U.S. patent number 3,706,306 [Application Number 05/120,475] was granted by the patent office on 1972-12-19 for combination blood sampling vacuum syringe centrifuge container and specimen cup.
Invention is credited to Harold J. Berger, Jerry G. Goldsmith.
United States Patent |
3,706,306 |
Berger , et al. |
December 19, 1972 |
COMBINATION BLOOD SAMPLING VACUUM SYRINGE CENTRIFUGE CONTAINER AND
SPECIMEN CUP
Abstract
An elongated, unitary, blood sampling vacuum syringe, centrifuge
container and specimen cup, for use with an ordinary tubular needle
holder is described. The device includes an evacuated blood sample
centrifuge container having a piercable diaphragm cap and being
supported in spaced relation within one end of a housing member,
the opposite end of which housing member is in the form of a
separable specimen cup. After obtaining a blood sample in the usual
fashion with use of an ordinary tubular needle holder, the device
is centrifuged as a unit to separate the blood serum into the upper
end of the centrifuge container. Vertically spaced openings
provided in an upper side wall portion the centrifuge container and
normally sealed off by means of a pressure-sensitive tear strip,
are thereafter sequentially opened by manual removal of the tear
strip to permit gravitation of the centrifuged blood serum down
into the specimen cup, after which said serum-filled specimen cup
can be separated for use in analysis.
Inventors: |
Berger; Harold J. (Surfside,
FL), Goldsmith; Jerry G. (Miami Beach, FL) |
Family
ID: |
22390541 |
Appl.
No.: |
05/120,475 |
Filed: |
March 3, 1971 |
Current U.S.
Class: |
600/575; 422/550;
422/401; 422/415; 600/577; 604/148 |
Current CPC
Class: |
A61B
5/150244 (20130101); A61B 5/15003 (20130101); A61B
5/150236 (20130101); A61B 5/150251 (20130101); A61B
5/150732 (20130101); A61B 5/150351 (20130101); A61B
5/150389 (20130101); A61B 5/154 (20130101); A61B
5/150213 (20130101); A61B 5/150755 (20130101); A61B
5/150267 (20130101); A61B 5/150496 (20130101); A61B
5/150221 (20130101); A61B 5/150259 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2F,2R,2B,DIG.5,276,275,272 ;233/26 ;23/258.5 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Howell; Kyle L.
Claims
What we claim as new and desire to secure by Letters Patent is:
1. For use with a conventional tubular blood sampling needle
holder, a combination holder, centrifuge container and specimen cup
comprising, in combination, an elongated tubular housing member,
and evacuated blood sample collecting tube, means supporting said
collecting tube in spaced relation within one end of said housing
member, the outer end of said collecting tube being fitted with a
needle pierceable closure cap member, the other end of said housing
member being closed, and normally-closed, manually-controlled
aperture means in a side-wall portion of the outer end portion of
said collecting tube for draining centrifuged blood serum from said
collecting tube into the closed end of said housing member and
means on said housing member allowing access to said
manually-controlled aperture means.
2. The invention as defined in claim 1, wherein said other end of
said housing member is in the form of a specimen cup having an open
end facing the inner end of said collecting tube in
longitudinally-space relation, and means for separating said
specimen cup from the remainder of said tubular housing member.
3. The invention as defined in claim 2, wherein said aperture means
comprises a plurality of vertically aligned openings in said
collecting tube, and a pressure-sensitive tear strip normally
adhered to said collecting tube in sealing relation with respect to
said plurality of openings.
4. The invention as defined in claim 3, wherein said means allowing
access comprises an elongated opening in said tubular housing
member permitting access for manual tearing away of said tear
strip.
5. The invention as defined in claim 4, wherein a lowermost
sub-plurality of openings of said plurality of openings are of
triangular shape.
6. The invention as defined in claim 5, wherein said tubular
housing member is integrally formed of a transparent synthetic
plastic material.
7. The invention as defined in claim 6, wherein said means for
separating comprises a peripheral weakened wall zone at the upper
end of said specimen cup to permit manual breakaway thereof after
being supplied with a serum specimen.
Description
This invention relates to medical syringes and is directed
particularly to improved vacuum syringe devices combining a blood
sample centrifuge container and a serum receiving specimen cup in a
unitary structure.
