Patent ID: 12186541

DETAILED DESCRIPTION

FIG.1shows a drug delivery device1. In particular, the drug delivery device1is an injection device. The drug delivery device1is a variable dose device such that a user can select the size of a dose. The drug delivery device1is 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.

The drug delivery device1comprises a housing3, an inner body4, an actuator5, an indicator6, a driver7, a piston rod9, a piston10, a last dose stop11, and a cartridge13. A needle arrangement comprising a needle hub and a needle cover may be provided as additional components.

The housing3is a generally tubular element. A distal part of the housing3forms a cartridge holder14for receiving the cartridge13.

The inner body4is a generally tubular element. The inner body4is received in the housing3and is permanently fixed therein to prevent any relative movement of the inner body4with respect to the housing3. An external thread15is provided on the outer surface of the inner body4. At its distal end, the inner body4comprises a further thread16.

The actuator5is configured as a button. The actuator5is rotationally and axially moveable with respect to the housing3and the inner body4. The actuator5is arranged at a proximal end of the drug delivery device1. The actuator5is configured to be operated in order to dispense a dose of medication.

The indicator6is a generally tubular element. In particular, the indicator6is configured as a rotation member43. In particular, the indicator6is configured to rotate with respect to the housing3during the setting and the dispensing of a dose. The indicator6is arranged concentrically around the inner body4. In particular, the indicator6comprises an internal thread19engaging with the external thread15of the inner body4. Thus, the indicator6is arranged between the inner body4and the housing3. A series of numbers is provided, e.g. printed, on the outer surface of the indicator6. The numbers are arranged on a helical line such that only one number or only a few numbers are visible through a window12of the housing3. The numbers indicate the amount of a set dose. At the end of a dose dispense operation, the indicator6may have returned in its initial position, thereby indicating the end of a dispense operation to a user.

The piston rod9is configured as a lead screw. In particular, the piston rod9comprises two counter-handed threads which overlap each other. One of the threads of the piston rod9engages with the inner thread16of the inner body4.

The driver7is a generally tubular element. An inner surface of the driver7has an inner thread18engaging with one of the external threads of the piston rod9. The driver7is at least partly located within the inner body4. A distal region of the driver7has an external thread17. The driver7is configured to rotate and axially move with respect to the housing3during the setting of a dose. During the dispensing of a dose, the driver7is axially moveable and rotationally fixed with respect to the housing3.

The last dose stop11is provided between the inner body4and the driver7. An internal thread of the last dose stop11engages with the external thread17of the driver7. The last dose stop11is configured to inhibit the setting of a dose which is larger than an amount of medication remaining in the cartridge13. This is achieved by the last dose stop11abutting an abutment feature of the driver7when a dose is set which corresponds to an amount of medication remaining in the cartridge13. The last dose stop11is configured as a nut.

In order to set a dose, the actuator5is rotated by a user. During the setting of a dose, the indicator6and the driver7are rotationally fixed with respect to the actuator5. Thereby, the actuator5, the indicator6and the driver7are rotated out of the housing3. Thereby, the driver7is rotated along the piston rod9in a proximal direction, while the piston rod9is axially and rotationally fixed with respect to the housing3during the setting of a dose. The indicator6is rotated along the thread15of the inner body4.

In order to dispense a dose, the actuator5is operated by a user. In particular, the actuator5is pushed in a direction towards a dispensing end of the device. During the dispensing of a dose, the actuator5and the driver7are rotationally fixed with respect to each other. The indicator6may rotate with respect to the actuator5and the driver6during the dispensing of a dose. Thereby, the indicator6may rotate back to its initial position and indicate the end of the dispense operation to a user. When the actuator5is operated, the driver7is also moved in a direction towards a dispensing end of the device. Thereby, the piston rod9is axially moved in a distal direction in order to dispense a dose of medication. In particular, the piston rod9is configured to rotate and axially move during the dispensing of a dose. When the actuator5has 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 actuator5may be its most distal position. In particular, the actuator5is in its end position when it is fully depressed.

