U.S. patent number 3,713,771 [Application Number 05/142,950] was granted by the patent office on 1973-01-30 for method for organized assay and bendable test tube rack therefor.
Invention is credited to Hubert N. Divelbiss, Billy W. Taylor.
United States Patent |
3,713,771 |
Taylor , et al. |
January 30, 1973 |
METHOD FOR ORGANIZED ASSAY AND BENDABLE TEST TUBE RACK THEREFOR
Abstract
Apparatus and method for systematic organization of samples.
Flexible gangs of sample holders are used permitting organization
in either a linear or a curved arrangement and transfer from one to
the other arrangement without changing the juxtaposition and
organization of individual samples. Identity strips are associated
with each sample holder to provide for both computerized and
non-computerized identification of the sample, recording
information concerning intended treatments, assays, determinations,
or data obtained therefrom.
Inventors: |
Taylor; Billy W. (Walnut Creek,
CA), Divelbiss; Hubert N. (Napa, CA) |
Family
ID: |
22501932 |
Appl.
No.: |
05/142,950 |
Filed: |
May 13, 1971 |
Current U.S.
Class: |
436/48; 141/9;
211/74; 422/915; 141/378; 422/534 |
Current CPC
Class: |
A61B
10/0096 (20130101); B01L 9/06 (20130101); A61B
10/00 (20130101); A61B 90/90 (20160201); B01L
3/5453 (20130101); Y10T 436/114165 (20150115); A61B
50/33 (20160201) |
Current International
Class: |
A47B
73/00 (20060101); A61B 19/00 (20060101); A61B
10/00 (20060101); B01L 9/00 (20060101); B01L
3/14 (20060101); B01L 9/06 (20060101); A61B
19/02 (20060101); A47b 073/00 (); B01l 009/00 ();
G01n 033/16 () |
Field of
Search: |
;23/23R,253R,259
;141/378,369 ;291/72,74,77 |
References Cited
[Referenced By]
U.S. Patent Documents
|
|
|
3526480 |
September 1970 |
Findl et al. |
3620678 |
November 1971 |
Guigan et al. |
3607097 |
September 1971 |
Auphan et al. |
|
Primary Examiner: Wolk; Morris O.
Assistant Examiner: Reese; R. M.
Claims
What is claimed is:
1. A method for carrying out assays on a plurality of samples,
whereby the sample containers are originally aligned in straight
rows and columns and then moved to a circular turntable, without
requiring the transfer of samples individually which comprises:
arranging a plurality of rows of flexibly connected sample
container holders, so that the sample holders having the same
position in each row form a substantially linear column,
distributing samples into sample containers situated in said sample
container holders; and transferring one or more of said rows to a
circular turntable, arching the flexible connections to conform
with the circular turntable.
2. A method according to claim 1, wherein an identifying marker
joined to each sample container holder having a sample, so as to
provide identification of the sample during an assay.
3. A method for carrying out a systematic and organized assay to
obtain accurate and reliable results and relate the results to a
particular sample which comprises: arranging a plurality of racks,
having a plurality of sample container holders flexibly
interconnected so as to provide a series of parallel rows of sample
container holders; connecting an identifying marker to at least
each sample container holder into which a sample is to be
introduced; introducing samples to be assayed into sample
containers in said sample container holders in conformance with the
identifying marker; moving the sample racks to either straight or
curving dispensing devices in accordance with the information on
the identifying markers; registering results obtained from the
determinations of the samples identified by the identifying
markers; and recording the results.
4. A method according to claim 3, wherein the results are punch
holed onto the identifying markers or indicia printed on the
identifying markers, so as to be capable of being read by a
computer.
5. A sample container holder for use in a systematic organization
of sample containers adapted for mounting on a flexible membrane
comprising: a receptacle member having a first curved side, a
second side opposite said first curved side, two side walls,
oppositely situated joining said first and second side, and forming
opposite corners where said side walls meet said second side, a
flat base surface; a circular channel extending through said
receptacle member downwardly, at least a portion of the way to said
base; extending from said base upwardly through said receptacle
member, slot means for mounting on a membrane, the slot means
forming openings in each of said side walls which are equidistant
from said corners; and an identifying marker holding means affixed
to said second side.
