JP2009078164A - 静脈薬剤混合・射出用システム、及びカセット - Google Patents
静脈薬剤混合・射出用システム、及びカセット Download PDFInfo
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Abstract
【解決手段】システムは、供給液体に接続される液体入口22、バイアル11a−11c、静脈薬剤を混合液体の形で患者に伝達する液体出口23から成る。システムは、伝達室27、混合室28及びバルブ機構31a−31iを含み得る。同機構は、液体出口23、伝達室27、混合室28、バイアル11a−11c及び液体入口22間の流れを制御するために作動される。システムは、伝達室27、混合室28の容量を変化させかつバルブ機構31a−31iを作動させて液体入口22からバイアル11a−11c内へ液体を導入して薬剤を液状化又は希釈し、薬剤を患者に伝達するようにする。液体入口22、バイアル11a−11c、伝達室27、混合室28、液体出口23及びバルブ機構31a−31iは、制御装置内に収容され得る使い捨てカセット内に配置される。
【選択図】図2
Description
本発明は、静脈薬剤の調製及び伝達の方法及び装置に関する。
より特定すれば、本発明は、以下の項目に関し得る。
(項目1)静脈薬剤を調製しかつバイアルから患者に伝達するシステムであって、供給液体に接続する液体入口と、バイアルレセプタクルと、可変容量を有する室と、混合された液状で患者に静脈薬剤を与えるための液体出口であって、上記液体出口、上記可変容量室、上記バイアルレセプタクル及び上記液体入口が互いに流体連通する出口と、上記液体出口、上記可変容量室、上記バイアルレセプタクル及び上記液体入口間の流れを制御するために作動され得るバルブ機構と、上記可変容量室の容量の変化を誘発させる装置と、上記バルブ機構を作動させる装置と、上記液体入口から上記バイアル内に液体を導入し、上記薬剤を上記患者に伝達するように、上記容量変化装置及び上記バルブ作動装置を制御する制御器とから成る薬剤調製・伝達システム。
(項目2)上記液体入口、上記バイアルレセプタクル、上記可変容量室、上記液体出口及び上記バルブ機構が、使い捨てカセット内に配置され、上記容量変化装置、上記バルブ作動装置及び上記制御器が、上記使い捨てカセットを受取る制御装置内に配置される、項目1のシステム。
(項目3)上記バルブ機構は、上記カセットが上記制御装置から除去されるとき上記液体出口を通る流れを妨げるために閉じられる、出口の自由流れを防止するバルブを含む項目2に記載のシステム。
(項目4)上記バルブ機構は、上記カセットが上記制御装置から除去されるとき上記液体入口を通る流れを妨げるために閉じられる、入口の自由流れを防止するバルブを含む、項目3のシステム。
(項目5)上記カセットが上記制御装置から除去されるとき上記入口及び出口自由流れ防止バルブが永久に閉じられる、項目4のシステム。
(項目6)上記バルブ機構が第1及び第2バルブ室を含み、上記第1及び第2室の各々が剛性壁及び可撓膜によって定められる、項目1のシステム。
(項目7)上記バルブ作動装置がカム及び一対のアクチュエータを含み、上記アクチュエータの動きが上記可撓膜上の圧力変化を生じさせるように上記アクチュエータが上記第1及び第2室の一方の上記可撓膜に隣接して配置され、上記カムが回転されると上記アクチュエータが移動されるように上記カム及びアクチュエータが互いに配置される、項目6のシステム。
(項目8)常に少なくとも一方のアクチュエータが対応する可撓膜を閉位置内に押し付けるように上記カムが形成される、項目7のシステム。
(項目9)上記液体出口、上記可変容量室、上記第1バイアルレセプタクル及び上記液体入口と流体連通する第2バイアルレセプタクルをさらに含み、上記第2バイアルレセプタクルに出入する流れを制御するために上記バルブ機構が作動され得る、項目1のシステム。
(項目10)上記液体出口、上記可変容量室、上記第1、第2バイアルレセプタクル及び上記液体入口と流体連通する第3バイアルレセプタクルをさらに含み、上記第3バイアルレセプタクルに出入する流れを制御するために上記バルブ機構が作動され得る、項目9のシステム。
