Inhaler

• US 7,322,352 B2
• Filed: 09/18/2003
• Issued: 01/29/2008
• Est. Priority Date: 09/21/2002
• Status: Active Grant

• Current Assignee: Auto Injection Technologies LLC
• Original Assignee: Aventis Pharma Ltd. (Sanofi )
• Inventors: Wells, Simon Paul, Lacy, Graham Keith, Minshull, Stephen John, Ledgeway, Andrew J., Swan, Julian Francis R., Young, Duncan Grant
• Primary Examiner(s): Douglas; Steven O.
• Application Number:
  US10/665,873
• Publication Number:
  US 20040211420A1
• Time in Patent Office: 1,594 Days
• Field of Search: 128/200.24, 128/203.15, 128/203.23, 128/205.23, 116/299, 116/314, 116/317, 222/23, 222/29
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/0073 on a ring
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: G06M 1/041 for drum-type indicating means
• CPC Class Codes: G06M 1/163 with drums
• CPC Class Codes: G06M 1/241 Drums

Abstract

Provided herein are dry powder inhalers for the delivery of metered doses of medicament, counters associated with the inhalers for counting and displaying the number of doses administered or remaining within the inhaler, and methods of use thereof.

Claims

1. A dry powder inhaler for administering a dose of a medicament, said inhaler comprising:

a reservoir holding said medicament;

an air channel assembly engaged with, and movable relatively to, said reservoir for receiving said dose of medicament upon said relative motion; and

a counter for counting a number of doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty said counter comprising a first indicator member which moves one increment in response to said relative motion, and a second indicator member which moves intermittently in response to motion of said first indicator member, a rotatory intermittent drive transfer mechanism being positioned between and engageable with said first and second indicator members, said first indicator member driving said rotatory intermittent drive transfer mechanism, said rotatory intermittent drive transfer mechanism driving said second indicator member intermittently upon motion of said first indicator member, said first and second indicator members having indicia thereon for displaying the number of said doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty.

2. The inhaler according to claim 1 adapted to administer said medicament orally.

3. The inhaler according to claim 1, wherein said reservoir is arranged circumferentially around a central axis, said air channel assembly being positioned coaxially with said reservoir and rotatably movable about said axis relatively thereto, said first indicator member and said second indicator member also being positioned coaxially with said reservoir and rotatably movable about said axis for counting said doses dispensed from said reservoir or doses that can still be delivered before the inhaler is considered empty.

4. The inhaler according to claim 1, further comprising a ratchet and pawl for connecting said first indicator member to said air channel assembly for motion of said first indicator member in response to motion of said air channel assembly relatively to said reservoir, said ratchet being mounted on one of said first indicator member and said air channel assembly and rotatable about said axis therewith, said pawl being mounted on the other of said first indicator member and said air channel assembly and engaging said ratchet for causing rotational motion of said first indicator member only in one direction about said axis.

5. The inhaler according to claim 4, wherein said pawl is mounted on said first indicator member and said ratchet is mounted on said air channel assembly.

6. The inhaler according to claim 4, further comprising a coupling positioned between said first indicator member and said air channel assembly, one end of said coupling interfacing with said first indicator member and comprising one of said ratchet and said pawl, the other end of said coupling having a plurality of legs extending therefrom for engaging said air channel assembly, said coupling transmitting relative motion of said air channel assembly to said counter for moving said first indicator member.

7. The inhaler according to claim 6, wherein said ratchet is mounted on said coupling and said pawl is mounted on said first indicator member, said ratchet engaging said pawl for rotating said first indicator member about said axis in response to motion of said air channel assembly.

8. The inhaler according to claim 1, wherein said first indicator member and second indicator member rotate in the same direction during operation.

9. The inhaler according to claim 1, wherein said first indicator member has a first surface on which said indicia appear, said first surface facing radially outwardly from said axis, said second indicator member has a second surface on which said indicia appear, said second surface being transparent and facing radially outwardly from said axis, said first indicator member being nested within said second indicator member, said indicia on said first indicator member aligning with said indicia on said second indicator member and being visible therethrough to display the number of said doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty.

10. The inhaler according to claim 1, wherein said rotatory intermittent drive transfer mechanism comprises a slave wheel rotatable about an offset axis offset from said central axis and substantially parallel thereto, said slave wheel having a drive transfer wheel on one face and a gear on an opposite face.

