Stopper for a medicament container

Patent metadata

Field	Value
Publication number	US-11266786-B2
Application number	US-201615752445-A
Country	US
Kind code	B2
Filing date	Jul 6, 2016
Priority date	Aug 13, 2015
Publication date	Mar 8, 2022
Grant date	Mar 8, 2022

Abstract

A stopper for use within a medicament container, preferably a plastic container, is presented having a main body defining an open distal end and a closed proximal end, where the main body has a longitudinal axis L. A cup shaped tip portion is integrally formed with the main body adjacent the closed proximal end and a distally extending flexible skirt extends from a distal end outer surface of the main body, where the distally extending flexible skirt has a rib which extends radially outward around a perimeter of the distally extending flexible skirt. A proximally extending flexible skirt extends from a proximal end outer surface of the main body, where the proximally extending flexible skirt has at least two ribs which extend radially outward around a perimeter of the proximally extending flexible skirt and that are axially spaced apart along the proximally extending flexible skirt.

First claim

What is claimed:

1. A stopper for use within a medicament container, the stopper comprising:
a main body defining an open distal end and a closed proximal end, the main body having a longitudinal axis L and an outer surface defining a first diameter;
a projection nose extending proximally from the closed proximal end of the main body, wherein the projection nose defines a hollow central cavity including an opening at a proximal-most end of the projection nose;
a distally extending flexible skirt extending from the open distal end of the main body, wherein the distally extending flexible skirt comprises a first rib which extends radially outward around a perimeter of the distally extending flexible skirt and defines a second diameter; and
a proximally extending flexible skirt extending from the closed proximal end of the main body, wherein the proximally extending flexible skirt comprises a second rib and a third rib that each extend radially outward around a perimeter of the proximally extending flexible skirt, wherein the second rib and the third rib are axially spaced apart along the proximally extending flexible skirt, wherein the second rib and the third rib are both positioned proximal to a connection point between the proximally extending flexible skirt and the main body, wherein at least one of the second rib and the third rib both define a third diameter, wherein the first diameter is less than the second diameter and the third diameter, wherein the third diameter is greater than the second diameter when the stopper is in a relaxed state outside of the medicament container, and wherein the third diameter comprises a maximum diameter of the stopper.

2. The stopper according to claim 1 , wherein the distally extending flexible skirt extends from a distal end outer surface of the main body.

3. The stopper according to claim 1 , wherein the proximally extending flexible skirt extends from a proximal end outer surface of the main body.

4. The stopper according to claim 1 , wherein the proximally extending flexible skirt comprises an integral part of the main body.

5. The stopper according to claim 4 , wherein a diameter of the projection nose is smaller than the first diameter of the main body.

6. The stopper according to claim 1 , wherein each of the ribs has an outer periphery configured to contact an inner surface of the medicament container to form an active seal.

7. The stopper according to claim 1 , wherein the outer surface is located between the distally extending flexible skirt and the proximally extending flexible skirt, wherein the outer surface is positioned a predetermined radial distance away from an outer periphery of the ribs to minimize an area of contact of the main body with an inner surface of the medicament container to reduce static friction between the distally extending flexible skirt and the proximally extending flexible skirt and the inner surface of the medicament container and to reduce break-loose force.

8. The stopper according to claim 1 , wherein the proximally extending skirt is configured to form a pocket that creates a positive fluid pressure chamber when the stopper is moved axially in a proximal direction within the medicament container.

9. The stopper according to claim 1 , wherein the main body includes an inner cavity having a curved contour surface formed from a sidewall portion of the main body.

10. The stopper according to claim 9 , wherein the inner cavity is configured to accept and connect a forward end of a plunger rod such that an axial force applied to the plunger rod in a proximal direction causes a radial force to be applied to the stopper such that the proximally extending flexible skirt engages an inner surface of the medicament container.

11. The stopper according to claim 1 , wherein the proximally extending flexible skirt projects radially outward from the longitudinal axis L by an angle α.

12. The stopper according to claim 11 , wherein angle α is less than about 10 degrees.

13. The stopper according to claim 11 , wherein the distally extending flexible skirt projects radially outward from the longitudinal axis L by an angle β.

14. The stopper according to claim 13 , wherein angle β is greater than angle α.

15. The stopper according to claim 1 , further comprising a core member comprising a circumferentially extending axially directed sealing lip.

16. The stopper according to claim 1 , wherein the main body includes an inner cavity including a first sidewall portioned at a distal end of the inner cavity and a second sidewall portion positioned at a proximal end of the inner cavity, and wherein a diameter of the first sidewall portion is greater than a diameter of the second sidewall portion.

17. The stopper according to claim 16 , wherein the first diameter is constant along an entire length of the first sidewall portion, and wherein the second diameter is constant along an entire length of the second sidewall portion.

18. The stopper according to claim 1 , wherein a diameter of the hollow central cavity of the projection nose decreases from the opening to a distal end of the hollow central cavity such that a shape of the hollow central cavity is a truncated cone.

Assignees

• Carebay Europe Ltd
• Shl Medical Ag

Inventors

• Dietl Thomas

Classifications

• A61M2005/31521

  Pistons with a forward extending skirt at their front end · CPC title

• A61M5/31513 Primary

  Piston constructions to improve sealing or sliding · CPC title