Note: Descriptions are shown in the official language in which they were submitted.
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APPARATUS FOR SAMPLING
AND TESTING A SPECIMEN
CROSS REFERENCE TO RELATED APPLICATIONS
The present application claims the benefit of U.S. Provisional
Application No. 60/242,915 filed October 24, 2000, and titled Apparatus for
Sampling and Testing a Specimen.
FIELD OF THE INVENTION
The present invention relates generally to a specimen testing
apparatus and, more specifically, to a self-contained, tamper-proof system
for screening for particular compounds (e.g., drugs and drug metabolites)
and/or hormones (as in pregnancy test kits).
BRIEF DESCRIPTION OF THE PRIOR ART
More businesses are requiring new employees to undergo pre-
employment drug testing before hiring. Also, post-accident drug testing is
almost routine, especially when flammable or hazardous waste hauling is
involved, or where the safety of a large number of people are concerned
(e.g., oil tanker captain, truck driver or high-speed train engineer).
Normally, a urine specimen is taken and tested by a local lab. If the test
turns up positive, the specimen must then be sent to a more sophisticated,
usually remotely located, testing lab.
In order to ensure that there has been no tampering with the
specimen and to prevent contamination of the specimen, several
companies have developed self-contained screening devices. These self-
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contained screening devices usually comprise a specimen container having
a screw-top lid and a plurality of reagent test strips suspended around the
inner perimeter of the specimen container. The test strips turn a specific
color in the presence of particular drug residues.
Home Pregnancy test kits operate in a similar manner. Each
pregnancy test kits comprise a test strip designed to turn a specific color or
to form a symbol (e.g. a "+" sign) in the presence of a hormone. The
hormone appears in a woman's urine only when she is pregnant.
Drug Free Enterprises, Inc., of Scott Valley, California, produces a
self-contained urinalysis screening device that it markets under the name
DRUGCHECK and claims to be able to detect a number of drug
metabolites in minutes. Phamatech, Inc. of San Diego, California, markets
a self-contained pregnancy test kit under the name CLEARCHOICE.
MMARY OF THE INVENTION
The present invention is a self-contained, tamper-proof
screening/testing apparatus. The present invention consists of a container,
a closure that snaps or screws onto the container and a cassette holding a
rapid test strip that matingly engages with the closure.
A liquid specimen is stored in the container. A series of windows or
inlets permit the operator of the testing apparatus to activate the test by
inserting the cassette and/or turning the cassette thereby controlling the
flow of the liquid specimen to the test strip. This invention is designed for
testing a sample specimen in the container without opening the container.
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Further, the cassette is engaged on to the closure, the test may be
conducted without having to physically access the specimen. The container
of the present invention can then be mailed to an independent testing lab to
confirm the test results without opening the closure, and without pouring
the specimen into a new, shippable container. This feature has two
important advantages; first, the nurse or other personnel supervising the
test is not exposed to the specimen; second, it limits a person's ability to
tamper with the specimen, especially if the closure is equipped with a
tamper-proof tape.
Besides providing means to physically activate the test when
desired, the cassette is designed to allow the sample specimen to be shut
off or isolated from the test area after the results are read, thereby
preserving the remainder of the specimen.
After a patient has provided a specimen, the container can be
sealed with the specially designed closure to prevent tampering and to
prevent the accidental spilling of the specimen.
In another preferred embodiment, the closure has a substantially
tubular portion that extends into the center of the container. This tubular
portion is sized to accept a pipe section of the cassette. The tubular
portion may be initially closed-off by a cap thereby forming a second, inner
container within the first or original specimen container.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing summary, as well as the following detailed description
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may be better understood when read in conjunction with the accompanying
drawings, which are incorporated in and form a part of the specification.
The drawings serve to explain the principles of the invention and illustrate
embodiments of the present invention that are preferred at the time the
application was filed. It should be understood, however, that the invention
is not limited to the precise arrangements and instrumentalities shown.
