TROUSSE D'ANALYSE DES LIQUIDES BIOLOGIQUES

BODILY FLUID TEST KIT

Abrégé français

Contenant jetable amélioré servant à recueillir et à analyser des échantillons de liquides corporels, notamment d'urine. Le contenant amélioré comprend un sac collecteur fixé à un tube muni au bas d'un robinet. Le sac collecteur est entouré d'un manchon de sécurité qui protège à la fois les mains du patient et celles du technicien au cours du transport et de la manipulation du contenant, une fois l'échantillon prélevé. Le tube comprend de préférence un dispositif supérieur d'obturation et une ouverture. Une fois que le prélèvement est recueilli dans le sac collecteur après être passé par le tube, le dispositif d'obturation prévu dans la partie supérieure du tube se referme et une bandelette réactive est introduite par l'ouverture. Le manchon est rabattu vers le haut et l'extrémité libre du manchon se referme, ce qui assure l'étanchéité du contenant jetable et de son contenu. La bandelette réactive et l'échantillon peuvent être examinés au travers du sac transparent.

Abrégé anglais

An improved disposable container is provided for the
collection and testing of bodily fluid samples, such as urine
specimens. The improved container includes a collection bag
sealably attached to a tubular member equipped with a lower valve
means. A protective sleeve surrounds the collection bag
and protects both the patient's hands as well as the medical
technician's hands during transport and handling of the container
once the specimen is deposited therein. The tubular member
preferably includes an upper closure means with an access hole
disposed therein. After the specimen is disposed through the
tubular member and into the collection bag, the closure means
disposed on top of the tubular member is closed and a test strip
is deposited through the access means. Then, the sleeve is
flipped upward and the open end of the sleeve is closed or sealed
thereby closing the disposable container and sealably containing
the specimen therein. The test strip and specimen may then be
examined through the clear collection bag.

Revendications

The embodiments of the invention in which an exclusive
property or privilege is claimed are defined as follows:
1. A kit for collecting and testing bodily
fluids,
the kit comprising:
a disposable container including
a tubular member having an upper end portion and a
lower end portion, the upper end portion including a closure
means and with an access hole disposed therein,
valve means sealably attached to the lower end portion
of the tubular member,
a collection bag, the bag including an upper portion
that is sealably attached to an outer surface of the tubular
member,
a sleeve including a first open end portion and a
second open end portion, the first open end porion being sealably
attached to the outer surface of the tubular member between an
upper end of the tubular member and the upper portion of the
collection bag,
the second open end portion of the sleeve folding
upward over the upper end of the tubular member and being
sealable
the upper portion of the
collection bag, which is sealably attached to the tubular member,
in combination with the valve means and the second open end
Page 1 of Claims

portion of the sleeve providing substantial containment of
fluid within the disposable
container after fluid is disposed therein;
a test strip having dimensions small enough to fit through
the access hole of the closure means so the test strip
may be deposited into fluid contained in the collection bag after
deposit of fluid therein.
2. The kit of claim 1,
further comprising a peg means for mounting on a wall, the
peg means accommodating the access hole in the closure
means enabling the container to be temporarily suspended from the
peg means.
3. The kit of claim 2,
wherein the tubular member is
generally conically-shaped.
4. The kit of claim 3,
wherein the closure means
includes two overlapping opposing flaps attached to
the upper end of the tubular member,
each flap folding inward, one on top of the other, to
substantially close the upper end of the tubular member.
5. The kit of claim 4,
wherein each flap includes an access hole , the
- Page 2 of Claims

two access holes of the flaps overlapping when the
flaps are folded inward,
the two overlapping access holes providing access to the
tubular member and collection bag when the upper end of the
tubular member is closed by the flaps.
6. The kit of claim 5,
wherein the collection bag is made from clear, flexible
plastic.
7. The kit of claim 6,
wherein the sleeve is made from clear, flexible plastic.
8. A disposable container for accepting
bodily fluid samples, the container comprising:
a conically-shaped tubular member including an upper end and
a lower end, the upper end of the conically-shaped tubular member
being of a larger diameter than the lower end of the
conically-shaped tubular member,
the upper end of the conically-shaped tubular member being
further characterized as including closure means to preclude
spillage of bodily fluid out the upper end of the
conically-shaped tubular member after passage of bodily fluid
through the conically-shaped tubular member to a collection bag,
the closure means including an access hole providing
access to the collection bag by a test strip after closure of the
conically-shaped tubular member, the access hole also
providing means for hanging the container from a hook or peg,
Page 3 of Claims

