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Claims  |
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That which is claimed is:
1. In a multiple blood bag system which comprises a first bag, a second
bag, and conduit means providing sealed flow communication between said
first bag and second bag in which said first bag is made of a plastic
material which comprises a different polymer entity from that of said
second bag, one of said bags being equipped with a blood collection tube,
and the polymer entity of the the first bag exhibiting the characteristic
of suppressing hemolysis of blood cells on long term storage, whereby the
first bag and second bag exhibit differing physical characteristics which
are selectively beneficial to their functions.
2. The multiple bag blood system of claim 1 in which a second transfer bag
is present, being made of a translucent, flexible, sterilizable material
which is free of blood-extractable plasticizers and exhibits a higher
carbon dioxide diffusion characteristic than the other bags in the system
whereby the pH of the platelets stored therein is resistant to reduction.
3. The multiple bag system of claim 1 in which said first bag is a donor
bag for receiving whole blood from a donor, said blood collection tube
being connected to the first bag, said second bag comprising a transfer
bag for receiving a blood component from the donor bag.
4. The multiple bag system of claim 1 in which said first bag contains an
amount of liquid plasticizer sufficient to suppress the amount of plasma
hemoglobin produced by blood stored therein, when compared with a
corresponding bag free of said plasticizer.
5. The multiple bag system of claim 1 in which said first bag contains an
amount of an ester-type material which is sufficient to suppress the
amount of plasma hemoglobin produced by blood stored therein, when
compared with a corresponding bag free of said ester-type material.
6. The multiple bag system of claim 1 in which said first bag contains an
ester-type plasticizer in a concentration sufficient to cause a reduction
in the plasma hemoglobin content of blood stored in said bag for 21 days,
when compared with a corresponding bag which is free of said material.
7. In a multiple blood bag system which comprises a first bag, a second
bag, and conduit means providing sealed flow communication between said
first and second bags, the improvement comprising: said second bag being
made of a translucent, flexible, sterilizable material which is free of
blood-extractable plasticizers, said first bag being made of a
translucent, flexible, sterilizable material which contains an amount of
liquid plasticizer selected from the group consisting of dioctylphthalates
and dioctyladipates sufficient to suppress the amount of plasma hemoglobin
produced by blood stored therein.
8. In a multiple blood bag system which comprises a donor bag for receiving
blood from a donor, at least one transfer bag for receiving a blood
component from said donor bag, and conduit means providing sealed, flow
communication between said donor bag and transfer bag, the improvement
comprising:
said transfer bag being made of a translucent, flexible, sterilizable
material which is free of blood-extractable plasticizers, said donor bag
being made of a translucent, flexible, sterilizable material which
contains from 5 to 50 percent by weight of a di-ester selected from the
group consisting of dioctylphthalates and dioctyladipates.
9. The blood bag system of claim 8 in which said liquid plasticizer is a
diethylhexylphthalate.
10. In a multiple blood bag system which comprises a donor bag for
receiving blood from a donor, at least one transfer bag for receiving a
blood component from said donor bag, and conduit means providing sealed,
flow communication between said donor bag and transfer bag, the
improvement comprising:
said transfer bag being made of a translucent, flexible, sterilizable
material, which is free of blood-extractable plasticizers, said donor bag
being made of a translucent, flexible, sterilizable material which
contains from 5 to 50 percent by weight of a diester selected from the
group consisting of di-2-ethylhexylphthalate and di-2-ethylhexyladipate.
11. In a multiple blood bag system which comprises a donor bag for
receiving blood from a donor, at least one transfer bag for receiving a
blood component from said donor bag, and conduit means providing sealed,
flow communication between said donor bag and transfer bag, the
improvement comprising:
said transfer bag being made of a transparent, flexible, autoclavable
material which is free of blood-extractable plasticizers, said donor bag
being made of a transparent, flexible, autoclavable material which
contains from 15 to 50 percent by weight of di-2-ethylhexylphthalate.