6. A sample container holder according to claim 5, wherein said
identifying marker holder means comprises: a relieved portion of
said second side providing a stepped wall; and at other than said
relieved portion, grooved side walls extending outwardly from said
second side.
7. A sample container holder according to claim 5, wherein at least
one of said sides of said receptacle member is notched at the top
surface to provide a convenient cup holder.
8. A sample container holder rack for use in systematic assaying of
samples whereby the sample containers are maintained in a stable
arrangement during the assay, which comprises: a plurality of
sample container holder means; interconnecting means for flexibly
interconnecting said sample container holding means in a uniformly
spaced relationship; sample identification means associated with
said sample container holder means, and two terminal sample
container holder means, having connecting means for connecting
racks in tandem.
9. A sample container holder rack according to claim 8, wherein
said interconnecting means is a flexible plastic web extending a
portion of the length of said sample container holder means.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
In clinical assaying, it has become extremely common to have a
large number of different samples, e.g., blood, which must be
distributed for a significant number of tests, each test requiring
specific reagents or characterizations related to that test. In
view of the importance of the results, it is essential that each
one of the samples be quickly and efficiently related to a specific
source. Where samples have to be moved about and the order of the
samples is continually being changed, errors in marking and
recording, or switching of samples, become extremely difficult to
police.
There is, therefore, a need for systematizing and organizing the
removal of samples from a source, the combination of the various
aliquots with different reagents, and the recording and organizing
of the results. The apparatus and method should be compatible with
the different pieces of equipment used for sample determination
employed today. Furthermore, it must be simple, easily understood,
and safe to handle and use.
2. Description of the Prior Art
Various pieces of equipment are available for clinical
laboratories, with a variety of sample holders, labeling
techniques, circular reagent dispensers and analyzers. Discussions
of laboratory techniques and equipment may be found in Benson, et
al., Multiple Laboratory Screening, Academic Press, 1969 and
Brittin, et al., Automation and Data Processing in the Clinical
Laboratory, Thomas, Springfield, Ill., 1970.
SUMMARY OF THE INVENTION
Apparatus and method are provided for organizing systematic
sampling and assay, by employing a flexible rack having a plurality
of sample container holders, so as to be suitable for use both in a
straight or arched structure. Each sample holder containing a
sample is associated with a particular marking device, which may be
color/coded, punched, tabbed, numbered, or given other indicia.
The rack can be assembled end-to-end and side-by-side forming a
systematic group for assigning different samples to each container
holder in the linear direction (column) and different aliquots in
the side direction (row). The rack is also supplied with both
sample and aliquot identification.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a rack holder having a plurality of
racks;
FIG. 2 is a circular rack holder, the individual racks in tandem
bending with the circumference;
FIG. 3 is a side view of a rack holder with individual designation
strips, as situated on a circular rack holder;
FIG. 4 is a top view of the rack holder;
FIG. 5 is a side view of the rack holder with specific strip
designations.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
In a clinical laboratory, one or more samples are brought in for a
series of the same or different tests. Frequently, depending on the
results of the tests, further tests may be carried out, with
additional samples being drawn from the original sample. It is
important during these tests that all of the aliquots withdrawn
from the original sample be easily and readily associated with the
original sample and that the results obtained be easily recorded
and identifiable with a particular sample.
In the present invention, a single or series of racks are used
which have a plurality of sample container holders (referred to as
sample holders) or receptacles joined in a flexible manner to
permit association with both rectangular or circular rack holders.
A variety of rack holders are possible which permit the linear
extension of the rack and allow for objects depending from the
individual sample holders, e.g., identity markers. One such rack
holder is indicated in FIG. 1. The rectangular rack holder is a box
having three sides, being open on one side for convenient access.
Samples of blood, urine or other biological fluid are brought into
the laboratory and can be placed one at a time in a fixed ordered
relationship. Each sample has some code designation.
