Nasal devices

• US 7,854,227 B2
• Filed: 04/25/2003
• Issued: 12/21/2010
• Est. Priority Date: 04/25/2002
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Yu; Justine R
• Assistant Examiner(s): Matter; Kristen C
• Application Number:
  US10/512,514
• Publication Number:
  US 20060096589A1
• Time in Patent Office: 2,797 Days
• Field of Search: 128/200.14, 12820017-20023, 12820312-20315, 128/203.18, 128/203.22, 128/203.23, 128/203.24, 128/207.18
• US Class Current: 128/203.18
• CPC Class Codes: A61M 15/0008 rotating by airflow
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• 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 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws

Abstract

A nasal delivery device and method are provided for delivering substance to a nasal airway of a subject, in particular one of a liquid, as a suspension or solution, or a powder containing a medicament, especially systemic or topical pharmaceuticals, or a vaccine to the nasal airway of a subject. The delivery device is characterized by: a nosepiece for fitting to a nostril of a subject; a delivery unit including a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray for delivery to a nasal airway of the subject; and an aerosol interactor operable to interact with an aerosol spray as generated by the at least one nozzle.

Claims

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

a mouthpiece through which a subject in use exhales;

a nosepiece for fitting to a nostril of the subject;

a delivery unit comprising a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray for delivery to a nasal airway of the subject; and

an aerosol interactor operable to interact with an aerosol spray during generation from the at least one nozzle such as at least to modify the particle size distribution of particles of the aerosol spray, wherein the aerosol interactor is configured such that operation thereof is actuated prior to actuation of the delivery unit.

2. The delivery device of claim 1, wherein the at least one nozzle is configured such as to deliver the aerosol spray towards the nosepiece.

3. The delivery device of claim 1, wherein the aerosol interactor comprises a flow director for directing an interacting gas flow at the aerosol spray such as to interact with the same.

4. The delivery device of claim 3, wherein the flow director includes at least one flow-directing channel downstream of the at least one nozzle for directing an interacting gas flow and delivering at least one interacting gas stream to interact with the aerosol spray.

5. The delivery device of claim 4, wherein the at least one flow-directing channel has an annular outlet disposed about a delivery path of the aerosol spray.

6. The delivery device of claim 3, further comprising:

a chamber in fluid communication with the nosepiece; and

wherein the flow director includes an annular flow channel for providing an annular gas flow over an inner periphery of the chamber.

7. The delivery device of claim 6, wherein the chamber includes a flow deflector disposed at the inner periphery thereof and downstream of the at least one nozzle which is such as to obstruct the annular gas flow generated at the inner periphery of the chamber and cause the same to be deflected inwardly and generate a turbulent zone downstream of the at least one nozzle.

8. The delivery device of claim 7, wherein the flow deflector comprises an annular member.

9. The delivery device of claim 3, wherein the aerosol interactor comprises a flow director for directing an interacting gas flow at the aerosol spray such as to interact with the same, and further comprising:

a gas supply unit for delivering a gas flow, the gas supply unit being fluidly connected to the flow director such that at least part of the delivered gas flow provides the interacting gas flow.

10. The delivery device of claim 1, wherein the aerosol interactor comprises a flow director for directing an interacting gas flow at the aerosol spray such as to interact with the same, and the mouthpiece is fluidly connected to the flow director such that at least part of the exhaled air flow provides the interacting gas flow.

11. The delivery device of claim 1, wherein the substance supply unit comprises an aerosol canister.

12. The delivery device of claim 1, wherein the substance supply unit comprises a delivery pump.

13. The delivery device of claim 12, wherein the delivery pump comprises a liquid spray pump.

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

a nosepiece for fitting to a nostril of a subject;

a delivery unit comprising a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray for delivery to a nasal airway of the subject; and

an aerosol interactor operable to interact with an aerosol spray during generation from the at least one nozzle such as at least to modify the particle size distribution of particles of the aerosol spray, wherein the aerosol interactor comprises a flow director which includes at least one flow-directing channel downstream of the at least one nozzle for directing an interacting gas flow and delivering at least one interacting gas stream to interact with the aerosol spray, and wherein the at least one flow-directing channel has an annular outlet disposed about a delivery path of the aerosol spray and the at least one flow-directing channel is configured such as to direct the at least one interacting gas stream substantially orthogonally to the delivery path of the aerosol spray.

