Metered dose inhaler add-on device, observance improvement system and method for improving observance of use in metered dose inhalers

Inventors

MARCOZ, AlainJEZ, EmmanuelDIOGO, SylvainGOURBET, PatricePereira, AlexandrePOLLARD, MathieuGILLET, Kevin

Assignees

Biocorp Production SAS

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Publication Number

US-11590300-B2

Patent

Publication Date

2023-02-28

Expiration Date


Abstract

The present invention relates to an add-on device for a metered dose inhaler, an observance improvement system, and a method for improving observance of use in metered dose inhalers, the add-on device comprising an observance system housing component comprising an observance system with at least one pressure sensor; a mouthpiece component configured to fit, surround and removably engage with an exterior surface of a mouthpiece outlet provided on the metered dose inhaler; wherein said observance system housing is configured to fit and removably engage with said mouthpiece component; and said mouthpiece component is specifically adapted to conform to the exterior surface of the mouthpiece outlet of the metered dose inhaler without obstructing delivery of a dose of drug through said outlet.

Core Innovation

The invention relates to a metered dose inhaler observance add-on device removably mountable on an exterior surface of a metered dose inhaler. The add-on device includes an observance system housing component with at least one pressure sensor and a mouthpiece component. The mouthpiece component has a wall defining a channel and an inhaler opening configured to fit, surround and removably engage an exterior surface of a mouthpiece outlet of the metered dose inhaler.

The mouthpiece component is specifically adapted such that an interior surface of the wall elastically engages and rests on the exterior surface of the mouthpiece outlet without obstructing delivery of a dose of drug through the mouthpiece outlet. The add-on device does not create any supplemental chamber through which the drug would have to pass, in addition to a chamber already provided by the metered dose inhaler. The observance system housing component is configured to fit and removably engage with the mouthpiece component.

The observance system is configured to provide inhaler event observance using the at least one pressure sensor in an air-flow passage. The system supports detecting inhalation start/end and drug release and may include a second pressure sensor for detecting user-activated cartridge compression and a motion/accelerometer sensor for detecting voluntary shaking or priming events. The system includes a micro-controller, data storage, and communications for providing feedback based on recorded event times and related correctness of inhalation performance.

Claims Coverage

The partial content identifies one independent claim, with multiple dependent claims refining sensor types, event detection, data handling, communications, and airflow-path geometry.

Removably mounted observance add-on with elastically engaging mouthpiece component

An add-on device removably mountable onto an exterior surface of a metered dose inhaler, comprising an observance system housing component with at least one pressure sensor and a mouthpiece component configured to fit, surround and removably engage with an exterior surface of a mouthpiece outlet such that medication flow is inhaled through the inhaler opening.

Non-obstructing elastic engagement without supplemental chamber

The mouthpiece component is specifically adapted such that an interior surface of the wall elastically engages and rests on the exterior surface of the mouthpiece outlet without obstructing delivery of a dose of drug through said mouthpiece outlet, and wherein the add-on device does not create any supplemental chamber through which the drug would have to pass in addition to a chamber already provided by the metered dose inhaler.

Motion sensing of voluntary vibration events during mounting

An observance system housing component includes a motion sensor configured to register user-induced vibration events of the metered dose inhaler occurring above a predetermined movement level when the device is mounted.

Acceleration movement detection within a predetermined range

A motion sensor is configured to detect predetermined acceleration movements in the range of about 1G to about 3G.

Micro-controller determination of primed status from vibration events

A micro-controller uses signals from a motion sensor to determine whether registered vibration events match voluntary user-induced vibrations, thereby determining whether the inhaler has been primed for drug delivery.

Micro-controller exchanging data with remote software application

The micro-controller is configured to exchange data with a software application running on a remote device, remote server, or distributed network system.

Airflow passage intermediate zone formed by direct airflow contact

An intermediate zone in the airflow passage is formed between a distal zone and a proximal zone by combining portions in the observance system housing component and a space at a distal end of the mouthpiece component in direct airflow contact.

Overall, the claim set coverage centers on a removably mounted inhaler observance add-on that uses a pressure-sensor-based observance system integrated into a non-obstructing, elastically engaging mouthpiece component that avoids creating a supplemental chamber. Dependent claims refine the observance system by adding motion/accelerometer-based detection of voluntary priming vibrations, micro-controller-based determination of primed status, micro-controller data exchange with a remote software application, and a defined airflow-passage intermediate zone via direct airflow contact.

Stated Advantages

Avoids obstructing delivery of a dose of drug through the mouthpiece outlet.

Does not create any supplemental chamber through which the drug would have to pass, in addition to a chamber already provided by the metered dose inhaler.

Documented Applications

Improving treatment compliance by providing an observance system that records inhaler-related events (e.g., inhalation performance) and provides feedback using recorded event times and related correctness.

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