Midstream urine specimen collecting device

A device for collecting a urine specimen, which is particularly adapted for females, is configured and adapted for use while the user is sitting on a toilet in the normal position for voiding. The device selectively collects the clean, contaminant-free mid-stream portion of urine. The device includes a urine specimen container releasably secured to a conduit extending from a collection exit in a urine receiving chamber. This exit is positioned in the chamber above a urine bleed-off exit adapted for removing the first portion of urine at a controlled rate. The collection exit is remote from the bleed-off exit, is shielded from urine splashing thereinto, as by a dome-shaped cap releasably secured thereover, and is below a urine overflow exit in the chamber. The chamber preferably is open topped and is supported on a hollow base within which the specimen container is disposed. An upwardly curved handle extends out from the chamber. The device is inexpensive, simple and disposable and the chamber, base, conduit and handle can be integrally molded in a single operation. The shield and specimen container can be separately formed.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
This invention generally relates to collecting devices and, more 
particularly, to portable urine collection devices, particularly for use 
by females. 
2. Description of the Prior Art 
Urine analysis is such a simple, common and useful diagnostic aid that the 
taking of a urine specimen is generally included in even the simplest of 
physical examinations. It is important not only as an indicator or 
detector of certain physical conditions and diseases, but it is also 
particularly useful in connection with the treatment of infections related 
to the urinary tract, which are much more common in females than males. 
However, the problem of collecting a suitable specimen is considerably 
more complex when a female patient is involved. 
Thus, in the collecting of a urine specimen from a female patient, it is 
important to take the specimen as a "mid-stream" or "clean catch" sample. 
When a female patient voids in the normal manner, the initial portion is 
more likely to contain contamination from foreign matter than that portion 
which follows. This is because the initial portion is expelled with less 
force and usually is voided as a mere trickle which is likely to trail 
along the labia and pick up whatever contamination is present in those 
areas. The mid-stream portion is expelled with the greatest force and is 
most likely to leave the urethral meatus directly as a stream without 
contacting the labia or, if it does, the labia will have had most of the 
contamination washed off by the initial portion. 
Some practitioners go to considerable lengths in an effort to obtain an 
uncontaminated urine sample from a female patient. With the patient in a 
reclining position, an attendant cleanses the area adjacent the urethral 
meatus with a suitable solution in an effort to wash off the contamination 
which is generally present in that area. Even with such precautions, 
however, contamination may develop in the collected urine sample to a 
level sufficient to give a false or misleading indication of the bacteria 
level in the sample. Moreover, taking a sample under such conditions is an 
extremely awkward and uncomfortable experience for the patient and is 
fairly costly, since the patient is required to be present in the 
physician's office or a hospital with a special attendant, usually a 
nurse, administering the procedure. 
What has been needed in some simple but effective, foolproof device, 
preferably disposable after a single use, which a patient can use with a 
minimum of instructions and without assistance, while voiding in the 
normal manner. The device should have the capability of receiving the 
entire amount of voided urine, rejecting the initial portion, selecting a 
portion corresponding to the mid-stream sample and transferring it to a 
specimen container, and rejecting the remainder of the voided urine by 
directing it, together with any overflow from the specimen container, into 
the toilet on which the patient is positioned in the normal attitude. 
Although the device set forth in U.S. Pat. No. 4,040,791 which issued on 
Aug. 9, 1977 to applicant of the present application and is entitled 
Specimen Collecting Device accomplishes the foregoing objects, such device 
has been found to be somewhat complicated and expensive to manufacuture. 
For example, it cannot be made in a single high-speed molding operation 
but must be assembled from a plurality of parts. Moreover, it requires 
certain close tolerances which demand high quality control. Therefore, it 
is not as simple and inexpensive as one would desire for a disposable 
device intended for extensive usage. Moreover, it is somewhat difficult to 
handle and orient while using it. Therefore, it would be desirable to 
provide an improved device of the same general type which would be as 
efficient but less expensive, and easier to handle, orient and use. 
