WO1989002305A1 - Filtre separateur de leucocytes - Google Patents

Filtre separateur de leucocytes Download PDF

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Publication number
WO1989002305A1
WO1989002305A1 PCT/JP1988/000943 JP8800943W WO8902305A1 WO 1989002305 A1 WO1989002305 A1 WO 1989002305A1 JP 8800943 W JP8800943 W JP 8800943W WO 8902305 A1 WO8902305 A1 WO 8902305A1
Authority
WO
WIPO (PCT)
Prior art keywords
porous membrane
blood
leukocyte
filter
present
Prior art date
Application number
PCT/JP1988/000943
Other languages
English (en)
Japanese (ja)
Inventor
Keiji Naoi
Original Assignee
Terumo Kabushiki Kaisha
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 Terumo Kabushiki Kaisha filed Critical Terumo Kabushiki Kaisha
Priority to AU23823/88A priority Critical patent/AU2382388A/en
Priority to KR1019890700881A priority patent/KR890701183A/ko
Publication of WO1989002305A1 publication Critical patent/WO1989002305A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/30—Polyalkenyl halides
    • B01D71/32—Polyalkenyl halides containing fluorine atoms
    • B01D71/34—Polyvinylidene fluoride
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • A61M1/3633—Blood component filters, e.g. leukocyte filters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D39/00—Filtering material for liquid or gaseous fluids
    • B01D39/14—Other self-supporting filtering material ; Other filtering material
    • B01D39/16—Other self-supporting filtering material ; Other filtering material of organic material, e.g. synthetic fibres
    • B01D39/1669—Cellular material
    • B01D39/1676—Cellular material of synthetic origin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D39/00—Filtering material for liquid or gaseous fluids
    • B01D39/14—Other self-supporting filtering material ; Other filtering material
    • B01D39/16—Other self-supporting filtering material ; Other filtering material of organic material, e.g. synthetic fibres
    • B01D39/1692—Other shaped material, e.g. perforated or porous sheets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/02—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
    • 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
    • A61M2202/0439—White blood cells; Leucocytes
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
    • B01D2239/12—Special parameters characterising the filtering material
    • B01D2239/1208—Porosity
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
    • B01D2239/12—Special parameters characterising the filtering material
    • B01D2239/1216—Pore size

