JP4376635B2 - 血液成分処理システム、装置、および方法 - Google Patents
血液成分処理システム、装置、および方法 Download PDFInfo
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Description
チャンバ4がエリア3に受け入れられ且つフィルタ31がキャビティ2に受け入れられているときに、図8に概略的に図解されているように、フィルタ31が、チャンバ内部8よりも回転軸Xに近くなるように配置される。このような配置は、チャンバ内部8において遠心力で分離される物質が同様の高い力に晒されるのを許容すると同時に、フィルタ31が比較的高い遠心力に晒されるのを回避し得る。いくつかの例においては、このように低減された量の遠心力がフィルタ31に印加されるようにすることが所望されるかもしれない。例えば、ある特定のフィルタ構成においては、比較的高い遠心力に晒すことが、フィルタハウジングの破裂に関連するある特定の潜在的な問題を生ずるかもしれず、あるいはおそらく濾過効力に悪く影響する。遠心力によって有意に衝撃を受けないであろうような、いくつかのフィルタについては、フィルタの代替的な配置も可能であるかもしれない。
図4は、図3に示された装置の一定の構成要素を示しているが、これらの構成要素のいくつかは、より小さな縮尺で描かれているかまたは図4においては視認されない。図4に示されるように、遠心分離機34は、完全に開き且つこの位置に固定されたこれの外蓋35を立てて示されている。遠心分離機内蓋6(図1および図1A参照)は、他の部品をさらに明確に示すことを省いている。また、遠心ロータ1およびチャンバ4は、ある一定の範囲まで、単純化された方法で描かれている。遠心制御パネル36も、概略的に示されている。
Claims (46)
- 血液成分を処理するためのシステムであって:
中で血液成分が遠心力で分離されるチャンバ内部(8)、および
このチャンバ内部(8)から遠心力で分離された血液成分の少なくともいくらかを通すための出口ポート(4b)を備えている分離チャンバ(4)と、
この分離チャンバの前記出口ポートと連通している流路(21)と、
前記分離チャンバ(4)を受け入れるように構成されている第1の部分(3)、および
第2の部分(2)
を備え、回転軸のまわりで回転されるように構成されている遠心ロータ(1)と、
前記流路(21)と連通しているフィルタ入口(31a)、
前記流路を経由してフィルタ(31)に通され、前記遠心力で分離された血液成分から少なくとも1種類の血液成分の少なくともいくらかを濾過するように構成されている多孔濾過媒体(31c)、および
濾過された血液成分のためのフィルタ出口(31b)
を備えているフィルタ(31)と、を具備し、
前記遠心ロータ(1)の第1および第2の部分(2,3)は、前記分離チャンバ(4)が遠心ロータ(1)の前記第1の部分(3)に受け入れられ且つ前記フィルタ(31)が前記遠心ロータ(1)の第2の部分(2)に受け入れられたときに、このフィルタ(31)が前記分離チャンバ内部(8)よりも前記回転軸に対して近づくように、相互に関して配置されており、
このシステムは、前記フィルタ(31)による前記少なくとも1種類の血液成分の少なくともいくらかの濾過の間に、前記ロータが回転するように構成され、また、
前記フィルタ(31)は、前記多孔濾過媒体(31c)を収容する内部空間を規定するフィルタハウジング(31d)を備えており、前記フィルタ入口(31a)およびフィルタ出口(31b)は、前記内部空間と流通しており、そして、このシステムは、前記遠心ロータ(1)の第2の部分(2)に前記フィルタ(31)が受け入れられたときに、血液成分が前記内部空間内で前記回転軸に向かう方向に前記多孔濾過媒体を介して流れるようにして前記フィルタ(31)が配置されるように構成されている、システム。 - このシステムは、前記遠心ロータ(1)の第2の部分(2)に前記フィルタ(31)が受け入れられたとき、このフィルタ(31)が、前記回転軸に対して偏心するように構成されている請求項1に記載のシステム。
- このシステムは、前記遠心ロータ(1)の第2の部分(2)に前記フィルタ(31)が受け入れられたとき、このフィルタ(31)が、少なくとも前記回転軸に近接するように構成されており、且つ前記回転軸は、前記フィルタ(31)によって規定されている内部流路と交差しない請求項1もしくは2に記載のシステム。
- 前記フィルタ(31)は、フィルタハウジング流入ポート(31e)およびフィルタハウジング流出ポート(31f)を備えており、このシステムは、前記遠心ロータ(1)の第2の部分(2)に前記フィルタ(31)が受け入れられたとき、前記フィルタハウジング流出ポート(31f)が前記フィルタハウジング流入ポート(31e)よりも前記回転軸に近接して配置されるように構成されている請求項1ないし3のいずれか1に記載のシステム。
- このシステムは、前記遠心ロータ(1)の第2の部分(2)に前記フィルタ(31)が受け入れられたとき、前記フィルタハウジング流出ポート(31f)が前記多孔濾過媒体(31c)よりも前記回転軸に近くなるように構成されている請求項4に記載のシステム。
