Nasal devices

• US 7,975,690 B2
• Filed: 06/12/2002
• Issued: 07/12/2011
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US10/480,582
• Publication Number:
  US 20050072430A1
• Time in Patent Office: 3,317 Days
• Field of Search: 128/203.12, 128/203.22, 128/203.15, 128/200.26, 128/207.18, 128/203.18, 128/200.13, 128/203.23, 128/203.24, 128/202.22, 128/204.11, 128/204.12, 604/275, 604/58, 604/206, 604/28
• US Class Current: 128/203.22
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 2202/064 Powder
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The present invention relates to a nasal delivery device for and a method of delivering a substance, in particular one of a liquid, as a suspension or solution, or a powder containing a medicament, especially systemic or topical pharmaceuticals, or a vaccine to the nasal airway of a subject.

Claims

1. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one inflatable cuff member;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject;

inflating the at least one cuff member simultaneously with, or in response to, the subject exhaling through the mouthpiece unit; and

delivering substance through the nozzle of the nosepiece.

2. The method of claim 1, further comprising the step of:

delivering the substance in response to exhalation by the subject.

3. The method of claim 1, wherein the at least one cuff member is configured such as, when inflated, to direct at least a distal end of the nozzle towards a site in the nasal airway of the subject.

4. The method of claim 3, wherein the at least one cuff member is one or both of shaped and sized such as, when inflated, to direct at least a distal end of the nozzle to a site in the nasal airway of the subject.

5. The method of claim 3, wherein the site includes at least a part of the superior meatus.

6. The method of claim 3, wherein the site includes at least a part of the superior nasal concha.

7. The method of claim 3, wherein the site includes at least a part of the olfactory region.

8. The method of claim 3, wherein the site includes at least a part of the inferior meatus.

9. The method of claim 3, wherein the site includes at least a part of the middle meatus.

10. The method of claim 9, wherein the site includes an inferior part of the middle meatus.

11. The method of claim 3, wherein the site includes at least a part of the inferior nasal concha.

12. The method of claim 3, wherein the site includes at least a part of the middle nasal concha.

13. The method of claim 3, wherein the site includes at least sinus ostia.

14. The method of claim 3, wherein the site includes at least sinus infundibulum.

15. The method of claim 3, wherein the site includes at least a part of the epipharynx.

16. The method of claim 3, wherein the site includes at least adenoids.

17. The method of claim 3, wherein the site includes at least tubal ostia.

18. The method of claim 1, wherein at least one of the at least one cuff member includes at least one lobe which, when the at least one of the at least one cuff member is inflated, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

19. The method of claim 18, wherein the nasal cavity region is a lower region of the nasal cavity of the subject.

20. The method of claim 18, wherein the nasal cavity region is a middle region of the nasal cavity of the subject.

21. The method of claim 18, wherein the nasal cavity region is an upper region of the nasal cavity of the subject.

22. The method of claim 1, further comprising the steps of:

providing a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the nosepiece; and

supplying a gas flow to the flow channel.

23. The method of claim 1, wherein at least one of the at least one cuff member includes a plurality of lobes which, when the at least one of the at least one cuff member is inflated, extend into regions of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

24. The method of claim 23, wherein the nasal cavity regions are lower and middle regions of the nasal cavity of the subject.

25. The method of claim 23, wherein the nasal cavity regions are lower and upper regions of the nasal cavity of the subject.

26. The method of claim 23, wherein the nasal cavity regions are middle and upper regions of the nasal cavity of the subject.

27. The method of claim 1, wherein at least one of the at least one cuff member includes a plurality of lobes which, when the at least one of the at least one cuff member is inflated, extend into regions of the nasal cavity of the subject such as to at least partially fill the same and prevent flow thereinto.

28. The method of claim 27, wherein the nasal cavity regions are lower and middle regions of the nasal cavity of the subject.

29. The method of claim 27, wherein the nasal cavity regions are lower and upper regions of the nasal cavity of the subject.

30. The method of claim 27, wherein the nasal cavity regions are middle and upper regions of the nasal cavity of the subject.

32. The method of claim 1 or 31, wherein the at least one inflatable cuff member is inflated by an air flow separate from an air flow generated by the subject by exhaling through the mouthpiece.

