JP2007506479A - 混合組成物を調製するための連結注射器システムおよびその方法 - Google Patents
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- B01F25/4512—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture with reciprocating pistons
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- A—HUMAN NECESSITIES
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- 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
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
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Abstract
【解決手段】本発明は、一般に治療組成物を混合、調製、および投与するための医療用デバイスに関し、より詳細には、2つの注射器(13、14)および固定リング(11)を含み、2つの組成物を投与する直前に2つの注射器間で混合するシステムに関する。
Description
本出願は、参照として本明細書に示される1999年9月25日出願の米国特許出願第09/405,463号の一部継続出願である、2003年8月5日出願の米国特許出願第10/634,656号の優先権を主張する。
医療機関では多くの薬物および他の薬剤が日常的に調製され患者に投与されている。場合によっては、治療組成物の2つの成分を投与する直前に混合する必要がある。治療組成物を投与する直前に混合する1つの方法では、2つの溶液を混合容器内で混合し、混合液を注射器内へと吸引し、次いで最終的な混合された組成物を患者の適切な部位に投与する。しかし、この方法は面倒であることが多く、多量の薬物を損失することがあり、かつ混合から投与までの間の時間が、敏感な組成物(すなわち、混合した直後に投与しなければならない組成物)にとって長過ぎることが多い。
本発明の連結注射器システムによれば、組成物を投与する直前に効果的に混合することができる。混合によって組成物は、かなりの量を損失することがない。さらに、敏感な組成物(例えば、混合後すぐに投与しなければならない組成物など)が化学的または物理的に変化しないように(すなわち、分解が最小限であるように)、組成物の混合から投与までの間の時間は最小限である。本発明の連結注射器システムを使用すると、内容物の栓流が起きることがない。さらに、連結注射器システムは簡便に分解することができ、雄型端部および固定リングを含む注射器に針を簡便に取り付けることができる。
LA−2575製剤30.0mgは、皮下に注射すると30.0mgの酢酸ロイプロリド(LA)を4カ月間にわたり送達する生物分解性インプラントを形成する。製剤は2つの別個の注射器から構成される。雌型Luer−Lokフィッティングを備える注射器Aは薬物送達ビヒクルを含み、雄型Luer−Lokフィッティングを備える注射器Bは凍結乾燥されたLAを含む。注入するための製品を調製するために、注射器Aおよび注射器Bを連結し、混合されるまで内容物を前後に移動させる。混合後、2つの注射器を分離し、皮下注射針を注射器Bに取り付け、調製した製剤を患者に皮下投与する。
注射器A、雌型Luer−Lok(登録商標)フィッティングとともに成形された1.2ml注射器(UltraTek)に、生体適合性溶剤N−メチル 2−ピロリドン(NMP)に溶解されたビヒクル75:25ポリ(D、L−ラクチド−コ−グリコリド)(PLG)を入れる。充填重量は560mgのビヒクルであった。
注射器B、雄型Luer−Lok(登録商標)フィッティングとともに成形された1.0mL注射器(Becton−Dickinson)に、凍結乾燥されたLAを入れる。充填重量は35.8mgの凍結乾燥LAであった。
6カ月持続製剤ELIGARD45.0mgは、皮下注射すると45.0mgの酢酸ロイプロリド(LA)を6カ月間にわたり送達する生分解性インプラントを形成する。製剤は2つの別個の注射器から構成される。雌型Luer−Lokフィッティングを備える注射器Aは薬物送達ビヒクルを含み、雄型Luer−Lokフィッティングを備える注射器Bは凍結乾燥されたLAを含む。注入するための製品を調製するために、注射器Aおよび注射器Bを連結し、混合されるまで内容物を前後に移動させる。混合後、2つの注射器を分離し、皮下注射針を注射器Bに取り付け、調製した製剤を患者に皮下投与する。
注射器A、雌型Luer−Lok(登録商標)フィッティングとともに成形された1.2ml注射器(UltraTek)に、生体適合性溶剤N−メチル 2−ピロリドン(NMP)に溶解されたビヒクル85:15ポリ(D、L−ラクチド−コ−グリコリド)(PLG)を入れる。ポリマービヒクルの充填重量は410±2mgであった。
注射器B、雄型Luer−Lok(登録商標)フィッティングとともに成形された3.0mL注射器(Becton−Dickinson)に、凍結乾燥されたLAを入れる。この注射器の充填重量は56.3mgのLAであった。
Claims (21)
- 第1の注射器開口近位端および第1の注射器遠位端を有する第1の注射器筒を含み、雄型端部を備えた第1の注射器先端をさらに含み、前記雄型端部が固定リングおよび先端を有し、前記第1の注射器筒が第1の注射器内面を有する第1の注射器と、
前記第1の注射器筒内に摺動可能に配設され、前記第1の注射器内面に流体密封係合している第1の注射器プランジャと、
第2の注射器開口近位端および第2の注射器遠位端を有する第2の注射器筒を含み、雌型端部を備えた第2の注射器先端をさらに含み、前記雌型端部が前記固定リングに脱着可能に係合するように適合された1つまたは複数の外部突出部材を有し、前記第2の注射器筒が第2の注射器内面を有する第2の注射器と、
