Abstrict The invention provides a biological sampling and storage container
which is easy and sanitary to use, may be shipped through regular
mail, and includes a drying material or desiccant for drying feces
samples that are stored therein. The sampling and storage container
consists of a body having a sampling chamber and a drying chamber
which are in gaseous communication with each other. Preferably,
a sampling wand is frictionally retained in the sampling chamber
and the drying material is disposed in the drying chamber.
Claims What is claimed is:
1. A container for collecting and storing biological samples comprising:
a tube comprised of a sampling chamber at one end of said tube and
a drying chamber at the other end; a sampling wand coaxially retained
within said sampling chamber, said wand having a sampling tip formed
on one end thereof extending into said sampling chamber; and a drying
material disposed in said drying chamber.
2. A container for collecting and storing biological samples comprising:
a tube comprised of a sampling chamber having a mouth and a drying
chamber having a mouth; a sampling wand coaxially retained within
said sampling chamber, said wand having a sampling tip formed on
one end thereof extending into said chamber and a plug formed on
the opposite end for closing said sampling chamber when the wand
is inserted; a plug shaped to be inserted into and retained in said
drying chamber mouth; and a drying material in said drying chamber.
3. The container of claim 2 wherein said tube is cylindrical in
shape.
4. The container of claim 2 further comprising a constriction positioned
between said sampling chamber and said drying chamber, said constriction
preventing said drying material from contacting the sample.
5. The container of claim 2 wherein said sampling-tip includes
a plurality of grooves formed thereon for collecting a sample within
said grooves.
6. The container of claim 2 wherein said sampling tip is spatula-like
in shape.
7. The container of claim 2 wherein said wand includes a cap positioned
to seal said sampling chamber mouth.
8. The container of claim 2 wherein said wand is frictionally retained
in said sampling chamber mouth.
9. The container of claim 2 wherein said wand is threadably retained
in said sampling chamber mouth.
10. The container of claim 2 wherein said drying material is selected
from the group consisting of silica gels or clays, vermiculite,
zeolite compounds, calcium chloride, anhydrous chemicals, desiccant
papers, activated alumina, molecular sieves, and chemical compositions
having hydrophilic properties.
11. The sampling and storage container of claim 2 wherein said
drying material is silica gel.
12. The container of claim 11 wherein said drying material is silica
clays.
13. The container of claim 11 wherein said drying material is molecular
sieves originating from zeolite compounds which absorb molecules
due to electrostatic attraction.
14. The container of claim 2 wherein a gas permeable membrane is
positioned between said sampling chamber and said drying chamber.
15. The container of claim 2 wherein a screen is positioned between
said sampling chamber and said drying chamber.
16. The container of claim 2 wherein a fine mesh cloth or screen
is positioned between said sampling chamber and said drying chamber.
17. The container of claim 2 wherein said wand includes a tab positioned
on an end thereof to facilitate removal of said wand from said mouth
of said sampling chamber.
18. The container of claim 2 wherein said mouth of said drying
chamber is mechanically closed thereby sealing said drying material
in said sampling chamber.
19. The container of claim 2 where said drying material is a combination
of silica gel and activated carbon.
Description BACKGROUND OF THE INVENTION
[0001] This invention relates to an instrument for sampling and
storing biological samples and particularly feces for use in biological
or medical testing that may be easily and sanitarily packaged and
sent via mail. More particularly, this invention relates to a disposable
feces sampling and storage device that is inexpensive to produce
and includes a desiccant to aid in drying a sample of feces that
is stored therein.