InFIGS.2to12B, different embodiments of a feedback feature are shown, which may indicate an end of a dispense operation to a user. In particular,FIGS.2to5and7to12Bshow different assemblies60for a drug delivery device1comprising different embodiments of a feedback feature2. The embodiments are illustrated in the context of a drug delivery device1as shown inFIG.1, but are not limited thereto. In particular, the feedback feature2may also be used in a reusable device or in a device having a different drive mechanism.

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 actuator5, the dispensing of the full amount of a set dose may be delayed due to a slight deformation of the piston10. The dwell period is the time between the moment when the actuator5has 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 piston10needs after an operation of the actuator5to relax to its undeformed state.

FIG.2shows a section through a proximal part of a drug delivery device1according toFIG.1comprising a feedback feature2. A first feedback element32of the feedback feature2is arranged at the actuator5. The first feedback element32is integrally formed with the actuator5. In particular, the actuator5may be an injection-moulded part, wherein the first feedback element32may be integrally moulded with the actuator5. The first feedback element32comprises at least one, in particular two resilient arms20, which stick out from the actuator5in a radial direction. In particular, the resilient arms20stick out in a direction away from a longitudinal axis26of the drug delivery device1. The resilient arms20may be configured as a snap feature. In particular, the resilient arms20are configured to snap over a second feedback element42of the feedback feature2. The resilient arms20extend in a proximal direction. In particular, each resilient arm20has one connection point with a main body of the actuator5and one free end. The free end is faced towards a proximal end of the device1. The driver7comprises a cavity27, wherein the feedback feature2, in particular the resilient arms20, extend through the cavity27.

When the actuator5is actuated by a user, the actuator5and thereby the first feedback element32is moved in a direction towards a distal end of the device1. During the movement of the actuator5towards the distal end of the device1, the first feedback element32interacts with the second feedback element42. The second feedback element42is configured as a protrusion. The second feedback element42is located at the inner body4. The second feedback element42may be configured as a full ring detent feature. This is beneficial in the case that the actuator5may have any rotational alignment relative to the inner body4.

During the movement of the actuator5towards the distal end of the device1, the first feedback element32is deflected in a radial direction towards the longitudinal axis26of the device1, i.e. radially inwards. In particular, the resilient arms20are deflected by the second feedback element42. When the actuator5has reached its end position, in particular at the end of a dispense operation, the resilient arms20lose contact with the second feedback element42and snap back in a direction away from the longitudinal axis26of the device1. Thereby, an audible and/or tactile feedback is created. In an alternative embodiment, the first feedback element32, in particular the resilient arms20, may be located on the inner body4, and the second feedback element42may be located on the actuator5.

During the setting of a dose, when the actuator5is moved in a direction away from the dispensing end of the device1, the resilient arms20are again deflected radially inwards by the second feedback element32. Thereby, the resilient arms20may slide back over the second feedback element42such that they are again in a proximal position relative to the second feedback element42.

FIG.3shows a section through a proximal part of a further embodiment of a drug delivery device1with a feedback feature2. The feedback feature2comprises a first feedback element32and a second feedback element42. The first feedback element32is located at the inner body4. The first feedback element32comprises two resilient arms20. The resilient arms20stick out from the inner body4in a radial direction towards the longitudinal axis26of the drug delivery device1. The resilient arms20extend in a proximal direction. The first feedback element32, in particular the resilient arms20, interact with the second feedback element42. The second feedback element42is located at the driver7. In particular, the second feedback element32is configured as a protrusion on the driver7. Since the driver7can have any rotational alignment to the inner body4, the second feedback element42may be configured as a full ring detent feature.

The operating principle is similar to the embodiment described inFIG.2. During the movement of the actuator5towards a distal end of the device, the driver7is also moved towards the distal end of the device. Thereby, the first feedback element32, in particular the resilient arms20, are deflected in a radial direction away from the longitudinal axis26of the device1, i. e. radially outwards. When the actuator5has travelled its full distance, in particular at the end of a dispense operation, the first feedback element32, in particular the resilient arms20, lose contact with the second feedback element42of the driver and snap back in a direction towards the longitudinal axis26of the device. Thereby, an audible and/or tactile feedback is created. In an alternative embodiment, the first feedback element32, in particular the resilient arms20, may be located at the driver7, and the second feedback element42may be located at the inner body4.

