Note: Descriptions are shown in the official language in which they were submitted.
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DUAL-CHAMBER LIQUID RECEIVING AND CONTAINING DEVICE
FIELD OF THE INVENTION:
The present invention relates to the general field of
devices for collecting and separately containing dual
samples of a liquid, more particularly to the collection and
separately containing of dual samples of body fluids, and
still more particularly to the collection and separate
containing of dual samples of urine for analysis.
BACKGROUND OF THE INVENTION:
Circumstances often arise wherein a desire~or necessity
exists for the collection and separate containment of
samples of a liquid. As one example, bacterial urinalysis
typically requires the collection of a flow of what is
generally termed "mid-stream" urine, as described below.
The best mid-stream urine specimen for bacteriologic
diagnostic examination is obtained directly from a patient's
urinary bladder by catheterization, ~r by following a very
rigorous 10-step body cleaning technique using various
antiseptic agents presently available in wide varieties of
mid-stream urinary collection systems. Generally, these
tedious and highly intimidating cleaning procedures are not
strictly followed due to ignorance or non-acceptance,
especially by younger female patients.
Added to the facts of inadequacy in the cleaning
process and heretofore unavailability of a competent
collection system capable of capturing and isolate the mid-
stream urinary specimen, a high incidences of "false
positive" diagnostic results has always remained a pit-fall
in clinical urinary tract infection management.
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The initial part of a patient's urinary flow is called
fore-stream urine. In females, in particular, this fore-
stream urine, while flowing through a poorly cleaned
external urogenital tract, is always regarded as
contaminated and unsuitable for urinalysis, especially for
microbiological or bacteriological examination. More often
than not, the fore-stream urine contaminants produce a high
incidence of false positive lab test results that are
unfortunately derived from external contaminants located
around the external urogenital anatomic parts. These
apparently "innocent" false contaminants are dragged along
the apparently clean urinary stream from the bladder during
its excretion process. When this unintentionally
contaminated fore-stream urine, while "rinsing" through the
patient's urogenital pathway, is collected in a conventional
single chamber collection container and then mixes with the
later cleaner, mid-stream sample, such badly mixed mid-
stream sample is regarded as unsuitable or unacceptable for
lab diagnosis procedures.
A problem associated with such mid-stream urine
collection is the assuring of an appropriate cleansing fore-
stream urine flow (which is not used for the bacteriological
analysis). If the fore-stream urine flow is too small, it
will result in inadequate rinsing of the urogenital pathway,
and the subsequently collected mid-stream urine flow may be
contaminated, thereby adversely affecting the bacterial
urinalysis. On the other hand, if the fore-stream urine
flow is too large, the patient may produce a mid-stream
urine flow quantitatively insufficient for urinalysis
purposes (typically 6 ml to 12 ml required).
Heretofore, to the knowledge of the present inventors,
the most commonly used mid-stream urine collection procedure
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requires that the patient continuously urinate into a
commode (or other receptacle) an amount of about 30 ml to 50
ml of urine (which will be discarded) estimated as
sufficient to rinse the anatomical pathway and provide a
cleaner specimen for the required uncontaminated mid-stream
urine flow, and then finish urinating into a container to
collect the subsequent urine flow for analysis. In such a
procedure, the amount of discharged fore-stream urine is
usually difficult to control for females, and if too small,
may result in a contaminated mid-stream urine flow and if
too large may result in too small a mid-stream urine flow
for accurate biological analysis. Moreover, such a
procedure involves the patient uninterrupting her (or his)
urine flow to collect the mid-stream flow--something that
may be difficult for collecting the mid-stream urine flow.
In any event, such a procedure may result in unintended,
unsanitary urination onto the patient's hand and/or the
urine collection container.
Therefore, it is highly desirable to provide a device
which automatically collects, as a first sample, a
predetermined amount of fore-stream urine flow and then
automatically collects, as a second, separate sample, a mid
stream urine flow. It is further important that the
collection device completely isolates the second, clean mid
stream urine sample from the first fore-stream urine sample
to prevent contamination of the mid-stream urine sample.
Another example of the need for collecting two
contemporary separate urine samples from the same individual
is for drug testing of the individual. Particularly when
legal issues are or may be involved, two contemporaneous
samples of urine from an individual being drug tested are
usually desired, if not legally required. A first one of
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these urine samples is used for on spot drug testing; the
second one of the urine samples is (or should be) maintained
in a tamper-proof, preserved condition for subsequent drug
testing in the event the on spot drug testing results are
contested, for example, in a legal dispute, and a second
drug test is required.
It is, therefore, a principal objective of the present
invention to provide a dual liquid, particularly urine,
sample receiving and retaining device, in which the two
samples are isolated from one another.
SUMMARY OF THE INVENTION:
A dual-chamber liquid receiving and retaining device
comprises a liquid receiving and retaining body having a
continuous outside wall, an open top and an open bottom; and
includes a detachable top cover and a detachable bottom
cover for the body. The device body, which is preferably
generally cylindrical in shape, is formed having a generally
funnel-shaped transverse inner wall that divides the body
into upper and lower liquid receiving and retaining
chambers, the transverse inner wall tapering downwardly
toward an orifice which enables liquid flow communication
between the upper and lower chambers. Preferably an annular
depending locking flange surrounding the orifice has a
narrow inner annular locking recess.
An orifice stopper disposed in the lower chamber, is
responsive to liquid filling the lower chamber to a
predetermined level that causes the stopper to float
upwardly into sealing engagement with the orifice to thereby
prevent further liquid flow into the lower chamber. The
stopper is preferably formed having a narrow external
annular bead shaped to latch into the locking flange annular
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recess when the stopper is tightly received into the
orifice. The orifice is circular in shape and is centrally
located in the transverse wall, and the stopper is formed
having an upper, conical orifice-sealing region.
It is preferred that the stopper be formed having an
outwardly flared circular skirt region. A ring-shaped float
having a height selected to provide the predetermined liquid
level in the lower chamber is preferably disposed beneath
the stopper circular skirt region for providing floating
stability to the stopper.
The device body preferably includes a narrow bead
around the outside thereof adjacent the open bottom, the
bottom cover being configured to snap upwardly over this
body bead for attachment of the bottom cover to the body.
Also preferably included is a bottom cover locking ring
sized to fit over the bottom cover and configured, in
conjunction with configuration of the body, for threadable
attachment to the body for locking the bottom cover tightly
to the body.
A variation device includes an adapter for diverting a
strong stream of liquid being received into the device
through the open top in a manner which might otherwise
prevent the stopper from sealing firmly into the orifice
when liquid received into the lower chamber floats the
stopper into the orifice. The diverting adapter includes an
attachment member removably attached to the open top of the
device body in lieu of the top cover. A dome-shaped element
attached to attachment member is located directly above the
stopper when said member is attached to the device body and
when the stopper is floated into the orifice by liquid
received into the lower chamber, the dome-shaped element
being shaped to divert the strong stream of liquid being
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received into the device onto a region of the transverse
wall surrounding the orifice. The attachment member includes
a handle and means for detachably attaching the handle to
the attachment member.
Means are preferably included for forcing the stopper
into a tight sealing relationship with the orifice so as to
assure that liquid does not leak between the upper and lower
chambers.
In one case, the stopper forcing means include an
annular, spring-like, flexible web formed in the bottom
cover around a downwardly extending bottom cover region, web
being responsive to a downward pushing on the device onto
the downwardly extending bottom cover region for deflecting
upwardly in a manner causing a central upstanding region of
the bottom cover to engage the stopper and force the stopper
upwardly into the orifice and latch the stopper external
annular bead into the looking flange annular recess for
tightly sealing the orifice against liquid leakage past the
stopper. When the web deflects upwardly to cause said bottom
cover upstanding region to force the stopper tightly into
the orifice and latch the stopper external annular bead into
the locking flange annular recess, the web locks over-center
to positively lock the stopper into the orifice and latch
the stopper external annular bead into the locking flange
annular recess so as to assure that liquid does not leak
past the stopper between the upper and lower chambers.
There is preferably provided a bottom cover extension
which is sized for attachment to the downwardly extending
bottom cover region, and sized to provide a larger device
body footprint and an additional height to the downwardly
extending bottom cover region so as to assure the over-
center locking of the web.
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A variation dual-chamber device includes a spring
disposed in the lower chamber beneath the stopper that is
held in a compressed condition by a fiber disc. The disc is
responsive to contact by an aqueous liquid received into the
lower chamber for a preestablished length of time, which is
preferably at least about 20 seconds, that softens the disc
sufficiently to release the spring from its compressed
condition so as to engage the stopper and force the stopper
upwardly into the orifice and latch the stopper, external
annular bead into the locking flange annular recess for
tightly sealing the orifice and to positively lock the
stopper into the orifice and latch the stopper external
annular bead into the locking flange annular recess so as to
assure that liquid does not leak past the stopper between
the upper and lower chambers.
