Integrated nebulizer and particle dispersion chamber for nasal delivery of medicament to deep nasal cavity and paranasal sinuses
Inventors
Assignees
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Publication Number
US-8001963-B2
Publication Date
2011-08-23
Expiration Date
Abstract
Particular aspects provide a novel integrated nebulizer and particle dispersion chamber (12), and novel methods of using same. Preferably, the particle dispersion chamber (12) provides for delivery of a vortical flow of nebulized particles to the nostrils. The inventive integrated nebulizer, delivery methods and breathing techniques allow for delivering medicament into the deep nasal cavity and paranasal sinuses of a user. Significantly, the inventive devices and methods allow for systemic and topical delivery of medicaments via the membranes of the nasal cavity and paranasal sinuses. Additional preferred embodiments provide complementary cartridge docking system that allows for user-specific nebulized drug delivery.
Core Innovation
The disclosed invention provides a nebulizer suitable for topical drug delivery to, or systemic drug delivery via, a deep nasal cavity or paranasal sinus. The nebulizer includes a nasal adapter with nasal proximal and nasal distal ends, and at least one nasal adapter channel communicating between apertures at the proximal and distal ends. It further includes a particle dispersion chamber integral or in direct communication with the nasal adapter, where internal dispersion channels communicate between input and output ends and a directed compressed fluid output channel directs output at an acute forward angle with respect to the output end.
The directed compressed fluid output is operative to impart vortical flow to aerosolized particles exiting the particle dispersion chamber through the nasal adapter. A nebulizing chamber integral or in direct communication with the particle dispersion chamber produces a nebulized particle stream using nebulizing means with at least one pressure release orifice. The nebulizer includes a nebulizing pressure feed having a compressor channel in communication with the pressure release orifice, and a dispersion feed channel communicating between the nebulizing pressure feed and the directed compressed fluid output channel.
The nebulizer is configured to deliver a vortical particle flow of nebulized particles exiting the nasal adapter to a deep nasal cavity or paranasal sinus. In a further configuration, the system employs a supplementary inhalation channel and an annular air curtain at a nasal-proximal end to stretch and increase vorticity of the vortical flow. The disclosure also describes dual particle dispersion chambers and dual vortical flow patterns that spiral in opposite directions, with a bifurcated or complementary nasal adapter to create opposite-direction vortical patterns targeted to each nostril.
The approach includes control of particle mean diameter by selecting a substantially uniform mean diameter within specified micrometer ranges. In one described delivery concept, a Controlled Particle Dispersion Breathing Technique includes breath holding and sinus pressure creation to support delivery to paranasal sinuses. Imaging and ventilation studies using a radiotracer are described as showing tracer activity in ethmoid and sphenoid sinuses with limited or no activity in frontal and maxillary regions depending on setup.
Claims Coverage
The partial document provides two independent claims (a device claim and a method claim). Across these, the claims include a particle dispersion chamber imparting vortical flow using a directed compressed fluid output at an acute forward angle, and a coupled nebulizing pressure feed with a dispersion feed channel delivering the vortical aerosol to a deep nasal cavity or paranasal sinus; dependent claim features refine particle size and dual-channel dual-opposite vortical patterns.
Acute-forward-angle directed compressed-fluid vortical particle dispersion
A nasal-adapter nebulizer with a particle dispersion chamber having an internal dispersion channel and a directed compressed fluid output channel directing output at an acute forward angle relative to the output end, where the fluid output imparts vortical flow to aerosolized particles exiting the particle dispersion chamber.
Integrated nasal-adapter nebulization pressure feed and dispersion feed channel
A nebulizing chamber with a pressure release orifice producing a nebulized particle stream, a nebulizing pressure feed having a compressor channel in communication with the pressure release orifice, and a dispersion feed channel communicating between the nebulizing pressure feed and the directed compressed fluid output channel of the particle dispersion chamber.
Substantially uniform mean diameter nebulized particles for deep nasal/paranasal delivery
A drug delivery method producing nebulized particles having a substantially uniform mean diameter selected from about 5 to about 30 µm, about 8 to about 25 µm, about 10 to about 20 µm, about 10 to about 17 µm, about 10 to about 15 µm, and about 12 to about 17 µm, for delivery to a deep nasal cavity or paranasal sinus.
Passing nebulized particles through an acute-forward-angle vortical dispersion chamber
A method where nebulized particles are passed prior to delivery through a particle dispersion chamber with a directed compressed fluid output channel in communication with an internal dispersion channel directing output at an acute forward angle, the fluid output imparting vortical flow to aerosolized particles exiting the particle dispersion chamber.
Dual opposite-direction vortical flow patterns for corresponding nostril apertures
A configuration in which the particle dispersion chamber provides dual vortical particle flow patterns that spiral in opposite directions and are directed to corresponding nostril apertures.
Overall, the independent claims center on delivering nebulized particles to deep nasal cavities or paranasal sinuses by combining a nebulizing pressure feed with a particle dispersion chamber that uses an acute forward-angle directed compressed-fluid output to impart vortical flow, with refinements including substantially uniform particle mean diameter and dual opposite-direction vortical patterns targeted to each nostril.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Topical drug delivery to, or systemic drug delivery via, a deep nasal cavity or paranasal sinus.
Sinus ventilation and radiotracer imaging studies using a radiopharmaceutical showing tracer activity in ethmoid and sphenoid sinuses with limited or no activity in frontal and maxillary regions depending on setup.
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