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Publication Number
US-10881583-B2
Publication Date
2021-01-05
Expiration Date
Abstract
Described are improvements to components of fluid transfer apparatuses comprising a first component, e.g. a syringe, a connector component configured to connect between the first component and an adapter component that is configured to allow connection of the connector component to a second component of the drug transfer apparatus, e.g. to a drug vial. The improvements include inter alia changes to the sealing elements that seal the proximal end of the syringe, redesign of a septum holder inside the connector component and corresponding redesign of the housing of the connector component; changes to the structure of the end of the connector component that connects to the first component to allow the first component to swivel relative to the connector component; and changes to the design of the adapter component to a second component of the drug transfer apparatus to allow it to mate with the redesigned housing of the connector component.
Core Innovation
The disclosed subject matter concerns a family of improved fluid transfer apparatus components for contamination-free hazardous-drug transfer. A connector component is provided with a septum holder and at least one hollow needle, where the septum holder and the at least one needle are surrounded by an outer housing. The septum holder comprises a septum, a cylindrically shaped annular body, and resilient elongated arms that project downwards from the body. Each arm includes a distal enlarged element with a rounded outwardly facing rear side and a pointed inwardly facing front side.
The outer housing has an open distal end and a proximal part adapted to connect to a first component of a fluid transfer system. Sockets are configured to hold the rounded outwardly facing rear sides of the distal enlarged elements at the bottom of each arm. Guiding channels are formed on the interior surface of the outer housing, configured to guide upward and downward movement of the arms inside the outer housing. An adapter component is attached by the arms to the septum holder during a connection or disconnection process between the connector component and the adapter component.
During the connection or disconnection process, the enlarged elements at a distal end of the arms move back and forth along lines parallel to chords of the circular cross-section of the body of the septum holder as the arms move upward and downward inside the outer housing. Isolation when disconnected is emphasized by functional isolation behavior, including needle ports blocked by needle-valve seats and prevention of fluid entry/exit by septum and bore walls, to prevent migration. Additional improvements include independent guiding channels to prevent connector deformation, reduction of connector geometry by removing a prior distal shoulder bulk, and a swivel-connector mechanism providing tamper-resistant uni-/bi-directional swiveling through coordinated tooth/flange structures and sealing elements, including a factory-assembled syringe-connector swivel via in-situ plastic flex and O-ring sealing. The document also describes an improved syringe proximal sealing element positioned inside the barrel, including an annular disk with a central bore and an O-ring, sealed by welding, gluing, or press-fit, to improve compatibility with syringe pumps.
Claims Coverage
The provided independent claim is clm-00001. It defines an overall connector component architecture with functional movement guidance and adapter coupling during connection/disconnection, and includes specific geometry and movement constraint features. Dependent claims refine the outer housing, proximal connection structures, isolation behavior when disconnected, and independence of guiding channels.
Connector component with resilient arms and chord-parallel enlarged element motion
A connector component comprising a septum holder and at least one hollow needle, the septum holder and the at least one needle surrounded by an outer housing, where the septum holder comprises a septum, a cylindrically shaped annular body, and at least one resilient elongated arm fixedly attached to the body projecting downwards, each arm comprising a distal enlarged element having a rounded outwardly facing rear side and a pointed inwardly facing front side, the outer housing comprises an open distal end and a proximal part adapted to connect to a first component, sockets configured to hold the rounded outwardly facing rear sides of distal enlarged elements at the bottom of each arm, guiding channels formed on the interior surface of the outer housing, the guiding channels guiding upward and downward movement inside the outer housing of the arms, and an adapter component attached by the arms during connection/disconnection, wherein the enlarged elements move back and forth along lines parallel to chords of the circular cross-section of the body of the septum holder as the arms are moved upward and downward inside the outer housing.
Outer housing geometry as right prism with square cross-section
The outer housing has the shape of a right prism with a generally square cross-section.
Proximal connection structures including Luer and swiveling
The proximal part of the outer housing is manufactured with one of: a straight or tapered interior-wall bore for press-fit/gluing/laser or ultrasound welding to a matching cylindrical or conical projection; a standard male or female Luer connector; and a Luer connector enabling uni-directional or bi-directional swiveling around the vertical symmetry axis.
Functional isolation when disconnected via septum and bore-wall compression
When the connector component is not connected to any other component of a fluid transfer system, the rounded rear side of distal enlarged elements engages sockets to isolate needle tips so that septum and bore-wall compression prevent fluids from entering or exiting the needle interiors.
Independent guiding channels to avoid deformation
Each arm and enlarged element has its own independent guiding channels that allow independent operation, thereby eliminating deformation of the outer housing or the guiding channels by forces from the enlarged elements.
Across the independent connector architecture and its dependent refinements, the claims focus on resilient arms with distal enlarged elements that move in a chord-parallel manner within an outer housing, a socket-and-guiding-channel arrangement for controlled motion and adapter attachment during connection/disconnection, and additional constraints for isolation when disconnected, proximal coupling options including Luer and swiveling, and independent guiding channels to prevent deformation.
Stated Advantages
Contamination-free hazardous-drug transfer.
Functional isolation when disconnected, including prevention of fluids entering or exiting needle interiors and prevention of migration.
Independently guided arm motion that eliminates deformation of the outer housing or guiding channels by forces from enlarged elements.
Tamper-resistant uni-/bi-directional swiveling for a swivel-connector mechanism.
Improved compatibility with syringe pumps via an improved syringe proximal sealing element.
Documented Applications
Hazardous-drug transfer using a fluid transfer system that includes a connector component and a syringe, with compatibility with syringe pumps.
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