Specimen kits and stopper therefor

An improvement in specimen kits that reduces significantly the possibility of contamination of the specimen by either user or container; of the patient by the swab used to obtain the specimen; and of a subsequent handler of the container by the specimen. It permits the collected specimen to be transported to the diagnostic processing laboratory in common, widely used medical specimen mailing containers, while permitting the use of swab lengths that are appropriate to the type of specimen desired. The improvement is made possible by a unique double-ended stopper that maintains the specimen container sterile until use, then acts as a cap for engaging the swab shaft for withdrawal while maintaining a tight and sterile shipping container after the specimen is taken and while it is subsequently handled.

BACKGROUND OF THE INVENTION 
This invention relates to improvements in kits for taking specimens and 
safeguarding them during transport to a diagnostic laboratory. More 
particularly, this invention relates to a unique stopper which enables the 
above activity to be conducted more efficiently, safely and surely. 
In the past, the taking of samples of all kinds for analysis has been 
attended with several problems. For example, there is always the danger of 
contaminating the samples, or being contaminated by them. Especially is 
this true with the taking of samples for medical analysis and diagnosis, 
where the problems are three-fold: that of infecting the patient with a 
contaminated swab; that of contaminating the sample or specimen with 
contaminated swabs or containers; and that of infecting a subsequent 
handler of the specimen by a contaminated swab or container. In addition 
to the above problems, there is also the problem of having swab-shafts of 
sufficient length to obtain deep samples from the various orifices of the 
body. Further, it is desirable that the sample or specimen container fit 
in standard medical mailing containers, such as that manufactured under 
the tradename METPATH, to take advantage of favorable mailing or shipping 
rates and handling. 
Specimen kits are available from several sources, packaged in sterilized 
plastic containers and containing a tube of any of several types with an 
appropriate one of several types of culture medium therein to maintain the 
specimens alive during transport to the analysis and diagnostic 
laboratory. One such kit features a swab located at one end of a metal or 
plastic shaft, the other end of which is affixed into an extruded plastic 
tube sealed at one end around the swab shaft to form a cap. This cap fits 
snugly over another, lengthier plastic tube, the lower end of which is 
sealed and which, with a second seal forming a small pocket, contains a 
small amount of a culture medium. In use, the shaft is withdrawn from its 
protective tube, is used to obtain a specimen, and is re-inserted into the 
protective tube. The seal into the culture medium is broken by pinching 
the ends toward one another, and the specimen is inserted into the medium, 
where it rests during shipment to the diagnostic processing laboratory. 
The shipping length of the used kit containing the speciment is about 
6.5", which is too large for the standard medical shipping container. The 
effective length of the swab shaft--that is, the depth to which it can 
penetrate a body orifice without the cap touching surrounding tissue and 
thereby becoming contaminated--is less than 3.4". In addition to the 
possibility of the cap becoming contaminated and thus posing a danger of 
infection to subsequent handlers, the protective tube is deformable, with 
the possibility of an opening developing which would permit the culture 
medium to dry out, thereby destroying the specimen. A significant 
proportion of specimens are lost in that manner with this particular kit. 
Another specimen kit in wide use uses a plastic shaft upon which to mount 
the swab material, and uses a molded plastic cap which is not subject to 
deformation and the drying out of the culture medium and subsequent loss 
of the specimen. The bottom end of the plastic tube which holds the swab 
prior to use contains a small amount of culture medium, and the swab is 
held about 0.5"-0.75" above the medium before use. The cap is sealed to 
the plastic tube with a tamper evident seal to insure sterility. In use, 
the cap is twisted to break the seal, the swab is withdrawn and is used to 
obtain the specimen, and is re-inserted into the tube and into the culture 
medium. The shipping length of the used kit containing the specimen is 
about 6.2", while the effective length of the swab is about 3.4". 
