Nasal delivery device

• US 9,119,932 B2
• Filed: 06/02/2006
• Issued: 09/01/2015
• Est. Priority Date: 03/03/1999
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): YOUNG, RACHEL T
• Application Number:
  US11/445,993
• Publication Number:
  US 20060219240A1
• Time in Patent Office: 3,378 Days
• Field of Search: 128/203.12, 128/203.15, 128/203.18, 128/200.14, 128/200.18, 128/200.23
• US Class Current: 1/1
• 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 device for delivering a substance to the nasal airway of a subject, comprising:

a flow resistor operably connected to a mouthpiece and configured to allow at least a fraction of an exhalation flow to flow downstream of the flow resistor, wherein the flow resistor comprises an element which is movable between a closed position and an open position and wherein the element is movable to the open position only when the exhalation flow exceeds a predetermined flow rate;

a nosepiece shaped and sized for insertion into a nostril of the subject comprising an outlet through which a substance may be delivered into the nasal airway of the subject, and a sealing member configured to seal the one nostril of the subject to the outlet, the sealing member having a first, distal end and a second, proximal end and being enlarged towards the proximal end to cause an anterior region of the nasal cavity into which the nosepiece is inserted to be enlarged; and

a substance supply unit for supplying a gas flow entraining a substance, wherein the substance supply unit is in fluid communication with the outlet of the nosepiece;

wherein the device is configured to create a positive pressure differential between the oral cavity of the subject and the nasal airway of the subject when the subject exhales against the flow resistor, thereby indirectly achieving closure of the oropharyngeal velum of the subject, and a fluid tight seal is maintained at all times while the subject is exhaling and under the full range of operational fluid flow pressures.

2. The device of claim 1, wherein the flow resistor is operably connected to the mouthpiece by a tubular section.

3. The device of claim 1, wherein the nosepiece is formed of a resilient material.

4. The device of claim 1, wherein the nosepiece is configured to extend into a nasal cavity of the subject so as to expand a valve region of the nasal cavity of the subject.

5. The device of claim 1, wherein the device is configured to deliver a substance entrained in the exhalation flow having a flow rate in the nasal airway of at least 20 liters per minute.

6. The device of claim 1, wherein the nosepiece is frusto-conical in shape.

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

a flow resistor operably connected to a mouthpiece and configured to allow at least a fraction of an exhalation flow to flow downstream of the flow resistor, wherein, the flow resistor defines a closed position and an open position and in use, the flow resistor is only able to transition from the closed position to the open position in response to the exhalation flow;

a nosepiece shaped and sized for insertion into a nostril of the subject to create a fluid tight seal with the nostril, the nosepiece comprising an outlet through which a substance may be delivered into the nasal airway of the subject;

a substance supply unit for supplying a gas flow entraining a substance, wherein the substance supply unit is in fluid communication with the outlet of the nosepiece; and

wherein the device is configured to create a positive pressure differential between the oral cavity of the subject and the nasal airway of the subject when the subject exhales against the flow resistor, thereby indirectly achieving closure of the oropharyngeal velum of the subject, and the device is configured to deliver a substance entrained in a gas flow having a positive pressure in the nasal airway of at least 50 cm H₂O.

8. The device of claim 7, wherein the flow resistor is operably connected to the mouthpiece by a tubular section.

9. The device of claim 7, wherein the device is configured deliver a substance entrained in the exhalation flow having a positive pressure in the nasal airway of at least 100 cm H₂O.

10. The device of claim 7, wherein the nosepiece is formed of a resilient material.

11. The device of claim 7, wherein the nosepiece is configured to extend into a nasal cavity of the subject so as to expand a valve region of the nasal cavity of the subject.

12. The device of claim 7, wherein the device is configured to deliver a substance entrained in the exhalation flow having a flow rate in the nasal airway of at least 20 liters per minute.

13. The device of claim 7, wherein the nosepiece is frusto-conical in shape.

14. The combination of the device of claim 7 and substance to be delivered.

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

a flow resistor being movable from a closed position at a first pressure to an open position at a second pressure greater than the first pressure, whereby the flow resistor can deliver the exhalation flow only when the exhalation flow is at or exceeds the second pressure;

a nosepiece shaped and sized for insertion into a nostril of the subject to create a fluid tight seal with the nostril, the nosepiece comprising an outlet through which a substance may be delivered into the nasal airway of the subject; and

a substance supply unit in fluid communication with the nosepiece and containing the substance to be entrained in the exhalation flow at a pressure sufficient to maintain a flow path beyond the posterior margin of the nasal septum of the subject;

wherein the device is configured to create a positive pressure differential between the oral cavity of the subject and the nasal airway of the subject when the subject exhales against the flow resistor, thereby indirectly achieving closure of the oropharyngeal velum of the subject.

