Nasal devices

• US 7,740,014 B2
• Filed: 02/26/2002
• Issued: 06/22/2010
• Est. Priority Date: 02/26/2001
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Douglas; Steven O
• Assistant Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US10/469,103
• Publication Number:
  US 20040112378A1
• Time in Patent Office: 3,038 Days
• Field of Search: 128/206.11, 128/203.18, 128/203.22, 128/207.18, 128/204.12
• 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 a substance to a nasal cavity of a subject, the delivery device including: a nosepiece for fitting to a nostril of a subject; a substance supply unit for supplying a substance for delivery through the nosepiece; and a delivery prevention mechanism for preventing delivery of a substance through the nosepiece until the nosepiece is properly fitted to the nostril of the subject.

Claims

1. A nasal delivery device for delivering a substance to a nasal cavity of a subject, including:

a nosepiece for insertion into a single nostril of a subject;

a substance supply unit operable to supply a substance for delivery through the nosepiece; and

a delivery prevention mechanism operable by insertion of a nosepiece into the nostril of the subject and being configured to prevent operation of the substance supply unit until the nosepiece achieves a sealing fit with the nostril of the subject.

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

first and second members movable relative to one another between first and second configurations, and a biasing element for normally biasing the first and second members to one of the first and second configurations, whereby a predetermined biasing force provided by the biasing element has to be overcome in properly fitting the nosepiece to the single nostril of the subject.

3. The delivery device of claim 1, further including:

a flow path fluidly connected to the nosepiece through which a gas flow is delivered to the nosepiece.

4. The delivery device of claim 3, wherein the delivery prevention mechanism comprises a blocking element which is movable to block the flow path, and thereby prevent the delivery of the gas flow to the nosepiece, until the nosepiece is properly fitted to the nostril of the subject.

5. The delivery device of claim 4, further including:

first and second members movable relative to one another between first and second configurations, one of the members defining at least a part of the flow path, and the other member including the blocking element and blocking the flow path in one of the first and second configurations.

6. The delivery device of claim 5, further including:

a biasing element for normally biasing the first and second members to the one of the first and second configurations, whereby a predetermined biasing force provided by the biasing element has to be overcome in properly fitting the nosepiece to the nostril of the subject.

7. The delivery device of claim 3, wherein the delivery prevention mechanism comprises a vent which is openable to vent the gas flow from the flow path, and thereby prevent the delivery of the gas flow to the nosepiece, until the nosepiece is properly fitted to the nostril of the subject.

8. The delivery device of claim 3, wherein the delivery prevention mechanism is provided by the nosepiece which comprises an outer member for engagement with a nostril of the subject, at least a part of which outer member is flexible, and an inner member configured such as to support the at least flexible part of the outer member when the nosepiece is properly inserted into the nostril of the subject.

9. The delivery device of claim 8, wherein the at least part flexible member is a resilient member.

10. The delivery device of claim 8, wherein the outer member is a flexible tubular member.

11. The delivery device of claim 8, wherein the inner member comprises a tubular member.

12. The delivery device of claim 3, wherein the delivery prevention mechanism is provided by the nosepiece which is expandable on generation of a pressure in the flow path to seal with a nostril of the subject.

13. The delivery device of claim 12, wherein the nosepiece includes an outer surface for engagement with a nostril of the subject, at least a part of which is flexible, and an inner surface in fluid communication with the flow path, at least a part of which is flexible, such that application of a pressure to the inner surface causes deflection of the outer surface such as to sealingly engage the nostril of the subject.

14. The delivery device of claim 3, wherein the delivery prevention mechanism is configured to prevent delivery of a substance through the nosepiece until a predetermined application force has been applied to the delivery device in fitting the nosepiece to a nostril of the subject.

15. The delivery device of claim 14, further including:

a biasing element for transferring the application force to the nosepiece.

16. The delivery device of claim 3, further including:

a mouthpiece through which the subject in use exhales; and

wherein the flow path fluidly connects the nosepiece and the mouthpiece, whereby exhaled air from an exhalation breath is delivered through the flow path.

17. The delivery device of claim 3, further including:

a gas supply unit for supplying a gas flow; and

wherein the flow path fluidly connects the nosepiece and the gas supply unit, whereby a gas flow from the gas supply unit is delivered through the flow path.

18. The delivery device of claim 17, further including:

a mouthpiece through which the subject in use exhales; and

wherein the gas supply unit is an exhalation breath-actuated unit and fluidly connected to the mouthpiece such as to be actuated on exhalation by the subject through the same.

19. The delivery device of claim 1, wherein the substance supply unit is actuatable to supply a substance, and the delivery prevention mechanism comprises an actuation prevention mechanism for preventing actuation of the substance supply unit until the nosepiece is properly fitted to the nostril of the subject.

20. The delivery device of claim 19, further including:

an exhalation breath-actuated trigger mechanism for actuating the substance supply unit.

21. The delivery device of claim 20, wherein the trigger mechanism is configured such as to prevent actuation thereof until a predetermined application force has been applied to the delivery device in fitting the nosepiece to a nostril of the subject.

