Nasal aerosol delivery system

Patent metadata

Field	Value
Publication number	US-10596334-B2
Application number	US-201414781547-A
Country	US
Kind code	B2
Filing date	Apr 3, 2014
Priority date	Apr 4, 2013
Publication date	Mar 24, 2020
Grant date	Mar 24, 2020

Abstract

A nasal delivery device can include a nasal prong and an activation member. The nasal prong can have an opening at a top and bottom portion of the prong to allow for the passage of an aerosolized treatment agent through the nasal prong. The activation member can be positioned on the nasal delivery device at a location that is spaced apart from the subject's oral cavity when the nasal prong is received into the nostril of the subject. The activation member can detect a desired exhalation state of the subject and upon detection of the desired exhalation state, the activation member activates the delivery of the aerosolized treatment agent.

First claim

We claim:

1. A nasal delivery device for delivering a treatment agent from a dose container to a subject, the nasal delivery device comprising:
a handpiece configured to be held by a user and having an activation member for triggering the delivery of the treatment agent to the subject;
an intranasal portion comprising a nasal prong extending from a distal end of the handpiece, wherein the nasal prong has a distal end opening and a proximal end opening, and the distal end opening is positioned farther away from the distal end of the handpiece than the proximal end opening of the nasal prong, the intranasal portion having a dose container receiving area and an aerosolizing member, the aerosolizing member having a vibrating-mesh nebulizer and a vibration actuator, and the aerosolizing member being configured to aerosolize the treatment agent and eject an aerosolized plume containing the treatment agent through the distal end opening and into a nare of the subject; and
a pressurizing feed system configured to engage with a reservoir of the dose container delivering treatment agent from the dose container to the aerosolizing member at a controlled rate,
wherein the vibrating-mesh nebulizer covers the distal end opening of the nasal prong and the vibration actuator is at least partially located in the nasal prong.

2. The nasal delivery device of claim 1 , wherein the vibrating-mesh nebulizer is angled relative to an axis of the intranasal portion configured to eject the aerosolized plume through a nasal valve of the subject.

3. The nasal delivery device of claim 1 , wherein the vibrating actuator comprising an ultrasonic actuator at least partially located in the handpiece.

4. The nasal delivery device of claim 3 , wherein the ultrasonic actuator comprises a horn actuator that comprises a first portion having a piezoelectric stack within the handpiece and a second portion that comprises a coupling tip that extends into the intranasal portion.

5. The nasal delivery device of claim 1 , wherein the dose container extends over the intranasal portion and configured to restrict direct contact between the intranasal portion and the subject.

6. The nasal delivery device of claim 1 , wherein the pressurizing feed system comprises a motor-driven depressor that compresses the reservoir, wherein the reservoir is a flexible dose bulb bulb of the dose container.

7. The nasal delivery device of claim 6 , wherein the motor-driven depressor comprises a stepper motor that causes the motor-driven depressor to pivot to engage with the flexible dose bulb.

8. The nasal delivery device of claim 6 , wherein the motor-driven depressor comprises a flat portion that contacts the flexible dose bulb.

9. The nasal delivery device of claim 6 , wherein the motor-driven depressor comprises a curved surface that contacts the flexible dose bulb.

10. The nasal delivery device of claim 6 , wherein the motor-driven depressor is configured to provide a first deployment stage in which a seal of the flexible dose bulb is breached and a second deployment stage in which the treatment agent is delivered from the dose container.

11. The nasal delivery device of claim 1 , further comprising an alignment device.

12. The nasal delivery device of claim 11 , wherein the alignment device further comprises an optical device generally collinearly aligned with a delivery axis of the aerosolized treatment agent to provide a view into the nare of the subject to facilitate alignment of the delivery axis of the aerosolized treatment agent with a nasal airway of the subject.

13. The nasal delivery device of claim 12 , wherein the alignment device further comprises an optical eyepiece for viewing into a nostril of the subject.

14. The nasal delivery device of claim 12 , wherein the alignment device further comprises a display screen for displaying an image of an interior of a nostril of the subject.

15. A dose delivery system comprising:
a dose container including:
a fluid delivery member comprising a flexible dose bulb and defining a fluid flow path from the dose bulb to a distal end of the fluid delivery member;
a body member sized to receive and at least partially surround the fluid delivery member, the body member having an opening adjacent to the distal end of the fluid delivery member when the fluid delivery member is received in the body member; and
a mesh member positioned at the opening in the body member; and

a nasal prong extending from a distal end of an intranasal portion of a nasal delivery device, the nasal prong having a distal end opening, a proximal end opening, and an exterior surface, the distal end opening being positioned farther away from the flexible dose bulb than the proximal end opening of the nasal prong, wherein the dose container is received on the exterior surface of the nasal prong with the mesh member of the dose container covering the distal end opening of the nasal prong.

16. The dose container of claim 15 , further comprising a breakable storage seal separating an area within the flexible dose bulb from the fluid flow path.

17. The dose container of claim 15 , wherein the body member comprises one or more transparent windows to allow an imaging device to obtain images through the one or more transparent windows.

Assignees

• The United State Of America As Represented By The Sec Dep Of Health And Human Service
• Creare Llc
• Us Health
• Creare Inc

Inventors

• Papania Mark J
• Barry James J
• Bagley Mark C
• Norris James
• Knaus Darin A
• Friets Eric M

Classifications

• A61B1/233

  for the nose, i.e. nasoscopes {, e.g. testing of patency of Eustachian tubes} · CPC title

• A61M2205/3569

  sublocal, e.g. between console and disposable · CPC title

• A61M2230/432

  partial CO2 pressure (P-CO2) · CPC title

• A61M2205/8206

  battery-operated · CPC title

• A61M2205/3368

  Temperature · CPC title