U.S. patent number 3,640,267 [Application Number 04/884,924] was granted by the patent office on 1972-02-08 for clinical sample container.
This patent grant is currently assigned to Damon Corporation. Invention is credited to Andres Ferrari, Carl R. Hurtig, Amin J. Khoury.
United States Patent |
3,640,267 |
Hurtig , et al. |
February 8, 1972 |
CLINICAL SAMPLE CONTAINER
Abstract
A container for the collection, storage and processing of a
sample of body fluid has a graduated receiving tube for collecting
the sample and which feeds a chamber that is resiliently
collapsible to aspirate the sample into the tube and thence into
the chamber. Initially, a frangible seal closes the tube-chamber
junction to maintain a sample-treating reagent within the chamber.
The tube and chamber are in a unitary, self-supporting structure
which also has a panel or the like for carrying indicia identifying
the sample.
Inventors: |
Hurtig; Carl R. (Scituate,
MA), Ferrari; Andres (Dover, MA), Khoury; Amin J.
(Dover, MA) |
Assignee: |
Damon Corporation (Needham
Heights, MA)
|
Family
ID: |
25385729 |
Appl.
No.: |
04/884,924 |
Filed: |
December 15, 1969 |
Current U.S.
Class: |
600/578;
73/864.11; 422/82.05; 436/174; 600/584; 206/463; 600/579;
422/562 |
Current CPC
Class: |
A61B
5/150251 (20130101); A61B 5/150259 (20130101); A61B
5/150099 (20130101); A61B 5/150343 (20130101); A61B
5/150022 (20130101); A61B 5/150946 (20130101); A61B
5/150274 (20130101); A61B 5/150755 (20130101); A61B
5/150786 (20130101); Y10T 436/25 (20150115); A61B
5/154 (20130101); A61B 5/150229 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61m 001/00 () |
Field of
Search: |
;128/2,216,231,232,233,276,278,DIG.5 ;73/425.6 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Claims
Having described the invention, what is claimed as new and secured
by Letters Patent is:
1. In clinical sample collection and storage apparatus having a
chamber resiliently maintaining a normal uncollapsed shaped and
being resiliently collapsible to diminish the volume therein, and
having a collection tube with a sample inlet end and feeding at the
other end into said chamber, the improvement comprising
A. a manually holdable frame mounting said tube and chamber, said
frame including a planar cardlike casing joined to the walls of
said tube along the tube length and joined to the walls of said
chamber along a path encircling the chamber,
B. at least one wall of said chamber bulging outwardly from said
planar casing when in the normal uncollapsed shape and deflecting
inward toward said casing to collapse said chamber, and
C. said sample inlet end of said collection tube protruding from
said casing frame to dispose said inlet end openly accessible
relative thereto.
2. In apparatus as defined in claim 1, the further improvement
wherein
A. said collection tube defines a fluid volume therein between said
ends thereof,
B. said chamber is resiliently collapsible to expel therefrom at
least twice said volume of fluid by way of said tube, and
resiliently recovers said normal uncollapsed shape when said inlet
end of said tube is open to aspirate fluid thereinto, and
C. said frame casing carries a volume-measuring scale disposed
along at least a portion of the length of said tube for indicating
the volume of liquid aspirated into said tube from said inlet end
thereof.
3. In apparatus as defined in claim 1 the further improvement
comprising
A. frangible fluidtight seal means for closing the fluid path of
said tube between said ends thereof, said seal means being disposed
adjacent said end of said tube feeding into said chamber, and
B. manually manipulatable means for opening said seal to provide
fluid communication between said chamber and said tube.
4. In apparatus as defined in claim 1, the further improvement
wherein said frame casing has at least two side-by-side coplanar
and conjoined sections a first of which carries said chamber and
said end of said tube feeding into said chamber, and the second of
which carries the rest of said tube.
5. In apparatus as defined in claim 4, the further improvement
wherein said frame casing has a third section disposed side-by-side
and coplanar with said first section and joined thereto, and
forming an indicia-supporting panel.
6. In apparatus as defined in claim 5, the further improvement
wherein said frame casing is severable along the juncture between
said first and second sections for removing said second section
with the tube length mounted thereon from the rest of said
apparatus.
