CA1231280A - Multiple blood bag system - Google Patents

Multiple blood bag system

Info

Publication number
CA1231280A
CA1231280A CA000379021A CA379021A CA1231280A CA 1231280 A CA1231280 A CA 1231280A CA 000379021 A CA000379021 A CA 000379021A CA 379021 A CA379021 A CA 379021A CA 1231280 A CA1231280 A CA 1231280A
Authority
CA
Canada
Prior art keywords
container
blood
physical characteristic
beneficial
imparts
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000379021A
Other languages
French (fr)
Inventor
Raleigh A. Carmen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Corp
Original Assignee
Miles Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Miles Laboratories Inc filed Critical Miles Laboratories Inc
Application granted granted Critical
Publication of CA1231280A publication Critical patent/CA1231280A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0209Multiple bag systems for separating or storing blood components

Abstract

ABSTRACT OF THE INVENTION
A multiple blood bag system for storage of blood and processing of blood into its components is disclosed comprising a donor bag and one or more satellite bags connected by flexible tubing. The donor bag is made of conventional PVC plasticized with di-2-ethylhexyl phthalate and is suitable for long term storage of whole blood or red cells. The satellite bag or bags is made of a material which is free of di-2-ethylhexyl phthalate so that this plasticizer, which is extracted by blood or plasma, will not contaminate blood components processed or stored in the satellite bags. A
preferred material for a satellite bag and particularly desirable for storage of platelets is a PVC formulation which contains a trioctyl trimellitate as plasticizer.

Description

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This invention relates to multiple blood bag systems for collecting and processing blood under sterile conditions.
For a number of years, blood has been collected and processed into various components such as packed red cells, plasma platelets and cryoprecipitate, using a system comprising two or more plastic bags interconnected by tubing. The blood is first collected from a donor into a primary or donor bag to which is connected one or more secondary or satellite bags. Both the donor and satellite bags have been routinely made of polyvinyl chloride (PVC) film containing as plasticizer di-2-ethylhexyl phthalate (DEHP). Such a film composi-tion is currently the only government approved material for blood bags in a multiple bag system.
For some time, however, it has been known that considerable amounts of DEHP are leached from the walls of the blood bags by the plasma in the blood when blood or packed red cells are stored for long periods of time. There has been concern over the potentially harmful effects of DEHP on patients repeatedly infused with blood or blood components even though there appears to be no significant toxicity based on animal studies.
Consequently, numerous plastic formulations have been tested in an attempt to find acceptable material for blood bags which would be flexible, translucent, steam sterilizable and substantially free of leachable plasticizers. The material should also have properties which are not detrimental to the components of blood; for example, the material should not cause undue hemolysis of red cells or decrease the viability of platelets upon storage to levels which would be clinically unacceptable.
It was shown very early that the commercially available blood bags which were made of PVC plasticized with DEHP, were generally better than glass containers for the long term storage of blood. Strumia et al (J. Lab. and Clin. Med. 46, 225, 1955) o i,' 3~

demonstrated the hemolysis was less and post transfusion survival of red cells was improved for blood stored in these plastic bags. This inherent property of PVC bags plasticized with DEHP has contributed to this being the only material for blood bags which was and still is acceptable and approved by Government regulatory agencies. It has been theorized that this condition of decreased hemolysis of red cells is attributable to the DEHP which is extracted from the bag by the blood and that the DEHP inhibits hemolysis.
The present invention concerns a multiple blood bag system which combines the known advantageous features of presently used blood bags with respect to minimizing hemolysis of red blood cells and yet provides a system wherein some of the other blood components may be processed or stored with essentially no contamination with blood-extractable plasticizers.
The multiple blood bag system of the invention 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.
Advantageously, one of said bags is equipped with a blood collection tube. The first bag and second bag exhibit differing physical characteristics which are selectively beneficial to their functions. Suitably, the polymer entity of the first bag exhibits the characteristic of suppressing hemolysis of blood cells on long term storage. Suitably, the second bag comprises a transfer bag being made of a translucent, flexible, sterilizable material which is free of blood-extractable plasticizers and exhib-its 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.