Yet a third specimen kit contains a plastic shaft with one end molded into 
a cap, and a swab mounted on the other end. The lower end of the tube 
which contains the swab before use has a glass ampule containing a 
solution to keep the specimen alive. In use, the swab is withdrawn, the 
speciment obtained, and the swab is reinserted into the protective tube. 
The glass ampule is broken by squeezing it, and the swab is pushed into 
contact with a moistened pledget. The cap of the tube contains a molded 
in, circumferential ring to provide a seal to prevent the solution from 
drying out. The shipping length of the used kit is 7.4", and the effective 
length of the swab shaft is about 4.0". 
Other speciment kits are available which have more-or-less the same 
characteristics as those described above. In addition to the short 
effective length of the swab shaft, they have excessive length to be 
shipped in the standard mailing container, which provide space for several 
specimen containers ranging in length from 3" to 5.0". In addition, those 
kits which use the cap for a handle suffer from the defect that the cap 
obstructs the physician's view when he is taking samples at the extreme 
effective length of the shaft. 
In summary, the specimen kits used in the past have problems in maintaining 
airtight seals to avoid drying out the culture medium and destroying the 
specimen; in obtaining specimens from substantial depth without 
contaminating the cap, with the danger of infecting subsequent handlers; 
of having a shipping length after use greater than the spaces available in 
standard mailing containers; and in having the cap, which acts as a 
handle, obstruct the physician's view when obtaining specimens at the 
extreme length of the swab shaft. 
SUMMARY OF THE PRESENT INVENTION 
The present invention offers a safe, efficient, convenient and economical 
way to obtain specimens and transport them to an analytical and diagnostic 
laboratory, while overcoming the aforementioned shortcomings and providing 
additional features hereinafter to be described. 
The present invention provides a unique, double-ended stopper having a male 
end and a female end, hereinafter to be described, for a specimen 
container which is a part of a specimen kit such as has been described 
hereinbefore. The specimen kit contains a plastic or metallic shaft with a 
swab mounted thereon which is not limited in effective length, as are the 
kits hereinbefore described. The swab is sealed into a sterile package 
with a specimen container closed by the aforementioned unique stopper. In 
use, the package is opened, the swab shaft withdrawn, and the specimen is 
taken, more-or-less as described above for conventional specimen kits. 
However, since the swab shaft does not have a cap mounted or molded 
thereon, there is nothing to be contaminated on its exterior when a deep 
specimen is sought at the limits of the shaft length. Even if the outer 
end of the shaft comes into contact with tissue surrounding the cavity 
from which a specimen is sought, this portion of the shaft is discarded 
during subsequent handling. When the swab with the specimen thereon is 
withdrawn from the cavity, the unique stopper hereinbefore mentioned is 
withdrawn from the specimen tube and the swab is inserted about 3/4 of the 
way into the specimen tube, whereupon it is broken off at a prescored 
point on the shaft by bending it against the side of the specimen tube and 
the excess length discarded. The unique stopper is inverted and the female 
end, with a special gripping means therein, hereinafter described, is 
placed over the protruding end of the broken shaft. As the stopper is 
pressed onto the mouth of the specimen tube, the broken end of the shaft 
is forced firmly into the gripping means, and the swab with the specimen 
thereon in forced into the culture medium. The specimen is nourished by 
the culture medium during transport to the diagnostic processing 
laboratory, the specimen container is tightly sealed which prevents dryout 
of the culture medium and destruction of the specimen, and the gripping 
means holds the shaft sufficiently tight to enable the swab to be 
withdrawn at the processing laboratory. In addition, the female end of the 
stopper covers the end of the specimen tube so that, in case the rim 
around the mouth of the specimen tube has become contaminated during 
insertion of the swab with the specimen thereon, a subsequent handler 
cannot come in contact with said contaminated portion and thereby become 
infected. This unique feature of the invention is accomplished by 
providing overlapping annular lips on the stopper, extended axially, so 
that the rim around the mouth of the specimen tube is covered both before 
and after use, as hereinafter more completely described. The overlapping 
annular lip on the male end of the stopper prevents the rim of the mouth 
of the specimen tube from becoming contaminated prior to use by accidental 
contact, and the aforedescribed overlapping annular lip of the female end 
of the stopper prevents a subsequent handler from coming into contact with 
any contamination accidentally deposited on the rim of the mouth of the 
specimen tube. 
