Note: Descriptions are shown in the official language in which they were submitted.
The present invention relates to liquid specimen
collector and testing devices specifically of the type
adapted for the sanitary sampling of human urine as an
indicator of various pathological conditions. As is often
the case, it is desirable to obtain such a sample free
from bacteria present in the body or in the urethra. Such
a specimen is taken during the middle of the period of
urination so that it is taken "in midstream" utilizing the
inherent property of the urine to wash away extraneous
0 bacteria to provide a relatively uncontaminated sample of
urlne .
Heretofore, it has been well known to utilize a
cup or jar or similar container to collect the urine spe-
cimen from the patient by having the patient urinate
directly into the container. In practice, however, the
container of urine may often be exposed unduly to airborne
bacteria and contamination and may be contaminated from
other sources as well. For example, it is often necessary
that the specimen be transferred to various testing
containers, such as, centrifuge tubes and the like, and
additional contamination may thereby result. Further con-
tamination may occur when the analyzing technician
requires a measured quantity of a specimen so that it is
necessary to utilize several receptacles for purposes of
the measurement and storage of the selected quantity.
Contamination can also occur due to bacteria on the sur-
face of the opening of the specimen collector container or
through overflow or imprecise filling of the container.
Midstream collectors have been developed in the
past which have recognized the problems of contamination
of the specimen. For example, United States Patent No.
l~t~
3,832,738 to Kliemann issued 3 September, 1974 and United
States Patent No. 3,711,871 to Sherin issued 23 January,
1973 disclose sanitary liquid specimen collectors having
enlarged mouths and tops to seal these mouths after the
specimen has been collected. United States Patent No.
3,923,040 to Beach issued 2 December, 1975 discloses the
use of a graduated tube having a funnel with a flexible
spout wherein the entire assembly is sealed by a cap
fitting arollnd the specimen tube and spout. In this
apparatus, the collector tube is in the form of a common
centrifuge tube so that it may be utilized for analysis
purposes as well. Similarly, United States Patent No.
3,518,164 issued 30 June, 1970 to Andelin et al, United
States Patent No. 4,026,433 issued 31 May, 1977 to Crippa
and United States Patent I;Jo. 4,106,490 issued 15 August,
1978 to Spilman et al all disclose sanitary urine collec-
tion apparatus including a graduated tube which may be
utilized for analysis purposes, especially with a centri-
fuge apparatus. A problem in the prior art, thoush, has
been the danger of breakage of the specimen tube when
centrifuged, especially where the collector tube is formed
with a sediment trap at its lower end.
The present invention, however, provides a novel
specimen collector which allows the sampling of a
midstream portion of fluid in such manner as to allow the
disposal of the excess fluid while providing a measured
amount thereof. Further, the present device has a rein-
forced sediment trap and is adaptable for use with stan-
dard centrifuge machines without requiring transfer of the
fluid to a special centrifuge tube.
9~1~
It is therefore an object of the present inven-
tion to provide a novel and improved urine specimen
collector device as a sanitary and effective means for
collecting and analyzing samples of human urine.
Another object of the present invention is to
provide a convenient means for collecting urine specimens
occurring "midstream" directly into a specimen tube.
Another object of the present invention is to
provide a urine specimen collector which allo~s collection
of a urine sample in a minimum number of steps while mini-
mizing the risk of contamination.
Still another object of the present invention is
to provide a two-piece urine collector which allows the
user to discard excess of the sample while automatically
providing a measured quantity for analysis all under sani-
tized conditions.
Still a further object of the present invention
is to provide a urine collector assembly wherein the
sample is conducted directly into an analysis tube having
a reduced portion of measured volume to retain a measured
amount of fluid upon inversion of the analysis tube and to
receive solid precipitate from that sample during centri-
fuge analysis.