11. The inhaler according to claim 1, wherein said first indicator member has a foot extending therefrom for engaging said drive transfer wheel, the second indicator member having gear teeth arranged circumferentially therearound for meshing with said gear on said opposite face, upon rotation of said first indicator member, said first indicator member engaging and rotating said slave wheel, said slave wheel engaging and rotating said second indicator member intermittently.

12. The inhaler according to claim 11, wherein said foot is mounted on said first indicator member and said gear teeth are positioned on said second indicator member.

13. The inhaler according to claim 1, wherein said first indicator member comprises a unit wheel and said second indicator member comprises a tens wheel, said second indicator member moving once for every ten movements of said unit wheel.

14. The inhaler according to claim 1, further comprising a third, and optionally a fourth, indicator member.

15. The inhaler according to claim 1, further comprising a cover mounted on an end of said inhaler opposite said air channel assembly, said cover comprising a bottom and an outwardly facing sidewall extending circumferentially around said bottom, said second indicator member (e.g. a tens wheel) having a projection mounted thereon, said cover bottom comprising a stop block positioned for engaging said projection and preventing a full rotation of said second indicator member (e.g. a tens wheel) relatively to said cover.

32. A method f or treating a respiratory disorder in a patient comprising the step of inhaling by a patient in need of such treatment, a therapeutically effective amount of a medicament using the dry powder inhaler of claim 1.

33. The method of claim 32, wherein the respiratory disorder is selected from the group consisting of asthma, chronic obstructive lung disease, cystic fibrosis, and pneumonia.

34. The method of claim 32, wherein the medicament is selected from the group consisting of a bronchodilator, an antihistamine, a lung surfactant, an antiviral agent, a corticosteroid, an anti-inflammatory agent, an anti-cholinergic, and an antibiotic.

35. A method for treating a respiratory disorder in a patient comprising the steps of:

providing the dry powder inhaler of claim 1;

actuating the medicament into the patient;

causing the counter to indicate the number of metered dosages dispensed from said reservoir or that can still be delivered before the inhaler is considered empty.

44. An article of manufacture, comprising the inhaler according to claim 1 packaged within containing means, and instruction means for using the inhaler.

45. The article according to claim 44, wherein the instructions means is a label or tag attached to the packaging, a printed package insert, or a combination thereof.

46. The article according to claim 44, further comprising a dry powder medication, instruction means for assembly of the inhaler, instruction means for use of the inhaler, or a combination thereof.

47. The inhaler according to claim 2, wherein said reservoir is arranged circumferentially around a central axis, said air channel assembly being positioned coaxially with said reservoir and rotatably movable about said axis relatively thereto, said first indicator member and said second indicator member also being positioned coaxially with said reservoir and rotatably movable about said axis for counting said doses dispensed from said reservoir or doses that can still be delivered before the inhaler is considered empty.

48. The inhaler according to claim 47, further comprising a ratchet and pawl for connecting said first indicator member to said air channel assembly for motion of said first indicator member in response to motion of said air channel assembly relatively to said reservoir, said ratchet being mounted on one of said first indicator member and said air channel assembly and rotatable about said axis therewith, said pawl being mounted on the other of said first indicator member and said air channel assembly and engaging said ratchet for causing rotational motion of said first indicator member only in one direction about said axis.

49. The inhaler according to claim 48, wherein said pawl is mounted on said first indicator member and said ratchet is mounted on said air channel assembly.

50. The inhaler according to claim 49, further comprising a coupling positioned between said first indicator member and said air channel assembly, one end of said coupling interfacing with said first indicator member and comprising one of said ratchet and said pawl, the other end of said coupling having a plurality of legs extending therefrom for engaging said air channel assembly, said coupling transmitting relative motion of said air channel assembly to said counter for moving said first indicator member.

51. The inhaler according to claim 50, wherein said ratchet is mounted on said coupling and said pawl is mounted on said first indicator member, said ratchet engaging said pawl for rotating said first indicator member about said axis in response to motion of said air channel assembly.

52. The inhaler according to claim 51, wherein said first indicator member and second indicator member rotate in the same direction during operation.

53. The inhaler according to claim 52, wherein said rotatory intermittent drive transfer mechanism comprises a slave wheel rotatable about an offset axis offset from said central axis and substantially parallel thereto, said slave wheel having a drive transfer wheel on one face and a gear on an opposite face.

