Device for delivering physiologically active agent in powdered form

• US 20030183230A1
• Filed: 06/06/2003
• Published: 10/02/2003
• Est. Priority Date: 08/10/2000
• Status: Active Grant

• Current Assignee: Pfizer Leasing UK Ltd. (Pfizer Inc.)
• Original Assignee: Pfizer Leasing UK Ltd. (Pfizer Inc.)
• Inventors: Scudamore, Andrew Peter, Martin, Jeffrey, Nelson, Craig Harvey
• Granted Patent: US 7,275,537 B2
• Time in Patent Office: Days
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0025 with caps
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• 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 16/0075 Bellows-type
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/075 Bulb type
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus

Abstract

A powder delivery device for the delivery into a patient'"'"'s nasal cavity of a physiologically active agent in powdered form. A closure restricts the unwanted ingress of moisture into the device when the device is not in use. The action of opening or closing this closure may be linked to charging an air reservoir with air and/or moving a fresh powder-containing receptacle into communication with a powder delivery passage.

Claims

1. A powder delivery device for the delivery into a patient'"'"'s nasal cavity of a physiologically active agent in powdered form, the device comprising a manually rechargeable air reservoir, a passage from said air reservoir terminating as a nasal tube for insertion into the nostril of the patient a closure for restricting the unwanted ingress of moisture into the device via said passage when the device is not in use, and a powder receiving section associated with said passage, whereby the rapid release of a charge of air from said reservoir along said passage will take a dose of powder from said section and entrain it in said released charge of air before expelling it from the nasal tube, wherein the air reservoir is constructed and arranged to be charged with air by the action of opening or closing said closure.

2. A device as claimed in claim 1, wherein the air reservoir is constructed and arranged to be freshly charged with air by the action of opening said closure in preparation for using the device for powder delivery.

3. A device as claimed in claim 1 or claim 2, further comprising a linkage between the reservoir and the closure.

4. A device as claimed in claim 3, wherein the closure is pivotable between its open and closed positions and said linkage is arranged to convert at least part of the pivoting movement of the closure into movement of part of the reservoir to cause air to be aspirated into the reservoir to recharge it.

5. A device as claimed in any one of claims 1 to 4, wherein the reservoir comprises a cylinder with a piston slidably and sealably received therein.

6. A device as claimed in any one of claims 1 to 4, wherein the reservoir is a bellows.

7. A device as claimed in claim 5 or claim 6, wherein the piston or bellows is displacable, against a spring bias, from a discharged reservoir condition to a charged reservoir condition so as to recharge the reservoir with air.

8. A device as claimed in claim 7, wherein a latching arrangement is provided to latch the piston or bellows in said charged condition.

9. A device as claimed in claim 8, wherein the latching arrangement is releaseable to enable the piston or bellows to change from its charged condition to its discharged condition under the influence of said spring bias.

10. A device as claimed in claim 8 or claim 9, wherein the latching arrangement is provided with a manually operable trigger to release it.

11. A device as claimed in ay one of claims 8 to 10, wherein the latching arrangement is arranged to be released by movement of said closure.

65. A device as claimed in any one of the preceding claims, wherein the physiologically active agent in powdered form is a compound or composition of matter which, when administered to an organism, induces a desired pharmacologic and/or physiologic effect by local and/or systemic action.

66. A device as claimed in any one of the preceding claims, wherein the physiologically active agent in powdered form is a drug, biopharmaceutical, vaccine or gene therapy.

67. A device as claimed in any one of the preceding claim, wherein the device is constructed and arranged to be used for delivering multiple doses of physiologically active agent in powdered form into the nasal cavity of a subject.

12. A device for delivering multiple doses of physiologically active agent in powdered form, the device comprising a bulk reservoir for containing multiple doses of powder, a powder delivery passage for the forced flow therealong to a patient of gas with a dose of said powder entrained therein, a closure for restricting the unwanted ingress of moisture into the device via said passage when the device is not in use, and a powder metering unit for metering out a dose of powder from said bulk reservoir and then aligning said metered dose with said gas flow passage, the device being so constructed and arranged that said metering unit is operated by the action of opening or closing said closure.

13. A device as claimed in claim 12, wherein said metering unit is arranged to be operated by the action of opening said closure in preparation for using the device for powder delivery.

14. A device as claimed in claim 12 or claim 13, wherein operation of said metering unit terminates in a metered dose of powder being transported into alignment with said powder delivery passage.

15. A device as claimed in any one of claims 12 to 14, wherein the metering unit comprises a movable element with a recess formed therein to receive powder from said bulk reservoir, the size of said recess corresponding to the size of said metered dose.

16. A device as claimed in claim 15, wherein the element is movable between a first position, in which said recess can receive powder from a powder exit of said bulk reservoir and is separated from said powder delivery passage, and a second position, displaced from said first position, in which second position said recess is aligned with said powder delivery passage and is separated from said powder exit.

17. A device as claimed in claim 16, wherein said element slides generally linearly between said first and second positions.