Yet another object of the present invention is to
provide a urine collector assembly including a funnel and
centrifuge tube which are configured for collecting a
controlled volume sample of the "midstream" portion of
urine in which a vapor lock is established between the
funnel and tube; and wherein the surface tension of the
fluid in a reduced portion of the tube is such that a
simple yet accurately measured volume of liquid sample or
solid precipitate can be collected while avoidin~ undue
contamination of the sample by the user.
The present invention is adapted to be used to
collect a midstream portlon of a urine specimen and inclu-
des a collector tube adapted to be employed with centri-
fuge machines and which tube has a lower reinforced reser-
voir tip at one end and an outwardly flared mouth opposite
the reservoir tip. The reservoir tip is of a selected
volume and is generally cylindrical having a mouth of
reduced diameter with respect to the main body of the
tube. Upon inversion of the tube, the surface tension of
the specimen fluid in the tip causes the tip to retain a
measured amount of fluid. The reservoir tip also receives
solid precipitate during the centrifuging operation. In
order to permit use of the collector tube during the
centrifuging operation, the reservoir tip has thickened
A sidewall portions-~crfcr~b~ ~n the form of a plurality of
circumferentially spaced external reinforcement ribs
extending in a longitudinal direction from -the sidewall of
the reservoir tip of the centrifuge collector tube whereby
to support the reservoir tip and reinforce it in circum-
ferential and longitudinal directions.
In order to facilitate collection and to enhance
sanitary collection of the specimen, the collector
assembly includes a funnel-shaped member having an
elongated spout provided with an angled tip or discharge
end which is adapted to be inserted into the main body
portion of the collector tube. The collector tube has an
outwardly flared mouth opposite the reservoir tip which is
shaped to conform to the external surface of the funnel so
that the funnel may firmly seat and be sealed in the mouth
i~7~
o~ the collector tube, and the mouth provides a lip
constructed to snap-fit with a sealing lid. Further, the
funnel has a plurality of ribs on its internal surface to
direct the flow of fluid toward the elongated spout for
conducting the fluid into the collector tube.
The collector tube is graduated so that the
volume of liquid contained therein may be readily
observed. A feature of the present invention resides in
the selection of length and size of the elongated spout of
0 the funnel and the seating of the funnel surface against
the flared mouth of the collector tube. Particularly, the
seating of the funnel and mouth of the collector tube
establish a vacuum or vapor lock when fluid is introduced
into the collector tube through the funnel to prevent
overflow; and, upon inversion of the apparatus, any por-
tion of the sample in the funnel may be exhausted.
Therefore, the positioning of the mouth of the elongated
tip defines the amount of fluid which will remain in the
collector tube so that a standard measurement quantity may
automatically be retained.
By constructing the funnel and tube out of a
plastic or plastic-like material, an inexpensive apparatus
may be provided and, if desired, this apparatus may be
disposable. Further, by constructing the apparatus out of
inexpensive materials, contamination can be reduced by
avoiding the need for reuse of the collector apparatus.
Contamination is also minimized in operation when a sample
is placed in the collector tube and automatically measured
A , ,~
by inverting the apparatus with the collector tube sn~e-
30 quently being usable in a centrifu~e so that there is no
need to contaminate the sample by transferring it to a special
receptacle.
In summary, the invention provides a urine specimen
collector tube assembly comprising an elongated tubular member
having an open end, a closed end opposite the open end, and a
surrounding sidewall between the open and closed ends, which
terminates in a rounded convergent end wall adjacent the closed
end. A reservoir tip at the closed end defines an axial
extension of the convergent end wall, the degree of convergency
being sufficient to prevent release of the portion of the
specimen contained in the tip when the tubular member is
inverted to pour out the specimen. External reinforcing means
extend between and are united with the reservoir tip and the end
wall.
A funnel-shaped member includes a generaily conical
sidewall and an elongated spout attached a-t one end to the
vertex of the sidewall in fluid communication with the interior
of the funnel member and having an opening at the opposite end.
The exterior of the sidewa]l is substantially smooth and
uninterrupted. Adjacent the sidewall, the spout is configured
for and disposed in c]ose-fitting engagement with the open end
of the tubular member so that the spout extends into the tube.
