NASAL DELIVERY DEVICES

• US 20150013670A1
• Filed: 02/25/2013
• Published: 01/15/2015
• Est. Priority Date: 02/24/2012
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle, Leclerc, Michael, Siwinski, Shane, Gordon, Joseph, Mahmoud, Rany A., Fisk, Justin
• Granted Patent: US 10,300,229 B2
• Time in Patent Office: Days
• US Class Current: 128/200.21
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2210/0618 Nose

Abstract

A nasal delivery device for and method of delivering substance to a nasal airway of a subject, the delivery device comprising: a nosepiece (117) for fitting to a nasal cavity of a subject; a mouthpiece (119) into which the subject in use exhales; a delivery unit, which comprises an actuation part which is manually displaceable to actuate the delivery unit to deliver substance from the nosepiece; and a valve assembly (127) which is fluidly connected to the nosepiece and the mouthpiece, wherein the valve assembly comprises a body element (128) and a valve element (131) which is movably disposed to the body element between closed and open configurations by manual displacement of the actuation part of the delivery unit to provide for an air flow through the nosepiece simultaneously with delivery of substance.

Claims

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

a nosepiece for fitting to a nasal cavity of a subject;

a mouthpiece into which the subject in use exhales;

a delivery unit, which comprises an actuation part which is manually displaceable to actuate the delivery unit to deliver substance from the nosepiece; and

a valve assembly which is fluidly connected to the nosepiece and the mouthpiece, wherein the valve assembly comprises a body element and a valve element which is movably disposed to the body element between closed and open configurations by manual displacement of the actuation part of the delivery unit to provide for an air flow through the nosepiece simultaneously with delivery of substance.

2. The delivery device of claim 1, wherein the body element includes a pivot, and the valve element comprises an arm, one end of which is pivoted to the pivot of the body element between the closed and open configurations.

3. The delivery device of claim 2, wherein the arm is at least in part resilient.

4. The delivery device of claim 2 or 3, wherein the body element includes a sliding surface, against which the other end of the arm is slideable.

5. The delivery device of any of claims 2 to 4, wherein the arm comprises a first arm section which is configured such that, when the valve element is in the closed configuration, the lower arm section is engageable by displacement of the actuation part of the delivery unit.

6. The delivery device of claim 5, wherein the arm is biased inwardly relative to the longitudinal axis of delivery device.

7. The delivery device of claim 5 or 6, wherein the arm is inclined inwardly relative to the longitudinal axis of the delivery device when the valve element is in the closed configuration.

8. The delivery device of any of claims 5 to 7, wherein the first arm section comprises a substantially rigid section.

9. The delivery device of any of claims 5 to 8, wherein the arm comprises a second arm section which engages the sliding surface of the body element.

10. The delivery device of claim 9, wherein the first and second arm sections enclose an obtuse angle.

11. The delivery device of claim 9 or 10, wherein the second arm section is a resilient section which acts to bias the valve element to the closed configuration.

12. The delivery device of any of claims 1 to 11, wherein the body element includes a valve seat which defines a valve opening, and the valve element comprises a seal which acts to close the valve opening when the valve element is in the closed position.

13. The delivery device of claim 12, wherein the seal comprises a resilient element.

14. The delivery device of claim 12 or 13, wherein the valve element comprises a support which supports a central region of the seal, such as to allow a peripheral region of the seal to engage the valve seat and the central region to be deflected relative to the peripheral region, thereby allowing for sudden release of the seal.

15. The delivery device of claim 12 or 13, wherein the valve element comprises a support which extends substantially across a width of the valve opening.

16. The delivery device of claim 12 or 13, wherein the seal is separate to and not supported by the arm, and displaced by movement of the arm.

17. The delivery device of claim 16, wherein the seal comprises a resilient element, and the arm comprises an engagement element which engages the seal with movement of the arm.

18. The delivery device of claim 17, wherein the seal comprises a resilient flap.

19. The delivery device of any of claims 1 to 18, wherein the valve assembly, on opening of the valve element, provides for a burst of air flow, having a first, initial burst phase followed by a second, extended burst phase, wherein the peak flow rate in the first burst phase has a higher flow rate than the average flow rate in the second burst phase, and the second burst phase is of substantially greater duration than the first burst phase.

20. The delivery device of claim 19, wherein the peak flow rate in the first burst phase is at least 10% greater than that of the average flow rate of the second burst phase in a period corresponding to ten times the duration of the period in which substance is delivered from the delivery unit.

21. The delivery device of claim 20, wherein the peak flow rate in the first burst phase is at least 15% greater than that of the average flow rate of the second burst phase in a period corresponding to ten times the duration of the period in which substance is delivered from the delivery unit.

22. The delivery device of claim 21, wherein the peak flow rate in the first burst phase is at least 20% greater than that of the average flow rate of the second burst phase in a period corresponding to ten times the duration of the period in which substance is delivered from the delivery unit.

