Drive mechanism of a drug delivery device

Abstract

A drive mechanism of a drug delivery device for dispensing of a dose of a medicament includes a housing extending in an axial direction, and a piston rod to operably engage with a piston of a cartridge to displace the piston in an axial distal direction. The drive mechanism further includes a last dose sleeve rotatably supported in the housing and being selectively engageable with a dose setting mechanism for setting of a dose, and a last dose member threadedly engaged to the housing, rotatably locked to the last dose sleeve and axially displaceable relative to the last dose sleeve.

Claims

1. A drive mechanism of a drug delivery device for dispensing a dose of a medicament, the drive mechanism comprising: a housing comprising a radial stop, a piston rod to operably engage with a piston of a cartridge to displace the piston in a distal direction along a longitudinal axis of the housing, a last dose sleeve rotatably supported in the housing and being selectively engageable with a user operable dose setting member for setting of the dose, wherein the last dose sleeve is configured to be coupled to the dose setting member during dose setting and to be decoupled from the dose setting member during dose dispensing, wherein the last dose sleeve is axially fixed relative to the housing, and a last dose member threadedly engaged to and rotatable relative to the housing, rotationally locked to the last dose sleeve, and axially displaceable relative to the last dose sleeve, wherein the last dose member comprises a radial counter stop configured to engage with the radial stop to prevent rotation of the last dose member, wherein the last dose sleeve is hollow, and at least one axially extending clutch member extending through the last dose sleeve is axially displaceable relative to the last dose sleeve for selectively engaging the dose setting member with the last dose sleeve exclusively during the dose setting.

2. The drive mechanism according to claim 1, wherein the last dose member is radially sandwiched between the housing and the last dose sleeve.

3. The drive mechanism according to claim 1, wherein the last dose member is arc-shaped and comprises an outer thread to engage with an inner thread of the housing.

4. The drive mechanism according to claim 1, wherein: one of the last dose member and the last dose sleeve comprises an axially extending groove, the other one of the last dose member and the last dose sleeve comprises a correspondingly shaped radially extending protrusion, and the axially extending groove is configured to receive the correspondingly shaped radially extending protrusion to inhibit relative rotation between the last dose member and the last dose sleeve.

5. The drive mechanism according to claim 1, wherein the radial counter stop extends radially at a circumferential end and is configured to engage with the radial stop during rotation of the last dose member relative to the housing, wherein the radial stop extends radially at an inside facing portion of the housing.

6. The drive mechanism according to claim 1, wherein the last dose sleeve comprises a radially outwardly extending flange portion at an axial end to support the last dose member in an initial assembly configuration.

7. The drive mechanism according to claim 1, wherein the last dose sleeve is axially constrained in the housing between a drive wheel and an insert axially fixed to the housing.

8. The drive mechanism according to claim 7, wherein the drive wheel is threadedly engaged with the piston rod, the piston rod being rotationally locked to the housing.

9. The drive mechanism according to claim 7, wherein the at least one axially extending clutch member is displaceable between a proximal stop position and a distal stop position, the at least one axially extending clutch member being engaged with the last dose sleeve in the proximal stop position such that torque is transferred from the at least one axially extending clutch member to the last dose sleeve and being engaged with the drive wheel in the distal stop position such that torque is transferred from the at least one axially extending clutch member to the drive wheel.

10. The drive mechanism according to claim 7, wherein the at least one axially extending clutch member comprises a crown wheel at its distal end face to engage with a corresponding crown wheel on a proximal end face of the drive wheel.

11. The drive mechanism according to claim 1, wherein the at least one axially extending clutch member comprises radially outwardly extending teeth at a distal end to selectively engage with correspondingly shaped radially inwardly extending teeth of the last dose sleeve.

12. The drive mechanism according to claim 1, wherein the at least one axially extending clutch member is axially displaceable in the distal direction against an action of a spring by means of a dose dispensing button located at a proximal end of the housing.

13. The drive mechanism according to claim 1, wherein the last dose member is configured to jointly rotate with the last dose sleeve and to move axially relative to the last dose sleeve during the dose setting.

14. The drive mechanism according to claim 1, wherein the last dose member and the last dose sleeve are configured to be axially fixed relative to the housing during the dose dispensing.

15. The drive mechanism according to claim 1, wherein the radial stop and the radial counter stop extend in both a radial direction and an axial direction, and the radial stop is configured to engage with the radial counter stop in a circumferential direction such that further rotation of the last dose sleeve and further rotation the last dose member are prevented when a last dose stop configuration of the drive mechanism has been reached.

16. A drug delivery device for dispensing a dose of a medicament, the drug delivery device comprising: a housing comprising a radial stop; a cartridge at least partially filled with the medicament and being arranged in the housing or in a cartridge holder fixed to the housing; and a drive mechanism comprising a piston rod to operably engage with a piston of the cartridge to displace the piston in a distal direction along a longitudinal axis of the housing, a last dose sleeve rotatably supported in the housing and being selectively engageable with a user operable dose setting member for setting the dose, wherein the last dose sleeve is configured to be coupled to the dose setting member during dose setting and to be decoupled from the dose setting member during dose dispensing, wherein the last dose sleeve is axially fixed relative to the housing, and a last dose member threadedly engaged and rotatable relative to the housing, rotationally locked to the last dose sleeve, and axially displaceable relative to the last dose sleeve, wherein the last dose member comprises a radial counter stop configured to engage with the radial stop to prevent rotation of the last dose member; wherein the last dose sleeve is hollow, and at least one axially extending clutch member extending through the last dose sleeve is axially displaceable relative to the last dose sleeve for selectively engaging the dose setting member with the last dose sleeve exclusively during the dose setting.

