U.S. patent number 3,782,382 [Application Number 05/223,236] was granted by the patent office on 1974-01-01 for means for blood administration and the like.
This patent grant is currently assigned to K-N Enterprises, Inc.. Invention is credited to Leon Kirschner, Henry Naftulin.
United States Patent |
3,782,382 |
Naftulin , et al. |
January 1, 1974 |
MEANS FOR BLOOD ADMINISTRATION AND THE LIKE
Abstract
Fluid or blood administration equipment comprising, a plastic
manifold, a plurality of flexible conduits connected at one end to
said manifold and at their opposite ends each respectively
connected to a bag for receiving blood, another flexible conduit
connected to said manifold at one end with the opposite end of said
flexible conduit adapted to be connected to a blood flow tube,
another flexible conduit adapted to be connected at one end to said
manifold with the opposite end thereof connected to an intravenous
needle, with said pair of conduits leading to said blood bags
having at their inner ends within said manifold a removable valve
and with said manifold having a filter at the inner end of the
conduit from the needle, and a band secured to said manifold
whereby said band is strapped around the wrist or arm of the
patient to prevent dislodgement of the needle if there should be
any pull on the equipment.
Inventors: |
Naftulin; Henry (Skokie,
IL), Kirschner; Leon (Skokie, IL) |
Assignee: |
K-N Enterprises, Inc. (Skokie,
IL)
|
Family
ID: |
22835646 |
Appl.
No.: |
05/223,236 |
Filed: |
February 3, 1972 |
Current U.S.
Class: |
604/6.09;
604/179; 604/6.1; 604/6.15 |
Current CPC
Class: |
A61M
5/1408 (20130101); A61M 5/14 (20130101) |
Current International
Class: |
A61M
5/14 (20060101); A61m 005/00 () |
Field of
Search: |
;128/213,214R,214D,214.2,272 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Kraus; Max R.
Claims
What is claimed is:
1. Means for blood administration and the like which comprises, a
manifold formed of a bag made of a transparent material which is
generally pliable and which is inert and nontoxic, an inlet tube
connected at one end to said manifold and a needle for insertion
into the vein connected to the opposite end of the inlet tube, a
blood receiving bag and a first tube connecting said manifold to
said blood receiving bag, a blood flow tube and a second tube
connecting said manifold to said blood flow tube, said first and
second tubes being connected to said manifold at the end opposite
said inlet tube connection, and filter means located within said
manifold on said inlet tube, said manifold being of a size so as to
be attached directly to the patient's limb.
2. Means as set forth in claim 1 in which the end of the tube
connecting the manifold to the blood receiving bag extends into the
manifold with a ball valve inside said end of the tube for blocking
the flow of blood into said tube, which ball valve may by manual
pressure applied against the manifold and the end of the tube eject
the ball valve from the tube into the manifold to unblock said
tube.
3. Means as set forth in claim 1 in which there is a pair of blood
receiving bags each connected by a tube to said manifold, which
tubes have a ball valve inside the end of the tube within the
manifold for blocking the flow of blood into said tube, which ball
valve may by manual pressure applied against the manifold and the
end of the tube eject the ball valve from the tube into the
manifold to unblock said tube.
4. Means as set forth in claim 3 in which a band is adapted to
encompass the hand or wrist of a patient so that accidental
withdrawal of the needle from the patient is prevented.
5. Means for blood administration and the like which comprises, a
manifold formed of a bag made of a transparent material which is
generally pliable and which is inert and nontoxic, an inlet tube
connected to one end of said manifold and a needle for insertion
into the vein connected to the opposite end of the inlet tube, a
blood receiving bag and a first tube connecting said manifold to
said blood receiving bag, a blood flow tube and a second tube
connecting said manifold to said blood flow tube, means connected
to said manifold adapted to engage around the arm or wrist of a
patient to prevent accidental removal of the needle from the
patient.
6. Means as set forth in claim 5 in which the means adapted to
engage around the arm or wrist comprises a band formed of flexible
material having hooking means and cooperating attaching means.
7. Means as set forth in claim 5 in which the end of the tube
connecting the manifold to the blood receiving bag extends into the
manifold with a ball valve inside said end of the tube for blocking
the flow of blood into said tube, which ball valve may by manual
pressure applied against the manifold and the end of the tube eject
the ball valve from the tube into the manifold to unblock said
tube.
8. Means as set forth in claim 5 in which the means adapted to
engage around the arm or wrist of a patient comprises a band of
attaching members formed of Velero material whereby the opposite
ends of the band are readily attachable and detachable from each
other.
Description
BRIEF SUMMARY OF THE INVENTION
This invention is an improvement on the equipment shown in U.S.
Pat. No. 3,459,182,the inventor of which is one of the inventors
herein. The said equipment utilizes a number of Y connectors in the
system which had serious objections, as more fully and specifically
set forth hereinafter, which could result in a serious consequence
to the donor, who in turn would also be the recipient as the blood
originally extracted from the donor would centrifuged and the donor
would become the recipient of the red blood cells which are
returned to the donor.