The aforementioned gripping means enables the swab shaft to be shortened 
after use and thereupon affixed to the stopper for subsequent handling, 
providing a convenient, simple and safe way to obtain deep specimens while 
at the same time having a specimen kit which can be shipped in standard 
medical mailing containers.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
Turning now to FIG. 1, we see at 10 a medical specimen kit which embodies 
the invention. A specimen tube 12 is capped by a double-ended stopper 14, 
hereinafter described in greater detail. The specimen tube 12 contains a 
quantity of a culture medium 16 in the lower end. Also included in the kit 
10 is a shaft 18 tipped with an absorbent material forming a swab 20 for 
obtaining specimens thereon. The shaft 18 is scored as indicated at 22, 
for a purpose hereinafter described. The specimen tube 12 and the swab 
shaft 18 are contained in a package of a type well known in the art, 
composed of a relatively stiff backing material 24 which is fronted by a 
clear flexible film 26 periphally sealed around the edges to backing 
material 24 as indicated by 28, so that an air and moisture-proof package 
is obtained. The package and its contents can be sterilized by any of 
several well known processes, including but not restricted to gamma 
radiation. The stiff backing material 24 and the more flexible film 26 can 
have instructions or other information printed on them if desired. 
In use, the tab of flexible material 26 is pulled from the backing material 
24, breaking the seal 28 and exposing the end of the swab shaft 18 and the 
double-ended ended stopper 14, which has the male 29 end pressed into the 
specimen tube 12. The swab shaft 18 is withdrawn and is used to obtain a 
desired specimen. Since the shaft 18 is shortened in a subsequent 
operation, hereinafter described, it can be supplied in any length that is 
appropriate for for the specimen involved. The double-ended stopper 14 is 
then withdrawn from the specimen tube 12, and the swab shaft 18 is 
inserted about 3/4 of the depth of the tube 12 and bent sharply, whereupon 
it breaks at the pre-scored line 22, and the broken-off portion of the 
shaft is discarded, eliminating the possibility of infection from that 
source for subsequent handlers. The remaining length of the swab shaft 18 
in the specimen tube 12 is appropriate for the next operation to be 
performed, as now described. The double-ended stopper 14 is inverted and 
the female 31 end, with gripping means 34 incorporated within, as seen 
more clearly in FIG. 2 and hereinafter more completely described, is 
pressed onto the broken end of the shaft 18, which presses the swab 20 
into the culture medium to preserve it until it can be processed at an 
analytical, diagnostic laboratory. The swab end of the shaft 18 encounters 
the closed end of the specimen tube 12, whereupon the gripping means 34 
will continue to be pressed onto the broken end of the shaft 18 until it 
encounters the stop 38, also seen in FIG. 2. At the same time as the 
gripping means 34 has been pushed onto the shaft 18, the female end 31 of 
the stopper 14 has been pushed over the rim of the open end of the 
specimen tube 12, effectively sealing it. Any contamination of the rim 
which might have occurred during insertion of the swab 20 will be covered 
by the annular overlapping lip 30 of the stopper 14, further reducing the 
danger of infection for subsequent handlers of the specimen tube 12. 
FIG. 2 depicts more clearly the details of the double-ended stopper 14, 
which incorporates a male end 29 and a female end 31. The male 29 end 24 
of the stopper 14 is the portion of the stopper originally inserted in the 
specimen tube 12 when it is initially presented to the user upon opening 
of the sealed sterile container. It has one or more circumferential rings 
26 molded onto its surface to provide an airtight seal when it is inserted 
in the specimen tube 12, thus preventing leakage of air or the drying out 
of the culture medium 16 before use. This end of the stopper 14 also 
incorporates an annular overlapping lip 28 which fits over the rim of the 
specimen tube 12, preventing it from being contaminated with a foreign 
substance prior to use. 