(項目11)上記液体出口、上記可変容量室、上記第1、第2、第3バイアルレセプタクル及び上記液体入口と流体連通するポートをさらに含み、上記ポートに出入する流れを制御するために上記バルブ機構が作動され得る、項目10のシステム。
(項目12)上記液体出口、上記可変容量室、上記第1、第2、第3バイアルレセプタクル、上記ポート及び上記液体入口と流体連通する通気孔をさらに含み、上記通気孔に出入する流れを制御するために上記バルブ機構が作動され得る、項目11のシステム。
(項目13)上記制御器が、上記容量変化装置及び上記バルブ作動装置を通して上記液体を上記バイアル及び上記室間を反復して移動させるようにする装置を含む、項目1のシステム。
(項目14)上記制御器が、上記容量変化装置及び上記バルブ作動装置を通して所望の濃度を得るために上記薬剤に追加量の液体を与えさせるようにする装置を含む、項目1のシステム。
(項目15)上記システムが伝達室をさらに含み、上記伝達室において上記追加量の液体が上記薬剤と混合される、項目14のシステム。
(項目16)バイアル内の静脈薬剤を調製しかつ患者に伝達する方法であって、液体入口と、バイアルレセプタクルと、室と、液体出口とを有する、混合された液状で患者に静脈薬剤を与える使い捨てカセットを提供し、上記液体入口に供給液体を取り付け、上記薬剤を含む上記バイアルを上記バイアルレセプタクルに取り付け、ある量の液体を上記バイアル内に導入し、上記バイアルから上記薬剤のすべてを除去するように、上記液体が反復して上記バイアル及び上記室間を流れるようにさせ、上記出口を通して上記薬剤を上記患者に伝達することから成る薬剤調製・伝達方法。
(項目17)上記薬剤が上記患者に伝達される前に、上記薬剤をさらに希釈するために追加量の液体が上記薬剤と混合される、項目16の方法。
(項目18)上記カセットは伝達室を備え、上記伝達室において上記追加量の液体が上記薬剤と混合される、項目17の方法。
(項目19)バイアル内の静脈薬剤を混合しかつ患者に伝達する使い捨てカセットであって、供給液体に接続される液体入口と、第1バイアルスパイクと、第2バイアルスパイクと、可変容量を有する室と、混合された液状で上記患者に上記静脈薬剤を伝達する液体出口であって、上記液体出口、上記可変容量室、上記第1及び第2バイアルスパイク及び上記液体入口が互いに流体連通される液体出口と、上記液体出口、上記可変容量室、上記バイアルレセプタクル及び上記液体入口間の流れを制御するために作動され得るバルブ機構とから成る薬剤混合・伝達用使捨てカセット。
(項目20)上記液体出口、上記可変容量室、上記第1及び第2バイアルレセプタクル及び上記液体入口と流体連通第3バイアルスパイクをさらに含み、上記第3バイアルスパイクへ出入する流れを制御するために上記バルブ機構が作動され得る、項目19のカセット。
(項目21)上記可変容量室が剛性壁及び可撓膜によって定められる、項目19のカセット。
(項目22)第1導管が上記可変容量室の上半部内に通じ、第2導管が上記可変容量室の下半部内に通じ、上記第1及び第2導管間の剛性壁内に溝が定められる、項目21のカセット。
(項目23)上記溝は、上記第1導管近くで浅くかつ第2導管近くで広い、項目22のカセット。
(項目24)上記バルブ機構は、それぞれ上記可変容量室に通じる管内に配置される、第1及び第2バルブ室を含み、上記第1及び第2バルブ室の各々が導剛性壁及び可撓膜によって定められる、項目19のカセット。
(項目25)上記バルブ機構は、上記バルブ機構を作動させる制御装置から上記カセットが除去されるとき上記液体出口を通る流れを妨げるために閉じられる出口自由流れ防止バルブを含む、項目19のカセット。
(項目26)上記バルブ機構は、上記バルブ機構を作動させる制御装置から上記カセットが除去されるとき上記液体入口を通る流れを妨げるために閉じられる入口自由流れ防止バルブを含む、項目25のカセット。