valve means being sealably attached to the lower end of the
conically-shaped tubular member,
the collection bag including a upper portion providing an
opening for the bag, the upper portion of the collection bag
being sealably attached to the outer surface of the
conically-shaped tubular member between the upper and lower ends
thereof,
a sleeve including a first open end portion and a second
open end portion, the first open end portion being sealably
attached to the outer surface of the conically-shaped tubular
member between the upper end of the conically-shaped tubular
member and the upper portion of the collection bag, the sleeve
being disposed around the collection bag and the second open end
portion of the sleeve being disposed near the closed lower
portion of the collection bag during the deposit of fluid into
the collection bag,
the second open end portion of the sleeve folding upward
over the upper end of the conically-shaped tubular member and
being closable, the upper portion
of the collection bag which is sealably attached to the outer
surface of the conically-shaped tubular member and the first end
portion of the sleeve to the conically-shaped tubular member in
combination with the valve means and a sealable closure of the
second open end portion of the sleeve substantially containing
fluid in the disposable container after deposit of fluid therein.
Page 4 of Claims

9. The container of claim 8,
wherein the closure means includes
two overlapping opposing flaps attached to the
upper end of the conically-shaped tubular member,
each flap folding inward, one on top of the other, to
substantially close the upper end of the conically-shaped tubular
member.
10. The container of claim 9,
wherein each flap includes a hole, the two holes of the
flaps overlapping when the flaps are folded inward,
the two overlapping holes providing access to the conically-
shaped tubular member and collection bag when the conically-
shaped tubular member is closed by the flaps thereby enabling the
insertion of a test strip downward into the collection bag after
closure of the conically-shaped tubular member with the flaps.
11. The container of claim 10,
wherein the collection bag and sleeve are made from clear,
flexible plastic.
12. The container of claim 11,
wherein the second open end portion of the sleeve includes
sealing means for providing a water-tight seal for containing
bodily fluids in the kit.
Page 5 of Claims

13. A method of depositing a bodily fluids into disposable
container and examination and testing said fluids,
the method comprising:
depositing bodily fluid into a disposable container, the
container including
a conically-shaped tubular member including an upper
end and a lower end, the upper end of the conically-shaped
tubular member being of a larger diameter than the lower end of
the conically-shaped tubular member, the upper end of the
conically-shaped tubular member being further characterized as
including lid means to substantially close the upper end of the
conically-shaped tubular member, the lid means including at least
one hole for the insertion of a testing device, the conically-
shaped tubular member including an outer surface,
valve means being sealably attached to the lower end of
the conically-shaped tubular member,
a collection bag, the bag including a upper portion
providing an opening for the bag, the upper portion of the
collection bag being sealably attached to the outer surface of
the conically-shaped tubular member between the upper and lower
ends thereof,
a sleeve including a first open end portion and a
second open end portion, the first open end portion being
sealably attached to the outer surface of the conically-shaped
tubular member between the upper end of the conically-shaped
tubular member and the upper portion of the collection bag,
Page 6 of Claims

the sleeve being disposed around the collection bag and
the second open end portion of the sleeve being disposed near the
closed lower portion of the collection bag during the deposit of
fluid into the collection bag,
closing the lid means of the conically-shaped tubular
member,
inserting the testing device through the hole in the lid
means thereby causing the testing device to drop downward into
contact with the bodily fluid,
folding the second open end portion of the sleeve upward
over the conically-shaped tubular member and sealing the second
open end portion of the sleeve,
visually examining the testing device through the collection
bag.
14. A disposable container for collecting, containing,
isolating and testing bodily fluids, the container comprising:
a tubular member having an upper end portion and a
lower end portion, the upper end portion including a closure and
with an access hole disposed therein,
a valve sealably attached to the lower end portion of
the tubular member,
a collection bag, the bag including an upper portion
that is sealably attached to an outer surface of the tubular
member,
a sleeve including a first open end portion and a
second open end portion, the first open end porion being sealably
attached to the outer surface of the tubular member between an
Page 7 of Claims