In the drawings:
Figure 1 is a perspective view of a self-contained, tamper-proof
screening apparatus in accordance with the present invention;
Figure 2 is a cross-sectional view of the closure of the screening
apparatus shown in Figure 1 taken along line 2-2;
Figure 3 is a longitudinal cross-sectional view of the cassette
assembly shown in Figure 1;
Figure 4 is a cross-sectional view of the cassette or closure having a
modified absorbent insert in accordance with the present invention;
Figure 5 is an enlarged perspective view of a collar used to align the
test strip and to apply a controlled amount of pressure on the test strip;
Figure 6A is an enlarged top view of a plug that may be used to
isolate the interior chamber of the closure from the specimen until a desired
event (i.e., unlocking the plug when a cassette is inserted);
Figure 6B is a perspective view of the plug shown in Figure 6A;
Figure 7 is a top view of the cassette cover illustrated in Figure 3;
Figure 8A is an enlarged top view of closure;
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Figure 8B is a detailed view of cover plug adapter to closure shaft
which is sealing the closure inlets and bottom opening of closure;
Figure 9 is a top view of another embodiment of a cassette having a
tapered interior bottom;
Figure 10 is a cross-sectional view of the cassette of Figure 9
showing the tapered interior forming a point;
Figure 11 is a special test strip with a tapered lower portion,
designed to fit into a tapered cassette or other tapered container;
Fig.12A is a top view of the testing and sampling apparatus
embodiment indicating multiple testing positions incorporated into a single
test;
Fig.12B is another embodiment of the sampling and testing
apparatus, which is adapted to a container that has multiple chambers, built
into the container;
Figure 13 is another embodiment of the testing apparatus disclosing
a second, separate inner container, that isolates a portion of the specimen
from the specimen in the outer container.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
In describing a preferred embodiment of the invention, specific
terminology will be selected for the sake of clarity. However, the invention
is not intended to be limited to the specific terms so selected, and it is to
be
understood that each specific term includes all technical equivalents that
operate in a similar manner to accomplish a similar purpose.
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The terms "right", "left", "top", "bottom", "lower" and "upper"
designate relative directions in the drawings to which reference is made.
The terms "inward" and "outward" will usually refer to an area inside or
outside of a particular structure.
Preferred embodiments of the present invention will now be
described in detail with reference to the accompanying drawings in which
an apparatus for testing and screening for specific compounds, in
accordance with the present invention, is generally indicated at 10.
Referring now to Figure 1, an apparatus 10 for testing and screening
for specific compounds, and in particular testing for drugs, is shown. The
apparatus 10 comprises an outer container 12, a closure 14, and a test
cassette 16. The container 12 has a closed end 13 and an open end 15,
The container 12 is designed to hold liquid specimen (e.g., urine, blood,
etc.) that is placed or poured into it. The container 12 may be one of a
number of standard specimen containers currently on the market.
The closure 14 is adapted to securely attach to the container 12
providing a liquid-tight seal between the closure and the container. The
closure 14 may be snapped on, screwed on, frictionally engaged or
secured by some adhesive to the open end 15 of the outer container 12.
In one embodiment, after the specimen is placed in the container,
tamper-proof tape,18, or other tamper prevention mechanism, may be
placed across the closure 14 and container used to indicate whether the
closure has been removed or separated from the container.
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Referring now to Figure 2, a cross-sectional view of the closure 14 is
illustrated. In a preferred embodiment, the container 12 and closure 14
have mating threads 18a and 18b, respectively, so that the closure 14 may
be screwed onto the top of the container 12. This permits a quick and
easy means of securing the closure 14 to the container. Of course, other
methods for securing the closure to the container may be used (e.g., a
snap top closure similar to prescription bottles, rubber O-ring with a mating
channel, etc.).
The container 12 need not have a cylindrical shape. If the container
has a square or triangular cross-section, a snap top or adhesive may be
used to secure the closure 14 to the container 12.
The threads 18b of the closure 14 are located on a head section 24
of the closure 14. As can be seen in Figure 1, the head section 24 is
preferably shaped to fit over the container 12. In the preferred
embodiment, the container 12 has a cylindrical shape; accordingly the head
section 24 of the closure 14 will have a circular shape to close and seal the
open end 15 of the container 12; this will ensure that the specimen stored
in the container 12 will not leak out.
The container 12 need not have a cylinder shape. If the container
has a square or triangular cross-section, a snap top or adhesive may be
used to secure the closure 14 to the container 12.
The container 12 must be large enough to hold enough liquid
specimen so that a testing lab can conduct at least one test and preferably
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several tests. A more detailed description of the reasons why it is desirable
for the container to hold enough specimen to perform several tests will
become evident after a reading of this disclosure.
The test cassette 16 is designated to be inserted into and removed
from the closure 14. The test cassette holds one or more test strips 20 that
are, at some point in time, exposed to the liquid specimen and change
color to indicate the presence or absence of a specific compound or
compounds.
Referring again to Figure 2, the closure 14 includes a lower shaft 26
that extends from the head section 24, and is designed to be inserted into
the container 12. The shaft 26 is tubular and defines and interior chamber
28. The shaft 26 has a closed distal end 25 and an inlet 22 near said distal
end 25.
