Assembly for a Drug Delivery Device Comprising a Feedback Feature

Abstract

An assembly for a drug delivery device is provided, the assembly comprising a feedback feature. The feedback feature is configured to indicate an end of the dispense operation to a user by giving an audible and/or tactile feedback.

Claims

1. An assembly for a drug delivery device (1), the assembly (60) comprising a feedback feature (2) being configured to indicate an end of a dispense operation to a user by giving and audible and/or tactile feedback, the assembly comprising an actuator (5) which is configured to be operated in order to dispense a dose, and wherein the feedback feature (2) creates a feedback when the actuator (5) reaches an end position at the end of a dispense operation.

2. The assembly according to claim 1, wherein the feedback feature (2) is configured to snap through when it is compressed above a certain load, thereby giving a feedback to a user.

3. The assembly according to any of the previous claims, wherein the feedback feature (2) comprises the shape of a dome.

4. The assembly according to any of claims 1 to 3, wherein the actuator (5) interacts with the feedback feature (2).

5. The assembly according to any of the previous claims, wherein the feedback feature (2) comprises a metal material.

6. The assembly according to any of the previous claims, wherein the feedback feature (2) comprises the shape of an arched disk with at least one recess (34).

7. The assembly according to any of the previous claims, wherein the feedback feature (2) comprises an opening (33), wherein at least one element of the assembly extends through the opening (33).

8. The assembly according to claim 1, wherein the feedback feature (2) comprises at least one resilient arm (20).

9. The assembly according to claim 8, wherein the resilient arm (20) extends in a proximal direction.

10. The assembly according to any of claims 1 to 8, comprising a rotation member (43) which is configured to rotate during the dispense of a dose, wherein the feedback feature (2) comprises a first feedback element (32) which is located at the rotation member (43).

11. The assembly according to claim 10, wherein the first feedback element (32) extends along a circumferential direction of the rotation member (43).

12. The assembly according to any of claim 10 or 11, wherein the feedback feature (2) is configured to give a feedback to a user during the dispensing of a dose, and wherein the feedback is increased at the end of the dispense operation.

13. The assembly according to claims 10 to 12, comprising a second feedback element (42), wherein the first feedback element (32) is configured to interact with the second feedback element (42), and wherein the first feedback element (32) is configured to interact with an enhancement feature (23) at the end of the dispense operation, wherein the enhancement feature (23) is configured to reinforce the interaction of the first feedback element (32) with the second feedback element (42).

14. The assembly according to any of the previous claims, wherein the feedback feature (2) is an integral part of the actuator (5).

15. A drug delivery device (1) comprising an assembly according to any of claims 1 to 14.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0095] Further features, refinements and expediencies become apparent from the following description of the exemplary embodiments in connection with the figures.

[0096] FIG. 1 shows a sectional view of a drug delivery device,

[0097] FIG. 2 shows a proximal part of a drug delivery device,

[0098] FIG. 3 shows a proximal part of a further embodiment of a drug delivery device,

[0099] FIGS. 4A and 4B show a proximal part of a further embodiment of a drug delivery device,

[0100] FIG. 5 shows a proximal part of a further embodiment of a drug delivery device,

[0101] FIG. 6A shows a schematic view of a feedback feature,

[0102] FIG. 6B shows a schematic view of a further feedback feature,

[0103] FIG. 7 shows a proximal part of a further embodiment of a drug delivery device,

[0104] FIG. 8 shows a proximal part of a further embodiment of a drug delivery device,

[0105] FIG. 9 shows a proximal part of a further embodiment of a drug delivery device,

[0106] FIG. 10 shows a proximal part of a further embodiment of a drug delivery device,

[0107] FIG. 11A shows a schematic view of an assembly for a drug delivery device,

[0108] FIG. 11B shows a section of an inner body of the assembly of FIG. 11A,

[0109] FIG. 12A shows a schematic view of a further assembly for a drug delivery device,

[0110] FIG. 12B shows a section of an inner body of the assembly of FIG. 12A.