[0002] In the field of medical care, lab tests that are performed
on samples of body tissue, blood, urine, feces, etc., have become
indispensable tools in aiding doctors with the diagnoses of the
illnesses of their patients. With the continual development of new
technology fueling the creation of new and improved lab equipment,
new testing procedures are developed and old testing procedures
are improved on an almost daily basis. While many of these tests
necessarily require that blood be drawn or tissue be removed in
order to perform the tests, it is generally desirable to use less
invasive testing procedures whenever possible. Furthermore, some
tests, such as the test for occult blood to verify the presence
of gastrointestinal bleeding and tests for intestinal infections
and parasites must be performed on fecal samples. Accordingly, testing
procedures which use samples that can be collected using non-invasive
procedures, such as urine and feces, have become increasingly popular
among doctors and patients in recent years.
[0003] With the development of increased numbers of testing procedures
which require the use of fecal samples, the demand for improved
devices to sanitarily sample and transport these samples has correspondingly
grown. In order to fill this need, there have been devices which
have been designed for this purpose. For example, U.S. Pat. No.
5149506 to Skiba et al. discloses a stool collection and transport
device which is composed of a vial having a sealable lid with an
aperture formed therein for engaging a second lid. The second lid
has a sampling spoon secured to the underside thereof so that a
stool sample may be collected using the spoon and then sanitarily
deposited in the collection vial.
[0004] While fecal sampling devices such as the one disclosed in
the Skiba patent may be useful for collecting large samples which
may then be sampled again using a smaller sampling device, these
types of devices are generally not conducive to being sent through
the mail. Furthermore, many of the latest fecal tests require that
the samples collected be treated in some way shortly after collection
in order to prevent degradation of the sample. For example, for
some tests that are used to determine the presence of occult blood
in a fecal sample, the sample must be stabilized in a liquid solution
shortly after collection. This stabilization procedure is necessary
to lessen the possibility that an inaccurate result is obtained
from the test. Examples of sampling devices that are particularly
useful for this type of test are disclosed in U.S. Pat. No. 5514341
to Urata et al. and U.S. Pat. No. 5543115 to Karakawa. Both of
these patents disclose devices for collecting and storing fecal
samples for use in testing procedures for the presence of occult
blood. In order to use these devices, the sample is collected on
the end of a sampling rod which is then inserted into a storage
container having a fixed amount of stabilizing solution, such as
glycosidase-type bacteriolytic enzyme, contained therein. Then,
the container is sealed and the sample is allowed to mix with the
stabilizing solution. Finally, when the sample is ready for testing,
the stabilized liquid is passed through a filter which is preferably
secured in the container. The testing procedure is then run on the
filtrate.
[0005] While the devices disclosed in these patents are useful
for testing procedures that determine the presence of occult blood
and require that the sample be stabilized shortly after collection
as described above, there are other testing procedures for which
these types of devices are not particularly well-suited. For example,
in some testing procedures, such as the occult blood assays that
detect labile exoantigens and cell associated antigens of C. difficile,
E. coli, it is preferred that the sample be as dry as possible.
Thus, the presence of a stabilization liquid, or any liquid at all
for that matter, is considered undesirable. Furthermore, since liquid
is not used in the stabilization procedure, the use of a filter
and dropper assembly as disclosed in the Urata patent is unnecessary.
[0006] Accordingly, it would be desirable to have a feces sampling
and storage container that can be used for easily collecting and
storing feces samples that need to be maintained in a relatively
dry atmosphere. Preferably, the container would be small and self
contained so that it would be easy and inexpensive to transport
or mail and would include a device or substance for aiding in the
drying of the sample, such as a desiccant. Preferably, the container
would be inexpensive to produce so that it would be disposable and
would be simple to use so that a patient or untrained individual
could easily use the device to collect a sample with little or no
instruction.
SUMMARY OF THE INVENTION
[0007] In accordance with the present invention, a feces sampling
and storage container is provided which is comprised of a generally
hollow body and a sampling wand shaped to frictionally or threadably
engage and plug one end of the body. The sampling wand is relatively
long and has a sampling tip positioned at its distal end that is
designed to collect a sample of at least a minimum size when the
sampling wand is inserted into a feces sample and removed. In a
preferred embodiment, the sampling tip of the wand is formed in
a broad tipped "spatula" shape having grooves and protrusions
formed thereon. Thus, when the sampling tip is inserted into a mass
of feces, an adequate amount of sample is collected in the grooves
and on the tip.