The shaft 26 should be long enough so that the distal end 25 (i.e.,
the end furthest from the closure 14 ) is ensured to be submerged into any
liquid specimen stored in the container 12, but the shaft 26should be short
enough so that the shaft does not engage the closed end 13 of the
container 12 when the closure is secured to the container 12.
In one embodiment, the shaft 26 has a circular cross-section. It
would be evident to one skilled in the art, after reading this disclosure,
that
the shaft 26 may have a rectangular (including square), oval or other cross-
sectioned shape.
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In one embodiment, the diameters of shaft 26 and pipe section 38
may be increased in order to minimize their linear length. This allows the
closure and cassette to be used with any manufacturer's container.
An inlet 22 is positioned near the bottom end of the shaft 26, as
illustrated in Figures 1 and 2. The inlet 22 defines a passageway from the
volume outside of the shaft 26 to the interior chamber 28 of the shaft.
When a liquid specimen is present in the container, the inlet 22 allows a
sample of the specimen to enter through the wall of the shaft 26 into the
interior chamber 28 and eventually exposing a test strip 20 in the test
cassette 16 to the liquid specimen. Other purposes of the inlet 22 and its
position on the shaft will become more evident after a complete reading of
this description.
Referring now to Figure 3, an enlarged cross-sectional view of one
type of the cassette 16 is illustrated. The cassette 16 comprises a cover
34, a top section 36, a body section 33, and a pipe section 38. As
illustrated, the pipe section 38 has a valve opening 37. The outer diameter
of pipe section 38 must be slightly less than the diameter of the interior
chamber 28 of shaft 26 of the closure 14; this permits the pipe section 38 to
slide into the interior chamber 28 of the shaft 26. The pipe section 38 is
designed to engage the interior side of the shaft 26 and rotate within the
interior chamber, but still provide a friction fit that prevents any of the
specimen from moving between the interior side of the shaft and the
exterior side of the pipe section 38. Detents 31 on the exterior side of the
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pipe section are designed to align with depressions in the shaft for locking
the cassette 16 into place and aligning the cassette 16 relative to the
closure 14.
The valve opening 37 of the cassette opens into inner cavity 39 of
the pipe section. The interior cavity 39 allows the valve opening 37 to
communicate with the top section 36 of the cassette 16.
A test strip 20 (preferably a rapid test strip) is positioned proximate
the top section 36 of the cassette 16 and is sandwiched between the top
section 36 and the cover 34, as illustrated in Figure 3. In order to allow a
technician a view of the test strip and determine the results of the test, the
cover 34 is clear (or at least the portion of the cover that overlies the test
strip).
Referring now to Figure 7, the cover 34 may also be designed with a
magnifying window 84 that enlarges the appearance of any markings or
colors on the test strip 20. The cover rnay contain indicia 85 to identify the
type of test strip or the metabolites or compounds the test strip will screen.
Other indicia on the cover may identify the patient, indicate the series of
the
particular test, identify the lab and its location or provide other
instructional
or even marketing information. The cover 34 may also provide a place for
the patient to sign his or her name.
As will be discussed herein, the cassette is designed to rotate with
respect to closure 14. The cover 34 is securely attached to the top section
of the cassette to prevent tampering of the test strip 20 and to ensure that
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the cassette rotates when a technician turns the cassette cover 34.
Accordingly, the cover 34 may include a pair of gripping ears 137 which
allow a technician to more easily rotate the entire cassette.
The cassette cover 34 may be sealed onto the cassette 16 during
manufacturing. The cover 34 will prevent any leakage or contamination of
the specimen once the test is activated. The cover also protects the test
strip and prevents tampering of the test strip.
Although Figure 3 only illustrates an apparatus 10 utilizing a single
test strip, multiple strips may be included. Further, each test strip 20 may
be designed to test for one drug, a plurality of drugs and/or biological
organisms or any application where a test strip may be applied (i.e., micro
toxins). The subject invention may be used independent of a test strip (e.g.,
to store and transport a specimen).
Referring again to Figures 1 and 3, the test strip 20 is bent or flexed
at a point designated by reference numeral 99. The test strip is in a vertical
position at its lower end (i.e., inside the pipe section 38 of the cassette
16)
and in a horizontal position at its upper end (i.e., the portion sandwiched
between the cover 34 and the top section 36). The flexing can take place
in or around the colloidal gold section of the strip. It is desired to have
the
viewing portion of the strip relatively flat; this allows the technician to
clearly
view the test results through the cover 34.
In a preferred embodiment, the test strip 20 extends into the inner
cavity 39 of the pipe section 38 and is bent so that a top portion of the test
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strip lays in the horizontal plane. In this embodiment, it is preferable to
use
a lateral flow colloidal gold test strip. Also, by flexing the test strip 20
the
lateral flow is enhanced by microscopically stretching (i.e., elongating) the
spherical pores of the test strip membrane in the lateral direction of the
flow
of any specimen at the point of flexing. The flexing of the test strip is just
one feature of the subject invention.