17. The drug delivery device according to claim 16, wherein: the last dose member is radially sandwiched between the housing and the last dose sleeve, and the last dose sleeve is axially constrained in the housing between a drive wheel and an insert axially fixed to the housing.

18. The drug delivery device according to claim 16, wherein the last dose member is configured to jointly rotate with the last dose sleeve and to move axially relative to the last dose sleeve during the dose setting.

19. The drug delivery device according to claim 16, wherein the last dose member and the last dose sleeve are configured to be axially fixed relative to the housing during the dose dispensing.

20. The drug delivery device according to claim 16, wherein the radial stop and the radial counter stop extend in both a radial direction and an axial direction, and the radial stop is configured to engage with the radial counter stop in a circumferential direction such that further rotation of the last dose sleeve and further rotation of the last dose member are prevented when a last dose stop configuration of the drive mechanism has been reached.

21. A method of operating a drug delivery device, the method comprising: setting a dose of medicament to be dispensed by the drug delivery device by operating a dose setting member, thereby causing a last dose sleeve axially fixed relative to a housing of the drug delivery device to rotate through the housing of the drug delivery device while a last dose member threadedly engaged to the housing of the drug delivery device, rotatable relative to the housing of the drug delivery device, and rotatably locked to the last dose sleeve advances axially through the housing of the drug delivery device, the last dose member being configured to inhibit rotation of the last dose sleeve to inhibit the dose from exceeding an amount of medicament remaining in the drug delivery device, a radial counter stop of the last dose member being configured to abut a radial stop on the housing of the drug delivery device, thereby inhibiting rotation of the last dose sleeve relative to the housing of the drug delivery device, wherein the last dose sleeve is hollow, and at least one axially extending clutch member extending through the last dose sleeve is axially displaceable relative to the last dose sleeve for selectively engaging the dose setting member with the last dose sleeve exclusively during dose setting; and dispensing the dose without causing the last dose member to advance axially through the housing while the last dose member is decoupled from the dose setting member.

22. The method according to claim 21, wherein setting the dose comprises rotating the dose setting member, wherein the last dose member is configured to inhibit rotation of the dose setting member to inhibit the dose from exceeding the amount of medicament remaining in the drug delivery device.

23. The method according to claim 22, wherein rotating the dose setting member causes rotation of a drive sleeve in a dose incrementing direction to set the dose, and dispensing the dose comprises depressing a dose dispensing button to disengage the dose setting member from the drive sleeve and to enable rotation of the drive sleeve in a dose decrementing direction to dispense the dose.

24. The method according to claim 21, wherein the radial stop and the radial counter stop extend in both a radial direction and an axial direction, and the radial stop is configured to engage with the radial counter stop in a circumferential direction such that further rotation of the last dose sleeve and rotation of the last dose member are prevented when a last dose stop configuration of the drug delivery device has been reached.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In the following, an embodiment will be described by making reference to the drawings, in which:

(2) FIG. 1 schematically illustrates a drug delivery device in longitudinal cross-section,

(3) FIG. 2 shows another longitudinal cross-section of the drug delivery device rotated about 90 around its longitudinal axis,

(4) FIG. 3 shows a cross-section along A-A according to FIG. 2,

(5) FIG. 4 shows a cross-section along B-B according to FIG. 2,

(6) FIG. 5 shows a cross-section along C-C according to FIG. 2,

(7) FIG. 6 shows a cross-section along D-D according to FIG. 2,

(8) FIG. 7 shows a cross-section along E-E according to FIG. 2,

(9) FIG. 8 shows a cross-section along F-F according to FIG. 2,

(10) FIG. 9 shows a cross-section along G-G according to FIG. 2,

(11) FIG. 10 shows an exploded view of the drug delivery device in perspective illustration,

(12) FIG. 11 shows a partially transparent view through the assembled drug delivery device,

(13) FIG. 12 is a perspective view of the dose indicating mechanism,

(14) FIG. 13 shows an isolated view of the dose indicating mechanism,

(15) FIG. 14 shows the dose limiting member in a zero dose configuration on the drive sleeve,

(16) FIG. 15 shows the dose limiting member according to FIG. 14 in a maximum dose configuration,

(17) FIG. 16 shows a perspective view of a last dose limiting mechanism,

(18) FIG. 17 shows an enlarged longitudinal cross-section through the last dose limiting mechanism,

(19) FIG. 18 shows another perspective view of the last dose limiting mechanism in a zero dose configuration,

(20) FIG. 19 shows a configuration of the last dose limiting mechanism in a last dose configuration,

(21) FIG. 20 shows a longitudinal cross-section through the proximal end of the drive mechanism in a dose setting configuration,

(22) FIG. 21 shows a proximal end of the drive mechanism in a dose dispensing configuration,

(23) FIG. 22 shows a longitudinal cross-section through a distal clutch member in dose setting configuration,

(24) FIG. 23 shows a longitudinal cross-section of the distal clutch member in a dose dispensing configuration,

(25) FIG. 24 is a perspective view of the dose limiting member at the beginning of a dose incrementing displacement,

(26) FIG. 24a shows the clicking member of the dose limiting member according to FIG. 24,

(27) FIG. 25 shows the dose limiting member during a dose decrementing displacement, and

(28) FIG. 25a shows an enlarged view of the clicking member of the dose limiting member according to FIG. 25.

