Dry powder delivery device and methods of use
Inventors
Hunter, Charles Eric • Hebrank, John H. • Germinario, Louis Thomas
Assignees
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Publication Number
US-11529476-B2
Publication Date
2022-12-20
Expiration Date
Abstract
A dry powder aerosol delivery device and related methods for delivering precise and repeatable dosages to a subject for pulmonary use is disclosed. The dry powder aerosol delivery device includes a housing, a cartridge, and a dry powder dispersion mechanism, and at least one differential pressure sensor. The dry powder delivery device is automatically breath actuated by the user when the differential pressure sensor senses a predetermined pressure change within housing. The dry powder aerosol delivery device is then actuated to generate a plume of particles 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.
Core Innovation
The disclosure describes a breath actuated dry powder delivery device for delivering a dry powder as a plume of particles to a pulmonary system of a subject. The device includes a housing with a mouthpiece located at an airflow exit side and a laminar flow element, and a cartridge disposed within or removably attached to the housing for receiving a volume of powder.
A powder dispersion mechanism generates and disperses a plume of particles from the volume of powder received in the cartridge. The mechanism includes an energy source configured to generate and disperse the plume of particles, where the energy source comprises a compressed gas source. At least one differential pressure sensor is positioned between the powder dispersion mechanism and the airflow exit side within the housing and is configured to activate the energy source upon sensing a pre-determined pressure change within the housing to generate the plume of particles.
The housing, the laminar flow element, and the mouthpiece facilitate laminar airflow across an exit side of the powder dispersion mechanism and provide sufficient laminar airflow through the housing during use. The plume of particles is directed into and through the housing at an approximate 90 degree change of trajectory prior to expulsion, and at least about 70% of the particles in the plume have an average particle diameter of less than about 6 microns.
The disclosure also describes delivery in conjunction with mechanical ventilators and CPAP machines, and it provides additional implementation features such as cartridge rotation, optional wireless communication, spray verification using an infrared transmitter and photodetector, and removable/cleanable mouthpiece components.
Claims Coverage
The independent claim contains multiple inventive elements that jointly define a breath-actuated dry powder delivery device. Across the independent claim and its dependent refinements, the inventive features include a housing with laminar airflow features, a cartridge holding powder, a compressed-gas energy source activated by differential pressure sensing, and particle-size and trajectory constraints.
Breath actuated dry powder plume delivery to a pulmonary system
A breath actuated dry powder delivery device for delivering a dry powder as a plume of particles to a pulmonary system of a subject, including a housing with a mouthpiece and a laminar flow element, and a cartridge for receiving a volume of powder.
Differential pressure sensor triggering an energy source
At least one differential pressure sensor positioned between the powder dispersion mechanism and the airflow exit side within the housing, configured to activate the energy source upon sensing a pre-determined pressure change within the housing to thereby generate the plume of particles.
Laminar airflow through housing with mouthpiece and laminar flow element
The laminar flow element located at an airflow entrance side of the housing, wherein the housing, the laminar flow element, and the mouthpiece are configured to facilitate laminar airflow across an exit side of the powder dispersion mechanism and to provide sufficient laminar airflow through the housing during use.
Approximate 90 degree trajectory change prior to expulsion
The dry powder delivery device configured such that the plume of particles are directed into and through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing.
Compressed gas energy source and respirable particle size constraint
The powder dispersion mechanism configured to generate the plume of particles wherein at least about 70% of the particles have an average particle diameter of less than about 6 microns, and wherein the energy source comprises a compressed gas source.
Compressed gas source specified as CO2
The dry powder delivery device wherein the compressed gas source comprises CO2.
Rotatable cartridge disk with unit dose reservoirs
The dry powder delivery device wherein the cartridge is a rotatable disk comprising one or more unit dose reservoirs configured to receive unit dose amounts of powder.
Wireless communication module
The dry powder delivery device additionally includes a wireless communication module.
Additional sensors including infrared transmitter and photodetector
The dry powder delivery device further includes one or more sensors selected from an infrared transmitter, a photodetector, an additional pressure sensor, and combinations thereof.
Quantitative respirable-range mass delivery and particle size distribution target
A breath actuated dry powder plume delivered to a subject’s pulmonary system such that at least 70% of the particles have an average diameter under about 6 microns and at least 70% of the particle mass is delivered in a respirable range.
Overall, the claim set emphasizes breath-actuated triggering of a compressed-gas powder dispersion mechanism by a differential pressure sensor, together with laminar airflow and an approximate 90 degree change of trajectory prior to expulsion. Dependent claims further narrow the compressed gas to CO2, define a rotatable disk cartridge with unit dose reservoirs, add a wireless communication module and optional additional sensing, and refine delivery performance with respirable-range mass and distribution targets.
Stated Advantages
Generates and disperses a breath actuated dry powder plume of particles into a subject’s pulmonary system.
Uses differential pressure sensing to activate the energy source upon sensing a pre-determined pressure change within the housing.
Facilitates laminar airflow across an exit side of the powder dispersion mechanism and provides sufficient laminar airflow through the housing during use.
Directs the plume of particles through the housing at an approximate 90 degree change of trajectory prior to expulsion.
Provides a particle plume where at least about 70% of the particles have an average particle diameter of less than about 6 microns.
Provides delivery performance such that at least 70% of particle mass is delivered in a respirable range.
Allows cartridge configuration using unit dose reservoirs in a rotatable disk.
Enables optional wireless communication.
Documented Applications
Delivery in conjunction with mechanical ventilators, including delivery into a subject through an endotracheal tube.
Delivery in conjunction with CPAP machines, including for sleep-associated cardiac-event drug administration.
Pulmonary delivery for administering tobramycin in a VAP-related context.
Pulmonary delivery of anti-arrhythmic drug(s) in the context of cardiac-event monitoring.
Delivery of therapeutic agents via the pulmonary route for broader therapeutic agent classes.
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