Medication Delivery Device

• US 20130053789A1
• Filed: 03/09/2012
• Published: 02/28/2013
• Est. Priority Date: 05/02/2008
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Harms, Michael, Webber, Dominic George, Howarth, James Robert, Beckett, Trevor John, Gray, Geoffrey Philip, Cross, John David, Raab, Steffen
• Granted Patent: US 8,579,867 B2
• Time in Patent Office: Days
• US Class Current: 604/211
• 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 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• 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 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• 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 5/31558 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• 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 medication delivery devices, in particular in pen-type injectors, preferably having dose setting means and a drive device enabling the administration of a medicinal product from a single- or multi-dose medication cartridge, to a use of such device, and to a method of manufacturing or assembling such device.

Claims

1. A medication delivery device comprising:

a housing having a proximal and a distal end,

a medication receptacle designed to be engaged with the housing

a piston rod which is moveable in a distal direction for medication delivery and

a drive device for rotating the piston rod in a first rotational direction and thereby moving the piston rod in the distal direction for medication delivery;

characterized in that

the piston rod comprises two threaded sections, wherein a first threaded section is provided for threaded engagement with a reset element and a second threaded section is provided for threaded engagement with the drive device and wherein the threads in the first and second threaded sections are oppositely disposed, wherein

in an operational state the reset element is prevented from rotation with respect to the housing, the piston rod thereby being prevented from moving in a proximal direction, and

in a resetting state the reset element is allowed to rotate with respect to the housing, the medication delivery device being resettable by rotating the piston rod and the reset element in a second rotational direction and moving the piston rod in the proximal direction.

2. The medication delivery device according to claim 1, characterized in that

when the medication receptacle is engaged with the distal end of the housing the reset element is in the operational state and

when the medication receptacle is disengaged from the distal end of the housing the reset element is in the resetting state.

3. The medication delivery device according to claim 1, characterized in that the medication receptacle is designed to be engaged with the distal end of the housing by engagement of first engagement means and second engagement means, the first engagement means and the second engagement means being moveable into engagement by a movement of the medication receptacle which comprises a rotational movement without axial movement of the medication receptacle with respect to the housing.

4. The medication delivery device according to claim 1, characterized in that the medication receptacle comprises an actuation means for bringing the reset element in the operational state.

5. The medication delivery device according to claim 4, characterized in that the first and second engagement means are designed such that when the medication receptacle and the housing are moved into engagement, the actuation means are first rotated and moved axially with respect to the housing and are thereafter rotated without being moved axially, the actuation means thereby bringing the reset element in the operational state.

6. The medication delivery device according to claim 3, characterized in that the medication receptacle or an insert of the medication receptacle comprises the first engagement means and that the housing or an insert of the housing comprises the second engagement means.

7. The medication delivery device according to claim 3, characterized in that the first engagement means is a thread of the medication receptacle and the second engagement means is an engaging element of the housing or of an insert of the housing for engagement with the thread of the medication receptacle, wherein the distal end of the thread of the medication receptacle merges into a annular groove such that the medication receptacle is engaged with the housing by first rotating and moving proximally with respect to the housing and then only rotating with respect to the housing.

8. The medication delivery device according to claim 3, characterized in that the distal end of the housing is provided with an insert comprising the second engagement means designed to engage with the first engagement means at the proximal end of the medication receptacle, the insert being secured against rotation but being free to move axially with respect to the housing, wherein distal axial movement of the insert is limited by a retaining means.

9. The medication delivery device according to claim 8, characterized in that the insert of the housing comprises an inner thread as a second engagement means for engaging a first engagement means which is an outer thread at the proximal end of the medication receptacle, the medication receptacle being rotated and moved axially with respect to the insert and the housing-in a first step for engaging the medication receptacle with the housing and the medication receptacle being rotated while axial movement of the medication receptacle is prevented with respect to the housing in a second step for engaging the medication receptacle with the housing, the insert being moved in the distal direction by the rotation of the medication receptacle during the second step.

