U.S. patent number 3,718,133 [Application Number 05/105,930] was granted by the patent office on 1973-02-27 for container unit for liquid samples.
This patent grant is currently assigned to Damon Corporation. Invention is credited to James F. Marten, Wesley G. Perry.
United States Patent |
3,718,133 |
Perry , et al. |
February 27, 1973 |
CONTAINER UNIT FOR LIQUID SAMPLES
Abstract
This invention relates to a disposable container unit for liquid
samples and is particularly useful for the collection of blood
specimens. It includes an elongated compressible bulb member having
an integral nozzle attached thereto. An elongated storage volume
having a closed and an open end and a small cross sectional area is
also provided, the open end being in communication with the bulb
member. Preferably but not necessarily the longitudinal axis of the
storage volume, the bulb and the nozzle are coaxial. If the
container unit is held vertically upward, liquid in the bulb will
not flow freely into the storage volume because of its small cross
sectional area. Similarly, if the storage volume contains liquid
and is turned upside down, the liquid will not flow from it into
the bulb.
Inventors: |
Perry; Wesley G. (Wayland,
MA), Marten; James F. (Cohasset, MA) |
Assignee: |
Damon Corporation (Needham
Heights, MA)
|
Family
ID: |
26803107 |
Appl.
No.: |
05/105,930 |
Filed: |
January 12, 1971 |
Current U.S.
Class: |
600/578; 422/547;
422/913; 73/864.11; 422/941; 73/864.91; 600/580 |
Current CPC
Class: |
A61B
5/150587 (20130101); A61B 5/150251 (20130101); A61B
5/150351 (20130101); A61B 5/150717 (20130101); B01L
3/5082 (20130101); A61B 5/150259 (20130101); A61B
5/150267 (20130101); B01L 3/50 (20130101); A61B
10/0045 (20130101); A61B 5/150022 (20130101); A61B
5/150755 (20130101); A61B 5/150946 (20130101); B01L
3/545 (20130101); A61B 5/150786 (20130101); A61B
5/150343 (20130101); A61B 5/150099 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61B 10/00 (20060101); B01L
3/14 (20060101); B01L 3/00 (20060101); A61b
010/00 () |
Field of
Search: |
;128/2F,2B,2R,2G,DIG.5,272,276,304 ;23/23B,259 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
124,141 |
|
May 1947 |
|
AU |
|
683,602 |
|
Apr 1964 |
|
CA |
|
1,031,641 |
|
Jun 1966 |
|
GB |
|
Primary Examiner: Howell; Kyle L.
Claims
Having described our invention what we claim is:
1. A container for the collection and storage of a liquid, said
container comprising in combination
1. a bulb member having collapsible and resiliently restoring walls
so as to be pumpable, and normally resiliently maintaining a first
storage volume therein and normally having a minimal internal
cross-section larger than a first area,
2. a nozzle affixed to said bulb member and having a liquid passage
communicating through the wall of said bulb member with the
interior thereof, and
3. a measurement and storage compartment having a second volume
therein smaller than said first volume and affixed to said bulb
member, the interior of said compartment communicating with the
interior of said bulb member through an aperture of lesser
cross-section than said first area and being fluid-tight except for
said aperture, said aperture being sufficiently small to block the
gravitational flow of liquid between said bulb member and said
compartment.
2. The combination defined in claim 1 further comprising
level-indicating means on said bulb member, said level-indicating
means being so located on said bulb member that the portion of said
first storage volume between said level-indicating means and said
aperture, when said container is oriented with said aperture
disposed directly below said level-indicating means, is
substantially equal to said second volume.
3. The combination defined in claim 1 in which said container is
made of low density polyethylene.
4. The combination defined in claim 1 in which said first volume is
at least three times said second volume.
5. The combination defined in claim 4 in which said container unit
is made of low density polyethylene.
6. The combination defined in claim 1 in which the cross-sectional
area of said aperture is less than 0.0177 square inches.
7. The combination defined in claim 1 in which chemical materials
to aid in the preservation of said specimen are included in said
bulb member.
