MULTI-DOSE MEDICAMENT DELIVERY DEVICE

Abstract

There is described a multi-unit dose dry powder medicament delivery device comprising: a first element comprising a single use nozzle located in a body which is at least partially lined with an inner member, said inner sleeve comprising an airway and a cartridge seat; and a second element adapted to be releasably attached to the first element, said second element comprising an actuator provided with an air source and a valve.

Claims

1. A multi-unit dose dry powder medicament delivery device comprising: a first element comprising a single use nozzle located in a body which is at least partially lined with an inner member, said inner sleeve comprising an airway and a cartridge seat; and a second element adapted to be releasably attached to the first element, said second element comprising an actuator provided with an air source and a valve.

2. A multi-unit dose dry powder medicament delivery device according to claim 1 wherein the inner sleeve comprises at least one baffle element.

3. A multi-unit dose dry powder medicament delivery device according to claim 1 wherein the releasable attachment of the first element to the second element comprises a screw fit.

4. A multi-unit dose dry powder medicament delivery device according to claim 1 wherein the inner sleeve is provided with a shuttle valve.

5. A multi-unit dose dry powder medicament delivery device according to claim 4 wherein the shuttle valve is dimensioned such that in the closed position it blocks the airway only until the device is primed by a user.

6. A multi-unit dose dry powder medicament delivery device according to claim 5 wherein the shuttle valve is provided with a pair of orifices which, when a device is primed, align with the airway of the device.

7. (canceled)

8. (canceled)

9. A multi-unit dose dry powder medicament delivery device according to claim 7 wherein the medicament cartridge comprises an elongate member provided with an inset cavity which acts as a medicament reservoir.

10. A multi-unit dose dry powder medicament delivery device according to claim 7 wherein the medicament cartridge is provided with a closure sleeve.

11. A multi-unit dose dry powder medicament delivery device according to claim 10 wherein the closure sleeve is slidably mounted around the inset cavity.

12. A multi-unit dose dry powder medicament delivery device according to claim 1 wherein the actuator in the second element comprises a spigot element which, when inserted into the first element, pushes the medicament container into position for delivery of the medicament.

13. A multi-unit dose dry powder medicament delivery device according to claim 12 wherein the spigot element is provided with at least one aperture to enable air to pass from the air source and valve through the spigot.

14. (canceled)

15. A multi-unit dose dry powder medicament delivery device according to claim 1 wherein the valve is a burst valve.

16. A multi-unit dose dry powder medicament delivery device according to claim 1 wherein the device is suitable for the treatment of a respiratory disorder.

17. A multi-unit dose dry powder medicament delivery device according to claim 16 wherein the device is a nasal inhaler.

18.-20. (canceled)

21. A multi-unit dose dry powder medicament delivery device kit comprising: a first element comprising a single use nozzle, said nozzle being located on a body which is at least partially lined with an inner sleeve, said inner sleeve comprising an airway and a cartridge seat; a second element adapted to be releasably attached to the first element, said second element comprising an actuator provided with an air source and a valve; and at least one cartridge comprising a dry powder medicament.

22. The kit according to claim 21 wherein the inner sleeve is provided with a shuttle valve.

23. (canceled)

24. (canceled)

25. A method of delivering a medicament to a patient which comprises the use of a dry powder medicament delivery device according to claim 1.

26. The method according to claim 25 wherein the inner sleeve is provided with a shuttle valve.

27.-29. (canceled)

30. A method of treatment of a patient with a disorder or prevention of a disorder which comprises the administration to the patient a suitable medicament using a medicament delivery device according to claim 1.

31.-33. (canceled)

34. A method of producing an aerosol of a dry powder which comprises positioning a dispersible dry powder material downstream of a burst valve member; wherein causing the burst valve member to flex and open produces a rapid depletion of the air pressure up-stream of the valve causing the dispersion and/or deagglomerates the dry powder material.

