Nasal delivery device

• US 20060219241A1
• Filed: 06/02/2006
• Published: 10/05/2006
• Est. Priority Date: 03/03/1999
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Granted Patent: US 8,555,878 B2
• Time in Patent Office: Days
• US Class Current: 128/200.180
• 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

1-34. -34. (canceled)

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

a flow resistor;

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 outlet of the nosepiece and configured to dispense a metered dose of substance into a gas flow when the gas flow has a predeterminable rate;

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.

36. The device of claim 35, wherein the flow resistor is operably connected to a tubular section configured to be held between the lips of the subject.

37. The device of claim 35, wherein the flow resistor is operably connected to a mouthpiece.

38. The device of claim 35, wherein the exhalation air flow entrains the substance for delivery.

39. The device of claim 35, wherein the substance supply unit comprises a dispersion mechanism operative to disperse the substance into the gas flow.

40. The device of claim 35, wherein an air flow separate from the exhalation air flow entrains the substance for delivery.

41. The device of claim 40, wherein the separate air flow is provided by atmospheric room air.

42. The device of claim 40, wherein the substance supply unit comprises a chamber comprising a propellant, and the separate air flow is provided by the propellant.

43. The device of claim 35, further comprising:

a pressure-triggered valve fluidly connected to the flow resistor, wherein the valve is configured to open when a predeterminable positive pressure is developed upon exhalation by the subject.

44. The device of claim 35, wherein the flow resistor is fluidly connected to the nosepiece and located upstream of the substance supply unit.

45. The device of claim 35, wherein the nosepiece is formed of a resilient material.

46. The device of claim 35, wherein the nosepiece is configured to extend into a nasal cavity of the subject so as to expand the valve region of the nasal cavity of the subject.

47. The device of claim 35, further comprising:

a positive pressure indicator or a flow rate indicator.

48. The device of claim 35, wherein the gas flow entraining a substance is delivered at a driving pressure sufficient to cause the gas to flow around the posterior margin of the nasal septum of the subject and out of the other nostril of the subject.

65. A combination of the device of claim 35 or claim 49 and a substance to be delivered.

66. The combination of claim 65, wherein the substance comprises particles principally in the range of about 1 to 10 μ

m.

67. A combination of the device of claim 35 or claim 49 and a separate outlet unit, wherein the separate outlet unit comprises a nosepiece shaped and sized for insertion into the other nostril of the subject, and a flow resistor located downstream of the other nostril, wherein the separate outlet unit is configured to cause the generation of a dynamic positive pressure in the nasal airway.

68. The combination of claim 67, wherein the separate outlet unit further comprises an indicator for signaling when a predeterminable positive pressure has been reached upstream of the indicator in the nasal airway of the subject.

69. The combination of claim 67, wherein the flow resistor is adjustable to allow for adjustment of the level of resistance and thereby provide control of the dynamic pressure in the nasal airway of the subject.

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

a flow resistor against which the subject in use exhales;

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 valve configured to move from a resting position to a substance-delivery position when the subject exhales against the flow resistor and the exhalation flow meets or exceeds a predeterminable flow rate;

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.

50. The device of claim 49, wherein the flow resistor is operably connected to a tubular section configured to be held between the lips of the subject.

51. The device of claim 49, wherein the flow resistor is operably connected to a mouthpiece.

52. The device of claim 49, wherein the valve is configured to return to the resting position when the flow rate drops below the predeterminable flow rate.

53. The device of claim 49, wherein the valve comprises a propeller rotatably mounted on a threaded shaft and normally biased to the resting position.

54. The device of claim 49, further comprising:

a dosing mechanism for delivering a dose of substance to the nasal airway of the subject, wherein movement of the valve to the substance-delivery position triggers the dosing mechanism to deliver the dose of substance.

55. The device of claim 54, wherein the movement of the valve to the substance-delivery position triggers release of a dose of the substance into an entraining gas flow.

56. The device of claim 55, wherein the movement of the valve to the substance-delivery position triggers generation of the entraining gas flow.

57. The device of claim 49, wherein the exhalation air flow entrains a substance for delivery.

58. The device of claim 57, wherein the flow resistor is fluidly connected to the nosepiece and located upstream of the valve.

59. The device of claim 49, wherein an air flow separate from the exhalation air flow entrains a substance for delivery.

60. The device of claim 59, wherein the separate air flow is provided by atmospheric room air.

61. The device of claim 49, wherein the nosepiece is formed of a resilient material.

62. The device of claim 49, wherein the nosepiece is configured to extend into a nasal cavity of the subject so as to expand the valve region of the nasal cavity of the subject.

63. The device of claim 49, further comprising:

a positive pressure indicator or a flow rate indicator.

64. The device of claim 49, wherein the gas flow entraining a substance is delivered at a driving pressure sufficient to cause the gas to flow around the posterior margin of the nasal septum of the subject and out of the other nostril of the subject.

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

a delivery unit for delivering a substance to one of the nostrils of the subject, wherein the delivery unit comprises a nosepiece including an outlet through which the substance is in use delivered to the one nostril and a sealing member for sealing the one nostril to the outlet, and an actuation mechanism operative, in response to oral exhalation by the subject, to actuate the delivery unit to deliver a dose of substance into a gas flow.

71. The device of claim 70, further comprising:

a flow resistor;

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.

72. The device of claim 71, wherein the flow resistor is operably connected to a tubular section configured to be held between the lips of the subject.

73. The device of claim 71, wherein the flow resistor is operably connected to a mouthpiece.

74. The device of claim 71, wherein the flow resistor is fluidly connected to the nosepiece.

75. The device of claim 70, wherein the delivery unit further comprises a gas supply unit for supplying a gas flow separate to the exhalation air flow of the subject.

76. The device of claim 75, further comprising:

a control unit for controlling the gas supply unit such as to control the flow rate of the delivered gas flow.

77. The device of claim 70, 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.

78. The device of claim 77, further comprising:

a dispensing unit for dispensing a dose of a substance into the delivery channel.

79. The device of claim 70, wherein the delivery unit comprises an aerosol spray generator for generating an aerosol spray of liquid droplets containing the substance.

80. The device of claim 70, wherein the delivery unit is configured to deliver the gas flow at a driving pressure which, with closure of the oropharyngeal velum of the subject, would be such as to cause the gas flow to flow around the posterior margin of the nasal septum and out of the other nostril of the subject.

81. The device of claim 70, 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 gas flow exiting the other nostril so as in use to maintain a positive dynamic pressure upstream thereof.

82. The device of claim 81, wherein the flow resistor of the outlet unit is adjustable to allow for adjustment of the flow resistance.

83. The device of claim 71, wherein the delivery unit further comprises an indicator for providing at least one of a visual or an audible signal on exhalation by the subject through the flow resistor.

84. The combination of the device of claim 70 and substance to be delivered.