Electronic breath actuated in-line droplet delivery device with small volume ampoule 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-11771852-B2
Publication Date
2023-10-03
Expiration Date
Abstract
A droplet delivery device with a small volume drug ampoule and related methods for delivering precise and repeatable dosages to a subject for pulmonary use is disclosed. The droplet delivery device is configured to facilitate the ejection of small, e.g., single use, volumes of a therapeutic agent. The droplet delivery device includes a housing, a mouthpiece, a small volume drug ampoule, an ejector mechanism, and at least one differential pressure sensor. The delivery device is automatically breath actuated by the user when the differential pressure sensor senses a predetermined pressure change within housing. The droplet delivery device is then actuated to generate a plume of droplets having an average ejected particle diameter within the respirable size range, e.g, less than about 5-6 μm, so as to target the pulmonary system of the user. The small volume drug ampoule may include a reservoir which comprises an internal flexible membrane separating two internal volumes, a first background pressure fluid volume and a second drug volume.
Core Innovation
The invention relates to an electronically actuated droplet delivery device for delivering a fluid as an ejected stream of droplets to the pulmonary system of a subject. The device includes a housing and a mouthpiece positioned at an airflow exit of the device, and the housing cooperates with an air inlet flow element positioned in the airflow at an airflow entrance of the device. The housing, air inlet flow element, and mouthpiece are configured to facilitate non-turbulent airflow across an exit side of an aperture plate and to provide sufficient airflow through the housing during use.
A small volume drug ampoule is disposed in or in fluid communication with the housing, and the drug ampoule includes a drug reservoir with an internal flexible membrane. The internal flexible membrane separates a first background pressure fluid volume and a second drug volume received by the drug reservoir. An electronically actuated ejector mechanism is in fluid communication with the drug reservoir and is configured to generate the ejected stream of droplets.
At least one differential pressure sensor is positioned within the housing and is configured to activate the ejector mechanism upon sensing a pre-determined pressure change within the mouthpiece, thereby generating the ejected stream of droplets. The ejector mechanism comprises a piezoelectric actuator and an aperture plate with a plurality of openings formed through its thickness, and the piezoelectric actuator oscillates the aperture plate at a frequency to generate the ejected stream of droplets.
The device is configured so that at least about 50% of the droplets have an average ejected droplet diameter of less than about 6 microns, such that at least about 50% of the mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system during use.
Claims Coverage
The independent claim contains multiple inventive features that together define a breath-actuated piezoelectric droplet plume delivery device configured for respirable droplet size distribution and non-turbulent airflow across an aperture plate exit side. The claim set also includes dependent features for aperture plate geometry, opening geometry, orientation, and materials, and method coverage aligned with the respirable droplet-mass performance constraints.
Differential-pressure-actuated droplet ejection to the pulmonary system
At least one differential pressure sensor is positioned within the housing and configured to activate the ejector mechanism upon sensing a pre-determined pressure change within the mouthpiece to generate the ejected stream of droplets.
Small volume drug ampoule with internal flexible membrane separation
A small volume drug ampoule is disposed in or in fluid communication with the housing, and includes a drug reservoir with an internal flexible membrane separating a first background pressure fluid volume and a second drug volume received by the drug reservoir.
Piezoelectric actuator oscillating an aperture plate with plurality of openings
The ejector mechanism comprises a piezoelectric actuator and an aperture plate having a plurality of openings formed through its thickness, and the piezoelectric actuator oscillates the aperture plate at a frequency to generate the ejected stream of droplets.
Non-turbulent airflow across the exit side of the aperture plate
The housing, air inlet flow element, and mouthpiece 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.
Respirable droplet mass through average droplet diameter threshold
At least about 50% of the droplets have an average ejected droplet diameter of less than about 6 microns, such that at least about 50% of the mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system of the subject during use.
Aperture plate openings with different cross-sectional shapes or diameters to vary droplet size
The aperture plate has a plurality of openings formed through its thickness, wherein the openings have different cross-sectional shapes and/or different diameters such that the ejected droplets have different average ejected droplet diameters.
Domed aperture plate geometry
The aperture plate has a domed shape.
Selected aperture plate materials
The aperture plate is made from a selected material chosen from PEEK, PVDF, polyimide, or metals and alloys including nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof, and combinations thereof.
Orientation of aperture plate exit side relative to airflow direction
The housing and the ejector mechanism orient the exit side of the aperture plate perpendicular to the direction of the airflow, such that the stream of droplets is ejected substantially parallel to the direction of airflow.
Therapeutic method using piezoelectric-actuated droplet stream with respirable-range droplet mass
A method delivers a therapeutic agent as a piezoelectric-actuated droplet stream to a subject’s lungs, wherein at least about 50% of the mass of the ejected stream of droplets is delivered in a respirable range to treat a pulmonary disease, disorder, or condition.
Overall, the claim set centers on activating a piezoelectric ejector using differential pressure sensed at a mouthpiece to generate a droplet stream for delivery to the pulmonary system, while configuring airflow to be non-turbulent across an aperture plate exit side. The claims further require a respirable-range mass delivery performance defined by at least about 50% of droplets having an average diameter below about 6 microns, and they refine aperture plate geometry, opening geometry, orientation, and materials, with method coverage directed to treating pulmonary disease using a therapeutic agent delivered as the piezoelectric-actuated droplet stream.
Stated Advantages
Delivering at least about 50% of the mass of the ejected stream of droplets in a respirable range to the pulmonary system of the subject during use.
Generating an ejected stream of droplets in which at least about 50% of the droplets have an average ejected droplet diameter of less than about 6 microns.
Facilitating non-turbulent airflow across an exit side of the aperture plate.
Providing sufficient airflow through the housing during use.
Documented Applications
Treating a pulmonary disease, disorder, or condition by delivering a therapeutic agent to a subject’s lungs as a piezoelectric-actuated droplet stream with at least about 50% mass delivered in a respirable range.
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