18. A device as claimed in claim 17, wherein the slidable element is constrained to move generally linearly and is anchored to another part of the device by a linkage, which linkage is arranged to be manipulated by the opening or closing of said closure to draw the slidable element towards or away from the anchor and thus to cause it to slide generally linearly.

19. A device as claimed in claim 16, wherein said element rotates between said first and second positions.

20. A device as claimed in any one of claims 16 to 19, wherein in moving from said first position to said second position the recessed surface of the movable element slides flushly with regard to a close fitting stationary surface to scribe flat the amount of powder contained in the recess.

21. A device as claimed in any one of claims 16 to 20, wherein it is the action of said element sliding its recess out of alignment with said powder exit of said bulk reservoir which regulates the amount of powder in said metered dose.

22. A device as claimed in any one of claims 16 to 21, wherein, when said closure is opened or closed, operation of said metering unit includes the movement of said moveable element to said second position.

23. A device as claimed in claim 22, wherein;

when said closure is opened or closed, operation of said metering unit includes the movement of said movable element to said second position from said first position.

24. A device as claimed in claim 22, wherein, when said closure is opened or closed, operation of said metering unit includes the movement of said movable element from said second position, to said first position, and then back to said second position.

25. A device as claimed in claim 23, wherein said element is also slidable to a third position in which said recess is neither capable of receiving powdered drug from said bulk reservoir powder exit nor coincident with said powder delivery passage, and when said closure is opened or closed, operation of said metering unit includes the movement off aid movable element from said third position to said first position and then to said second position.

26. A device as claimed in any one of claims 16 to 21, wherein, when said closure is opened or closed, operation of said metering unit includes the movement of said movable element to said first position.

27. A device as claimed in claim 26, wherein, when said closure is opened or closed, operation of said metering unit includes the movement of said element to said first position from said second position.

28. A device as claimed in any one of claims 12 to 27, wherein the downstream end of the powder delivery passage forms a nasal tube, to enable the device to be used for nasal powder delivery.

29. A device as claimed in any one of claims 12 to 27, wherein the downstream end of the powder delivery passage forms a mouthpiece, to enable the device to be used for pulmonary powder delivery.

30. A device as claimed in claim 28 or claim 29, wherein the closure is mounted on the distal end of the nasal tube or mouthpiece.

31. A device as claimed in claim 28 or claim 29, wherein the device further comprises a main body from which the nasal rube or mouthpiece extends and the closure is mounted on the main body.

32. A device as claimed in any one of claims 12 to 31, wherein the closure is openable and closable by a hinging movement, and it is the hinging open of the closure in preparation for using the device that operates the drug metering unit.

33. A device as claimed in any one of claims 12 to 32, wherein the device further comprises a source of gas which can be triggered to produce a burst of gas to entrain therein a said metered dose of powder and to deliver said entrained dose out of the downstream end of the powder delivery passage.

34. A device as claimed in claim 33, wherein the source of gas is a manually rechargeable air reservoir.

35. A device as claimed in claim 34, wherein the manually rechargeable air reservoir comprises a cylinder and piston arrangement, the piston being provided with a spring bias, and the action of opening or closing said closure moves the piston against the spring bias to sweep the cylinder to charge the reservoir with air ready for triggering.

36. A device as claimed in claim 34, wherein the manually rechargeable air reservoir comprises an inflatable bellows, the bellows being provided with a spring bias, and the action of opening or closing said closure expands the bellows against the spring bias to charge the bellows with air ready for triggered release.

37. A device as claimed in any one of claims 33 to 36, wherein movement of said closure also triggers the production of said burst of gas to entrain the metered dose of powder.

38. A device as claimed in either of claims 33 and 36, wherein the device further comprises a trigger for triggering the rapid release of air from the cylinder or bellows to produce said burst of gas.

39. A device for delivering multiple doses of physiologically active agent in powdered form, the device comprising:

upstream air supply passage for the forced flow therealong of air;

a downstream powder delivery passage for the forced flow therealong of air with powder entrained therein; and

a drug metering slide having first and second parallel planar faces with a powder-containing recess recessed in one of said faces, said recess opening only into said one face;

wherein said upstream and downstream passages are not connected when said slide is in a first position and said slide is slidable from said first position to a second position in which said upstream and downstream passages are connected via said recess whereby, when the recess is filled with powder, the forced flow of air into said recess from said upstream passage will displace the powder from said recess and cause it to exit the recess though said downstream passage entrained in the forced air flow.

40. A device as claimed in claim 39, wherein the slide is arranged so that the receptacle may, in use, be filled by the influence of gravity from a bulk reservoir of powder, such that in use, said one face is the upper face and said other face is the lower face.

41. A device as claimed in claim 39 or claim 40, wherein the recess is generally cup-shaped, with the top of the cup opening into said first face of said slide.

