Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler

• US 20060037612A1
• Filed: 07/18/2005
• Published: 02/23/2006
• Est. Priority Date: 07/16/2004
• Status: Active Grant

• Current Assignee: Astrazeneca AB (Astrazeneca PLC)
• Original Assignee: Sofotec GmbH & Co. KG.
• Inventors: Goede, Joachim, Herder, Martin, Mett, Ingo
• Granted Patent: US 8,051,851 B2
• Time in Patent Office: Days
• US Class Current: 128/203.150
• 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 15/007 Mechanical counters
• CPC Class Codes: A61M 15/0073 on a ring
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 2202/064 Powder

Abstract

In order to improve the security and reliability of administration of powdered pharmaceuticals through dry powder inhalers, the invention proposes an inhaler (1) for powdered medicaments, comprising an activating device (4) for manual engagement by the patient for repeatedly metering a dose of medicament to be administered to the patient, and further comprising an advancing mechanism (25) for advancing a counter or indexing means (8) each time the activating device (4) has been engaged by the patient so that a dose of medicament has been released for administration to the patient, wherein the counter or indexing means (8) comprises an index (9), the index (9) being detectable by a detection means (10) of the inhaler, and the detection means (10) being coupled to a locking mechanism (12), the locking mechanism (12) blocking the activating device (4) and/or any transportation mechanism (5) of the inhaler (1) delayed by a predetermined number of metering cycles since detection of the index (9), and a cartridge (3).

Claims

1. An inhaler (1) for powdered medicaments, for providing a large number of doses of pharmaceutical powder of medicament from a single reservoir space (2) or a multiplicity of reservoir spaces, which medicament can be received by a patient by means of an air stream, the inhaler further comprising an activating device (4) for manual engagement by the patient for repeatedly metering a dose of medicament to be administered to the patient, and further comprising an advancing mechanism (25) for advancing a counter or indexing means (8) each time the activating device (4) has been engaged by the patient so that a dose of medicament has been released for administration to the patient, wherein the counter or indexing means (8) comprises an index (9), the index (9) being detectable by a detection means (10) of the inhaler, and the detection means (10) being coupled to a locking mechanism (12), the locking mechanism (12) blocking the activating device (4) and/or any transportation mechanism (5) of the inhaler (1) delayed by a predetermined number of metering cycles since detection of the index (9).

2. The inhaler of claim 1, wherein the predetermined number of metering cycles since detection of the index (9) is one.

3. The inhaler of claim 1, comprising a reservoir space (2) for a large number of doses of pharmaceutical powder medicament, the activating device (4) for manual engagement by the patient being connected to a transportation mechanism (5) for moving a metering means at least from a filling position for receiving a dose of medicament powder from the reservoir space (2) into an emptying position for releasing said dose of medicament powder into an air duct (7), for repeatedly metering a dose of medicament to be administered to the patient, and further the advancing mechanism (25) being connected to the transportation mechanism (5) for advancing the counter or indexing means (8) each time the transportation mechanism (5) moved the metering means so that a dose of medicament has been released for administration to a patient, wherein the locking mechanism (12) blocks the activating device (4) and/or the transportation mechanism (5) after the predetermined number of metering cycles since detection of the index (9).

4. The inhaler of claim 1, wherein the inhaler (1) comprises a receptacle (30) for a pharmaceutical powder cartridge (3) comprising a reservoir space (2) for a large number of doses of pharmaceutical powder medicament.

5. The inhaler of claim 1, wherein the index (9) is formed by a signaling section of a mechanical counter or indexing means (8).

6. The inhaler of claim 5, wherein the signaling section (9) is formed by a notch or cam (38).

7. The inhaler of claim 6, wherein the detection means (10) comprises a signaling lever (13) for biased engagement with the signaling section of the counter or indexing means (8).

8. The inhaler of claim 7, wherein the signaling lever (13) is in hinged connection with a rest lever (14) such that a movement of the signaling lever (13) is transmitted to the rest lever (14), the rest lever (14) comprising a pilot section (15) allowing the rest lever (14) being biased against the activating device (4) and/or the transportation mechanism (5), and the rest lever (14) being in positive engagement with the activating device (4) and/or the transportation mechanism (5) by means of a hook/notch arrangement, after the transportation mechanism (5) reaches the emptying position for releasing a dose of medicament powder, and thus arresting the activating device (4) and/or the transportation mechanism (5) so that no further dosing cycle can be performed.