Another variation dual-chamber device includes an
aqueous liquid, highly expandable, hydrophilic element
disposed in the lower chamber beneath the stopper. The
hydrophilic element is responsive to contact by an aqueous
liquid received into the lower chamber for causing the
element to greatly expand into contact with the stopper and
force the stopper upwardly into the orifice and latch the
stopper external annular bead into the locking flange
annular recess for tightly sealing the orifice and to
positively lock the stopper into the orifice and the latch
the stopper external annular bead into the locking flange
annular recess so as to assure that liquid does not leak
past the stopper between the upper and lower chambers.
In still another dual-chamber device variation the
stopper forcing means includes an aqueous liquid-soluble
effervescent tablet disposed in the lower chamber beneath
the stopper. The effervescent tablet is responsive to
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contact by an aqueous liquid received into the lower chamber
for providing a large quantity of gaseous bubbles rising to
contact the stopper and thereby force the stopper upwardly
into the orifice and latch the stopper external annular bead
into the locking flange annular recess for tightly sealing
the orifice.
An a further variation dual-chamber device, the stopper
forcing means includes a secondary bottom cover having a
central region extending upwardly through the bottom cover,
the central region having an elongate, upstanding stopper
engaging pin. A removable spacer is disposed between the
bottom cover and the secondary bottom cover to maintain
device pre-use separation therebetween. Post-use weight of
the device and liquid contained therein causing, when the
spacer is removed, causes the secondary bottom cover pin to
move upwardly to force the stopper into the orifice and
latch the stopper external annular bead into the locking
flange annular recess for tightly sealing the orifice.
After the spacer is removed and the secondary bottom cover
2-0 pin forces the stopper tightly into the orifice and latches
the stopper external annular bead into the locking flange
annular recess, and the device is pressed downwardly onto
the secondary bottom cover, the secondary bottom cover is
caused to snap upwardly over the bottom cover to cause the
secondary bottom cover pin to positively lock the stopper
into the orifice and latch the stopper external annular bead
into the locking flange annular recess so as to assure that
liquid does not leak past the stopper between said upper and
lower chambers.
The stopper forcing means of yet another variation
dual-chamber device includes a magnetic element fixed to the
stopper and another magnetic element fixed to the
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transverse wall adjacent the orifice, and includes a
removable spacer disposed between the stopper and the
orifice to prevent device pre-use magnetic attraction of the
stopper into the orifice, and wherein as liquid is
introduced into the lower chamber to an extent floating the
stopper upwardly into the orifice, the stopper is
magnetically pulled tightly into the orifice and the stopper
external annular bead is latched into the locking flange
annular recess by the magnetic elements for tightly sealing
the orifice. When the stopper is magnetically pulled
tightly into the orifice and the stopper external annular
bead is latched into the locking flange annular recess, the
magnetic elements positively lock the stopper into the
orifice and latch the stopper external annular bead into the
locking flange annular recess so as to assure that liquid
does not leak past the stopper between the upper and lower
chambers.
In a further variation dual-chamber device, an aqueous
liquid-activated adhesive is applied to the transverse wall
around the orifice and a removable spacer is disposed
between the stopper and the orifice to prevent device pre-
use adhering of the stopper into the orifice. As liquid is
introduced into the lower chamber so as to float the stopper
upwardly into the orifice, the adhesive is activated,
thereby positively locking the stopper into the orifice so
as to assure that liquid does not leak past the stopper
between the upper and lower chambers.
In a still further dual-chamber device variation means
are provided for diverting a strong stream of liquid being
received into the device through the open top thereof so as
to prevent the stopper from sealing firmly into the orifice
when liquid received into the lower chamber floats the
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stopper into the orifice. The diverting means includes an
attachment member removably attachable to the open top of
the device body in lieu of the top cover, and a dome-shaped
element attached to the attachment member in a position to
be directly above the stopper when the member is attached to
the device body and when the stopper is floated into the
orifice by liquid received into the lower chamber. The
dome-shaped element is shaped to divert the strong stream of
liquid being received into the device onto a region of the
transverse wall surrounding the orifice. Included is a
handle and means for detachably attaching the handle to the
attachment member.
It is preferred that the device body be constructed of
a rigid plastic material which comprises a high density
polypropylene, and that the upper and lower chambers have
respective volumes of about 80 ml and about 100 ml for use
of the device for urine collection.
In general, there is included an elongate handle and
means for detachable attachment of the handle to an upper
region of the container outside wall so that the handle
projects outwardly therefrom in a generally radial
direction, the handle being formed having a gripping region
that angles upwardly and outwardly when the handle is
attached to the container outside wall.
In any version of the dual-chamber device there may be
included an elastomeric member installed in the container
outside wall in the region of the lower chamber, the
elastomeric member being puncturable by a hypodermic needle
so as to permit the removal of liquid from the lower
chamber. The elastomeric element is self-sealing after a
hypodermic needle is withdrawn therefrom, and there is
preferably included a cover securely covering the
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elastomeric element, the cover being detachable from the
elastomeric element, but not reattachable thereto after
removal, thereby providing a visual indication that liquid
in the lower chamber may have been tampered with.
A pressure relieving means may be provided in order to
vent air from the lower chamber so as to prevent pressure-
caused bleeding of liquid from the lower chamber into the
upper chamber. The pressure relieving means may include a
pinhole formed through a side wall of the device body into
the lower chamber above the predetermined liquid level, the
pinhole preferably having a diameter between above 0.01 mm
and about 0.1 mm.
BRIEF DESCRIPTION OF THE DRA4~7INGS:
The present invention can be more readily understood by
a consideration of the following detailed description when
taken in conjunction with the accompanying drawings, in
which:
2.0 FIG. 1 is an exterior, elevational view of the dual
liquid receiving and containing device in accordance with.
the present invention, showing a device body having a
removable top cover, a bottom cover with a locking ring, and
an ergonomic handle detachably attached to the device body,
the body shown having a small pressure relief hole adjacent
the handle-body attachment region;
FIG. 2 is a top, plan view of the containment device
of FIG. 1 showing features of the top cover and showing the
handle detachably attached to the device body;
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FIG. 3 is a perspective view of the handle of FIGS. 1
and 2, showing, at a lower end, a T-slot element whereby the
handle can be detachably attached to the device body;
FIG. 4 is a detail perspective drawing of a attachment
element formed on the collection device body for receiving
the T-slot element of the handle of FIG. 3 to thereby enable
detachable attachment of the handle to the device;
FIG. 5 is a top view of the device body with the top
cover removed, showing a transverse wall that divides the
body into two chambers, the transverse wall shown having a
circular inlet orifice between the two chambers;
FIG. 6 is a vertical cross sectional view looking along
line 6-6 of FIG. 5, showing the transverse inner wall that
is generally funnel shaped and which divides the device body
into upper and lower liquid receiving and retaining
chambers, and showing an annular, undercut locking flange
located around the transverse inner wall orifice;
FIG. 6a is a vertical cross sectional view looking
along line 6a-6a of FIG. 5, showing the transverse inner
wall that is generally funnel shaped and which divides the
device body into upper and lower liquid receiving and
retaining chambers, and showing an annular, undercut locking
flange located around the transverse inner wall orifice, and
showing the pressure relief hole formed through a device
body wall in an upper region of the lower chamber;
FIG. 7 is a front elevational view of a stopper for
closing the orifice in the transverse inner wall, showing an
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upper, sonically-shaped orifice closing region and a lower,
flared skirt region having a depending guide column;
FIG. 8 is a vertical cross sectional drawing taken
along line 8-8 of FIG. 7, showing internal structure of the
orifice stopper;
FIG. 9 is a bottom view, looking upwardly along line 9-
9 of FIG. 7, showing internal structure of the orifice
stopper, in particular ribs for stiffening and strengthening
the upper orifice closing region of the stopper;
FIG. 10 is a side view of an annular, ultralight float
that fits upwardly into the flared skirt region of the
orifice stopper shown in cross section in FIG. 8;
FIG. 11 is a top view of the annular float of FIG. 10,
showing a central opening that enables the float to fit
loosely around the orifice stopper support and pushing
column shown in FIGS. 7-9;
FIG. 12 is a transverse cross sectional drawing taken
along line 12-12 of FIG. 11, showing internal configuration
of the float ;
FIG. 13 is a top view of the device body lower cover of
FIG. 1, showing construction features;
FIG. 14 is a transverse cross sectional drawing taken
along line 14-14 of FIG. 13, showing a bottom cover flat
base surrounded by a thin, flexible, annular, spring-acting
web, the web shown in its normal, un-flexed condition, the
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bottom cover terminating in a pair of slightly spaced-apart
annular upstanding flanges by means of which the bottom
cover is attached to the bottom of the device body, and
showing a split, upwardly extending pushing column which
~ fits around the orifice stopper guide column of FIGS. 7-9;
FIG. 15 is a side elevational view of the bottom cover
of FIGS. 13 and 14, showing the annular web in its un-flexed
condition;
FIG. 16 is a side view of the bottom cover of FIGS. 13
-15, showing the annular web in its downwardly-flexed
condition associated with pushing the orifice stopper
upwardly tightly into the transverse inner wall orifice;
FIG. 17 is a transverse cross sectional drawing similar
to FIG. 14, but showing the annular web in its downwardly-
flexed condition, thereby forcing the bottom cover pushing
