Drug delivery device inner housing having helical spline

• US 8,317,757 B2
• Filed: 11/14/2011
• Issued: 11/27/2012
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Plumptre, David
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/295,658
• Publication Number:
  US 20120172809A1
• Time in Patent Office: 379 Days
• Field of Search: 604/207, 604/208, 604/209, 604/210, 604/211
• US Class Current: 604/211
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• 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 5/31543 piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button

Abstract

A dose setting mechanism for a drug delivery device is disclosed. The mechanism comprises an outer housing and an inner housing having an external groove and a helical spline. The inner housing helical spline guides a driver to dispense a set dose. A dial sleeve is disposed between the outer and inner housing and is rotatably engaged with the inner housing. When a dose is set, the dial sleeve is rotated and translates away from both the outer housing and the inner housing.

Claims

1. A drug delivery device comprising:

a housing,

a number sleeve,

a button,

a spindle not rotating during dose setting and rotating during injection,

a driver engaged with the spindle via a groove, wherein the driver follows a helical path when setting a dose and a helical path in an opposite direction when delivering the dose, and

a clutch engaged with the button such that the button is rotationally coupled with the driver during dose setting and decoupled during dose delivery.

2. The drug delivery device of claim 1, wherein the dose can be set by rotating the number sleeve.

3. The drug delivery device of claim 2 wherein rotation of the button rotates the number sleeve so that the dose can be set.

4. The drug delivery device of claim 2 wherein when the dose is set by rotating the number sleeve, the dial sleeve moves in a proximal direction.

5. The drug delivery device of claim 1 wherein the number sleeve comprises a surface that is configured to be in threaded engagement with a portion of the housing.

6. The drug delivery device of claim 1 wherein when delivering the set dose, the button moves in a distal direction, and the driver moves in the distal direction and drives the spindle in an axial direction to act on a stopper of a cartridge that is contained within a cartridge holder of the drug delivery device.

7. The drug delivery device of claim 1 wherein when the dose is set by rotating the button, the dose is viewable by way of a scale arrangement provided along an outer surface of the number sleeve, this scale arrangement is viewable only by way of a window provided by the housing.

8. A dose setting mechanism configured to be secured to a cartridge holder for use as a drug delivery device, the dose setting mechanism comprising:

a tubular shaped housing extending from a distal end to a proximal end, the distal end configured to be secured to a cartridge holder;

a dial sleeve positioned within the tubular shaped housing,

a button positioned near the proximal end of the cylindrically shaped housing,

a rotatable spindle that rotates during administration of a dose,

a driver threadedly engaged with the spindle, wherein the driver rotates in a first direction when setting a dose and rotates in a second direction that is opposite the first direction when delivering the set dose, and

a clutch engaged with the button such that the button is rotationally coupled with the driver during dose setting and decoupled during dose delivery.

9. The dose setting mechanism of claim 8 further comprising a dial sleeve thread provided on the dial sleeve wherein a pitch of the dial sleeve thread is different than the pitch of the thread provided on the spindle.

10. The dose setting mechanism of claim 8 wherein the driver further comprises an internal thread, the internal thread allowing the driver to be rotatably engaged with at least a portion of the spindle so that when the driver advances in an axial direction during dose administration, the driver advances the spindle in the distal direction.

11. The dose setting mechanism of claim 10 wherein the internal thread is provided near a distal end of the driver.

12. The dose setting mechanism of claim 8 wherein when delivering the set dose, the button moves an axial distance that is generally equal to an axial movement that the spindle moves when delivering the set dose.

13. The dose setting mechanism of claim 8 wherein the driver comprises a tubular shaped driver, the tubular shaped driver having a length that is generally equal to a length of the spindle.

14. The dose setting mechanism of claim 8 wherein the driver comprises a first driver portion and a second driver portion.

15. The dose setting mechanism of claim 8 wherein the driver radially surrounds at least a portion of the spindle and resides between the spindle and the dial sleeve.

16. The dose setting mechanism of claim 15 wherein the dial sleeve radially surrounds at least a portion of the driver and resides between the driver and the housing.

17. The dose setting mechanism of claim 8 wherein the driver is coupled to the dial sleeve when setting the dose.

18. The dose setting mechanism of claim 8 further comprising a clutch wherein the driver is releasably coupled to the dial sleeve during a dose setting step by way of the clutch.

19. The dose setting mechanism of claim 8 wherein the driver is decoupled from the dial sleeve when delivering the set dose.