35. The method according to claim 34 wherein the inner sleeve is provided with a shuttle valve.

36.-44. (canceled)

46. (canceled)

Description

[0071] The invention will now be described by way of example only and with reference to the accompanying drawings in which

[0072] FIG. 1 is a cross-sectional view of a nozzle with an inner sleeve and cartridge assembly;

[0073] FIG. 2 is a cross-sectional view of a nozzle with an inner sleeve and a cartridge assembly inserted into the nozzle;

[0074] FIG. 3 is a cross-sectional view of a first element nozzle assembly and a second element comprising an actuator provided with an air source and a valve;

[0075] FIGS. 4a, 4b and 4c are cross-sectional views of a first element nozzle assembly attached to a second element and engaging with the cartridge assembly;

[0076] FIG. 5 is a cross-sectional view of a first element nozzle assembly including a shuttle valve and a cartridge assembly with a slidable outer sleeve;

[0077] FIG. 6 is a cross-sectional view of a first element nozzle assembly including a shuttle valve and a cartridge assembly with a slidable outer sleeve inserted into the nozzle;

[0078] FIG. 7 is a cross-sectional view of a first element nozzle assembly including a shuttle valve and a second element comprising an actuator provided with an air source and a valve;

[0079] FIGS. 8a, 8b and 8c are cross-sectional views of a first element nozzle assembly including a shuttle valve attached to a second element and engaging with the cartridge assembly;

[0080] FIG. 9 is a cross-sectional view of the complete assembly after activation;

[0081] FIG. 10 is a perspective view of a pyramid valve in the closed position;

[0082] FIG. 11 is a cross-sectional view of a pyramid valve in the closed position;

[0083] FIG. 12 is a perspective view of a pyramid valve in the open position; and

[0084] FIG. 13 is a cross-sectional view of a pyramid valve in the open position.

[0085] Referring to FIG. 1 a multi-unit dose dry powder medicament delivery device 1 comprises a first element 2. The first element 2 comprises a nozzle 3 located in a body 4, the nozzle 3 being provided with an airway 5 and an inner sleeve 6. At one end 7 the body 4 is provided with a circumferential rim 8. The airway 5 has an outlet 5a and an inlet 5b. The inner sleeve 6 is provided with an airway 9, which corresponds with the airway 5 of the nozzle. The airway 9 of the inner sleeve 6 is provided with a baffle 10 and a cartridge assembly seat 11 and cartridge facing lips 12 and 13.

[0086] A cartridge assembly 14 is also shown, said cartridge assembly comprising an elongate member 15 with a first end wall 16 and a second end wall 17. The elongate member 15 is provided with a cavity 18 for housing a medicament (not shown) and a closure sleeve 19.

[0087] FIG. 2 illustrates the cartridge assembly 14 inserted into the body 4 such that the closure sleeve 19 abuts the cartridge facing lips 12 and 13.

[0088] Referring to FIG. 3, the first element 2 is shown as described in FIGS. 1 and 2. Also shown is a second element 20 comprising an adaptor element 21, a burst valve 22 and bellows 23. The adaptor element 21 comprises a cylinder 24 with an internal screw thread 25 in the form of the helical grooves and a spigot 26 provided with an aperture 26a.

[0089] Referring to FIGS. 4a, 4b and 4c, in operation the second element 20 is attached to the first element 2, by locating the spigot 26 in the body 4 of the first element. The circumferential rim 8 of the first element 2 is located into the screw thread 25 of the second element 20.

[0090] When a user is ready to administer medication, the device is primed. The body 4 of the first element 2 is held still and the second element 20 is rotated, screwing the adaptor element 21 onto the body 4 as the circumferential rim 8 is rotated in the helical grooves of the screw thread 25. As this is done, the spigot 26 engages with the first end wall 16 of the cartridge assembly 14 and pushes the cartridge assembly 14 within the body 4. As the adaptor element 21 is screwed further onto the body 4 the spigot 26 continues to engage with the first end wall 16 of the cartridge assembly 14. The closure sleeve 19 of the cartridge assembly engages with the cartridge facing lips 12 and 13 of the inner sleeve 6, causing the travel of closure sleeve 19 to stop whilst the (now open) cavity 18 continues to travel to the cartridge assembly seat 11, located under and aligned with the airway 9.

