U.S. patent number 3,731,806 [Application Number 05/119,729] was granted by the patent office on 1973-05-08 for specimen analysis device.
This patent grant is currently assigned to Pelam Inc.. Invention is credited to James B. McCormick.
United States Patent |
3,731,806 |
McCormick |
May 8, 1973 |
**Please see images for:
( Certificate of Correction ) ** |
SPECIMEN ANALYSIS DEVICE
Abstract
A device is provided for separating a biological fluid specimen
into liquid and solid constituents for analysis. The illustrated
device includes a receptacle for containing a quantity of the
specimen in overlying relation to a filter in sheet form supported
on a flat surface, and a vacuum source positioned beneath the
filter to draw the liquid portion of the specimen through the
filter while leaving the solid constituents on the upper surface of
the filter for subsequent microscopic analysis.
Inventors: |
McCormick; James B. (Hinsdale,
IL) |
Assignee: |
Pelam Inc. (Hinsdale,
IL)
|
Family
ID: |
22386009 |
Appl.
No.: |
05/119,729 |
Filed: |
March 1, 1971 |
Current U.S.
Class: |
210/94; 210/233;
210/406 |
Current CPC
Class: |
G01N
33/493 (20130101) |
Current International
Class: |
G01N
33/483 (20060101); B01d 035/00 () |
Field of
Search: |
;210/25,94,233,248,406 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Zaharna; Samih N.
Claims
What is claimed is:
1. A device for separating a biological fluid specimen such as
urine into liquid and solid constituents for analysis, said device
comprising: plate means including a hollow needle portion defining
an elongated passageway having an inlet at one end and an outlet at
its opposite end, said needle portion being adapted to connect said
elongated passageway to a source of vacuum, said plate means
including a generally flat light transmitting plate portion
provided with a grid area spaced laterally from said needle
portion, a liquid transporting canal interconnecting said grid area
and said elongated passageway in said hollow needle portion, a
filter in sheet form supported by said grid area, said filter sheet
being light transmitting impervious to the passage of the
biological fluid therethrough under the influence of gravity alone
but being pervious to the passage of the fluid but not solids
contained in the fluid under the influence of a pressure
differential created when said outlet of said elongated passageway
is connected to a vacuum source, wall means defining a reservoir
adapted to contain a quantity of the biological fluid specimen in
fluid communication with said elongated passageway inlet through
said filter sheet, said grid area being adapted to support said
filter sheet in generally planar form, and means to facilitate
fracturing of said plate means so as to permit said needle portion
to be separated from said grid area and the portion of the filter
sheet overlying said grid area to render the remaining portion of
said plate means usable as a slide for the microscopic examination
of solids which have accumulated on the surface of said filter
sheet after the outlet of said elongated passageway has been
connected in fluid communication with a vacuum source and the
liquid portion of the sample has passed through said filter
sheet.
2. A device in accordance with claim 1, wherein said wall defining
a reservoir is proportioned so as to extend upwardly from said
plate in encircling relation to said filter sheet.
3. A device in accordance with claim 1, wherein said generally flat
plate portion is further provided with a rim encirclinG said grid
area to which said filter sheet is attached in overlying relation
to said grid area, and wherein said wall defining a reservoir is
provided with a flange adjacent its lower edge adapted to overlie
portions of said rim of said plate.
4. A device in accordance with claim 1, wherein means are provided
for maintaining the lower portion of said wall defining a reservoir
in a predetermined location relative to said filter sheet.
5. A device in accordance with claim 4, wherein said means
comprises a releasable adhesive layer on the lower portion of said
wall.
6. A device in accordance with claim 1, wherein means are provided
for releasably securing said wall defining a reservoir in
fluidtight relation to said plate.
7. A device as defined in claim 1 wherein said plate means includes
a tab portion of lesser width then said generally flat plate
portion, said hollow needle portion being formed integral with said
tab portion and depending downwardly from the lower surface
thereof, and wherein said means to facilitate fracturing of said
plate means comprises a line of weakness defined between said tab
portion and said flat plate portion along which said tab portion
may be broken away from said flat plate portion.