(項目27)上記カセットが上記制御装置から除去されるとき上記入口及び出口自由流れ防止バルブが永久に閉じられる、項目26のカセット。
(項目28)上記液体出口、上記可変容量室、上記第1及び第2バイアルレセプタクル及び液体入口と流体連通する雌ガラス部品をさらに含み、上記雌ガラス部品へ出入する流れを制御するために上記バルブ機構が作動され得る、項目19のカセット。
(項目29)上記液体出口、上記可変容量室、上記第1及び第2バイアルレセプタクル、雌ガラス部品及び液体入口と流体連通する通気孔をさらに含み、上記通気孔へ出入する流れを制御するために上記バルブ機構が作動され得る、項目28のカセット。
(項目30)静脈ラインを通る流れを制御するシステムであって、使い捨てカセットを供給し、上記カセットが第1剛性壁及び第1可撓膜によって定められる第1バルブ室と、第2剛性壁及び第2可撓膜によって定められる第2バルブ室とを有するようにし、制御装置であって、カムと、上記第1可撓膜に隣接して配置される第1アクチュエータであって、上記第1アクチュエータの動きが上記第1可撓膜上の圧力変化を生じさせるようにする第1アクチュエータと、上記第2可撓膜に隣接して配置される第2アクチュエータであって、上記第2アクチュエータの動きが上記第2可撓膜上の圧力変化を生じさせるようにする第2アクチュエータとを有し、上記カム及びアクチュエータは、上記カムが回転されるにつれて上記アクチュエータが移動されるように互いに配置される制御装置とから成る静脈ライン流制御システム。
(項目31)常に少なくとも1つのアクチュエータが対応する可撓膜を閉位置内に押し付けるように上記カムが形成される、項目30のシステム。
(項目32)上記カセットは、上記第1及び第2バルブ室間の流体通路内に配置される、圧力伝導室をさらに含む、項目31のシステム。
(項目33)IV溶液を受取る液体入口と、薬剤を含むバイアルを受取るバイアル入口と、上記IV溶液と混合される上記薬剤を患者に伝達する出口と、上記カセットが上記バルブを作動させる制御装置から除去されるとき上記出口を通る流れを妨げるために永久に閉じられる出口自由流れ防止バルブとから成る使い捨てカセット。
(項目34)上記出口自由流れ防止バルブが、上記カセット及び膜の剛性部分によって定められるバルブ室を含み、上記膜が上記カセットの外部に向けて伸びる折返し部分を含み、上記制御装置からのアクチュエータが上記折返し部分を押すとき上記膜が上記バルブ室内へくずれ込んでそこを通る流れを制限させるようにする、項目33のカセット。
(項目35)上記カセットが上記制御装置から除去されるとき上記入口を通る流れを妨げるために永久に閉じられる入口自由流れ防止バルブをさらに含む、項目33のカセット。
(項目36)上記出口及び入口自由流れ防止バルブの各々が、上記カセット及び膜の剛性部分によって定められるバルブ室を含み、上記膜が上記カセットの外部に向けて伸びる折返し部分を含み、上記制御装置からのアクチュエータが上記折返し部分を押すとき上記膜が上記バルブ室内へくずれ込んでそこを通る流れを制限させるようにする、項目35のカセット。
(項目37)適用量の薬剤を患者に伝達する方法であって、カセットを供給し、上記カセットが供給薬剤に通じる入口及び上記患者に通じる出口を有する可変容量室と、上記供給薬剤及び上記室間に流体連通を与えるマニホールドと、上記マニホールドと流体連通する通気孔と、上記室から出る流れを制御する出口バルブと、上記室及び上記マニホールド間の流れを制御する入口バルブと、上記通気孔及び上記マニホールド間の流れを制御する空気バルブとを有するようにし、第1容量の薬剤を上記供給薬剤から上記マニホールドを通して上記室へ移動させ、上記第1容量の薬剤を上記室から上記患者に伝達し、第2容量の薬剤を上記供給薬剤から上記マニホールドを通して上記室へ移動させ、すべての薬剤を上記マニホールドから上記室内へ押し込むために上記通気孔から上記マニホールドを通して空気を押し込み、第2容量の薬剤を上記室から上記患者に伝達することから成る薬剤伝達方法。
(項目38)上記室に空気が入っているかどうかを決定し、上記室から上記内へ上記空気を押し込むことをさらに含む、項目37の方法。
