U.S. patent number 3,750,648 [Application Number 05/108,766] was granted by the patent office on 1973-08-07 for means for collecting specimens of urine.
Invention is credited to Manfred R. Bottaccini, Donald M. Gleason, Robert J. Reilly.
United States Patent |
3,750,648 |
Gleason , et al. |
August 7, 1973 |
MEANS FOR COLLECTING SPECIMENS OF URINE
Abstract
A device for collecting, from human females, specimens of urine
substantially free from external contamination. The device includes
a hollow body having a mouth adapted to be placed around the meatus
of the female and between the labia, a conduit passing through one
wall of the hollow body and having an opening at one end thereof
within the hollow body and completely spaced from the walls of the
hollow body for receiving the high trajectory uncontaminated
portion of the urine flow, a collecting vessel at the other end of
the conduit for collecting the uncontaminated urine, and means for
separately conducting the urine flow not entering the opening.
Inventors: |
Gleason; Donald M. (Tucson,
AZ), Bottaccini; Manfred R. (Tucson, AZ), Reilly; Robert
J. (Tucson, AZ) |
Family
ID: |
22323923 |
Appl.
No.: |
05/108,766 |
Filed: |
January 22, 1971 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
31204 |
Apr 23, 1970 |
|
|
|
|
Current U.S.
Class: |
600/574; 600/575;
4/144.3; 604/329 |
Current CPC
Class: |
A61B
10/007 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2F,2R,295,294
;4/110 ;73/425.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,144,483 |
|
Mar 1969 |
|
GB |
|
794,640 |
|
Sep 1968 |
|
CA |
|
Primary Examiner: Howell; Kyle L.
Parent Case Text
This is a continuation-in-part of U. S. Pat. application Ser. No.
31,204 filed Apr. 23, 1970, now abandoned.
Claims
What is claimed is:
1. A device for collecting a sample of urine from the midstream
portion of a voiding stream of a human female comprising:
a hollow body having an oval laterally presenting mouth, an upper
surface and side walls, and a back wall opposite said mouth, said
mouth adapted to fit between and separate the labia and at least
partially surround the meatus and remain spaced therefrom during
voiding;
a conduit having an upper end and a lower end, the upper end of
said conduit extending into said hollow body through a wall and
having an opening at the end completely spaced from all of the
walls of said hollow body and facing said mouth so that no urine
flowing along the surface of any of the walls may flow into the
opening and through which urine samples from the midstream portion
can pass, and the lower end of said conduit having means for
connecting the conduit to a specimen container; and
a specimen collecting container, mounted to said means for
connecting, to collect the urine entering said opening.
2. A device for collecting a sample of urine from the midstream
portion of a voiding stream of a human female comprising
a hollow body having an oval laterally presenting mouth, upper and
side walls, and a back wall opposite said mouth, said mouth adapted
to fit between and separate the labia and at least partially
surround the meatus and remain spaced therefrom during voiding;
a generally elbow-shaped conduit having an upper end and a lower
end, the upper end of said conduit extending into said hollow body
through said back wall and having an opening at the end completely
spaced from all of the walls of said hollow body so that no urine
flowing along the surface of any of the walls may flow into the
opening and through which urine samples from the midstream portion
can pass, and the lower end of said conduit having means for
connecting the conduit to a specimen container; and
a specimen collecting container, mounted to said means for
connecting, to collect the urine entering said open-ing.
3. A device according to claim 2 wherein said mouth includes means
defining a notch at the lower end thereof for permitting immediate
discharge of all of the urine not flowing into said opening and
preventing the accumulation of any urine in said hollow body.
4. A device according to claim 3 wherein said upper end of said
conduit is a hollow projection which is substantially rectangular
in cross-section and which protrudes into said hollow body
substantially perpendicularly from said back wall.
5. A device according to claim 4 wherein the upper end of said
conduit protrudes into said hollow body from said back wall a
distance substantially equal to one-third the length of the upper
wall of said hollow body.
Description
This invention relates to a device for collecting specimens of
urine from female patients, and more particularly for collecting
specimens of urine substantially free from external contamination,
and truly representing the conditions of the main body of the urine
as it actually exists in the bladder.
