Note: Descriptions are shown in the official language in which they were submitted.
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FLUID SPECIMEN COLLECTING AND TESTING APPARATUS
Related Applications
This application is a continuation-in-part of
patent application serial number 08/851,548, filed May
5, 1997.
Field of the Invention
The present invention is directed to a fluid
specimen collecting and testing apparatus suitable for
field or laboratory use. More particularly, the
present invention is directed to an apparatus for
collecting and testing biological fluids in a single
apparatus while preserving the integrity of the
originally collected specimen.
Background of the Invention
In the health-care industry, diagnostic testing of
body fluids is a common place activity. Employers,
government agencies, sports teams and other
organizations have also become increasingly involved in
diagnostic testing to maintain safety in the workplace
and to ensure compliance with laws, rules and
regulations.
It is generally necessary in diagnosing and
testing for the presence of a predetermined analyte
(eTa. drugs and/or disease) to collect biological
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fluids from an animal or human, i.e., urine, blood,
sputum, pleural, cavity and peritoneal cavity fluids
for analysis. Maintaining the integrity of the
collected biological fluid specimens is vital to
obtaining reliable test results and to preserving an
uncontaminated sample for subsequent confirmatory
testing. It is of utmost importance during the
collection and handling of biological fluid specimens
that the potential for specimen contamination be
minimized or eliminated. It is also important to
minimize the potential for specimen damage during the
collection process and testing process.
Many known devices for collecting and testing body
fluids involve multiple steps and/or multiple
containers. Generally, these devices require
collection of a fluid specimen in one device, isolation
or segregation of the fluid specimen into an aliquot in
the same device and transfer of the specimen to a
different device for analysis. Separate collection,
and testing requires an undesirable amount of handling
of the specimen and is likely to lead to unacceptable
levels of contamination.
Examples of the related art may be found in EP-A-0
322 572, US-A-4 736 859, and in US-A-3 894 845. The
'572 application discloses an apparatus and process for
obtaining an aliquot of serial liquid samples. A
measured aliquot of each serial liquid sample is
obtained and passed to an aliquot storage chamber with
discard of the remains of the remainder of each liquid
sample.
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There is a long felt need in the industry for a
unitary device that performs collection, isolation and
testing of a specimen that preserves the integrity of a
portion of the specimen, isolates a separate portion of
the specimen for testing, and minimizes the risk of
misidentification. One of the difficulties in
realizing such a device is that current U.S. federal
regulations may prohibit mixing the collected specimen
with the aliquot specimen or the test specimen.
Existing prior art devices that perform collection,
isolation
p~AEI~OED S~~
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3
and testing have not adequately maintained separation
between the collected fluid specimen, the aliquot and
the test specimen. These devices have also failed to
provide a totally sealed system in that bodily fluids
leak to the outside environment. Furthermore, existing
prior art devices have experienced undesirably high
error rates in their function and in their test
results.
Summary of_ the Invention
The present invention involves an integrated fluid
collection and testing apparatus that may be used with
any type of fluid specimen, and is particularly useful
for urine, blood and saliva specimens. The apparatus
collects a fluid specimen, isolates a predetermined
portion of the specimen, and exposes only the isolated
portion of the specimen to diagnostic or testing
structures and/or reagents. The isolated portion may
be isolated as the fluid is collected in the apparatus,
i.e., without any additional manipulation by testing
personnel. The isolated portion is then independently
tested in isolation from the collected fluid specimen.
In accordance with one embodiment of the
invention, the fluid specimen collecting and testing
apparatus includes a collecting chamber for collecting
the fluid specimen, an isolation chamber for isolating
an aliquot of the fluid specimen for testing, and a
- test chamber or region for testing the specimen. In
accordance with the invention, the collection chamber
is never in fluid communication with or open to the
test chamber. Preferably, when the collection chamber
is in fluid communication with the isolation chamber,
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4
the test chamber is closed to the isolation chamber.
When the isolation chamber is in fluid communication
with the test chamber, the collection chamber is closed
to the isolation chamber. Preferably, the isolation
chamber is in fluid communication with the collection
chamber so that the aliquot can be readily isolated
without complex manipulation by collection personnel.
A test chamber is provided for performing diagnostic
testing on the aliquot.
Furthermore, in accordance with the invention, the
isolated portion of the fluid does not contact the
remainder of the collected sample once the isolated
portion comes in contact with contaminating structures
or reagents. In accordance with the invention, the
collected sample is maintained in a pristine or
unadulterated state. Such a characteristic of the
present invention is advantageous in that it permits
independent and/or confirmatory testing of the same
sample that was screened using a device of the present
invention. Also in accordance with the invention, a
totally closed (sealed) system is provided which
prevents the fluid specimen from leaking to the outside
environments. Other advantages will be clear to those
skilled in the art upon reading the description and
drawings below.
In view of the importance of testing the aliquot
in isolation from the collected fluid specimen, the
test chamber is sealed from the collection chamber. Tc
initiate testing, communication between the isolation
chamber and the test chamber is established. In a
preferred embodiment of the invention, a fluid
releasing device is provided that opens the
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communication between the isolation chamber and the
test chamber and establishes a fluid flow path to the
test chamber. To prevent undesirable flow through the
collected fluid specimen to the test chamber via the
5 isolation chamber, the fluid releasing device may also
establish a seal between the collecting chamber and the
isolation chamber.
In accordance with another aspect of the present
invention, the specimen container may include a tamper
evident lid which provides an identification of whether
or not the container has been opened which may indicate
that the contents of the container have been
compromised. In a preferred embodiment, a tamper strip
may be releasably attached to the tamper evident lid
which, in combination with the specimen container,
permits one way rotation of the lid. Removal of the
lid after closure to the locked position preferably
results in partial or complete disconnection of the
tamper strip from the lid. This feature reduces the
possibility of sample adulteration and aids in ensuring
the integrity of the diagnostic testing.