Referring now to Figure 5, a collar 52 having a living hinge 56 may
be used to align the test strip 20 inside the inner cavity 39. The collar
ensures that the test strip is bent at an appropriate angle and remains
substantially in the center of the inner cavity 39 of the pipe section 38 as
illustrated in Figure 3.
Referring again to Figure 3, in addition to aligning the test strip 20,
the collar 52 acts as a barrier that prevents contamination of the area
above the collar 52 (i.e., proximate the active region of the test strip).
This
ensure that the test strip 20 is exposed to a controlled or desired quantity
of
specimen.
The living hinge 56 of the collar is designed to apply controlled
pressure on the test strip 20. In prior art test cassettes, the test strip
lays
in a horizontal plane secured to a test bed; the technician places a few
drops of a specimen onto the sample area of the cassette. The prior art
cassette's interior has small protruding platforms that apply pressure to the
test strip. The pressure is required to improve the functionality of the test
strip (i.e., the test strip is made from many layers of material and many
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different chemicals which tend to separate if not for the exterior pressure).
In the present invention, the collar 52 replaces the need for protruding
platforms or other similar structures in prior art cassettes.
Although the test strip material (preferably without the chemically
reactive portion) may extend vertically to the bottom of the inner cavity 39,
it
is preferable to have the test strip overlap an absorbent wick 78. (See
Figure 3 again.) The absorbent wick is more efficient at moving the
specimen upwards toward the active portion of the test strip 20.
Referring again to Figure 5, the area the portion of the test strip 20
above the collar 52 and the cover 36 will be protected from contamination
by the specimen. The only way the specimen can contact this area is by
migrating through the test strip by means of capillary attraction.
Referring now to Figure 4, an alternate embodiment is shown. This
embodiment illustrates a specially designed absorbent pad 79 that
eliminates the requirement of a collar 52 and absorbent wick 78. The
absorbent pad 79 grips the test strip for the purpose of positioning the test
strip, provides the needed pressure that improves the performance of the
chemical portion of the test strip, and wicks the specimen up to the test
strip 20.
This absorbent pad 79 also helps position the test strip during
assembly. The absorbent pad 79 includes at the upper end a collar 77
somewhat similar to living hinge 52. The collar 77 will provide pressure on
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the test strip when the collar is inserted into the cassette. The collaris
designed to provide a more controlled wetting of the test strip.
The absorbent pad in Fig. 4 prevents excess liquid from washing
onto the test strip membrane region. It may be desired to have a testing
apparatus that is not in the upright position or in the case the specimen has
spilled, the absorbent pad will control the amount of sample onto the test
strip. It may also be used as a filter or buffer (adding a reagent) to work in
connection with the strip. The absorbent pad 79 may be chemically treated
or coated to provide additional flexibility to the testing apparatus. This
treatment of the absorbent pad may provide a reagent mix to the sample at
the appropriate time.
In another embodiment, the test strip may have an extended
absorbent section that extends to the distal end at the inner cavity 39
thereby replacing the absorbent pad. The cassette's inner cavity 39 may be
geometrically similar to that of the strip (rectangular), thus allowing the
test
strip to fit into the cassette in a more controlled fashion.
The portion of the test strip that lays against top section 36 may
terminate with an absorption pad. The absorption pad assists in the
wicking process and may also absorb any excess specimen that may have
been wicked up to the chemically reactive portion of the test strip.
Rails 120 be incorporated in the top section 36 of the cassette to
position the test strip and enclose the absorption pad. A gully 92 may be
positioned on the top section 36 to accommodate the absorption pad. The
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rails 120 also help to prevent the lid 34 from compressing the test strip by
maintaining a safe distance between the lid 34 and the top section 36. By
maintaining a safe distance, the specimen will not contact the viewing area
where it may stain, block or distort the reading of the test strip.
Referring now to Figures 2 and 3, primary detents 55 of the cassette
will seat into the arcuate grooves 54 of the closure 14. These will provide
snap stops and control the distance that the cassette 16 can rotate relative
to the closure 14, thus guaranteeing proper positioning of the closure and
cassette during activation.
Specific features of the subject apparatus 10 will become apparent
through the explanation of a screening for drug metabolites in a urine
specimen. Cassette 16 may be snapped into closure 14 at the
manufacturer or may be snapped in by the testing personnel. Closure 14
may have lips 61 that provide a snap fit. The cassette 16 is uniquely
designed to cooperate with the closure 14.
