Syringe

• US 5,137,511 A
• Filed: 11/16/1989
• Issued: 08/11/1992
• Est. Priority Date: 07/08/1987
• Status: Expired due to Term

• Current Assignee: Duoject Medical Systems, Inc
• Original Assignee: Duoject Medical Systems, Inc
• Inventors: Reynolds, David L.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Lewis, Ralph A.
• Application Number:
  US07/437,203
• Time in Patent Office: 999 Days
• Field of Search: 604/82, 604/87, 604/88, 604/89, 604/91, 604/92, 604/191, 604/200, 604/201, 604/413, 604/414, 604/416
• US Class Current: 604/88
• CPC Class Codes: A61M 2005/3139 Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
• CPC Class Codes: A61M 5/1411 Drip chambers A61M5/162, A61M5/1689, A61M5/40 take precedence
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing

Abstract

A prefilled syringe for one or two component medicaments is based upon the use of a vial containing a medicament or one component of a medicament, the vial having an open bottom closed by a piston. When a flexible extension of the piston is coupled with a tubular plunger, and an adaptor cap having an internal needle and an external connection for a needle is placed over a cap of the vial, the latter is converted into a prefilled syringe. The piston may have an axial passage closed by a resealable septum, so that a separate diluent stored in a flexible capsule may be introduced into the vial through the piston by a double ended needle mounted on a further cap applied to the capsule, the further cap being coupled within the tubular interior of the plunger so that the double ended needle penetrates the septum in the piston. The capsule is pushed forward onto the double ended needle when its contents are to be expelled into the vial. The capsule and its cap are then removed and discarded. In an alternative arrangement, the cap of the capsule is coupled to the adaptor cap and the diluent introduced into the vial through a closure secured by the cap of the vial, after which the capsule is removed from the plunger and the latter is coupled to the piston.

Claims

1. A vial formed of rigid transparent material and consisting of a cylindrical body, said body having an open bottom end having an external diameter at most only slightly greater than that of the remainder of the body, but sufficient relative to the height and center of gravity of the vial as a whole to support the latter in a stable manner when conveyed standing on its open end through vial filling and capping machinery, injectable material within the body, comparatively wide neck at the top of the body through which said injectable material is filled into the body, an external peripheral flange surrounding the neck, an elastomeric closure applied to the neck, a cylindrical cap clamped onto the flange of the neck and having an annular inward extending flange at a top end overlapping the closure to secure the closure to the neck with the closure presenting a needle penetrable central portion, an impervious substantially solid piston of resilient material sealingly received within said body at its lower end beneath said injectable material and above said open bottom end, and a flexible reduced diameter extension integral with said piston, projecting downwardly from said piston but wholly within the body, for establishing a flexible connection to a syringe plunger in a zone between the piston and said open end of the body, whereby said vial may be converted into a syringe for ejection of the injectable material on movement of the piston towards the neck, by connection of said syringe plunger to said extension and connection of fluid conduit coupling means to said cylindrical cap, wherein the piston and its extension are formed of rubber of at least 50 durometer hardness, and the extension is formed with a central bore to increase its flexibility.

2. A vial according to claim 1, wherein the piston is formed with multiple axially spaced peripheral ribs in compressive engagement with an inside cylindrical wall of the vial body.

3. A syringe comprising a vial according to claim 1, an outer cap which is a push fit over the cap of the vial and incorporates a needle mounting adaptor concentric with said needle penetrable portion of the closure, and a tubular cylindrical syringe plunger for coupling to said flexible extension of the piston.

4. A syringe according to claim 3, further including an inwardly directed hollow needle received within the needle mounting adaptor, and a sleeve secured to an outer end of the needle projecting beyond the adaptor such that pressure on the sleeve when an injection needle is coupled to the adapter will force the hollow needle through the needle penetrable portion of the closure of a vial to which the outer cap is applied.

