Prefilled vial syringe
First Claim
1. A pharmaceutical vial used for forming a barrel and a piston of a syringe after being filled and capped, comprising a cylindrical glass vial body having at one end an integral open neck and a peripheral external flange around an outer end of the neck, a peripheral rounded edge defining an inner periphery of an open opposite end, and a piston of resilient material having a cylindrical head within and concentric with the cylindrical glass body, the piston maintaining a slidable hermetically sealing relationship with a main inner cylindrical surface of the body, and being located to define a chamber of volume equal to the nominal capacity of the vial between the piston head and the neck of the vial, the piston having integral coupling structure wholly within the body for subsequent connection to a syringe plunger, and the vial being stable when standing on the open end of the body such that it can be conveyed while so standing through vial filling and capping machinery without tipping over, the body being formed adjacent said open end with peripheral radially extending positive retention means for engagement with complementary configurations of a tubular piston retaining member subsequently inserted within said open end of the body to resist overpressure within the body, wherein the retention means is formed by shaping a lower end portion of the body to have a reduced internal diameter such that the retention means is formed by an upwardly facing shoulder at the top of the lower end portion which projects inwardly of the projected circumference of said main interior cylindrical surface, and the lower end portion is located essentially within the projected circumference of a main cylindrical external surface of the body such as to leave the external surface of the body free of projections having an adverse effect on the stability of the vial;
- said vial further including a pharmaceutically project within the chamber, a needle penetrable stopper inserted in the neck, and an annular cap crimped over said stopper and the flange of the neck to retain the stopper in hermetic engagement with the neck, the cap being provided with a concentric tubular outward extension for receiving one of a double ended hollow needle and an adaptor for receiving a single ended hollow needle such that one end of the double ended needle, or a hollow needle provided on the adaptor, can penetrate the stopper, and including a finger grip and piston retainer member, wherein the piston retainer member includes a tubular member which is a press fit within the open end of the body of the vial, and a flange at an outer end of the tubular member providing outwardly extending finger tabs, the tubular member being recessed in its external surface adjacent the flange in the vicinity of the finger tabs so as to receive the retention means inward of the interior wall of the body.
1 Assignment
0 Petitions
Accused Products
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 open bottom of the vial is configured so as not to interfere with handling of the vials by conventional vial sterilizing, filling and capping machinery, and may be formed so as to provide an internal shoulder which will secure a piston retention member.
75 Citations
14 Claims
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1. A pharmaceutical vial used for forming a barrel and a piston of a syringe after being filled and capped, comprising a cylindrical glass vial body having at one end an integral open neck and a peripheral external flange around an outer end of the neck, a peripheral rounded edge defining an inner periphery of an open opposite end, and a piston of resilient material having a cylindrical head within and concentric with the cylindrical glass body, the piston maintaining a slidable hermetically sealing relationship with a main inner cylindrical surface of the body, and being located to define a chamber of volume equal to the nominal capacity of the vial between the piston head and the neck of the vial, the piston having integral coupling structure wholly within the body for subsequent connection to a syringe plunger, and the vial being stable when standing on the open end of the body such that it can be conveyed while so standing through vial filling and capping machinery without tipping over, the body being formed adjacent said open end with peripheral radially extending positive retention means for engagement with complementary configurations of a tubular piston retaining member subsequently inserted within said open end of the body to resist overpressure within the body, wherein the retention means is formed by shaping a lower end portion of the body to have a reduced internal diameter such that the retention means is formed by an upwardly facing shoulder at the top of the lower end portion which projects inwardly of the projected circumference of said main interior cylindrical surface, and the lower end portion is located essentially within the projected circumference of a main cylindrical external surface of the body such as to leave the external surface of the body free of projections having an adverse effect on the stability of the vial;