8. A device for separating a biological fluid specimen such as
urine into liquid and solid constituents for analysis, said device
comprising: means defining an elongated passageway having an inlet
at one end and an outlet at its opposite end, means at said
passageway outlet adapted to connect said passageway in fluid
communication with a source of vacuum, a filter in sheet form
disposed adajcent said passageway, said filter sheet being
impervious to the passage of the biological fluid therethrough
under the influence of gravity alone but being pervious to the
passage of the fluid but not solids contained in the fluid under
the influence of a pressure differential created when said outlet
of said passageway is connected to said vacuum source, wall means
defining a reservoir adapted to contain only a predetermined
quantity of the biological fluid specimen in fluid communication
with said passageway inlet through said filter sheet, means
including an overflow in said wall means defining a trap in
communication with said reservoir for receiving a limited amount of
fluid introduced into said reservoir in excess of said
predetermined quantity, and means for maintaining said filter sheet
in generally planar form for subsequent microscopic examination fo
the solids which have accumulated on the surface thereof after the
outlet of said passageway has been connected in fluid communication
with a vacuum source and the liquid portion of the sample has
passed through said filter sheet.
9. A device in accordance with claim 8, wherein a plate is provided
for supporting said filter sheet in planar relation, said plate
being provided with an opening and with an upstanding ring
encircling said opening, said filter sheet being secured to the
upper edge of said ring in overlying relation to said opening, and
wherein said wall defining a reservoir includes a flange adapted to
encircle said ring and be wedged into tight fitting, fluid-tight
contact with the outer surface thereof.
10. A device in accordance with claim 8, wherein a plate is
provided for supporting said filter sheet in planar relation,
wherein said plate is provided with an opening defining a portion
of said elongated passageway, wherein said filter sheet overlies
said opening and is in communication therewith, and wherein said
means adapted to connect said passageway in fluid communication
with a source of vacuum is adapted to tbe releasably secured to
said plate in fluid-tight relation and in fluid communication with
said passageway.
11. A device in accordance with claim 10, wherein said plate
defines a socket, and wherein said means adapted to connect said
passageway in fluid communication with a source of vacuum includes
a portion adapted to be received in said socket.
12. A device in accordance with claim 8, wherein said means at said
passageway outlet adapted to connect said passageway in fluid
communication with a source of vacuum includes an elongated hollow
needle terminating at said passageway outlet and adapted to
penetrate the stopper of a tube previously evacuated to provide a
partial vacuum therein, said means at said passageway outlet
further including means extending generally parallel to said needle
for engaging the outer peripheral surface of the previously
evacuated tube to provide guidance as the tube and needle are moved
relative to each other incident to the penetration of the stopper
of the tube by said needle.
13. A device in accordance with claim 12, wherein means are
provided for supporting said means at said passageway outlet
adapted to connect said passageway in fluid communication with a
source of vacuum on a flat surface with the needle depending
generally vertically downwardly and with the point of the needle
adjacent to, but spaced from, the flat surface.
Description
The present invention is directed to a device for separating a
biological fluid specimen such as urine into solid and liquid
components for subsequent analysis.
It is desirable to collect and test fresh urine for biochemical
content and sediment. Generally, this involves separating the solid
and liquid constituents by centrifugation, performing numerous
chemical tests in which selected reagents are separately exposed to
small portions of the liquid to determine the presence of albumin,
sugar, protein, etc. in the sample, and placing the sediment, if
any, upon a slide for microscopic examination. A conventional
urinalysis, therefore, is quite time-consuming in that it entails
numerous steps and involves not only frequent handling of the
centrifuged liquid but the application of the sediment to a slide
as well.
A principal object of the present invention is to provide an
improved device for separating a fluid sample such as a urine
specimen into its solid and liquid components.