In this example, the test strip is pre-positioned in the cassette and
the cover 34 is secured to the top section 36 of the cassette.
The exterior wall of pipe section 38 abuts the interior wall of shaft 26.
Initially, valve opening 37 is not aligned with inlet 22. The test subject
places a sample of his urine in the specimen container 12. Closure 14 is
screwed onto the top of container 12. If desired, a tamper-proof seal (not
shown) may be placed over the edge of the closure 14 and the outside of
the container 12.
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When the closure 14 is initially secured to the container, inlet 22 is
closed off by the friction fit of pipe section 38 against the interior side
wall of
shaft 26, accordingly, the specimen within the container 12 is isolated from
the interior cavity 39 and from the test strip 20. The container 12 is totally
self-contained and there is no reason for a technician in the local lab to
open the closed container 12. The container may be shipped to a remote
lab in this condition.
The drug test or drug screening in this example is activated by
rotating the top section 36 of cassette 16 relative to the closure 14. The
ears 37 may be pushed in the desired direction (i.e., clockwise or
counterclockwise) by a technician. When the cover 34 and top section 36
are rotated, the cassette's pipe section 38 is also rotated and the valve
opening 37 in the cassette will eventually align with the inlet 22 of the
shaft
28. As the top section of the cassette rotates with respect to the stationary
closure 14, the detents 55 move in an arcuate direction within the grooves
54. The arcuate length of the grooves 54 determine the total amount of the
rotation of the cassette 16. After about a third of a turn, detents travel
from
one end of the grooves 54 to the opposite end, and the valve opening 37
aligns with the inlet 22 of the shaft. If the container contains a liquid
specimen, when the alignment of the valve opening with the inlet occurs,
the inner cavity 39 of the cassette is flooded with the specimen.
The test strip absorption section is located within the inner cavity 39.
When the liquid specimen comes in contact with the absorption material 78,
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the liquid is wicked upwards toward the test strip 20. When the specimen
reaches the flexed area 99, the flow becomes more efficient and eventually
delivers an amount of specimen that activates the test strip 20. The
horizontal portion of the test strip 20 is readable through the cassette cover
34 and the results of the test are readily ascertainable.
The collar 56 that fits around the test strip may be designed to
prevent excess specimen from entering the viewing area. The cassette's
design provides an air lock to keep unwanted sample material from
contaminating the chemistry section of the test strip. (Similarly, if the
cover
34 is removed, accidentally or otherwise, the air lock prevent the specimen
in the container from being contaminated.)
Not shown are small vent openings in the upper half of shaft 26 and
in the upper half of the pipe section of the cassette. The vent openings
may aid in air-to-liquid displacement. The vent openings are usually
positioned directly over the corresponding inlet or valve opening so that the
vent openings are closed when the inlet/valve opening is closed, and are
aligned to let air or liquid in when the cassette is rotated in order to
activate
the test. Detents may be placed proximate the various vent opening(s), to
assist in aligning the cassette with respect to the closure and to ensure a
snug frictional engagement between the pipe section and the inner wall of
the shaft of the closure 14.
In another embodiment of this invention, illustrated in Figures 6A and
6B, a plug 70 may be adapted to snap into the interior chamber 28 of the
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shaft 26 via knobs 98 thereby isolating the interior chamber 28 from the
specimen in the container. The plug 70 includes a control opening 72 that
when the plug is rotated by a cassette, the inlet 22, the control opening 72
and the valve opening 37 are all aligned thereby allowing the specimen to
enter the inner cavity 39 of the cassette. By using the plug 70, a technician
can sample the container's specimen and without exposing the technician
to an open container.
In an embodiment that utilizes the plug 70, the pipe section 38 of the
cassette 16 may include a key that matingly engages a key opening 93 in
the plug 70. Key opening 93 in plug 70 will ensure proper positioning of the
cassette with respect to the closure, and will prevent the cassette from
being removed prior to sealing the inlet, thereby preventing any of the
specimen from spilling out.
Referring again to Figure 6A, the plug 70 has a unique key opening
93. This plug will be placed near the bottom end of the shaft to seal the
inlet 22 in the closure if a cassette is not shipped with the closure or will
be
used at a later time. The key 93 may help align the plug 70 within the shaft
of the closure and will only allow a mating cassette to turn the plug 70.
With the plug 70 in place, the closure can function as a standard lid
completely sealing the container 12. A cassette 16 may be inserted into
the closure at any time to test the specimen stored in the container.