column upwardly;
FIG. 18 is an exploded external elevational drawing of
a first variation dual-chamber device, showing the device
body, its top cover, the handle, the orifice stopper, the
annular float, the bottom cover with the annular web in its
un-flexed condition, and the bottom cover locking ring, and
showing for the first time a circular bottom cover
extension, and further showing top cover, bottom cover
locking ring and orifice stopper sealing rings;
FIG. 19 is a top view of the bottom cover locking ring,
showing general features thereof;
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FIG. 20 is an exterior elevational view of a fully
assembled, first variation dual sample receiving and
containing device in a post-use configuration with the top
cover attached to the device body, showing the bottom cover
base extension resting on a hard, flat surface;
FIG. 21 is an exterior elevational view of the fully
assembled first variation dual sample receiving and
containing device of FIGS. 18 and 20, the device shown
pushed downwardly on a hard, flat surface in a manner
forcing the bottom cover base and extension upwardly into
the device body for forcing the orifice stopper upwardly
into a tight sealing arrangement with the inner wall
orifice;
FIG. 22 is a vertical cross sectional drawing of the
first variation device of FIGS. 18 and 20-21 in its
assembled, pre-use condition, but with the top cover
removed, showing the device ready for use, with internal
regions of the orifice stopper resting on top of the bottom
cover pushing column with the annular float resting on the
bottom cover web, and showing the bottom cover locking ring
attached to lower regions of the device body, and further
showing the bottom base extension attached to the bottom
cover base region and supporting the assembled device on a
flat surface ;
FIG. 23 is a vertical cross sectional drawing similar
to FIG. 22, but showing a flow of liquid being discharged
into the upper chamber of the first variation device, with
the lower chamber having first been filled to a level
causing the annular float to push the stopper upwardly until
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the upper orifice sealing region of the stopper engages the
orifice between the upper and lower chambers so as to stop
the flow of liquid into the lower chamber and prevent liquid
leakage between the two chambers;
FIG. 23a is a vertical cross sectional drawing similar
to FIG. 23 but sectioned in order to illustrate the pressure
relief hole;
FIG. 24 is a vertical cross sectional drawing similar
to FIG. 23, but showing the upper chamber filled with liquid
and the top cover attached to the device body, and showing
the device pushed downwardly onto the flat surface
sufficiently to flex the bottom cover web in a over-center
locking condition pushing the bottom cover base upwardly
into the lower chamber and thereby pushing' the stopper
orifice sealing region into positively locked engagement
with the orifice and the orifice looking flange, thereby
assuring no liquid. leakage can occur between the two
chambers;
FIG. 24a is a vertical cross sectional drawing similar
to FIG. 24 but sectioned in order to illustrate the pressure
outlet hole;
FIG. 25 is a partial cross sectional view of a
variation lower wall region of the device body of FIG. 24,
showing the installation in the body outside wall of a
capped, hypodermic needle, self-sealing port assembly which
may be provided to enable external access to liquid
contained in the lower liquid receiving chamber;
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FIG. 26 is a partial cross sectional view similar to
FIG. 25, showing a hypodermic needle extending through the
uncapped, self-sealing port assembly for extracting liquid
from the lower liquid containing chamber;
FIG. 27 is a top perspective of an optional flow
diverter and sanitary barrier member configured for
attachment to the open top of a dual-chamber device similar
to that depicted in FIGS. 18-24, showing a central dome-
shaped liquid diverter supported by four ribs, the liquid
diverter preventing a strong flow of liquid entering the
device upper chamber from impinging directly onto the
orifice stopper and possibly unseating it when the stopper
reaches its intended orifice sealing engagement, also
showing a fitting whereby the device handle can be
detachably attached to the flow diverter and sanitary
barrier member;
FIG. 28 is a top view of the optional flow diverter of
FIG. 27, showing construction thereof.
FIG. 29 is a side view of the optional flow diverter of
FIG. 26, showing construction thereof and showing the liquid
diverter in relationship to upper, orifice sealing regions
of the stopper, and further depicting the diverting of a
flow of liquid past the diverter dome onto the sloping
transverse inner wall;
FIG. 30 is a side view of the optional flow diverter
similar to FIG. 29, but showing the liquid diverter
detachably attached to the open top of a representative
device body;
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FIG. 31 is an exploded elevational drawing, similar to
FIG. 18, of a second variation dual-chamber device to which
the flow diverter of FIGS. 27-30 is positioned for
detachable attachment;
FIG. 32 is a top view of an automatic, spring-loaded
orifice stopper locking assembly, showing a cylindrical
housing having an partially open top with a liquid-
softening, compressed spring retaining element positioned
just beneath the partially open top;
FIG. 33 is a vertical cross sectional drawing taken
along line 33-33 of FIG. 32, showing a sonically shaped
spring attached inside a bottom of the housing and held in a
compressed condition by the spring retaining element, and
showing a side air vent and a bottom liquid inlet;
FIG. 34 is a bottom view of ,the housing of FIG. 33,
showing the liquid inlet and showing a slotted region
provided for assisting threaded attachment of the bottom to
sides ~f the housing;
FIG. 35 is a vertical cross sectional drawing, similar
to FIG. 22, showing the spring-loaded orifice stopper
locking assembly of FIGS. 32-34 in a spring compressed
condition installed in the lower chamber of a third
variation dual-chamber device in engagement with the orifice
stopper, the spring-loaded orifice stopper locking assembly
being shown attached to a screw-on flat bottom cover and the
orifice stopper being similar to that shown in FIGS. 7-9,
except having a shorter depending guide column;
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FIG. 36 is a vertical cross sectional drawing similar
TO fig. 24 and corresponding generally to FIG. 36, showing
liquid contained in the lower and upper chambers of the
third variation device of FIG. 35, showing the orifice
stopper floated upwardly into engagement with the orifice
between the upper and lower chambers and showing the spring
of the spring-loaded orifice stopper locking assembly, still
in its compressed state;
FIG. 37 is a vertical cross sectional drawing similar
to FIG. 36, but showing the spring of the spring-loaded
orifice stopper locking assembly released after the spring
retaining element has been degraded by liquid in the lower
chamber, the spring thereby forcing the orifice stopper
tightly upwardly into the orifice and holding it there
against accidental dislodgment;
FIG. 38 is an expanded view of the released spring of
the spring-loaded orifice stopper locking assembly of FIG.
37, showing the liquid-degraded spring retaining element
pushed upwardly through the housing top opening by the force
of the compressed spring, thereby releasing the spring;
FIG. 39 is a vertical cross sectional drawing of a
fourth variation dual-chamber device corresponding generally
to FIGS. 22 and 35, showing a variation bottom cover
containing an expandable, hydrophilic material having an
upper surface in contact with the orifice stopper;
FIG. 40 is a vertical cross sectional drawing similar
to FIG. 39, showing liquid contained in the upper and lower
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chambers of the dual-chamber device and showing the expanded
hydrophilic material pushing the orifice stopper upwardly
into a tight, locked engagement with the orifice;
FIG. 41 is a vertical cross sectional drawing of a
fifth dual-chamber device corresponding generally to FIG.
35, showing a bottom cover containing a housing containing a
aqueous liquid-activated effervescent tablet;
FIG. 42 is an enlarged side view drawing of the housing
containing the liquid-activated effervescent tablet, showing
liquid entry apertures and gas escape openings in the
housing;
FIG. 43 is a vertical cross sectional drawing similar
to FIG. 41, showing the device upper and lower chambers
containing a received liquid and showing the orifice stopper
floated upwardly into sealing engagement with the orifice
and forced tightly thereinto by gases generated by the
liquid-activated tablet when contacted by liquid in the
lower chamber;
FIG. 44 is an enlarged drawing of the housing
containing the liquid-activated effervescent tablet showing
generation of gas bubbles when the tablet is contacted by
liquid in the device lower chamber;
Fig. 45 is a vertical cross sectional drawing
corresponding generally to FIG. 22 and 35 showing~a sixth
variation dual-chamber device, showing a variation bottom
cover and associated variation orifice stopper and showing a
secondary bottom cover having an upstanding orifice stopper
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pushing pin and separated from the primary bottom cover by a
removable, highly-flexible split ring spacer;
FIG. 46 is a perspective drawing of the removable,
flexible split ring spacer of FIG. 45, showing its general
shape and configuration;
FIG. 47 is a vertical cross sectional drawing
corresponding generally to FIGS. 24 and 45, showing the
lower and upper chambers of the dual-chamber device
containing a received liquid and showing the removable,
flexible split ring spacer removed so that the weight of the
liquid-containing device pushes the secondary bottom cover
upwardly into contact with the primary bottom cover, the
stopper pushing pin shown pushing the orifice stopper
tightly upward into the orifice;
FIG. 40 is a side view of the removable, flexible split
ring spacer after its removal from the sixth variation dual
chamber device;
FIG. 49 is a transverse cross sectional drawing taken
along line 49-49 of FIG. 45, showing details of the
secondary bottom cover with the flexible spacer installed
therein;
FIG. 50 is a vertical cross sectional drawing similar
to FIGS. 22, 35, 39 and 43 showing a seventh variation dual-
chamber device having a flexible spongy or foamy member
removably installed between the orifice stopper and orifice
to maintain the pre-use separation between annular magnets
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installed under the flared skirt region of the stopper and
adjacent the orifice;
FIG. 51 is a cutaway perspective drawing of the removed
spongy or foamy member of FIG. 50, showing general
configuration thereof;
FIG 52 is a vertical cross sectional drawing similar to
FIG. 50 showing the flexible spongy or foamy member removed
and showing liquid contained in the device upper and lower
chambers with the orifice stopper floated upwardly into
engagement with the orifice and held in such engagement by
the magnets on the stopper and adjacent the orifice;
FIG. 53 is a vertical cross sectional drawing
corresponding generally to FIG 50, showing an eighth.