8. The combination defined in claim 1 in which said compartment is
elongated and said second volume therein is of uniform
cross-sectional area between the ends thereof with a value not
greater than 0.0177 square inches.
9. Container apparatus for the collection of liquid material and
for the storage thereof, said apparatus comprising
1. a collapsible and resiliently restoring pumpable aspirating bulb
member normally having a first storage volume and having a nozzle
for aspirating said liquid material thereinto, and
2. a measurement and storage compartment
a. having a known second storage volume less than said first
volume,
b. having an open end feeding into said storage volume thereof from
said bulb member for passing said liquid material from said bulb
member into said compartment,
c. forming with said bulb member a normally-closed vessel open only
at said nozzle, and
d. having the liquid-passing cross-section of said open end
sufficiently small to preclude the free flow under at least
gravitational force of liquid material between said compartment and
said bulb member.
Description
FIELD OF THE INVENTION
Our invention relates to container units for collecting, storing
and treating liquid samples for analysis and is particularly useful
for the collection of blood samples.
BACKGROUND OF THE INVENTION
Automatic analysis apparatus for performing a relatively large
number of analyses on human blood samples is widely used in modern
medicine as an aid in diagnosis and for screening large
populations. In general, in the past it has been the practice to
collect the blood for such analysis in a container which has been
at least partially evacuated and to which a hollow hypodermic
needle is attached. After the needle has been inserted in a vein of
the subject, the passage between the hollow passage in the needle
and the evacuated container is opened and the blood is sucked into
the container. While this procedure has been widely used for the
collection of blood samples in the past it has suffered from some
deficiencies.
Among these is the fact that the container in which the blood is
collected is not itself used to hold the blood sample for analysis.
Rather, when analysis is to be done the blood is transferred to a
receptacle used by the analysis machine and this blood is then
analyzed. This transfer procedure presents opportunity for loss of
sterility, spillage and possibly loss of patient identity because
of clerical error.
Another problem with the prior collection and container systems was
that relating to blood sample size. Conventional analysis machines
require substantial amounts of blood for the generation of a
complete profile of tests. Typically volumes of the order of 3
milliliters to 4 milliliters are required. By way of contrast,
recently developed analysis machines may require only a few hundred
microliters of blood for a complete blood profile. Such small
volumes of blood may readily be obtained from children or elderly
patients as well as healthy adults without trauma. Also these small
volumes for analysis are obtainable from small animals without
injury. Typically such small samples are obtained by cutting the
finger, ear lobe or the like with a small lancet and collecting the
blood by compressing a sterile bulb to which a nozzle is attached
and then sucking the blood welling to the surface of the skin into
the bulb. A novel disposable lancet for making precise incisions
for the collection of small blood samples is disclosed in the
co-pending application entitled "Snap Acting Surgical Lancet" filed
Dec. 15, 1969, Ser. No. 884,861, which is assigned to the assignee
of this application, and is in the name of W. Perry now U.S. Pat.
No. 3,659,608.
Disposable sterile container units which can be used as the sample
container in the analysis machine and are particularly useful in
the collection of small blood samples have also been heretofore
developed. Such containers are shown, for example in the following
pending U.S. patent applications, assigned to the assignee of the
present invention:
Inventors Title Ser. No. Filed C. Hurtig et al Clinical 884,924
Dec. 15, 1969 Sample Container A. Ferrari Dialyzing 65,540 Aug. 20,
1970 Liquid Collecting Container C. Hurtig Liquid 69,767 Sept. 4,
1970 Container Having Pressure- Protected Dialyzing Membrane
These applications are now issued as U.S. Pat. Nos. 3,640,267;
3,640,388; and 3,640,393, respectively.
While the containers described in the patent applications cited
above are useful, they do anticipate use by a skilled technician to
measure precise volumes. In practice it has been found that despite
careful instruction, sometimes technicians do not collect the
required volume of blood.