In blood analysis for medical diagnosis or research it is
frequently necessary to separate the blood serum from the cellular
blood matter for independent chemical analysis. This is usually
done by centrifuging a blood sample or specimen taken from the
patient or donor with the use of an ordinary pistoncontrolled or
vacuum actuated medical syringe. Because freshly drawn blood has a
tendency to change in character due to enzymatic action, it is
essential that separation and removal of the blood serum be
effected as soon as possible after collection to insure valid
analysis. It is also important that the procedure undertaken in the
centrifuging of the blood sample and removal of the serum specimen
be such as to minimize any possibility of contamination. Since, in
medical diagnosis, a substantial portion of the blood samples for
analysis are taken in private clinics or physician's treatment
facilities, and since such facilities vary over a wide range as to
laboratory capability, availability and competence of technical
personel, the preparation for analysis of blood sample serum is not
infrequently of less than optimum quality. It should also be noted
that samples obtained in this manner are frequently shipped over
long distances before being subjected to chemical analysis. If the
cellular blood mass is not properly and totally separated from the
serum, a faulty result will be obtained by the receiving
laboratory. In such cases the specimen collection agency, and not
the receiving laboratory, is at fault. The medical literature as
well as the publications in the field of clinical chemistry have,
in the past, expressed great concern over these deficiencies and
stated that the following determinations are particularly affected.
Thus, it is well known that a number of changes ensue when whole
blood is allowed to stand without removal of the cellular fraction.
The glucose concentration diminishes rapidly, electrolytes migrate
across cell membranes to establish new equilibria; phosphatases
cleave intracellular organic phosphate esters, increasing the
inorganic phosphorous level, and cellular enzymes may leak out
causing false serum levels. When hemolysis occurs these effects
become exaggerated and, in addition, complications develop with the
technical aspects of certain test procedures.
The removal of the centrifuged blood serum from the blood sample
for analysis was heretofore accomplished either by manually pouring
the serum from the top of the container or tube into the serum
specimen cup, or by vacuum withdrawal by mouth with the use of a
pipette tube lowered into the blood serum for subsequent release
into separate specimen cups. It can readily be understood that
either of these two commonly used serum removal methods are subject
to sources of contamination. These methods of separation, moreover,
are readily subject to contamination of the serum by migrating
blood cells unless great care is taken in the separating process.
For this reason, several spinnings in a centrifuge are generally
necessary in order to obtain a serum sample which lends itself to
reliable and valid chemical analysis. This process of separation
takes much of the technician's time and, in addition, necessitates
the uneconomic use of glassware.
It is, accordingly, the principal object of this invention to
provide a new and improved blood sampling vacuum syringe,
centrifuge container and specimen cup that obviates the above
described deficiencies of blood serum specimen preparation devices
and procedures heretofore devised.
A more particular object of the invention is to provide a
combination blood sampling vacuum syringe, centrifuge container and
specimen cup of the character above described that will be of
unitary structure including an enclosed blood sample centrifuge
container and specimen cup for use with an ordinary tubular needle
holder for vacuum drawing a blood sample into the centrifuge
container, and which includes means for gravitationally removing a
predetermined quantity of subsequently centrifuged blood serum in
said container into the specimen cup for analysis upon the manual
manipulation of the device in a simple and non-critical manner.
Still another object of the invention is to provide a vacuum
syringe device of the above nature wherein the specimen cup forms a
separable lower end portion of a housing member in the upper end of
which the centrifuge container is disposed in coaxially-spaced
relation, the centrifuge container being provided, in an upper side
wall portion thereof, with vertically-spaced openings normally
sealed off by means of a pressure sensitive tear strip adapted to
be removed for sequentially unsealing said openings to permit
gravitation of centrifuge blood serum down into the specimen
cup.
And yet another object of the invention is to provide a vacuum
syringe device in the above nature including means for readily
tranversely severing or breaking away the specimen cup end portion
of the device housing to permit easy removal of the filled serum
specimen cup for laboratory analysis. Quicker and more efficient
separation of serum from cells is thus achieved with less labor and
a higher degree of accuracy than heretofore possible.
Yet another object of the invention is to provide a vacuum syringe
device of the above nature which will be of such simple and
inexpensive construction as to be readily disposable or expendable
after use, while at the same time providing under a clean
environment a capped blood serum containing specimen cup for
interchangeable use in automatic multiple test laboratory
analyzers.
