NASAL DELIVERY DEVICES

• US 20160095989A1
• Filed: 07/13/2015
• Published: 04/07/2016
• 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
• Granted Patent: US 10,398,859 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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, which means are provided, for example, by providing the container in a replaceable container-containing member, by a pressure-sensitive valve which normally closes the fluid connection between the container chamber and the mouthpiece, and a temperature regulator upstream of the container chamber.

Claims

1. (canceled)

2. A nosepiece unit for use with a nasal delivery device in delivering a substance to a nasal cavity of a subject by an exhalation air flow, the nosepiece unit comprising:

a nosepiece for fitting to a nostril of the subject; and

a container-containing member operatively connected to and in fluid communication with the nosepiece, the container-containing member including an elongate flow passage, a fluid inlet, and a fluid outlet;

wherein the container-containing member is configured to house a substance-containing container which contains the substance to be delivered to the nasal cavity of the subject; and

wherein a cross sectional opening of the fluid inlet is smaller than the cross sectional opening of the elongate flow passage forming a flow restriction.

3. The nosepiece unit of claim 2, wherein the container is a capsule containing a powdered substance.

4. The nosepiece unit of claim 2, wherein the fluid inlet forms a seat configured to support the substance-containing container at least when the container-containing member is in an upright orientation.

5. The nosepiece unit of claim 2, wherein the container-containing member further includes first and second apertures disposed in a lateral wall thereof configured to respectively permit first and second piercing elements to selectively extend into the elongate flow passage.

6. The nosepiece unit of claim 2, wherein the container-containing member is configured to permit a flow of exhalation breath through the elongate flow passage.

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

a housing;

a nosepiece unit mounted at least partially within the housing, the nosepiece unit including a nosepiece for fitting to a nostril of the subject and a container-containing member operatively connected to and in fluid communication with the nosepiece, the container-containing member including an elongate flow passage, a fluid inlet, and a fluid outlet; and

a mouthpiece through which the subject in use exhales to deliver an exhalation flow through the housing and into the nosepiece unit;

wherein the container-containing member is configured to house a substance-containing container which contains a substance to be delivered to the nasal cavity of the subject via the exhalation flow, wherein a cross sectional opening of the fluid inlet is smaller than the cross sectional opening of the elongate flow passage thereby forming a flow restriction.

8. A nosepiece unit for use with a nasal delivery device configured to deliver a substance to a nasal cavity of a subject by an exhalation flow, the nosepiece unit comprising:

a nosepiece for fitting to the nasal cavity of the subject; and

a container-containing member in fluid communication with the nosepiece and configured to house a substance-containing container that contains the substance to be delivered to the nasal cavity of the subject;

wherein the container-containing member includes a flow passage in which the substance-containing container is disposed and an inlet aperture in fluid communication with the flow passage; and

wherein the exhalation flow of the subject flows through the inlet aperture and the flow passage of the container-containing member.

9. The nosepiece unit of claim 8, further comprising first and second piercing apertures in a lateral wall of the flow passage of the container-containing member which are configured to receive first and second piercing elements of a container-opening mechanism and permit the first and second piercing elements to extend into the flow passage of the container-containing member.

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

a container-receiving unit comprising a chamber and a container-containing member slidingly fitted within the container chamber and configured to move between a first position and a second, operative position;

the container-containing member comprising a flow passage and configured to house a substance-containing container in the flow passage, the substance-containing-container containing the substance to be delivered to the nasal cavity of the subject;

the container-containing member also comprising an inlet at an upstream end of the flow passage and an outlet at a downstream end of the flow passage, and first and second apertures in a lateral wall thereof;

a nosepiece unit including a nosepiece for fitting to the nasal cavity of the subject;

a mouthpiece unit including a mouthpiece in fluid communication with the inlet through which the subject in use exhales so as to deliver an exhalation flow through the mouthpiece and the flow passage of the container-containing member, the exhalation flow configured to entrain substance from the substance-containing container; and

a container-opening mechanism configured to open the substance-containing container when the substance-containing container is disposed in the container-containing member, wherein the container-opening mechanism comprises first and second piercing elements which are arranged to pass through the first and second apertures in the lateral wall of the container-containing member only when the container-containing member is in the second, operative position.

11. The delivery device of claim 10, wherein the mouthpiece unit further comprises a chamber which fluidly connects the mouthpiece to the inlet of the container chamber.

12. The delivery device of claim 11, wherein the chamber has a volume greater than that of the container chamber.

13. The delivery device of claim 10, wherein the nosepiece unit includes the container containing member.

14. The delivery device of claim 13, wherein the nosepiece unit is removable.

15. The delivery device of claim 10, wherein the inlet provides a flow restriction to an exhalation flow as delivered therethrough.

16. The delivery device of claim 15, wherein the inlet forms a seat on which a first end of the substance-containing container is seated prior to delivery of an exhalation flow through the flow passage.

17. The delivery device of claim 10, wherein the substance-containing container is a capsule containing a powdered substance.

18. A nosepiece unit comprising a container-containing member which includes a flow passage in which a container is disposed and an inlet aperture in fluid communication with the flow passage, wherein the inlet aperture provides a seat on which a first end of the container is seated prior to delivery of an exhalation air flow through the inlet aperture, whereby the substance is released from the container only on delivery of the exhalation air flow through the inlet aperture.

19. A nasal delivery device comprising:

a container chamber which is configured to slidingly receive a container-containing member between a first position and a second, operative position, the container-containing member comprising a flow passage, in which a substance-containing container is disposed, and a lateral wall, having first and second apertures formed therein; and

a container-opening mechanism which is configured to selectively open the substance containing container disposed in the container-containing member, the container-opening mechanism comprising first and second piercing elements which are arranged to pass through the first and second apertures in the lateral wall of the container-containing member only when the container-containing member is in the second, operative position.