In lieu of the Y connectors shown in U.S. Pat. No. 3,459,182 there
is provided a plastic manifold made of the same material as the
tubes, to which plastic manifold is connected the various tubes
leading to the blood bags and to the blood flow tube, with another
tube connected at one end to the said manifold and with the
opposite end thereof connected to a needle which is intravenously
inserted in the patient.
The manifold of this invention has the following advantages over
the Y connectors shown in the aforementioned patent.
1. The manifold reduces the incidence of clotting as compared with
the Y connectors.
2. The manifold provides means for observing the progress of
plasmapheresis at a central location, which is not the case with
the separate and several Y connectors.
3. The manifold constitutes a substantial savings by replacing the
several Y connectors.
4. The Y connectors by their very construction cause the presence
of dead ends, i.e., residual blood enters the dead end of one leg
of the Y where it is trapped in the bleeding process and where it
often clots and the clots may be reincorporated in the infusion
stage when saline and/or the centrifuged blood cells are returned
to the patient. This is a potential hazard with every Y connector
in the present plasmapheresis art. This hazard is prevented by the
use of the manifold and the valved construction shown in this
application which permits no residual blood to remain in the tubing
and thereby eliminates dead ends.
The donor and the recipient will for the purpose of this
description be referred to as the "patient" since in one capacity
he serves as the donor and in the other capacity he is the
recipient of the blood cells.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings:
FIG. 1 is a diagrammatic view of the blood collection and
administration apparatus, with the collection components shown in
full lines and the administration components in phantom lines.
FIG. 2 is an enlarged plan view partly in section of the manifold
and the means for attaching same to the wrist or arm of the
patient.
FIG. 3 is a view taken on line 3--3 of FIG. 2, and
FIG. 4 is an enlarged sectional view taken on line 4--4 of FIG.
2.
Since the apparatus herein is an improvement of the apparatus of
U.S. Pat. No. 3,459,182, certain of the components referred to in
said patent will not be described in detail but will be referred to
generally, sufficiently to understand the invention herein.
The apparatus is to be used in plasmapheresis, which involves the
withdrawal of whole blood from the patient, followed by removal of
the plasma which in turn is followed by a return to said patient of
the red blood cell content of the withdrawn blood.
The apparatus embodied in this invention includes a manifold
generally designated by the numeral 10 which, as shown, is of
generally rectangular shape and is made of a plastic transparent
material which is pliable, which is inert, nontoxic and of medical
grade quality, such as polyethylene, vinyl plastic, or polyvinyl
chloride. Connected to one end of the manifold is a flexible
transparent plastic tube 12, the inner end of which tube extends
into the manifold, as indicated by the numeral 14. Attached to the
opposite end of said conduit is an intravenous needle 16 which is
adapted to be inserted in the vein of the patient. When not in use
the needle may be covered by a removable shield. Positioned inside
the manifold 10 and surrounding the end 14 of the tube 12 in the
manifold is a filter 18 which is a nylon mesh monofilament filter,
which serves to filter out any possible clots that may form between
the first and second bleeding.
Connected to the opposite end of the manifold is a pair of flexible
tubes or conduits 20 and 22, the inner ends 20' and 22' of which
extend into the manifold 10. Positioned within each of the inner
ends of each of said tubes is a single small metallic bead or
metallic ball 24 and 26 respectively. These beads are made
preferably of a metal and serve as valves when positioned inside
their respective tube ends, however, each of said beads may be
ejected from their respective tube ends by pressing against the
manifold adjacent thereto and against the tube end and thus are
expelled from the tube end into the manifold so that the inner end
of said respective tube is unblocked. This is done in connection
with the operation of the unit, as will be more fully
explained.
Also connected to the same end of the manifold is a flexible tube
28, the inner end of which extends into the manifold, similar to
that previously described. Said tube 28 has no valve means
therewithin. The opposite end of tube 28 is adapted to be connected
to the blood flow tube designated generally by the numeral 30. The
blood flow tube 30 is of the character illustrated and described in
U.S. Pat. No. 3,459,182 and therein also designated by the numeral
30.
All of the tubes referred to herein are made of the same
transparent plastic material as is the manifold, such as
polyethylene, vinyl plastics, etc.
The tube 20 is connected at its opposite end to a first blood bag
32. Tube 22 is connected to a second blood bag 34. Said blood bags
are made of the material described in the aforementioned patent, or
of any other suitable material well-known in the art, and each
blood bag is provided at the top thereof with outlet ports for
allowing separate removal of the blood plasma and the red blood
cells respectively, as will be more fully explained. Removable caps
are provided for closing each of said outlet ends. The first blood
bag 32 has outlet ports 36 and 38 which are closed by removable
caps 36' and 38' respectively. The second blood bag 34 has outlet
ports 40 and 42 which are closed by removable caps 40' and 42'
respectively.