Other objects, features and advantages of the invention will be
apparent from the following description when read with reference to
the accompanying drawings. In the drawings, wherein like reference
numerals denote corresponding parts throughout the several
views:
FIG. 1 is a longitudinal cross-sectional view of a vacuum syringe
device embodying the invention shown partially inserted in a
tubular holder preparatory to the taking of a blood sample;
FIG. 2 is a vertical cross-sectional view similar to that of FIG.
1, but showing the vacuum syringe device fully depressed within the
needle holder after a blood sample has been taken, and further
showing the blood sample which has been withdrawn into the
centrifuge chamber of the device;
FIG. 3 is a vertical cross-sectional view of the vacuum syringe
device of FIG. 2, shown separately after centrifuging of the blood
sample;
FIG. 4 is a longitudinal cross-sectional fiew similar to that of
FIG. 3, but showing removal of the associated vent opening tear
strip for gravity feed of the centrifuged blood serum into the
specimen cup; and
FIG. 5 is a vertical cross-sectional view similar to that of FIG.
4, but showing how the upper portion of the cylindrical housing of
the device can be broken away to separate the serum containing
specimen cup.
Referring now in detail to the drawings, reference numeral 10
designates, generally, a combination blood sampling vacuum syringe,
centrifuge container and specimen cup embodying the invention, the
same being shown, in FIGS. 1 and 2, being used in association with
a hollow needle holder 11. The needle holder 11 is of standard
known construction, and may be of the type commonly used with
ordinary vacuum syringes. As such, it comprises a tubular body
portion 12 the lower end of which, as illustrated, is open to
receive an evacuated blood collection tube and provided with an
outwardly-extending peripheral flange 13 for manual grip and
control. The opposite end of the tubular body portion 12 is closed
with a bottom wall portion 14 provided with an in
internally-threaded axial opening 15 into which a disposable hollow
needle assembly or cannibis 16 may be removably fitted in known
fashion. The needle assembly 16 comprises an outwardly-extending
end 17 for insertion into the patient's vein upon the taking of a
blood sample, and an inwardly-extending end 18 for piercing the
centrifuge chamber of the vacuum syringe device, as is hereinbelow
more particularly described.
The vacuum syringe device 10 embodying the invention comprises an
elongated cylindrical housing member 19 coaxially jointed at its
lower end with a reduced-diameter specimen cup 20 through a short,
frusto-conical connector wall portion 21. The cylindrical housing
member 19, connector wall portion 21 and specimen cup 20 are
preferably integrally formed of a tough, transparent synthetic
plastic material. The specimen cup 20 comprises a cylindrical outer
wall 22 having an outwardly-extending, peripheral flange 23 near
its upper or open end, and a substantially frusto-conical bottom
wall 24 at its closed or lower end, as illustrated in the drawings.
The specimen cup 20 is of a shape typical of those used in
automatic blood chemistry analyzers, and therefore constitutes no
part of the present invention in and of itself.
Coaxially disposed within the cylindrical housing member 19 is a
cylindrical blood sample collecting tube 25 having a rounded bottom
wall and being generally in the form of an ordinary test tube. The
upper or open end of the collecting tube 25 is hermetically sealed
with a diaphragm plug cap member 27 having a radially-extending
peripheral upper end flange portion 28 an underside portion of
which seats in abutting engagement against the upper edge or rim of
said collecting tube. An outer marginal portion of the underside of
the diaphragm plug cap flange portion 28 seats against the upper
open edge of the cylindrical housing member 19 and is affixed
thereto in any convenient manner, such as by the use of a suitable
adhesive. Alternatively, an annular groove could be formed in the
underside of the flange portion 28 to frictionally retain the upper
end of the collecting tube in place. The outer diameter of the
blood sample collecting tube 25 is of somewhat lesser diameter than
the internal diameter of the cylindrical housing member 19 within
which it is coaxially disposed to provide spacing therebetween for
the purpose hereinafter appearing.
