U.S. patent number 3,911,918 [Application Number 05/457,569] was granted by the patent office on 1975-10-14 for blood collection, storage and administering bag.
Invention is credited to Ralph D. Turner.
United States Patent |
3,911,918 |
Turner |
October 14, 1975 |
Blood collection, storage and administering bag
Abstract
A method and bag or container for storing a viable fluid, such
as blood, constructed of an integrally formed flexible plastic
material having two storage compartments connected in fluid flow
communication by a transfer conduit neck portion. One of the
storage compartments is detailed in size to contain approximately
60% of a predetermined quantity of blood with the other storage
compartment and the transfer conduit neck portion detailed in size
to contain the remainder of the predetermined quantity of blood.
The transfer conduit neck portion is constructed of a material
which is capable of being sealed so that the container can be
divided into a number of separate self-contained compartments and
in another use of the container, the transfer conduit neck portion
is sealed adjacent each of the storage compartments to divide the
container into three separate self-contained compartments, one
compartment containing the liquid plasma portion of a quantity of
blood, the transfer conduit neck portion containing the blood
platelets and the other storage compartment containing the
remaining red blood cells.
Inventors: |
Turner; Ralph D. (Atlanta,
GA) |
Family
ID: |
26935951 |
Appl.
No.: |
05/457,569 |
Filed: |
April 3, 1974 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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243575 |
Apr 13, 1972 |
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Current U.S.
Class: |
604/410; 222/94;
422/44; 206/438; 422/41 |
Current CPC
Class: |
A61J
1/10 (20130101); A61M 1/029 (20130101) |
Current International
Class: |
A61J
1/00 (20060101); A61M 1/02 (20060101); B65D
035/22 (); A61J 001/00 () |
Field of
Search: |
;128/227,214R,214D,272
;233/26 ;229/56 ;23/292,259 ;150/8 ;215/1C ;206/47A,DIG.29,DIG.35
;222/94 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Newton, Hopkins & Ormsby
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This is a continuation-in-part of my copending application, Ser.
No. 243,575 filed Apr. 13, 1972 and now abandoned.
Claims
What is claimed is:
1. A plastic bag for storing viable fluid comprising a pair of
generally flat, flexible, face-to-face, opposed and peripherally
joined side walls defining:
a. a relatively large upper storage compartment;
b. a relatively large lower storage compartment spaced a
predetermined distance from said upper storage compartment;
c. a means for selectively defining an intermediate third
compartment comprising a relatively narrow transfer conduit neck
formed by a pair of rupturable seals, one at the bottom of said
upper compartment and another at the top of said lower compartment,
said intermediate third compartment providing fluid flow
communication between the two compartments while potentially
defining a third storage compartment;
d. said upper compartment tapering downwardly toward said neck to
provide a progressively narrowing upper compartment approaching
said conduit neck; and,
e. said side walls being normally in a collapsed condition and
being deformable outwardly by receipt of the viable fluid.
2. A container as defined in claim 1 further characterized in that
said upper compartment is of a size to contain approximately 60% of
a predetermined amount and wherein said lower storage compartment
and said transfer conduit neck is detailed in size to contain
approximately 40% of said predetermined amount.
3. A container as defined in claim 1 further characterized in that
each of said storage compartments includes fluid entrance and fluid
discharge means at the ends of said container.
4. A container as defined in claim 5 further characterized in that
said predetermined capacity of said third compartment is
approximately 50 cc.
5. A bag for the storage and gravity separation of viable fluids
comprising a pair of opposed complimentary elastomeric sheets
respectively provided with flat border flanges, each of said
flanges confining within its border a relatively wide upper wall, a
relatively wide lower wall and a relatively narrow intermediate
wall joining the upper wall and lower wall at their central
portions, said flanges being joined in contiguous abutting
relationship; the flanges, adjacent said upper walls of said
sheets, forming an upper, essentially straight, laterally
extending, flange portion and a pair of opposed downwardly
extending upper side flange portions, said upper side flange
portions converging downwardly; said flanges, adjacent said
intermediate walls, having a pair of intermediate flange portions
in spaced relationship to each other and joined to said downwardly
converging portions; said flanges, adjacent said lower walls,
forming a pair of opposed downwardly diverging lower side flange
portions and an essentially straight, lower flange portion joining
the lower ends of said lower side flange portions, said upper walls
defining a relatively large upper compartment tapering downwardly
toward said intermediate walls, said lower walls defining a
relatively large lower compartment tapering upwardly toward said
intermediate walls, said intermediate walls defining a relatively
small intermediate compartment providing communication between the
upper and the lower compartments, said upper flanges being provided
with hole means which permit the container to be supported, said
flanges being provided with port means through which said viable
fluid can be introduced into the compartments and removed
therefrom, said intermediate walls being collapsible and having
transverse spaced portions selectively sealable to each other and
severable so that the upper and lower portions of said bag can be
separated from each other and from said small intermediate
compartment.