42. A device for delivering multiple doses of physiologically active agent in powdered form, the device comprising a manually rechargeable air reservoir, an air intake for the aspiration of air into said air reservoir upon recharging of said air reservoir, an air exit passage from said air reservoir, and a powder receiving section associated with said exit passage, whereby the rapid release of a charge of air from said reservoir along said exit passage will take a dose of powder from said station and entrain it in said released charge of air before expelling it via the exit passage, wherein the device further comprises a single openable closure for restricting the unwanted ingress of moisture into the device via said exit passage and via said air intake when the device is not in use and the closure is closed.

43. A device as claimed in claim 42, wherein the device is for the delivery of powder into the nasal cavity of a patient, with the air exit passage terminating in a nasal tube for insertion in the nostril of a patient.

44. A device as claimed in claim 42 or claim 43, wherein the closure is constructed and arranged so that, on removing the closure to prepare the device for use, both said exit passage and said air intake are exposed to atmosphere.

45. A device as claimed in any one of claims 42 to 44, wherein the device further comprises a main body enclosing at least the air reservoir and said closure is hinged to the main body to enable the closure to be opened by hinging it back.

46. A device as claimed in any one of claims 42 to 44, where the device further comprises a main body enclosing at least the air reservoir and said closure is arranged to be opened by being separated from said main body.

47. A device as claimed in claim 45 or claim 46, wherein a sealing strip is provided between the main body and the closure to enhance sealing therebetween when the closure is closed.

48. A device as claimed in claim 47, wherein the sealing strip is an O-ring.

49. A device as claimed in any one of claims 43 to 46, wherein the interior of the main body is sealed from the atmosphere when the closure is closed.

50. A device as claimed in any one of claims 42 to 49, wherein the device further comprises a bulk reservoir for containing multiple doses of said powder and a powder metering unit for metering out a dose of said powder from said bulk reservoir and associating said metered dose with said air exit passage the device being so constructed and arranged that said metering unit is operated by the action of opening or closing said closure.

51. A device as claimed in any one of claims 42 to 50, wherein me air reservoir is constructed and arranged to be recharged with air by the action of opening or closing said closure.

52. A device for delivering multiple doses of physiologically active agent in powdered form, the device comprising a powder container defining therein a plurality of individual receptacles, each receptacle containing a discrete metered dose of powder, a powder delivery passage for the forced flow therealong to a patient of gas with a said metered dose of powder entrained therein so as substantially to empty a said receptacle, a closure for restricting the unwanted ingress of moisture into the device via said passage when the device is not in use, and a container indexing mechanism for indexing movement of said container to move a substantially empty said receptacle out of communication with said powder delivery passage and to move a fresh powder-containing said receptacle into communication with said powder delivery passage, the device being so constructed anid arranged that said container indexing mechanism is operated by the action of opening or closing said closure.

53. A device as claimed in claim 52, wherein said container indexing mechanism is arranged to perform a said indexing movement upon the action of opening said closure in preparation for using the device for powder delivery.

54. A device as claimed in claim 52 or claim 53, wherein the powder container is arranged to revolve around an axis when a said indexing movement is performed.

55. A device as claimed in any one of claim 52 to 54, further comprising an air supply passage for the forced flow therealong of air wherein, when a said receptacle is in communication with said gas delivery passage that same said receptacle is also in communication with said air supply passage, whereby said forced flow of air along said air supply passage can be used to dislodge the discrete metered dose of powder from the said receptacle and to entrain said dislodged powder in said air for delivery of the entrained powder to the patient via said powder delivery passage.

56. A device as claimed in claim 55, wherein each receptacle provided in said powder container is generally cup-shaped and has a single opening, wherein each receptacle is arranged to communicate with said air supply passage and said powder delivery passage via its said single opening

57. A device as claimed in claim 55, wherein each receptacle provided in said powder container is a through bore having open first and second opposite ends, wherein each reservoir is arranged to communicate with said air supply passage and said powder delivery passage via its first and second ends respectively, such that in use the forced flow of air passes general longitudinally through the throughbore.

58. A device as claimed in any one of claims 52-57, wherein the container indexing mechanism comprises an indexing element arranged to move upon opening or closing of said closure, which element is arranged to index movement of said powder container.

59. A device as claimed in claim 58, wherein the indexing element is arranged to act directly on the powder container to cause said indexing movement.

60. A device as claimed in claim 59, wherein the indexing element comprises a flexible indexing finger, which finger is arranged to contact the periphery of the powder container to cause said indexing movement.

61. A device as claimed in claim 58, wherein the indexing element is arranged to act indirectly on the powder container to cause said indexing movement.

62. A device as claimed in claim 61, wherein the indexing element comprises a flexible indexing finger, which finger is arranged to act on a gear wheel separate from and meshed with the powder container.

63. A device as claimed in claim 60 or claim 62, wherein the tip of the flexible indexing finger is arranged to contact and push on a gear tooth to convert generally longitudinal motion of the flexible indexing finger into generally rotational movement of said powder container.

64. A device as claimed in claim 63, wherein said gear teeth resemble a ratchet, and a pawl is provided to inhibit unwanted movement of said ratchet.