As is best illustrated in FIG. 5, the blood sample collecting tube
25 is provided in its side wall with a plurality of substantially
equidistantly-spaced, vertically-aligned through openings 29, 30,
31, and 32. The uppermost opening 29 is located directly below the
inner end of the diaphragm plug cap member 27, whereas the
lowermost opening 32 is located a short distance below the
longitudinal center of the collection tube 25. The upper through
opening 29 may be round, while the remaining opening 30, 31 and 32
are preferably triangular with upwardly directed apices, for the
purpose hereinafter appearing. Prior to use of the vacuum syringe
device, the openings 29 through 32 are sealed off from the outside
by means of a separable elongated seal strip 33 the upper end of
which terminates in loose pull-tab portion 34. The seal strip 33 is
retained in place in sealing engagement against the outside of the
blood sample collection tube 25 and in sealing engagement with
respect to the openings 29 through 32 by use, preferably, of a
pressure-sensitive adhesive. To insure that the separable seal
strip 33 be impervious to air leakage, it is preferably fabricated
of aluminum foil, or the like dense, film-like material strong
enough to permit pull away separation from the collecting tube 25
while at the same time being flexible or bendable enough to peal
away for successive venting of the openings 29, 30, 31 and 32 one
at a time, in a controlled manner. An elongated access opening 35,
(see FIG. 5), is provided in the side wall of the cylindrical
housing member 19, in register with the separable seal strip 33 of
the collecting tube 35, to permit manual pulling away of said seal
strip in the manner and for the purpose hereinbelow more
particularly described.
Considering now the operation of the vacuum syringe device 10, the
same will first be fitted loosely in a typical needle holder 11 as
described above preparatory to insertion of the outwardly-extending
end portion 17 of the needle assembly 16 in the distended vein of
the patient giving the blood sample. As illustrated in FIG. 2,
immediately upon insertion of the needle, the blood sample
collecting tube 25 will become filled with blood, indicated at B in
FIG. 2, drawn inwardly under the influence of the contained vacuum.
The vacuum syringe device 10 will thereupon be withdrawn from the
needle holder 11, and the diaphragm plug cap 37, being of a
resilient material such as natural or synthetic rubber, will seal
off the contained blood upon separation from the inwardly-extending
needle portion 18. The blood containing vacuum syringe device 10 is
now ready for centrifuging to separate the blood cell mass from the
serum, such separation being illustrated in FIG. 3 by the cells C
shown in the lower end portion of the collecting tube 25 and the
blood serum, designated S, at the upper end portion of said
collecting tube. As illustrated by reference character D in FIGS.
3, 4 and 5, after centrifuging there will be a rather sharp plane
of demarcation between the dense blood cell mass C and the now
separated blood serum S.
The method and means by which the separated blood serum S in the
collecting tube 25 is transferred to the specimen cup 20 will now
be described with reference to FIGS. 3 and 4. As illustrated in
FIG. 3, the vacuum syringe device 10 will be supported in an
upright position and the loose pull-tab 34 at the upper end of the
separable seal strip 33 will be grasped between thumb and
forefinger and pulled upon gently so as first to open the top vent
opening 29 of the collecting tube 25 and thereafter successively
open the remaining serum drain openings 30, 31 and 32. As
illustrated in FIG. 4, upon the above described openings 29, 30, 31
and 32, being opened, the centrifuged serum S will flow
successively through the openings 30, 31 and 32 to trickle down
into the specimen cup 20. In this connection, it is to be noted
that the lowermost flow opening 32 will be well above the plane of
separation D in any centrifuge blood sample to obviate any
possibility of serum contamination by blood cells. It is also to be
noted that if smaller quantities of centrifuged blood serum are
required, the opening of only the first or the first two of the
serum flow openings 30 and 31 will provide for such lesser amounts
in the specimen cup 20.
As is best illustrated in FIG. 5, means is provided for quickly and
easily separating the serum containing specimen cup 20 from the
used vacuum syringe device. To this end, the zone of juncture
between the upper end of the specimen cup 20 and the frusto-conical
connector wall portion 21 is provided with an annular groove 38
defining a weakened wall zone permitting lateral breakaway upon the
imposition of a slightly manually applied twisting and/or bending
force upon said specimen tube with respect to the elongated
cylindrical housing member 19.
While we have illustrated and described herein only one form in
which our invention can conveniently be embodied in practice, it is
to be understood that this form is given by way of example only and
not in a limiting sense. The invention, in brief, comprises all the
embodiments and modifications coming within the scope and spirit of
the following claims.
* * * * *