Delivery device and method

• US 8,171,929 B2
• Filed: 02/14/2007
• Issued: 05/08/2012
• Est. Priority Date: 02/14/2006
• Status: Active Grant

• Current Assignee: OptiNose AS (OptiNose, Inc.), Waterway Plastics Incorporated
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle, Boden, Keith McMurray
• Primary Examiner(s): Crow, Stephen
• Application Number:
  US12/279,291
• Publication Number:
  US 20100051022A1
• Time in Patent Office: 1,910 Days
• Field of Search: 128/200.13, 128/200.14, 128/200.21, 128/200.22, 128/200.23, 128/203.12, 128/203.13, 128/203.15, 128/203.16, 128/203.18, 128/203.22, 128/203.23, 128/203.24, 128/203.26, 128/203.27
• US Class Current: 128/200.23
• CPC Class Codes: A61M 11/08 Pocket atomisers of the injector type aerosol cans A61M15/009
• 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 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 15/0095 Preventing manual activation in absence of inhalation
• 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 2016/0042 in the expiratory circuit
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/75 with filters

Abstract

A delivery device for and method of delivering substance to a nasal airway of a subject, the delivery device comprising: at least one nosepiece unit (21) for insertion into one nasal cavity of a subject and comprising a nosepiece (25) for fitting to the respective nostril of the subject; and at least one delivery unit (23) which is operative to deliver a substance through the at least one nosepiece unit into the one nasal cavity of the subject, wherein the at least one delivery unit includes a substance supply unit (27) for delivering a substance and an actuation unit (29) which is operable to actuate the substance supply unit, either automatically or manually, in response to nasal exhalation or at least attempted nasal exhalation by the subject.

Claims

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

at least one nosepiece unit for insertion into one nasal cavity of a subject and comprising a nosepiece for fitting to the respective nostril of the subject; and

at least one delivery unit which is operative to deliver a substance through the at least one nosepiece unit into the one nasal cavity of the subject, wherein the at least one delivery unit includes a substance supply unit for delivering a substance and an actuation unit which is operable to actuate the substance supply unit in response to nasal exhalation or at least attempted nasal exhalation by the subject.

2. The delivery device of claim 1, wherein the substance supply unit is configured to deliver an aerosol spray.

3. The delivery device of claim 2, wherein the aerosol spray is a liquid aerosol.

4. The delivery device of claim 2, wherein the aerosol spray is a powder aerosol.

5. The delivery device of claim 1, wherein the substance supply unit is configured to deliver a liquid jet.

6. The delivery device of claim 1, wherein the substance supply unit is configured to deliver a powder jet.

7. The delivery device of claim 1, wherein the nosepiece is configured to provide a fluid-tight seal with the one nostril of the subject.

8. The delivery device of claim 1, wherein the actuation unit includes a pressure sensor for sensing the pressure at the nosepiece and actuating the substance supply unit in response to a predeterminable pressure.

9. The delivery device of claim 1, wherein the actuation unit includes a flow sensor for sensing the flow rate at the nosepiece and actuating the substance supply unit in response to a predeterminable flow rate.

10. The delivery device of claim 1, wherein the actuation unit includes a pressure sensor for sensing the pressure at the nosepiece and is operative such as to allow for manual actuation of the substance supply unit only in response to the pressure sensor sensing a predeterminable pressure.

11. The delivery device of claim 1, wherein the actuation unit includes a flow sensor for sensing the flow rate at the nosepiece and is operative such as to allow for manual actuation of the substance supply unit only in response to the flow sensor sensing a predeterminable flow rate.

12. The delivery device of claim 1, wherein the substance supply unit is configured to deliver substance with sufficient force as to be directed to a posterior region of the one nasal cavity, and be entrained by an exhalation air flow through the other nasal cavity.

13. The delivery device of claim 1, wherein the substance supply unit is configured to deliver substance into the one nasal cavity, and be drawn from the one nasal cavity by an exhalation air flow through the other nasal cavity.

14. The delivery device of claim 1, comprising:

first and second nosepiece units for fitting to the respective nostrils of the subject, wherein the substance supply unit is in fluid communication with the first nosepiece unit such that substance is in use delivered into the one nasal cavity and the actuation unit is in fluid communication with the second, outlet nosepiece unit.

15. The delivery device of claim 14, wherein the delivery unit includes a filter unit which is in fluid communication with the second, outlet nosepiece unit.

16. The delivery device of claim 1, wherein the actuation unit includes a release mechanism which is manually operable to unlock the actuation unit, such as to render the actuation unit operative in response to nasal exhalation or at least attempted nasal exhalation by the subject.