upper end of the tubular member and the upper portion of the
collection bag,
the second open end portion of the sleeve folding
upward over the upper end of the tubular member and being
sealable,
the upper portion of the collection bag, the valve and
the second open end of the sleeve combining to provide
substantial containment of fluid within the disposable container
after fluid is disposed therein.
15 . A kit for collecting and testing bodily fluids,
the kit comprising:
a disposable container including
a tubular member having an upper end portion and a
lower end portion, the upper end portion including a closure and
with an access hole disposed therein,
a valve sealably attached to the lower end portion of
the tubular member,
a collection bag, the bag including an upper portion
that is sealably attached to an outer surface of the tubular
member,
a sleeve including a first open end portion and a
second open end portion, the first open end porion being sealably
attached to the outer surface of the tubular member between an
upper end of the tubular member and the upper portion of the
collection bag,
Page 8 of Claims

the second open end portion of the sleeve folding
upward over the upper end of the tubular member and being
sealable,
the upper portion of the collection bag, the valve and
the second open end of the sleeve combining to provide
substantial containment of fluid within the disposable container
after fluid is disposed therein;
a test strip having dimensions small enough to fit through
the access hole of the closure so the test strip may be deposited
into fluid contained in the collection bag after deposit of fluid
therein.
Page 9 of Claims

Description

2131611
Attorney Docket No.: GKR 107-US
BODILY FLUID TF8T ~lT
FI~LD OF TH~ INVENTION
This invention relates generally to a kit including a
disposable container for accepting bodily fluid specimens and a
test strip for testing said specimens. More specifically, the
invention relates to a disposable specimen container which
includes a valved tubular member through which bodily fluid flows
into a collection bag. An outer protective sleeve protects the
user's hand against contact with the bodily fluid. The upper end
of the tubular member is closable but includes a means for
inserting a test strip into the collection bag after closing.
The sleeve folds upward and is sealable to provide safe transport
of the bodily fluid specimens.
R~GR~ND OF THB INVENTION
The concept of disposable containers for the collection of
bodily fluid specimens such as urine specimens is well known.
The most common form of such a container is a plastic or paper
cup. Most of such cup-type disposable containers include some
sort of closure lid. The disadvantages to cup-type containers
for the collection of specimens are at least three-fold. First,
the cups are rather small in volume with relatively small
openings, and patients, especially women, sometimes find it
difficult to deposit a bodily fluid specimen such as urine in the
cup without spillage or overflow. Second, once the fluid is
deposited in the container, the fluid is sometimes spilled in the

2131611
process of being delivered to a nurse or technician for testing.
Third, there is no easy way to deposit a test strip in the fluid
so that it can be visually inspected in the fluid. Placing a
test strip in the fluid requires that the lid of the container be
removed, and this requirement enhances the likelihood of the
specimen being spilled and coming into contact with the nurse or
technician.
U.S. Patent Nos. 3,797,734 and 4,990,145 show a disposable
bag of the type with which the present invention is intended to
be used. Specifically, the '734 patent shows a bag having a
tubular funnel sealingly engaging a plastic bag. The bag is
sealably attached to the outer surface of the tubular member.
The lower end of the tubular member includes a funnel means
comprised of a flattenable plastic tube which allows entry of the
fluid through the tubular member into the bag, but which prevents
fluid from escaping upward and reentering the tubular member.
The '145 patent provides an improvement to the embodiment
disclosed in the '734 patent by means of a protective outer
sleeve or shroud for protecting the user's skin against fluid
contact. As noted in the '145 patent, products made in
accordance with both patents have been sold in substantial
numbers.
It is imperative that nurses and other medical personnel
avoid contact with the bodily fluids of their patients.

21316 l 1
`hepatitis B virus, HIV (human immunodeficiency virus) and
other di~eA~~~ may be transmitted as a result of contact with
bodily fluids. Further, the Occupational Safety and Health
Administration (OSHA) has issued regulations covering medical
employees that medical practices must comply with (see 29 C.F.R.
1910.1030 et seq.).
Thus, there is a need for a disposable ~pecimen container
that-is easy to use and protects both the patient and medical
tec~nician against coming in contact with the bodily fluids.
Second, there is a need for a disposable specimen container that
may be transported or handed from the patient to a technician
without the risk of spillage, either on the patient or on the
tec-hnician. Third, there is a need for a disposable specimen
container that facilitates the insertion of a test strip into the
fluid and further facilitates the viewing of the test strip while
it is in the fluid without requiring the tec~nician to reach down
into the container to retrieve the test strip for inspection.
As discussed below, the present invention satisfies all
three of the aforenoted criteria.
8~MHARY OF THF PR~8ENT INVFNTION
The present invention makes a significant contribution to
the disposable medical container art by providing an improved
disposable container for accepting and transporting bodily
- 3 -

