Pen-type injector

• US 8,992,486 B2
• Filed: 06/04/2013
• Issued: 03/31/2015
• Est. Priority Date: 03/03/2003
• Status: Active Grant

• 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:
  US13/909,681
• Publication Number:
  US 20130267906A1
• Time in Patent Office: 665 Days
• Field of Search: 604/187, 604207-211, 604/218, 604/221, 604/224, 604/232
• US Class Current: 604/209
• 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

A housing for a dispensing apparatus. The housing comprising a main housing and a dose dial sleeve. The dose dial sleeve comprising a helical groove configured to engage a threading provided by the housing. A dose knob is disposed near a proximal end of the dose dial sleeve and a piston rod is provided within the housing. The piston rod is non-rotatable during a dose setting step. A driver comprises an internal threading near a distal portion of the driver and is adapted to engage an external thread of the piston rod. A tubular clutch is located adjacent a distal end of the dose knob and operatively coupled to the dose knob. The dose dial sleeve may extend circumferentially around at least a portion of the tubular clutch.

Claims

1. A housing part for a medication dispensing apparatus, said housing part comprising:

a main housing, said main housing extending from a distal end to a proximal end;

a dose dial sleeve positioned within said housing, said dose dial sleeve comprising a helical groove configured to engage a threading provided by said main housing;

a dose knob disposed near a proximal end of said dose dial sleeve;

a piston rod provided within said housing, said piston rod is non-rotatable during a dose setting step relative to said main housing;

a driver extending along a portion of said piston rod, said driver comprising an internal threading near a distal portion of said driver, said internal threading adapted to engage an external thread of said piston rod; and

,

a tubular clutch located adjacent a distal end of said dose knob, said tubular clutch operatively coupled to said dose knob,

wherein said dose dial sleeve extends circumferentially around at least a portion of said tubular clutch.

2. The housing part of claim 1, wherein said tubular clutch is directly coupled to said dose knob.

3. The housing part of claim 1, wherein said main housing comprises a window through which at least a portion of an outer surface of said dose dial sleeve may be viewable.

4. The housing part of claim 3, wherein said window is located near a proximal end of said main housing and near a helical rib provided on an inner surface of said outer housing.

5. The housing part of claim 1, wherein said driver comprises a cylindrical shape.

6. The housing part of claim 1, wherein said dose knob extends circumferentially around at least a portion of said tubular clutch.

7. The housing part of claim 1, wherein during a dose dispensing step, said dose knob is activated in a distal direction and said tubular clutch disengages such that said dose dial sleeve rotates back towards said proximal end of said main housing.

8. The housing part of claim 7, wherein during said dose dispensing step, said dose dial sleeve and said tubular clutch rotate together.

9. The housing part of claim 1, further comprising

a container housing operatively coupled to said main housing, said container housing comprising a fluid container,

wherein said fluid container defines a medicament filled reservoir with a movable plunger at a proximal end and an outlet at a distal end,

said plunger movable by said piston rod to be advanced toward an outlet of said fluid container when said piston rod is moved distally, wherein

during a dose dispensing step, said driver advances axially in a distal direction relative to said main housing, and

said driver advances said piston rod in said distal direction so as to dispense said medicament from said outlet at said distal end of said fluid container.

10. The housing part of claim 1, wherein said dose setting knob is coupled in part by said clutch to said dose dial sleeve so as to prevent relative movement between said dose setting knob and said dose dial sleeve during a dose setting step.

11. The housing part of claim 1, wherein said dose setting knob is partially secured to said dose dial sleeve so as to allow relative movement between said dose setting knob and said dose dial sleeve during a dose dispensing step.

12. The housing part of claim 1, wherein said driver comprises at least one flange.

13. The housing part of claim 12, wherein said at least one flange is located near a distal portion of said driver.

14. The housing part of claim 1, further comprising a clicker, said clicker providing at least an audible feedback to a user when said dose knob is rotated.

15. The housing part of claim 14, wherein said clicker provides tactile feedback to a user when said dose knob is rotated.

16. The housing part of claim 14, wherein said clicker provides audible feedback when said dose knob is rotated in a dose increasing direction.

17. The housing part of claim 14, wherein said clicker provides audible feedback when said dose knob is rotated in a dose decreasing direction.

18. The housing part of claim 14, wherein said clicker comprises,

at least one flexible arm, said flexible arm comprising at least one tooth member, and

at least one spline,

wherein when said dose knob is rotated, said at least one flexible arm deforms and drags said tooth member over said at least one spline so as to provide said audible feedback.

19. The housing part of claim 14, wherein said clicker is disposed between said clutch and a proximal end of said piston rod.

20. The housing part of claim 14, wherein

said clicker generally comprises a cylindrical shape having a first and a second end, and

said cylindrical shape is provided at said first end with at least one flexible extending arm.

21. The housing part of claim 1, wherein

said tubular clutch comprises a plurality of teeth formed near an end of said tubular clutch,

said plurality of teeth remaining meshed during a dose setting step, and

said plurality of teeth becoming unmeshed during a dose dispensing step.

22. The housing part of claim 21, wherein said plurality of teeth comprise a plurality of dog teeth.

23. The housing part of claim 1, wherein said piston rod comprises a generally circular cross section.

24. The housing part of claim 1 wherein said external thread of said piston rod comprises a part thread.

25. The housing part of claim 1,

wherein said piston rod comprises a first thread and a second thread, and

wherein at least one of said first or said second thread comprises at least one part threads rather than a complete thread.

26. The housing part of claim 1, wherein said dose dial sleeve is provided outside said tubular clutch and radially inward of said main housing.