[0008] Preferably, the body of the container is tubular in shape
and has at least two chambers. One of the chambers, the sampling
chamber, is designed to receive the sampling wand. The other chamber,
the drying chamber, is designed to hold a drying device, such as
a desiccant. The drying chamber is maintained in gaseous communication
with the sampling chamber so that water vapor from the sample may
be drawn away from the sample to the desiccant. Preferably a screen
or other device, such as a constriction in the body, a wad of cotton,
or a gas permeable membrane, is used to hold the desiccant in the
drying chamber and away from direct contact with the sample. This
is desired because direct contact between the desiccant and the
sample could contaminate the sample causing inaccurate test results.
Furthermore, the desiccant could become fouled thereby affecting
its ability to remove water from the sample as desired.
[0009] In a preferred embodiment, the sampling wand includes a
stopper end which is constructed to be frictionally received and
held in a mouth of the body. The stopper seals the container preventing
water vapor from getting into the container once the sample is collected
while simultaneously preventing any of the sample from leaking out.
This is important because the integrity of the container must be
maintained during shipping and handling due to sanitary concerns.
Furthermore, this prevents contamination of the sample from outside
contaminants, helping to insure that the tests performed on samples
retrieved and stored using the sampling and storage container of
the present invention yield results which are as accurate as possible.
Additionally, in a preferred embodiment, a thumb tab is formed on
the top of the stopper to assist a user in the insertion and removal
of the wand from the body, as well as in the sanitary collection
of a sample.
[0010] Preferably the sampling and storage container of the present
invention is made from a lightweight inexpensive plastic, such as
polyethylene, which is liquid and gas impermeable. In a preferred
construction, the container is composed of three separate pieces:
the body, the sampling wand, and a plug, although other constructions
are possible and considered within the scope of the invention. For
example, acceptable alternate embodiments would include crimping
the end of the body shut once the desiccant is placed in the drying
chamber or forming the drying chamber with a closed end and inserting
the desiccant from the top. Preferably, the body is molded to form
a hollow tube that includes the aforementioned sampling and drying
chambers. The wand, preferably formed from a relatively rigid plastic,
is shaped as described above and has a stopper end with a diameter
sized so that it may be frictionally fit into the sampling chamber
end of the tube shaped body. A plug, having a similarly sized diameter,
is also provided to close the mouth of the drying end of the tube
once the desiccant has been placed in the drying chamber.
[0011] These and other objects and advantages of the present invention
will be more fully understood and appreciated by reference to the
following description, the accompanying drawings and the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a side elevational view of a feces storage and
transport container utilizing a desiccant in accordance with the
present invention;
[0013] FIG. 2 is a side elevational view of a body for use with
the feces storage and transport container of FIG. 1;
[0014] FIG. 3 is an end view of the body of FIG. 2;
[0015] FIG. 4 is a side elevational view of a wand for use with
the feces storage and transport container of FIG. 1;
[0016] FIG. 5 is a side elevational view of the wand of FIG. 4
taken along line 5-5; and
[0017] FIG. 6 is an end view of the wand of FIG. 4.
DETAILED DESCRIPTION
[0018] Referring to FIG. 1 the feces sampling and transport container
utilizing a desiccant of the present invention, generally designated
10 is comprised mainly of a body 12 a sampling wand 14 and a
plug 16. Preferably, as shown best in FIGS. 2 and 3 the body 12
is tubular in shape and has a relatively small diameter and length
(approximately 3/8 of an inch in diameter and 5 inches in length)
so that it may be sent through regular mail in a standard flat envelope.