20. The dose setting mechanism of claim 8 wherein the driver is decoupled from the dial sleeve when delivering the set dose by way of axial movement of the driver.

21. The dose setting mechanism of claim 8 further comprising a rotational stop provided by the dial sleeve, the rotational stop configured to engage a rotational stop provided along an inner surface of the tubular shaped housing so as to prevent movement of the dial sleeve at a predetermined limit of travel.

22. The dose setting mechanism of claim 8 wherein the button is rotatable and, wherein if the button is rotated in a first direction to set an incorrect dose amount, the button may be rotated in a second direction until a correct dose amount is displayed in a window provided by the housing.

23. The dose setting mechanism of claim 8 wherein the dose setting mechanism comprises a resettable dose setting mechanism.

24. The dose setting mechanism of claim 8 wherein the dose setting mechanism comprises a non-resettable dose setting mechanism.

25. The dose setting mechanism of claim 8 wherein the button comprises a cylindrically shaped button and is disposed about an outer surface of the dial sleeve.

26. The dose setting mechanism of claim 8 wherein when delivering the set dose, the spindle rotates due to a threaded engagement to the tubular housing.

27. The dose setting mechanism of claim 8 further comprising a spring mechanism, the spring mechanism provided between the driver and the dial sleeve.

28. The dose setting mechanism of claim 8 further comprising a coupling

wherein when setting the dose, the coupling rotationally couples the button to the driver so that the coupling prevents the button from rotating relative to the driver.

29. The dose setting mechanism of claim 8 further comprising a clicker, the clicker operatively coupled to a plurality of grooves provided along an inner surface of the tubular shaped housing wherein when the button is rotated, due to the engagement of the clicker with the plurality of grooves, a tactile feedback is provided.

30. A dose setting mechanism for use with a drug delivery device, the dose setting mechanism comprising:

a housing portion, the housing portion extending from a distal end to a proximal end;

a dose dial grip operably positioned near the proximal end of the housing portion, wherein rotation of the dose dial grip causes a dose to be set by the dose setting mechanism;

an axially moveable push button configured to initiate an administration of a set dose, the axially moveable push button operably disposed adjacent the dose dial grip;

a rotatable dial sleeve, the rotatable dial sleeve comprising a surface configured to be in threaded engagement with the housing portion;

a rotatable spindle, the rotatable spindle comprising at least one thread that is provided along at least a portion of an outer surface of the spindle,

the spindle configured so that it does not rotate and does not move in an axially direction when the dose setting member is rotated to set a dose, and the spindle configured to rotate and move axially during the administration of the set dose;

a driver that drives the spindle in a distal direction during the administration of the set dose, the driver comprising a thread that is in threaded engagement with the spindle; and

a clutch engaged with the button such that the button is rotationally coupled with the driver during dose setting and decoupled during dose delivery;

wherein when the dose is set,

the dose dial grip rotates to set a dose that is viewable by way of a window provided by the housing, while the dose dial grip does not move in an axial direction,

the axially moveable push button does not rotate and does not move in an axial direction;

the dial sleeve rotates, and

the driver rotates.

31. The dose setting mechanism of claim 30 wherein when the dose is set, the driver rotates and moves in a proximal direction.

32. The dose setting mechanism of claim 30 wherein the dial sleeve comprises a number sleeve, the number sleeve rotates during dose setting while also moving in a proximal direction.

33. The dose setting mechanism of claim 30 wherein during a dose administration step:

the dose dial grip does not rotate or move in an axially direction.

34. The dose setting mechanism of claim 30 wherein during a dose administration step:

the axially moveable push button is moved in a distal direction but does not rotate.

35. The dose setting mechanism of claim 30 wherein during a dose administration step, the dial sleeve rotates.

36. The dose setting mechanism of claim 35 wherein during the dose administration step, the dial sleeve rotates back to a zero dose position.

37. The dose setting mechanism of claim 35 wherein during the dose administration step, the driver rotates and moves in an axially direction.

38. The dose setting mechanism of claim 33 wherein during the dose administration step, the spindle rotates.

39. The dose setting mechanism of claim 38 wherein during the dose administration step, the spindle moves in an axial direction.

40. The dose setting mechanism of claim 30 further comprising a compressible spring, the compressible spring surrounding at least a portion of the driver.

41. The dose setting mechanism of claim 40 wherein the compressible spring is located between an outer surface of the driver and an inner surface of the dial sleeve.

