US3257072A - Whole blood storage structure - Google Patents

Whole blood storage structure Download PDF

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US3257072A
US3257072A US249942A US24994263A US3257072A US 3257072 A US3257072 A US 3257072A US 249942 A US249942 A US 249942A US 24994263 A US24994263 A US 24994263A US 3257072 A US3257072 A US 3257072A
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bag
blood
passage
container
whole blood
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Martin M Reynolds
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Cryogenic Engineering Co
BankBoston NA
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Cryogenic Engineering Co
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    • 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
    • A61M1/029Separating blood components present in distinct layers in a container, not otherwise provided for
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00Fluid handling
    • Y10T137/4673Plural tanks or compartments with parallel flow

Definitions

  • the plasma and the glucose-red cells mixture are thawed in a 37 C. water bath. After thawing, the major portion of the glucose is separated from the red cells by spinning in a centrifuge for three I minutes and then decanting. The original whole blood is then reconstituted by adding its thawed plasma and is ready for use in the human body.
  • Another object of my invention is to provide a simple, durable and sterile container for storage and processing of whole bloodwhich is transparent or translucent and permits visual inspection of its contents at all times, and which is of such low cost as to be treated as a disposable item.
  • a further object of the invention is to provide a multiple compartment container for whole blood storage and processing which is sterile and permits transfer of whole blood components and compatible solution as required for cryogenic storage and for later reconstituting, and which is formed of clear material permitting visual inspection of its contents at all times to and including introduction of the reconstituted blood into a patent.
  • Still another object of the invention is to provide a system of using a multiple compartment sterile container in the cryogenic storage and subsequent reconstituting of whole blood which prevents any accidental mixing of separated plasma and red cells from different blood in the reconstituting procedure.
  • FIG. 1 is a front elevation of a container being used in the processing and storage of whole blood withpassage-sealing members shown in dash lines;
  • FIG. 2. is a section taken approximately on the line 2-2, FIG. 1, with clamping members shown in operating relation to other structure; and 7 FIG. 3 is a developed section taken a roximately along the line 33, FIG. 1, and showing the position of contents at a different stage of the processing than depicted in FIG. 2.
  • the container 5 is formed as a circumferentially closed bag-like member of a clear ma terial, such as Teflon FEP fluorinated ethylene propylene, which will permit heat sealing and is clear for visual inspection, possesses the desired mechanical strength, clinically acceptable, and is flexible at liquid nitrogen temperature.
  • a clear ma terial such as Teflon FEP fluorinated ethylene propylene
  • a passage 10 is provided in partition 6 to permit exchange of stored material between compartments 7 and 8 and a similar passage 11 permits interchange of stored material between compartments 7 and 9.
  • Each of the passages 10 and 11 may be selectively closed and secured against interchange of material :by a pinch-type device indicated by the dash lines 12.
  • a headed passage 13 into compartment 7 permits introduction into and withdrawal of material from container 5 and a valve 14 which may be a clamping device is accessible from the outside of the container and effectively seals the entrance passage 13 except during introduction and withdrawal of material.
  • a measured quantity of isotonic saline glucose solution is introduced through opening 13 with passage 11 open and the bag disposed with the opening 13 at its top.
  • the charge to chamber 7 is directed through passage 11 into compartment 9 and when the complete charge is disposed therein, the clamp 12 is applied to close passage 11 and prevent interchange of material between compartments 7 and 9.
  • a measured quantity of Whole blood is next introduced through passage 13 and when the entire charge is confined, the clamping member 14 is secured to complete the hermetic circumferential seal of container 5.
  • Container 5 is next disposed in the position shown in FIG. 1 and is centrifuged for 3 minutes. After removal from The interior of the bag is partitioned-as the centrifuging operation, the red cells are collected in the bottom in a distinct layer separated from the plasma which stands above such cells.
  • a clamping member 15 is then applied to the exterior of bag 5 along the lines of such separation and exerts suflicient force to completely separate blood cells from the plasma.
  • the clamping member securing passage is then removed and the plasma is directed to flow through passage It) and fill compartment 8.
  • the clamping member is again actuated to seal passage 10, after which clamping member is removed and the clamping member 12 securing passage 11 also is removed to permit outflow of the solution from compartment 9 into compartment 7 where it mixes with the red cells confined therein.
  • the container 5 is then frozen in liquid nitrogen or cold nitrogen gas, and the portion of the bag containing the red cells will be restrained into a physical shape to have a thickness of 2 /2 centimeters more or less for proper freezing.
  • the stored plasma in compartment 8 also is frozen to liquid nitrogen temperature and the plasma and red cells glucose solution may be stored at such temperatures for long periods without deterioration.
  • the entire unit will be thawed in a warm water bath accompanied by agitation until the contents resume the liquid form.
  • the unit is centrifuged again for 3 minutes to separate the glucose layer from the red cells.
  • Clamping member 15 is affixed along the line of separation and passage 11 is opened to permit outflow of the solution into compartment 9.
  • clamp 12 is applied to close passage 11 and the other clamp 12 is removed to open passage 10, permitting the plasma to descend into the compartment 7 and reconstitute the wholev blood.