Brief Descriation of the Drawings
Figure 1 depicts a cross sectional view of the
fluid collecting and testing apparatus according to the
present invention in a first phase of operation.
Figure 2 illustrates a cross sectional view of the
fluid collecting and testing apparatus according to the
first embodiment of the present invention in a second
phase of operation.
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6
Figure 3 is an exploded cut away view of the fluid
specimen collecting apparatus according to the first
embodiment of the present invention.
Figure 4 illustrates a test chamber in accordance
with one embodiment of the present invention.
Figure 5 is a side view of the fluid releasing
device according to one embodiment of the present
invention.
Figure 6 illustrates a section of an isolation
chamber in accordance with an alternative embodiment of
the present invention.
Figure 6a illustrates the section of the isolation
chamber of Figure 6 with a porous membrane covering the
apertures.
Figure 7 illustrates a cross sectional view of the
specimen collecting cup in accordance with another
alternative embodiment of the present invention.
Figure 8 is a side view of the specimen collecting
apparatus according to the present invention
illustrating structure for observing the results of the
diagnostic testing.
Figure 9 is an exploded cut away view of the fluid
specimen collecting apparatus according to an
alternative embodiment of the present invention.
Figure 10 depicts a cross sectional view of the
fluid collecting and testing apparatus according to an
alternative embodiment of the present invention in a
first phase of operation.
Figure 11 illustrates a cross sectional view of
the fluid collecting and testing apparatus according to
the alternative embodiment of the present invention in
a second phase of operation.
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Figure 12 illustrates a side view of the tamper
evident lid in accordance with the present invention.
. Figure 13 illustrates a bottom view of the tamper
evident lid shown in Figure 12.
Figure 19 illustrates a side view of the fluid
testing and collecting apparatus to which the tamper
evident lid is attached.
Figure 15 illustrates a cross-sectional view of
the fluid testing and collecting apparatus and the
tamper evident lid in accordance with the present
invention.
Figure 16 illustrates a top view of the fluid
testing and collecting apparatus illustrated in figure
14.
Figure 17 illustrates a cross sectional view of
the specimen collecting cup in accordance with yet
another alternative embodiment of the present
invention.
Figure 18 illustrates a cross sectional view of
the fluid collecting and testing apparatus according to
another alternative embodiment of the present invention
in a first phase of operation.
Figure 19 illustrates a cross sectional view of
the fluid collecting and testing apparatus according to
the embodiment of Figure 1B in a second phase of
operation.
Figure 20 depicts a cross sectional view of the
fluid collecting and testing apparatus according to an
another alternative embodiment of the present invention
in a first phase of operation.
Figure 21 illustrates a cross sectional view of
the fluid collecting and testing apparatus according to
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8
the embodiment of Figure 20 in a second phase of
operation.
Figure 22 illustrates a fluid releasing element in
accordance with another embodiment of the present
invention.
Detailed Description of the Invention
The present invention provides a unitary fluid
collecting and testing apparatus for collecting fluid,
isolating a portion of the fluid and performing
diagnostic testing on the isolated fluid. The
invention is particularly effective in collecting and
testing human or animal body fluids such as blood,
saliva or urine. The fluid may be untreated, e.g.,
taken directly from the subject, or may be mixed with a
diluent, test reagent, preservative, anti-coagulant, or
the like. In a preferred embodiment of the invention,
if the fluid is combined with another substance, such
action should occur only in the isolation chamber or
test chamber.
The present invention also provides a method for
treating a sample, or a method for collecting and
testing a sample, that comprises collecting a sample to
be tested, isolating a portion of the sample, and
testing the isolated portion, wherein the isolating
step and the subsequent testing step is completely
separate from the remaining sample collected in the
first step.
To ensure integrity in diagnostic testing, the
collected fluid is completely isolated from the portion
of the fluid exposed to the test reagents and/or
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9
structures. In one embodiment, the invention includes
a specimen container provided with several chambers or
regions. The specimen container may include a
collection chamber for collecting the fluid specimen to
be tested. The specimen container may also include an
isolation chamber in fluid communication with the
collection chamber for isolating an appropriate amount
of fluid to be tested. In a preferred embodiment of
the invention, the isolation chamber is sized to
accommodate a pre-selected or pre-determined amount of
fluid. However, the invention includes an isolation
chamber of any size or configuration.
The specimen container may further include a test
chamber for testing the fluid from the isolation
chamber. The isolation chamber may be sealed or
separated from the test chamber to preserve the
integrity of the diagnostic test to be performed.
Isolation refers to structure that separates the
collection chamber from the testing chamber so that a
fluid portion isolated for testing never recontacts the
originally collected sample.
One skilled in the art will recognize that any of
a number of tests can be used in conjunction with the
present invention. Exemplary tests include, but are
not limited to drugs, drugs of abuse, therapeutic
drugs, PSA, insulin, cancer, cancer markers, infectious
diseases, HIV, cholesterol, proteins, antigens,
antibodies, allergens, and the like. Other exemplary
tests are listed in U.S. Patent 4,366,241, incorporated
herein by reference. It is intended that the invention
is not to be limited by the type or number of tests in
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each device. Exemplary tests and test methodologies
are described in more detail below.
In order to initiate testing, a fluid releasing
element is provided that activates or controls the
5 movement of fluid from the collection chamber into the
isolation chamber. In one embodiment of the invention,
the apparatus comprises a fluid releasing element that
breaks or opens a seal between the isolation chamber
and the test chamber. The fluid releasing element also
10 releases fluid from the isolation chamber into the test
chamber and, concurrently seals the isolation chamber
from the collecting chamber so that fluid is not able
to flow from the collecting chamber directly into the
test chamber.