(項目39)上記室から空気を押し込む段階が、上記室に圧力をかけると共に上記入口バルブを開閉させ、上記入口バルブが閉じた後で上記室内に空気が残留しているかどうかを決定することを含む、項目38の方法。
(項目40)上記入口バルブが部分的にのみ開かれる、項目39の方法。
(項目41)適用量の薬剤を患者に伝達するシステムであって、カセットであって、供給薬剤に通じる入口及び上記患者に通じる出口を有する可変容量室と、上記供給薬剤及び上記室間に流体連通を与えるマニホールドと、上記マニホールドと流体連通する通気孔と、上記室から出る流れを制御する出口バルブと、上記室及び上記マニホールド間の流れを制御する入口バルブと、上記通気孔及び上記マニホールド間の流れを制御する空気バルブとを有するカセットと、制御装置であって、上記室の容量変化を誘発させる装置と、上記出口バルブ、上記入口バルブ及び上記空気バルブを作動させる装置と、上記容量変化装置及び上記バルブ作動装置を制御する制御器であって、第1量の薬剤を上記供給薬剤から上記マニホールドを通して上記室へ移動させ、上記第1量の薬剤を上記室から上記患者に伝達し、第2量の薬剤を上記供給薬剤から上記マニホールドを通して上記室へ移動させ、すべての薬剤を上記マニホールドから上記室内へ押し込むために上記通気孔から上記マニホールドを通して空気を押し込み、第2量の薬剤を上記室から上記患者に伝達するようにさせる制御器とを有する制御装置とから成る薬剤伝達システム。
(項目42)上記制御器が、空気が上記室に入っているかどうかを決定する装置、及び上記室から上記マニホールド内へ上記空気を押し込む装置を含む、項目41のシステム。
(項目43)バルブ作動装置が上記入口を部分的にのみ開く装置を含む、項目42のシステム。
(項目44)バイアル内に与えられる薬剤を混合させるシステムであって、流体通路と、上記流体通路及び上記バイアル内部間の流体連通を与えるバイアルレセプタクルと、頂部及び底部を有する可変容量室と、上記流体通路及び上記室の頂部間に流体連通を与える頂部ポートと、上記流体通路及び上記室の底部間に流体連通を与える底部ポートと、上記頂部及び底部ポートを通る流れを制御するバルブ機構とか成る薬剤混合システム。
(項目45)上記流体通路と連通する通気孔をさらに含み、上記バルブ機構が上記空気孔を通る流れをさらに制御する、項目44のシステム。
(項目46)上記バルブ機構がそれぞれ別の時において、空気が上記頂部ポートから上記バイアルへ流れ、液体が上記底部ポートから上記バイアルへ流れることを可能にする、項目45のシステム。
(項目47)バイアル内に与えられる薬剤を混合させる方法であって、バイアルレセプタクル及び可変容量室の頂部及び底部と流体連通する流体通路を与え、上記流体通路及びバイアルレセプタクルを通して液体を上記室の頂部から上記バイアルへ移動させ、上記流体通路及びを通して空気を上記室の頂部から上記バイアルへ移動させ、上記バイアルレセプタクル及び上記流体通路を通して液体を上記バイアルから上記室へ移動させることから成る薬剤混合方法。
(項目48)上記バイアルレセプタクル及び上記流体通路を通して空気を上記バイアルから上記室へ移動させることをさらに含む、項目47の方法。
(項目49)上記流体通路と連通して通気孔ガ与えられる、項目47の方法。
図1は、本発明の望ましい実施形態による薬剤調製及び伝達システムを示す。粉末化薬剤がバイアル11内に与えられ、システムによって容器13内に与えられる液体と混合される。システムは、使い捨てカセット17を含み、それは患者と制御装置15との間に配置される。制御装置は、カセットを受容しかつ制御し、繰り返し用いられる。概して、容器13から流れる液体は、カセット17によってバイアルに向けられ、粉末化薬剤を液状に戻すか若しくは液状薬剤を適切な濃度に希釈し、その後カセットによって患者に向けられる。薬剤伝達期間に亘り、容器13からの液体は、薬剤と混合されることなくカセット17によって直接患者に向けられ得る。予め混合された薬剤がシステムによってバイアルから、またガラスポート(図3及び3の品目26)に接続されるバッグから患者へ伝達され得る。ここで論議される特殊な実施形態は、別々の混合及び伝達室を用いる。当業者によって、単一可変容量室が混合及び伝達の双方を行うのに用いられ得ることは理解されるであろう。