The female end 31 of the stopper 14 is the end that is placed over the rim 
of the opening of the specimen tube 12 after a specimen has been obtained 
on the swab 20 and has been inserted therein and broken off. This female 
end 31 of the stopper 14 contains several features which will be described 
individually, since they are important aspects of the present invention. 
As stated before, this end 31 of the stopper contains therein a gripping 
means 34, which can be any of several well-known designs but is preferably 
embodied as fingers 34. These fingers 34 are extended axially from the 
inside of the base of the stopper, and are designed with tapering inner 
surface 34A so that they will exert a greater and greater pressure on the 
shaft 18 as the stopper 14 is pushed thereunto. This feature creates a 
stable and usable grip when it is necessary at the diagnostic processing 
laboratory to withdraw the swab 20 from the specimen tube 12 and smear the 
specimen onto culture plates. However, if further processing requires that 
the swab be left in another receptacle, it is necessary only to force the 
swab shaft 18 against the side of said other receptacle and bend the 
stopper 14 against the resistance thereof, and the gripping fingers 34 
will resiliently release the shaft 18. 
The deep annular overlapping lip 30 is designed to fit over the rim of the 
opening of the specimen tube 12 after a specimen has been inserted 
therein, to protect a subsequent handler from the danger of being infected 
by accidental contact with contamination which might have been deposited 
thereon when the specimen was inserted. The deep annular overlapping lip 
30 preferably has one or more circumferential rings 32 molded onto its 
inner surface to provide an airtight seal to prevent the destruction of a 
specimen by drying out of the culture medium. 
An exemplary further use of the stopper 14 is illustrated in FIG. 3. In the 
case of a male suspected of having contracted gonorrhea, specimens for 
diagnosis are usually obtained from the urethral canal, and the plastic 
shaft 18 described in the foregoing embodiment could possibly cause 
discomfort during insertion therein because of its relatively large size. 
Consequently, a thin swab shaft 42, fabricated for example of a thin 
metallic wire with an absorbent material forming a swab 20 on the end 
thereof, may be used. The cavities 40 of FIG. 2, located on either side of 
the web 36 connecting two opposing fingers 34, are designed specifically 
to accept wire 42 of the size normally used for such purposes, the wire 
being slightly larger than the width of the cavity 40 so that it is 
resiliently gripped by the plastic of the stopper 14. Such a use does not 
require the long shaft 18 of the earlier described swab 20, and can be 
packaged already inserted in the stopper 14, of a correct length to be 
fully inserted into the specimen tube 12 without shortening, as is 
necessary with the longer shaft 18. 
The specimen tube 12, with either the shortened longer shaft 18 or the 
shorter, smaller diameter shaft 42 inserted therein and capped with the 
stopper 14, is of a proper length to be contained in a standard medical 
mailing container such as is usually encountered in the trade. 
It should be emphasized that, although the above detailed description has 
been in terms of medical specimen kits, it is expressly intended to be 
used for specimens of any kind where there is a substantial possibility of 
contamination of specimens or users. Thus, it could be used to collect 
chemical, geological, biological or any other type of specimen where there 
is a desire to avoid contamination of the specimen by the user, of the 
user by the specimen, or to avoid contamination of the specimen tube by 
foreign substances. The kit and the unique stopper therefor will be 
appropriate for collection and safeguarding of specimens under widely 
varying conditions, and the lack of mention of such conditions is not 
meant to exclude them from being covered hereby. The terms and expressions 
which have been employed in the foregoing specification are used therein 
as terms of description and not as terms of limitation, and there is no 
intention, in the use of such terms and expressions, of excluding 
equivalents of the features shown and described, or portions thereof, it 
being recognized that the scope of the invention is defined and limited 
only by the claims which follow: