Pen-type injector

• US 9,526,844 B2
• Filed: 05/17/2016
• Issued: 12/27/2016
• Est. Priority Date: 03/03/2003
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Veasey, Robert Frederick, Perkins, Robert, Plumptre, David Aubrey
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US15/156,616
• Publication Number:
  US 20160256633A1
• Time in Patent Office: 224 Days
• Field of Search: 604208-211, 604/68, 128/DIG.12, 128/DIG.13
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• 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 5/31528 by means of rotational movements, e.g. screw-thread mechanisms
• CPC Class Codes: A61M 5/31533 Dosing mechanisms, i.e. setting a dose administrating mechanisms A61M5/31565
• 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 5/31536 Blocking means to immobilize a selected dose, e.g. to administer equal doses
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/31565 Administration mechanisms, i.e. constructional features, modes of administering a dose dosing mechanisms for setting a dose A61M5/31533
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31578 based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: A61M 5/31593 : Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/32 : Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

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.

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.