variation dual-chamber device having a flexible paper member
removably installed between the orifice stopper and orifice
to protect an aqueous liquid-activated cement applied around
the orifice;
FIG. 54 is an enlarged view showing portions of the
flexible paper member covering a region of aqueous liquid-
activated cement around the orifice;
FIG. 55 is a vertical cross sectional drawing similar
to FIG. 53, showing the flexible paper member removed and
with the device upper and lower chambers containing a
received liquid and showing the orifice stopper floated
upwardly into sealing engagement with the orifice and locked
thereinto by the aqueous liquid-activated cement around the
orifice;
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FIG. 56 is an enlarged view showing the orifice stopper
locked into the orifice by the aqueous liquid-activated
cement around the orifice;
FIG. 57 is a series of diagrams depicting a number of
steps showing operational use of the dual-chamber device of
FIGS. 19-24, FIG. 57A showing the dual-chamber device
assembled as depicted in FIG. 20, except the handle is not
yet attached and showing the top cover sealed with a
sterile-evident tape identifying the device as "STERILE";
FIG. 57B depicting the handle about to be attached to the
dual device body; FIG. 57C depicting the handle being
upwardly attached to the dual device body; FIG. 57D
depicting removal of the top cover tape; FIG. 57E depicting
a flow of liquid being discharged into the device upper
chamber after removal of the top cover; FIG. 56F depicting
installation of the top cover after the liquid has been
received into the device body; FIG. 57G depicting the final
step of pushing downwardly on the dual-chamber device to
lock the stopper in the orifice (as shown in FIG. 24); and
FIG. 57H depicting the dual-chamber device in its final,
post use condition.
In the various FIGS. the same elements and features are
given the same reference number and corresponding elements
and features are given the original reference numbers
followed by an "a," "b," or "c," and so on as appropriate.
DESCRIPTION OF THE PREFERRED EMBODIMENT:
There is shown in FIG. 1 a dual-chamber, liquid
receiving and containing device 100 (hereinafter, for the
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sake of brevity, usually referred to as the "dual-chamber
device") which may advantageously be used to receive a flow
of urine from a patient and contain the urine flow as
separate fore-stream and mid-stream flow portions, as
described below.
Shown comprising dual-chamber device 100, as more
particularly described below, are a generally cylindrical
device body or liquid cup 102, a top cover or cap 104 that
is detachably attached at an open upper end of the body, a
bottom cover or cap 106 that is attached to an open bottom
of the body, a bottom cover locking ring 108 that is
threaded onto the body to secure the bottom cover to the
body (as discussed below) , and an angled handle 110 that is
detachably attached to the body by a tapered fitting 112
projecting from upper regions of the body. Shown adjacent
fitting 112 is a microscopic pressure relief hole 120 that
extends through a device body outer wall 124 at the highest
point or lower chamber 144 so as to be as high as possible
above liquid collected in the lower chamber. Hole 120
(which is shown greatly exaggerated in size in all relevant
FIGS . for purposes of clarity) may be between about 0 . 01 mm
and about 0.05 mm in diameter.
Top cover 104 is shown in FIG. 2 as having an annular
device sealing recess or groove 116. Handle 110 is shown in
FIG. 3 as having, at a distal end, an attachment region 118
shaped and sized to fit upwardly onto body fitting 112 (FIG.
4) in a tapered tongue and groove manner. When dual-chamber
device 100 (and below-described variations thereof) is used
to collect fore-stream and mud-stream urine samples, handle
110 is especially shaped for ergonomically convenient and
effective use by female patients for easy accessibility
during urine sample collection. As such, handle 110
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preferably has an overall length, Ll, that may be about 4.5
inches and has a generally central bend, a, that may be
about 45 degrees; moreover, in combination, handle
attachment region 118 and device body fitting 112 mount the
handle at an upward angle, (3, of about 30 degrees (FIG. 1).
Fig . 5 shows a top view of device body 102 , which may
be constructed of a rigid plastic material, such as high
density polypropylene, and may be either transparent,
translucent or opaque. As shown in the vertical cross
section of FIGS. 6 and 6a device body 102 is formed having
an outside wall 124 with a height, Hl, which may, for urine
specimen collection, be about 3.5 inches; an open top 126
having an outside diameter, D1, that may be about 2.5 inches
and an open bottom 128 having an outside diameter, D2, that
1.5 may be about 2.25 inches. Body wall 124 may have a
thickness, T1, that is about 0.05 inches.
A first, externally threaded top cover receiving region
130 is formed on body wall 124 below-adjacent open top 126
and a second, externally threaded bottom lock ring receiving
2'0 region 132 is formed on the body wall above-adjacent open
bottom 128. An external annular bead 134 is formed around
body wall 124 at bottom open end 128.
Formed internally across device outer wall 124 is a
funnel-shaped transverse inner wall 140 that divides device
25 body 102 into respective upper and lower chambers 142 and
144 having respective volumes for urine collection of about
80 ml and about 100 ml. A central, circular orifice 146 in
transverse inner wall 140 is defined by a depending
peripheral orifice ring 148 having an entrance opening of
30 diameter, D3, that may be about 0.80 inches, the orifice
ring being sonically-shaped, that is, is slightly enlarged
toward lower chamber 144.
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A narrow colored ring 136 on an outside surface 138 of
body wall 124 below-adjacent first threaded region 130 is
provided as a visual "full" guide when introducing liquid
into upper chamber 142.
Depending from transverse inner wall 140 and
surrounding orifice ring 148, and extending therebelow, is a
stopper securing ring 150 having outer diameter, D4, that
may be about 1.25 inches. A narrow, shallow inner annular
stopper latching groove or recess 152 is formed around
stopper securing ring 148 above-adjacent a stopper securing
ring lower edge 156.
A buoyant orifice stopper 160, shown in FIGS. 7-9,
comprises a hollow, upper, sonically-shaped orifice sealing
region 162 and a lower, radially-flared skirt region 164,
and has an overall height, H2, that may be about 1.25
inches. Orifice sealing region 162 is shaped and sized to
fit closely into above-described orifice ring 148 to thereby
seal orifice 146. Surrounding a lower region of orifice
sealing region 162 is an annular locking bead 166 that is
shaped and sized to fit closely into stopper securing ring
annular locking groove 152 (also described above). Forming
part of orifice stopper 160 is a depending guide or pushing
column 168. Formed around a lower region of guide or column
168 is an annular latching ring 170 of saw-tooth shape
(FIGS. 7 and 8) .
As shown in FIGS. 8 and 9, several (six being shown)
internal stiffeners 172 are provided for imparting rigidity
to orifice sealing region 162. Stopper 160 is preferably
constructed from the same rigid plastic material as device
body 102. Orifice stopper skirt 164 preferably has an
outside diameter, D5, at a lower skirt peripheral edge 174,
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which may be about 0.59 inches. Column 168 has an outside
diameter, D6, that may be about 1.97 inches.
An annular orifice stopper float 180, shown in FIGS.
10-12, is preferably constructed from a closed cell
polystyrene foam so as to be buoyant. Float 180 is shaped
and sized to fit upwardly under orifice stopper skirt region
164 to provide buoyancy to orifice stopper 160, as described
below. For such purpose, float 180 has an diameter, D~, of
an inner surface 182, that may be about 1.0 inch, so as to
fit loosely over orifice stopper guide or column 168 and an
outside diameter, D8, of an outer surface 184, that may be
about 1.57-inches so as to fit loosely under orifice stopper
skirt region 164. An upper peripheral region 186 of float
180 is beveled at about 45 degrees so that the float fits
under orifice stopper skirt region 164. Float 180 has a
thickness, Ta, that may, for example, be about 0.39 inch,
but is selected according to the desired liquid containing
volume of lower chamber 144 (FIG. 6). Float 180 functions to
raise orifice stopper 160 into engagement with orifice 146
even when device body 102 is tilted, according to patient
skill while discharging urine (or other liquid) into lower
chamber 144, even though the orifice stopper is itself
generally buoyant.
