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Publication Number
US-12337151-B2
Publication Date
2025-06-24
Expiration Date
Abstract
A stopper for use in a cartridge or syringe of a medical device [SL6]is configured to be disposed within a container closure system. The stopper comprises a shell comprising a closed end and an open end with sidewalls extending between the closed end and the open end along a longitudinal axis of the shell. The open end defines a cavity and the sidewalls define an exterior surface sized and shaped to fit inside the container closure system. An insert is configured to be inserted into the cavity, receive a force from a plunger rod, and distribute the force to the shell in order to advance the shell into the container closure system. The closed end of the shell in the cavity defining a convex surface configured to be contacted and deflected by the insert upon insertion into the cavity includes an elastic and/or plastic deformable material.
Core Innovation
The disclosed invention relates to a stopper for use in a cartridge or a syringe of a medical device. The stopper is disposed within a container closure system and includes a shell having a closed end and an open end with sidewalls extending along a longitudinal axis. The open end defines a cavity, and the sidewalls define an exterior surface sized and shaped to fit inside the container closure system.
An insert is configured to be inserted into the cavity and includes a distal end and a proximal end that receive a force from a plunger rod to distribute force to the shell to advance the shell into the container closure system. The closed end of the shell in the cavity defines a convex surface that is curved into the cavity and is configured to be contacted and deflected by the insert upon insertion of the insert into the cavity. The cavity includes an interior step element, and the insert includes a corresponding step element configured to abut the interior step element and distribute at least a portion of the force from the plunger rod to the interior step element.
The closed end is made of an elastic and/or plastic deformable material, and the insert is constructed of a plurality of segments that decrease in size toward the distal end of the insert. In a further aspect, a container closure system is provided that includes a cartridge or a syringe having a housing, and a stopper as described for force distribution and deflection. The shell is configured to be inserted into the housing prior to the container closure system being filled with a medical product, and the insert is configured to be inserted into the stopper after the container closure system has been filled with the medical product.
Claims Coverage
The partial content includes three independent claims. Across these independent claims, the core inventive structure is a deformable shell with a convex curved closed-end arch region in a cavity, and a segmented insert that receives plunger-rod force and distributes it to the shell, including cooperative interior/corresponding step elements.
Force-distributing insert for advancing a deformable shell
An insert configured to be inserted into the cavity, the insert comprising a distal end and a proximal end and being sized and shaped to receive a force from a plunger rod and distribute the force to the shell to advance the shell into the container closure system.
Convex curved closed-end contact and deflection
The closed end of the shell in the cavity defines a convex surface that is curved into the cavity and configured to be contacted and deflected by the insert upon insertion of the insert into the cavity.
Elastic and/or plastic deformable closed end
The closed end of the shell is made of an elastic and/or plastic deformable material.
Interior/corresponding step element force distribution by abutment
The cavity comprises an interior step element, and the insert comprises a corresponding step element configured to abut the interior step element and distribute at least a portion of the force from the plunger rod to the interior step element.
Segmented insert decreasing in size toward the distal end
The insert is constructed of a plurality of segments, whereby the segments decrease in size toward the distal end of the insert.
Container closure system with stopper insert assembly after filling
The shell is configured to be inserted into the housing prior to the container closure system being filled with a medical product, and the insert is configured to be inserted into the stopper after the container closure system has been filled with the medical product.
Arch region with convex surface in cavity and concave exterior surface
The closed end of the shell defines an arch region defining a convex surface that is curved into the cavity and a concave exterior surface of the closed end of the shell, wherein the arch region is configured to be deflected by the insert contacting the convex surface upon insertion into the cavity.
The independent claims collectively cover a medical-device stopper in which a plunger-rod-driven, segmented insert distributes force to a deformable shell, including cooperative abutting interior/corresponding step elements. The shell’s closed end forms a convex curved surface or arch region that is contacted and deflected by the insert, and one independent claim further specifies a container closure system where the shell is inserted before filling and the insert is inserted after filling.
Stated Advantages
Documented Applications
No documented applications found
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