Nasal delivery devices

• US 20040112380A1
• Filed: 02/12/2004
• Published: 06/17/2004
• Est. Priority Date: 02/26/2001
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Granted Patent: US 7,347,201 B2
• Time in Patent Office: Days
• US Class Current: 128/203.12
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/006 operated by applying mechanical pressure to the liquid to be sprayed or atomised
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• 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 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/071 hand operated
• CPC Class Codes: A61M 2205/073 : Syringe, piston type
• CPC Class Codes: A61M 2205/13 : with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2210/0668 : Middle ear
• CPC Class Codes: A61M 2230/43 : Composition of exhalation

Abstract

An exhalation breath-actuated nasal delivery device for and a method of delivering a substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece (40) for fitting to a nostril of a subject; a mouthpiece (42) through which the subject in use exhales; and delivery unit (64), as one of a mechanical delivery pump (66) or a nebulizer (115), for delivering a substance to the nosepiece (40); and an actuation mechanism (74) for actuating the delivery unit in response to oral exhalation through the mouthpiece, and preferably when at least one or both of the pressure at or the flow rate through the nosepiece exceeds a predetermined threshold.

Claims

1. An exhalation breath-actuated nasal delivery device for delivering a substance to a nasal cavity of a subject, comprising:

a nosepiece for fitting to a nostril of a subject;

a mouthpiece through which the subject in use exhales;

a nozzle for directing a substance through the nosepiece;

a mechanical delivery pump fluidly connected to the nozzle for delivering a substance to the nozzle; and

an actuation mechanism for actuating the mechanical delivery pump in response to oral exhalation through the mouthpiece.

2. The delivery device of claim 1, wherein the actuation mechanism includes a trigger mechanism for actuating the delivery pump at a predeterminable pressure.

3. The delivery device of claim 1, wherein the actuation mechanism includes a trigger mechanism for actuating the delivery pump at a predeterminable flow rate.

4. The delivery device of claim 1, wherein the actuation mechanism includes a trigger mechanism for actuating the delivery pump at one or both of a predeterminable pressure and a predeterminable flow rate.

5. The delivery device of any of claims 1 to 4, further comprising:

a flow channel fluidly connecting the nosepiece and the mouthpiece, whereby exhaled air from an exhalation breath is in use delivered through the nosepiece.

6. The delivery device of any of claims 1 to 4, further comprising:

a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is in use delivered; and

a gas supply unit for supplying a gas flow to the flow channel.

7. The delivery device of claim 6, wherein the gas supply unit is configured to be actuated by exhalation through the mouthpiece.

8. The delivery device of any of claims 1 to 7, wherein the delivery pump comprises a liquid delivery pump for delivering a metered volume of a liquid.

9. The delivery device of any of claims 1 to 7, wherein the delivery pump comprises a powder delivery pump for delivering a metered amount of a powder.

10. The delivery device of any of claims 1 to 9, wherein the nozzle is configured to deliver an aerosol.

11. The delivery device of any of claims 1 to 9, wherein the nozzle is configured to deliver a jet.

12. An oral exhalation breath-actuated mechanical nasal delivery pump unit for delivering a substance to a nasal cavity of a subject, the pump unit including an outlet nozzle and a mechanical delivery pump.

13. The delivery pump unit of claim 12, wherein the delivery pump comprises a liquid delivery pump for delivering a metered volume of a liquid.

14. The delivery pump unit of claim 12, wherein the delivery pump comprises a powder delivery pump for delivering a metered amount of a powder.

15. The delivery pump unit of any of claims 12 to 14, wherein the nozzle is configured to deliver an aerosol.

16. The delivery pump unit of any of claims 12 to 14, wherein the nozzle is configured to deliver a jet.

17. A method of delivering a substance to a nasal cavity of a subject, comprising the steps of:

providing a nasal delivery device to the nasal cavity of a subject, the delivery device including a nosepiece for fitting to a nostril of the subject, a mouthpiece through which the subject exhales, a nozzle for directing a substance through the nosepiece, and a mechanical delivery pump fluidly connected to the nozzle for delivering a substance to the nozzle; and

actuating the delivery pump in response to oral exhalation through the mouthpiece to deliver a substance through the nosepiece.

18. The method of claim 17, wherein the step of actuating the delivery pump comprises the step of:

actuating the delivery pump in response to oral exhalation through the mouthpiece on generation of a predeterminable pressure at the nosepiece.

19. The method of claim 17, wherein the step of actuating the delivery pump comprises the step of:

actuating the delivery pump in response to oral exhalation through the mouthpiece on generation of a predeterminable flow rate through the nosepiece.