54. The inhaler according to claim 53, wherein said first indicator member has a foot extending therefrom for engaging said drive transfer wheel, the second indicator member having gear teeth arranged circumferentially therearound for meshing with said gear on said opposite face, upon rotation of said first indicator member, said first indicator member engaging and rotating said slave wheel, said slave wheel engaging and rotating said second indicator member intermittently.

55. The inhaler according to claim 54, wherein said foot is mounted on said first indicator member and said gear teeth are positioned on said second indicator member.

56. The inhaler according to claim 55, wherein said first indicator member comprises a unit wheel and said second indicator member comprises a tens wheel, said second indicator member moving once for every ten movements of said unit wheel.

57. The inhaler according to claim 56, further comprising a third, and optionally a fourth, indicator member.

58. The inhaler according to claim 57, further comprising a cover mounted on an end of said inhaler opposite said air channel assembly, said cover comprising a bottom and an outwardly facing sidewall extending circumferentially around said bottom, said second indicator member (e.g. a tens wheel) having a projection mounted thereon, said cover bottom comprising a stop block positioned for engaging said projection and preventing a full rotation of said second indicator member (e.g. a tens wheel) relatively to said cover.

78. The article according to claim 44, wherein the instructions means is a label or tag attached to the packaging, a printed package insert, or a combination thereof.

79. The inhaler according to claim 52, wherein said first indicator member has a first surface on which said indicia appear, said first surface facing radially outwardly from said axis, said second indicator member has a second surface on which said indicia appear, said second surface being transparent and facing radially outwardly from said axis, said first indicator member being nested within said second indicator member, said indicia on said first indicator member aligning with said indicia on said second indicator member and being visible therethrough to display the number of said doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty.

16. A dry powder inhaler for administering a dose of a medicament, said inhaler comprising:

a reservoir holding said medicament;

an air channel assembly engaged with and movable relatively to said reservoir for receiving said dose of medicament upon said relative motion; and

a counter for counting a number of doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty, said counter comprising a coupling engaging said air channel assembly and a first indicator member and imparting rotation to said first indicator member on rotation of said air channel assembly, a second indicator member which rotates intermittently in response to motion of said first indicator member, one of said indicator members having a transparent side surface facing outwardly, the other of said indicator members being nested coaxially within the one wheel and having an inwardly and outwardly facing side surface, said outwardly facing side surface positioned adjacent to the transparent side surface, said surfaces having indicia thereon for displaying the number of said doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty.

17. The inhaler according to claim 16 adapted to administer said medicament orally.

18. The inhaler according to claim 16, further comprising a rotatory intermittent drive transfer mechanism positioned between and engageable with said first indicator member and said second indicator member, said first indicator member driving said rotatory intermittent drive transfer mechanism, said rotatory intermittent drive transfer mechanism driving said second indicator member intermittently upon motion of said first indicator member.

19. The inhaler according to claim 18, wherein said rotatory intermittent drive transfer mechanism comprises a slave wheel rotatable about an offset axis offset from said central axis and substantially parallel thereto, said slave wheel having a drive transfer wheel on one face and a gear on an opposite face.

20. The inhaler according to claim 19, wherein said first indicator member has a foot extending therefrom for engaging said drive transfer wheel, the second indicator member having gear teeth arranged circumferentially therearound for meshing with said gear on said opposite face, upon rotation of said first indicator member, said first indicator member engaging and rotating said slave wheel, said slave wheel engaging and rotating said second indicator member intermittently.

21. The inhaler according to claim 20, wherein said foot is mounted on said first indicator member and said gear teeth are positioned on said second indicator member.

22. The inhaler according to claim 16, wherein said second indicator member moves one increment for every ten increments of said first indicator member.

23. The inhaler according to claim 16, wherein said reservoir is arranged circumferentially around a central axis, said air channel assembly being positioned coaxially with said reservoir and rotatably movable about said central axis relatively thereto, said first and said second indicator members also being positioned coaxially with said reservoir and rotatably movable about said central axis for counting said doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty.

24. The inhaler according to claim 16, wherein said first indicator member is nested coaxially within said second indicator member, said second indicator member having said transparent side surface.