13 容器
15 制御装置
17 カセット
22 入口ポート
24 通気孔
23 出口ポート
26 ガラスポート
27 伝達室
Claims (1)
- バイアル内の静脈薬剤を調製しかつ患者に伝達する方法であって、液体入口と、バイアルレセプタクルと、室と、液体出口とを有する、混合された液状で患者に静脈薬剤を与える使い捨てカセットを提供し、該液体入口に供給液体を取り付け、該薬剤を含む該バイアルを該バイアルレセプタクルに取り付け、ある量の液体を該バイアル内に導入し、該バイアルから該薬剤のすべてを除去するように、該液体が反復して該バイアル及び該室間を流れるようにさせ、該出口を通して該薬剤を該患者に伝達することから成る薬剤調製・伝達方法。
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US11938094B2 (en) | 2017-03-24 | 2024-03-26 | Carefusion 303, Inc. | Dry disconnect cartridge and dual lumen needle for automatic drug compounder |
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Also Published As
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US20130178831A1 (en) | 2013-07-11 |
US6210361B1 (en) | 2001-04-03 |
US9408966B2 (en) | 2016-08-09 |
US20040176724A1 (en) | 2004-09-09 |
WO1999010028A1 (en) | 1999-03-04 |
JP2013144114A (ja) | 2013-07-25 |
DE69828619T2 (de) | 2006-01-05 |
JP5096298B2 (ja) | 2012-12-12 |
US6234997B1 (en) | 2001-05-22 |
EP1003579A1 (en) | 2000-05-31 |
JP2001513404A (ja) | 2001-09-04 |
US20010007932A1 (en) | 2001-07-12 |
US6726656B2 (en) | 2004-04-27 |
US7214210B2 (en) | 2007-05-08 |
US20070085049A1 (en) | 2007-04-19 |
AU9028498A (en) | 1999-03-16 |
DE69828619D1 (de) | 2005-02-17 |
EP1003579B1 (en) | 2005-01-12 |
US20060241550A1 (en) | 2006-10-26 |
US20140343492A1 (en) | 2014-11-20 |
US8251953B2 (en) | 2012-08-28 |
JP5575052B2 (ja) | 2014-08-20 |
US8968244B2 (en) | 2015-03-03 |
US20030060766A1 (en) | 2003-03-27 |
JP4291506B2 (ja) | 2009-07-08 |
JP2011183174A (ja) | 2011-09-22 |
US6464667B1 (en) | 2002-10-15 |
US20110230825A1 (en) | 2011-09-22 |
US7798997B2 (en) | 2010-09-21 |
TW394695B (en) | 2000-06-21 |
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