Claims for Patent: 9,526,844

Summary for Patent: 9,526,844

Title:	Pen-type injector
Abstract:	The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.
Inventor(s):	Veasey; Robert Frederick (Warwickshire, GB), Perkins; Robert (Warwickshire, GB), Plumptre; David Aubrey (Worcestershire, GB)
Assignee:	SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:	15/156,616
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,526,844
Patent Claims:	1. A drive mechanism for use in a drug delivery device comprising: a housing comprising an inner surface; a dose dial sleeve threadedly engaged with the inner surface of the housing through an outer thread having a first lead; an insert that is rotationally and axially fixed relative to the housing; a piston rod engaged with the insert, where the piston rod is threaded with a second lead and remains axially fixed relative to the housing during dose setting and moves axially relative to the insert during dose delivery; a clutch operatively engaged with the dose dial sleeve to allow rotation of the dose dial sleeve during dose setting and dose delivery; and a drive sleeve that extends about the piston rod and is operatively engaged with the clutch, where the clutch connects the drive sleeve and dose dial sleeve so they rotate together and disconnects the drive sleeve and dose dial sleeve so the dose dial sleeve can rotate relative to the drive sleeve, wherein during dose delivery the drive sleeve and the piston rod are configured to rotate relative to one another and the drive sleeve is configured to traverse axially towards the distal end. 2. The drive mechanism of claim 1 where the first lead and second lead are different. 3. The drive mechanism of claim 1 where the dose dial sleeve rotates and moves axially relative to the piston rod during dose setting and dose delivery. 4. The drive mechanism of claim 1 where the piston rod has a circular cross-section. 5. The drive mechanism of claim 1 where the clutch provides audible and tactile feedback indicative of unit doses of medicament. 6. The drive mechanism of claim 1 where the clutch provides audible clicks during dose cancelling, where each click is equal to a unit dose of medicament. 7. The drive mechanism of claim 6 where the clutch allows the dose cancelling without dispensing medicament. 8. The drive mechanism of claim 1 further comprising a T-shaped button having a skirt that extends distally from a head portion of the button and is seated in an annular recess of a dose dial grip on a proximal end of the dose dial sleeve. 9. The drive mechanism of claim 8 where the button further comprises a stem extending in an opening in the dose dial grip. 10. The drive mechanism of claim 8 where the button is rotatable relative to the dose dial sleeve. 11. The drive mechanism of claim 8 where axial movement movement of the button caused by distally applied pressure to the head initiates dose delivery by displacing the clutch axially with respect to the dose dial sleeve and drive sleeve. 12. The drive mechanism of claim 1 further comprising a clicker that provides audible clicks during dose setting, where each click is equal to a unit dose of medicament. 13. The drive mechanism of claim 1 where the dose dial sleeve rotates and moves axially during dose setting and dose delivery. 14. The drive mechanism of claim 1 further comprises a nut that tracks each set dose of medicament delivered. 15. The drive mechanism of claim 14 where the nut is threaded, axially slidable and rotationally fixed relative to the housing. 16. The drive mechanism of claim 14 where the nut moves axially in a proximal direction relative to the housing and drive sleeve for each dose set and delivered. 17. The drive mechanism of claim 14 where the drive sleeve further comprises a final dose stop. 18. The drive mechanism of claim 17 where the nut further comprises a corresponding final dose stop that engages the final dose stop on drive sleeve. 19. The drive mechanism of claim 18 where engagement of the final dose stop and the corresponding final dose stop prevent rotation of the dose dial sleeve during dose setting. 20. A drug delivery device comprising; a cartridge holder; a cap; and the drive mechanism of claim 1. 21. A drug delivery device comprising: a housing comprising a dose dispensing end and a first thread; a dose indicator comprising a second thread that engages with the first thread; a driving member comprising a third thread; a sleeve that is (i) disposed between the dose indicator and the driving member and (ii) releasably connected to the dose indicator; a piston rod comprising either an internal or an external fourth thread that is engaged with the third thread; a piston rod holder that is rotatably fixed relative to the housing and configured to (i) prevent the piston rod from rotating during dose setting and (ii) permit the piston rod to traverse axially towards the distal end during dose dispensing; wherein: the housing is disposed at an outermost position of the drug delivery device; the dose indicator is disposed between the housing and the sleeve and is configured to (i) rotate and traverse axially away from the dose dispensing end during dose setting and (ii) rotate and traverse axially towards the dose dispensing end during dose dispensing; the driving member is configured to rotate relative to the piston rod; the sleeve is rotatably fixed relative to the driving member and configured to traverse axially with the dose indicator; and the piston rod and the driving member are configured to rotate relative to one another during dose dispensing; and the piston rod is configured to traverse axially towards the dose dispensing end during dose dispensing. 22. The drug delivery device of claim 21 where the piston rod has a circular cross-section. 23. The drug delivery device of claim 21 further comprising a clutch. 24. The drug delivery device of claim 23 where the clutch provides audible and tactile feedback indicative of unit doses of medicament. 25. The drug delivery device of claim 24 where the clutch provides audible clicks during dose cancelling, where each click is equal to a unit dose of medicament. 26. The drug delivery device of claim 24 where the clutch allows the dose cancelling without dispensing medicament. 27. The drug delivery device of claim 24 further comprising a button seated in an annular recess of a dose dial grip on a proximal end of the dose indicator, where the button is rotatable relative to the dose indicator. 28. The drug delivery device of claim 27 where axial movement movement of the button caused by distally applied pressure to the button initiates dose delivery by displacing the clutch axially with respect to the dose indicator and driving member. 29. The drug delivery device of claim 21 further comprising a clicker that provides audible clicks during dose setting, where each click is equal to a unit dose of medicament. 30. The drug delivery device of claim 21 further comprises a nut that tracks each set dose of medicament delivered.