DETAILED DESCRIPTION

(29) In FIGS. 1, 2 and 10 the drive mechanism 3 of the drug delivery device 10 is illustrated in an assembled and in an exploded view, respectively. The drug delivery device 10 may be of pen-injector type and may comprise a substantially cylindrical and axially elongated shape. In the present set of Figures, the axial direction is denoted with reference number 1 and the opposite proximal direction is indicated by reference number 2. The drug delivery device 10 comprises a proximal housing component 30 to receive and to accommodate the drive mechanism 3 and in particular the functional and moveable components, the drive mechanism 3 is made of.

(30) In distal direction 1, the housing 30 is connected with a cartridge holder 12 which is adapted to accommodate and to receive a cartridge 14 containing the medicament to be dispensed by the drug delivery device 10. The cartridge 14 typically comprises a vitreous barrel 18 of cylindrical shape which is sealed in distal direction 1 by a pierceable sealing member, such like a septum.

(31) In proximal direction 2, the cartridge 14 is sealed by a piston 16 slidably arranged in the vitreous barrel 18 of the cartridge 14. Displacement of the piston 16 in distal direction 1 leads to a respective built-up of a fluid pressure inside the cartridge 14. When the distal outlet of a cartridge 14 is connected with e.g. a needle assembly 20, as shown in FIG. 1, a predefined amount of the liquid medicament contained in the cartridge 14 can be expelled and dispensed via an injection needle 25 of the needle assembly 22.

(32) In FIG. 2 however, a needle cap 24 to protect the double-tipped injection needle 25 is indicated. The needle assembly 20 is typically arranged on a distal end portion of the cartridge holder 12. Typically, a distally located socket of the cartridge holder 12 and a needle hub 22 of the needle assembly 20 comprise mutually corresponding threads to screw the needle assembly 20 onto the cartridge holder 12 in a releasable and removable way.

(33) The cartridge holder 12 and hence the cartridge 14 is to be protected and covered by a protective cap 26 which is shown in FIGS. 1 and 2. Prior to setting and/or dispensing of a dose, the protective cap 26 as well as the inner needle cap 24 are to be removed. After dispensing or injecting of the medicament into biological tissue, the needle assembly 20 is typically to be discarded and the distal end of the drug delivery device 10 is to be covered by the protective cap 26.

(34) The drive mechanism 3 as illustrated in an exploded view in FIG. 10 and as shown in cross section in its fully assembled configuration in FIGS. 1 and 2 comprises numerous functional components by way of which a dose of variable size can be set and subsequently dispensed.

(35) The dose dispensing procedure comes along with a distally directed advancing displacement of the piston rod 90 relative to the housing 30. The drive mechanism 3 therefore comprises at least a housing 30, a piston rod 90, a drive wheel 80 or drive nut and a drive sleeve 40 which can be selectively and operably coupled for setting and dispensing of a dose, respectively.

(36) The dose dispensing procedure comes along with a distally-directed advancing displacement of the piston rod 90 relative to the housing 30. As illustrated for instance in FIG. 2, the piston rod 90 comprises an outer thread 91 which is typically rotably locked to a radially inwardly extending support 34 of the housing 30. Advancing of the piston rod 90 in distal direction relative to the housing 30 is typically achieved by a rotation of the drive wheel 80 threadedly engaged with the piston rod 90 and beeing axially fixed in the housing 30.

(37) In the following, setting of a dose is described.

(38) For setting of a dose, a user typically takes the drug delivery device 10 and starts to rotate the proximally located dose setting member 85 relative to the proximal housing 30. Here, the dose setting member 85 comprises a dose dial, which is axially fixed to the housing 30 and which may be arbitrarily dialled either clockwise or counter-clockwise for incrementing and decrementing a dose to be set accordingly.

(39) As in particular illustrated in FIG. 3, the dose setting member 85 comprises a rippled structure 86 at its outer circumference, which allows and supports a slip-free gripping and dialling thereof. Moreover, the dose setting member 85 has the form of a hollow sleeve and features two diametrically oppositely located and radially inwardly extending protrusions 87 engaging with a toothed geared rim 53 of a proximal clutch member 50 being rotatably supported in the housing 30.