12. The multiple blood bag system of claim 11 in which said transfer bag is
made of a polyolefin material.
13. The multiple blood bag system of claim 12 in which said donor bag is
made of a polyester material.
14. The multiple blood bag system of claim 12 in which said donor bag is
made of a formulation of polyvinyl chloride plasticized with said
di-2-ethylhexyl phthalate.
15. The multiple blood bag system of claim 12 in which said donor bag
contains from 15 to 40 percent by weight of di-2-ethylhexyl phthalate.
16. The multiple blood bag system of claim 12 in which said conduit means
comprises flexible tubing made of the same translucent, flexible
autoclavable material as the transfer bag.
17. The multiple blood bag system of claim 12 in which a plurality of
transfer bags are present, being in communication through said conduit
means with the donor bag.
18. The multiple blood bag system of claim 12 in which at least one of said
transfer bags is made of a copolymer comprising from 10 to 40 percent by
weight of a polyolefin consisting essentially of propylene units; from 40
to 85 percent by weight of a block copolymer, having thermoplastic rubber
characteristics, consisting essentially of (1) a central block comprising
50 to 85 percent by weight of the copolymer molecule, of a rubbery olefin
polymer of generally equal proportions of ethylene and butylene units, and
(2) terminal blocks of polystyrene; and from 0 to 40 percent by weight of
a softening agent selected from the group consisting of polyethylene and
poly(ethylene-vinyl acetate) containing no more than 35 percent by weight
of vinyl acetate.
19. The multiple blood bag system of claim 18 in which a second transfer
bag is present which is made of a flexible polyester material, and said
donor bag is made of polyvinyl chloride plasticized with said
di-2-ethylhexylphthalate.
20. The multiple blood bag system of claim 11 in which said transfer bag is
made of a polyolefin material which exhibits a relatively high
low-temperature strength, whereby the bag may be frozen for collection of
cryoprecipitate.
21. In a multiple blood bag system which comprises a donor bag for
receiving blood from a donor, at least one transfer bag for receiving a
blood component from said donor bag, and conduit means providing sealed,
flow communication between said donor bag and transfer bag, the
improvement comprising: said transfer bag being made of a translucent,
flexible, sterilizable polyolefin material which is free of
blood-extractable plasticizers and exhibits a relatively high carbon
dioxide diffusion characteristic whereby the pH of platelets stored
therein is resistent to reduction, said donor bag being made of a
translucent, flexible, sterilizable plastic material which contains from
15 to 50 percent by weight of a blood-extractable plasticizer selected
from the group consisting of dioctylphthalates and dioctyladipates.
22. The multiple blood bag system of claim 21 in which said extractable
plasticizer is di-2-ethylhexylphthalate.
23. The multiple blood bag system of claim 22 in which said donor bag is
made of a polyvinyl chloride formulation plasticized with
di-2-ethylhexylphthalate.
24. In a multiple blood bag system which comprises a donor bag for
receiving blood from a donor, at least one transfer bag for receiving a
blood component from said donor bag, and conduit means providing sealed,
flow communication between said donor bag and transfer bag, the
improvement comprising: said transfer bag being made of a translucent,
flexible, sterilizable, polyester material, free of ester-type blood
extractable materials, said donor bag being made of a translucent,
flexible, sterilizable, polyvinyl chloride plastic material which contains
from 5 to 50 percent by weight of di-2-ethylhexylphthalate.
25. In a multiple blood bag system which comprises a donor bag for
receiving blood from a donor, at least one transfer bag for receiving a
blood component from said donor bag, and conduit means providing sealed,
flow communication between said donor bag and transfer bag, the
improvement comprising: said transfer bag being made of a translucent,
flexible, sterilizable material which is free of blood-extractable
plasticizer, said donor bag being made of a translucent, flexible,
sterilizable plastic material, said donor bag containing in its interior
an insert portion of plastic material which contains at least 5 percent by
weight of a blood-extractable plasticizer selected from the group
consisting of dioctylphthalates and dioctyladipates.