These and other objects, advantages and features will
become more readily appreciated and understood when taken
together with the following detailed description in conjunction
with the accompanying drawings, in which:
Figure 1 is a front elevational view of the mids-tream
collector assembly according to the 2referred embodiment of the
present invention;
Figure 2 is a top plan view of the collector assembly
according to the preferred embodiment Gf the present invention;
Figure 3 is a cross-sectional view of the preferred
embodiment of the present invention taken about lines 3-3 of
Figure 2;
Figure 4 is a bottom plan view of the preferred
embodiment of the present invention taken about lines 4-4 of
F'igure 3; and
Figure 5 is a cross-sectional view of the upper por-
tion of the preferred collector tube including a sealing plug
therefor.
As is shown in Figure 1, collector assembly 10
includes a graduated collector tube 12 and a funnel 14. Tube
12 has an elongated cylindrical main body 16 which is closed
at one end by a sediment trap in the form of a reservoir tip 18
and which has an outwardly flared mouth 20 with an e~posed
edge 39 at an end opposite reservior tip 18. Funnel 14 is
adapted to be inserted into collector tube 12 and includes a
conical body portion 22 which has an upper circular rim 24 and
an elongated spout 26 opposite circular rim 24 at the vortex of
conical body
li'7~3~3~
portion 22. As is shown in Figures 2 and 3, funnel 14
has a smooth uninterrupted outer surface 28 and is pro-
vided on its interior surface 30 with a plurality of ribs
32. Ribs 32 function to direct or guide a fluid sample
entering funnel 14 towards spout 26 for discharge into
collector tube 12.
Elongated spout 26 is tapered so 'chat its
sidewall 34 converges to a mouth or open end 36. Open end
36 may be formed in a plane at an angle to the longitudi-
nal axis of funnel 14 and functions as is hereinafter
described. As may be noted in Figure 3, midportion 3~ of
funnel 14 is configured in a shape which conforms to that
of flared mouth 20 of collector tube 12 so that an annular
A portion of funnel~t~ abuts the upper frustoconical portion
of flared mouth 20 of collector tube 12.
An important feature of the present invention is
found in the construction of the closed end 40 of collec-
tor tube 12. Closed end 40 is formed by a convex rounded,
downwardly convergent end wall 42 of main hody 16 tapering
sharply at an angle o greater than 4S into a closed
cylindrical reservoir tip 18 which is coaxial with main
body 16 to define a sediment trap in the form of a
cylindrical nose portion of tube 12. As noted, reservoir
tip 18 has a closed rounded tip 44 and a cylindrical
sidewall 46 with cylindrical sidewall 46 having a smaller
diameter than main body 16, the end wall 42 rapidly
increasing in diameter away from the upper edge of
sidewall 46 so that a sharp ~dge or shoulder is formed at
the juncture between the end wall 42 and sidewall 46. A
particular problem among the prior art in forming a reser-
voir tip such as tip 18 has been the fragile nature of
this construction so that the tuhe is not readily adap-
table to analytical measurement machines for fear of
breakage. The present invention, however, removes this
disa~vantage by having a plurality of support ribs 48 at
equally spaced intervals around the reservoir tip 18
defining thickened sidewall portions therefor, with these
thickened sidewall portions being somewhat thicker than
main body 16. Specifically, ribs 48 extend lengthwise and
are tapered downwardly from rounded end wall 42, along
cylindrical sidewall 46 to points adjacent tip 44 of
reservoir tip 18. In this manner, the entire length of
reservoir tip 18 is reinforced by ribs 48 a]ong spaced
intervals about its sidewall 46. While in the preferred
embodiment four such ribs 48 are provided, any number may
be employed so long as suitable reinforcement is present
for tip 18. Ribs 48 are generally triangular and
A ~ fin-shaped and may be of the same thicXness as
the sidewall of collector tube 12, but may also be fabri-
cated with a reduced thickness on the order of one-half
that of the sidewall cf tube 12. It is important,
however, to increase substantially the effective thickness
and strength of the sidewall of tip 18 so as not to be
subject to breakage during a centrifuging procedure. As
shown in Figures 1 and 3, ribs 48 are triangularly shaped
so as to join end wall 42 and tip 44 while having a suf-
ficient width so that the unconnected inclined edge of the
triangle tapers or converges downwardly along a line bet-
ween the sidewall of collector tube 12 and the end of
reservoir tip ~4.