Further, the containers described contemplated the dilution of the
blood sample and possibly its dialysis in the container itself. It
has been found that in some cases it is more desirable to ingest a
precise measured volume of the sample into the analysis machine and
thereafter to precisely dilute it. Separation of the blood serum,
which is used in analysis, from the red blood cells may
conveniently be accomplished by centrifugation rather than
dialysis, thus simplifying container construction.
Finally as has been mentioned above, it is a significant advantage
if the collection container is disposable. The units described in
the cited patent applications are relatively costly to manufacture
as compared to the container of our invention.
From the foregoing it will be apparent that as automatic analysis
machines have improved, a need has developed for a blood collecting
and storage container, particularly for small blood samples, that
would be relatively simple in use, economic in manufacture, adapted
to centrifugation or other methods of serum separation, and useful
not only to collect blood but also adaptable for use as a sample
container in machine analysis.
It is therefore among the principal objects of our invention to
provide a container unit which meets the foregoing
requirements.
Another object of our invention is to provide a container unit of
the type described in which the red blood cells and the blood serum
may be separated in the field and then maintained in a separated
condition during shipment to a central analysis location. A further
object of our invention is to provide a container unit of the type
described which may be manufactured by either blow molding or
injection molding techniques conventionally used for the
manufacture of large quantities of plastic products in an
inexpensive manner.
A still further object of our invention is to provide a container
of the type described which is convenient for the user to handle
and which also may be used by relatively unskilled personnel.
Yet a further object of our invention is to provide a container
unit of the type described which is generally useful for the
collection, storage and treatment of liquid samples. These and
other objects of our invention will be more apparent from the
following detailed description and the accompanying drawings.
GENERAL DESCRIPTION OF THE INVENTION
Container units made in accordance with our invention include an
elongated compressible bulb member at one end of which is formed a
nozzle through which the liquid to be collected is ingested into
the bulb. The bore through the nozzle is preferably but not
necessarily coaxial with the longitudinal axis of the bulb. An
elongated storage container is also attached to the bulb,
preferably at the end of the bulb opposite to that of the nozzle.
Preferably, but not necessarily, the longitudinal axis of the
storage volume is coaxial with that of the bulb. The entire unit
may be molded of a translucent or semi-transparent plastic such as
low density polyethylene.
The cross sectional area of the storage volume i.e., its area
measured in a plane normal to its longitudinal axis at the point of
communication with the bulb, is sufficiently small so that the
storage volume is not self-venting. This means that the liquid to
be sampled may be aspirated into the bulb member and the unit then
held vertically upward i.e., with the open end of the storage
volume upward and its longitudinal axis vertical. Because the
storage volume is not self-venting, no liquid flows into it. A
marker on the portion of the bulb immediately adjacent the storage
volume indicates that fraction of the volume of the bulb which is
just sufficient to fill the storage volume. If sufficient liquid to
fill the storage volume has not been ingested, more can be
aspirated. If sufficient liquid is in the bulb, the technician
merely "shakes down" the liquid into the storage volume in the same
manner as one "shakes down" a clinical thermometer.
When the storage volume is filled, it may be inverted but the
liquid therein will not flow outwardly because the volume is not
vented. Any excess liquid in the bulb beyond that required to fill
the bulb may be expressed from the nozzle.
The volume of the bulb is substantial as compared to the volume of
the storage volume, usually being at least three times the storage
volume.
DESCRIPTION OF FIGURES
A more complete description of container units made according to
our invention is included in the following detailed description and
the accompanied drawings in which:
FIG. 1 is a perspective view of the container unit of my
invention;
FIG. 2 is a side plan view, partially in section, of a first
embodiment of my invention;
FIG. 3 is a cross-section taken on the line 3--3 of FIG. 2;
FIG. 4 is a partial side plan view, partially broken away, showing
the manner in which the liquid sample is contained in the bulb
before being "shaken down" into the storage volume;
FIG. 5 is a view, similar to FIG. 4 showing the appearance of the
storage volume after the sample has been "shaken down;"
FIG. 6 is a side plan view, partially broken away, showing the
manner in which liquid is retained in the storage volume when in
the inverted position;
FIG. 7 is a view similar to FIG. 5 showing the appearance of the
storage volume after a blood sample collected therein has been
separated into serum and red blood cells;
FIG. 8 is a view similar to FIG. 2 of an alternative embodiment of
my invention specifically designed for molding by injection molding
techniques; and
FIG. 9 is a sectional view taken along the lines 9--9 of FIG.