Definitions

  • the present invention relates to a filter for separating leukocytes. More specifically, the present invention relates to a leukocyte separation filter that exhibits stable and efficient capture of leukocytes.o
  • red blood cell concentrate CRC
  • PC platelet-rich plasma
  • PPP platelet-poor plasma
  • the erythrocyte concentrate separated in this way is used as a component preparation of erythrocytes, and is widely used for component blood in patients who need erythrocytes.
  • the erythrocyte concentrate contains many white blood cells and platelets.
  • the concept of a so-called whole blood component is becoming established, and patients who need only red blood cells are transfused with a large amount of white blood cells and platelets together with the red blood cell concentrate. It has been problematic.
  • the white blood cells and platelets contained in the red blood cell fraction, such as red blood cell concentrate have side effects after transfusion. In order to prevent this, it is necessary to remove as much as possible. For this reason, more efforts have been made than before.
  • Methods for increasing the purity of red blood cell preparations include gravity centrifugation using the specific gravity difference of blood cells, use of a trapping material using the action of adhesion or adhesion of blood cells, and separation of white blood cells using a red blood cell agglutinating agent. The method is used.
  • the method using a trapping material is widely used because of its high leukocyte removal efficiency and the simplicity of the procedure.
  • Natural cellulose, polyester, boriamid, boriacrilonitrile, glass It is used in many cases where very small fibers such as fibers with a very small fiber diameter are packed in a column as they are, and those processed secondarily into nonwoven fabrics and the like.
  • an object of the present invention is to provide a novel filter for removing leukocytes.
  • Another object of the present invention is to provide a leukocyte removal filter which has high and stable capturing ability for leukocytes and can separate leukocytes more efficiently from blood.
  • Another object of the present invention is to provide a leukocyte removal filter capable of performing a safe leukocyte removal operation without fear of outflow of foreign matter during operation.
  • Another object of the present invention is to provide a filter for removing leukocytes, which simplifies the manufacturing process of the filter and has less variation in product performance.
  • the pore shape is substantially ft-circular
  • the average value of the minor axis is 3 to 30 oi
  • the average value of the major axis is 1.5 times or more the average value of the minor axis.
  • the present invention also provides a leukocyte separation filter wherein the porosity of the porous membrane is from 20 to 85%.
  • the present invention also provides a leukocyte separation filter in which the porous membrane is made of a fluororesin.
  • the porous membrane further comprises poly (vinyl chloride), polyvinylidene fluoride, polyvinyl chloride, polyvinylidene fluoride, tetrafluoroethylene copolymer, and vinylidene fluoride hexafluoropro Pyrene copolymer, vinylidene fluoride-propylene copolymer,
  • FIG. 1 shows a leukocyte separation filter selected from the group consisting of a trafluoroethylene-propylene copolymer and a tetrafluoroethylene-ethylene copolymer.
  • FIG. 1 is a cross-sectional view showing an embodiment of the leukocyte separation filter of the present invention
  • FIG. 2 is a circuit diagram showing a blood processing circuit incorporating the embodiment of the leukocyte separation filter of the present invention.
  • FIG. 3 is an electron micrograph showing the fine structure of one embodiment of the porous membrane used in the leukocyte separation filter of the present invention.
  • the leukocyte-removing filter of the present invention has a pore shape substantially in the shape of an ellipse, and the average value of its minor axis is 3 to 30 in. Further, the present invention is characterized by having a porous membrane having an average value of the major axis of which is at least 1.5 times the average value of the minor axis.
  • a leukocyte suspension such as blood or erythrocyte concentrate
  • the leukocytes contained in the leukocyte suspension have a pore diameter of 3 to 30 in the porous membrane. ⁇ m., so that they are trapped without passing through the pores.
  • the major axis of the pores is more than 1.5 times the minor axis and the pore area is relatively large.
  • the liquid permeation rate is fast enough to efficiently separate leukocytes.
  • the matrix of the porous membrane is stable due to its continuous structure, In addition, problems such as outflow of foreign matter from the porous body or channel channeling in the flow path do not essentially occur.
  • the pore shape is substantially oval, the average value of the minor axis is 3 to 30 ⁇ in, and the average value of the major axis is the average value of the minor axis. It is characterized by having a porous membrane that is at least 1.5 times as large as the above. In the porous membrane according to the present invention, the pore shape does not need to be strictly elliptical. If the pore has a similar shape to a circle in which the major axis and minor axis are different, some irregularities are present on the circumference. It may be one or a slit.
  • such a pore shape greatly affects the blood cell fractionation characteristics and the liquid permeation rate. That is, the particle size of the fraction depends on the minor diameter of the pores, while the liquid permeation rate depends on the area of the pores, so that the pore shape of the porous membrane is substantially oblong. Furthermore, if the relationship between the minor axis and the major axis is optimized, leukocytes contained in leukocyte suspensions such as blood and red blood cell concentrates can be efficiently captured with high precision. It becomes something.
  • the average value of the minor axis of the substantially oval pores is set to 3 to 30 m when the average value of the minor axis is less than 3 ⁇ ⁇ .
  • the average value of the major axis of the substantially oval pores is set to 1.5 times or more of the average value of the minor axis if the major axis is smaller than this. This is because an improvement in the pore area cannot be expected, and a desired filtration efficiency cannot be obtained.
  • the upper limit is not particularly limited, but is preferably about 5 times from the viewpoint of film strength.
