Nasal devices

• US 7,543,581 B2
• Filed: 02/26/2002
• Issued: 06/09/2009
• Est. Priority Date: 02/26/2001
• Status: Expired due to Fees

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US10/469,105
• Publication Number:
  US 20040149289A1
• Time in Patent Office: 2,660 Days
• Field of Search: 128/203.12, 128/200.18, 128/200.23, 128/200.14, 128/203.15, 128/203.19, 128/203.23, 222/36, 222/38, 222/162
• US Class Current: 128/200.14
• 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. The nasal delivery device and method 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 supply 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 to close the oropharyngeal velum;

a breath analyzer configured to detect the concentration of at least one component in air exhaled during exhalation through the mouthpiece; and

a substance supply unit for supplying at least one substance into the nasal cavity through the nosepiece during exhalation through the mouthpiece, the substance supply unit including a control unit configured to control 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 lease one substance at a predeterminable pressure.

3. The delivery device of claim 1, wherein the control unit is configured to actuate the substance supply unity 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 claim 1, 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 claim 1, 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 claim 1, 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.

36. The delivery device of claim 1, wherein the substance supply unit is operative to deliver a metered dose of the at least one substance, and the control unit is operative to meter delivery of the at least one substance in response to the detected concentration.

16. 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 to close the oropharyngeal velum;

a breath analyzer configured to detect the concentration of at least one component in air exhaled during exhalation through the mouthpiece;

a substance supply unit for supplying at least one substance into the nasal cavity through the nosepiece during exhalation through the mouthpiece, the substance supply unit including a control unit configured to control the same to control supply of the at least one substance in response to the detected concentration; and

an outlet unit comprising;

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

an exit flow analyzer configured to analyze 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 subject, a mouthpiece through which the subject exhales, a breath analyzer configured to analyze 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 claim 18, 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 claim 18, 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 claim 18, 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.

37. The method of claim 18, wherein the substance supply unit delivers a metered dose of the at least one substance, and the step of controlling supply of the at least one substance comprises metering delivery of the at least one substance in response to the detected concentration.

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

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 configuration to analyze 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 breathe analyzer;

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 configured to analyze 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, 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.

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

a first nosepiece for fitting to one, inlet nostril of a subject;

a second nosepiece for fitting to the other, outlet nostril of the subject;

a mouthpiece through which the subject in use exhales to close the oropharyngeal velum;

an exit flow analyzer configured to analyze the concentration of at least one component in an air flow exiting the outlet nostril; and

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

39. The delivery device of claim 38, 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.

40. 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 first nosepiece for fitting to one, inlet nostril of a subject, a mouthpiece through which the subject exhales, and a substance supply unit for supplying at least one substance, and an outlet unit comprising a second nosepiece for fitting to the other, outlet nostril of the subject, and an exit flow analyzer configured to analyze the concentration of at least one component in an air flow exiting the outlet nostril;

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 exit flow analyzer.

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

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

42. The method of claim 41, 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.

43. The method of claim 41, 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.