8.
SPECIFIC DESCRIPTION OF ILLUSTRATED EMBODIMENTS
As shown in FIGS. 1, 2 and 3 the container unit of our invention
includes a relatively large bulb member 10 having a nozzle
generally indicated at 12 integrally formed therewith. The storage
volume, generally indicated at 14 is shown also preferably formed
by a wall member which is integral with that which forms the bulb.
A separable cap 16 is also provided for reasons to be explained
below.
The embodiment of our invention illustrated in FIGS. 2 and 3 is
particularly adapted and designed to be blow molded of low-density
polyethylene or similar semi-transparent plastic material which is
also at least somewhat resilient. The drawings of FIGS. 2 and 3 are
scale drawings at twice the size of an actual device made in
accordance with our invention.
The bulb member as shown in FIGS. 1 and 2 is an elongated cylinder
with hemispherical ends, the length including the ends being about
six times the internal diameter. The walls of the bulb are
relatively thin so that they may readily be compressed by finger
pressure to reduce the internal volume of the bulb. In an
embodiment of a device fabricated of low density polyethylene the
bulb walls were about 0.015 inch thick.
The nozzle 12 includes a cylindrical portion 12a, immediately
adjacent the bulb and a tapering portion 12b. A bore of
substantially uniform size extends through both portions of the
nozzle into the bulb interior.
The cap 16 has an internal bore 16a whose surface engages the outer
surface of the cylindrical portion 12a of the nozzle with a sliding
frictional fit so that the cap may be readily removed, yet will
remain in place when attached to the unit.
The storage volume chamber is formed by an elongated hollow
cylindrical member attached to the bulb member at the end of the
bulb opposite the nozzle end. As shown, the end of the storage
volume secured to the bulb is open and the end farthest from the
bulb is closed. It will be observed that the cross-section of the
storage volume is quite small as compared to the diameter of the
bulb. In the illustrated embodiment the internal diameter was
approximately 0.131 inches, giving a cross-sectional area of 0.0135
square inches. The storage volume length was about 1.81 inches, the
closed end being hemispherical in shape. This volume is sufficient
to contain approximately 400 microliters of liquid. By way of
contrast, in the illustrated embodiment, the total volume of the
bulb is about 2,550 microliters. A "flag" or card 18 is integrally
molded with the side walls which define the storage volume 14. This
card is thicker than the side walls of the bulb and storage
container. As illustrated it extends from just below the bottom of
the storage volume part way up the bulb. In the embodiment
illustrated, if the bulb chamber 10 is filled with an amount of
liquid such that, when the container is held vertically upright,
the upper surface of the liquid is in line with the top of the card
and this liquid is then "shaken down," it will just fill the
storage volume. Thus the volume of the portion of the bulb from its
bottom to the top of the card is made just equal to the storage
volume.
The card serves to stiffen the side walls of the storage volume and
the bottom of the bulb so that they are comparatively rigid as
compared to the upper portion of the bulb. It will also be observed
that the card extends to the right of the container unit, as seen
in FIGS. 2 and 3, a greater distance than to the left. This makes
the unit relatively easy to handle and also permits the unit to be
readily positioned in a tray or other unit provided with a suitable
slot.
A slit 18a is provided in the card about mid-way between the two
ends of the storage volume. The purpose of this slit will be
hereinafter described.
When container units of my invention are to be used for blood
sample collection, they are sterilized in any convenient manner and
a solution of conventional anti-coagulant and anti-foaming
materials in a volatile vehicle such as distilled water is placed
in the bulb. The vehicle containing these materials is evaporated,
leaving the walls of the bulb coated with crystals of
anti-coagulant and anti-foaming material.
