Dose setting mechanism and method of using same

Patent metadata

Field	Value
Publication number	US-9707351-B2
Application number	US-201113878463-A
Country	US
Kind code	B2
Filing date	Oct 11, 2011
Priority date	Oct 13, 2010
Publication date	Jul 18, 2017
Grant date	Jul 18, 2017

Abstract

The present invention relates to a dose setting mechanism for a drug delivery device and a method of using same. The mechanism comprises a drug delivery device housing, a dose dial sleeve positioned at least partly in the housing and being rotatable during dose setting and dose delivery, a clutch rotatable during dose setting and non-rotatable during dose delivery, and a clutch nut, that is threadedly engaged with the clutch and is splined to the housing to prevent rotation of the clutch nut.

First claim

The invention claimed is:

1. A dose setting mechanism for a drug delivery device, the mechanism comprising:
a drug delivery device housing;
a dose dial sleeve positioned at least partly in the housing and is rotatable during dose setting and dose delivery,
a clutch rotatable during dose setting and non-rotatable during dose delivery; and
a clutch nut, that is threadedly engaged with the clutch and is splined to the housing to prevent rotation of the clutch nut,
wherein the clutch nut is fixed to the dose dial sleeve from a dose of 0 to a predetermined minimum dose by means of interacting splines or by means of a one-directional coupling or ratchet and is disengaged from the dose dial sleeve when a dose greater than the predetermined minimum dose is set,
wherein the dose dial sleeve is non-rotatable and locked from movement in a distal direction during attempted dose delivery if the set dose is from 0 to less than a predetermined minimum dose.

2. The mechanism of claim 1 , wherein the clutch nut is releasably coupled to the dose dial sleeve such that a relative rotation between the clutch nut and the dose dial sleeve is prevented in at least one rotational direction.

3. The mechanism of claim 1 , wherein the clutch nut is in ratchet engagement with the dose dial sleeve to allow the dose dial sleeve to rotate in only a single direction.

4. The mechanism of claim 1 , wherein the clutch nut is fixed to the dose dial sleeve from a dose larger than a predetermined maximum dose by means of interacting splines or by means of a one-directional coupling or ratchet.

5. The mechanism of claim 1 , wherein the clutch nut is threadedly engaged with the clutch through flexible fingers.

6. The mechanism of claim 1 further comprising a dose button for initiating and/or executing injection of a set dose, wherein when the dose button is pushed the clutch nut is not engaged with the dose dial sleeve when a dose greater than the predetermined minimum dose has been set.

7. The mechanism of claim 1 further comprising a dose button for initiating and/or executing injection of a set dose, wherein when the dose button is pushed the clutch nut is not engaged with the dose dial sleeve when a dose smaller than the predetermined maximum dose has been set.

8. The mechanism of claim 1 , wherein the dose dial sleeve is non-rotatable and locked from movement in a distal direction during attempted dose delivery if the set dose is above a predetermined maximum dose.

9. A method of delivering at least a predetermined minimum dose of a medicament from a drug delivery device comprising
rotating a dose dial sleeve in a first direction relative to a device housing, where the dose dial sleeve is in ratchet engagement with a clutch nut such that there is no relative rotation between the dose dial sleeve and the clutch nut in a second direction opposite the first direction when a dose of from 0 to less than a predetermined minimum dose set;
preventing rotation of the clutch nut relative to the housing; and
allowing rotation of the dose dial sleeve in the second direction when a dose above a predetermined maximum dose is set causing the ratchet engagement between the clutch nut and dose dial sleeve to disengage.

10. A method of delivering at least a predetermined minimum dose of a medicament from a drug delivery device comprising
rotating a dose dial sleeve in a first direction relative to a device housing, where the dose dial sleeve is in ratchet engagement with a clutch nut, where rotation in the first direction causes the dose dial sleeve wind outwardly relative to the housing and the clutch nut;
moving the clutch nut in an axial distal direction relative to and opposite to the winding outward of the dose dial sleeve during dose setting;
disengaging the clutch nut from the dose dial sleeve when a dose above a predetermined minimum dose and has been set; and

pushing a dose button to deliver the dose.

Assignees

• Leak David Martin
• Butler Joseph
• Sanofi Aventis Deutschland

Inventors

• Leak David Martin
• Butler Joseph

Classifications

• A61M5/31585

  performed by axially moving actuator, e.g. an injection button · CPC title

• A61M5/31571

  Means preventing accidental administration (for automatic syringes A61M5/20) · CPC title

• A61M5/31538

  Permanent blocking, e.g. by medical personnel · CPC title

• A61M5/31525 Primary

  Dosing (burettes, pipettes B01L3/02) · CPC title

• A61M5/31551

  including axial movement of dose setting member · CPC title