Dose setting mechanism and method of using the same

1. A dose setting mechanism for a drug delivery device, the mechanism comprising:

a drug delivery device housing;

a dose dial sleeve positioned in the housing and rotatable during dose setting and dose delivery,

a clutch rotatable during dose setting and non-rotatable during dose delivery, wherein the clutch releasably couples the dose dial sleeve to a driver during dose setting and uncouples the dose dial sleeve and the driver during dose delivery; and

a clutch ring, which is engageable with the clutch and which is engaged with the housing in a first rotatable configuration until a predetermined minimum dose is reached and in a second non-rotatable configuration, wherein allowing the clutch ring to rotate in its first rotatable configuration prevents dose dispensing.

2. The mechanism of claim 1 , wherein the clutch has clutch teeth located at a distal end thereof, wherein the clutch ring is engaged with the clutch teeth of the clutch such that relative rotation between the clutch ring and the clutch is allowed during dose setting and relative rotation between the clutch ring and the clutch is prevented during dose dispensing.

3. The mechanism of claim 1 , wherein rotation of the clutch relative to the housing prevents dispensing of a set dose.

4. The mechanism of claim 1 , wherein the clutch ring has a radial protrusion that engages a combined helical and axial track in the housing.

5. The mechanism of claim 4 , wherein during dose setting below a predetermined minimum dose the radial protrusion is in a first path of the track allowing the clutch ring to move helically.

6. The mechanism of claim 4 , wherein during dose setting equal to or greater than a predetermined minimum dose the radial protrusion is in a second path of the track allowing the clutch ring to move only axially.

7. The mechanism of claim 1 , further comprising a biasing member in contact with a distal surface of the clutch ring.

8. The mechanism of claim 5 , wherein the first track path has a helical distance directly proportional to a predetermined minimum set dose.

9. The mechanism of claim 5 , wherein a set dose cannot be delivered when the radial protrusion is in the first path of the track.

10. The mechanism of claim 5 , further comprising a non-return member located at a transition point between the first and second paths of the tracks.

11. The mechanism of claim 4 , wherein the combined helical and axial paths of the track comprises an insert that can be affixed inside the housing during device assembly.

12. The mechanism of claim 4 where the clutch ring is engaged with clutch teeth formed on the clutch in a first non-rotatable configuration, a second rotatable configuration and in a third non-rotatable configuration, and wherein the combined helical and axial paths of the track is configured to allow priming dose to be set and expelled from the device, such that the priming dose is less than a predetermined minimum dose.

13. The mechanism of claim 1 , wherein clutch ring is integrally formed with a flexible washer spring having clutch ring protrusions and clutch ring teeth for releasably engaging clutch teeth formed on the clutch.

14. A method of delivering at least a predetermined minimum dose of a medicament comprising:

setting a dose by rotating a dose dial sleeve in a first direction relative to a device housing, wherein the dose dial sleeve is in clutched engagement with a driver causing the driver and the dose dial sleeve to move in a proximal axial direction;

moving a clutch ring in a helical path until a predetermined minimum dose is reached and then having the clutch ring move in an axial path), wherein the clutch ring engages a clutch in a rotatable manner during dose setting and engages the clutch in a non-rotatable manner during dose dispensing.

15. The method of claim 14 , wherein dispensing of a set dose is prevented when the clutch ring is in the helical path and the dose is less than the predetermined minimum dose.