JP5833648B2 - 収集目標値を自動調整する血液処理方法 - Google Patents
収集目標値を自動調整する血液処理方法 Download PDFInfo
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Description
献血後最小許容血小板数により課せられる最大目標収量(YMP)は、手順条件とは独立して、次式により与えられる。
YMP=10-5(CPRE−CPOMIN)VB≧0 [1011plts] (1)
ここで、
CPRE=献血前ドナー血小板数 [106plts/ml]
CPOMIN=献血後最小設定血小板数 [106plts/ml]
VB=ドナーTBV [ml]
である。
血小板収集フェーズのために処理される注入量の関数として、手順時間の線形外挿は、次式により与えられる。
tPMAX=tPP+[(VINTARG)MAX/(VINTARG)P−1]tPCP
又は、
(VINTARG)MAX/(VINTARG)P=1+(tPMAX−tPP)/tPCP (2)
ここで、
tPMAX=最大設定手順時間 [分]
tPP=前回予想からの手順時間 [分]
tPCP=前回予想からの血小板収集時間 [分]
(VINTARG)P=前回予想からの血小板収集吸入量 [ml]
(VINTARG)MAX=最大血小板収量のための最大血小板収集注入量 [ml]
である。
(VINTARG)MAX/(VINTARG)P=[1−C1ln(1−C2YMT)]/[1−C1ln(1−C2YP)] (3)
であり、
C1=VB/(ECPVSU) (4)
C2=105/(CPREVB) (5)
である。
YMT=[1−exp(−C3/C1)]/C2 (6)
であり、
C3=[1+(tPMAX−tPP)/tPCP][1−C1ln(1−C2YP)]−1≧0 (7)
ここで、
ECP=前回予想からの血小板収集効率
VSU=開始量 [ml]
YP=前回予想の収量 [1011plts]
である。
収集可能な最大量により課せられる最大目標収量は、線形外挿により次式により与えられる。
VPMAXP=VPMIN+105CB(YMV−YP)
又は、
YMV=YP+10-5(VPMAXP−VPMIN)/CB (8)
ここで、
VPMAXP=前回予想から使用可能な最大血漿 [ml]
VPMIN=収集される最小受容可能血漿 [ml]
CB=設定バッグ濃度 [106plts/ml]
である。
VPMIN=特定の固定血漿量に対するVPTARG
=最大血小板又はMC血漿のための最小設定量 (9)
=血漿無しが指定された場合は、ゼロ。
YAMAP=MIN(YMP,YMT,YMV)−YMAR≧YMIN (10)
ここで、
YAMAP=最大血小板収量
YMAR=予想限界 [1011plts]
YMIN=最小設定最大血小板収量 [1011plts]
である。
1.収量、YP
2.手順時間、tPP
3.血小板収集時間、tPCP
4.利用可能な最大血漿量、VPMAXP
5.血小板収集効率、ECP
一連の手順の最大血小板収量を設定するために、様々な収束手順が使用される。今から使用される、以下に詳細に説明される手順は、以下の制限を採用することにより、計算の正確さとスピードのバランスを優先する。
YMAR=予想限界 [1011plts]=0.05
NP=手順予想の回数
最大NP=10
0.10以内の収束の場合、NP≦4
0.25以内の収束の場合、NP>4
他の制限は、ある特定の機器で利用可能なコントローラの処理スピード及び手順の数、並びに他の同様な因子に基づき、選択されるであろう。
Claims (12)
- ドナーの献血において適格であるとされる血小板最大量を特定する工程と、
前記最大量を含み且つ個々の血小板製剤量に関連付けられた許容される血小板量を含む血小板量範囲を特定する工程と、
複数の血液収集手順のそれぞれに対して、前記最大量未満であり且つ前記範囲内であり且つある特定の手順に対する最大血小板目標値である、手順に固有な血小板量を特定する工程と、
前記手順に固有な血小板量に関連付けされた特定の手順に関連して、前記手順に固有な血小板量を収集する工程と、
を有し、
手順に固有な血小板量を特定する前記工程では、前記範囲の最小値を下限とし前記血小板最大量を上限として確定されるエリアを複数の部分(Q1〜Q4)に分割し、前記複数の部分のうち最大の部分(Q1)から前記最大血小板目標値である前記血小板量の探索を開始する、遠心血液分離装置(2)の制御方法。 - 請求項1記載の方法は、複数の範囲を特定する工程をさらに有し、各範囲は、区域によって、隣接範囲から分離されることを特徴とする方法。
- 請求項2記載の方法において、前記複数の範囲は1倍の製剤範囲、2倍の製剤範囲、3倍の製剤範囲を含むことを特徴とする方法。
- 請求項3記載の方法において、それぞれの範囲は、予め選択された最大収量及び予め選択された最小収量により定義されることを特徴とする方法。
- 請求項2記載の方法において、前記手順に固有な血小板量は、前記区域内で値をとることが許されないことを特徴とする方法。
- 請求項1記載の方法は、手順の間、前記特定する工程を繰り返し行う工程と、前記手順に固有な血小板量を調整する工程と、をさらに有することを特徴とする方法。
- 請求項6記載の方法は、選択された間隔で、又は作動している状況において選択された変化がある場合、前記特定する工程を繰り返す工程をさらに有することを特徴とする方法。
- 請求項7記載の方法は、ある範囲内で血小板収量目標値を自動的に調整する工程をさらに有することを特徴とする方法。
- 請求項7記載の方法は、
調整された前記手順に固有な量が範囲の間の区域に又は他の範囲に入るかどうかを決定する工程と、
調整された前記手順に固有な量が範囲の間の前記区域に又は他の範囲に入る場合、オペレータに新しい手順を選択することを通知する工程と、
をさらに有することを特徴とする方法。 - 請求項6記載の方法は、
選択された手順が、受容可能な血小板量を収集することにもはや適していない場合に、別の手順を選択する工程と、
前記別の手順に関連付けられた手順に固有な血小板量を収集する工程と、
