U.S. patent number 3,647,386 [Application Number 04/864,945] was granted by the patent office on 1972-03-07 for sample processing container.
This patent grant is currently assigned to Gilford Instrument Laboratories, Inc.. Invention is credited to Saul R. Gilford.
United States Patent |
3,647,386 |
Gilford |
March 7, 1972 |
SAMPLE PROCESSING CONTAINER
Abstract
A sample processing container, especially for use with samples
of some fluid such as blood or blood serum contained in a short
length of capillary tubing. The container comprises a flexible
plastic bag having its lower end closed and having its upper end
sealed to a relatively rigid header. The length of capillary tubing
is arranged to be inserted into an elongate cavity or chamber that
is formed in the center of the header along its length by way of an
entrance at one end of the header. The opposite end of the cavity
or chamber communicates with the interior of the bag so that when
the length of capillary tubing is disposed in the cavity or
chamber, a nozzle may be inserted into the entrance and diluent of
a given amount forced through the length of tubing into the bag.
This washes the length of tubing clean and provides the proper
dilution for a mixture that is to be sampled. The entrance is
plugged or, in the alternative, there is a valve in the connection
between the header cavity or chamber and the bag that prevents
reverse flow out of the bag. The bag can be shaken or kneaded
manually or mechanically to assure homogeneity of the sample. A
normally blocked entrance to the bag through the top of the header
enables sample to be removed by a hollow needle or snorkle for
testing as desired. In the alternative, an independent lateral
passageway is provided in the header for withdrawing a sample by a
dip tube. A second valve is provided at the lower end of the
independent passageway at the bottom of the header to prevent
reverse flow out of the bag. The header may have a slot, either
open or closed for insertion of an identifying label that will be
carried with the container. The header may be constructed for
mounting on a suitable carrier, so that a plurality may be handled,
stored, and viewed together.
Inventors: |
Gilford; Saul R. (Oberlin,
OH) |
Assignee: |
Gilford Instrument Laboratories,
Inc. (Oberlin, OH)
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Family
ID: |
25344384 |
Appl.
No.: |
04/864,945 |
Filed: |
September 26, 1969 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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793504 |
Jan 23, 1969 |
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Current U.S.
Class: |
436/179; 422/411;
383/93; 383/80; 206/221; 383/96; 422/944 |
Current CPC
Class: |
G01N
1/38 (20130101); B01L 3/505 (20130101); Y10T
436/25625 (20150115) |
Current International
Class: |
B01L
3/00 (20060101); G01N 1/38 (20060101); G01n
001/10 (); Go1n 021/02 (); B65d 032/00 () |
Field of
Search: |
;23/230,253,259,292
;206/47A,47R ;229/56,62.5 ;128/2,272,DIG.24 |
References Cited
[Referenced By]
U.S. Patent Documents
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3476515 |
November 1969 |
Johnson, et al. |
3266298 |
August 1966 |
Whitehead et al. |
3526125 |
September 1970 |
Gilford, et al. |
3297152 |
January 1967 |
Corella, et al. |
3189252 |
June 1965 |
Miller |
|
Primary Examiner: Wolk; Morris O.
Assistant Examiner: Katz; Elliott A.
Parent Case Text
REFERENCE TO RELATED APPLICATIONS
This is a continuation-in-part application to application Ser. No.
793,504, filed Jan. 23, 1969, now abandoned.
Claims
What is desired to be secured and claimed by Letters Patent of the
United States is:
1. A sample processing and holding container, comprising
A. an imperforate flexible bag formed of liquid impervious
material,
B. an elongate hollow header having an elongate cavity formed
therein and of a dimension selected fully to retain at least one
length of capillary tubing, and said header having the bag sealed
thereto,
C. means at the entrance end of said cavity for enabling the
introduction into and full deposition of at least one length of
capillary tubing entirely within said cavity and spaced from said
entrance,
D. antiblocking means at the outlet end of said cavity to maintain
free passage from the tube bore to the bag when the tube is
bottomed at said outlet end,
E. a passageway in said header, connecting said cavity at said
outlet end to the interior of said bag to lead liquid from said
cavity into said bag for retention therein, and
F. blocking means for preventing inadvertent loss of liquid from
said bag by way of said passageway and cavity.
2. The container as claimed in claim 1 in which the blocking means
comprises a one-way check valve for blocking said passageway and
cavity flow out of the bag while permitting flow into the bag.
3. The container as claimed in claim 1 in which the blocking means
comprises a removable plug inserted into the entrance end of said
cavity.
4. The container as claimed in claim 1 and an identification card,
means carried by said header for mounting said identification card
removably thereon so that said card will accompany the container
during the processing of the sample introduced therein, said header
having a vertically arranged slot therein spaced laterally from
said bag and said identification card is capable of being inserted
and held in said slot.
5. The container as claimed in claim 4 in which said slot is
arranged parallel to an elongate edge of said header and has the
center portion thereof open to said edge so that said
identification card may be buckled to pass through said open
portion and released to engage the closed ends of the slot.
6. The container as claimed in claim 5 and said identification card
being of sufficient flexibility to permit buckling and recovery
thereof and having lateral notches engaged in the ends of the
slot
7. The container as claimed in claim 6 in which the notches in the
card are generally angular and the slot ends have configurations
which substantially conform to the shapes of said notches.