  • the minor axis of the substantially oval-shaped pore is 3 to 15 ⁇ . Since the pores of the porous membrane according to the present invention are quite large, and the measurement by the mercury porosimeter method and the butanol impregnation method is not appropriate as the method for measuring the pore diameter, a measurement method using a microscope is preferable. Things. The average value of the major axis and minor axis of the pores described in this specification is obtained by measuring the major axis and minor axis of 50 randomly selected pores from electron micrographs, and arithmetically calculating them. It is the average value.
  • the porosity is preferably 20 to 85%, more preferably 40 to 80%.
  • the porosity of the porous membrane is an important factor that affects the membrane properties such as the liquid permeation rate. If the porosity exceeds 80%, the membrane strength may not be sufficient if the porosity exceeds 80%.
  • the material constituting the porous membrane according to the present invention is not particularly limited as long as it does not affect the blood components contained in the white blood cell suspension such as the blood to be processed and the red blood cell concentrate.
  • various resins such as fluororesin, olefin resin, vinyl chloride resin, acryl resin, vinyl acetate resin, polysulfone resin, and polycarbonate are preferably used.
  • fluororesins are preferred.
  • the fluororesin include various homopolymers and copolymers such as random copolymers, block copolymers, and graft copolymers.
  • Rifidani pinylidene, polyvinylidene vinyl, vinylidene fluoride-tetrafluoroethylene copolymer, vinylidene fluoride-hexafluoropropylene copolymer And vinylidene fluoride-propylene copolymer, tetrafluoroethylene-propylene copolymer, and tetrafluoroethylene-ethylene copolymer are preferred.
  • the average value of the minor axis is 3 to 3 ° in and the average of the major axis is The value is not particularly limited as long as the value can be 1.5 times or more the average value of the minor axis, but, for example, pores are formed by hot stretching after film formation.
  • a method may be employed in which the porous membrane obtained by a solvent extraction method or the like is further subjected to a stretching treatment so as to obtain a predetermined pore shape.
  • FIG. 1 is a cross-sectional view showing an embodiment of the leukocyte separation filter of the present invention.
  • the filter for leukocyte separation 1 is provided with a porous membrane 5 having the above-described configuration in a housing 4 having a blood inlet 2 and a blood outlet 3 in a housing 4. It is cut off and provided.
  • liquid-permeable supports 6a and 6b are provided before and after the porous membrane 5, It is optional to sandwich the porous membrane 5 between the support members 6a and 6b.
  • the leukocyte separation filter 1 is actually used, for example, incorporated in a circuit as shown in FIG. In the circuit shown in FIG.
  • the blood bag 7 containing the blood to be processed and the saline bag 8 containing the physiological saline are positioned above the leukocyte separation filter 1, and the clamps 9 respectively.
  • a, 9b are connected to the blood inlet 2 of the leukocyte separation filter 1 by the liquid guiding tubes 10a, 10b, and below the leukocyte separation filter 1.
  • a physiological saline collection bag 11 and a blood collection bag 12 for collecting the processed blood are located in the container, and a liquid guide tube 10 provided with clamps 9c and 9d, respectively.
  • e, 1 ⁇ d for leukocyte separation It is connected to the blood outlet 3 of the port 1.
  • the clamps 9b and 9c are opened, physiological saline is poured from the saline bag 8 into the filter 1 for leukocyte separation with the clamps 9a and 9d closed, and the leukocyte separation is performed. Priming inside filter 1 for use. The physiological saline used for the priming is collected in a physiological saline collection bag 10. After performing the priming, the clamps 9b and 9c are closed, and then the clamps 9a and 9d are opened. Then, the blood fluid flows from the blood bag 7 to the leukocyte separation filter 1.
  • the leukocyte separation filter 1 when the blood passes through the porous membrane 5 having the above configuration, the leukocyte component is captured by the porous membrane 5, and the leukocytes are separated.
  • the blood from which leukocyte components have been removed in this manner is collected in the communicating blood collection bag 12.
  • the remaining blood in the leukocyte separation filter 1 is pushed out again by flowing physiological saline into the blood collection bag 12 and collected in the blood collection bag 12.When almost all the blood has been collected, clamp 9d is closed and clamp 9c is closed. Then, the physiological saline used for blood collection is collected in the physiological saline collection bag 11 and the white blood cell separation operation is completed.
  • Example 15 parts by weight of vinylidene polyfluoride, 80 parts by weight of acetone and 5 parts by weight of glycerin were dissolved at 100 under pressure to form a uniform solution.
  • the resulting stock solution was cast on a glass plate, placed in a sealed container, 1 0 0 ° 1 the autogenous pressure C in the system. 5 ⁇ cell with pressure controls such that the K / cm 2 The ton was removed. After 2 hours, the pressure was returned to normal pressure, and the obtained film was simultaneously stretched in water at 85 ° C by 4.5 times in the X direction and 1.5 times in the Y direction.
  • the obtained film had an average minor axis of 3 ⁇ and an average major axis of 15 m, and had a porosity of 70% having oval pores.
  • the pore shape of this porous membrane was taken by electron micrograph of the porous membrane, and the short and long diameters of 50 randomly selected pores were measured. This is obtained by calculating the average value.
  • a leukocyte separation filter as shown in FIG. 1 was prepared, and CPD-added blood was applied to the leukocyte separation filter using a circuit as shown in FIG. Shed.
  • the leukocyte removal rate calculated from the blood cell counts before and after the treatment was 96%.
  • the pore shape is substantially oval, the average value of the minor axis is 3 to 3 0 111, and the average value of the major axis is 1.5 times the average value of the minor axis.
  • the filter for leukocyte separation is characterized by having a porous membrane as described above, it has a high and stable trapping ability for leukocytes, blood, and erythrocytes. It can efficiently separate leukocyte components from leukocyte suspensions such as concentrated liquids, and can safely perform leukocyte removal operation without fear of foreign matter entering due to falling off of the filter medium during operation. For example, it can provide a red blood cell fraction used in component transfusions with higher purity and safety, and greatly contributes to medical and medical fields.
  • the porosity of the porous membrane is 20 to 85%, and the porous membrane is made of fluororesin, more preferably polyfluoride.

