NASAL DELIVERY DEVICES

• US 20110088690A1
• Filed: 10/03/2008
• Published: 04/21/2011
• Est. Priority Date: 10/03/2007
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Sheldrake, Colin David, Djupesland, Per Gisle
• Granted Patent: US 9,067,034 B2
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61M 11/006 operated by applying mechanical pressure to the liquid to be sprayed or atomised
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 11/08 Pocket atomisers of the injector type aerosol cans A61M15/009
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0015 located upstream of the dispenser, i.e. not traversed by the product
• CPC Class Codes: A61M 15/002 with air flow regulating means
• 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 15/0095 Preventing manual activation in absence of inhalation
• 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 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/8281 spring operated

Abstract

A nasal delivery device for and a method of delivering substance to a nasal airway of a subject, the nasal delivery device comprising : a mouthpiece (519) through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject; a nosepiece (517) for fitting to a nostril of a subject, the nosepiece including a nozzle (549) through which substance is in use delivered to the nasal airway; and a manually-actuatable substance supply unit (520) for delivering substance through the nozzle of the nosepiece.

Claims

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

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

a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is in use delivered to the nasal airway; and

a manually-actuatable substance supply unit for delivering substance through the nozzle of the nosepiece.

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

a latch mechanism which is operative between a first, inoperative configuration in which the substance supply unit is inactuatable and a second, operative configuration in which the substance supply unit is actuatable.

3. The delivery device of claim 2, wherein the latch mechanism is a breath-operated mechanism which comprises a latch member which is movable on exhalation by the subject between a first, inoperative position in which the substance supply unit is inactuatable and a second, operative position in which the substance supply unit is actuatable, optionally the latch mechanism comprises a biasing element for biasing the latch member to the inoperative position, optionally the latch mechanism comprises an operative element which is coupled to the latch member and operated by the exhalation breath of the subject to move the latch member to the operative position, optionally the operative element comprises an inflatable element which is expanded on exhalation by the subject.

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

a valve assembly which is fluidly connected to the mouthpiece and the nosepiece, and operable between a closed configuration in which there is no fluid communication path between the mouthpiece and the nosepiece and an open configuration on actuation of the substance supply unit, such as to provide for an air flow through the nosepiece on actuation of the substance supply unit.

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

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

9. The delivery device of claim 1, wherein the substance supply unit is configured to be manually depressed by the subject.

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

a loading mechanism which is operable to be primed with a loading force and manually actuated to apply the loading force to the substance supply unit, such as to actuate the same.

11. The delivery device of claim 1, wherein the substance supply unit comprises a substance-containing chamber which provides a volume of substance for delivery by the delivery device, optionally the substance supply unit further comprises a piston member which is movable relative to the substance-containing chamber to deliver a dose of substance from the substance-containing chamber.

13. The delivery device of claim 11, wherein the piston member is movable between a plurality of respective positions, such as to deliver a metered dose of substance with each advance of the piston member between respective ones of the positions, optionally the piston member is movable relative to a body member and one of the piston member and the body member includes a track which includes track sections which define each of the respective positions, and the other of the piston member and the body member includes a follower which is located in the track and moved in succession to each of the respective positions on actuation of the piston member, optionally the substance supply unit is a duo-dose pump unit, with the piston member being movable to two separate positions.

16. The delivery device of claim 11, wherein the substance-containing chamber comprises first and second chambers which each separately contain a respective substance component and provide for re-constitution of the substance components to provide a re-constituted substance for delivery by the delivery device, optionally the substance-containing chamber further comprises a frangible member which normally separates the first and second chambers and when ruptured provides for re-constitution of the substance components to provide a re-constituted substance for delivery by the delivery device, optionally the delivery device includes a rupturing element which is configured to rupture the frangible member on fitting the substance-containing chamber to the housing.

19. The delivery device of claim 1, wherein the substance supply unit provides for the delivery of a powder or liquid substance.

21. The delivery device of claim 19, wherein the substance is delivered as an aerosol or a jet.

23. The delivery device of claim 1, wherein the nosepiece includes a sealing member which provides for a tight sealing fit with the nostril of the subject.

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

a flow regulator which is configured, with actuating movement of the substance supply unit, to regulate flow characteristics, such as flow rate, flow profile and flow duration, of an exhalation air flow as delivered through the nosepiece, optionally the flow regulator includes an aperture into which extends a movable part of the substance supply unit, such that, with actuating movement of the substance supply unit, the effective area of a flow channel to the nosepiece has a predeterminable profile over the actuating movement of the substance supply unit.

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

providing a delivery device which comprises a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is delivered, and a manually-actuatable substance supply unit for delivering substance through the nozzle of the nosepiece;

fitting the nosepiece to a nostril of a subject; and

manually actuating the substance supply unit to deliver substance to the nasal airway of the subject.

27. The method of claim 26, wherein the nosepiece fitting step comprises the step of:

fitting the nosepiece to a nostril of a subject, such that the nosepiece is in sealing engagement with the nostril of the subject.

28. The method of claim 26, further comprising the step of:

closing the oropharyngeal velum of the subject;

optionally the delivery device further comprises a mouthpiece, and the oropharyngeal velum closing step comprises the step of;

the subject exhaling through the mouthpiece such as to close the oropharyngeal velum of the subject.