Description
BACKGROUND OF THE INVENTION
This invention relates to a flexible plastic bag or container and
is more particularly concerned with a container which is capable of
being separated to form a number of individual self-contained
storage compartments containing predetermined separated blood
portions.
A number of flexible plastic containers have been provided for use
in storing blood, with these containers capable of being divided
into a number of independent storage compartments. However, the
prior art blood storage containers are not detailed in shape and
size to contain a predetermined percent of a predetermined quantity
of blood, with the predetermined percent being representative to
the liquid plasma portion of the blood.
In the collection, storage and administration of whole blood, it is
often necessary to separate the cellular components of the whole
blood from the liquid plasma portion, so that the liquid plasma
portion of the blood can be administered to certain patients, the
platelet portion of the whole blood can be administered to certain
patients and the remaining red blood cells can be administered to
certain patients.
The prior art blood storage containers do not provide a container
designed with a specific shape and with specific size storage
compartments to automatically separate the liquid plasma portion,
the platelet portion and the remaining red blood cells of a
quantity of blood by sedimentation during storage insuitable
refrigeration means. Since the prior art blood containers are not
designed such that the containers can be sealed and separated to
contain a prescribed portion of the blood, other complex methods
are utilized to separate the desired portion to be given to a
patient from the remaining portion of the whole blood.
Further, it is often necessary to perform a number of specific
laboratory analysis of donar blood in order to determine the
donor's state of health. These prior art laboratory methods of
analyzing blood to determine the donor's state of health is time
consuming and expensive to SE.
The following patents exemplify the prior art: U.S. Pat. Nos.
3,692,493, 3,554,256, 3,545,671, 3,520,47l, 3,375,824, 3,257,072,
3,187,750, 2,848,995.
SUMMARY OF THE INVENTION
The above disadvantages have been overcome by the present invention
which basically includes an integrally formed flexible plastic
container having two storage compartments connected in fluid flow
communication by a narrow transfer conduit portion, with the
transfer conduit portion capable of being sealed so that the
container can be divided into a number of self-contained storage
compartments.
One important feature of the present invention is that the storage
compartments are detailed in size whereby one storage compartment
has a capacity representative of the plasma portion of whole blood,
the other storage compartment has the capacity representative of
the red blood cells and wherein the transfer neck portion has a
capacity representative of the platelet portion of whole blood.
Another important feature of the present invention resides in the
shape and size of the storage compartments with the interconnecting
transfer conduit neck portions so that the transfer conduit neck
portion will trap separated blood platelets, and wherein the
transfer conduit neck portion is adapted to be sealed adjacent each
of the storage compartments whereby the container can be separated
into three separate self-contained compartments, one compartment
containing the liquid plasma portion of a quantity of blood, the
other storage compartment containing the red blood cells and the
transfer conduit neck portion containing the blood platelets.
It is therefore a primary object of the present invention to
provide a container capable of storing and separating the
components of blood into a number of predescribed compartments
which can be individually separated into self-contained storage
means.
A further object of the present invention is to provide a method of
separating donor blood into liquid plasma, blood platelets and red
blood cells.
Another object of the present invention is to provide a container
capable of providing a ready reference to a donor's state of
health.
An additional object of the present invention is to provide a blood
collection, storage and administering container which is simple in
construction and use, economical to manufacture and reliable in
performance.
These and other objects and advantages of the details of
construction will become apparent after reading the following
description of the illustrative embodiment with reference to the
attached drawing wherein like reference numerals have been used to
refer to like parts throughout the several figures, and
wherein:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front elevational perspective view of a container
embodying the principles of the present invention, shown in a
partially filled stage so as to give it a bulbous appearance;
and,
FIG. 2 is a side elevational view of FIG. 1 in the deflated
state.
DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS
Referring now to the drawing, a storage container embodying the
principles of the present invention is shown and generally
represented by the reference numeral 10. Storage container 10 is
integrally formed and constructed of flexible plastic material
having a large storage compartment 11 and a smaller storage
compartment 12. The storage compartments 11 and 12 are connected by
a relatively small transfer conduit neck portion 13. The storage
compartments 11 and 12 tapers toward the transfer conduit neck
portion 13 which is substantially narrower and smaller than storage
compartments 11 and 12 so as to give the container an overall
appearance of an hourglass. Thus compartments 11 and 12 provide
progressively narrowing compartments as they approach neck 13 from
opposite ends. Each of the storage compartments 11, 12 is provided
at their outer ends, i.e., their upper and lower ends with port
means 14, 15, respectively, which have removable caps C and are
operable for receiving spike means (not shown) utilized to drain
the storage compartments in administering the blood portions to a
patient. Each of the compartments 11, 12 is provided with an
opening having a stopper element 16, 17, respectively, which is
operable for receiving a drainage needle (not shown).
In more detail, the container 10 depicted in the drawing, is formed
of a pair of opposed complimentary plastic sheets 21 and 22, each
of which is an integral elastomeric web member. Sheets 21 and 22
are respectively provided with flat contiguous endless perimeters
or border flanges 23 and 24.
Within and defined by the perimeter flange 23 are the upper,
intermediate, and lower compartment defining walls 25, 26 and 27.
The upper wall 25 integrally merges with the flange 23 while the
lower wall edge 31 integrally merges with the upper edge of
intermediate wall 26.
The upper portions of flanges 23 and 24 are secured together and,
as viewed in FIG. 1, provide an upper edge or flange portion 30
which is essentially straight, extending laterally or horizontally
across the top of the bag. The ends of the upper flange portion 30
merge with the ends of downwardly extending side edges or flange
portions 28 and 29. From the ends of upper edge 30, the edges 28
and 29 curve outwardly and downwardly and then inwardly about radii
within the upper wall 25. Thence, the intermediate and lower
portions of the side edges or flanges 28 and 29 are straight and
taper downwardly, converging toward the narrowed upper throat at
the lower end portion of compartment 11, i.e., at the junction of
compartment 11 and conduit neck portion 13.
At the upper throat, the edges 28 and 29 respectively merge with
the spaced opposed edges approximately parallel to intermediate
edges or flange portions 32 and 33 of the intermediate wall 26,
which forms conduit neck portion 13.
The lower wall 27 is congruent in shape to the upper wall 25, but
is smaller. The side edges or flange portions 34 and 35 of wall 27
therefore are straight, being reversely tapered or diverging and
then curving arcuately inwardly to merge with the lower edge or
bottom portion 36, which is essentially straight and parallel to
upper edge 30. The throat line 37 of wall 27 integrally merges with
the lower edge of wall 26 in the same manner as the merger of
throat line 31.
The sheet 22 has a complimentary structure to that of sheet 21
having upper wall 45, intermediate wall 46 and lower wall 47
encompassed by border 24.
As seen in FIG. 2, the opposed upper walls 25 and 45 are spaced
from each other and converge downwardly defining a progressively
narrowing compartment as it approaches the throat lines 31. Also,
the opposed lower walls 27 and 47 converge upwardly, defining an
upwardly narrowing compartment as throat line 37 is approached. The
intermediate walls, such as wall 26, form the straight tubular
cylindrical or eliptical junction or neck 13.
It is understood that the sheets 23 and 24 can be readily and
easily vacuum formed and the flanges glued together. The bag 10 can
also be readily blow molded as an entirely integral member.
In the embodiment shown in FIGS. 1 and 2, the port means 14, 15, 16
and 17 are formed integrally in or between the opposed flanges 23
and 24.
As shown in FIG. 1, container 10 is provided with a pair of holes
or openings 17, 18 adjacent an upper portion of storage compartment
11. Openings 17, 18 are provided for use in suspending container 10
during storage and for use in suspending the container while
administering blood to a patient. Container 10 is also provided
with a single opening 19 adjacent a bottom edge of storage
compartment 12 which is operable for use in suspending the
container in a blood administering operation.
The above described flexible plastic blood storage container is
referred to as a "hemocrit" since it is operable for determining
the ratio of the volume of red blood cells to the volume of whole
blood as will be described in more detail below.
Container 10 can be constructed of a number of sizes for
accommodating various quantities of whole blood. However, the bag
is normally constructed in three sizes, namely: the large size
having a capacity of 512 ml., the intermediate size having a
capacity of 256 ml., and a small size having a capacity of 128 ml.
