Medicinal inhaler refill assemblies comprising a lockout mechanism
Inventors
Richardson, William T. • May, Robert • Groombridge, Christopher B. J.
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Assignees
Member
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-11110234-B2
Publication Date
2021-09-07
Expiration Date
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 member (117) movable between (i) a first (locked) position in which the adapter is not movable from its first position to its second position, and (ii) a second (unlocked) position in which the adapter is movable from its first position to its second position.
Core Innovation
The invention relates to a refill assembly for use in a medicinal inhaler that is 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, with the adapter movable between a first position in which a dose of medicament is not released and a second position in which the dose of medicament is released.
A lockout member controls adapter movement and is rotatable between a first position in which the adapter is not movable from its first position to its second position and a second position in which the adapter is movable from its first position to its second position. The lockout member is in its first position when the refill assembly is not coupled to the reusable assembly, and in its second position when the refill assembly is coupled to the reusable assembly.
The adapter is configured to receive at least a portion of a canister having a medicament and a dose release valve, and the adapter is movable between the first position in which the dose release valve is not actuated to release a dose of medicament and the second position in which the dose release valve is actuated to release a dose of medicament. The reusable assembly further includes a dose-release firing system, with embodiments including breath-actuated firing and stored-energy-driven firing defining primed and fired states, and a flow governor along an air flow path with optional pressure sensors and electronics for control and power.
Optional Bluetooth communication and retention of inhalation data within a memory device of the refill assembly are also described. The refill assembly and reusable assembly operation is supported by coupling-based motion relationships, including an axis defining an axial direction and relative axial movement between the adapter and the lockout member when the lockout member is in its second position.
Claims Coverage
The provided material includes two independent claims: clm-00001 and clm-00018. Across these independent claims, the coverage centers on a removable refill assembly with a patient port, a movable adapter that controls medicament dose release, and a lockout member that prevents or permits adapter movement based on coupling state, including a canister-dose release valve interface and relative axial movement between the adapter and the lockout member.
Removably coupled refill assembly with patient port and movable adapter for medicament dose release
A refill assembly for use in a medicinal inhaler removably coupled to a reusable assembly, comprising a patient port and an adapter configured to cause a dose of medicament to be released, the adapter movable between a first position in which a dose is not released and a second position in which the dose is released.
Rotatable lockout member that blocks adapter movement when uncoupled and permits movement when coupled
A lockout member rotatable between a first position in which the adapter is not movable from its first position to its second position and a second position in which the adapter is movable from its first position to its second position, wherein the lockout member is in its first position when the refill assembly is not coupled to the reusable assembly and is in its second position when the refill assembly is coupled to the reusable assembly.
Canister interface with dose release valve actuation controlled by adapter positions
The adapter is configured to receive at least a portion of a canister having a medicament and a dose release valve, wherein the adapter is movable between the first position in which the dose release valve is not actuated to release a dose of medicament and the second position in which the dose release valve is actuated to release a dose of medicament.
Axial direction enabling relative axial movement between adapter and lockout member
The refill assembly includes an axis that defines an axial direction extending along or substantially parallel to the axis, and the adapter and the lockout member are movable in the axial direction relative to one another when the lockout member is in its second position.
Collectively, the independent claims cover a refill assembly that prevents dose release when uncoupled by using a lockout member to control adapter movement, while enabling medicament dose release when coupled. The first independent claim further ties adapter positions to dose-release valve actuation on a canister, and the second independent claim adds axial-direction relative motion between the adapter and the lockout member when the lockout member permits movement.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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