EP0120875A1 - Procede et conteneur de stockage de plaquettes sanguines - Google Patents

Procede et conteneur de stockage de plaquettes sanguines

Info

Publication number
EP0120875A1
EP0120875A1 EP83902868A EP83902868A EP0120875A1 EP 0120875 A1 EP0120875 A1 EP 0120875A1 EP 83902868 A EP83902868 A EP 83902868A EP 83902868 A EP83902868 A EP 83902868A EP 0120875 A1 EP0120875 A1 EP 0120875A1
Authority
EP
European Patent Office
Prior art keywords
container
platelet
range
gtr
storage container
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.)
Pending
Application number
EP83902868A
Other languages
German (de)
English (en)
Other versions
EP0120875A4 (fr
Inventor
Gerald A. Grode
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.)
Baxter International Inc
Original Assignee
Baxter Travenol 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 Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Publication of EP0120875A1 publication Critical patent/EP0120875A1/fr
Publication of EP0120875A4 publication Critical patent/EP0120875A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/10—Preservation of living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/10—Preservation of living parts
    • A01N1/14—Mechanical aspects of preservation; Apparatus or containers therefor
    • A01N1/146—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0427—Platelets; Thrombocytes

Definitions

  • the present invention relates to the storage of blood components. More particularly, the present invention relates to the storage of platelets in concentrated form.
  • Blood may be collected and processed under sterile conditions to obtain various blood components as may be desired, such as packed red cells, plasma, platelets and cryoprecipitate, for example.
  • the individual components may then be stored for a limited period of time and then utilized as desired.
  • platelet concentrates may be used in the treatment of thrombocytopenia. Since platelets are generally stored for a period of time before use, effective storage techniques are needed.
  • preferred storage conditions for platelet concentrates include storage in medical grade polyvinyl chloride (PYC) bags at about 22°C.
  • PYC polyvinyl chloride
  • Several available storage bags for platelets contain polyvinyl chloride materials which are heat stabilized with epoxidized vegetable oils.
  • Typical epoxidized vegetable oils which are used as heat stabilizers for PVC include epoxidized soybean oil and epoxidized linseed oil.
  • PVC polyvinyl chloride
  • Typical epoxidized vegetable oils which are used as heat stabilizers for PVC include epoxidized soybean oil and epoxidized linseed oil.
  • such platelet storage bags are disclosed in U.S. Patent No. 4,280,497 to Warner et al.
  • a unit of platelet concentrate (the amount of platelet concentrate obtained from a unit of blood) whould have at least 0.55 x 10 11 viable platelets according to the American Association of Blood Banks.
  • a unit of platelets will contain from about 0.55 x 10 11 to about 1.5 x 10 11 platelet cells.
  • the amount of platelet cells obtained from a unit of blood can vary widely.
  • a unit of platelet cells contains from about 0.55 x 10 11 to about 1.5 x 10 11 .
  • the absolute number of platelet cells present in a unit of normal human blood can be as high as about 2.0 x 10 11 .
  • Currently available platelet cell harvesting techniques generally permit harvesting about 80%, or in some cases, about 90%, of the total number of platelets present in whole blood. It is anticipated that in the future, improved harvesting techniques may become available, and such improved techniques will not affect the spirit or scope of the present invention and appended claims.
  • the number of platelets present in a container markedly affects the storage characteristics of the platelets. Since the number of platelets collected from a unit of blood generally varies between about 0.55 x 10 11 and 1.5 x 10 11 , it would be highly desirable to be able to provide a container and method for storing platelets which optimize storage conditions for this particular number or number range of platelet cells or some, other number or number range of platelet cells in order to maximize the storage time and viability of the stored platelet cells.
  • certain types of storage conditions are more conducive to platelet viability over storage periods of up to at least five days. More specifically, it has been discovered that improved platelet viability results when platelet cells are stored in a container which has a carbon dioxide gas permeability transfer rate through the container within a certain range relative to the number of platelet cells stored therein. Platelet viability of the stored cells diminishes when the carbon dioxide permeability transfer rate is not within the specified range, thus, it has been discovered that either too little or too much carbon dioxide gas transfer through the container is deleterious to the viability of stored platelets.
  • the container should be such that the following range is satisfied: 110 ⁇ R ⁇ 360 wherein and wherein R is in units of (nanomoles CO 2 )x(min. x 10 11 platelet cel l s-cm Hg co2 ) ; C represents a unit conversion constant of 2.68 x 10 -4 in units of (nanomoles-sec)/(cc-min) ; represents the CO 2 gas permeabil ity constant for the container material in units of barrer SA represents the total surface area of the container in square centimeters; and
  • FT represents the thickness of the container material in centimeters.
  • the container should meet the R value requirements for any number of platelet cells between 0.55 x 10 11 and 1.5 x 10 11 .
  • the number of platelet cells to be stored therein will be greater than about 0.75 x
  • an improved platelet storage container for maintaining a unit of plaatelets at an acceptable level of viability is provided wherein the gas transfer rate (GTR) of the container satisfies the following range: 85 ⁇ GTR ⁇ 180