SUMMARY OF THE INVENTION 
The foregoing objects have been achieved by the improved device of the 
present invention. The device is substantially as set forth in the 
Abstract above. Not only is it very simple, but it can be rapidly 
manufactured into a unitary product in a single low-cost molding 
operation, preferably from inexpensive material, such as plastic, rubber 
or the like. Moreover, it is highly efficient in isolating and collecting 
contaminant-free urine. The device is particularly adapted for convenient 
use by a female patient while she is sitting on a toilet. Thus, she can 
void urine into the device and the urine can be easily and simply 
collected. For such purposes the improved device of the invention 
comprises a urine-receiving chamber having a urine-receiving opening at 
its upper end and three urine exits at different levels. The first exit is 
adjacent the lower end of the chamber and may be in a recess or pocket. It 
is for bleeding first-voided urine from the chamber and device at a slow 
controlled rate into the toilet so that as voiding continues the urine 
level rises to the second exit which is above the first exit and 
preferably remote therefrom. Thus, the second exit passes clean, 
contaminant-free mid-stream urine to a detachable urine specimen container 
positioned therebelow within a hollow support base for the chamber and 
connected thereto by a conduit. As voiding continues the urine level in 
the chamber may rise above the second exit, particularly when the specimen 
container becomes filled. When the urine level reaches the height of the 
third exit (above the level of the second exit) excess urine passes 
through that exit and from the chamber and the device to the toilet. Thus, 
only the clean mid-stream urine is retained in the specimen container. At 
cessation or diminishing of voiding rate, the excess urine trapped in the 
chamber below the third exit level bleeds out through the first exit until 
only the urine sample in the specimen container remains. 
An upwardly and outwardly curved handle is preferably disposed on the 
device on the side opposite the first and third urine exits to facilitate 
urine run-off into the toilet and correct positioning of the device. The 
handle may be serrated and have a finger stop. The second exit is 
preferably centrally located as, for example, in a central vertical stand 
pipe in the chamber, and a urine-deflecting shield may be releasably 
attached over the stand pipe and second exit to prevent inadvertent entry 
of first flow urine into the second exit. Further details of the invention 
are set forth in the following detailed description and accompanying 
drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENT 
Now referring more particularly to FIGS. 1-6 of the accompanying drawings, 
a preferred embodiment of the improved urine specimen collecting device of 
the present invention is schematically depicted therein. Thus, device 10 
is schematically shown in side elevation in FIG. 1. Device 10 includes a 
generally cylindrical housing 12 comprising an open-topped upper 
urine-receiving chamber 14 integrally secured to a lower hollow support 
base 16, and a urine specimen container 18 disposed within base 16 and 
releasably attached to chamber 14 by a depending conduit 20. 
Chamber 14 is defined by the vertical annular sidewall 22 of housing 12 and 
by a curved closed bottom 24 (FIG. 3). Bottom 24 generally slopes down 
toward the base of a central vertical hollow stand pipe 26 (FIGS. 1 and 
3). However, a ramp portion 28 is provided in bottom 24, which ramp slopes 
down from the base of standpipe 26 to a generally vertical narrow pocket 
or recess 30 defined in part by a portion of the periphery (sidewall 22) 
of device 10. Recess 30 has a generally horizontal wall or bottom 32 
adjacent its lower end and the lower end of device 10, which wall 32 
defines a narrow vertical urine bleed hole 34 down through which urine 
exits device 10. Recess 30 is also defined by a pair of spaced, hollow, 
open-topped vertical columns 36 disposed on opposite sides of recess 30 
and which extend to the bottom 38 of device 10 and which also rise above 
the upper level of standpipe 26 in chamber 14. Columns 36 are each defined 
by intersecting walls 40 and 42 terminating at side-wall 22 (FIG. 2). 
Columns 36 define passageways 44 which channel excess urine from chamber 
14 and device 10, such urine exiting from the bottom 38 of device 10. 
Standpipe 26 comprises a joined pair of hollow open-topped vertical tubes 
46 and 48, tube 46 terminating at a higher level than tube 48 above bottom 
24 and serving to relieve air from the specimen container 18 as urine 
enters through the tube 48. Both tuber 46 and 48 terminate well below the 
top of columns 36. Tubes 46 and 48 depend below chamber 14 and form a dual 
conduit 50 received within a central opening 52 (FIG. 5) in the removable 
cover portion 54 of urine specimen container 18 to permit the filling of 
container 18 from chamber 14. Thus container 18 is slidably releasably 
received over conduit 50. Preferably, a portion 56 of the lower end 58 of 
conduit 50 is tapered so that container 18 can be easily slipped on and 
off conduit 50. A releasable closure 51 is connected to the top of cover 
54 via a flexible strip 53 which permits opening 52 to be sealed when 
container 18 is filled. 