(40) As further illustrated in FIGS. 1 and 2, the housing 30 comprises a proximal closure or lid 32 which is axially intersected by the dose setting member 85, by the proximal clutch member 50 and by a dose dispensing button 55 proximally protruding from the dose setting member 85. As further indicated in FIGS. 1, 2 and in FIGS. 20, 21, the dose setting member 85 comprises a distally extending projection 88 of rim or ring-like shape extending into or through the proximal closure 32 of the housing 30. By means of the projection 88, the dose setting member 85 may be axially fixed to the housing 30.

(41) The proximal clutch member 50 comprises or forms an axially extending shaft portion to axially and rotatably engage with a main clutch member 60 featuring a sleeve-like geometry. The proximal clutch member 50 typically comprises a fastening or fixing element 54 at its distal end of its shaft portion to rotatably and to axially engage with the main clutch member 60. In this way, a rotation of the proximal clutch member 50 typically induced by dialling of the dose setting member 85 can be equally and directly transferred into a respective rotation of the main clutch member 60.

(42) The main clutch member 60 is rotatably engaged with the drive sleeve 40 adapted to accommodate both, a distal end of the proximal clutch member 50 and almost the entirety of the main clutch member 60 extending almost all the way through the drive sleeve 40 in distal direction 1. As shown in FIGS. 5 and 6, the main clutch member 60 comprises a radially outwardly and axially extending ridge or protrusion 61 serving as a fastening element to rotatably engage with a correspondingly shaped groove or notch 43 provided at an inside facing portion of the drive sleeve 40.

(43) By means of the radially outwardly extending protrusion 61 of the main clutch member 60 and the correspondingly shaped groove 43 of the drive sleeve 40, a splined engagement of main clutch member 60 and drive sleeve 40 can be provided. Consequently, the drive sleeve 40 and the main clutch member 60 are rotatably locked but the main clutch member 60 is free to be displaced in axial direction 1, 2 relative to the drive sleeve 40.

(44) As illustrated in FIGS. 6 and 12 the drive sleeve 40 is connected with one end of a helical spring 48 extending around and enclosing the distal portion of the drive sleeve 40. The opposite end of the spring 48 is connected to an insert 120 which is fixedly connected to the housing 30. In this way, the drive sleeve 40 is rotatable in a dose incrementing direction 4 against the action of the helical spring 48.

(45) As further shown in FIG. 9 a pawl-like and radially outwardly extending ratchet member 62 is adapted to engage with a toothed ring portion 122 of the insert 120. The toothed ring 122 comprises a saw tooth profile such that the radially outwardly biased ratchet member 62 of the main clutch member 60 consecutively and stepwise engages with the toothed ring 122 in order to store and save mechanical energy of the strained helical spring 48 during a dose setting procedure. Here, the main clutch member 60 and the drive sleeve 40 rotatably locked therewith can be rotated in a dose incrementing direction 4 in discrete steps, e.g. corresponding to an international unit in case of a drug delivery device adapted for administering of insulin.

(46) The engagement of the ratchet member 62 and the toothed ring 122 is such, that also a dose decrementing rotation 5 is possible when a respective torque is applied to the dose setting member 85 and hence to the main clutch member 60. The toothed flanks of the ratchet member 62 and the teeth of the toothed ring 122 are designed such, that also a well-defined and precise dose decrementing rotation of the main clutch member 60 and hence of the drive sleeve 40 is possible, in particular for correcting and for decrementing a dose that would be too large otherwise.

(47) As for instance illustrated in FIGS. 6, 7 and 12, 14 and 15 there is also provided a dose limiting member 110 acting as a single dose limiting member during a dose setting procedure. The dose limiting member 110 is threadedly engaged with the drive sleeve 40. As illustrated in FIG. 13, the drive sleeve 40 comprises only a limited axial portion provided with an outer thread 41. Said outer thread 41 is located offset from a distal end as well as from a proximal end of the drive sleeve 40. Adjacent to the threaded portion 41, the outer circumference of the drive sleeve 40 is rather smooth shaped.

(48) As shown in FIGS. 6 and 7, the dose limiting member 110 is of shell-like shape and extends only partially around the outer circumference of the drive sleeve 40. As further illustrated in FIG. 6, a distal end of the dose limiting member 110 extends radially between the drive sleeve 40 and the helical spring 48. Moreover, the distal end of the drive sleeve 40 comprises a radially outwardly extending spring mount 46 to engage with the distal end of the helical spring 48.

(49) According to FIG. 15, the dose limiting member 110 comprises an inner thread 111 to engage with the outer threaded portion 41 of the drive sleeve 40. As further illustrated in FIGS. 7 and 14 the dose limiting member 110 comprises two diametrically oppositely located radially outwardly extending protrusions 112 engaging with correspondingly formed recesses 121 of the insert 120.

(50) The cross-section according to FIG. 7 further illustrates that the insert 120 almost entirely fills the interior volume of the surrounding housing 30. Therefore, the insert 120 is fixedly connected to the housing 30 and serves as a housing portion to provide a mounting base for various functional components of the drive mechanism 3.

(51) By means of mutually engaging protrusions 112 and grooves 121 the dose limiting member 110 is rotatably locked to the insert 120 and hence to the housing 30.

