JP6411213B2 - 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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- JP6411213B2 JP6411213B2 JP2014535858A JP2014535858A JP6411213B2 JP 6411213 B2 JP6411213 B2 JP 6411213B2 JP 2014535858 A JP2014535858 A JP 2014535858A JP 2014535858 A JP2014535858 A JP 2014535858A JP 6411213 B2 JP6411213 B2 JP 6411213B2
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- container
- wall
- injector
- needle
- cleaning
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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
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- A—HUMAN NECESSITIES
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- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
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- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
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- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- 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
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
- B65B55/08—Sterilising wrappers or receptacles prior to, or during, packaging by irradiation
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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
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
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- B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
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- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
- B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
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- A61M2005/2006—Having specific accessories
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Toxicology (AREA)
- Diabetes (AREA)
- Environmental & Geological Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Joints Allowing Movement (AREA)
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 (24)
- 注入器であって、
内腔と前記内腔の第一末端と流体交通する開口部を限定する壁を含む容器;、
容器の開口部を横断して配置された密封アセンブリーであって、当該密封アセンブリーが、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、および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た清浄バリアを含み、前記容器と密封アセンブリーは、医薬品が充填された閉鎖滅菌レザバーを限定する、密封アセンブリー;
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;
前記容器の外部に配置される第一先端と、貯蔵状態では、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、および、送達状態では前記密封アセンブリーの柔軟性壁の内表面を通して前記滅菌レザバー中に配置される第二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。
- 前記容器の壁が第二柔軟性壁を含む、請求項1記載の注入器。
- 前記柔軟性壁が、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的に付着した隔壁を限定する、請求項1記載の注入器。
- 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1記載の注入器。
- 前記清浄バリアと前記柔軟性壁との間のスペースと、前記容器の外部環境を流体交通させる通気孔を含む、請求項1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6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6記載の注入器。
- 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的に付着した隔壁を限定する、請求項1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に受容されてい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1〜9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1〜10のいずれか一項に記載の注入器。
- 前記作動装置が、入力が受容された後の貯蔵状態から送達状態への前記容器針の動きを遅延するよう構成される、請求項1〜11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入力装置をさらに含む、請求項1〜12のいずれか一項に記載の注入器。
- 前記医薬品がある容積の赤血球生成刺激剤を含む、請求項1〜13のいずれか一項に記載の注入器。
- 前記医薬品がある容積の顆粒球コロニー刺激因子を含む、請求項1〜13のいずれか一項に記載の注入器。
- 前記医薬品がある容積のTNF遮断薬を含む、請求項1〜13のいずれか一項に記載の注入器。
- 前記医薬品がある容積のペグ化顆粒球コロニー刺激因子を含む、請求項1〜13のいずれか一項に記載の注入器。
- 前記医薬品がある容積のインターロイキン−受容体特異的抗体を含む、請求項1〜13のいずれか一項に記載の注入器。
- 前記医薬品がある容積の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1〜13のいずれか一項に記載の注入器。
- 前記医薬品がある容積のTGF−特異的抗体を含む、請求項1〜13のいずれか一項に記載の注入器。
- 前記医薬品がある容積のPCSK9(プロタンパク質転換酵素サブチリシン/ケキシン9型)特異的抗体を含む、請求項1〜13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、前記容器の内腔の第一末端に配置された密封アセンブリー、および前記内腔の第二末端に移動可能に配置されたストッパーにより限定され、当該密封アセンブリーが、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、および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清浄バリアを含むこと;
前記滅菌レザバーを充填した後に、容器針の第一先端を前記容器の外部に配置し、前記容器針の第二先端を、清浄室条件下で、前記清浄バリアを通して前記密封アセンブリーの前記清浄スペースに挿入し、貯蔵状態を限定し、前記容器針は清浄非被覆剛性であること;
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、ここで送達状態では、前記容器針の第二先端は前記密封アセンブリーの柔軟性密封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22記載の方法。
- 前記容器の壁が第二柔軟性壁である、請求項22記載の方法。
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