Figure 1 illustrates a fluid specimen collection
and testing apparatus 10, in accordance with the
present invention. The apparatus generally includes a
specimen container 15, and a cover or lid 20. The
specimen container 15 has an opening 25, best shown in
Figure 3, that allows a fluid specimen to be placed
into the container. Preferably, the specimen container
15 includes a bottom wall 50 and a generally
cylindrical wall (container wall) 35 extending from the
bottom wall 50, as shown in Figure 3. A collection
chamber 40 for collecting the fluid specimen,
illustrated by element 41, may be disposed within or
may be defined by the walls of the specimen container
15. The collection chamber 40 may preferably include
an opening 45, a bottom wall 50 and a generally
cylindrical wall (collection chamber wall) 55 extending
from at least a portion of the bottom wall 50. The
container wall 35 preferably includes a rim 60 that
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extends beyond the collection chamber wall 55. The rim
60 may be threaded to accommodate a screw-on lid 20.
Alternatively, the rim 60 may include a flange or lip
to accommodate a snap fit lid.
Referring to Figures 1-3, an isolation chamber 65
is provided to isolate a predetermined portion, e.g.,
an aliquot, of the fluid specimen for testing. The
isolation chamber 65 is arranged to be in fluid
communication with the collection chamber 40.
Preferably, the isolation chamber 65 may be disposed
between the container wall 35 and the collection
chamber wall 55 and extends from the bottom wall 50 of
the collection chamber 40 to a point below the rim 60.
The isolation chamber 65 may include an open end 70.
In accordance with the present invention, the isolation
chamber may include any of a number and/or quantity of
structures that permit fluid to flow from the
collection chamber into the isolation chamber. For
example, the isolation chamber may include an open top
end, as illustrated in Figures 1-3, or may include one
or more apertures 72 or channels into an isolation
chamber wall 79 of the isolation chamber, as
illustrated in Figure 6. Preferably, the open end 70
is positioned below the rim 60 to promote or permit
fluid communication between the collection chamber 40
and the isolation chamber 65 so that as the collection
chamber 40 is filled, the fluid specimen can freely
flow to the isolation chamber 65. As the fluid enters
isolation chamber 65, the air in isolation chamber 65
preferably may be displaced around the fluid releasing
element 100 and through the collection chamber. The
fluid releasing element 100 in an open position is not
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air tight which allows air to flow through the
collection chamber and through opening 45.
The isolation chamber 65 may also include a
frangible bottom wall 75, preferably a liquophobic seal
such as a puncturable membrane. In a preferred
embodiment, the frangible bottom wall 75 may be a thin
layer of an olefinic, polymeric material, such as
polypropylene or nylon. In a most preferred
embodiment, the fluid contacting structures are
liquophobic or hydrophobic, or may include a surface
treatment that makes the surface liquophobic or
hydrophobic. Such surface treatments, such as those
used to change the critical surface tension (CST) or
the critical wetting surface tension (CWST), are well
known in the art. The frangible bottom wall may be
raised from the bottom wall 50 of the specimen
container 15.
In accordance with the invention, the specimen
container 15 may be provided with one or more test
regions or chambers 80. The test chamber 80 is sealed
from the collection chamber_ 40 and is preferably sealed
from the isolation chamber 65. The test chamber 80 may
include an opening 85 that is preferably disposed
proximate to the bottom wall 50 of the specimen
container 15 and a closed end 90 that is preferably
disposed proximate to the opening 25 of the specimen
container 15. To facilitate diagnostic testing, the
test chamber 80 may be provided with a test agent 95 of
the type generally known in the art, i.e., a substance,
device, or strip that reacts with one or more
substances in the fluid specimen. Preferred test
agents include test strips, e.g., antigen/antibody test
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strips such as any conventional immunochromatograph
strip tests, as noted above.
In accordance with another embodiment of the
invention, the test chamber 80 may be provided with a
plurality of regions or chambers each of which contains
a test agent 95 physically separated from the other
test agents, as illustrated in Figure 4. In this
embodiment, test chamber 80 includes a top wall portion
92, side wall portions 79 and a back wall portion 87.
The side walls 79 extend to the bottom wall 50 of the
collection chamber 90, as illustrated in Figures 1 and
2. The bottom region of the test chamber 80 and the
test agents 95 are in fluid communication with the
fluid flow path 32 through opening 85. However, all of
testing chamber 80 is physically isolated from and has
a fluid tight seal that separates it from the
collection chamber 40.
In this embodiment of the invention, the testing
chamber may include one or more structures that
position or place test agents 95 in a pre-determined
location or place. For example, the top wall portion
92 of testing chamber 80 may contain structure for
supporting and physically separating the test agents
95. In a preferred embodiment, test agent support
elements 81 and 82 may be connected together by a hinge
structure which enables relative rotation of the
elements about the axis of the hinge, as illustrated in
Figure 4. When test agent support elements 81 and 82
are closed, protuberances 83 press against the test
agents 95 thereby maintaining the test agents in the
chambers or regions 84. Support elements 81 and 82 are
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closed to support test agent 95 prior to insertion or
formation into the specimen container.
The test chamber may include spacers 86 to
maintain multiple test agents 95 in a spaced apart
S relationship. Test chamber 80 may also include a flood
wall 89 that prevents the fluid sample from contacting
the test agents 95 at locations above the flood wall 89
other than through capillary action of the fluid
specimen. Although five chambers or regions 84 are
illustrated in Figure 4, it is understood that a larger
or smaller number of chambers may be provided. The
test chamber 80 also may be curved to conform to a
cylindrical shape of the wall 35 of the specimen
container, as illustrated in Figure 3.
The test chamber 80 illustrated in Figure 4
represents only one embodiment for positioning or
supporting test agents 95 in a predetermined locations
and is not intended to be limiting. Other structures
may also be used as would be known by those skilled in
the art. In one embodiment, test chamber 80 is
integral to the specimen container and the collection
chamber (i.e., it is formed at least partially of walls
of those structures). In another embodiment, test
chamber 80 may be a cassette which may be inserted into
the region between a wall of the collection chamber and
a wall of the specimen cup.
