Stoppers used in pre-filled syringes

• US 8,740,856 B2
• Filed: 04/05/2010
• Issued: 06/03/2014
• Est. Priority Date: 06/04/2007
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Quinn, Michael Vincent, Schiller, Eric, Ju, Gang, Guan, E
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US12/754,101
• Publication Number:
  US 20110034882A1
• Time in Patent Office: 1,520 Days
• Field of Search: 604/218, 604/222, 604/230, 604/228, 604/229
• US Class Current: 604/228
• CPC Class Codes: A61M 2005/31521 Pistons with a forward extending skirt at their front end
• CPC Class Codes: A61M 2005/31523 for reducing reflux
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod

Abstract

A stopper adapted for attachment with a plunger rod for use within a syringe barrel is disclosed. The stopper includes a main body defining an open rearward end and a closed front end. The open rearward end is adapted to receive a front forward end attachment portion of the plunger rod. The stopper also includes a core member integrally formed with the main body adjacent the closed front end. The core member includes a nose portion having a conical tip configured for entering an outlet opening of the syringe barrel. The closed front end of the stopper has a profile configured to cooperate with an internal surface of the syringe barrel wall to prevent reflux and reduce dead space within the barrel.

Claims

1. A stopper adapted for attachment with a plunger rod for use within a syringe barrel, said stopper comprising:

(a) a main body defining an open rearward end and a closed front end, said open rearward end adapted to receive a front forward end attachment portion of such plunger rod, said main body including an inner surface;

(b) a core member integrally formed with said main body adjacent said closed front end, said core member including a nose portion having a conical tip configured for entering an outlet opening of the syringe barrel, said core member including a stopper center post protruding from an interior of the core member toward the open rearward end, said stopper center post including a back core portion adapted for contact with said front forward end attachment portion of the plunger rod;

(c) at least a first rib extending radially outward around a perimeter of said main body; and

(d) a taper provided on said inner surface of said main body, said taper adapted for contact with a corresponding taper on the front forward end attachment portion of the plunger rod, said taper and corresponding taper cooperating together to cause the stopper to apply a radial force to the syringe barrel upon the application of a forward force to the plunger rod.

2. The stopper of claim 1, including at least a second rib extending radially outward around a perimeter of said main body, said second rib adapted for forming an active seal with such syringe barrel;

and

wherein the main body includes a sidewall having a first diameter for containment within a syringe barrel having a first internal diameter wall portion, the conical tip has a second diameter for contacting the barrel outlet having a second internal diameter wall portion, and the closed front end has a tapered wall profile configured for cooperating with a tapered wall portion of the internal barrel wall extending between the first and second barrel internal diameter wall portions for preventing reflux which reduces dead space between the stopper and the internal barrel wall.

3. The stopper of claim 2, wherein said main body includes at least a third rib and wherein said first, second, and third ribs extend radially outward around a perimeter of said main body and are axially spaced apart along said main body.

4. The stopper of claim 2, wherein said closed front end has a first slope extending from the nose portion to the first rib and the taper of the syringe barrel extending from the outlet opening of the barrel to a top sidewall portion of the syringe barrel has a second slope and wherein the first slope is steeper than the second slope.

5. The stopper of claim 4, wherein upon the application of a forward force to the plunger rod, the nose portion of the stopper contacts the barrel outlet to prevent reflux and the cooperation of the first and second slopes and radial pressure of the internal barrel wall with respect to at least the first rib causes longitudinal extension of the stopper such that the nose portion extends into the barrel outlet preventing reflux.

6. The stopper of claim 5, wherein an angle of the first slope is approximately 1°

less than an angle of the second slope.

7. The stopper of claim 6, wherein the longitudinal expansion of the stopper upon application of a forward force to the plunger rod results in an angle increase of approximately 2.8°

of the first slope.

8. The stopper of claim 1, wherein said main body includes at least one undercut portion extending axially inward of said open rearward end, said undercut portion adapted for locking such front forward end attachment portion of such plunger rod within said stopper.

9. The stopper of claim 1, wherein said taper of said inner surface of said main body is a continuous contour from a side wall portion of said main body to said core member.

10. The stopper of claim 1, wherein the open rearward end is defined by a perimetrical edge portion and wherein an outer surface of the edge portion includes at least one protrusion extending therefrom.

11. The stopper of claim 1, wherein the core member includes a back core portion defined by a sidewall portion extending from a bottom core surface to a taper surface of the stopper and wherein the sidewall portion is essentially straight substantially along its entire length.

12. A syringe comprising:

(a) a cylindrical barrel including a proximal end, a distal end, and a sidewall having a first internal diameter extending between the proximal and distal end, said distal end terminating in an outlet opening having a second internal diameter which is less than said first internal diameter, said cylindrical barrel including a second sloped surface extending between the outlet opening and the barrel sidewall;

(b) a plunger rod extendable into said barrel through an opening in the proximal end of the barrel, said plunger rod including a front forward attachment portion; and