The rack holder has a series of compartments which may be used for
holding samples, identification tabs or both, so that portions
taken from the original sample, will be associated with a specific
order originally established in the rack holder. Perpendicular to
and extending from the terminal portion of the fixed series of
cells or compartments are two sides upon which the ends of the
racks rest. The series of racks are supported by these sides and
the individual sample holder in each rack conforms with and is
aligned with each of the compartments in the fixed line. Therefore,
one can have any number of racks from 1 to n and there is an
individual sample holder in each rack which is aligned with the
fixed cell.
Special designation slips are provided which fit into a housing
provided on the sample holders in the racks. Therefore, with each
sample, a color or other simple code designation may be used to
indicate from which of the samples material has been taken and
introduced into the sample holders in the racks. Other designations
may also be provided on the identification slips, such as the test
to be carried out, reagents to be added or other information which
is considered pertinent during the determinations. Furthermore, the
slips may be marked with the results, so that at the end of all the
determinations, the slips may be removed and the results
recorded.
After aliquots have been withdrawn from the original sample and
introduced into the sample vials, cups or other containers in the
sample holders of the racks, the racks may now be moved to any site
in accordance with the scheduled tests. The identification marker
stays with the individual sample, and provides ready identification
of the sample and what is to be done with the sample. The racks may
be mounted linearly or on a turntable for automated addition of
reagents or reading of results. The racks have a pin at one end and
pin holder at the other, so that they may be aligned in long rows
and retain a predetermined distance between the samples and
individual racks.
The identifying markers may extend beyond, both below and above,
the sample holder. This permits punching of the identifying marker
with results which may be read on a computer. Therefore, by having
automated reading of results, and automated punching to indicate
the results, the possibility of error is minimized in relating the
sample and result.
For a more detailed description of the method as well as the
apparatus, turn now to a consideration of FIG. 1. A box 10 is
provided which conveniently has a floor 12 and two side walls 14
and 16, perpendicular to the floor 12. The box is open at one end
18 and closed at the other end 20. At the closed end is provided a
series of square compartments indicated by the exemplary
compartment 22. The compartments are divided and spaced evenly by
walls, only one wall being given a number designation 24. The
remaining side of the individual compartment is enclosed by a wall
26.
The dimensions of the individual compartments may be varied widely
depending on their function. If the compartments are to be used as
vial holders, the dimensions will be determined by the size of the
vial. If the cells are primarily to hold the identifying markers,
the depth and other dimensions will conform to the markers. The
dimensions can be varied quite widely to fit any particular
container, vial, or marker; most commonly, the container will not
be larger than about a 50 cc test tube and the markers will be from
2 to 4 inches long and 1/3 to 3/4 inch wide, and may vary in
dimension. Any number of compartments may be present, although
conveniently, the number would usually vary from 8 to 20, more
usually from about 10 to 16, so that the racks are of convenient
size for manipulation and transfer.
While not indicated, various simple methods may be used for
identification of the original sample. These identifying means may
be associated with the compartment or fitted onto the container
itself or both. The particular mode chosen will generally be one of
convenience and be governed to some degree by the methods employed
in assembling the samples.
Walls 14 and 16 are diminished in height for a portion of their
distance from 28 to 30 and 32 to 34 respectively. Thus, stops 36
and 38 are provided at the ends of the wall to prevent a rack from
slipping off and to limit the number of racks.
As indicated previously, a compartment 22 can be used for the
identification tabs. That is, in each row, tabs will be associated
with a particular row and have some identifying mark specific to
that row. Therefore, any samples in that row will always be
identified with that row by its identifying marker.
When an assay or other determination is to be carried out, the
racks are set up in the box 10. Any number of racks may be
employed, depending on the number of repetitive determinations on
samples; that is, how many samples are to be associated with a row
or particular identification. The dimensions of the box 10 are such
so as to insure substantial alignment of each sample holder
(therefore, each sample) in a row, perpendicular to the fixed
compartment.
