prevented to counteract rupture of the clicking member's material due to creep.

LIST OF REFERENCE NUMBERS

(83) 1 distal direction

(84) 2 proximal direction

(85) 3 rotation axis

(86) 4 axial direction

(87) 5 dose incrementing direction

(88) 6 dose decrementing direction

(89) 7 coupling axis

(90) 10 injection device

(91) 11 medicament

(92) 12 cartridge

(93) 13 cartridge holder

(94) 14 piston

(95) 16 socket

(96) 18 drive mechanism

(97) 19 protective cap

(98) 20 display arrangement

(99) 22 first display member

(100) 23 body

(101) 24 second display member

(102) 25 geared section

(103) 26 coupling member

(104) 28 display surface

(105) 29 symbol

(106) 30 retaining ring

(107) 31 recess

(108) 32 cam

(109) 33 cam segment

(110) 34 cam segment

(111) 35 cam slit

(112) 36 inner surface

(113) 37 shaft

(114) 38 geared section

(115) 40 shaft

(116) 42 first geared section

(117) 43 tooth

(118) 44 second geared section

(119) 45 tooth

(120) 46 retaining section

(121) 47 retaining tooth

(122) 47a,b side flank

(123) 48 retaining arrangement

(124) 49 separating disc

(125) 60 housing

(126) 62 window

(127) 63 cover

(128) 64 support

(129) 65 inner thread

(130) 67 geared section

(131) 70 inlay

(132) 72 bearing

(133) 80 insert

(134) 81 groove

(135) 82 toothed structure

(136) 90 piston rod

(137) 91 outer thread

(138) 92 pressure piece

(139) 94 groove

(140) 100 dose setting member

(141) 101 toothed structure

(142) 102 protrusion

(143) 105 dose button

(144) 106 end face

(145) 107 bulged portion

(146) 110 drive sleeve

(147) 111 protrusion

(148) 112 annular recess

(149) 113 geared section

(150) 114 detent

(151) 115 beveled portion

(152) 116 geared structure

(153) 117 threaded section

(154) 118 crown wheel portion

(155) 119 stop member

(156) 120 last dose limiting mechanism

(157) 122 last dose limiting member

(158) 124 stop member

(159) 125 protrusion

(160) 130 dispensing spring

(161) 136 drive spring

(162) 138 sidewall portion

(163) 139 receptacle

(164) 140 dial sleeve

(165) 141 crown wheel portion

(166) 142 groove

(167) 143 distal portion

(168) 144 neck portion

(169) 145 proximal portion

(170) 146 threaded section

(171) 147 stop

(172) 148 stop

(173) 149 recess

(174) 150 single dose limiting member

(175) 152 threaded section

(176) 154 protrusion

(177) 156 stop

(178) 158 recess

(179) 160 ring gear

(180) 162 geared section

(181) 163 radially widened portion

(182) 164 geared structure

(183) 170 planet gear

(184) 180 collar

(185) 181 wing

(186) 182 geared structure

(187) 190 clicking member

(188) 194 nose portion

(189) 196 bulged portion