Granted Patent B2

US 12,434,006 · App. 17/297,959 · Granted Oct 7, 2025

Inventors: Stefan Blancke (Frankfurt am Main, DE); Michael Jugl (Frankfurt am Main, DE)

Assignee: Sanofi

A61M5/31568A61M5/2422A61M5/31551A61M5/31581A61M5/31593A61M2207/00

Abstract

Claims (57)

1. An assembly for a drug delivery device, comprising

a housing having a proximal end and a distal end;

a dose setting and drive mechanism comprising:

a dose setting member which is moveable relative to the housing in a dose setting operation from an initial position to a dose set position in order to set a dose of drug; and

a piston rod which, after the dose setting operation, is displaceable in a distal direction relative to the housing in a dose delivery operation of the dose setting and drive mechanism, wherein, during the dose delivery operation, the piston rod is displaced relative to the housing by a displacement distance which is determined by the set dose;

a guide track;

a tracking member which is configured to cooperate with the guide track; and

a coupling mechanism which is configured to operatively couple the tracking member to the dose setting and drive mechanism, wherein the coupling mechanism has two different states, a coupled state and a non-coupled state;

wherein, in the coupled state, a coupling interface is established, wherein the tracking member is operatively coupled to the dose setting and drive mechanism via the coupling interface such that in the dose setting operation a distance between the tracking member and an end position of the tracking member along the guide track is reduced by an amount which is determined by the dose which is set in the dose setting operation; and

wherein, in the non-coupled state, the coupling interface is not established, wherein the coupling mechanism is configured to be switchable from the non-coupled state into the coupled state, and wherein the assembly is configured such that in order to enable switching from the non-coupled state to the coupled state at least one dose delivery operation of the dose setting and drive mechanism has to be initiated.

2. The assembly of claim 1 , wherein the displacement distance is determined by a size of the set dose.

3. The assembly of claim 1 , wherein the assembly is configured such that the coupling mechanism, after having switched into the coupled state, is constrained to the coupled state.

4. The assembly of claim 1 , wherein the assembly is configured such that in the coupled state of the coupling mechanism, the tracking member is operatively coupled to the dose setting member via the coupling interface such that a movement of the dose setting member from the initial position to the dose set position results in relative displacement between the tracking member and the guide track towards the end position.

5. The assembly of claim 1 , wherein the assembly is configured such that in the non-coupled state of the coupling mechanism, a movement of the dose setting member from the initial position to the dose set position does not change the distance of the tracking member from the end position as seen along the guide track.

6. The assembly of claim 1 , wherein the coupling mechanism is configured to switch from the non-coupled state to the coupled state at the end of the first dose delivery operation.

7. The assembly of claim 1 , wherein the coupling mechanism is configured to switch from the non-coupled state to the coupled state at the initiation of the first dose delivery operation.

8. The assembly of claim 1 , wherein the dose setting member is rotatable relative to the housing in an incremented fashion in unit dosage increments for the dose setting operation such that each settable dose is a whole-number multiple of the unit dosage increment.

9. The assembly of claim 8 , wherein the coupling mechanism is configured such that the switching from the non-coupled state into the coupled state is possible in different relative angular coupling positions between the dose setting member and the housing, wherein two adjacent angular coupling positions are separated by an angle which is defined by the unit dosage increment.

10. The assembly of claim 1 , wherein the assembly comprises an actuation member, wherein the actuation member has to be manipulated in order to initiate the dose delivery operation, wherein the actuation member is movable from a first position, where the assembly is in a dose setting mode of operation, into a second position, where the assembly is in a dose delivery mode of operation.

11. The assembly of claim 10 , wherein the second position is closer to the proximal end of the housing than the first position.

12. The assembly of claim 10 , wherein the second position is axially offset from the first position in a direction towards the end position of the tracking member along the guide track.

13. The assembly of claim 10 , wherein in the non-coupled state of the coupling mechanism, a movement of the actuation member from the first position to the second position is transferable to the tracking member in order to switch the coupling mechanism from the non-coupled state to the coupled state.

14. The assembly of claim 1 , wherein the guide track comprises a helical thread, wherein the tracking member is engaged with the helical thread in the coupled state and disengaged from the helical thread in the non-coupled state.

15. The assembly of claim 14 , wherein the assembly is configured such that in the non-coupled state of the coupling mechanism, the tracking member is engaged with an axially extending section of the guide track, wherein the axially extending section leads into the helical thread.

16. The assembly of claim 1 , wherein the assembly is configured such that in the non-coupled state of the coupling mechanism, the dose setting member is rotatable relative to the tracking member and relative to the guide track.

17. The assembly of claim 1 , wherein in the coupled state of the coupling mechanism, the dose setting member is rotationally locked to the tracking member during the dose setting operation.