をさらに有することを特徴とする方法。 - 請求項1記載の方法において、ドナーの献血において適格であるとされる血小板最大量を特定する前記工程は、体重、性別及び血小板数を含むドナー固有のパラメータから最大量を算出する工程をさらに有することを特徴とする方法。
- 請求項1記載の方法において、ドナーの献血において適格であるとされる血小板最大量を特定する前記工程は、データベースからの前記ドナーの献血の記録にアクセスする工程をさらに有することを特徴とする方法。
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US11386993B2 (en) | 2011-05-18 | 2022-07-12 | Fenwal, Inc. | Plasma collection with remote programming |
US10872307B2 (en) * | 2013-12-27 | 2020-12-22 | Fenwal, Inc. | System and method for blood component supply chain management |
US11481395B2 (en) * | 2015-05-08 | 2022-10-25 | Fenwal, Inc. | Database query processing system for blood donation tracking system |
CN108697738A (zh) * | 2016-01-07 | 2018-10-23 | 塞鲁斯公司 | 用于制备血小板的系统和方法 |
US10391213B2 (en) * | 2016-06-08 | 2019-08-27 | Fenwal, Inc. | Systems and methods for therapeutic platelet depletion |
US11412967B2 (en) | 2018-05-21 | 2022-08-16 | Fenwal, Inc. | Systems and methods for plasma collection |
US12033750B2 (en) | 2018-05-21 | 2024-07-09 | Fenwal, Inc. | Plasma collection |
CN112587740B (zh) | 2018-05-21 | 2024-08-02 | 汾沃有限公司 | 用于采集血浆的系统 |
CN112495596B (zh) * | 2019-09-16 | 2022-07-26 | 汾沃有限公司 | 用于血液成分的分离和收集的算法的动态调整 |
EP4232117A4 (en) * | 2020-10-23 | 2024-02-28 | Fenwal, Inc. | PLASMA COLLECTION WITH REMOTE PROGRAMMING |
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US4425112A (en) | 1976-02-25 | 1984-01-10 | The United States Of America As Represented By The Department Of Health And Human Services | Flow-through centrifuge |
US5658240A (en) * | 1992-03-04 | 1997-08-19 | Cobe Laboratories, Inc. | Blood component collection system with optimizer |
US5496265A (en) * | 1992-03-04 | 1996-03-05 | Cobe Laboratories, Inc. | Blood component collection system with optimizer |
US5674173A (en) | 1995-04-18 | 1997-10-07 | Cobe Laboratories, Inc. | Apparatus for separating particles |
US6053856A (en) | 1995-04-18 | 2000-04-25 | Cobe Laboratories | Tubing set apparatus and method for separation of fluid components |
JP3196838B2 (ja) * | 1998-09-11 | 2001-08-06 | ヘモネティクス・コーポレーション | アフェレーシス装置及び血液製剤の製造方法 |
WO2002069793A2 (en) * | 2001-03-01 | 2002-09-12 | Gambro, Inc. | Extracorporeal blood processing information management system |
CA2672076A1 (en) * | 2000-03-01 | 2001-09-07 | Caridianbct, Inc. | Extracorporeal blood processing information management system |
US8782543B2 (en) * | 2008-02-27 | 2014-07-15 | Fenwal, Inc. | Product options calculator for a blood processing system |
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JP6031155B2 (ja) | 2016-11-24 |
JP2015186574A (ja) | 2015-10-29 |
EP2590698A1 (en) | 2013-05-15 |
US20120010062A1 (en) | 2012-01-12 |
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