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

a nosepiece for fitting to a nostril of a subject;

a delivery unit comprising a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray for delivery to a nasal airway of the subject; and

an aerosol interactor operable to interact with an aerosol spray during generation from the at least one nozzle such as at least to modify the particle size distribution of particles of the aerosol spray, wherein the aerosol interactor comprises a flow director which includes at least one flow-directing channel downstream of the at least one nozzle for directing an interacting gas flow and delivering at least one interacting gas stream to interact with the aerosol spray, and wherein the at least one flow-directing channel has an annular outlet disposed about a delivery path of the aerosol spray and the at least one flow-directing channel is configured such as to direct the at least one interacting gas stream in a direction inclined to the delivery path of the aerosol spray and away from the nosepiece.

16. The delivery device of claim 15, wherein the at least one flow-directing channel is an annular, frusto-conical channel configured to deliver a conical, annular interacting gas stream to the delivery path of the aerosol spray.

17. The delivery device of claim 16, wherein the at least one flow-directing channel is configured such that an apex of the conical, annular interacting gas stream delivered thereby is co-incident with the delivery path of the aerosol spray.

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

a nosepiece for fitting to a nostril of a subject;

a delivery unit comprising a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray for delivery to a nasal airway of the subject; and

an aerosol interactor operable to interact with an aerosol spray during generation from the at least one nozzle such as at least to modify the particle size distribution of particles of the aerosol spray, wherein the aerosol interactor comprises a flow director which includes a plurality of flow-directing channels in spaced relation downstream of the at least one nozzle for directing an interacting gas flow and delivering a plurality of interacting gas streams to interact with the aerosol spray.

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

a mouthpiece through which a subject in use exhales;

a chamber into which an aerosol spray is delivered;

a nosepiece for fitting to a nostril of the subject and being in fluid communication with the chamber;

a delivery unit comprising a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray into the chamber for delivery to a nasal airway of the subject; and

an aerosol interactor operable to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a movable element disposed downstream of the at least one nozzle and being moved by a gas flow delivered through the chamber.

20. The delivery device of claim 19, wherein the aerosol interactor is disposed in opposed relation to the at least one nozzle.

21. The delivery device of claim 20, wherein the aerosol interactor is configured such as to present a continuous surface to the aerosol spray.

22. The delivery device of claim 19, wherein the aerosol interactor is disposed relative to the at least one nozzle such that the aerosol spray is reflected thereby.

23. The delivery device of claim 19, wherein the movable element comprises a rotatable element.

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

a nosepiece for fitting to a nostril of a subject;

a delivery unit comprising a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray for delivery to a nasal airway of the subject; and

an aerosol interactor operable to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a movable element disposed downstream of the at least one nozzle, and the movable element comprises first and second rotatable elements coupled so as to rotate in unison, the first rotatable element including vanes oriented in one sense such as to be rotated in one sense by a gas flow thereover, and the second rotatable element being disposed downstream of the at least one nozzle and including vanes oriented in the other, opposite sense to the vanes of the first rotatable element such as to generate an interacting gas flow in an upstream direction towards the at least one nozzle on being rotated in the one sense by rotation of the first rotatable element.

25. The delivery device of claim 24, wherein the first rotatable element is disposed upstream of the at least one nozzle.

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

a nosepiece for fitting to a nostril of a subject;

a delivery unit comprising a substance supply unit and a nozzle unit including at least one nozzle fluidly connected to the substance supply unit for generating an aerosol spray for delivery to a nasal airway of the subject, wherein the nozzle unit includes a tubular element which extends downstream of the at least one nozzle and includes a plurality of apertures for providing a plurality of flow paths therethrough; and

an aerosol interactor operable to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a movable element disposed downstream of the at least one nozzle, and the aerosol interactor comprises a rotatable element disposed at a downstream end of the tubular element, the rotatable element including first, outer vanes oriented in one sense and disposed radially beyond the tubular element such that the rotatable element is rotated in one sense by a gas flow thereover, and second, inner vanes oriented in the other, opposite sense to the outer vanes such as to generate an interacting gas flow in an upstream direction towards the at least one nozzle with rotation of the rotatable element, which interacting gas flow is such as to interact with the aerosol spray and pass through the apertures in the tubular element.

27. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

a subject exhaling through a mouthpiece;

fitting a nosepiece to a nostril of the subject;

actuating a delivery unit to generate an aerosol spray from at least one nozzle for delivery to a nasal airway of the subject; and

operating an aerosol interactor to interact with an aerosol spray as generated by the at least one nozzle, wherein operation of the aerosol interactor is actuated prior to actuation of the delivery unit.

28. The method of claim 27, wherein the aerosol spray is delivered towards the nosepiece.

29. The method of claim 27, wherein the aerosol interactor comprises a flow director;

and

the step of operating the aerosol interactor comprises the step of;

directing an interacting gas flow at the aerosol spray such as to interact with the same.

30. The method of claim 29, wherein the flow director includes at least one flow-directing channel downstream of the at least one nozzle, and

the step of operating the aerosol interactor comprises the step of:

directing an interacting gas flow to deliver at least one interacting gas stream to interact with the aerosol spray.

31. The method of claim 30, wherein the at least one flow-directing channel has an annular outlet disposed about a delivery path of the aerosol spray.

32. The method of claim 29, wherein the aerosol spray is delivered into a chamber in fluid communication with the nosepiece;

and

further comprising the step of;

providing an annular gas flow over an inner periphery of the chamber.

33. The method of claim 32, wherein the chamber includes a flow deflector disposed at the inner periphery thereof and downstream of the at least one nozzle;

and

further comprising the step of;

obstructing the annular gas flow generated at the inner periphery of the chamber such as to cause the same to be deflected inwardly and generate a turbulent zone downstream of the at least one nozzle.

34. The method of claim 33, wherein the flow deflector comprises an annular member.

35. The method of claim 29, wherein the aerosol interactor comprises a flow director, and the step of operating the aerosol interactor comprises the step of:

directing an interacting gas flow to deliver at least one interacting gas stream to interact with the same, and further comprising the step of;

supplying a gas flow from a gas supply unit, at least part of the supplied gas flow being delivered to the flow director as the interacting gas flow.

36. The method of claim 27, wherein the aerosol interactor comprises a flow director, and the step of operating the aerosol interactor comprises the step of:

directing an interacting gas flow to deliver at least one interacting gas stream to interact with the same, wherein the mouthpiece is fluidly connected to the flow director such that at least part of the exhaled air flow provides the interacting gas flow.

37. The method of claim 27, wherein the aerosol spray is from an aerosol canister.

38. The method of claim 27, wherein the aerosol spray is from a delivery pump.

39. The method of claim 38, wherein the delivery pump comprises a liquid spray pump.

40. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

fitting a nosepiece to a nostril of a subject;

actuating a delivery unit to generate an aerosol spray from at least one nozzle for delivery to a nasal airway of the subject; and

operating an aerosol interactor to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a flow director which includes at least one flow-directing channel downstream of the at least one nozzle, the at least one flow-directing channel having an annular outlet disposed about a delivery path of the aerosol spray, and wherein operation of the aerosol interactor comprises directing an interacting gas flow to deliver at least one interacting gas stream substantially orthogonally to the delivery path of the aerosol spray to interact with the aerosol spray.

41. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

fitting a nosepiece to a nostril of a subject;

actuating a delivery unit to generate an aerosol spray from at least one nozzle for delivery to a nasal airway of the subject; and

operating an aerosol interactor to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a flow director which includes at least one flow-directing channel downstream of the at least one nozzle, the at least one flow-directing channel having an annular outlet disposed about a delivery path of the aerosol spray, and wherein operation of the aerosol interactor comprises directing an interacting gas flow to deliver at least one interacting gas stream in a direction inclined to the delivery path of the aerosol spray and away from the nosepiece to interact with the aerosol spray.