DETAILED DESCRIPTION

[0111] FIG. 1 shows a drug delivery device 1. In particular, the drug delivery device 1 is an injection device. The drug delivery device 1 is a variable dose device such that a user can select the size of a dose. The drug delivery device 1 is configured for multiple dose applications. The device can be delivered to a user in a fully assembled condition ready for use. The device has a low part count and is particularly attractive for cost-sensitive device applications.

[0112] The drug delivery device 1 comprises a housing 3, an inner body 4, an actuator 5, an indicator 6, a driver 7, a piston rod 9, a piston 10, a last dose stop 11, and a cartridge 13. A needle arrangement comprising a needle hub and a needle cover may be provided as additional components.

[0113] The housing 3 is a generally tubular element. A distal part of the housing 3 forms a cartridge holder 14 for receiving the cartridge 13.

[0114] The inner body 4 is a generally tubular element. The inner body 4 is received in the housing 3 and is permanently fixed therein to prevent any relative movement of the inner body 4 with respect to the housing 3. An external thread 15 is provided on the outer surface of the inner body 4. At its distal end, the inner body 4 comprises a further thread 16.

[0115] The actuator 5 is configured as a button. The actuator 5 is rotationally and axially moveable with respect to the housing 3 and the inner body 4. The actuator 5 is arranged at a proximal end of the drug delivery device 1. The actuator 5 is configured to be operated in order to dispense a dose of medication.

[0116] The indicator 6 is a generally tubular element. In particular, the indicator 6 is configured as a rotation member 43. In particular, the indicator 6 is configured to rotate with respect to the housing 3 during the setting and the dispensing of a dose. The indicator 6 is arranged concentrically around the inner body 4. In particular, the indicator 6 comprises an internal thread 19 engaging with the external thread 15 of the inner body 4. Thus, the indicator 6 is arranged between the inner body 4 and the housing 3. A series of numbers is provided, e.g. printed, on the outer surface of the indicator 6. The numbers are arranged on a helical line such that only one number or only a few numbers are visible through a window 12 of the housing 3. The numbers indicate the amount of a set dose. At the end of a dose dispense operation, the indicator 6 may have returned in its initial position, thereby indicating the end of a dispense operation to a user.

[0117] The piston rod 9 is configured as a lead screw. In particular, the piston rod 9 comprises two counter-handed threads which overlap each other. One of the threads of the piston rod 9 engages with the inner thread 16 of the inner body 4.

[0118] The driver 7 is a generally tubular element. An inner surface of the driver 7 has an inner thread 18 engaging with one of the external threads of the piston rod 9. The driver 7 is at least partly located within the inner body 4. A distal region of the driver 7 has an external thread 17. The driver 7 is configured to rotate and axially move with respect to the housing 3 during the setting of a dose. During the dispensing of a dose, the driver 7 is axially moveable and rotationally fixed with respect to the housing 3.

[0119] The last dose stop 11 is provided between the inner body 4 and the driver 7. An internal thread of the last dose stop 11 engages with the external thread 17 of the driver 7. The last dose stop 11 is configured to inhibit the setting of a dose which is larger than an amount of medication remaining in the cartridge 13. This is achieved by the last dose stop 11 abutting an abutment feature of the driver 7 when a dose is set which corresponds to an amount of medication remaining in the cartridge 13. The last dose stop 11 is configured as a nut.

[0120] In order to set a dose, the actuator 5 is rotated by a user. During the setting of a dose, the indicator 6 and the driver 7 are rotationally fixed with respect to the actuator 5. Thereby, the actuator 5, the indicator 6 and the driver 7 are rotated out of the housing 3. Thereby, the driver 7 is rotated along the piston rod 9 in a proximal direction, while the piston rod 9 is axially and rotationally fixed with respect to the housing 3 during the setting of a dose. The indicator 6 is rotated along the thread 15 of the inner body 4.

