Circumferential aerosol device
Inventors
Hoekman, John D. • Ho, Rodney J. Y.
Assignees
University of Washington Center for Commercialization • Impel Pharmaceuticals Inc
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Publication Number
US-10016582-B2
Publication Date
2018-07-10
Expiration Date
Abstract
The present application discloses devices and methods for delivering a therapeutic compound to the olfactory epithelium of an animal or human. The device having one or more channels for imparting a circumferential and axial velocity to the discharged fluid, and an outlet that discharges an aerosol spray having a circumferential and axial velocity as it enters the nasal cavity of a user. The device is designed to displace the air in the upper nasal cavity in order to specifically deposit a therapeutic agent on the olfactory epithelium while minimizing pressure and discomfort experienced by the user.
Core Innovation
The patent discloses a pressurized olfactory drug delivery device that imparts axial velocity and circumferential velocity to an aerosol spray, thereby displacing residual air in the upper nasal cavity. By using the generated velocity profile, the device deposits therapeutic compounds on the olfactory epithelium while minimizing respiratory deposition and pressure/discomfort. The device includes a container at a distal end containing a mixture of a pressurized fluid and a therapeutic compound, and a nozzle delivery device that delivers the mixture as an aerosol.
The nozzle delivery device is configured with inner axial member and outer cylindrical member structures that define a plurality of helical channels. Each helical channel comprises an inlet and an outlet located at a proximal-most end of the device, where the outlets are configured to produce an aerosol spray with axial velocity and circumferential velocity. The axial and circumferential velocity produced by each outlet converge into a single spray plume having a circumferential velocity.
Multiple embodiments are described, including a PODD device using a spin chamber with coiled wire to create circumferential helical gas flow that aerosolizes liquid via a narrow gap and a needle valve, as well as alternate nozzle/no-spin-chamber-less designs. In the alternate designs, radially disposed oblique vents or helical axial channels lead to converging outlets that form a single narrow circumferentially-directed spray plume. The disclosure provides therapeutic compound/formulation scope and includes experimental and flow simulation evidence showing improved delivery behavior, including particle size distribution, rat dye penetration and nelfinavir brain-region distribution versus nose drops, and flow simulations showing improved cone penetration with multiple circumferential outlets.
Claims Coverage
The provided material contains one independent claim (clm-00001), which broadly covers a pressurized olfactory drug delivery device with a helical-channel nozzle and a metering device that discharges a pressurized-fluid/therapeutic-compound mixture into an aerosol spray whose axial and circumferential velocity converge into a single circumferential-velocity spray plume. Dependent claims (clm-00002, clm-00004 through clm-00007) refine structural and composition aspects, including a congruent conical extension and specified therapeutic-compound/formulation categories.
Pressurized olfactory drug delivery device with distal pressurized-fluid/therapeutic-compound container
A container at a distal end comprises a mixture of a pressurized fluid and a therapeutic compound, and the nozzle delivery device delivers that mixture as an aerosol spray for olfactory drug delivery.
Nozzle delivery device with plurality of helical channels between inner axial and outer cylindrical members
A nozzle delivery device defining a longitudinal axis includes an inner axial member having a cylindrical core and a plurality of helical channels, where each helical channel has a basal surface contacting an outer surface of the axial member and an apical surface contacting an outer cylindrical member.
Metered discharge through helical channels to produce converging axial and circumferential velocities into a single spray plume
A metering device selectively discharges the mixture through the helical channels, where each helical channel includes an inlet and a proximal-most outlet configured to produce an aerosol spray having axial velocity and circumferential velocity, such that the axial and circumferential velocity produced by each outlet converge into a single spray plume having a circumferential velocity.
Congruent conical extension at the proximal-most end
The pressurized olfactory drug delivery device further includes a conical extension at the proximal-most end that is congruent with the inner axial member.
Therapeutic compound selected from specified biomolecule categories
The therapeutic compound includes at least one of small molecules, peptides, proteins, antibodies, antibody fragments, aptamers, or nucleic acids.
Liquid or lyophilized therapeutic compound delivery form
The pressurized olfactory drug delivery device delivers liquid or lyophilized therapeutic compounds.
Formulation including stabilizers, preservatives, or additives
The pressurized olfactory drug delivery device delivers the therapeutic compound in a formulation that includes stabilizers, preservatives, or additives.
Formulation including colloids, nanoparticles, liposomes, or micelles
The pressurized olfactory drug delivery device delivers the therapeutic compound as a formulation comprising colloids, nanoparticles, liposomes, or micelles.
Overall claim coverage centers on a pressurized olfactory drug delivery device that uses helical channels at proximal-most outlets to generate axial velocity and circumferential velocity that converge into a single circumferential-velocity spray plume, with dependent refinements directed to proximal geometry (congruent conical extension) and to defined therapeutic-compound and formulation categories.
Stated Advantages
Deposits therapeutic compounds on the olfactory epithelium.
Minimizes respiratory deposition.
Minimizes pressure/discomfort.
Documented Applications
Olfactory drug delivery into the upper nasal cavity aimed at depositing therapeutic compounds on the olfactory epithelium.
Naso-brain delivery, supported by disclosed rat dye penetration and nelfinavir brain-region distribution versus nose drops.
Aerosol spray deposition performance supported by particle size distribution measurements and flow simulations showing improved cone penetration with multiple circumferential outlets.
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