JP3868261B2

JP3868261B2 - Blood component separator

Info

Publication number: JP3868261B2
Application number: JP2001329084A
Authority: JP
Inventors: 淳広田; 正徳丹生
Original assignee: Kawasumi Laboratories Inc
Current assignee: SB Kawasumi Laboratories Inc
Priority date: 2001-10-26
Filing date: 2001-10-26
Publication date: 2007-01-17
Anticipated expiration: 2021-10-26
Also published as: JP2003130865A

Description

【０００１】
【発明の属する技術分野】
本発明は、血液（全血）を収納した血液バッグ（親バッグ）を遠心分離処理した後、分離した各血液成分を自動的に各血液成分の分離容器（子バッグ）に分取することができる血液成分分離装置の改良に関する
【０００２】
【従来技術及び発明が解決しようとする課題】
現在使用されている血液成分分離装置は、親バッグから血漿層、界面層（バフィーコート層）を各血液成分の子バッグに移送するために上部支点方式、下部支点方式、平行移動方式が採用されている。
図７は現在使用されている親バッグの押圧手段の一例を示す概略図で、（Ａ）は上部支点方式、（Ｂ）は下部支点方式、（Ｃ）は平行移動方式である。
図８は全血を遠心分離により血漿層２１と界面層２２と赤血球層２３の各層に分離した親バッグ４１を装着して、界面層（バフィーコート層）２２が界面検出位置Ｌ１で検出されるまで血漿層２１を子バッグ３２に移送した後の親バッグ４１の概略図で、（Ａ）はＨｔ値が高い場合の上部支点方式、（Ｂ）はＨｔ値が低い場合の上部支点方式、（Ｃ）はＨｔ値が高い場合の下部支点方式、（Ｄ）はＨｔ値が低い場合の下部支点方式、（Ｅ）はＨｔ値が高い場合の平行移動方式、（Ｆ）はＨｔ値が低い場合の平行移動方式である。
血液（全血）によりＨｔ値（赤血球÷全血×１００［％］）の個体差がある。
ここではＨｔ値が高い場合または低い場合として表す。
【０００３】
図９は親バッグ４１において界面層（バフィーコート層）２２が界面検出位置Ｌ1で検出されるまで血漿層２１を子バッグ３２に移送した後、界面層（バフィーコート層）２２を子バッグ３３に移送するが、設定した一定量を移送するため、わずかであるが血漿層２１と血球層２３も含まれる。前記「一定量」とは界面層（バフィーコート層）２２の全量を子バッグ３３に移送するために少なくとも、界面検出位置Ｌ１付近に残った血漿層と前記界面層（バフィーコート層）の全量と、わずかな血球層であり、前記３層を移送するための「一定量」のことである。
従って前記子バッグ３３内の血液成分を表した概略図で、Ｈｔ値の高い場合の前記押圧手段の（Ａ）（Ｃ）（Ｅ）とＨｔ値の低い場合の前記押圧手段（Ｂ）（Ｄ）（Ｆ）に区別した。
上部支点方式とは、図８の（Ａ）（Ｂ）のように補助押圧板４３と押圧板４５の上部に支点４０を介して、前記補助押圧板４３と押圧板４５の間に親バッグ３１を装着する方式であり、下部支点方式とは図８の（Ｃ）（Ｄ）のように前記補助押圧板４３と押圧板４５の下部に支点４０を介して親バッグ４１を装着する方式で、双方とも前記補助押圧板４３と押圧板４５で親バッグ４１を押しつぶして、容器内の血液成分を押し出している。
平行移動方式とは図８の（Ｅ）（Ｆ）のように補助押圧板４３と押圧板４５の二枚を平行に配置し、前記補助押圧板４３と押圧板４５の間に親バッグ４１を装着する方式である。
図７の駆動手段４７は前記押圧手段を動作させ、例えばスプリング圧、圧搾空気圧、モータ駆動力等が採用することができる。
【０００４】
子バッグ３３へ移送される血漿層２１、界面層（バフィーコート層）２２、赤血球層２３の割合は図８より以下のようになる。
前記図８の（Ａ）（Ｂ）においてＨｔ値が高いと補助押圧板４３と押圧板４５の角度が大きくなり血漿層２１の容量が多くなる。逆にＨｔ値が低いと前記角度も小さくなり血漿層２１の容量も少なくなる。ここで図８の（Ａ）のθ1と（Ｂ）のθ２の関係は、θ１＞θ２となる。同様に下部支点方式の（Ｃ）のθ３と（Ｄ）のθ４の関係もθ３＞θ４となり、前記平行移動方式（Ｅ）の幅Ｌ２と（Ｆ）のＬ３の関係もＬ２＞Ｌ３となる。
▲１▼前記図８の（Ａ）（Ｃ）（Ｅ）のようにＨｔ値が高い場合、界面層（バフィーコート層）２２を子バッグ３３に移送される際、界面層（バフィーコート層）２２と一緒に移送される血漿層２１の容量は多くなり、図８の（Ｂ）（Ｄ）（Ｆ）のＨｔ値が低い場合子バッグ３３に移送される界面層（バフィーコート層）２２と一緒に移送される血漿層２１の容量は少なくなる。
▲２▼子バッグ３３に移送される界面層（バフィーコート層）２２の容量は、血液のＨｔ値の高い場合や低い場合にかかわらずほぼ一定である。
▲３▼赤血球層２３は、界面層（バフィーコート層）２２を子バッグ３３に移送する際、設定された一定の容量から前記▲１▼の血漿層２１と界面層（バフィーコート層）２２の容量を差し引いたものになる。従って前記▲１▼の血漿層２１の容量および前記▲２▼の界面層（バフィーコート層）２２の容量からＨｔ値が高い場合に子バッグ３３に界面層（バフィーコート層）２２と一緒に移送される赤血球層２３の容量が少なくなり、Ｈｔ値が低い場合に子バッグ３３に界面層（バフィーコート層２２と一緒に移送される前記赤血球層２３の容量が多くなる。
血液中に含まれる白血球は輸血等により人体に影響があり除去しなければならない。前記白血球は主として界面層（バフィーコート層）２２に含まれるが、該界面層の上下に隣接する血漿層２１及び血球層２３との界面付近にも存在する。
従って前記図９の（Ａ）（Ｃ）（Ｅ）の場合のように血漿層２１の割合が多いとき、赤血球層２３の割合が少なくなり赤血球層２３に存在する白血球が確保できず、また（Ｂ）（Ｄ）（Ｆ）の場合のように血漿層２１の割合が少ないとき、血漿層２１に存在する白血球が確保できない。
このように、血液のＨｔ値の個体差により子バッグ３３に移送された血漿層２１、界面層（バフィーコート層）２２、赤血球層２３の割合にばらつきが生じるため白血球の確保がうまくいかない。つまり白血球の除去率が安定しない。
そこで、本発明者らは以上の課題を解決する為に鋭意検討した結果、次の発明に到達した。
【０００５】
【課題を解決するための手段】
［１］本発明は、親バッグ（３１）と複数の子バッグ（３２）（３３）（３４）を有する血液バッグ（３０）を装着し、遠心分離により各層に分離された親バッグ（３１）内の血液成分を自動的に各子バッグ（３２）（３３）（３４）に移送する血液成分分離装置（１）において、
上部押圧板（１１）と下部押圧板（１２）を有する親バッグ（３１）の押圧手段（４）と、遠心分離により各層に分離された血液成分の界面検出手段（３）と、前記界面検出手段（３）と前記押圧手段（４）の主制御部（６）から構成され、前記主制御部（６）により、前記押圧手段（４）の動きを制御して、血液のＨｔ値とは無関係に界面検出位置（Ｌ１）と界面待ち位置（Ｌ１２）が同じになるように制御することができる血液成分分離装置（１）を提供する。
［２］本発明は、親バッグ（３１）と複数の子バッグ（３２）（３３）（３４）を有する血液バッグ（３０）を装着し、遠心分離により各層に分離された親バッグ（３１）内の血液成分を自動的に各子バッグ（３２）（３３）（３４）に移送する血液成分分離装置（１）において、
前記押圧手段（４）と子バッグ（３２）（３４）の押圧手段（４ａ）（４ｂ）と、
親バッグ（３１）と各子バッグ（３２）（３３）（３４）の連結チューブ（３５ａ）（３５ｂ）（３５ｃ）のクランプ及び／又はシール手段（２）（２ａ）（２ｂ）と、前記界面検出手段（３）と、
血漿層（２１）の重量を測定する子バッグ（３２）の重量測定手段（５ａ）と、
界面層（バフィーコート層）（２２）の重量を測定する子バッグ（３３）の重量測定手段（５ｂ）と、血液保存液（２４）の重量を測定する子バッグ（３４）の重量測定手段（５ｃ）と、
前記押圧手段（４）（４ａ）（４ｂ）、クランプ及び／又はシール手段（２）（２ａ）（２ｂ）、前記界面検出手段（３）、重量測定手段（５ａ）（５ｂ）（５ｃ）の各手段を連動制御する主制御部（６）から構成した前記［１］に記載の血液成分分離装置（１）を提供する。
［３］本発明は、前記親バッグ（３１）の押圧手段（４）は、補助押圧板（１３ａ）と上部押圧板（１１）と下部押圧板（１２）と、これを駆動させる駆動手段（７ａ）（７ｂ）と前記上部押圧板（１１）及び下部押圧板（１２）の動きを制御するリミットスイッチ（１０ａ）（１０ｂ）により構成され、前記上部押圧板（１１）と補助押圧板（１３ａ）を平行に配置し、
下部押圧板（１２）は上部押圧板（１１）より分離独立して補助押圧板（１３ａ）と平行に配置するか、または
上部押圧板（１１）と下部押圧板（１２）の間に支点（２０）を装着し前記下部押圧板（１２）が前記支点（２０）を軸として補助押圧板（１３ａ）方向に回動することができるように形成した前記［１］ないし［２］に記載の血液成分分離装置（１）を提供する。
［４］本発明は、前記子バッグ（３２）（３４）の押圧手段（４ａ）（４ｂ）は上部押圧板（１５）（１５ａ）を駆動させる駆動手段（７ａ）（７ｂ）と前記押圧板（１５）（１５ａ）の動きを制御するリミットスイッチ（１０ｃ）（１０ｄ）により構成され、