5. A vial formed of rigid transparent material and consisting of a cylindrical body, said body having an open bottom end having an external diameter at most only slightly greater than that of the remainder of the body, but sufficient relative to the height and center of gravity of the vial as a whole to support the latter in a stable manner when conveyed standing on its open end through vial filling and capping machinery, injectable material within the body, a comparatively wide neck at the top of the body through which said injectable material is filled into the body, an external peripheral flange surrounding the neck, an elastomeric closure applied to the neck, a cylindrical cap clamped onto the flange of the neck and having an annular inward extending flange at a top end overlaying the closure to secure the closure to the neck with the closure presenting a needle penetrable central portion, an impervious substantially solid piston or resilient material sealingly received within said body at its lower end beneath said injectable material and above said open bottom end, and a flexible reduced diameter extension integral with said piston, projecting downwardly from said piston but wholly within the body, for establishing a flexible connection to a syringe plunger in a zone between the piston and said open end of the body, whereby said vial may be converted into a syringe for ejection of the injectable material on movement of the piston towards the neck, by connection of said syringe plunger to said extension and connection of fluid conduit coupling means to said cylindrical cap;

wherein the extension is formed with external screw threads for engagement with complementary threads on the plunger, and with abutment means to limit the distance through which the plunger can be screwed onto said threads, such as to prevent rigid abutment of the plunger against the piston and to enable the extension to form a flexible connection between the plunger and the piston.

6. A vial formed of rigid transparent material and consisting of a cylindrical body, said body having an open bottom end terminating in a peripheral bead having an external diameter at most only slightly greater than that of the remainder of the body, but sufficient relative to the height and center of gravity of the vial as a whole to support the latter in a stable manner when conveyed freestanding on said bead through vial filling and capping machinery, injectable material within the body, a comparatively wide neck at the top of the body through which said injectable material is filled into the body, an external peripheral flange surrounding the neck, an elastomeric closure applied to the neck, a cylindrical cap clamped onto the flange of the neck and having an annular inward extending flange at a top end overlaying the closure to secure the closure to the neck with the closure presenting a needle penetrable central portion, an impervious substantially solid piston of resilient material sealingly received within said body at its lower end beneath said injectable material and above said bead, and a flexible reduced diameter extension integral with said piston, projecting downwardly from said piston but wholly within the body, for establishing a flexible connection to a syringe plunger in a zone between the piston and said open end of the body, whereby said vial may be converted into a syringe for ejection of the injectable material on movement of the piston towards the neck, by connection of said syringe plunger to said extension and connection of fluid conduit coupling means to said cylindrical cap, wherein the weight of the piston and its extension is at least a major portion of that of the vial body, and the height of the vial body does not exceed about 2.5 times the external diameter of the bead.

7. A vial formed of rigid transparent material and consisting of a cylindrical body, said body having an open bottom end having an external diameter at most only slightly greater than that of the remainder of the body, but sufficient relative to the height and center of gravity of the vial as a whole to support the latter in a stable manner when conveyed standing on its open end through vial filling and capping machinery, injectable material within the body, a comparatively wide neck at the top of the body through which said injectable material is filled into the body, an external peripheral flange surrounding the neck, an elastomeric closure applied to the neck, a cylindrical cap clamped onto the flange of the neck and having an annular inward extending flange at a top end overlaying the closure to secure the closure to the neck with the closure presenting a needle penetrable central portion, an impervious substantially solid piston of resilient material sealingly received within said body at its lower end beneath said injectable material and above said open bottom end, and a flexible reduced diameter extension integral with said piston, projecting downwardly from said piston but wholly within the body, for establishing a flexible connection to a syringe plunger in a zone between the piston and said open end of the body, whereby said vial may be converted into a syringe for ejection of the injectable material on movement of the piston towards the neck, by connection of said syringe plunger to said extension and connection of fluid conduit coupling means to said cylindrical cap,

wherein the closure substantially fills the neck of the body, and has a top flange overlying the neck and defines a central bore extending from the bottom of the closure to a point beneath said needle penetrable central portion, and wherein the closure further defines a cross bore extending from an outer wall of the closure beneath the flange to said central bore, whereby said cross bore and said central bore together constitute a vent from the interior of the vial when the closure is partially inserted in the neck of the vial body.