  • GTR is in units of (nanomoles)/(min.-cm
  • a method of storing platelet cells includes containing the platelet cells in a container wherein the following range is satisfied: 110 ⁇ R ⁇ 360
  • R, C, PCO 2 , SA and FT being the same variables as in equation (1) and generally, more than about 0.75 x 10 11 platelet cells are stored therein.
  • a method of storing a unit of platelet cells includes containing the unit of platelet cells in a container wherein the following range is satisfied:
  • a container suitable for storing platelets and having a concentrate of platelet cells stored therein includes a container which satisfies the following range:
  • the container will have at least about 0.75 x 10 11 platelet cells stored therein.
  • a container having a concentrated unit of viable platelet cells stored therein which is suitable for intravenous use includes a container which satisfies the range: 85 ⁇ GTR ⁇ 180 wherein the variables being as previously defined.
  • the number of platelet cells to be stored in the container can be set forth as a number range so that an optimum storage container with a specific GTR is provided for the number range of platelet cells that will be encountered.
  • optimized containers for storing a unit of platelet cells are provided.
  • a method for manufacturing a platelet storage container of the proper size, volume and thickness for storing a given number or range of platelet cells under improved conditions so that an acceptable level of platelet viability is maintained during storage.
  • a platelet storage container is manufactured for containing a number or number range of platelet cells in which the following range is satisfied: 110 ⁇ R ⁇ 360,
  • the number of platelet cells to be stored in the container will be greater than about 0.75 x 10 11 .
  • the container will be constructed of a flexible polymer film material of a suitable type.
  • suitable types of polymers include plastlcized polyvinyl chloride compositions, polyethylene materials and polyolefin materials.
  • Fig. 1 is a plan view of a platelet storage container in accordance with the invention.
  • platelet storage container in accordance with the present invention which is a platelet storage bag 10.
  • Platelet storage bag 10 may be of conventional construction, with the exception of the type of materials of which it is made and the size and thickness of the container.
  • platelet storage bag 10 includes an inlet port 14 to which is connected a length of flexible tubing 16 to a donor bag (not shown), for example. Alternately, tubing 16 may communicate with the interior of another container (not shown).
  • the container includes a number of normally sealed, selectively operable access ports 12.
  • the container satisfies the range 110 ⁇ R ⁇ 360.
  • R is greater than 120 and even more preferably, R is greater than 140.
  • R is greater than 160.
  • R is less than 270 and most preferably, R is less than 210.
  • the gas transfer rate, "GTR" is within the range 85 ⁇ GTR ⁇ 180.
  • GTR is within the range 100 ⁇ GTR ⁇ 170 and more preferably 120 ⁇ GTR ⁇ 170.
  • the most preferred range for GTR for storing a unit of platelet cells is from about 160 to about 170.
  • a platelet storage container can be provided which is optimized for storing a number of platelet cells within a given range.
  • a container is provided such that the GTR of the container preferably provides an R value within the range of 110 ⁇ R ⁇ 360 and more preferably 120 ⁇ R ⁇ 270 for the entire range of platelet cells which may be stored in the container.
  • the GTR of the container preferably provides an R value within the range of 110 ⁇ R ⁇ 360 and more preferably 120 ⁇ R ⁇ 270 for the entire range of platelet cells which may be stored in the container.
  • an optimum platelet container is desired for storage of a unit of platelet concentrate, which generally may contain from about 0.5 x 10 11 to about 1.5 x 10 11 platelet cells
  • a container having a GTR of 165 would have an R of 110 when 1.5 x 10 11 platelets are stored therein and an R of 330 when 0.5 x 10 11 platelets are stored therein.
  • an R value could be provided within the more preferred R range of 120 ⁇ R ⁇ 270.
  • storage of platelet celIs in a container having a GTR of between about 150 and 180 would always result in an R value in the range of 120 ⁇ R ⁇ 240 when from 0.75 x 10 11 to 1.25 x 10 11 platelet cells are stored therein.
  • the invention allows platelet storage containers to be optimized for storage of a wide range of platelet cells, such as the range encountered when units of platelet concentrate are obtained from units of blood.
  • Platelet storage bag 10 may be constructed of a material of a suitable type.
  • polymer material such as a plasticized polyvinyl chloride resin compositions, polyethylene material and polyolefin material may be used.
  • Such materials may be plasticized and heat stabilized as desired by any suitable material or materials known to those skilled in the art, as long as the resulting material is suitable for storing platelets and the value of R or GTR is within the desired range.
  • Other types of materials, polymers or nonpolymers, may be used, as long as the requirements for gas transfer are provided.
  • combinations of materials could be used and materials having various thickness could also be used, as long as the overall gas transfer requirements are met.
  • a container could have a very thick, relatively non-porous portion or portions with other portions of the container being relatively porous, as long as the overall gas transfer requirements are met.
  • the invention is not limited to containers of a certain material or design or to materials having a uniform thickness. Polymers and polymer films are generally useful in practicing the invention.