- このシステムは、前記遠心ロータ(1)の第2の部分(2)に前記フィルタが受け入れられたとき、前記フィルタハウジング流出ポート(31f)が前記フィルタハウジング流入ポート(31e)の上方になるように構成されている請求項4もしくは5に記載のシステム。
- 前記遠心ロータ(1)の第2の部分(2)は、前記フィルタ(31)を受け入れるように構成された棚(32)とスロット(57)との少なくとも1つを備え、前記棚(32)とスロット(57)との少なくとも1つは、前記遠心ロータ(1)の頂面の下方に配置されている請求項1ないし6のいずれか1に記載のシステム。
- 前記遠心ロータ(1)は、このロータ(1)に前記フィルタ(31)を保持させるように構成されたホルダ(32,66)を備えている請求項1ないし7のいずれか1に記載のシステム。
- 前記流路は、
前記分離チャンバ(4)の出口ポート(4b)に結合された一端と前記フィルタ入口(31a)に結合された他端とを有する第1の管系部分(21a)と、
前記フィルタ出口(31b)に結合された一端を有する第2の管系部分(21b)とを有し、この第2の管系部分(21b)は、前記回転軸から離れる方向に延びている請求項1ないし8のいずれか1に記載のシステム。 - 前記流路は、前記第2の管系部分(21b)の下流に第3の管系部分(21c)をさらに有し、この第3の管系部分(21c)は、前記回転軸に向かう方向に延びている請求項9に記載のシステム。
- 前記遠心ロータ(1)は、前記第2および第3の管系部分(21b、21c)の少なくともいくつかを受け入れるように構成された溝(60)を有している請求項10に記載のシステム。
- このシステムは、前記フィルタ出口(31b)と連通している入口(33a)を備えている収集容器(33)をさらに具備しており、前記遠心ロータ(1)の前記第2の部分は、前記フィルタ(31)および前記収集容器(33)を受け入れるように構成されたキャビティ(2)を備えている請求項1ないし11のいずれか1に記載のシステム。
- 前記回転軸は、前記遠心ロータ(1)の前記第2の部分(2)を通って延びている請求項1ないし12のいずれか1に記載のシステム。
- 前記チャンバ(4)は、このチャンバ内部(8)が可変の容積を有するように構成されている請求項1ないし13のいずれか1に記載のシステム。
- 前記分離チャンバは、血液成分分離袋(4)を備えている請求項1ないし14のいずれか1に記載のシステム。
- 前記血液成分分離袋(4)の少なくとも一部分は、前記チャンバ内部(8)が可変の容積を有するように、可撓性および半剛性の材料の少なくとも1つのシートにより形成されている請求項15に記載のシステム。
- 前記分離袋(4)は、中央開口(19)を規定する環状リング形状を有している請求項15もしくは16に記載のシステム。
- 前記チャンバ内部(8)は、前記出口ポート(4b)へ導く先細状部分(75)を含んでいる請求項15ないし17のいずれか1に記載のシステム。
- このシステムは、前記分離チャンバを支持するように構成された少なくとも1つの支持体(9,10,11)を備えている請求項1ないし18のいずれか1に記載のシステム。
- 前記ロータ(1)は、前記回転軸に関して非対称に配置された複数の支持体(9、10、11)を備えている請求項19に記載のシステム。
- 前記少なくとも1つの支持体(9,10,11)は、前記管系ライン(21)の一部を受け入れるように構成されたガイド溝(12)、ならびにこのガイド溝(12)に関連する溶着機と制御可能なクランプとの少なくとも一方を備えている請求項19もしくは20に記載のシステム。
- 前記分離チャンバ(4)は、複数のガイド孔を備え、これらガイド孔の各々は、前記少なくとも1つの支持体(9,10,11)を受け入れるように構成されている少なくとも1つのガイド孔(109,110、111)を有している請求項19ないし21のいずれか1に記載のシステム。
- 前記分離チャンバ(4)は、リング形状を有している請求項1ないし22のいずれか1に記載のシステム。
- 前記遠心ロータ(1)に少なくとも1つの管系クランプをさらに具備し、この管系クランプは、前記遠心ロータ(1)の回転の間に、前記血液成分の少なくともいくらかの流れを制御するように構成されている請求項1ないし23のいずれか1に記載のシステム。
- 前記遠心ロータ(1)に少なくとも1つの管系溶着機をさらに具備し、この管系溶着機は、前記遠心ロータ(1)の回転の間に封止を形成するように構成されている請求項1ないし24のいずれか1に記載のシステム。
- 前記遠心ロータ(1)の回転の間に、前記流路(21)を経由して前記チャンバ(4)から前記フィルタ(31)へ、前記遠心力で分離された血液成分の少なくともいくらかをポンプ送りするように構成されたポンプ(80)をさらに具備する請求項1ないし25のいずれか1に記載のシステム。
- 前記チャンバ(4)は、前記チャンバ内部が可変の容積を有するように構成されており、且つ前記ポンプ(80)は、作動液によって前記チャンバ(4)に圧力を印加して前記チャンバ内部の容積を減小させるように構成されている請求項26に記載のシステム。
- ポンプ送りされた血液成分の圧力を検知するように構成されたセンサ(70)をさらに具備し、このセンサ(70)は、前記作動液の圧力を検知する請求項27に記載のシステム。