補助押圧板（１３ｂ）（１３ｃ）と押圧板（１５）（１５ａ）の間に支点（２０Ａ）を装着して、前記押圧板（１５）（１５ａ）が前記支点（２０Ａ）を軸として補助押圧板（１３ｂ）（１３ｃ）方向に回動することができるように形成した前記［１］ないし［３］に記載の血液成分分離装置（１）を提供する。
［５］本発明は、連結チューブ（３５ａ）、（３５ｂ）、（３５ｃ）の各子バッグ（３２）、（３３）、（３４）側にクランプ手段２ａ（２ａ１、２ａ２、２ａ３）と、連結チューブ（３５ａ）の子バッグ３２側にシール手段（２ｂ）と、連結チューブ（３５ａ）の親バッグ３１側にクランプ／シール手段（２）配置し、
前記シール手段（２ｂ）は親バッグ（３１）と子バッグ（３２）（３４）の連結チューブ（３５ａ）（３５ｃ）を２本同時に挟持してシールできるように形成した前記［１］ないし［４］に記載の血液成分分離装置（１）を提供する。
［６］本発明は、前記子バッグ（３３）の収納手段（１４）を有し、該収納手段（１４）には、前記子バッグ（３３）の載置皿（２６）と該載置皿（２６）の底部に重量測定手段５ｂが配置され、
前記子バッグ（３２）（３４）の収納手段（１６）（１９）を有し、該収納手段（１６）（１９）には前記押圧手段（４ａ）（４ｂ）と該押圧手段（４ａ）（４ｂ）の補助押圧板（１３ｂ）（１３ｃ）の底部に重量測定手段（５ａ）（５ｃ）を配置した前記［１］ないし［５］に記載の血液成分分離装置（１）を提供する。
［７］本発明は、前記子バッグ（３２）（３４）の液体排出管理手段として、（ａ）重量管理手段、（ｂ）時間管理手段、（ｃ）押圧板と補助押圧板間の隙間管理手段、（ｄ）子バッグ（３２）（３４）内にあるエアー検出管理手段の少なくとも一つ以上の前記（ａ）重量管理手段、（ｂ）時間管理手段、（ｃ）隙間管理手段、（ｄ）エアー管理手段を有している前記［１］ないし［６］に記載の血液成分分離装置（１）を提供する。
【０００６】
【発明の実施の形態】
図１は本発明の血液成分分離装置１の概略図で、図２は血液成分分離装置１のブロック図である。図３は本発明の親バッグ３１の押圧手段の概略図で、（Ａ）は二段平行移動方式、（Ｂ）は中間支点方式の概略図である。図４は４連バッグシステムで構成される血液バッグ３０で、全血を遠心分離し血漿層２１、界面層（バフィーコート層）２２、赤血球層２３に分離したときの概略図ある。図５は前記二段平行移動方式（Ａ）（Ｂ）と中間支点方式（Ｃ）（Ｄ）に各血液成分が分離されたバッグ３１を装着して界面検出位置Ｌ１に達した時の断面図である。詳述すれば（Ａ）（Ｃ）は採血者のＨｔ値が高い場合で（Ｂ）（Ｄ）は低い場合である。
図６はＨｔ値が高い場合の（Ａ）（Ｃ）と低い場合の（Ｂ）（Ｄ）を子バッグ３３内に移送した後の該子バッグ３３内の血漿層２１、界面層２２、赤血球層２３の各割合を表した概略図である。
本発明は遠心分離により各層に分離された親バッグ３１内の血液成分を自動的に各子バッグ３２、３３、３４に移送する血液成分分離装置１であり、上部押圧板１１と下部押圧板１２を有する親バッグ３１の押圧手段４と、遠心分離により各層に分離された血液成分の界面検出手段３と、該界面検出手段３と前記押圧手段４の主制御部６から構成されている。
前記主制御部６により、前記押圧手段４の動きを制御して、血液のＨｔ値とは無関係に界面検出位置Ｌ１と界面待ち位置Ｌ１２が同じようになるように制御することができる。
さらに前記押圧手段４と、子バッグ３２、３４の押圧手段４ａ、４ｂと親バッグ３１と各子バッグ３２、３３、３４の連結チューブ３５ａ、３５ｂ、３５ｃのクランプ及び／又はシール手段２、２ａ、２ｂと、前記界面検出手段３と、血漿層２１の重量を測定する子バッグ３２の重量測定手段５ａと、界面層（バフィーコート層）２２の重量を測定する子バッグ３３の重量測定手段５ｂと、血液保存液２４の重量を測定する子バッグ３４の重量測定手段５ｃの各手段を連動制御する主制御部６から構成される。
【０００７】
少なくとも本発明の血液成分分離装置１を構成する前記押圧手段４、４ａ、４ｂ、クランプ及び／又はシール手段２、２ａ、２ｂ、前記界面検出手段３、重量測定手段５ａ、５ｂ、５ｃは主制御部６により連動制御される。
親バッグ３１の押圧手段４は、補助押圧板１３ａと上部押圧板１１と下部押圧板１２と、これを駆動させる駆動手段７ａ、７ｂと前記上部押圧板１１及び下部押圧板１２の動きを制御するリミットスイッチ１０ａ、１０ｂにより構成され、前記上部押圧板１１と補助押圧板１３ａは平行に配置されている。
上部押圧板１１及び下部押圧板１２の動きはリミットスイッチ１０ａ、１０ｂにより制御される。
前記親バッグ３１の押圧手段は二段平行移動方式と中間支点方式がある。
二段平行移動方式（Ａ）は上部押圧板１１に駆動手段７ａが装着され、下部押圧板１２に駆動手段７ｂがそれぞれ分離独立して二段に装着されている。
中間支点方式（Ｂ）は上部押圧板１１の下端部に支点２０を介して下部押圧板１２を装着している。上部押厚板１１及び下部押圧板１２には前記二段平行移動方式（Ａ）と同様に駆動手段７ａ、７ｂが装着されている。
前記二段平行移動方式（Ａ）は本件出願人により特許第２５２８０５８号及び第３１８４０５２号で開示しており、上層に血漿層、中間に界面層（バフィーコート層）、下層に赤血球層に分離された親バッグから界面層（バフィーコート層）の乱れを極小に抑え各血液成分を子バッグに分離することができる。
中間支点方式は、支点２０により上部押圧板１１と下部押圧板１２間の隙間がなくなり界面検出が確実にできる。
前記リミットスイッチ１０ａは上部押圧板１１の動きを制御し、原点ｅ、中間点ｆ、界面待ち位置ｇ、ｈの４つのリミットスイッチから構成されている。
前記原点ｅは例えば４００ｍｌバッグに対する上部押圧板１１の分離開始位置を定めるスイッチであり、中間点ｆは２００ｍｌバッグに対する上部押圧板１１の分離開始位置を定めるスイッチであり、界面待ち位置ｇ、ｈは２００ｍｌと４００ｍｌの各バッグの界面待ち位置を定めるスイッチである。
前記リミットスイッチ１０ｂは下部押圧板１２の動きを制御し、原点ｅ１、中間点ｆ１、端点ｉの３つのスイッチから構成されている。前記原点ｅ１は２００ｍｌ及び４００ｍｌバッグ共通で下部押圧板１２の分離開始位置を定めるスイッチであり、前記中間点ｆ１は２００ｍｌバッグ分離時の下部押圧板１２の一時停止位置を定めるスイッチであり、前記端点ｉは下部押圧板１２がこれ以上補助押圧板１３ａ方向に移動できない位置を定めるスイッチである。
【０００８】
子バッグ３２、３３の押圧手段４ａ、４ｂは押圧板１５、１５ａを駆動させる駆動手段７ｃ、７ｄと前記押圧板１５、１５ａの動きを制御するリミットスイッチ１０ｃ、１０ｄと支点２０Ａにより構成されている。
前記押圧手段４ａ、４ｂは補助押圧板１３ｂ、１３ｃと押圧板１５、１５ａに支点２０Ａを装着し、前記押圧板１５、１５ａが前記支点２０Ａを軸として補助押圧板１３ｂ、１３ｃ方向に回動することができる。
前記クランプ及び／又はシール手段２、２ａ、２ｂは、連結チューブ３５ａの子バッグ３２側にクランプ手段２ａ１と連結チューブ３５ｂの子バッグ３３側にクランプ手段２ａ２と連結チューブ３５ｃの子バッグ３４側にクランプ手段２ａ３のクランプ手段２ａが配置され、連結チューブ３５ａの子バッグ３２側にシール手段２ｂが配置され、連結チューブ３５ａの親バッグ３１側にクランプ／シール手段２により構成されている。前記シール手段２ｂ及びクランプ／シール手段２のシール方式は、高周波ウェルダー方式、加熱方式、超音波方式等があり、何れの方式でも採用することができる。
前記界面検出手段３は上部押圧板１１の中央に配置されている。前記界面検出手段３で採用される光センサは上部押圧板１１の縦方向に形成されており反射型、透過型どちらでもよく、一対でも複数対形成してもよい。
前記重量測定手段５ａ、５ｂ、５ｃはロードセルであり、該重量測定手段５ａ、５ｂ、５ｃにより子バッグ３２、３４、３３に移送または前記子バッグから排出される血液成分または血液保存液の重量を監視し且つ移送または排出設定量に達したらクランプ／シール手段２及びクランプ手段２ａ（２ａ１、２ａ２、２ａ３）が閉じるように制御されている。
【０００９】
さらに本発明の血液成分分離装置１は、前記子バッグ３３の収納手段１４を有し、該収納手段１４には、前記子バッグ３３の載置皿２６と該載置皿２６の底部に重量測定手段５ｂが配置されている。
また、前記子バッグ３２、３４の収納手段１６、１９を有し、該収納手段１６、１９には前記押圧手段４ａ、４ｂと該押圧手段４ａ、４ｂの補助押圧板１３ｂ、１３ｃの底部に重量測定手段５ａ、５ｃを配置している。
前記押圧手段４ａのリミットスイッチ１０ｃには開点ｊと閉点ｋが装着され、前記押圧手段４ｂのリミットスイッチ１０ｄには開点ｊ１と閉点ｋ１がそれぞれ装着されている。
前記開点ｊ、ｊ１は押圧板１５、１５ａが開いた位置を検出し、閉点ｋ、ｋ１は前記押圧板１５、１５ａが閉じた位置、つまり押圧板１５、１５ａと補助押圧板１３ｂ、１３ｃが合わさり閉じた位置を検出する。従って前記補助押圧板１３ｂ、１３ｃの上に配置した子バッグ３２、３４の液体を排出することができる。
記憶部１７は、ＲＯＭ、ＥＥＰＲＯＭ、ＲＡＭからなり、停電時でも設定記憶内容を保持させることができる。
親バッグ３１と子バッグ３４の上部には、遮断開放部３６（以下、連通ピース）が配置されているので、分離開始前に連通ピース３６を破壊してから分離を開始する。前記連通ピース３６を外部から破壊することのできる連通ピース破壊手段９（９ａ、９ｂ）を設けることもできる。前記連通ピース破壊手段９（９ａ、９ｂ）は手動または自動でも良い。
表示部８は本発明の血液成分分離装置１の例えば重量測定手段５ａ、５ｂ、５ｃの重量等が表示される。
電源部１８は本発明の血液成分分離装置１のメインスイッチのことである。
【００１０】
実施例
血液を各成分に分離する場合の実施例について説明する。