26. The multiple blood bag system of claim 25 in which 15 to 50 percent by
weight of said blood extractable plasticizer is present in said interior
plastic insert.
27. The multiple blood bag system of claim 26 in which the outer walls of
said donor bag are essentially free of blood extractable plasticizers.
28. The multiple blood bag system of claim 26 in which said interior
plastic insert comprises a polyvinyl chloride formulation containing a
blood-extractable plasticizer.
29. In a multiple blood bag system which comprises a donor bag for
receiving blood from a donor, at least one transfer bag for receiving a
blood component from said donor bag, and conduit means providing sealed,
flow communication between said donor bag and transfer bag, the
improvement comprising:
said transfer bag being made of a translucent, flexible, sterilizable
material which is free of blood-extractable plasticizers, said donor bag
being made of a translucent, flexible, sterilizable material which
contains sufficient amount of an ester material selected from the group
consisting of dioctylphthalates and dioctyladipates to cause a reduction
in the plasma hemoglobin content of blood stored in said bag for 21 days,
when compared with a corresponding bag which is free of said material.
30. The blood bag system of claim 29 in which said ester material contains
branched octyl radicals.
31. The blood bag system of claim 30 in which said ester material is
di-2-ethylhexylphthalate.
32. The multiple blood bag system of claim 29 in which said transfer bag is
made of a polyolefin material.
33. The multiple blood bag system of claim 32 in which said donor bag is
made of a polyester material.
34. The multiple blood bag system of claim 33 in which said donor bag is
made of a formulation of polyvinyl chloride plasticized with said
di-2-ethylhexylphthalate.
35. The multiple blood bag system of claim 34 in which a plurality of
transfer bags are present, being in communication through said conduit
means with the donor bag.
36. The multiple blood bag system of claim 29 in which at least one of said
transfer bags is made of a copolymer comprising from 10 to 40 percent by
weight of a polyolefin consisting essentially of propylene units; from 40
to 85 percent by weight of a block copolymer, having thermoplastic rubber
characteristics, consisting essentially of (1), a central block comprising
50 to 85 percent by weight of a copolymer molecule, of a rubbery olefin
polymer of generally equal proportions of ethylene and butylene units and
(2) terminal blocks of polystyrene; and from 0 to 40 percent by weight of
a softening agent selected of the group consisting of polyethylene and
poly(ethylene-vinyl acetate) containing no more than 35 percent by weight
of vinyl acetate.
37. The multiple bag system of claim 36 in which a second transfer bag is
present which is made of a flexible polyester material, and said donor bag
is made of polyvinyl chloride which contains di-2-ethylhexylphthalate. |
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Claims  |
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Description  |
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BACKGROUND OF THE INVENTION
Multiple blood bags are commercially available from the Fenwal Division of
Baxter Travenol Laboratories, Inc., for collecting and processing blood
under sterile conditions to obtain various blood components as may be
desired, for example, packed red cells, plasma, platelets, and
cryoprecipitate.
The currently-available blood bags are made of a polyvinyl chloride
formulation, which includes, as an ester-type plasticizer,
di-2-ethylhexylphthalate. This blood bag system has served extremely well
in the storage and processing of blood and blood components, exhibiting a
high survival rate, with a resultingly low plasma hemoglobin content
after, for example, 21 days of storage.
However, some concern has been expressed from various sources about the
potential undesirability of the plasticizer leaching from the plastic
material, and entering the blood, from where it is infused to the patient
upon infusion of the blood or blood components. This is so despite the
lack of any apparent significant toxicity of the particular plasticizer
used, the concern being about long-term and subtle effects not yet
discovered.
