U.S. patent number 3,557,778 [Application Number 04/776,347] was granted by the patent office on 1971-01-26 for blood specimen collection assembly.
Invention is credited to Elbert L. Hughes.
United States Patent |
3,557,778 |
Hughes |
January 26, 1971 |
BLOOD SPECIMEN COLLECTION ASSEMBLY
Abstract
A blood specimen collection assembly having a fluid inlet and a
fluid outlet with valve means disposed within the assembly for
movement to and from an open and closed position whereby to prevent
the backflow of testing fluid from a specimen receptacle, which is
coupled with the assembly, into the patient's bloodstream during
use of the assembly. The specimen receptacle is in the form of an
evacuated container and is coupled with the collection assembly
when the same is in use, the receptacle being in communication with
the assembly to provide negative pressure through the assembly for
opening the valve and withdrawing the specimen, the valve resuming
its closed position upon filling of the receptacle.
Inventors: |
Hughes; Elbert L.
(Independence, MO) |
Family
ID: |
25107134 |
Appl.
No.: |
04/776,347 |
Filed: |
November 18, 1968 |
Current U.S.
Class: |
600/579; 604/236;
600/577 |
Current CPC
Class: |
A61B
5/150221 (20130101); A61B 5/150259 (20130101); A61B
5/150351 (20130101); A61B 5/15003 (20130101); A61B
5/154 (20130101); A61B 5/150496 (20130101); A61B
5/150389 (20130101); A61M 39/24 (20130101); A61M
2039/248 (20130101); A61M 2039/242 (20130101); A61M
2039/2473 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61M 39/00 (20060101); A61M
39/24 (20060101); A61m 001/00 () |
Field of
Search: |
;128/2,218NV,288.1,218.1P,276,(Blood Sampler/ Digest)/ |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Camp; Warner H.
Claims
I claim:
1. A blood specimen collection assembly comprising:
a partially evacuated specimen receptacle;
a body having a chamber provided with a fluid inlet at one end and
a fluid outlet at the opposite end, said chamber having a conical
sidewall adjacent said fluid inlet and a plurality of radially
spaced flutes adjacent said fluid outlet, surrounding said outlet
and extending into said chamber;
a hollow needle extending from said one end of the body and in
fluid communication with the chamber through said inlet;
a fitting closing said opposite end of the chamber and having said
fluid outlet formed therein, said fluid outlet being in
communication with said receptacle; and
check valve means in said chamber to permit flow of fluid through
said chamber in one direction only, said check valve means
including a ball larger in diameter than said fluid inlet and
shiftable from a position in engagement with said conical wall
whereby to close said fluid inlet and a position supported by said
flutes in spaced relationship from said fluid outlet whereby to
permit flow of fluid through said chamber, out of said outlet and
into said receptacle.
Description
This invention relates to improvements in devices used for taking
blood samples from patients, and more specifically, to a blood
collection assembly having check valve means therein to prevent
backflow of the blood specimen and testing solution into the
bloodstream of the patient.
Although blood specimen collection devices have been used in the
past for obtaining a quantity of blood from the patient suitable
for subsequent mixing with a test solution, such devices have
generally been so constructed that after withdrawing the blood
specimen in one container, it was then necessary to transfer the
blood into another container carrying the test fluid. This process
subjected the blood specimen to possible contamination from various
sources and subsequently increased the changes of obtaining invalid
results from the test.
In more recent times devices have been developed which combine the
specimen container and the test fluid container into one unit such
that the blood specimen, upon being withdrawn through a hollow
needle inserted in the patient's vein, flows directly into the
container having the testing solution therein. The test is thus
carried out without requiring that the blood be transferred from
one container to another. Since the needle remains in the patient's
arm during mixing of the blood specimen with the test fluid,
however, there is a very grave danger that some of the mixture may
flow back into the vein before the needle can be removed.
Oftentimes the test fluid is of such a nature that only a very
small amount need be released into the bloodstream before causing
serious damage or even death to the patient being examined.
A primary object of the present invention is to provide a blood
specimen collection assembly which includes an evacuated specimen
receptacle normally containing an amount of testing fluid therein,
which receptacle is adapted to directly receive the blood specimen
withdrawn from the patient by the assembly, the assembly
additionally including check valve means whereby to prevent
backflow of the blood and fluid mixture from the receptacle into
the bloodstream of the patient.