7. A container for the collection of a sample of a liquid and the
storage thereof, said container comprising
A. a generally rectangular flat casing having a small thickness
relative to the length and width thereof and including at least
first and second side-by-side and conjoined sections,
B. means forming a serpentine-configured tubular passage on said
casing second section with passage walls bulging from said casing
along the direction of the casing thickness and having an inlet
end, an outlet end, and a storage length therebetween with said
inlet end protruding nozzlelike beyond the rectangular
configuration of said casing, and
C. means forming a pouchlike chamber
1. having opposed walls joined together along a chamber-encircling
path,
2. mounted on said casing first section along said path to dispose
said walls accessible from opposite sides of said casing,
3. connected to said outlet end of said passage to provide fluid
communication from the interior of said chamber through said
passage to said inlet end thereof, and
4. having said opposed walls resiliently collapsible to diminish
the chamber volume and resiliently resuming a normal uncollapsed
position where they bulge outwardly from said casing along the
direction of the casing thickness.
8. A surgical container for the collection of a sample of animal
body liquid and for the storage thereof, said container
comprising
A. a manually holdable flat cardlike body casing,
B. sample collection means forming a tubular passage carried by
said casing with an openly accessible inlet end extending outwardly
from said casing, an outlet end, and a storage length
therebetween,
C. a volume-indicating scale carried by said casing having
graduations arranged along said passage from said inlet end for
indicating the volume of liquid in said passage measuring from said
inlet end,
D. means forming a pouchlike chamber
1. carried by said casing,
2. connected with said outlet end of said passage to provide fluid
communication from the interior of said chamber through said
passage to said inlet end thereof, and
3. having opposed resilient walls engageable from opposite sides of
said casing, and collapsible to diminish the chamber volume and
resiliently resuming a normal uncollapsed position where they bulge
outwardly from said casing, and
E. means forming a record panel on said casing for bearing a
readable message.
9. A container as defined in claim 8 in which said casing is
arranged with first and second sections, said first section
carrying said inlet end and said storage length of said passage and
said scale associated therewith, said second section adjoining said
first section along a first junction and carrying said chamber and
said record panel, said casing sections being so arranged that
severing said casing along said first junction separates said
sections and severs said passage adjacent said outlet end
thereof.
10. A container as defined in claim 8 further comprising
A. means forming a frangible seal closing said passage along said
outlet end thereof, thereby to seal said chamber closed, and
B. seal-opening means carried on said casing and manually
manipulatable for opening said seal, thereby to provide fluid
communication between said chamber and said passage, said seal and
said opening means being so arranged that said passage and chamber
are fluidtight, except for the opening at said passage inlet end,
when said seal is open.
11. A container as defined in claim 8 further characterized in that
said casing has a peripheral edge that forms the peripheral edge of
said container, except at said passage inlet end.
Description
BACKGROUND
This invention relates to clinical sample container equipment and
in particular provides such equipment for collecting a measured
volume of the sample and for storing it under aseptic conditions.
The equipment, hereinafter for ease in reference designated as a
container system or simply container, can further be used to feed
the sample directly to diagnostic analysis equipment. The container
includes a panel for carrying indicia identifying the sample and,
where desired, designating the analysis to be performed on it.
A myriad of sample-handling liquid-containing structures are known
in the medical arts, and particularly in the field of clinical
diagnosis equipment. In general, capillary or syringe structures
are used in the prior art to collect a sample, for example from a
dermal puncture. The collected sample is then transferred to a
storage vessel, and the collecting device discarded. The storage
vessel or still another container is then used to carry the sample
through whatever diagnostic analysis operations are desired.
These prior practices require a number of fluid containers, and the
transfer from one to the other subjects the sample to spillage as
well as contamination. Also, the label identifying the sample is
subject to loss and mixup each time the sample is transferred.
In addition, much prior art sample container equipment is too
costly to be disposable, and hence requires preparation for each
use. The prior container apparatus is also deficient in regard to
providing ease in storage, handling and operation.
