NASAL DELIVERY

• US 20090314293A1
• Filed: 03/06/2007
• Published: 12/24/2009
• Est. Priority Date: 03/06/2006
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Granted Patent: US 8,550,073 B2
• Time in Patent Office: Days
• US Class Current: 128/203.180
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• 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 15/0091 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 15/085 Fixing means therefor
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A nasal delivery device for and method of delivering substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece unit (20, 24) including a nosepiece (17) for fitting to a nostril of a subject and a nozzle (45) through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the respective nasal cavity, wherein at least a tip element of the nosepiece has, at least in one configuration, an elongate lateral section which has a longer dimension in a first, sagittal direction than a second direction orthogonal to the sagittal direction, such that, when the nosepiece is inserted in the nasal cavity of the subject, the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity, preferably at the nasal valve, and expand the same in the sagittal plane; and a delivery unit (43, 49, 51) for delivering substance through the nozzle of the nosepiece.

Claims

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

a nosepiece unit including a nosepiece for fitting to a nostril of a subject and a nozzle through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the respective nasal cavity, wherein at least a tip element of the nosepiece has, at least in one configuration, an elongate lateral section which has a longer dimension in a first, sagittal direction than a second direction orthogonal to the sagittal direction, such that, when the nosepiece is inserted in the nasal cavity of the subject, the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity and expand the same in the sagittal plane; and

a delivery unit for delivering substance through the nozzle of the nosepiece.

2. The delivery device of claim 1, wherein the elongate lateral section of the tip element of the nosepiece is substantially elliptical or substantially rectangular.

5. The delivery device of claim 1, wherein the tip element of the nosepiece is inclined in the vertical, sagittal plane relative to the longitudinal axis of the nosepiece and preferably the tip element of the nosepiece is inclined upwardly.

7. The delivery device of claim 1, wherein at least the tip element of the nosepiece has a pre-defined shape and configuration, and preferably at least the tip element of the nosepiece comprises one of a substantially rigid structure a semi-rigid structure or a flexible structure or the nosepiece comprises a flexible nosepiece member which defines at least the tip element of the nosepiece and a supporting member which acts structurally to support the nosepiece member, preferably the supporting member is configured such as to render the nosepiece member substantially rigid in the vertical sagittal plane, but otherwise render flexibility to the nosepiece member, preferably such as to allow for bending in the horizontal plane and torsional flexing about the longitudinal axis of the nosepiece, and preferably the supporting member comprises an elongate plate which extends along an axial length of the nosepiece member in the sagittal plane.

14. The delivery device of claim 1, wherein at least the tip element of the nosepiece is expandable, such as to have an elongate lateral section when expanded, preferably the nosepiece unit includes pivoting arms which are manually operated to provide for expansion of the nosepiece preferably the tip element of the nosepiece comprises a tubular section of a flexible material which expands in the vertical sagittal direction when compressed in the horizontal direction and preferably the tip element of the nosepiece includes supporting elements which extend from inner surfaces of the lateral sections of the tip element of the nosepiece, such as to prevent compression of the lateral sections of the tip element of the nosepiece beyond a predeterminable separation.

18. The delivery device of claim 1, wherein the nozzle provides for the delivery of a single jet or a plurality of jets which define a jet spray, preferably the jet spray has an asymmetric profile, with the jet spray having a greater spray angle in the vertical, sagittal direction than in the horizontal direction, preferably the spray angle in the vertical sagittal direction is greater than about 35°

, preferably greater than about 40°

, preferably greater than about 45° and

preferably greater than about 50°

, and preferably the spray angle in the horizontal direction is not more than about 35°

, preferably not more than about 30°

, preferably not more than about 25°

, preferably not more than about 20°

, preferably not more than about 15°

, preferably not more than about 10° and

preferably approaching 0°

.

32. The delivery device of claim 18, wherein the one or more jets comprise a liquid jet or a powder jet.

34. The delivery device of claim 1, wherein the nozzle provides for the delivery of an aerosol spray, preferably the aerosol spray has an asymmetric profile, with the aerosol spray having a greater spray angle in the vertical, sagittal direction than in the horizontal direction, preferably the spray angle in the vertical, sagittal direction is greater than about 35°

, preferably greater than about 40°

, preferably greater than about 45° and

preferably greater than about 50°

, and preferably the spray angle in the horizontal direction is not more than about 35°

, preferably not more than about 30°

, preferably not more than about 25°

, preferably not more than about 20° and

preferably not more than about 15°

.