The storage compartments 11 and 12 and the transfer conduit portion
13 are constructed to make a blood collection, storage and
administering container which is easy to use, versatile and
scientifically efficient. Storage compartment 11 is detailed in
size to have a capacity representing approximately 60 % of the
entire capacity of the container, since the human whole blood
includes approximately 60% plasma. The smaller storage compartment
12 is detailed in size to have a capacity of approximately 40 % of
the capacity of the entire container and will be operable for
containing the remaining cellular components of whole blood,
including the white cells, the lymphocytes, the platelets, and the
red blood cells. In use, the smaller storage compartment 12 will be
used to store the red blood cells and the larger compartment 11
will be used to contain the liquid plasma portion of the blood. The
transfer conduit portion 13 will be utilized for storing the white
cells and platelet portions of whole blood.
In using container 10, the donor blood is introduced into the
container through one of the port openings in a conventional
manner. After the container 10 has been filled with blood, the
container is properly sealed and immediately placed in a suitable
refrigeration storage means. Container 10 is stored with the larger
compartment 12 in an elevated position so that during storage, the
red blood cells, being heavier, will settle to the smaller
compartment 12. When the heavier blood cells settle to the smaller
storage compartment 12, the liquid plasma will remain in the upper
or larger storage compartment 11. After sedimentation, the white
cells and platelets are trapped in the narrow transfer conduit
portion 13. Storage container 10 can also be utilized in a
conventional centrifuging process so that the red blood cells can
be more quickly separated from the liquid plasma portion of the
whole blood. A centrifuging process for separating blood is
desirable in a plasmapheresis technique, wherein the red blood
cells have been separated from the plasma portion, and are
transfused back into the blood donor. The donor's plasma is kept
for use as liquid plasma, or it can be used for blood testing and
blood typing since it contains desirable antibodies, such as
specific agglutinins.
After the blood contained in container 10 has been separated either
by sedimentation or in a centrifuging process, these containers can
be sealed along an intermediate portion of the transfer conduit
portion represented by letter A. The transfer conduit neck portion
is sealed by utilizing a conventional heat sealing process.
Container 10 is separated into two self-contained storage
compartments by making a cut along line A after a heat sealing
operation has been performed. When container 10 is separated into
two self-contained storage compartments 11, 12, storage compartment
11 will contain the blood plasma and storage compartment 12 will
contain the red blood cells. The red cells contained in storage
compartment 12 are administered to certain anemic patients who need
the red blood cells but who do not need whole blood. For example, a
geriatric patient may need two units of red blood cells. However,
if two units of whole blood were administered, his circulatory
system might well be overloaded and this might produce injurious
effects to the patient.
The plasma portion of the blood contained in storage compartment 11
can be administered to those patients who are best helped by
receiving blood plasma. For example, plasma is administered to
patients in shock.
As indicated above, after the blood has been allowed to separate
either by sedimentation or centrifuging, the transfer conduit
portion 13 will contain the white cells and platelets. It is often
desirable to administer only the white cells and platelets to
certain patients. If only the white cells and platelets are to be
administered to a patient, a sealing operation is made along line B
transversely across the transfer conduit portion 13 adjacent
compartment 11 and is made along line C transversely across conduit
neck portion adjacent compartment 12. By making a heat seal along
lines B and C, a cut can be made along lines B and C to separate
the container 10 into three self-contained storage compartments,
with storage compartment 11 including the blood plasma portion,
storage compartment 12 including the red blood cells and with blood
storage compartment 13 containing the white cells and
platelets.
In administering white cells or platelets, they are withdrawn from
the transfer conduit neck portion 13 by a hypodermic syringe under
aseptic conditions. This concentrated dose of platelets can be
administered to those patients who are deficient in platelets.
Also, by separating the white cells and platelets from the plasma
and red blood cells, the plasma and red cells can be administered
to a small percentage of patients who are hypersensitive or
allergic to white cells.
The above described container 10 is useful in determining the
donor's state of health. If the donor is anemic, not having a
normal quantity of red blood cells, this will be quickly reflected
as the bottom or smaller storage compartment 12 will not be filled
with red blood cells. Further, those patients with polycythemia can
be readily detected, since those patients will have too many red
blood cells, and the red blood cells will extend up into the upper
storage compartment 11. Since polycythemia is a disease syndrome,
such blood would not be used for administering to other
patients.
It now becomes obvious that the above described blood collection,
storage and administering container is capable of obtaining the
above stated objects and advatages. It is obvious that those
skilled in the art may make modifications in the details of
construction without departing from the spirit of the invention
which is to be limited only by the scope of the appended
claims.
* * * * *