Injectable micro-glass vial

Details Injectable micro-glass vial Injectable micro-glass vial

2000-06-16

2004-01-27

Sykes, Angela D. (Department: 3762)

Surgery

Container for blood or body treating material, or means used...

Container with piercable closure

C604S411000

Reexamination Certificate

active

06682518

ABSTRACT:

FIELD OF THE INVENTION
This invention is directed to a glass vial for storing a fluid and which can be pierced with a needle to permit subsequent removal of the fluid.
BACKGROUND OF THE INVENTION
It is common in many industries, such as laboratory, medical, and photographic, to use volatile and toxic fluids. Often, these fluids are supplied in containers which store a measured quantity of the substance, such as a single unit or dose. A typical container used for these purposes is a glass autosampler jar
10
, such as illustrated in FIG.
1
. The jar
10
includes a body
12
for containing the fluid and a cap
14
. The jar is sealed using an elastomeric closure, such as a rubber septum
18
placed between the cap
14
and the jar's mouth. To permit safe removal of the contained fluid, the cap
14
has an opening
16
in it which exposes the underlying rubber septum
18
. The fluid is extracted from the jar by piercing the septum
18
with a hollow needle and drawing the fluid through the needle. Extraction can be performed manually, such as when the jar contains a unit dose of medicine to be injected into a patient by a doctor, or automatically, as when the jars are processed by automated machinery.
Although an elastomeric closure is generally required to provide a secure seal, elastomeric closures are not suitable for use with many types of compounds. In some cases, the fluid compound in the jar can leach through the closure and escape, posing a health risk to the handler. In other instances, the stored compound can cause breakdown in the closure material which can result in escape of the fluid or contamination of the fluid sample itself from chemicals escaping the closure. See, e.g., J. Milano and L. Bailey, “
Evaluation of Current Compendial Physiochemical Test Procedures for Pharmaceutical Elastomeric Closures and Development of an Improved HPLC Procedure
,” PDA Journal of Pharmaceutical Science & Technology, Vol. 53, No. 4, p. 202-210 (July 1999).
One solution to this problem is to limit the amount of time the fluid is stored within the needle-piercable jar
10
by filling the jar shortly before it is to be used.
To this end, many volatile and toxic fluids are provided in sealed glass vials
20
, such as illustrated in FIG.
2
. The vial is filled with the desired fluid
22
and the vial is sealed by melting the glass at the open top. To open the vial
20
, the neck
24
is scored using a diamond scribe or other tool to create a weakened area and the top
26
of the vial
20
is snapped off. The fluid is then extracted from the vial
20
and added to the autosampler jar
10
, e.g., by pouring the fluid in or transporting it via a syringe or pipette.
Various techniques have been developed to safely remove the top of a sealed vial
20
and then transport the fluids from the vial into the jar
10
. However, because in all cases the vial
20
is opened before its contents are placed in the jar
10
, the risk of contamination or escape of the fluid is always present. Accordingly, there is a need to provide a method for supplying volatile and toxic fluids in a manner which permits them to be placed in a jar
10
sealed with an elastomeric closure without risking contamination or escape of the fluid or breakdown of the closure.
SUMMARY OF THE INVENTION
An improved vial for supplying fluids, such as volatile and toxic fluids, without risking contamination or escape of the fluid is disclosed. The vial comprises a glass body having a sealed first end and an open second end. The first end has a weakened area therein of a predetermined thickness which is sufficiently thin that the weakened area can be pierced by a needle without damaging the needle. The vial is filled with the desired fluid and then the second end is sealed, e.g., by melting the glass at the second end using a micro-flame.
In use, the vial is placed within a standard autosampler jar such that the weakened first end is adjacent to the elastomeric closure through which samples are to be drawn. An elastic spacer can be placed on the second end of the vial to protect it within the jar and to press the weakened end of the vial upwards against the closure. Samples are drawn in the conventional manner by plunging a needle through an exposed portion of the closure and into the jar. When the needle is inserted into the jar, it also pierces the weakened area of the vial providing safe access to the fluid contained therein.
Advantageously, the fluid contained in the vial remains sealed until the moment when the sample is drawn. This greatly minimizes the likelihood of the sample being contaminated or operators coming into contact with the fluid. In addition, because the closure is not exposed to the fluid until the sample is actually drawn, the fluid (within the sealed vial) can be stored inside the vial for extended periods of time without concern as to whether the fluid will interact detrimentally with the closure.


REFERENCES:
patent: 4094641 (1978-06-01), Friswell
patent: 4979630 (1990-12-01), Rose et al.
patent: 5213860 (1993-05-01), Laing
patent: 5221311 (1993-06-01), Rising et al.
patent: 5470537 (1995-11-01), Siegel
patent: 6357489 (2002-03-01), Zinger

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