INHALATION DEVICE FOR DRUGS IN POWDER FORM

• US 20100012120A1
• Filed: 12/21/2007
• Published: 01/21/2010
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Astrazeneca AB (Astrazeneca PLC)
• Original Assignee: Laboratories Almirall SA (Grupo Corporativo Landon SL)
• Inventors: Ludanek, Gerhard, Herder, Martin, Mett, Ingo
• Granted Patent: US 8,567,394 B2
• Time in Patent Office: Days
• US Class Current: 128/203.150
• CPC Class Codes: A61M 15/0015 located upstream of the dispenser, i.e. not traversed by the product
• CPC Class Codes: A61M 15/0026 Hinged caps
• 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 15/0076 on a drum
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 15/0096 Hindering inhalation before activation of the dispenser
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8293 Solar

Abstract

To provide an inhalation device which has improved use properties, particularly advanced moisture protection while in use, an inhalation device (1) for powder drugs is proposed comprising at least one storage chamber (13) for accommodating a plurality of drug powder doses and a dosing device which includes at least one dosing slider (15) which is movable approximately with a translatory movement in a dosing slider passage (16) at least from a filling position into an emptying position, wherein the inhalation device (1) further includes a device for inhalation-triggered automatic movement of the dosing slider (15) from its filling position into the emptying position and a return device for automatic movement of the dosing slider (15) back into the filling position.

Claims

1. An inhalation device for powder drugs comprising at least one storage chamber for accommodating a plurality of drug powder doses and a dosing device which includes at least one dosing slider which is movable approximately with a translatory movement in a dosing slider passage at least from a filling position into an emptying position, wherein the inhalation device further includes a device for inhalation-triggered automatic movement of the dosing slider from its filling position into the emptying position and a return device for automatic movement of the dosing slider back into the filling position.

2. An inhalation device according to claim 1 wherein the dosing slider passage with the at least one dosing slider and the storage chamber is sealed off relative to the environment at least in the filling position of the dosing slider.

3. An inhalation device (1) according to claim 1 wherein said at least one storage chamber has at least one outlet opening through which the powder drug can issue under the influence of the force of gravity and the dosing slider has at least one dosing cavity, wherein the dosing cavity in the filling position is under the outlet opening and the dosing slider is movable out of its filling position into the emptying position approximately transversely with respect to the outflow direction of the drug powder from the outlet opening of the at least one storage chamber.

4. An inhalation device according to claim 3 further comprising a mouthpiece having an inhalation opening and an air passage which is in flow communication with the mouthpiece and through which a patient can suck an airflow for inhalation, wherein the dosing cavity in the emptying position of the dosing slider is in the air passage.

5. An inhalation device according to claim 4 wherein arranged in the air passage is a trigger device for signaling when a predetermined minimum airflow in the air passage is exceeded.

6. An inhalation device according to claim 5 further comprising a valve device in the air passage in order to substantially close the air passage, wherein the valve device is operatively connected to the trigger device for inhalation-triggered opening of a substantial part of the flow cross-section of the air passage when a predetermined minimum airflow in the air passage is signaled as being exceeded.

7. An inhalation device according to claim 6 wherein the valve device is part of the device for inhalation-triggered automatic movement of the dosing slider.

8. An inhalation device according to claim 5 wherein the trigger device comprises a pivotably mounted, directly or indirectly spring-loaded flap arranged in the air passage and the air passage in the region of the flap is of a cross-sectional area which is large in relation to the inhalation opening.

9. An inhalation device according to claim 8 wherein the flap is pivotable about a pivot axis and the pivot axis extends through or close to the centre of gravity of the flap.

10. An inhalation device according to claim 8 wherein the flap is coupled to a thrust rod which is operatively connected to the device for inhalation-triggered automatic movement of the dosing slider in such a way that the device for inhalation-triggered automatic movement of the dosing slider is held in a biased position by the thrust rod when the flap is in its rest position and the thrust rod releases the device for inhalation-triggered automatic movement of the dosing slider when the flap is deflected out of its rest position at least by a predetermined amount.