17. The delivery device of claim 16, wherein the release mechanism comprises a movable member which is manually operable between a first, locking configuration in which the actuation unit is locked to prevent operation in response to nasal exhalation or at least attempted nasal exhalation by the subject, and a second, unlocked configuration in which the actuation unit is unlocked to allow for operation in response to nasal exhalation or at least attempted exhalation by the subject.

18. The delivery device of claim 17, wherein the movable member in use extends into the other nasal cavity, such that the other nostril of the subject is closed when the movable member is in the unlocked configuration.

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

providing a delivery device comprising a nosepiece unit including a nosepiece for fitting to one nasal cavity of a subject, and a delivery unit including a substance supply unit for delivering substance and an actuation unit which is operable to actuate the substance supply unit in response to nasal exhalation or at least attempted nasal exhalation by the subject;

fitting the nosepiece unit to one nasal cavity of a subject;

the subject exhaling nasally or at least attempting to exhale nasally; and

actuating the substance supply unit to deliver substance to the one nasal cavity in response to nasal exhalation or at least attempted nasal exhalation.

20. The method of claim 19, wherein the substance supply unit is delivered as an aerosol spray.

21. The method of claim 20, wherein the aerosol spray is a liquid aerosol.

22. The method of claim 20, wherein the aerosol spray is a powder aerosol.

23. The method of claim 19, wherein the substance is delivered as a liquid jet.

24. The method of claim 19, wherein the substance is delivered as a powder jet.

25. The method of claim 19, wherein the actuation unit includes a pressure sensor for sensing the pressure at the nosepiece and is operative to actuate the substance supply unit in response to the pressure sensor sensing a predeterminable pressure.

26. The method of claim 19, wherein the actuation unit includes a flow sensor for sensing the flow rate at the nosepiece and is operative to actuate the substance supply unit in response to the flow sensor sensing a predeterminable flow rate.

27. The method of claim 19, wherein the actuation unit includes a pressure sensor for sensing the pressure at the nosepiece and is configured to allow for manual actuation of the substance supply unit only in response to the pressure sensor sensing a predeterminable pressure, and the actuating step comprises the step of:

manually actuating the substance supply unit to deliver substance to the one nasal cavity.

28. The method of claim 19, wherein the actuation unit includes a flow sensor for sensing the flow rate at the nosepiece and is configured to allow for manual actuation of the substance supply unit only in response to the flow sensor sensing a predeterminable flow rate, and the actuating step comprises the step of:

manually actuating the substance supply unit to deliver substance to the one nasal cavity.

29. The method of claim 19, wherein the nosepiece unit is configured to close the one nostril of the subject.

30. The method of claim 19, wherein the nosepiece unit is configured to allow an air flow from the one nostril of the subject on nasal exhalation by the subject.

31. The method of claim 19, wherein the substance supply unit is configured to deliver substance with sufficient force as to be directed to a posterior region of the one nasal cavity, and an exhalation air flow is generated through the other nasal cavity which acts to entrain the delivered substance.

32. The method of claim 19, wherein the substance supply unit is configured to deliver substance into the one nasal cavity, and an exhalation air flow is generated through the other nasal cavity which acts to draw the delivered substance from the one nasal cavity.

33. The method of claim 19, wherein the delivery device comprises first and second nosepiece units for fitting to the respective nostrils of the subject, wherein the substance supply unit is in fluid communication with the first nosepiece unit such that substance is delivered into the one nasal cavity and the actuation unit is in fluid communication with the second, outlet nosepiece unit.

34. The method of claim 33, wherein the delivery unit includes a filter unit which is in fluid communication with the second, outlet nosepiece unit and acts to trap any substance as delivered from the other nostril of the subject.

35. The method of claim 19, wherein the actuation unit includes a release mechanism which is manually operable to unlock the actuation unit, such as to render the actuation unit operative in response to nasal exhalation or at least attempted nasal exhalation by the subject.

36. The method of claim 35, wherein the release mechanism comprises a movable member which is manually operable between a first, locking configuration in which the actuation unit is locked to prevent operation in response to nasal exhalation or at least attempted nasal exhalation by the subject, and a second, unlocked configuration in which the actuation unit is unlocked to allow for operation in response to nasal exhalation or at least attempted nasal exhalation by the subject.

37. The method of claim 36, wherein the movable member extends into the other nasal cavity, such that movement of the movable member to the unlocked configuration requires closure of the other nostril of the subject.