Another important object of this invention is to provide a blood
specimen collection assembly for communication with a specimen
receptacle, the assembly having a body provided with a chamber
therein, a hollow needle in communication with the chamber and
extending from one end of the body for penetrating a vein of the
patient, valve means within the chamber shiftable to and from an
open and closed condition permitting inflow of blood through the
needle and a fluid outlet whereby said assembly is placed in
communication with said receptacle to permit blood to be drawn
through said assembly by the negative pressure exerted from the
receptacle through the assembly.
Yet another object of the instant invention is the provision of a
blood specimen collection assembly comprising a combination of
components including check valve means within the body of the
assembly, the check valve means having a ball adapted for a sealing
the fluid inlet of the assembly against backflow and structure for
spacing the ball from the fluid outlet during flow of blood through
the assembly to the specimen receptacle.
A yet further object of the present invention is to provide a blood
specimen collection assembly wherein the blood specimen is
withdrawn from the patient into the specimen receptacle by means of
a negative pressure exerted through the assembly by virtue of said
receptacle being evacuated, the negative pressure causing shifting
movement of a check valve to initially permit inflow of blood into
the assembly and therethrough into the receptacle, the check valve
then being permitted to shift to a closed position whereby to
preclude backflow of the blood and testing mixture into the vein of
the patient.
Other objects of this invention include many details of
construction which will become apparent from following
specification and accompanying drawing, wherein:
FIG. 1 is a fragmentary, elevational view partially in section and
showing one form of the invention with a specimen receptacle and
holder;
FIG. 2 is an enlarged, fragmentary, substantially central sectional
view thereof with the receptacle and holder removed;
FIG. 3 is a sectional view taken along line 3 -3 of FIG. 2;
FIG. 4 is a side elevational view of another form of the invention
with the specimen receptacle and holder removed;
FIG. 5 is an enlarged, fragmentary, substantially central sectional
view of the assembly shown in FIG. 4; and
FIG. 6 is a sectional view taken along line 6 -6 of FIG. 5.
The blood specimen collection assembly 10 as illustrated in the
embodiment of the invention shown in FIG. 1 includes, as its
primary components, a body 12 having coupled therewith a specimen
receptacle 14, there being a holder 16 provided for said receptacle
in order that the assembly 10 may be utilized in the manner
hereinafter described.
The body 12 is best illustrated in the sectional showing of FIG. 2
of the drawing, the same including a head 18 and a fitting 20, said
head 18 and fitting 20 preferably being formed of compatible
materials whereby the same may be fitted together in cooperating
relationship whereby to define a chamber 22 therebetween, the
forwardmost end of said chamber being defined by a conical sidewall
24 formed interiorly of head 18, the normally rearmost end of the
chamber 22 being defined by a face 26 presented by an inner end of
fitting 20.
A fluid inlet passage 28 extends through head 18 and is in
communication with chamber 22, there being a hollow needle 30
carried within and extending substantially outwardly from said
passage 28, which needle is penetrated into the vein of the patient
during utilization of the assembly 10.
A fluid outlet passageway 32 is formed substantially centrally of
fitting 20 and carries tubular member 34 which extends rearwardly
or to the right of the assembly 10 viewing FIGS. 1 and 2.
In the embodiment of the invention illustrated in FIGS. 1-- 3, the
chamber 22 has check valve means disposed therein, said check valve
means including a shiftable ball 36 and a plurality of
ball-supporting flutes 38 formed as a part of the face 26 of
fitting 20. Said check valve means permits longitudinal shifting
movement of the ball 36 within the passage from the full line
position shown in FIG. 2 of the drawing wherein the ball is in
sealing engagement with the sidewall 24 whereby to close fluid
inlet needle 30 to the dotted line position of FIG. 2 wherein the
ball 36 is in engagement with the outer inclined edges 40 of the
flutes 38, such engagement spacing ball 36 from the mouth 42 of
tubular outlet member 34 whereby blood may pass through said outlet
tube 34 and into the specimen receptacle when the assembly 10 is
utilized in the manner hereinafter described.
In order to permit such utilization of the assembly 10 the same is
normally coupled with specimen receptacle 14, which receptacle
contains a predetermined amount of testing material in the nature
of a suitable liquid or powder which is intended to react with the
blood in a predetermined manner in order to indicate certain
desired characteristics. It is important that the blood, when mixed
with such testing material, not be permitted to flow back through
assembly 10 and into the bloodstream of the patient whose blood is
being tested. In order to achieve this result, a negative pressure
is drawn on the receptacle 14 and the open end thereof is tightly
closed by a stopper 44 having a centrally disposed thin section 46,
to the opposite end of receptacle 14 being permanently sealed
inasmuch as the same is in the nature of a test tube or the
like.