2131611
fl~ids, including urine. The invention features a tubular member
with a valve means attached to the lower end of the tubular
member. A collection bag is sealably attached to an outer
surface of the tubular member. The closed bottom end of the
collection bag provides a space for the collection of fluid and
the valve means provides a means for containing the fluid in the
collection bag and preventing it from spilling upward through the
tubular member. An optional sleeve may be sealably attached to
the outer surface of the tubular member at or slightly above the
area where the collection bag is sealably attached to the tubular
member. During initial use of the container by the patient, the
sleeve is folded downward and provides a skirt for the collection
bag. Holes in the closure means di~ e~ at the top of the
tubular member allow the container to hang from a peg in the
examination room or bathroom stall. The peg may be supplied as
part of the kit.
After the patient has completed depositing fluid in the
collection bag, the patient then hands the container to a nurse
or technician who, if a sleeve is employed, will slip his/her
hand up under the sleeve between the sleeve and the collection
bag thereby grasping the container and protecting the nurse or
t~hnician's hand from contact with the bodily fluid. As
disc~ above, in the preferred embodiment, the upper end of
the tubular member will include a closure means such as a lid or
closure flaps to further preclude any spillage or splatter of
-- 4 --

2131~11
~9dily fluid during the transfer between the patient and the
nurse or tech~ician. Also in the preferred embodiment, the
closure means includes an access hole which enables the nurse or
techn;cian to easily insert a test strip down into the collection
bag and into the bodily fluid for examination and testing of the
fluid. The access hole, as noted above, also provides the bag
with means for hanging the bag from a peg before or after use by
the patient.
After the test strip has been inserted into the fluid, the
sleeve may be folded upward over the upper end of the tubular
member and the distal end of the sleeve may be sealed with a
twist-tie or other equivalent sealing means. The distal end of
the sleeve may also include a built-in sealing mechAnism. After
the distal end of the sleeve is sealed, the disposable container,
the fluid and the test strip may be safely transported without
fear of spilling the fluid. After the test strip has been
examined, the entire container, including the fluid and the test
strip may be safely disposed of.
Female patients find the preferred embodiment of the present
invention far superior to a cup or cylindrical container because
the configuration of the present invention is designed to be
easily used by women without spillage. Male patients also find
the preferred embodiment of the present invention easier to use
because it prevents overflow.

2131611
The preferred embodiment features a conical or funnel-shaped
tubular member with a wider upper end for easy use by the
patient. The narrow lower end of the tubular member effectively
deposits the fluid into the center of the collection bag and
also provides additional room so that the patient and nurse or
techn;cian may easily slide his/her hand between the collection
bag and the sleeve to grasp the upper portion of the collection
bag and the tubular member.
The present invention also lends itself to an improved
method for depositing bodily fluids into a disposable container.
The method includes the patient taking a disposable container
made in accordance with the present invention which may or may
not have been hung from a peg and opening the closure means that
is di~ at the upper end of the tubular member. After the
closure means is opened, the patient then deposits the fluid
sample down through the tubular member and through the valve
means and into the collection bag. After the patient has
completed depositing fluid in the bag, the container may be hung
on a wall by inserting a wall mounted peg through the access
means. The patient then removes the container from the peg and
closes the closure means disposed at the upper end of the tubular
member. The patient then hands the disposable container to a
nurse or tech~ician who takes the container by inserting his/her
hand upward between the collection bag and the outer sleeve to
grasp the tubular member. The nurse or technician then inserts

æl3l6ll
test strip downward through an access means disposed in the
closure means of the tubular member. The test strip falls
through the tubular member and into the fluid now dis~o-~ in
the collection bag. The tech~ician then pulls the outer sleeve
upward and sealably closes the distal end of the protective
sleeve with a twist-tie or other sealing mech~n;~m that may or
may not be built in to distal end of the protective sleeve.
It is therefore an object of the present invention to
provide an improved disposable container for accepting and
transporting bodily fluid samples.
It is another object of the present invention to provide
and improved disposable container for bodily fluid samples that
reduces the likelihood of any spillage of the bodily fluid
samples thereby reducing the likelihood of the patient or
tec~nician coming into contact with the fluid.
Yet another object of the present invention is to provide a
disposable bodily fluid specimen bag that effectively prevents
the possibility of a nurse or medical technician contacting HBV
(hepatitia B virus), HIV (human immunodeficiency virus) and
further helps medical practices to comply with the relevant OSHA
regulations (37 C.F.R. 1910.1030 et seq.).