(52) Moreover, since the dose limiting member 110 is also threadedly engaged with the drive sleeve 40, a rotation of the drive sleeve 40 in dose incrementing direction 4, as illustrated in FIG. 24 leads to a proximally directed displacement of the dose limiting member 110. An oppositely directed rotation of the drive sleeve 40 in dose decrementing direction 5 leads to a respective opposite, hence distally directed displacement of the dose limiting member 110 relative to the insert 120, the housing 30 and relative to the drive sleeve 40 as illustrated in FIG. 25.

(53) Moreover, FIGS. 7, 12, 14 and 15 show that the dose limiting member 110 comprises a radially inwardly extending first stop 113 near its proximal end which is adapted to circumferentially abut with a correspondingly shaped but radially outwardly extending first stop 47 of the drive sleeve 40. The configuration as indicated in FIGS. 7 and 15 may relate to a maximum dose configuration, in which the mutual abutment of first stops 47, 113 of drive sleeve 40 and dose limiting member 110 inhibits a further rotational displacement of the drive sleeve 40 in dose incrementing direction 4. In this way, a maximum dose for a single dose dispensing procedure can be effectively limited.

(54) Later on and during dose dispensing or during dose correction, i.e. when the drive sleeve 40 is rotated in a dose decrementing direction 5, the dose limiting member 110 will be displaced in distal direction 1 in order to return into its initial zero dose configuration as it is indicated for instance in FIG. 14. Also here, mutually corresponding second stops 44, 114 of drive sleeve 40 and dose limiting member 110 are provided. While the second stop 44 of the drive sleeve 40 extends radially outwardly from a distally located rim of the drive sleeve 40 the second stop 114 of the dose limiting member 110 is located at a distal and circumferential edge of the shell-shaped dose limiting member 110. In particular, the second stop 114 is provided at a leading edge with respect to a rotation in dose decrementing direction 5.

(55) In contrast to that, the first and radially inwardly extending stop 113 of the dose limiting member 110 extends substantially midway between the diametrically oppositely located radially outwardly extending protrusions 112. Moreover, the protrusions 112 and the first stop 113 are located in a common transverse plane as indicated in FIG. 7.

(56) In this way, forces or torque introduced into the dose limiting member 110 via the rotating drive sleeve 40 can be smoothly and directly transferred to the insert 120.

(57) Since the dose limiting member 110 almost completely extends through the helical spring 48 in axial direction a rather compact and space saving arrangement for the dose limiting member 110 can be attained.

(58) As further illustrated for instance in FIG. 12 the drive mechanism 3 also comprises a dose indicating mechanism 130 featuring first and second spools 140, 142 rotatably supported in the housing 30 and being oriented substantially parallel to each other as well as being oriented substantially parallel to the drive sleeve 40 and the piston rod 90 extending therethrough. The two spools 140, 142 are further mutually connected by means of a dose indicating tape 146 having several numbers 148 printed thereon.

(59) As shown in FIGS. 2 and 12 the first spool 140 is rotatably engaged with the drive sleeve 40 by means of a series of gear wheels 42, 131. Here, the drive sleeve 40 comprises a gear wheel 42 that mates with a sprocket 132 of a gear wheel 131. Said gear wheel 131 is further geared and engaged with a corresponding gear wheel 145 of the first spool 140. In this way, a rotative movement of the drive sleeve 40 can be directly transferred into a roll off and roll up rotation of the first spool 140.

(60) The second spool 142 is further engaged with a spool spring 144. In this way, unwinding or unrolling the dose indicating tape 146 from the second spool 142 may take place against the action of the spool spring 144. By means of the spool spring 144 the dose indicating tape 146 can be strained and can be kept substantially free of slack. Additionally and as shown in FIG. 12, the housing comprises a support 36a to provide a basis for the flexible dose indicating tape 146.

(61) As further indicated in FIG. 2, the first spool 140 comprises a proximally located bobbin integrally formed with a distally located bearing portion 134. The bearing portion 134 is located and supported in a cup-shaped receptacle of the insert 120, thereby forming a bearing 128 for the first spool 140. In a corresponding way also the second spool 142 can be rotatably supported in the insert 120. As indicated in FIG. 7, the respective bearing portion 136 of the second spool 142 is only partially formed by an insert portion 123 of the insert 120.

(62) The residual portion of the respective bearing 129 is formed directly from a radially outwardly extending receptacle portion 38 of the housing 30. As further indicated in FIGS. 2 and 7, the spool spring 144 radially extends between the outer circumference of the bearing portion 136, the inside facing sidewall portions of the insert portion 123 and the receptacle portion 38 of the housing 30.

(63) As it is further illustrated in FIG. 7, the drug delivery device 10 in an axial portion comprises a T-like shape in cross-section to accommodate the dose indicating mechanism 130, wherein the two spools 140, 142 are located in receptacle portions 37, 38 being furthest away from each other. Therebetween and on one side there extends a radially outwardly extending receptacle portion 39 of the housing 30. Opposite the receptacle portion 39, the housing 30 comprises a dose indicating window 36 through which the numbers 148 of the dose indicating tape 146 can be visualised.

(64) The lobe-shaped receptacle portions 37, 38 and 39 of the housing 30 are almost entirely occupied with correspondingly shaped insert portions 125, 123 and 124 of the insert 120, respectively.

