JP2019013780A - 薬の安全な移送のための配合システムおよび方法 - Google Patents
薬の安全な移送のための配合システムおよび方法 Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
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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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
- B65B3/10—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material
- B65B3/12—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
- B65B63/08—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for heating or cooling articles or materials to facilitate packaging
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2068—Venting means
- A61J1/2072—Venting means for internal venting
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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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3114—Filling or refilling
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/26—Methods or devices for controlling the quantity of the material fed or filled
- B65B3/28—Methods or devices for controlling the quantity of the material fed or filled by weighing
Abstract
Description
本出願は、2014年4月25日に出願された米国仮出願第61/984,144号および2013年8月2日に出願された米国仮出願第61/861,680号のそれぞれの利益を主張するものであり、それらの各開示内容全体が参照により本明細書に組み込まれる。
調製システム1000は、最高級の調製システムに統合されるサブシステムを構成する多くの部品を備える。この手法は2つの理由で考案された。すなわち、この手法により、調製システム1000をより早期に開発するためにパーツに分けることができ、製造事例においては、保守、修理およびアップグレードのための「プラグ・アンド・プレイ」動作が可能になる。
調製システム1000の動作は、多くの独立したサブルーチンに依存する。調製システム1000は、注射器「I」、注射器アダプタ11、バイアル「V」およびバイアルアダプタ13のそれぞれ1つを利用して、流体「L」(すなわち、薬など)のバイアル「V」から注射器「I」への移送を実行することができる。このプログラムの流れは、以下の表1のとおりである。
Claims (9)
- 液体および非液体材料のうちの一方を含むバイアルから薬溶液を調製するための自動または半自動の調製システムのための部品ホルダであって、
第1の顎および第2の顎を含む第1の対の固定および離間された顎と、
第1の顎および第2の顎を含む第2の対の固定および離間された顎と、
を備える把持部を備え、
前記第1の対の顎は、前記第2の対の顎に対して並進可能であり、かつ
前記第1の対の顎の前記第1の顎は、前記第2の対の顎の間に挿入され、かつ前記第2の対の顎の前記第2の顎は、前記第1の対の顎の間に挿入される、部品ホルダ。 - 前記把持部の動作は、
前記第1の対の顎の前記第1の顎と前記第2の対の顎の前記第1の顎との間に位置する第1の把持位置、
前記第1の対の顎の前記第2の顎と前記第2の対の顎の前記第1の顎との間に位置する第2の把持位置、および
前記第1の対の顎の前記第2の顎と前記第2の対の顎の前記第2の顎との間に位置する第3の把持位置で、
部品を把持するための前記第1の対の顎の前記第2の対の顎に対する並進を含む、請求項1に記載の部品ホルダ。 - 前記第1の対の顎は、1つのラックを支持し、かつ前記第2の対の顎は、1つのラックを支持し、ピニオンにより前記各ラックを相互接続し、前記ピニオンの回転により、前記第1の対の顎および前記第2の対の顎を互いに対して軸方向並進させる、請求項2に記載の部品ホルダ。
- 液体および非液体材料のうちの一方を含むバイアルから薬溶液を調製するための自動または半自動の調製システムの動作方法であって、
大量の薬を含む予め選択したバイアルを前記調製システムの部品ホルダに装着する工程と、
バイアルアダプタを前記調製システムの部品ホルダに装着する工程と、
注射器を前記調製システムの部品ホルダに装着する工程と、
注射器アダプタを前記調製システムの部品ホルダに装着する工程と、
前記バイアルと前記バイアルアダプタとを近づける工程と、
前記バイアルおよび前記バイアルアダプタを機械的かつ流体的に結合してアセンブリを形成する工程と、
前記注射器と前記注射器アダプタとを近づける工程と、
前記注射器および前記注射器アダプタを機械的かつ流体的に結合してアセンブリを形成する工程と、
次いで、前記注射器アダプタを移動させて前記バイアルアダプタに係合させる工程であって、前記注射器アダプタのシールを前記バイアルアダプタのシールに接続する工程と、
前記バイアルの栓が前記バイアルアダプタの前記シールに係合するまで、前記注射器アダプタを前記バイアルアダプタに向かって前進させる工程と、
前記注射器のプランジャーを前記注射器の外筒に対して後退させて、流体を前記バイアルから抜き出し始める工程と、
前記注射器の前記プランジャーを前記注射器の前記外筒に対して前進させて、流体を前記バイアルの中に注入して戻す工程と、
前記注射器の前記プランジャーを前記注射器の前記外筒に対して後退させて、前記流体を前記バイアルから抜き出して、薬の前記バイアルから前記注射器への移送を完了させる工程と、
を含む薬抜き出しプロセスを実行する工程と、
前記注射器アダプタを前記バイアルアダプタから取り外す工程と、
を含む方法。 - 前記薬を含む前記注射器を容器に接続する工程と、前記薬を前記容器に注入する工程とをさらに含む、請求項4に記載の方法。
- 前記バイアルに含まれている凍結乾燥した薬を再構成する工程をさらに含み、前記再構成する工程は、
希釈剤を前記凍結乾燥した薬を含む前記バイアルに注入する工程と、
前記凍結乾燥した薬を含む前記バイアルを撹拌して、前記凍結乾燥した薬を溶解させる工程と、
を含む、請求項5に記載の方法。 - 前記バイアルアダプタを前記注射器アダプタに接続した後に前記再構成する工程を行う、請求項6に記載の方法。
- 前記再構成する工程は、前記バイアルアダプタを前記注射器アダプタに接続した後に、前記注射器、前記注射器アダプタ、前記バイアルアダプタおよび前記バイアルを反転させる工程を含む、請求項7に記載の方法。
- 前記再構成する工程の前に前記バイアルの重量を測定する工程と、
前記再構成する工程の後に前記バイアルの重量を測定する工程と、
をさらに含む、請求項8に記載の方法。
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US201361861680P | 2013-08-02 | 2013-08-02 | |
US61/861,680 | 2013-08-02 | ||
US201461984144P | 2014-04-25 | 2014-04-25 | |
US61/984,144 | 2014-04-25 |
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JP2018174428A Active JP6712624B2 (ja) | 2013-08-02 | 2018-09-19 | 薬の安全な移送のための配合システムおよび方法 |
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US (2) | US9877895B2 (ja) |
EP (2) | EP3415136B1 (ja) |
JP (2) | JP6410271B2 (ja) |
AU (2) | AU2014295975B2 (ja) |
CA (2) | CA2920199C (ja) |
IL (1) | IL243821A0 (ja) |
MX (1) | MX371346B (ja) |
NZ (1) | NZ716552A (ja) |
WO (1) | WO2015017858A1 (ja) |
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Also Published As
Publication number | Publication date |
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