18. The assembly of claim 1 , wherein when the coupling mechanism is in the coupled state, the dose setting member is rotationally locked to a guide member including the guide track during the dose setting operation.

19. The assembly of claim 1 , wherein the assembly is configured such that in the non-coupled state of the coupling mechanism, the tracking member is rotationally locked to a guide member with the guide track, and wherein when the coupling mechanism is in the coupled state one of the tracking member and the guide member rotates relative to the other one of the tracking member and the guide member when the dose setting member is rotated for setting a dose in the dose setting operation.

20. A drug delivery device comprising the assembly of claim 1 , wherein the coupling mechanism is in the coupled state, the drug delivery device further comprising a cartridge unit, the cartridge unit comprising a cartridge, the cartridge comprising a drug and a bung movably retained in a cartridge body of the cartridge, wherein an initial distance or gap between the piston rod and the bung is greater than or equal to another displacement distance determined by or corresponding to the smallest dose settable with the dose setting and drive mechanism of the assembly in the dose setting operation.

21. The drug delivery device of claim 20 , wherein the other displacement distance corresponds to one unit dosage increment.

22. A method of producing a drug delivery device, the method comprising the following steps:

providing a cartridge unit, the cartridge unit comprising a cartridge containing a drug, wherein a bung is movably retained in a cartridge body of the cartridge;

providing a housing unit, which comprises:

a housing having a distal end and a proximal end,

a dose setting and drive mechanism comprising:

a dose setting member, which is moveable relative to the housing for a dose setting operation from an initial position to a dose set position in order to set a dose of drug; and

a piston rod which, after the dose setting operation, is displaceable in a distal direction relative to the housing in a dose delivery operation of the dose setting and drive mechanism, wherein, during the delivery operation, the piston rod is displaced relative to the housing by a displacement distance which is determined by the set dose;

a guide track;

a tracking member which is configured to cooperate with the guide track, the tracking member having an end position relative to the guide track, wherein a distance from the end position to the tracking member is indicative for an amount of drug remaining in the cartridge;

determining a bung position of the bung relative to the cartridge body;

determining, based on the determined bung position, a desired piston rod position of the piston rod relative to the housing, wherein the desired piston rod position is determined such that, if the housing unit and the cartridge unit are connected, the piston rod and the bung are arranged at a predetermined distance relative to one another;

determining a particular displacement distance by which the piston rod has to be displaced relative to the housing in the distal direction to be in the desired piston rod position;

moving the dose setting member relative to the housing to a dose set position to set a dose required to displace the piston rod relative to the housing by the particular displacement distance;

performing the dose delivery operation to displace the piston rod by the particular displacement distance to move the piston rod into the desired piston rod position relative to the housing;

during or after performing the dose delivery operation, operatively connecting the tracking member to the dose setting and drive mechanism such that when the next dose setting or delivery operation has been performed using the dose setting and drive mechanism, the tracking member is arranged closer to the end position along the guide track; and

after setting the dose required to displace the piston rod by the particular displacement distance, connecting the cartridge unit and the housing unit to one another for the drug delivery device.

23. An assembly for a drug delivery device, comprising

a housing having a proximal end and a distal end;

a dose setting and drive mechanism comprising:

a dose setting member which is moveable relative to the housing in a dose setting operation from an initial position to a dose set position in order to set a dose of drug; and

a piston rod which, after the dose setting operation, is displaceable in a distal direction relative to the housing in a dose delivery operation of the dose setting and drive mechanism, wherein, during the dose delivery operation, the piston rod is displaced relative to the housing by a displacement distance which is determined by the set dose;

a guide track;

a tracking member which is configured to cooperate with the guide track; and

a coupling mechanism which is configured to operatively couple the tracking member to the dose setting and drive mechanism, wherein the coupling mechanism has two different states, a coupled state and a non-coupled state;

wherein, the coupling mechanism is established using at least one first coupling feature and at least one second coupling feature which do not engage one another in the non-coupled state but engage one another in the coupled state;

wherein, in the coupled state, a coupling interface is established, wherein the tracking member is operatively coupled to the dose setting and drive mechanism via the coupling interface such that in the dose setting operation a distance between the tracking member and an end position of the tracking member along the guide track is reduced by an amount which is determined by the dose which is set in the dose setting operation; and

wherein, in the non-coupled state, the coupling interface is not established, wherein the coupling mechanism is configured to be switchable from the non-coupled state into the coupled state, and wherein the assembly is configured such that in order to enable switching from the non-coupled state to the coupled state at least one dose delivery operation of the dose setting and drive mechanism has to be initiated.

Assignments (1)

Priority Claims (1)

Continuity (1)

References Cited (26)