(65) Here, the insert 120 may provide a mounting basis to preassemble the dose indicating mechanism 130 and to insert the entire dose indicating mechanism 130 in one step into the housing 30 during assembly of the drug delivery device 10.

(66) As further indicated in FIG. 5, also the gear wheel 131 is rotatably supported by a pin-shaped bearing 127 of the insert 120.

(67) As further shown in FIGS. 2 and 10, the proximal closure 32 of the housing 30 provides axial fixing of the two spools 140, 142 inside the housing 30. Hence, the two spools 140, 142 can be axially constrained by the insert 120 and by the proximal closure 32 of the housing 30.

(68) In FIGS. 2, 12 and in FIGS. 16 to 20 a last dose sleeve 100 rotatably supported in the housing 30 is shown. The last dose sleeve 100 comprises a radially outwardly extending flange portion 102 by way of which the last dose sleeve 100 axially abuts with a proximal sleeve portion 126 of the insert 120. Moreover, the last dose sleeve 100 comprises an axially extending groove 101 intersecting a rather smooth shaped outer circumference thereof.

(69) Said groove 101 is engaged with a radially inwardly extending protrusion 107 of a last dose member 105, which is designed as a last dose nut or as a half nut. As for instance indicated in FIG. 18 the last dose member 105 comprises a semi-circular arcuate shape and features radial stop faces 108, 109 at its opposite circumferential ends. Moreover, the last dose member 105 comprises an outer thread 106 to threadedly engage with a correspondingly shaped threaded portion 33 of the housing 30. In this way, the last dose limiting member 105 is threadedly engaged with the housing 30 but is rotatably locked to the last dose sleeve 100.

(70) In FIGS. 1, 22 and 23 a distal clutch member 70 is illustrated, which is axially as well as rotatably engaged with the main clutch member 60. Hence, a rotation of the main clutch member 60 equally transfers to the distal clutch member 70. Moreover, also an axial displacement of the main clutch member 60 relative to the housing 30 or relative to the drive sleeve 40 is equally transferrable to a respective axial displacement of the distal clutch member 70. In order to provided axial and rotational engagement between the main clutch with the distal clutch 70 and/or with the proximal clutch 50 the main clutch 60 may further exhibit a notch or groove 63 as shown in FIG. 4 to engage with a correspondingly shaped snap member of e.g. the proximal clutch 50, which is not particularly illustrated. Moreover and as indicated in the cross sections of FIGS. 9 and 22 the distal clutch member 70 comprises three circumferentially distributed snap elements 73 to axially engage with correspondingly shaped recesses of the main clutch 60.

(71) In a dose setting configuration as illustrated in FIG. 22, the distal clutch member 70 is rotatably locked to the last dose sleeve 100. As shown for instance in cross-section according to FIG. 8, the distal clutch member 70 comprises radially outwardly extending teeth 72 engaging with a correspondingly shaped toothed structure 104 at an inside facing sidewall portion of the last dose sleeve 100. In this way, a rotation of the drive sleeve 40 and hence a rotation of the clutch members 50, 60, 70 can transfer to a respective rotation of the last dose sleeve 100.

(72) As a consequence, the last dose member 105 will travel in axial direction relative to the last dose sleeve 100 during a dose setting procedure. The lead of the threaded engagement of the last dose member 105 and the housing 30 as well as the axial elongation of the last dose sleeve 100 is designed such that a stop configuration as for instance illustrated in FIG. 19 correlates with the maximum allowable distal position of the piston rod 90 relative to the barrel 18 of the cartridge 14.

(73) In FIG. 19 mutual abutment of one of the stop faces 108, 109 with a radially inwardly extending stop 31 of the housing 30 is shown. Also here and in comparison with the single dose limiting member 110 radially extending stops 108, 109, 31 may provide a well-defined blocking of the mutually engaging components 105, 110 and housing 30.

(74) Since the last dose sleeve 100 is only selectively coupled with the drive sleeve 40 and/or with the distal clutch member 70 during a dose setting procedure, the last dose member 105 will always rest in its axial position during a dose dispensing procedure.

(75) Hence, during consecutive dose setting procedures, the last dose member 105 successively advances towards a last dose limiting configuration. In situations where the amount of medicament left in the cartridge 12 is less than the size of a single dose to be set during a dose setting procedure, the last dose limiting member 105 will be advanced in distal direction 1 and will engage with the radial stop 31 of the housing 30 thereby blocking a further rotation of the last dose sleeve 100 and hence of the clutches 50, 60, 70 and the dose setting member 85, accordingly. In this way it can be effectively prevented that a user selects and dials a dose exceeding the amount of medicament left in the cartridge 14.

(76) In the following, dispensing of a dose is described.

