JPH01320064A - Blood component separating system - Google Patents

Blood component separating system

Info

Publication number
JPH01320064A
JPH01320064A JP63153464A JP15346488A JPH01320064A JP H01320064 A JPH01320064 A JP H01320064A JP 63153464 A JP63153464 A JP 63153464A JP 15346488 A JP15346488 A JP 15346488A JP H01320064 A JPH01320064 A JP H01320064A
Authority
JP
Japan
Prior art keywords
blood
bag
component separation
blood component
plasma
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.)
Granted
Application number
JP63153464A
Other languages
Japanese (ja)
Other versions
JPH0659304B2 (en
Inventor
Toru Kuroda
徹 黒田
Takao Nishimura
隆雄 西村
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.)
Asahi Kasei Medical Co Ltd
Original Assignee
Asahi Medical Co Ltd
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 Asahi Medical Co Ltd filed Critical Asahi Medical Co Ltd
Priority to JP63153464A priority Critical patent/JPH0659304B2/en
Priority to DE68902698T priority patent/DE68902698C5/en
Priority to EP89306284A priority patent/EP0349188B1/en
Priority to AU36713/89A priority patent/AU617265B2/en
Priority to KR1019890008735A priority patent/KR910004326B1/en
Priority to US07/370,750 priority patent/US4985153A/en
Publication of JPH01320064A publication Critical patent/JPH01320064A/en
Priority to GR920400962T priority patent/GR3005581T3/el
Publication of JPH0659304B2 publication Critical patent/JPH0659304B2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Abstract

PURPOSE:To provide possibility of obtaining three types of blood components having got rid of leucocyte by connecting a blood gathering bag with one end of a leucocyte removing filter, whose other end is connected with at least three bags for blood component separation. CONSTITUTION:The blood gathered is introduced into a blood gathering bag 1 and sent to a leucocyte removing filter 2, and the blood having passed therethrough is forwarded to No.1 blood component separating bag 3. Then this separating bag 3 is cut away, and only blood component separating bags 3, 4, 5 are put into a centrifugal separator device. This process separates the blood in the No.1 separating bag 3 into layers, to produce a supernatent consisting of blood plasma with many platelets and a deposit consisting of condensed erythrocyte having got rid of leucocyte. Thereafter the supernatent is transferred to No.2 blood component separating bag 4 to undergo another centrifugal separation, and now the blood plasma with many platelets in the No.2 separating bag 4 produces a supernatent as blood plasma and a deposit as condensed platelet blood plasma having got rid of leucocyte. Then the blood plasma in the supernatent is transferred to No.3 separating bag 5, and the bags 3, 4, 5 are cut away.

Description

【発明の詳細な説明】 (産業上の利用分野) 本発明は、血液をその成分毎に分離する為に用いるバッ
グと白血球除去フィルターとより成る分離システムに関
するものである。
DETAILED DESCRIPTION OF THE INVENTION (Industrial Application Field) The present invention relates to a separation system comprising a bag and a leukocyte removal filter used to separate blood into its components.

更に詳細に述べると、採血に用いられる抗凝固剤入りの
採血バッグと、血漿、赤血球、血小板は通過させるが白
血球は通過させない白血球除去フィルターおよび少なく
とも3つの血液成分分離用バッグを組み合わせる事によ
り、無菌的に白1肛球除去濃厚赤血球、白血球除去濃縮
血小板血漿、+f+を漿の3種類の血液成分を同時に分
離しようとするシステムに関するものである。
More specifically, by combining a blood collection bag containing an anticoagulant used for blood collection, a leukocyte removal filter that allows plasma, red blood cells, and platelets to pass through but not white blood cells, and at least three blood component separation bags, the system is sterile. The present invention relates to a system that simultaneously separates three types of blood components: concentrated red blood cells from which white blood cells have been removed, concentrated platelet plasma from which white blood cells have been removed, and +f+ plasma.

(従来技術) 近年、医学、特に免疫学の進歩により、血液をその成分
毎に分離し、治療の目的に適した血液成分のみを輸血す
る、いわゆる成分輸血が普及して来た。しかしながら成
分輸血の際、輸血用の血液成分中に混入して来る白血球
は患者にとっては他人の白血球であり、赤血球のABO
型を合わせたとしても白血球の血液型は種類が多く、白
血球の型を完全に一致させて輸血する事は困難である。
(Prior Art) In recent years, with advances in medicine, particularly immunology, so-called component transfusion, in which blood is separated into its components and only blood components suitable for the purpose of treatment are transfused, has become widespread. However, when blood components are transfused, the white blood cells mixed into the blood components for transfusion are seen by the patient as someone else's white blood cells, and the red blood cell ABO
Even if the blood types are matched, there are many types of white blood cells, and it is difficult to transfuse blood with completely matching white blood cell types.