Accordingly, it is an object of the present invention to provide a
single container for the initial collection of a sample of body
fluid, the subsequent storage thereof with or without reagents, and
for the ultimate containment or delivery of the sample for
analysis.
A further object of the invention is to provide such a container
carrying with secure attachment the record identifying the sample,
the analysis to be preformed on it, and whatever other information
is desired.
It is also an object of the invention to provide a container of the
above character that maintains a reagent sealed therein without
spillage but which is readily placed in use without the likelihood
of introducing contamination.
A further object of the invention is to provide a container of the
foregoing character in which a sample can be transported without
further packaging.
Another object of the invention is to provide a container of the
above character that can be manufactured at such a low cost that it
can, with practical economy, be discarded after a single use.
Other objects of the invention will in part be obvious and will in
part appear hereinafter.
The invention accordingly comprises the features of construction,
combinations of elements, and arrangement of parts exemplified in
the constructions hereinafter set forth, and the scope of the
invention is indicated in the claims.
SUMMARY OF INVENTION
In brief, the invention provides a unitary and self-supporting
container system having a liquid-collecting collection tube, the
volume of which is graduated therealong from the point of liquid
entry. The tube feeds into a liquid-storing chamber, and a panel
for carrying whatever indicia are pertinent to the sample is
secured to the container system. The chamber is collapsible, and
resiliently resumes its normal shape, to enable the operator to
aspirate the sample into the collecting tube and then into the
chamber from the tube.
In addition to sealing the complete container in a sterile wrap or
otherwise sealing the receiving end of the collecting tube to
ensure that it is free of contaminants, the entry of the tube into
the chamber is sealed so that whatever liquid or gas is provided in
the chamber during manufacture does not spill or otherwise escape,
or conversely become contaminated. This seal is opened immediately
prior to using the container, and in such a way that the container
system, throughout the collecting tube length and the chamber,
remains closed from the environment.
A still further feature of the container is that the collecting
tube portion can be removed from it, and the chamber opened for
access to the contained sample, to facilitate delivering the sample
for diagnostic analysis.
The invention thus provides a clinical container system for
collecting a liquid sample in measured volume directly from a
patient, for containing the sample during storage and transport,
and for direct delivery of the sample to analysis equipment. The
sample thus contained is never exposed to the spillage,
contamination, or label loss inherent with prior clinical equipment
that requires the sample to be transferred from one container to
another. Further, the present container is of low cost so as to be
economically practical to discard after a single use.
BRIEF DESCRIPTION OF FIGURES
For a fuller understanding of the nature and objects of the
invention, reference should be had to the following detailed
description taken in connection with the accompanying drawings, in
which:
FIG. 1 is a pictorial view of a container embodying the invention
disposed for collecting a blood sample from a dermal puncture in a
patient's finger;
FIGS. 2 and 3 are cross-sectional views of the container of FIG. 1,
but prior to opening of the frangible seal therein, taken along
lines 2--2 and 3--3 respectively, of FIG. 1; and
FIG. 4 is a perspective view of the container of FIG. 1, with
portions thereof cut off, for disposition in sample analyzing
equipment.
DESCRIPTION OF ILLUSTRATED EMBODIMENT
FIG. 1 shows a container 10 embodying the invention being used to
collect a blood sample from a dermal puncture in a patient's
finger. The drawing shows that approximately 50 microliters of
blood have already been collected in a collection tube 12 that
feeds into a chamber 14. The chamber walls 16 are shown slightly
collapsed, as the medical technician or other operator normally
would do during the sample collection process simply by squeezing
the chamber prior to placing the tube entry end 12a into the fluid
being collected. Upon being released by the operator, the
resiliency of the chamber walls restores the chamber to an
uncollapsed condition, thereby drawing the sample into the
collection tube under positive pressure conditions. The operator
controls the expansion of the chamber walls until he has collected
the desired volume of sample, at which point he simply removes the
container from the fluid source and fully releases the chamber
walls, allowing them to aspirate the collected sample into the
chamber 14.
After the desired volume of sample is collected, the entry end of
the collection tube 12 can be sealed shut either by the use of a
cap 17 carried on the casing 30 but readily removable therefrom, by
means of a metallic clamp, or a heat seal, all of which are
conventional.