(77) As shown in FIG. 17, the piston rod or lead screw 90 operably engaged with a proximal end face of the piston 16 of the cartridge 14 is axially guided by the radially inwardly extending support 34 or web of the housing 30. As shown in cross section in FIG. 8, the piston rod 90 not only comprises an outer thread 92 but also two diametrically opposite and axially extending grooves 93. By means of said grooves 93 the piston rod 90 is rotatably locked to the housing 30. Hence, the piston rod 90 is splined to the housing 30. The piston rod 90 further comprises a radially widening pressure piece 91 or a pressure foot at its distal end in order to homogeneously transfer axially directed thrust to the piston 16 of the cartridge 14 during dose dispensing.

(78) The piston rod 90 is further threadedly engaged with a drive wheel 80 comprising an inner thread 82 engaged with the outer thread 92 of the piston rod 90. Due to the threaded engagement with the drive wheel 80 and the splined engagement with the housing 30, the piston rod 90 experiences a distally directed translational displacement when the drive wheel 80 rotates in a dose decrementing direction 5 during dose dispensing. In order to transfer a dose dispensing torque to the drive wheel 80 or drive nut the drive wheel 80 comprises a crown wheel portion 81 at its proximally facing side to engage with a correspondingly shaped crown wheel portion 71 of the distal clutch member 70.

(79) By displacing the distal clutch member 70 in distal direction 1 the mutually corresponding crown wheel portions 71, 81 of distal clutch member 70 and drive wheel 80 mutually engage. In this way, a rotation of the distal clutch member 70 can be equally transferred to a rotation of the drive wheel 80, which transfers to a distally directed displacement of the piston rod 90.

(80) A distally direction displacement of the distal clutch member 70 can be attained by depressing the dose dispensing button 55 in distal direction 1 as indicated by a comparison of FIGS. 20 and 21. The dose dispensing button 55 comprising a shaft portion 56 extending into the hollow shaft portion of the proximal clutch member 50 is displaceable in distal direction 1 until a stepped portion 58 radially outwardly extending from the shaft portion 56 axially abuts with a proximal end of the proximal clutch member 50.

(81) In this way, axially and distally directed displacement of the dose dispensing button 55 against the action of an integrated spring 57 can be transferred into a respective distally directed displacement of the mutually engaging clutch members 50, 60 and 70. Since the clutch members 50, 60 and 70 are axially engaged in both directions, the proximal clutch member 50 can be displaced in distal direction 1 against the action of another integrated spring 52, which axially abuts with a proximal end face of the drive sleeve 40 and/or with a stepped portion of the dose setting member 85.

(82) Distally directed displacement of the proximal clutch member 50 relative to the dose setting member 85 also disengages the protrusions 87 and the geared rim 53. In the dose dispensing configuration as shown in FIG. 21, the dose setting member 85 is therefore substantially functionless. It may be rotated in any direction without having connection to the proximal clutch member 50.

(83) The proximal clutch member 50 is depressible in distal direction 1 against the action of the spring 52. Since the proximal clutch member 50 is axially engaged with the main clutch member 60, e.g. by means of a snap fit engagement, and since the main clutch member 60 is also axially connected with the distal clutch member 70, a release of the dose dispensing button 55 allows and induces a proximally directed return motion of the proximal clutch member 50 under the effect of the relaxing spring 52.

(84) In this way, the distal clutch member 70 can be selectively engaged and disengaged with the drive wheel 80. Moreover, by means of the integrated spring 57 also the dose dispensing button 55 will return into its initial proximal end configuration in which the dose dispensing button 55 at least partially extends from the proximal end face of the dose setting member 85.

(85) As shown in FIG. 20, the integrated spring 57 of the dose dispensing button 55 axially abuts against a radially outwardly extending flange portion 51 of the proximal clutch member 50.

(86) By means of a distally directed displacement of the distal clutch member 70 the distal clutch member 70 not only rotatably locks to the drive wheel 80 but also disengages from the last dose sleeve 100 as becomes apparent from a comparison of FIGS. 22 and 23. As illustrated there, the distal clutch member 70 comprises an inclined or tapered toothed structure 104 at its inner circumference near its distal end.

(87) Accordingly, the last dose sleeve 100 comprises a correspondingly shaped inclined toothed portion 74 to engage with the toothed portion 104 of the last dose sleeve 100 when in dose setting configuration, hence when the distal clutch member 70 is in its proximal stop position.

(88) As further indicated in FIG. 22 the ratchet member 62 of the main clutch 60 is rotatably locked to the toothed ring portion 122 of the insert 120. Additionally and as shown in FIG. 22 the main clutch 60 comprises a radially outwardly extending flange 66 which serves as a stop to engage with a distal end face of the drive sleeve 40. In this way the proximally directed displacement of the main clutch 60 under the effect of the springs 52, 57 can be delimited.

(89) By displacing the three clutch members 50, 60, 70 simultaneously in distal direction 1, the crown wheel portion 71 of the distal clutch member 70 will engage with the corresponding crown wheel portion 81 of the drive wheel 80 before the ratchet member 62 disengages from the toothed ring portion 122 of the insert 120. The mutual engagement of the two crown wheel portions 71, 81 is designed such, that at least a further distally directed displacement of the distal clutch member 70 towards the drive wheel 80 is still possible when the distal clutch member 70 and the drive wheel 80 are already rotatably coupled.