その1b輸血された白血球の表面に存在する抗原に対し
、患者の体内には抗体が産生され、繰り返し輸血された
患者の場合、患者体内の坑口血球抗体と輸血血液中の白
血球とが抗原抗体反応を起こし、発熱、J麻疹等の輸血
副作用を起こす事が多い。この為、輸血用血液成分中に
含まれる自fIIL球を除去する目的に使用される白血
球除去フィルターが近年開発されて来ている。これらの
白血球除去フィルターは全血または成分毎に分離された
血液成分中の白血球を効率良く除去する事ができるので
、輸血を受ける患者にとっては副作用が抑えられ、非常
にμばれている。
1b Antibodies are produced within the patient's body in response to antigens present on the surface of transfused white blood cells, and in patients who have received repeated blood transfusions, the antigen-antibody reaction occurs between the port blood cell antibodies in the patient's body and the white blood cells in the transfused blood. This often causes blood transfusion side effects such as fever and J measles. For this reason, leukocyte removal filters used for the purpose of removing autologous fIIL cells contained in blood components for transfusion have been developed in recent years. These leukocyte removal filters can efficiently remove leukocytes from whole blood or separated blood components, so side effects are suppressed and are very popular among patients receiving blood transfusions.

(発明が解決しようとする問題点) しかしながら、これらの白血球除去フィルターはrm血
液バッグ接続する際、完全に無菌状態で接続する事が不
可能である為、白血球を除去した律液製剤は製造後24
時間以内に使用する事か義務付けられている。白血球を
除去していない血液製剤は、これよりもずっと長い期間
保存する事ができるので、無菌的に白l1lL球を除去
するシステムがあれば非常に有用である事は言うまでも
無い。こわを解決しようとする試みが米国特許第459
6657号であるが、このシステムは、採血バッグに少
なくとも2つのバッグを接続し、採血バッグと一方のバ
ッグとの間に白血球除去フィルターを組み込んたもので
あり、使用方法は、先ず採血バッグ中の金山[を遠心分
離し、その後、血小板を含む血漿は白血球除去フィルタ
ーが接続されていないバッグに移され、濃厚赤血球が白
血球除去フィルターを通してもう一方のバッグに移され
る。この発明によれば白血球除去濃厚赤血球と白血球、
血小板を含む血漿が11Pられる事になる。すなわち、
濃厚赤龜球中に含まれる白血球は除去できるか、血小板
を含む血漿中に混入する白血球は除去できず、更には、
白血球除去フィルターが血液バッグと一緒に遠心分離機
により遠心される為白血球除去フィルターの容器やバッ
グの破損があり、安心して使え無い為広く一般に斤反す
るには至っていない。
(Problem to be Solved by the Invention) However, when these leukocyte removal filters are connected to the rm blood bag, it is impossible to connect them in a completely sterile condition, so the lymph preparations from which leukocytes have been removed cannot be used after manufacturing. 24
It is mandatory to use it within the specified time. Since blood products from which leukocytes have not been removed can be stored for a much longer period of time, it goes without saying that a system for aseptically removing leukocytes would be extremely useful. U.S. Patent No. 459 is an attempt to solve the stiffness problem.
No. 6657, this system connects at least two bags to a blood collection bag and incorporates a leukocyte removal filter between the blood collection bag and one of the bags. Kanayama is centrifuged, and then the plasma containing platelets is transferred to a bag to which no leukocyte removal filter is connected, and the concentrated red blood cells are transferred to the other bag through the leukocyte removal filter. According to this invention, leukocyte-removed concentrated red blood cells and white blood cells,
Plasma containing platelets will be 11P. That is,
Is it possible to remove the white blood cells contained in the concentrated red blood cells, or is it possible to remove the white blood cells mixed in the plasma containing platelets?
Because the leukocyte removal filter is centrifuged together with the blood bag in a centrifuge, the leukocyte removal filter container or bag may be damaged, making it impossible to use with confidence, so it has not been widely used.

本発明者らは上記した様な従来技術の欠点を解決し、遠
心分離操作を行なう際には、白血球除去フィルターを取
り外すIGができ、すなわち、フィルター容器やバッグ
の破H1の心配が無く、白血球を除去した濃厚赤血球、
白血球を除去した濃縮血小板血漿、血漿等の3つの血液
成分を無菌的に一気に分離できるシステムを提供する事
を目的に鋭意研究した結果、本発明を成すに至った。
The present inventors have solved the above-mentioned drawbacks of the prior art, and have made it possible to remove the leukocyte removal filter when performing a centrifugation operation. In other words, there is no need to worry about the filter container or bag being destroyed, and the leukocyte removal filter can be removed. concentrated red blood cells from which
As a result of intensive research aimed at providing a system that can aseptically separate three blood components such as platelet concentrate plasma from which white blood cells have been removed and plasma, the present invention has been achieved.

(問題点を解決する為の手段) すなわち本発明は、採血バッグに血漿、赤血球、血小板
は通過させるが白血球は通過させない白血球除去フィル
ターの1端が接続され、白血球除去フィルターの他端に
は少なくとも3つの血液成分分離用バッグが接続されて
成る事を特徴とする血液成分分間システムである。
(Means for Solving the Problem) That is, in the present invention, one end of a leukocyte removal filter that allows plasma, red blood cells, and platelets to pass through but does not allow white blood cells to pass through is connected to a blood collection bag, and the other end of the leukocyte removal filter is connected to at least one end of the leukocyte removal filter. This is a blood component separation system characterized by connecting three blood component separation bags.