A record panel 18 for bearing the identification of the sample
being collected, the identification of the patient, his physician,
and the designation of the diagnostic tests to be performed on the
sample, extends from the container along the side of the chamber 14
and serves, together with the coiled collection tube and chamber,
as a handle for the secure holding of the container during the
sample collecting process.
Considering FIGS. 1, 2 and 3 in greater detail, the illustrated
container 10 has a generally cardlike rectangular outline, from
which the collection tube 12 protrudes to its entry end 12a. The
tube 12 has a nozzle section 12b extending from the entry end 12a,
a feed end 12d that feeds into the chamber 14, and a coiled section
12c between the nozzle section and the feed end. The illustrated
section 12c of the tube is arranged in a serpentinelike, single
layer coil and compactly accommodates the length of tubing
necessary to contain the maximum volume of sample that is to be
collected and processed with the particular container.
A scale 20 has graduations disposed along the length of the tube 12
calibrated, for example in microliters, to indicate the volume of
the tube along the length thereof beginning from the entry end 12a.
The scale 20 thus enables the operator to measure the volume of
sample being collected directly, as it is being collected.
Adjacent the juncture of the tube with the chamber 14, i.e., at the
tube feed end 12d, the tube is initially closed with a frangible
seal 22 shown in FIGS. 2 and 3. The seal, which is fluidtight,
illustratively is formed by compressing the tube closed and sealing
the opposed walls together, roughly along a tube diameter. As shown
in FIG. 3, the seal is in the plane of the cardlike container
shape. At the site of the seal, pull tabs 24 and 26 are secured to
the walls of the tube on either side of the seal. With this
arrangement, the operator places the container in condition for use
simply by pulling the tabs apart, which pulls the opposed tube
walls apart and hence opens the seal.
With further reference to FIGS. 1, 2 and 3, the chamber 14 is a
tubular pouch with resiliently collapsible opposed sidewalls
16--16. The chamber is oriented in the container alongside the
collection tube coiled section 12c, with the chamber bottom
adjacent the tube end near the nozzle 12b. The chamber top is
adjacent the entry of the feed end of the tube into the chamber.
The chamber is fluidtight except for this connection with the
tube.
The chamber volume is tailored to the maximum volume of sample
which is to be collected in the tube of the container. The
illustrated chamber contains this volume of sample, and a
corresponding amount of a reagent 28, in roughly one-half to
two-thirds of the chamber volume.
As noted, the opposed chamber walls 16--16 can be depressed inward,
to reduce the chamber volume by at least twice the volume of the
tube 12. Upon being released, the walls restore automatically to
their normal concave shape, shown in FIG. 2, with sufficient
resilient force to aspirate the sample liquid into the tube 12 and
thence into the chamber.
The reagent 28 is selected according to the sample being collected
and the analysis to be performed on it. It can for example be an
anticoagulant, or a preservative. A known volume of the reagent
preferably is placed in the chamber 14 prior to effecting the seal
22 at the time the container 10 is initially manufactured. Then the
physician, technician or other user of the container is free from
concern as to the identity, volume or quality of the reagent. Also,
the container with the desired reagent already in it is ready for
use simply upon removing it from its sterile wrap (not shown).
The collection tube 12 is made of a nonwetting material inert to
the sample with which the container is to be used and to the
reagent 28, and which can be processed to provide the frangible
seal 22. The material for the chamber 14 has the same inert
qualities and has the desired resiliency for the chamber walls
16--16. Polyethylene and polyvinyl chloride are considered
preferable materials for both the tube and the chamber, with a
density that has considerable flexibility.
The illustrated container 10 has the complete collection tube 12
and chambers 14 structure, with the tube seal 22 and the tabs 24
and 26 thereon, mounted in a casing 30. The casing thus forms a
manually holdable frame for mounting the tube and chamber. The
casing is formed of two opposed and mating panels 32 and 34. Each
panel is recessed with a channel to receive the collection tube,
and has a cutout through which the opposed chamber sidewalls 16--16
protrude and are accessible for the pumping operation that
aspirates the sample. The seal-opening tabs 24 and 26 also pass
through the panels 32 and 34, respectively.