8. The container as claimed in claim 1 and means in the header to
enable withdrawal of a quantity of liquid from the bag, said means
comprising a normally obstructed conduit in said header, aligned
with said passageway, for permitting the introduction of a dip tube
into said bag for said withdrawal of a quantity of liquid from said
bag.
9. The container as claimed in claim 8 in which said header has a
hollow riser protruding from the upper side thereof, said normally
obstructed conduit including the hollow bore of said riser, and the
upper end of said hollow bore having a piloting entrance capable of
guiding entry of said dip tube therein.
10. The container as claimed in claim 8 in which said normally
obstructed conduit has a sealing plug therein which is capable of
being pierced by said dip tube.
11. The container of claim 10 in which said sealing plug is of
elastomeric material and has a diaphragm at the location where it
will be pierced.
12. The container as claimed in claim 11 in which said header has
an upper surface all of which lies substantially in the same plane
and said normally obstructed conduit has an opening which opens to
said upper surface with said sealing plug comprising a stopper
engaging in said opening and having a portion telescoped within
said conduit, said diaphragm being in said telescoped portion.
13. The container as claimed in claim 1, and means in the header
for selectively withdrawing liquid from said bag comprising a
second passageway opening at its upper end to the upper surface of
the header, extending from said upper surface of said header to the
lower surface of said header, said second passageway having its
lower end opening to said lower surface, and second blocking means
for preventing inadvertent loss of liquid from said bag by way of
said additional passageway.
14. The container as claimed in claim 13, in which both blocking
means comprise first and second check valves.
15. The container as claimed in claim 14 in which the second check
valve is mounted at the lower surface of the header and constructed
normally to block the lower end of said additional passageway.
16. The container as claimed in claim 15, in which the check valves
are flapper valves mounted to the lower surface of the header.
17. The container as claimed in claim 16, in which the two flapper
valves are formed from an integral plastic member, the center part
of which is attached to the lower surface of the header.
18. A sample handling container for use with capillary tubing
lengths carrying precise quantities of liquid therein and
comprising
A. an imperforate bag of flexible sheet material having insulating
qualities, and being impervious to the samples to be contained
therein,
B. an elongate relatively rigid header of insulating material
impervious to the samples to be contained in said bag and having
the bag secured thereto to depend therefrom when the header is
arranged with its longer dimension horizontally, said header
having
i. a central elongate chamber therein having an entrance at one end
of the header and an outlet end at the opposite end thereof, said
chamber being formed of dimension enabling receipt entirely therein
of at least one capillary tube so as to occupy substantially the
transverse area of the chamber so that liquid introduced at said
entrance will, to some substantial extent, flow through the bore of
said capillary tube,
ii. a first passageway connecting said chamber to the interior of
the bag at said outlet end, and the bag being otherwise fully
enclosed, whereby any liquid forced into said entrance will pass
into and be accumulated in said bag, and in so passing will flush
the bore of the tubing if same is disposed in said chamber,
iii. and antiblocking means at said outlet end of said chamber to
maintain flow from said outlet, and
C. blocking means for preventing the escape of liquid in said bag
by way of said first passageway and chamber.
19. The container as claimed in claim 18 and means in the header
for selectively withdrawing liquid from the bag, said means
comprising a vertical passageway in the header opening to the upper
side of the header when oriented with the bag in depending
condition, said vertical passageway being aligned with said
first-mentioned passageway so that a dip tube may be inserted
through said vertical passageway into the bag to remove a quantity
of sample, and means for normally obstructing said vertical
passageway.
20. The container as claimed in claim 18 in which said blocking
means comprise a one-way check valve in the first passageway where
it opens to said bag interior.
21. The container as claimed in claim 18 in which said flexible bag
comprises a tubular length of plastic sheeting having a sealed
bottom end and an upper open end defining an open mouth, said upper
end having a circumferential dimension somewhat smaller than the
peripheral dimension around the lower edge of the header taken
along its length, said upper end being tightly and sealingly
engaged over the lower edge of said header, said first passageway
having an outlet at the surface of the lower edge of the header and
within the mouth of said bag.
22. The container as claimed in claim 21 in which said blocking
means comprise a one-way flapper valve mounted to the lower edge of
the header normally closing said passageway and adapted to open
into said mouth to provide entry to said bag from said outlet.
23. The container as claimed in claim 22 in which said first
passageway is in the lower part of said header and means to enable
withdrawal of liquid from the bag comprising a second passageway in
the upper part of said header in axial alignment with said first
passageway and having an opening to the upper side of said header,
said second passageway normally being obstructed to prevent escape
of liquid therethrough, but adapted to receive a dip tube thereinto
for withdrawal of liquid from said bag, said second passageway
having an obstructing means capable of being overcome by an
inserted dip tube so that the dip tube may be inserted from the
upper side of the header, through both passageways and into the
bag.
