U.S. patent number 3,645,253 [Application Number 04/873,903] was granted by the patent office on 1972-02-29 for instrument for the withdrawal of body fluids.
This patent grant is currently assigned to Organon Inc.. Invention is credited to Rijkent Hendrik Drost, Bastiaan Cornelis Goverde, Bernardus Louwerens.
United States Patent |
3,645,253 |
Goverde , et al. |
February 29, 1972 |
INSTRUMENT FOR THE WITHDRAWAL OF BODY FLUIDS
Abstract
An improved syringe for the withdrawal of body fluids,
especially adapted for transport and storage as well as for the
centrifugation of the fluid samples, preferably blood samples,
comprises a tube having a hermetically end, the closure of which,
being a stopper or cap, is entirely or partly made of resilient
material, through which a needle, preferably of stainless steel,
extends, which ends in or is tightly pressured against a piston
mounted in the tube. Said piston is preferably provided with a
concave at the side where the needle ends. Thus a hermetically
sealed compartment is obtained through which the needle extends.
Said Compartment is suitable for aseptic storage of auxiliaries
such as anticoagulants and/or antiseptics.
Inventors: |
Goverde; Bastiaan Cornelis
(Oss, NL), Drost; Rijkent Hendrik (Oss,
NL), Louwerens; Bernardus (Berghem, NL) |
Assignee: |
Organon Inc. (West Orange,
NJ)
|
Family
ID: |
19805129 |
Appl.
No.: |
04/873,903 |
Filed: |
November 4, 1969 |
Foreign Application Priority Data
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|
|
|
Nov 12, 1968 [NL] |
|
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6816121 |
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Current U.S.
Class: |
600/578;
604/228 |
Current CPC
Class: |
A61B
5/153 (20130101); A61B 5/15003 (20130101); A61B
5/150755 (20130101); A61B 5/150236 (20130101); A61B
5/150717 (20130101); A61B 5/150351 (20130101); A61B
5/150595 (20130101); A61B 5/150244 (20130101); A61B
5/150389 (20130101); A61B 5/150496 (20130101); A61B
5/150251 (20130101); B01L 3/50825 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2,276,216,217,218,2F,2G ;73/425.6 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Chamblee; Hugh R.
Claims
It is claimed:
1. An instrument for the withdrawal of body fluids comprising a
tube having an open end and a hermetically closed opposite end, the
interior of said tube being at substantially atmospheric pressure,
a closure member at the closed end of the tube providing said
hermetic seal which is at least partly made of resilient material
through which material a hollow needle extends which terminates in
and is sealed by a piston slidably mounted in the interior of said
tube provide a hermetically sealed compartment between said closure
member and said piston, said compartment being penetrated by said
needle, said piston being provided with means for moving the piston
away from the closed end of the tube.
2. The instrument of claim 1, in which said closure has a concave
communicating with the interior of the tube.
3. The instrument of claim 1, in which said piston possesses a
concave portion at the side where the needle terminates in the
piston.
4. The instrument of claim 1, in which said piston is fitted with
means for fastening a piston rod.
5. The instrument of claim 1, in which the open end of said tube is
closed with a cap fitted in the middle with a film which can easily
be penetrated by a piston rod.
6. The instrument of claim 1 which includes a piston rod attached
to said piston.
7. The instrument of claim 1 in which said needle is provided with
a guard to prevent further penetration into said tube.
Description
BACKGROUND OF THE INVENTION
An instrument which is frequently applied for drawing body fluids
more particularly blood, is a hypodermic syringe. When this syringe
is not used for injection purposes, but for taking samples of a
body fluid, this fluid after the puncture has to be transferred
into a container in order to transport said fluid or to perform
clinical-chemical determinations in it. The drawbacks of such a
method are obvious as these operations take much time and the
chance of mistakes is increased. Moreover, after the use the
syringe has to be cleaned and, if necessary or desired, sterilized
again and provided with fresh anticoagulants and/or
antiseptics.
Of the hypodermic syringes which have been developed so far for the
withdrawal of body fluids no variants are known which are also
suitable for the storage, the transport and the centrifugation of
these fluids.
Since there is at present a strong tendency towards greater
efficiency and, connected therewith, greater uniformity of
apparatuses to be used in clinical-chemical determinations, the
need is felt of a fluid drawing instrument which is also equipped
for the transport, the storage and the centrifugation of the
fluid.
