JP7254754B2 - 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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- JP7254754B2 JP7254754B2 JP2020190671A JP2020190671A JP7254754B2 JP 7254754 B2 JP7254754 B2 JP 7254754B2 JP 2020190671 A JP2020190671 A JP 2020190671A JP 2020190671 A JP2020190671 A JP 2020190671A JP 7254754 B2 JP7254754 B2 JP 7254754B2
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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
- A61M5/178—Syringes
- A61M5/31—Details
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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
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
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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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
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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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
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- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
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- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
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- A—HUMAN NECESSITIES
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- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
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- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- 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
- A61M5/172—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 electrical or electronic
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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
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- 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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- A—HUMAN NECESSITIES
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- 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
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- 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
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- 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
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
- B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
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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
- 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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- 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
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- A61M2005/2006—Having specific accessories
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- A61M2005/247—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 by piercing without internal pressure increase with fixed or steady piercing means, e.g. piercing under movement of ampoule
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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
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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- A61M2005/2474—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 by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady
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- A—HUMAN NECESSITIES
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- 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
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- 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
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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
- A61M5/14—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
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 (15)
- 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隔壁を含む容器であり、前記壁および前記隔壁の内表面は、レザバーを限定する、容器;
前記容器内に位置付けられたストッパー;
先端を有する容器針を含む流体送達系であって、前記容器針が、貯蔵状態および送達状態を有する、流体送達系;ならびに
清浄バリアであって、前記隔壁および清浄バリアが前記隔壁および清浄バリア間に配置される封入清浄スペースを限定するように、前記隔壁の外側に位置付けられた清浄バリアを含み、
前記容器針の先端は、貯蔵状態では前記封入清浄スペース内に配置され、及び前記隔壁から離れており、および送達状態では前記隔壁を通して配置され、
ここで、前記清浄バリアの位置は、前記清浄バリアと前記隔壁との間隔が貯蔵状態および送達状態で実質的に同じであるように、前記隔壁の位置に対して固定されている、注入器。 - 前記清浄バリアが前記隔壁と接触していない、請求項1に記載の注入器。
- 前記清浄バリアが、前記容器の壁に対して移動不可である、請求項1に記載の注入器。
- 前記容器針の先端が貯蔵状態では前記清浄バリアを貫通するように、前記清浄バリアが前記容器針と連結されている、請求項1に記載の注入器。
- 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、請求項1に記載の注入器。
- 前記作動装置と連結される機械的入力装置をさらに含む、請求項5に記載の注入器。
- 前記作動装置と連結される電気的または電気機械的入力装置をさらに含む、請求項5に記載の注入器。
- 前記隔壁が柔軟性一体成形壁を含む、請求項1に記載の注入器。
- 患者内に挿入するための注射針;および
前記容器針と注射針を接続する柔軟性管を含む、請求項1に記載の注入器。 - 前記容器内に配置された医薬品を含み、前記医薬品は、少なくとも1つの顆粒球コロニー刺激因子、ペグ化顆粒球コロニー刺激因子、PCSK9特異的抗体、赤血球生成刺激剤、TNF遮断薬、インターロイキン-受容体特異的抗体、IGF-受容体特異的抗体、またはTGF-特異的抗体を含む、請求項1に記載の注入器。
- 注入器の組立方法であって、
医薬品を容器のレザバーに充填し、ここで前記充填後のレザバーは、前記容器の壁の内表面、隔壁の内表面、および前記容器内に位置付けられたストッパーにより限定されること;
清浄バリアを、前記隔壁および清浄バリアが前記隔壁および清浄バリア間に配置される封入清浄スペースを限定するように、前記隔壁の外側に位置付けること;ならびに
容器針の先端を、前記封入清浄スペース内に位置付け、及び隔壁から離すことで貯蔵状態を規定し、前記容器針の先端は、送達状態では前記隔壁を通して配置されるように構成されており、ここで、前記清浄バリアの位置は、前記清浄バリアと前記隔壁との間隔が貯蔵状態および送達状態で実質的に同じであるように、前記隔壁の位置に対して固定されていること
を含む、方法。 - 前記清浄バリアが前記隔壁と接触していない、請求項11に記載の方法。
- 前記清浄バリアが、前記容器の壁に対して移動不可である、請求項11に記載の方法。
- 前記容器針の先端が貯蔵状態では前記清浄バリアを貫通するように、前記清浄バリアが前記容器針と連結されている、請求項11に記載の方法。
- 前記医薬品が、少なくとも1つの顆粒球コロニー刺激因子、ペグ化顆粒球コロニー刺激因子、PCSK9特異的抗体、赤血球生成刺激剤、TNF遮断薬、インターロイキン-受容体特異的抗体、IGF-受容体特異的抗体、またはTGF-特異的抗体を含む、請求項11に記載の方法。
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