24. The method of diluting and providing for testing of a liquid
sample made up of a liquid concentrate and a liquid diluent, the
concentrate having previously been entrained as a known volume in a
length of capillary tubing comprising: mounting said length in a
container which has an enclosed flexible bag and a tubing
supporting header having a communication passageway between header
and bag, the length of capillary tubing being disposed in the
header, forcing a known volume of diluent into the header so that a
portion thereof washes through the hollow bore of the length of
capillary tubing and flows into the bag, closing off the container,
manipulating the container and withdrawing a portion of the
resulting mixed liquid through a wall of the container.
25. The method as claimed in claim 24 in which the container is
made out of a resinous material that is nonreactive to
high-frequency radiation and the said mixed liquid is heated by
subjecting the entire container and contents to high-frequency
radiation before withdrawing a part of said mixed liquid.
26. The method as claimed in claim 24 in which the wall of the
container through which the portion is withdrawn is a part of the
bag, and the withdrawing is done by piercing the bag without
otherwise opening the container.
27. The method as claimed in claim 26 in which a hollow pointed
instrument is used to pierce and withdraw.
28. The method as claimed in claim 24 in which the wall of the
container through which the portion is withdrawn is a part of the
header and is provided with a second normally blocked
passageway.
29. The method as claimed in claim 28 in which the withdrawing is
done by a hollow dip tube which is inserted in said second
passageway and unblocks the same while being moved into the bag,
opening the container while so inserting and moving.
Description
While it is believed that the disclosures of the several
applications which will be identified hereinafter are not needed
for a complete understanding of the invention, nevertheless, it
will be convenient to refer to them so that some of the various
aspects of the invention and the advantages thereof will be
appreciated.
The basic concept of using lengths of capillary tubing for
entraining precise volumes of concentrated fluid is disclosed in an
application Ser. No. 472,294, filed July 15, 1965, now U.S. Pat.
No. 3,475,127. As taught in said application, by using accurately
formed capillary tubing, one may measure out a precise volume of
sample by cutting a measured length of tubing. Thereafter, the
length can be dropped into a quantity of diluent and agitated or
diluent washed through the length into a container so that the
resulting sample is a desired dilution.
Cuvettes for holding and handling lengths of tubing to enable
dilution of the entrained liquid are disclosed in application Ser.
No. 691,783, filed Dec. 19, 1967 and entitled Biological Fluid
Sample Processing Apparatus, now U.S. Pat. No. 3,545,932.
Apparatus for drawing samples of blood at a patient's bedside
directly into the lengths of capillary tubing preparatory for
centrifuging and later cutting the long lengths into smaller
sections is disclosed in application Ser. No. 781,386, filed Dec.
5, 1968 and entitled "Apparatus for Sampling Blood or the Like
Fluid." A sample identifying system and apparatus suitable for use
with the containers of the invention are disclosed and claimed in
application Ser. No. 691,751, filed Dec. 19, 1967 and entitled
"Sample Identifying System and Apparatus for Use in Connection
Therewith," now U.S. Pat. No. 3,526,125.
All of the above-identified applications and patent are owned by
the assignee of this application.
FIELD OF THE INVENTION AND DISCUSSION OF PRIOR ART
The field of this invention is broadly testing of liquids, and the
specific direction toward which the invention is pointed is the
provision of novel containers for processing and holding liquid
samples.
While the invention has relatively wide scope and broad
implications insofar as its field of use is concerned, it was
developed principally for use in the medical and biological testing
and research field, where biological fluids are gathered, diluted,
and/or processed and tested. To an even more specific extent, the
invention has important advantages where it is used in handling
blood and blood serum. The description of the preferred embodiments
and the discussion will be specifically directed to the handling of
blood and the like biological fluids, but no limitations on the
coverage of the invention are intended thereby.
As previously mentioned, the invention resides primarily in the
construction of a container for a liquid sample that has been
introduced into the container by flushing a diluent through a short
length of capillary tubing. This technique per se, not considering
the container which is described and claimed herein, and which
comprises simply entraining a quantity of concentrate in a
capillary tube and using a precise length to make a dilution, is a
new one. It departs from classical methods of gathering and
diluting biological fluids in some important respects that are
detailed in the U.S. Pat. No. 3,475,127 above-referred to. The
primary difference lies in the use of a long length of capillary
tubing to achieve precise volumetric measurements of liquids
entrained therein.
Capillary tubing is used to obtain small quantities of capillary
blood at the bedside of patients in most hospitals. These small
lengths of tubing are not used for any measurements because they
are handled by the technician without regard to contamination of
the ends; no known techniques and apparatus are available for
handling, measuring and cutting the same other than described to
some extent in the patent and applications above referred to; and
because other types of fluid-gathering techniques and apparatus are
normally used for the majority of cases. The known capillary tubing
uses include a technique in which the samples are gathered by
simple capillary action at bedside following which each is plugged
by wax or clay at one end, spun down in a centrifuge to pack the
cells at one end, scored and broken through above the packed cells,
and the resulting section with serum entrained is blown into a
small container so that it may be diluted suitably for test runs.
The relative lengths of the packed cell volume and the serum volume
may be measured before breaking the length of tubing in order to
ascertain hematocrit index, but in view of the very short lengths
of such tubing used, the accuracy of this kind of comparative
measurement is not too reliable.
It will be appreciated that the entire technique described above
requires a piece by piece manual handling, and that the discharged
serum is required to be measured after it leaves the length of
capillary tubing.