  • one preferred type of polyvinyl chloride composition includes PVC resin, an effective amount of tri-(2-ethylhexyl) trimellitate to plasticize the PVC, less than about one percent by weight of the total composition of the heat stabilization system and optionally an effective amount of an antiblock agent.
  • the amount of plasticizer can be chosen such that the desired degree of flexibility is obtained.
  • Compositions containing a relatively low quantity of plasticizer may be harder and less flexible than desired and those with a relatively high quantity of plasticizer may be softer and more flexible than desired.
  • an effective amount of plasticizer for this type of composition will be from about 25 to 90 parts per 100 parts resin by weight.
  • the amount of plasticizer is from about 63 to 85 parts per 100 parts resin by weight and most preferably about 74 parts.
  • the heat stabilization system should generally be present in an amount greater than about 0.15 percent by weight of the total composition and is preferably present in an amount of between about 0.26 and 0.35 parts per 100 parts resin by weight. Generally, as the amount of heat stabilizer is increased, increased leaching occurs and hazing may also result if the amount of heat stabilizer is high enough.
  • the antiblock agent when utilized, will be present in an amount sufficient to provide the desired antiblock effect, or stated otherwise, to prevent adhesion of films made from the composition.
  • the amount of antiblock agent will usually be from about 0.2 to about 0.6 parts per 100 parts resin by weight and preferably about 0.4 parts. Again, generally as the amount of wax increases, increased leaching also results.
  • the preferred amount of antiblock agent is generally the minimum amount which will prevent adhesion of films made from the composition.
  • An especially preferred composition is, per 100 parts of PVC resin, 74 parts of tri(2-ethylhexyl) trimellitate, 0.3 parts of a calcium stearate and zinc stearate heat stabilizer sold by the trade designation "CZ-11-P" by the Interstab
  • Such a composition has a at 25°C of about 49 bar.
  • the ingredients of a composition can generally be suitably mixed by a blender, for example.
  • a composition can be formed into sheets by conventional methods such as by calendaring or by extrusion to a desired thickness.
  • a mixing screw type apparatus may be used in extruding the material.
  • the materials are processed under suitable conditions so that unacceptable heat degradation or color change of the material does not occur.
  • the type and amount of heat stabilizer will affect the processing conditions to which the composition may be subjected without the occurrence of significant degradation or color change. For example, a PVC composition without calcium stearate is more likely to undesirably darken during processing than a PVC composition containing calcium stearate and zinc stearate.
  • the polyvinyl chloride resin can be any suitable type. Those types of PVC resins which relatively easily absorb the plasticizer are preferred. Especially suitable resins are those known as "blotter” resins. One such preferred resin is marketed by the B.F. Goodrich Chemical Co. under the trade designation “GEON 80X80.” Another preferred resin is marketed by the Wacker Co. under the trade designation "VINNOL H70DF”.
  • the plasticizer which may be utilized tri(2-ethylhexyl) trimellitate, is commercially available.
  • One source is the Hatco Chemical Corp. marketing the plasticizer under the trade designation "HATCOL 200".
  • the heat stabilization system may be calcium stearate, zinc stearate or mixtures thereof. More generally, the heat stabilization system can be at least one salt of C 10 to C 26 saturated fatty acids. A 1:1 weight ratio of zinc stearate/calcium stearate is preferred. A suitable co ⁇ mercial source of the zinc stearate/calcium stearate combination is the Interstab Company which markets such a heat stabilizer under the trade designation "CZ-11-P". "CZ-11-P" formulation may also contain minor amounts of calcium palmitate, zinc palmitate and C 18 fatty acids.
  • the antiblock agent which may be present generally may be any material that provides the desired antiblock effect without an undesired degree of leaching and which is not otherwise objectionable.
  • Preferred antiblock agents are low viscosity, high melting point waxes, such as wax marketed under the trade designation "Acrawax C" by Glycol Chemicals, Inc. High viscosity oils may also be utilized. In general, oils will leach to a greater degree than waxes. Mixtures of antiblock agents may also be used. Reference is made to United States Patent Application Serial No. 424,679 filed September 27, 1982 for a more complete description of such PVC compositions. Other PVC compositions may contain an epoxidized vegetable oil or oils which function as a heat stabilizer. Such compositions are disclosed in U.S. Patent No.4,280,497 to Warner et al. and reference is made thereto for further descriptions thereof. However, it should be kept in mind that the scope and spirit of the present invention is not limited to particular materials or compositions.
  • the thickness of the polymer material will be between about 0.01 centimeter and 0.05 centimeter.
  • platelet storage materials may be used including those previously described and other which are known to those skilled in the art.
  • Bag Volume/Surface Area 300 ml/365 cm 2 1000 ml/644 cm 2
  • Bag Volume/Surface Area 300 ml/280 cm 2 600 ml/398 cm 2
  • Thickness 300 ml bag: 0.015 cm 600 ml bag: 0.015 cm
  • Thickness 0.038 cm
  • Platelet concentrate was obtained from single units of blood or from a continuous centrifugation system in which blood was continuously withdrawn, centrifuged to remove platelets and returned to the donor.
  • the platelets were stored at ambient temperature and the following results were obtained after storage for about three and five days:

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Environmental Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Materials For Medical Uses (AREA)
  • External Artificial Organs (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Procédés et conteneurs de stockage de cellules de plaquettes sanguines. Selon un aspect de l'invention, un conteneur amélioré de stockage d'une unité de cellules de plaquettes sanguines à un niveau acceptable de viabilité est fabriqué avec un matériau polymère, et ce conteneur remplit les conditions suivantes de vitesse de transmission de gaz: 85 <= GTR <= 180; dans cette relation, GTR =$(6,)$où GTR et calculé en unités de (nanomoles)/(min.-cm Hgco2); C est une constante de conversion d'unités de 2,68 x 10-4 en unités de (nanomoles-sec.)/(cc-min.); Pco2 est la constante de perméabilité du gaz CO2 pour le matériau du conteneur en unités de barrière$(7,)$SA est la surface totale du conteneur en centimètres carrés; et FT est l'épaisseur du matériau du conteneur en centimètres; selon l'invention, des conteneurs et des procédés sont décrits, lesquels permettent une optimisation du stockage d'un nombre particulier ou plage de nombres de cellules de plaquettes sanguines de manière à rendre la viabilité et le temps de stockage maximum.
EP19830902868 1982-09-27 1983-08-22 Procede et conteneur de stockage de plaquettes sanguines. Pending EP0120875A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US42467882A 1982-09-27 1982-09-27
US424678 1982-09-27

