Medication Delivery Device

• US 20090275916A1
• Filed: 08/20/2008
• Published: 11/05/2009
• Est. Priority Date: 05/02/2008
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi ), Sanofi-Aventis (Sanofi-Synthélabo SA)
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: BESENHARDT, Norbert, HOWARTH, James Robert, STREHL, Michael, HARMS, Michael, GREGORY, George Richard, COCKER, Robin Craig, LEUSCHNER, Udo, CHARPENTIER, Anthony Raymond
• Granted Patent: US 8,647,309 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2488 via rotation, e.g. threads or bayonet
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/585 having magnification means, e.g. magnifying glasses
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/31543 piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The present invention relates to a medication delivery device, to dosing mechanisms suitable for use in such medication delivery device, in particular in pen-type injectors, preferably having a dose setting member and a drive device enabling the dose setting and the administration of a medicinal product from a multi-dose medication cartridge, to methods using such device, and to methods of manufacturing and assembly of such device.

Claims

1. A medication delivery device (1) comprising

a medication receptacle (6),

a dosing mechanism comprising

a piston rod (17) which is moveable in a distal direction for medication delivery

a drive device (19) for moving the piston rod (17) in the distal direction for medication delivery,

a dose setting member (27) for setting a dose of medication to be delivered and

a dose limiting member (28) which prevents the setting of a dose of medication which exceeds an amount of medication contained in the medication receptacle (6) and

a housing (3) which houses at least part of the dosing mechanism, characterized in that

the dose limiting member (28) is designed for axial movement in a proximal direction with respect to the piston rod (17) during dose setting and the dose limiting member (28) comprises a first stop element (35) and the piston rod (17) comprises a second stop element (36), the first and second stop elements (35, 36) stopping an axial movement of the dose limiting member (28) in the proximal direction with respect to the piston rod (17) when the first and second stop elements (35, 36) catch, thereby limiting a movement of the dose setting member (27) for increasing a set dose of medication to be delivered, wherein the dose limiting member (28) and the piston rod (17) only interact directly, when the first and second stop elements (35, 36) catch.

2. The medication delivery device according to claim 1, characterized in that the dose limiting member (28) is engaged with the dose setting member (27), the dose limiting member (28) stopping a movement of the dose setting member (27) for increasing a set dose of medication to be delivered when the axial movement of the dose limiting member (28) is stopped.

3. The medication delivery device according to claim 1, characterized in that the dose limiting member (28) is coupled to or engaged with the dose setting member (27)

so that the dose limiting member (28) is moved in the proximal direction with respect to the housing (3) and with respect to the piston rod (17) during dose setting when the set dose of medication to be delivered is increased by moving the dose setting member (27) in a dose increasing direction and

so that the dose limiting member (28) is moved in the distal direction with respect to the housing (3) during medication delivery.

4. The medication delivery device according to claim 3, characterized in that the dose limiting member (28) is engaged with an internal thread of the dose setting member or engaged with a threaded insert (53, 74) of the dose setting member (27).

5. The medication delivery device according to claim 1, characterized in that the dose setting member is a dose dial sleeve (27) which is threadedly engaged with the housing (3) and therefore rotates and moves proximally with respect to the housing (3) during setting of a higher dose, rotates and moves distally with respect to the housing (3) during reducing of a set dose and rotates and moves distally with respect to the housing (3) during dose delivery.

6. The medication delivery device according to claim 1, characterized in that the dose limiting member (28) comprises an essentially tubular sleeve which is threadedly engaged with the dose setting member (27) or with an insert (53, 74) of the dose setting member (27).

7. The medication delivery device according to claim 1, characterized in that the dose limiting member (28) comprises an opening (38), wherein the piston rod (17) extends through the opening (38) and wherein the first stop element (35) is provided as a surface surrounding the opening (38).

8. The medication delivery device according to claim 1, characterized in that the first stop element (35) is an abutment surface of an internal flange (37) of the dose limiting member (28).