The apparatuses and methods of the present
invention may be used to perform a number of tests
and/or a number of test methodologies. In one
embodiment of the invention, a method or apparatus
according to the invention includes test structures for
performing one or more tests for a single analyte. For
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example, such a device or method may include at least
one test strip for detecting a drug of abuse. In
another embodiment, a method or apparatus according to
the invention includes test structures for performing
5 multiple tests for multiple analytes. For example,
such a device or method may include at least two test
strips, preferably about five or six test strips, with
each test strip testing for a different analyte. For
example, such a device or method may test for the
10 presence of THC, cocaine or its metabolites, PCP, a
barbiturate, and an opiate. The device or method also
may test for, e.g., amphetamines or benzothiazapines.
In accordance with the invention, to promote or
permit fluid communication between the isolation
15 chamber 65 and the test chamber 80, a fluid releasing
element 100 is provided that opens the isolation
chamber 65 and releases fluid from the isolation
chamber 65 allowing the fluid to be directed to the
test chamber 80. In addition, the fluid releasing
element 100 seals the isolation chamber 65 from the
collecting chamber concurrently with releasing the
fluid from the isolation chamber 65 (as illustrated in
Figure 2). As described above, the isolation chamber
65 may include a frangible bottom wall 75. In
accordance with a preferred embodiment, the fluid
releasing element 100 penetrates or breaks the
frangible bottom wall 75. Thus, fluid releasing
element 100 may include a penetrating portion at one
end which preferably is in the form of a spike 102.
Other suitable penetrating members include a plunger, a
plug, or any like device. For example, see plug 140
described below in connection with Figures 9-11.
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Alternatively, the fluid releasing element may be
any structure the movement of which permits fluid to
flow into the isolation chamber or the test chamber.
As described in more detail below, the fluid releasing
element may be any shape, and is preferably shaped to
conform to the channel or shape of the isolation
chamber. For example, in an open, unactivated, or
first position, illustratively shown in Figure 1, the
fluid releasing element permits fluid to flow in and
around its base or lower end. In its closed,
activated, or second position, illustratively shown in
Figure 2, the fluid releasing element opens
communication between the fluid and the test chamber.
At the same time, the shape of a portion 105 of the
fluid releasing element 100, in conjunction with the
one or more portions of the isolation chamber, seals
the isolation chamber from the collection chamber.
Advantageously, the fluid releasing element 100
not only penetrates the frangible bottom wall 75 of the
isolation chamber 65 but also seals the isolation
chamber 65 from the collection chamber 40. To
facilitate sealing, the fluid releasing element 100 may
include a top portion 105 which~forms a fluid tight
seal in the open end 70 of isolation chamber 65, as
illustrated in Figure 2, thereby preventing fluid
communication between the collection chamber 40 and the
isolation and testing chambers. Sealing may be
initiated by applying pressure to the fluid releasing
element 100 to force the top portion 105 thereof into
engagement with the side walls of the isolation chamber
65 thus creating a fluid tight seal. For example, as
the lid 20 is coupled to the container, the lid 20 may
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contact a top portion of the fluid releasing element
100 and drive the device through the frangible bottom
wall 75 of the isolation chamber 65 while plugging the
open end 70 of the isolation chamber 65, as illustrated
in Figure 2.
Fluid releasing element 100 preferably includes
the top portion 105 at one end and the spike 102 at the
opposite end. The top end 105 preferably may be of a
size and shape to complement the size and shape of the
isolation chamber 65 and, as pressure is applied, to
form a fluid tight seal therewith. The fluid releasing
element 100 and the isolation chamber 65 are preferably
cylindrically shaped, but other shapes, e.g., square or
rectangular, also may be used. Alternatively, the
fluid releasing element 100 may have a diameter or
thickness that gradually tapers from one end of the
device to the other. For example, Figure 5 illustrates
a top portion 105 and spike 102 which are gradually
tapered in the direction of spike 102. In such an
embodiment, as pressure is applied to the fluid
releasing element 100, a top portion of fluid releasing
element 100 forms a friction fit, fluid tight seal over
the open end 70 of the isolatio:: chamber 65.
In another embodiment, fluid releasing element 100
includes a fluid tight seal section 107, as illustrated
in Figure 5. Fluid tight seal section 107 has a
uniform diameter and is sized to form a fluid tight
- seal with open end 70 of isolation chamber 65 as the
fluid releasing device is driven through the frangible
bottom wall 75.
In operation, fluid is moved from one portion of
the apparatus to another portion of the apparatus in
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phases or steps that prevent the isolated portion of
the collected sample from re-contacting the remainder
of the collected sample. In a first phase, the
apparatus functions as a fluid specimen collection
device. Figure 1, depicts the apparatus in the first
phase. Fluid may be readily placed in the device
through the container opening and collected in the
collection chamber 90. As the collection chamber 40 is
filled, a portion of the fluid specimen may be
transferred to the isolation chamber 65 because the
isolation chamber 65 and the collection chamber 40 are
in fluid communication. In a second phase, the fluid
specimen collected in the isolation chamber 65 is
passed to the test chamber 80 for diagnostic testing.
Figure 2 depicts the apparatus in the second phase.
This stage may be initiated by coupling the lid 20 to
the specimen container 15 to activate the fluid
releasing element 100. When the lid 20 is coupled with
specimen container 15, the fluid releasing element 100
is driven through the frangible bottom wall 75 to
direct the fluid specimen to the fluid flow path 32 and
to the test chamber 80. In addition, the fluid
releasing element 100 arrests fluid flow from the
collection chamber 40 to the isolation chamber 65 in
such a manner as to prevent establishment of a direct
flow path between the collection chamber 90 and the
test chamber 80.
Alternatively, a first stage may include
collecting the fluid in the collection chamber 40, a
second stage may include transferring the portion of
the fluid from the isolation chamber 65, and a third
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stage may include transferring the portion of the fluid
from the isolation chamber 65 into test chamber 80.
In an embodiment of the invention, it may be
desirable to isolate or separate a predetermined
portion or amount of fluid from the collected fluid.