  • the blood is ready for use and the container 5 may be transported to the site of use and hung in the usual manner for withdrawal of the blood in treating a patient. Because of its relatively low cost, container 5 may be treated as a disposable item and disposed of when the whole blood charge is withdrawn.
  • the container 5 as described above affords several advantages.
  • the blood is collected and processed in one hermetically sealed unit and the red cells of the blood are never separated from its own plasma except within the confines of the container, thus avoiding any possible mixing of cells from one source with plasma from another source.
  • the provision of a clear container permits visual observation of contents at all stages of the processing and during the final withdrawal of the reconstituted blood from the container, as during a transfusion.
  • Teflon material in forming the bag meets all required criteria including the maintenance of sterile conditions, hermetical sealing after blood is placed in the container and adequate heat transfer during the freezing and thawing procedures. It possesses the requisitemechanical strength to withstand the centrifuging procedure and is compatible with blood and liquid nitrogen. Teflon is resistant to heat and can be sterilized. Two forms of Teflon are available commercially and suited for use in the practice of my invention. Teflon TFE is polytetrafluoroethylene, also sold as Halon TFE. The other sold under the name Teflon FEP is fluorinated ethylene propylene, a copolymer of TFE and hexafluoropropylene.
  • partitioning arrangement providing a three compartment bag
  • partitioning arrangement may be modified to provide any plurality of compartments required in such procedures and to maintain the contents of such compartments under sterile hermetically sealed condition as required.
  • a container for the treatment and storage of whole blood comprising a flexible bag of translucent composition sterilized after fabrication and. having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for selective introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one liquid-sealing partition dividing the interior of the "bag into a plurality of treatment compartments, a passage in said partition for selective exchange of stored material between compartments, and means exteriorly of the bag for closing said passage by forcing opposite sides of the bag into sealing engagement in said passage, and said bag being characterized by:
  • a container for the treatment and storage of whole blood comprising a flexible bag of a translucent composition selected from the group consisting of polytetrafluoroethylene and fiuorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for selective introduction and withdrawal of fluent material including a measured quantity of blood .at the beginning and end of a storage period, at least one horizontal partition dividing the interior of the bag into at least one upper and one lower treatment compartment, a passage in said compartment for selective exchange of stored material between adjoining upper and lower compartments, and means exteriorly of the bag for closing said passage by forcing opposite sides of the bag into sealing engagement in said passage, and said bag being characterized by:
  • a container for the treatment and storage of whole blood comprising a flexible bag of a translucent compositlon selected from the group consisting of polytetrafluoroethylene and fluorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for SBIGCUVC introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one vertical partition dividing the interior of the bag into adjoining treatment compartments, a passage in one wall of each compartment for selective exchange of stored material between said compartments and an adjoining interior portion of the bag, and means exteriorly of the bag for closing said pas- (e) being flexible at all temperatures in a range from ambient to the temperature of liquid nitrogen.
  • a container for the treatment and storage of whole blood comprising a flexible bag of a translucent composition selected from the group consisting of polytetrafluoroethylene and fluorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for selective introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one horizontal partition between opposed sides of the bag, a vertical partition extending from the horizontal partition to an outer edge of the bag, said partitions dividing the interior of the bag into an elongated material receiving compartment and two smaller exchange compartments, a passage at each end of the horizontal partition for selective exchange of stored material between the receiving compartment and an adjoining exchange compartment, and means exteriorly of the bag for closing said passage by forcing opposite sides of the bag into sealing engagement in said passage, and said bag being characterized by:
  • a container for the treatment and storage of whole blood comprising a flexible bag of a translucent composition selected from the group consisting of polytetrafluoroethylene and fluorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means on the outside of the bag for selective introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one horizontal partition between opposed sides of the bag, a vertical partition extending from the horizontal partition to an outer edge of the bag, said partitions dividing the interior of the bag into an elongated material receiving compartment and two smaller exchange compartments, a passage at each end of the horizontal partition for selective exchange of stored material between the receiving compartment and an adjoining exchange compartment, means exteriorly of the bag for closing said passages by forcing opposite sides of the bag into sealing engagement in each said passage, pinch-type clamping means disposed on the exterior of the receiving compartment throughout its lengthwise extent for selective segregation of its contents according to

Description

June 21, 1966 M. M. REYNOLDS 3,
WHOLE BLOOD STORAGE STRUCTURE Filed Jan. 7, 1963 5 2 I I I K5 ii iyz l 15 ,I'ZZIIZZZIIIIIZI:2:12:12:
m w J Ti J P I g 03 INVENTOR.
Marfin M. Reynolds ATTORNEYS United States Patent 3,257,072 I WHOLE BLOOD STORAGE STRUCTURE Martin M. Reynolds, Denver, Colo., assignor to Cryogenie Engineering Company, Denver, Colo., a corporation of Colorado Filed Jan. 7, 1963, Ser. No. 249,942 Claims. (Cl. 23326) This invention relates to a method and means for storage of whole blood and has particular application to a novel type of multiple compartment clear container used in blood storage.
Until quite recently the accepted practice for storage and use of whole blood in this country has been to collect whole blood and store it at temperatures of about 38 F. It has been found that the blood cells break down at the rate' of about 1 percent per day and by the time 20 percent of the blood cells are hemolyzed, use of the stored blood in the human body may be dangerous. Consequently, a three week limit has been placed on the retention of whole blood under these conditions.