11. An inhalation device according to claim 10 wherein the coupling between the flap and the thrust rod is formed by way of a toothed ring segment on the flap and a portion on the thrust rod, which is in the form of a rack.

12. An inhalation device according to claim 8 wherein the flap is pivotable about an axis and has a claw which is pivotable together with the flap about the axis and which holds a spring-loaded securing element and the contact face of which, with the securing element, is formed by a sliding or rolling pairing, wherein the securing element is operatively connected to the device for inhalation-triggered automatic movement of the dosing slider in such a way that the device for inhalation-triggered automatic movement of the dosing slider is held in a biased position by the securing element when the flap is in its rest position and the securing element releases the device for inhalation-triggered automatic movement of the dosing slider when the flap is deflected out of its rest position by at least a predetermined amount.

13. An inhalation device according to claim 5 wherein the trigger device has a piston connected to the air passage and the air passage in the region of the piston has a cross-section which is large in relation to the inhalation opening, wherein the piston is coupled to a thrust rod which is operatively connected to the device for inhalation-triggered automatic movement of the dosing slider in such a way that the device for inhalation-triggered automatic movement of the dosing slider is held in a biased position by the thrust rod when the piston is in its rest position and the thrust rod releases the device for inhalation-triggered automatic movement of the dosing slider when the piston is deflected out of its rest position by at least a predetermined amount by a predetermined minimum airflow in the air passage, which is initiated by a user of the inhalation device.

14. An inhalation device according to claim 1 wherein the device for inhalation-triggered automatic movement of the dosing slider out of its filling position into the emptying position has a drive element which can be moved into a readiness position against the force of a biasing spring and which has at least one sliding guide, an entrainment portion or a cam portion which is operatively connected to the dosing slider in its filling position and is releasably arrested in its readiness position by a trigger device, wherein the sliding guide, the entrainment portion or the cam portion is so designed that the drive element upon a movement out of the readiness position into a rest position moves the dosing slider at least into the emptying position thereof by way of entrainment portions.

15. An inhalation device according to claim 14 wherein the trigger device has an engagement portion interacting with a stepped stop element of the drive element, wherein the stepped stop element has a first step and the drive element is arrested in an intermediate position when the engagement portion of the trigger device interacts with the first step, and a second step and the drive element is held in its rest position when the engagement portion of the trigger device interacts with the second step.

16. An inhalation device according to claim 15 wherein the dosing slide is held in the emptying position by entrainment portions of the drive element and the dosing slide, respectively, in the intermediate position of the drive element.

17. An inhalation device according to claim 14, further comprising a return device for automatic movement of the dosing slider back into the filling position, the return device including a return spring.

18. An inhalation device according to claim 17 wherein the dosing slider is connected to the return spring and the sliding guide, the entrainment portion or the cam portion is also so designed that in the rest position of the drive element the dosing slider can return into the filling position due to the force of the return spring.

19. An inhalation device according to claim 17 wherein the drive element in its rest position is out of engagement with the dosing slider.

20. An inhalation device according to claim 14 wherein the drive element is formed by a linearly movable sliding guide carrier.

21. An inhalation device according to claim 14 further comprising a return device for automatically moving the dosing slider back into the filling position, wherein the return device includes a further sliding guide portion.

22. An inhalation device according to claim 14 wherein the sliding guide or the cam portion is of a rectilinear configuration.

23. An inhalation device according to claim 14 wherein the sliding guide or the cam portion is of a curved configuration, in particular of an eccentrically curved configuration or of a helical configuration.

24. An inhalation device according to claim 14 wherein the drive element is formed by a drive rocker pivotable about a first pivot axis.

25. An inhalation device according to claim 14 wherein the biasing spring and/or the return spring is a spring selected from a group of springs consisting of a coil spring, a spiral spring, a torsion spring, an elastically deformable shaped body and a compressed air storage means, wherein preferably the biasing spring has a non-linear characteristic.

