NASAL DELIVERY

• US 20090320832A1
• Filed: 03/23/2007
• Published: 12/31/2009
• Est. Priority Date: 03/23/2006
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupestand, Per Gisle
• Granted Patent: US 9,272,104 B2
• Time in Patent Office: Days
• US Class Current: 128/200.23
• 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 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/075 Bulb type
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth

Abstract

A delivery device for and method of delivering a dose of substance for systemic uptake to a nasal cavity of a subject, the delivery device comprising: a nosepiece unit for insertion into a nasal cavity of a subject and comprising an outlet unit which includes at least one nozzle for delivering substance for systemic uptake substantially only to surfaces in one or both of the anterior region and an anterior section of the posterior region of the nasal cavity of the subject; and a substance supply unit which is operable to deliver a dose of substance to the at least one nozzle.

Claims

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

a nosepiece unit for insertion into a nasal cavity of a subject and comprising an outlet unit which includes at least one nozzle for delivering substance for systemic uptake to surfaces in one or both of the anterior region and an anterior section of the posterior region of the nasal cavity of the subject; and

a substance supply unit which is operable to deliver substance to the at least one nozzle.

2. The delivery device of claim 1, wherein the anterior section of the posterior region comprises an anterior third of the posterior region or the anterior section of the posterior region comprises a mid-anterior third of the posterior region.

4. The delivery device of claim 1, wherein the at least one nozzle is configured to deliver substance substantially only to surfaces in one or both of the anterior region and an anterior section of the posterior region or the at least one nozzle is configured to deliver substance substantially only to the anterior region.

6. The delivery device of claim 1, wherein the at least one nozzle is configured to deliver an aerosol spray, wherein the aerosol spray is a liquid aerosol or a powder aerosol.

9. The delivery device of claim 1, wherein the at least one nozzle is configured to deliver a liquid jet or a powder jet.

11. The delivery device of claim 1, wherein the at least one nozzle is substantially laterally directed, to direct substance to a lateral surface within the anterior region.

12. The delivery device of claim 1, wherein the outlet unit includes a plurality of nozzles.

13. The delivery device of claim 1, wherein the outlet unit includes at least one first nozzle for delivering substance for systemic uptake to the anterior region, and at least one second nozzle for delivering substance for systemic uptake to the anterior section of the posterior region.

14. The delivery device of claim 1, wherein the outlet unit further comprises at least one further nozzle for delivering further substance, other than the substance as delivered to the anterior region, to the posterior region.

15. The delivery device of claim 1, wherein the outlet unit includes an anterior nosepiece member which is configured to obstruct the opening of the nasal cavity into which the nosepiece unit is inserted.

16. The delivery device of claim 1, wherein the outlet unit includes a posterior nosepiece member which is configured to obstruct the nasal cavity at a position therealong and partition the anterior and posterior regions, such that substantially all of the dose of substance as delivered from the at least one nozzle is delivered to the anterior region.

17. The delivery device of claim 16, wherein the posterior nosepiece member obstructs a region of the nasal airway which is posterior of the nasal valve, is configured to close the nasal valve, or both obstructs a region of the nasal airway which is posterior of the nasal valve and is configured to close the nasal valve.

19. The delivery device of claim 16, wherein the posterior region represents the posterior two-thirds of the nasal cavity and the anterior region represents the anterior one-third of the nasal cavity.

20. The delivery device of claim 16, wherein the posterior nosepiece member comprises an expandable member, a resilient member which expands on insertion into the nasal cavity to obstruct the nasal cavity and partition the same or an inflatable member which is configured to be inflated subsequent to insertion into the nasal cavity to obstruct the nasal cavity and partition the same.

23. The delivery device of claim 1, wherein the outlet unit includes a first, anterior nosepiece member which in use is configured to obstruct the opening of the nasal cavity into which the nosepiece unit is inserted, and a second, posterior nosepiece member which in use is configured to obstruct the nasal cavity at a position therealong and partition the anterior and posterior regions, such that substantially all of the dose of substance as delivered from the at least one nozzle is delivered to the anterior region between the anterior and posterior nosepiece members.

24. The delivery device of claim 23, wherein the posterior nosepiece member obstructs a region of the nasal airway which is posterior of the nasal valve, acts to close the nasal valve, or both obstructs a region of the nasal airway which is posterior of the nasal valve and acts to close the nasal valve.