25. The inhaler according to claim 16, further comprising a ratchet and pawl for rotating said first indicator member in response to the rotation of said air channel assembly and said coupling, said ratchet being mounted on one of said first indicator member and said coupling, and rotatable about said central axis therewith, said pawl being mounted on the other of said first indicator member and said coupling and engaging said ratchet for causing rotational motion of said first indicator member only in one direction about said central axis.

26. The inhaler according to claim 25, wherein said pawl is mounted on said first indicator member.

27. The inhaler according to claim 16, wherein said ratchet comprises a plurality of teeth positioned circumferentially around said axis in spaced relation to one another, said spaced relation between said teeth being predetermined to allow lost motion between said coupling and said first indicator member.

28. The inhaler according to claim 16, further comprising a cover mounted on an end of said inhaler opposite said air channel assembly, said cover comprising a bottom and an outwardly facing sidewall extending circumferentially around said bottom, said second indicator member having a projection mounted thereon, said cover bottom comprising a stop block positioned for engaging said projection and preventing a full rotation of said second indicator member relatively to said cover.

29. The inhaler according to claim 16, wherein said first indicator member comprises a unit wheel and said second indicator member comprises a tens wheel.

30. The inhaler according to claim 16, wherein said first indicator member and second indicator member rotate in the same direction during operation.

31. The inhaler according to claim 16, further comprising a third and optionally a fourth indicator member.

59. The inhaler according to claim 17, further comprising a rotatory intermittent drive transfer mechanism positioned between and engageable with said first indicator member and said second indicator member, said first indicator member driving said rotatory intermittent drive transfer mechanism, said rotatory intermittent drive transfer mechanism driving said second indicator member intermittently upon motion of said first indicator member.

60. The inhaler according to claim 59, wherein said rotatory intermittent drive transfer mechanism comprises a slave wheel rotatable about an offset axis offset from said central axis and substantially parallel thereto, said slave wheel having a drive transfer wheel on one face and a gear on an opposite face.

61. The inhaler according to claim 60, wherein said first indicator member has a foot extending therefrom for engaging said drive transfer wheel, the second indicator member having gear teeth arranged circumferentially therearound for meshing with said gear on said opposite face, upon rotation of said first indicator member, said first indicator member engaging and rotating said slave wheel, said slave wheel engaging and rotating said second indicator member intermittently.

62. The inhaler according to claim 61, wherein said foot is mounted on said first indicator member and said gear teeth are positioned on said second indicator member.

63. The inhaler according to claim 62, wherein said second indicator member moves one increment for every ten increments of said first indicator member.

64. The inhaler according to claim 63, wherein said reservoir is arranged circumferentially around a central axis, said air channel assembly being positioned coaxially with said reservoir and rotatably movable about said central axis relatively thereto, said first and said second indicator members also being positioned coaxially with said reservoir and rotatably movable about said central axis for counting said doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty.

65. The inhaler according to claim 64, wherein said first indicator member is nested coaxially within said second indicator member, said second indicator member having said transparent side surface.

66. The inhaler according to claim 65, further comprising a ratchet and pawl for rotating said first indicator member in response to the rotation of said air channel assembly and said coupling, said ratchet being mounted on one of said first indicator member and said coupling, and rotatable about said central axis therewith, said pawl being mounted on the other of said first indicator member and said coupling and engaging said ratchet for causing rotational motion of said first indicator member only in one direction about said central axis.

67. The inhaler according to claim 66, wherein said pawl is mounted on said first indicator member.

68. The inhaler according to claim 67, wherein said ratchet comprises a plurality of teeth positioned circumferentially around said axis in spaced relation to one another, said spaced relation between said teeth being predetermined to allow lost motion between said coupling and said first indicator member.

69. The inhaler according to claim 68, further comprising a cover mounted on an end of said inhaler opposite said air channel assembly, said cover comprising a bottom and an outwardly facing sidewall extending circumferentially around said bottom, said second indicator member having a projection mounted thereon, said cover bottom comprising a stop block positioned for engaging said projection and preventing a full rotation of said second indicator member relatively to said cover.

70. The inhaler according to claim 69, wherein said first indicator member comprises a unit wheel and said second indicator member comprises a tens wheel.

71. The inhaler according to claim 70, wherein said first indicator member and second indicator member rotate in the same direction during operation.

72. The inhaler according to claim 71, wherein said first indicator member and second indicator member rotate in the same direction during operation.

76. An article of manufacture, comprising the inhaler according to claim 31 packaged within containing means, and instruction means for using the inhaler.

