Preservative-free single dose inhaler systems

Inventors

Patton, John S.Patton, Ryan S.Kuo, Mei-changIvri, Yehuda

Assignees

Aerami Therapeutics Inc

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Publication Number

US-11833291-B2

Patent

Publication Date

2023-12-05

Expiration Date


Abstract

An aerosolization system includes a container that is configured to deliver a unit dosage of a liquid when squeezed a single time. The system also includes an aerosolizer that is constructed of a housing defining a mouthpiece, and an aerosol generator disposed in the housing. The aerosol generator includes a vibratable membrane having a front face and a rear face, and a vibratable element used to vibrate the membrane. Further, the housing includes an opening that is adapted to receive a unit dosage of the liquid from the container. The opening provides a liquid path to the rear face of the vibratable membrane.

Core Innovation

The invention relates to aerosolizing a volume of liquid medicament using an inhaler in which liquid medicament is supplied to the rear face of a membrane of an aerosol generator. The aerosol generator includes a membrane having a front face and a rear face with a plurality of apertures extending between the front face and the rear face, and includes a vibratable element. The vibratable element is activated in response to detecting fluid flow through the mouthpiece as a user inhales, so that a dosage of liquid medicament supplied to the rear face of the membrane is aerosolized during inhalation.

A visual indicator is provided for user feedback, including an indication that the entire dosage of liquid has been aerosolized. The visual indicator is positioned so that an inlet end of an opening is positioned between, and in general alignment with, the mouthpiece and the visual indicator, with the visual indicator and the opening positioned on a same surface of the housing. The visual indicator is oriented to be visible to the user while the user inhales through the mouthpiece, and may also indicate that the dosage has been received by the inhaler via a receiving chamber.

The invention further specifies how the liquid is routed to the membrane using an opening formed through a housing and, in refinements, using a funnel coupled with the opening to direct the liquid medicament to the rear face of the membrane. Geometric constraints on the opening and funnel are described, including that a slope of the funnel is at least 30 degrees relative to a central axis of the opening. Additional refinements specify the aerosol generator actuation using a vibratable element and a dome-shaped membrane, and may define delivery of the entire dosage with quantified delivery-efficiency thresholds.

Claims Coverage

The document provides three independent method claims for aerosolizing liquid medicament. Across these independent claims, the coverage repeatedly includes flow-sensor detection of inhalation through a mouthpiece, activation of an aerosol generator to aerosolize a dosage supplied to a rear face of a membrane, and a visual indicator providing an indication that the entire dosage has been aerosolized, with a particular physical relationship between the opening, mouthpiece, and visual indicator on a housing surface.

Flow-sensor activation of membrane-based aerosolization

Detecting fluid flow through a mouthpiece of an inhaler as a user inhales through the mouthpiece using a flow sensor of the inhaler, and activating an aerosol generator in response to detecting the fluid flow to aerosolize a dosage of the liquid medicament supplied to a rear face of a membrane as the user inhales via the mouthpiece.

Visual indication of entire dosage aerosolized

Providing an indication that the entire dosage of liquid has been aerosolized using a visual indictor of the inhaler while the user inhales through the mouthpiece, wherein the visual indictor provides the indication to the user.

Opening and visual indicator alignment on the same housing surface

Positioning an inlet end of the opening between, and in general alignment with, the mouthpiece and the visual indictor, with the visual indictor and the opening positioned on a same surface of the housing and the visual indictor oriented such that the visual indictor is visible to the user while the user inhales through the mouthpiece.

Membrane apertures with vibratable element

Providing an aerosol generator comprising a membrane having a front face, a rear face, and a plurality of apertures that extend between the front face and the rear face, and a vibratable element.

Overall, the independent claim set centers on flow-sensor-driven activation of a vibratable, membrane-based aerosol generator to aerosolize a liquid medicament dosage during inhalation, paired with a visual indicator that communicates completion of the entire dosage and a specified placement and alignment of the opening and visual indicator on the inhaler housing surface. Additional coverage in refinements includes funnel directing to the membrane rear face, quantified delivery-efficiency thresholds, and specific membrane geometry for the aerosol generator.

Stated Advantages

Provides an indication to the user that the entire dosage of liquid has been aerosolized.

Provides a visual indicator visible to the user while the user inhales through the mouthpiece.

Documented Applications

A method of aerosolizing a volume of liquid medicament using an inhaler, including liquid medicament such as insulin, during user inhalation through a mouthpiece.

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