As shown in FIGS. 13-17, bottom cover 106, which has an
overall height, H3, which may be about 1.06 inches,
comprises a rigid, upwardly-recessed, central bottom base
190 having a diameter, D9, which may be about 1.18 inches.
Central bottom base 190 is surrounded by a thin, flexible,
upwardly-arched annular web 192 that has spring-like
properties and that extends a distance, dl, that may be
about 0.63 inch above a bottom base lower surface 194.
Radial outer end of web 192 terminate in an annular,
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upwardly-extending first devise body attachment flange 196,
having an inwardly facing bead 198; and an annular,
upwardly-extending second devise body sealing flange 200.
Projecting upwardly from bottom base is an orifice stopper
guide 208. Formed around the inside of guide 208 is a saw-
toothed latching ring 210 that is shaped in a complimentary
manner relative to orifice stopper latching ring 170 (FIGS 7
and 8). An outside diameter, Dlo, of guide 208 may be about
0.75 inch.
Bottom cover 106 is shown, in a side view, in FIGS. 15-
17 attached to device body 102 (shown in phantom lines),
FIG. 15 showing bottom cover 106 with annular web 192 in its
un-compressed condition. FIG. 16 shows bottom cover 106
with web 192 (not shown) in its compressed condition
achieved by pressing downwardly on the bottom cover that is
resting on a rigid surface 211 until base region 190 is no
longer visible. FIG. 17 is a vertical cross sectional
drawing (corresponding to FIG. 14, and derived from FIG. 16)
showing bottom cover web 192 flexed into its over-center
locking condition as a result of bottom cover 106 being
pushed downwardly onto surface 211, thereby pushing orifice
stopper 160 upwardly into tight sealing relationship with
orifice 146, including "latching" stopper locking bead 166
into orifice locking recess 152, and positively locking the
stopper into the orifice to assure no liquid leakage occurs
between upper and lower chambers 142 and 144.
Bottom cover 106 is preferably constructed of a
relatively high density polypropylene that is less rigid
than device body 102 so that web 192 can flex in the manner
described above. Because of the relative flexibility of
bottom cover 106, the unlikely possibility exists that an
offset pushing of the bottom cover (that is, device 100) to
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flex web 192 into its over-center locking condition, to
thereby force stopper 160 tightly into orifice 146 and lock
it there (as above-described, some region of bottom cover
flange 196 might be dislodged from device body annular bead
134 sufficiently to permit liquid,leakage from lower chamber
144. To prevent this remote possibility, bottom cover
locking ring 108, which is made of the same rigid plastic
material as device body 102, is tightly threaded onto the
device body threaded region 132 to lock bottom cover 106 to
the device body.
FIRST VARIATION DUAL-CHAMBER DEVICE 100a:
A first variation dual-chamber device 100a, depicted in
disassembled, ordered form in FIG. 18, comprises above
described dual-chamber body 102, top cover 104, bottom cover
106, bottom cover locking ring 108, handle 110, orifice
stopper 160, orifice stopper float 180, a top cover sealing
ring 212, a bottom cover locking ring/ bottom cover sealing
ring 214 and a orifice stopper sealing ring 216. Sealing
rings 212, 214 and 216 are preferably constructed from
rubber (for example, neoprene) or an elastomeric plastic
(for example, silicone).
To the above extent previously-discussed dual-chamber
device 100 is identical to above-described dual-chamber
device 100a, except that included in, and forming the
distinguishing feature of, dual-chamber device 100a is a
circular bottom cover extension member 220 that fits onto
central bottom cover base 190 to provide additional bottom
cover height (defined below). Extension member 220
comprises an annular, upwardly-extending attachment flange
222 s a ed for attaching the member to bottom cover central
base 190. An inner surface 223 of flange 222 has a
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curvature matching the curvature of bottom cover web 192.
Flange 222 is preferably colored red for easy visibility.
Forming part of member 220 is an enlarged, flat circular
support plate region 224 which provides dual-chamber device
100a with a larger "foot print" on surface 211 than that
provided by central bottom cover base 190, and which assures
over-center locking of bottom cover web 192 and consequent
locking of orifice stopper 160 into orifice 146, as
described below. Support plate 224 is formed having a
relatively thin, narrow annular, peripheral latching region
226 which mates with bottom cover locking ring 108, also as
more particularly described below. Support plate region 224
has a central opening 225 that enables extension member 220
to fit upwardly onto bottom cover region 190.
Also shown in FIG. 18, for the first time, is a
threaded region 230 on the inside of top cover 104 into
which sealing ring 212 is received, and a similar threaded
region 232 on the inside of bottom cover locking ring 108
into which sealing ring 214 is received. Top cover threaded
region 230 mates with threaded region 130 on device body 102
and bottom cover locking ring threaded region 232 mates with
threaded region 132 on the device body. As shown in FIG.
19, bottom cover locking ring 108 has a central aperture 240
with a diameter, D~,1, which may be about 2 . 09 inches . And a
diameter, Dlz, to flaps 241, that may be about 1.97 inches.
Dual-chamber device 100a is shown in FIG. 20 in its
fully assembled, pre-use condition. Bottom cover extension
support plate region 224 is shown to have diameter, D13-
Bottom cover extension 220 provides a distance, d~, from
surface 211 to bottom cover locking ring 108, which may be
about 0.55 inch, and which is greater than above-described
bottom cover height, dl, (FIG. 14). This distance, d2,
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represents the total amount of flexing of bottom cover web
192 when dual-chamber device 100a is pressed downwardly onto
surface 211 as shown in FIG. 21, which depicts the post-use
condition of the dual-chamber device. In this regard, the
red color of bottom cover extension region 222 is no longer
visible when device 100a is in the post-use, compressed
condition depicted in FIG. 21.
Dual-chamber device 100a is shown, in vertical cross
section in FIG. 22, in its fully assembled, pre-use
condition with top cover 104 removed, and thus corresponds
to FIG. 20 without the top cover. Orifice stopper 160,
with orifice stopper seal 216 attached thereto below-
adjacent stopper region 162, is shown in its lowermost
position, below orifice 146 and resting on bottom cover
guide column 210. Float ring 180 is shown in its lowermost
position resting on bottom cover web 192. Bottom cover seal
214 is shown installed in bottom cover locking ring 108,
threaded region 232 of which is shown treaded onto device
body threaded region 132.
In the vertical cross sectional drawing of FIG. 23, 23a
which is similar to FIG. 22, but represents a subsequent
operational stage of dual-chamber device 100a, liquid 250,
such as a patient's urine, is shown being discharged into
upper chamber 142 of device body 102, lower chamber 144
being shown already filled with the liquid (urine) which has
caused float 180 to push orifice stopper 160 upwardly so
that stopper region 162 is pushed into sealing relationship
with orifice 146, whereupon the liquid has then started
filling upper chamber 142. Assuming that device 100a is used
for the collection of a patient's urine for bacteriological
analysis, urine 252 contained in lower chamber 144 should
constitute fore-stream urine, the lower chamber having
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sufficient volume to assure that urine 254 being collected
in upper chamber 142 will constitute uncontaminated mid-
stream urine . An upper surface 253 of urine 252 coincides
with the predetermined urine level in lower chamber 144 to
which orifice stopper 160 is responsive for being floated
upwardly into sealing engagement with orifice 146.
Vertical support column 168 depending from orifice
stopper skirt region 164 is telescopically received into the
larger diameter guide column 208 extending upwardly from
bottom cover 106. The upward movement of orifice stopper 160
is thus perfectly guided and restricted within bottom cover
~ guide column 208. At this point, bottom cover annular
flexible web 192 remains in its device pre-use, unflexed
condition.
Orifice stopper locking ring 150 stabilizes stopper
sealing region 162 as it is directed into orifice 146
whenever device body 102 is tilted at different angles
during its use. Therefore, irrespective of how each patient
positions her (or his) device body 102 during the liquid
(urine)collection process, the mechanical integrity of the
entire dual-chamber device 100 involving fore stream urine
capturing, isolation, and precise orifice stopper sealing
and closure, always remain constant and intact with the
stabilizing action of float 180.
In the vertical cross sectional drawing of FIGS. 24,
24a which are similar to FIGS. 23, 23a dual-chamber device
100a is shown in its post-use condition with top cover 104
attached to device body 102 and with handle 110 removed from'
member 112. Device 100a is also shown pressed downwardly
onto firm surface 211 so that bottom cover base region 190
and bottom cover extension 220 are fully recessed into
device body 102, which causes bottom cover column 210 to
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push orifice stopper 160 upwardly into tight sealing
relationship with orifice 146 with. stopper seal 216 forced
in a sealing relationship against lower regions of orifice
ring 148 and including "latching" stopper locking bead 166
into orifice locking recess 152, and positively locking the
stopper into the orifice to assure no liquid leakage occurs
between upper and lower chambers 142 and 144. In this
condition, colored bottom extension flange 222 will be
hidden, thereby providing a visual indication that proper
locking has occurred. At times, some nervous and less
knowledgeable patients may leave dual-chamber device 100a
unlocked. This red colored flange 222 will then be clearly
visible to nursing and technician staffs and will
immediately remind them to lock device 100a before
transporting it to the analysis laboratory.