The manner in which the container unit of our invention may be used
will now be described with particular reference to FIGS. 4 through
7. If blood is to be collected for example, the skin is incised as
previously described and blood is allowed to well to the surface.
The cap is then removed from a sterile container unit and the
middle and upper bulb portion is squeezed between the finger and
thumb to reduce the bulb volume. With the bulb in this condition,
the nozzle is placed in the blood droplet and the pressure removed
from the bulb. As it returns to normal volume it sucks in blood.
The unit is then held vertically. If the sample collected is
sufficient to fill the bottom of the bulb to the top of the card 18
(or such other marker as is provided) collection may cease. If it
is not, additional blood is collected until the required volume has
been obtained. It will be noted that in this process, none of the
collected blood goes into the storage volume. When a sufficient
sample of blood has been collected, the bottom portion of the
container unit will appear as in FIG. 4.
Thereafter, the blood is shaken down into the storage volume by
holding the container unit by the bulb portion and snapping the
wrist in the same manner as one shakes down the mercury column in a
clinical thermometer prior to use. The bottom portion of the
container unit then appears as in FIG. 5.
If an excess beyond that required to fill the storage volume has
been collected, after shaking down, the unit may be inverted and,
as shown in FIG. 6, the excess blood will flow to the portion of
the bulb immediately adjacent the nozzle, where it may be expressed
to waste simply by squeezing the bulb. It will be noted however
that the blood in the storage volume remains in place, even when
inverted and does not flow into the bottom of the bulb 10.
A blood sample of known volume has thus been collected for analysis
and the container may then be capped and sent to the analysis
location. Alternatively, before sending the sample to the analysis
location, the sample may be centrifuged to separate the serum from
the red blood cells while in the container. After centrifugation
the blood sample will appear as shown in FIG. 7 with the less dense
serum portion in the upper portion of the storage volume as
indicated by 19a and the denser red blood cells in the lower
portion as indicated by 19b. To maintain the separation of serum
and red blood cells between centrifugation and analysis, the
storage container may be folded by folding the card 18 about the
line 18b extending across the card from the slit 18a. Such folding
collapses the side walls of the storage volume thus insuring a seal
between the red blood cells and the serum. For shipment, the two
portions of the folded card may be clipped together by a suitable
clip and this may be removed at the analysis machine and the card
unfolded.
For use as a sample container for analysis machines, the upper
portion of the bulb may be simply cut off immediately above the top
of the card 18 and the container unit placed in a suitable sample
tray. The container unit of our invention has been designed
particularly for use with the automatic analysis apparatus
disclosed in the commonly assigned co-pending U.S. patent
application of D. I. Kozowsky, A. Ferrari and C. R. Hurtig entitled
"Constituents Measuring Chemical Analyzer Having Multiple
Concurrently Operated Aliquot Processing Conveyors," said
application having Ser. No. 105,805 and having been filed on the
same date as the present application. Sampling apparatus
particularly designed for use with the container units of our
invention is disclosed in the commonly-assigned co-pending U.S.
patent application of J. Bannister, M. Jordan and J. Peters
entitled "Liquids Sampler With Probe Bathing Chamber," said
application having Ser. No. 105,803 and having been filed on the
same date as this application.
In FIGS. 8 and 9 we have illustrated another embodiment of a
container unit of our invention. As mentioned above, this design is
particularly designed for manufacture by injection molding. FIGS. 8
and 9 are also scale drawings of an actual unit and are twice
actual size.
The unit of FIGS. 8 and 9 is made in two parts and these are fitted
together to form the complete unit. The upper part generally
indicated at 20 includes a nozzle portion 22, the upper portion of
the bulb member 24, a cap 25 and an integral attaching strap 25a to
permanently attach the cap 25 to the unit. The lower part,
generally indicated at 26 includes the lower portion of the bulb
member 28, the storage volume 30 and the "flag" or card 32.