2131611
Still another object of the present invention is an improved
device for the collection of urine specimens from female and male
patients.
Yet another object of the present invention is to provide an
improved disposable container for bodily fluid specimens that
facilitates the safe transport and testing of fluid specimens.
BRIEF D~8~TPTION OF TRE DRA~TN~8
This invention is illustrated more or less diagrammatically
in the accompanying drawings, wherein:
Figure 1 is a front elevational view of a disposable
container kit made in accordance with the present i~nvention;
Figure 2 is a top plan view of the disposable container
shown in Figure l;
Figure 3 is a front elevational view of the disposable
container shown in Figure 1 as held by a user or medical
techn;cian;
Figure 4 is a front elevational view of the disposable
container shown in Figure 3 after the deposit of a specimen
therein and further illustrating the insertion of a test strip
downward into the container; and

2131611
Figure 5 is yet another front elevational view of the
disposable container shown in Figure 3 with the outer protective
- sleeve folded upward and sealed and further illustrating the easy
examination of the test strip, now contained within the fluid
sample.
It should be understood that the drawings are not
necescArily to scale and details which are not n~ce~s~ry for an
understanding of the present invention or which render other
details difficult to perceive may have been omitted. It should
also be understood, of course, that the invention is not
n~cecs~rily limited to the particular embodiment illustrated
herein.
n~TAIT~n ~ PTPTION OF THF INVENTION
Like reference numerals will be used to refer to like or
similar parts from figure to figure in the following description
of the drawings.
The dramatic improvement contributed by the present
invention is best understood after consideration of how
convention specimen containers are used. First, conventional
specimen containers are merely paper or plastic cups with an open
top end. While a wide top is preferable for the insertion of the
bodily fluid in the container by the patient, it also enables
the fluid to easily spill out of the container. Further, many

2131611
patients, especially female patients, find that the size or width
of the upper end of the containers now in use is too small and
that the fluid is often spilled during the deposit of the fluid
in the container. Male patients find the volume of the cup-type
containers too small and often overfill them or spill the
contents after the deposit is made. Finally, after fluid is
deposited in the cont~in~r~ the fluid may be spilled before a lid
is placed on the container and the lid must be removed afterward
prior to the insertion of a test strip or the removal of a
portion of the fluid specimen for testing.
As seen below, the present invention overcomes all these
disadvantages by providing a disposable container with a wide
open end to facilitate the deposit of fluid in the container and
with at least two features that help protect against spillage of
the fluid during and after deposit of the fluid in the container.
The present invention also makes it safe and easy to deposit of a
test strip in the fluid and further facilitates the examination
of the test strip once deposited therein.
Figure 1 is an illustration of a kit 10 which may include a
~ispos~hle container 11 as well as a test strip 12 and a peg for
hanging the container 11 on an examination room wall or in a
bathroom stall (the peg is not shown). The container 11 includes
the following components. A tubular member, shown generally at
13 is preferably funnel or conical shaped. The upper end 14 is
-- 10 --

2~ 31611
p~eferably wider than the lower end 15 which makes it easier for
a patient to deposit bodily fluids in the upper end 14 of the
tubular member 13. The lower end 15 of tubular member 13 is
sealably attached to valve means 21. The lower end 2la of the
valve means 21 allows fluid to flow downward through the valve
means 21 to the lower end 22 of the collection bag 19 but does
not allow liquid to exit the bag 19. Also illustrated in Figure
1 is the closure means 16 which, in the case of the embodiment
shown in Figure 1, includes a flap 16 attached to the upper end
14 of the tubular member 13. The aperture 17 provides a means
for inserting the test strip 12 after fluid i8 deposited in the
container 11 and after the closure means or lid 16 is shut. The
aperture or access means 17 may also be used to hang the
container 11 from a peg or hook (not shown).
Still referring to Figure 1, the container 11 of the present
invention includes a collection bag 19 and a sleeve 20. The
collection bag 19 includes a lower closed end 22 which serves as
the receptacle for the fluid sample. The upper open end 23 of
the collection bag 19 is sealably attached to the outer surface
or outer periphery 26 of the tubular member 13.
The outer sleeve 20 is disposed around the collection bag
19. Both the upper end 24 and the lower end 25 of the sleeve 20
are initially open. The upper end 24 is sealably attached to the
outer surface 26 of the tubular member 13 at or slightly above
-- 11 --