By using this special keyed plug 70, multiple test cassettes may be
introduced to sample the same specimen sealed within container 12
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without contaminating the specimen. The test cassettes 16 will snap into
the closure and the plug; the cassette will not be activated until the
cassette
is rotated and the valve opening 37, inlet 22 and plug opening 72 are all
aligned (i.e., all three holes must be in proper position to allow the
specimen from continuing to enter the inner cavity 39).
The utilization of this keyed plug 70 offers more flexibility to the
subject invention by providing a means to perform different tests on the
same specimen in the sealed container by interchanging the test cassettes.
It may be desired to have a sample sealed in a container and after the
sample is sent to the lab a technician can decide which test cassette to
use. Also, when a positive test comes back, the local testing lab will
usually have to send the specimen to a more sophisticated, usually
remotely located lab. This can easily be done by twisting the cassette in
the opposite direction thereby closing inlet 22 with plug 70, and removing
the cassette, this procedure reseals the container and shipping the
container can be shipped to the remote lab without spilling or contaminating
the specimen. The technician at the remote lab may conduct the same test
by inserting a fresh cassette into the closure, rotating the cassette in the
appropriate direction thereby allowing specimen to flow through inlet 22
and into inner chamber 39. Additional tests may be performed by inserting
additional cassettes having the same or different test strips.
Another embodiment (not shown), would be to utilize a plug that will
receive the test cassette and instead of rotating the cassette, when the
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cassette 16 is placed into the closure 14, the plug is forced downward and
opens the passageway for the specimen to flow into the cassette. This
embodiment would not require an operator to rotate the cassette, but only
to insert the cassette into the closure. It would also allow the container and
closure to be shipped and used independently of the test cassette. Only at
the time of testing will the cassette be introduced.
The typical use of a chemical reagent test strip includes positioning
the test strip into a specimen in a small open container, where the test strip
remains in a vertical position, or with the use of a holder a few drops of a
specimen are placed onto the holder's ,ample section, with the entire test
strip in a horizontal position.
Referring again to Figure 3, a collar 52 provides a slight pressure to
enhance the function of the test strip and to protect the active or upper
section of the test strip from contamination. In this particular design there
is
a airlock that also protects the upper portion of the test strip from
contamination
An aspect of the invention is that once the closure and the built-in
test cassette are secured to the container 12, a sample specimen in the
container can be tested without opening the container. Another aspect is
that it provides a means for test personnel to have physical control over the
cassette and to physically activate the test when desired. This reduces the
opportunity for the person being tested to tamper with the test procedure.
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Also, the present invention allows the sample specimen to be isolated from
the test area after the results are read.
It is also designed to provide a leak proof seal between the outer
walls of the cassette and the inner wall of the closure. If desired the inlet
22 can be adapted with a keyed plug (Fig.6) to prevent the closure from
leaking if the cassette is not adapted to the closure. It maybe desired to use
the container and closure without a cassette or it may be desired to use
multiple cassettes with one container. The keyed plug provides means to
sample the specimen with a cassette or use the container and closure
without a cassette.
If one test stripe is used the window will start at the near center and
go outward. If more than one strip is used the window may consist of the
entire diameter of the surface.
On the underside of the cassette cover there is a grove that helps
position the test strip and positions the test strips absorbent well. The
grove
may be deeper at the outer edge to encapsulate the heavier absorbent
material.
Represents the body of the cassette and the snaps that seal the
cassettes cover to the cassette.
There may be an additional hole in both the cassette and closure
that also are aligned when the test is activated. These additional holes are
for the purpose of venting, providing air to specimen displacement. They
would be placed in the upper portion of the cassettes shaft.
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The subject invention illustrated in Figure 13 provides means to
isolate the tested specimen from the remaining specimen. This may be
desired in cases where there may be legal ramifications that may imply that
the tested sample has potential to contaminate the remaining sample. THIS
ISOLATOR SYSTEM INCORPORATES A SECOND CONTAINER WITHIN
THE FIRST CONTAINER. In areas like the Drug of Abuse screening, if a
positive result is recorded, the remaining sample is sent to an outside
laboratory for verification. By incorporating the Isolator System into the
container, there can be no allegation that the remaining sample has been
contaminated. It is important to note that even though Figure 13. shows the
Isolator System having a round shape and shaft section , the Isolator
System may have a rectangular shaped shaft and complimentary cone
shapes or any other desired shape, to work with other test cassette
configurations that may already be on the market, including the type that
use a card type tester that dips into the cup through the lid.