血液成分分離装置１には親バッグ３１を連結チューブ３５ａを介して子バッグ３２、連結チューブ３５ｂを介して子バッグ３３、連結チューブ３５ｃを介して子バッグ３４と接続することにより構成される血液バッグ３０が装着される。
これらの親バッグ３１と子バッグ３３、３２、３４と連結チューブ３５ａ、３５ｂ、３５ｃ、はすべて可塑性合成樹脂により構成されている。
【００１１】
分離動作であるが、まず親バッグ３１の上部の血漿層２１を子バッグ３２に移送し、次いで中間部の界面層（バフィーコート層）２２を子バッグ３３に移送し、子バッグ３４の血液保存液（ＭＡＰ液）２４を親バッグ３１に移送して、子バッグ３２の血漿層２１を設定量に合わせて子バッグ３４に移送し、連結チューブ３５ａ、３５ｂ、３５ｃをシール後に切断して分離を終了とする。
【００１２】
まず遠心分離で血漿層２１、界面層（バフィーコート層）２２、赤血球層２３に分離された親バッグ３１を吊具２５に掛止し補助押圧板１３ａと上部押圧板１１及び下部押圧板１２の間に装着する。
子バッグ３３は重量測定手段５ｂと載置皿２６を備えた収納手段１４内の載置皿２６上に配置する。子バッグ３２は押圧手段４ａと重量測定手段５ａを備えた収納手段１６内の補助押圧板１３ｂ上に配置する。子バッグ３４は押圧手段４ｂと重量測定手段５ｃを備えた収納手段１９内の補助押圧板１３ｃ上に配置する。
連結チューブ３５ａの親バッグ３１側にはクランプ／シール手段２が配置され、連結チューブ３５ａの子バッグ３２側にはシール手段２ｂとクランプ手段２ａ１が配置され、連結チューブ３５bにはクランプ手段２ａ２が配置され、連結チューブ３５ｃにはクランプ手段２ａ３が配置される。
また連結チューブ３５ａの子バッグ３２側と連結チューブ３５ｃの２本にシール手段２ｂを配置させることもできる。
【００１３】
図１を基に前記分離動作の一例について詳細に説明する。
表示部８に配置されている開始スイッチ（図示せず）を押し、連結チューブ３５ａの親バッグ３１側をクランプ／シール手段２、連結チューブ３５ａの子バッグ３２側をクランプ手段２ａ１、連結チューブ３５ｂをクランプ手段２ａ２、連結チューブ３５ｃをクランプ手段２ａ３で遮断後に、親バッグ３１と子バッグ３４の連通ピース３６を連通ピース破壊手段９（９ａ、９ｂ）により破壊する。ここで再度、開始スイッチを押すとクランプ／シール手段２、クランプ手段２ａ１を開放して分離が開始される。
［分離第１段階］
親バッグ３１の上部の血漿層２１を、連結チューブ３５ａを経て子バッグ３２へ移送する。この血漿層２１の移送は上部押圧板１１が分離開始位置より補助押圧板１３ａの方向へ親バッグ３１を押圧しながら移動し、最終的に予め設定された界面待ち位置Ｌ１２（補助押圧板３１ａと上部押圧板１１の隙間、例えば２００ｍｌバッグの場合界面待ち位置Ｌ１２の設定は７ｍｍで、４００ｍｌバッグの場合の界面待ち位置Ｌ１２は１１ｍｍに設定される。）で停止後に、親バッグ３１の血漿成分出口に設定された界面検出位置Ｌ１（血漿成分出口から界面検出手段３による界面層（バフィーコート層）の検出位置までの距離）で、例えば１５ｍｍ、２０ｍｍ、２５ｍｍ、３０ｍｍの４段階のうちいずれか一つを選択することができる。前記界面検出手段３で界面層（バフィーコート層）２２を検出してクランプ手段２ａ１を遮断すれば血漿層２１の移送は終了する。
このとき下部押圧板１２は分離開始位置より補助押圧板１３ａの方向へ、界面検出を行うまで、血液（全血）のＨｔ値に合わせて親バッグ３１を押圧しながら任意の位置へと移動する。また前記上部押圧板１１と下部押圧板１２の動作はリミットスイッチ１０ａ、１０ｂを利用して制御することができる。
【００１４】
［分離第２段階］
クランプ手段２ａ１を開放して界面検出後の親バッグ３１の上部の血漿層２１を連結チューブ３５ａを経て子バッグ３２へ移送する。
この血漿層２１の移送量は予め設定してあり、重量測定手段５ａで測定を行い設定量に達してクランプ手段２ａ１を遮断すれば血漿層２１の移送は終了である。このとき上部押圧板１１は設定した界面待ち位置Ｌ１２で停止しており、下部押圧板１２は補助押圧板１３ａの方向へ親バッグ３１を押圧しながら移動する。
この分離段階はできるだけ血漿層２１を子バッグ３２に移送したい時に使用する。
【００１５】
［分離第３段階］
クランプ手段２ａ２を開放して親バッグ３１内の界面層（バフィーコート層）２２を、連結チューブ３５ｂを経て子バッグ３３へ移送する。
この界面層（バフィーコート層）２２の移送量は予め設定してあり、重量測定手段５ｂで測定を行い設定量に達したらクランプ／シール手段２、クランプ手段２ａ２を遮断して界面層（バフィーコート層）２２の移送は終了である。このとき上部押圧板１１は界面待ち位置Ｌ１２で停止しており、下部押圧板１２は補助押圧板１３ａの方向へ、親バッグ３１を押圧しながら移動する。
本発明の上部押圧板１１及び下部押圧板１２に２分割された二段平行移動方式及び中間支点方式の分離において、子バッグ３３内の血液成分の割合は図６のようになる。
親バッグ３１において界面層（バフィーコート層）２２が界面検出位置Ｌ１で検出されるまで血漿層２１を子バッグ３２に移送する。その後界面層（バフィーコート層）２２の全量を子バッグ３３に移送するが前記段落番号［０００２］で記載した「一定量」を移送する。
子バッグ３３に移送した時の該子バッグ３３内の血漿層２１、界面層（バフィーコート層）２２、赤血球層２３の割合を表した前記図６の概略図のように、Ｈｔ値の高い場合の前記押圧手段の（Ａ）（Ｃ）とＨｔ値の低い場合の前記押圧手段（Ｂ）（Ｄ）に区別する。
ここで図５より、図６のＨｔ値の高い場合の前記押圧手段の（Ａ）（Ｃ）とＨｔ値の低い場合の前記押圧手段（Ｂ）（Ｄ）は以下のようになる。
▲１▼子バッグ３３へ移送される血漿層２１の容量は、界面層（バフィーコート層）２２が界面検出位置Ｌ１で検出された時に親バッグに残る血漿層２１の容量と等しい。また親バッグ３１上部に残る血漿層２１部分を直方体と仮定して容量（容積）を求めると計算式は次のようになる。計算式：容量＝縦×横×高さ
（縦は界面待ち位置Ｌ１２、横は親バッグ３１を正面から見たときの幅、高さは界面検出位置Ｌ１）
ここで界面検出位置Ｌ１は血漿層を子バッグに３２に移送して、親バッグ３１の界面層の上に残る血漿層の高さで、予め設定されてるため血液のＨｔ値が高い場合や低い場合にかかわらず同じになる。前記親バッグ３１の幅も製品の規格で寸法が決まっているため血液のＨｔには無関係である。
界面待ち位置Ｌ１２は補助押圧板１３ａと上部押圧板１１間の距離であり、予め設定されているため血液のＨｔ値とは無関係なので同じになる。従って血液のＨｔ値とは無関係に縦、横、高さが同じであるので、容量も同じになるように制御することができる。
【００１６】
また従来の押圧手段では、Ｈｔ値の個体差よる赤血球層２３の容量の違いが界面検出時に親バッグの上部に残る血漿層２１の容量（押圧板４５の開き角度）に影響していたが、本発明では下部押圧板１２が赤血球層２３の容量に合わせて任意の位置へと移動することにより影響がない。従ってＨｔ値が高い場合や低い場合にかかわらず子バッグ３３へ移送される血漿層２１の容量は、等しくなる。
▲２▼子バッグ３３へ移送される界面層（バフィーコート層）２２の容量は、血液のＨｔ値の高い場合や低い場合にかかわらずほぼ一定である。
この状態は従来の上部支点方式、下部支点方式、平行移動方式でも同様である。
▲３▼赤血球層２３は、界面層（バフィーコート層）２２を子バッグ３３に移送する際、設定された一定容量から前記▲１▼の血漿層２１と前記▲２▼の界面層（バフィーコート層）の容量を差し引いたものになる。従って前記▲１▼の血漿層２１の容量および前記▲２▼の界面層（バフィーコート層）２２の容量からＨｔ値が高い場合や低い場合にかかわらず子バッグ界面層（バフィーコート層）２２と一緒に３３へ移送される血漿層と赤血球層の容量は等しくなる。
従って、子バッグ３３と一緒に移送される血漿層２１、界面層（バフィーコート層）２２、赤血球層２３の割合は図６のように血液のＨｔ値の個体差にかかわらず等しくなる。前記段落番号［０００３］に記載のように子バッグ３３に移送される血液成分の割合にばらつきが生じることがなく、常に血液成分の割合が一定なので白血球の確保が安定する。つまり白血球の除去率が安定する。
【００１７】
［分離第４段階］
クランプ手段２ａ１、２ａ２を開放して子バッグ３２に移送された血漿層２１を連結チューブ３５ａ、３５ｂを経て子バッグ３３へ移送する。この血漿層２１の移送量は予め設定してあり、重量測定手段５ｂで測定を行い設定量に達してクランプ手段２ａ１、２ａ２を遮断すれば血漿層２１の移送は終了である。
この血漿層２１の移送は連結チューブ３５ｂ内に付着した界面層（バフィーコート層）２２を洗浄するのが主目的である。
【００１８】
［分離第５段階］
クランプ／シール手段２、クランプ手段２ａ３を開放して子バッグ３４中の血液保存液２４を連結チューブ３５ｃ、３５ａを経て赤血球層２３の残った親バッグ３１に全て移送してクランプ／シール手段２、クランプ手段２ａ３を遮断すれば血液保存液２４の移送は終了である。
ここで子バッグ３４から血液保存液２４を移送する手段は、押圧手段である。押圧板１５ａ、これを駆動させる駆動手段７ｄは例えばスプリング圧、圧搾空気圧、モータの駆動力などがあり、補助押圧板１３ｃにより子バッグ３４を押圧することにより、血液保存液２４を移送する。
また、血液保存液２４の液体排出（移送）管理手段として、（ａ）重量管理手段、（ｂ）時間管理手段、（ｃ）押圧板１５ａと補助押圧板１３ｃ間の隙間管理手段、（ｄ）子バッグ３４内にあるエアー検出管理手段を有しており、これにより血液保存液２４の排出（移送）終了を検出して速やかに、次の分離段階へ移行することができる。