[0091] To administer the medicament (dry powder formulation) the bellows 23 is depressed to cause air pressure to build in bellows 23 to a point where the burst valve 22 opens releasing a burst of air into airway 9. The burst of air travels through the apertured spigot 26, down the airway 9 until it hits baffle 10 which deflects the air into the open cavity 18, thus entraining the dry powder formulation contained in the cavity 18 into the air stream and out via the airway 5 of the nozzle 3.

[0092] After administration, the first element 2 is unscrewed from the second element 20 and can be discarded. The second element 20, comprising an adaptor element 21 a burst valve 22 and bellows 23, can be retained for use in conjunction with a first element 2 and any subsequent elements.

[0093] FIGS. 5, 6, 7, 8a, 8b, 8c and 9 illustrate a further embodiment of the multi-unit dose medicament delivery device. In this embodiment the airway 9 of the of the inner sleeve 6 is provided with a shuttle valve 27. The shuttle valve 27 is held in the closed position by a detent 28 in the inner sleeve 6. The shuttle valve 27 is dimensioned such that in the closed position it blocks both airway 9 and airway 5. In addition, the nozzle 3 is provided with a stop 29 capable of arresting movement of the shuttle valve 27. The shuttle valve 27 is provided with orifices 27a and 27b.

[0094] The use of a shuttle valve is advantageous in that it acts to prevent powder spillage, for example if the device is inverted and/or shaken after being primed but before the medicament is administered.

[0095] The operation of the multi-unit dose medicament delivery device of this embodiment is the same as herein described for FIGS. 1 to 4.

[0096] As the spigot 26 abuts the shuttle valve 27 it engages with it and pushes the shuttle valve 17 to release it from detent 28. At this point the airways 5 and 9 remain closed preventing any powdered medicament (not shown) from escaping from the device.

[0097] The procedure to administer the drug is as described above for the first embodiment. When air is released through the burst valve 22 the compressed air enters the shuttle valve 27 driving the shuttle valve 27 forwards to the stop 29. The orifices 27a and 27b of the shuttle valve 27 align with the airway 9, such that the air blast can then pass through the shuttle valve 27, airway 9, the medicament cavity 18, entraining the powdered medicament in the airflow, and through airway 5.

[0098] Referring to FIGS. 10 to 13 the burst valve 22 comprises a moulded flexible polymer disc 30 provided with a circumferential flange 31 to provide a sealing ring. Substantially in the centre of the disc there is provided a four sided pyramid structure 32 which forms a closure. The four sided pyramid structure 32 is provided with walls 33a, 33b, 33c and 33d. The pyramid structure 32 is provided with a slit 34 cut along a diagonal of the pyramid 32. In the valve's dormant state the slit 34 remains closed.

[0099] In the operation of the assembled device herein described (i.e. depressing the bellows 23), air pressure acts upon the outer surface of the pyramid 32 and walls (33a, 33b, 33c and 33d). The pyramid and wall structure is inherently a strong structure and the material (TPE) is compressed with the slit 34 being forced tightly dosed, however as pressure builds the pyramid is overcome and collapses and the slit 34 opens to create an orifice 35, allowing the compressed air to pass through the orifice 35. When the air pressure has diminished to ambient pressure, the pyramid 32 regains its moulded form. As the bellows 23 is released the outer surface of the pyramid 32 and walls (33a, 33b, 33c and 33d) are subjected to a negative pressure whilst the inner surfaces are subject to ambient pressure, the result is that the walls (33a, 33b, 33c and 33d) deflect outwardly relieving the forces on the slit 34, the effect being that air can leak back into the bellows.