A protective urine shield 60 is preferably releasably disposed in the upper 
end 62 of tube 46. Shield 60 is mushroom shaped. Thus, it comprises a 
protective dome 64 with an index tab 66 to help align depending blade or 
stem 68 slidably received in end 62 so that a portion of dome 64 will 
extend over the open upper ends 70 of tube 48 and 71 of tube 46. It will 
be noted that stem 68 may be vertically asymmetrically disposed relative 
to dome 64 to permit dome 64 to extend far enough over to protect ends 70 
and 71. Thus, when urine is voided down into chamber 14, dome 64 prevents 
it from running or splashing directly into ends 70, 71. End 70 forms a 
urine collection exit which continues as tube 48 of conduit 50. 
Thus, it will be noted that chamber 14 is, in part, characterized by the 
presence of three separate urine exists at different levels: namely, exit 
34 at the bottom of recess 30 near bottom 38 of device 10; exit 70 at the 
top of tube 48 well above the level of exit 34; and exit 72 at the open 
upper ends 73 of columns 36 well above the level of exit 70. When urine 
voiding into device 10 is initiated, preferably while the female patient 
is sitting on a toilet holding device 10 immediately below her urethra, 
the contaminated first portion of urine passes down into chamber 14, and 
may strike dome 64 in doing so, but in any event passes down into recess 
30 and begins to leave device 10 through exit 34. Since exit 34 is small 
(preferably about 3/32 inch diameter), urine leaves device 10 slowly 
enough so that recess 30 becomes filled and, by the time midstream urine 
is being voided, urine rises to the level of exit 70 in chamber 14 and 
begins to pass down conduit 50 and into container 18. The urine which 
passes down conduit 50 is laregly that of the mid-stream portion, so that 
the urine specimen collected in container 18 is essentially contaminant 
free. Once container 18 is filled, urine backs up in conduit 50 and the 
level of urine in chamber 14 rises above exit 70 to the level of overflow 
exit 72, passes into columns 36 and exits device 10 from bottom 38. 
Preferably exit 70 is remote from exit 34. Moreover, although exit 34 
could theoretically be dispensed with, it is highly desirable in order to 
remove the most contaminated urine (first flow) immediately from device 10 
so as to enhance the purity of the specimen ultimately passed to container 
18. It is also useful to empty the collecting chamber 14 after the 
specimen container 18 is filled. 
In order to facilitate holding device 10 conveniently in the right 
position, a handle 74 is provided which is curved outwardly and upwardly 
from housing 12 in the area of chamber 14 (FIG. 1) and which preferably 
terminates at a point level with the top of chamber 14. This is to 
facilitate molding of handle 74, chamber 14, conduit 50, standpipe 26 and 
base 16 from rubber, polyethylene, polyvinyl, plastic or the like into a 
single unitary body in a single, inexpensive, one-step high-speed molding 
operation. Shield 60 and container 18 can be separately formed in 
high-speed forming operations from plastic, rubber or the like and thus 
are also inexpensive. Handle 74 preferably has serrations 76 along the 
upper surface 78 to facilitate gripping of handle 74 with the user's 
thumb, and a finger stop 80 adjacent the outer end 82 thereof, again to 
facilitate gripping of handle 74. This arrangement is symmetrical to 
facilitate use by both right-handed and left-handed persons. Handle 74 
permits device 10 to be easily packaged, stocked and stored, and also to 
be placed upside down to fit container 18 in place. In addition, base 16 
is cut away at a number of spaced locations to provide finger openings 84 
to facilitate gripping container 18 while device 10 is in the upright 
position, for example, in removing a urine filled container 18 from device 
10. Closure 51 may also be used to help pull container 18 free of conduit 
50, whereupon closure 51 can be secured to opening 52 to seal urine in 
container 18 against contamination or leakage before testing thereof. 
It is preferred to have exits 34 and 72 on the side of device 10 away from 
(that is, opposite) the handle 74 so that the slight tilt usually given by 
the patient to device 10 held in the normal position during voiding will 
help to keep urine flowing from exits 34 and 72 until the chamber 14 is 
empty. 
Thus, device 10 is simple, compact, inexpensive, easy to use and 
disposable. It can be made from readily available materials at high speed 
in a single molding operation (except for the optional dome and the 
container). Moreover, it facilitates the most efficient and rapid 
collection of contaminant free urine from a female without any mess, 
inconvenience or embarrassment. Other advantages are as set forth in the 
foregoing. 
Various changes, modifications, alterations and additions can be made in 
the improved urine specimen collecting device of the present invention and 
in the components and parameters thereof. All such changes, modifications, 
alterations and additions as are within the scope of the appended claims 
form part of the present invention.