The initial stream, at the beginning of the voiding operation,
contains all of the accumulated debris and mucous collected in the
urethra since the previous voiding, and therefore, either by itself
or mixed with the rest of the urine, does not constitute a true
sample of the condition of the main body of the urine in the
bladder free from this initial flow. The initial discharge must
therefore be separated from the rest of the urine in the bladder
before taking a sample of this main body of urine. The initial
discharge is washed out by the first few spoonfuls of normal urine
as the flow continues.
The principal object of the invention is to devise means for
effectively separating this initial discharge from what we shall
call the "midflow stream." We have discovered that the initial
stream is discharged from the urethra with relatively low energy or
velocity, while the midflow stream comes out with relatively high
energy or velocity. The trajectories of the two streams are
therefore widely different. Based on this discovery, we have
devised as one form of the invention, apparatus which enables us to
automatically separate and direct into different conduits the
liquid delivered by the two streams.
This apparatus comprises a rigid body formed with a relatively wide
mouth, shaped to be inserted between the labia so as to separate
them. The rim of this mouth encloses but is spaced from the meatus
from which the streams issue. This body is provided with two
rigidly connected conduits, these conduits, when the device is in
use, having vertically extending portions, the lower open end of at
least one of which is connected with the upper end of a vertically
disposed receptacle. The difference in the trajectories of the two
streams causes the streams to selectively enter the two conduits
and thus be effectively separated.
In another form of the invention, a valve is used to block flow
through one conduit while the initial stream is discharged from the
other, thus effectively separating the two streams.
In order that the invention may be readily understood, reference is
had to the accompanying drawings, forming part of this
specification and in which:
FIG. 1 is a diagrammatic fragmentary side elevation showing in
broken lines the patient in sitting position, and illustrating how
she herself can apply our device without any help from an
attendant;
FIG. 2 is a vertical section, on an enlarged scale, throughout the
device when in position for use, parts of the patient's anatomy
being indicated in broken lines;
FIG. 3 is a front elevation of the body of the device when viewed
from the plane of the line 3--3 of FIG. 2, looking in the direction
of the arrows;
FIG. 4 is a fragmentary section on the line 4--4 of FIG. 2, looking
in the direction of the arrows, parts of the patient's anatomy
being illustrated in broken lines;
FIG. 5 is a side elevation of a modified form of the invention,
parts being shown in section, and portions of the patient's anatomy
being indicated in broken lines, as in FIG. 2;
FIG. 6 is a front elevation of the modification shown in FIG. 5,
looking from the line 6--6 of FIG. 5 in the direction of the
arrows;
FIG. 7 is a vertical section through the body and conduits only of
the form of the invention shown in FIG. 2, all other parts being
omitted for the sake of clearness;
FIG. 8 is a vertical section through the body of a further
embodiment of the invention;
FIG. 9 is a front elevation of the device of FIG. 8;
FIGS. 10 and 11 are respectively a front elevation and a vertical
section through a further embodiment of the invention, and FIGS. 12
and 13, are, respectively, a front elevation and a vertical section
through yet another embodiment in accordance with the
invention.
Referring to the drawings in detail, and more particularly first to
FIGS. 1, 2, 3 and 4, our device comprises a rigid body 1, formed of
suitable plastic, and having a relatively large, laterally
presenting mouth 2. The device is designed to be applied to the
patient in natural sitting position, and when so applied, the body
and mouth are disposed in substantially vertical position, the
mouth being of vertically elongated shape, as clearly shown in FIG.
3. A barrier 3, closing the lower end of the mouth, is preferably
employed to aid in controlling the flow of urine.
Associated with body 1 are two downwardly directed conduits 4 and
5, the conduit 4 opening directly from the bottom of the body, and
the conduit 5 extending horizontally from the upper part of the
body and then bending downwardly. The conduit 5 may either be
formed integral with the body, or separately fabricated and
attached to the body, as by welding, as shown in FIGS. 2 and 7.
The purpose of these two conduits, connected with opposite ends of
the body is to effectively separate the initial discharge from the
uretha from the midstream urine discharge coming from the bladder
later on, after the elapse of a certain time interval, as
hereinafter described.
As shown in FIG. 2, the end of the conduit 4 is illustrated as
being formed with a vent 8 and as having a recpetacle 6 secured
thereto, but this conduit may, in most cases, be connected to
waste. The end of conduit 5, however, has a receptacle 7 secured
thereto, provided with a vent 9. This receptacle is ncessary to
collect the desired specimen of urine.