詳述すれば、例えば子バッグ３４の血液保存液の（ａ）重量管理手段は例えばロードセルを採用することに排出開始時から子バッグ３４の血液保存液の重量分軽くなれば排出が完了することになる。
（ｂ）時間管理手段は例えばタイマーを採用することにより排出時間開始時より押圧板１５ａの押圧設定時間が経過すれば排出が完了することになる。
（ｃ）押圧板１５ａと補助押圧板１３ｃの隙間管理手段は例えばリミットスイッチ１０ｄを採用することにより隙間を管理して、前記押圧板１５ａと補助押圧板１３ｃが合わされば、つまり隙間がなくなれば排出が完了することになる。
（ｄ）子バッグ３４内のエアー検出管理手段は例えば気泡感知器を採用することにより子バッグ３４内にエアーが数ｃｃ入っているので、該エアーが検出されれば排出が完了することになる。前記エアー検出管理手段は連結チューブ３５ｃのクランプ手段２ａ３の親バッグ３１側に配置される。前記エアー検出管理手段は光学センサからなり、反射型、透過型のどちらでもよく一対でも複数形成しても良い。
【００１９】
［分離第６段階］
クランプ手段２ａ１、２ａ３を開放して子バッグ３２に移送された血漿層２１を連結チューブ３５ａ、３５ｃを経て空になった子バッグ３４へ移送する。
この血漿層２１の移送量は予め設定してあり、重量測定手段５ｃで測定を行い設定量に達してクランプ手段２ａ１、２ａ３を遮断すれば血漿層２１の移送は終了である。
ここで子バッグ３２から血漿層２１を移送する手段は、押圧手段である。押圧板１５、これを駆動させる駆動手段７ｃは前記駆動手段７ｄと同様にスプリング圧、圧搾空気圧、モータの駆動力等があり、補助押圧板１３ｂにより子バッグ３２を押圧して、血漿層２１を移送する。
【００２０】
［分離第７段階］
シール手段２ｂにより各連結チューブ３５ａ、３５ｃのシールを行い、シール終了後に全クランプ手段２（２ａ１、２ａ２、２ａ３）を開放して血液バッグ３０を血液成分分離装置１より取り外し、各連結チューブ３５ａ、３５ｂ、３５ｃのシール部を切断して一連の分離動作を終了する。
クランプ／シール手段２は連結チューブ３５ａの親バッグ３１側をシールし、シール手段２ｂは1点シール（連結チューブ３５ａの子バッグ３２側）または２点同時シール（連結チューブ３５ａの子バッグ３２側と連結チューブ３５ｃ）を行う。
【００２１】
【発明の作用効果】
▲１▼親バッグ３１を押圧する押圧板を上下２分割にし、前記押圧板の押圧手段４と界面検出手段が主制御部６と連動制御できることにより、血液（全血）のＨｔ値の個体差にかかわらず、界面検出位置Ｌ１と界面待ち位置Ｌ１２が同じになるように制御できることにより、子バッグ３３に界面層（バフィーコート層）２２と一緒に移送される血漿層２１、界面層（バフィーコート層）２２、赤血球層２３の割合を常に一定にすることができるので安定した白血球除去率を確保することができる。
▲２▼クランプ機能とシール機能を兼用するクランプ／シール手段２と連結チューブを２本同時にシール可能なシール手段２ｂを有しているのでクランプ手段とシール手段を必要最低限にできるため装置がコンパクトにできる。
▲３▼液体の移送（子バッグ３４から親バッグ３１への血液保存液２４の移送、子バッグ３２から子バッグ３４への血漿層２１の移送）を押圧手段で行うため移送時間が短縮できる。
▲４▼液体の移送管理手段は、（ａ）重量管理手段のロードセル、（ｂ）時間管理手段のタイマー、（ｃ）押圧板と補助押圧板間の隙間管理手段のリミットスイッチ１０ｄ、（ｄ）子バッグ内にあるエアー検出管理手段の気泡感知器、を有しているため移送が確実に行うことができ、また移送時間が短縮できる。
【図面の簡単な説明】
【図１】本発明の血液成分分離装置１の概略図
【図２】本発明の血液成分分離装置１のブロック図
【図３】本発明の親バッグ３１の押圧手段の概略図で（Ａ）は二段平行移動方式（Ｂ）は中間支点方式
【図４】４連バッグシステムで構成される血液バッグ３０の概略図
【図５】前記図３の押圧手段の界面検出時の親バッグ３１内部の概略図で（Ａ）はＨｔ値が高い場合の二段平行移動方式、（Ｂ）はＨｔ値が低い場合の二段平行移動方式、（Ｃ）はＨｔ値が高い場合の中間支点方式（Ｄ）Ｈｔ値が低い場合の中間支点方式
【図６】前記図５の（Ａ）（Ｃ）と（Ｂ）（Ｄ）の界面層（バフィーコート層）２２を子バッグ３３に移送したときの血液成分割合の概略図
【図７】従来の親バッグの押圧手段の概略図で（Ａ）は上部支点方式（Ｂ）は下部支点方式（Ｃ）は平行移動方式
【図８】前記図７の押圧手段の界面検出時の親バッグ３１内部の概略図で、（Ａ）はＨｔ値が高い場合の上部支点方式、（Ｂ）はＨｔ値が低い場合の上部支点方式、（Ｃ）はＨｔ値が高い場合の下部支点方式、（Ｄ）はＨｔ値が低い場合の下部支点方式、（Ｅ）はＨｔ値が高い場合の平行移動方式、（Ｆ）はＨｔ値が低い場合の平行移動方式
【図９】前記図８の（Ａ）（Ｃ）（Ｅ）と（Ｂ）（Ｄ）（Ｆ）の界面層（バフィーコート層）２２を子バッグ３３に移送したときの血液成分割合の概略図
【符号の説明】
１血液成分分離装置
２クランプ／シール手段
２ａ（２ａ１、２ａ２、２ａ３）クランプ手段
２ｂシール手段
３界面検出手段
４、４ａ、４ｂ押圧手段
５（５ａ、５ｂ、５ｃ）重量測定手段
６主制御部
７（７ａ、７ｂ、７ｃ、７ｄ）駆動手段
８表示部
９（９ａ、９ｂ）連通ピース破壊手段
１０（１０ａ、１０ｂ、１０ｃ、１０ｄ）リミットスイッチ
１１上部押圧板
１２下部押圧板
１３ａ、１３ｂ、１３ｃ、４３補助押圧板
１４、１６、１９収納手段
１５、１５ａ、４５押圧板
１７記憶部
１８電源部
２０、２０Ａ、４０支点
２１血漿層
２２界面層（バフィーコート層）
２３赤血球層
２４血液保存液（ＭＡＰ液）
２５吊具
２６皿
３０血液バッグ
３１、４１親バッグ
３２、３３、３４子バッグ
３５ａ、３５ｂ、３５ｃ連結チューブ
３６遮断開放部（連通ピース）
Ｌ１界面検出位置
Ｌ２、Ｌ３、Ｌ１２界面待ち位置
ｅ、ｅ１原点
ｆ、ｆ１中間点
ｇ、ｈ界面待ち位置
ｉ端点
ｊ、ｊ１開点
ｋ、ｋ１閉点[0001]
BACKGROUND OF THE INVENTION
In the present invention, after the blood bag (parent bag) containing the blood (whole blood) is centrifuged, each separated blood component is automatically separated into each blood component separation container (child bag). Improvement of blood component separation device
[0002]
[Prior Art and Problems to be Solved by the Invention]
Currently used blood component separators employ the upper fulcrum method, lower fulcrum method, and parallel movement method to transfer the plasma layer and interface layer (buffy coat layer) from the parent bag to the child bag of each blood component. ing.
FIG. 7 is a schematic diagram showing an example of a pressing means for a parent bag that is currently used. (A) is an upper fulcrum system, (B) is a lower fulcrum system, and (C) is a parallel movement system.
In FIG. 8, a parent bag 41 in which whole blood is separated into each of the plasma layer 21, the interface layer 22, and the red blood cell layer 23 by centrifugation is attached, and the interface layer (buffy coat layer) 22 is detected at the interface detection position L1. (A) is an upper fulcrum method when the Ht value is high, (B) is an upper fulcrum method when the Ht value is low, and (B) is a schematic view of the parent bag 41 after transferring the plasma layer 21 to the child bag 32. (C) is the lower fulcrum method when the Ht value is high, (D) is the lower fulcrum method when the Ht value is low, (E) is the parallel movement method when the Ht value is high, and (F) is when the Ht value is low. This is a parallel movement method.