34. The method of claim 1 or 31, wherein the at least one inflatable cuff member is inflated by the air flow generated by the subject on exhalation through the mouthpiece.

31. A method of delivering substance to a nasal cavity of a subject, comprising the steps of:

fitting a nosepiece to a nasal cavity of a subject, the nosepiece including a nozzle through which substance is delivered to the nasal cavity, and at least one inflatable cuff member which is configured such as, when inflated, to provide a fluid-tight seal between the nosepiece and an inner wall of the nasal cavity of the subject;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject;

inflating the at least one cuff member simultaneously with, or in response to, the subject exhaling through the mouthpiece unit; and

delivering substance through the nozzle of the nosepiece.

35. The method of claim 31, further comprising the step of:

delivering the substance in response to exhalation by the subject.

36. The method of claim 31, wherein the at least one cuff member is configured such as, when inflated, to direct at least a distal end of the nozzle towards a site in the nasal airway of the subject.

37. The method of claim 36, wherein the at least one cuff member is one or both of shaped and sized such as, when inflated, to direct at least a distal end of the nozzle to a site in the nasal airway of the subject.

38. The method of claim 36, wherein the site includes at least a part of the superior meatus.

39. The method of claim 36, wherein the site includes at least a part of the superior nasal concha.

40. The method of claim 36, wherein the site includes at least a part of the olfactory region.

41. The method of claim 36, wherein the site includes at least a part of the inferior meatus.

42. The method of claim 36, wherein the site includes at least a part of the middle meatus.

43. The method of claim 42, wherein the site includes an inferior part of the middle meatus.

44. The method of claim 36, wherein the site includes at least a part of the inferior nasal concha.

45. The method of claim 36, wherein the site includes at least a part of the middle nasal concha.

46. The method of claim 36, wherein the site includes at least sinus ostia.

47. The method of claim 36, wherein the site includes at least sinus infundibulum.

48. The method of claim 36, wherein the site includes at least a part of the epipharynx.

49. The method of claim 36, wherein the site includes at least adenoids.

50. The method of claim 36, wherein the site includes at least tubal ostia.

51. The method of claim 31, wherein at least one of the at least one cuff member includes at least one lobe which, when the at least one of the at least one cuff member is inflated, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

52. The method of claim 51, wherein the nasal cavity region is a lower region of the nasal cavity of the subject.

53. The method of claim 51, wherein the nasal cavity region is a middle region of the nasal cavity of the subject.

54. The method of claim 51, wherein the nasal cavity region is an upper region of the nasal cavity of the subject.

55. The method of claim 31, further comprising the steps of:

providing a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the nosepiece; and

supplying a gas flow to the flow channel.

33. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one inflatable cuff member;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject;

providing a flow channel fluidly connecting the nosepiece and the mouthpiece unit, whereby exhaled air from an exhalation breath is delivered through the nosepiece

inflating the at least one cuff member; and

delivering substance through the nozzle of the nosepiece.

56. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, which includes at least one lobe, and which is configured such as, when fitted in the nasal cavity of the subject, to extend into a region of the nasal cavity of the subject and to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a required site in the nasal airway of the subject;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject; and

delivering substance through the nozzle of the nosepiece.

57. The method of claim 56, wherein the at least one cuff member is one or both of shaped and sized such as to direct at least a distal end of the nozzle to a site in the nasal airway of the subject.

58. The method of claim 56, wherein a major fraction of the particle size distribution is in the range of from about 1 μ

m to about 80 μ

m.

59. The method of claim 58, wherein a major fraction of the particle size distribution is in the range of from about 1 μ

m to about 50 μ

m.

60. The method of claim 59, wherein a major fraction of the particle size distribution is in the range of from about 1 μ

m to about 30 μ

m.

61. The method of claim 60, wherein a major fraction of the particle size distribution is in the range of from about 10 μ

m to about 30 μ

m.

62. The method of claim 61, wherein a major fraction of the particle size distribution is in the range of from about 10 μ

m to 20 μ

m.

63. The method of claim 61, wherein a major fraction of the particle size distribution is in the range of from about 15 μ

m to about 30 μ

m.

64. The method of claim 56, wherein the site includes at least a part of the superior meatus.

65. The method of claim 56, wherein the site includes at least a part of the superior nasal concha.

66. The method of claim 56, wherein at least one of the at least one cuff member includes at least one lobe which, when the at least one of the at least one cuff member is fitted in the nasal cavity of the subject, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

67. The method of claim 66, wherein the nasal cavity region is a lower region of the nasal cavity of the subject nosepiece.