Another known type of technique involves providing a short length
of capillary tubing having a precise dimension and representing a
known volume. The technician uses this short length to gather the
samples at bedside, and then works with the resulting filled
length. This technique does not involve any precision cutting but
does have the disadvantages of the usual techniques in that the end
of the length is usually wiped by the technician to eliminate
excess and/or may have some of the fluid wetted on the exterior. In
either case, there can be serious contamination or variations in
total entrained volume. In this latter technique the length of
capillary tubing is emptied and rinsed into a predetermined volume
of reagent or diluent that is properly related to the volume of the
length of tubing.
According to the disclosures of the applications above-identified,
the technician uses a container which carries a plurality of
lengths of capillary tubing within a vacuum and pierces one end of
a double-ended canulla into the patient's vein while inserting the
opposite end into container. This fills all of the lengths of
tubing with venous blood simultaneously and retains them in a
sterile container. The lengths are longer than readily can be
handled without breakage in ordinary usage by technicians. While
still in the container, the lengths are all centrifuged and
thereafter are introduced into a suitable measuring and cutting
apparatus from which they can be dropped directly into
containers.
The cut lengths have the entrained serum or could as easily have
other biological fluids, but have not thus far been contaminated.
They were accurately broken from long lengths along with their
respective columns of entrained fluid and have not been wiped or
touched during the processes.
The invention herein provides suitable containers for receiving
these lengths of capillary tubing with their entrained liquids
directly from the cutting machine or other apparatus. One would
bring the container under the apparatus and have the length fall
into the container as it is cut or broken from a larger length.
Thereafter, one would introduce a nozzle into the container and
force diluent or reagent into the container. According to the
invention, the length of capillary tubing is in the path of the
incoming fluid so that the contents of the length of tubing will be
flushed into the container along with the diluent.
While providing an excellent form of container suitable for most
purposes when used with these short lengths of capillary tubing,
the structures of application Ser. No. 691,783 referred to above
have substantially been improved upon by the invention herein.
Likewise, the invention herein provides advantages and benefits not
contemplated either by the invention of the earlier applications or
by known prior containers. Prior containers were open, giving rise
to evaporation, dust deposit and spillage during handling. They
occupied a substantial space and posed problems of thorough mixing.
Where heating was required the prior containers were incapable of
being used in simplified heating techniques. Handling, storing,
transporting and identifying were important problems not solved as
readily by prior containers as with the invention herein.
SUMMARY OF THE INVENTION
According to the invention, the container comprising an embodiment
thereof is formed of plastic materials such as polyethylene or
other synthetic resins, capable of being formed by extrusion,
molding and other techniques. These containers are highly
economical and disposable so that they can be used once and will
thus be sterile for the particular testing being done.
A flexible bag is provided which is sealingly secured to the lower
side of a relatively rigid header. The bag is closed on its bottom
edge and along its two side edges, and its mouth is engaged to the
lower edge of the header. A single entrance into the bag is
provided by a passageway from one end of the header into the
chamber constituting the interior of the bag, which is otherwise
fully enclosed. In the header along the length thereof there is
provided a cavity or chamber which opens to one end of the header
and thus provides an entrance to the cavity or chamber, the
opposite end being partially closed off. At said opposite end, the
cavity or chamber connects with the aforementioned passageway, and
the said passageway is preferably arranged vertically. Since the
length of capillary tubing is engaged into the cavity and will
bottom at the end therein, some means are provided so that when
this occurs the hollow central bore of the length of tubing will
still be unobstructed. When the diluting liquid or reagent is
forced into the cavity from the same open end that the capillary
tubing was introduced, a goodly portion thereof must flush through
the hollow bore of the length of capillary tubing so that the
entrained liquid will be washed out of the length of tubing, the
chamber and into the bag by way of the passageway. Several ways of
standing the end of the length of tubing away from the bottom of
the cavity or chamber are suggested in the specification.
In another embodiment of the invention, a lateral passageway is
provided through the header which is independent of the lateral
passageway connecting the second end of the chamber or cavity with
the interior of the bag.
Although the bag is expected to be perforable or capable of being
cut to draw a sample of the diluted liquid therefrom for testing,
it can be appreciated that this is somewhat destructive of the
container. The sample in the bag may have to be caught in another
receptacle if it is to be used in multiple tests, or used for just
the one test and discarded. The contents will flow out or leak once
the bag has been pierced or cut, unless an integral nipple is
formed on the bag surface for constriction around the piercing
member so that no fluid is lost in the transfer. While this latter
concept is included in the scope of the invention, it unnecessarily
complicates the structure.
The preferred embodiments have a second passageway opening to the
top of the header, normally blocked, but capable of being pierced
or opened by a dip tube. Thus, the second passageway will be
aligned axially with the first passageway and will not come into
use while the sample is being introduced into the bag by way of the
chamber and the first passageway. After the dilution has been made
and is fully contained within the bag, there may be some processing
through which the container will be passed, such as heating,
agitating and/or kneading to mix the sample thoroughly. At this
point, it is desired to withdraw one or more samples from the bag
to perform the desired tests. The dip tube referred to may be a
hypodermic needle, a so-called plastic snorkle tube or a
combination of both. It is introduced into the first passageway and
pushes the obstructing member aside, or pierces it. This embodiment
has an elastomeric plug which has its center easily pierced by a
hollow needle. The dip tube is pushed further through the aligned
first passageway and past a check valve which is disposed at the
outlet end of the first passageway to prevent escape of liquid from
the bag while it is being mixed or heated.