本発明で言う採血バッグとは、採血針を備える採+fi
tチューブを連結し、内部にはACD (アシッドサイ
トレートデキストローズ)、CPD (サイトレート・
フォスフェート・デキストローズ)等の抗凝固剤を封入
したバッグであり、一般の採血に使用する採血バッグを
使用する事ができる。
The blood collection bag referred to in the present invention refers to a blood collection bag equipped with a blood collection needle.
T-tubes are connected, and inside are ACD (acid citrate dextrose) and CPD (citrate dextrose).
This bag is filled with an anticoagulant such as phosphate (dextrose), and can be used with blood collection bags used for general blood collection.

白血球除去フィルターとは、血液中の白血球は捕捉する
が他の血液成分すなわち血漿、赤証球、血小板は捕捉し
ないフィルターであり、繊維状物質、多孔性物質、粒子
状物質等を充填したフィルターを用いる事ができる。フ
ィルターの素材としては親水性材料、疎水性材料いずれ
も使用する事ができるが、匣小板の通過性の観点から親
水性表面を持つ材料の方が好ましい。フィルター素材の
形態としては、繊維状のものが白血球の捕捉効率が良く
推奨できる。[ff状物質の形態としては、織布状、不
織布状、綿状いずれも使用できるが、血液の通液性の観
点から不織布状のものが特に好ましい結果を与える。
A leukocyte removal filter is a filter that captures white blood cells in the blood but does not capture other blood components such as plasma, red blood cells, and platelets. It can be used. Both hydrophilic and hydrophobic materials can be used as the material for the filter, but materials with a hydrophilic surface are preferred from the viewpoint of passability through the box platelets. Regarding the form of the filter material, a fibrous material is recommended because it has good leukocyte capture efficiency. [As for the form of the ff-like substance, any of woven fabric, non-woven fabric, and cotton-like forms can be used, but from the viewpoint of blood permeability, a non-woven fabric gives particularly preferable results.

−F記自白血球除去フィルター、例えば繊維状物質の集
合体である不織布をフィルターの主要材料として容器に
充填して用いるが、血小板の通過性をより良くする為に
不織布表面を親水性高分子でコーティングしたり、抗血
栓性材料でコートする事もできる。繊維の直径は、0.
3μmから20μm程度の物が用いられ、繊維の素材と
しては、合成繊維、再生セルロースの様な半合成繊維、
綿の様な天然繊維、無機繊維等が用いられる。中でも合
成繊維、例えばポリエチレンテレフタレート、ナイロン
、ポリプロピレン、ポリアクリロニトリル等の繊維が好
ましく用いられる。また、コート材としては、ヒドロキ
シエチルアクリレート、ヒドロキシエチルメタクリレー
トの様にヒドロキシル基を有する高分子材料、ジエチル
アミノエチル(メタ)アクリレートとヒドロキシエチル
(メタ)アクリレートとの共11に合体の様に塩基性含
窒素官能基を有する高分子材料、ポリエーテルウレタン
、アブコサン等を用いる事ができる。
- F. A white blood cell removal filter is used, for example, by filling a container with a non-woven fabric, which is an aggregate of fibrous substances, as the main material of the filter, but in order to improve the passage of platelets, the surface of the non-woven fabric is coated with a hydrophilic polymer. It can also be coated or coated with an antithrombotic material. The fiber diameter is 0.
Fibers with a diameter of about 3 μm to 20 μm are used, and the fiber materials include synthetic fibers, semi-synthetic fibers like regenerated cellulose,
Natural fibers such as cotton, inorganic fibers, etc. are used. Among these, synthetic fibers such as polyethylene terephthalate, nylon, polypropylene, and polyacrylonitrile fibers are preferably used. In addition, as a coating material, polymer materials having hydroxyl groups such as hydroxyethyl acrylate and hydroxyethyl methacrylate, and basic materials such as a combination of diethylaminoethyl (meth)acrylate and hydroxyethyl (meth)acrylate (11) can be used. Polymer materials having nitrogen functional groups, polyether urethane, abscosan, etc. can be used.

血液成分分離用バッグとは、全血を濃厚赤血球、濃縮血
小板血漿、血漿等に分離する為に用いられる液密性のバ
ッグであり、・一般に用いられている血液成分分離用バ
ッグを用いる事ができる。
A blood component separation bag is a liquid-tight bag that is used to separate whole blood into concentrated red blood cells, concentrated platelet plasma, plasma, etc.A generally used blood component separation bag can be used. can.

また、少なくとも濃縮血小板血漿を保存する1′bに用
いられる唾液成分分離用バッグは、グロー放電処理した
軟質ポリ塩化ビニールバッグ、通気量を大きくしたバッ
グ、ポリオレフィン系エラストマー製のバッグ、炭素数
の多いフタル酸エステルを可塑剤として使用したバッグ
等血小板の機能低下を起こし難い素材より成るバッグを
使用する事が好ましい。
In addition, the bags for saliva component separation used in 1'b, which stores at least concentrated platelet plasma, are soft polyvinyl chloride bags treated with glow discharge, bags with increased ventilation, bags made of polyolefin elastomer, and bags with a large number of carbon atoms. It is preferable to use a bag made of a material that does not easily cause a decline in platelet function, such as a bag using phthalate as a plasticizer.

