Inhaler to deliver substances for prophylaxis or prevention of disease or injury caused by the inhalation of biological or chemical agents

Inventors

Curtis, Robert M.Donovan, Martin J.SMYTH, HUGH

Assignees

Respira Therapeutics Inc

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Publication Number

US-10463815-B2

Patent

Publication Date

2019-11-05

Expiration Date


Abstract

A dry powder inhaler may include a powder storage region, an inlet channel, a dispersion chamber, and an outlet channel. A geometry of the inhaler may be such that a flow profile is generated within the dispersion chamber that causes an actuator to oscillate, enabling the actuator when oscillating to deaggregate powdered medicament within the dispersion chamber to be aerosolized and entrained by the air and delivered to a patient through the outlet channel.

Core Innovation

The invention describes a compact breath-actuated dry powder inhaler system for prophylaxis or prevention and therapy against exposure to particular biological and chemical agents using pulmonary drug delivery. The system includes a receptacle containing an amount of powdered medicament, an elongate inlet channel receiving air and powdered medicament, and a chamber defined by a chamber wall. The chamber receives air and powdered medicament from the inlet channel and includes an actuator movably contained within the chamber to disperse the powdered medicament.

A grid is positioned between the receptacle and the inlet channel near the inlet of the inlet channel, and the inlet channel comprises continuous interior walls that extend from the grid to the chamber so that air is prevented from entering the inlet channel except through a proximal end of the inlet channel. The inlet channel outlet comprises a bottom surface that is disc shaped and perpendicular to the chamber wall. These structural relationships cooperate to generate a flow profile that causes the oscillating actuator to oscillate freely in a generally axial direction along the longitudinal axis of the chamber.

The geometric parameters define the oscillation-driven dispersion mechanism, including an actuator diameter between 0.5 and 15 mm and a ratio of the chamber second diameter to the inlet first diameter about 1.1 to about 3, with the chamber length about 1.5 to about 3 times the actuator diameter. The oscillating actuator effectively disperses powdered medicament passing through the chamber to be aerosolized and entrained by the air for delivery to a patient through an outlet channel. The document further addresses system configurations including coupling to existing inhalers and multi-chamber configurations for combination therapies.

Claims Coverage

The partial content includes two independent claims. Each independent claim centers on a breath-actuated dry powder inhaler architecture that uses a movably contained actuator to oscillate freely in a chamber to disperse powdered medicament into an aerosol entrained by air, with specific structural diameter and length relationships to generate an axial oscillation flow profile.

Oscillation chamber driven by inlet-to-chamber diameter ratio and chamber length

A dry powder inhaler system having an inlet channel and a chamber, wherein a ratio of the second diameter to the first diameter is about 1.1 to about 3, and wherein the length of the chamber is about 1.5 to about 3 times the actuator diameter to generate a flow profile that causes the actuator to oscillate freely in a generally axial direction along a longitudinal axis of the chamber for effectively dispersing powdered medicament to be aerosolized and delivered through the outlet channel.

Disc-shaped, perpendicular inlet outlet bottom surface that supports axial oscillation dispersion

The outlet of the inlet channel comprises a bottom surface that is disc shaped such that it is perpendicular to the chamber wall, in combination with the specified diameter ratio and chamber-length relationship, to enable the oscillating actuator to effectively disperse powdered medicament passing through the chamber to be aerosolized and entrained by air for delivery to a patient.

Inlet channel geometry constrained by a grid and continuous interior walls

The system includes a grid positioned between the receptacle and the inlet channel near the inlet of the inlet channel and an inlet channel comprising continuous interior walls extending from the grid to the chamber such that air is prevented from entering the inlet channel except through a proximal end of the inlet channel, thereby directing air and powdered medicament into the chamber where the actuator oscillates to disperse the medicament.

Freely oscillatable actuator inside the chamber for aerosolizing powdered medicament

An actuator movably contained within the chamber, wherein the actuator has an actuator diameter between 0.5 and 15 mm, and wherein the actuator oscillates freely within a frequency range in a generally axial direction to disperse powdered medicament passing through the chamber to be aerosolized and entrained by the air and delivered to the patient through the outlet channel.

Top end of the chamber larger than the actuator in communication with the outlet channel

The dry powder inhaler further defines that the chamber has a top end in communication with the outlet channel, wherein the top end is larger in size than the actuator, in the context of the inlet channel outlet, grid-coupled inlet, and specified diameter and length relationships that enable actuator oscillation and medicament dispersion.

Across the two independent claims, the inventive focus is on a breath-actuated dry powder inhaler in which an inlet channel and dispersion chamber are dimensioned so that a freely oscillating actuator inside the chamber disperses powdered medicament into an aerosol entrained by air, with diameter ratio and chamber-length-to-actuator-diameter relationships generating an axial oscillation flow profile; Claim 10 additionally requires a chamber top end larger than the actuator in communication with the outlet channel.

Stated Advantages

Improved fine particle fraction (FPF), fine particle dose (FPD), and emitted FPF when using the bead dispersion attachment versus no attachment, including performance across multiple drugs and bead sizes.

Higher emitted FPF/FPD and dose-range efficiency are reported in the experimental performance results.

Documented Applications

Prophylaxis or prevention and therapy against exposure to particular biological and chemical agents via pulmonary drug delivery using the breath-actuated dry powder inhaler system.

Combination therapies via series/parallel multi-chamber configurations.

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