9. The medication delivery device according to claim 1, characterized in that the second stop element (36) is a protrusion (58) which extends radially from the piston rod (17), the axial position of the protrusion (58) on the piston rod (17) being related to the total amount of medicament to be dispensed.

10. The medication delivery device according to claim 1, characterized in that the second stop element (36) is the end of a thread (16) on the piston rod (17).

11. The medication delivery device according to claim 1, characterized in that the piston rod (17) comprises two threaded regions (15, 16), a first threaded region (15) which does not influence axial movement of the dose limiting member (28) and a second threaded region (16), wherein one end of a thread (16) in the second threaded region forms the second stop element (36).

12. The medication delivery device according to claim 1, characterized in that the dose limiting member (28) is allowed to move axially and is prevented from rotation with respect to the housing (3).

13. The medication delivery device according to claim 12, characterized in that the dose limiting member (28) is splined to the housing (3) and is thereby prevented from rotation with respect to the housing (3).

14. The medication delivery device according to claim 1, characterized in that the piston rod (17) comprises two threaded regions, the two threaded regions having threads (15, 16) which are oppositely disposed.

15. The medication delivery device according to claim 1, further comprising a drive device (19) which is engaged with the piston rod (17) and releasably engaged with the dose setting member (27).

16. The medication delivery device according to claim 15, characterized in that the piston rod (17) comprises two threaded regions, the two threaded regions having threads (15, 16) which are oppositely disposed, wherein a second threaded region (16) is provided for threaded engagement with the drive device (19).

17. The medication delivery device according to claim 1, further comprising a clutch means (24) located between the dose setting member (27) and the drive device (19) which is provided to releasably couple the drive device (19) with the dose setting member (27), wherein when the dose setting member (27) and the drive device (19) are coupled, both are allowed to rotate with respect to the housing (3) and when the dose setting member (27) and the drive device (19) are decoupled, rotation of the dose setting member (27) with respect to the housing (3) is allowed, whilst rotation of the drive device (19) with respect to the housing (3) is not allowed and axial movement of the drive device (19) is allowed so that a force is transferred to the piston rod (17) in the distal direction.

18. The medication delivery device according to claim 1, characterized in that the dose limiting member (28) comprises a tubular part which surrounds the piston rod (17), a drive sleeve (19) and a clutch means (24) and which is surrounded by the dose setting member (27).

19. The medication delivery device according to claim 1, characterized in that the dosing mechanism comprises at least one locking member (64) for locking the dose setting member (27) with the housing (3), thereby preventing rotation of the dose setting member (27) with respect to the housing (3) in a dose increasing direction, the locking member (64) being activated when the first stop element (35) of the dose limiting member (28) catches the second stop element (36) of the piston rod (17) and when a force is exerted on the dose setting member (27) in the dose increasing direction.

20. The medication delivery device according to claim 19 comprising at least one locking member (64) which interacts directly with or is connected to the dose setting member (27) and/or which interacts directly with or is connected to an insert (53, 74) of the dose setting member (27), which insert (53, 74) is in engagement with the dose limiting member (28) and designed for movement with respect to the dose setting member (27).

21. The medication delivery device according to claim 20 comprising at least one locking member (64) which is a separate part and which is connected to the dose setting member (27) via a swivel axis.

22. The medication delivery device according to claim 19, characterized by an insert (53, 74) of the dose setting member (27), the dose setting member (27) being allowed to perform a movement in a dose increasing direction with respect to the insert (53, 74) when the first and second stop elements (35, 36) abut, thereby moving the at least one locking member (64) and at least one locking feature (66) of the housing (3) into engagement.

23. The medication delivery device according to claim 22, characterized in that the insert (53, 74) is a threaded insert which is threadedly engaged with the dose limiting member (28).

24. The medication delivery device according to claim 19, characterized in that the at least one locking member (64) is swivelled out by means of at least one ramp feature (65) when activated, thereby engaging at least one locking feature (66) of the housing (3).

