JP5490966B2 - 自動化された血小板洗浄のためのシステムおよび方法 - Google Patents
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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
- A61M1/3693—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
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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
- A61M1/3692—Washing or rinsing blood or blood constituents
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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
- A61M1/3693—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
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B11/00—Feeding, charging, or discharging bowls
- B04B11/04—Periodical feeding or discharging; Control arrangements therefor
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B13/00—Control arrangements specially designed for centrifuges; Programme control of centrifuges
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B15/00—Other accessories for centrifuges
- B04B15/06—Other accessories for centrifuges for cleaning bowls, filters, sieves, inserts, or the like
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0602—Vertebrate cells
- C12N5/0634—Cells from the blood or the immune system
- C12N5/0644—Platelets; Megakaryocytes
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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
- A61M1/02—Blood transfusion apparatus
- A61M1/0281—Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
Description
Claims (42)
- 血小板洗浄のための方法であって、
(a)血小板製剤を含有する血小板製剤コンテナに抗凝固剤を導入するステップ;
(b)血小板製剤コンテナから抗凝固化された血小板製剤を取り出すステップ;
(c)抗凝固化された血小板産物を遠心ボウルへと導入し、遠心ボウルが血小板を上清から分離するステップ;
(d)洗浄溶液を遠心ボウルへと導入し、洗浄溶液がボウルから廃液コンテナへと上清を追い出すステップ;
(e)血小板添加溶液を遠心ボウルへと導入し、血小板添加溶液が遠心ボウルから廃液コンテナへと洗浄溶液を追い出すステップ;
(f)遠心ボウルを加速し、減速することで遠心ボウルを揺り動かすステップ;
(g)少なくとも1回ステップ(f)を繰り返し、それによって血小板添加溶液中に血小板を再懸濁するステップ
を含有する、方法。 - 再懸濁された血小板および血小板添加溶液を、洗浄された血小板貯蔵コンテナへと移動させるステップをさらに含有する、請求項1に記載される方法。
- ステップ(f)が4回繰り返される、請求項1に記載される方法。
- (h)再懸濁された血小板および血小板添加溶液の一部分を遠心ボウルから洗浄された血小板貯蔵コンテナへと移動させるステップ;
(i)少なくとも1回ステップ(f)を繰り返すステップ;ならびに
(j)遠心ボウル中に残された血小板および血小板添加溶液を洗浄された血小板貯蔵コンテナへと移動させるステップ、
をさらに含有する、請求項1に記載される方法。 - ステップ(i)がステップ(f)を4回繰り返すことを含む、請求項4に記載される方法。
- ステップ(j)の後に血小板添加溶液で遠心ボウルをリンスするステップ;ならびに
遠心ボウル中の血小板添加溶液を血小板貯蔵コンテナへと移動させるステップ、