10. The medication delivery device according to claim 1, characterized in that the reset element is a nut means threadedly engaged with an external thread of the piston rod.

11. The medication delivery device according to claim 1, characterized in that the drive device comprises a drive sleeve and the second threaded section of the piston rod is provided for threaded engagement with the drive sleeve.

12. The medication delivery device according to claim 11, characterized in that the drive sleeve is engaged with the piston rod for driving the piston rod in the distal direction during medication delivery, the drive sleeve being moved axially and being prevented from rotation with respect to the housing during medication delivery, thereby causing axial movement and rotation of the piston rod.

13. The medication delivery device according to claim 11, characterized by stop means, the stop means being designed such that

during dose setting the drive sleeve is allowed to move axially and rotate with respect to the housing while the drive sleeve is not allowed to move axially without rotation with respect to the housing and

during dose delivery rotation of the drive sleeve with respect to the housing is not allowed while the drive sleeve is allowed to move axially in the distal direction without rotation with respect to the housing.

14. The medication delivery device according to claim 13, characterized in that the stop means comprises a clutch means which is non-rotatably engaged with the drive sleeve.

15. The medication delivery device according to claim 11, comprising a dosing mechanism which includes the piston rod and the drive device, the dosing mechanism further comprising:

a dose dial sleeve having a helical thread engaged with a helical thread of the housing, the drive sleeve being releasably coupled with the dose dial sleeve and

a clutch means located between the dose dial sleeve and the drive sleeve, wherein,

a) when the dose dial sleeve and the drive sleeve are coupled, both are allowed to rotate with respect to the housing, and

b) when the dose dial sleeve and the drive sleeve are de-coupled, rotation of the dose dial sleeve with respect to the housing is allowed, whilst rotation of the drive sleeve with respect to the housing is not allowed and axial movement of the drive sleeve is allowed in the distal direction thereby transferring a force in the distal direction to the piston rod.

16. The medication delivery device according to claim 1, characterized in that the medication delivery device comprises a locking means which is non-rotatable with respect to the housing and which is engaged with the reset element in the operational state, thereby locking the reset element for preventing rotation of the reset element with respect to the housing.

17. The medication delivery device according to claim 16, characterized in that the reset element is a nut means which is threadedly engaged with the piston rod and which is engaged with the locking means in the operational state.

18. The medication delivery device according to claim 16, characterized in that locking means and the reset element comprise face teeth which interlock when the locking means and the reset element are engaged in the operational state.

19. The medication delivery device according to claim 16, characterized in that the locking means and the reset element disengage under the force of a biasing means when the medication receptacle is disengaged from the housing.

20. The medication delivery device according to claim 16, characterized in that when the medication receptacle is disengaged from the housing, the locking means and the reset element are disengaged, whereby the reset element is free to rotate with respect to the housing in the resetting state.

21. The medication delivery device according to claim 1, characterized in that the medication receptacle is a cartridge holder which is designed to receive a cartridge filled with medication.

22. The medication delivery device according to any of claim 1, characterized in that the medication receptacle and the housing are provided with snap-in features by means of which the medication receptacle and the housing are held in releasable engagement.

23. The medication delivery device according to claim 1, characterized in that in the first threaded section the piston rod has a thread with a first pitch and in the second threaded section the piston rod has a thread with a second pitch, wherein the first pitch is smaller than the second pitch.

24. The medication delivery device according to claim 1 which is a pen-type device.

25. The medication delivery device according to claim 1 which is an injector-type device.

26. The medication delivery device according to claim 1, characterized in that medication delivery device comprises a needle.

27. The medication delivery device according to claim 1 provided for dispensing a medicinal product.

28. The medication delivery device according to claim 27 provided for dispensing 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.

29. The method of manufacturing or assembling a medication delivery device, as defined in claim 1.