During the setting of a dose, when the actuator5is moved in a direction away from the dispensing end of the device1, the resilient arms20are again deflected radially outwards by the second feedback element42. Thereby, the resilient arms20may slide back over the second feedback element42such that they are again in a distal position relative to the second feedback element42.

FIGS.4A and4Bshow a section through a proximal part of a further embodiment of a drug delivery device1comprising a feedback feature2. The feedback feature2comprises a first feedback element32and a second feedback element42.

The first feedback element32is arranged at the indicator6. The first feedback element32may be an integral part of the indicator6. In particular, the first feedback element32extends along a circumferential direction of the indicator6. In particular, the first feedback element32comprises a resilient arm20. When the indicator6rotates relative to the actuator5and the inner body4during the dispensing of a dose, the first feedback element32, in particular the resilient arm20, interacts with a second feedback element (not shown) inside the actuator5to provide an audible click with each unit dispensed. The second feedback element inside the actuator5may comprise, for example, teeth or splines. At the inner body4, an enhancement feature23is arranged. The enhancement feature23is configured to interact with the first feedback element32.

FIG.4Bshows the interaction of the first feedback element32and the enhancement feature23. The enhancement feature23interacts with the first feedback element32at the end of a dispense operation. Due to the interaction of the first feedback element32and the enhancement feature23, support is provided to the first feedback element32at least when the final unit of a dose is injected. In particular, the enhancement feature23interacts with the first feedback element32such that a deflection of the first feedback element32in a radially inward direction is limited. Thereby, the stiffness of the first feedback element32in particular of the resilient arm20, is increased. Thereby, the interaction of the first feedback element32and the second feedback element inside the actuator5is increased. Thereby, a louder or a noticeably different click is produced, signalling to the user the end of a dispense operation.

FIG.5shows a further embodiment of a drug delivery device1comprising a feedback feature2. The feedback feature2is configured as a snap feature. In particular, the feedback feature2is configured as a snap dome. The feedback feature2comprises or consists of a metal material. The feedback feature2comprises an opening33, wherein the actuator5extends through the opening.

A feedback feature2being configured as a snap dome is shown inFIG.6A. In particular, the feedback feature2is configured as an arched disc. Furthermore, the feedback feature2comprises at least one recess34. The recess34is configured as a concave cavity. In particular, the feedback feature2comprises four recesses34. Due to the cavities, the snap dome possesses a sufficient flexibility. The feedback feature2is configured to snap through when it is compressed above a certain load. Thereby, the feedback feature2creates an audible click and/or a tactile feedback at the end of a dispense operation.

In an alternative embodiment as shown inFIG.6B, the feedback feature2is configured without any recess. Thereby, the feedback feature2may comprise a high stiffness. Thereby, the feedback signal may be more distinct. In particular, the feedback feature2is configured as an arched ring. In particular, the feedback feature2comprises an opening.

As illustrated inFIG.5, the feedback feature2is operated by an axially moveable member50. In particular, the axially moveable member50is a sleeve member24which is arranged between the actuator5and the indicator6. The sleeve member24can move axially relative to the actuator5between two stops35,36when it does not interact with the feedback feature2. The feedback feature2pushes apart the actuator5and the sleeve member24to preload the sleeve member24against one of these stops35,36. In particular, one stop35is provided by the housing3and the other stop36is provided by the actuator5. When the actuator5approaches its end position, the sleeve member24contacts the stop35at the housing3. When the actuator5is further moved towards its end position, the feedback feature2is compressed. Thereby, the feedback feature2is 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.

When the load which is exerted on the feedback feature2by the sleeve member24is released during the setting of a dose, the feedback feature2snaps back into its uncompressed shape. Thereby, the feedback feature2may push the actuator5to an extended position.