42. The dose setting mechanism of claim 30 wherein the dose setting mechanism is secured to a cartridge holder.

43. The dose setting mechanism of claim 42 wherein the dose setting mechanism is removably secured to the cartridge holder.

44. The dose setting mechanism of claim 43 wherein the cartridge holder comprises a medicinal filled cartridge.

45. The dose setting mechanism of claim 30 further comprising

a rotatable housing member, the rotating housing member in threaded engagement with a portion of the spindle, the housing member provided near a distal end of the housing portion.

46. The dose setting mechanism of claim 30 wherein the dial sleeve further comprises at least one radial stop, the radial stop prevents a user from setting a dose with the dose setting mechanism that is greater than an intended maximum dose.

47. The dose setting mechanism of claim 30 wherein the dial sleeve further comprises at least one radial stop, the radial stop prevents a user from setting a dose with the dose setting mechanism that is less than a zero dose.

48. The dose setting mechanism of claim 30 wherein when starting to set the dose, the dial sleeve resides in a zero position defined by a rotational stop and during a dose administration step, the number sleeve returns to the zero position defined by the rotational stop.

49. The dose setting mechanism of claim 30 wherein after the set dose has been administered, the spindle moves the same distance in the distal direction as the driver moves in the distal direction.

50. The dose setting mechanism of claim 30 wherein the drug delivery device comprises a pen type drug delivery device, the pen type drug delivery device comprising a distal threaded end configured to receive a double ended threaded needle.

51. The dose setting mechanism of claim 30 wherein the housing portion comprises an inner housing.

52. The dose setting mechanism of claim 30 wherein the dose dial grip is disposed about an outer surface of a proximal end of the dial sleeve.

53. The dose setting mechanism of claim 30 wherein the driver comprises a generally cylindrical driver and further comprises at least one radially extending flange positioned at one end of the generally cylindrical driver.

54. The dose setting mechanism of claim 30 further comprising a spindle guide that guides the spindle during a dose administration step, the spindle guide comprising a circular member defining an aperture, the aperture configured to engage the spindle, such that during a dose administration step, the spindle guide is rotationally fixed relative to the spindle, so that when the driver drives the spindle in the distal direction, the spindle rotates as it passes through the spindle guide aperture.

55. The dose setting mechanism of claim 30 wherein the spindle resides in a threaded connection to a housing member.

56. The dose setting mechanism of claim 55 wherein said housing member comprises an inner housing.

57. A method of setting a dose with a dose setting mechanism, where the dose setting mechanism comprises,

a housing,

a dose dial grip,

a button,

a piston rod not rotating during dose setting and rotating during injection,

a driver engaged with the piston rod via a groove, wherein the driver follows a helical path when setting a dose and a helical path in an opposite direction when delivering the dose, and

a clutch engaged with the button such that the button is rotationally coupled with the driver during dose setting and decoupled during dose delivery,

wherein the method comprises the steps of

rotating a dose dial grip in a first direction;

causing a driver to rotate in the first direction;

translating the driver along a piston rod in a proximal direction, a proximal movement of the driver representative of a dose set by the dose setting mechanism;

establishing a selected dose after the dose dial grip and the driver have been rotated in the first direction;

providing a scale arrangement along an outer surface of a rotatable dial sleeve;

causing the dial sleeve to rotate along with the dose setting button and the driver; and

viewing the scale arrangement representative of the selected dose through a window of the drug delivery device wherein the scale arrangement of the dial sleeve is only visible by way of the window.

58. The method of claim 57, wherein during dose setting, the scale arrangement of the dial sleeve is only visible by way of the window.

59. The method of claim 57 further comprising the step of correcting an incorrect dose set by the dose setting mechanism by rotating the dose dial grip in a second direction that is opposite to the first direction.

60. The method of claim 57 further comprising the step of prior to setting a dose, connecting a cartridge holder to the dose setting mechanism.

61. The method of claim 57 further comprising the step of injecting the set dose by pressing a dose button and urging the dose button in a distal direction.

62. The method of claim 57 wherein the dose button is a separate component from the dose dial grip.

63. The method of claim 57 further comprising the step of rotating the dose dial grip to a maximum dose allowable by the dose setting mechanism, and hiding the scale arrangement of the dial sleeve within the housing.

64. The method of claim 57 wherein the window through which the scale arrangement may be viewed comprises an aperture in the housing.

65. The method of claim 57 wherein the window through which the scale arrangement may be viewed comprises a lens.

66. The method of claim 57 wherein the window through which the scale arrangement may be viewed comprises a window designed to magnify the scale arrangement.