Another object of the invention is to provide a device for
separating the solid and liquid components of a urine sample in
such a manner as to provide in the process a slide containing a
thin film of sediment suitable for microscopic analysis.
These and other objects of the invention will become apparent with
reference to the following detailed description and accompanying
drawings, in which:
FIGS. 1 and 2 are prespective views of two separable elements of a
device showing various of the features of the present
invention;
FIG. 3 is a perspective view of the elements shown in FIGS. 1 and 2
in working relationship with each other and with a third element
illustrating how the device may be used;
FIG. 4 is a perspective view showing the form in which the solid
and liquid constituents of a sample are supported and contained
after the device has been used in accordance with FIG. 3;
FIG. 5 is an enlarged sectional elevational view taken along line
5--5 of FIG. 3;
FIG. 6 is an elevational view of a device constituting an alternate
embodiment of the invention;
FIG. 7 is an enlarged sectional elevational view taken along line
7--7 of FIG. 6;
FIG. 8 is an enlarged fragmentary top plan view of the device of
FIG. 6; and
FIG. 9 is a perspective view of a portion of the device of FIG. 6
as it might appear being prepared for storage or shipment.
Very generally, there is shown in FIGS. 1-5 of the drawings a
device 10 comprising a substantially flat plate 12 defining a
recessed grid 14 adjacent its upper surface and having a hollow
needle 16 depending from its lower surface. A passageway 18 extends
from the grid 14 to and through the needle 16. A filter in the form
of a microporous sheet 20 overlies the grid 14, and a retainer 22
having upstanding walls which encircle the grid is positioned on
top of the plate 12. The retainer 22 is adapted to contain a
quantity of the fluid sample above the filter sheet 20.
In a preferred method of using the device, a sample of a liquid
such as urine is placed within the cavity defined by the retainer
22 and the needle 16 is inserted through the puncturable
self-sealing closure 24 of a previously evacuated or vacuumized
tube 26. This brings the passageway 18 into fluid communication
with the interior of the tube 26, causing the liquid portion of the
sample to be drawn through the filter sheet 20 into the tube, from
which it can be removed as needed for biochemical analysis. Any
sediment within the sample, however, is retained on the surface of
the filter sheet 20 where it is available without further transfer
for microscopic analysis.
More particularly, the plate 12 is preferably formed of a
transparent plastic material such as styrene, polypropylene or the
like and, in a preferred embodiment, includes a generally
rectangular main body portion 28 and a tab 30 which projects from
one end edge of the body portion 28 and is of a lesser width. The
body portion 28 approximates in size the standard microscope slide,
i.e., it is approximately three inches in length by 1 inch in
width. The side edges of the tab 30 are provided with a notch 32 at
the juncture of the tab and body, and a groove 34 is provided in
the lower surface of the plate and interconnects the lower ends of
the notches 32. the notches 32 and groove 34 define a line of
weakness along which the tab may be fractured or broken away from
the body 28 for reasons which will become apparent shortly.
The grid 14 provides support for the filter sheet 20 while at the
same time providing for movement of the filtered liquid beneath the
sheet to and through the passageway 18. While the grid may be
defined in various ways, in the illustrated embodiment, it is
formed by providing a plurality of parallel V-shaped small
passageways or grooves 36 (FIG. 5) in a generally square area of
the upper surface of that end of the body 28 of the plate 12 which
is adjacent the tab 30. The grooves are closely spaced and are
separated by ridges terminating in peaks 38. The filter sheet 20
rests upon and is supported by the peaks as well as by the rim of
the body portion 28 surrounding the grid. Fluid communication
between the grooves and throughout the grid 14 is provided by
channels 40 (FIGS. 2 and 4) which extend transversely of the
grooves and interconnect the ends thereof. Thus, liquid passing
through the filter sheet 20 flows into the grooves 36 and channels
40 of the grid 14, from which it is free to flow through the
passageway 18 and, ultimately, into the evacuated tube 26, as
hereinafter described.