In order to permit utilization of the assembly 10, the holder 16,
which is tubular in nature, having an open right-hand end viewing
FIG. 1 (not shown) is provided at its opposite end with a closure
wall 48 having a central aperture 50 which is threaded to
complementally engage the threads 52 carried exteriorly of fitting
20. Thus, holder 16 may be coupled with the assembly 10 by
interengagement of the threads thereof and the receptacle 14 can
then be telescoped into the holder 16, it being noted that holder
16 could be provided with a pair of oppositely disposed
finger-engaging flanges (not shown) whereby to permit the user of
the complete assembly to easily grasp the holder 16 and exert, as
by pressing thereupon with his thumb, a longitudinally directed
force upon the receptacle 14. When such force is directed against
the receptacle 14, the same, as it is being telescoped into the
holder 16, will cause the central section 46 of stopper 44 to move
into initial engagement with the sharpened end 54 of the tubular
outlet member 34 whereby to cause end 54 to slightly penetrate
section 46.
When the assembly has been prepared as by bringing the various
components into the relative engagement hereinabove described, the
patient's arm is prepared as by placing a constricting band
thereabout and a venipuncture is made below the band with the tip
of needle 30. Receptacle 14 is then pushed further into the holder
16 thereby causing section 46 to be fully punctured by tubular
member 34 and thereby place the evacuated receptacle 14 in
communication with assembly 10 through said member 34, chamber 22
and needle 30 and thus into communication with the vein of the
patient. The evacuated nature of receptacle 14 causes the negative
pressure therein to be created through the assembly 10 thereby
shifting ball 36 from the full line to the dotted line position of
FIG. 2, thence opening fluid inlet 56 of chamber 22 and permitting
flow of blood through needle 30 into the chamber 22 and thence
outwardly through mouth 42 into tubular member 34 and into the
specimen receptacle 14 where it mixes with the testing
material.
When receptacle 14 is sufficiently full of the blood specimen, the
constricting band is released and the needle 30 removed from the
vein of the patient, Release of the constricting band creates a
negative pressure in the area above the band's former position and
this pressure is transferred through the assembly 10. In the past,
when collection devices of this nature were not provided with any
check valve means, it was a simple matter to accidentally allow
some of the blood and testing material mixture to be drawn back
through the assembly and into the patient's bloodstream under the
negative vein pressure, often resulting in serious illness or
death. With the present invention, however, the negative pressure
created by releasing the constricting band draws ball 36 toward
wall 24 and thereby seals inlet 56, precluding backflow of the
blood and testing material mixture into the vein of the
patient.
The embodiment of the invention illustrated in FIGS. 4-- 6 of the
drawing is generally similar in nature to that of FIGS. 1-- 3 and
is likewise adapted to be coupled with a specimen receptacle and
holder, although the same are not shown in FIGS. 4-- 6.
Thus there is provided an assembly 110 having a body 112 comprised
of a head 118 and a fitting 120, the same being coupled together
whereby to cooperated to define a chamber 122, the normally
forwardmost portion of said chamber being defined by a conical
sidewall 124 and the rearmost end of said chamber being defined by
a face 126 of fitting 120. A passage 128 is provided through head
118 and receives a needle 130. Likewise, fitting 120 has a central
passage 132 therethrough which carries a tubular member 134.
Check valve means is disposed in the passage 122 and includes a
shiftable ball 136 which is movable between the full line and
dotted line position of FIG. 5. A coil spring 140 normally urges
ball 136 toward sidewall 124 thereby closing the fluid inlet 156.
When a negative pressure is exerted through the assembly 110 the
ball is caused to move from its dotted line position against spring
140 and toward the fluid outlet mouth 142, the ball being retained
in a position spaced from said mouth by the spring 140, thereby
permitting blood to flow through the assembly as by moving through
needle 130, chamber 122 and tubular member 134 and thence into the
specimen receptacle which has been suitably coupled with the
assembly 110.
In either form of the invention the assembly safely and
sufficiently precludes any backflow of the blood and testing
material into the blood stream of the patient inasmuch as the check
valve means is positioned in the flow path ahead of the point of
mixture of the blood with the testing material. Thus, at any time
that the constricting band about the patient's arm is released, it
will cause shifting movement of the ball to a closed, sealing
condition thereby effectively and fully precluding the flow of any
of the blood and testing material mixture back through the assembly
from the specimen receptacle 14 into the bloodstream of the
patient.
* * * * *