22. The delivery device of claim 21, further including:

a biasing element for transferring the application force to the nosepiece.

23. The delivery device of claim 20, wherein the trigger mechanism is configured to actuate the substance supply unit at a predetermined pressure.

24. The delivery device of claim 20, wherein the trigger mechanism is configured to actuate the substance supply unit at a predetermined flow rate.

25. The delivery device of claim 20, wherein the trigger mechanism is configured to actuate the substance supply unit at one or both of a predetermined pressure and a predetermined flow rate.

26. The delivery device of claim 1, wherein the substance supply unit includes a dosing unit for supplying at least one substance.

27. The delivery device of claim 26, wherein the dosing unit comprises a nebulizer for supplying an aerosol.

28. The delivery device of claim 26, wherein the dosing unit comprises an aerosol canister for supplying an aerosol.

29. The delivery device of claim 26, wherein the dosing unit comprises a delivery pump unit for supplying an aerosol.

30. The delivery device of claim 29, wherein the dosing unit comprises a liquid pump unit for supplying a liquid aerosol.

31. The delivery device of claim 29, wherein the dosing unit comprises a powder pump unit for supplying a powder aerosol.

32. The delivery device of claim 26, wherein the dosing unit comprises a powder delivery unit for delivering a powder aerosol.

33. A nasal delivery device for delivering a substance to a nasal cavity of a subject, including:

a nosepiece for insertion into a nostril of a subject;

a substance supply unit operable to supply a substance for delivery through the noseplece;

a flow path fluidly connected to the nosepiece through which a gas flow is delivered to the nosepiece; and

a delivery prevention mechanism operable by insertion of the nosepiece into the nostril of the subject and being configured to prevent operation of the substance supply unit until the nosepiece achieves a sealing fit with the nostril of the subject, wherein the delivery prevention mechanism comprises first and second members movable relative to one another between first and second configurations, one of the members defining at least a part of the flow path and defining at least in part a vent which is openable to vent the gas flow from the flow path and thereby prevent the delivery of the gas flow to the nosepiece until the nosepiece achieves a sealing fit with the nostril of the subject, and the other member being configured such that the vent is open in one of the first and second configurations and closed in the other of the first and second configurations.

34. The delivery device of claim 33, further including:

a biasing element for normally biasing the first and second members to the one of the first and second configurations, whereby a predetermined biasing force provided by the biasing element has to be overcome in properly fitting the nosepiece to the nostril of the subject.

35. The delivery device of claim 33, wherein the other member comprises the nosepiece.

36. A nasal delivery device for delivering a substance to a nasal cavity of a subject, including:

a nosepiece for insertion into a nostril of a subject;

a substance supply unit operable to supply a substance for delivery through the nosepiece;

a flow path fluidly connected to the nosepiece through which a gas flow is delivered to the nosepiece; and

a delivery prevention mechanism operable by insertion of the nosepiece into the nostril of the subject and being configured to prevent operation of the substance supply unit until the nosepiece achieves a sealing fit with the nostril of the subject, wherein the delivery prevention mechanism is provided by the nosepiece which includes at least one aperture in the outer surface thereof, the at least one aperture being fluidly connected to the flow path and configured such as to be closed by the nostril when the nosepiece is properly inserted in the nostril of the subject, the substance supply unit being inoperable when the at least one aperture is open to atmosphere and operable when the at least one aperture is closed by the nostril of the subject.

37. The delivery device of claim 36, wherein the nosepiece includes a plurality of apertures disposed about the outer periphery thereof.

38. A nasal delivery device for delivering a substance to a nasal cavity of a subject, including:

a nosepiece for fitting to a single nostril of a subject through which a gas flow from an exhalation breath or a gas supply unit is in use delivered; and

a substance supply unit for supplying a substance to the nosepiece for delivery to the nasal cavity of the subject, the substance supply unit including a trigger mechanism for actuating the substance supply unit on detection of the gas flow achieving or exceeding both a predetermined pressure and a predetermined flow rate.

39. A nasal delivery device for delivering a substance to a nasal cavity of a subject, including:

a mouthpiece through which the subject in use exhales to cause closure of the oropharyngeal velum of the subiect;

a nosepiece for insertion into a nostril of a subject; and

a flow path fluidly connected to the nosepiece;

wherein the nosepiece is expandable and configured such as to expand on generation of a pressure in the flow path, thereby sealing with the nostril of the subject and providing for expansion of the nasal cavity of the subject, wherein the flow path fluidly connects the nosepiece and the mouthpiece, whereby exhaled air from an exhalation breath is delivered through the flow path.

40. A nasal delivery device for delivering a substance to a nasal cavity of a subject, including:

a nosepiece for insertion into a single nostril of a subject;

a substance supply unit operable to supply a substance for delivery through the nosepiece; and

a delivery prevention mechanism operable by insertion of the nosepiece into the single nostril of the subject and being configured to prevent operation of the substance supply unit until the nosepiece achieves a sealing fit with the single nostril of the subject.