Methods for the systemic delivery of therapeutic agents to the pulmonary system using a droplet delivery device
Inventors
Germinario, Louis Thomas • Hebrank, John H. • Hunter, Charles Eric • Stern, Thomas P.
Assignees
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Publication Number
US-11285274-B2
Publication Date
2022-03-29
Expiration Date
Abstract
A droplet delivery device and related methods for delivering precise and repeatable dosages to a subject for pulmonary use is disclosed. The droplet delivery device includes a housing, a reservoir, and ejector mechanism, and at least one differential pressure sensor. The droplet 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 stream of droplets having an average ejected droplet diameter within the respirable size range, e.g, less than about 5 μm, so as to target the pulmonary system of the user.
Core Innovation
The invention relates to a method for systemic delivery of a therapeutic agent as an ejected stream of droplets generated via a piezoelectric actuated droplet delivery device to the pulmonary system of a subject. The method is characterized by droplet generation performance in which at least about 70% of the ejected stream of droplets have an average ejected droplet diameter of less than about 5 µm, and by delivery performance in which at least about 70% of the mass of the ejected stream of droplets is delivered to the pulmonary system during use.
The device includes a housing having a mouthpiece located at an airflow exit and an airflow inlet flow element positioned at an airflow entrance, with airflow configured to facilitate non-turbulent airflow across an exit side of an aperture plate and to provide sufficient non-turbulent airflow through the device during use. A fluid ampoule disposed within or in fluid communication with the housing provides a fluid reservoir for receiving a volume of fluid comprising the therapeutic agent.
An electronically actuated ejector mechanism in fluid communication with the fluid ampoule is 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, where the piezoelectric actuator oscillates the aperture plate at a frequency to thereby generate the ejected stream of droplets. At least one differential pressure sensor positioned within the housing activates the ejector mechanism upon sensing a pre-determined pressure change within the housing.
Claims Coverage
The provided independent claim defines a systemic pulmonary delivery method using a piezoelectric actuated droplet delivery device. Across the claim, the key inventive features comprise droplet size and mass-delivery performance, differential pressure sensor activation, piezoelectric oscillation of an aperture plate with openings, and device airflow configuration for non-turbulent airflow to the pulmonary system.
Systemic pulmonary droplet delivery with respirable-range droplet size and delivered mass
Generating an ejected stream of droplets via a piezoelectric actuated droplet delivery device and delivering the ejected stream of droplets to the pulmonary system such that at least about 70% of the ejected stream of droplets have an average ejected droplet diameter of less than about 5 µm and at least about 70% of the mass of the ejected stream of droplets is delivered to the pulmonary system during use to thereby systemically deliver the therapeutic agent.
Differential pressure sensor activation of the ejector mechanism
Providing at least one differential pressure sensor positioned within the housing, configured to activate the ejector mechanism upon sensing a pre-determined pressure change within the housing to thereby generate the ejected stream of droplets.
Piezoelectric actuator oscillating an aperture plate with openings
Configuring the ejector mechanism to include a piezoelectric actuator and an aperture plate, the aperture plate having a plurality of openings formed through its thickness, and operable to oscillate the aperture plate at a frequency to thereby generate the ejected stream of droplets.
Non-turbulent airflow through housing across the aperture plate exit side
Configuring the housing, airflow inlet flow element, and mouthpiece to facilitate non-turbulent airflow across an exit side of the aperture plate and to provide sufficient non-turbulent airflow through the device during use.
The claim coverage centers on a piezoelectric droplet delivery approach for systemic delivery to the pulmonary system, defined by respirable-range droplet size and delivered mass performance, with differential pressure sensor activation and a piezoelectric aperture-plate droplet generator, together with non-turbulent airflow configuration.
Stated Advantages
At least about 70% delivered droplet mass to the pulmonary system during use while systemically delivering the therapeutic agent.
At least about 70% of ejected droplets in the droplet diameter range of less than about 5 µm.
Documented Applications
Treating a disease, disorder or condition by systemic delivery of a therapeutic agent via droplet delivery to the pulmonary system of a subject.
Example diseases/conditions explicitly listed for treatment in dependent claim context include diabetes mellitus, rheumatoid arthritis, plaque psoriasis, Crohn's disease, hormone replacement therapy, neutropenia, nausea, and influenza.
Example therapeutic-agent categories explicitly listed for selection in dependent claim context include growth factors, insulin, vaccines, antibodies, Fc-fusion protein, hormones, enzymes, gene therapies, RNAi cell therapies, antibody-drug conjugates, cytokines, anti-infective agents, polynucleotides, and oligonucleotides, including combinations.
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