42. The method of claim 41, wherein the at least one interacting gas stream is a conical, annular interacting gas stream.

43. The method of claim 42, wherein an apex of the conical, annular interacting gas stream is co-incident with the delivery path of the aerosol spray.

44. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

fitting a nosepiece to a nostril of a subject;

actuating a delivery unit to generate an aerosol spray from at least one nozzle for delivery to a nasal airway of the subject; and

operating an aerosol interactor to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a flow director which includes a plurality of flow-directing channels in spaced relation downstream of the at least one nozzle, wherein operation of the aerosol interactor comprises directing an interacting gas flow to deliver a plurality of interacting gas streams to interact with the aerosol spray.

45. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

a subject exhaling through a mouthpiece;

fitting a nosepiece to a nostril of the subject;

actuating a delivery unit to generate an aerosol spray from at least one nozzle into a chamber in fluid communication with the nosepiece for delivery to a nasal airway of the subject; and

operating an aerosol interactor to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a movable element disposed downstream of the at least one nozzle; and

the step of operating the aerosol interactor comprises the step of;

delivering a gas flow through the chamber to move the movable element downstream of the at least one nozzle such as to interact with the aerosol spray.

46. The method of claim 45, wherein the aerosol interactor is disposed in opposed relation to the at least one nozzle.

47. The method of claim 46, wherein the aerosol interactor is configured such as to present a continuous surface to the aerosol spray.

48. The method of claim 46, wherein the aerosol interactor is disposed relative to the at least one nozzle such that the aerosol spray is reflected thereby.

49. The method of claim 45, wherein the movable element comprises a rotatable element.

50. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

fitting a nosepiece to a nostril of a subject;

actuating a delivery unit to generate an aerosol spray from at least one nozzle for delivery to a nasal airway of the subject; and

operating an aerosol interactor to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a movable element disposed downstream of the at least one nozzle, and the movable element comprises first and second rotatable elements coupled so as to rotate in unison, the first rotatable element including vanes oriented in one sense such as to be rotated in one sense by a gas flow thereover, and the second rotatable element being disposed downstream of the at least one nozzle and including vanes oriented in the other, opposite sense to the vanes of the first rotatable element such as to generate an interacting gas flow in an upstream direction towards the at least one nozzle on being rotated in the one sense by rotation of the first rotatable element, and the step of operating the aerosol interactor comprises the step of;

driving a gas flow over the first rotatable element such as to cause rotation of the same and thereby rotate the second rotatable element such as to generate an interacting gas flow in an upstream direction towards the at least one nozzle which interacts with the aerosol spray.

51. The method of claim 50, wherein the first rotatable element is disposed upstream of the at least one nozzle.

52. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

fitting a nosepiece to a nostril of a subject;

actuating a delivery unit to generate an aerosol spray from at least one nozzle for delivery to a nasal airway of the subject, wherein the step of actuating the delivery unit to generate an aerosol spray comprises the step of;

actuating the delivery unit to generate an aerosol spray from at least one nozzle into a tubular element which extends downstream of the at least one nozzle, the tubular element including a plurality of apertures for providing a plurality of flow paths therethrough; and

operating an aerosol interactor to interact with an aerosol spray as generated by the at least one nozzle, wherein the aerosol interactor comprises a movable element disposed downstream of the at least one nozzle, and the step of operating the aerosol interactor comprises the steps of;

moving a rotatable element disposed at a downstream end of the tubular element, the rotatable element including first, outer vanes oriented in one sense and disposed radially beyond the tubular element such that the rotatable element is rotated in one sense by a gas flow thereover, and second, inner vanes oriented in the other, opposite sense to the outer vanes such as to generate an interacting gas flow in an upstream direction towards the at least one nozzle with rotation of the rotatable element; and

driving a gas flow over the outer vanes of the rotatable element to cause rotation of the same and thereby cause the inner vanes of the rotatable element to generate an interacting gas flow in an upstream direction towards the at least one nozzle, which interacting gas flow is such as to interact with the aerosol spray and pass through the apertures in the tubular element.