(c) a stopper having a main body having an open rearward end, a closed front end, and a sidewall portion extending between said open rearward end and said closed front end, said open rearward end adapted to receive said front forward attachment portion of such plunger rod, a core member integrally formed with said main body adjacent said closed front end, said core member including a nose portion having a conical tip configured for entering the outlet opening of the syringe barrel, said core member including a stopper center post protruding from an interior of the core member toward the open rearward end, said stopper center post including a back core portion adapted for contact with said front forward attachment portion of the plunger rod, said closed front end including a first sloped surface extending from said conical tip to said stopper sidewall portion,

wherein said first sloped surface of said stopper is steeper than the second sloped surface of the cylindrical barrel such that an application of a forward force to said plunger rod causes the conical tip of the stopper to enter into the outlet opening to result in essentially zero reflux and wherein the first and second slopes cooperate together to reduce dead space within the barrel, and

wherein said main body includes an inner surface having a taper adapted for contact with a corresponding taper on the front forward end attachment portion of the plunger rod, said taper and corresponding taper cooperating together so that said stopper applies a radial force to the syringe barrel upon the application of a forward force to the plunger rod.

13. The syringe of claim 12, wherein said main body includes a first rib extending radially outward around a perimeter of said main body, and at least a second rib extending radially outward around a perimeter of said main body spaced a distance away from said first rib, the at least said second rib adapted for forming an active seal with the syringe barrel.

14. The syringe of claim 12, wherein said taper of said inner surface of said main body is a continuous contour from a side wall portion of said main body to said core member.

15. The syringe of claim 12, wherein said main body includes at least one undercut portion extending axially inward from said open rearward end, said undercut portion adapted for locking the front portion of such plunger rod within said stopper.

16. The syringe of claim 12, wherein upon the application of a forward force to the plunger rod, the nose portion of the stopper contacts the barrel outlet to prevent reflux and the cooperation of the first and second slopes and radial pressure of the internal barrel wall with respect to at least the first rib causes longitudinal extension of the stopper such that the nose portion extends into the barrel outlet preventing reflux.

17. The syringe of claim 16, wherein an angle of the first slope is at least 1°

less than the angle of the second slope and wherein the longitudinal expansion of the stopper upon application of a forward force to the plunger rod results in an angle increase of approximately 2.8°

of the first slope.

18. A stopper adapted for attachment with a plunger rod for use within a syringe barrel, said stopper comprising:

(a) a main body defining an open rearward end and a closed front end, said open rearward end adapted to receive a front forward end attachment portion of such plunger rod;

(b) a core member integrally formed with said main body adjacent said closed front end, said core member including a nose portion, said core member including a stopper center post protruding from an interior of the core member toward the open rearward end, said stopper center post including a back core portion adapted for contact with said front forward end attachment portion of the plunger rod, said nose portion having a profile adapted to create a positive seal with an outlet opening of such syringe barrel;

(c) at least one rib extending radially outward around a perimeter of said main body for forming an active seal with such syringe barrel; and

(d) an inward shoulder portion on an inner surface of said main body, said inward shoulder portion adapted for contact with a taper on the forward end of the plunger rod,

wherein contact of said inward shoulder portion with said taper causes the stopper to apply a radial force to said at least one rib and the syringe barrel upon the application of a forward force to the plunger rod, and

wherein said inward shoulder portion includes a first cylindrical wall portion extending from the closed front end of said main body, said first wall portion having a substantially flat surface profile, said inward shoulder portion further including a second cylindrical wall portion extending toward the open rearward end of said main body, and a sloped portion extending between the first wall and the second wall.

19. The stopper of claim 18, wherein said core member includes a front portion, a back portion, and a central portion positioned between said front and back portion, said front portion extending beyond the front end of said main body and said central portion is interconnected with said main body via a flexible membrane extending between said core member and said main body.

20. The stopper of claim 18, wherein said main body includes at least one forward extending skirt extending from a front end of said main body wherein said skirt is adapted for creating a positive pressure chamber therein.

21. The stopper of claim 18, wherein said core member includes a back portion and wherein at least one of said back portion of said core member and an inner surface of said closed front end includes at least one concentric groove formed therein.

22. The stopper of claim 21, wherein at least one of said back portion of said core member and said inner surface of said closed front wall includes stopper material adapted for contacting the front forward end attachment portion of the plunger rod upon an application of forward force to the plunger rod.

23. A plunger rod and stopper assembly adapted for use with a syringe barrel, said assembly comprising:

(a) a plunger rod having a front attachment end and a back end and extending along a longitudinal axis, said front attachment end including a taper and a front flange extending therefrom;

(b) a stopper having a main body defining an open rearward end, a closed front end, and a core member integrally formed with said main body adjacent said closed front end, said core member including a stopper center post protruding from an interior of the core member toward the open rearward end, said stopper center post including a back core portion adapted for contact with said front attachment end of the plunger rod, said open rearward end defined by an inside wall surface, said open end adapted for receiving said front attachment end of said plunger rod and locking said plunger rod within said stopper;

(c) at least one rib extending radially outward around a perimeter of said main body for forming an active seal with the syringe barrel;

(d) a taper formed on an inner surface of said main body, said taper having a sloped portion adapted for contact with said taper on the front attachment end of such plunger rod, said contacting tapers forming an active seal surface for cooperating together causing said stopper to apply a radial force to said at least one rib and the syringe barrel upon the application of a forward force to the plunger rod; and

(e) an open space defined by the inner surface of the main body, a portion of said core member, and said taper on the inner surface of said main body,

wherein said front flange extending from said front attachment end of said plunger rod extends into said open space.