Systems and methods for aerosol delivery of agents

Inventors

Papania, Mark JamesBarry, James J.Elkouh, Nabil A.Bagley, Mark C.

Assignees

Creare LLCCenters of Disease Control and Prevention CDC

Publication Number

US-8544462-B2

Publication Date

2013-10-01

Expiration Date

2022-03-13

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Abstract

Aerosol delivery systems and methods for delivering an agent to a patient are described herein. In particular embodiments, an insulated receptacle is connected to a housing and holds a vial of an agent to be delivered to a patient. The vial is located in an inverted position within the receptacle. One or more reusable thermal packs can be located on the inner sides of the receptacle, to maintain a selected temperature surrounding the vial. The agent is administered to a patient by placing a prong into one of the patient's orifices and then activating an aerosol delivery system. Such systems can include jet aerosolization and pneumatic and ultrasonic nebulizers and preferably are portable.

Core Innovation

The invention relates to systems and methods for aerosol delivery of agents to patients using portable devices. The system includes an insulated receptacle connected to a housing, holding an inverted vial of an agent such as a drug or vaccine. One or more reusable thermal packs are positioned on the inner sides of the receptacle to maintain a controlled temperature for the vial. The agent is administered by placing a prong into a patient's orifice and activating the aerosol delivery system, which may employ jet aerosolization, pneumatic, or ultrasonic nebulization.

The problem addressed is the need for effective, needle-free systems and methods that deliver agents in aerosol form in accurate dosages. Existing delivery methods such as needles, syringes, and current aerosol devices have significant drawbacks, including safety risks, inefficient dosing, large equipment size, need for external power or air sources, and poor control over droplet size and dosage, leading to inefficiency, wastage, and difficulty in patient use or teaching.

The disclosed invention overcomes these drawbacks through designs that provide portable, self-contained aerosol delivery devices with features for insulating and maintaining agent temperature, minimizing contamination, and ensuring precise single-dose administration. The systems utilize controlled mixtures of air and aerosolized agents, prongs with anti-backflow valves for secure administration, and user-actuated triggers, all integrated within a hand-held or easily transportable housing.

Claims Coverage

The patent includes three independent claims (claims 1, 34, and 42) covering distinct inventive features involving portable aerosol delivery systems, their structural components, and operational mechanisms.

System for administering an agent using positive pressure and reciprocating nebulizer

A system comprising: - A housing with an air source operable to provide positive pressure air. - A nebulizer that receives an agent from a vial coupled to the housing and converts the agent into an aerosolized agent, including: - A pair of spaced apart plate members defining a liquid-receiving chamber, one with a plurality of orifices for producing droplets, and an actuating mechanism to reciprocate at least one plate member toward the other for aerosolization. - A mixing chamber to receive aerosolized agent and positive pressure air from the air source. - A release mechanism for dispensing a quantity of agent from the vial to the nebulizer, electrically coupled to the nebulizer to control the actuation cycle. - A prong with an inlet for the aerosolized agent/air mixture and an outlet for delivery to a patient when inserted into a patient's orifice.

Apparatus for administering a therapeutic agent with ultrasonic nebulizer and fluid conduit

An apparatus comprising: - A housing with a removable container (such as a vial) containing an agent to be aerosolized. - An ultrasonic nebulizer including: - An actuator, a first member, and a second member with multiple agent-ejecting orifices, the two defining a liquid-receiving chamber. - The actuator reciprocates the first member toward and away from the second member, forcing the agent from the chamber through the orifices to form aerosol when the first member moves toward the second, and refilling the chamber from the container when the first member moves away. - A fluid conduit fluidly connecting the container and the chamber for agent flow.

Apparatus for administering a therapeutic agent with reciprocating nebulizer

An apparatus comprising: - A housing coupled to a removable container (containing the agent). - A nebulizer having: - An actuator, a first member, and a second member with agent-ejecting orifices, defining a liquid-receiving chamber for agent. - The actuator operates to reciprocate the first member toward and away from the second, so the agent in the chamber is forced through the orifices for aerosolization, and agent from the container flows into the chamber during retraction.

The inventive features emphasize portable aerosol delivery systems designed for precise, efficient, and safe administration of agents using reciprocating plate nebulizers, integrated with air supplies, controlled delivery mechanisms, and temperature management.

Stated Advantages

Eliminates the use of needles and syringes, reducing safety risks, needle stick injuries, and biomedical waste.

Provides a portable, needle-free aerosol delivery system that allows rapid and accurate dosing of agents without reliance on bulky equipment or external power supplies.

Maintains agent temperature during storage and delivery, preventing degradation from external temperature influences.

Enables controlled and consistent dosage delivery, minimizing agent wastage and risk of overdose.

Facilitates easy administration by less-trained staff, contributing to cost savings and expanded accessibility.

Reduces likelihood of system contamination through anti-backflow valve designs and disposable prongs.

Can deliver multiple doses (e.g., vaccines) to many patients efficiently, supporting mass immunization needs.

Delivers agents via aerosol in droplet sizes suitable for effective lung absorption and treatment outcomes.

Provides compact, hand-held forms for increased convenience and mobility, including backpack-mounted air supplies for large-scale use.

Reduces patient fear or anxiety through a non-threatening appearance and easy-to-clean/disassemble components.

Documented Applications

Delivery of vaccines, including measles, mumps, and rubella, or combinations thereof, via aerosol administration.

Delivery of chemotherapeutics, pharmaceuticals, immune agents, nucleic acids, insulin, hormones, antibodies, receptors, proteins, carbohydrates, fats, nutrients, anesthetics, narcotics, and pain relievers to patients or living organisms.

Administration of agents for mass immunization procedures using portable or backpack-mounted aerosol delivery systems.

Single or multiple dose administration to human or non-human patients through respiratory or airway delivery using nasal or oral prongs.

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