Accordingly, various plastic formulations which are flexible, translucent,
sterilizable, and free of liquid plasticizers capable of leaching have
been tested as blood bag materials. Many of the plastic formulations which
have been tested have physical characteristics which are different from
each other and from the current polyvinyl chloride formulations. For
example, some plastic formulations have an improved capacity to transfer
carbon dioxide, so that it would be of advantage to make one or more of
the transfer packs of a multiple blood bag of such a material to permit an
increased diffusion rate of carbon dioxide through the transfer pack
during platelet storage so that the pH decrease of the platelets during
storage is reduced.
It has been surprisingly found that the presence of certain ester-type
plasticizers such as di-2-ethylhexylphthalate and di-2-ethylhexyladipate
in plastics causes a significant lowering of the plasma hemoglobin content
during long-term storage of blood in containers made of such plastics.
Accordingly, in accordance with this invention, the overall contact of
blood plasma and other components to the blood-extractable plasticizer may
be minimized, while still attaining low plasma hemoglobin levels in
long-term storage, by providing a multiple blood bag system in which the
donor bag is made of a plastic which contains a blood extractable
plasticizer, preferably a branched dioctyl phthalate ester plasticizer,
but the transfer bags are free of blood extractable plasticizers.
Accordingly, the red blood cells, which normally are retained in the donor
bag, are stabilized and preserved by the surprising benefit which has been
found by the presence of the specific plasticizers described above. At the
same time, the plasma and other blood components may be removed from the
donor bag, being thus freed from further exposure to the plasticizer, and
stored in transfer bags of different materials of different desirable
characteristics, for example, transfer bags made of a material having
relatively high carbon dioxide diffusion capability.
Accordingly, in accordance with this invention, the specific properties of
the various bags of the multiple blood bag of this invention may be
optimized by the use of different materials for each of the bags as
desired, with one bag material being chosen for the donor bag in order to
minimize the formation of plasma hemoglobin and to maximize the life of
the red cells, while the transfer packs may be made of material having
other characteristics, for example, the relatively high carbon dioxide
diffusion capability.
DESCRIPTION OF THE INVENTION
The multiple blood bag system of this invention comprises a donor bag for
receiving blood from a donor, and at least one transfer bag for receiving
a blood component from the donor bag. The donor bag and transfer bag are
connected together by conduit means providing sealed flow communication
between them.
In accordance with this invention, the donor bag and transfer bag may be
made of plastic materials which each comprise a different polymer entity
so that the respective bag materials exhibit different characteristics
which may be specifically selected for beneficial effect in the specific
function of each of the transfer and donor bags.
For example, the transfer bag or bags may be made of a translucent,
flexible, sterilizable material which is free of blood-extractable
plasticizers. On the other hand, the donor bag may be made of a
transparent, flexible, sterilizable material which contains an amount of
blood-extractable plasticizer selected from the group consisting of
dioctylphthalates and dioctyladipates, preferably
di-2-ethylhexylphthalate, and preferably in a concentration in the
flexible material of 5 to 50 weight percent, and typically about 15 to 40
weight percent.
This can result in a substantial reduction in plasma hemoglobin produced by
blood stored under normal conditions for 21 days in the donor bag, when
compared with blood in a corresponding donor bag, free of blood
extractable plasticizers and stored under equivalent conditions.
If desired, only portions of the bag materials which are in contact with
the blood contained therein may contain the blood-extractable plasticizers
of this invention, although preferably the entire bag material contains
the plasticizer. Alternatively, a plastic insert member such as a sheet of
plastic or the like positioned within the blood bag may contain the
blood-extractable plasticizer material, while the actual bag walls may be
relatively free of plasticizer. Both of these circumstances are generally
equivalent to the preferred use of blood-extractable plasticizer
throughout essentially the entire material of the donor bag.
It is specifically desirable for the concentration and configuration of
plasticizer in the bag to be such that when the bag is filled with blood
and stored on a long term basis, the concentration of the
blood-extractable plasticizer in the blood rises to typically about 30 to
100 micrograms per ml., and preferably from about 50 to 80 micrograms of
the plasticizer per ml., in the blood in 21 days. This takes place due to
the extraction of the plasticizer from the plastic material in dissolved
form into the blood.