There has been a recent development of a clinically acceptable system for whole blood storage which permits the blood to be stored for relatively long periods without breakdown of the cells and which may be reconstituted at any time for safe use in the hurrnan body. This system involves introducing the whole blood into a container and centrifuging it for about 3 minutes. This serves to separate the red cells from-plasma and they are then moved to separate stonage areas. An isotonic saline citrated glucose solution is next added to the red cells to result in a 15 percent glucose solution. The separated plasma and the glucose-red cells mixture are then frozen separately and stored at liquid nitrogen temperature.
When it is desired to take the frozen blood for use in the human body, the plasma and the glucose-red cells mixture are thawed in a 37 C. water bath. After thawing, the major portion of the glucose is separated from the red cells by spinning in a centrifuge for three I minutes and then decanting. The original whole blood is then reconstituted by adding its thawed plasma and is ready for use in the human body.
One of the chief difficulties in the new storage system is the care that must be exercised to prevent contamination of the red cells or the plasma while separated and to insure the same red cell-plasma mixture being brought together in the reconstituting procedure.
Accordingly, it is an object of this invention to provide a storage container for whole blood which permits minimum handling to maintain sterility and keep out pyrogens, which is capable of being sterilized, which provides proper heat transfer during freezing and thawing operations, which has adequate mechanical strength to withstand the centrifuging operations, which is compatible with blood and liquid nitrogen and which confines the blood from the time of initial introduction until Withdrawal after reconstituting for use in the human body while permitting the specified separations within its hermetically sealed interior.
Another object of my invention is to provide a simple, durable and sterile container for storage and processing of whole bloodwhich is transparent or translucent and permits visual inspection of its contents at all times, and which is of such low cost as to be treated as a disposable item.
3,257,072 Patented June 21, 1966 A further object of the invention is to provide a multiple compartment container for whole blood storage and processing which is sterile and permits transfer of whole blood components and compatible solution as required for cryogenic storage and for later reconstituting, and which is formed of clear material permitting visual inspection of its contents at all times to and including introduction of the reconstituted blood into a patent.
Still another object of the invention is to provide a system of using a multiple compartment sterile container in the cryogenic storage and subsequent reconstituting of whole blood which prevents any accidental mixing of separated plasma and red cells from different blood in the reconstituting procedure.
Other objects reside in novel details of construction and novel combinations and arrangements of parts, all of which will be set forth in detail in the course of the following description.
The practice of my invention will be described with reference to the drawings illustrating one form of container embodying features of the invention. In the drawings, in the several views of which like parts bear similar reference numerals,
FIG. 1 is a front elevation of a container being used in the processing and storage of whole blood withpassage-sealing members shown in dash lines;
FIG. 2. is a section taken approximately on the line 2-2, FIG. 1, with clamping members shown in operating relation to other structure; and 7 FIG. 3 is a developed section taken a roximately along the line 33, FIG. 1, and showing the position of contents at a different stage of the processing than depicted in FIG. 2.
As shown in FIG. 1, the container 5 is formed as a circumferentially closed bag-like member of a clear ma terial, such as Teflon FEP fluorinated ethylene propylene, which will permit heat sealing and is clear for visual inspection, possesses the desired mechanical strength, clinically acceptable, and is flexible at liquid nitrogen temperature. shown at 6 and 6' by heat sealing, forming a larger blood storage chamber 7 and smaller storage containers 8 and 9, the functioning of which'will be described subsequently.
A passage 10 is provided in partition 6 to permit exchange of stored material between compartments 7 and 8 and a similar passage 11 permits interchange of stored material between compartments 7 and 9. Each of the passages 10 and 11 may be selectively closed and secured against interchange of material :by a pinch-type device indicated by the dash lines 12. A headed passage 13 into compartment 7 permits introduction into and withdrawal of material from container 5 and a valve 14 which may be a clamping device is accessible from the outside of the container and effectively seals the entrance passage 13 except during introduction and withdrawal of material.
At the beginning of a given operation, a measured quantity of isotonic saline glucose solution is introduced through opening 13 with passage 11 open and the bag disposed with the opening 13 at its top. The charge to chamber 7 is directed through passage 11 into compartment 9 and when the complete charge is disposed therein, the clamp 12 is applied to close passage 11 and prevent interchange of material between compartments 7 and 9.
A measured quantity of Whole blood is next introduced through passage 13 and when the entire charge is confined, the clamping member 14 is secured to complete the hermetic circumferential seal of container 5. Container 5 is next disposed in the position shown in FIG. 1 and is centrifuged for 3 minutes. After removal from The interior of the bag is partitioned-as the centrifuging operation, the red cells are collected in the bottom in a distinct layer separated from the plasma which stands above such cells. A clamping member 15 is then applied to the exterior of bag 5 along the lines of such separation and exerts suflicient force to completely separate blood cells from the plasma. The clamping member securing passage is then removed and the plasma is directed to flow through passage It) and fill compartment 8. When all of the plasma has been removed in this manner, the clamping member is again actuated to seal passage 10, after which clamping member is removed and the clamping member 12 securing passage 11 also is removed to permit outflow of the solution from compartment 9 into compartment 7 where it mixes with the red cells confined therein. The container 5 is then frozen in liquid nitrogen or cold nitrogen gas, and the portion of the bag containing the red cells will be restrained into a physical shape to have a thickness of 2 /2 centimeters more or less for proper freezing. In this same action, the stored plasma in compartment 8 also is frozen to liquid nitrogen temperature and the plasma and red cells glucose solution may be stored at such temperatures for long periods without deterioration.