前記第2の注射器筒内に摺動可能に配設され、前記第2の注射器内面に流体密封係合している第2の注射器プランジャと、
中に開口を有し、前記開口が前記雄型端部の先端を中に受けるサイズおよび形状になっている雌型端部とを含み、
前記固定リングが、前記雄型端部の先端が前記雌型端部内に配設されて流体密封係合を形成するとき、前記第1の注射器と前記第2の注射器を連結する、連結注射器システム。 - 前記雌型端部が前記固定リングに脱着可能に係合するように適合された1つまたは複数の外部突出部材を含む、請求項1に記載の連結注射器システム。
- 前記固定リングが射出アセンブリに脱着可能に連結する形状である、請求項1に記載の連結注射器システム。
- 前記射出アセンブリが針を含む、請求項3に記載の連結注射器システム。
- 前記第2の注射器の前記雌型端部が前記固定リングを介して前記第1の注射器の前記雄型端部に脱着可能に連結されている、請求項1に記載の連結注射器システム。
- 前記第2の注射器の前記雌型端部が前記第1の注射器の前記雄型端部から取り外される、請求項1に記載の連結注射器システム。
- 前記第1の注射器の近位端付近に外向きに突出するフランジをさらに含む、請求項1に記載の連結注射器システム。
- 前記第2の注射器の近位端付近に外向きに突出するフランジをさらに含む、請求項1に記載の連結注射器システム。
- 前記固定リングが前記雄型端部に回転可能に連結される、請求項1に記載の連結注射器システム。
- 前記固定リングが前記雌型端部の外面上に配設された1つまたは複数の突起に嵌入して連結されている、請求項4に記載の連結注射器システム。
- 前記雄型端部が前記雌型端部内に配設されている、請求項1に記載の連結注射器システム。
- 前記固定リングが前記雄型端部に回転可能に連結され、前記固定リングが前記雌型端部の外面上に配設された1つまたは複数の突起に嵌入して連結されている、請求項1に記載の連結注射器システム。
- 前記第1および第2の注射器の少なくとも一方が、薬物送達システムを含む組成物を中に含む、請求項1に記載の連結注射器システム。
- 他方の注射器が薬物を中に含む、請求項13に記載の連結注射器システム。
- 注射器内で薬物を再配合するための方法であって、
請求項3から4のいずれか1つによる注射器アセンブリを提供し、前記第1の注射器が薬物を含むステップと、
前記第2の注射器プランジャを前記第2の注射器筒から取り外すステップと、
希釈液と連通する前記射出アセンブリを配置するステップと、
前記第1の注射器プランジャを近位側にかつ前記第1の注射器の遠位端から離すように押し出し、それにより希釈液を、射出アセンブリを通りかつ第1の注射器の遠位端を通るように押し出し、それにより薬物に接触させ、かつ薬物を効果的に再配合するステップとを含む方法。 - 前記薬物が凍結乾燥薬物、粉末薬物、および粒子薬物から選択される、請求項15に記載の方法。
- 凍結乾燥薬物が酢酸ロイプロリドである、請求項16に記載の方法。
- 前記第1の注射器および第2の注射器がガラスおよびプラスチックから選択される材料で製造される、請求項15に記載の方法。
- 前記第1の注射器、第1の注射器プランジャ、第2の注射器、第2の注射器プランジャの少なくとも1つが天然ゴム、合成ゴム、および熱可塑性エラストマーから選択される材料で製造される、請求項15に記載の方法。
- 前記薬物が濾過によって滅菌される、請求項15に記載の方法。
- 前記第1の注射器、第1の注射器プランジャ、第2の注射器、および第2の注射器プランジャの少なくとも1つがガンマ照射によって滅菌される、請求項15に記載の方法。
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Application Number | Priority Date | Filing Date | Title |
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US10/634,656 US8226598B2 (en) | 1999-09-24 | 2003-08-05 | Coupling syringe system and methods for obtaining a mixed composition |
PCT/US2004/025290 WO2005016442A1 (en) | 2003-08-05 | 2004-08-05 | Coupling syringe system and methods for obtaining a mixed composition |
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EP (1) | EP1660171A4 (ja) |
JP (1) | JP2007506479A (ja) |
AU (1) | AU2004264341A1 (ja) |
CA (1) | CA2534671A1 (ja) |
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Also Published As
Publication number | Publication date |
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MXPA06001403A (es) | 2007-01-26 |
US8226598B2 (en) | 2012-07-24 |
US20040127846A1 (en) | 2004-07-01 |
CA2534671A1 (en) | 2005-02-24 |
EP1660171A4 (en) | 2007-09-12 |
EP1660171A1 (en) | 2006-05-31 |
WO2005016442A1 (en) | 2005-02-24 |
AU2004264341A1 (en) | 2005-02-24 |
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