With this construction, the tube and chamber structure is placed
between the casing panels and the two panels are then bonded or
otherwise sealed together with the collection tube sandwiched
between them and with the tabs 24 and 26 and chamber sidewalls
16--16 protruding through the panels at the appropriate apertures.
A relatively inert and stiff, protective and self-supporting
synthetic resin is preferred for the casing panels. The illustrated
chamber 14 has a peripheral flange 14a that is sandwiched between
the panels along the periphery of the chamber cutouts therethrough
to secure the chamber in the casing 30. Also, the scale 20 can be
carried on one or both panels of the casing 30.
The illustrated record panel 18 of the container 10 is formed by
the casing panels 32 and 34 along the side of the chamber 14
opposite from the coiled tube section 12c. The panel 18 is
illustrated as having a mat surface on which indicia can be
written. However, other forms of record panel can be used. One
alternative arrangement is to form a record pocket (not shown)
between the opposed casing panels 32 and 34 for carrying a document
bearing the desired indicia. Another alternative is simply to
attach a document onto the outer surface of the record panel 18,
using any one of many conventional fastening means including
adhesives, mechanical clips, buttons and the like.
Whatever construction is used for the record panel 18, the indicia
it carries can be machine readable, i.e., readable with optical
character recognition techniques, magnetically detectable or
optically detectable, where this is desired.
With further reference to FIG. 1, the container 10 is arranged
overall in three side-by-side sections 10a, 10b and 10c. The
collection tube 12 is in an end section 10a, the chamber 14 is in
the central section 10b, and the record panel 18 is in the other
end section 10c.
One reason for this three-section arrangement of the container 10
is that it enables the chamber and record panel to be separated
from the collection tube. The separation can be effected by cutting
or otherwise severing the container into two parts along the dashed
construction line 36 at the boundary between sections 10a and 10b.
This separation may be desired to diminish the size of the
container elements that are present during analysis of the
collected sample, which may be of particular benefit where the
analysis is performed with automated equipment. The showing in FIG.
4 in both solid and phantom illustrates the container elements that
would remain intact after the container section 10a, bearing the
collection tube, is thus removed by cutting along the construction
line 36.
With reference to FIG. 4 a conventional fluid coupling (not shown)
can be inserted into the short length of collection tube 12d
leading from the chamber to draw the collection sample out for the
analysis.
Further, where the sample is to be openly available during
analysis, the container chamber section 10b is severed along the
dashed construction line 38, shown in FIG. 1, to remove the top
portion of the chamber, including the collection tube entry
therein, and leaving only the analysis container 40 shown in solid
lines in FIG. 4. The record panel 18 is preferably foreshortened
relative to the other sections of the container 10, as shown in
FIG. 1, so that when the container is cut along the construction
line 38 to provide the analysis container 40 (FIG. 4) the record
panel 18 remains intact.
The analysis container 40 of FIG. 4, with or without the upper
section shown in phantom, can be placed in automatic analysis
equipment and the sample stored therein analyzed according to
instructions recorded on the record panel 18.
Although the illustrated container 10 is described as fabricated
with a collection tube and chamber encased between two panels, the
invention can be practiced with other types of construction.
Perhaps the lowest cost construction, at least for large volume
manufacture, is to use panels that are molded to provide by
themselves the passage for collecting the sample and the chamber
for storing it. Each such panel is molded to form essentially half
of the collection tube, or passage, and half of the chamber.
Also, alternative to bonding the tube 12 walls together to form the
seal 22, other construction can be employed. One such alternative
is to conventional crimp or squeeze the tube closed with a
conventional clip or clamp applied from outside the container.
Further, the container system of the invention is of course not
limited to collecting a sample from a finger puncture; this
particular use is shown only by way of specific illustration.
It will thus be seen that the objects set forth above, among those
made apparent from the preceding description, are efficiently
attained and, since certain changes may be made in the above
constructions without departing from the scope of the invention,
all matter contained in the above description or shown in the
accompanying drawings shall be interpreted as illustrative rather
than in a limiting sense.
* * * * *