It has been found to be difficult to dissolve the blood-extractable
plasticizers used herein in bulk in the blood, and it has been found that
a greater beneficial effect is provided by placing the extractable
plasticizer in the plastic material of the blood bag for extraction by the
blood during the storage period.
The transfer bag or bags and optionally the tubing in the blood bag of this
invention may be made of a polyester material in accordance with the
teachings of U.S. Pat. No. 4,045,431.
It may also be desirable to make the donor bag of the multiple bag system
of this invention out of a similar polyester material to the transfer bag,
but containing blood-extractable plasticizer.
Alternatively, bags of this invention may be made out of a blood-compatible
polyurethane formulation.
Another type of material which is suitable for the transfer bag of this
invention comprises a mixture of from 10 to 40 percent by weight of a
polyolefin consisting essentially of propylene units; from 40 to 85
percent by weight of a block copolymer, having thermoplastic rubber
characteristics, consisting essentially of (1) a central block comprising
50 to 85 percent by weight of the copolymer molecule of a rubbery olefin
polymer (and preferably consisting of generally equal proportions of
ethylene and butylene units); and (2) terminal blocks of polystyrene; and
as a third, optional ingredient, from 0 to 40 percent by weight of a
softening agent such as polyethylene or poly(ethylene-vinyl acetate)
containing no more than 35 percent by weight of vinyl acetate units. This
polyolefin formulation exhibits relatively good low temperature strength
and good carbon dioxide transfer characteristics, and thus is suitable for
use as transfer bags for collecting cryoprecipitate or storing platelets.
The above material is further described in U.S. patent application Ser. No.
819,924 filed July 28, 1977 now U.S. Pat. No. 4,140,162.
The above block copolymer is commercially available from the Shell Chemical
Company under the trademark KRATON or KRATON-G, the latter class of
materials being preferred.
Other materials from which the transfer bags of this invention, and
optionally the tubing, may be made include poly(ethylene-vinyl acetate)
copolymers, and polyethylene formulations, all of the above material being
preferably essentially free of the blood-extractable plasticizers.
The donor bag, as described above, contains a blood extractable liquid
plasticizer as described above, the plasticizer being generally present in
a concentration of 5 to 50 percent by weight of the overall plasticized
plastic material making up the donor bag.
Preferably, a conventional formulation of polyvinylchloride, plasticized
with a dioctyl phthalate such as di-2-ethylhexylphthalate, similar to
present commercial formulations, may be used. Alternatively, other
plastics such as a polyester bag formulation may be used, for example
utilizing the above-described polyester, in which preferably from 15 to 40
percent by weight of the di-2-ethylhexylphthalate plasticizer is present,
either by formulation along with the original plastic material, or by
allowing the plastic to soak in the diethylhexylphthalate until the
desired amount of plasticizer has been taken up by the material.
Typically, the polyester formulation may contain about 20 percent by
weight of the ester plasticizer.
Alternatively, di-2-ethylhexyladipate or an equivalent material may be used
as the blood-extractable plasticizer.
Referring to the drawings, FIG. 1 is a plan view of a multiple blood bag
system in accordance with this invention.
Blood bag system 10 includes a donor bag 12 which may be of conventional
construction, being made of a pair of plastic sheets, being sealed at
periphery 14, and containing a blood collection tube 16 having the usual
donor needle, and a pair of access ports 18.
Transfer tubing 20 is connected to donor bag 12, for fluid flow through the
transfer tubing, being controlled by conventional valving means 22, such
as a cannula and diaphragm valve. Transfer tubing 20 communicates through
Y site 23 to transfer bags 24, 26 which may also be of conventional
construction, with the exception of the materials of which they are made,
having the conventional access ports 28 and other known design features.