There are individual differences in Ht values (red blood cells / whole blood × 100 [%]) depending on blood (whole blood).
Here, the case where the Ht value is high or low is shown.
[0003]
9 shows that the plasma layer 21 is transferred to the child bag 32 until the interface layer (buffy coat layer) 22 is detected at the interface detection position L1 in the parent bag 41, and then the interface layer (buffy coat layer) 22 is transferred to the child bag 33. Although it is transported, the plasma layer 21 and the blood cell layer 23 are also included in order to transport a predetermined amount. The “constant amount” means at least the plasma layer remaining in the vicinity of the interface detection position L1 and the total amount of the interface layer (buffy coat layer) in order to transfer the entire amount of the interface layer (buffy coat layer) 22 to the child bag 33. This is a slight blood cell layer, which is a “certain amount” for transferring the three layers.
Therefore, in the schematic diagram showing the blood components in the child bag 33, (A), (C), (E) of the pressing means when the Ht value is high and the pressing means (B) (D) when the Ht value is low ) And (F).
In the upper fulcrum method, as shown in FIGS. 8A and 8B, the parent bag 31 is interposed between the auxiliary pressing plate 43 and the pressing plate 45 via the fulcrum 40 above the auxiliary pressing plate 43 and the pressing plate 45. The lower fulcrum method is a method of attaching the parent bag 41 to the lower part of the auxiliary pressing plate 43 and the pressing plate 45 via the fulcrum 40 as shown in FIGS. In both cases, the parent bag 41 is crushed by the auxiliary pressing plate 43 and the pressing plate 45 to push out blood components in the container.
With the parallel movement method, as shown in FIGS. 8E and 8F, two auxiliary pressing plates 43 and 45 are arranged in parallel, and the parent bag 41 is placed between the auxiliary pressing plate 43 and the pressing plate 45. It is a method of wearing.
The driving means 47 in FIG. 7 operates the pressing means, and for example, spring pressure, squeezing air pressure, motor driving force and the like can be employed.
[0004]
The ratio of the plasma layer 21, the interface layer (buffy coat layer) 22, and the red blood cell layer 23 transferred to the child bag 33 is as follows from FIG.
In FIGS. 8A and 8B, when the Ht value is high, the angle between the auxiliary pressing plate 43 and the pressing plate 45 increases and the volume of the plasma layer 21 increases. Conversely, when the Ht value is low, the angle becomes small and the volume of the plasma layer 21 decreases. Here, the relationship between θ1 in FIG. 8A and θ2 in FIG. 8B is θ1> θ2. Similarly, the relationship between θ3 in (C) and θ4 in (D) in the lower fulcrum method is θ3> θ4, and the relationship between the width L2 in the parallel displacement method (E) and L3 in (F) is also L2> L3.
(1) When the Ht value is high as shown in FIGS. 8A, 8C and 8E, when the interface layer (buffy coat layer) 22 is transferred to the child bag 33, the interface layer (buffy coat layer) The volume of the plasma layer 21 transferred together with the surface layer 22 increases, and when the Ht values of (B), (D), and (F) in FIG. 8 are low, the interface layer (buffy coat layer) 22 transferred to the child bag 33 The volume of the plasma layer 21 transferred together is reduced.
(2) The volume of the interface layer (buffy coat layer) 22 transferred to the child bag 33 is substantially constant regardless of whether the Ht value of blood is high or low.
(3) When transferring the interfacial layer (buffy coat layer) 22 to the child bag 33, the erythrocyte layer 23 has a constant volume that is set between the plasma layer 21 and the interfacial layer (buffy coat layer) 22 of (1) above. The capacity is subtracted. Therefore, when the Ht value is high from the volume of the plasma layer 21 of (1) and the volume of the interface layer (buffy coat layer) 22 of (2), it is transferred to the child bag 33 together with the interface layer (buffy coat layer) 22. When the Ht value is low, the capacity of the red blood cell layer 23 transferred to the child bag 33 together with the buffy coat layer 22 is increased.
White blood cells contained in blood have an effect on the human body due to blood transfusion and must be removed. The white blood cells are mainly contained in the interface layer (buffy coat layer) 22 but also exist in the vicinity of the interface between the plasma layer 21 and the blood cell layer 23 adjacent to the upper and lower sides of the interface layer.
Therefore, when the ratio of the plasma layer 21 is large as in the case of (A), (C), and (E) of FIG. 9, the ratio of the red blood cell layer 23 decreases and the white blood cells present in the red blood cell layer 23 cannot be secured. B) When the proportion of the plasma layer 21 is small as in (D) and (F), white blood cells present in the plasma layer 21 cannot be secured.
As described above, since the ratios of the plasma layer 21, the interface layer (buffy coat layer) 22, and the red blood cell layer 23 transferred to the child bag 33 vary due to individual differences in the Ht value of blood, white blood cells cannot be secured. That is, the white blood cell removal rate is not stable.
Therefore, as a result of intensive studies to solve the above problems, the present inventors have reached the following invention.
[0005]
[Means for Solving the Problems]
[1] According to the present invention, a parent bag (31) is attached to a blood bag (30) having a parent bag (31) and a plurality of child bags (32), (33), and (34) and separated into layers by centrifugation. In the blood component separation device (1) for automatically transferring the blood components in each child bag (32) (33) (34),
The pressing means (4) of the parent bag (31) having the upper pressing plate (11) and the lower pressing plate (12), the interface detecting means (3) for blood components separated into each layer by centrifugation, and the interface detection Means (3) and the main control part (6) of the pressing means (4). The main control part (6) controls the movement of the pressing means (4) to determine the Ht value of blood. Provided is a blood component separation device (1) that can be controlled so that the interface detection position (L1) and the interface waiting position (L12) are the same regardless.
[2] According to the present invention, a parent bag (31) is attached to a blood bag (30) having a parent bag (31) and a plurality of child bags (32), (33), and (34) and separated into layers by centrifugation. In the blood component separation device (1) for automatically transferring the blood components in each child bag (32) (33) (34),
The pressing means (4) and the pressing means (4a) (4b) of the child bag (32) (34);
Clamping and / or sealing means (2) (2a) (2b) of the connecting tube (35a) (35b) (35c) of the parent bag (31) and each child bag (32) (33) (34), and the interface Detection means (3);
A weight measuring means (5a) for the child bag (32) for measuring the weight of the plasma layer (21);
Weight measuring means (5b) of the child bag (33) for measuring the weight of the interface layer (buffy coat layer) (22), and weight measuring means (34) for measuring the weight of the blood preservation solution (24) ( 5c) and
Of the pressing means (4) (4a) (4b), clamp and / or sealing means (2) (2a) (2b), the interface detecting means (3), weight measuring means (5a) (5b) (5c) The blood component separation device (1) according to the above [1], comprising a main control section (6) for controlling each means in an interlocked manner, is provided.
[3] In the present invention, the pressing means (4) of the parent bag (31) includes an auxiliary pressing plate (13a), an upper pressing plate (11), a lower pressing plate (12), and driving means for driving the auxiliary pressing plate (13a). 7a) (7b) and limit switches (10a) (10b) for controlling the movement of the upper pressing plate (11) and the lower pressing plate (12), and the upper pressing plate (11) and the auxiliary pressing plate (13a). ) In parallel,
The lower pressing plate (12) is separated from the upper pressing plate (11) and arranged in parallel with the auxiliary pressing plate (13a), or
A fulcrum (20) is mounted between the upper pressing plate (11) and the lower pressing plate (12), and the lower pressing plate (12) rotates in the direction of the auxiliary pressing plate (13a) about the fulcrum (20). The blood component separation device (1) according to the above [1] or [2] formed so as to be able to be provided.
[4] According to the present invention, the pressing means (4a) (4b) of the child bag (32) (34) is a driving means (7a) (7b) for driving the upper pressing plate (15) (15a) and the pressing plate. (15) It is composed of limit switches (10c) and (10d) for controlling the movement of (15a),
A fulcrum (20A) is mounted between the auxiliary pressing plates (13b) (13c) and the pressing plates (15) (15a), and the pressing plates (15) (15a) are auxiliary pressed around the fulcrum (20A). The blood component separation device (1) according to the above [1] to [3], which is formed so as to be able to rotate in the direction of the plates (13b) and (13c).
[5] The present invention connects the clamp means 2a (2a1, 2a2, 2a3) on the side of each child bag (32), (33), (34) of the connection tube (35a), (35b), (35c). The sealing means (2b) is arranged on the child bag 32 side of the tube (35a), and the clamp / sealing means (2) is arranged on the parent bag 31 side of the connecting tube (35a),
[1] to [4] The sealing means (2b) is formed so that two connecting tubes (35a) (35c) of the parent bag (31) and the child bag (32) (34) can be sandwiched and sealed at the same time. The blood component separation device (1) described in the above.
[6] The present invention includes a storage means (14) for the child bag (33), and the storage means (14) includes a placement dish (26) for the child bag (33) and the placement dish. The weight measuring means 5b is arranged at the bottom of (26),
It has storage means (16) (19) for the child bags (32) (34), and the storage means (16) (19) includes the pressing means (4a) (4b) and the pressing means (4a) ( The blood component separation device (1) according to the above [1] to [5], in which weight measuring means (5a) (5c) are arranged at the bottom of the auxiliary pressing plates (13b) (13c) of 4b).
[7] In the present invention, as the liquid discharge management means of the child bags (32) and (34), (a) weight management means, (b) time management means, (c) gap management between the pressing plate and the auxiliary pressing plate Means (d) at least one or more of the air detection management means in the child bag (32) (34) (a) weight management means, (b) time management means, (c) gap management means, (d ) The blood component separation device (1) according to the above [1] to [6] having an air management means.