As used herein, a predetermined portion refers to the
quantity of fluid that is collected in the isolation
chamber, or the amount of fluid that is exposed to the
test structures. As may be recognized by one skilled
in the art, it may be desirable to select the amount of
fluid isolated in the isolation chamber by adjusting
the size and/or shape of the spike relative to the size
and/or shape of the isolation chamber. In a preferred
embodiment of the invention, the predetermined amount
is approximately equal to the void volume in the
isolation chamber when the fluid releasing element is
in its first or inactivated position. In a most
preferred embodiment of the invention, a predetermined
amount is an aliquot, or about 1.5 cc.
For example, as illustrated in Figures 3 and 5,
spi~:e 102 preferably includes grooves 125 which are
sized to permit, in combination with the diameter of
the isolation chamber 65, a predetermined amount of
fluid in the isolation chamber 65. The predetermined
amount is most preferably an aliquot of fluid,
typically about 1.5 cc. The isolation chamber 65 and
grooves 125, of course, may be sized to permit fluid
amounts greater or lesser than about 1.5 cc.
In these embodiments, fluid communication between
collection chamber 40 and isolation chamber 65 may be
accomplished by any means that is closeable. As used
herein, closeable refers to engagement of one or more
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portions or structures to establish a fluid tight seal
that separates the fluid in the collection chamber from
the fluid in the isolation chamber or the fluid in the
test chamber. In accordance with the invention,
5 various alternative structures may be involved, either
separately or in combination. For example, in one
embodiment of the invention a top portion of the fluid
releasing element may engage the side walls of the
isolation chamber to form a fluid tight fit and/or
10 closing open end 70. Alternatively, if the isolation
chamber 65 is closed at the top and includes one or
more spaced apertures 72 in an isolation chamber wall
74, as illustrated in Figure 6, spike tip 105 may
engage wall 74 to form a fluid tight fit and/or closing
15 of apertures 72.
To facilitate fluid communication between the
isolation chamber 65 and the test chamber 80, the
specimen container 15 may include a fluid flow path 32.
The open end 85 of the test chamber 80 communicates
20 with the fluid flow path 32. When the frangible bottom
wall 75 of the isolation chamber 65 is opened as
described above, the isolation chamber 65 is coupled to
the fluid flow path 32 and the fluid specimen is free
to flow along the fluid flow path 32 to the test
chamber 80, while the fluid in the collection chamber
40 is inhibited from flowing into the isolation chamber
65 and the test chamber 80.
Fluid flow path 32 is formed by any structure or
structures that establish fluid communication between
the isolation chamber and the test chamber. In one
embodiment of the invention, the fluid flow path is the
space below the frangible wall 75. In this embodiment
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21
of the invention, test agents 95 are positioned
directly below or adjacent to frangible wall 75. In a
preferred embodiment of the invention, the fluid flow
path 32 includes additional structures that further
separate the test region from the frangible wall 75.
An exemplary configuration is shown in the Figures.
In a preferred embodiment, the fluid flow path 32
forms a groove-shaped channel having a generally "V-
shaped" cross section, as illustrated in Figures 1-3.
While not intending to be limited by a particular
theory of operation, it is believed that the groove-
shaped flow path 32 causes the fluid sample to be
concentrated toward the bottom of the groove-shaped
structures thereby facilitating maximum utilization of
the fluid sample. In another embodiment, the fluid
flow path may be provided with structures known to
those skilled in the art which restrict fluid flow to
only a portion of the entire flow path, such as for
example, the portion between the isolation chamber and
the testing chamber. Such fluid flow restriction also
may facilitate maximum utilation of the fluid sample.
The fluid flow path 32 may have other shapes as
illustrated in Figures 9-11.
In one embodiment, the fluid flow path 32 may be
formed from a bottom wall 30. The bottom wall 30 may
be integrally formed with the specimen container 15 or
may be a structural insert that is sealed to the bottom
of the specimen container 15. In accordance with an
embodiment of the invention, the bottom wall 30 may
include a platform 115 which contacts the lower wall of
the collection chamber 40. The fluid flow path 32 may
traverse the platform 115, or, as shown in the Figures,
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22
may circumscribe the platform 115. In another
embodiment, the fluid flow path 32, without bottom wall
30, is integrally formed with the specimen container
15. Although not necessary for the operation of the
invention, and in yet another embodiment, a wick may be
provided in the fluid flow path between the isolation
chamber and the test chamber.
The present invention may be used to collect and
test fluid samples having varying sizes. For example,
a urine or blood sample from a child may be smaller
than such a sample from an adult. Saliva samples also
tend to be smaller in volume. In an alternative
embodiment, the specimen container 15 may include a
false bottom wall 37 in collection chamber 40, as
illustrated in Figure 7, which reduces the volume of
sample needed to create fluid communication between
collection chamber 40 and the isolation chamber 65.
Preferably, false bottom wall 37 may be placed at any
location between the bottom wall 50 and the open end 70
of isolation chamber 65 to accommodate a fluid sample
of any size. In another embodiment, false bottom wall
37 may have an angled or sloped portion which angles or
slopes down to the open end 70 of isolation chamber 65.
For example, in this embodiment, the false bottom wall
may be conically shaped (not shown) which drains into
open end 70 of the isolation chamber.
It should be noted that the lid 20 may be provided
with a stop so that the lid 20 may be engaged with the
specimen container 15 without activating the fluid
releasing device 100. For example, in one embodiment,
the lid 20 may be provided with a tab 26 and the
specimen container may be provided with a tab lock 27,
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23
as illustrated in Figure 3. In this embodiment, lid 20
is rotatable around the rim 60 of the specimen
container 15 until tab 26 engages the tab lock 27
thereby preventing any further rotation of the lid 20,
as illustrated in Figure 1. At this stage of rotation,
the lid 20 preferably forms a fluid tight seal with the
specimen container 15 and fluid releasing element 100
does not penetrate the frangible bottom wall 75. To
activate the fluid releasing element 100, the tab lock
preferably is pushed down or broken off to release and
permit further rotation of the lid 20. The lid 20 then
may be further rotated around rim 60, driving the fluid
releasing element 100 down, and rupturing the frangible
bottom wall 75, as illustrated in Figure 2. In an
alternative embodiment, the tab 26, and not the tab
lock 27, may be removed permitting further rotation of
the lid 20.