Another embodiment has an independent passageway extending
laterally through the header from the top to the bottom thereof. It
has a check valve at the bottom of the header at the lower end of
the passageway. No plug is required in this passageway, and the dip
tube does not require a sharp end (for piercing the plug).
When the dip tube is under the surface of the liquid sample, a
quantity may be withdrawn for colorimetric, chemical or mechanical
testing. Other samples may be withdrawn from the bag subsequently,
since the dip tube does not destroy the container or affect either
the elastomeric plug or the check valve.
The structure of the invention advantageously may include some
means for mounting an identification card on the header so that the
sample in the container is fully identified throughout the period
of time that it is being produced, handled and used. A special
arrangement of identification card combined with the container is
described and claimed. Means are provided for storing and carrying
a plurality of containers with facility. A novel track type of
carrier is described and claimed in combination with the
container.
Many advantages and features will become apparent from the
description, and others will specifically be pointed out.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an exploded perspective view of a sample processing
container constructed in accordance with the invention, and showing
therewith an identification card and a length of capillary tubing
both disposed for association with the container.
FIG. 2 is a side elevational view of the container of FIG. 1 taken
from the left side thereof as viewed in FIG. 1 and showing the
identification card attached thereto.
FIG. 3 is a median sectional view taken generally along the line
3--3 of FIG. 1 and in the direction indicated, showing the length
of capillary tubing in place on the interior of the header, the
identification card not being shown in this view.
FIG. 4 is a fragmentary sectional view of that portion of the
container generally located at the upper right-hand corner of FIG.
3, but in this case a modified form is illustrated.
FIG. 5 is an exploded perspective view of a simplified form of the
container of the invention having an identification card or member
attached to the header, and showing a length of capillary tubing
about to be engaged inside of the header.
FIG. 6 is a median sectional view through the container of FIG. 5
taken generally along the line 6--6 of said FIG. 5 and in the
indicated direction, but in this view the length of capillary
tubing has been disposed on the interior of the header, a fragment
of a nozzle is shown forcing diluent through the length of tubing
past the check valve and into the bag. The view also illustrates an
alternate form of liquid blocking means to prevent escape of liquid
from the container when handled.
FIG. 7 is a sectional view taken through the container of FIG. 6
along the line 7--7 of FIG. 6 and in the indicated direction.
FIG. 8 is a fragmentary perspective view of a container showing the
construction of means of mounting and carrying the container.
FIG. 9 is a view similar to that of FIG. 8 but showing a modified
form of mounting and carrying means.
FIG. 10 is a top plan view of a fragment of a support structure for
carrying a plurality of containers whose construction is generally
the same as that of FIGS. 1 through 4, and showing one such
container mounted thereon.
FIG. 11 is a sectional view taken generally along the line 11--11
of FIG. 10 and in the indicated direction.
FIG. 12 is a top plan view of a container of the same general
construction as that of FIGS. 1 through 4, but illustrating a
modified form of means for mounting an identification card to the
header.
FIG. 13 is a sectional view taken generally along the line 13--13
of FIG. 12 and in the indicated direction.
FIG. 14 is a fragmentary perspective exploded view of the container
of FIGS. 12 and 13, showing the type of identification card which
is adapted to be combined therewith.
FIG. 15 is a top plan view of the apparatus of FIG. 10 showing
means for effecting transfer of a container from the support
structure to another without handling the container manually.
FIG. 16 is a fragmentary sectional view taken generally along the
line 16--16 of FIG. 15 and in the indicated direction.
FIG. 17 is a diagrammatic view showing a rack of containers
disposed in a high frequency oven for heating the same.
FIG. 18 is a median sectional view similar to that of FIG. 3, but
taken on a container having a header which is provided with an
independent lateral passageway.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In FIGS. 1, 2 and 3 there is illustrated a sample container which
is constructed in accordance with the invention and having several
advantageous features which enhance the efficacy of the use of a
structure of this kind.
The container of FIGS. 1, 2 and 3 is designated generally by the
reference character 20. The body of the container is in the form of
a flexible bag 22 about an inch square, conveniently formed of an
extruded length of plastic tubing. The side walls 24 and 26 are
thus devoid of seams. The bottom end 28 is closed by a transverse
seal 30 which may be achieved thermally, electronically or by means
of a suitable cement. The bag as thus far described would have an
open upper mouth designated generally 32.
The material from which the bag 22 is made is preferably rather
thin and transparent. For example, a wall thickness of 0.0015 to
0.0025 inch is practical because it provides the necessary
strength, is easily sealed by heat, and can readily be kneaded.
Extruded polyethylene tubing will meet practically all of the
requirements of the bag. Other flexible plastic materials could be
used. Obviously these materials should be chemically inert with
respect to the liquid solvents used and the samples to be carried
by the bag 22. As will be seen hereinafter this form of plastic or
synthetic resin has another advantage in connection with heating
the sample.