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  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • External Artificial Organs (AREA)
  • Filtering Materials (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Filtre séparateur de leucocytes, comprenant une membrane poreuse comportant de fins pores de forme essentiellement ovale présentant un diamètre court moyen compris entre 3 et 30 mum et un rapport moyen entre le diamètre le plus long et le diamètre le plus court égal ou supérieur à 1,5. Les leucocytes contenus dans une suspension de leucocytes sont collectés sans traverser les fins pores, étant donné que le diamètre le plus court des pores de la membrane est suffisamment petit, alors qu'à cause de la forme ovale des pores, la vitesse de passage de la suspension est comparativement élevée, et permet la séparation efficace des leucocytes. En outre, étant donné que la matrice de la membrane poreuse possède une structure continue, elle est stable et ne présente virtuellement aucun problème de fuite de particules étrangères du corps poreux ou de formation de canaux dans le chemin d'écoulement pendant le processus.
PCT/JP1988/000943 1987-09-18 1988-09-16 Filtre separateur de leucocytes WO1989002305A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU23823/88A AU2382388A (en) 1987-09-18 1988-09-16 Leucocyte-separating filter
KR1019890700881A KR890701183A (ko) 1987-09-18 1988-09-16 백혈구 분리용 필터

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP62/232067 1987-09-18
JP62232067A JPS6475015A (en) 1987-09-18 1987-09-18 Filter for separating leukocytes

Publications (1)

Publication Number Publication Date
WO1989002305A1 true WO1989002305A1 (fr) 1989-03-23

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ID=16933467

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP1988/000943 WO1989002305A1 (fr) 1987-09-18 1988-09-16 Filtre separateur de leucocytes

Country Status (3)

Country Link
JP (1) JPS6475015A (fr)
KR (1) KR890701183A (fr)
WO (1) WO1989002305A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0419346A2 (fr) * 1989-09-18 1991-03-27 Terumo Kabushiki Kaisha Filtre pour la purification des plaquettes
EP0877648A1 (fr) * 1996-09-25 1998-11-18 Baxter International Inc. Systeme de filtrage des fluides medicaux et biologiques
US9713669B2 (en) 2013-12-26 2017-07-25 Fenwal, Inc. Method for sized-based cell separation using spinning membrane filtration

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1517740T (pt) * 2002-06-19 2017-01-31 Northwest Biotherapeutics Inc Dispositivos de filtração de fluxo tangencial e métodos para enriquecimento de leucócitos
DE502007001929D1 (de) 2007-10-20 2009-12-17 Trumpf Sachsen Gmbh Maschinelle Anordnung für die Blechbearbeitung mit einer Blechbearbeitungseinrichtung sowie mit einer Transportvorrichtung
KR102230435B1 (ko) 2013-09-30 2021-03-22 도레이 카부시키가이샤 다공질막, 다공질막을 내장하는 혈액 정화용 모듈 및 다공질막의 제조 방법

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5446811A (en) * 1977-09-20 1979-04-13 Asahi Chem Ind Co Ltd Method for removing leukocytes from blood
JPS55136955A (en) * 1979-04-13 1980-10-25 Asahi Chem Ind Co Ltd Filter for catching and gathering leucocyte
JPS596231A (ja) * 1982-07-05 1984-01-13 Mitsubishi Rayon Co Ltd フッ素樹脂多孔質膜の製造方法
JPS5964055A (ja) * 1982-08-30 1984-04-11 三菱レイヨン株式会社 血液処理装置
JPS6139060B2 (fr) * 1979-04-13 1986-09-02 Asahi Chemical Ind

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5446811A (en) * 1977-09-20 1979-04-13 Asahi Chem Ind Co Ltd Method for removing leukocytes from blood
JPS55136955A (en) * 1979-04-13 1980-10-25 Asahi Chem Ind Co Ltd Filter for catching and gathering leucocyte
JPS6139060B2 (fr) * 1979-04-13 1986-09-02 Asahi Chemical Ind
JPS596231A (ja) * 1982-07-05 1984-01-13 Mitsubishi Rayon Co Ltd フッ素樹脂多孔質膜の製造方法
JPS5964055A (ja) * 1982-08-30 1984-04-11 三菱レイヨン株式会社 血液処理装置

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0419346A2 (fr) * 1989-09-18 1991-03-27 Terumo Kabushiki Kaisha Filtre pour la purification des plaquettes
EP0419346A3 (en) * 1989-09-18 1991-06-19 Terumo Kabushiki Kaisha Filter for purification of platelets
US5234593A (en) * 1989-09-18 1993-08-10 Terumo Kabushiki Kaisha Filter for purification of platelets
EP0877648A1 (fr) * 1996-09-25 1998-11-18 Baxter International Inc. Systeme de filtrage des fluides medicaux et biologiques
EP0877648A4 (fr) * 1996-09-25 2002-10-09 Baxter Int Systeme de filtrage des fluides medicaux et biologiques
US9713669B2 (en) 2013-12-26 2017-07-25 Fenwal, Inc. Method for sized-based cell separation using spinning membrane filtration

Also Published As

Publication number Publication date
JPS6475015A (en) 1989-03-20
KR890701183A (ko) 1989-12-19

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