Nasal devices

• US 20040149289A1
• Filed: 03/29/2004
• Published: 08/05/2004
• 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 7,543,581 B2
• Time in Patent Office: Days
• US Class Current: 128/207.18
• 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

A nasal delivery device for and a method of delivering at least one substance to a nasal cavity of a subject, and a nasal resistance measurement device for and a method of determining a flow resistance of a nasal airway of a subject. The nasal delivery device includes a delivery unit comprising: a nosepiece for fitting to a nostril of a subject; a mouthpiece through which the subject in use exhales; a breath analyzer for analyzing the concentration of at least one component in exhaled air from an exhalation breath; and a substance supply unit for supplying at least one substance, the substance supply unit including a control unit for controlling the same to control supply of at least one substance in response to the detected concentration.

Claims

1. A nasal delivery device for delivering at least one substance to a nasal cavity of a subject, including a delivery unit comprising:

a nosepiece for fitting to a nostril of a subject;

a mouthpiece through which the subject in use exhales;

a breath analyzer for analyzing the concentration of at least one component in exhaled air from an exhalation breath; and

a substance supply unit for supplying at least one substance, the substance supply unit including a control unit for controlling the same to control supply of the at least one substance in response to the detected concentration.

2. The delivery device of claim 1, wherein the control unit is configured to actuate the substance supply unit to supply the at least one substance at a predeterminable pressure.

3. The delivery device of claim 1, wherein the control unit is configured to actuate the substance supply unit to supply the at least one substance at a predeterminable flow rate.

4. The delivery device of claim 1, wherein the control unit is configured to actuate the substance supply unit to supply the at least one substance at one or both of a predeterminable pressure and a predeterminable flow rate.

5. The delivery device of any of claims 1 to 4, wherein the delivery unit further comprises:

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

6. The delivery device of claim 5, wherein the substance supply unit includes a flow regulator for regulating the exhaled air flow.

7. The delivery device of claim 6, wherein the flow regulator is operably coupled to the control unit such as to allow for control of the same.

8. The delivery device of any of claims 1 to 4, wherein the delivery unit further comprises:

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

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

9. The delivery device of any of claims 1 to 8, wherein the substance supply unit includes a dosing unit for supplying at least one substance.

10. The delivery device of claim 9, wherein the dosing unit comprises a nebulizer for supplying an aerosol.

11. The delivery device of claim 9, wherein the dosing unit comprises an aerosol canister for supplying an aerosol.

12. The delivery device of claim 9, wherein the dosing unit comprises a delivery pump unit for supplying an aerosol.

13. The delivery device of claim 12, wherein the dosing unit comprises a liquid pump unit for supplying a liquid aerosol.

14. The delivery device of claim 12, wherein the dosing unit comprises a powder pump unit for supplying a powder aerosol.

15. The delivery device of claim 9, wherein the dosing unit comprises a powder delivery unit for delivering a powder aerosol.

16. The delivery device of any of claims 1 to 15, further including an outlet unit comprising:

a nosepiece for fitting in the other, outlet nostril of the subject; and

an exit flow analyzer for analyzing the concentration of at least one component in an air flow exiting the outlet nostril.

17. The delivery device of claim 16, wherein the exit flow analyzer is operably connected to the control unit, and the control unit is configured to control the substance supply unit in response to a concentration detected by the exit flow analyzer.

18. A method of delivering at least one substance to a nasal cavity of a subject, comprising the steps of:

providing a delivery device including a delivery unit comprising a nosepiece for fitting to a nostril of a subject, a mouthpiece through which the subject exhales, a breath analyzer for analyzing the concentration of at least one component in exhaled air from an exhalation breath, and a substance supply unit for supplying at least one substance;

actuating the substance supply unit to supply at least one substance; and

controlling supply of the at least one substance by the substance supply unit in response to a concentration as detected by the breath analyzer.

19. The method of claim 18, wherein the step of actuating the substance supply unit comprises the step of:

actuating the substance supply unit to supply the at least one substance at a predeterminable pressure.

20. The method of claim 18, wherein the step of actuating the substance supply unit comprises the step of:

actuating the substance supply unit to supply the at least one substance at a predeterminable flow rate.

21. The method of claim 18, wherein the step of actuating the substance supply unit comprises the step of:

actuating the substance supply unit to supply the at least one substance at one or both of a predeterminable pressure and a predeterminable flow rate.

22. The method of any of claims 18 to 21, wherein the delivery unit further comprises:

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

23. The method of claim 22, further comprising the step of:

regulating the exhaled air flow.

24. The method of any of claims 18 to 21, further comprising the step of:

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

25. The method of any of claims 18 to 24, wherein the substance supply unit includes a dosing unit for supplying at least one substance.

26. The method of claim 25, wherein the dosing unit comprises a nebulizer for supplying an aerosol.

27. The method of claim 25, wherein the dosing unit comprises an aerosol canister for supplying an aerosol.

28. The method of claim 25, wherein the dosing unit comprises a delivery pump unit for supplying an aerosol.

29. The method of claim 28, wherein the dosing unit comprises a liquid pump unit for supplying a liquid aerosol.

30. The method of claim 28, wherein the dosing unit comprises a powder pump unit for supplying a powder aerosol.

31. The method of claim 25, wherein the dosing unit comprises a powder delivery unit for delivering a powder aerosol.

32. The method of any of claims 18 to 31, wherein the delivery device further includes an outlet unit comprising a nosepiece for fitting in the other, outlet nostril of the subject, and an exit flow analyzer for analyzing the concentration of at least one component in an air flow exiting the outlet nostril.