After the fluid releasing device has been
activated and the sample fluid has been introduced into
the fluid flow path 32, the sample fluid advances along
the test agent 95 preferably through capillary action
and is tested, for example, for the presence of a
predetermined analyte as described above. In one
embodiment, the specimen container may include a
transparent side wall portion to enable visual
observation of test results, or to enable measurement
by instrumentation. In a preferred embodiment, visual
observation of test results may be made through windows
66 located preferably in the side of the container, as
illustrated in Figure 8. In this embodiment, the
windows 66 may show a section of test agents 95 which
illustrate a visual indication of the test results,
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29
such as, for example, a "+" for a positive test result
and a blank for a negative test result. However, any
number of different symbols may be used to identify the
test results, as known to those skilled in the art.
The windows 66 may also enable visual observation of a
control test result, indicating the appropriate
operation of the test, as known to those skilled in the
art.
In another embodiment, the specimen container 15
may be made partially or completely constructed of a
clear material, for example a suitable plastic, which
permits visual observation or measurement by
instrumentation of test agents 95 through the side of
the container. In yet another embodiment, the specimen
container may be provided with a window 69 which will
permit visual confirmation that fluid has entered the
isolation chamber 65, such as during a specimen
collection phase, and visual confirmation that fluid
has left the isolation chamber 65, such as during a
testing phase. The window 69 preferably located in the
side of the specimen container, or a portion thereof,
and permits visual observation of the isolation chamber
65, as illustrated in Figure 3 and 8.
In another aspect of the present invention, the
specimen container may be provided with a filter to
filter the fluid specimen before it is tested. In one
embodiment, the isolation chamber 65 may be provided
with a porous membrane which can filter the fluid
specimen before it enters the isolation chamber.65.
For example, a porous membrane 133 may be provided over
an opening 3 above open end 70 of isolation chamber 65,
as illustrated in Figures 3 and 16. In one embodiment,
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porous membrane 133 may be provided preferably with an
adhesive backing which will enable attachment to
structure forming opening 3. In another embodiment, a
porous membrane 71, preferably with an adhesive
5 backing, may be provided over apertures 72, as
illustrated in Figure 6a.
While several embodiments of the invention have
been described in some detail, it should be understood
that the invention encompasses various modifications
10 and alternative forms of those embodiments. For
example, in an alternate embodiment, the isolation
chamber 65 may be initially sealed from the collection
chamber 40 instead of the test chamber 80. In this
embodiment, the fluid releasing element 100 may break
15 the seal on the isolation chamber 65 for a sufficient
period of time to allow a specified amount of the fluid
sample to flow into the isolation chamber 65. Once the
specified amount of fluid has entered the isolation
chamber 65, the fluid releasing element 100 must then
20 re-seal the isolation chamber 65.
In still another embodiment, the isolation chamber
65 may be initially sealed from both the collecting
chamber and the test chamber 80. In this embodiment,
the fluid releasing element 100 breaks the seal between
25 the isolation chamber 65 and the collecting chamber
thus allowing the aliquot to flow into the isolation
chamber 65. Subsequently, the fluid releasing element
100 breaks the seal between the isolation chamber 65
and the test chamber 80 while re-creating a seal
between the collection chamber 90 and the isolation
chamber 65 so that only the aliquot flows to the test
chamber 80.
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26
In yet another embodiment of the present
invention, a fluid releasing element in the form of a
plug 140 may be inserted into the isolation chamber 145
of a specimen container 150, as illustrated by Figures
9-11. In this embodiment, the isolation chamber 145
may be in fluid communication with collection chamber
143 through an open end 147 of the isolation chamber.
The isolation chamber also may include a frangible
bottom wall 149. Preferably, the plug 140 may be
provided with a penetrating member 144 which, when
pressure is applied from the lid 160, may penetrate or
break the frangible bottom wall 149 enabling the fluid
sample to flow to a fluid flow path 152, as illustrated
in Figure 11. At the same time that it breaks the
frangible bottom wall 149, plug 140 seals the isolation
chamber 145 from the collection chamber 143. To
facilitate sealing, the plug 140 may include a stopper
142 at a first end, as illustrated in Figure 9.
Sealing may be initiated by applying pressure to the
plug 140 to force the stopper 142 into engagement with
the open end 147 of the isolation chamber 145 thereby
creating a fluid tight seal. For example, as lid 160
is coupled to the container, the lid 160 may apply
pressure on the plug 140, drive the element through the
frangible bottom wall 149 of the isolation chamber 145,
while plugging the open end 197 of the isolation
chamber 145, as illustrated in Figure 11.
In an alternative embodiment, the penetrating
member 144 of plug 140 may be sized so that it forms a
fluid tight seal at or near the bottom of the isolation
chamber 145, while permitting fluid to enter the
isolation chamber through the open end 147. By
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27
applying pressure to the upper portion of plug 140, the
stopper 142 is forced into the open end 147 of the
isolation chamber 145 forming a fluid tight seal. The
penetrating member 144 concurrently may be forced
through the bottom end of the isolation chamber 145
thereby opening communication with the fluid path 152.
In this embodiment, frangible bottom wall 149 is not
provided in isolation chamber 145, and a fluid tight
seal is maintained at all time between the test chamber
155 and the collection chamber 145.
In still another embodiment of the present
invention, the specimen container may include a tamper
evident lid that provides an indication of whether or
not the container has been opened which may indicate
that the contents of the container have been
compromised. As illustrated in Figure 12, the tamper
evident lid 120 may include a top portion having rib
structures 124, which facilitate rotation of the lid
around the specimen container, and may include a tamper
strip 126. As illustrated in Figure 13, tamper strip
126 may be attached to lid 120 by connection knobs 127
disposed around the inner periphery of strip 126.
