Nasal delivery method

• US 8,327,844 B2
• Filed: 03/30/2004
• Issued: 12/11/2012
• Est. Priority Date: 03/03/1999
• Status: Expired due to Term

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US10/813,326
• Publication Number:
  US 20040182388A1
• Time in Patent Office: 3,178 Days
• Field of Search: 128/200.13, 128/203.23, 128/204.24, 128/207.18, 128/203.22, 128/200.23, 128/203.12, 128/203.15, 128/203.18
• US Class Current: 128/203.22
• 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 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• 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 16/0866 Passive resistors therefor
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2205/59 Aesthetic features, e.g. distraction means to prevent fears of child patients
• CPC Class Codes: A61M 2206/10 Flow characteristics
• CPC Class Codes: A61M 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 : Mouth
• CPC Class Codes: A61M 3/0202 : with electronic control means or interfaces
• CPC Class Codes: A61M 3/0233 : characterised by liquid supply means, e.g. from pressurised reservoirs
• CPC Class Codes: A61M 3/0279 : Cannula; Nozzles; Tips; their connection means

Abstract

A delivery device (20, 22) for and a method of delivering a substance to the nasal airway (1) of a subject, in particular the posterior region of the nasal airway, the delivery device comprising: a closure unit for causing the closure of the oropharyngeal velum of the subject; and a delivery unit for delivering a gas flow entraining a substance to one of the nostrils of the subject at such a driving pressure as to flow around the posterior margin of the nasal septum and out of the other nostril of the subject, wherein the delivery unit comprises a nosepiece (30, 40, 58, 82, 102, 132) which includes an outlet through which the gas flow is in use delivered to the one nostril and a sealing member for sealing the one nostril to the outlet such as in use to prevent the escape of the gas flow through the one nostril.

Claims

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

sealing one of the nostrils of a subject to an outlet of a delivery unit such as to prevent the escape of a gas flow through the one nostril;

closing the oropharyngeal velum of the subject; and

delivering a gas flow entraining a substance through the outlet at such a driving pressure as to flow around the posterior margin of the-nasal septum and out of the other nostril of the subject, wherein the gas flow entraining a substance is provided by actuation of a supply unit device.

2. The method of claim 1, wherein the gas flow entraining a substance is separate to an exhalation flow of the subject.

3. The method of claim 2, wherein the supply unit is actuated by the exhalation flow of the subject.

4. The method of claim 1, further comprising the step of controlling the flow rate of the gas flow delivered by the supply unit device.

19. The method of claim 1, 6, 14 or 15, wherein the gas flow entraining a substance is provided by an exhalation flow of the subject, the substance is a dry powder contained in a dispersion chamber prior to being exposed and entrained in the exhalation flow, and there is a moisture-absorbing element disposed upstream of the dispersion chamber.

20. The method of claim 19, wherein the moisture-absorbing element is a desiccant.

21. The method of claim 19, wherein the moisture-absorbing element is a filter.

22. The method of claim 21, wherein the filter acts as a flow resistor to the exhalation flow.

25. The method of claim 1, 6, 14, 15 or 23, wherein the gas flow entraining a substance is provided by an exhalation flow of the subject, the substance is a dry powder, and the surface properties of the powder have been modified to prevent agglomeration of the powder when it comes into contact with the exhalation flow.

26. The method of claim 1, 5, 6, 14, 15 or 23, wherein velum closure is provided by exhalation by the subject.

27. The method of claim 26, wherein the exhalation is through a flow resistor so as to maintain a positive pressure differential between an oral cavity and the nasal airway of the subject sufficient to maintain the velum in a closed position.

28. The method of claim 27, wherein the flow resistor is configured to maintain a positive pressure differential of at least about 5 cm H₂O between the oral cavity and the nasal airway of the subject.

29. The method of claim 1, 6, 14, 15 or 23, wherein the gas flow entraining a substance is provided by an exhalation flow of the subject.

30. The method of claim 1, 5, 6, 14, 15 or 23, further comprising the step of:

providing at least one of a visual or an audible signal on exhalation by the subject.

31. The method of claim 30, wherein the visual signal comprises a movement of a display member into view.

32. The method of claim 1, 5, 6, 14, 15 or 23, wherein the substance comprises a dry powder.

33. The method of claim 32, wherein the powder has a particle size distribution, a major fraction of which is in a range of about 1 to 10 μ

m.

34. The method of claim 32, wherein the powder has a particle size distribution substantially in a range of about 1 to 10 μ

m.

35. The method of claim 1, 5, 6, 14, 15 or 23, wherein the substance comprises liquid droplets.

36. The method of claim 35, wherein the liquid droplets comprise one of a solution or a suspension.

37. The method of claim 35, wherein the liquid droplets have a particle size distribution, a major fraction of which is in the range of about 1 to 10 μ

m.

38. The method of claim 35, wherein the liquid droplets have a particle size distribution substantially in a range of about 1 to 10 μ

m.

