NASAL DELEVERY DEVICES

• US 20080161771A1
• Filed: 12/21/2007
• Published: 07/03/2008
• Est. Priority Date: 02/26/2001
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: DJUPESLAND, Per Gisle
• Granted Patent: US 8,511,303 B2
• Time in Patent Office: Days
• US Class Current: 604/503
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• 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 15/002 with air flow regulating means
• 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 15/0091 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 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/071 hand operated
• CPC Class Codes: A61M 2205/073 : Syringe, piston type
• CPC Class Codes: A61M 2205/13 : with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2210/0668 : Middle ear
• CPC Class Codes: A61M 2230/43 : Composition of exhalation

Abstract

An exhalation breath-actuated nasal deliver device for and a method of delivering a substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece for fitting to a nostril of a subject; a mouthpiece through which the subject in use exhales; and delivery unit, as one of a mechanical delivery pump or a nebulizer, for delivering a substance to the nosepiece; and an actuation mechanism for actuating the delivery unit in response to oral exhalation through the mouthpiece, and preferably when at least one or both of the pressure at or the flow rate through the nosepiece exceeds a predetermined threshold.

Claims

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

a nosepiece for fitting in or to a nostril of a subject;

a mouthpiece into which the subject in use exhales;

a substance supply unit fluidly connected to the nosepiece and actuatable to deliver a substance to the nosepiece; and

a trigger mechanism for actuating the substance supply unit in response to exhalation through the mouthpiece.

2. The delivery device of claim 1, wherein the substance supply unit delivers a metered dose of substance on actuation thereof.

3. The delivery device of claim 1, wherein the substance supply unit comprises a mechanical delivery pump.

4. The delivery device of claim 1, further comprising a resilient actuating element, preferably a spring, for applying an actuating force to actuate the substance supply unit.

5. The delivery device of claim 1, wherein the trigger mechanism includes a diaphragm which is deflected by the exhalation breath of the subject on exhalation into the mouthpiece to operate the trigger mechanism and actuate the substance supply unit.

6. The delivery device of claim 5, wherein the trigger mechanism includes at least one arm which is engaged by the diaphragm when deflected by the exhalation breath of the subject to operate the trigger mechanism.

7. The delivery device of claim 1, wherein the trigger mechanism actuates the substance supply unit at one of a predeterminable pressure or a predeterminable flow rate.

8. The delivery device of claim 1, wherein the mouthpiece is fluidly connected to the nosepiece, whereby exhaled air from an exhalation breath is in use delivered through the nosepiece.

9. The delivery device of claim 1, wherein the mouthpiece is fluidly isolated from the nosepiece, whereby exhaled air from an exhalation breath is not delivered through the nosepiece.

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

11. The delivery device of claim 1, wherein the substance supply unit provides for the delivery of one of an aerosol or a jet.

12. A nasal drug delivery system comprising:

a container containing a substance to be delivered into the nasal passages of a user;

a nasal shaft extending from the drug delivery system for placement in or at the nose of user, said nasal shaft in fluid communication with a valve of said container;

an oral shaft, extending from the drug delivery system for placement in the mouth of a user; and

a pressure activated diaphragm trigger means, wherein upon application of pressure to the oral shaft the diaphragm trigger means releases a predetermined amount of said substance from said container to said nasal shaft.

13. The nasal drug delivery system of claim 12 wherein the oral shaft is in fluid communication with said nasal shaft.

14. The nasal drug delivery system of claim 13, wherein the pressure activated diaphragm trigger means comprises a follower.

15. The nasal drug delivery system of claim 14, wherein the pressure activated diaphragm trigger means comprises a follower assembly.

16. The nasal drug delivery system of claim 12, further comprising an activation spring.

17. A method of delivering a predetermined amount of medication to the nasal epithelia of a user comprising the steps of:

providing a drug applicator having a container containing a substance to be delivered, a nasal shaft, extending from the drug applicator for placement in or at the nose of user, with said nasal shaft in fluid communication with a valve of said container, an oral shaft extending from the drug applicator for placement in the mouth of a user, and a pressure activated diaphragm trigger means;

inserting the oral shaft into the mouth of a user;

inserting the nasal shaft into or at the nose of a user

pressurizing the oral shaft which activates the diaphragm trigger means; and

releasing a predetermined amount of medicament from the container into the nasal shaft and into the nasal passage of the user.

18. The method of claim 17, wherein the drug applicator further includes a lumen connecting the nasal shaft and the oral shaft and further comprising a step of causing an airflow from said oral shaft to said nasal shaft.

19. The method of claim 18, wherein the airflow assists in dispersing the medication into the nasal passage of the user.

20. The method of claim 17, wherein pressurizing of the oral shaft displaces a diaphragm.