をさらに含有する請求項4に記載される方法。 - 遠心ボウルを加速することが遠心ボウルを停止状態から始動させることを含み、そして遠心ボウルを減速することが遠心ボウルを停止させることを含む、請求項4に記載される方法。
- 遠心ボウルを加速することが遠心ボウルを逆向きに始動させることを含む、請求項7に記載される方法。
- ステップ(j)の後で、血小板添加溶液を、洗浄された血小板貯蔵コンテナへと添加し、予め決められた洗浄された血小板容量を達成する、請求項4に記載される方法。
- ステップ(j)の後で、血小板添加溶液を、洗浄された血小板貯蔵コンテナへと添加し、予め決められた洗浄された血小板収量を達成する、請求項4に記載される方法。
- 洗浄溶液が生理食塩水グルコース溶液である、請求項1に記載される方法。
- 洗浄溶液を遠心ボウルへと導入する前に、洗浄溶液に抗凝固剤を導入するステップをさらに含有する、請求項1に記載される方法。
- 抗凝固剤を血小板製剤コンテナへと導入するときに血小板製剤コンテナを攪拌するステップをさらに含有する、請求項1に記載される方法。
- 前記血小板製剤が多血小板血漿であり、前記上清が血漿である請求項1に記載される方法。
- ステップ(f)の最中に、前記遠心ボウルが減速の前に2秒間加速される、請求項1に記載される方法。
- ステップ(f)の前に再懸濁された血小板および血小板添加溶液の一部分を移動させるステップをさらに含有する、請求項1に記載される方法。
- 自動化された血小板洗浄のためのシステムであって、
血小板製剤コンテナをシステムへと接続し、血小板製剤コンテナから血液製剤を取り出すための無菌接続;
血小板製剤を血小板と上清に分離するための遠心ボウル、前記遠心ボウルは上清を廃液コンテナへと送るよう構成される;
遠心ボウルへと流体接続され、洗浄溶液を遠心ボウルへと送るよう構成された洗浄溶液源;
遠心ボウルへと流体接続され、血小板添加溶液を遠心ボウルへと送るよう構成された血小板添加溶液源;ならびに
遠心ボウルの操作を制御するためのコントローラ、前記コントローラは血小板添加溶液が血小板へと添加しそして上清が廃液コンテナへと送られた後に、遠心ボウルを複数回加速および減速し、血小板を血小板添加溶液へと再懸濁する、
を含有する、システム。 - 前記遠心ボウルの加速が遠心ボウルを停止状態から始動することを含み、遠心ボウルの減速が遠心ボウルを停止させることを含む、請求項17に記載されるシステム。
- 前記コントローラが遠心ボウルを始動および停止されるときに、遠心ボウルの開始を時計回り方向と反時計回り方向とで変更する、請求項18に記載されるシステム。
- 前記コントローラが遠心ボウルの加速と減速を4回実施する、請求項17に記載されるシステム。
- 洗浄された血小板コンテナをさらに含有し、コントローラが遠心ボウルを始動および停止した後にシステムが再懸濁された血小板の一部分を前記洗浄された血小板コンテナへと移動させる、請求項17に記載されるシステム。
- 再懸濁された血小板の部分を洗浄された血小板コンテナへと移動させた後にコントローラが遠心ボウルの加速および減速を繰り返す、請求項21に記載されるシステム。
- コントローラが加速と減速とを繰り返した後にシステムが残余の血小板および血小板添加溶液を洗浄された血小板コンテナへと移動させる、請求項21に記載されるシステム。
- 予め決められた容量を達成するために、システムが残余の血小板および血小板添加溶液を洗浄された血小板コンテナへと移動させた後にコントローラが血小板添加溶液を洗浄された血小板貯蔵コンテナへと添加するよう構成された、請求項23に記載されるシステム。
- 予め決められた収量を達成するために、システムが残余の血小板および血小板添加溶液を洗浄された血小板コンテナへと移動させた後にコントローラが血小板添加溶液を洗浄された血小板貯蔵コンテナへと添加するよう構成された、請求項23に記載されるシステム。
- 前記血小板製剤が多血小板血漿であり、前記上清が血漿である、請求項17に記載されるシステム。
- 前記コントローラがボウルを停止する前に遠心ボウルを2秒間加速する、請求項17に記載されるシステム。
- 前記洗浄溶液が抗凝固化された生理食塩水グルコースである、請求項17に記載されるシステム。
- 抗凝固剤源をさらに含有し、システムが抗凝固剤を抗凝固剤源から血小板製剤コンテナへと導入する、請求項17に記載されるシステム。
- 血小板洗浄のためのシステムであって、
抗凝固剤を血小板製剤コンテナへと導入するための手段、前記血小板製剤は上清中に懸濁された血小板を含有する;
抗凝固化された血小板製剤を血小板製剤コンテナより取り出す手段;
血小板を上清から分離するための遠心ボウル;
洗浄溶液を遠心ボウルへと導入するための手段、前記洗浄溶液は上清をボウルから廃液コンテナへと追い出す;
血小板添加溶液を遠心ボウルへと導入するための手段、前記血小板添加溶液は洗浄溶液を遠心ボウルから廃液コンテナへと追い出す;
遠心ボウルの操作を制御するためのコントローラ、前記コントローラは、血小板添加溶液が血小板および上清へと添加され洗浄溶液が廃液コンテナに送られた後に遠心ボウルを複数回加速および減速して血小板添加溶液中の血小板を再懸濁する;
を含有する、システム。 - 再懸濁された血小板および血小板添加溶液を洗浄された血小板貯蔵コンテナへと移動させる手段をさらに含有する、請求項30に記載されるシステム。
