Stopper

Patent metadata

Field	Value
Publication number	US-2021001053-A1
Application number	US-201916968735-A
Country	US
Kind code	A1
Filing date	Feb 8, 2019
Priority date	Feb 12, 2018
Publication date	Jan 7, 2021
Grant 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.

First claim

1 - 17 . (canceled)

18 . A stopper for use in a cartridge or a syringe of a medical device, the stopper configured to be disposed within a container closure system, the stopper comprising:
a shell comprising a closed end and an open end with sidewalls extending between the closed and the open end along a longitudinal axis of the shell, the open end defining a cavity and the sidewalls defining an exterior surface sized and shaped to fit inside the container closure system; and an insert configured to be inserted into the cavity, the insert being sized and shaped to 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, wherein the closed end of the shell in the cavity defines a convex surface configured to be contacted and deflected by the insert upon insertion of the insert into the cavity, and wherein the closed end of the shell is made of an elastic and/or plastic deformable material.

19 . The stopper of claim 18 , wherein the closed end of the shell defines an arch region defining the convex surface in the cavity and a concave surface of the exterior of the closed end of the shell, and wherein the arch region is configured to be deflected by the insert contacting the convex surface during insertion of the insert into the cavity.

20 . The stopper of claim 18 , wherein the cavity defines inwardly tapering sidewalls from the open end to the closed end of the shell, and wherein the inwardly tapering sidewalls are configured to maintain an inward taper when the arch region is deflected by the insert.

21 . The stopper of any of claim 18 , wherein the cavity comprises an interior step element, and wherein 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.

22 . The stopper of claim 21 , wherein the cavity defines a snap-fit feature extending into the cavity, the snap-fit feature configured to retain the insert in the cavity by being deflected or deformed by the insert during insertion of the insert into the cavity until the snap-fit feature relaxes into a corresponding depression in the insert, and wherein an exterior surface of the insert defines the corresponding depression being sized and positioned to accept the snap-fit feature.

23 . The stopper of claim 21 , wherein the corresponding step element is sized and positioned to retain the interior step element and resist radial deflection of the interior step element by the force applied to the insert.

24 . The stopper of claim 21 , wherein the interior step element defines a first interface surface, and wherein the corresponding step element defines a second interface surface, and wherein the first interface surface abuts against the second interface surface when the insert is inserted into the shell.

25 . The stopper of claim 24 , wherein the first interface surface and the second interface surface define acute angles about the closed end of the shell.

26 . The stopper of claim 18 , wherein the cavity comprises at least one venting channel extending from the closed end of the shell towards the open end of the shell, the at least one venting channel being sized and positioned to enable air and/or fluid in the cavity to be expelled though the at least one venting channel during insertion of the insert into the cavity.

27 . The stopper of claim 26 , wherein the at least one venting channel extends only partially towards the open end of the shell.

28 . The stopper of claim 18 , wherein the insert defines a conically tapering exterior surface configured to enable venting of air in the cavity around the exterior of the insert during insertion of the insert into the cavity.

29 . The stopper of claim 18 , wherein the insert comprises an electronic device having a sensor configured to generate a sensing signal, wherein the closed end of the shell is configured to allow the sensing signal to pass therethrough.

30 . The stopper of claim 29 , wherein the sensor is configured to be responsive to a position of the stopper in the container closure system.

31 . A container closure system comprising:
a cartridge or a syringe comprising a housing; and a stopper, comprising:
a shell comprising a closed end and an open end with sidewalls extending between the closed and the open end along a longitudinal axis of the shell, the open end defining a cavity and the sidewalls defining an exterior surface sized and shaped to fit inside the container closure system; and
an insert configured to be inserted into the cavity, the insert being sized and shaped to 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,
wherein the closed end of the shell in the cavity defines a convex surface configured to be contacted and deflected by the insert upon insertion of the insert into the cavity,
wherein the closed end of the shell is made of an elastic and/or plastic deformable material; and
wherein 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.

32 . The container closure system of claim 31 , wherein the container closure system is a syringe, and the housing is a housing of the syringe, and wherein the insert is disposed at a distal end of a plunger rod of the syringe and is configured to be inserted into the shell of the stopper after the syringe is assembled into a medical device.

33 . The container closure system of claim 31 , wherein the cartridge or the syringe is configured for use with one or more of: an autoinjector, a pen injector, and an injection pump.

34 . The container closure system of claim 31 , wherein the cartridge or the syringe contains a liquid medicament.

35 . The container closure system of claim 31 , wherein the cavity defines inwardly tapering sidewalls from the open end to the closed end of the shell, and wherein the inwardly tapering sidewalls are configured to maintain an inward taper when the arch region is deflected by the insert.

36 . The container closure system of claim 31 , wherein the insert comprises an electronic device having a sensor configured to generate a sensing signal, wherein the closed end of the shell is configured to allow the sensing signal to pass therethrough.

37 . A stopper configured to be disposed within a container closure system, the stopper comprising:
a shell having 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, and an insert configured to be inserted into a cavity of the stopper, the insert being sized and shaped to 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, wherein the open end of the stopper defines the cavity and the sidewalls define an exterior surface sized and shaped to fit inside the container closure system, wherein the closed end of the shell defines an arch region defining a convex surface at a closed end of the cavity and a concave surface of the exterior of the closed end of the shell, and wherein the arch region is configured to be deflected by the insert contacting the convex region upon

Assignees

• Sanofi Sa

Inventors

• Kuehn Bernd

Classifications

• A61M5/31563 Primary

  interacting with a displaceable stop member · CPC title

• A61M2205/3327

  Measuring · CPC title

• A61M5/20

  Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 {, A61M5/46} take precedence; {hypodermic projectiles F42B12/54}) · CPC title

• A61M5/31513

  Piston constructions to improve sealing or sliding · CPC title

• A61M5/31511 Primary

  Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence) · CPC title