In order to illustrate the operation of the device we have
endeavored to indicate in FIGS. 2 and 4 some of the parts of the
female anatomy. Thus, the uretha leading from the bladder is shown
at A, and the orifice at the outer end, from which the streams
issue, and which is called the meatus, is shown at B. The position
of the labia, when the device is in place, is indicated at C.
It will be noted, by reference to FIGS. 2 and 3 that the upper end
of the mouth 2 is rather narrow or pointed, as shown at 2a.
OPERATION
Normally, the meeting sides or edges of the labia, especially the
labia majora, at each side of the center, are substantially in
contact, overlying and covering up the meatus. For the purpose of
obtaining clean and uncontaminated samples of urine as it existed
in the bladder, it is desirable to get the labia out of the way, so
that the stream of urine may issue freely from the meatus without
coming in contact with the labia. To achieve this, the pointed end
2a of the mouth 2 is inserted between the lower part of the labia
and the mouth is then pushed upwardly and inwardly until it
completely separates the labia and uncovers the meatus, as shown in
FIGS. 2 and 4. When in this position, the rim of the mouth
surrounds and encloses the meatus, but is spaced from it on all
sides, especially at points above and below it. When inserting the
device between the labia, the pushing may be continued until
further movement is stopped by engagement of the rim of the mouth
with the vestibule, but as illustrated in FIG. 4, it is not
necessary for the rim of the mouth to contact the vestibule.
With the device in position as shown, voiding is begun. As above
mentioned, the initial discharge from the uretha is likely to be
mixed with all of the accumulated debris and mucous collected in
the urethra, and is not suitable for diagnostic purposes as a true
specimen of the urine existing in the bladder. Also, as already
mentioned, this initial discharge issues with relatively little
energy and at relatively low velocity. This initial stream
therefore follows a trajectory somewhat as indicated by the dotted
line X in FIG. 2, passing through the conduit 4 at the bottom of
the body into the receptacle 6 or waste.
After a brief interval, and without interruption of the voiding,
however, the midflow stream automatically begins; as previously
mentioned, this midflow stream issues from the meatus at relatively
high velocity, and thus follows a trajectory somewhat as shown by
the broken line Y. This is discharged substantially horizontally,
passing into the conduit 5 through the opening 5a. It strikes the
inner curved surface of the wall of this conduit and is thereby
deflected downwardly, as indicated at Z, into the receptacle 7. The
specimen collected in this receptacle is a true, uncontaminated
sample of the urine contained in the bladder, and may be used with
confidence for diagnostic purposes.
The opening 5a, providing communication between the body 1 and
conduit 5 is preferably somewhat restricted; that is to say, it is
made as small as practicable so that if the stream of midflow urine
should tend to spray before reaching the opening, only the central
portion of the stream will enter said opening, while the outer
fringes of the spray will impinge upon the surrounding surfaces and
trickle down the same to waste. This tends to further reduce the
possibility of contamination of the specimen collected in the
receptacle 7.
It will be particularly noted that while the rim 2 of the mouth
completely surrounds and encloses the meatus, it is spaced
laterally therefrom in all directions, so that the interior of the
mouth and body provide sufficient free space to permit the streams
to follow different trajectories.
While it has been assumed in the preceeding discussion that in most
cases the only desired specimen is that obtained during the midflow
stream and collected in receptacle 7, while the initial discharge
may be discarded, it will be recognized that, for purposes of
certain diagnostic procedures, it may be desirable to collect and
retain the initial flow in as undiluted form as possible. A
significant advantage of the invention is that the separation is
accomplished automatically without special preparation, instruction
or apparatus other than that shown in FIGS. 1-4, and that the
specimens collected in either or both of the receptacles 6 and 7
can be examined, if desired.
A modified embodiment of the invention, illustrated in FIGS. 5 and
6 shows another way of effectively separating the initial discharge
from the desired midflow stream.
While the embodimwnt shown in FIG. 2 operates automatically to
effect the separation, the modified arrangement of FIGS. 5 and 6 is
not automatic but requires manual adjustment by the patient.