25. The medication delivery device according to claim 24, characterized in that an insert (53, 74) of the dose setting member (27) comprises the at least one ramp feature (65), the dose setting member (27) being allowed to perform a rotational movement in a dose increasing direction with respect to the insert (53, 74), thereby moving the at least one ramp feature (65) along the at least one locking member (64), the locking member (64) thereby swivelling out and engaging the at least one locking feature (66) of the housing (3).

26. The medication delivery device according to claim 19, characterized in that the at least one locking member (64) or the at least one locking feature (66) of the housing (3) is held in a first deactivated position by a biasing means (63, 76).

27. The medication delivery device according to claim 25, characterized in that the at least one locking member (64) or the at least one locking feature (66) of the housing (3) is held in a first deactivated position by a biasing means (63, 76).

28. The medication delivery device according to claim 19, comprising at least one locking member (64) which is an integral part of an insert (53, 74) of the dose setting member (27), the locking member (64) extending through an opening in the dose setting member (27), the dose setting member (27) being allowed to perform a rotational movement in the dose increasing direction with respect to the insert, thereby moving an edge of the opening against the locking member (64), the locking member (64) thereby swivelling out and engaging a locking feature (66) of the housing (3).

29. The medication delivery device according to claim 19, characterized in that the at least one locking member (64) is engaged with grooves or splines (66) in the housing (3) when the locking member (64) is activated, thereby preventing a movement of the dose setting member (27) with respect to the housing (3) in a dose increasing direction.

30. The medication delivery device according to claim 19, characterized in that the at least one locking member (64) is a hook which is hooked into at least one hooking feature of the housing (3) when the locking member (64) is activated, thereby preventing a movement of the dose setting member (27) with respect to the housing (3) in a dose increasing direction.

31. The medication delivery device according to claim 19, having a locking member (64) comprising at least one tooth (73) for engaging a locking feature (66) of the housing (3), the locking member (64) being connected to or interacting directly with the dose setting member (27) and the locking feature (66) being connected to or interacting directly with the housing (3) or with an insert of the housing (3) such that a movement of the locking feature (66) with respect to the housing (3) in a dose increasing direction is prevented, thereby preventing a movement of the dose setting member (27) with respect to the housing (3) in a dose increasing direction when the locking member (64) and the locking feature (66) are engaged.

32. The medication delivery device according to claim 31, characterized in that the locking member (64) is a first toothed ring (68) connected to a dose dial sleeve (27) and the locking feature (66) is a second toothed ring (69), the second toothed ring (69) being prevented from rotation with respect to the housing (3), thereby preventing rotation of the dose dial sleeve (27) with respect to the housing (3) when the two toothed rings (68, 69) are engaged.

33. The medication delivery device according to claim 32, characterized in that the dose dial sleeve (27) has a threaded insert (53, 74) which is engaged with the dose limiting member (28), the second toothed ring (69) being prevented from moving axially with respect to the threaded insert (53, 74) and the threaded insert (53, 74) being provided for axial movement with respect to the dose dial sleeve (27) when the first and second stop members (35, 36) catch and a further force is exerted on the dose dial sleeve (27) in a dose increasing direction, the first and second toothed rings (68, 69) thereby being moved into engagement.

34. The medication delivery device according to claim 19, characterized in that a biasing means (63, 76) is located between the locking member (64) and a locking feature (66) of the housing (3) for keeping the locking member (64) and the locking feature (66) disengaged until the locking member (64) is activated.

35. The medication delivery device according to claim 1, further comprising a cartridge (6) which contains the medication, the cartridge (6) comprising a piston (7) which is moved in a distal direction by the piston rod (17) for medication delivery, wherein the dose limiting member (28) is provided to prevent setting of a dose of medication which exceeds the amount of medication left in the cartridge (6).

36. A method for dispensing a medicinal product comprising dispensing said product from a medication delivery device according to claim 1.

37. A method according to claim 36 wherein the medicinal product is a pharmaceutical formulation comprising an active compound selected from the group consisting of insulin, growth hormone, low molecular weight heparin, their analogues and their derivatives.

38. A method of manufacturing or assembling a medication delivery device (1) according to claim 1.