[0121] In order to dispense a dose, the actuator 5 is operated by a user. In particular, the actuator 5 is pushed in a direction towards a dispensing end of the device. During the dispensing of a dose, the actuator 5 and the driver 7 are rotationally fixed with respect to each other. The indicator 6 may rotate with respect to the actuator 5 and the driver 6 during the dispensing of a dose. Thereby, the indicator 6 may rotate back to its initial position and indicate the end of the dispense operation to a user. When the actuator 5 is operated, the driver 7 is also moved in a direction towards a dispensing end of the device. Thereby, the piston rod 9 is axially moved in a distal direction in order to dispense a dose of medication. In particular, the piston rod 9 is configured to rotate and axially move during the dispensing of a dose. When the actuator 5 has been operated and reached an end position, a feedback is given to a user. In particular, the feedback may indicate the end of a dispense operation. The end position of the actuator 5 may be its most distal position. In particular, the actuator 5 is in its end position when it is fully depressed.

[0122] In FIGS. 2 to 12B, different embodiments of a feedback feature are shown, which may indicate an end of a dispense operation to a user. In particular, FIGS. 2 to 5 and 7 to 12B show different assemblies 60 for a drug delivery device 1 comprising different embodiments of a feedback feature 2. The embodiments are illustrated in the context of a drug delivery device 1 as shown in FIG. 1, but are not limited thereto. In particular, the feedback feature 2 may also be used in a reusable device or in a device having a different drive mechanism.

[0123] The feedback may be an audible or tactile signal at the end of a dispense operation. This may improve the ease of use and the dose accuracy for a user, in particular for a visually impaired user. Furthermore, the signal can be used to indicate the start of a dwell period. At the end of a dispense operation, i. e. after a user has operated the actuator 5, the dispensing of the full amount of a set dose may be delayed due to a slight deformation of the piston 10. The dwell period is the time between the moment when the actuator 5 has reached its end position and the moment when the full amount of a dose has been dispensed. In particular, the dwell period may be the time the piston 10 needs after an operation of the actuator 5 to relax to its undeformed state.

[0124] FIG. 2 shows a section through a proximal part of a drug delivery device 1 according to FIG. 1 comprising a feedback feature 2. A first feedback element 32 of the feedback feature 2 is arranged at the actuator 5. The first feedback element 32 is integrally formed with the actuator 5. In particular, the actuator 5 may be an injection-moulded part, wherein the first feedback element 32 may be integrally moulded with the actuator 5. The first feedback element 32 comprises at least one, in particular two resilient arms 20, which stick out from the actuator 5 in a radial direction. In particular, the resilient arms 20 stick out in a direction away from a longitudinal axis 26 of the drug delivery device 1. The resilient arms 20 may be configured as a snap feature. In particular, the resilient arms 20 are configured to snap over a second feedback element 42 of the feedback feature 2. The resilient arms 20 extend in a proximal direction. In particular, each resilient arm 20 has one connection point with a main body of the actuator 5 and one free end. The free end is faced towards a proximal end of the device 1. The driver 7 comprises a cavity 27, wherein the feedback feature 2, in particular the resilient arms 20, extend through the cavity 27.

[0125] When the actuator 5 is actuated by a user, the actuator 5 and thereby the first feedback element 32 is moved in a direction towards a distal end of the device 1. During the movement of the actuator 5 towards the distal end of the device 1, the first feedback element 32 interacts with the second feedback element 42. The second feedback element 42 is configured as a protrusion. The second feedback element 42 is located at the inner body 4. The second feedback element 42 may be configured as a full ring detent feature. This is beneficial in the case that the actuator 5 may have any rotational alignment relative to the inner body 4.