Referring now in detail to FIGS. 5 and 6, this form of the
invention includes a rigid body 1 having a laterally presenting
mouth 2', and conduits 4 and 5', generally similar to the
arrangement of FIG. 2. In the modified form, however, a valve 10 is
provided, extending across the entrance to the conduit 5', and when
closed, as shown in full lines in FIG. 5, blocking the flow of
liquid into this conduit. The valve 10 is secured at its end to a
transverse shaft 11, journaled in the conduit, and having a
manually operable handle 12, by means of which it may be oscillated
so as to swing the valve from the full line closed position, to the
open position shown in broken lines, or visa-versa.
When it is desired to take a urine specimen, the mouth of the
device is inserted between the labia, as described in connection
with FIG. 2, and the valve 10 shifted to closed position, as shown
in full lines. Then when voiding begins, the initial discharge
stream, follows a path somewhat as indicated by the dotted line X',
impinges against the closed valve 10, and is deflected downwardly,
and escapes through conduit 4 to waste.
After a short interval, the valve 10 is manually swung to the open,
dotted line position, leaving the entrance to conduit 5' free and
unobstructed. By this time, the midflow stream has started, and,
moving at relatively high velocity, follows a straight path from
the meatus B into the entrance of conduit 5', somewhat as indicated
by the broken line Y'. It then strikes the curved wall of the
conduit and is deflected downwardly into the receptacle 7, as in
FIG. 2.
It will of course be understood that the specific arrangement of
the valve as shown in FIGS. 5 and 6 is illustrative only, as many
other manually adjustable arrangements for preventing the entrance
of the initial discharge into the receptacle 7 can be readily
devised.
A further embodiment shown in FIGS. 8 and 9 in accordance with the
invention includes a substantially rigid body indicated generally
at 20 having a donwwardly extending portion 21 and a laterally
extending portion 22 which are joined to form an essentially
elbow-shaped hollow body or conduit. Downwardly extending portion
21 is coupled to a container 23, only the upper portion of which is
shown in FIG. 8, container 23 constituting specimen storing
means.
Body portion 22 terminates in a laterally presenting mouth 24 which
is essentially oval in shape and which is formed, as previously
described, to fit between and separate the labia and to surround,
but remain spaced from, the meatus during the voiding of urine to
collect a sample. At the lower end of mouth 24 the material of the
body is cut away to form a notch 25 to permit disposal of urine
which is not desired to be collected in the specimen.
A barrier 26, which can be formed integrally with the remainder of
the body, extends transversely across the hollow interior or the
body and is spaced inwardly from mouth 24. The barrier is joined at
the lower end side interior walls of the body but terminates in an
upper edge 27 which is substantially closer to the upper interior
wall of the body than to the lower interior wall thereof, thereby
defining a passage of relatively small size, compared with the
total size of the mouth, near the top of the portion 22.
As previously described, the mid-stream portion of the urine
voiding is characterized by a significantly higher pressure than
either of the initial voiding stream or the final voiding stream.
The object of the embodiment shown in FIGS. 8 and 9 is to provide a
passage through which only this highest velocity portion of the
voiding stream can pass to the specimen storing means, this passage
being defined by the upper interior walls of body portion 22 and
the upper edge 27 of barrier 26. The highest portion stream,
identified as Y in FIG. 8, passes over the barrier impinges on the
back wall of the body, and falls, as indicated at Z, into the
receptacle 23. Lower pressure portions of the stream indicated at
X, contact barrier 26, flow downwardly therefrom, and are
discharged through notch 25. It will therefore be seen that the
upper edge 27 and the upper interior walls of the body form a
passage which is approximately indicated by the dotted line 28 in
FIG. 9 through which only the desired portions of the specimen can
pass.
A further embodiment in accordance with the invention is shown in
FIGS. 10 and 11 in which a first body portion 30 terminates in a
laterally presenting mouth 31 having a suitable curvature, and
being suitably dimensioned, to fit between the labia and
essentially surround the meatus. It will be observed that the mouth
terminates in an edge which is continuous around the sides and the
upper portion of the mouth but is interrupted at the lower portion
thereof to create a notch or recess 32. Inwardly spaced from the
mouth and closing the back of the cavity formed by body 30 is a
back wall 33, the lower edge of which terminates at notch 32. A
generally rectangular projection 34 protrudes generally
perpendicularly from wall 33 toward mouth 31, extending into the
cavity. The rectangular projection constitutes four relatively thin
walls defining a rectangular opening 35 which extends through wall
33 and into a second cavity formed by an adjoining body 36. Body 36
is essentially an L shaped or elbow structure having a conduit
extending therethrough, the conduit being an extension of opening
35. Liquid entering opening 35 passes through the conduit 37 and is
directed downwardly. The lower end of body 36 terminates in a
nipple portion 38 of diminished outer diameter, the diameter
thereof being dimensioned to fit within the neck 39 of a container
40.