20. The method of claim 17, wherein the step of actuating the delivery pump comprises the step of:

actuating the delivery pump in response to oral exhalation through the mouthpiece on generation of one or both of a predeterminable pressure at or a predeterminable flow rate through the nosepiece.

21. The method of any of claims 17 to 20, wherein:

the delivery device further comprises a flow channel fluidly connecting the nosepiece and the mouthpiece, whereby exhaled air from an exhalation breath is delivered through the nosepiece.

22. The method of any of claims 17 to 20, further comprising the step of:

delivering a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, through the nosepiece.

23. The method of any of claims 17 to 22, wherein the delivery pump comprises a liquid delivery pump for delivering a metered volume of a liquid.

24. The method of any of claims 17 to 22, wherein the delivery pump comprises a powder delivery pump for delivering a metered amount of a powder.

25. The method of any of claims 17 to 24, wherein the substance is delivered as an aerosol.

26. The method of any of claims 17 to 24, wherein the substance is delivered as a jet.

27. A method of delivering a substance to a nasal cavity of a subject, comprising the step of actuating a mechanical nasal delivery pump unit, the pump unit including an outlet nozzle and a mechanical delivery pump fluidly connected thereto, on oral exhalation by the subject to deliver a substance to a nasal cavity of the subject.

28. The method of claim 27, wherein the delivery pump comprises a liquid delivery pump for delivering a metered volume of a liquid.

29. The method of claim 27, wherein the delivery pump comprises a powder delivery pump for delivering a metered amount of a powder.

30. The method of any of claims 27 to 29, wherein the substance is delivered as an aerosol.

31. The method of any of claims 27 to 29, wherein the substance is delivered as a jet.

32. An exhalation breath-actuated nasal delivery device for delivering a substance to a nasal cavity of a subject, comprising:

a nosepiece for fitting to a nostril of a subject;

a mouthpiece through which the subject in use exhales;

a nebulizer for delivering an aerosol including a substance to the nosepiece; and

an actuation unit for actuating the nebulizer when at least one or both of the pressure at or the flow rate through the nosepiece exceeds a predetermined threshold in response to oral exhalation through the mouthpiece.

33. The delivery device of claim 32, further comprising:

a flow channel fluidly connecting the nosepiece and the mouthpiece, whereby exhaled air from an exhalation breath is in use delivered through the nosepiece.

34. The delivery device of claim 33, wherein the actuation unit includes a flow regulator for regulating a flow of exhaled air from an exhalation breath.

35. The delivery device of claim 32, further comprising:

a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is in use delivered; and

a gas supply unit for supplying a gas flow to the flow channel.

36. The delivery device of claim 35, wherein the gas supply unit is configured to be actuated by exhalation through the mouthpiece.

37. The delivery device of any of claims 32 to 36, wherein the nebulizer comprises an ultrasonic nebulizer.

38. The delivery device of any of claims 32 to 36, wherein the nebulizer comprises a flow-generated nebulizer.

39. The delivery device of any of claims 32 to 36, wherein the nebulizer comprises an electrohydrodynamic nebulizer.

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

providing a nasal delivery device comprising a nosepiece for fitting to a nostril of a subject, a mouthpiece through which the subject exhales, and a nebulizer for delivering an aerosol including a substance to the nosepiece; and

actuating the nebulizer when at least one or both of the pressure at or the flow rate through the nosepiece exceeds a predetermined threshold in response to oral exhalation through the mouthpiece.

41. The method of claim 40, wherein:

the delivery device further comprises a flow channel fluidly connecting the nosepiece and the mouthpiece, whereby exhaled air from an exhalation breath is delivered through the nosepiece.

42. The method of claim 41, wherein:

the delivery device further comprises a flow regulator for regulating a flow of exhaled air from an exhalation breath.

43. The method of claim 40, further comprising the step of:

delivering a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, through the nosepiece.

44. The method of any of claims 40 to 43, wherein the nebulizer comprises an ultrasonic nebulizer.

45. The method of any of claims 40 to 43, wherein the nebulizer comprises a flow-generated nebulizer.

46. The method of any of claims 40 to 43, wherein the nebulizer comprises an electrohydrodynamic nebulizer.

47. A nasal delivery device for delivering a substance to a nasal cavity of a subject substantially as hereinbefore described with reference to any of FIGS. 2(a) to (d), FIGS. 3(a) to (d), FIG. 4 or FIG. 5 of the accompanying drawings.

48. A method of delivering a substance to a nasal cavity of a subject substantially as hereinbefore described with reference to any of FIGS. 2(a) to (d), FIGS. 3(a) to (d), FIG. 4 or FIG. 5 of the accompanying drawings.