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The physical characteristics of the second bag suitably include improved gas transmission characteristics for improved platelet survival.
In a particular further embodiment the -First bag is made of a translucent, flexible, sterilizable material and containing su-fficient di-2-ethylhexyl phthalate as plasticizer so as to suppress hemolysis of blood cells on long term storage therein; and the second bag is made of a polyvinyl chloride formulation which contains a trioctyl trimellitate as plasticizer, said second bag being translucent, flexible, sterilizable, and suitable for maintaining the viability of platelets stored therein for at least three days.
In a further particular embodiment the invention provides a multiple blood bag system comprising a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second contai.ner,-and conduit means providing sealed flow communication between said first container and said second container; the second physical characteris-tic particularly includes improved gas transmission characteristics for improved platelet survival. Generally, the second physical characteristic imparted by the second container material is beneficial to the storage of the blood component.
The second container material particularly includes a plasticizer other than a blood-extractable plasticizer employed in the first container material. In a particular embodiment the material of the second container may include a polyolefin or a polyester, or may be a vinyl chloride plastic essentially free of .~
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a blood-extractable plasticizer and in particular plasticized with a trioctyl trimellitate.
In a further particular embodiment there may be a plurality of second containers in communication through the conduit means with the first container, at least one of the second containers including a material which exhibits a higher carbon dioxide diffusion charac-teristic than the material of any other one of the containers.
The invention is illustrated in an especially preferred embodiment by reference to the accompanying drawing in which figure 1 illustrates schematically a multiple blood bag system of the invention.
With further reference to Figure 1, a multiple blood bag system 10 has a donor bag 12 joined to one or more satellite bags, in this case two satellite bags 18 and 20, by flexible tubiny 22 and a Y-connector 24. The donor and satellite bags may have one or more access ports 16 and donor bag 12 is equipped with a blood collection tube 14 leading to a donor needle (not shown). Fluid flow through tubing 22 from bag 12 is controlled by any conventional valving means 26.
The donor bag 12 was made from a conventional PVC formula-tion which contained about 28 percent by weight of DEHP as plasticizer.
It is contemplated that other PVC formulations could be used in which the DEHP content could vary between about 20 and about 40 percent by weight and provide donor bags suitable for their intended use. Both satellite bags were made from a PVC formulation which contained about 37 percent by weight of a trioctyl trimellitate as plasticizer. It is also contemplated that satellite bags made from PVC containing from about 30 to about 50 percent by weight of a trioctyl trimellitate would also be suitable for their intended use. As examples of acceptable isomers of the octyl moiety of this class of trimellitate esters, tri-isooctyl and tri-2-ethylhexyl trimellitate in PVC

formulations have been used. These satellite bags were Flexible, steam-sterilizable, transparent and substantially none of the plasticizer was extracted by blood stored therein for up to 21 days at about 5C. The PVC formulation which contains the trimellitate ester is suitable for maintaining the viability of platelets stored therein for at least three days. This was in sharp contrast to the donor bags where large amounts of DEHP plasticizer was extracted into blood stored therein under the same conditions. The amount of hemolysis of red blood cells in blood stored in the satellite bags was somewhat higher than that for blood stored in the donor bags.
As an example of how the multiple blood bag system of the invention was used, blood was collected from a donor into the donor bag of the type specifically described above which contained CPD
anticoagulant solution. Following centrifugation, the valving means was actuated and the plasma was expressed into one of the satellite bags (of the type described above, i.e., the PVC formulation contain-ing about 37 percent of tri-isooctyl trimellitate) where it was further centrifuged at an appropriate speed to cause the platelets to separate from the plasma. The platelet poor plasma was expressed into the second satellite bag and the platelets in about 50 ml. of plasma were gently agitated in the first satellite bag for three days. It was demonstrated that the arnount of viable platelets remaining at the end of this period was as good as that For platelets stored for the same period of time in PVC-DEHP plasticized bags of the type described for the donor bags.
In addition to PVC plasticized with a trioctyl trimellitate, bags were also made from certain polyesters, polyurethanes and poly-olefins such as polybutylene which would be suitable as satellite bags.

o The above has been presented for a further understanding of the invention and is not intended to limit the invention which is fully defined by the claims which follow.