Body 37 also carries two laterally extending tab members 41 and 42
which protrude outwardly from the outer surfaces of body 37 and are
advantageously formed integrally therewith.
In use, as described with reference to FIG. 1, the user places her
first and second fingers beneath tabs 41 and 42 with the ends of
the fingers pointing in the direction of the mouth of the device.
The upper edge of mouth 30 is then inserted at the lower end of the
labia, separating the labia, and the device is moved upwardly until
the mouth is essentially in the same position as that shown in FIG.
2. During voiding, the initial, or low-pressure, portion of the
stream impinges against the lower portion of wall 33 and is
discharged through notch 32. The midstream, or high-pressure
portion of the stream is characterized by a higher velocity and a
flatter trajectory which enters opening 35 in projection 34 and
passes downwardly through conduit 37 into container 40. The
protruding walls 34 prevent any liquid impinging forcefully on the
lower portion of wall 33 from inadvertently entering opening 35,
thereby assuring a specimen which is uncontaminated by earlier
portions of the stream and is sampled only from the midstream
portion.
Yet another embodiment is shown in FIGS. 12 and 13, this embodiment
being of a type which is designed to separately collect both the
early portions of the stream as well as the midstream portions. As
shown in FIGS. 12 and 13, a body portion 50 opens at a laterally
presenting mouth 51 which is continuous around the opening of the
cavity formed by body 50. A conduit 52 extends upwardly through the
lower portion of body 50, conduit 52 being of substantially
cylindrical shape and of somewhat smaller diameter than the width
of the interior of body 50. The upper end of conduit 52 is closed
by an upper end wall 53 and has a front opening 54 which faces in
the same direction as mouth 51. The lower extremity of opening 54
is spaced above the lower wall of the cavity formed by body portion
50.
Conduit 52 also extends downwardly from the outer surface of body
50 and terminates in a nipple portion 55 of reduced diamter which
is dimensioned to fit within the neck 56 of a container 57. As seen
in FIG. 13, a central passageway 58 within conduit 54 is available
to conduct fluid between opening 54 and the opening at the lower
end of nipple 55.
At the rear of body portion 50 a semi-annular wall portion 59
interconnects body portion 50 with a substantially cylindrical body
portion 60 which is, essentially, a continuation of body portion
50. Body portion 60 defines a second cavity which communicates with
the cavity adjoining the mouth 51 so that fluid which does not
enter opening 54 can pass around conduit 52, through the cavity
within body portion 60 and into a conduit 61 which lies at the rear
of body 60 and extends in a downward direction. It will be observed
that the floor of the cavity formed by body portion 60 is a
continuation of the floor of the cavity formed by body portion 50,
and that the floors together form a continuous downwardly sloping
surface, in use, leading to conduit 61. The lower rear portion of
body 60 terminates in a nipple of reduced diameter which is
dimensioned to fit within the neck 62 of a container 63.
Body portion 60 is also provided with laterally extending tabs 64
and 65 which extend outwardly from the outer surfaces of the body
and can be integrally formed therewith.
The use of the apparatus of FIGS. 12 and 13 is similar to that of
FIGS. 10 and 11 wherein the user places her first and second
fingers beneath tabs 65 and 65 and inserts the device as previously
described. It will be observed that urine entering mouth 51 will
necessarily be caused to pass either through opening 54, through
conduit 58 and into container 57, or around conduit 52, through
body 60 and into container 63. As previously described, only the
midstream portions will have sufficient pressure to enter opening
54, confining the material in container 57 to sample from that
midstream portion.
While certain advantageous embodiments have been chosen to
illustrate the invention, it will be undertsood by those skilled in
the art that various changes and modifications can be made therein
without departing from the scope of the invention as defined in the
appended claims.
* * * * *