16. The device of claim 15, wherein the flow resistor is operably connected to the mouthpiece by a tubular section.

17. The device of claim 15, wherein the substance supply unit comprises an aerosol spray generator for generating an aerosol spray of liquid droplets containing the substance.

18. The device of claim 15, wherein the nosepiece is formed of a resilient material.

19. The device of claim 15, wherein the nosepiece is configured to extend into a nasal cavity of the subject so as to expand a valve region of the nasal cavity of the subject.

20. The device of claim 15, wherein the device is configured to deliver a substance entrained in the exhalation flow having a flow rate in the nasal airway of at least 20 liters per minute.

21. The combination of the device of claim 15 and substance to be delivered.

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

a first flow resistor operably connected between a mouthpiece and a first nosepiece, the first flow resistor being configured to allow at least a fraction of an exhalation flow to flow downstream of the first flow resistor, wherein the flow resistor defines a closed position and an open position and in use, the flow resistor is only able to transition from the closed position to the open position in response to the exhalation flow;

a delivery unit comprising the first nosepiece for delivering a substance in the exhalation flow to one of the nostrils of the subject via the first nosepiece at a driving pressure sufficient to cause the exhalation flow to flow around the posterior margin of the nasal septum and out of the other nostril of the subject, wherein the delivery unit includes an outlet through which the exhalation flow is in use delivered to the one nostril and a sealing member to prevent the escape of the exhalation flow through the one nostril; and

an outlet unit comprising a second nosepiece for fitting in the other nostril and a second flow resistor for providing a flow resistance to the exhalation flow exiting the other nostril so as in use to maintain a positive pressure upstream thereof;

wherein the device is configured to create a positive pressure differential between the oral cavity of the subject and the nasal airway of the subject when the subject exhales against the first flow resistor, thereby indirectly achieving closure of the oropharyngeal velum of the subject.

23. The device of claim 22, wherein the first flow resistor is operably connected to the mouthpiece by a tubular section.

24. The device of claim 22, wherein the delivery unit further comprises a delivery channel fluidly connected to the first nosepiece and configured to receive a substance to be delivered to the one nostril.

25. The device of claim 22, wherein the delivery unit comprises an aerosol spray generator for generating an aerosol spray of liquid droplets containing the substance.

26. The device of claim 22, wherein the delivery unit further comprises an actuation mechanism for actuating the delivery unit in response to exhalation by the subject.

27. The device of claim 22, wherein the second flow resistor is adjustable to allow for adjustment of the flow resistance of the second flow resistor.

28. The device of claim 22, wherein the device is configured to deliver the exhalation flow at a flow rate in the nasal airway of at least 20 liters per minute.

29. The combination of the device of claim 22 and substance to be delivered.

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

a flow resistor against which the subject in use exhales such as to cause closure of the oropharyngeal velum of the subject, wherein the flow resistor is operably connected to a mouthpiece and configured to allow at least a fraction of the exhalation flow to flow downstream of the flow resistor after the flow resistor opens in response to a pressure of the exhalation flow reaching a predetermined pressure upstream of the flow resistor;

wherein the flow resistor is, in use, only able to open in response to the pressure of the exhalation flow;

and

a delivery unit for delivering a substance in an exhalation flow to one of the nostrils of the subject, wherein the delivery unit comprises a nosepiece including an outlet through which the substance and exhalation flow is in use delivered to the one nostril and a sealing member configured to provide a fluid tight seal between the one nostril to the outlet when inserted into the one nostril and maintain the fluid tight seal during operation of the device.

31. The device of claim 30, wherein the flow resistor is operably connected to the mouthpiece by a tubular section.

32. The device of claim 30, wherein the mouthpiece is fluidly connected to a nosepiece.

33. The device of claim 30, wherein the delivery unit further comprises a delivery channel fluidly connected to the nosepiece and configured to receive a substance to be delivered to the one nostril.

34. The device of claim 30, wherein the delivery unit comprises an aerosol spray generator for generating an aerosol spray of liquid droplets containing the substance.

35. The device of claim 30, wherein the delivery unit further comprises an actuation mechanism for actuating the same in response to exhalation by the subject.

36. The device of claim 30, wherein the delivery unit is configured to deliver the exhalation flow at a driving pressure which, with closure of the oropharyngeal velum of the subject, would be such as to cause the exhalation flow to flow around the posterior margin of the nasal septum and out of the other nostril of the subject.

37. The device of claim 30, further comprising:

an outlet unit comprising a nosepiece for fitting to the other nostril and a flow resistor for providing a flow resistance to the exhalation flow exiting the other nostril so as in use to maintain a positive dynamic pressure upstream thereof.

38. The device of claim 37, wherein the flow resistor of the outlet unit is adjustable to allow for adjustment of the flow resistance of the flow resistor of the outlet unit.

