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Publication Number
US-11612687-B2
Publication Date
2023-03-28
Expiration Date
Abstract
A drug delivery device comprising a delivery unit (2) including an internal reservoir (8), a subcutaneous delivery mechanism (6), a pump for pumping liquid from the internal reservoir to the subcutaneous delivery system, and a liquid filling mechanism (12) configured for injecting liquid from an external vial (16) or reservoir into the internal reservoir. The liquid filling mechanism comprises a filling port (14) and a valve mechanism (18) selectively operable to: open a first fluid path (54) extending from the filling port to the internal fluid reservoir and close a second fluid path (56) extending from the internal reservoir to the subcutaneous delivery member, or close the first fluid path and open the second fluid path. The valve mechanism comprises a valve housing (48) fixedly mounted in relation to a housing of the drug delivery device and a valve stem (50) rotatably received within the valve housing, whereby the first fluid path and the second fluid path are selectively operated by the rotational position of the valve stem in relation to the valve housing, such that when the valve stem is in a first position, the first fluid path is open while the second fluid path is closed, and when the valve stem is in a second position, the second fluid path is open while the first fluid path is closed.
Core Innovation
A drug delivery device includes a delivery unit including an internal reservoir, a subcutaneous delivery mechanism, and a pump for pumping liquid from the internal reservoir to the subcutaneous delivery mechanism. The device further includes a liquid filling mechanism configured for injecting liquid from an external reservoir or vial into the internal reservoir. The liquid filling mechanism includes a filling port and a valve mechanism selectively operable to control fluid communication between the filling port, the internal reservoir, and the subcutaneous delivery mechanism.
The valve mechanism opens a first fluid path extending from the filling port to the internal fluid reservoir while closing a second fluid path extending from the internal reservoir to the subcutaneous delivery mechanism, or alternatively closes the first fluid path and opens the second fluid path. The valve mechanism comprises a valve housing fixedly mounted and rigidly coupled in relation to a housing of the drug delivery device and a valve stem received within the valve housing. The valve stem is arranged to rotate about an axial direction of the filling port, and the first fluid path and the second fluid path are selectively operated by the rotational position of the valve stem in relation to the valve housing.
When the valve stem is in a first position, the first fluid path is open while the second fluid path is closed, and when the valve stem is in a second position, the second fluid path is open while the first fluid path is closed. Fluid switching is achieved by bridging first and second angular seals with corresponding valve stem channels at two valve-stem rotational positions, with optional angular separation constraints. The device further includes a vial adapter for coupling to the filling port using a keyed aperture and keyed member and a locking arrangement, sealing via an annular seal, optional piercing of a vial septum with venting, and position indicators that guide alignment to open the filling path.
Claims Coverage
The independent claim defines a drug delivery device architecture with a valve mechanism that selectively operates first and second fluid paths based on a rotational position of a valve stem in a fixed valve housing. Main inventive features are captured for the independent claim family as reflected in dependent refinements describing the valve stem channels and angular seals, vial adapter coupling and guidance, and related mechanical interfaces.
Rotatable valve stem in fixed valve housing for selective first/second fluid path operation
A valve mechanism comprises a valve housing fixedly mounted and rigidly coupled in relation to a housing of the drug delivery device, and a valve stem received within the valve housing arranged to rotate about an axial direction of the filling port so that the first fluid path and the second fluid path are selectively operated by the rotational position of the valve stem.
Valve stem positional switching between first and second fluid paths
When the valve stem is in a first position, the first fluid path is open while the second fluid path is closed, and when the valve stem is in a second position, the second fluid path is open while the first fluid path is closed.
First/second valve stem channels and angular seal bridging
A valve housing has a cavity holding a valve stem portion with first and second valve stem channels, and first and second angular seals respectively control fluid communication so that bridging by corresponding valve stem channels establishes flow from the filling port to the internal reservoir and flow from the internal reservoir to the subcutaneous delivery mechanism.
Vial adapter coupling by keyed engagement and locking
A vial adapter couples to the filling port using mating male-female connecting members and a locking arrangement including an axial insertion with rotation and/or a spiral axial-rotational locking so that the coupling state corresponds to open/closed first and second fluid paths.
Position indicator alignment to valve stem second position
A vial adapter includes a position indicator that cooperates with a position indicator on a liquid filling mechanism to guide turning the vial adapter to a required angle where the valve stem is in the second position.
Optional piercing member for vial septum
A second connecting portion includes a piercing member adapted to penetrate a septum, membrane, or cover of a vial.
Angular separation constraint for valve stem fluid channels
A valve stem includes first and second fluid channels that are angularly separated by between 90° and 180°.
Across the independent claim and its refinements, the core claim coverage centers on selective routing between a filling port, an internal reservoir, and a subcutaneous delivery mechanism using a rotational valve stem in a fixed valve housing. Dependent features further specify channel-and-angular-seal bridging, keyed and locked vial adapter coupling, position-indicator guided alignment to a valve-stem second position, optional vial septum piercing, and an angular separation range for valve-stem fluid channels.
Stated Advantages
Documented Applications
No documented applications found
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