Nasal drug delivery apparatus and methods of use
Inventors
Hebrank, John H. • Maurer, Christopher W. • Hunter, Charles Eric • Li, Chengjie • Germinario, Louis Thomas
Assignees
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Publication Number
US-11458267-B2
Publication Date
2022-10-04
Expiration 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.
Core Innovation
An automatically actuated nasal droplet delivery device is described for delivering a fluid as an ejected stream of droplets to the nasal passageways and sinus cavities of a subject. The device includes a housing with a nosepiece positioned at an airflow exit and a reservoir for receiving a volume of fluid, and an electronically actuated ejector mechanism configured to generate the ejected stream of droplets.
The ejector mechanism includes a piezoelectric actuator and an aperture plate having a plurality of openings formed through its thickness. Activation is provided by at least one differential pressure sensor positioned within the housing, where the sensor activates the ejector mechanism upon sensing a pre-determined pressure change within the nosepiece.
The piezoelectric actuator oscillates the aperture plate at a frequency to thereby generate the ejected stream of droplets. 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.
The device is further defined by droplet and mass performance, including generating 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, and wherein at least about 50% of the mass of the ejected stream of droplets is delivered into the nasal passageways and sinus cavities during use.
Claims Coverage
The document provides one independent claim covering the nasal droplet delivery device architecture and its sensor-activated piezoelectric ejection with airflow and droplet and mass performance thresholds.
Sensor-activated piezoelectric nasal droplet ejection
An automatically actuated nasal droplet delivery device in which at least one differential pressure sensor activates an electronically actuated ejector mechanism upon sensing a pre-determined pressure change within the nosepiece, wherein the ejector mechanism includes a piezoelectric actuator and an aperture plate with a plurality of openings formed through its thickness and configured to oscillate the aperture plate to generate the ejected stream of droplets.
Non-turbulent airflow across the aperture plate exit side
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.
Droplet diameter and mass delivery thresholds to nasal passageways and sinus cavities
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.
Overall, the independent claim requires a nosepiece-based airflow exit with a differential-pressure-sensor activated piezoelectric aperture-plate ejector, non-turbulent airflow across the aperture plate exit side, and quantitative thresholds for droplet size distribution and mass delivered into nasal passageways and sinus cavities.
Stated Advantages
Facilitates consistent/repeatable dosing as described in the document summary.
Minimizes pulmonary system deposition as described in the document summary.
Provides monitoring/coaching via LED/audio/voice and dose counting/data logging as described in the document summary.
Supports altitude insensitivity via a superhydrophobic filter and a vapor barrier/spiral channel as described in the document summary.
Documented Applications
Delivering a fluid as an ejected stream of droplets to the nasal passageways and sinus cavities of a subject.
Delivering a therapeutic agent to treat a disease, disorder or condition that is associated with nasal passageways and sinus cavities, using a piezoelectrically generated droplet stream with the stated droplet and mass thresholds [procedural detail omitted for safety].
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