Secured to the manifold adjacent one end thereof is a wrist or arm
band generally designated by the numeral 44 which is made of two
cooperating hooking sections 46 and 48, with the inner ends of each
of said sections permanently secured and affixed to the manifold.
The sections 46 and 48 extend in opposite directions from the
manifold, as shown in FIG. 2, but when positioned around the wrist
or arm of the patient cooperatively hook to each other to form a
band around the wrist or arm, as shown in FIG. 1.
The section 46 includes a flexible strip 46' to which is adhesively
or otherwise secured a strip of flexible material 47 which has on
the face side thereof a hooking surface 47'. The inner end of the
strip 46' is permanently affixed to the manifold 10.
The oppositely extending section 48 includes a flexible strip 48'
to which is adhesively or otherwise secured an attaching strip of
flexible material 49 which has a facing surface 49' which when in
engagement with the hooking surface 47' will hold it attached
thereto. The hooking strip and the cooperating attaching strip are
components of a trademarked product VELCRO which, as far as is
known to applicants, is manufactured and distributed by John Dritz
& Sons of New York City, N. Y.
As best seen in FIG. 1, the two sections 46 and 48 forming the band
44 are positioned preferably around the wrist of the patient, with
the outer ends of the sections interlocked so that the band in its
locked position surrounds the wrist of the patient at a point
removed from where the needle 16 enters the arm. Therefore, any
pull or outward pressure that might be applied accidentally or
otherwise against the manifold or the flexible tubes connected
thereto will not be transmitted to the needle 16. With the band 44
wrapped around the patient's wrist or arm no amount of pull will
have any affect on the tube 12 carrying the needle so that the
needle will not be dislodged from the patient.
Referring to FIG. 1, the blood from the patient will be allowed to
flow into the first blood bag 32 and then subsequently into the
second blood bag 34 in the following manner. As the blood flows
through the needle 16 and tube 12 into the manifold 10, it cannot
pass into either tube 20 or tube 22 unless the inner ends of the
tubes are unblocked by their respective ball valves. Thus, for
example, to fill the first blood bag 32 the ball valve 24 is
manually pressed out of the end of tube 20' so that the ball valve
passes into the interior of the manifold and unblocks the end 20'
of the tube 20 to open the inlet into the tube. At this point the
ball valve 26 is still retained in the end 22' of tube 22 and
blocks entrance into tube 22. The blood will flow first through
tube 20 to the first blood bag 32.
When the first blood bag is filled, the tube 20 is heat-sealed and
the bag is placed in a conventional blood bag centrifuge in order
to force the red blood cells to the bottom of the bag. After the
blood is centrifuged the plasma is removed by conventional plasma
extraction techniques. The red cells remaining in the first blood
bag 32 are then returned to the patient in the manner as generally
described in U.S. Pat. No. 3,459,182. Briefly, blood bag 32 is
connected through its outlet 38 to the flexible tube 50 which
connects to the blood flow tube 30 which is described in detail in
said patent, and the outlet end of the flow tube 30 is connected to
the tube 28, previously described, from the manifold.
After the phlebotomy and during the period of time that blood is
not being collected from the patient, it is common practice to
allow a small amount of saline solution to flow into the vein in
order to prevent clotting at the needle and to help replace a
portion of the blood volume given by the donor. The bottle 52
containing the saline solution flows to the patient through tube
54, blood flow tube 30, tube 28, through the manifold 10, through
the filter 18, through the tube 12 and the needle 16 to the
patient.
To obtain the flow of red blood cells from the bag 32 back to the
patient, the outlet port 38 of said bag is connected through tube
50 to blood flow tube 30 so that the blood will flow together with
the saline solution through the filter in the blood flow tube 30
and the tubing to the patient's vein. Suitable clamps are connected
to the tubing at certain locations in order to control the flow
within the respective tube.
After the red blood cells have been returned to the patient another
unit of blood can be collected in the second blood bag 34 in the
same manner as in the first blood bag. The process is repeated and
after the blood is collected in the second blood bag and
centrifuged, the plasma is extracted from the second bag and the
red blood cells remaining in the second bag are returned to the
patient. The outlet port 42 of the second bag 34 is connected by
flexible tube 56 to blood flow tube 30 so that the red blood cells
can flow back to the patient through tube 28, manifold 10, tube 12
and needle 16. It will also be seen that the manifold is secured to
the wrist or arm of the patient so that it cannot be yanked or
jerked away therefrom.
The apparatus herein is not limited to plasmapheresis techniques
but is also useful in connection with the administration of blood,
serums, biological or pharmaceutical fluids whenever desired. The
apparatus is used preferably as a disposable single use
apparatus.
While the invention is shown in connection with two blood bags,
namely, a first and a second blood bag, it will be understood that
it can be utilized with a single blood bag or with any number of
blood bags, and instead of a pair of tubes leading from the
manifold to separate blood bags there could be a single tube
leading to a single blood bag or the number can be increased as
desired.
* * * * *