After such a storage period when it is desired to use the stored contents, the entire unit will be thawed in a warm water bath accompanied by agitation until the contents resume the liquid form. At this time, the unit is centrifuged again for 3 minutes to separate the glucose layer from the red cells. Clamping member 15 is affixed along the line of separation and passage 11 is opened to permit outflow of the solution into compartment 9. When the entire solution charge is confined therein, clamp 12 is applied to close passage 11 and the other clamp 12 is removed to open passage 10, permitting the plasma to descend into the compartment 7 and reconstitute the wholev blood. At this stage, the blood is ready for use and the container 5 may be transported to the site of use and hung in the usual manner for withdrawal of the blood in treating a patient. Because of its relatively low cost, container 5 may be treated as a disposable item and disposed of when the whole blood charge is withdrawn.
Use of the container 5 as described above affords several advantages. The blood is collected and processed in one hermetically sealed unit and the red cells of the blood are never separated from its own plasma except within the confines of the container, thus avoiding any possible mixing of cells from one source with plasma from another source. The provision of a clear container permits visual observation of contents at all stages of the processing and during the final withdrawal of the reconstituted blood from the container, as during a transfusion.
The utilization of the Teflon material in forming the bag meets all required criteria including the maintenance of sterile conditions, hermetical sealing after blood is placed in the container and adequate heat transfer during the freezing and thawing procedures. It possesses the requisitemechanical strength to withstand the centrifuging procedure and is compatible with blood and liquid nitrogen. Teflon is resistant to heat and can be sterilized. Two forms of Teflon are available commercially and suited for use in the practice of my invention. Teflon TFE is polytetrafluoroethylene, also sold as Halon TFE. The other sold under the name Teflon FEP is fluorinated ethylene propylene, a copolymer of TFE and hexafluoropropylene.
By utilizing such a container in conjunction with the newly developed blood storage system, it is possible to safely store whole blood for long indefinite periods and to reconstitute it with original qualities and characteristics when it is to be used. The mixing of the red cells and glucose solution has been adequately tested and is an accepted method for preparing red cells for long period storage at liquid nitrogen temperatures.
While I have shown a partitioning arrangement provid ing a three compartment bag, it will be understood that the partitioning arrangement may be modified to provide any plurality of compartments required in such procedures and to maintain the contents of such compartments under sterile hermetically sealed condition as required. I have also indicated a preferred material for use in forming the container of the present invention, but it will be understood that any material possessing equivalent properties and characteristics may be used for this purpose.
I claim:
1. A container for the treatment and storage of whole blood, comprising a flexible bag of translucent composition sterilized after fabrication and. having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for selective introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one liquid-sealing partition dividing the interior of the "bag into a plurality of treatment compartments, a passage in said partition for selective exchange of stored material between compartments, and means exteriorly of the bag for closing said passage by forcing opposite sides of the bag into sealing engagement in said passage, and said bag being characterized by:
(a) its ability to withstand centrifugal forces of centrifuging,
(b) maintaining sterility of its contents,
(0) providing proper heat transfer in freezing and thawing operations,
(d) being compatible with blood and liquid nitrogen,
and
(e) being flexible at all temperatures in a range from ambient to the temperature of liquid nitrogen.
2. A container for the treatment and storage of whole blood, comprising a flexible bag of a translucent composition selected from the group consisting of polytetrafluoroethylene and fiuorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for selective introduction and withdrawal of fluent material including a measured quantity of blood .at the beginning and end of a storage period, at least one horizontal partition dividing the interior of the bag into at least one upper and one lower treatment compartment, a passage in said compartment for selective exchange of stored material between adjoining upper and lower compartments, and means exteriorly of the bag for closing said passage by forcing opposite sides of the bag into sealing engagement in said passage, and said bag being characterized by:
(a) its ability to Withstand centrifugal forces of centrifuging,
(b) maintaining sterility of its contents,
(0) providing proper heat transfer in freezing and thawing operations,
(d) going compatible with blood and liquid nitrogen,
(e) being flexible at all temperatures in a range from ambient to the temperature of liquid nitrogen.
3. A container for the treatment and storage of whole blood, comprising a flexible bag of a translucent compositlon selected from the group consisting of polytetrafluoroethylene and fluorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for SBIGCUVC introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one vertical partition dividing the interior of the bag into adjoining treatment compartments, a passage in one wall of each compartment for selective exchange of stored material between said compartments and an adjoining interior portion of the bag, and means exteriorly of the bag for closing said pas- (e) being flexible at all temperatures in a range from ambient to the temperature of liquid nitrogen.