26. An inhalation device according to claim 14 further comprising a rotary knob which is operatively connected to the drive element and which has an operating handle, wherein the drive element can be moved into its readiness position against the force of the biasing spring by a user with the rotary knob.

27. An inhalation device according to claim 14 further comprising an actuating button operatively connected to the drive element, wherein the drive element can be moved into its readiness position against the force of the biasing spring with the actuating button by a user.

28. An inhalation device according to claim 4 further comprising a closure cap for the mouthpiece, wherein the closure cap is non-losably connected to the inhalation device and is movable from a closure position in which the closure cap covers the mouthpiece into an operative position in which the mouthpiece is accessible to a patient.

29. An inhalation device according to claim 28 wherein the closure cap or the sliding guide carrier has one or more entrainment portions and the closure cap is movable out of the closure position and is pivotable into the operative position, wherein the closure cap or the sliding guide carrier has a sliding guide complementary to the entrainment portion or portions in such a way that the sliding guide carrier is movable by the movement of the closure cap out of the closure position into the operative position against the force of the biasing spring from its rest position into its readiness position.

30. An inhalation device according to claim 29 wherein the complementary sliding guide has a track for the entrainment portion or portions so that the closure cap is also movable in the readiness position of the sliding guide into the closure position.

31. An inhalation device according to claim 30 wherein the track is such that the sliding guide carrier is fixed in its readiness position by entrainment portions of the closure cap independently of the trigger device when the closure cap is in its closure position.

32. An inhalation device according to claim 29 wherein the complementary sliding guide is inclined with respect to the guide at an angle α

of between 15° and

45°

.

33. An inhalation device according to claim 29 wherein the complementary sliding guide extends non-rectilinearly.

34. An inhalation device according to claim 29 wherein the closure cap has at least one entrainment portion and the closure cap is movable out of the closure position along a guide substantially rectilinearly into an intermediate position and is pivotable out of the intermediate position into the operative position, wherein the inhalation device further has an eccentric disc operatively connected to the sliding guide carrier so that the eccentric disc is rotated by the entrainment portion of the closure cap upon the rectilinear movement thereof about a fixing axis in such a way that the sliding guide carrier is movable from its rest position into its readiness position by the movement of the closure cap out of the closure position into the intermediate position by way of the eccentric disc against the force of the biasing spring.

35. An inhalation device according to claim 29 wherein the closure cap has a pressure lever and the closure cap is pivotable out of the closure position into the operative position, wherein the pressure lever of the closure cap is pivotable about an axis in such a way that the sliding guide carrier is movable from its rest position into its readiness position by the movement of the closure cap out of the closure position into the operative position by way of the pressure lever against the force of the biasing spring.

36. An inhalation device according to claim 24 wherein the closure cap has at least one entrainment portion and a transmission rocker which is operatively connected to the driver rocker and which is pivotable about a second pivot axis and the closure cap is pivotable out of the closure position into the operative position about a third axis, wherein the at least one entrainment portion of the closure cap co-operates with at least one operative end of the transmission rocker in such a way that the drive rocker is movable out of its rest position into its readiness position by the movement of the closure cap about the third axis out of the closure position into the operative position by way of the transmission rocker against the force of the biasing spring.

37. An inhalation device according to claim 36 wherein the drive rocker and the transmission rocker are in mutual engagement in such a way that their rotation takes place in opposite relationship about the first and second pivot axes.

38. An inhalation device according to claim 37 wherein the moment of inertia of the drive rocker about the first pivot axis and the moment of inertia of the transmission rocker about the second pivot axis are approximately equal.

39. An inhalation device according to claim 36 wherein the at least one operative end of the transmission rocker is of such a configuration that the operative end is connected in positively locking relationship by the at least one entrainment portion of the closure cap upon movement of the closure cap out of the closure position into the operative position about the third axis and transmits the moment applied by the at least one entrainment portion to the transmission rocker and elastically evades the entrainment portion upon movement of the closure cap out of the operative position into the closure position.