A partial, but by no means ideal solution of the above-mentioned
problems was found in the use of an apparatus comprising the
following two essential parts:
1. a vacuum ampoule fitted at one side with a cap or stopper of
resilient material;
2. a holder with a needle pointed at both ends in which the vacuum
ampoule can be placed.
By means of such an apparatus blood can be taken by inserting the
needle into a blood vessel and then exerting pressure on the
ampoule so that the needle will pierce the resilient cap of the
ampoule. However, such a device is rather expensive, due to the
fact that special vacuum ampoules are required. Another great
objection is that the movement which has to be made to withdraw the
fluid (exerting such a pressure on the vacuum ampoule that the
needle will pierce the cap of the ampoule) is essentially contrary
to the movement made when an ordinary hypodermic syringe is used.
Moreover, so much pressure should be exerted that there is a danger
of the needle piercing the vein, which can give rise to hematomae
and other injuries. Besides the ampoule cannot be filled up
completely there will always remain a certain space above the blood
containing air or another gas, in consequence of which undesired
changes may occur during the transport of the blood.
SUMMARY OF THE INVENTION
An instrument has now been found adapted to be employed for the
withdrawal of body fluids. This instrument is also suitable for the
transport and the storage of these fluids, as well as for the
centrifugation and other preparatory operations prior to the
performance of clinical-chemical determinations, to which
instrument no such drawbacks as those mentioned above are attached.
It can be constructed at such a low cost that after a single use
the instrument can be discarded.
The instrument according to the invention is characterized by a
tube having one hermetically closed end, the closure of which is
entirely or partly made of resilient material, through which
material a needle extends which ends in a piston mounted in the
tube, which piston is fitted with a device which enables said
piston to be moved.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The instrument according to the invention is illustrated in FIG. I
in the sheet of drawings, representing one of the possible
embodiments of the invention.
The process of taking body-fluids with such a device is very
simple. The needle is inserted into the body in the conventional
manner, after which the fluid is withdrawn by moving the piston
backwards. After the puncture the detachable parts of the
instrument, including the needle, are removed, after which the body
of the instrument, a handy tube, containing a hermetically sealed
quantity of fluid, remains. If a specimen of blood has been taken
which is to be transported over long distances, for instance, by
airmail, the air has to be removed from the tube, because, due to
excessive shaking during the transport, hemolysis may be caused.
For this purpose the needle is not immediately entirely removed
from the tube, but only in part, so that the end of the needle just
remains in communication with a concave which should preferably be
made in the closure. By moving the piston towards the needle while
keeping the tube in a vertical position, the air first collects in
the concave, after which it is removed through the needle. Then the
needle can be entirely drawn from the closure.
Now, the tube containing the fluid (FIG. III) can be stored or
transported and, if desired, centrifuged to separate any solid
substance from the fluid.
The parts of the instrument according to the invention are
illustrated further with reference to FIG. I in the sheet of
drawings.
The tube (1), e.g., of cylindrical shape, should preferably be made
of transparent material. Tubes made of synthetic material, such for
example as polystyrene, acrylstyrene, polypropylene and
polymethylpentene or other polyolefins, are very suitable for this
purpose. The dimensions and the content of the tube depend, of
course, on the purpose for which the instrument according to the
invention is used, but it is a prerequisite that the tube should be
adapted to be used in the common laboratory centrifuges. For the
performance of most clinical-chemical determinations in the blood
of adults a blood sample of 10 ml. is sufficient.
At one end the tube is hermetically closed, for example with a cap
or a stopper partly or entirely made of resilient material, for
example, rubber. There should preferably be a concave (3) in the
closure communicating with the interior of the tube, which permits
any air present in the tube to be removed easily, as described
above. The needle (4) which should be made of durable material,
preferably stainless steel, extends through the resilient part of
the closure either centrically or eccentrically according to the
location of the concave. Moreover, the needle should preferably be
fitted with a guard (5) preventing the needle from penetrating
further into the tube.
The end of the needle which is in the tube should end in or tightly
press against a piston (7). Preferably the needle reaches to the
interior of the piston so that on injection it can no more move
sidelong. Hence a needle which is pointed at both ends is the most
suitable needle to employ in the instrument according to the
invention. Thus a perfectly hermetically sealed compartment (6) is
obtained, through which the needle extends either centrically or
eccentrically.