4. A container for the treatment and storage of whole blood, comprising a flexible bag of a translucent composition selected from the group consisting of polytetrafluoroethylene and fluorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means for selective introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one horizontal partition between opposed sides of the bag, a vertical partition extending from the horizontal partition to an outer edge of the bag, said partitions dividing the interior of the bag into an elongated material receiving compartment and two smaller exchange compartments, a passage at each end of the horizontal partition for selective exchange of stored material between the receiving compartment and an adjoining exchange compartment, and means exteriorly of the bag for closing said passage by forcing opposite sides of the bag into sealing engagement in said passage, and said bag being characterized by:
(a) its ability to withstand centrifugal forces of centrifuging,
(b) maintaining sterility of its contents,
(c) providing proper heat transfer in freezing and thawing operations,
(d) being compatible with blood and liquid nitrogen,
and
(e) being flexible at all temperatures in a range from ambient to the temperature of liquid nitrogen.
5. A container for the treatment and storage of whole blood, comprising a flexible bag of a translucent composition selected from the group consisting of polytetrafluoroethylene and fluorinated ethylene propylene, said composition being sterilized after fabrication and having a circumferential enclosure providing a hermetic seal for the contents of the container, valve-controlled means on the outside of the bag for selective introduction and withdrawal of fluent material including a measured quantity of blood at the beginning and end of a storage period, at least one horizontal partition between opposed sides of the bag, a vertical partition extending from the horizontal partition to an outer edge of the bag, said partitions dividing the interior of the bag into an elongated material receiving compartment and two smaller exchange compartments, a passage at each end of the horizontal partition for selective exchange of stored material between the receiving compartment and an adjoining exchange compartment, means exteriorly of the bag for closing said passages by forcing opposite sides of the bag into sealing engagement in each said passage, pinch-type clamping means disposed on the exterior of the receiving compartment throughout its lengthwise extent for selective segregation of its contents according to composition, and said bag being characterized by:
(a) its ability to withstand centrifugal forces of centrifuging, (b) maintaining sterility of its contents, (c) providing proper heat transfer in freezing and thawing operations, ((1) being compatible with blood and liquid nitrogen,
and (e) being flexible at all temperatures in range from ambient to the temperature of liquid nitrogen.
References Cited by the Examiner UNITED STATES PATENTS 2,437,518 3/ 1948 Groenwall et al. 167-78 2,695,614 11/1954 Lockhart 128-272 2,753,990 7/1956 Chalfin et al 206-47 2,808,829 10/1957 Butler 128-272 2,833,691 5/1958 Klaas et al. 167-78 2,838,046 6/1958 Butler 128-272 2,893,547 7/ 1959 Earl et al 206-47 3,064,647 11/1962 Earl.
3,064,802 11/1962 Jess et a1. 206-47 3,082,867 3/1963 Gelpey 206-47 M. CARY NELSON, Primary Examiner.
EARL J. DRUM'MOND, Examiner.
J. CASKIE, H. KLI'NK'SIEK, Assistant Examiners.

Claims (1)

1. A CONTAINER FOR THE TREATMENT AND STORAGE OF WHOLE BLOOD, COMPRISING A FLEXIBLE BAG OF TRANSLUCENT COMPOSITION STERILIZED AFTER FABRICATION AND HAVING A CIRCUMFERENTIALL ENCLOSURE PROVIDING A HERMETIC SEAL FOR THE CONTENTS OF THE CONTAINER, VALVE-CONTROLLED MEANS FOR SELECTIVE INTRODUCTION AND WITHDRAWAL OF FLUENT MATERIAL INCLUDING A MEASURED QUANTITY OF BLOOD AT THE BEGINNING AND END OF A STORAGE PERIOD, AT LEAST ONE LIQUID-SEALING PARTITION DIVIDING THE INTERIOR OF THE BAG INTO A PLURALITYL OF TREATMENT COMPARTMENTS, A PASSAGE IN SAID PARTITION FOR SELECTIVE EXCHANGE OF STORED MATERIAL BETWEEN COMPARTMENTS, AND MEANS EXTERIORLY OF THE BAG FOR CLOSING SAID PASSAGE BY FORCING OPPOSITE SIDES OF THE BAG INTO SEALING ENGAGEMENT IN SAID PASSAGE, AND SAID BAG BEING CHARACTERIZED BY: (A) ITS ABILITY TO WITHSTAND CENTRIFUGAL FORCES OF CENTRIFUGING, (B) MAINTAINING STERILITY OF ITS CONTENTS, (C) PROVIDING PROPER HEAT TRANSFERE IN FREEZING AND THAWING OPERATIONS, (D) BEING COMPATIBLE WITH BLOOD AND LIQUID NITROGEN, AND (E) BEING FLEXIBLE AT ALL TEMPERATURES IN A RANGE FROM AMBIENT TO THE TEMPERATURE OF LIQUID NITROGEN.