以ド、図面を用いて本発明血液成分分離システムを更に
詳細に説明する。
Hereinafter, the blood component separation system of the present invention will be explained in more detail using the drawings.

第1図は、本発明の基本構成を示す模式図であり、第2
図は第1図のシステムに赤血球保護液としての赤血球保
存液入りバッグを配したものであり、第3図は第1図の
システムに白血球除去フィルターに滞留する血液を回収
する為の生理的溶液入りバッグを配したものであり、第
4図は、第2図と第3図を組み合わせたものである。
FIG. 1 is a schematic diagram showing the basic configuration of the present invention, and FIG.
The figure shows the system in Figure 1 with a bag containing red blood cell preservation solution as a red blood cell protection solution, and Figure 3 shows the system in Figure 1 with a physiological solution for collecting blood retained in the leukocyte removal filter. Figure 4 is a combination of Figures 2 and 3.

第1図において、供血者から採血された血液は採血バッ
グlに導入され、採血バッグ内に存在する抗凝固剤と混
合され、唾液が凝固するのを防止される。採血された血
液は白血球除去フィルター2に重力により、または、採
血バッグを押える等の方法により送られ、白血球除去フ
ィルター2を通過した血液は第1の血液成分分離用バッ
グ3に送られる。血液は白血球除去フィルター2を通過
する事により白血球を除去されるので、第1の血液成分
分離用バッグに送られた血液に含まれるのは赤血球、血
小板および血漿である。この後、白血球除去フィルター
2と第1の血液成分分離用バッグ3との間のチューブを
アルミリングで圧着、あるいはヒートシーラーで熱融着
した後切り離し、血液成分分離用バッグ3.4.5だけ
を遠心分離装置にかけ、遠心する。この操作により第1
の血液成分分離用バッグ3中の血液は層分離し、上清に
多血小板血漿、沈漬に白血球除去濃厚赤血球か得られる
In FIG. 1, blood collected from a donor is introduced into a blood collection bag 1 and mixed with an anticoagulant present in the blood collection bag to prevent saliva from coagulating. The collected blood is sent to the leukocyte removal filter 2 by gravity or by pressing the blood collection bag, and the blood that has passed through the leukocyte removal filter 2 is sent to the first blood component separation bag 3. Since the blood passes through the leukocyte removal filter 2 to remove leukocytes, the blood sent to the first blood component separation bag contains red blood cells, platelets, and plasma. After this, the tube between the leukocyte removal filter 2 and the first blood component separation bag 3 is crimped with an aluminum ring or heat-sealed with a heat sealer and then separated, leaving only the blood component separation bag 3.4.5. Place in a centrifuge and centrifuge. With this operation, the first
The blood in the blood component separation bag 3 is separated into layers to obtain platelet-rich plasma as a supernatant and concentrated red blood cells from which leukocytes have been removed as a precipitate.

この後上清を第2の血液成分分離用バッグ4に移し、更
にもう1度遠心分離操作を行なうと第2の血液成分分離
用バッグ4中の多血小板血漿は上清に血漿、沈漬に白血
球除去濃縮血小板餌漿が得られる。
After this, the supernatant is transferred to the second blood component separation bag 4 and centrifugation is performed once more, so that the platelet-rich plasma in the second blood component separation bag 4 becomes plasma in the supernatant and submerged. Leukocyte-depleted platelet concentrate serum is obtained.

第2回目の遠心分離操作を行なう前に第1の血液成分分
離用バッグ3は、前述した操作と同じ様にして切り離し
てしまい、残りの2つの血液成分分離用バッグ4.5だ
け、第2回目の遠心分離操作にかけても良い。第2回目
の遠心分離操作の後、上清の血漿を第3の血液成分分離
用バッグ5に移し、前述した操作の様にして血液成分分
離用バッグ3.4.5を切り躍せば第1のバッグ3に白
血球除去濃厚赤血球、第2のバッグ4に白血球除去濃縮
面小坂血漿、第3のバッグ5に血漿がそれぞれ無菌的に
得られる(説明中、血液成分を1つのバッグから別のバ
ッグへ移す際等のチューブのクランプ操作は省略した。
Before performing the second centrifugation operation, the first blood component separation bag 3 is separated in the same manner as described above, and only the remaining two blood component separation bags 4.5 are separated from the second blood component separation bag 3. It may be subjected to a second centrifugation operation. After the second centrifugation operation, the supernatant plasma is transferred to the third blood component separation bag 5, and the blood component separation bag 3.4.5 is opened as described above. Leukocyte-depleted concentrated red blood cells are obtained in the first bag 3, leukocyte-depleted concentrated Kosaka plasma is obtained in the second bag 4, and plasma is obtained in the third bag 5 in a sterile manner. Clamping the tube when transferring it to a bag was omitted.