33. The method of claim 32, further comprising the step of:

controlling the substance supply unit in response to a concentration as detected by the exit flow analyzer.

34. The method of claim 33, wherein the step of controlling the substance supply unit in response to a concentration as detected by the exit flow analyzer comprises the step of:

actuating the substance supply unit to supply further of the at least one substance in response to detection of a concentration of the at least one substance by the exit flow analyzer.

35. The method of claim 33 or 34, wherein the step of controlling the substance supply unit in response to a concentration as detected by the exit flow analyzer comprises the step of:

actuating the substance supply unit to supply a reference substance; and

controlling the substance supply unit in response to a concentration of the reference substance as detected by the exit flow analyzer.

36. A nasal resistance measurement device for determining a flow resistance of a nasal airway of a subject, comprising:

a nosepiece for fitting to a nostril of a subject;

a mouthpiece through which the subject in use exhales; and

one or both of a pressure detector for detecting a pressure and a flow meter for detecting a flow rate of a gas flow delivered through the nosepiece.

37. The measurement device of claim 36, comprising:

a pressure detector for detecting a pressure of a gas flow delivered through the nosepiece.

38. The measurement device of claim 36, comprising:

a flow meter for detecting a flow rate of a gas flow delivered through the nosepiece.

39. The measurement device of claim 36, comprising:

a pressure detector for detecting a pressure of a gas flow delivered through the nosepiece; and

a flow meter for detecting a flow rate of a gas flow delivered through the nosepiece.

40. The measurement device of any of claims 36 to 39, wherein the pressure detector comprises a mechanical pressure detector.

41. The measurement device of any of claims 36 to 39, wherein the pressure detector comprises an electronic pressure detector.

42. The measurement device of any of claims 36 to 41, wherein the flow meter comprises a mechanical flow meter.

43. The measurement device of any of claims 36 to 41, wherein the flow meter comprises an electronic flow meter.

44. The measurement device of any of claims 36 to 43, wherein the nosepiece comprises a frusto-conical nosepiece for insertion into a nostril.

45. The measurement device of any of claims 36 to 43, wherein the nosepiece comprises a sealing ring for fitting externally to a nostril.

46. The measurement device of any of claims 36 to 45, further comprising:

a determination unit for determining a nasal resistance from one or both of a pressure and flow rate as detected.

47. The measurement device of any of claims 36 to 46, further comprising:

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

48. The measurement device of claim 47, further comprising:

a flow regulator for regulating the exhaled air flow.

49. The measurement device of any of claims 36 to 46, 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 a subject, is in use delivered, and a gas supply unit for supplying a gas flow to the flow channel.

50. A method of determining a flow resistance of a nasal airway of a subject, comprising the steps of:

providing a measurement device comprising a nosepiece for fitting to a nostril of a subject, and a mouthpiece through which the subject exhales; and

detecting one or both of a pressure and a flow rate of a gas flow delivered through the nosepiece.

51. The method of claim 50, wherein the step of detecting one or both of a pressure and a flow rate of a gas flow delivered through the nosepiece comprises the step of:

detecting a pressure of a gas flow delivered through the nosepiece.

52. The method of claim 50, wherein the step of detecting one or both of a pressure and a flow rate of a gas flow delivered through the nosepiece comprises the step of:

detecting a flow rate of a gas flow delivered through the nosepiece.

53. The method of claim 50, wherein the step of detecting one or both of a pressure and a flow rate of a gas flow delivered through the nosepiece comprises the step of:

detecting a pressure and a flow rate of a gas flow delivered through the nosepiece.

54. The method of any of claims 50 to 53, wherein the nosepiece comprises a frusto-conical nosepiece for insertion into a nostril.

55. The method of any of claims 50 to 53, wherein the nosepiece comprises a sealing ring for fitting externally to a nostril.

56. The method of any of claims 50 to 55, further comprising the step of:

determining a nasal resistance from one or both of a pressure and flow rate as detected.

57. The method of any of claims 50 to 56, wherein the measurement 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.

58. The method of claim 57, further comprising the step of:

regulating a flow rate of an exhaled air flow.

59. The method of any of claims 50 to 55, further comprising the step of:

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

60. A nasal delivery device for delivering at least one substance to a nasal cavity of a subject substantially as hereinbefore described with reference to any of FIGS. 2, 3 or 4 of the accompanying drawings.

61. A method of delivering at least one substance to a nasal cavity of a subject substantially as hereinbefore described with reference to any of FIGS. 2, 3 or 4 of the accompanying drawings.

62. A nasal resistance measurement device for determining a flow resistance of a nasal airway of a subject substantially as hereinbefore described with reference to any of FIGS. 5, 7 or 8, optionally when taken in conjunction with FIG. 6, of the accompanying drawings.

63. A method of determining a flow resistance of a nasal airway of a subject substantially as hereinbefore described with reference to any of FIGS. 5, 7 or 8, optionally when taken in conjunction with FIG. 6, of the accompanying drawings.