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Cited By (59)

* Cited by examiner, † Cited by third party
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US3521454A (en) * 1968-10-17 1970-07-21 Foundation Sciences Inc Bearing pad and method of preparing
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US3809224A (en) * 1972-02-14 1974-05-07 D Greenwood Compartmented pouch
US3847279A (en) * 1969-11-20 1974-11-12 American Cyanamid Co Package for plural reactable components with rupturable ultrasonic seal
US3911918A (en) * 1972-04-13 1975-10-14 Ralph D Turner Blood collection, storage and administering bag
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FR2389383A1 (en) * 1977-05-04 1978-12-01 Johnson & Johnson
WO1981003275A1 (en) * 1980-05-12 1981-11-26 Pennwalt Corp Article for storage and transport of biogenic fluids
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EP0069247A1 (en) * 1981-07-03 1983-01-12 Gambro Lundia AB An apparatus for measuring the concentration of a low-molecular compound in a complex medium, especially whole blood
US4403992A (en) * 1980-10-06 1983-09-13 Sis-Ter S.P.A. Continuous peritoneal dialysis bag device
WO1984002091A1 (en) * 1982-11-26 1984-06-07 Seroteknik Hb Method and apparatus for centrifugal batch separation of blood
US4545481A (en) * 1983-04-19 1985-10-08 Marvin Elkins Stencilling device
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US5176634A (en) * 1990-08-02 1993-01-05 Mcgaw, Inc. Flexible multiple compartment drug container
US5257985A (en) * 1989-12-04 1993-11-02 Richard Puhl Multi-chamber intravenous bag apparatus
WO1993021892A1 (en) * 1992-04-23 1993-11-11 Seroteknik Hb System and method for centrifugal separation of two or more fractions from a composite liquid, and a bag intended therefor
WO1994011086A1 (en) * 1992-11-06 1994-05-26 Baxter International Inc. Method for filtering a body fluid using rinse chamber bag
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US20060084178A1 (en) * 2004-10-15 2006-04-20 Peyton Barbara M Trace ammonia colorimetric test apparatus
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Cited By (103)

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US3521454A (en) * 1968-10-17 1970-07-21 Foundation Sciences Inc Bearing pad and method of preparing
US3660033A (en) * 1969-09-29 1972-05-02 Leroy L Schwartz Disposable specimen collection and analysis bag
US3847279A (en) * 1969-11-20 1974-11-12 American Cyanamid Co Package for plural reactable components with rupturable ultrasonic seal
US3809224A (en) * 1972-02-14 1974-05-07 D Greenwood Compartmented pouch
US3911918A (en) * 1972-04-13 1975-10-14 Ralph D Turner Blood collection, storage and administering bag
US4051804A (en) * 1976-03-01 1977-10-04 Garnett-Mckeen Chemical Corporation Thaw-indicator device
FR2389383A1 (en) * 1977-05-04 1978-12-01 Johnson & Johnson
US4235233A (en) * 1977-05-04 1980-11-25 Johnson & Johnson Bag for collecting, storing and administering including filtering blood, blood components, intravenous fluids and similar fluids
US4346710A (en) * 1978-06-16 1982-08-31 Pennwalt Corporation Article for storage and transport of biogenic fluids
WO1981003275A1 (en) * 1980-05-12 1981-11-26 Pennwalt Corp Article for storage and transport of biogenic fluids
US4403992A (en) * 1980-10-06 1983-09-13 Sis-Ter S.P.A. Continuous peritoneal dialysis bag device
FR2497724A1 (en) * 1981-01-09 1982-07-16 Anatros Corp METHOD AND APPARATUS FOR FORMING A PLASTIC ENCLOSURE FOR CONTAINING FLUIDS AND COMPRISING INTERIOR COMPARTMENTS CONNECTED THEREBY BETWEEN THEM
US4548023A (en) * 1981-01-09 1985-10-22 Anatros Corporation Method and apparatus for forming a plastic enclosure for fluids with selectively interconnectable internal compartments
EP0069247A1 (en) * 1981-07-03 1983-01-12 Gambro Lundia AB An apparatus for measuring the concentration of a low-molecular compound in a complex medium, especially whole blood
WO1984002091A1 (en) * 1982-11-26 1984-06-07 Seroteknik Hb Method and apparatus for centrifugal batch separation of blood
US4617009A (en) * 1982-11-26 1986-10-14 Seroteknik Hg Method and apparatus for centrifugal batch separation of blood
US4545481A (en) * 1983-04-19 1985-10-08 Marvin Elkins Stencilling device
US4602910A (en) * 1984-02-28 1986-07-29 Larkin Mark E Compartmented flexible solution container
EP0167955A2 (en) * 1984-07-13 1986-01-15 Miles Inc. Plasma bags
EP0167955A3 (en) * 1984-07-13 1987-06-16 Miles Laboratories, Inc. Plasma bags
US4731053A (en) * 1986-12-23 1988-03-15 Merck & Co., Inc. Container device for separately storing and mixing two ingredients
EP0272864A2 (en) * 1986-12-23 1988-06-29 Merck & Co. Inc. Container device for separately storing and mixing two ingredients