77. The article according to claim 76, wherein the instructions means is a label or tag attached to the packaging, a printed package insert, or a combination thereof.

36. A method of administering a dose of a medicament to a patient in need thereof, from a dry powder inhaler, said method comprising the steps of:

providing a reservoir holding said medicament, said reservoir fits coaxially within a barrel, and a mandrel of an air channel assembly fits coaxially within the reservoir;

providing an air channel assembly comprising a mouthpiece, or nasalpiece, a collar and a mandrel, said air channel assembly engaged with, and movable relatively to, said reservoir for receiving said dose of medicament upon said relative motion;

providing a counter for counting a number of doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty, said counter comprising a first indicator member which moves one increment in response to said relative motion, and a second indicator member which moves intermittently in response to motion of said first indicator member;

providing a rotatory intermittent drive transfer mechanism positioned between and engageable with said first and second indicator members, said first indicator member driving said rotatory intermittent drive transfer mechanism, said rotatory intermittent drive transfer mechanism driving said second indicator member intermittently upon motion of said first indicator member, said first and second indicator members having indicia thereon for displaying the number of said doses dispensed from said reservoir or that can still be delivered before the inhaler is considered empty; and

rotating the cap and barrel relative to one another through an angle of about 105°

about the central axis with the cap rotating clockwise and the barrel counterclockwise when viewed from the cap end of the inhaler;

engaging a tab in said cap which engages a notch in the collar, causing the entire air channel assembly to rotate clockwise along with the cap;

then rotating the cap and barrel in the reverse direction through the same angle;

reciprocally rotating the cap and air channel assembly causing a metered dose of powdered medicament to be scraped from the reservoir and deposited in the air channel assembly;

removing the cap;

placing the patient'"'"'s lips or nasal passage on the mouthpiece, or nasalpiece; and

inhaling.

37. A device for administering a dose of a medicament to a patient in need thereof, comprising:

an air channel assembly comprising a mandrel;

a counter comprising a coupling, a first indicator member, a slave wheel, a second indicator member and a cover in which the first indicator member, slave wheel and second indicator member are rotatably mounted, wherein the coupling has a plurality of legs which extend from the counter into the barrel and engage tabs on the mandrel of the air channel assembly, wherein the legs are arranged in spaced relation to one another so as to provide for lost motion between the mandrel and the coupling;

wherein on the coupling opposite to the legs is mounted a ratchet which engages inner pawls on the first indicator member; and

a second ratchet positioned on the end of the barrel;

wherein the second ratchet faces radially inwardly to engage outer pawls which are mounted on the first indicator member.

38. The device according to claim 37, wherein the air channel assembly is capable of forward rotation through about 105°

, said rotation is transmitted to the first indicator member by the coupling, wherein the legs engage the mandrel on the air channel assembly to transmit the motion, wherein the forward rotation of the coupling causes the ratchet on the coupling to forward rotate relatively to pawls on the first indicator member, resulting in the pawls slipping over the ratchet teeth and being positioned on the other side of the teeth, so that the position of the pawls and teeth are such that they are ready to move the first indicator member upon the reverse rotation of the air channel assembly.

39. The device according to claim 38, wherein the first indicator member is prevented from forward rotating, when the pawls engage and slip over the teeth, by the second ratchet located in the barrel, engaged by outer pawls on the first indicator member.

40. The device according to claim 39, wherein the air channel assembly is capable of reverse rotation through about 105°

, causing the loading of a dose of medicament into the air channel assembly; and

causing the counter to indicate the number of metered dosages dispersed from the dry powder inhaler or that can still be delivered before the inhaler is considered empty.

41. The device according to claim 37, wherein said first indicator member comprises a unit wheel and said second indicator member comprises a tens wheel, said second indicator member moving once for every ten movements of said unit wheel.

42. The device according to claim 37, wherein said first indicator member and second indicator member rotate in the same direction during operation.

43. The device according to claim 37, further comprising a third and optionally a fourth indicator member.

73. The device according to claim 40, wherein said first indicator member comprises a unit wheel and said second indicator member comprises a tens wheel, said second indicator member moving once for every ten movements of said unit wheel.

74. The device according to claim 73, wherein said first indicator member and second indicator member rotate in the same direction during operation.

75. The device according to claim 73, further comprising a third and optionally a fourth indicator member.