said vial further including a pharmaceutically project within the chamber, a needle penetrable stopper inserted in the neck, and an annular cap crimped over said stopper and the flange of the neck to retain the stopper in hermetic engagement with the neck, the cap being provided with a concentric tubular outward extension for receiving one of a double ended hollow needle and an adaptor for receiving a single ended hollow needle such that one end of the double ended needle, or a hollow needle provided on the adaptor, can penetrate the stopper, and including a finger grip and piston retainer member, wherein the piston retainer member includes a tubular member which is a press fit within the open end of the body of the vial, and a flange at an outer end of the tubular member providing outwardly extending finger tabs, the tubular member being recessed in its external surface adjacent the flange in the vicinity of the finger tabs so as to receive the retention means inward of the interior wall of the body. - View Dependent Claims (2)
- 3. A bottomless pharmaceutical vial for incorporation into a syringe, comprising a generally upright cylindrical hollow body with a narrower neck at its top end, a side wall of the body being formed with a bottom edge surrounding a flared bottom opening, with an inner surface of a lower portion of the side wall of the body adjacent said bottom opening extending upwardly to an outward jog in said inner surface, the jog forming an upwardly facing annular shoulder, and the lower portion of the side wall being substantially wholly within a downward projection of an outer surface of the remainder of the side wall, a piston within the body, and a piston retainer ring inserted into the bottom opening of the body beneath the piston, the piston retainer ring having an outer surface with an upper portion tapered to enter the flare of the inner wall of the body adjacent said bottom opening, a lower portion of reduced external diameter, and a downwardly facing shoulder connecting said upper and lower outer face portions, such that the ring may be pressed into said bottom opening until the shoulder snaps over the shelf to retain the ring.
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8. Syringe kit, comprising:
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(i) a first subassembly comprising; (a) a glass pharmaceutical vial having an external configuration which is that of a glass serum vial and handleable by filling and caping machinery designed for filling and capping serum vials, but with a circular bottom opening in a horizontal plane defined by a bottom edge if a cylindrical side wall of the vial, any external projection at said bottom edge of the said wall being insufficient to prejudice the stability of the vial when converyed free-standing through such filling and capping machinery; (b) a piston including means for subsequent coupling of said piston to a plunger, the piston being formed of resilient material and having sufficient solidity in the absence of the plunger to ensure an hermetic seal with said vial side wall, the piston, including said coupling means, being received wholly within said vial; (c) a pharmaceutical filled within said vial above said piston through an open neck thereof by a vial filling machine; and (d) a closure applied to the open neck at the top of the vial and retained thereon by an annular cap, the cap and closure being applied by vial capping machinery; (ii) means applicable to said annular cap and axially displaceable on use of the syringe to project a cannula through said closure into said vial and thus place said vial in communication with means for injecting its contents; (iii) a plunger engageable with said coupling means to enable the piston to be projected towards said neck within said side wall to expel said pharmaceutical through said injection means; and wherein a shoulder is formed within said bottom edge of the cylindrical side wall, and further including a piston retainer ring engageable with the shoulder within the vial. - View Dependent Claims (9, 10)
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11. In a method of producing a prefilled syringe for administering a pharmaceutical preparation, said syringe comprising a generally cylindrical syringe body having a neck at one end and a side wall having a bead finish at the other end, at least a component of the preparation filled into said body, an elastomeric closure closing the body at the neck end and secured by a cap, and an elastomeric piston at said other end forming a hermetic seal with an inside surface of said side wall, needle means for movement relative to the cap to penetrate the elastomeric closure, and plunger means for connection to an outer side of the piston, the improvement wherein:
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the syringe is produced by associating components, including said plunger and said needle, with a prefilled vial produced by; forming said body with height to diameter ratio such that the body is stable, and so that any outward extent of the bead is insufficient to result in interference such as would cause tipping, when the body is conveyed standing on said other end through equipment for filling and capping pharmaceutical vials; inserting said elastomeric piston wholly within said other end of the body to form a vial open at the neck; and filling said vial through said neck with said pharmaceutical preparation component, and then applying said elastomeric closure on said cap, whilst conveying the vial standing on said other end through equipment for filling and capping pharmaceutical vials. - View Dependent Claims (12, 13, 14)
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Specification