EP0272864A3 (en) * 1986-12-23 1988-09-07 Merck & Co. Inc. Container device for separately storing and mixing two ingredients
WO1990010690A1 (en) * 1989-03-10 1990-09-20 Baxter International Inc. Method and apparatus for in vitro reproduction and growth of cells in culture medium
US5017490A (en) * 1989-03-10 1991-05-21 Baxter International Inc. Method for in vitro reproduction and growth of cells in culture medium
US4994056A (en) * 1989-11-09 1991-02-19 Ikeda Daniel P Unit dose medicament storing and mixing system
US5257985A (en) * 1989-12-04 1993-11-02 Richard Puhl Multi-chamber intravenous bag apparatus
US5394907A (en) * 1990-07-19 1995-03-07 Pharmacia Ab Device and method for dosing a liquid product
US5176634A (en) * 1990-08-02 1993-01-05 Mcgaw, Inc. Flexible multiple compartment drug container
WO1993021892A1 (en) * 1992-04-23 1993-11-11 Seroteknik Hb System and method for centrifugal separation of two or more fractions from a composite liquid, and a bag intended therefor
WO1994011086A1 (en) * 1992-11-06 1994-05-26 Baxter International Inc. Method for filtering a body fluid using rinse chamber bag
AU665140B2 (en) * 1992-11-06 1995-12-14 Baxter International Inc. Method for filtering a body fluid using rinse chamber bag
US5316681A (en) * 1992-11-06 1994-05-31 Baxter International Inc. Method of filtering body fluid using a rinse chamber bag
EP0708674A4 (en) * 1994-05-11 1998-10-28 Baxter Int Blood collection system
EP0708674A1 (en) * 1994-05-11 1996-05-01 Baxter International Inc. Blood collection system
US7169547B2 (en) 1994-12-05 2007-01-30 New York Blood Center, Inc. High concentration white blood cells as a therapeutic product
US6491678B1 (en) * 1994-12-05 2002-12-10 New York Blood Center, Inc. Freezer bag
US20070179424A1 (en) * 1994-12-05 2007-08-02 Pablo Rubinstein High concentration white cells, a method for agglomeration of the high concentration and a bag set for use in conjunction therewith
US6468377B1 (en) 1996-05-13 2002-10-22 B. Braun Medical Inc. Flexible medical container with selectively enlargeable compartments and method for making same
US6996951B2 (en) 1996-05-13 2006-02-14 B. Braun Medical Inc. Flexible multi-compartment container with peelable seals and method for making same
US20040068960A1 (en) * 1996-05-13 2004-04-15 Smith Steven L. Flexible multi-compartment container with peelable seals and method for making same
US6165161A (en) * 1996-05-13 2000-12-26 B. Braun Medical, Inc. Sacrificial port for filling flexible, multiple-compartment drug container
US6198106B1 (en) 1996-05-13 2001-03-06 B. Braun Medical, Inc. Transport and sterilization carrier for flexible, multiple compartment drug container
US6203535B1 (en) 1996-05-13 2001-03-20 B. Braun Medical, Inc. Method of making and using a flexible, multiple-compartment drug container
US5910138A (en) * 1996-05-13 1999-06-08 B. Braun Medical, Inc. Flexible medical container with selectively enlargeable compartments and method for making same
US5944709A (en) * 1996-05-13 1999-08-31 B. Braun Medical, Inc. Flexible, multiple-compartment drug container and method of making and using same
US20030000632A1 (en) * 1996-05-13 2003-01-02 Sperko William A. Flexible medical container with selectively enlargeable compartments and method for making same
US6764567B2 (en) 1996-05-13 2004-07-20 B. Braun Medical Flexible medical container with selectively enlargeable compartments and method for making same
US5928213A (en) * 1996-05-13 1999-07-27 B. Braun Medical, Inc. Flexible multiple compartment medical container with preferentially rupturable seals
US6846305B2 (en) 1996-05-13 2005-01-25 B. Braun Medical Inc. Flexible multi-compartment container with peelable seals and method for making same
WO1998007828A1 (en) * 1996-08-16 1998-02-26 Roche Diagnostics Gmbh Device with a reaction bag for multi-step culturing/separation operations and/or reactions in several steps
US6186998B1 (en) * 1997-12-09 2001-02-13 Hosokawa Yoko Co., Ltd. Bag for infusion solution and method of manufacturing same
WO2000000242A3 (en) * 1998-06-29 2000-02-24 Orbon Corp Drug dispenser
US6123696A (en) * 1998-07-16 2000-09-26 Thermogenesis Corp. Centrifugation bag with yieldable partitions
US7678097B1 (en) 1999-11-12 2010-03-16 Baxter International Inc. Containers and methods for manufacturing same
US20070144923A1 (en) * 1999-11-12 2007-06-28 Vincent Houwaert Peelable seal closure assembly
US7770611B2 (en) 1999-11-12 2010-08-10 Baxter International Inc. Peelable seal closure assembly
US20040065679A1 (en) * 2000-11-13 2004-04-08 Marc Peuker Device for storing and dispensing flowable compositions
US7097075B2 (en) * 2000-11-13 2006-08-29 3M Espe Ag Device for storing and dispensing flowable compositions