68. The method of claim 66, wherein the nasal cavity region is a middle region of the nasal cavity of the subject.

69. The method of claim 66, wherein the nasal cavity region is an upper region of the nasal cavity of the subject.

70. The method of claim 56, further comprising the step of:

delivering the substance in response to exhalation by the subject.

71. The method of claim 56, further comprising the steps of:

providing a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the nosepiece; and

supplying a gas flow to the flow channel.

72. The method of claim 56, wherein the site includes at least a part of the inferior meatus.

73. The method of claim 56, wherein the site includes at least a part of the middle meatus.

74. The method of claim 73, wherein the site includes an inferior part of the middle meatus.

75. The method of claim 56, wherein the site includes at least a part of the inferior nasal concha.

76. The method of claim 56, wherein the site includes at least a part of the middle nasal concha.

77. The method of claim 56, wherein the site includes at least sinus ostia.

78. The method of claim 56, wherein the site includes at least sinus infundibulum.

79. The method of claim 56, wherein the site includes at least a part of the epipharynx.

80. The method of claim 56, wherein the site includes at least adenoids.

81. The method of claim 56, wherein the site includes at least tubal ostia.

82. The method of claim 56, wherein at least one of the at least one cuff member includes a plurality of lobes which, when the at least one of the at least one cuff member is fitted in the nasal cavity of the subject, extend into regions of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

83. The method of claim 82, wherein the nasal cavity regions are lower and middle regions of the nasal cavity of the subject.

84. The method of claim 82, wherein the nasal cavity regions are lower and upper regions of the nasal cavity of the subject.

85. The method of claim 82, wherein the nasal cavity regions are middle and upper regions of the nasal cavity of the subject.

86. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, at least one of the at least one cuff member including at least one lobe which, when the at least one of the at least one cuff member is fitted in the nasal cavity of the subject, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject; and

delivering substance through the nozzle of the nosepiece.

87. The method of claim 86, wherein the nasal cavity region is a lower region of the nasal cavity of the subject.

88. The method of claim 86, wherein the at least one cuff member is configured such as, when fitted in a nasal cavity of the subject, to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a site in the nasal airway of the subject.

89. The method of claim 88, wherein the at least one cuff member is one or both of shaped and sized such as to direct at least a distal end of the nozzle to a site in the nasal airway of the subject.

90. The method of claim 88, wherein the site includes at least a part of the superior meatus.

91. The method of claim 88, wherein the site includes at least a part of the superior nasal concha.

92. The method of claim 88, wherein the site includes at least a part of the olfactory region.

93. The method of claim 88, wherein the site includes at least a part of the inferior meatus.

94. The method of claim 88, wherein the site includes at least a part of the middle meatus.

95. The method of claim 94, wherein the site includes an inferior part of the middle meatus.

96. The method of claim 88, wherein the site includes at least a part of the inferior nasal concha.

97. The method of claim 88, wherein the site includes at least a part of the middle nasal concha.

98. The method of claim 88, wherein the site includes at least sinus ostia.

99. The method of claim 88, wherein the site includes at least sinus infundibulum.

100. The method of claim 88, wherein the site includes at least a part of the epipharynx.

101. The method of claim 88, wherein the site includes at least adenoids.

102. The method of claim 88, wherein the site includes at least tubal ostia.

103. The method of claim 86, wherein the substance comprises a powder.

104. The method of claim 103, wherein the substance is delivered as a powder aerosol.

105. The method of claim 103, wherein a major fraction of the particle size distribution is in the range of from about 1 μ

m to about 80 μ

m.

106. The method of claim 105, wherein a major fraction of the particle size distribution is in the range of from about 1 μ

m to about 50 μ

m.

107. The method of claim 106, wherein a major fraction of the particle size distribution is in the range of from about 1 μ

m to about 30 μ

m.

108. The method of claim 107, wherein a major fraction of the particle size distribution is in the range of from about 10 μ

m to about 30 μ

m.

109. The method of claim 108, wherein a major fraction of the particle size distribution is in the range of from about 10 μ

m to about 20 μ

m.