In accordance with this invention, transfer bags 24, 26 are made of a
material which may be translucent (e.g., transparent), flexible, and
preferably autoclavable to permit sterilization, being made of a material
which is free of blood-extractable plasticizers, for example, a material
as described above. Accordingly, plasma and other blood components which
are expressed into transfer bags 24, 26 enter an environment free of
additional exposure to plasticizers. In fact, the plasticizer-free
formulations of bags 24, 26 can reduce the plasticizer level in the blood
components by absorption thereof if the blood bag material of the transfer
bags is of an appropriately plasticizer-compatible material.
It is specifically preferable for at least one of the transfer bags 24, 26
to be made of a material which has a relatively high capability to permit
the diffusion of carbon dioxide, so that the bag may be desirably used as
a platelet storage bag. Specifically, such a bag may be made from the
polyolefin-thermoplastic rubber formulation described above and in the
cited U.S. patent application Ser. No. 819,924, filed July 28, 1977, or
other formulations described therein. Alternatively, the same transfer bag
may be used to collect and store cryoprecipitate in view of its good low
temperature strength.
The other of the two transfer bags may be made of the polyester formulation
described above. Accordingly, one preferred embodiment the multiple bag
shown in the drawings may comprise a pair of transfer bags 24, 26, each of
which is made of a different material from the other. Alternatively, they
may be the same.
Tubing 20 may be made of a flexible material, free of blood-extractable
plasticizers, similar to that of one of the transfer bags 24, 26, if
desired, or it may be made of the material of donor bag 12, or any other
desired material.
Donor bag 12 is made of a transparent, flexible, preferably autoclavable
material which contains the desired amount of blood-extractable
plasticizer as described above, to cause a substantial reduction in the
plasma hemoglobin of blood stored under normal conditions for 21 days in
the donor bag 12, when compared with a corresponding extractable
plasticizer-free donor bag stored under equivalent conditions.
As stated above, a commercial polyvinyl chloride blood bag formulation may
be used, which contains di-2-ethylhexyl phthalate. Alternatively, another
plastic such as a polyester material as described above, containing the
desired amount of compatible liquid plasticizer, may be used.
If desired, an optional plastic insert 32 may be inserted within the donor
bag 12. Insert 32 may be made of a similar material to donor bag 12, or a
material which is particularly compatible to the desired blood-extractable
plasticizer used herein. Accordingly, the material of bag 12 may be
relatively free of the desired blood-extractable plasticizer, but insert
32 within the bag may carry any desired amount of the plasticizer,
preferably from 15 to 70 percent by weight, to provide the extractable
plasticizer to the blood which is placed in bag 12. It has been found that
the desirable results of this invention can be achieved by this alternate
technique. Insert 32 may be a single sheet, or a plurality of plastic
beads, or any other convenient structure.
For example, the blood bag may be made out of a polyolefin such as
polyethylene, polypropylene, the polyolefin block copolymer formulation
described previously, polyester, polyurethane, or any other
blood-compatible, inert, flexible plastic material. Insert 32, on the
other hand, may be made of a blood-compatible polyvinyl chloride
formulation and may contain most preferably up to about 50 percent of
di-2-ethylhexylphthalate or di-2-ethylhexyladipate, to be extracted into
the blood over the storage period. If desired, higher concentrations than
50 percent of the extractable plasticizer may be used in insert 32, since
there is no need for insert 32 to exhibit a high tensile strength, as
would be necessary if it were part of the bag wall itself.
Correspondingly, the specific bag material chosen for use may be free of
the extractable plasticizer, while the advantages of this invention are
still achieved.
Accordingly, as blood is collected through the donor tube 16 into the blood
bag 12, mixing with blood preservative 30 such as ACD or CPD solution in
bag 12, the blood may then be processed or stored as desired. During
storage, the presence of the plasticizer effectively suppresses the amount
of plasma hemoglobin which is generated over a period of time, compared
with blood stored in a bag made of a formulation which is free of
blood-extractable plasticizers.