[0006]
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 is a schematic diagram of a blood component separation device 1 according to the present invention, and FIG. 2 is a block diagram of the blood component separation device 1. 3A and 3B are schematic views of the pressing means of the parent bag 31 of the present invention, in which FIG. 3A is a schematic view of a two-stage parallel movement method, and FIG. FIG. 4 is a schematic view of a blood bag 30 composed of a quadruple bag system when whole blood is centrifuged and separated into a plasma layer 21, an interface layer (buffy coat layer) 22, and an erythrocyte layer 23. FIG. 5 is a cross-sectional view when the bag 31 from which each blood component is separated is attached to the two-stage parallel movement method (A) (B) and the intermediate fulcrum method (C) (D) and the interface detection position L1 is reached. It is. More specifically, (A) and (C) are cases where the Ht value of the blood sampler is high and (B) and (D) are low.
FIG. 6 shows the plasma layer 21, the interface layer 22 and the red blood cells in the child bag 33 after transferring (A) and (C) when the Ht value is high and (B) and (D) when the Ht value is low into the child bag 33. FIG. 6 is a schematic view showing each ratio of a layer 23.
The present invention is a blood component separation device 1 that automatically transfers blood components in a parent bag 31 separated into layers by centrifugation to each child bag 32, 33, 34, and includes an upper pressing plate 11 and a lower pressing plate 12. The pressing means 4 of the parent bag 31 having the interface, the interface detecting means 3 of the blood component separated into each layer by centrifugation, the interface detecting means 3 and the main controller 6 of the pressing means 4.
The main control unit 6 can control the movement of the pressing means 4 so that the interface detection position L1 and the interface waiting position L12 are the same regardless of the Ht value of blood.
Further, the pressing means 4, the pressing means 4a, 4b of the child bags 32, 34, the parent bag 31, and the connection tubes 35a, 35b, 35c of the child bags 32, 33, 34 and / or the sealing means 2, 2a, 2b, the interface detecting means 3, the weight measuring means 5a of the child bag 32 for measuring the weight of the plasma layer 21, and the weight measuring means 5b of the child bag 33 for measuring the weight of the interface layer (buffy coat layer) 22. The main control unit 6 controls the respective means of the weight measuring means 5c of the child bag 34 for measuring the weight of the blood preservation solution 24.
[0007]
At least the pressing means 4, 4a, 4b, the clamp and / or sealing means 2, 2a, 2b, the interface detecting means 3, and the weight measuring means 5a, 5b, 5c constituting the blood component separation device 1 of the present invention are main controlled. The interlocking control is performed by the unit 6.
The pressing means 4 of the parent bag 31 controls the movement of the auxiliary pressing plate 13a, the upper pressing plate 11, the lower pressing plate 12, and the driving means 7a and 7b for driving the auxiliary pressing plate 13a, the upper pressing plate 11 and the lower pressing plate 12. The upper pressing plate 11 and the auxiliary pressing plate 13a are arranged in parallel.
The movement of the upper pressing plate 11 and the lower pressing plate 12 is controlled by limit switches 10a and 10b.
The pressing means for the parent bag 31 includes a two-stage parallel movement method and an intermediate fulcrum method.
In the two-stage parallel movement method (A), the driving means 7a is mounted on the upper pressing plate 11, and the driving means 7b is mounted on the lower pressing plate 12 in two separate stages.
In the intermediate fulcrum method (B), the lower pressing plate 12 is attached to the lower end portion of the upper pressing plate 11 via the fulcrum 20. Driving means 7a and 7b are mounted on the upper pressing plate 11 and the lower pressing plate 12 as in the two-stage parallel movement method (A).
The two-stage translation method (A) is disclosed by the present applicant in Japanese Patent Nos. 2528058 and 3184052, and is separated into a plasma layer in the upper layer, an interface layer (buffy coat layer) in the middle, and a red blood cell layer in the lower layer. Each blood component can be separated into child bags while minimizing the disturbance of the interface layer (buffy coat layer) from the parent bag.
In the intermediate fulcrum system, the gap between the upper pressing plate 11 and the lower pressing plate 12 is eliminated by the fulcrum 20, and the interface detection can be reliably performed.
The limit switch 10a controls the movement of the upper pressing plate 11, and is composed of four limit switches: an origin e, an intermediate point f, an interface waiting position g, and h.
The origin e is, for example, a switch for determining the separation start position of the upper pressing plate 11 with respect to the 400 ml bag, the intermediate point f is a switch for determining the separation starting position of the upper pressing plate 11 with respect to the 200 ml bag, and the interface waiting positions g, h are It is a switch that determines the interface waiting position of each bag of 200 ml and 400 ml.
The limit switch 10b controls the movement of the lower pressing plate 12, and is composed of three switches: an origin e1, an intermediate point f1, and an end point i. The origin e1 is a switch for determining the separation start position of the lower pressing plate 12 common to 200 ml and 400 ml bags, and the intermediate point f1 is a switch for determining a temporary stop position of the lower pressing plate 12 when separating the 200 ml bag. i is a switch for determining a position where the lower pressing plate 12 cannot move further in the direction of the auxiliary pressing plate 13a.
[0008]
The pressing means 4a, 4b of the child bags 32, 33 are constituted by driving means 7c, 7d for driving the pressing plates 15, 15a, limit switches 10c, 10d for controlling the movement of the pressing plates 15, 15a, and a fulcrum 20A. .
The pressing means 4a, 4b are attached to the auxiliary pressing plates 13b, 13c and the pressing plates 15, 15a with a fulcrum 20A, and the pressing plates 15, 15a rotate in the direction of the auxiliary pressing plates 13b, 13c about the fulcrum 20A. be able to.
The clamping and / or sealing means 2, 2a and 2b are clamped on the side of the child bag 32 of the connecting tube 35a and on the side of the child bag 33 of the connecting means 35a and the connecting tube 35b and clamped on the side of the child bag 34 of the connecting means 35a and the connecting tube 35c. The clamping means 2a of the means 2a3 is arranged, the sealing means 2b is arranged on the child bag 32 side of the connecting tube 35a, and the clamping / sealing means 2 is configured on the parent bag 31 side of the connecting tube 35a. The sealing method of the sealing means 2b and the clamp / sealing means 2 includes a high frequency welder method, a heating method, an ultrasonic method and the like, and any method can be adopted.
The interface detecting means 3 is arranged at the center of the upper pressing plate 11. The optical sensor employed in the interface detecting means 3 is formed in the longitudinal direction of the upper pressing plate 11 and may be either a reflective type or a transmissive type, and may be formed as a pair or a plurality of pairs.
The weight measuring means 5a, 5b, and 5c are load cells. The weight measuring means 5a, 5b, and 5c measure the weight of the blood component or blood preservation solution that is transferred to or discharged from the child bags 32, 34, and 33 by the weight measuring means 5a, 5b, and 5c. The clamp / seal means 2 and the clamp means 2a (2a1, 2a2, 2a3) are controlled to close when they are monitored and reach the transfer or discharge set amount.
[0009]
Furthermore, the blood component separation device 1 of the present invention has the storage means 14 for the child bag 33, and the storage means 14 measures the weight on the mounting tray 26 of the child bag 33 and the bottom of the mounting tray 26. Means 5b are arranged.
Further, the storage means 16 and 19 for the child bags 32 and 34 are provided, and the storage means 16 and 19 have a weight at the bottom of the pressing means 4a and 4b and the auxiliary pressing plates 13b and 13c of the pressing means 4a and 4b. Measuring means 5a and 5c are arranged.
An opening point j and a closing point k are attached to the limit switch 10c of the pressing means 4a, and an opening point j1 and a closing point k1 are attached to the limit switch 10d of the pressing means 4b.
The open points j and j1 detect the positions where the pressing plates 15 and 15a are opened, and the closing points k and k1 are positions where the pressing plates 15 and 15a are closed, that is, the pressing plates 15 and 15a and the auxiliary pressing plates 13b and 13c. The closed position is detected by combining. Accordingly, the liquid in the child bags 32 and 34 disposed on the auxiliary pressing plates 13b and 13c can be discharged.
The storage unit 17 includes a ROM, an EEPROM, and a RAM, and can retain setting storage contents even in the event of a power failure.
Since the shut-off opening part 36 (hereinafter referred to as a communication piece) is arranged on the upper part of the parent bag 31 and the child bag 34, the separation is started after the communication piece 36 is destroyed before the separation is started. A communication piece breaking means 9 (9a, 9b) capable of breaking the communication piece 36 from the outside can also be provided. The communication piece breaking means 9 (9a, 9b) may be manual or automatic.
The display unit 8 displays, for example, the weight of the weight measuring means 5a, 5b, 5c of the blood component separation device 1 of the present invention.
The power supply unit 18 is a main switch of the blood component separation device 1 of the present invention.
[0010]
Example
An example in the case of separating blood into components will be described.
The blood component separating apparatus 1 includes a blood bag configured by connecting a parent bag 31 to a child bag 32 via a connecting tube 35a, a child bag 33 via a connecting tube 35b, and a child bag 34 via a connecting tube 35c. 30 is mounted.
These parent bag 31, child bags 33, 32, and 34 and connecting tubes 35a, 35b, and 35c are all made of a plastic synthetic resin.
[0011]
In the separation operation, first, the plasma layer 21 at the upper part of the parent bag 31 is transferred to the child bag 32, and then the interface layer (buffy coat layer) 22 at the intermediate part is transferred to the child bag 33. The liquid (MAP liquid) 24 is transferred to the parent bag 31, the plasma layer 21 of the child bag 32 is transferred to the child bag 34 according to the set amount, and the connecting tubes 35a, 35b, 35c are cut and separated after sealing. End.
[0012]
First, a parent bag 31 separated into a plasma layer 21, an interface layer (buffy coat layer) 22, and a red blood cell layer 23 by centrifugation is hung on a hanging tool 25, and the auxiliary pressing plate 13 a, the upper pressing plate 11, and the lower pressing plate 12. Install in between.
The child bag 33 is disposed on the mounting plate 26 in the storage unit 14 including the weight measuring unit 5 b and the mounting plate 26. The child bag 32 is disposed on the auxiliary pressing plate 13b in the storage means 16 provided with the pressing means 4a and the weight measuring means 5a. The child bag 34 is disposed on the auxiliary pressing plate 13c in the storage means 19 provided with the pressing means 4b and the weight measuring means 5c.
The clamp / seal means 2 is disposed on the parent bag 31 side of the connection tube 35a, the seal means 2b and the clamp means 2a1 are disposed on the child bag 32 side of the connection tube 35a, and the clamp means 2a2 is disposed on the connection tube 35b. Then, the clamping means 2a3 is disposed in the connection tube 35c.