While the above-described grid formation has proven to be quite
satisfactory, it would also be possible to insert a pre-formed grid
into a shallow cavity provided in the plate 12, or to roughen the
surface of the plate, as by sandblasting or etching, to provide for
the desired fluid flow beneath the filter sheet 20.
Extending through the tab 30 between its top and bottom surfaces is
a hole 42, and secured to the lower surface of the tab is the
needle 16. The needle is hollow and its bore 44 defines a portion
of the passageway 18, as does the hole 42 which is coaxial with the
needle bore. The needle is of a stiff, rigid construction, is
reinforced by a hub 46 at its upper end, and terminates in a
sharpened point 48 which defines the outlet of the passageway 18.
It is thus strong enough and sharp enough to penetrate the sealed
closure 24 of the evacuated tube 26. A canal 50 (FIGS. 2, 4 and 5)
provided in the upper surface of the plate 12 extends between the
upper end of the hole 42 and the grid 14, thus connecting the
grooves 36 and channels 40 of the grid with the bore of the needle
16 and, thus, with the interior of the evacuated tube 26 when the
needle has penetrated the stopper 24.
Secured to the upper surface of the palte 12 in overlying relation
to the grid 14, the rim of the plate which encircles the grid, and
tab 30 is the filter sheet 20. The filter sheet rests upon and is
supported by the peaks 38 defined by the ridges between the grooves
36 and is secured by a layer 51 of a suitable permanent adhesive to
the rim of the plate and to the tab 30 (FIG. 5). Desirably, the
filter sheet 20 is a microporous membrane of the millipore type and
is comprised of cellulose nitrate, cellulose acetate or a mixture
thereof. The pores of the membrane are small enough to be
impervious to the passage of the liquid specimen therethrough
solely under the influence of gravity and the liquid can thus be
supported above the membrane without leakage through the membrane.
However, the pores are of a size which will permit the liquid
portion but not the sediment of the specimen to pass through the
membrane under the additional influence of the pressure
differential applied to the specimen when the passageway 18 is
placed in communication with the interior of the evacuated tube 26.
The sheet is preferably optically transparent so that it is capable
of forming a part of a microscopic slide through which light will
pass during the examination of the sediment retained by the
filter.
Disposed above the filter sheet 20 in overlying relation to the rim
of the plate 12 which surrounds the grid 14, and also in overlying
relation to the canal 50 and hole 42 of the plate, is the retainer
22. The retainer comprises four interconnected upstanding walls 52
and a flange 54 extending horizontally from the lower edges
thereof. The retainer is so proportioned that when properly
positioned upon the upper surface of the plate 12, the walls 52
extend upwardly from adjacent the outer edges of the grid 14 and
the flange 54 extends laterally outwardly to the adjacent side
edges of the plate 12. At its forward end, the flange is contoured
to the configuration of the tab 30. As thus positioned, the walls
52, together with the plate 12 and filter sheet 20, define a fluid
reservoir 56 above the filter sheet 20 which is adapted to contain
a quantity of the liquid specimen, while the flange 54 not only
provides an area of contact between the upper surface of the plate
(or filter sheet) and the retainer walls 52, but also overlies and
seals off the exposed upper end of the hole 42 and the upper
portion of the canal 50, thereby sealing these potential openings
and preventing air from being drawn therethrough in place of the
fluid from the reservoir 56, as is intended. In a preferred
embodiment, the reservoir is dimensioned so as to enable it to
conveniently contain approximately 5 ml. of the specimen.
To facilitate attachment of the retainer 22 onto the upper surface
of the plate 12, it is preferably distributed to the user with a
layer or coating 58 of a releasable or contact adhesive applied to
the lower surface of the flange 54 and protected by a suitable
backing sheet. The user can thus peel the sheet 60 from the flange
54 and place the retainer on the plate in a relatively secure
manner. However, the releasable nature of the adhesive permits the
retainer to be removed from the plate after the liquid specimen has
been drawn out of the reservoir 56 through the filter sheet 20,
thereby rendering the plate and filter sheet conveniently usable as
a microscope slide.