The preferred embodiment of the Isolator System is shown in Figure
13. When closure 14 is placed onto a filled specimen cup with a tapered
bottom 186 the specimen will fill up the cone section of the cup first. As the
closure 14 is placed into the cup the specimen will also seeks its level
inside of the isolator shaft 182. When the closure 14 is sealed onto the cup
the cone section 184 of the Isolator .System will snap around the shaft
section 182 of the Isolator System sealing a portion of the specimen inside
of the inner -most container 180 from the outer most container. It may be
CA 02425624 2003-04-22
23
desired that the cone section 184 and the shaft section 182 of the Isolator
System do not lock or snap together until the introduction of a cassette. At
such a time the cassette would force downward the plug/cover 70 when the
cassette applied pressure to plug/cover 70 seat 131. The downward motion
would then move the cone 184 by the cone extension 190 and snap and
lock onto the shaft 182 of the Isolator System. Depending on the desired
configuration the cone section 184 of the Isolator System may be attached
by friction to the bottom of the cup 192. If the cone section 184 of the
Isolator System is connected to the shaft section 182 before the specimen
cup is used then windows or opening (not shown) must be used in the shaft
182 and cone 184 of the Isolator System. The windows may be in the open
position when the closure 14 is placed onto to cup. The windows can be
closed by the introduction of a cassette which would slide the plug/cover 70
downward, which would slide the cone 184 downward by forcing probe 190
on cone 184 downward. Or the windows can be closed by the exact
opposite, thus the cone 184 can hit the bottom of the cup when the closure
14 is put onto the container. The cone 184 would then be forced upward
closing off the windows in both the shaft 182 and cone 184 of the present
invention. In the alternative, it should be noted that the windows can in the
closed position and opened by the cassette . There may be applications
where it is desired to mix the contents of the the inside container 180 with
the contents of the outer container.
14. Top view of closure
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125. Top view of closure sealed off by cover
127. Alignment control grove in cover
129. Upper window in cover
22. Upper window in closure
131. Interior landing area of bottom plug
72. Lower window of cover
133. Outer area of bottom plug
70. Cover/plug
26. Lower shaft of closure
Referring now to Figure 8, an elongated cover 70A may be adapted
to the closure/system 14, that will seal the entire lower shaft 26 of the
closure in the absence of a cassette. The elongated cover 70A performs
many of the same functions of the plug 70 which was described in Figures
6A and 6 B.
The elongated cover 70 A is not keyed, although when a cassette is
introduced into the closure's shaft the bottom plug 133 of the cover 70A is
forced downward when the cassette pushes on the landing area 131 of the
cover 70A; simultaneously the entire cover is slid downward aligning the
windows 129 and 72 of the cover 70A relative to the gates inlets/outlets of
the closure 14. In this position, the sampling /testing apparatus will
function
as normal, thus by rotating the cassette/dial, the gate of the cassette, the
gate of the closure, and the windows of the cover will all be aligned and the
sample specimen will inter into the inner chamber /cassette.
CA 02425624 2003-04-22
The windows129 and 72 of the cover are also designed to mate with
an insert or filter if desired. The windows 129 and 72 may also be meshed
to prevent unwanted sample specimen from entering the inner chamber
during activation. The cover 70 may also have an alignment control 127.
This will align the cover 70 in the proper position when it is adapted to the
shaft of the closure. Also, the bottom plug 133 of the cover may incorporate
a locking mechanism (not shown) that will latch onto the bottom of the
cassette so that when the cassette is removed the cover will be pulled
upward and reseal the entire system by closing off windows 129 and 72
relative to the closures gates/inlets 22.
Fig 9. Top View of a cassette with a tapered interior bottom
134. Interior bottom point of cassette
16. Top view of cassette
Fig.lO. Another embodiment of a cassette with a tapered interior
forming a pointed bottom.
38. Lower shaft of a cassette
134. The tapered interior of the bottom portion of a cassette forming a
pointed bottom.
136. The interior of the cassette, which encloses a tapered test strip in
Fig. 11.
Fig.11A. Special test strip with a tapered lower portion, designed to fit
into a tapered cassette or other tapered container.
The cassette and test strip as illustrated in Figures 10 and 11 is
CA 02425624 2003-04-22
26
designed for times when there is only a small amount of a specimen and/or
additional reagents added to a test strip. By forming a tapered bottom in a
chamber the samples will be focused into a small location thus assuring that
the entire volume may be absorbed into or through the tapered test strip.
All known test strips are designed with a flat bottom. The test strip in
accordance with the present invention is particularly useful when very small
amounts of sample specimen are available or desired. There are several test
performed in the lab that require a sample specimen and then a few drops of
one or more chemical reagents to the absorbent area of a test strip. By
incorporating this special cassette in Fig.10 and test strip in Fig.11 the
Sampling apparatus can be designed to receive multiple samples and or
reagents that can all be focused on the tapered portion of the test strip
allowing each to be absorbed through the test strip. This will allow the
system
to be used for numerous applications such as an HIV, STD's, bacteriological,
chemical or urinalysis testing just to name a few.