In FIG. 1, extending across the box are a plurality of sample
holder racks 40, 42 and 44. The racks are merely illustrative;
there could only be one, or there could be many more, depending on
the particular capacity of the storage box 10. Extending over one
wall 14 is an arm 46 (affixed to the terminal sample holder 47)
having a pin 48. Affixed to the sample holder 49 at the other end
of the rack 40 and extending across the opposite wall 16, is an arm
50, having a pin housing 86. The racks can be aligned in tandem by
having the pin 48 of one rack housed in the pin housing 86 of
another rack.
The pin and pin housing are used for alignment, both in the lower
position and for fitting the racks on a turntable. One or more
boxes 10 may be set, side-by-side, and the pin 48 of the rack 40
set into the pin housing 86 of the adjacent rack, so that a
continuous row of racks is obtained. Usually, each row will be
intended for sample aliquots, which are either derived from the
same initial sample, or more usually, will be used in the same test
procedure.
The rack 40 is supported by arms 46 and 50 lying on the walls 14
and 16. The other racks have similar arms and are similarly
supported. Each of the sample holders lines up with a fixed cell so
that there is a line of sample holders in a specific row. Affixed
to each sample holder in the row is a marker housing 52 having a
window 54. An identifying marker(s) 56 is held in the housing 52 to
identify the sample, if present. In organizing the samples, one can
provide long rows of sample holders for a particular test and
columns of sample holders (the aligned sample holders in adjacent
racks) associated with a particular sample. Depending on the tests
to be carried out on the sample aliquots of the sample would be
placed in the appropriate containers. Each row of racks would be
for a particular test, so that some rows would be skipped, when the
particular assay was not required for the sample. Therefore, in
distributing the sample, the operator would go down a column
introducing aliquots only in rows concerned with the assays which
were requested for the sample.
For more detailed consideration of the sample holder rack, turn now
to a consideration of FIGS. 4 and 5. The sample holder 58 (all the
sample holders being equivalent, only one will be considered) can
have a hemispherical or arcuate portion 59 which extends and joins
to a rectangular portion 60 providing two side walls 67 to be
substantially rectangular. A tubular opening or channel 62 extends
through the entire length of the sample holder. A notch 63 can be
provided in the rim 65 to permit nesting of cups of varying
diameters. Adjacent the bottom end of the tubular portion is a
circularly constricted shoulder portion 69, extending about 1/4 to
1/2 inch up the tubular opening 62. The shoulder provides insurance
against a vial slipping through the sample holder, and provides
added strength.
If a continuous membrane is to be used to join the sample holders,
at about 1/3 the way down the sample holder 58, indicated at 64,
two slots or grooves 66 and 68 are introduced, extending the
remaining length of the sample holder 58 and being present on
opposite sides of the sample holder, determining a plane parallel
to the flat side 70 of the sample holder. The slots are equidistant
from the corner of the flat side 70. Extending through the slots is
a membrane or flexible plastic sheet 72 having its bottom edge 74
substantially aligned with the bottom of the sample holder 75. The
membrane extends through a series of sample holder slots, the
sample holders being evenly spaced a few millimeters apart. The
spacing is adjusted to fit into the automated equipment which is
available in the laboratory, so as to provide the proper spacing
for the timing or movement of the equipment during the addition or
removal of reagents to or from the vials in the sample holders.
The membrane is dimensioned so as to provide a support for the
number of sample holders to be on an individual rack. The membrane
will be anywhere from 6 inches to 2 feet long, usually from 9
inches to 18 inches long (the transverse dimension). The width of
the membrane will be determined by the slot size, the membrane
normally extending the full length of the slot, preferably not
extending beyond the base of the sample holder. In this way, the
sample holders, which have a flat base, provide a relatively stable
conformation, which can stand unsupported on a bench top. Usually
the width (upward dimension) will be from 3/4 of an inch to 2
inches, when dealing with sample holders for vials of from about
1.0 to 50 cc. capacity.
The thickness of the membrane can be varied widely, depending on
the tensile and elastic properties of the material employed.
Usually, the polymer will be at least 1/32 inch thick and not more
than 8/32 inch thick, more usually from about 2/32 to 5/32 inch in
thickness. The particular dimensions are primarily a matter of
convenience, adapted to the size of the sample holders to be
accommodated.