US6769231B2 (en) 2001-07-19 2004-08-03 Baxter International, Inc. Apparatus, method and flexible bag for use in manufacturing
US20030017066A1 (en) * 2001-07-19 2003-01-23 Baxter International Inc. Apparatus, flexible bag and method for dispensing
US20040007588A1 (en) * 2001-07-19 2004-01-15 Baxter International Inc. Flexible bag for use in manufacturing
US20040094573A1 (en) * 2001-07-19 2004-05-20 Baxter International Inc. Flow control apparatus for use in dispensing fluent material
US6905314B2 (en) 2001-10-16 2005-06-14 Baxter International Inc. Pump having flexible liner and compounding apparatus having such a pump
US7546918B2 (en) 2002-10-17 2009-06-16 Baxter International Inc. Peelable seal
US7175614B2 (en) 2002-10-17 2007-02-13 Baxter International Inc. Peelable seal
US20040078023A1 (en) * 2002-10-17 2004-04-22 Paul-Andre Gollier Peelable seal
US20070088314A1 (en) * 2002-10-17 2007-04-19 Paul-Andre Gollier Peelable seal
US20040144799A1 (en) * 2003-01-24 2004-07-29 Baxter International Inc. Liquid dispenser and flexible bag therefor
US7007824B2 (en) 2003-01-24 2006-03-07 Baxter International Inc. Liquid dispenser and flexible bag therefor
US7237691B2 (en) 2003-01-24 2007-07-03 Baxter International Inc. Flexible bag for fluent material dispenser
US20040144800A1 (en) * 2003-01-24 2004-07-29 Baxter International, Inc. Liquid dispenser and flexible bag therefor
US20050011908A1 (en) * 2003-07-16 2005-01-20 Baxter International, Inc. Dispenser and pressure/vacuum converting machine
US20070251838A1 (en) * 2003-12-02 2007-11-01 Fuso Pharmaceutical Industries, Ltd Multi-Chamber Container
US8336705B2 (en) * 2003-12-02 2012-12-25 Fuso Pharmaceuticals Industries, Ltd. Multi-chamber container
US20050194060A1 (en) * 2004-03-03 2005-09-08 Vincent Houwaert Peelable seal closure assembly
US20080004594A1 (en) * 2004-07-29 2008-01-03 Olof Pahlberg Flexible Multi-Chamber Container for the Preparation of Medical Mixed Solutions
US20080017543A1 (en) * 2004-07-29 2008-01-24 Olof Pahlberg Medical Container With Improved Peelable Seal
US7875016B2 (en) * 2004-07-29 2011-01-25 Fresenius Kabi Deutschland Gmbh Flexible multi-chamber container for the preparation of medical mixed solutions
US7875015B2 (en) 2004-07-29 2011-01-25 Fresenius Kabi Deutschland Gmbh Medical container with improved peelable seal
US20060084178A1 (en) * 2004-10-15 2006-04-20 Peyton Barbara M Trace ammonia colorimetric test apparatus
US20060132247A1 (en) * 2004-12-20 2006-06-22 Renesas Technology Corp. Oscillator and charge pump circuit using the same
US9004761B2 (en) 2006-05-01 2015-04-14 Baxter International Inc. Multiple chamber container with mistake proof administration system
US20100281886A1 (en) * 2006-09-11 2010-11-11 Core Dynamics Limited Systems, devices and methods for freezing and thawing biological materials
US20100120596A1 (en) * 2007-05-23 2010-05-13 Ge Healthcare Bio-Sciences Ab Separation device
US20110022022A1 (en) * 2007-07-19 2011-01-27 Tatsuro Tsuruoka Multi-chamber bag
US8845611B2 (en) * 2007-07-19 2014-09-30 Otsuka Pharmaceutical Factory, Inc. Multi-chamber bag
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US9615570B2 (en) * 2013-11-20 2017-04-11 Cellulis, S.L. Method of freezing cells
US20150140656A1 (en) * 2013-11-20 2015-05-21 Cellulis, S.L. Method of freezing cells
US10077423B2 (en) * 2014-02-05 2018-09-18 Muffin Incorporated Compartmented cryopreservation container and uses thereof
JP2017506097A (en) * 2014-02-05 2017-03-02 マフィン・インコーポレイテッドMuffin Incorporated Compartmented cryopreservation container and use thereof
EP3102031A4 (en) * 2014-02-05 2018-02-21 Muffin Incorporated Compartmented cryopreservation container and uses thereof
US20150216763A1 (en) * 2014-02-05 2015-08-06 Muffin Incorporated Compartmented cryopreservation container and uses thereof
US11261423B2 (en) 2014-02-05 2022-03-01 Muffin Incorporated Compartmented cryopreservation container and uses thereof
WO2015180908A1 (en) * 2014-05-28 2015-12-03 Ge Healthcare Bio-Sciences Ab Bag assembly for cultivation of cells
US10450540B2 (en) 2014-05-28 2019-10-22 Ge Healthcare Bio-Sciences Ab Bag assembly for cultivation of cells
US10731118B2 (en) 2014-05-28 2020-08-04 Ge Healthcare Bio-Sciences Corp. Bag assembly for cultivation of cells
US11525111B2 (en) 2014-05-28 2022-12-13 Cytiva Sweden Ab Bag assembly for cultivation of cells
EP3127998A3 (en) * 2015-08-04 2017-04-19 Olympus Corporation Cell culture apparatus and method of culturing cells
US10308906B2 (en) 2015-08-04 2019-06-04 Olympus Corporation Cell culture apparatus and method of culturing cells
DE102018128010A1 (en) * 2018-11-08 2020-05-14 Bastian Steudel Bioreactor for the cultivation of photoautotrophic microorganisms and their use
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