As an alternative to the adhesive coating 58 referred to above for
facilitating the positioning of the retainer 22 on the plate 12,
the lower surface of the flange 54 and the upper surface of the rim
of the plate surrounding the grid 14 can be provided with
interfitting grooves, and suitable means could also be provided for
clamping the flange 52 to the plate.
The evacuated tube 26 and closure 24 are of the type frequently
used in obtaining blood samples. The tube 26 is in the form of a
conventional test tube and is therefore compatible with other
laboratory equipment. It has been previously evacuated prior to
delivery to the user, and its interior is under a partial vacuum
maintained by the closure 24. The closure 24 is formed of a soft
rubber which can be readily penetrated by the sharp needle 16, is
capable of maintaining a partial vacuum in the tube 26, and seals
the opening occupied by the needle when the needle is withdrawn,
thereby maintaining the filtered liquid within the tube and
preventing bacteria or other contaminants from entering the
tube.
While the use of a previously evacuated tube 26 having a
self-sealing soft rubber closure 24 is preferred because of the
ease with which it can be used and the economy which it provides,
it would be possible in the alternative to employ a previously
evacuated tube having a closure provided with a valve adapted to be
opened upon the insertion of a needle or other tubular member into
the closure. In such an instance, the needle would not have to be
capable of puncturing the closure but the tube would still collect
the liquid portion of the specimen. As still another alternative,
the vacuum source could be a chamber continuously evacuated by a
pump, with the chamber being adapted to be connected to the needle
16 or other tubular member through a valve, and with suitable means
provided for collecting the liquid portion of the specimen.
The use of the device 10 can best be described with reference to
the sequence illustrated in FIGS. 1-4 of the drawings. Assuming a
specimen of urine has been obtained in the usual manner, the user
removes a plate 12 with needle 16 and filter sheet 20 permanently
attached, a retainer 22, and an evacuated closed tube 26 from a
suitable kit or carton. The backing sheet 60 is removed from the
lower surface of the flange 54 of the retainer (FIG. 1) and the
retainer is placed in overlying relation to the filter sheet 20,
with side edges of the flange contiguous to the side edge of the
plate and with the suitably contoured extension of the flange
overlying the tab 30 of the plate, including the canal 50 and hole
42. The adhesive layer 58 maintains the retainer on the plate. When
so positioned, the walls 52 of the retainer extend upwardly from
adjacent the side edges of the grid 14 and define a reservoir 56
into which a quantity such as 5 ml. of the liquid sample is placed.
Because of the microporous nature of the filter sheet 20 and the
adhesive interconnection between the flange of the retainer and
filter sheet, the liquid specimen will remain in the reservoir and
neither pass through the filter sheet by gravity nor pass between
the flange 54 of the retainer and the filter sheet.
With the capped evacuated tube 26 held in one hand and the
assembled plate 12 and filled retainer 22 held in the other, the
point 48 of the needle 16 is placed in contact with the center
portion of the top surface of the closure 24 and is forced through
the closure by the application of a force, as with the thumb, to
the upper surface of the extension of the flange 54 which overlies
the tab 30. This brings the bore 44 of the needle 16 and, hence,
the hole 42 of the tab 30, the canal 50 of the plate, and the
grooves and channels 36 and 40 of the grid 14 into communication
with the interior of the evacuated tube, creating a pressure
differential across the filter sheet 20 and causing the liquid in
the reservoir 56 to be drawn through the filter sheet and into the
tube. However, the sediment or solid particles, if any, in the
specimen will not pass through the filter sheet but will accumulate
in a thin layer on the upper surface thereof, as illustrated in
FIG. 4.