To seal collector tube 12, a plug 60 has a
cylindrical sidewall 62 which has a tapered nose 64 ter-
minatinq in a flat end wall 66. Sidewall 62 has an upper
117~
surrounding shoulder 68 opposite end wall 66 which is con-
figured to abut flared mouth 20 when inserted in collector
tube 12 as shown in Figure 5. Tab 70 is attached to end
wall 66 internally of sidewall 62 and extends outwardly of
plug 60 so that it may be easily gripped by the user to
withdraw plug 60 fro~ collector tube 12.
Utilization of the collector tube and funnel
according to the present invention may now be appreciated
with respect to the particular configuration of funnel 14
and flared mouth 20 as well as reservoir tip 18. In use,
funnel 14 is placed in collector tube 12 so that midpor-
tion 38 abuts flared mouth 20 around an annular portion of
collector tube 12. The patient then fills collector tube
12 with a biological specimen by means of funnel 14 so
that the biological specimen fills collector tube 12 and
covers open end 36 of elongated spout 26. This creates a
vapor lock at a fluid level defined by the position of
open end 36 so that excess fluid does not enter tube 12.
If an excess of the specimen is taken so that the fluid
level extends into funnel 14, the patient may drain the
excess fluid. An automatically measured amount of fluid
is therefore obtained by the vacuum seal After the
measured amount of fluid is provided in collector tube 12,
the sample may be sealed with plug 60.
At this point, the sample is ready for analysis.
Preferably the spout has an internal diameter of
approximately 0.65 cm or .25 inch where a urine specimen
is to be collected. It is important, for a selected
fluid, that the diameter of the spout be sufficiently
large to allow venting of the air in the collector tube.
If the diameter is too small, the surface tension of a
il'~t~3~14
viscous fluid will cause the stream of fluid entering the
funnel member to seal the spout thereby preventing the
escape of air from the collector and consequent]y pre~
venting entry of fluid into the collector tube.
Further preparation for analysis of the sample
may be undertaken directly in collector tube 12 since, by
having reinforced reservoir tip 18, the sample may be
directly centrifuged without the need for transferring
containers. Reservoir tip is sized to have a volume of
0 .25 milliliters in the preferred embodiment but may be
sized for other volumes such as .5 milliliters, 1.0 milli-
liters or in another desired volume. When a urine speci-
men is centrifuged in collector tube 12, suspended solids
are then collected and concentrated in reservoir tip 18 to
form a sediment or semi-solid material having the volume
of reservoir tip 18. The fluid portion of the sample may
then be transferred to another container or disposed of
with the solid plug of material being ready for further
analysis as a pre-measured volume. ~eservoir tip 18 also
permits the automatic measuring of an amount of fluid
corresponding to its volume upon inversion of tuhe 12
since the diameter of its mouth is relatively small so
that the surface tension of the fluid holds the fluid in
the reservoir tip. Analysis of the fluid may then be
conducted.
It will be evident that while the preferred form
of this invention has been described specifically in con-
junction with its use for urine specimen analysis, it is
conformable for use in other applications, such as for
instance, radioimmunoassay determinationc. Generally,
therefore, it has application to any determination in
-- 10 --
which a limited but measured volume of material is to be
collected and analyzed. Accordlngly, although the present
invention has been described with particularity relative
to the foregoing detailed description of the preferred
embodiment, various modifications, changes, additions and
applications other than those specifically mentioned
herein will be readily apparent to those having normal
skill in the art without departing from the spirit and
scope of this invention.
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