以下同じ)。遠心分離操作の際には血液成分分離用バッ
グ3.4.5のみを遠心すれば良いので自撞球除去フィ
ルター2の容器が破損したり血液成分分離用バッグ3.
4.5が白血球除去フィルター2の容器に押し潰されて
破れる様な事が無く、安全である。
same as below). During the centrifugation operation, only the blood component separation bag 3.4.5 needs to be centrifuged, so the container of the self-ball removal filter 2 may be damaged or the blood component separation bag 3.4.5 may be centrifuged.
4.5 will not be crushed and torn by the container of leukocyte removal filter 2, and it is safe.

第2図は第1図に赤血球保存液入りのバッグ6を取り付
けたものであるが、赤血球保存液は、第1回[Iの遠心
分離操作を行ない、上清の多血小板血漿を第2の唾液成
分分離用バッグ4に移した後、第1の血液成分分離用バ
ッグ3内に残る濃厚赤血球に加えられる。赤血球保存液
を濃厚赤捕球に加える事で赤血球の保存日数を更に長く
しても輪作に用いる事が可能になる。赤血球保存液の例
としては、アデニン、マンニトール、ソルビトール、グ
アノシン等を1柿類以上含む生理的溶液が挙げられる。
Fig. 2 is the same as Fig. 1 with the bag 6 containing the red blood cell preservation solution attached. After being transferred to the saliva component separation bag 4, it is added to the concentrated red blood cells remaining in the first blood component separation bag 3. By adding red blood cell preservation solution to the concentrated red catch ball, red blood cells can be stored for even longer periods and used for crop rotation. Examples of red blood cell preservation solutions include physiological solutions containing one or more of persimmons, such as adenine, mannitol, sorbitol, and guanosine.

第3図は、第1図に生理的溶液入りのバッグ7を取り付
けたものであるが、生理的溶液は、血液を採血バッグ1
から白血球除去フィルター2に流し終えた後、白血球除
去フィルター2に送られ、白血球除去フィルター2の中
に少量残存する血液を第1の血液成分分離用バッグ3に
回収する為に用いられる。この操作により、赤血球、証
小板、血漿の回収率が高くなる。生理的溶液は生理食塩
水、リンゲル液等血液成分に対してダメージをケえ難く
、生体にとって安全なものであれば全て使える。
FIG. 3 shows a bag 7 containing a physiological solution attached to FIG.
After flowing through the leukocyte removal filter 2, the blood is sent to the leukocyte removal filter 2 and used to collect a small amount of blood remaining in the leukocyte removal filter 2 into the first blood component separation bag 3. This operation increases the recovery rate of red blood cells, platelets, and plasma. Physiological solutions such as physiological saline and Ringer's solution can be used as long as they do not easily damage blood components and are safe for living organisms.

第4図は、第2図と第3図を組み合わせたものであり、
使用方法も前述のとうりである。
Figure 4 is a combination of Figures 2 and 3,
The method of use is also as described above.

また、血漿の回収率を高くする為に、第1の唾液成分分
離用バッグ3を更に強く遠心し、L清の+f+を漿を第
3の血液成分分離用バッグ5に移す為のバイパス回路を
血液成分分離用バッグ3.5間に設ける事も本発明に含
まれる。更に、第1図から第4図までの例では血液成分
分離用バッグ3.4.5が直列の位置関係で示されてい
るが、並列の位置関係にしても血液成分を分離する操作
上特別な問題は無く、この様な接続の仕方も本発明に含
まれる。
In addition, in order to increase the recovery rate of plasma, a bypass circuit is installed to centrifuge the first saliva component separation bag 3 more strongly and transfer +f+ of the L serum to the third blood component separation bag 5. The present invention also includes providing the bag between the blood component separation bags 3.5. Furthermore, although the blood component separation bags 3.4.5 are shown in a serial position in the examples shown in FIGS. There is no problem, and this method of connection is also included in the present invention.

また、先に述べた血液成分分離操作では、濃縮血小板血
漿を得る際に遠心分離を行ない、沈渣として血小板を得
ているが、第2回目の遠心分離をせずに第1回目の遠心
分離操作後第1の血液成分分離用バッグ3から上清のう
ち血小板濃度の薄い部分を血液成分分離用バッグ5に移
した後、血小板濃度の濃い部分を血液成分分離用バッグ
4に移す方法もとれる。この操作の場合は、血液成分分
離用バッグ3.4.5は並列の位置関係である事か好ま
しい。
In addition, in the blood component separation operation described above, centrifugation is performed when obtaining concentrated platelet plasma, and platelets are obtained as a sediment, but the first centrifugation operation is performed without performing the second centrifugation. Alternatively, a portion of the supernatant with a low platelet concentration may be transferred from the first blood component separation bag 3 to the blood component separation bag 5, and then a portion with a high platelet concentration may be transferred to the blood component separation bag 4. In the case of this operation, it is preferable that the blood component separation bags 3.4.5 are in a parallel positional relationship.