20. Test strip
138. Tapered portion of a test strip.
140. Pointed end of test strip, designed to fit into a tapered chamber.
Referring to Figure 12A, a top view of another embodiment of the
testing and sampling apparatus using multiple test compartments incorporated
into a single test. A cassette cover with viewing window and finger grips 146
is illustrated. Thev finger grips 46 are used to rotate the cassette in order
to
receive multiple samples and or reagents into the cassette's chamber.
CA 02425624 2003-04-22
27
Reference positions 142 represent the multiple positions to which the
dial may be adjusted to during a test. In this case position a. b. and c.
Referring now to Figure12B, another embodiment of the sampling and
testing apparatus, which is adapted to a container that has multiple chambers,
built into the container. This embodiment may also be designed to be built as
an insert that is attached to the shaft 26 of the closure 14.
It may be desired to incorporate a multi-chambered container to the
testing apparatus. There are many applications where more than one sample
or reagent may be desired as part of a testing assay. Providing a multi-
chambered container allows the operator to rotate the finger grips 146 on the
cover 34 of the cassette into multiple positions, a, b, c etc. When the
cassette
is properly aligned to the various inlets 148and 158, which are aligned to
separate chambers, the contents of each chamber will be introduced into the
center cassettes chamber. If a test strip is being used in the cassettes
chamber the samples or reagents can be control to meet the required testing
procedure. In this case there are tapered chambers 154 and 152 that focus
their contents to a small point 156 in the bottom of their chambers. An
example of a test that may utilize a multi-chambered insert or container may
be to incorporate a large window that allows a whole blood sample to be
applied directly onto an absorbent or test strip. Then afterwards placing the
closure with cassette into an multi chambered container. At this point the
sample may be treated with reagents and eventually designed to give a visual
reading of a test result.
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16. Cassette
34. Cassette cover
14. Closure
Multiple openings 148 may be used as vents to displace the contents of
inner chamber when contents of outer chamber enter. The inlets of the outer
chambers and the closure shaft are fixed. When the cassette is rotated to the
aligned position the vents or the inlets/gates will allow interaction or
communication between the chambers.
158. Gates or inlets
152. Chamber
154. Chamber
150. Sealing lid for each chamber
38. Shaft of cassette
156. A tapered bottom to collect small samples in a focused location
An apparatus for isolating a sample of a liquid specimen and testing
said sample without contaminating the remaining liquid specimen is illustrated
in Figure 13. The apparatus includes an outer container having a first end
that
is open and a second end that is closed, the outer container being capable of
holding a liquid specimen; a closure having a top side and a bottom side, the
bottom side facing the interior of the container, the closure having means to
releasably attach to the first end of the container, the closure includes an
elongated tube that extends away from the closure and into the container,
said tube having an isolator bottom attached to the distal end of the tube,
the
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29
isolator bottom having at least one window for allowing at least a portion of
any liquid specimen stored in the outer container into the interior of the
tube,
the closure communicates with the bottom of the outer container via said tube
and isolator assembly to close said window in the isolator bottom, when said
window is closed the tube and isolator bottom define an inner container within
the outer container for isolating said at least portion of the liquid specimen
from any liquid specimen present in the outer container.
Continuing to refer to Figure 13, the apparatus further includes a shaft
having a hollow interior and a distal end that is designed to extend inside
said
tube from the closure towards said second end of the outer container, the
distal end attached to an isolator bottom that partially seals off said distal
end,
the isolator bottom having at least one window that defines a passage from
the exterior of the shaft to the hollow interior of the shaft, the hollow
interior of
the shaft communicates with the closure, thereby relating a pathway from a
point within said inner container to the top side of the closure;
an elongated shaft cover having a first end and a second end, said
second end of the shaft cover being closed off, said shaft cover having an
interior dimension slightly larger than the exterior dimension of the shaft so
that the shaft cover functions as a sheath over said shaft and has an initial
position that sealedly isolates the interior of the shaft from the interior of
the
tube;
wherein said elongated body section has a sufficiently long longitudinal
dimension such that it engages the closed end of the shaft cover before the
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test cassette is secured to the closure so that when the test cassette is
secured to the closure said elongated body section applies a longitudinal
force
to the shaft cover thereby moving said shaft cover in said pre-determined
manner.
Although this invention has been described and illustrated by reference
to specific embodiments, it will be apparent to those skilled in the art that
various changes and modifications may be made which clearly fall within the
scope of this invention. The present invention is intended to be protected
broadly within the spirit and scope of the appended claims.