27. The housing part of claim 1, wherein said main housing further comprises a helical rib, said helical rib adapted to be seated in said helical groove provided along an outer surface of said dose dial sleeve.

28. The housing part of claim 27, wherein said helical rib extends for at least a single sweep of said inner surface of said main housing.

29. The housing part of claim 27, wherein said helical rib comprises a single start helical rib.

30. The housing part of claim 1, wherein said dose dial sleeve comprises at least one radial stop, said radial stop positioned near an end of said helical groove.

31. The housing part of claim 30, wherein when said dose dial sleeve is rotated to set a maximum dose of said medication dispensing apparatus, said radial stop near said end of said helical groove abuts an end of said threading provided on said inner surface of said main housing and thereby prevents rotation of said dose dial sleeve.

32. The housing part of claim 30, wherein said radial stop is positioned near a distal end of said helical groove.

33. The housing part of claim 1, wherein if a user inadvertently dials said dose knob in one direction beyond a desired dose, said dose knob may be rotated in a second direction so as to allow said dialed dose to be reduced.

34. The housing part of claim 1, wherein, to dispense a set dose, said dose knob is activated, and wherein activation of said dose knob disengages said tubular clutch in an axially direction with respect to said dose dial sleeve.

35. The housing part of claim 1, further comprising

a container housing operatively coupled to said main housing, said container housing comprising a fluid container,

wherein said fluid container defines a medicament filled reservoir with a movable plunger at a proximal end and an outlet at a distal end,

said plunger movable by said piston rod to be advanced toward an outlet of said fluid container when said piston rod is moved distally, wherein said housing part is configured such that a user is prevented from dialing a dose of medicament greater than said medicament remaining in said fluid container.

36. The housing part of claim 1, wherein said housing part and said container comprises a disposable device.

37. The housing part of claim 1, wherein said housing part and said container comprises a re-usable device.

38. The housing part of claim 1, further comprising an insert, said insert provided at a distal end of the main housing, said insert secured against rotation.

39. The housing part of claim 1, further comprising an insert, said insert provided at a distal end of the main housing, and said insert secured against longitudinal motion.

40. The housing part of claim 39, wherein said insert comprises an opening extending therethrough, such that said piston rod is configured to extend through said opening.

41. The housing part of claim 40, wherein said opening comprises a threaded opening, and wherein during a dose dispense step, an external thread of said piston rod threadingly engages said threaded opening so that said piston rod rotates during a dose dispense step.

42. The housing part of claim 1, wherein said helical groove of the dose dial sleeve has a first lead and said internal threading of said driver has a second lead, and wherein said first lead and said second lead are the same.

43. A pen type drug delivery device, said device comprising:

an external housing comprising a threading along a portion of an inner surface of said external housing, said external housing extending from a distal end to a proximal end;

a dialing element positioned within said housing, said dialing element comprising an outer surface extending from a distal end to a proximal end of said dialing element,

wherein said outer surface comprises a helical threading that defines a groove configured to engage said threading provided on said inner surface of said external housing;

an actuator disposed about an outer surface of an end of said dialing element near said proximal end of said main housing;

a driver extending along at least a portion of a piston rod, said driver comprising a thread adapted to threadingly engage an external thread of a piston rod; and

,

a clutch positioned at least partially within an open proximal end of said dialing element and located adjacent a distal end of said actuator and operatively coupled to said actuator,

wherein said dialing element extends circumferentially around at least a portion of said clutch;

a tubular barrel retainer operatively coupled to said external housing, said tubular barrel retainer comprising a cartridge containing a medicament, said cartridge comprising a reservoir, a piston, a septum, and a cap;

said piston movable by said piston rod to be advanced toward an outlet of said cartridge when said piston rod is moved distally.

44. The pen type drug delivery device of claim 43, wherein said tubular barrel retainer is permanently coupled to said external housing.

45. The pen type drug delivery device of claim 43, wherein said tubular barrel retainer is removably coupled to said external housing.

46. The pen type drug delivery device of claim 43, wherein said pen type drug delivery device comprises a prefilled, variable dose pen type drug delivery device.

47. The pen type drug delivery device of claim 43, wherein said outer surface of said dialing element further comprises dosage indicator markings.

48. The pen type drug delivery device of claim 43, wherein said external housing further comprises a housing window, and wherein said housing window allows said dosage indicator markings to be visible during use of said pen type drug delivery device.

49. The pen type drug delivery device of claim 43, wherein said driver comprises a cylindrical, tube-shaped body.

50. The pen type drug delivery device of claim 43, wherein said clutch comprises a cylindrical clutch.

51. A clutch for use within a pen type drug delivery device, said clutch comprising

a tubular body, said tubular body extending from a distal end to a proximal end;

and said distal end of said tubular body having a diameter sized such that said distal end of said tubular body may be positioned within a proximal end of a dial member.

52. The clutch of claim 51, wherein said proximal end of said tubular body is configured to reside within an inner space of a dose knob.

53. The clutch of claim 52, wherein when said dose knob is activated to dispense a dose of a medicament contained within said pen type delivery device, said clutch is moved in a distal direction.

54. The clutch of claim 52, wherein said pen type drug delivery device further comprises

a cartridge containing a medicament, said cartridge comprising a reservoir, a stopper, a septum and a ferrule.

55. The clutch of claim 54, wherein said cartridge comprises a multidose cartridge.

56. The clutch of claim 51, further comprising a plurality of axially extending teeth formed in an interior of a flange of said clutch.

57. The clutch of claim 51, wherein said clutch is positioned within an open proximal end of said dial member and located adjacent a distal end of said dose knob and operatively coupled to said dose knob, and wherein said dial member extends circumferentially around at least a portion of said clutch.