39. The method of claim 1, 5, 6, 14, 15 or 23, wherein the substance contains a medicament.

40. The method of claim 39, wherein the medicament is for a treatment of a nasal condition.

41. The method of claim 1, 5, 6, 14, 15 or 23, wherein the substance comprises a cleansing agent for cleansing the nasal airway.

42. The method of claim 1, 5, 6, 14, 15 or 23, wherein the substance comprises an irrigating agent for irrigating the nasal airway.

43. The method of claim 1, 5, 6, 14, 15 or 23, in delivering a substance to a posterior region of the nasal airway.

44. The method of claim 1, 5, 6, 14, 15 or 23, in the treatment of nasal inflammation.

45. The method of claim 44, in the treatment of rhinitis.

46. The method of claim 1, 5, 6, 14, 15 or 23, in the treatment of nasal polyps.

47. The method of claim 1, 5, 6, 14, 15 or 23, in the treatment of hypertrophic adenoids.

48. The method of claim 1, 5, 6, 14, 15 or 23, in the treatment of secretory otitis media.

49. The method of claim 1, 5, 6, 14, 15 or 23, in the treatment of reduced olfaction.

50. The method of claim 1, 5, 6, 14, 15 or 23, wherein the substance comprises a pharmaceutical.

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

sealing one of the nostrils of a subject to an outlet of a delivery unit such as to prevent the escape of a gas flow through the one nostril;

closing the oropharyngeal velum of the subject; and

delivering a gas flow entraining a substance through the outlet at such a driving pressure as to flow around the posterior margin of the-nasal septum and out of the other nostril of the subject, wherein the gas flow entraining a substance is provided by an impeller driven by an exhalation flow of the subject.

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

sealing one of the nostrils of a subject to an outlet of a delivery unit such as to prevent the escape of a gas flow through the one nostril;

closing the oropharyngeal velum of the subject;

delivering a gas flow entraining a substance through the outlet at such a driving pressure as to flow around the posterior margin of the-nasal septum and out of the other nostril of the subject; and

providing a flow resistance to the gas flow exiting the other nostril of the subject such as to maintain a dynamic positive pressure in the nasal airway of the subject, wherein the gas flow, while under resistance, continues exiting the other nostril.

7. The method of claim 6, wherein the dynamic positive pressure is of sufficient magnitude as to force open at least one of the auditory tubes or the sinus tubes.

8. The method of claim 6, further comprising the step of adjusting the flow resistance in maintaining the dynamic positive pressure in the nasal airway of the subject.

9. The method of claim 6, wherein the dynamic positive pressure is at least 5 cm H₂O.

10. The method of claim 9, wherein the dynamic positive pressure is at least 50 cm H₂O.

11. The method of claim 10, wherein the dynamic positive pressure is at least 100 cm H₂O.

12. The method of claim 11, wherein the dynamic positive pressure is at least 200 cm H₂O.

13. The method of claim 6, further comprising the step of providing at least one of a visual or an audible signal when a predeterminable pressure has been achieved in the nasal airway.

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

sealing one of the nostrils of a subject to an outlet of a delivery unit such as to prevent the escape of a gas flow through the one nostril;

closing the oropharyngeal velum of the subject; and

delivering a gas flow entraining a substance through the outlet at such a driving pressure as to flow around the posterior margin of the-nasal septum and out of the other nostril of the subject, wherein the gas flow entraining a substance is delivered at a rate of at least 20 liters per minute and provided by actuation of a supply unit device.

17. The method of claim 6, 14, or 15, further comprising the step of using a pressure-sensitive valve to trigger release of the substance when a predetermined flow rate has been achieved.

18. The method of claim 17, wherein the pressure-sensitive valve is not opened until the subject has maintained a predetermined flow rate, and can be closed when the flow rate drops below the predetermined flow rate so as to stop delivery of the substance.

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

sealing one of the nostrils of a subject to an outlet of a delivery unit such as to prevent the escape of a gas flow through the one nostril;

closing the oropharyngeal velum of the subject;

and delivering a gas flow entraining a substance through the outlet at such a driving pressure as to flow around the posterior margin of the-nasal septum and out of the other nostril of the subject, wherein the gas flow entraining a substance is delivered at a rate of about 1 to 20 liters per minute and provided by actuation of a supply unit device.

16. The method of claim 15, wherein the gas flow entraining a substance is delivered at a rate of about 3 to 15 liters per minute.

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

sealing one of the nostrils of a subject to an outlet of a delivery unit such as to prevent the escape of a gas flow through the one nostril;

closing the oropharyngeal velum of the subject; and

delivering a gas flow entraining a substance through the outlet at such a driving pressure as to flow around the posterior margin of the-nasal septum and out of the other nostril of the subject, wherein a metered dose of the substance is mechanically dispensed into a delivery chamber and wherein the gas flow entraining a substance is provided by actuation of a supply unit device.

24. The method of claim 23, wherein the substance after being dispensed is gradually released from the delivery chamber into the gas flow.