45. The delivery device of claim 34, wherein the aerosol spray comprises a liquid spray or a powder spray.

47. The delivery device of claim 1, wherein the nosepiece is configured, when inserted into the nasal cavity, to extend into the nasal valve, such that the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity at the nasal valve and expand the same in the sagittal plane.

48. The delivery device of claim 1, further comprising:

a housing to which the nosepiece unit is attached; and

wherein the nosepiece unit includes a flexible coupling which couples the nosepiece to the housing, such as to allow for bending movement of the nosepiece relative to the housing, preferably the flexible coupling comprises a resilient coupling, and preferably the flexible coupling allows for axial compression of the nosepiece relative to the housing.

51. The delivery device of claim 48, wherein the nosepiece comprises a flexible nosepiece member which defines at least the tip element of the nosepiece and a supporting member which acts structurally to support the nosepiece member, and the flexible coupling is defined by the supporting member, preferably the flexible coupling is defined at the proximal, base section of the supporting member.

53. The delivery device of claim 1, further comprising:

a mouthpiece unit through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject; and

preferably further comprising one of;

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

or

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 in use delivered to the nosepiece; and

a gas supply unit for supplying a gas flow to the flow channel.

56. The delivery device of claim 1, wherein the delivery unit is manually actuatable, or further comprising:

an actuation mechanism for actuating the delivery unit in response to oral exhalation by the subject.

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35-44. -44. (canceled)

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

a nosepiece unit including a nosepiece for fitting to a nostril of a subject and a nozzle through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the respective nasal cavity, wherein the nozzle is configured to deliver substance with an asymmetric profile, such that the profile has a greater angle in a first, sagittal direction than a second direction orthogonal to the sagittal direction; and

a delivery unit for delivering substance through the nozzle of the nosepiece.

59. The delivery device of claim 58, wherein the nozzle provides for the delivery a jet spray, preferably defined by a plurality of jets, preferably the jet spray has a greater spray angle in the vertical, sagittal direction than in the horizontal direction, preferably the spray angle in the vertical, sagittal direction is greater than about 35°

, preferably greater than about 40°

, preferably greater than about 45° and

preferably greater than about 50°

, and preferably the spray angle in the horizontal direction is not more than about 35°

, preferably not more than about 30°

, preferably not more than about 25°

, preferably not more than about 20°

, preferably not more than about 15°

, preferably not more than about 10° and

preferably approaching 0°

.

72. The delivery device of claim 59, wherein the jets comprise liquid jets or powder jets.

74. The delivery device of claim 58, wherein the nozzle provides for the delivery of an aerosol spray, preferably the aerosol spray has a greater spray angle in the vertical, sagittal direction than in the horizontal direction, preferably the spray angle in the vertical, sagittal direction is greater than about 35°

, preferably greater than about 40°

, preferably greater than about 45° and

preferably greater than about 50°

, and preferably the spray angle in the horizontal direction is not more than about 35°

, preferably not more than about 30°

, preferably not more than about 25°

, preferably not more than about 20° and

preferably not more than about 15°

.

85. The delivery device of claim 74, wherein the aerosol spray comprises a liquid spray or a powder spray.

87. The delivery device of claim 58, wherein at least a tip element of the nosepiece has, at least in one configuration, an elongate lateral section which has a longer dimension in the first, sagittal direction than the second direction orthogonal to the sagittal direction, such that, when the nosepiece is inserted in the nasal cavity of the subject, the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity and expand the same in the sagittal plane, preferably the elongate lateral section of the tip element of the nosepiece is substantially elliptical or substantially rectangular.

91. The delivery device of claim 87, wherein the tip element of the nosepiece is inclined in the vertical, sagittal plane relative to the longitudinal axis of the nosepiece, and preferably the tip element of the nosepiece is inclined upwardly.

93. The delivery device of claim 87, wherein at least the tip element of the nosepiece has a pre-defined shape and configuration, and preferably at least the tip element of the nosepiece comprises one of a substantially rigid structure, a semi-rigid structure or a flexible structure or the nosepiece comprises a flexible nosepiece member which defines at least the tip element of the nosepiece and a supporting member which acts structurally to support the nosepiece member, preferably the supporting member is configured such as to render the nosepiece member substantially rigid in the vertical, sagittal plane, but otherwise render flexibility to the nosepiece member, preferably such as to allow for bending in the horizontal plane and torsional flexing about the longitudinal axis of the nosepiece, and preferably the supporting member comprises an elongate plate which extends along an axial length of the nosepiece member in the sagittal plane.

