Medicinal inhaler refill assemblies comprising a lockout override mechanism
Inventors
Richardson, William T. • May, Robert • Groombridge, Christopher B. J.
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Assignees
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.
Abstract
A refill assembly (129) for use in a medicinal inhaler (100). The refill assembly includes a patient port (110), and an adapter (118) configured to cause a dose of medicament to be released. The adapter is movable between a first position in which a dose of medicament is not released and a second position in which a dose of medicament is released. The refill assembly further includes a lockout mechanism positioned to lock the adapter in its first position, and a lockout override actuator (223). The lockout override actuator is movable between a first position in which the lockout mechanism is in a first locked state, and a second position in which the lockout mechanism is in a second unlocked state and the adapter is movable from its first position to its second position even when the refill assembly is not coupled to a reusable assembly.
Core Innovation
The invention relates to medicinal inhaler refill assemblies that are removably coupled to a reusable assembly of the medicinal inhaler. The refill assembly includes a patient port and an adapter configured to cause a dose of medicament to be released by moving between a first position where a dose is not released and a second position where a dose is released.
A lockout mechanism is positioned to lock the adapter in the first position when the refill assembly is not coupled to the reusable assembly, thereby inhibiting movement that would permit dose release. The lockout mechanism is adapted to be releasable in response to the refill assembly being coupled to the reusable assembly, thereby permitting adapter movement to the dose-releasing second position when coupling occurs.
The refill assembly further adds a lockout override actuator that can move between positions providing a first locked state and a second unlocked state. In the second unlocked state, the adapter is movable from the first position to the second position even when the refill assembly is not coupled to the reusable assembly, including an embodiment intended to be irreversible to prevent subsequent dose-count inaccuracies.
The disclosed implementation includes integration with pMDI components such as a canister and a dose release valve, together with a firing system that uses breath-actuated and electronically triggered stored-energy operation with primed and fired stored-energy states. The disclosed reusable firing system further includes a flow governor, sensors such as pressure sensors and an inspiratory flow detection system, a controller with access to a memory device when coupled, and a display and data logging for firing-related operation.
Claims Coverage
The independent claim coverage centers on three inventive features: a patient port and adapter with two positions, a coupling-dependent lockout mechanism, and a lockout override actuator that can allow adapter movement even when uncoupled. Additional dependent claims refine engagement and alignment relationships and add inhaler-level features including canister/valve interaction, stored-energy primed and fired operation, and coupling of a memory device to a controller.
Removably coupled refill assembly with dose-releasing adapter movement positions
A refill assembly for use in a medicinal inhaler configured to be removably coupled to a reusable assembly, including a patient port and an adapter movable between a first position of the adapter in which a dose of medicament is not released and a second position of the adapter in which a dose of medicament is released.
Coupling-dependent lockout mechanism inhibiting adapter dose release when uncoupled
A lockout mechanism positioned to lock the adapter in the first position of the adapter, the lockout mechanism adapted to be releasable in response to the refill assembly being coupled to the reusable assembly, such that movement of the adapter between the first position and the second position is permitted when coupled and inhibited when not coupled.
Lockout override actuator enabling adapter movement even when not coupled
A lockout override actuator movable between a first position in which the lockout mechanism is in a first locked state and a second position in which the lockout mechanism is in a second unlocked state, such that the adapter is movable from the first position to the second position even when the refill assembly is not coupled to the reusable assembly.
Across the claim set, the core inventive coverage is the adapter’s two-position dose-release movement controlled by a coupling-dependent lockout mechanism, together with a lockout override actuator that can place the lockout mechanism in an unlocked state to permit adapter movement even when uncoupled. Dependent claims further refine engagement and alignment relationships and add canister/valve dose release actuation, stored-energy primed and fired states, and a memory device operatively coupled to a controller when coupled.
Stated Advantages
Prevents adapter movement to the dose-releasing position when the refill assembly is not coupled to the reusable assembly.
Permits adapter movement to the dose-releasing position when the refill assembly is uncoupled by using the lockout override actuator.
Is intended to be irreversible to prevent subsequent dose-count inaccuracies.
Documented Applications
Medicinal inhaler use with a removably coupled refill assembly and reusable assembly, including an embodiment intended for stand-alone press-and-breathe emergency use.
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