(発明の効果) 以上述べた様に、本発明を用いる′1(により、全血か
ら1つの血液成分分離システムを用いるだけで、完全に
無菌的に、白血球を除去した濃厚赤血球、白血球を除去
した濃縮血小板血漿、血漿の3種類の唾液成分を同時に
得る事ができる様になった。更に遠心分離操作を行なう
際、白血球除去フィルターを取り外してしまう事が可能
な為、遠心時に白If11球除去フィルターが破損した
り、血液成分分離用バッグが破損される事が無い為非常
に安全な血液成分分離システムとする事ができた。
(Effects of the Invention) As described above, by using the present invention'1, concentrated red blood cells and white blood cells from whole blood can be removed completely aseptically by using only one blood component separation system. It is now possible to simultaneously obtain three types of saliva components: platelet concentrate plasma and plasma.Furthermore, since the leukocyte removal filter can be removed when centrifuging, white If11 cells can be removed during centrifugation. Since the filter is not damaged or the blood component separation bag is not damaged, a very safe blood component separation system can be achieved.

また、1目1ul1球を除去した血液製剤が得られる為
、微小凝集物の発生も少なく、溶面等も少なくな)た。
In addition, since a blood product from which 1 ul of 1 cell was removed was obtained, there was less generation of microaggregates and less soluble surface, etc.).

以下、実m例により本発明をより詳細に説明する。Hereinafter, the present invention will be explained in more detail using actual examples.

(実施例) 実h’ts例1 唾液成分分離システムとして第1図に示すものを用いた
(Example) Actual h'ts Example 1 The saliva component separation system shown in FIG. 1 was used.

白血球除去フィルター2としては、・ト均直径1.8μ
mのポリエチレンテレフタレート製不織布を67mmX
67mmの正方形に切断したものを重ねて、第5図に示
すようにカラム内にセットした後、後述するコポリマー
をコートしたものを用いた。不織イaフィルター層11
は、2枚の角型の枠体9.9′を組み合わせてできてい
るカラム本体8の中にセットされており、その周辺部は
圧着されている。10.10′はカラムの内側に設けら
れた突起であり、不織布フィルターの中央部を部分的に
支持している。12は処理血液人口、13は分離血液出
口である。不織布フィルターの有効断面積は60mmX
60mm=3600mm2であり、厚みは7mm、重量
は4.2gである。
The leukocyte removal filter 2 has an average diameter of 1.8μ.
m polyethylene terephthalate nonwoven fabric 67mm
The pieces cut into 67 mm squares were stacked and set in a column as shown in FIG. 5, and then coated with a copolymer to be described later. Non-woven filter layer 11
is set in the column body 8, which is made by combining two rectangular frames 9 and 9', and the periphery of the column body 8 is crimped. 10.10' is a protrusion provided inside the column, which partially supports the central part of the nonwoven fabric filter. 12 is a processed blood population, and 13 is a separated blood outlet. The effective cross-sectional area of the non-woven filter is 60mm
60mm=3600mm2, thickness is 7mm, and weight is 4.2g.

コポリマーの合成及び不織布へのコーティングは以下の
様に行なった。
Synthesis of the copolymer and coating on the nonwoven fabric were performed as follows.

2−ヒドロキシエチルメタアクリレート(以下HEMA
と略称する)とジエチルアミノエチルメタアクリレート
(以下DEAMAと略称する)のコポリマーを通常の溶
液ラジカル「F合によって合成した。重合条件としては
、エタノール中の千ツマー濃度1モル/j2で開始剤と
してアゾイソブチロニトリル(A I BN)1/20
0モル/2存在下、60℃で8時間重合反応を行った。
2-Hydroxyethyl methacrylate (hereinafter referred to as HEMA)
A copolymer of diethylaminoethyl methacrylate (abbreviated as DEAMA) and diethylaminoethyl methacrylate (hereinafter abbreviated as DEAMA) was synthesized by a conventional solution radical "F" reaction.The polymerization conditions were as follows. Isobutyronitrile (A I BN) 1/20
The polymerization reaction was carried out at 60° C. for 8 hours in the presence of 0 mol/2.

上記ポリマーをIg/diの濃度になる様にエタノール
に溶解したものを前述の不織布フィルターに充填した後
、余分なポリマーを乾燥窒素を送り込む事により除去し
、更にそのまま窒素を送り続け、乾燥した。このフィル
ターを更に16時間真空乾燥した後、白血球除去フィル
ター2とした。コーティングしたHEMAとDEAMA
とのコポリマー中のDEAMA単位の含量は5モル%と
した。
The above-mentioned polymer dissolved in ethanol to a concentration of Ig/di was filled in the non-woven filter, excess polymer was removed by feeding dry nitrogen, and nitrogen was continued to be fed to dry it. This filter was further vacuum-dried for 16 hours, and then used as leukocyte removal filter 2. Coated HEMA and DEAMA
The content of DEAMA units in the copolymer with was 5 mol%.

採血バッグ1はCPD入りの採血バッグ、血液成分分離
用バッグ3.4.5は市販のものを用いた。
Blood collection bag 1 was a blood collection bag containing CPD, and blood component separation bags 3.4.5 were commercially available ones.

供血者からの血液400gを採血バッグ1に導入した後
、重力により白血球除去フィルター2を経由して、第1
の面域成分分離用バッグ3に流した。血液全てを流し終
えるまでの時間は20分であった。
After introducing 400 g of blood from a blood donor into the blood collection bag 1, it passes through the leukocyte removal filter 2 due to gravity and is transferred to the first blood collection bag.
It was poured into a bag 3 for separating area components. It took 20 minutes to drain all the blood.

