Three-position plungers, film coated plungers and related syringe assemblies
Inventors
Giraud, Jean-Pierre • Sol, Bernard • Pangborn, Robert J. • Abrams, Robert S. • Rogers, Joseph W. • Sagona, Peter J. • Mims, Michael J.
Assignees
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Publication Number
US-11857771-B2
Publication Date
2024-01-02
Expiration Date
Abstract
A three-position plunger is provided including a sleeve having an opening at a distal end, a pre-load cavity proximal to and in communication with the opening, a first cavity proximal to and in communication with the pre-load cavity, a second cavity proximal to and in communication with the pre-load cavity, and at least one rib. The rib(s) is generally aligned with the first cavity. The plunger further includes an insert configured to be displaced from the pre-load cavity to the first cavity and from the first cavity to the second cavity. The insert is configured to provide support for the compression of the rib(s) when the insert is positioned in the first cavity.
Core Innovation
The invention relates to a prefilled syringe comprising a barrel with a drug product contained within a product containing area and a three-position plunger disposed in its entirety within the barrel. The three-position plunger includes a sleeve having an opening at a distal end, a nose cone, and a sidewall that comprises a storage sealing section having at least one rib and a liquid sealing section disposed between the nose cone and the storage sealing section.
The sleeve includes a pre-load cavity proximal to and in communication with the opening, a first cavity proximal to and in communication with the pre-load cavity, and a second cavity proximal to and in communication with the first cavity. An insert is pre-inserted into the pre-load cavity in a pre-load mode and is configured to be displaced from the pre-load cavity to the first cavity and from the first cavity to the second cavity, with the at least one rib generally aligned with the first cavity and compressed outwardly when the insert is positioned in the first cavity.
The storage sealing section is generally aligned with the first cavity to maintain an expanded state by the insert being disposed within the first cavity. The insert applies outward radial pressure against an interior surface of the three-position plunger at a location radially inward of the storage sealing section, thereby providing a compressive force of the storage sealing section against the inner wall.
The three-position plunger is reducible to a constricted state such that compressive force against the inner wall is reduced or removed entirely by effectuating axial displacement of the insert from the first cavity to the second cavity upon application of force onto the three-position plunger in a direction toward the drug product. The liquid sealing section provides a liquid tight seal against the inner wall both when the three-position plunger is in the expanded state and when the three-position plunger is in the constricted state.
Claims Coverage
Independent claim clm-00001 defines a three-position plunger in a prefilled syringe with four inventive features: cavity-defined insert displacement, rib outward compression in the expanded state, axial insert relocation to reduce or remove compressive force in the constricted state, and liquid tight sealing in both states.
Insert-displaced expanded-to-constricted sealing states via cavity sequence
An insert is pre-inserted into a pre-load cavity and is configured to be displaced from the pre-load cavity to a first cavity and from the first cavity to a second cavity, where the storage sealing section maintains an expanded state when the insert is disposed within the first cavity and the compressive force against the inner wall is reduced or removed entirely by axial displacement of the insert from the first cavity to the second cavity.
Rib outward compression to maintain storage sealing in expanded state
The insert compresses at least one rib outwardly when positioned in the first cavity, and the storage sealing section is generally aligned with the first cavity such that the insert applies outward radial pressure against an interior surface of the three-position plunger at a location radially inward of the storage sealing section, providing compressive force of the storage sealing section against the inner wall.
Axial displacement reduces force required for constricted state
The three-position plunger is reducible to a constricted state wherein the compressive force against the inner wall is reduced or removed entirely, and the three-position plunger in the constricted state provides less compressive force against the sidewall than when in the expanded state, such that force needed to axially displace the three-position plunger in the constricted state is less than would be required in the expanded state.
Liquid tight seal in both expanded and constricted states
The liquid sealing section provides a liquid tight seal against the inner wall both when the three-position plunger is in the expanded state and when the three-position plunger is in the constricted state.
The claim coverage centers on an insert displaced among pre-load, first, and second cavities to maintain an expanded storage sealing condition by rib outward compression, then reduce or remove compressive force in a constricted state via axial insert displacement, while preserving liquid tight sealing in both states.
Stated Advantages
Force needed to axially displace the three-position plunger in the constricted state is less than would be required in the expanded state.
Documented Applications
Not explicitly described in patent.
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