39. The device of claim 30, wherein the device is configured to deliver the substance entrained in the exhalation flow at a flow rate in the nasal airway of at least 20 liters per minute.

40. The device of claim 30, wherein the nosepiece is frusto-conical in shape.

41. The combination of the device of claim 30 and substance to be delivered.

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

a flow resistor against which the subject in use exhales such as to cause closure of the oropharyngeal velum of the subject, wherein the flow resistor is operably connected to a mouthpiece and configured to allow at least a fraction of an exhalation flow to flow downstream of the flow resistor, and wherein the flow resistor defines a closed position and an open position and in use, the flow resistor is only able to transition from the closed position to the open position in response to the exhalation flow;

and,

a delivery unit for delivering a substance in the exhalation flow to one of the nostrils of the subject, wherein the delivery unit comprises a nosepiece including an outlet through which the substance and the exhalation flow is in use delivered to the one nostril and a sealing member configured to provide a fluid tight seal between the one nostril to the outlet, wherein the device is configured to maintain a positive pressure in the nasal airway of at least 50 cm H₂O.

43. The device of claim 42, wherein the device is configured to maintain a positive pressure in the nasal airway of at least 100 cm H₂O.

44. The device of claim 42, wherein the flow resistor is operably connected to the mouthpiece by a tubular section.

45. The device of claim 42, wherein the delivery unit further comprises a delivery channel fluidly connected to the nosepiece and configured to receive a substance to be delivered to the one nostril.

46. The device of claim 42, wherein the delivery unit comprises an aerosol spray generator for generating an aerosol spray of liquid droplets containing the substance.

47. The device of claim 42, wherein the delivery unit further comprises an actuation mechanism for actuating the same in response to exhalation by the subject.

48. The device of claim 42, wherein the delivery unit is configured to deliver the exhalation flow at a driving pressure which, with closure of the oropharyngeal velum of the subject, would be such as to cause the exhalation flow to flow around the posterior margin of the nasal septum and out of the other nostril of the subject.

49. The device of claim 42, further comprising:

an outlet unit comprising a nosepiece for fitting to the other nostril and a flow resistor for providing a flow resistance to the exhalation flow exiting the other nostril so as in use to maintain a positive dynamic pressure upstream thereof.

50. The device of claim 49, wherein the flow resistor of the outlet unit is adjustable to allow for adjustment of the flow resistance of the flow resistor of the outlet unit.

51. The device of claim 42, wherein the device is configured to deliver the exhalationgas flow at a flow rate in the nasal airway of at least 20 liters per minute.

52. The device of claim 42, wherein the nosepiece is frusto-conical in shape.

53. The combination of the device of claim 42 and substance to be delivered.

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

a first flow resistor through which the subject in use exhales such as to cause closure of the oropharyngeal velum of the subject, wherein the flow resistor is operably connected to a mouthpiece and configured to allow at least a fraction of an exhalation flow to flow downstream of the flow resistor, wherein the flow resistor comprises an element which is movable between a closed position and an open position and wherein the element moves to the open position only when the exhalation flow exceeds a predetermined flow rate;

a delivery unit comprising a first nosepiece for delivering the substance in the exhalation flow to one of the nostrils of the subject at a driving pressure which would be such as to cause the exhalation flow to flow around the posterior margin of the nasal septum and out of the other nostril of the subject, wherein the delivery unit includes an outlet through which the exhalation flow is in use delivered to the one nostril and a sealing member to prevent the escape of the exhalation flow through the one nostril; and

an outlet unit comprising a second nosepiece for fitting in the other nostril and a second flow resistor for providing a flow resistance to the exhalation flow exiting the other nostril so as in use to maintain a positive pressure upstream thereof.

55. The device of claim 54, wherein the first flow resistor is operably connected to the mouthpiece by a tubular section.

56. The device of claim 54, wherein the delivery unit further comprises a delivery channel fluidly connected to the first nosepiece and configured to receive a substance to be delivered to the one nostril.

57. The device of claim 54, wherein the delivery unit comprises an aerosol spray generator for generating an aerosol spray of liquid droplets containing the substance.

58. The device of claim 54, wherein the delivery unit further comprises an actuation mechanism for actuating the same in response to exhalation by the subject.

59. The device of claim 54, wherein the delivery unit is configured to deliver the exhalation flow at a driving pressure which, with closure of the oropharyngeal velum of the subject, would be such as to cause the exhalation flow to flow around the posterior margin of the nasal septum and out of the other nostril of the subject.

60. The device of claim 54, wherein the second flow resistor of the outlet unit is adjustable to allow for adjustment of the flow resistance of the second flow resistor.

61. The device of claim 54, wherein the device is configured to deliver the exhalation flow at a flow rate in the nasal airway of at least 20 liters per minute.

62. The combination of the device of claim 54 and substance to be delivered.