The membrane provides a stop 76 to prevent the via from going to
the bottom of the sample holder. By extending about one-half to
two-thirds the length of the tubular opening 62, to the stop 76,
the vial is held in a tubular section about one-half to one-third
the length of the tubular opening 62. The particular size will be
fixed by the vials to be used, although one size, can accommodate a
number of different vials of diminishing diameter, at or below the
diameter of the tubular opening 62. In addition, the membrane 72
provides a mounting support for a plurality of sample holders,
which can be maintained in a fixed predetermined spatial
relationship. The sample holders may be mounted on the membrane in
a variety of ways, either fixedly or removably. For example, a
plurality of notches may be introduced in one edge of the membrane,
being spaced apart so that the sample holder fits down over the
notch and is locked into position at a fixed distance from the next
sample holder. Alternatively, the sample holder may be glued to the
membrane so as to fixedly retain its position in relationship to
the other sample holders. Various ways may be used in accordance
with the particular needs in a laboratory.
Instead of mounting the complete holder on the membrane, the
membrane may be bonded to the back side of the sample holders. No
notches would be required for insertion of the membrane. Any
bonding material could be used, or the entire rack could be molded
as an integral piece. This mode would leave the channel open.
The membrane is characterized in having sufficient rigidity so as
to maintain the sample holders in a substantially straight line and
at a fixed distance. At the same time, it has sufficient
flexibility to bend to provide a mild arc, so as to be adapted to a
turntable, yet, when removed from the confines of the turntable,
the membrane has sufficient resistance to deformation to return
substantially to its original straight position. Various plastic
sheets of material may be employed which have the necessary tensile
properties. Illustrative plastics include polyethylene,
polypropylene, polystyrene, etc.
Of course, other means can be employed which would fulfill the
function of the flexible membrane. Flexible interconnectors could
be bonded to the sides of the sample holders, such as spring steel,
which have the necessary resilience and rigidity. The facets of the
interconnecting means is the maintenance of the spatial
relationship of the sample holders, sufficient resilience to permit
arching, and sufficient rigidity to return substantially to a
straight line when the restraint inducing the curving is
removed.
Another embodiment is to prepare the rack in a single mold, where
the plastic material employed provides the desired flexibility
between the sample holder. In this embodiment, the web would not
enter the container channel, so that the channel would be open for
most, or all, of its length.
Rigidly fixed to the flat wall 70 of the sample holder are two
small extension walls 78 and 80, extending outwardly from the wall
and beginning at about 1/5 of the way down the back wall of the
sample holder at positions 82 and 84 and extending to the bottom of
the sample holder. The extension may be grooved to aid in holding
the markers. The grooved extensions are sufficient to hold the
identity marker 56, but may be joined by a clear wall 54 to form a
housing or enclosure 52 for holding the identity marker 56. The
clear wall can be any clear material, particularly Lucite or other
clear plastic, and may be bonded or fastened to the extension walls
78 and 80 so as to provide the desired enclosure.
Preferably, the identity marker is displaced a short distance from
wall 70 by stepped wall 81. Conveniently, the stepped wall extends
the full length of the housing 52 so that the positions of the
identity marker 56 extending beyond the walls 78 and 80 of the
enclosure do not lie flat against the sample holder wall 70, the
stepped wall providing a relieved portion 83. This can be
convenient or in some instances necessary for ease of removal of
the identity markers 56 or for sensing of information printed on
the marker, particularly on the portion above the enclosure 52.
The identifying marker 56 has an expanded head 88 and shoulders 90
and 92 which rest on the extension wall top edges 82 and 84
respectively. The shoulders 90 and 92 of the marker head which rest
on the edges 82 and 84, prevent the marker from slipping through
the housing 52. Other means may be provided for holding the marker
in place. The marker then extends down having a strip which fits
between the extension walls 78 and 80 and extends below the bottom
of the sample holder, providing a portion 94 for carrying
information or actuating the various devices. For example, holes 96
and 98 can be cut in the marker 56, which when the sample holder is
in the proper position will actuate a device to add a particular
reagent or take a particular reading. By appropriate mechanisms,
the reading can then be recorded by introducing additional holes
100 and 102, which can be read on a computer and provide the
results in relationship to the particular sample.
The marker may have a channel 103 cut into one side, so as to flex
against the extension wall 80 to provide enhanced retention of the
marker 56 in the enclosure 52. If desired, the marker need extend
only a portion of the distance down into the housing 54, only the
head 56 extending outside the housing 54. A notch 103 may be used
so as to provide a tight fit for the marker and retain the marker
in the housing during the various manipulations.
Turning now to a consideration of a particular mode of operation.
For illustrative purposes, only one sample will be considered,
although it must be understood, that the same procedure could be
repeated with a plurality of samples and in a wide diversity of
ways. Let us assume that three different assays are to be carried
out on the same sample. Three vials are provided 104, 106 and 108,
situated in sample holders 110, 112 and 114 respectively. The
reagents appropriate for the determinations are present in the
vials and markers 116, 118 and 120 indicate the particular test
that is to be carried out. As previously mentioned, this can be
indicated by a color code, number code or other convenient
designation, which can be read by an instrument. The appropriate
amount of the sample to be assayed is introduced into the three
vials 104, 106 and 108, and the appropriate code indication
indicated on the markers 116, 118 and 120 respectively, designating
the particular sample.
For purposes of the present discussion, it will be assumed that the
assay will be carried out on a turntable 122. The racks 40, 42 and
44 are removed from the box 10 and placed on the turntable in
appropriate positions, forming a circle around the turntable. The
racks are connected at positions 124 a, b, c and d by the pin and
pin slots, so as to provide a continuous circle of samples with
appropriate spacings between the samples. Above the turntable, not
indicated in the drawing, are a plurality of reagent holders,
feeding to a common syringe. Each one can be accommodated with its
own valve mechanism, which is automatically operated. The turntable
is automatically operated turning to provide an individual sample
under the syringe according to a predetermined schedule. A side
view of the turntable is indicated in FIG. 3. When vial 104
approaches the position under the syringe, the marker 116 has the
necessary information to indicate what additional reagents should
be added to the vial. By appropriate mechanisms, the reagents are
introduced into the vial 104 and agitated, either mechanically or
manually, as convenient.
In many instances it may be desirable to mount only one rack on the
turntable. Therefore, the table can be provided with various
connectors or holders for holding the rack in place. Posts can be
provided having an opening at the top to receive the female housing
86. An adaptor can be provided for the pin 48 to provide a snug fit
in the post opening. Alternatively or in addition, a series of
spaced pins can be mounted on the turntable, onto which the sample
holders could be mounted. Other mounts or flexible holders could be
employed, as convenient.
If a completely automated system is desired, and, for example,
colorimetry is being used for analysis, the sample may at the same
station, or at a different station, be read by a colorimeter. The
result can then be indicated on the marker by any convenient means,
such as punch holes, printed numbers, etc. When all of the assays
have been carried out, the vials may be used for other purposes if
convenient or be discarded and the identifying markers removed.
Each identifying marker will now indicate the particular test
carried out, the identity of the sample, and the results of the
assay. By using computerized methods, all of these values will be
read from the same marker and will be associated one with the
other. Furthermore, the markers provide a permanent record of the
results, which can be referred to as required.
The present system provides a versatile method for clinical
determinations, insuring accuracy and efficiency. The sample
holders conveniently maintain a vial in relationship to an
identifying marker, which can be repeatedly marked as the sample is
carried through the various procedures. The marker then maintains a
permanent record of the history of the particular sample.
Furthermore, the sample holders can be supported by a membrane so
as to be maintained in a fixed ordered relationship. The samples in
the sample holders can then be maintained in the same relationship
while being carried from one procedure to the next. The samples can
be used where they are aligned in a straight line relationship or
in an arced relationship about a turntable. By using the rack,
assay methods can be simply and efficiently organized in a
repetitive manner to insure accuracy in recording results and
relating the results to the particular sample. In addition,
relatively unskilled people can be rapidly taught the method and be
brought to a high degree of proficiency within a short period of
time.
* * * * *