NASAL DELIVERY DEVICES

• US 20100300439A1
• Filed: 11/28/2007
• Published: 12/02/2010
• Est. Priority Date: 11/28/2006
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle, Sheldrake, Colin David
• Granted Patent: US 9,010,325 B2
• Time in Patent Office: Days
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0026 Hinged caps
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0035 Piercing means
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 15/0043 Non-destructive separation of the package, e.g. peeling
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth

Abstract

A nasal delivery device for and method of delivering particulate substance to the nasal airway of a subject, the delivery device comprising: a body assembly (3) including a mouthpiece unit (9) which includes a mouthpiece through which the subject in use exhales, and a substance-supply unit which is fluidly connected to the mouthpiece unit and actuatable to provide particulate substance for delivery to the nasal airway of the subject; wherein the body assembly is configured to receive a replaceable nosepiece unit (5) which includes a nosepiece and contains a container containing particulate substance.

Claims

1. A nasal delivery device for delivering particulate substance to the nasal airway of a subject, the delivery device comprising:

a body assembly including a mouthpiece unit which includes a mouthpiece through which the subject in use exhales, and a substance-supply unit which is fluidly connected to the mouthpiece unit and configured to receive a replaceable nosepiece unit which includes a nosepiece and contains a container containing particulate substance, wherein the substance-supply unit is actuatable to provide particulate substance for delivery to the nasal airway of the subject.

2. The delivery device of claim 1, further comprising:

a replaceable nosepiece unit which includes a nosepiece for fitting to a nostril of a subject, and a container chamber which contains a container containing particulate substance.

3. The delivery device of claim 1, where configured to prevent operation until a nosepiece unit is fitted to the body assembly.

4. The delivery device of claim 3, wherein the body assembly includes an actuation mechanism which is manually actuatable by the subject to open the container, and the delivery device is configured to prevent actuation of the actuation mechanism until the nosepiece unit is fitted to the body assembly.

5. The delivery device of claim 4, wherein the substance-supply unit includes an interlock mechanism which adopts a first, locking configuration when a nosepiece unit is not fitted to the body assembly, in which the actuation mechanism is not actuatable, and a second, released configuration when a nosepiece unit is fitted to the body assembly, in which the actuation mechanism is actuatable.

6. The delivery device of claim 5, wherein the interlock mechanism comprises an interlock member which is movably disposed between locking and released positions and normally biased to the locking position.

7. The delivery device of claim 1, wherein the substance-supply unit includes a valve unit which is operable between a first, closed configuration in which a fluid communication path with the mouthpiece is closed, and a second, open configuration in which the fluid communication path is open.

8. The delivery device of claim 5, wherein the substance-supply unit includes a valve unit which is operable between a first, closed configuration in which a fluid communication path with the mouthpiece is closed, and a second, open configuration in which the fluid communication path is open, and the interlock mechanism is configured to lock the valve unit in the closed configuration when the interlock mechanism is in the locking configuration and allow operation of the valve unit when the interlock mechanism is in the released configuration.

9. The delivery device of claim 8, wherein the valve unit includes a locking element which is engaged by the interlock mechanism when the interlock mechanism is in the locking configuration to prevent operation of the valve unit.

10. A nasal delivery device for delivering particulate substance to the nasal airway of a subject, the delivery device comprising:

a mouthpiece unit which includes a mouthpiece through which the subject in use exhales;

a nosepiece unit which includes a nosepiece for fitting to a nostril of the subject; and

a substance-supply unit which is configured to receive a container containing particulate substance and operable to provide a metered amount of substance in fluid communication with the mouthpiece and nosepiece units, such that an exhalation air flow delivered through the substance-supply unit entrains the substance.

11. The delivery device of claim 10, wherein the container comprises first and second parts which together define an enclosed chamber and are movable between a first, closed configuration in which the container is closed and a second, open configuration in which the container is open, and the substance-supply unit is operable to move the first and second parts of the container to the open configuration.

12. The delivery device of claim 11, wherein the first and second parts of the container are slideably disposed relative to one another and each include at least one aperture, which are closed with the first and second parts in the closed configuration and opened by sliding of the first and second parts to the open configuration.

13. The delivery device of claim 11, wherein the substance-supply unit comprises a support member, and a body section which is movable relative to the support member between a first, container-receiving position for receiving a container in the closed configuration, and a second, operative position in which the container is opened and disposed in fluid communication with the mouthpiece and nosepiece units.

14. The delivery device of claim 13, wherein the body section is rotatably disposed to the support member.

15. The delivery device of claim 14, wherein the body section includes a container-receiving aperture, which allows for introduction of a container thereinto when the body section is in the container-receiving position and is closed when the body section is in the operative position.

16. The delivery device of claim 14, wherein one of the support member and the body section includes an inlet aperture which is fluidly isolated from the mouthpiece unit when the body section is in the container-receiving position and fluidly connected to the mouthpiece unit when the body section is in the operative position.

17. The delivery device of claim 13, wherein the support member and the body section each include an engagement feature for engaging respective ones of the first and second parts of the container, and the support member and the body section are axially movable relative to one another, such that, on movement of the body section from the container-receiving position to the operative position, the first and second parts of the container are moved to the open configuration.