[0126] During the movement of the actuator 5 towards the distal end of the device 1, the first feedback element 32 is deflected in a radial direction towards the longitudinal axis 26 of the device 1, i.e. radially inwards. In particular, the resilient arms 20 are deflected by the second feedback element 42. When the actuator 5 has reached its end position, in particular at the end of a dispense operation, the resilient arms 20 lose contact with the second feedback element 42 and snap back in a direction away from the longitudinal axis 26 of the device 1. Thereby, an audible and/or tactile feedback is created. In an alternative embodiment, the first feedback element 32, in particular the resilient arms 20, may be located on the inner body 4, and the second feedback element 42 may be located on the actuator 5.

[0127] During the setting of a dose, when the actuator 5 is moved in a direction away from the dispensing end of the device 1, the resilient arms 20 are again deflected radially inwards by the second feedback element 32. Thereby, the resilient arms 20 may slide back over the second feedback element 42 such that they are again in a proximal position relative to the second feedback element 42.

[0128] FIG. 3 shows a section through a proximal part of a further embodiment of a drug delivery device 1 with a feedback feature 2. The feedback feature 2 comprises a first feedback element 32 and a second feedback element 42. The first feedback element 32 is located at the inner body 4. The first feedback element 32 comprises two resilient arms 20. The resilient arms 20 stick out from the inner body 4 in a radial direction towards the longitudinal axis 26 of the drug delivery device 1. The resilient arms 20 extend in a proximal direction. The first feedback element 32, in particular the resilient arms 20, interact with the second feedback element 42. The second feedback element 42 is located at the driver 7. In particular, the second feedback element 32 is configured as a protrusion on the driver 7. Since the driver 7 can have any rotational alignment to the inner body 4, the second feedback element 42 may be configured as a full ring detent feature.

[0129] The operating principle is similar to the embodiment described in FIG. 2. During the movement of the actuator 5 towards a distal end of the device, the driver 7 is also moved towards the distal end of the device. Thereby, the first feedback element 32, in particular the resilient arms 20, are deflected in a radial direction away from the longitudinal axis 26 of the device 1, i. e. radially outwards. When the actuator 5 has travelled its full distance, in particular at the end of a dispense operation, the first feedback element 32, in particular the resilient arms 20, lose contact with the second feedback element 42 of the driver and snap back in a direction towards the longitudinal axis 26 of the device. Thereby, an audible and/or tactile feedback is created. In an alternative embodiment, the first feedback element 32, in particular the resilient arms 20, may be located at the driver 7, and the second feedback element 42 may be located at the inner body 4.

[0130] During the setting of a dose, when the actuator 5 is moved in a direction away from the dispensing end of the device 1, the resilient arms 20 are again deflected radially outwards by the second feedback element 42. Thereby, the resilient arms 20 may slide back over the second feedback element 42 such that they are again in a distal position relative to the second feedback element 42.

[0131] FIGS. 4A and 4B show a section through a proximal part of a further embodiment of a drug delivery device 1 comprising a feedback feature 2. The feedback feature 2 comprises a first feedback element 32 and a second feedback element 42.

[0132] The first feedback element 32 is arranged at the indicator 6. The first feedback element 32 may be an integral part of the indicator 6. In particular, the first feedback element 32 extends along a circumferential direction of the indicator 6. In particular, the first feedback element 32 comprises a resilient arm 20. When the indicator 6 rotates relative to the actuator 5 and the inner body 4 during the dispensing of a dose, the first feedback element 32, in particular the resilient arm 20, interacts with a second feedback element (not shown) inside the actuator 5 to provide an audible click with each unit dispensed. The second feedback element inside the actuator 5 may comprise, for example, teeth or splines. At the inner body 4, an enhancement feature 23 is arranged. The enhancement feature 23 is configured to interact with the first feedback element 32.

[0133] FIG. 4B shows the interaction of the first feedback element 32 and the enhancement feature 23. The enhancement feature 23 interacts with the first feedback element 32 at the end of a dispense operation. Due to the interaction of the first feedback element 32 and the enhancement feature 23, support is provided to the first feedback element 32 at least when the final unit of a dose is injected. In particular, the enhancement feature 23 interacts with the first feedback element 32 such that a deflection of the first feedback element 32 in a radially inward direction is limited. Thereby, the stiffness of the first feedback element 32 in particular of the resilient arm 20, is increased. Thereby, the interaction of the first feedback element 32 and the second feedback element inside the actuator 5 is increased. Thereby, a louder or a noticeably different click is produced, signalling to the user the end of a dispense operation.

