Nasal delivery device

• US 8,555,878 B2
• Filed: 06/02/2006
• Issued: 10/15/2013
• Est. Priority Date: 03/03/1999
• Status: Expired due to Fees

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US11/445,994
• Publication Number:
  US 20060219241A1
• Time in Patent Office: 2,692 Days
• Field of Search: 606/202.22, 606/203.12, 606/203.15, 606/203.21, 606/203.22, 606/203.24, 606/200.24, 606/204.11, 606/204.12, 482/13, 128/200.23, 128/203.15, 128/203.18, 128/203.22, 128/207.18
• US Class Current: 128/203.22
• 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. A manually-actuated device for delivering a substance to the nasal airway of a subject, comprising:

a flow resistor; and

a nosepiece shaped and sized for insertion into a nostril of the subject comprising an outlet through which a substance may be delivered into the nasal airway of the subject, and a sealing member configured to seal the one nostril of the subject to the outlet, the sealing member having a first, distal end and a second, proximal end and being enlarged towards the proximal end to cause an anterior region of the nasal cavity into which the nosepiece is inserted to be enlarged; and

a substance supply unit in fluid communication with the outlet of the nosepiece and including a dispensing unit which is manually actuated to dispense a metered dose of substance into an exhalation air flow, wherein the exhalation air flow has a flow rate of at least 10 liters per minute;

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.

2. The device of claim 1, wherein the flow resistor is operably connected to a tubular section configured to be held between the lips of the subject.

3. The device of claim 1, wherein the flow resistor is operably connected to a mouthpiece.

4. The device of claim 1, wherein the flow resistor is fluidly connected to the nosepiece and located upstream of the substance supply unit.

5. The device of claim 1, wherein the nosepiece is formed of a resilient material.

6. The device of claim 1, 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.

7. The device of claim 1, further comprising:

a positive pressure indicator or a flow rate indicator.

8. The device of claim 1, 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.

9. A combination of the device of claim 1 and a substance to be delivered.

10. The combination of claim 9, wherein the substance comprises particles principally in the range of about 1 to 10 μ

m.

11. A combination of the device of claim 1 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.

12. The combination of claim 11, wherein the separate outlet unit further comprises an indicator for signaling when a predetermined positive pressure has been reached upstream of the indicator in the nasal airway of the subject.

13. The combination of claim 11, 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.

14. The device of claim 1, wherein the substance comprises a liquid.

15. The device of claim 1, wherein the substance comprises a powder.

16. The device of claim 1, wherein the exhalation air flow has a flow rate of at least 15 liters per minute.

17. The device of claim 1, wherein the exhalation air flow has a flow rate of at least 20 liters per minute.

18. The device of claim 1, wherein the exhalation air flow has a flow rate of about 10 to 20 liters per minute.

19. The device of claim 1, wherein the exhalation air flow has a delivery time of about 2 to 5 seconds.

20. The device of claim 1, further configured to cause the generation of a dynamic positive pressure of at least 5 cm H₂0 in the nasal airway.

21. The device of claim 1, further configured to cause the generation of a dynamic positive pressure of at least 50 cm H₂0 in the nasal airway.

22. The device of claim 1, further configured to cause the generation of a dynamic positive pressure of at least 100 cm H₂0 in the nasal airway.