23. The delivery device of any of claims 1 to 22, further comprising:

a housing which includes an aperture through which the actuation part of the delivery unit extends.

24. The delivery device of claim 23, wherein the housing further comprises a sealing member which slideably receives the actuation part to prevent air flow from the aperture in the housing.

25. The delivery device of any of claims 1 to 24, wherein the valve assembly provides for a pre-actuation efficiency of less than 5 L/min when a user is developing an exhalation pressure of 3 kPa.

26. The delivery device of claim 25, wherein the valve assembly provides for a pre-actuation efficiency of less than 5 L/min when a user is developing an exhalation pressure of 10 kPa.

27. The delivery device of claim 25, wherein the valve assembly provides for a pre-actuation efficiency of less than 1 L/min when a user is developing an exhalation pressure of 3 kPa.

28. The delivery device of claim 25, wherein the valve assembly provides for a pre-actuation efficiency of less than 1 L/min when a user is developing an exhalation pressure of 10 kPa.

29. The delivery device of claim 25, wherein the valve assembly provides for a pre-actuation efficiency of 0 L/min when a user is developing an exhalation pressure of 3 kPa.

30. The delivery device of claim 25, wherein the valve assembly provides for a pre-actuation efficiency of 0 L/min when a user is developing an exhalation pressure of 10 kPa.

31. The delivery device of any of claims 1 to 30, wherein the delivery device is configured to provide at least 80% of the air as delivered into the mouthpiece to the nosepiece when delivered at a flow rate of 50 L/min and an exhalation pressure of 3 kPa.

32. The delivery device of claim 31, wherein the delivery device is configured to provide at least 88% of the air as delivered into the mouthpiece to the nosepiece when delivered at a flow rate of 50 L/min and an exhalation pressure of 3 kPa.

33. The delivery device of claim 32, wherein the delivery device is configured to provide at least 90% of the air as delivered into the mouthpiece to the nosepiece when delivered at a flow rate of 50 L/min and an exhalation pressure of 3 kPa.

34. The delivery device of any of claims 1 to 33, wherein the delivery unit provides for delivery of substance subsequent to opening of the valve element.

35. The delivery device of claim 34, wherein the delivery unit provides for delivery of substance in a period less than about 250 ms from opening of the sealing member.

36. The delivery device of claim 35, wherein the delivery unit provides for delivery of substance in a period less than about 200 ms from opening of the sealing member.

37. The delivery device of claim 35, wherein the delivery unit provides for delivery of substance in a period less than about 150 ms from opening of the sealing member.

38. The delivery device of claim 35, wherein the delivery unit provides for delivery of substance in a period less than about 150 ms from opening of the sealing member.

39. The delivery device of claim 35, wherein the delivery unit provides for delivery of substance in a period less than about 100 ms from opening of the sealing member.

40. The delivery device of any of claims 34 to 39, wherein the delivery unit provides for delivery of substance commencing less than about 150 ms subsequent to opening of the valve element.

41. The delivery device of claim 40, wherein the delivery unit provides for delivery of substance commencing less than about 100 ms subsequent to opening of the valve element.

42. The delivery device of claim 40, wherein the delivery unit provides for delivery of substance commencing less than about 50 ms subsequent to opening of the valve element.

43. The delivery device of claim 40, wherein the delivery unit provides for delivery of substance commencing less than about 25 ms subsequent to opening of the valve element.

44. The delivery device of claim 40, wherein the delivery unit provides for delivery of substance commencing less than about 15 ms subsequent to opening of the valve element.

45. The delivery device of any of claims 1 to 44, wherein the delivery unit comprises an outlet unit from which substance is delivered through the nosepiece and a substance-supply unit which is actuatable to deliver substance to the outlet unit.

46. The delivery device of claim 45, wherein the outlet unit comprises a spray nozzle.

47. The delivery device of claim 45 or 46, wherein the actuation part of the delivery unit comprises a substance-containing chamber of the substance-supply unit.

48. The delivery device of any of claims 1 to 47, wherein the substance-supply unit comprises a mechanical delivery pump which is actuatable by depression of the substance-containing chamber.

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

fitting a nosepiece to a nasal cavity of a subject;

the subject exhaling into a mouthpiece;

providing a delivery device which comprises;

a delivery unit, which comprises an actuation part which is manually displaceable to actuate the delivery unit to deliver substance from the nosepiece; and

a valve assembly which is fluidly connected to the nosepiece and the mouthpiece, wherein the valve assembly comprises a body element and a valve element which is movably disposed to the body element between closed and open configurations by manual displacement of the actuation part of the delivery unit; and

manually displacing the actuation part of the delivery unit to move the valve element of the valve assembly relative to the body element of the valve assembly between closed and open configurations and provide an air flow through the nosepiece simultaneously with delivery of substance.