Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
1999-07-20
2001-07-10
Sykes, Angela D. (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
C604S905000, C604S256000, C604S415000, C604S201000, C604S086000, C215S247000, C206S363000, C206S365000, C206S364000
Reexamination Certificate
active
06258078
ABSTRACT:
S
TATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable.
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to luer connectors.
Luer connectors are devices for enabling a connection to be made between the nozzle of a hypodermic syringe and the interior of a pharmaceutical vial through a puncturable rubber closure, so that for example water can be introduced into such a vial to reconstitute a drug substance within the vial, and the reconstituted solution of drug substance can be subsequently sucked out of the vial via the luer connector into the body of the syringe. The nozzle of the syringe may then be detached from the luer connector and a hypodermic needle attached to the syringe nozzle. The luer connector therefore avoids the need to insert a hypodermic needle through the closure and facilitates a sterile connection between the syringe and the vial. Luer connectors generally comprise a luer port, i.e. a small female port into which the syringe nozzle can be inserted, connected to a tubular conduit with a sharpened end which can be driven through the rubber vial closure.
2. Description of the Related Art
A number of luer connectors are known, for example that disclosed in WO 97/10156, which is mounted upon a vial and requires the nozzle of the syringe to be inserted into its luer lock and the body of the syringe to be then used as a driver to drive the sharpened end of its conduit through the vial closure. This can cause premature operation of the syringe during the driving operation. Other constructions of luer connector are disclosed in U.S. Pat. No. 530372, EP 0351643A and EP 0587347A.
BRIEF SUMMARY OF THE INVENTION
It is an object of this invention to provide an improved luer connector.
DETAILED DESCRIPTION OF THE INVENTION
According to this invention a luer connector comprises;
a luer comprising a luer port connectable to a syringe and being in communication with a first end of a channel passing longitudinally through a tubular conduit, the conduit extending longitudinally from the luer port to a second end of the channel, the end of the tubular conduit remote from the luer port being sharpened so as to be capable of being driven through a puncturable vial closure to thereby puncture the closure;
a luer support, mountable on a vial when the vial is sealed with a puncturable vial closure, the support initially supporting the luer longitudinally moveable in a first position in which the sharpened end of the conduit is pointed toward the closure;
a luer driver, mounted on the support and moveable relative to the support, the luer and driver having respective engagement parts such that movement of the driver relative to the support causes the engagement part(s) of the driver to bear upon the engagement part(s) of the luer so as to drive the luer longitudinally into a second position in which the sharpened end of the conduit is driven through the closure to puncture the closure and to enter the vial.
The luer port may be of essentially conventional type comprising a small female port suitable for male-female engagement with the nozzle of a conventional hypodermic syringe. The luer may be provided with features, e.g. a connection for an adapter, to enable the luer to be locked to a hypodermic syringe to minimise the risk of accidental disconnection.
The luer port and the conduit may be of integral construction, e.g. the conduit being an integral extension of the port, and the port and conduit may be made of plastics materials. Alternatively the luer port and conduit may be made separately and may be connected together. For example the conduit may be made of metal, e.g. in the form of a steel needle, and the luer port may be made of plastics material, the port and conduit being bonded together e.g. by adhesive or by moulding the luer port around the metal conduit. The use of a sharpened metal rather than a plastics material, conduit may allow the use of lower puncturing force. The sharpened end of the channel may be of any conventionally sharpened shape known for such conduits on known luers. The channel may conveniently open sideways out of the sharpened end of the conduit to allow the conduit to have a sharp point.
The luer support may comprise a sleeve which is mountable e.g. by a snap-fit, screw fit, friction fit etc., or other methods apparent to those skilled in the art, around the neck of the vial, so as to be thereby retained on the neck. As most conventional vials have an enlarged bead around their mouth opening a snap-fit over this bead is a convenient way by means of which the sleeve may be mounted on the vial. By such means the support may be mounted in a way on the neck of the vial which does not allow it to rotate, or move longitudinally, or otherwise move on the neck of the vial. There are known means for mounting such a support in the form of a sleeve on a vial. For example one known means is that used in the COMAR™ “Harmony”™ system in which the sleeve and the neck of the vial are provided with co-operating “gear teeth” type structures which engage and prevent relative rotation, whilst a snap-fit engaging groove and bead on the sleeve and vial neck respectively prevent longitudinal detachment of the sleeve from the vial neck. For example another known means is resilient longitudinally extending fingers on the sleeve which grip around a bead on the neck of the vial, the fingers being locked into this position by means of a restraining collar around the fingers. A system of this type is disclosed in inter alia WO 97/10156 and is also used commercially in the LYO-JECT™ system supplied by Vetter Injekt System GmbH.
When mounted on the vial the support suitably extends above the mouth of the vial (directions are defined relative to the bottom of the vial when this is stood upright, although it is to be understood that the luer connector of the invention is useable with the vial in other orientations, e.g. with its mouth downwards) and may include a part, e.g. internal flange or rim parts, which bear upon the puncturable closure and help to hold the closure in place, for example compressing the closure down toward the lip of the mouth of the vial. Such flange or rim parts suitably include a central aperture to allow the sharpened end of the luer to pass through the closure. This central aperture may be sealed with a puncturable sealing membrane, which may be integral with (e.g. being a thin film of the support material) or may be attached to the flange or rim parts.
When mounted on the vial the upper part of the support above the mouth of the vial may form a guide for the luer, for example in the form of a generally tubular e.g. cylindrical extension defining a compartment extending above the vial closure, of suitable dimensions that the luer can be supported therein in its first position with the sharpened end of the conduit pointed toward the closure. Within such a cylindrical compartment the luer may be supported with its longitudinal axis e.g the axis of its channel and/or conduit coaxial with the cylindrical axis. In the first position of the luer the sharpened end may be in non-puncturing contact with the upper surface of the closure or distanced from it. Suitably the inner surfaces of the compartment and facing parts of the outer surface of the luer may include guides, e.g. cooperating projections and longitudinal grooves or slots so that as the luer is driven from its first position to its second position its movement is guided so as to be smooth and with the minimum amount of deviation from a non longitudinal path. For example the guides may comprise a plurality of longitudinally extending slots on the support into which corresponding projections, e.g. in the form of legs or ribs etc. from the luer fit and within which they may move longitudinally. Alternatively the projections may be on the luer driver and the slots or grooves on the luer. As discussed in more detail below such guides may also serve to prevent the luer from rotating relative to the support.
The luer is suitably provided with one or more ab
Harris, Jr. Ron
Kerekes Zoltan
Kinzig Charles M.
SmithKline Beecham Biologicals (S.A.)
Sykes Angela D.
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