9. The inhaler of claim 8, wherein the activating device (4) is arrested in a position different from normal operation position to unambiguously indicate the blocking state of the inhaler.

10. The inhaler of claim 7, wherein the position of the signaling lever (13) and the rest lever (14) is reset to normal operating position, releasing the activating device (4) and/or the transportation (5) from the blocked state, on insertion of a fresh unused pharmaceutical powder cartridge (3).

11. The inhaler of claim 4, wherein the receptacle (30) for a pharmaceutical powder cartridge comprising a pharmaceutical powder cartridge (3) is closed by a lid (29) of the non-removable snap on type.

12. Pharmaceutical powder cartridge for use with an inhaler (1) according to claim 1, comprising at least one reservoir space (2) for receiving a large number of doses of pharmaceutical powder medicament, having a dose counter or indexing ring (8) carrying a multiplicity of numbers or graphical or colored visual information for a user, which ring (8) is movable relative to a cartridge body (26) by an advancing mechanism (25) of the inhaler (1), the counter or indexing ring (8) comprising a signaling section (9) for activating a locking mechanism (12) of the inhaler (1) once the counter or indexing ring (8) reaches a predetermined position relative to the cartridge body (26).

13. Pharmaceutical powder cartridge according to claim 12, wherein the signaling section (9) is formed by a notch or cam (11) for activating a signaling lever of the inhaler.

14. Pharmaceutical powder cartridge according to claim 12, wherein the dose counter or indexing means (8) comprises a securing means (27) preventing the counter or indexing ring (8) from unintended rotation with respect to the cartridge body (26) by applying a frictional force, or a notch/cam type security arrangement.

15. Pharmaceutical powder cartridge according to claim 12, further comprising an opening (32) for engagement of a signaling lever (13) of a locking mechanism (12) of the inhaler (1) with the counter or indexing ring (8).

16. Pharmaceutical powder cartridge according to claim 12, wherein there is a ratchet mechanism (33) provided in the cartridge body (26) interacting with a toothed section (34) of the counter or indexing ring (8) preventing the counter or indexing ring (8) from being reversed even by user manipulation.

17. Pharmaceutical powder cartridge according to claim 12, wherein the counter or indexing ring (8) further comprises a notch or hook (37) for forced engagement with a corresponding hook or notch (33) within the cartridge body (26) once the counter or indexing ring (8) reaches a position indicating that the predetermined number of medicament doses have been removed, preventing any further movement of the counter or indexing ring (8) in either direction, once engaged.

18. Pharmaceutical powder cartridge according to claim 12, further comprising a lid (38), the lid (38) covering an opening (31) of the at least one reservoir space (2) for receiving a large number of doses of pharmaceutical powder medicament, and a groove (28) surrounding said opening (31) containing the dose counter or indexing ring (8), wherein the lid (38) and the interior edge (39) of the opening (31) comprise each a collar (40) to provide a tight snap-on fastening of the lid (38), so that the at least one reservoir space (2) is sufficiently sealed against the environment and the counter or indexing ring (8) cannot be removed without destroying the cartridge.

19. Use of an inhaler (1) according to claim 1 together with a pharmaceutical powder cartridge (3) according to claim 12.

20. A method for operating an inhaler for powdered medicaments, comprising the steps of:

releasing a medicament dose from a reservoir space (2), on engagement of an activating device of the inhaler by a patient,

advancing a counter or indexing means (8) comprising an index (9),

displaying the counter or indexing means (8) to the patient or user of the inhaler,

detecting whether the index (9) of the counter or indexing means (8) reached a predetermined position indicating an “

empty”

state of the inhaler, and

on detection of the index (9) at the predetermined position indicating an “

empty”

state of the inhaler, blocking the activating device and/or any transportation means after a predetermined number of additional releasing steps since detection of the “

empty”

state.

21. Method according to claim 20, wherein the number of additional releasing steps is 1 to 6, preferably one.