The over-center locking of bottom cover web 192 which
results, locks bottom cover 190 in its upward position
shown, thereby securely locking orifice stopper 160 into
orifice 146 (as described above) so that regardless of any
rough handling of device 100a, no liquid 252 can leak from
lower chamber 144 into liquid 254 held in upper chamber
142. Bottom cover locking ring 108, with installed seal 114,
prevents liquid leakage at the periphery of bottom cover 106
that might occur if device 100a is not pressed squarely down
onto surface 211 during the above-described locking process.
As bottom cover base 190 with bottom cover extension 220
attached thereto are retracted upwardly, as above described,
bottom cover extension peripheral latching region 226 flexes
downwardly to bypass bottom cover locking ring radial
projections 241 adjacent central opening 240 and then
projects outwardly thereover to help maintain bottom cover
web 192 in its over-center locked condition.
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Assuming lower chamber liquid 252 is fore-stream urine
and upper chamber liquid 254 is mid-stream urine, the upper
chamber mid-stream urine would be used for bacteriological
analysis, and device 100a still containing lower chamber
fore-stream urine would then be discarded.
It will be appreciated that when device 100a, or device
100 (without bottom cove extension 220) is pushed downwardly
to flex bottom cover web 192 and cause bottom cover central
region pedestal 190 and bottom cover extension (for device
100a) to be pushed upwardly into lower chamber 144, the
lower chamber volume is decreased, causing a high air
pressure in the lower chamber region above liquid 252. This
high air pressure may be sufficient to cause bleeding of
liquid 252 from lower chamber 144 past orifice stopper 160
into upper chamber 142 and possible contamination of upper
chamber liquid 254. Device body hole 120 is provided for
venting air from lower chamber 144 to relieve pressure
therein and thereby prevent any liquid 252 from bleeding
past orifice stopper 160.
In some situations it may, however, be necessary or
desirable to have access to urine 252 in lower chamber 144
after orifice stopper 160 (and variations thereof) has been
locked into orifice 146, as described above. For example,
when testing for drugs in an individual's urine it may be
necessary, or required by law, to retain, in a tamperproof
manner, a reserve or second portion of the individual's
urine specimen. A spot drug test would be performed on
urine 254 obtained from upper chamber 142, and the second
urine 252 portion would be held locked (as described above)
in lower chamber 144 until needed to verify the spot drug
test results, should they be disputed or require
verification.
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However, after orifice stopper 160 is locked into
orifice 146 as described above, the stopper cannot be
unlocked from the orifice without destroying device 100a.
Therefore for drug testing use of dual-chamber device 100a
(and other dual-chamber device variations, described
herein), as depicted in FIGS. 25 and 26, outer wall 138 of
device body 102 in the region of lower chamber 144 would
have installed therein a self-sealing syringe access port
260 covered by a detachable metal or hard plastic protective
cap 262 which is swaged or heat sealed in place. As shown
in FIG. 26, after protective cap 262 is removed, it cannot
be manually reattached, thereby assuring a tamper-proof
specimen in lower chamber 144 and providing a visual
indication that urine 252 in lower chamber 144 may already
been accessed or possibly treated in some manner so as to
adversely affect any drug testing of the urine. A syringe
needle 264 is then inserted through port 260 and an attached
syringe 266 is used to withdraw from lower chamber 144 a
quantity of urine 252 that may be used for secondary drug
testing.
SECOND VARIATION DUAL-CHAMBER DEVICE 100b:
The present inventors have determined that in some
situations wherein a strong, torrential flow of liquid 250
(for example, urine discharged from a female patient) into
device upper chamber 142 and impinging on orifice stopper
160 may possibly cause cocking of the stopper to the extent
that proper orifice sealing is hindered when the stopper is
floated up into orifice 146. As a result, it is within the
scope of the present invention to provide a flow diverting
and sanitary barrier adapter 270, as shown in FIGS. 27-31
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and which comprises part of a second variation dual-chamber
device 100b.
Shown comprising flow diverting and sanitary barrier
adapter 270 are a peripheral mounting ring 272 and a central
dome 274 supported from the mounting ring by equally spaced
apart, slender, downwardly-angled beams 276 (four such beams
being shown). A handle attachment fitting 112a is fixed to
mounting ring 272 for receiving handle 110.
As shown in FIG. 29, when flow diverting and sanitary
barrier adapter 270 is snapped onto the upper edge of device
body 102a, central dome 274 is located directly above
orifice 146 and stopper 160. As depicted, an introduced
urine flow 250 (shown in broken lines) flows downwardly
around dome 274 and then onto transverse wall 140 and then
downwardly onto side regions of stopper 160, the liquid flow
being thereby reduced in force onto the stopper.
Second variation dual-chamber device 100b is depicted
in FIG. 31, showing handle 110 detachably attached to
fitting 112b formed on diverter mounting ring 272. Except
for sanitary barrier adapter 270 with attached handle 110,
and except that device body 102a does not have handle
fitting 112 attached thereto, dual-chamber device 100b is
the same as above-described device 100a and is internally
constructed and operates in the above-described manner of
device 100a. After liquid has been discharged into body
102a, adapter 270 with attached handle 110 is removed from
device body 102a and is discarded. Adapter 270 also
provides a sanitary barrier to maintain sterility of body
102a against accidental contamination by contact with the
patient's unclean external body regions. Top cover 104 is
then threaded onto device body 102a to seal device 100b for
subsequent urinalysis.
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THIRD VARIATION DUAL-CHAMBER DEVICE 100c:
It will be appreciated that a locking of orifice stopper
160 into orifice 146 (as described above for devices 100,
100a and 100b) in a more automatic manner will, at least in
some circumstances, be more desirable than the mechanical
locking method described above which requires manually
pushing down on dual-chamber device 100 or 100a to flex
bottom cover web 192 into its over-center locking condition.
To this end, there is disclosed in FIGS. 32-38 a
spring-type orifice stopper locking assembly 280 for a third
variation dual-chamber device 100c (FIGS. 35-37). As shown,
locking assembly 280 comprises a relatively small,
preferably cylindrical, housing 282 which includes an upper
member 284 having a top 286 and a cylindrical side wall 288.
A housing base 290 is threaded upwardly onto the bottom of
side wall 288 (FIGS. 32-33). Housing 282 has a height, H4,
that may be about 0.31 inch.
As best seen from FIG. 33, a relatively large,
centrally-located aperture 292 is formed in housing top 286.
A sonically-shaped compression spring 294 is retained inside
housing 282 by a circular member 296 fixed to housing base
290, and is maintained in its compressed condition by a
rigid, aqueous liquid-softenable, spring-retaining disc 298,
which may be formed from a suitable fiber material, such as
cardboard, that is positioned above compressed spring 294
and directly beneath top aperture 292.
Housing base 290, which has a diameter, D14, that may be
about 0.63 inch, is formed with a central liquid entry
aperture 300 and having a plurality of small, short feet 302
that space locking assembly 280 upwardly from device bottom
cover 106a so that liquid (urine) collected in lower chamber
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144 can enter housing 282 through base aperture 300 to
soften spring-retaining disc 298 and release the compression
of spring 294. An air vent 304 is provided in housing side
wall 288. A groove 306 is provided in base lower surface
308 (FIG. 34) to receive a screw driver blade for
facilitating screwing housing base 290 onto housing side
wall 288.
Shown in vertical cross section in FIGS. 35-37 third
variation dual-chamber device 100c incorporates above
described spring-type orifice stopper locking assembly 280.
Shown further comprising dual-chamber device 100c is a
device body 102b, a bottom cover 106a, an orifice stopper
160a, float 180 and handle 110. Dual-chamber device 100c,
for reasons described below, eliminates bottom cover locking
ring 108 as unnecessary.
Device body 102b is shown identical in all respects to
above-described device body 102, except that a lower
threaded region 132a is formed directly above a lower end of
the device body for the threadable attachment of bottom
cover 106a.
Orifice stopper 160a is identical in all respects to
above-described orifice stopper 160 except that depending
column 170a is shorter than column 170 shown in FIGS 7 and
8, and is closed at a lower end 310. Bottom cover 106a is
similar to above-described bottom cover 106 (FIGS. 13-17),
except that annular web 192 is eliminated, permitting a base
194a to be entirely flat and extend entirely across device
body 102b, and is formed having a peripheral internally
threaded attachment region 312 that mates with device body
threaded region 132a upon assembly of dual-chamber device
100c.
