JP2020510486A - 再構成装置、システムおよび方法 - Google Patents
再構成装置、システムおよび方法 Download PDFInfo
- Publication number
- JP2020510486A JP2020510486A JP2019548877A JP2019548877A JP2020510486A JP 2020510486 A JP2020510486 A JP 2020510486A JP 2019548877 A JP2019548877 A JP 2019548877A JP 2019548877 A JP2019548877 A JP 2019548877A JP 2020510486 A JP2020510486 A JP 2020510486A
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- vial
- injection device
- diluent
- holder
- transfer
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
- A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
-
- 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
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
-
- 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
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
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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
- A61M5/46—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 having means for controlling depth of insertion
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/2202—Mixing compositions or mixers in the medical or veterinary field
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2215/00—Auxiliary or complementary information in relation with mixing
- B01F2215/04—Technical information in relation with mixing
- B01F2215/0413—Numerical information
- B01F2215/0436—Operational information
- B01F2215/0454—Numerical frequency values
Abstract
Description
本出願の図1〜20およびこの段落以降「移送装置」と題されたセクションまでの関連する説明は、主に共通して所有の以前に公開された、ここに参照として全体が組み込まれる国際出願日が2014年6月17日のPCT出願の国際公開第W2014/204894 A2から得られる。
図21〜34は、再構成または希釈を必要とする注射剤に特に適した移送装置250の実施形態に関する。この移送装置には、2つのバイアルアダプタと、以下で説明する対応する流路の構成が含まれている。図31に見られるように、この移送装置250は、注射装置7が連結されたときにその上に載る基部252を含む。基部は支持面254を形成し、そこから注射装置の充填ポート81への挿入のために流体移送ポート254が突出する。隆起した周壁258は、支持面から上方に延び、一緒になって、注射装置を受け入れるための入れ子またはドッキング部位を画定する。
本主題は、上記のものに加えて、以下のような様々な態様を含む。
Claims (20)
- 注射装置を受け入れるように構成されたインジェクタ支持面、前記支持面で受けたときに液体を注射装置に移送するために前記支持面から上方に延びる流体移送ポート、凍結乾燥薬物を収容するバイアルを受け入れるように構成された凍結乾燥薬物バイアルアダプタ、希釈剤を含むバイアルを受け入れるように構成されている希釈剤バイアルアダプタ、シリンジを受け入れるように構成されているシリンジアダプタ、前記凍結乾燥薬物バイアルアダプタと前記シリンジアダプタとの間、前記希釈剤バイアルアダプタと前記シリンジアダプタの間、および、前記シリンジアダプタと前記流体移送ポートとの間を連絡するように配置され得る流体流路、および、選択的に、前記希釈剤バイアルアダプタを前記シリンジアダプタと接続し、前記凍結乾燥薬物バイアルを前記シリンジアダプタと接続し、または、前記シリンジアダプタを前記流体移送ポートと接続するための前記液体流路の手動弁とを備える、使い捨て流体移送装置。
- 前記移送装置に連結された注射装置を保持するための解放可能なハーネスを含む、請求項1に記載の使い捨て流体移送装置。
- 前記使い捨て流体移送装置に連結され、前記連結された位置に解放可能に保持される注射装置を含む、請求項1に記載の使い捨て流体移送装置。
- 前記注射装置は、内部の弾性の拡張可能部材と、液体を前記拡張可能部材に導入するための充填ポートとを含み、前記移送装置の前記流体移送ポートは、前記注射装置が前記移送装置に連結されているときに前記充填ポート内に延びる、請求項3に記載の使い捨て流体移送装置。
