JP2019022696A - 注入器および組立方法 - Google Patents
注入器および組立方法 Download PDFInfo
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- JP2019022696A JP2019022696A JP2018178432A JP2018178432A JP2019022696A JP 2019022696 A JP2019022696 A JP 2019022696A JP 2018178432 A JP2018178432 A JP 2018178432A JP 2018178432 A JP2018178432 A JP 2018178432A JP 2019022696 A JP2019022696 A JP 2019022696A
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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
- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
- A61M2005/3109—Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
-
- 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
-
- 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
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
- A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
-
- 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
- A61M2207/00—Methods of manufacture, assembly or production
-
- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
-
- 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
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
Abstract
Description
(i)米国特許公開番号2006/0040358(2006年2月23日公開)、2005/0008642(2005年1月13日公開)、2004/0228859(2004年11月18日公開)に記載されたもの、例えば抗体1A(DSMZ寄託番号 DSM ACC 2586)、抗体8(DSMZ寄託番号 DSM ACC 2589)、抗体23(DSMZ寄託番号 DSM ACC 2588)および抗体18(これらに限定されない);
(ii)PCT公告 WO 06/138729(2006年12月28日公開)およびWO 05/016970(2005年2月24日公開)、ならびにLu et al., 2004, J Biol. Chem. 279:2856-65に記載されたもの、例えば抗体2F8、A12およびIMC−A12(これらに限定されない);
(iii)PCT公告 WO 07/012614(2007年2月1日公開)、WO 07/000328(2007年1月4日公開)、WO 06/013472(2006年2月9日公開)、WO 05/058967(2005年6月30日公開)およびWO 03/059951(2003年7月24日公開);
(iv)米国特許公開番号2005/0084906(2005年4月21日公開)に記載されたもの、例えば抗体7C10、キメラ抗体C7C10、抗体h7C10、抗体7H2M、キメラ抗体*7C10、抗体GM607、ヒト化抗体7C10 バージョン1、ヒト化抗体7C10 バージョン2、ヒト化抗体7C10 バージョン3および抗体7H2HM(これらに限定されない);
(v)米国特許公開番号2005/0249728(2005年11月10日公開)、2005/0186203(2005年8月25日公開)、2004/0265307(2004年12月30日公開)および2003/0235582(2003年12月25日公開)、ならびにMaloney et al.,2003,Cancer Res. 63:5073-83に記載されたもの、例えば抗体EM164、表面再構成型EM164、ヒト化EM164、huEM164 v1.0、huEM164 v1.1、huEM164 v1.2およびhuEM164 v1.3(これらに限定されない);
(vi)米国特許第7,037,498号(2006年5月2日発行)、米国特許公開番号2005/0244408(2005年11月30日公開)および2004/0086503(2004年5月6日公開)、ならびにCohen、et al., 2005, Clinical Cancer Res. 11:2063-73に記載されたもの、例えば抗体CP−751,871、例えばATCC寄託番号PTA−2792、PTA−2788、PTA−2790、PTA−2791、PTA−2789、PTA−2793を有するハイブリドーマにより産生される各抗体、ならびに抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2および4.17.3(これらに限定されない);
(vii)米国特許公開番号2005/0136063(2005年6月23日公開)および2004/0018191(2004年1月29日公開)に記載されたもの、例えば抗体19D12、ならびにATCC番号PTA−5214で寄託されたプラスミド15H12/19D12 HCA(γ4)におけるポリヌクレオチドによりコードされる重鎖、およびATCC番号PTA−5220で寄託されたプラスミド15H12/19D12 LCF(κ)におけるポリヌクレオチドによりコードされる軽鎖を含む抗体(これらに限定されない);ならびに