After the liquid has passed through the filter sheet, which will
generally be accomplished in a very short period of time, the
needle 16 is withdrawn from the closure 24 and, because of the
self-sealing nature of the closure, the liquid is thereby
encapsulated in a sealed tube and can be set aside or shipped to an
appropriate laboratory for subsequent analysis. The retainer 22,
being only releasably bonded to the plate 22, is then removed from
the plate and the tab portion 30 of the plate, to which the needle
16 is attached, is fractured from the remainder or body 28 of the
plate along the line of weakness defined by the notches 32 and
groove 34. This leaves the filter sheet 20, containing the
sediment, supported on the upper surface of the plate body 28 (FIG.
4) which is of the size and shape of a conventional microscope
slide, permitting and greatly facilitating microscopic examination
of the sediment.
There is illustrated in FIGS. 6-9 a device 120 which constitutes an
alternate embodiment of the invention. Referring to these figures,
there is provided a plate 122 which preferably measures 1 inch by 3
inches, the dimensions of a conventional slide used for microscopic
examination. Located generally centrally of the plate 122 is an
opening 124, and encircling the opening is a raised ring 125 formed
by a flange reversed upon itself to provide an upwardly extending
inner, generally central wall 126, a generally flat annular ledge
128, and a depending, generally cylindrical skirt 130. The inner
wall 126 and the skirt 130 define therebetween a generally
cylindrical socket 131, the surfaces of which taper inwardly
slightly toward the ledge 128 to permit the upper cylindrical wall
of a base 132, hereinafter described, to be wedged into the socket
with a sufficiently tight fit to provide an essentially airtight
seal. A taper of 1.degree. has been found to be satisfactory.
Preferably, the ring 125 forms an integral part of the plate 122,
which is molded from a suitable plastic. The portions of the plate
122 surrounding the ring are strengthened against warping and
bending by a rib 134 which is provided on the lower surface of the
plate and extends longitudinally thereof adjacent each of its
longitudinal side edges.
Secured to the annular ledge 128 of the ring 125, and spanning the
cavity defined thereby in vertically spaced relation to the opening
124, is a filter sheet 136. The filter sheet 136 is of the
millipore type previously referred to and is cemented or welded to
the shoulder 128. In the embodiment of FIGS. 6-9, the filter sheet
is not supported by a grid, as in the embodiment previously
described. However, a thin plastic grid could be secured to the
shoulder 128 beneath the filter sheet 136, if desired.
A retainer 138 is also provided and is adapted to be placed in
overlying relation to the ring 125 and to contain a quantity of
fresh urine for passage through the filter sheet 136 while leaving
behind on the upper surface of the filter sheet any residue or
sediment in the urine. The retainer is preferably molded from a
plastic such as polyethylene and includes a genrally cylindrical
side wall 140 defining a liquid retaining chamber which is tapered
so as to be of slightly greater diameter at its lower end than at
its upper end.
The lower edge of the side wall 140 of the retainer is offset
outwardly and then downwardly to provide a generally annular,
horizontally disposed shoulder 142 and a depending, generally
cylindrical flange 144. The retainer is so proportioned that it
will seat with a watertight seal on the ring 125 of the plate 122,
with the flange 144 encircling the skirt 130 of the ring and
resting upon the peripheral portion of the filter sheet 136 secured
to the ledge 128, and with the inner surface of the wall 140 in
generally vertical alignment with the innter surface of the inner
wall 126 of the ring. In order to insure such a seal, the outer
surface of the skirt 130 and the innter surface of the flange 144
are preferably tapered slightly to permit a wedging action. This
can be most easily achieved by flaring the skirt and flange
outwardly slightly, thereby providing the desired taper to the
generally cylindrical socket 131 as well. A taper of 1.degree. has
been found to be satisfactory.
The upper portion of the side wall 140 of the retainer is flared
outwardly significantly to provide the upper portion of the
retainer with a lip 146 defining a wide mouth which facilitates the
introduction of the fresh urine into the retainer.