18. The delivery device of claim 17, wherein the support member and the body section are coupled by a cam mechanism, which provides that the engagement features thereof are moved between a first spacing in which the container is received therebetween, a second, closer spacing in which the first and second parts of the container are moved to the open configuration, and a third spacing in which the container is moveable axially between the engagement features.

19. The delivery device of claim 10, further comprising:

a housing which supports the mouthpiece unit, the nosepiece unit and the substance-supply unit.

20. The delivery device of claim 19, wherein the substance-supply unit includes a container-receiving member which is movably disposed to the housing between an open position for enabling loading of a container thereinto, and a closed position in which the container is contained within the housing.

21. The delivery device of claim 20, wherein the container-receiving member includes a cavity which defines an air flow channel between the mouthpiece and nosepiece units, such that an air flow is delivered therethrough on exhalation by the subject through the mouthpiece, and a support section for supporting the container in the cavity.

22. The delivery device of claim 21, wherein the container comprises a main body part and first and second bearing support parts at the respective ends of the body part, and the support section includes first and second container supports for rotatably supporting the respective support parts of the container.

23. The delivery device of claim 22, wherein the support parts of the container comprise part-spherical projections and the container supports comprise part-spherical recesses.

24. The delivery device of claim 20, wherein the substance-supply unit includes a locking mechanism for locking the container-receiving member in the closed position.

25. A nasal delivery device for delivering particulate substance to the nasal airway of a subject, the delivery device comprising:

a body assembly including a mouthpiece unit which includes a mouthpiece through which the subject in use exhales, and a substance-supply unit which is fluidly connected to the mouthpiece unit and actuatable to provide particulate substance for delivery to the nasal airway of the subject;

wherein the body assembly is configured to receive a replaceable nosepiece unit which includes a nosepiece and contains a container containing particulate substance.

26. The delivery device of claim 25, further comprising:

a replaceable nosepiece unit which includes a nosepiece for fitting to a nostril of a subject, and a container chamber which contains a container containing particulate substance.

27. The delivery device of claim 25, where configured to prevent operation until a nosepiece unit is fitted to the body assembly.

28. The delivery device of claim 27, wherein the body assembly includes an actuation mechanism which is manually actuatable by the subject to open the container, and the delivery device is configured to prevent actuation of the actuation mechanism until the nosepiece unit is fitted to the body assembly.

29. The delivery device of claim 28, wherein the actuation mechanism is locked in a locked configuration when a nosepiece unit is not fitted to the body assembly, such as to prevent operation of the actuation mechanism.

30. The delivery device of claim 29, wherein the nosepiece unit includes a release member for releasing the actuation mechanism from the locked configuration on fitting the nosepiece unit to the body assembly.

31. The delivery device of claim 30, wherein the actuation mechanism includes an actuation member which is latched in a locked position in the locked configuration of the actuation mechanism, and the release member of the nosepiece unit is operative to release the latched actuation member on fitting the nosepiece unit to the body assembly.

32. The delivery device of claim 30, wherein the nosepiece unit is fitted to the body assembly in one, fitting sense and removed from the body assembly in the opposite, removal sense, and the release member includes a support element, an engagement element for engaging the actuation mechanism and a frangible connection element which connects the support element to the engagement element, wherein the engagement element presents a substantially rigid structure when the nosepiece unit is fitted in a first instance to the body assembly and is operative to release the actuation mechanism from the locked configuration, and is deformed on removing the nosepiece unit from the body assembly.

33. The delivery device of claim 25, wherein the body assembly further comprises a locking mechanism for locking the actuation mechanism from further operation following a predeterminable number of operations of the actuation mechanism.

34. The delivery device of claim 33, wherein the locking mechanism comprises a rotatable element which is indexed with each actuation of the actuation mechanism and locks the actuation mechanism to prevent further operation thereof following a predeterminable number of operations of the actuation mechanism.

35. A container comprising first and second body parts which together define an enclosed chamber and are movable between a first, closed configuration in which the container is closed and a second, open configuration in which the container is open.

36. The container of claim 35, wherein the first and second body parts are slideably disposed relative to one another and each include at least one aperture, which are closed with the first and second body parts in the closed configuration and opened by sliding of the first and second body parts to the open configuration, optionally the first and second body parts include inter-engaging guides which provide for axial sliding of the first and second body parts without substantially any rotation thereof.

38. The container of claim 35, wherein the container is an elongate container and/or a capsule.

40. The container of claim 35, wherein the container is for containing particulate substance.

37. (canceled)

39. (canceled)

41. A container comprising a main body part and first and second bearing support parts at the respective ends of the main body part which provide bearing supports about which the container is rotatable.

42. The container of claim 41, wherein the support parts comprise part-spherical projections, optionally substantially hemi-spherical projections.

43. The container of claim 41, wherein the container is an elongate container and/or a capsule.

45. The container of claim 41, wherein the container is for containing particulate substance.

44. (canceled)

46. (canceled)

47. (canceled)