Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
2001-11-27
2004-12-21
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...
C604S414000, C604S403000
Reexamination Certificate
active
06832994
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a vial access adapter connected to a vial which contains a medical fluid therein and is closed by an elastomeric stopper.
Reported Developments
Vials made of glass or polymeric materials, the walls of which are non-collapsible, require an air inlet when medical fluid is withdrawn therefrom to prevent the formation of vacuum therein. Typically, vials containing a medical fluid are closed by rubber stoppers which are pierced by a dual spike having a medical fluid passage and an air inlet passage therein. The air inlet passage contains a filter to prevent entry of particulate matter or bacteria into the vials during the medicament withdrawal process.
An improvement in the present invention over the prior art is the spatial configuration of the medical fluid access spike which, on positioning of the vial access adapter over a vial having a rubber stopper, allows essentially complete withdrawal of the medical fluid contained in the vial.
The present invention comprises at least three embodiments. In a first embodiment the medical fluid access spike penetrates the rubber stopper and just clears the bottom surface of the rubber stopper. The vial, to which the vial access adapter is attached, is turned upside down during the withdrawal process. In a second embodiment the medical fluid access spike penetrates the rubber stopper and extends to the bottom of the vial. The vial in this embodiment is held in an upright position during the withdrawal process. Both embodiments allow essentially complete withdrawal of the medical fluid contained in the vial.
A third embodiment of the present invention concerns handling large and/or heavy liquid drug containers, and specifically containers for nuclear drugs (e.g. radiopharmaceuticals). Based on safety guidelines issued by the Food and Drug Administration, including the 1991 Bloodborne Pathogens Standard (29 CFR 1910.1030) and the most recent revision to that standard (H.R. 5178), medical device manufacturers are instructed to strengthen safety requirements relating to the use of safety-engineered sharp devices. Typically, medicaments contained in vials are accessed using a steel needle or with a point-of-use needleless adapter. When vials contain nuclear imaging products it is required that shielding is in place in front of the technician who removes the nuclear products from the vial for administration to patients. In addition, it is also required that the nuclear drug itself is to be placed in a protective container, often referred to as PIG, that is constructed of lead or a lead-containing alloy. This latter requirement is difficult to meet considering, for example, that a lead PIG for a 30 ml vial could weigh up to seven pounds. Inverting the vial and inserting the steel needle to remove some or all of its contents is extremely difficult due to the weight of the PIG. Since the vial is held upside-down in the PIG cover, a means to hold the vial in the PIG is necessary so that it does not fall out by the affect of gravity. Attempts were made to hold the vial in the PIG by friction fit. However, this made the removal of the vial from the PIG unsafe and difficult due to the force required to remove the vial from the PIG. When a vial is nearly empty, the radio pharmacist has to manipulate the steel needle, whether the vial is right-side-up or upside-down, to ensure that as much of the nuclear drug as possible is removed from the vial to minimize waste.
The present invention addresses this requirement by providing a vial having a flat, concave, V-shaped bottom and a needleless access means which allow close to complete removal of the nuclear medicine contained in the vial standing right-side-up on a table top or a similar flat horizontal surface.
SUMMARY OF THE INVENTION
In accordance with a first embodiment of the present invention, there is provided a vial access adapter for use with a glass vial or a rigid or semi-rigid polymeric vial containing a liquid medicament, diagnostic agent, or nutritional formulation therein. The vial access adapter body comprises:
a horizontal top wall having a plurality of vent holes therein;
a horizontal second wall spaced parallel from the horizontal top wall;
a cylindrical side wall integral with the horizontal top wall and the horizontal second wall enclosing a chamber therebetween and extending downward from the horizontal second wall forming a skirt and terminating in a bottom rim;
a first spike centrally located in the vial access adapter body having a top portion extending above the horizontal wall and terminating in an externally threaded luer connector, and a bottom portion extending downward and terminating in a sharp point;
a fluid flow channel in the first spike designed for carrying the liquid medicament;
a second spike positioned parallel to the first spike extending downward from the horizontal second wall and terminating in a sharp point;
an air flow channel in the second spike designed for air flow from the chamber between the horizontal top wall and the horizontal second wall into the vial during withdrawal of the liquid medicament from the vial; and
an elastomeric membrane within the luer connector for sealing the fluid flow channel.
Preferably, the elastomeric membrane reseals itself upon repeated penetration by an external luer connector and allows repeated withdrawal of the liquid medicament from the vial without risk of contamination from atmospheric environment.
In accordance with a second embodiment of the present invention, there is provided a vial access adapter used in combination with a glass vial or a rigid or semi-rigid polymeric vial containing a liquid medicament, diagnostic agent, or nutritional formulation therein. The vial comprises:
a cylindrical side wall;
a flat bottom portion; and
a constricted neck portion terminating in a rim.
The constricted neck portion and the rim define an open area which is closed by an elastomeric stopper hermetically sealing the content of the vial. The elastomeric stopper comprises a cylindrical side wall and flat top and bottom surfaces.
The vial access adapter is designed to be placed on the constricted neck portion of the vial and to pierce the elastomeric stopper by a dual spike, one serving as a fluid flow channel and the other as an air flow channel. The vial access adapter, having a vial access adapter body, comprises:
a horizontal top wall having a plurality of vent holes therein;
a horizontal second wall spaced parallel from the horizontal top wall;
a cylindrical side wall integral with the horizontal top wall and the horizontal second wall enclosing a chamber therebetween and extending downward from the horizontal second wall forming a skirt and terminating in a bottom rim;
a first spike centrally located in the vial access adapter body having a top portion extending above the horizontal wall and terminating in an externally threaded luer connector, and a bottom portion extending downward to the flat bottom portion of the vial and terminating in a sharp point,
a fluid flow channel in the first spike adapted to carry the liquid medicament from the vial;
a second spike positioned parallel to the first spike extending downward from the horizontal second wall and terminating in a sharp point, said second spike extending just below the bottom surface of the elastomeric stopper;
an air flow channel in the second spike designed for air flow from the chamber between the horizontal top wall and the horizontal second wall into the vial during withdrawal of the liquid medicament from the vial; and
an elastomeric membrane within the luer connector for sealing the fluid flow channel.
Preferably, the elastomeric membrane reseals itself upon repeated penetration by an external luer connector and allows repeated withdrawal of the liquid medicament from the vial without risk of contamination from atmospheric environment.
The vial and vial access adapter combination provides a delivery system for a medical fluid from the vial wherein the vial is in an upright position during the withdrawal process by the u
Niedospial Jr. John J.
Voytilla Jason M.
Bracco Diagnostics Inc.
Deak Leslie R.
Noone M. Caragh
Peckjian Bryan
Sykes Angela D.
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