It is desirable that a fixed quantity of urine be passed through
the filter sheet 136 so that the amount of sediment per unit volume
can be determined and compared with known standards, so that a
fixed quantity of liquid urine will be available for analysis, and
so that the amount of urine placed in the retainer will not exceed
the capacity of the vacuumized tube or the ability of the vacuum to
withdraw the entire amount of urine from the retainer. Accordingly,
the lip 146 of the retainer is provided with a spill-over aperture
148 (FIG. 8) which assures that the upper level of the liquid in
the retainer will not rise above the lower edge of the lip 146, and
thereby assures that the quantity of liquid in the retainer
available for passage through the filter sheet 136 will not exceed
a predetermined amount. In a preferred embodiment, this amount is
3cc. The liquid which spills over from the lip through the aperture
138 is caught in a trap 150 in the form of a pocket formed adjacent
one side of the lip and side wall 140. Thus, it is not necessary to
pre-measure a precise quantity of urine for deposition into the
retainer but merely to fill the retainer until liquid begins to
spill over into the trap 150.
The base 132 is adapted to facilitate the placing of the lower
surface of the filter sheet 136 into fluid communication with a
vacuum source such as the vacuumized tube previously referred to.
The base is also adapted to rest on a flat surface and support the
plate 122 and retainer 138 supported on the plate, as when the two
are interconnected and the retainer is filled with a urine
specimen.
The base includes a generally cylindrical tubular body 152, the
upper edge of which is proportioned so as to enable it to be wedged
into the socket 131 of the plate 122 to provide a vacuum-tight fit,
thereby preventing leakage of air adjacent the periphery of the
filter sheet and inefficient use of the vacuum. Disposed internally
of the body 152 is a generally funnel-shaped partition 154 which
extends downwardly and inwardly from the inner surface of the body
wall and terminates in an axial conduit 156 having a vertically
extending bore within which is secured a needle 160. The needle may
be secured within the bore of the conduit 156 by any suitable
bonding agent such as, for example, a potting resin. The needle
terminates short of the lower edge of the tubular body 152 so that
when the base is supported on a flat surface such as a table top,
the point of the needle is disposed above such surface and will not
interfere with a stable disposition of the base on the surface.
As in the previously described embodiment, the needle 158 is
adapted to penetrate the closure 24 of a suitably evacuated tube 26
when the tube and needle are moved in the direction of each other.
To guide the base 132 and tube 26 during such relative movement,
the inner walls of the body 152 are provided with inwardly
projecting guide wings 162. In the illustrated embodiment, four
such wings spaced circumferentially 90.degree. are provided, and
the space defined by the wings is slightly greater than the
diameter of either the closure 24 or tube 26. The inner edges of
the wings converge slightly from their lower ends toward their
upper ends, and the lower ends of the wings are cut at an angle to
facilitate the introduction of the tube 26 into the interior of the
body 152. In order to facilitate gripping of the base for
subsequent separation of the base and tube 26, and for subsequent
separation of the device into its three components, the lower
portion of the outer surface of the tubular body 152 is provided
with a plurality of closely spaced, longitudinally extending ribs
164.
In use, the device 120 is assembled by placing the retainer 138 on
top of the plate 122, adnd by placing the plate and retainer on top
of the base 132, these three components of the device 120 being
securely held together by virtue of the wedging action previously
described. The device is then supported on a flat surface, this
being made possible by the fact that the lower end or point of the
needle 160 is recessed upwardly relative to the lower edge of the
base.
A freshly passed urine sample is poured into the retainer 138 until
the sample begins to overflow into the trap 150. At this point,
there will be a predetermined quantity, e.g., 3 cc. of urine, above
the filter sheet 136. The device is then carefully raised and with
a previously evacuated tube 26 provided with a penetrable closure
24 supported on a flat surface and stabilized with one hand, and
with the device 120 grasped firmly in the other, the device is
forced downwardly relative to the tube until the needle 160
penetrates the closure, creating a pressure differential across the
filter sheet and drawing the fluid portion of the specimen through
the sheet while leaving any sediment including cells, crystals, and
bacteria supported on the sheet. The liquid portion of the specimn
is thus collected in the tube 26 for subsequent chemical and
physical testing.