In the piston there should preferably be a concave at the side
where the needle ends, which offers advantages on examination of
the sediment obtained after centrifuging, which has collected in
the concave. Also, the piston is fitted with, or can be fitted with
a device for moving it. For this purpose a piston rod is mostly
used. With a view to centrifuging the fluid, the piston rod should
be detachable annexed, in any case that part which sticks out of
the tube after withdrawal of the fluid. To fulfill this requirement
the piston rod can be provided with, for example, a breaking point.
However, it is to be preferred to provide the piston with a device
(8), for example a screw thread or a catch, to fasten a loose
piston rod, but other devices, too, can be used in the instrument
according to the invention to move the piston.
The other open end of the tube can be closed with a cap (9), which
can be provided with an opening, if desired, through which quite
easily a piston rod can be put. For special purposes said opening
is closed by a film, for example, of rubber or plastic (10). Such a
closure is required if microbiological determinations are to be
performed in connection with which not only compartment (6), but
the whole inner side of the tube should be sterile.
The part of the needle extending out of the tube can be protected
with a cover, which serves a double purpose: it protects the needle
and keeps it sterile. The material of which said cover is made
should preferably be pervious to sterilizing gases such as
ethylene-oxide.
The device according to the invention can be supplied perfectly
sterile and is constructed in such a way that the sterility will be
maintained for a virtually unlimited time.
To the instrument according to the invention, which is illustrated
in FIG. I in the sheet of drawings and which is one of the possible
embodiments of the invention, belongs a loose piston rod, which
must be mounted on the piston before use. Such a piston rod (FIG.
II) can be made of durable material, for example stainless steel.
If the sterility should be extremely great on taking the fluid, the
piston rod can be sterilized before it is fitted in the tube, for
example, by flaming.
The fluid-withdrawal instrument according to the invention is
destroyed or discarded after use; a piston rod of durable material
can be used over and over again. However, the piston rod can also
be made of synthetic material, in which case it is discarded
together with the fluid-withdrawal instrument after one-time use.
If sterility is required, such a loose piston rod of synthetic
material can be manufactured in a sterilized package.
In practice most determinations have been performed in blood serum
so far, that is to say, in the fluid that remains after clotting
has taken place. The instrument according to the invention enables
this serum to be prepared a short time after the puncture and free
from hemolysis.
However, a number of determinations in blood are performed starting
from whole blood or blood plasma, that is to say, starting from
blood which has not been allowed to clot.
Examples of such determinations are: the determination of amino
acids, amino-nitrogen, ascorbic acid, lactic acid and alcohol, and
further, for example, the hematocrite value, the oxygen-binding
capacity, the prothrombin time and the erythrocyte-sedimentation
time.
Dependent on the determinations to be performed in blood, the
following anticoagulants are often used: sequestering agents such
as salts of ethylenediamine-tetraacetic acid, for example,
potassium or sodium EDTA, heparin, for example, potassium, sodium
or lithium salts, sodium fluoride, sodium citrate, potassium or
sodium oxalate or potassium-ammonium oxalate.
Said coagulants, in a solid or in a liquid form, can be passed
aseptically into the sterilized device according to the invention,
and that into the compartment (6) between the piston and the
closure. As the needle presses tightly against or reaches to the
interior of the piston, said substances cannot penetrate into the
needle so that they cannot constitute a danger to the patient or
block up the needle. The instruments according to the invention
filled with different coagulants should be clearly distinguishable
from each other, for example, by a clear code and/or differences in
color.
The following four types of blood withdrawal instruments are
suitable for most clinical-chemical determinations:
1. blood-withdrawal instrument having an empty sterile space
between stopper and piston;
2. blood-withdrawal instruments having a sequestering agent in the
compartment in question, for example, tri-potassium EDTA;
3. blood-withdrawal instrument containing heparin in the form of
the sodium salt;
4. blood-withdrawal instrument containing sodium citrate.
For determinations to be performed in body fluids other than blood,
such as lumber fluid, interarticular fluid and pleural fluid, other
auxiliaries such as antiseptics, can be present in the instrument
according to the invention. It stands to reason that the nature of
the determination to be performed plays a part in the choice of the
auxiliary. Likewise the diameter and the length of the needle must
be adapted to the field of application.
* * * * *