Moreover, the sealing means 2b can also be arrange | positioned at the child bag 32 side and the connection tube 35c of the connection tube 35a.
[0013]
An example of the separation operation will be described in detail with reference to FIG.
A start switch (not shown) disposed on the display unit 8 is pushed, the parent bag 31 side of the connecting tube 35a is clamped / sealed, the child bag 32 side of the connecting tube 35a is clamped 2a1, and the connecting tube 35b is pressed. After the clamp means 2a2 and the connecting tube 35c are shut off by the clamp means 2a3, the communication piece 36 of the parent bag 31 and the child bag 34 is destroyed by the communication piece breaking means 9 (9a, 9b). Here, when the start switch is pressed again, the clamp / seal means 2 and the clamp means 2a1 are opened and separation is started.
[Separation 1st stage]
The plasma layer 21 at the top of the parent bag 31 is transferred to the child bag 32 via the connecting tube 35a. The transfer of the plasma layer 21 moves while the upper pressing plate 11 presses the parent bag 31 in the direction of the auxiliary pressing plate 13a from the separation start position, and finally the interface waiting position L12 (the auxiliary pressing plate 31a and the auxiliary pressing plate 31a). In the gap of the upper pressing plate 11, for example, in the case of a 200 ml bag, the interface waiting position L12 is set to 7 mm, and in the case of a 400 ml bag, the interface waiting position L12 is set to 11 mm. At the interface detection position L1 (distance from the plasma component outlet to the detection position of the interface layer (buffy coat layer) by the interface detection means 3), for example, any one of four stages of 15 mm, 20 mm, 25 mm, and 30 mm You can choose one. When the interface detecting means 3 detects the interface layer (buffy coat layer) 22 and shuts off the clamping means 2a1, the transfer of the plasma layer 21 is completed.
At this time, the lower pressing plate 12 moves from the separation start position toward the auxiliary pressing plate 13a to an arbitrary position while pressing the parent bag 31 according to the Ht value of blood (whole blood) until interface detection is performed. . The operations of the upper pressing plate 11 and the lower pressing plate 12 can be controlled using limit switches 10a and 10b.
[0014]
[Separation second stage]
The clamp means 2a1 is opened and the plasma layer 21 on the upper side of the parent bag 31 after the interface detection is transferred to the child bag 32 through the connecting tube 35a.
The transfer amount of the plasma layer 21 is set in advance, and the transfer of the plasma layer 21 is completed when the measurement is performed by the weight measuring means 5a, the set amount is reached and the clamp means 2a1 is shut off. At this time, the upper pressing plate 11 stops at the set interface waiting position L12, and the lower pressing plate 12 moves while pressing the parent bag 31 in the direction of the auxiliary pressing plate 13a.
This separation step is used when it is desired to transfer the plasma layer 21 to the child bag 32 as much as possible.
[0015]
[Separation third stage]
The clamping means 2a2 is opened, and the interface layer (buffy coat layer) 22 in the parent bag 31 is transferred to the child bag 33 through the connecting tube 35b.
The transfer amount of the interface layer (buffy coat layer) 22 is set in advance. When the set amount is measured by the weight measuring means 5b, the clamp / seal means 2 and the clamp means 2a2 are shut off to interrupt the interface layer (buffy coat layer). The transfer of layer 22 is complete. At this time, the upper pressing plate 11 is stopped at the interface waiting position L12, and the lower pressing plate 12 moves while pressing the parent bag 31 in the direction of the auxiliary pressing plate 13a.
In the separation of the two-stage parallel movement method and the intermediate fulcrum method divided into the upper pressing plate 11 and the lower pressing plate 12 of the present invention, the ratio of the blood components in the child bag 33 is as shown in FIG.
The plasma layer 21 is transferred to the child bag 32 until the interface layer (buffy coat layer) 22 is detected at the interface detection position L1 in the parent bag 31. Thereafter, the entire amount of the interface layer (buffy coat layer) 22 is transferred to the child bag 33, but the “certain amount” described in paragraph [0002] is transferred.
When the Ht value is high as shown in the schematic diagram of FIG. 6 showing the ratio of the plasma layer 21, the interface layer (buffy coat layer) 22, and the red blood cell layer 23 in the child bag 33 when transferred to the child bag 33. (A) and (C) of the pressing means and the pressing means (B) and (D) when the Ht value is low.
Here, from FIG. 5, (A) and (C) of the pressing means when the Ht value is high in FIG. 6 and the pressing means (B) and (D) when the Ht value is low are as follows.
(1) The volume of the plasma layer 21 transferred to the child bag 33 is equal to the volume of the plasma layer 21 remaining in the parent bag when the interface layer (buffy coat layer) 22 is detected at the interface detection position L1. Further, when the volume (volume) is obtained assuming that the plasma layer 21 remaining on the upper part of the parent bag 31 is a rectangular parallelepiped, the calculation formula is as follows. Formula: Capacity = Vertical x Horizontal x Height
(Vertical is the interface waiting position L12, horizontal is the width and height when the parent bag 31 is viewed from the front, and the interface detection position L1)
Here, the interface detection position L1 is the height of the plasma layer remaining on the interface layer of the parent bag 31 when the plasma layer is transferred to the child bag 32, and is set in advance, so that the Ht value of blood is high or low. It will be the same regardless of the case. The width of the parent bag 31 is also irrelevant to the Ht of blood because the dimensions are determined by the product standards.
The interface waiting position L12 is the distance between the auxiliary pressing plate 13a and the upper pressing plate 11 and is the same because it is set in advance and is not related to the Ht value of blood. Therefore, since the vertical, horizontal, and height are the same regardless of the Ht value of blood, the volume can be controlled to be the same.
[0016]
Further, in the conventional pressing means, the difference in the volume of the red blood cell layer 23 due to the individual difference in the Ht value has affected the volume of the plasma layer 21 (the opening angle of the pressing plate 45) remaining on the upper part of the parent bag when detecting the interface. In the present invention, the lower pressing plate 12 is not affected by moving to an arbitrary position in accordance with the capacity of the red blood cell layer 23. Therefore, the volume of the plasma layer 21 transferred to the child bag 33 is equal regardless of whether the Ht value is high or low.
(2) The volume of the interface layer (buffy coat layer) 22 transferred to the child bag 33 is substantially constant regardless of whether the blood Ht value is high or low.
This state is the same in the conventional upper fulcrum method, lower fulcrum method, and parallel movement method.
(3) When transferring the interfacial layer (buffy coat layer) 22 to the child bag 33, the erythrocyte layer 23 is transferred from the set constant volume to the plasma layer 21 of (1) and the interface layer (buffy coat of (2). The capacity of the layer is subtracted. Therefore, regardless of whether the Ht value is high or low from the volume of the plasma layer 21 of (1) and the volume of the interface layer (buffy coat layer) 22 of (2), the child bag interface layer (buffy coat layer) 22 and The volume of the plasma layer and the red blood cell layer transferred to 33 together is equal.
Accordingly, the proportions of the plasma layer 21, the interface layer (buffy coat layer) 22, and the red blood cell layer 23 transferred together with the child bag 33 are equal regardless of individual differences in blood Ht values as shown in FIG. As described in paragraph [0003], there is no variation in the proportion of blood components transferred to the child bag 33, and since the proportion of blood components is always constant, securing of white blood cells is stable. That is, the leukocyte removal rate is stabilized.
[0017]
[Separation 4th stage]
The plasma means 21 transferred to the child bag 32 by opening the clamping means 2a1 and 2a2 is transferred to the child bag 33 through the connecting tubes 35a and 35b. The transfer amount of the plasma layer 21 is set in advance, and the transfer of the plasma layer 21 is completed when the weight measurement unit 5b performs measurement and reaches the set amount to shut off the clamp units 2a1 and 2a2.
The main purpose of the transfer of the plasma layer 21 is to wash the interface layer (buffy coat layer) 22 adhered in the connecting tube 35b.
[0018]
[Separation 5th stage]
The clamp / seal means 2 and the clamp means 2a3 are opened, and the blood preservation solution 24 in the child bag 34 is all transferred to the parent bag 31 where the red blood cell layer 23 remains through the connection tubes 35c and 35a, and the clamp / seal means 2, If the clamp means 2a3 is shut off, the transfer of the blood preservation solution 24 is completed.
Here, the means for transferring the blood preservation solution 24 from the child bag 34 is a pressing means. The pressing plate 15a and the driving means 7d for driving the pressing plate 15a have, for example, spring pressure, squeezing air pressure, motor driving force, and the like, and the blood storage solution 24 is transferred by pressing the child bag 34 with the auxiliary pressing plate 13c.
Further, as liquid discharge (transfer) management means of the blood preservation solution 24, (a) weight management means, (b) time management means, (c) gap management means between the pressing plate 15a and the auxiliary pressing plate 13c, (d) An air detection management means is provided in the child bag 34, so that the end of the discharge (transfer) of the blood preservation solution 24 can be detected, and the process can immediately proceed to the next separation stage.
More specifically, for example, (a) the weight management means of the blood preserving liquid in the child bag 34 adopts a load cell, for example, the discharge is completed if the blood preserving liquid in the child bag 34 becomes lighter from the start of discharging. become.
(B) The time management means adopts a timer, for example, and the discharge is completed when the pressing set time of the pressing plate 15a elapses from the start of the discharging time.
(C) The gap management means between the pressing plate 15a and the auxiliary pressing plate 13c manages the gap by adopting, for example, a limit switch 10d, and discharges if the pressing plate 15a and the auxiliary pressing plate 13c are combined, that is, if there is no gap. Will be completed.
(D) The air detection management means in the child bag 34 employs, for example, a bubble sensor so that several cc of air is contained in the child bag 34, and thus the discharge is completed when the air is detected. . The air detection management means is arranged on the parent bag 31 side of the clamping means 2a3 of the connecting tube 35c. The air detection management means is composed of an optical sensor, and may be either a reflection type or a transmission type, and a pair or a plurality of them may be formed.
[0019]
[Separation 6th stage]
The plasma means 21 transferred to the child bag 32 by opening the clamping means 2a1 and 2a3 is transferred to the empty child bag 34 via the connecting tubes 35a and 35c.