The device is then separated from the tube 26 and disassembled into
its three components. The ribs 164 facilitate grasping of the base
132 to aid in such separation and disassembly. The retainer 138 and
base 132 may then be discarded. A small amount of stain
preservative is then preferably placed on the filter sheet 136 to
preserve all elements of the sediment and provide a clear specimen
for microscopic examination. The following formula for a stain
preservative has been found preferable:
Part I Crystal violet 0.03gm Ammononium oxalate 0.05gm No. 600
Polyox carbowax 10.00gm Part II Safranin 0 0.2gm Ethyl alcohol
10.0gm Glyoxal 2.0gm
The two parts are mixed togther in 100 ml of water.
The stain preserved sediment slide and sealed tube 26 are then
shipped to a laboratory for chemical, physical and microscopic
examination. To protect the sediment supported on the filter sheet
136 during such shipment, a cap 166 is preferably provided (FIG. 9)
which snaps onto the ring 125 of the plate 122 in overlying
relation to the upper surface of the filter sheet, with the lower
surface of the central portion of the cap spaced slightly from the
sediment to avoid contact therewith. Alternatively, provision may
be made for fracturing the plate 122 so as to separate the ring
from the remainder of the plate, thereby rendering the ring of a
suitable size for accommodation within an automatic analysis
apparatus. As a still further alternative, provision could be made
for rendering the ring 125 fracturable from the remainder of the
plate 122 and adapting it for attachment as a cap to the tube 26
and closure 24, thereby permitting shipment of the sediment and
liquid portions of the specimen together as a unit to provide added
assurance that they will be properly identified during laboratory
analysis.
It should be apparent from the above description that devices
formed in accordance with the present invention are suitable for
use in the analysis of a wide range of liquid specimens and that
their use is not confined to the separation of urine into its
liquid and solid components. Also, devices formed in accordance
with the present invention can be employed in various manners to
achieve different desired results.
For example, devices formed in accordance with the present
invention could be used to separate bacteria from virus when both
are contained in a liquid specimen, or in a specimen previously
diluted with liquid, by using a membrane or filter which will pass
the virus but not the bacteria. When the invention is employed to
separate bacteria from a liquid specimen, the device employed is
preferably gas sterilized, as with ethylene oxide, prior to use and
a cover, such as that indicated by the numeral 168 in FIG. 6, seals
the inlet of the retainer until the device is used. Fluid for
bacterial analysis, such as a "clean catch" urine specimen, would
be deposited into the retainer immediately after the cap 168 has
been removed and is subsequently drawn through the membrane in the
manner previously described. The bacteria is retained on the
surface of the membrane and a thin layer of nutrient agar is then
poured onto the surface of the membrane to a thickness of 1 or 2
millimeters. The nutrient agar supports bacterial growth in an
incubator, and colony count or other bacteriologic processes can
follow incubation.
A device formed in accordance with the present invention can also
be effectively used in connection with the flotation technique for
separating solid but very minute particles from a specimen. For
example, in separating parasites or ova from a stool specimen, the
retainer of a device embodying the present invention is filled with
a salt solution of the proper specific gravity and a small amount
of the stool specimen is added. The parasites and ova, being of a
lighter specific gravity, rise to the top of the liquid. If a cap,
such as the cap 168, is applied and the device inverted, the
parasites and ova will be immediately beneath the membrane. If a
vacuum is then applied through the membrane, liquid will be drawn
through the membrane and draw the parasites and ova against the
membrane where they will be retained for examination after the
device is disassembled.
Also, chemical testing could be conducted on a liquid specimen to
determine such characteristics as the pH value of the specimen by
placing a suitable indicator (e.g., a piece of chemically
impregnated paper) on or adjacent the membrane or within the
receiving tube 26.
Various of the features of the invention are set forth in the
following claims.
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