この後、ヒートシーラーを用いて白血球除去フィルター
2と第1の血液成分分離用バッグ3との間のチューブを
2ケ所溶着し、その間をはさみで切断し、唾液成分分離
用バッグ3.4.5を22℃の遠心分離機にセットし、
300gで18分遠心した。この後遠心分離機より血液
成分分離用バッグ3.4.5を取り出し、第1の血液成
分分離用バッグ3を押えつけながら上清を第2の血液成
分分離用バッグ4に移した。この後もう1度22℃の遠
心分離機にセットし、3000gで6分遠心した。その
後遠心分離機から血液成分分離用バッグ3.4.5を取
り出し、第2の血液成分分離用バッグ4に20m1の血
漿を残す様にして上清を第3の唾液成分分履用バッグ5
に移した。
After this, the tube between the leukocyte removal filter 2 and the first blood component separation bag 3 is welded at two places using a heat sealer, and the space between them is cut with scissors, and the saliva component separation bag 3.4.5 Place it in a centrifuge at 22℃,
Centrifugation was performed at 300g for 18 minutes. Thereafter, the blood component separation bag 3.4.5 was taken out from the centrifuge, and the supernatant was transferred to the second blood component separation bag 4 while pressing the first blood component separation bag 3. Thereafter, the mixture was placed in a centrifuge at 22° C. and centrifuged at 3000 g for 6 minutes. Thereafter, the blood component separation bag 3.4.5 is taken out from the centrifuge, and the supernatant is transferred to the third saliva component separation bag 5, leaving 20ml of plasma in the second blood component separation bag 4.
Moved to.

以上の様にして得られた各血液成分分離用バッグ中の成
分を実験に供した血液と比較して分析したところ、第1
の血液成分分離用バッグ3中に含まれる濃厚赤血球中に
は実験に供した赤血球の91%が回収され、混入した白
血球は実験に供した白血球の0.8%であった。第2の
血液成分分離用バッグ4中に含まれる濃縮血小板血漿中
には実験に供した血小板の62%が回収され、混入した
白血球は実験に供した白血球の0.9%であった。第3
の血液成分分離用バッグ5中には164m1の血漿が回
収できた。操作中血液成分分離用バッグ、回路等の破損
は無かった。
When the components in each blood component separation bag obtained as described above were compared and analyzed with the blood used in the experiment, it was found that
91% of the red blood cells used in the experiment were recovered in the concentrated red blood cells contained in the blood component separation bag 3, and the amount of contaminated white blood cells was 0.8% of the white blood cells used in the experiment. 62% of the platelets used in the experiment were recovered in the concentrated platelet plasma contained in the second blood component separation bag 4, and the number of leukocytes mixed in was 0.9% of the white blood cells used in the experiment. Third
164 ml of plasma was collected in the blood component separation bag 5. There was no damage to the blood component separation bag, circuit, etc. during the operation.

実施例2 血液成分分離システムとして、第3図に示すものを用い
た。生理的溶液を含むバッグ7としては、生理食塩液3
0mjZを含むポリ塩化ビニル製バッグを用いた。これ
以外の構成部品は全て実施例1と同じにした。
Example 2 The blood component separation system shown in FIG. 3 was used. The bag 7 containing a physiological solution includes a physiological saline solution 3.
A polyvinyl chloride bag containing 0mjZ was used. All other components were the same as in Example 1.

操作方法も、採血バッグl中の血液を全て流し終わった
後、生理的溶液を含むバッグ7中の生理食塩液を白血球
除去フィルター2に流した事態外は、実施例1と同様に
操作を行なった。
The operation method was the same as in Example 1, except that after all the blood in the blood collection bag 1 had been drained, the physiological saline in the bag 7 containing the physiological solution was poured into the leukocyte removal filter 2. Ta.

得られた各血液成分分離用バッグ中の成分を実施例1と
同様に分析したところ、第1の血液成分分離用バッグ3
中に含まれる濃厚赤血球中には実験に供した赤直球の9
6%が回収され、混入した白血球は実験に供した白血球
の0.8%であった。第2の血液成分分離用バッグ4中
に含まわる濃縮血小板血漿中には実験に供した血小板の
66%が回収され、混入した白血球は実験に供した白血
球の0.9%であった。第3の血液成分分難用バッグ5
中には178mILの血漿が回収できた。
When the components in each blood component separation bag obtained were analyzed in the same manner as in Example 1, it was found that the first blood component separation bag 3
The concentrated red blood cells contained in it contain 9 of the red blood cells used in the experiment.
6% were recovered, and the contaminated leukocytes accounted for 0.8% of the leukocytes used in the experiment. In the concentrated platelet plasma contained in the second blood component separation bag 4, 66% of the platelets used in the experiment were recovered, and the amount of mixed white blood cells was 0.9% of the white blood cells used in the experiment. Third blood component separation bag 5
178 mL of plasma was recovered.

操作中血液成分分離用バッグ、回路等の破損は無く、実
施例1に比べ、赤+m球、直小板、血漿の回収率か高く
なった。
There was no damage to the blood component separation bag, circuit, etc. during the operation, and the recovery rate of red + m bulbs, platelets, and plasma was higher than in Example 1.