2131613.
~he point where the upper end 23 of the collection bag 19 is
sealably attached to the outer surface 26 of the tubular member.
The upper outer edges 24a and 24b are sealed to form a closed
sleeve around the collection bag 19 and to prevent any fluid from
entering the sleeve through the upper end 24 and further to
prevent fluid from coming into contact with the patient's hand.
The lower end 25 of the sleeve 20 remains open to facilitate the
insertion of a hand up through the lower end 25 and between the
lower end 25 of the sleeve 20 and the lower end 22 of the
collection bag 19.
Figure 2 presents a top view of the disposable collection
bag initially shown in Figure 1. The closure means or closure
flap 16 has been flipped downward to cover the upper end 14 of
the tubular member 13. It will be noted that the tubular member
13 is made of flexible material such as plastic or cardboard and
the distal ends 27, 28 are squeezed inward toward each other to
widen the surface area of the upper end 14 (see also Figure 1)
of the tubular member 13. Upon release of the ends 27, 28, the
opposing side walls 31, 32 move toward each other and the distal
ends 27, 28 move away from each other to partially close the
upper end 14 of the tubular member and the valve means 21 which
precludes spillage of the liquid specimen. The position of the
container 11 shown in Figure 2 is illustrative of the position of
the container 11 after a fluid sample has been deposited in the
collection bag 19. The patient has closed the flap 16 and hands

2131611
tne container 11 to the nurse. The flap 16 includes the aperture
or access means 17 so as to facilitate the insertion of a test
strip 12 (see Figure 1) through the closure means or flap 16 and
through the valve means 21 and down into the fluid as discussed
s below.
Figure 3 is an illustration of the container 11 prior to use
by a patient. The patient grasps the collection bag 19 between
the Gollection bag 19 and the sleeve 20 up towards the upper end
23 of the collection bag 19 and around the tubular member 13. As
discussed above with respect to Figure 2, squeezing the distal
ends 27, 28 of the tubular member 13 together widens the upper
end 14 of the tubular member and makes the container 11 easier to
use.
After depositing fluid 29 through the tubular member 13 and
valve means 21 and down towards the lower end 22 of the
collection bag 19, the patient then flips the two closure flaps
16 downward to close the upper end 14 of the tubular member 13.
Before closing the flaps 16, the container 11 may be hung by the
hole 17 on a hook or peg while the patient gets dressed. After
taking the container 11 from the patient or removing the
container 11 from a peg or hook, the nurse or technician inserts
a test strip 12 down through the access holes 17 disposed in the
flaps or closure means 16.

21315~1
As seen in Figure 5, the test strip 12 may be easily
examined through the clear collection bag 19. After the test
strip 12 is inserted through the access holes 17, the nurse or
technician grasps the lower end 25 of the sleeve 20 and pulls
5 it upward above the upper end 14 of the tubular member 13. The
now-upper end 25 of the sleeve 20 may be sealed with a wire-type
twist-tie 18 or another sealing means may be employed. For
example, the end 25 of the sleeve 20 may be equipped with a
built-in sealing means such a plastic zipper lock or other
10 equivalent sealing means.
The container 11 shown in Figure 5 is leak proof due to the
multiple seal provided by the valve means 21 and the sealable
attachment of the upper end 23 of the collection bag 19 to the
15 outer surface 26 of the tubular member 13 and the sealable
attachment of the end 24 of the sleeve 20 to the outer surface 26
of the tubular member 13. As seen in Figure 5, the container 11
may be placed on a counter top without fear of leakage. After
the examination of the test strip 12 is completed, the entire
20 container 11 as shown in Figure 5 is thrown away.
From the above description of the preferred embodiment,
it is apparent that the objects of the present invention have
been achieved. While only one embodiment has been set forth,
25 alternative embodiments and various modifications will be
apparent from the above description to those skilled in the art.

~or example, the shape of the tubular member 13 may be molifle
to be more funnel-shaped or more cylindrically-shApe~. Further,
the collection bag 19 and sleeve 20 may be fabricated from a
single piece of plastic and attached to the outer surface or
outer periphery 26 of the tubular member 13. As noted above, the
end 25 of the sleeve 20 may be equipped with a self-sealing means
or a zipper-type closure along the end 25 of the sleeve. Such
closures are disclosed in U.S. Patent Nos. 4,601,694 to Ausnit,
3,980,225 to Kan and 4,055,109 to Xan. It will also be noted
that the test strip or test means may be pre-attached to the
interior of the collection bag. These and other alternatives are
considered equivalents and within the spirit and scope of the
present invention.
Accordingly, it is intended that the scope of the invention
be limited solely by the scope of the hereafter appended claims
and not by any specific wording in the foregoing description.

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