26. The delivery device of claim 23, wherein the posterior region represents the posterior two-thirds of the nasal cavity and the anterior region represents the anterior one-third of the nasal cavity.

27. The delivery device of claim 23, wherein the posterior nosepiece member comprises an expandable member, a resilient member which expands on insertion into the nasal cavity to obstruct the nasal cavity and partition the same or an inflatable member which is inflated subsequent to insertion into the nasal cavity to obstruct the nasal cavity and partition the same.

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

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

31. The delivery device of claim 20 or 27, further comprising:

a mouthpiece through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject, wherein the mouthpiece is fluidly connected to the posterior nosepiece member, whereby in use exhaled air from an exhalation breath of the subject inflates the posterior nosepiece member.

32. The delivery device of claim 16 or 23, further comprising:

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

wherein the outlet unit further comprises a delivery channel which fluidly connects the partitioned anterior region to the mouthpiece, whereby in use exhaled air from an exhalation breath of the subject is delivered to the anterior region to expand the same.

33. The delivery device of claim 16 or 23, further comprising:

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

wherein the outlet unit further comprises at least one further nozzle for delivering further substance, other than the substance as delivered to the anterior region, to the posterior region, and a delivery channel which fluidly connects the partitioned posterior region to the mouthpiece, whereby in use exhaled air from an exhalation breath of the subject is delivered as an air flow to the posterior region to entrain substance as delivered from the at least one further nozzle.

34. The delivery device of claim 20 or 27, wherein the outlet unit further comprises a delivery channel through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is in use delivered to the posterior nosepiece member to inflate the same, and the delivery device further comprises:

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

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

35. The delivery device of claim 16 or 23, wherein the outlet unit further comprises a delivery channel through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is in use delivered to the partitioned anterior region, whereby the gas flow is delivered to the anterior region to expand the same, and the delivery device further comprises:

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

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

36. The delivery device of claim 16 or 23, wherein the outlet unit further comprises at least one further nozzle for delivering further substance, other than the substance as delivered to the anterior region, to the posterior region, and a delivery channel through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is in use delivered to the posterior region, whereby the gas flow is delivered to the posterior region to entrain substance as delivered from the at least one further nozzle, and the delivery device further comprises:

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

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

37. The delivery device of claim 1, wherein the substance supply unit is breath actuated on oral exhalation by the subject or on nasal exhalation by the subject, or the substance supply unit is manually actuated.

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40. A method of delivering substance for systemic uptake to a nasal cavity of a subject, the method comprising the steps of:

disposing a nosepiece unit in the nasal cavity of the subject, the nosepiece unit comprising at least one nozzle for delivering substance for systemic uptake to surfaces in one or both of the anterior region and an anterior section of the posterior region of the nasal cavity of the subject; and

delivering substance from a substance supply unit to the at least one nozzle, such that the substance is delivered to surfaces in one or both of the anterior region and the anterior section of the posterior region.

41. The method of claim 40, wherein the anterior section of the posterior region comprises an anterior third of the posterior region or the anterior section of the posterior region comprises a mid-anterior third of the posterior region.

43. The method of claim 40, wherein the at least one nozzle delivers substance substantially only to surfaces in one or both of the anterior region and the anterior section of the posterior region or the at least one nozzle delivers substance substantially only to the anterior region.

45. The method of claim 40, wherein the at least one nozzle delivers an aerosol spray, wherein the aerosol spray is a liquid aerosol or a powder aerosol.

48. The method of claim 40, wherein the at least one nozzle delivers a liquid jet or a powder jet.

50. The method of claim 40, wherein the at least one nozzle is substantially laterally directed, to direct substance to a lateral surface within the anterior region.

51. The method of claim 40, wherein the nosepiece unit includes a plurality of nozzles.

52. The method of claim 40, wherein the nosepiece unit includes at least one first nozzle for delivering substance for systemic uptake to the anterior region, and at least one second nozzle for delivering substance for systemic uptake to the anterior section of the posterior region.

53. The method of claim 40, wherein the nosepiece unit further comprises at least one further nozzle for delivering further substance, other than the substance as delivered to the anterior region, to the posterior region, and the substance delivery step comprises the steps of:

delivering the one substance to the at least one nozzle; and

delivering the further substance to the at least one further nozzle.

54. The method of claim 40, wherein the nosepiece unit includes an anterior nosepiece member which obstructs the opening of the nasal cavity into which the nosepiece unit is inserted.