Publications (2)

Publication Number Publication Date
EP0120875A1 true EP0120875A1 (fr) 1984-10-10
EP0120875A4 EP0120875A4 (fr) 1985-12-05

Family

ID=23683483

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19830902868 Pending EP0120875A4 (fr) 1982-09-27 1983-08-22 Procede et conteneur de stockage de plaquettes sanguines.

Country Status (4)

Country Link
EP (1) EP0120875A4 (fr)
JP (1) JPS59501733A (fr)
CA (1) CA1227432A (fr)
WO (1) WO1984001292A1 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8427285D0 (en) * 1984-10-29 1984-12-05 Bellhouse Medical Products Ltd Blood bag
JPH0435670A (ja) * 1990-05-31 1992-02-06 Nissho Corp 血液分離装置
US5683768A (en) * 1994-12-21 1997-11-04 Baxter International Inc. Plastic formulations for platelet storage containers and the like
EP1684579A1 (fr) 2003-10-22 2006-08-02 Fred Hutchinson Cancer Research Center Methodes, compositions et dispositifs d'induction de stase dans des cellules, des tissus, des organes, et des organismes
EP2211046B1 (fr) 2008-12-29 2011-03-02 C.R.F. Società Consortile per Azioni Système d'injection de carburant doté d'une répétabilité et d'une stabilité élevées pour le fonctionnement d'un moteur à combustion interne
WO2012125955A2 (fr) 2011-03-16 2012-09-20 Mayo Foundation For Medical Education And Research Procédés et matériaux pour prolonger le stockage utile des préparations d'hématies et des préparations de plaquettes
US9440011B2 (en) 2012-07-12 2016-09-13 Terumo Bct, Inc. Hybrid blood component storage bag and method of making such bag
CN114600872A (zh) 2022-04-13 2022-06-10 西安北光医学生物技术有限公司 一种细胞、组织或器官的抗损伤保存的方法及保存系统

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3928294A (en) * 1972-02-22 1975-12-23 Owens Illinois Inc Biocompatible articles including polymeric membranes having high permeability to gases and uses thereof
US4132594A (en) * 1976-06-28 1979-01-02 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Gas diffusion liquid storage bag and method of use for storing blood
US4082509A (en) * 1976-08-05 1978-04-04 Dow Corning Corporation Method of storing blood and a blood storage bag therefor
AU489541B2 (en) * 1976-08-24 1978-01-19 Green Cross Corporation, The Medical appliance made of plastic
JPS5841862B2 (ja) * 1977-01-08 1983-09-14 テルモ株式会社 医療用器具
US4228032A (en) * 1978-11-06 1980-10-14 Dow Corning Corporation Method of storing blood and a blood storage bag therefore
JPS5676955A (en) * 1979-11-27 1981-06-24 Sekisui Chemical Co Ltd Manufacture of medical resin molding
US4496361A (en) * 1981-08-05 1985-01-29 E. I. Du Pont De Nemours And Company Platelet storage container

Also Published As

Publication number Publication date
JPS59501733A (ja) 1984-10-18
WO1984001292A1 (fr) 1984-04-12
CA1227432A (fr) 1987-09-29
EP0120875A4 (fr) 1985-12-05

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