8. A syringe comprising:

A vial formed of rigid transparent material and consisting of a cylindrical body, said body having an open bottom end terminating in a peripheral bead having an external diameter at most only slightly greater than that of the remainder of the body, but sufficient relative to the height and center of gravity of the vial as a whole to support the latter in a stable manner when conveyed freestanding on said bead through vial filling and capping machinery, injectable material within the body, a comparatively wide neck at the top of the body through said injectable material is filled into the body, an external peripheral flange surrounding the neck, an elastomeric closure applied to the neck, a cylindrical cap clamped onto the flange of the neck and having an annular inward extending flange at a top end overlying the closure to secure the closure to the neck with the closure presenting a needle penetrable central portion, an impervious substantially solid piston of resilient material sealingly received within said body at its lower end beneath said injectable material and above said bead, and a flexible reduced diameter extension integral with said piston, projecting downwardly from said piston but wholly within the body, for establishing a flexible connection to a syringe plunger in a zone between the piston and said open end of the body, whereby said vial may be converted into a syringe for ejection of the injectable material on movement of the piston towards the neck, by connection of said syringe plunger to said extension and connection of fluid conduit coupling means to said cylindrical cap;

an outer cap which is a push fit over the cap of the vial and incorporates a needle mounting adaptor concentric with said needle penetrable portion of the closure; and

a syringe plunger for coupling to said flexible extension of the piston, wherein a tubular cylindrical front end of the syringe plunger is press fitted onto a front end of the outer cap to form a separately sterilized subassembly.

9. A syringe, comprising:

A vial formed of rigid transparent material and consisting of a cylindrical body, said body having an open bottom end terminating in a peripheral bead having an external diameter at most only slightly greater than that of the remainder of the body, but sufficient relative to the height and center of gravity of the vial as a whole to support the latter in a stable manner when conveyed freestanding on said bead through vial filling and capping machinery, injectable material within the body, a comparatively wide neck at the top of the body through which said injectable material is filled into the body, an external peripheral flange surrounding the neck, an elastomeric closure applied to the neck, a cylindrical cap clamped onto the flange of the neck and having an annular inward extending flange at a top end overlaying the closure to secure the closure to the neck with the closure presenting a needle penetrable central portion, an impervious substantially solid piston of resilient material sealingly received within said body at its lower end beneath said injectable material and above said bead, and a flexible reduced diameter extension integral with said piston, projecting downwardly from said piston but wholly within the body, for establishing a flexible connection to a syringe plunger in a zone between the piston and said open end of the body, whereby said vial may be converted into a syringe for ejection of the injectable material on movement of the piston towards the neck, by connection of said syringe plunger to said extension and connection of fluid conduit coupling means to said cylindrical cap;

an outer cap which is push fit over the cap of the vial and incorporates a needle mounting adaptor concentric with said needle penetrable portion of the closure; and

a syringe plunger having a tubular cylindrical end portion for coupling to said flexible extension of the piston;

wherein a piston stabilizer ring is a snap fit on the bead, the piston stabilizer ring having flanges extending into the vial body between the inner wall of the body and the plunger to limit tilting of the plunger and prevent withdrawal of the piston from the body.

10. A syringe comprising a vial formed of rigid transparent material and consisting of a cylindrical body, said body having an open bottom end having an external diameter at most only slightly greater than that of the remainder of the body, but sufficient relative to the height and center of gravity of the vial as a whole to support the latter in a stable manner when conveyed standing on its open end through vial filling and capping machinery, injectable material within the body, a comparatively wide neck at the top of the body through which said injectable material is filled into the body, an external peripheral flange surrounding the neck, an elastomeric closure applied to the neck, a cylindrical cap clamped onto the flange of the neck and having an annular inward extending flange at a top end overlaying the closure to secure the closure to the neck with the closure presenting a needle penetrable central portion, an impervious substantially solid piston of resilient material sealingly received within said body at its lower end beneath said injectable material and above said open bottom end, and an extension integral with said piston, projecting downwardly from said piston but wholly within the body, a needle mounting adaptor concentric with said needle penetrable portion of the closure, and an elongated syringe plunger for coupling to said flexible extension of the piston;

wherein the syringe plunger is moulded from synthetic plastic having hinge-forming capability, and has an outwardly extending flange at its rear end, a peripheral portion of this flange being separated form the remainder around about half of its circumference, and the ends of the separated portion being connected to the remainder by integrally formed hinges to form a loop which can be pulled rearwardly of the flange.

11. A syringe plunger comprising an elongated stem defining a cylindrical recess at one end moulded from synthetic plastic material having hinge-forming capability, a cylindrical rubber piston of greater diameter than the plunger, an axial extension at one end of the piston entering within and releasably engaged with said cylindrical recess at one end of the plunger, and an outwardly extending flange at the other end of the plunger, a peripheral portion of this flange being separated from the remainder around about half of its circumference, and the ends of the separated portion being connected to the remainder by integral hinge-forming bridges to form a loop which can be pulled rearwardly of the flange.