【図面の簡単な説明】[Brief explanation of the drawing]

第1図は本発明血液成分分離システムの基本構成を示す
模式図であり、第2図は第1図のシステムに赤血球保存
液入りバッグを配したシステムの模式図であり、第3図
は第1図のシステムに生理的溶液入りバッグを配したシ
ステムの模式図であり、第4図は第2図と第3図を組み
合わせたシステムの模式図である。第5図は実施例で用
いた白血球除去フィルターの構成を示す断面模式図であ
る。 1、採血バッグ 2、白血球除去フィルター 3.4.5.血液成分分離用バッグ 6、赤血球保存液入りバッグ 7、生理的溶液入りバッグ 8、カラム本体 9.9’ 、枠体 10.10’、突起 11、不織布フィルター層 12、血液人[1 13,1111液出L1
FIG. 1 is a schematic diagram showing the basic configuration of the blood component separation system of the present invention, FIG. 2 is a schematic diagram of a system in which a bag containing a red blood cell preservation solution is arranged in the system of FIG. This is a schematic diagram of a system in which a bag containing a physiological solution is arranged in the system of FIG. 1, and FIG. 4 is a schematic diagram of a system that combines FIGS. 2 and 3. FIG. 5 is a schematic cross-sectional view showing the configuration of a leukocyte removal filter used in Examples. 1. Blood collection bag 2. Leukocyte removal filter 3.4.5. Blood component separation bag 6, bag 7 containing red blood cell preservation solution, bag 8 containing physiological solution, column body 9.9', frame body 10.10', protrusion 11, non-woven filter layer 12, blood cell [1 13, 1111 Liquid output L1

Claims (4)

【特許請求の範囲】[Claims] (1)採血バッグに血漿、赤血球、血小板は通過させる
が白血球は通過させない白血球除去フィルターの1端が
接続され、白血球除去フィルターの他端には少なくとも
3つの血液成分分離用バッグが接続されてなる事を特徴
とする血液成分分離システム。
(1) One end of a leukocyte removal filter that allows plasma, red blood cells, and platelets to pass through but not white blood cells is connected to the blood collection bag, and at least three blood component separation bags are connected to the other end of the leukocyte removal filter. A blood component separation system featuring:
(2)血液成分分離用バッグの中、少なくとも濃縮血小
板血漿保存用に用いられるバッグが血小板の機能低下を
起こし難い素材よりなる請求項1記載の血液成分分離シ
ステム。
(2) The blood component separation system according to claim 1, wherein at least the bag used for storing concentrated platelet plasma among the blood component separation bags is made of a material that does not easily cause a decline in platelet function.
(3)白血球除去フィルターから濃縮赤血球保存用に用
いられる血液成分分離用バッグまでの間の少なくとも1
ケ所に、赤血球保存液を含むバッグが接続されている請
求項1または2記載の血液成分分離システム。
(3) At least 1 part between the leukocyte removal filter and the blood component separation bag used for storing concentrated red blood cells.
3. The blood component separation system according to claim 1, wherein a bag containing a red blood cell preservation solution is connected to the blood component separation system.
(4)採血バッグから白血球除去フィルターまでの間の
少なくとも1ケ所に、生理的溶液を含むバッグが接続さ
れている請求項1〜3のいずれか1つに記載の血液成分
分離システム。
(4) The blood component separation system according to any one of claims 1 to 3, wherein a bag containing a physiological solution is connected to at least one location between the blood collection bag and the leukocyte removal filter.
JP63153464A 1988-06-23 1988-06-23 Blood component separation method Expired - Lifetime JPH0659304B2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
JP63153464A JPH0659304B2 (en) 1988-06-23 1988-06-23 Blood component separation method
DE68902698T DE68902698C5 (en) 1988-06-23 1989-06-22 Method for separating blood into blood components and unit for separating blood components.
EP89306284A EP0349188B1 (en) 1988-06-23 1989-06-22 Method for separating blood into blood components, and blood components separator unit
AU36713/89A AU617265B2 (en) 1988-06-23 1989-06-22 Method for separating blood into blood components, and blood components separator unit
KR1019890008735A KR910004326B1 (en) 1988-06-23 1989-06-23 Method for separating blood into blood components and blood components separator unit
US07/370,750 US4985153A (en) 1988-06-23 1989-06-23 Method for separating blood into blood components, and blood components separator unit
GR920400962T GR3005581T3 (en) 1988-06-23 1992-09-03

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP63153464A JPH0659304B2 (en) 1988-06-23 1988-06-23 Blood component separation method

Publications (2)

Publication Number Publication Date
JPH01320064A true JPH01320064A (en) 1989-12-26
JPH0659304B2 JPH0659304B2 (en) 1994-08-10

Family

ID=15563137

Family Applications (1)

Application Number Title Priority Date Filing Date
JP63153464A Expired - Lifetime JPH0659304B2 (en) 1988-06-23 1988-06-23 Blood component separation method

Country Status (1)

Country Link
JP (1) JPH0659304B2 (en)

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JP2009090136A (en) * 2009-01-08 2009-04-30 Terumo Corp Blood component separating apparatus
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