FIG.7shows a section through a proximal part of a further embodiment of a drug delivery device1comprising a feedback feature2. The embodiment shown inFIG.7is similar to the embodiment shown inFIG.5, apart from that the embodiment shown inFIG.7does not comprise a sleeve member24. The feedback feature2directly interacts with the actuator5and the housing3. In particular, the housing3comprises a collar37. The collar37is configured to interact with the feedback feature2. In particular, the feedback feature2is compressed between the collar37of the housing3and the actuator5when the actuator5approaches the housing3during the dispensing of a dose.

FIG.8shows a proximal part of a different embodiment of a drug delivery device1comprising a feedback feature2. The embodiment shown inFIG.8is similar to the embodiment shown inFIG.5, apart from that the feedback feature2is integrated into the axially moveable member50, which is configured as a sleeve member24. In particular, the sleeve member24may be an injection-moulded part, and the feedback feature2may be integrally moulded with the sleeve member24. The feedback feature2may 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 inFIG.5, with the feedback feature2snapping through, thereby creating an audible and/or tactile feedback for a user at the end of a dispense operation.

FIG.9shows a section through a proximal part of a further embodiment of the drug delivery device1comprising a feedback feature2. The feedback feature2is arranged between the indicator6and the housing3. In particular, the feedback feature2is positioned inside a cavity in the housing3. The feedback feature2is configured as a snap dome with a relatively large diameter. The actuator5, the driver7, the inner body4and a part of the housing3extend through the opening.

When the indicator6approaches its end-of-dispense position, it makes contact with the feedback feature2and compresses the feedback feature2, 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.

FIG.10shows a section through a proximal part of a further embodiment of a drug delivery device1comprising a feedback feature2. The embodiment shown inFIG.10is similar to the embodiment shown inFIG.9, apart from that the feedback feature2is arranged between the driver7and the inner body4. The feedback feature2is arranged on a protrusion31of the inner body4. When the driver7approaches its end-of-dispense position, it makes contact with the feedback feature2and compresses the feedback feature2, thereby causing the feedback feature2to snap through. Thereby, an audible and/or tactile feedback is created, indicating the end of a dispense operation to a user.

FIG.11Ashows the actuator5, the indicator6and the inner body4of a drug delivery device1according toFIG.1. The indicator6comprises a first feedback element32, which is configured as a resilient arm20. The first feedback element32extends along a circumferential direction of the indicator6. The feedback feature2, in particular the resilient arm20, is arranged at a distal end of the indicator6. A thread28, which is configured to interact with the feedback feature2, is formed on the inner body4. A second feedback element42is formed in the thread28. The second feedback element42is configured as a step29in the thread28. At the end of a dispense operation, the resilient arm20passes over the step29. When the resilient arm20passes over the step29, it is preloaded in an axial direction. In particular, the resilient arm20is preloaded in a direction towards the proximal end of the device1. This preload could be retained throughout the travel of the indicator6. Alternatively, the thread pitch could alter such that the resilient arm20is preloaded near to the end of the dispense operation. As a result of this preload, the resilient arm20accelerates rapidly as it drops off the step29. Thereby, the resilient arm20strikes the thread wall30near the bottom of the step29. Thereby, and audible and/or tactile signal is created, which indicates the end of a dispense operation to a user.FIG.11Bshows a section of the inner body4showing the step29in the thread28in more detail.

FIG.12Ashows the actuator5, the indicator6and the inner body4of a drug delivery device1according toFIG.1. The embodiment according toFIG.12Ais similar to the embodiment shown inFIG.11A. The indicator6also comprises a first feedback element32comprising a resilient arm20, which is configured to interact with a thread28formed on the inner body4. In the embodiment shown inFIG.12A, the resilient arm20is configured to be preloaded radially outwards by the floor of the thread28. This preload could be retained throughout the travel of the indicator6. Alternatively, the preload could be generated when the indicator6is approaching its end of dispense position. In particular, the floor of the thread28could be raised such that the resilient arm20is preloaded near the end of the dispense operation. In the embodiment shown inFIG.12A, the second feedback element42, or the step29, respectively, is radial, causing the resilient arm20to accelerate radially inwards and hit the inner body4. Thereby, an audible and/or tactile signal is created, which indicates the end of a dispense operation to a user.FIG.12Bshows a section of the inner body4showing the step29in the thread28in more detail.