Teeth 122 preferably are disposed about the inner
periphery of strip 126 and permit one-way rotation of
the lid 120 around the specimen container. Teeth 122
form an acute angle with the strip 126 as illustrated
in Figure 13.
In one embodiment of the invention, the tamper
evident lid 120 may be rotatable around a rim 160 of a
specimen container 115, which is illustrated in Figures
14-16. The specimen container preferably may include a
ledge 129 provided on the circumference of the specimen
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28
container and preferably may be located at or below the
lower edge of rim 160. Ledge 129 also preferably may
include barbs 128 extending upward therefrom which are
mateable with teeth 122 of the tamper evident strip
126. The bards 128 and teeth 122 allow for easy
rotation of the lid 120 around the rim 160 during
closure. However, when the lid 120 is turned in an
opposite direction, the barbs 128 mate with the teeth
122 on strip 126 thereby preventing further rotation of
the lid 120. If sufficient force is applied to lid 120
in an attempt to continue opening the container, the
connection knobs 127 will break causing the strip 126
to be completely or partially disconnected from the lid
120. Evidence that the strip 126 has been partially or
completely disconnected from the lid 120 may reflect
that the specimen container 115 has been tampered with
and that the contents of the container have been
compromised.
In a preferred embodiment, the tamper evident lid
120 may be rotatable to a first position forming a
fluid tight seal over the specimen container, and then
to a second position which activates the fluid
releasing element 100. The first position may be
characterized by rotation of the lid 120 to a region
where the teeth 122 begin to engage the barbs 128.
This first position is signified by a clicking sound of
the teeth engaging the barbs. In a further aspect of a
preferred embodiment, teeth 122 may first engage the
barbs 128 after approximately 360 degrees of rotation.
Of course, the lid 120 and specimen container 115 may
be constructed such that the teeth 122 first engage the
barbs 128 after a smaller or larger angle of rotation.
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29
In one embodiment, the lid 120 does not cause
activation of the fluid releasing device 100 in the
first position.
When it is desired to initiate the diagnostic
S testing of the fluid sample, the tamper evident lid 120
may be rotated from the first position to a second
position which activates the fluid releasing device
100. In a preferred embodiment, the second position
may be reached after approximately 360 degrees of
rotation from tree first position. Of course, the
second position may be reached after a smaller or
larger rotation from the first position.
In another aspect of a preferred embodiment, the
tamper strip 126 may be removed at any time using any
suitable structure for removal such as, for example,
the tab 129, as illustrated in Figure 12.
In yet another embodiment of the present
invention, the specimen container 15 may be provided
with an isolation chamber 65 which is located in the
center of the collection chamber 90, as illustrated in
Figure 17. As described above in connection with
Figures 1-3, the fluid enters the isolation chamber 65
through the open end 70 thereof. When the lid 20 is
coupled with specimen container 15, the fluid releasing
element 100 is driven through the frangible bottom wall
75 to direct the fluid specimen to the fluid flow path
32 and to the test chamber 80. In addition, the fluid
releasing element 100 arrests fluid flow from the
collection chamber 40 to the isolation chamber 65 in
such a manner as to prevent establishment of a direct
flow path between the collection chamber 40 and the
test chamber 80, as described above.
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In another embodiment, the fluid releasing device
100 may be mounted to and is rotatable with the lid 20,
as illustrated in Figure 17. In operation, the fluid
specimen is placed in collection chamber 40 and enters
5 isolation chamber 65 through the open end 70. The
fluid releasing element 100 connected to lid 20 may be
inserted into the isolation chamber 65. The lid 20 and
isolation chamber 65 are rotatable together to close
the lid 20 around the rim 60 of the specimen container
10 15. Lid 20 and fluid releasing element 100 preferably
are rotatable to a first phase, as illustrated in
Figure 17 and described above in connection with Figure
1, and to a second phase, as described above in
connection with Figure 2.
15 In this embodiment, the lid 20 and fluid releasing
element 100 may be connected together by any suitable
means. For example, the lid 20 and fluid releasing
element 100 may be formed of a single, unitary
structure. In an alternative embodiment, the fluid
20 releasing device may be mounted to the lid by a
suitable adhesive.
In still another embodiment of the present
invention, a fluid releasing element 170 may be
inserted into an isolation chamber 65 of a specimen
25 container 15, as illustrated in Figures 18-22. As
shown in Figure 22, the fluid releasing element 170 has
a solid portion 174 at one end and a plug 172 at the
other end. Plug 172 is sized so that it forms a fluid
tight seal at or near the bottom of the isolation
30 chamber 65. Plug 172 may have a structure around a base
thereof which facilitates the formation of the fluid
tight seal. In a preferred embodiment, an o-ring 175
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31
may be provided on plug 172, as illustrated in Figure
22, to facilitate the formation of the fluid tight
seal. Solid portion 174 is sized so that a fluid tight
seal may be formed between the isolation chamber 65 and
the collection chamber 40 through open end 70. Fluid
releasing element 170 may also include a shaft 176
which connects the solid portion 174 with the plug 172.
Shaft 176 is sized so as to permit, in combination with
the diameter of isolation chamber, a predetermined
amount of fluid in the isolation chamber.
In this embodiment, the isolation chamber 65 does
not include a frangible bottom wall, but instead has an
open end, as illustrated in Figures 18-21. A fluid
tight seal is maintained between the test chamber 80
and the collection chamber 40 by the plug 172 on the
fluid releasing element 170. The plug 172 may provide
a fluid tight seal at or near the bottom of the
isolation chamber 65, while fluid is permitted to enter
the isolation chamber 65 through the open end 70, as
illustrated in Figures 18 and 20. By applying pressure
to the upper portion of the fluid releasing element
170, the solid portion 174 is forced into the open end
70 of the isolation chamber forming a fluid tight seal
between the collection chamber 40 and the isolation
chamber 65. The plug 172 concurrently may be forced
through the bottom end of the isolation chamber 65
thereby opening communication between the isolation
chamber 65 and the fluid flow path 32, as illustrated
in Figures 19 and 21. For example, as lid 20 is
coupled to the container, the lid 20 may apply pressure
on the fluid releasing element 170, driving the plug
172 through the bottom end of the isolation chamber,
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32
while plugging the open end 70 of the isolation chamber
65 with the solid portion 174. In this embodiment, as
with the other embodiments, a fluid tight seal is
maintained at all times between the test chamber 80 and
the collection chamber 40.