[0134] FIG. 5 shows a further embodiment of a drug delivery device 1 comprising a feedback feature 2. The feedback feature 2 is configured as a snap feature. In particular, the feedback feature 2 is configured as a snap dome. The feedback feature 2 comprises or consists of a metal material. The feedback feature 2 comprises an opening 33, wherein the actuator 5 extends through the opening.

[0135] A feedback feature 2 being configured as a snap dome is shown in FIG. 6A. In particular, the feedback feature 2 is configured as an arched disc. Furthermore, the feedback feature 2 comprises at least one recess 34. The recess 34 is configured as a concave cavity. In particular, the feedback feature 2 comprises four recesses 34. Due to the cavities, the snap dome possesses a sufficient flexibility. The feedback feature 2 is configured to snap through when it is compressed above a certain load. Thereby, the feedback feature 2 creates an audible click and/or a tactile feedback at the end of a dispense operation.

[0136] In an alternative embodiment as shown in FIG. 6B, the feedback feature 2 is configured without any recess. Thereby, the feedback feature 2 may comprise a high stiffness. Thereby, the feedback signal may be more distinct. In particular, the feedback feature 2 is configured as an arched ring. In particular, the feedback feature 2 comprises an opening.

[0137] As illustrated in FIG. 5, the feedback feature 2 is operated by an axially moveable member 50. In particular, the axially moveable member 50 is a sleeve member 24 which is arranged between the actuator 5 and the indicator 6. The sleeve member 24 can move axially relative to the actuator 5 between two stops 35, 36 when it does not interact with the feedback feature 2. The feedback feature 2 pushes apart the actuator 5 and the sleeve member 24 to preload the sleeve member 24 against one of these stops 35, 36. In particular, one stop 35 is provided by the housing 3 and the other stop 36 is provided by the actuator 5. When the actuator 5 approaches its end position, the sleeve member 24 contacts the stop 35 at the housing 3. When the actuator 5 is further moved towards its end position, the feedback feature 2 is compressed. Thereby, the feedback feature 2 is caused to snap, thereby creating an audible click. In particular, a clear audible and tactile feedback is provided for a user at the end of a dispense operation.

[0138] When the load which is exerted on the feedback feature 2 by the sleeve member 24 is released during the setting of a dose, the feedback feature 2 snaps back into its uncompressed shape. Thereby, the feedback feature 2 may push the actuator 5 to an extended position.

[0139] FIG. 7 shows a section through a proximal part of a further embodiment of a drug delivery device 1 comprising a feedback feature 2. The embodiment shown in FIG. 7 is similar to the embodiment shown in FIG. 5, apart from that the embodiment shown in FIG. 7 does not comprise a sleeve member 24. The feedback feature 2 directly interacts with the actuator 5 and the housing 3. In particular, the housing 3 comprises a collar 37. The collar 37 is configured to interact with the feedback feature 2. In particular, the feedback feature 2 is compressed between the collar 37 of the housing 3 and the actuator 5 when the actuator 5 approaches the housing 3 during the dispensing of a dose.

[0140] FIG. 8 shows a proximal part of a different embodiment of a drug delivery device 1 comprising a feedback feature 2. The embodiment shown in FIG. 8 is similar to the embodiment shown in FIG. 5, apart from that the feedback feature 2 is integrated into the axially moveable member 50, which is configured as a sleeve member 24. In particular, the sleeve member 24 may be an injection-moulded part, and the feedback feature 2 may be integrally moulded with the sleeve member 24. The feedback feature 2 may be configured as a plastic dome or a series of resilient arms. The resilient arms may be arched, such that they form a dome with slots. The operating principle is the same as in the embodiment shown in FIG. 5, with the feedback feature 2 snapping through, thereby creating an audible and/or tactile feedback for a user at the end of a dispense operation.