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As shown in FIGS. 35-37, compressed spring orifice
stopper locking assembly 280 is attached to an upper surf ace
318 of bottom cover 106a inside column 208a and directly
beneath orifice stopper closed lower end or bottom 310.
Column 208a is formed having a plurality of vertical slits
(not shown) to allow aqueous liquid access to locking
assembly 280 and disc 298.
In the pre-use condition of dual-chamber device 100c,
depicted in FIG. 35, orifice stopper 160a is resting on top
286 of locking assembly housing 282, and float 180 is
resting on bottom cover upper surface 318.
As depicted in FIG. 36, which corresponds to FIG. 35,
but represents a subsequent operation or use stage of dual-
chamber device 100c, liquid (urine) is being introduced into
dual-chamber device 100c, having filled lower chamber 144 to
the extent that orifice stopper 160a has been floated
upwardly into sealing engagement with orifice 146, and upper
chamber 142 has subsequently been partially filled with
liquid (urine) 154. At this depicted point in time, spring
retaining disc 298 has not yet been sufficiently softened by
aqueous liquid 152 in lower chamber 144 to release locking
spring 294 from its shown compressed state.
Preferably at least about 20 seconds of immersion in
aqueous liquid (urine) is required to soften spring
retaining disc 298 sufficiently for ,it to release spring
294, which allows sufficient time for orifice stopper 160a
to be floated upwardly into orifice 146 to stop liquid flow
into lower chamber 144. This softening of spring-retaining
disc 298, releases spring 294 which then expands and pushes
the disc upwardly through housing opening 296 and expands
further to push orifice stopper 160 upwardly into tight
sealing relationship with orifice 146 with stopper seal 216
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forced in a sealing relationship against lower regions of
orifice ring 148, and including "latching" stopper locking
bead 166 into orifice locking recess 152, and positively
locking the stopper into the orifice to assure no liquid
leakage occurs between upper and lower chambers 142 and 144,
as depicted in FIG. 37. FIG. 38 is an enlargement of region
38 of FIG. 37 depicting the above-described actuation of
spring-type orifice stopper locking assembly 180.
It will be appreciated that the above-described tight
locking of orifice stopper 160a into orifice 146 by orifice
stopper locking assembly 280 is completely automatic and
operates solely in response to liquid (urine) 154 filling
device body lower chamber 144 without requiring any manual
intervention.
FOURTH VARIATION DUAL-CHAMBER DEVICE 100d:
A fourth dual-chamber device 100d is depicted in FIGS.
39-40 which utilizes a quantity or element of highly
expandable, hydrophilic material capsule or element 330 to
provide automatic locking of above-described orifice stopper
160a into orifice 146, the process being otherwise similar,
and comparable, to that described above for spring-type
orifice stopper locking assembly 280 (FIGS. 35-38).
As shown in the vertical cross sectional pre-use
drawing of FIG. 39, expandable, hydrophilic material capsule
or element 330 is disposed within orifice stopper column 170
above bottom cover 106a and in contact with a transverse
stopper closing member 332. Orifice stopper column 168a
rests on hydrophilic material capsule 330 and float 180 is
resting on bottom cover upper surface 318 of bottom cover
106a.
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As depicted in the vertical cross sectional post-use
drawing of FIG. 40 (which corresponds to FIG. 39), as
aqueous liquid (urine) 252 fills lower chamber 144, the
liquid flows through above-described openings in column 208a
and contacts hydrophilic material capsule 330 causing the
material to greatly expand (swell), thereby exerting an
upward force on stopper bottom 310 to push orifice stopper
160 upwardly into tight sealing relationship with orifice
146 with stopper seal 216 forced in a sealing relationship
against lower regions of orifice ring 148, and including
"latching" stopper locking bead 166 into orifice locking
recess 152, thereby positively locking the stopper into the
orifice to assure no liquid leakage occurs between upper and
lower chambers 142 and 144
Again, as in the case of the spring-type orifice stopper
locking assembly 280, the use of expandable, hydrophilic
material capsule 330, provides for the automatic locking of
orifice stopper 160b into orifice 146 solely in response to
liquid (urine) 154 filling device body lower chamber 144
without requiring any manual intervention.
FIFTH VARIATION DUAL-CHAMBER DEVICE 100e:
A fifth variation dual-chamber device 100e is depicted
in FIGS. 41-43. Dual-chamber device 100e utilizes a gas
generator assembly 340 comprising an aqueous liquid
activated effervescent tablet or element 342 disposed in a
cylindrical tablet housing 344 to achieve automatic locking
of orifice stopper 160b into orifice 146. Dual-chamber
device 100e is similar in many respects to both above
described dual-chamber devices 100c and 100d.
As shown in the vertical cross sectional drawings of
FIGS. 41-44 gas generator assembly 340 is installed in dual-
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chamber device 100e within orifice stopper column 168b and
is attached to bottom cover upper surface 318. As shown in
the pre-use condition of FIG. 41, orifice stopper column
168b is resting on bottom cover upper surface 318, as is
float 180.
Shown in detail in FIG. 42, gas generator assembly
tablet housing 344 includes a top 350, a cylindrical side
wall 352 and a bottom 354. Housing bottom 354 is formed
having a plurality of small, short feet 356 that space gas
generator assembly 340 upwardly from device bottom cover
upper surface 318 so that liquid collected in lower chamber
144 can enter through above-described slits in bottom cover
column 208a and then through holes 358 formed in housing
bottom 354 to activate effervescent tablet 342. Holes 360
are provided in housing top 350 to enable generated gas
bubbles 362 to escape from housing 344 (FIGS. 43 and 44). A
hole 366 is formed in housing side wall 352 to enable the
escape of air from housing 344 during initial activation of
effervescent tablet 342.
As depicted in the vertical cross sectional drawing of
FIG. 43, gas bubbles 362 rising from gas generator 340
pushs orifice stopper 160 upwardly into tight sealing
relationship with orifice 146 with stopper seal 216 forced
in a sealing relationship against lower regions of orifice
ring 148, and including °latching" stopper locking bead 166
into orifice locking recess 152, thereby positively locking
the stopper into the orifice to assure no liquid leakage
occurs between upper and lower chambers 142 and 144.
Similarly to above-described dual-chamber devices 100c and
100d, the generated gas locking of orifice stopper 160b into
orifice 146 is accomplished when lower chamber 144 is filled
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with aqueous liquid (urine) 152 and without any manual
intervention.
SIXTH VARIATION DUAL-CHAMBER DEVICE 100f:
A sixth variation dual-chamber device 100f, shown in
FIGS. 45-49, comprises device body 102b, an orifice stopper
160c, a bottom cover 106b, an orifice stopper pushing base
380 and a very soft removable sponge element 382 disposed
between the bottom cover and the stopper pushing base.
Shown in FIGS. 45 and 47 comprising bottom cover 106b
are a centrically-located, upwardly extending, lower tubular
portion 384, which is open at the bottom and which
terminates in a smaller diameter, upwardly-extending upper
tubular region 386. Otherwise bottom cover 106b is the same
as above-described bottom cover 106a.
Orifice stopper 160c is formed having a slender,
central, depending tubular pushing pin guide 388 which fits
closely into bottom cover upper tubular region 386. Orifice
stopper 160c rests, in the pre-use condition of dual-chamber
device 100f on an upper end region 390 of bottom cover lower
tubular regi~n 384 (FIG. 45). Otherwise, ~rifice stopper
160c is substantially the same as above-described orifice
stopper 160a.
Pushing base 380 is formed having a flat bottom 392 with
a centrally-located, upwardly-extending column 394 which
fits closely into bottom cover lower tubular region 384.
Extending upwardly from a top 396 of column 394 is an
elongate slender orifice stopper pushing pin 400 which
extends upwardly in a close-fitting relationship through
orifice stopper pin guide 388. As shown in FIG. 45, top 396
of pushing base column top 396 is spaced substantially below
upper end region 390 of bottom cover lower tubular region
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384. Pushing base 380 is formed having a recessed; well
region 402 surrounding column 394 into which sponge element
382 is received, the recessed region being further defined
by a peripheral attachment flange 406 configured for
snapping upwardly onto bottom cover 106b, as shown in FIG.
47. Peripheral attachment flange 406 extends about 270
degrees around pushing base 380 (FIG. 29) to provide
suitable space for withdrawing of sponge element 382 from
the pushing base, as described below.
As shown in FIG. 46, sponge element 382 has a central
diameter, D15, that may be about 0.08 inch, so as to fit
loosely around column 394 and a height, H5, that may be
about 0.4 inch. A relatively wide gap 410 is formed in
sponge element 382 to permit withdrawal of the element from
pushing base recessed region 402. A thin, projecting finger
tab 412 is joined to sponge element 382 opposite gap 410.
Before liquid (urine) is introduced into device 100f, sponge
element 382 is withdrawn from pushing base recess 402 and is
discarded. Friction between column 394 and tubular region
384 retains pushing base 380 in its pre-sponge removal
condition until liquid (urine) filled device 100f is
subsequently set onto surface 211, as described below.