The body 12 includes at least two chambers 18 20. The sampling
chamber 18 includes a mouth 22 which is shaped to frictionally receive
and retain the sampling wand 14 or includes threads to threadedly
receive a threaded stopper end of a sampling wand (not shown). The
drying chamber 20 is positioned adjacent to and in gaseous communication
with the sampling chamber 18 and also includes a mouth 24 which
is shaped to receive and frictionally retain the plug 16. The drying
chamber 20 is structured to hold a drying material, such as a desiccant,
26. Examples of drying materials that would be operative in the
present invention include, but are not limited to, silica gels or
clays, vermiculite, desiccant papers, activated alumina, zeolite
compounds, calcium chloride, molecular sieves, or anhydrous chemicals
such as calcium sulfate, etc. Preferably a constriction 28 cloth
or screen (not shown), or gas permeable membrane (not shown), is
placed between the sampling chamber 18 and the drying chamber 20
in order to keep the drying material 26 from intermixing with and
contaminating or becoming fouled by the sample (not shown).
[0019] As can best be seen in FIGS. 4 5 and 6 the sampling wand
16 is relatively long and thin and is comprised of a sampling tip
30 a shank 32 a stopper end 34 and a thumb tab 36. The sampling
tip 30 is positioned at the distal end of the wand 16 and is designed
to collect a sample of at least a minimum size when the sampling
wand 16 is inserted into and removed from a fecal sample (not shown).
In a preferred embodiment, the sampling tip 30 is formed in a broad
"spatula-like" shape and has grooves 38 and protrusions
40 formed thereon. This configuration is advantageous because when
the sampling tip 30 is inserted into a mass of feces (not shown),
an adequate amount of sample is collected on the tip 30 as well
as in between the grooves 38 and protrusions 40.
[0020] Continuing up the wand 16 a shank 32 is provided between
the tip 30 and the stopper end 34. In order to increase the rigidity
of the wand 16 thereby making it easier to insert into a fecal
sample (not shown), the shank 32 widens into an "X" shaped
branch 42 prior to joining the stopper end 34. The stopper end 34
has an effective outer diameter, formed by the legs of the "X"
shaped branch 42 that is slightly larger than the inner diameter
of the mouth 22 so that the wand 16 can be frictionally received
and retained in the body 12. A cap 44 is formed on the wand 16 and
is shaped to cover the mouth 22 thereby preventing moisture from
getting into the body 12 as well as prevent sample from getting
out. The thumb tab 34 is positioned above the cap 44 and includes
ribs 46 positioned thereon to facilitate the removal and replacement
of the wand 16 to and from the body 12.
[0021] The operation of the feces sampling and transport container
utilizing a desiccant 10 of the present invention is as follows.
A drying material 26 is loaded into the drying chamber 20 of the
body 12 and the plug 16 is placed in the mouth 24 thereby sealing
the drying material 26 therein. A user grasps the thumb tab 36 of
the sampling wand 16 and urges it outward in order to remove the
wand 16 from the body 12. The sampling tip 30 is then inserted into
a feces sample (not shown). Preferably the wand 16 is rotated while
in the sample in order to insure that an adequate amount of sample
is collected on the sampling tip 30 as well as in the grooves 38.
The user then reinserts the wand 16 into the mouth 22 of the body
12 being careful not to touch the sampling tip 30 to the outside
of the body 12. The wand 16 is then securely seated in the body
12 until the cap 44 rests flush against the mouth 22. At this point
the drying material 26 begins operating to draw moisture away from
the sample (not shown) as is desired. Thus, the feces sampling and
transport container 10 is in condition for shipping or transportation
to a lab for testing.
[0022] While the device illustrated employs a plug 24 to seal the
drying chamber 20 the tube can also be extruded with a closed end
and filled with drying material from the open sampling end. The
drying chamber can then be closed by inserting a cloth, screen or
a ball of a material such as cotton.
[0023] While the form of the apparatus herein described constitutes
a preferred embodiment of the invention, it is to be understood
that the invention is not limited to this precise form of apparatus,
and that changes may be made therein without departing from the
scope of the invention. |