An elongate header 34 is mounted in the mouth 32 of the bag 22,
closing the same off fully except for a passageway which shortly
will be described, thereby providing an interior chamber or space
36 for reception of a quantity of liquid sample, such as for
example that which is designated 38 in FIG. 3. The header 34 is
formed as an elongate upper portion 40 of generally rectangular
cross section having a central lower boss or projection 42 that is
relatively smaller in plan than the dimensions of the upper portion
40. This gives rise to a peripheral overhanging shoulder 44
surrounding the boss 42, the shoulder 44 having advantageous uses
which will be described. It will be seen that the boss or
projection 42 is tightly engaged within the mouth 32 of the bag 22
and sealed at that point Since the header 34 preferably is made of
the same synthetic resin as the bag, such as for example
polyethylene, it is a simple matter to provide such weld or seal at
46, as for example by heat or an adhesive, to achieve the tight
connection. If the bag mouth 32 has a circumference slightly
smaller than the periphery of the boss 42 so that the mouth must be
stretched to engage the boss, the attachment will be frictionally
tight in any event.
Through the center of the upper portion 40 of the header 34 there
is provided an elongate cavity or chamber 48 having a flared
entrance at 50. A length of capillary tubing is designated 52, and
this length of tubing is adapted to be inserted into the cavity or
chamber 48 by way of the entrance 50. The flared entrance serves as
a pilot for introduction of one or more lengths of capillary tubing
and to enable insertion of a source of diluent.
While the insertion along the line 54 as viewed in FIG. 1 can be
accomplished by any mechanical means, it is practical to turn the
bag on its side 24 thereby elevating the entrance 50 so that the
cavity 48 is arranged vertically. A suitable apparatus which cuts
and separates the small section 52 from a larger length of
capillary tubing can then drop the small length of tubing into the
cavity 48 by gravity. It is assumed that the length of tubing 52
will have a concentrate of some fluid, such as for example whole
blood, entrained therein and it is intended that the liquid sample
38 will consist of a dilution of this concentrated fluid.
As shown in FIG. 3, the right-hand end of the cavity 48 is provided
with a narrow cross section connecting conduit 56 which leads to a
vertical first passageway 58, the bottom end of which opens to the
chamber 36, being blocked at this lower point by means of blocking
means comprising a flapper valve 60. The flapper valve 60 may be a
simple plastic member welded to the lower surface 62 of the boss 42
at the point 64. The flapper valve 60 functions as a check valve
and it could be located anywhere in the conduit 48, conduit 56 or
passageway 58, since its purpose is to contain the liquid 38 when
it is being agitated, kneaded or otherwise shaken.
The presence of the narrow cross section conduit 56 provides
antiblocking means comprising a blocking structure 66 at the bottom
end, that is, the right-hand end as viewed in FIG. 3, of the
conduit or chamber 48. If the length of capillary tubing 52 is
bottomed and it is intended that diluent or other reagent be
flushed through the hollow bore of the length of tubing, it is
essential that there be free flow into the passageway 58. If the
structure 66 is not used some other antiblocking means for
providing unobstructed flow must be provided.
There is a second vertical passageway 68 that is coaxial and hence
aligned with the first passageway 58, the second passageway 68
opening to a flared pilot entrance 70 that is formed in a nipple or
projection 72 integral with the header 34 and protruding from the
upper face 74 thereof. This projection is called a hollow riser
hereafter. The passageway 68 is normally blocked by means of a
small plug 76 of rubber or other elastomeric material compatible
with the liquids being used. The purpose of the plug is to enable
the dilution to be made before mixing the sample and drawing the
test amount.
As thus far described, the sample container 20 is useful to achieve
the principal ends of the invention. After a length of capillary
tubing 52 has been inserted into the chamber 48, and with the plug
76 in place, a nozzle, such as for example that which is
illustrated at 78 in FIG. 6, is inserted into the entrance 50 in a
fluidtight mating engagement. A predetermined amount of diluent or
reagent is forced into the cavity or chamber 48, passes through the
length of capillary tubing 52 through the small conduit 56 into the
passageway 58, forcing the flapper valve 60 open, and then flows
down into the chamber 36.
It is essential that there be sufficient blockage of the conduit 48
by the length of capillary tubing 52 so that a portion of the
diluting liquid will flush through the hollow bore of the length of
tubing 52. In view of the quantity of diluent used, and depending
upon the pressure with which it is forced into the chamber 48, the
diameter, and hence the transverse area of a cross section of the
conduit 48 could be several times greater than the diameter or
cross-sectional area of the length of capillary tubing 52. There
normally will be a sufficient flow such that even though a major
portion of the diluting liquid flows around the length of tubing 52
that portion which actually traverses the hollow bore will flush
the same. This enables a header 34 to be constructed with a conduit
or chamber 48 whose cross-sectional area is large enough to receive
several lengths of tubing 52 arranged parallel with one another.
The cross-sectional configuration of the cavity or chamber 48 need
not be cylindrical but could be cruciform, triangular or even
polyfoliate to provide lobes within which lengths of capillary
tubing may be accommodated. Obviously, the cross section of the
length or lengths of tubing must provide sufficient interception of
the transverse area of the chamber 48 to capture enough diluent to
result in flushing.
