Medicinal inhaler comprising a lockout override mechanism
Inventors
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Assignees
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Kindeva Drug DeliveryKindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Kindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Publication Number
US-11583642-B2
Publication Date
2023-02-21
Expiration Date
Abstract
A refill assembly configured to be removably coupled to a reusable assembly of a medicinal inhaler is disclosed and includes a patient port, a canister actuable by the reusable assembly to deliver a dose of medicament to the patient port, and a sleeve which is selectively actuable by a user independently of the reusable assembly so as to act on the canister to deliver a dose of medicament. The refill assembly further includes an override element which engages the sleeve, the override element being moveable from a first position in which the sleeve is retained in a first position by the override element and a second position in which the sleeve is permitted to move to a second position upon depression of the sleeve by a user to cause a dose of medicament to be delivered to the patient port.
Core Innovation
The invention relates to a refill assembly for use in a medicinal inhaler, configured to be removably coupled to a reusable assembly of a medicinal inhaler. The refill assembly includes a patient port and a canister configured to be actuable by the reusable assembly to deliver a dose of medicament to the patient port. The refill assembly further includes a sleeve that is selectively actuable by a user independently of the reusable assembly so as to act on the canister to deliver a dose of medicament.
The sleeve has a first position in which the sleeve cannot be actuated to cause a dose of medicament to be released from the canister and a second position in which the sleeve is actuable to cause a dose of medicament to be delivered to the patient port. An override element engages the sleeve and is moveable from a first position to a second position. In the first position the override element retains the sleeve in the first position, and upon depression of the sleeve by a user the sleeve is permitted to move to the second position.
The override element is movable from the first position to the second position and cannot be moved from the second position to the first position. As a result, when overridden the refill assembly can act as a stand-alone emergency inhaler in which a user can operate the sleeve to deliver a dose without the reusable assembly. The reusable assembly cannot be re-coupled to the refill assembly after override, to prevent dose-counter or data inaccuracies by using an irreversible lockout that prevents returning to the normal condition.
Claims Coverage
The document includes one independent claim. It defines a refill assembly removably coupled to a reusable medicinal inhaler assembly, with a user-actuated, two-position sleeve and an override element that moves only in one direction and cannot be reversed, thereby governing whether medicament delivery is enabled or inhibited.
Removably coupled medicinal inhaler refill assembly
A refill assembly configured to be removably coupled to a reusable assembly of a medicinal inhaler, including a patient port and a canister configured to deliver a dose of medicament to the patient port when actuated by the reusable assembly.
Two-position user-actuated sleeve for medicament delivery control
A sleeve selectively actuable by a user independently of the reusable assembly to act on the canister, with a first position where the sleeve cannot be actuated to cause medicament release and a second position where the sleeve is actuable to cause medicament delivery to the patient port.
Irreversible one-way override element locking the sleeve
An override element engaging the sleeve and movable from a first position where the sleeve is retained in the first position to a second position where the sleeve is permitted to move to the second position upon depression of the sleeve by a user, wherein the override element cannot be moved from the second position back to the first position.
Overall, the claim coverage centers on a refill assembly that uses a selectively user-actuated, two-position sleeve to control medicament delivery, combined with an override element that provides an irreversible, one-way lockout that prevents returning to the normal condition after override.
Stated Advantages
Prevents dose-counter or data inaccuracies by making the override irreversible and preventing re-coupling to the reusable assembly after override.
Documented Applications
Stand-alone emergency inhaler operation in which, after the override, the refill assembly can be used to deliver a dose without the reusable assembly (press-and-breathe emergency use).
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