The use of dual-chamber device 100f is evident from FIGS
47-48. As liquid (urine) fills device lower chamber 144,
orifice stopper 160c is floated upwardly into a sealing
relationship with orifice 146, whereupon liquid (urine) is
collected in device upper chamber 142. After liquid (urine)
152 is collected in lower chamber 144 and liquid (urine) 154
is collected in upper chamber 142 is set on surface 211.
The weight of the liquid (urine) 152 and 154 in device body
102b, then causes the device body with bottom cover 106b to
settle downwardly into pushing base recess 402, thereby
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causing pushing pin 400 to push upwardly against orifice
stopper 160c in a manner pushing the orifice stopper 160
upwardly into tight sealing relationship with orifice 146
with stopper seal 216 forced in a sealing relationship
against lower regions of orifice ring 148, and including
"latching" stopper locking bead 166 into orifice locking
recess 152.
Subsequent to such downward settling of device body
102b, cover 104 is installed on the device body and device
100f is manually pressed downwardly on surface 211 to cause
pushing base peripheral flange 406 to snap up over the
bottom cover periphery to retain pushing base 380 onto
bottom cover 106b. This positively locks stopper 160c into
orifice 146 and device 100f can then be handled (even
carelessly) without the possibility of the stopper being
dislodged from the orifice and causing liquid (urine) 152 to
leak past the orifice stopper between upper and lower
chambers 142 and 144.
SEVENTH VARIATION DUAL-CHAMBER DEVICE 100g:
A seventh variation dual-chamber device 1008, shown in
FIGS. 50-52, provides a magnetic locking of orifice stopper
160d into orifice 146 in the manner described below. As
shown in FIG. 50, above-described orifice stopper 160d,
which corresponds to above-described orifice stopper 160b
(FIG. 41) is formed having a magnetic member 420 attached
(as by cementing) to and around an under surface 422 of
stopper skirt 164. Magnetic member 420 may constitute a
single-piece, annular magnet or may comprise two or more
magnetic segments. A corresponding magnetic member 424 is
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attached to an outer surface 426 of orifice locking ring 150
spaced above stopper magnetic member 420.
A removable soft-type sponge spacer 430 is shown in FIG.
50 initially installed in dual-chamber device body 102b
between locking ring magnetic member 424 and orifice stopper
160d to keep magnetic members 424 and 420 separated before
use of device 1008. Forming spacer 430 is a conically
shaped separation region 432 to which is joined a finger tab
434. Initially orifice stopper 160d rests on bottom cover
106a, as does float 180.
When, as depicted in FIG. 52, spacer 430 is removed from
device body 102b and orifice stopper 160d is floated
upwardly into engagement with orifice 146 by liquid (urine)
152 collected in lower chamber 142, magnet members 424 and
420 attract each other, thereby drawing the orifice stopper
tightly into orifice 146 with stopper seal 216 forced in a
sealing relationship against lower regions of orifice ring
148 and with stopper locking bead 166 "latched" into orifice
looking recess 152, thereby positively locking the stopper
into the orifice to assure no liquid leakage occurs between
upper and lower chambers 142 and 144.
EIGHTH VARIATION DUAL-CHAMBER DEVICE 100h:
An eighth variation dual-chamber device 100h, shown in
FIGS. 53-56, provides locking of orifice stopper 160 into
orifice 146 by a liquid-activated cementing process in the
manner described below. As shown in the pre-use condition
of FIG. 53, dual-chamber device 100h comprises device body
1020, orifice stopper 160, float 180 and bottom cover 106a.
Orifice stopper 160 and float 180 are shown resting on
bottom cover 106a below orifice 146. A coating 440 of an
aqueous liquid (urine) activated cement (adhesive) is
applied to and around inner surface 442 of orifice ring 148
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(also FIG. 54), and is initially protected by a flexible,
removable "release" 444, which may be made from waxed paper
or plastic material.
As shown in the post-use condition of FIGS. 55 and 56,
"release" 444 has been withdrawn from orifice ring 148 to
expose cement coating 440 to, and be activated by, liquid
(urine) flowing into device body 102b. As liquid 252 is
collected in lower chamber 144, orifice stopper 160 is
floated upwardly into sealing engagement with orifice 146,
thereby contacting activated cement coating 440, which then
cements the orifice stopper into orifice ring 148. This
causes orifice stopper 160 to be permanently locked and
strongly sealed into orifice ring 148, thereby preventing
any leaking of liquid 252 between upper and lower chambers
142 and 144, regardless of any subsequent handling or
mishandling of dual-chamber device 100h.
SUMMARY OF USE OF EXEMPLARY DUAL-CHAMBER DEVICE 100a
The operational use of exemplary dual-chamber device
100a is depicted step-wise in FIGS. 57A-57H. When a patient
with a unclean or poorly clean anatomic part uses device
100a, the earlier fore-stream urine volume (40 to 70 ml) is
regarded as favorably useful because, it helps to flush,
rinse and clean the external urogenital tract, which extends
from the urethra to device 100a. Such flushing and rinsing
mechanism creates a cleaner tract for the subsequent mid-
stream sample flowing through this same tract into dual-
chamber device 100a. Thus, (referring to FIGS. 22-24) dual-
chamber device 100a has the ability to capture the earlier
"rinsing" contaminated fore-stream urine and isolate it in
separate lower chamber 144. Dual-chamber device 100a will
then continue to collect the later cleaner mid-stream sample
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in upper chamber 142, which is separated from lower chamber
144 by orifice stopper 160. This separation and isolation
renders dual-chamber device 100a completely free from mixing
the contaminated fore-stream sample with the clean mid-
stream sample. (The foregoing applies to all above-
described dual-chamber devices 100 and 100b-100h).
FIG. 57A depicts dual-chamber device 100a (minus handle
110) in its assembled, initial, pre-use condition and
corresponds generally to above-described FIG. 20. Device
body 102 is shown closed by top cover 104 which is, in turn,
sealed by a sterile-marked adhesive sealing strip 450
indicating that the device is in a sterile condition.
Bottom cover 106 (not shown) is retained by locking ring 108
and rests on bottom extension member 220.
In FIG. 57B, handle 110 is shown being fitted upwardly
onto device body fitting 112, with adhesive sealing strip
450 still in place. Handle 110 being shown in FIG. 57C
fully received onto device body fitting 112. FIG. 57D shows
adhesive sealing strip 450 in the process of being removed
and top cover 104 in the process of being unscrewed from
device body 102.
FIG. 57E depicts liquid (urine) 250 being discharged
into upper chamber 142 of device body 102, and corresponds
to FIG. 22. Although not shown in this FIG., the highly
contaminated fore-stream urine first flows into lower
chamber 144 through orifice 146 located between it and upper
chamber 142 situated directly above, this configuration
resembling an hourglass. As soon as the fore-stream urine
floods lower chamber 144, it creates an air pocket
underneath the orifice stopper skirt region 164. The
progressively increased fluid level within lower chamber 144
elevates the orifice stopper sealing region 162, directing
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it towards orifice 146 to plug off the lower chamber.
Simultaneously, stabilizing float 180 floats upwards by
buoyancy and further elevates orifice stopper 160, directing
it even more forcibly and rapidly towards orifice 146 to
close it off. When the fore-stream sample has reached a pre
determined volume of (between 40 to 70m1), orifice stopper
sealing region 164 has already ascended maximally through
orifice 146, producing a tight sealing contact between the
stopper sealing region and orifice ring 148 to shut off
further liquid (urine) inflow into lower chamber 144.
FIG. 57F shows device body upper chamber 142 filled
with. liquid (urine) 254 and with top cover about to be
installed onto device body 102 for the closing thereof . Top
cover 104 is screwed onto device body 102, while using
handle 110 to steady and counter rotate the device body
while the top cover is being screwed onto the device body.
FIG. 57G shows liquid (urine) containing device 100a
being pressed downwardly onto surface 211 to cause flexing
of bottom cover web 192 (not shown) into an orifice stopper
locking condition (corresponding to FIG. 24). Finally, FIG.
57H shows dual-chamber device 100a in its post-use condition
with bottom cover extension member 220 forced upwardly into
device body 102 and the red-colored extension member is no
longer visible (also corresponding to FIG. 24).
With respect to the foregoing, it is preferred that
device body 102a-102d, handle 110, orifice stopper 160 and
160a-d, top cover 104, bottom cover locking ring 108, bottom
cover 106a-b, bottom cover extension 220, secondary bottom
cover 380, and sanitary barrier adapter 270 each be
constructed of a rigid plastic material, such as the high
density polyethylene plastic as disclosed above as
preferred for device body 102.
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Thus, there has been described above a dual-chamber
device for collecting and storing liquid samples
(specifically urine samples) and several variations thereof
for purposes of illustrating the manner in which the present
invention may be used to advantage. It will, however, be
appreciated that the invention is not limited thereto but
includes any and all variations and modifications which may
occur to those skilled in the art without violating the
scope and. spirit of the claims as appended hereto.
50
