Ventilation circuit adaptor and proximal aerosol delivery system

Inventors

Mazela, JanHenderson, Christopher

Assignees

Windtree Therapeutics Inc

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Publication Number

US-9592361-B2

Patent

Publication Date

2017-03-14

Expiration Date


Abstract

An adaptor for delivering an aerosolized active agent to a patient with concomitant positive pressure ventilation includes an aerosol flow channel having an aerosol inlet port and a patient interface port, and defining an aerosol flow path from the aerosol inlet port to and through the patient interface port; and a ventilation gas flow channel in fluid communication with the aerosol flow channel and having a gas inlet port and a gas outlet port, and defining a ventilation gas flow path from the gas inlet port to and through the gas outlet port, wherein the ventilation gas flow path is at least partially offset from the aerosol flow path and at least partially encircles the aerosol flow path. Systems and methods for delivering an aerosolized active agent to a patient with concomitant positive pressure ventilation incorporate the adaptor.

Core Innovation

The invention provides an adaptor for delivering an aerosolized active agent or a gasified active agent to a patient with concomitant positive pressure ventilation. The adaptor includes a patient interface port and an aerosol flow channel with an aerosol inlet port and an aerosol outlet port, wherein the aerosol flow channel encloses an aerosol flow along its length.

The aerosol flow channel extends from the aerosol inlet port at one end of a chamber through the chamber to the aerosol outlet port within the chamber, such that the aerosol outlet port is recessed from the patient interface port at the opposite end of the chamber. The adaptor further includes a ventilation gas flow channel in fluid communication with the patient interface port and the aerosol outlet port, separated from the aerosol flow channel and at least partially offset from the aerosol outlet port while at least partially encircling the aerosol flow channel.

The ventilation gas flow channel forms a chamber that includes the gas inlet port, the gas outlet port, and the patient interface port, while the aerosol flow channel is at least partially nested within the chamber. The described system-level architectures include an aerosol entrainment chamber with diverted inspiratory flow as a sheath or carrier gas, optionally heated, and auxiliary conduits to deliver propelled aerosol to the adaptor while avoiding added dead space.

Claims Coverage

The claim coverage centers on an adaptor architecture with a separated aerosol flow channel nested within a chamber formed by an offset ventilation gas flow channel during concomitant positive pressure ventilation. The inventive features encompass the recessed aerosol outlet port, sufficient aerosol channel length relative to gas entrance and exit, and dependent features adding valves and geometric relationships.

Concomitant positive pressure delivery adaptor with separated nested channels

An adaptor for delivering an aerosolized active agent or a gasified active agent to a patient with concomitant positive pressure ventilation, comprising a patient interface port; an aerosol flow channel with an aerosol inlet port and an aerosol outlet port enclosing an aerosol flow; and a ventilation gas flow channel separated from the aerosol flow channel and at least partially offset from the aerosol outlet port while at least partially encircling the aerosol flow channel, wherein the ventilation gas flow channel forms a chamber that includes the gas inlet port, the gas outlet port and the patient interface port.

Recessed aerosol outlet within the chamber

The aerosol flow channel is at least partially nested within the chamber and extends from the aerosol inlet port at one end of the chamber through the chamber to the aerosol outlet port within the chamber such that the aerosol outlet port is recessed from the patient interface port at the opposite end of the chamber.

Aerosol channel length extending beyond gas entrance and exit

The aerosol flow channel is of a sufficient length to extend below an entrance of a gas from the gas inlet port into the chamber and below an exit of the gas from the chamber into the gas outlet port.

Aerosol inlet valve

The adaptor includes a valve at the aerosol inlet port.

Flexible valve permitting instrument insertion while maintaining positive pressure

The adaptor includes a sufficiently flexible valve that permits insertion of an instrument, catheter, tube, or fiber through the aerosol flow channel and/or patient interface port while maintaining positive ventilatory pressure.

Cross-sectional area relationship between aerosol inlet and interface

The adaptor includes an aerosol flow channel with a larger cross-sectional area at the aerosol inlet port than at the patient interface port.

Recess distance threshold for aerosol outlet

The aerosol outlet port is recessed from the patient interface port by at least about 8 millimeters.

One-way valve at the aerosol outlet port

The adaptor includes a one-way valve at the aerosol outlet port.

Across the claim set, the coverage is centered on an adaptor that nests a separated aerosol flow channel within a chamber formed by an offset ventilation gas flow channel, with a recessed aerosol outlet port and sufficient aerosol channel length relative to gas entrance and exit. Dependent features add an aerosol inlet valve, a flexible valve for instrument, catheter, tube, or fiber insertion while maintaining positive ventilatory pressure, geometric cross-sectional relationships, a minimum outlet recess distance, and a one-way valve at the aerosol outlet.

Stated Advantages

Reduces aerosol dilution and losses.

Provides efficient aerosol delivery without adverse events in a preclinical preterm lamb study.

Provides efficacy toward prevention of RDS using aerosolized lucinactant delivered with the adaptor.

Documented Applications

Delivering aerosolized active agents, including a preferred pulmonary surfactant (lucinactant), using a proximal aerosol delivery system during concomitant positive pressure ventilation.

Use in neonatal CPAP/IMV/SIMV contexts, as described in the disclosed ventilation circuit adaptor and PADS system architectures.

Preclinical preterm lamb study for efficient aerosol delivery without adverse events and efficacy toward prevention of RDS using aerosolized lucinactant delivered with the adaptor.

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