Nasal delivery devices

• US 8,590,530 B2
• Filed: 05/14/2012
• Issued: 11/26/2013
• Est. Priority Date: 09/15/2004
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle, Hafner, Roderick Peter, Sheldrake, Colin David
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/471,146
• Publication Number:
  US 20130098362A1
• Time in Patent Office: 561 Days
• Field of Search: 128/200.13, 128/203.22, 128/203.23, 128/203.24, 128/207.18, 128/202.22, 128/203.12, 128/203.15, 128/203.21, 128/204.11, 128/204.12
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0008 rotating by airflow
• 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 15/0035 Piercing means
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• 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 16/1055 bacterial
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/1075 by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 2202/064 Powder

Abstract

A nasal delivery device for and method of delivering substance to a nasal cavity of a subject, the delivery device comprising: a container-receiving unit comprising a container chamber for receiving a substance-containing container which contains substance to be delivered to the nasal cavity of the subject, the container chamber including an inlet and an outlet; a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject and being in fluid communication with the outlet of the container chamber; a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the container chamber and through which the subject in use exhales, such as to entrain substance from the container and deliver the same through the nosepiece; and moisture-mitigation means for mitigating an effect of moisture in an exhaled breath on the entrainment of substance from the container.

Claims

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

a container-receiving unit comprising a container chamber for receiving a substance-containing container which contains substance to be delivered to the nasal cavity of the subject, the container chamber including an inlet and an outlet;

a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject, the nosepiece being in fluid communication with the outlet of the container chamber; and

a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the container chamber and through which the subject in use exhales, so as to entrain substance from the container and deliver the same through the nosepiece, and an air chamber which fluidly connects the mouthpiece to the inlet of the container chamber, wherein the air chamber incorporates a temperature regulator for regulating a temperature of an air flow as exhaled therethrough.

2. The delivery device of claim 1, wherein the air chamber has a greater volume than the container chamber.

3. The delivery device of claim 2, wherein the air chamber has a volume at least twice that of the container chamber.

4. The delivery device of claim 1, wherein the temperature regulator is operative to cool the exhaled air flow.

5. The delivery device of claim 1, wherein the temperature regulator is located at least at an upstream end of the air chamber.

6. The delivery device of claim 1, wherein the temperature regulator substantially fills the air chamber.

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

a pressure-sensitive valve in fluid communication with the inlet of the container chamber and being configured so as to close the inlet of the container chamber until a predetermined pressure is developed upstream of the pressure-sensitive valve.

8. The delivery device of claim 7, wherein the container-receiving unit includes the pressure-sensitive valve.

9. The delivery device of claim 1, wherein the nosepiece unit is removable.

10. A combination of the delivery device of claim 1 and a container in the form of a capsule containing a powdered substance.

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

a container-receiving unit comprising a container chamber for receiving a container-containing member which contains a substance-containing container which contains substance to be delivered to the nasal cavity of the subject, wherein the container chamber includes an inlet and an outlet and the container-containing member includes a flow passage in which the container is disposed so as to be rotatable therewithin when an air flow is delivered therethrough;

a nosepiece unit including a nosepiece for fitting to a nasal cavity of the subject, the nosepiece being in fluid communication with the outlet of the container chamber; and

a mouthpiece unit including a mouthpiece in fluid communication with the inlet of the container chamber and through which the subject in use exhales so as to entrain substance from the container and deliver the same through the nosepiece.

12. The delivery device of claim 11, wherein the mouthpiece unit further comprises an air chamber which fluidly connects the mouthpiece to the inlet of the container chamber.

13. The delivery device of claim 12, wherein the air chamber has a volume greater than that of the container chamber.

14. The delivery device of claim 12, wherein the air chamber incorporates a temperature regulator for regulating a temperature of an air flow as exhaled therethrough.

15. The delivery device of claim 11, further comprising:

a pressure-sensitive valve in fluid communication with the inlet of the container chamber and being configured so as to close the inlet of the container chamber until a predetermined pressure is developed upstream of the pressure-sensitive valve.

16. The delivery device of claim 15, wherein the container-receiving unit comprises the pressure-sensitive valve.

17. The delivery device of claim 11, wherein the nosepiece unit is removable.

18. The delivery device of claim 17, wherein the nosepiece unit includes the container-containing member which contains the container, and the container-containing member is fitted in the container chamber when fitting the nosepiece unit.

19. The delivery device of claim 11, wherein the container-containing member includes an inlet aperture in fluid communication with one, upstream end of the flow passage, and the inlet aperture provides a flow restriction to an air flow as delivered therethrough.

20. The delivery device of claim 19, wherein the inlet aperture provides a seat on which a lower end of the container is seated prior to delivery of an air flow through the flow passage.

21. The delivery device of claim 11, further comprising:

a replaceable container-containing member which contains the container and is in use fitted in the container chamber.

22. The delivery device of claim 11, wherein the container-containing member is replaceable separately of the nosepiece, which is re-usable.

23. The delivery device of claim 11, wherein the container is replaceable and the nosepiece and the container-containing member are re-usable.

24. The delivery device of claim 11, further comprising:

a container-opening mechanism which is operative to open a container as received in the container chamber.

25. The delivery device of claim 24, wherein the container is only partially filled and the container-opening mechanism includes first and second piercing elements, with one of the piercing elements being configured to pierce the container at a height above a level to which the container is filled and the other of the piercing elements being configured to pierce an upper region of the container.

26. A combination of the delivery device of claim 11 and a container in the form of a capsule containing a powdered substance.

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

disposing a substance-containing container which contains substance to be delivered to the nasal cavity of the subject in a container chamber, the container chamber including an inlet and an outlet;

fitting a nosepiece in fluid communication with the outlet of the container chamber to a nasal cavity of the subject;

the subject exhaling through a mouthpiece and an air chamber which fluidly connects the mouthpiece to the inlet of the container chamber, the air chamber incorporating a temperature regulator for regulating a temperature of an air flow as exhaled therethrough so as to deliver an air flow through the container chamber and entrain substance from the container and deliver the same through the nosepiece and into the nasal cavity of the subject; and

drawing moisture from the exhaled air flow upstream of the container chamber so as to reduce condensation at or downstream of the container chamber, by regulating a temperature of an air flow as exhaled through the temperature regulator.

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

disposing a container-containing member which contains a substance-containing container which contains substance to be delivered to the nasal cavity of the subject in a container chamber, wherein the container chamber includes an inlet and an outlet and the container-containing member includes a flow passage in which the container is disposed so as to be rotatable therewithin when an air flow is delivered therethrough;

fitting a nosepiece in fluid communication with the outlet of the container chamber to a nasal cavity of the subject; and

the subject exhaling through a mouthpiece which is in fluid communication with the inlet of the container chamber so as to deliver an air flow through the container chamber and rotate the container within the flow passage of the container-containing member, and entrain substance from the container and deliver the same through the nosepiece and into the nasal cavity of the subject.