During the introduction of diluent or reagent into the container
20, the plug 76 is in place. After having introduced the diluent so
that the liquid sample 38 is in the bottom of the bag as shown in
FIG. 3, it is a simple matter to agitate the same, knead it or
shake it without danger. The check valve 60 blocks any possible
loss of liquid and even if located in the cavity 48, the plug 76
prevents emergence of any liquid by way of the second passageway
68. In this form, the container and its sample may be stored,
transported or even heated without difficulty.
In FIG. 17 for example, there is illustrated in diagrammatic form,
an oven 80 having a radiation energy distributing horn 82 driven by
a generator of microwave high frequency energy, such as for example
a magnetron 84 which is energized by suitable power supply 86. A
rack 88 carrying a plurality of sample containers 20 is shown
mounted in the oven. Since the type of high frequency energy which
is obtained from a microwave generator does not affect the type of
synthetic resin from which it is preferred that the containers 20
be made, this forms a highly advantageous structure and method for
heating the sample 38 quickly.
After the sample 38 has thoroughly been mixed, a quantity is to be
withdrawn for testing purposes. The invention contemplates that the
bag 22 may be pierced or cut to release the sample in which case
the passageway 68 is not needed. A structure of this kind is
illustrated in FIGS. 5, 6 and 7. It is preferred, however, that a
sample be withdrawn by way of the passageways 68 and 58 in a manner
which is not destructive of the container 20 or wasteful with
respect to the sample 38. In this way, several samples may be
withdrawn if desired.
The pilot entrance 70 is adapted to receive a dip tube 90 therein,
this dip tube 90 being either a hollow hypodermic needlelike member
with a sharp point 92, or it may be in the form of a snorkle
passing through the center of the hollow member 90. Thus, since a
sharp point 92 may damage or hang up on the flapper of the check
valve 60, it will pierce the plug 76 and its entry stopped at this
point. Then a center hollow tube may be telescopically pushed down
into the body of sample 38 to withdraw the same for testing. The
designation dip tube is used hereinafter to include any form of
hollow member which is introduced to pass into the chamber 36 of
the bag 22 to withdraw some of the liquid 38, whether a single
member or a plurality of telescoping members. Instead of being
imperforate, the plug 76 may have a form of normally tightly closed
slit therein which can be invaginated by a blunt ended snorkle
without the likelihood of causing damage to the check valve 60. The
lips of the slit would have to be fluid tight normally to prevent
leakage when the sample is being introduced into the bag 22.
In FIG. 4 a modified form of container designated 20' is
illustrated. The only difference between the containers 20 and 20'
is that in the container 20' there is no riser 72 protruding from
the upper surface 74 of the header 34. Instead, there is a
relatively large socket 94 formed in the upper portion 40 of the
header below the surface thereof and in said socket there is
inserted an elastomeric cap 96 whose central portion 98 is in the
form of a pierceable diaphragm giving access to the first
passageway 58. In all other respects, the container 20' is
substantially the same at the container 20.
FIG. 18 illustrates another embodiment of container designated 420.
This container differs from container 20 in that there is provided
in the header 434 a lateral passageway 468 extending from a flared
pilot entrance 470 in the upper part of the header to the lower end
of the header. The passageway 468 is independent from and is not
connected with the chamber or cavity 448 nor with the passageway
458 which connects chamber 448 with the interior of the bag
420.
A first flapper valve 460, similar to valve 60 is welded to the
lower surface 462 of the header 434 at the point 464. At the same
point, a second flapper valve 461 is welded to the surface 462. The
valves 460 and 461 serve as check valves for passages 458 and 468
respectively. The valves 460 and 461 may be an integral plastic
member, the center portion of which is welded at point 464 to
surface 462. The header 434 has certain advantages over the header
34 of FIGS. 1 to 3.
The passageway 468 does not require a plug 76 as in passageway 68
of header 34, because passageway 468 does not communicate with
chamber 448. A dip tube 490 used for withdrawing a sample from the
bag 422 does not have to have a sharp tip 92 as is necessary for
piercing plug 76 in header 34.
For identification purposes, it is preferred that a system used
with the container that is disclosed in above-identified
application Ser. No. 691,751. This system utilizes a type of
identification card 100 that has pertinent identifying information
imprinted thereon at 102 such as patient name, doctor name, test
identification and so forth and may have an area 104 within which
the test results will be imprinted. It is contemplated that such
test results will be imprinted at substantially the same time or
quite close in time to testing the sample withdrawn from the
container 20. The area 104 may be on an adhesive label.
As shown, the header 34 has a slot 106 cut or otherwise formed
along one edge substantially parallel therewith, and the card 100
is engaged in this slot. If the slot 106 is closed at its center
instead of being open as shown at 108, the identification card 100
may be inserted from an end thereof an drawn through the slot to
any desired location, as for example, would be controlled by
protuberances (which are not shown) on the edges of the card 100.
The slot is laterally spaced from the bag as best seen in FIG. 11
so as not to interfere with the proper use of the container 20.