Claims (22)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. The 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 bay in which said first bay 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 first bay and second bag exhibit differing physical characteristics which are selectively beneficial to their functions, and the polymer entity of the first bag exhibiting the characteristic of suppressing hemolysis of blood cells on long term storage, said second bag comprising a transfer bag 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.
2. 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 first bag being made of a translucent, flexible, sterilizable material and containing sufficient di-2-ethylhexyl phthalate as plasticizer so as to suppress hemolysis of blood cells on long term storage therein; said second bag being made of a polyvinyl chloride formulation which contains a trioctyl trimellitate as plasticizer, said second bag being translucent, flexible, sterilizable, and suitable for maintaining the viability of platelets stored therein for at least three days.
3. The multiple blood bag system of claim 2, where said trioctyl trimellitate is selected from the group consisting of tri-isooctyl trimellitate and tri-2-ethyl-hexyl trimellitate.
4. The multiple blood bag system of claim 3 in which the amount of tri-isooctyl or tri-2-ethylhexyl trimellitate present is about 30 to about 50 percent by weight.
5. The multiple blood bag system of claim 4 wherein the amount of tri-isooctyl or tri-2-ethylhexyl trimellitate present is about 37 percent by weight.
6. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, said second container is intended to receive a blood component from said first container, and wherein said second physical characteristic imparted by said second container material is beneficial to the storage of said blood component, and said second physical characteristic includes improved gas transmission characteristics for improved platelet survival.
7. A multiple blood bag system of claim 6, wherein said first physical characteristic imparted by said first container material includes the suppression of hemolysis of red cells during long term storage.
8. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, said first container material includes a blood-extractable plasticizer, and said second container material includes a plasticizer other than said blood-extractable plasticizer in said first container material.
9. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, said first physical characteristic imparted by said first container material includes the suppression of hemolysis of red cells during long term storage, said first container material includes a blood-extractable plasticizer, and said second container material includes a plasticizer other than said blood-extractable plasticizer in said first container material.
10. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, said second container is intended to receive a blood component from said first container, and wherein said second physical characteristic imparted by said second container material is beneficial to the storage of said blood component, said first container material includes a blood-extractable plasticizer, and said second container material includes a plasticizer other than said blood-extractable plasticizer in said first container material.
11. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, said material of said second container includes a polyolefin or a polyester or a polyurethane or a polyvinyl chloride plastic essentially free of a blood-extractable plasticizer.
12. A multiple blood bag system of claim 11, wherein said first physical characteristic imparted by said first container material includes the suppression of hemolysis of red cells during long term storage.
13. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, said second container is intended to receive a blood component from said first container, and wherein said second physical characteristic imparted by said second container material is beneficial to the storage of said blood component, and said material of said second container includes a polyolefin or a polyester or a polyurethane or a polyvinyl chloride plastic essentially free of a blood-extractable plasticizer.
14. A multiple blood bag system of claim 11, 12, or 13, wherein said polyvinyl chloride material of said second container is plasticized with tri-2-ethylhexyl trimellitate.
15. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, said second container is intended to receive a blood component from said first container, and wherein said second physical characteristic imparted by said second container material is beneficial to the storage of said blood component, and said second physical characteristic imparted by said material of said second container includes a relatively high carbon dioxide diffusion characteristic, whereby the pH of platelets stored in said second container is resistant to reduction.
16. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, wherein said first physical characteristic imparted by said first container material includes the suppression of hemolysis of red cells during long term storage, said second container is intended to receive a blood component from said first container, and wherein said second physical characteristic imparted by said second container material is beneficial to the storage of said blood component, and said second physical characteristic imparted by said material of said second container includes a relatively high carbon dioxide diffusion characteristic, whereby the pH of platelets stored in said second container is resistant to reduction.
17. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication between said first container and said second container, wherein a plurality of second containers are in communication through said conduit means with said first container, and at least one of said second containers includes a material which exhibits a higher carbon dioxide diffusion characteristic than the material of any other one of said containers.
18. A multiple blood bag system comprising: a first container intended to receive blood from a donor, at least a portion of which container includes a material which imparts a predetermined first physical characteristic which is beneficial to the storage of blood in said first container, a second container including a material which imparts a predetermined second physical characteristic which is different than said first physical characteristic and which is beneficial to the intended function of said second container, and conduit means providing sealed flow communication bteween said first container and said second container, wherein said first physical characteristic imparted by said first container material includes the suppression of hemolysis of red cells during long term storage, wherein a plurality of second containers are in communication through said conduit means with said first container, and at least one of said second containers includes a material which exhibits a higher carbon dioxide diffusion characteristic than the material of any other one of said containers.
19. A multiple blood bay system of claim 11 or 13 wherein said material of said second container includes a polyolefin.
20. A multiple blood bag system of claim 11 or 13 wherein said material of said second container includes a polyester.
21. A multiple blood bag system of claim 11 or 13 wherein said material of said second container includes a polyurethane.
22. A mutliple blood bag system of claim 11 or 13 wherein said material of said second container includes a polyvinyl chloride plastic essentially free of a blood extractable plasticizer.
CA000379021A 1981-03-27 1981-06-04 Multiple blood bag system Expired CA1231280A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24808481A 1981-03-27 1981-03-27
US248,084 1981-03-27

Publications (1)

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CA1231280A true CA1231280A (en) 1988-01-12

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0420757A2 (en) * 1989-09-27 1991-04-03 Terumo Kabushiki Kaisha Multiple blood bag system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0420757A2 (en) * 1989-09-27 1991-04-03 Terumo Kabushiki Kaisha Multiple blood bag system
EP0420757A3 (en) * 1989-09-27 1991-05-02 Terumo Kabushiki Kaisha Multiple blood bag system

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