It will be observed that the storage volume 30 and the lower
portion of the bulb 28 are formed with walls of substantially
greater thickness (about 0.030 inches) than the walls of the upper
part of the bulb on part 20. The walls of the upper part of the
bulb are about 0.015 inches thick in one embodiment and these are
readily compressible when molded of low density polyethylene. It
will also be observed that in the embodiment of FIGS. 8 and 9 the
storage volume is not a right cylinder but tapers. This taper
facilitates the withdrawal of the injection molded part from the
mold. However the mean diameter is substantially equal to the mean
diameter of the blow-molded unit shown in FIGS. 2 and 3.
A cylindrical collar 34 for receiving the lower portion of the part
20 is formed on the upper portion of the part 26. Several small
hemispherical protruberances 36 are provided on the collar to
facilitate the attachment of an identification device during
processing if desired. The inner diameter of the collar 36 and the
outer diameter of the lower portion of the bulb 24 forming a
portion of part 20 are selected to form a close interference fit so
that the two parts, when assembled as shown are sealed against
leakage. The bulb member is provided with an integral shoulder 38
which engages the upper surface of the collar 36 to limit downward
motion of the upper part when the two parts 20 and 26 are
assembled.
It will be apparent that the container unit shown in FIGS. 8 and 9
will function in the same manner as that illustrated in FIGS. 2 and
3. It does have the advantage that the top need not be cut off when
it is desired to use the lower portion of the bulb and the storage
volume as a sample container. Rather the top portion 20 may be
simply pulled out of engagement with the collar 34.
As has been described above, the storage volume of units made
according to our invention is not self-venting as is a conventional
water glass for example. As the diameter of the storage volume is
increased, a size will be reached where this volume is self-venting
and the liquid in the bulb will simply flow into the storage
volume. We have found that in circular container units of our
invention this largest diameter is of the order of 0.150 inches for
water, blood etc. or the cross-sectional area is about 0.0177
square inches. If the diameter is larger than about this value, the
storage volume may fill as the liquid is aspirated by the bulb and
thus there will be no opportunity for determining when the desired
volume has been obtained. Further there will be no assurance that
the liquid, once in the storage volume will not flow out as the
container unit is placed in various positions during shipment. If
the storage volume is made smaller than about 0.040 inches in
diameter, it is difficult to shake the liquid in the bulb into the
storage volume.
While we have described the storage volume of our device as simply
a relatively narrow closed container which is filled by "shaking
down" the liquid in the bulb, it will of course be understood that
the storage volume might include a vent opening at its lower end
which is normally closed by a valve. When the liquid sample is
contained in the bulb, this valve could be opened and the liquid
would flow into the vented storage volume. Thereafter the valve
could be closed to seal the vent and the liquid would not
thereafter freely flow from the storage volume.
Additionally, while we have disclosed the concept of folding the
storage volume to maintain the serum and red blood cells separated,
it is apparent that the plastic tubing forming the storage volume
might be heat sealed or a valve located about mid-way between the
ends of the storage volume might be closed to achieve
separation.
The storage volume of the container unit of this invention can be
termed as being provided by a compartment. Further, it will now be
apparent that this compartment provides a chamber that provides
both a storage function and a measurement function.
It will also be apparent that, while we have described the use of
the container unit of our invention in connection with the
sampling, treatment and storage of blood samples, it will be
equally useful in sampling other types of liquids such as urine or
water in a sterile manner and providing a container from which they
can be removed by the sampler of an analysis machine.
Thus, we have provided a low-cost container in which a known small
volume of liquid may be collected, treated (as by centrifuging) and
stored and which will retain the liquid once stored therein despite
container unit orientation. With the upper portion of the unit
removed, the lower portion may serve as a sample cup in connection
with machine analysis of the sample. Thus the sample, once taken
need never be removed from the sterile container in which it was
collected. Because of the container units simple construction with
resultant low cost, the entire unit may be disposed of once it has
been used.
It will thus be apparent that this construction achieves the
objects set forth above as well as those made apparent from the
specific description.
* * * * *