JP2015186574A - 血液細胞収集システム - Google Patents
血液細胞収集システム Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/38—Removing constituents from donor blood and storing or returning remainder to body, e.g. for transfusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36222—Details related to the interface between cassette and machine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36224—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with sensing means or components thereof
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36225—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with blood pumping means or components thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362262—Details of incorporated reservoirs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362266—Means for adding solutions or substances to the blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
- A61M1/3696—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/0209—Multiple bag systems for separating or storing blood components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362265—Details of valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
- A61M2202/0427—Platelets; Thrombocytes
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- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
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- Cardiology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- External Artificial Organs (AREA)
- Centrifugal Separators (AREA)
Abstract
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。
8…バッグ・チューブセット 12…血液処理容器
Claims (9)
- 遠心分離機ロータ(20)と、
前記ロータ(20)に取り付けられる血液処理チャンバ(134)と、
余剰の血小板を収集することなく、選択された血小板製剤のために血小板最大量を収集するための手段(140)とを備え、
(a)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ことと、
(b)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ことと、
(c)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ことと、
(d)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ことと、
を行うための手段をさらに備え、
手順に固有な血小板量を特定する前記(c)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血小板量の探索を開始する、血液細胞収集システム(2)。 - 請求項1記載の血液細胞収集システムは、複数の範囲を特定するための手段をさらに備え、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血液細胞収集システム。
- 請求項2記載の血液細胞収集システムにおいて、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血液細胞収集システム。
- 請求項3記載の血液細胞収集システムにおいて、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血液細胞収集システム。
- 請求項2記載の血液細胞収集システムにおいて、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血液細胞収集システム。
- 請求項1記載の血液細胞収集システムは、手順の間、前記特定することを繰り返し、前記手順に固有な血小板量を調整するための手段をさらに備えることを特徴とする血液細胞収集システム。
- 請求項6記載の血液細胞収集システムは、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、前記特定することを繰り返す手段をさらに備えることを特徴とする血液細胞収集システム。
- 請求項7記載の血液細胞収集システムは、ある範囲内で血小板収量目標値を自動的に調整する手段をさらに備えることを特徴とする血液細胞収集システム。
- 請求項7記載の血液細胞収集システムは、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ための手段と、
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ための手段と、
をさらに備えることを特徴とする血液細胞収集システム。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US36302610P | 2010-07-09 | 2010-07-09 | |
US61/363,026 | 2010-07-09 |
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JP2013518459A Division JP5833648B2 (ja) | 2010-07-09 | 2011-06-20 | 収集目標値を自動調整する血液処理方法 |
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JP2015186574A true JP2015186574A (ja) | 2015-10-29 |
JP6031155B2 JP6031155B2 (ja) | 2016-11-24 |
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JP2013518459A Active JP5833648B2 (ja) | 2010-07-09 | 2011-06-20 | 収集目標値を自動調整する血液処理方法 |
JP2015098932A Active JP6031155B2 (ja) | 2010-07-09 | 2015-05-14 | 血液細胞収集システム |
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Country | Link |
---|---|
US (1) | US20120010062A1 (ja) |
EP (1) | EP2590698A1 (ja) |
JP (2) | JP5833648B2 (ja) |
WO (1) | WO2012005934A1 (ja) |
Families Citing this family (9)
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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 |
SG11201805771XA (en) * | 2016-01-07 | 2018-08-30 | Cerus Corp | Systems and methods for preparation of platelets |
US10391213B2 (en) | 2016-06-08 | 2019-08-27 | Fenwal, Inc. | Systems and methods for therapeutic platelet depletion |
EP3954407B1 (en) | 2018-05-21 | 2023-07-12 | Fenwal, Inc. | Systems and methods for optimization of plasma collection volumes |
US11412967B2 (en) | 2018-05-21 | 2022-08-16 | Fenwal, Inc. | Systems and methods for plasma collection |
US11957828B2 (en) * | 2019-09-16 | 2024-04-16 | Fenwal, Inc. | Dynamic adjustment of algorithms for separation and collection of blood components |
CN116490230A (zh) * | 2020-10-23 | 2023-07-25 | 汾沃有限公司 | 利用远程编程进行血浆采集 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH07178162A (ja) * | 1993-10-21 | 1995-07-18 | Cobe Lab Inc | 最適化器を備えた血液成分収集装置 |
JP2000084066A (ja) * | 1998-09-11 | 2000-03-28 | Haemonetics Corp | アフェレーシス装置及び血液製剤の製造方法 |
JP2005500087A (ja) * | 2001-03-01 | 2005-01-06 | ガンブロ、 インコーポレイテッド | 体外血液処理情報管理システム |
US20090217202A1 (en) * | 2008-02-27 | 2009-08-27 | Foley John T | Product options calculator for a blood processing system |
Family Cites Families (5)
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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 |
US6053856A (en) | 1995-04-18 | 2000-04-25 | Cobe Laboratories | Tubing set apparatus and method for separation of fluid components |
US5674173A (en) | 1995-04-18 | 1997-10-07 | Cobe Laboratories, Inc. | Apparatus for separating particles |
WO2001065463A2 (en) * | 2000-03-01 | 2001-09-07 | Gambro, Inc. | Extracorporeal blood processing information management system |
-
2011
- 2011-06-20 US US13/164,586 patent/US20120010062A1/en not_active Abandoned
- 2011-06-20 JP JP2013518459A patent/JP5833648B2/ja active Active
- 2011-06-20 EP EP11727902.6A patent/EP2590698A1/en not_active Withdrawn
- 2011-06-20 WO PCT/US2011/041107 patent/WO2012005934A1/en active Application Filing
-
2015
- 2015-05-14 JP JP2015098932A patent/JP6031155B2/ja active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH07178162A (ja) * | 1993-10-21 | 1995-07-18 | Cobe Lab Inc | 最適化器を備えた血液成分収集装置 |
JP2000084066A (ja) * | 1998-09-11 | 2000-03-28 | Haemonetics Corp | アフェレーシス装置及び血液製剤の製造方法 |
JP2005500087A (ja) * | 2001-03-01 | 2005-01-06 | ガンブロ、 インコーポレイテッド | 体外血液処理情報管理システム |
US20090217202A1 (en) * | 2008-02-27 | 2009-08-27 | Foley John T | Product options calculator for a blood processing system |
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Publication number | Publication date |
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US20120010062A1 (en) | 2012-01-12 |
JP5833648B2 (ja) | 2015-12-16 |
EP2590698A1 (en) | 2013-05-15 |
JP6031155B2 (ja) | 2016-11-24 |
WO2012005934A1 (en) | 2012-01-12 |
JP2013531536A (ja) | 2013-08-08 |
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