In accordance with another embodiment of the
present invention, a small section of a bottom portion
of the isolation chamber 65 may be removed to enhance
fluid flow from the isolation chamber 65 to the testing
chamber 80. For example, as illustrated by Figures 18-
19, a notch 177 may be removed from bottom of isolation
chamber 65 which provides an increased area through
which fluid may flow from the isolation chamber. In
another embodiment, a nick 179 may be removed from the
bottom of isolation chamber 65 which provides an
increased area through which fluid may flow from the
isolation chamber, as illustrated in Figures 20 and 21.
In accordance with a preferred embodiment, notch 177
and nick 179 are both removed from bottom of isolation
chamber 65 to enhance fluid flow from the isolation
chamber to the testing chamber. As shown in Figures 18
and 20, the plug 172 maintains a fluid tight seal in
the isolation chamber at or above the notch 177 and/or
nick 179.
Also in accordance with a preferred embodiment,
the notch 177 formed in the isolation chamber is larger
than nick 179. Further, the notch 177 may be formed in
the wall of the isolation chamber that is closest to
the testing chamber, and nick 179 may be formed in the
wall of the isolation chamber furthest from the testing
chamber.
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33
The various embodiments of the invention as
described above refer to chambers. It is intended that
the invention is not limited to a chamber, but may
include any structure that functions as described
above. For example, the collection chamber may be a
region; or the isolation chamber may be a channel or
conduit. Furthermore, it is intended that the
invention is not to be limited by the number or
relative sizes of chambers. For example, an embodiment
of the invention may include a two-part isolation
chamber, each part separated by a fluid tight seal or
the like. In this embodiment of the invention, the
first part of the isolation chamber comprises
structures used to separate a portion of the fluid from
the fluid in the collection chamber. The second part
of the isolation chamber may include the test
structures.
As noted above, the structure and function of the
lid may include various structures, and closing the lid
may include a number of stages of closure. It is
intended that in some embodiments of the invention, the
lid is merely a mechanism for providing a fluid-tight
seal. In other embodiments of the invention, the lid
may also be used to activate or establish fluid
communication between the collection chamber and the
isolation chamber. Alternatively, the lid may include
a resilient portion that permits the operator to
manually push the fluid releasing element through the
frangible seal. In another alternative, the lid may
include a piercing or slicing member on the inside
underside of the lid that can open a membrane or the
like that covers the top of the isolation chamber.
CA 02286910 1999-09-03
. . .. ..
Substitute page 34
,. ~y _ ..
.. . . 1 , :,
'. ~ ~,
~:, l ' ,., ~,:.
.. L .. ~ , '.. .
As noted above, the preferred position of the test
chamber is on a side wall of testing apparatus 10. It
is intended that the invention is not to be limited by
the location or size of the test chamber, except that
the test chamber is not to be in direct fluid
communication with the collection chamber. For
example, the test chamber or test structures may be a
discrete portion of the isolation chamber, may be in a
bottom region of the testing apparatus, or may be
positioned in the lid.
In an embodiment of the invention in which the
test structure is located in the lid, the lid
preferably closes the testing apparatus in at least two
stages. In a first stage, the lid seals the collection
chamber. This first stage may further include opening
fluid communication between the collection chamber and
the isolation chamber. In a second stage, such as
further closing a rotatable lid, the lid includes
structures that open or establish communication between
the isolation chamber and the test area in the lid.
For example, the isolation chamber may be a channel
(without a plunger or spike) open at the bottom or
having sealable apertures, and having a frangible
covering on a top portion of the channel. When the lid
is moved to its second position, a portion of the lid
breaks the seal, thereby establishing fluid
A~AENO~D SHEET
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communication between the isolation channel and the
test area.
In another embodiment of the invention, a method
or apparatus according to the invention includes test
5 structures for performing multiple tests for a single
analyte, wherein each tests for a different quantity,
threshold amount, or cut-off amount of the analyte.
For example, such a device or method may include at
least two test strips, preferably about five or six
10 test strips, with the first test strip providing an
indication of the presence of 10 mg of analyte in the
sample, the second test strip indicating 20mg, the
third test strip indicating 30 mg, and so on as
desired. Such an embodiment of the invention may be
15 particularly suited for determining the presence and
amount of cholesterol or alcohol in the sample. In
these and other examples, it may be desirable for the
first two or three test strips to provide an indication
of the amount of analyte in the sample that is below a
20 legal or desirable amount. Another test strip may
indicate the exact legal or desirable amount, and other
test strips may indicate progressively higher amounts
over the legal or desirable amount. In these
embodiments of the invention, the method and apparatus
25 provides quantitative or semi-quantitative test
results.
In yet another embodiment of the invention, a
method or apparatus according to the invention includes
multiple devices that include one or more test
30 structures for performing multiple tests for multiple
analytes. For example, a first device or method may
include at least one test for a class of analytes, e.g.
CA 02286910 1999-09-03
..,' . ., ..
Substitute page 36
a series of allergens. If the first device provides a
positive indication for a particular class, a second
device or method may include divisions or species
within that class. For example, if the first device is
positive for pollen, a second device may test various
types of pollen. Thus, in accordance with an
embodiment of the invention, multiple devices may be
used in conjunction with each other to specifically
diagnose or detect a specific analyte or a specific
type of analyte.
~.. ' . ,. , . ~ . .... ~ '
,
,.
p~pIIENOEd SET