- 前記コントローラが遠心ボウルを加速および減速することを4回行う、請求項30に記載されるシステム。
- 再懸濁された血小板および血小板添加溶液の一部分を遠心ボウルから洗浄された血小板貯蔵コンテナへと移動させる手段、前記コントローラは、再懸濁された血小板の一部分が洗浄された血小板貯蔵コンテナに移動された後に遠心ボウルを加速および減速することを繰り返すように構成される;ならびに
残余の再懸濁された血小板および血小板添加溶液を遠心ボウルから洗浄された血小板貯蔵コンテナへと移動させる手段
をさらに含有する、請求項30に記載されるシステム。 - 前記コントローラが加速と減速を4回繰り返す、請求項33に記載されるシステム。
- 洗浄溶液が抗凝固化された生理食塩水グルコース溶液である、請求項33に記載されるシステム。
- 洗浄溶液を遠心ボウルへと導入する前に抗凝固剤を洗浄溶液へと導入する手段をさらに含有する、請求項33に記載されるシステム。
- 予め決められた容量を達成するために、システムが残余の血小板および血小板添加溶液を洗浄された血小板貯蔵コンテナへと移動させた後に前記コントローラが血小板添加溶液を洗浄された血小板貯蔵コンテナへと添加するようにさらに構成された、請求項33に記載されるシステム。
- 予め決められた収量を達成するために、システムが残余の血小板および血小板添加溶液を洗浄された血小板貯蔵コンテナへと移動させた後に前記コントローラが血小板添加溶液を洗浄された血小板貯蔵コンテナへと添加するようにさらに構成された、請求項33に記載されるシステム。
- 遠心ボウルを加速することが、遠心ボウルを停止状態から始動することを含み、遠心ボウルを減速することが遠心ボウルを停止させることを含む、請求項30に記載されるシステム。
- 遠心ボウルを始動および停止するときに、前記コントローラがボウルの始動を時計回り方向と反時計回り方向とで変更するよう構成された、請求項39に記載されるシステム。
- シェーカーをさらに含有し、抗凝固剤が血小板製剤コンテナーに導入されるときに前記シェーカーが血小板製剤コンテナーを攪拌する、請求項30に記載されるシステム。
- 前記血小板製剤が多血小板血漿であり、前記上清が血漿である、請求項30に記載されるシステム。
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US41073810P | 2010-11-05 | 2010-11-05 | |
US61/410,738 | 2010-11-05 | ||
PCT/US2010/056722 WO2012060848A1 (en) | 2010-11-05 | 2010-11-15 | System and method for automated platelet wash |
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JP2013537650A Active JP5490966B2 (ja) | 2010-11-05 | 2010-11-15 | 自動化された血小板洗浄のためのシステムおよび方法 |
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JP (1) | JP5490966B2 (ja) |
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2010
- 2010-11-15 US US13/883,518 patent/US8808978B2/en active Active
- 2010-11-15 CN CN201080069996.1A patent/CN103221078B/zh active Active
- 2010-11-15 JP JP2013537650A patent/JP5490966B2/ja active Active
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EP2635320B1 (en) | 2015-03-18 |
US9833794B2 (en) | 2017-12-05 |
HK1187562A1 (zh) | 2014-04-11 |
EP2635320A1 (en) | 2013-09-11 |
US20130309652A1 (en) | 2013-11-21 |
US8808978B2 (en) | 2014-08-19 |
EP2881127A1 (en) | 2015-06-10 |
JP2013545526A (ja) | 2013-12-26 |
WO2012060848A1 (en) | 2012-05-10 |
CN103221078B (zh) | 2015-09-16 |
EP2881127B1 (en) | 2017-01-04 |
CN103221078A (zh) | 2013-07-24 |
US20140329656A1 (en) | 2014-11-06 |
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