The preferred structure is as shown in FIGS. 1 and 2. As stated the
slot 106 has its center portion open to the outer edge of the
header 34 thereby providing closed ends 110 for the slot 106. The
card 100 has conforming notches which are relatively rectangular as
shown at 112. To insert the card 100, it is buckled in its center
and slipped into place and then permitted to recover its flat
condition. Preferably the width of the card 100 is somewhat greater
than the distance between the ends of the slot 106 so that when
released from buckled condition there will be portions overlaying
the top surface 74 and underlying the shoulder 44 of the upper part
40 of the header 34. This is best shown in FIG. 2.
The container 120 shown in FIGS. 5, 6 and 7 is a highly simplified
version of the container 20 previously described. The bag 122 is
not substantially different although the header 134 departs to some
extent from the construction of the header 34. There is no riser 72
and as a matter of fact there is no provision for sampling by means
of a dip tube. Instead the central cavity or chamber 148 intersects
a first passageway 158 and is prevented from bottoming by a
structure 166. The upper surface 174 is unobstructed. The liquid is
introduced through the nozzle 78 as previously mentioned, passes
through the length of capillary tubing 52, passes into the first
passageway 158 past the flapper valve 160 and enters the chamber
136 to fill or partially fill the bag 122 and provide the diluted
sample 138. Identification card 200 is attached to suitable buttons
206 which are integral with the header 134 and pass through
perforations 210 which may be provided in the identification card
200. In all other respects, the container 120 is similar to the
container 20.
It will be noted that instead of the flapper valve 160, a small
rubber plug 160' may be inserted into the entrance 150 to block
liquid from flowing out of the container during the time it is
being mixed, transported or kneaded.
In addition to the advantages which have been described in
connection with the container 20 and 120, there are others which
relate to its characteristic of being collapsible. When first
provided by the manufacturer, the bag 122 may be perfectly flat
without any air in it. Accordingly, when liquid is introduced into
the bag it will expand without the need for providing a relief for
air escape. Additionally, the pressure applied by means of the
nozzle 78 can be quite high since the bag is enclosed, and yet
there will be no splashing or spraying as in the case of open
containers. Likewise, with the bag fully sealed, as for example by
the flapper valve 160 or the plug 160', any heating of the
containers will result merely in an expansion of the bag 122
without any loss of fluid and without any undue pressures being
generated.
The containers 20 and 120 both illustrate a type of header 34 and
134, respectively, provided with shoulders. The shoulders are 44 in
the first form of the invention and 144 in the second form of the
invention. While it is not essential to use such overhanging
shoulders, they are of convenience in mounting, storing or
transferring the containers as will be described in connection with
FIGS. 10, 11, 15, and 16. Other ways of carrying or storing
containers do not depend upon the shoulders. Thus the containers
220 and 320 of FIGS. 8 and 9 need not have any shoulders but
instead the respective headers 234 and 334 are provided with
supporting means for carrying or hanging the containers on a
suitable rack or brackets or other carrying device. In FIG. 8 the
header has a dovetail notch 208 cooperating with a tongue or rod
245 along which the container 220 may slide. The container 320 of
FIG. 9 has a pair of loops 308 integral with the header 334 to be
received upon a pair of rods 345 for the same purpose as previously
described.
FIGS. 10 and 11 illustrate the manner in which a carrying device 88
having tracks 145 secured thereto may be used for carrying or
storing the type of containers such as 20 and 120 that have
shoulders thereon. Such shoulders are designated 44 and 144 in the
several views. The tracks 145 each comprise a pair of members 147
which while here shown in the form of facing channel-shaped
structural members need only have the lower flange formations 149.
These flange formations are separated by a distance somewhat less
than the width of the upper portions 40 and 140 of the respective
headers 34 and 134 so that the container 20 or 120 will straddle
the flange formations 149 with the bag 22 or 122 depending in
between. The particular container illustrated in FIGS. 10 and 11 is
the container 20 characterized by the presence of the riser 72, but
any structure with shoulders would be suitable for use with the
tracks 145. It will be noted that identification card 100 is clear
of the flanged formation 149.
A structure eliminating the shoulders 44 or 144 but having
outwardly extending flanges on the header itself could cooperate
with tracks having grooves instead of the flange formations
149.
In place of the notches 112 which are shown in the structure of
FIGS. 1 and 2, the identification card 100 may be constructed as
shown at 100' in FIG. 14. In this case, the notches 112' are
angular, being generally triangular in this case. The container 20'
is identical in all respects to the container 20 except that the
slot end 110' has conforming configurations being generally pointed
so that they fit into the angular notches 112'. The identification
card 110' will thus be accurately seated in the slot 106'.
The advantage of the riser or nipple 72 will become obvious from an
examination of the structures in FIGS. 15 and 16. In these figures
the container illustrated is identical to that of FIGS. 1, 2 and 3
with the exception that the identification card 100 is not included
in the illustration. In this case the container 20 shown mounted on
the track 145 of the carrying device 88 is to be transferred to a
similar track 145' carried, for example, on another carrying
device, bracket or on a moving belt or the like. The upwardly
protruding nipple or hollow riser 72 is engaged by a forked
transfer mechanism 151 and easily moved as desired. Other
mechanisms for transferring the container 20 may be used, either
with or without the riser 72 being incorporated into the header 34
of the container 20.
It will be obvious that considerable variation is capable of being
made in the several structures without departing from the spirit or
scope of the invention as defined in the appended claims.
* * * * *