55. The method of claim 40, wherein the nosepiece unit includes a posterior nosepiece member which obstructs the nasal cavity at a position therealong and partitions the anterior and posterior regions, such that substantially all of the dose of substance as delivered from the at least one nozzle is delivered to the anterior region.

56. The method of claim 55, wherein the posterior nosepiece member obstructs a region of the nasal cavity which is posterior of the nasal valve, closes the nasal valve, or both obstructs a region of the nasal cavity which is posterior of the nasal valve and closes the nasal valve.

58. The method of claim 55, wherein the posterior region represents the posterior two-thirds of the nasal cavity and the anterior region represents the anterior one-third of the nasal cavity.

59. The method of claim 55, wherein the posterior nosepiece member comprises an expandable member, a resilient member which expands on insertion into the nasal cavity to obstruct the nasal cavity and partition the same or an inflatable member which is inflated subsequent to insertion into the nasal cavity to obstruct the nasal cavity and partition the same.

62. The method of claim 40, wherein the nosepiece unit includes a first, anterior nosepiece member which obstructs the opening of the nasal cavity into which the nosepiece unit is inserted, and a second, posterior nosepiece member which obstructs the nasal cavity at a position therealong and partitions the anterior and posterior regions, such that substantially all of the dose as delivered from the at least one nozzle is delivered to the anterior region between the anterior and posterior nosepiece members.

63. The method of claim 62, wherein the posterior nosepiece member obstructs a region of the nasal airway which is posterior of the nasal valve, closes the nasal valve, or both obstructs a region of the nasal airway which is posterior of the nasal valve and closes the nasal valve.

65. The method of claim 62, wherein the posterior region represents the posterior two-thirds of the nasal cavity and the anterior region represents the anterior one-third of the nasal cavity.

66. The method of claim 62, wherein the posterior nosepiece member comprises an expandable member a resilient member which expands on insertion into the nasal cavity to obstruct the nasal cavity and partition the same or an inflatable member which is inflated subsequent to insertion into the nasal cavity to obstruct the nasal cavity and partition the same.

69. The method of claim 40, further comprising the step of:

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

70. The method of claim 59 or 66, further comprising the step of:

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

wherein the mouthpiece is fluidly connected to the posterior nosepiece member, whereby exhaled air from an exhalation breath of the subject inflates the posterior nosepiece member.

71. The method of claim 55 or 62, further comprising the step of:

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

wherein the nosepiece unit further comprises a delivery channel which fluidly connects the partitioned anterior region to the mouthpiece, whereby exhaled air from an exhalation breath of the subject is delivered to the anterior region to expand the same.

72. The method of claim 55 or 62, wherein the nosepiece unit further comprises at least one further nozzle for delivering further substance, other than the substance as delivered to the anterior region, to the posterior region, and a delivery channel which fluidly connects the partitioned posterior region to the mouthpiece, whereby exhaled air from an exhalation breath of the subject is delivered as an air flow to the posterior region to entrain substance as delivered from the at least one further nozzle, the substance delivery step comprises the steps of:

delivering the one substance to the at least one nozzle; and

delivering the further substance to the at least one further nozzle; and

further comprising the step of;

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

73. The method of claim 59 or 66, wherein the nosepiece unit further comprises a delivery channel through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the posterior nosepiece member to inflate the same, and further comprising the steps of:

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

supplying a gas flow to the delivery channel.

74. The method of claim 55 or 62, wherein the nosepiece unit further comprises a delivery channel through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the partitioned anterior region, whereby the gas flow is delivered to the anterior region to expand the same, and further comprising the steps of:

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

supplying a gas flow to the delivery channel.

75. The method of claim 55 or 62, wherein the nosepiece unit further comprises at least one further nozzle for delivering further substance, other than the substance as delivered to the anterior region, to the posterior region, and a delivery channel through which a gas flow, separate to an exhaled air flow from an exhalation breath of the subject, is delivered to the posterior region, whereby the gas flow is delivered to the posterior region to entrain substance as delivered from the at least one further nozzle, the substance delivery step comprises the steps of:

delivering the one substance to the at least one nozzle; and

delivering the further substance to the at least one further nozzle;

and further comprising the steps of;

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

supplying a gas flow to the delivery channel.

76. The method of claim 40, wherein the substance supply unit is breath actuated on oral exhalation by the subject or on nasal exhalation by the subject, or the substance supply unit is manually actuated.

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