(viii)米国特許公開番号2004/0202655(2004年10月14日公開)に、特にIGF−1受容体を標的にする前記の抗体、ペプチボディおよび関連タンパク質等に関して記載されたもの、例えば抗体PINT−6A1、PINT−7A2、PINT−7A4、PINT−7A5、PINT−7A6、PINT−8A1、PINT−9A2、PINT−11A1、PINT−11A2、PINT−11A3、PINT−11A4、PINT−11A5、PINT−11A7、PINT−11A12、PINT−12A1、PINT−12A2、PINT−12A3、PINT−12A4、and PINT−12A5(これらに限定されない);(これらの記載内容は各々、参照により本明細書中で援用される);
Claims (30)
- 注入器であって、
内表面を有する壁および内表面を有する密封アセンブリーを含む容器であり、前記壁および前記密封アセンブリーの内表面は、医薬品が充填された閉鎖滅菌レザバーを限定する、容器;
貯蔵状態では一部のみ前記密封アセンブリーを通して配置されたおよび送達状態では前記密封アセンブリーの内表面を通して前記滅菌レザバー中に配置された先端を有する清浄な非被覆剛性容器針を含む、流体送達系;ならびに
前記容器針を貯蔵状態から送達状態に動かすよう構成された、作動装置
を含む、注入器。 - 前記容器の壁が剛性壁を含む、請求項1記載の注入器。
- 前記容器の壁が柔軟性壁を含む、請求項1記載の注入器。
- 前記密封アセンブリーが、前記密封アセンブリーの内表面を限定する内表面を有する柔軟性一体成形壁からなる、請求項1〜3のいずれか一項に記載の注入器。
- 前記柔軟性一体成形壁が、開口部を横断して配置されたおよび前記容器の壁に固定された隔壁を限定する、請求項4記載の注入器。
- 前記容器の壁が内腔を限定し、前記一体成形壁が、前記内腔に沿って移動可能なストッパーを限定する、請求項4記載の注入器。
- 前記容器の壁が、ストッパーの反対側にある閉端および前記ストッパーが配置される開端を限定する、請求項6記載の注入器。
- 前記容器の壁が、内腔の第一末端と流体交通する開口部を有する前記内腔を限定し、および前記柔軟性一体成形壁が、開口部を横断して配置されたおよび前記容器の壁に固定された隔壁を限定し、前記容器が、前記内腔の第二末端内に配置されたおよび前記内腔に沿って移動可能なストッパーをさらに含む、請求項4記載の注入器。
- 前記密封アセンブリーが、前記密封アセンブリーの内表面を限定する内表面を有する柔軟性壁、ならびに前記柔軟性壁および清浄バリア間の封入清浄スペースを限定する前記柔軟性壁の外側に配置される前記清浄バリアを含み、容器針の先端が、保存状態で前記清浄バリアを通して前記清浄スペースの中に配置される、請求項1〜3のいずれか一項に記載の注入器。
- 前記容器の壁が内腔を限定し、前記柔軟性壁および前記清浄バリアが各々、前記内腔に沿って移動可能なストッパーを限定する、請求項9記載の注入器。
- 前記容器が、前記清浄バリアと前記柔軟性壁との間のスペースと流体交通する通気孔を含む、請求項9記載の注入器。
- 前記通気孔が前記清浄バリア中に形成される、請求項11記載の注入器。
- 前記通気孔が前記容器の壁の内表面内に形成される、請求項11記載の注入器。
- 前記容器の壁が、ストッパーの反対側にある閉端および前記ストッパーが配置される開端を限定する、請求項9記載の注入器。
- 前記容器の壁が内腔の第一末端と流体交通する開口部を有する前記内腔を限定し、前記柔軟性壁および前記清浄バリアが各々、開口部を横断して配置されたおよび前記容器の壁に固定された隔壁を限定し、前記容器が前記内腔の第二末端内に配置されたおよび前記内腔に沿って移動可能なストッパーをさらに含む、請求項9記載の注入器。
- 前記流体送達系が、第一末端で前記剛性容器針に接続され、第二末端で清浄剛性注入針を遮断する清浄カバー内で受取る前記清浄剛性注入針に接続される清浄柔軟性管を含む、請求項1〜15のいずれか一項に記載の注入器。
- 前記作動装置が、貯蔵状態と送達状態との間で反復的に前記容器針を動かすよう構成される、請求項1〜16のいずれか一項に記載の注入器。
- 前記作動装置が、投入物の受取り後に貯蔵状態から送達状態へ前記容器針の動きを遅延するよう構成される、請求項1〜17のいずれか一項に記載の注入器。
- 前記作動装置と連結される機械的、電気機械的または電子的投入装置をさらに含む、請求項1〜18のいずれか一項に記載の注入器。
- 前記医薬品が多量の赤血球生成刺激剤を含む、請求項1〜19のいずれか一項に記載の注入器。
- 前記医薬品が多量の顆粒球コロニー刺激因子を含む、請求項1〜19のいずれか一項に記載の注入器。
- 前記医薬品が多量のTNF遮断薬を含む、請求項1〜19のいずれか一項に記載の注入器。
- 前記医薬品が多量のペグ化顆粒球コロニー刺激因子を含む、請求項1〜19のいずれか一項に記載の注入器。
- 前記医薬品が多量のインターロイキン−受容体特異的抗体を含む、請求項1〜19のいずれか一項に記載の注入器。
- 前記医薬品が多量のIGF−受容体(インスリン成長因子受容体)特異的抗体を含む、請求項1〜19のいずれか一項に記載の注入器。
- 前記医薬品が多量のTGF−受容体特異的抗体を含む、請求項1〜19のいずれか一項に記載の注入器。
- 前記医薬品が多量のPCSK9(プロタンパク質転換酵素酢サブチリシン/ケキシン9型)特異的抗体を含む、請求項1〜19のいずれか一項に記載の注入器。
- 注入器の組立方法であって、
滅菌条件下で医薬品を容器の滅菌レザバーに充填し、ここで前記滅菌レザバーは、前記容器の壁の内表面および密封アセンブリーの内表面により限定されること;
前記滅菌レザバーを充填して貯蔵状態を限定した後に、清浄な、非被覆剛性容器針の先端を清浄室条件下で前記密封アセンブリーに部分的に通して挿入すること;
清浄室条件下で前記容器針を作動装置に付け、ここで前記作動装置は、前記容器針を貯蔵状態から送達状態に動かすよう構成され、前記容器針は前記密封アセンブリーの内表面を通して前記滅菌レザバー中に配置されること
を含む、方法。 - 前記容器の壁が剛性壁である、請求項28記載の方法。
- 前記容器の壁が柔軟性壁である、請求項28記載の方法。
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