The blood may be centrifuged, with the red cells settling to the bottom of
donor bag 12, and the plasma and other components being expressed through
tubing 20 into transfer bags 24, 26. Thereafter, the expressed blood
components are free from exposure to plasticizer, while the red cells in
bag 12 may be stored with appropriate treatment to continue to receive the
benefit of the presence of plasticizer in the material of transfer bag 12.
The materials from which transfer bags 24, 26 are made may also exhibit
other benefits; for example, polyolefins and other materials may have
improved gas transmission characteristics for improved platelet survival,
since the carbon dioxide diffuses through the bag wall more readily than
with polyvinyl chloride, with the result that the pH remains more stable.
Also, if desired, donor bag 12 and transfer bags 24, 26 may be separate
bags that have been connected together during use by means of a sterile
connector system, for example, that shown in U.S. Pat. No. 4,004,586, or
any other sterile connector system.
The following examples are for illustrative purposes only, and are not
intended to limit the invention described herein.
EXAMPLE 1
Blood bags were prepared of a design similar to the commercially-available
Fenwal donor bag, but made of a polyester as described in U.S. Pat. No.
4,045,431. The blood bags were sterilized in accordance with commercial
standards, and while blood was drawn into the blood bags.
The first group of bags was made of the same polyester and was
plasticizer-free, while the second group of bags was soaked to about a 20
weight percent concentration of di-2-ethylhexylphthalate plasticizer.
The blood was divided between first group and second group of bags in equal
quantities in a conventional manner, and the bags were sealed off.
Thereafter, the bags were stored at 4.degree. C. for 21 days.
Then, the amount of plasma hemoglobin was measured in the two groups of
bags, with the results as shown in Table I below.
TABLE I
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Plasma Hemoglobin (mg. %)
First Group of Bags Second Group of Bags
(plasticizer free) Containing Plasticizer
______________________________________
Multiple
Bag No. 1 40.7 mg. % 16.5 mg. %
2 36.7 21.3
3 11.5 7.2
4 21.1 9.4
5 20.9 12.3
6 42.6 9.8
7 62.7 21.4
8 34.0 18.4
9 44.6 14.6
10 31.8 9.7
Average 34.7 14.1
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The above data shows the significant reduction in plasma hemoglobin which
results from storing whole blood for 21 days under conventional storage
conditions in a blood bag which contains plasticizer, even when the
plasticizer is not necessary for its usual purpose of obtaining desired
characteristics in the plastic of the blood bag.
EXAMPLE 2
Blood bags were made out of the commercial polyvinyl chloride formulation
utilized by Travenol Laboratories, Inc. and containing from 25 to 30
percent by weight of di-2-ethylhexylphthalate. Other blood bags were made
out of different formulations as indicated in Table II below, and were
essentially free of blood-extractable ester plasticizers.
Multiple samples of all of the blood bags were filled with whole blood and
were stored for 21 days. Table II below illustrates the numbers of samples
tested and the average amount of plasma hemoglobin expressed in terms of
milligram percent for the various groups of sample bags.
TABLE II
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No. Mean Amount of
of Samples
Plasma
Tested Hemoglobin (mg. %)
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Commercial polyvinyl chloride
blood bag formulation of
21 20.4
Travenol Laboratories, Inc.
Polyvinyl chloride plasti-
cized with tri-ethylhexyl
10 51.7
mellitate
Polyolefin blend as described
in Example 2 of the U.S. Pat.
10 48.8
S.N. 819,924 cited above
Flexible polyester
8 45.2
Ethylene vinyl acetate
copolymer 4 43.2
Polyethylene 4 45.0
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The above shows that the presence of the extractable ester plasticizer
provides a substantial reduction in the creation of plasma hemoglobin in
stored blood.
Suitable multiple blood bags may be made in accordance with this example,
with the donor bag being made from the commercial Travenol polyvinyl
chloride formulation, and the transfer bags being made of one or more of
the remaining formulations described in Table II.
The above has been offered for illustrative purposes only, and is not
intended to limit the invention of this application, which is as defined
in the claims below.
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Description  |
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