100. The delivery device of claim 87, wherein at least the tip element of the nosepiece is expandable, such as to have an elongate lateral section when expanded, preferably the nosepiece unit includes pivoting arms which are manually operated to provide for expansion of the nosepiece, preferably the tip element of the nosepiece comprises a tubular section of a flexible material which expands in the vertical, sagittal direction when compressed in the horizontal direction, and preferably the tip element of the nosepiece includes supporting elements which extend from inner surfaces of the lateral sections of the tip element of the nosepiece, such as to prevent compression of the lateral sections of the tip element of the nosepiece beyond a predeterminable separation.

104. The delivery device of claim 58, wherein the nosepiece is configured, when inserted into the nasal cavity, to extend into the nasal valve, such that the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity at the nasal valve and expand the same in the sagittal plane.

105. The delivery device of claim 58, further comprising:

a housing to which the nosepiece unit is attached; and

wherein the nosepiece unit includes a flexible coupling which couples the nosepiece to the housing, such as to allow for bending movement of the nosepiece relative to the housing, preferably the flexible coupling comprises a resilient coupling, and preferably the flexible coupling allows for axial compression of the nosepiece relative to the housing.

108. The delivery device of claim 105, wherein the nosepiece comprises a flexible nosepiece member which defines at least the tip element of the nosepiece and a supporting member which acts structurally to support the nosepiece member, and the flexible coupling is defined by the supporting member, and preferably the flexible coupling is defined at the proximal, base section of the supporting member.

110. The delivery device of claim 58, further comprising:

a mouthpiece unit through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject; and

preferably further comprising one of;

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

or

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 in use delivered to the nosepiece;

and a gas supply unit for supplying a gas flow to the flow channel.

113. The delivery device of claim 58, wherein the delivery unit is manually actuatable, or further comprising:

an actuation mechanism for actuating the delivery unit in response to oral exhalation by the subject.

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

a nosepiece unit including a nosepiece for fitting to a nostril of a subject and a nozzle through which substance is in use delivered to the respective nasal cavity, wherein the nozzle provides for the delivery of a plurality of jets which define a jet spray; and

a delivery unit for delivering substance through the nozzle of the nosepiece.

116. The delivery device of claim 115, wherein the jets comprise liquid jets or powder jets.

118. The delivery device of claim 115, wherein the jet spray has an asymmetric profile, such that the profile has a greater angle in a first direction than a second direction orthogonal to the first direction preferably the spray angle in the first direction is greater than about 35°

, preferably greater than about 40°

, preferably greater than about 45° and

preferably greater than about 50°

, and preferably the spray angle in the second direction is not more than about 35°

, preferably not more than about 30°

, preferably not more than about 25°

, preferably not more than about 20°

, preferably not more than about 15°

, preferably not more than about 10° and

preferably approaching 0°

.

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130. A nosepiece for fitting to a nostril of a subject through which substance is delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to a nasal cavity of the subject, wherein at least a tip element of the nosepiece has, at least in one configuration, an elongate lateral section which has a longer dimension in a first, sagittal direction than a second direction orthogonal to the sagittal direction, such that, when the nosepiece is inserted in the nasal cavity of the subject, the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity and expand the same in the sagittal plane.

131. A nosepiece unit for delivering substance to a nasal cavity of a subject, the nosepiece unit comprising a nosepiece for fitting to a nostril of the subject and a nozzle through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the nasal cavity, wherein the nozzle is configured to deliver substance with an asymmetric profile, such that the profile has a greater angle in a first, sagittal direction than a second direction orthogonal to the sagittal direction.

132. A nozzle for delivering substance to a nasal cavity of a subject, wherein the nozzle is configured to deliver substance with an asymmetric profile, such that the profile has a greater angle in a first direction than a second direction orthogonal to the first direction.

133. A nosepiece unit for delivering substance to a nasal cavity of a subject, the nosepiece unit comprising a nosepiece for fitting to a nostril of the subject and a nozzle through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the nasal cavity, wherein the nozzle provides for the delivery of a plurality of jets which define a jet spray.

134. A nozzle for delivering substance to a nasal cavity of a subject, wherein the nozzle is configured to deliver a plurality of jets which define a jet spray.

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

providing a nosepiece for fitting to a nostril of a subject, wherein at least a tip element of the nosepiece has, at least in one configuration, an elongate lateral section which has a longer dimension in a first, sagittal direction than a second direction orthogonal to the sagittal direction;

inserting the nosepiece into the nasal cavity of the subject, such that the longer dimension of the nosepiece engages lower and upper surfaces of the nasal cavity, preferably surfaces at the nasal valve, and expands the same in the sagittal plane; and

delivering substance through the nosepiece, preferably substantially axially to a longitudinal axis of the nosepiece, to the nasal cavity of the subject.