Methods for treatment of pulmonary lung diseases with improved therapeutic efficacy and improved dose efficiency
Inventors
Germinario, Louis Thomas • Hebrank, John H. • Hunter, Charles Eric • Stern, Thomas P.
Assignees
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Publication Number
US-11285284-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 delivering a therapeutic agent as an ejected stream of droplets generated via a piezoelectric actuated droplet delivery device to the pulmonary system of a subject for the treatment of a pulmonary disease, disorder or condition. The method generates the ejected stream of droplets such that at least about 70% of the ejected stream of droplets have an average ejected droplet diameter of less than about 5 ȳm, and delivers the ejected stream such that at least about 70% of the mass of the ejected stream is delivered to the pulmonary system during use.
The piezoelectric actuated droplet delivery device includes a housing with a mouthpiece located at an airflow exit and an airflow inlet flow element positioned at an airflow entrance. A fluid ampoule disposed within or in fluid communication with the housing includes a fluid reservoir for receiving a volume of fluid comprising the therapeutic agent, and an electronically actuated ejector mechanism in fluid communication with the fluid ampoule generates the ejected stream of droplets.
The device further includes 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. The ejector mechanism comprises 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 generate the ejected stream; the housing, airflow inlet flow element, and mouthpiece facilitate non-turbulent airflow across an exit side of the aperture plate and provide sufficient non-turbulent airflow through the device during use.
Claims Coverage
The partial content provides three independent claims: one for a general method of delivering a therapeutic agent for pulmonary disease treatment, and two that specifically recite treating COPD and treating asthma. Across these independent claims, the core inventive structure is consistently defined as a piezoelectric actuated droplet delivery device with differential-pressure-triggered ejection and non-turbulent airflow across an aperture plate, paired with quantitative droplet size and delivered mass performance requirements.
Respirable droplet stream delivery to pulmonary system with size and mass thresholds
Generating an ejected stream of droplets via a piezoelectric actuated droplet delivery device such that at least about 70% of the ejected stream droplets have an average ejected droplet diameter of less than about 5 ȳm, and delivering the ejected stream to the pulmonary system such that at least about 70% of the mass of the ejected stream is delivered to the pulmonary system during use to thereby treat the pulmonary disease, disorder or condition.
Differential pressure sensor activated piezoelectric ejector mechanism
Including 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, where the ejector mechanism comprises a piezoelectric actuator and an aperture plate.
Aperture plate oscillation to generate droplets with non-turbulent airflow across aperture exit side
The ejector mechanism comprising a piezoelectric actuator operable to oscillate the aperture plate at a frequency, where the aperture plate has a plurality of openings formed through its thickness, and wherein the housing, airflow inlet flow element, and mouthpiece are configured to facilitate non-turbulent airflow across an exit side of the aperture plate and provide sufficient non-turbulent airflow through the device during use.
COPD treatment via piezoelectric droplet delivery with specified droplet size and delivered mass
Treating COPD by generating an ejected stream of droplets comprising a therapeutic agent for the treatment of COPD via a piezoelectric actuated droplet delivery device such that at least about 70% of the ejected stream of droplets have an average ejected droplet diameter of less than about 5 ȳm, and delivering the ejected stream to the pulmonary system such that at least about 70% of the mass of the ejected stream is delivered to the pulmonary system during use to thereby treat COPD.
Asthma treatment via piezoelectric droplet delivery with specified droplet size and delivered mass
Treating asthma by generating an ejected stream of droplets comprising a therapeutic agent for the treatment of asthma via a piezoelectric actuated droplet delivery device such that at least about 70% of the ejected stream of droplets have an average ejected droplet diameter of less than about 5 ȳm, and delivering the ejected stream to the pulmonary system such that at least about 70% of the mass of the ejected stream is delivered to the pulmonary system during use to thereby treat asthma.
The independent claims share a common combination of: (i) generation of a piezoelectrically actuated respirable-range droplet stream with quantitative droplet diameter and delivered mass requirements, (ii) device activation by a differential pressure sensor upon sensing a pre-determined pressure change, (iii) droplet generation by oscillation of a pierced aperture plate by a piezoelectric actuator, and (iv) housing and airflow features configured to facilitate non-turbulent airflow across the aperture plate exit side and provide sufficient non-turbulent airflow through the device during use. The COPD and asthma independent claims further limit the method to the respective pulmonary disease, disorder, or condition.
Stated Advantages
Delivers a therapeutic agent to the pulmonary system such that at least about 70% of the mass of the ejected stream is delivered to the pulmonary system during use.
Generates an ejected stream where at least about 70% of droplets have an average ejected droplet diameter of less than about 5 ȳm.
Facilitates non-turbulent airflow across an exit side of the aperture plate and provides sufficient non-turbulent airflow through the device during use.
Provides differential-pressure-triggered activation of the ejector mechanism upon sensing a pre-determined pressure change within the housing.
Documented Applications
Treatment of COPD in a subject in need thereof via delivering a piezoelectrically generated ejected stream of droplets comprising a therapeutic agent.
Treatment of asthma in a subject in need thereof via delivering a piezoelectrically generated ejected stream of droplets comprising a therapeutic agent.
Treatment of a pulmonary disease, disorder or condition in a subject for which the method delivers a therapeutic agent to the pulmonary system using a piezoelectric actuated droplet delivery device.
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