- このシステムは、少なくとも前記センサ(70)によって検知された圧力に基づいて前記ポンプ(80)を制御するように構成されている請求項28に記載のシステム。
- このシステムは、前記検知された圧力に基づいて血液成分間の少なくとも1つの境界面の位置を判定するようになっており、前記境界面は前記ポンプ送りされる血液成分に関連している、請求項28もしくは29に記載のシステム。
- 少なくとも1つの時間間隔にて前記圧力センサ(70)によって検知される圧力間の差分を計算し、
前記計算された差分が少なくともあらかじめ設定された量であるときを判定し、そして
少なくとも、前記計算された差分が少なくともあらかじめ設定された量であるとの判定に応答して前記ポンプ(80)を制御するように構成されている請求項28ないし30のいずれか1に記載のシステム。 - 少なくとも1つの光学センサ(52,55)をさらに具備し、このシステムは、少なくとも1つの光学センサ(52,55)によって検知された少なくとも情報に基づいて前記ポンプを制御するように構成されている請求項26ないし31のいずれか1に記載のシステム。
- 少なくとも1つの光学センサ(52,55)は、前記チャンバ(4)内の血液成分を検知するように配設された第1の光学センサ(52)を有する請求項32に記載のシステム。
- 少なくとも1つの光学センサ(52,55)は、前記フイルタ(31)と連通した前記管系ライン(21)内の血液成分を検知するように配設された第1の光学センサ(52)を有する請求項32もしくは33に記載のシステム。
- 血液成分を処理する方法であって、
遠心ロータ(1)の第1の部分(3)内に分離チャンバ(4)を、また、この分離チャンバ内部(8)よりも前記遠心ロータ(1)の前記回転軸に近接して配置されるように遠心ロータ(1)の第2の部分(2)内に、多孔濾過媒体(31c)を有するフィルタ(31)を配置することと、
前記血液成分が、前記チャンバ内部(8)にて遠心力で分離されるように、前記遠心ロータ(1)と前記分離チャンバ(4)と前記フィルタ(31)とを前記回転軸のまわりで回転させることと、
前記遠心力で分離された血液成分の少なくともいくらかを、前記分離チャンバ(4)から分離チャンバ(4)の出口ポート(4b)を経由して除去することと、
前記除去された血液成分から少なくとも1種類の血液成分の少なくともいくらかを濾過するように前記除去された血液成分をフィルタで濾過することとを具備し、
前記濾過の少なくとも一部は、前記回転させることの間に起こり、
前記フィルタ(31)は、前記多孔濾過媒体(31c)を収容する内部空間を規定するハウジング(31d)を備えており、且つこの方法は、前記回転軸に向かう方向に前記多孔濾過媒体を介して、前記フィルタ(31)の前記内部空間に血液成分を流すことを具備する方法。 - 前記遠心ロータ(1)上の少なくとも1つの管系クランプに、この遠心ロータ(1)の回転の間における前記血液成分の少なくともいくらかの流れを制御させることをさらに具備する請求項35に記載の方法。
- 前記遠心ロータ(1)上の少なくとも1つの管系溶着機に、この遠心ロータ(1)の回転の間に封止を形成させることをさらに具備する請求項35もしくは36に記載の方法。
- 前記遠心ロータ(1)の回転の間に、前記遠心力で分離された血液成分の少なくともいくらかを前記チャンバ(4)から前記フィルタ(31)へポンプ送りすることをさらに具備する請求項35ないし37のいずれか1に記載の方法。
- 前記ポンプ送りは、前記チャンバ内部(8)の容積を減小させることを有している請求項38に記載の方法。
- 前記ポンプ送りは、作動液を介して前記チャンバ(4)へ圧力を印加することを有している請求項38もしくは39に記載の方法。
- ポンプ送りされている血液成分の圧力を検知すること、および少なくとも前記検知された圧力に基づいて前記ポンプ送りを制御することをさらに具備する請求項38ないし40のいずれか1に記載の方法。
- 前記検知された圧力に基づいて血液成分間の少なくとも1つの境界面の位置を判定することをさらに具備し、前記境界面は、前記ポンプ送りされた血液成分に関連している、請求項41に記載の方法。
- 少なくとも1つの時間間隔にて検知された圧力間の差分を計算することと、
前記計算された差分が少なくともあらかじめ設定された量であるときを判定することと、
少なくとも、前記計算された差分が少なくともあらかじめ設定された量であるとの判定に応答して前記ポンプ送りを制御することとをさらに具備する請求項41もしくは42に記載の方法。 - 前記ポンプ送りされている血液製剤を光学的に検知することと、光学的に検知された情報と検知された圧力との少なくとも一方に基づいてポンプ送りを制御することと、をさらに具備する請求項38ないし43のいずれか1に記載の方法。
- 前記光学的に検知することは、前記チャンバ(4)内の血液成分を光学的に検知することを有する請求項44に記載の方法。
- 前記光学的に検知することは、前記フィルタ(31)と連通している管系ライン(21)内の血液成分を光学的に検知することを有する請求項44に記載の方法。
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