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Publication Number
US-9682205-B2
Publication Date
2017-06-20
Expiration Date
Abstract
The present invention provides a method for delivering a substance to the nasal cavity of a subject in which drawing air from a mouthpiece triggers release of a substance to a subject's nasal cavities. The device comprises a container for containing the substance in fluid communication with a nosepiece, a valve with an active configuration and an inactive configuration, and a trigger mechanism to reconfigure the valve from its inactive configuration to its active configuration and vice versa. Drawing air from the mouthpiece, e.g., when the subject takes in air by mouth, activates the trigger mechanism, thereby reconfiguring the valve from its inactive configuration to its active configuration for a predetermined period of time and delivering the substance from the device to a nasal cavity of the subject.
Core Innovation
The invention provides a method for delivering a substance to a nasal cavity of a subject using an air-intake actuated device. The device includes a container for the substance, a nosepiece for placement in proximity to the subject’s nose, and a mouthpiece for placement in the subject’s mouth, and the nosepiece is in fluid communication with the container. A valve prevents delivery in an inactive configuration and enables delivery of a predetermined amount in an active configuration.
A trigger mechanism reconfigures the valve between the inactive and active configurations in response to the subject taking in air through the mouthpiece. When activated, the method fluidly connects the container to the nosepiece to enable delivery of the predetermined amount of the substance from the container to the nosepiece for a predetermined period of time. The disclosure also describes pulsation sequencing for multi-dose per pulse and alternative inhaling-actuated mechanisms with intermediate compartments and unidirectional valves.
The disclosure emphasizes coordinating swallowing/swallow-breath physiology to isolate nasal passageways from pulmonary flow to support accurate dosing and reduced lung or pulmonary deposition. It also describes improving patient compliance and eliminating bad flavor via “throat washing.”
Claims Coverage
The patent includes one independent method claim with an air-intake actuated, valve-reconfigured nasal delivery mechanism. Dependent claims add refinements to the timing and pulsation, structural and delivery parameters, actuation alternatives, and the scope and forms of the delivered substance.
Air-intake actuated valve reconfiguration for timed nasal delivery
A method for delivering a substance to a nasal cavity using an air-intake actuated device in which a valve is reconfigured from an inactive configuration to an active configuration in response to the subject taking in air through a mouthpiece, thereby enabling fluid communication between a container and a nosepiece to deliver a predetermined amount of the substance for a predetermined period of time.
Pulsation mechanism with sequential valve switching for multi-dose per pulse
The method further provides a pulsation mechanism that sequentially switches a valve between inactive and active configurations using pulses of predetermined length to deliver a predetermined amount of a substance to a nasal cavity, delivering at least two doses per pulse.
Valve and nosepiece operation tied to spray nozzle diameter
The method uses a nosepiece connected to a valve through a spray nozzle such that a spray nozzle diameter affects a predetermined period of time.
Flexible membrane actuation or intermediate compartment delivery
The method selects at least one step option that uses either a flexible membrane mechanically coupled to a valve and actuates it by intaking air through a mouthpiece, or loads an intermediate compartment with a predetermined amount of the substance so delivery occurs from the intermediate compartment.
Drug scope explicitly selected from listed drug classes and agents
The method specifies that the substance is delivered as a drug chosen from a specified group of drug classes and listed agents, with options and combinations thereof.
Selected substance forms including powder, aerosol, and mouth wash/drink
The method specifies that the substance is delivered in a selected form including powders, granules, cachets, capsules, tablets, pastes, creams, gels, ointments, salves, foams, lotions, oil suspensions, sprays, suspensions, solutions, emulsions, patches, sticks, mouth wash, Venturi-effect aerosols, or drinks.
Overall claim coverage centers on an air-intake activated trigger mechanism that reconfigures a valve between inactive and active configurations to enable timed nasal delivery of a predetermined amount through a nosepiece, with dependent refinements covering pulsation sequencing, nozzle diameter tied to a predetermined period of time, alternative actuation and loading options, explicit drug scope, and enumerated delivery forms.
Stated Advantages
Supports accurate dosing by isolating nasal passageways from pulmonary flow using swallowing/swallow-breath coordination.
Reduces lung or pulmonary deposition.
Improves patient compliance.
Eliminates bad flavor via “throat washing.”
Documented Applications
Delivery of a wide range of substances to a nasal cavity of a subject, including drugs and vaccines with carriers or adjuvants, proteins or peptides, cytokines, hormones, clotting factors, monoclonal antibodies, natural oils, and probiotics, LAB, bifidobacteria.
Therapeutic use across various diseases and conditions listed in the document.
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