[0141] FIG. 9 shows a section through a proximal part of a further embodiment of the drug delivery device 1 comprising a feedback feature 2. The feedback feature 2 is arranged between the indicator 6 and the housing 3. In particular, the feedback feature 2 is positioned inside a cavity in the housing 3. The feedback feature 2 is configured as a snap dome with a relatively large diameter. The actuator 5, the driver 7, the inner body 4 and a part of the housing 3 extend through the opening.

[0142] When the indicator 6 approaches its end-of-dispense position, it makes contact with the feedback feature 2 and compresses the feedback feature 2, thereby causing it to undergo snap-through buckling. Thereby, an audible and/or tactile feedback is created to indicate the end of a dispense operation to a user.

[0143] FIG. 10 shows a section through a proximal part of a further embodiment of a drug delivery device 1 comprising a feedback feature 2. The embodiment shown in FIG. 10 is similar to the embodiment shown in FIG. 9, apart from that the feedback feature 2 is arranged between the driver 7 and the inner body 4. The feedback feature 2 is arranged on a protrusion 31 of the inner body 4. When the driver 7 approaches its end-of-dispense position, it makes contact with the feedback feature 2 and compresses the feedback feature 2, thereby causing the feedback feature 2 to snap through. Thereby, an audible and/or tactile feedback is created, indicating the end of a dispense operation to a user.

[0144] FIG. 11A shows the actuator 5, the indicator 6 and the inner body 4 of a drug delivery device 1 according to FIG. 1. The indicator 6 comprises a first feedback element 32, which is configured as a resilient arm 20. The first feedback element 32 extends along a circumferential direction of the indicator 6. The feedback feature 2, in particular the resilient arm 20, is arranged at a distal end of the indicator 6. A thread 28, which is configured to interact with the feedback feature 2, is formed on the inner body 4. A second feedback element 42 is formed in the thread 28. The second feedback element 42 is configured as a step 29 in the thread 28. At the end of a dispense operation, the resilient arm 20 passes over the step 29. When the resilient arm 20 passes over the step 29, it is preloaded in an axial direction. In particular, the resilient arm 20 is preloaded in a direction towards the proximal end of the device 1. This preload could be retained throughout the travel of the indicator 6. Alternatively, the thread pitch could alter such that the resilient arm 20 is preloaded near to the end of the dispense operation. As a result of this preload, the resilient arm 20 accelerates rapidly as it drops off the step 29. Thereby, the resilient arm 20 strikes the thread wall 30 near the bottom of the step 29. Thereby, and audible and/or tactile signal is created, which indicates the end of a dispense operation to a user. FIG. 11B shows a section of the inner body 4 showing the step 29 in the thread 28 in more detail.

[0145] FIG. 12A shows the actuator 5, the indicator 6 and the inner body 4 of a drug delivery device 1 according to FIG. 1. The embodiment according to FIG. 12A is similar to the embodiment shown in FIG. 11A. The indicator 6 also comprises a first feedback element 32 comprising a resilient arm 20, which is configured to interact with a thread 28 formed on the inner body 4. In the embodiment shown in FIG. 12A, the resilient arm 20 is configured to be preloaded radially outwards by the floor of the thread 28. This preload could be retained throughout the travel of the indicator 6. Alternatively, the preload could be generated when the indicator 6 is approaching its end of dispense position. In particular, the floor of the thread 28 could be raised such that the resilient arm 20 is preloaded near the end of the dispense operation. In the embodiment shown in FIG. 12A, the second feedback element 42, or the step 29, respectively, is radial, causing the resilient arm 20 to accelerate radially inwards and hit the inner body 4. Thereby, an audible and/or tactile signal is created, which indicates the end of a dispense operation to a user. FIG. 12B shows a section of the inner body 4 showing the step 29 in the thread 28 in more detail.