110. The method of claim 108, wherein a major fraction of the particle size distribution is in the range of from about 15 μ

m to about 30 μ

m.

111. The method of claim 86, wherein the substance comprises a liquid.

112. The method of claim 111, wherein the liquid is one of a solution or a suspension.

113. The method of claim 111, wherein the substance is delivered as a liquid aerosol.

114. The method of claim 111, wherein the substance is delivered as a liquid jet.

115. The method of claim 86, further comprising the step of:

delivering the substance in response to exhalation by the subject.

116. The method of claim 86, wherein the nasal cavity region is a middle region of the nasal cavity of the subject.

117. The method of claim 86, wherein the nasal cavity region is an upper region of the nasal cavity of the subject.

118. The method of claim 86, wherein at least one of the at least one cuff member includes a plurality of lobes which, when the at least one of the at least one cuff member is fitted in the nasal cavity of the subject, extend into regions of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto.

119. The method of claim 118, wherein the nasal cavity regions are lower and middle regions of the nasal cavity of the subject.

120. The method of claim 118, wherein the nasal cavity regions are lower and upper regions of the nasal cavity of the subject.

121. The method of claim 118, wherein the nasal cavity regions are middle and upper regions of the nasal cavity of the subject.

122. The method of claim 86, further comprising the steps of:

providing a flow channel fluidly connected to the nosepiece through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the nosepiece; and

supplying a gas flow to the flow channel.

123. A method of delivering substance to a nasal cavity of a subject, comprising the steps of:

fitting a nosepiece to a nasal cavity of a subject, the nosepiece including a nozzle through which substance is delivered to the nasal cavity, and at least one inflatable cuff member which is configured such as, when inflated, to provide a fluid-tight seal between the nosepiece and an inner wall of the nasal cavity of the subject;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject;

providing a flow channel fluidly connecting the nosepiece and the mouthpiece unit, whereby exhaled air from an exhalation breath is delivered through the nosepiece;

inflating the at least one cuff member; and

delivering substance through the nozzle of the nosepiece.

124. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, which includes at least one lobe, and which is configured such as, when fitted in the nasal cavity of the subject, to extend into a region of the nasal cavity of the subject and to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a required site in the nasal airway of the subject;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject;

providing a flow channel fluidly connecting the nosepiece and the mouthpiece unit, whereby exhaled air from an exhalation breath is delivered through the nosepiece; and

delivering substance through the nozzle of the nosepiece.

125. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, which includes at least one lobe, and which is configured such as, when fitted in the nasal cavity of the subject, to extend into a region of the nasal cavity of the subject and to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a required site in the nasal airway of the subject;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject; and

delivering substance through the nozzle of the nosepiece, wherein the substance comprises a powder.

126. The method of claim 125, wherein the substance is delivered as a powder aerosol.

127. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, which includes at least one lobe, and which is configured such as, when fitted in the nasal cavity of the subject, to extend into a region of the nasal cavity of the subject and to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a required site in the nasal airway of the subject;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject; and

delivering substance through the nozzle of the nosepiece, wherein the substance comprises a liquid.

128. The method of claim 127, wherein the liquid is one of a solution or a suspension.

129. The method of claim 127, wherein the substance is delivered as a liquid aerosol.

130. The method of claim 127, wherein the substance is delivered as a liquid jet.

131. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, which includes at least one lobe, and which is configured such as, when fitted in the nasal cavity of the subject, to extend into a region of the nasal cavity of the subject and to engage an inner wall of the nasal cavity of the subject and direct at least a distal end of the nozzle towards a required site in the nasal airway of the subject;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject; and

delivering substance through the nozzle of the nosepiece, wherein the site includes at least a part of the olfactory region.

132. 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 nosepiece including a nozzle through which substance is delivered to the nasal airway, and at least one cuff member, at least one of the at least one cuff member including at least one lobe which, when the at least one of the at least one cuff member is fitted in the nasal cavity of the subject, extends into a region of the nasal cavity of the subject such as to at least partially obstruct the same and prevent flow thereinto;

the subject exhaling through a mouthpiece unit to cause closure of the oropharyngeal velum of the subject;

providing a flow channel fluidly connecting the nosepiece and the mouthpiece unit, whereby exhaled air from an exhalation breath is delivered through the nosepiece; and

delivering substance through the nozzle of the nosepiece.