30. The method of claim 28, wherein the delivery device further comprises a valve assembly which is fluidly connected to the mouthpiece and the nosepiece, and operable between a closed configuration in which there is no fluid communication path between the mouthpiece and the nosepiece and an open configuration on actuation of the substance supply unit, whereby an exhalation air flow is delivered through the nosepiece on actuation of the substance supply unit.

31. The method of claim 26, wherein the delivery device further comprises a latch mechanism which is operative between a first, inoperative configuration in which the substance supply unit is inactuatable and a second, operative configuration in which the substance supply unit is actuatable.

32. The method of claim 31, wherein the latch mechanism is a breath-operated mechanism which comprises a latch member which is movable on exhalation by the subject between a first, inoperative position in which the substance supply unit is inactuatable and a second, operative position in which the substance supply unit is actuatable, optionally the latch mechanism comprises a biasing element for biasing the latch member to the inoperative position, optionally the latch mechanism comprises an operative element which is coupled to the latch member and operated by the exhalation breath of the subject to move the latch member to the operative position, optionally the operative element comprises an inflatable element which is expanded on exhalation by the subject.

36. The method of claim 26, further comprising the step of:

re-constituting the substance from at least first and second substance components.

37. The method of claim 26, further comprising the step of:

regulating flow characteristics, such as flow rate, flow profile and flow duration, of an exhalation air flow as delivered through the nosepiece using a flow regulator, optionally the flow regulator includes an aperture into which extends a movable part of the substance supply unit, such that, with actuating movement of the substance supply unit, the effective area of a flow channel to the nosepiece has a predeterminable profile over the actuating movement of the substance supply unit.

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

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

a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is in use delivered to the nasal airway;

a manually-actuatable substance supply unit which is manually actuatable by the subject to deliver substance through the nozzle of the nosepiece; and

a latch mechanism which is operative between a first, inoperative configuration in which the substance supply unit is inactuatable and a second, operative configuration in which the substance supply unit is manually actuatable by the subject.

40. The delivery device of claim 39, further comprising:

a latch mechanism which is operative between a first, inoperative configuration in which the substance supply unit is inactuatable and a second, operative configuration in which the substance supply unit is actuatable.

41. The delivery device of claim 40, wherein the latch mechanism is a breath-operated mechanism which comprises a latch member which is movable on exhalation by the subject between a first, inoperative position in which the substance supply unit is inactuatable and a second, operative position in which the substance supply unit is actuatable, optionally the latch mechanism comprises a biasing element for biasing the latch member to the inoperative position, optionally the latch mechanism comprises an operative element which is coupled to the latch member and operated by the exhalation breath of the subject to move the latch member to the operative position, optionally the operative element comprises an inflatable element which is expanded on exhalation by the subject.

46. The delivery device of claim 39, 42 or 43, wherein the substance supply unit is configured to be manually depressed by the subject.

47. The delivery device of claim 39, 42 or 43, wherein the substance supply unit provides for the delivery of a powder or liquid substance.

48. The delivery device of claim 39, 42 or 43, wherein the substance is delivered as an aerosol or a jet.

49. The delivery device of claim 39, 42 or 43, wherein the nosepiece includes a sealing member which provides for a tight sealing fit with the nostril of the subject.

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

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

a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is in use delivered to the nasal airway;

a manually-actuatable substance supply unit which is manually actuatable by the subject to deliver substance through the nozzle of the nosepiece; and

a valve assembly which is fluidly connected to the mouthpiece and the nosepiece, and operable between a closed configuration in which there is no fluid communication path between the mouthpiece and the nosepiece and an open configuration on manual actuation of the substance supply unit by the subject, such as to provide for an air flow through the nosepiece on manual actuation of the substance supply unit by the subject.

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

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

a nosepiece for fitting to a nostril of a subject, the nosepiece including a nozzle through which substance is in use delivered to the nasal airway;

a manually-actuatable substance supply unit for delivering substance through the nozzle of the nosepiece, wherein the substance supply unit comprises a body part which is movable from a first, rest position to a second, actuated position on manual actuation of the substance supply unit; and

a body member which receives the substance supply unit, wherein the body member includes an inlet which is in fluid communication with the mouthpiece and an outlet which is in fluid communication with the nosepiece;

wherein the inlet of the body member is opened when the body part of the substance supply unit is moved to the actuated position, thereby providing for an air flow through the nosepiece simultaneously with manual actuation of the substance supply unit.

44. The delivery device of claim 43, further comprising:

a latch mechanism which is operative between a first, inoperative configuration in which the substance supply unit is inactuatable and a second, operative configuration in which the substance supply unit is actuatable, optionally the latch mechanism is a breath-operated mechanism which comprises a latch member which is movable on exhalation by the subject between a first, inoperative position in which the substance supply unit is inactuatable and a second, operative position in which the substance supply unit is actuatable.

45. The delivery device of claim 44, wherein the latch mechanism comprises a biasing element for biasing the latch member to the inoperative position, optionally the latch mechanism comprises an operative element which is coupled to the latch member and operated by the exhalation breath of the subject to move the latch member to the operative position, optionally the operative element comprises an inflatable element which is expanded on exhalation by the subject.