Nasal drug delivery apparatus and methods of use

Patent metadata

Field	Value
Publication number	US-2020289770-A1
Application number	US-201816754885-A
Country	US
Kind code	A1
Filing date	Oct 17, 2018
Priority date	Oct 17, 2017
Publication date	Sep 17, 2020
Grant date	—

Abstract

A nasal droplet delivery device and related methods for delivering precise and repeatable dosages to a subject via the nasal passageways and sinus cavities is disclosed. The droplet delivery device includes a housing, a nosepiece, a reservoir, an ejector mechanism, and at least one differential pressure sensor. The droplet delivery device is automatically actuated by the user when the differential pressure sensor senses a predetermined pressure change within the nosepiece. The droplet delivery device is then actuated to generate a plume of droplets having an average ejected particle diameter of greater than about 6 microns, preferably greater than about 10 micron, so as to target the nasal passageways and sinus cavities of the user.

First claim

What is claimed:

1 . An automatically actuated nasal droplet delivery device for delivering a fluid as an ejected stream of droplets to the nasal passageways and sinus cavities of a subject, the device comprising:
a housing; a nosepiece positioned at an airflow exit of the device; an air inlet flow element positioned in the airflow at an airflow entrance of the device; a reservoir disposed within or in fluid communication with the housing for receiving a volume of fluid; an electronically actuated ejector mechanism in fluid communication with the reservoir and configured to generate the ejected stream of droplets; at least one differential pressure sensor positioned within the housing, the at least one differential pressure sensor configured to activate the ejector mechanism upon sensing a pre-determined pressure change within the nosepiece to thereby generate the ejected stream of droplets; the ejector mechanism comprising a piezoelectric actuator and an aperture plate, the aperture plate having a plurality of openings formed through its thickness and the piezoelectric actuator operable to oscillate the aperture plate at a frequency to thereby generate the ejected stream of droplets; wherein the housing, air inlet flow element, and nosepiece are configured to facilitate non-turbulent airflow across an exit side of the aperture plate and to provide sufficient airflow through the housing during use; and wherein the ejector mechanism is configured to generate the ejected stream of droplets wherein at least about 50% of the droplets have an average ejected droplet diameter of greater than about 10 microns, such that at least about 50% of the mass of the ejected stream of droplets is delivered into the nasal passageways and sinus cavities of the subject during use.

2 . The droplet delivery device of claim 1 , wherein the housing and ejector mechanism are oriented such that the exit side of the aperture plate is perpendicular to the direction of airflow and the stream of droplets is ejected in parallel to the direction of airflow.

3 . The droplet delivery device of claim 1 , wherein the housing and ejector mechanism are oriented such that the exit side of the aperture plate is parallel to the direction of airflow and the stream of droplets is ejected substantially perpendicularly to the direction of airflow such that the ejected stream of droplets is directed through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing.

4 . The droplet delivery device of claim 1 , wherein the air inlet flow element is positioned within the nosepiece.

5 . The droplet delivery device of claim 4 , wherein the air inlet flow element is positioned behind the exit side of the aperture plate along the direction of airflow.

6 . The droplet delivery device of claim 4 , wherein the air inlet flow element is positioned in-line or in front of the exit side of the aperture plate along the direction of airflow.

7 . The droplet delivery device of claim 1 , wherein the air inlet flow element comprises one or more openings formed there through and configured to increase or decrease internal pressure resistance within the droplet delivery device during use.

8 . The droplet delivery device of claim 7 , wherein the air inlet flow element comprises an array of one or more openings.

9 . The droplet delivery device of claim 7 , wherein the air inlet flow element comprises one or more interior baffle or cylinder flow elements.

10 . The droplet delivery device of claim 9 , wherein the one or more interior baffles or cylinders comprise one or more airflow openings.

11 . The droplet delivery device of claim 1 , wherein the aperture plate comprises a domed shape.

12 . The droplet delivery device of claim 1 , wherein the aperture plate is composed of a material selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, metal alloys thereof, and combinations thereof.

13 . The droplet delivery device of claim 1 , wherein one or more of the plurality of openings have different cross-sectional shapes or diameters to thereby provide ejected droplets having different average ejected droplet diameters.

14 . The droplet delivery device of claim 1 , wherein the nosepiece is removably coupled with the device.

15 . The droplet delivery device of claim 1 , wherein the reservoir is removably coupled with the housing.

16 . The droplet delivery device of claim 1 , wherein the reservoir is coupled to the ejector mechanism to form a combination reservoir/ejector mechanism module, and the combination reservoir/ejector mechanism module is removably coupled with the housing.

17 . The droplet delivery device of claim 1 , further comprising a wireless communication module.

18 . The droplet delivery device of claim 1 , wherein the device further comprises one or more sensors selected from an infra-red transmitter, a photodetector, an additional pressure sensor, and combinations thereof.

19 . A method for delivering a therapeutic agent as an ejected stream of droplets to the nasal passageways and sinus cavities of a subject for the treatment of a disease, disorder or condition, the method comprising:
(a) generating an ejected stream of droplets via a piezoelectric actuated droplet delivery device of claim 1 , wherein at least about 50% of the ejected stream of droplets have an average ejected droplet diameter of greater than about 10 μm; and (b) delivering the ejected stream of droplets to the nasal passageways and sinus cavities of the subject such that at least about 50% of the mass of the ejected stream of droplets is delivered into the nasal passageways and sinus cavities of the subject during use to thereby treat the disease, disorder or condition.

20 . The method of claim 19 , wherein the disease, disorder, or condition is a local nasal or sinus disease, disorder or condition.

21 . The method of claim 19 , wherein the disease, disorder, or condition is a system disease, disorder or condition.

Assignees

• Pneuma Respiratory Inc

Inventors

• Hebrank John H
• Maurer Christopher W
• Hunter Charles Eric
• Li Chengjie
• Germinario Louis Thomas

Classifications

• A61M15/008

  Electronic counters · CPC title

• A61M2205/502

  User interfaces, e.g. screens or keyboards · CPC title

• A61M2205/13

  with means for the detection of operative contact with patient, e.g. lip sensor · CPC title

• A61M15/08 Primary

  Inhaling devices inserted into the nose · CPC title

• A61M2205/3592

  using telemetric means, e.g. radio or optical transmission · CPC title