Pre-filled syringe and pre-filled cartridge having an improved plunger and plunger rod for reducing syringing force

• US 5,411,488 A
• Filed: 05/06/1994
• Issued: 05/02/1995
• Est. Priority Date: 05/06/1994
• Status: Expired due to Term

• Current Assignee: GE Healthcare As (GE Healthcare Technologies, Inc.)
• Original Assignee: Sterling Winthrop, Inc. (GlaxoSmithKline PLC)
• Inventors: Bachorik, Robert J. II, Liebert, Richard T., Pagay, Shrikant N.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/239,092
• Time in Patent Office: 361 Days
• Field of Search: 604/218, 604/187, 604/228, 604/230, 604/232, 604/221, 604/222, 604/110
• US Class Current: 604/218
• CPC Class Codes: A61M 2005/3112 Incorporating self-aspirating means, e.g. to provide flashback
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding

Abstract

Disclosed are pre-filled syringes equipped with an improved plunger and a plunger rod, characterized by a leak-proof seal and easy sliding property.

Claims

1. A syringe designed to be pre-filled and stored ready for injection comprising:

(a) a barrel having an inner surface defining a cylindrical chamber for retaining an injectable fluid therein;

said barrel having distal end terminating in a tapered tip to which an injection needle can be attached; and

a proximal end for receiving a plunger;

(b) a cup-shaped plunger slideably mounted in said barrel and positioned close to the proximal end of the barrel to provide a seal with the inner surface of the barrel, said plunger comprising;

(1) a distal convex face which is to interface with the injectable fluid contained in the barrel;

(2) a proximal flat or concave face essentially parallel with the distal convex face;

(3) outside wall contiguous with the distal convex face having thereon;

distal ring, proximal ring and center ring extending radially outwardly and forming a slideable seal with the inner surface of the barrel;

(4) inside wall having female threads thereon;

(5) bottom rim which together with the inside wall defines a circular opening in the cup-shaped plunger through which a plunger rod can be inserted for engagement; and

(c) a plunger rod having distal and proximal ends, for engaging the lunger comprising;

(1) a plunger rod tip, located at the distal end of the plunger rod, having a semi-circular shape with convex face projecting in the direction of the plunger, the diameter of which is substantially smaller than the diameter of the plunger, and is designed to contact the proximal flat or concave inside face of the plunger at the center portion thereof;

(2) neck portion, contiguous with the plunger rod tip, designed to receive a slideable cylinder;

(3) slideable cylinder, positioned around the neck portion, comprising;

an inside wall and an outside wall, the inside wall defines a cylinder the diameter of which is smaller than the diameter of the plunger rod tip so as to prevent the slideable cylinder slipping off of the neck portion, the outside wall having male threads for engagement of female threads of the plunger when the plunger rod is inserted into the plunger for operation of the syringe.

2. The syringe of claim 1 wherein said syringe barrel is made of an inert gas impermeable material selected from the group consisting of glass, polyethylene, polypropylene, polystyrenes, acrylic polymers and methacrylic polymers.

3. The syringe of claim 1 wherein said plunger is made of a compressible, elastomeric material.

4. The syringe of claim 1 wherein said plunger rod is made of a material selected from the group consisting of polyethylene, polypropylene, polystryenes, acrylic polymers and methacrylic polymers.

5. The syringe of claim 1 wherein said plunger rod further comprises a handle located at the proximal end thereof to facilitate exertion of manual force by an operator.

6. The syringe of claim 1 wherein said plunger is circumferentially deformed in the direction of the distal end of the barrel upon exertion of a manual force on the plunger rod, thereby pulling said distal ring, proximal ring and center ring inwardly from the inner surface of the barrel and reducing the radial force exerted on the inner surface of the barrel.

7. The syringe of claim 1 wherein said distal ring, proximal ring, and center ring are pulled inward by elastic forces when pressure is exerted on said plunger rod.

8. A method of delivering a liquid medium into a patient from a pre-filled syringe, said syringe comprising:

(a) a barrel having an inner surface defining a cylindrical chamber for retaining an injectable fluid therein;

said barrel having distal end terminating in a tapered tip to which an injection needle can be attached; and

a proximal end for receiving a plunger;

(b) a cup-shaped plunger slideably mounted in said barrel and positioned close to the proximal end of the barrel to provide a seal with the inner surface of the barrel, said plunger comprising;

(1) a distal convex face which is to interface with the injectable fluid contained in the barrel;

(2) a proximal flat or concave face essentially parallel with the distal convex face;

(3) outside wall contiguous with the distal convex face having thereon;

distal ring, proximal ring and center ring extending radially outwardly and forming a slideable seal with the inner surface of the barrel;

(4) inside wall having female threads thereon;

(5) bottom rim which together with the inside wall defines a circular opening in the cup-shaped plunger through which a plunger rod can be inserted for engagement; and

(c) a plunger rod having distal and proximal ends, for engaging the plunger comprising;

(1) a plunger rod tip, located at the distal end of the plunger rod, having a semi-circular shape with convex face projecting in the direction of the plunger, the diameter of which is substantially smaller than the diameter of the plunger, and is designed to contact the proximal concave inside face of the plunger at the center portion thereof;

(2) neck portion, contiguous with the plunger rod tip, designed to receive a slideable cylinder; and

(3) slideable cylinder, position around the neck portion, comprising;

an inside wall and an outside wall, the inside wall defines a cylinder the diameter of which is smaller than the diameter of the plunger rod tip so as to prevent the slideable cylinder slipping off of the neck portion, the outside wall having male threads for engagement of female threads of the plunger when the plunger rod is inserted into the plunger for operation of the syringe;

said method comprising the steps of;

(i) engaging a hypodermic needle with the tapered tip of said barrel;

(ii) threading the slideable cylinder at the distal end of the plunger rod into the plunger;

(iii) gaining entry into the desired injection site on the patient;

(iv) exerting a slight pressure on the plunger rod to expel head gas from the barrel;

(v) releasing the pressure applied on the plunger rod to create vacuum in the syringe and drawing a small amount of body fluid from the patient and into the distal end of the barrel; and

(vi) exerting pressure on the plunger rod to move the plunger thereby delivering the liquid medium into the patient.

9. The method of claim 8 wherein said syringe barrel is made of an inert gas impermeable material selected from the group consisting of glass, polyethylene, polypropylene, polystyrenes, acrylic polymers and methacrylic polymers.

10. The method of claim 8 wherein said plunger is made of a compressible, elastomeric material.

11. The method of claim 8 wherein said plunger rod is made of a material selected from the group consisting of polyethylene, polypropylene, polystryenes, acrylic polymers and methacrylic polymers.

12. The method of claim 8 wherein said plunger rod further comprises a handle located at the proximal end thereof to facilitate exertion of a manual force by an operator.

13. The method of claim 8 wherein said plunger is circumferentially deformed in the direction of the distal end of the barrel upon exertion of a manual force on the plunger rod, thereby pulling said distal ring, proximal ring and center ring inwardly from the inner surface of the barrel and reducing the radial force exerted on the inner surface of the barrel.

14. The method of claim 8 wherein said distal ring, proximal ring, and center ring are pulled inward by elastic forces when pressure is exerted on said plunger rod.

15. The method of claim 8 wherein said liquid medium is a pharmaceutical composition.

16. The method of claim 8 wherein said liquid medium is a diagnostic composition.

17. The method of claim 16 wherein said diagnostic composition is a contrast agent.

18. The method of claim 8 wherein said liquid medium is a biological agent.