40. An inhalation device according to claim 36 wherein the transmission rocker has two rocker elements which are arranged on both longitudinal sides of the inhalation device pivotably about the second pivot axis and are connected together with at least one yoke, wherein the thrust rod holds the transmission rocker in the biased position of the drive rocker by engagement with the yoke when the flap is in its rest position and the thrust rod enables the travel movement of the yoke when the flap is deflected out of its rest position at least by a predetermined amount so that the transmission rocker and the drive rocker are movable by the biasing spring out of their readiness position into their rest position.

41. An inhalation device according to claim 15 wherein there is further provided a counting device for detecting the number of delivered drug doses, wherein the counting device individually detects each dosing operation and is connected to a locking device which blocks the closure cap upon the attainment of a predetermined number of delivered doses so that the closure cap is no longer movable into the closure position.

42. An inhalation device according to claim 41 wherein the counting device is connected to the engagement portion of the trigger device and that the stepped stop element of the drive element has an opening or recess, and the drive element is urged by the biasing spring to a blocking position, when the engagement portion engages with the opening or recess.

43. An inhalation device according to claim 42 wherein the drive element in its blocking position engages blockingly into the path of the closure cap so that the closure cap can no longer be moved into the closure position.

44. An inhalation device according to claim 41 wherein the counting device includes a dose-accurate display.

45. An inhalation device according to claim 41 wherein the locking device has a spring-loaded locking element which engages into a groove which is opened at a predetermined number of doses and in that case blockingly engages into a sliding guide of the mechanism of the closure cap so that the closure cap can no longer be moved into the closure position.

46. An inhalation device according to claim 45 wherein the locking element of the locking device is coupled to a signal plate which is displayed upon blocking engagement of the locking device.

47. An inhalation device according to claim 41 wherein the locking device has a spring-loaded blocking rod which is movable from a rest position into a blocking position upon the attainment of a predetermined number of delivered doses and in its blocking position engages blockingly into the path of the closure cap so that the closure cap can no longer be moved into the closure position.

48. An inhalation device according to claim 1 wherein the at least one storage chamber has at least one outlet opening through which the powder drug can issue under the influence of the force of gravity, and a filling opening which is disposed substantially in opposite relationship to the outlet opening, wherein the filling opening is sealingly closed.

49. An inhalation device according to claim 48 wherein the filling opening is closed with an aluminium blister film and sealed with a LDPE layer.

50. An inhalation device according to claim 1 wherein the dosing slider passage has at its one end towards the environment an opening through which a part of the dosing slider can pass and a contact surface for a seal is provided around the opening, wherein the dosing slider has a sealing surface which is provided in a plane approximately in transverse relationship with its direction of movement out of the filling position into the emptying position.

51. An inhalation device according to claim 50 wherein an elastic seal is provided on the dosing slider and/or the contact surface, wherein the elastic seal is formed by injection on the dosing slider passage and/or the dosing slider.

52. An inhalation device according to claim 51 wherein the sealing integrity can be formed by a sealing rib on the dosing slider passage and/or the dosing slider, which is sealingly deformable by a biasing force which holds the dosing slider in the dosing slider passage.

53. An inhalation device according to claim 1 wherein the inhalation device further has a display for signaling inhalation readiness and/or successful delivery of the medicament.

54. An inhalation device according to claim 4 further comprising a breaking-down device for breaking down agglomerates and the like in the drug powder in flow communication with the mouthpiece, wherein the mouthpiece and the breaking-down device are removable for cleaning by the user and the mouthpiece and the breaking-down device are so adapted that they can only be removed or fitted together or are of a one-piece nature.

55. An inhalation device according to claim 1 wherein the at least one storage chamber is provided by a cartridge holder device and a lid, wherein the lid has a shape capable of receiving the drug powder content of the storage chamber in an upside-down position of the inhalation device.

56. An inhalation device according to claim 55 wherein the lid is sealingly fixed onto the cartridge holder by snap connectors.

57. An inhalation device according to claim 55 wherein the cartridge holder device comprises two storage chambers each covered by a lid, wherein the cartridge holder device comprises a twin dosing slider.