- 前記支持面が上面および下面を有し、前記注射装置が前記上面に対して受容可能であり、前記弁および流体流路が前記支持面の前記下面で担持される、請求項1に記載の使い捨て移送装置。
- a.バイアル容器を含むハウジング;
b.前記ハウジングの前記バイアル容器に接続され、凍結乾燥製剤を含む第1バイアルおよび希釈剤を含む第2バイアルを保持するように構成されたバイアルホルダー;
c.希釈剤を前記第2バイアルから前記第1バイアルに移送するように構成された加圧流体供給システム;
d.前記バイアルホルダーが前記バイアル容器に接続されたときに前記バイアルホルダーに接続され、前記第2バイアルから前記第1バイアルに移送された希釈剤で前記第1バイアルの前記凍結乾燥製剤が再構成されるように前記第1バイアルを振動させるように構成されたモータ
を備える、凍結乾燥製剤を再構成するための装置。 - 前記凍結乾燥製剤が薬物を含む、請求項6に記載の装置。
- トリガー機構および電子制御部をさらに備え、前記電子制御部が前記モータを制御するように構成され、前記トリガー機構が前記バイアル容器および前記電子制御部に接続される、請求項6または請求項7に記載の装置。
- バイアルホルダー台をさらに備え、前記バイアルホルダー台は、前記バイアルホルダーを収容し、前記バイアルホルダーが前記バイアルホルダー台に接続されたときに前記トリガー機構を作動させるように構成され、前記モータは、前記バイアルホルダー台を振動させるように構成される、請求項8に記載の装置。
- 前記バイアルホルダーが前記バイアルホルダー台に挿入された後、前記バイアルホルダーを前記バイアルホルダー台内にロックするように構成されたバイアル保持器をさらに備える、請求項9に記載の装置。
- 前記モータは偏心回転質量モータである、請求項6から請求項10までのいずれか1項に記載の装置。
- 前記ハウジングは注射装置容器をさらに備え、前記注射装置容器は注射装置を受容するように構成され、前記加圧流体供給システムはさらに、再構成された製剤を前記第1バイアルから前記注射装置容器に接続された注射装置に移送するように構成されている、請求項6から請求項11までのいずれか1項に記載の装置。
- 前記モータは、500Hz未満の周波数で前記第1バイアルを振動させるように構成されている、請求項6から請求項12までのいずれか1項に記載の装置。
- 前記バイアルホルダーが前記ハウジングの前記バイアル容器に接続された時に前記バイアルホルダーに接続されるように構成される振動減衰器をさらに備える、請求項6から請求項13までのいずれか1項に記載の装置。
- 前記バイアルホルダーは、前記第1バイアルおよび第2バイアルを倒立位置で保持するように構成されている、請求項6から請求項14までのいずれか1項に記載の装置。
- a.注射装置;および
b.i)凍結乾燥製剤を含む第1バイアルおよび希釈剤を含む第2バイアルを保持するように構成されたバイアルホルダー;
ii)希釈剤を前記第2バイアルから前記第1バイアルに移送し、再考し得された薬物を前記第1バイアルから前記注射装置に移送するように構成された加圧流体供給システム;
iii)前記バイアルホルダーに接続され、前記第2バイアルから前記第1バイアルに移送された希釈剤で前記第1バイアルの前記凍結乾燥製剤が再構成されるように前記第1バイアルを振動させるように構成されたモータ
を備える、凍結乾燥製剤を再構成するための装置
を備える、薬物を注射するための装置。 - 以下の工程を含む、薬物を再構成する方法:
a.凍結乾燥薬物を含む第1バイアルと希釈剤を含む第2バイアルを用意する工程;
b.希釈剤を第2バイアルから第1バイアルに移す工程;
c.前記第1バイアル内の凍結乾燥薬物が前記第2バイアルからの希釈剤と再構成されるように前記第1バイアルを振動させる工程。 - 前記cの工程の振動は、500Hz未満の周波数で発生する、請求項17に記載の方法。
- a.凍結乾燥製剤を含む第1バイアルおよび希釈剤を含む第2バイアルを保持するように構成されたバイアル容器
b.希釈剤を前記第2バイアルから前記第1バイアルに移送するように構成された加圧流体供給システム;
c.前記第2バイアルから前記第1バイアルに移送された希釈剤で前記第1バイアルの前記凍結乾燥製剤が再構成されるように、前記第1バイアルが前記バイアル容器によって保持された時に前記第1バイアルを振動させるように構成されたモータ
を備える、凍結乾燥製剤を再構成するための装置。 - 注射装置容器をさらに備え、前記注射装置容器は、注射装置を受け入れるように構成され、前記加圧流体供給システムは、再構成された製剤を前記第1バイアルから前記注射装置容器に接続された注射装置に移送するようにさらに構成される、請求項19に記載の装置。
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CN111132710B (zh) | 2022-08-19 |
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JP7269294B2 (ja) | 2023-05-08 |
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AU2023200184A1 (en) | 2023-02-16 |
EP3592405A1 (en) | 2020-01-15 |
JP2021191465A (ja) | 2021-12-16 |
CN111132710A (zh) | 2020-05-08 |
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