(90) During this further distally directed displacement of the distal clutch member 70 and when reaching the distal stop configuration, the ratchet member 62 displaces or has displaced in distal direction 1 relative to the toothed ring 122 and is then no longer inhibited to rotate under the action of the relaxing helical spring 48. As indicated in FIG. 23, the ratchet member 62 is disengaged from the insert 120 and hence it is effectively released from the housing 30.

(91) The main clutch member 60 further comprises a pawl-shaped clicking member 64 as illustrated in FIGS. 9 and 23. Said clicking member 64 is arranged axially offset from the ratchet member 62. It may engage with another recessed structure 122a featuring numerous and equidistantly arranged recesses 122a located on the inside facing wall of the insert 120 when reaching the dose dispensing configuration as illustrated in FIG. 23.

(92) The clicking member 64 is oriented symmetrically to the ratchet member 62 and engages with the recess structure 122a when the ratchet member 62 disengages from the toothed ring 122. Since the main clutch member 60 is now allowed to rotate in a dose decrementing direction 5 the clicking member 64 is operable to generate a frequent clicking sound when meshing with the recessed structure 122a, thereby audibly indicating to a user, that a dose dispensing procedure is in progress.

(93) Moreover the clicking member 64 and the recessed structure 122a of the insert 120 may be shaped and designed in such a way that only a rotation in dose decrementing direction 5 is allowed while an oppositely directed rotation in dose incrementing direction 4 of the distal clutch 60 relative to the insert 120 and hence relative to the housing 30 is effectively blocked. In this way the clicking member 64 and the recessed structure 122a act as a further ratchet mechanism operable to impede a proximally directed displacement of the piston rod 90.

(94) In order to provide a substantially slipless switching from dose setting mode to the dose dispensing mode and vice versa, the distal clutch member 70 engages with the drive wheel 80 before the main clutch member 60 disengages from the insert 120 or housing 30. Also in the event of a premature release of the dose dispensing button 55 during a dose dispensing procedure, a rotational interlock of the main clutch member 60 with the insert 120 will be re-established before distal clutch member 70 and drive wheel 80 become operably disengaged.

(95) Since the drive sleeve 40 rotates in dose decrementing direction 5 during dose dispensing also the dose limiting member 110 will return into its initial configuration, i.e. in a zero dose configuration, in which the second stop 114 of the dose limiting member 110 engages with a radially extending second stop 44 of the drive sleeve 40.

(96) Moreover, and as shown in FIG. 6, the dose limiting member 110 comprises a circumferentially extending clicking member 115 operable to audibly engage with a ledge 45 provided at a recess 49 of the drive sleeve 40. Here, the pawl-like clicking member 115 is biased radially inwardly so as to generate a click sound before or just when a zero dose configuration as illustrated in FIG. 6 is reached. Since the dose limiting member 110 travels in proximal direction 2 during dose incrementing rotation and travels in distal direction 1 during dose dispensing the audible click sound provided by the mutual engagement of the clicking member 115 with the ledge 45 is indicative to a user, that a dose dispensing procedure just terminates.

(97) Accordingly and since the drive sleeve 40 is permanently engaged with the gear wheel 145 of the respective dose indicating mechanism 130, the numbers 148 of the dose indicating tape 146 that show up in the dose indicating window 36 will continuously count down until a zero dose configuration coinciding with the mutual engagement of the second stops 114, 44 is reached.

(98) Moreover, as can be seen from the longitudinal cross-section according to FIG. 2, the drive wheel 80 is axially constrained between the radially inwardly extending protrusions 34 or of the housing and the last dose sleeve 100, which itself is in axial abutment with the distal sleeve portion 126 of the insert 120. In this way, fixing of the insert 120 in the housing 30 effectively fixes the last dose sleeve 100 and the drive wheel 80 in axial direction inside the housing 30.

(99) Moreover, the insert 120 itself can be axially fixed in the housing 30 by means of the two spools 140, 142 extending axially between the bearing portion 128, 129 of the insert 120 and the proximal closure 32 of the housing 30.

(100) As further shown in FIGS. 2 and 17, the housing 30 also comprises a distally extending appendix 35 extending in distal direction from the radially inwardly extending support 34. As indicated in FIG. 17, said appendix 35 may be operable to connect the proximal housing 30 with the cartridge holder 12. Cartridge holder 12 and housing 30 may either be releasably connected in order to provide a reusable drug delivery device, allowing to replace an empty cartridge 14 by a new one.

(101) Alternatively, the drug delivery device 10 may also be designed as a disposable device, wherein cartridge holder 12 and proximal housing 30 are typically inseparably connected.

(102) The present design and assembly of the components of the drive mechanism 3 allow for an axial adjustment of the piston rod 90 during a final step of assembly. In particular, prior to a final assembly of the dose dispensing button 55, effectively closing the housing 30 in proximal direction 2, the piston rod 90 is accessible by e.g. introducing an adjustment rod (not illustrated) through the hollow assembly of proximal clutch 50 and main clutch 60. In this way the piston rod 90 can be pushed in distal direction 1 to get in direct abutment with the piston 16 of the cartridge 14. In this way a conventional priming procedure typically to be executed by the end user prior to an initial use of the device 10 may become substantially superfluous.