The transfer amount of the plasma layer 21 is set in advance, and the transfer of the plasma layer 21 is completed when the weight measurement means 5c is measured and reaches the set amount and the clamp means 2a1 and 2a3 are shut off.
Here, the means for transferring the plasma layer 21 from the child bag 32 is a pressing means. The pressing plate 15 and the driving means 7c for driving the same have spring pressure, compressed air pressure, motor driving force, etc., like the driving means 7d. The child bag 32 is pressed by the auxiliary pressing plate 13b, and the plasma layer 21 is pressed. Transport.
[0020]
[Separation stage 7]
Each connecting tube 35a, 35c is sealed by the sealing means 2b. After the sealing is completed, all the clamping means 2 (2a1, 2a2, 2a3) are opened, the blood bag 30 is removed from the blood component separation device 1, and each connecting tube 35a, The sealing portions 35b and 35c are cut to complete a series of separation operations.
The clamp / seal means 2 seals the parent bag 31 side of the connecting tube 35a, and the sealing means 2b is a one-point seal (on the child bag 32 side of the connecting tube 35a) or a two-point simultaneous seal (on the child bag 32 side of the connecting tube 35a). Connecting tube 35c) is performed.
[0021]
[Effects of the invention]
(1) The pressure plate that presses the parent bag 31 is divided into upper and lower parts, and the pressure means 4 and the interface detection means of the pressure plate can be controlled in conjunction with the main control unit 6 so that the individual difference in the Ht value of blood (whole blood) Regardless of whether the interface detection position L1 and the interface waiting position L12 can be controlled to be the same, the plasma layer 21 and the interface layer (buffy coat) transferred to the child bag 33 together with the interface layer (buffy coat layer) 22 Layer) 22 and the ratio of the red blood cell layer 23 can be kept constant, so that a stable leukocyte removal rate can be ensured.
(2) Since the clamp / seal means 2 having both the clamp function and the seal function and the seal means 2b capable of simultaneously sealing the two connecting tubes are provided, the clamp means and the seal means can be minimized so that the apparatus is compact. Can be.
{Circle around (3)} Since the liquid is transferred (the blood preservation solution 24 is transferred from the child bag 34 to the parent bag 31 and the plasma layer 21 is transferred from the child bag 32 to the child bag 34) by the pressing means, the transfer time can be shortened.
(4) The liquid transfer management means includes (a) a load cell of the weight management means, (b) a timer of the time management means, (c) a limit switch 10d of a gap management means between the pressing plate and the auxiliary pressing plate, (d) Since the bubble detector of the air detection management means in the child bag is provided, the transfer can be performed reliably and the transfer time can be shortened.
[Brief description of the drawings]
FIG. 1 is a schematic view of a blood component separation device 1 of the present invention.
FIG. 2 is a block diagram of the blood component separation device 1 of the present invention.
FIG. 3 is a schematic view of the pressing means of the parent bag 31 of the present invention, where (A) is a two-stage parallel movement method (B) is an intermediate fulcrum method.
FIG. 4 is a schematic view of a blood bag 30 configured by a quadruple bag system.
FIGS. 5A and 5B are schematic views of the inside of the parent bag 31 when the interface of the pressing means in FIG. 3 is detected. FIG. 5A is a two-stage parallel movement method when the Ht value is high, and FIG. Step-parallel movement method, (C) Intermediate fulcrum method when Ht value is high (D) Intermediate fulcrum method when Ht value is low
6 is a schematic diagram of a blood component ratio when the interface layer (buffy coat layer) 22 of (A), (C), (B), and (D) of FIG. 5 is transferred to a child bag 33. FIG.
FIG. 7 is a schematic view of a conventional means for pressing a parent bag, (A) is an upper fulcrum method (B) is a lower fulcrum method (C) is a parallel movement method;
8A and 8B are schematic views of the inside of the parent bag 31 when the interface of the pressing means in FIG. 7 is detected, where FIG. 8A is an upper fulcrum method when the Ht value is high, and FIG. 8B is an upper fulcrum when the Ht value is low. (C) is the lower fulcrum method when the Ht value is high, (D) is the lower fulcrum method when the Ht value is low, (E) is the parallel movement method when the Ht value is high, and (F) is the Ht value. Translation method when low
9 is a schematic diagram of blood component ratios when the interface layer (buffy coat layer) 22 of (A), (C), (E), and (B), (D), and (F) of FIG. 8 is transferred to a child bag 33. FIG. Figure
[Explanation of symbols]
1 Blood component separation device
2 Clamp / seal means
2a (2a1, 2a2, 2a3) Clamping means
2b Sealing means
3 Interface detection means
4, 4a, 4b pressing means
5 (5a, 5b, 5c) Weight measuring means
6 Main control unit
7 (7a, 7b, 7c, 7d) Driving means
8 Display section
9 (9a, 9b) Communication piece destruction means
10 (10a, 10b, 10c, 10d) Limit switch
11 Upper pressing plate
12 Lower pressure plate
13a, 13b, 13c, 43 Auxiliary pressing plate
14, 16, 19 Storage means
15, 15a, 45 Press plate
17 Memory unit
18 Power supply
20, 20A, 40 fulcrum
21 Plasma layer
22 Interface layer (buffy coat layer)
23 Red blood cell layer
24 Blood preservation solution (MAP solution)
25 Suspension
26 dishes
30 Blood Bag
31, 41 Parent bag
32, 33, 34 Child bag
35a, 35b, 35c Connecting tube
36 Shut-off opening (communication piece)
L1 interface detection position
L2, L3, L12 Interface waiting position
e, e1 origin
f, f1 midpoint
g, h Interface waiting position
i End point
j, j1 open point
k, k1 closing point

Claims

A blood bag (30) having a parent bag (31) and a plurality of child bags (32), (33) and (34) is mounted, and blood components in the parent bag (31) separated into each layer by centrifugation are automatically removed. In the blood component separation device (1) to be transferred to each child bag (32) (33) (34),
The pressing means (4) of the parent bag (31) having the upper pressing plate (11) and the lower pressing plate (12), the interface detecting means (3) for blood components separated into each layer by centrifugation, and the interface detection Means (3) and the main control part (6) of the pressing means (4). The main control part (6) controls the movement of the pressing means (4) to determine the Ht value of blood. The blood component separation device (1) is characterized in that it can be controlled so that the interface detection position (L1) and the interface waiting position (L12) are the same regardless.

A blood bag (30) having a parent bag (31) and a plurality of child bags (32), (33) and (34) is mounted, and blood components in the parent bag (31) separated into each layer by centrifugation are automatically removed. In the blood component separation device (1) to be transferred to each child bag (32) (33) (34),
The pressing means (4) and the pressing means (4a) (4b) of the child bag (32) (34);
Clamping and / or sealing means (2) (2a) (2b) of the connecting tube (35a) (35b) (35c) of the parent bag (31) and each child bag (32) (33) (34), and the interface Detection means (3);
A weight measuring means (5a) for the child bag (32) for measuring the weight of the plasma layer (21);
Weight measuring means (5b) of the child bag (33) for measuring the weight of the interface layer (buffy coat layer) (22), and weight measuring means (34) for measuring the weight of the blood preservation solution (24) ( 5c) and
Of the pressing means (4) (4a) (4b), clamp and / or sealing means (2) (2a) (2b), the interface detecting means (3), weight measuring means (5a) (5b) (5c) The blood component separation device (1) according to claim 1, wherein the blood component separation device (1) is configured by a main control unit (6) for controlling each means in an interlocked manner.

The pressing means (4) of the parent bag (31) includes an auxiliary pressing plate (13a), an upper pressing plate (11), a lower pressing plate (12), driving means (7a) (7b) for driving this, It is composed of limit switches (10a) and (10b) that control the movement of the upper pressing plate (11) and the lower pressing plate (12), and the upper pressing plate (11) and the auxiliary pressing plate (13a) are arranged in parallel,
The lower pressing plate (12) is separated from the upper pressing plate (11) and arranged in parallel with the auxiliary pressing plate (13a), or a fulcrum (between the upper pressing plate (11) and the lower pressing plate (12) ( 20) and the lower pressing plate (12) is formed so as to be able to rotate in the direction of the auxiliary pressing plate (13a) about the fulcrum (20). The blood component separation device (1) described in 1.

The pressing means (4a) (4b) of the child bags (32) (34) are the driving means (7a) (7b) for driving the upper pressing plates (15) (15a) and the pressing plates (15) (15a). It is composed of limit switches (10c) and (10d) that control movement,
A fulcrum (20A) is mounted between the auxiliary pressing plates (13b) (13c) and the pressing plates (15) (15a), and the pressing plates (15) (15a) are auxiliary pressed around the fulcrum (20A). The blood component separation device (1) according to any one of claims 1 to 3, wherein the blood component separation device (1) is formed so as to be able to rotate in a plate (13b) (13c) direction.

Clamping means 2a (2a1, 2a2, 2a3) on the side of each child bag (32), (33), (34) of the connecting tube (35a), (35b), (35c), and a child bag of the connecting tube (35a) Place the sealing means (2b) on the 32 side and the clamping / sealing means (2) on the parent bag 31 side of the connecting tube (35a),
The said sealing means (2b) is formed so that it can pinch and seal two connection tubes (35a) (35c) of a parent bag (31) and a child bag (32) (34) simultaneously. Item 5. A blood component separation device (1) according to items 1 to 4.

The child bag (33) has a storage means (14), and the storage means (14) has a weight on the mounting tray (26) of the child bag (33) and the bottom of the mounting dish (26). Measuring means 5b is arranged,
It has storage means (16) (19) for the child bags (32) (34), and the storage means (16) (19) includes the pressing means (4a) (4b) and the pressing means (4a) ( The blood component separation device (1) according to any one of claims 1 to 5, wherein weight measuring means (5a) (5c) are arranged at the bottom of the auxiliary pressing plates (13b) (13c) of 4b).

As the liquid discharge management means of the child bags (32) and (34), (a) weight management means, (b) time management means, (c) gap management means between the pressing plate and the auxiliary pressing plate, (d) child bag (32) At least one of the air detection management means in (34) includes (a) weight management means, (b) time management means, (c) gap management means, and (d) air management means. 7. The blood component separation device (1) according to claim 1, wherein the blood component separation device (1).