JP6971961B2 - 固定及び/または戻りが真空によって支援された薬物送達装置 - Google Patents
固定及び/または戻りが真空によって支援された薬物送達装置 Download PDFInfo
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- A—HUMAN NECESSITIES
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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
- A61M5/14—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
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
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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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- 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
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
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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
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
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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
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1586—Holding accessories for holding infusion needles on the body
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3344—Measuring or controlling pressure at the body treatment site
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- Dermatology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
2015年2月17日に出願された米国仮特許出願第62/117,420号に対して優先権を主張する。本仮特許出願の全ての内容は、参照によって本明細書に明示的に組み込まれる。
本開示は、薬物送達装置に関する。より具体的には、本開示は、固定及び患者/操作者からの戻りが真空によって支援された薬物送達装置に関する。
(i)米国公報第2006/0040358号(2006年2月23日公開)、米国公報第2005/0008642号(2005年1月13日公開)、米国公報第2004/0228859号(2004年11月18日公開)。これらの公報に記載されているように、例えば、抗体1A(DSMZ寄託番号DSMACC2586)、抗体8(DSMZ寄託番号DSMACC2589)、抗体23(DSMZ寄託番号DSMACC2588)及び抗体18を非限定的に含む;
(ii)PCT公報第06/138729号(2006年12月28日公開)、PCT公報第05/016970号(2005年2月24日公開)、ならびにLu et al.(2004),J.Biol.Chem.279:2856−2865。これらの文献に記載されているように、抗体2F8、A12及びIMC−A12を非限定的に含む;
(iii)PCT公報第07/012614号(2007年2月1日公開)、PCT公報第07/000328号(2007年1月4日公開)、PCT公報第06/013472号(2006年2月9日公開)、PCT公報第05/058967号(2005年6月30日公開)及びPCT公報第03/059951号(2003年7月24日公開);
(iv)米国公報第2005/0084906号(2005年4月21日公開)。この公報に記載されているように、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及び抗体7H2HMを非限定的に含む;
(v)米国公報第2005/0249728号(2005年11月10日公開)、米国公報第2005/0186203号(2005年8月25日公開)、米国公報第2004/0265307号(2004年12月30日公開)及び米国公報第2003/0235582号(2003年12月25日公開)、ならびにMaloney et al.(2003),Cancer Res.63:5073−5083。これらの文献に記載されているように、抗体EM164、表面が再構成されたEM164、ヒト化EM164、huEM164 v1.0、huEM164 v1.1、huEM164 v1.2及び、huEM164 v1.3を非限定的に含む;
(vi)米国特許第7,037,498号(2006年5月2日発行)、米国公報第2005/0244408号(2005年11月30日公開)及び米国公報第2004/0086503号(2004年5月6日公開)、ならびにCohen, et al.(2005),Clinical Cancer Res.11:2063−2073、例えば、抗体CP−751、871。これらの文献に記載されているように、ATCC受け入れ番号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って生成された抗体、ならびに抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2及び4.17.3、のそれぞれを非限定的に含む;
(vii)米国公報第2005/0136063号(2005年6月23日公開)及び米国公報第2004/0018191号(2004年1月29日公開)。これらの公報に記載されているように、抗体19D12、ならびにATCCの下の番号PTA−5214で寄託されたプラスミド15H12/19D12HCA(γ4)におけるポリヌクレオチドによってコード化された重鎖及びATCCの下の番号PTA−5220で寄託されたプラスミド15H12/19D12LCF(κ)におけるポリヌクレオチドによってコード化された軽鎖を含む抗体を非限定的に含む;
(viii)米国公報第2004/0202655号(2004年10月14日公開)。この公報に記載されているように、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及びPINT−12A5を非限定的に含み、これらのそれぞれ及び全ては、特にIGF−1受容体を標的とする上記抗体、ペプチボディ及び関連タンパク質などに関して、その全体が参照によって本明細書に組み込まれる;
Claims (15)
- 薬物送達装置であって、
少なくとも1つの第1の溝または開口を有する表面を含む剛性の基部を備えるハウジングと、
前記基部を覆って、または前記基部の表面に配置された、前記薬物送達装置を身体組織に粘着的に取り付けるための粘着剤層であって、少なくとも1つの第1の溝または開口と整列させた少なくとも1つの第2の溝または開口を有し、前記薬物送達装置を身体組織に取り付けたとき、前記溝または開口は前記身体組織の一部に対して開口している、前記粘着剤層と、
少なくとも1つの第1の溝または開口および少なくとも1つの第2の溝または開口を介して身体組織の一部と圧力連通する圧力センサであって、負圧を検出することによって、前記薬物送達装置が前記粘着剤層によって前記身体組織に適切に取り付けられているかどうかを判定するための圧力センサと
を備える、前記薬物送達装置。 - 前記圧力センサは蛇腹または隔壁を備える、請求項1に記載の薬物送達装置。
- 前記蛇腹または前記隔壁は、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧を発生させることが可能かどうかを検出するために伸長される、請求項2に記載の薬物送達装置。
- 前記圧力センサは、前記蛇腹または前記隔壁に取り付けられた棒と、電動コイルであって、前記電動コイルが励磁されたときに前記棒を引いて前記蛇腹または前記隔壁を伸長するための前記電動コイルとを更に備える、請求項3に記載の薬物送達装置。
- 前記励磁されたコイルによって前記棒を引いて前記蛇腹または前記隔壁を伸長するときの速度により、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧が発生しているかどうかを判定する、請求項4に記載の薬物送達装置。
- 前記棒が移動しないか、遅く移動している場合、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧が発生しており、それにより前記薬物送達装置が前記粘着剤層によって前記身体組織に適切に取り付けられていることを示す、請求項4または請求項5に記載の薬物送達装置。
- 前記棒が移動しているか、速く移動している場合、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧がほとんどまたは全く発生しておらず、それにより前記薬物送達装置が前記粘着剤層によって前記身体組織に不適切に取り付けられていることを示す、請求項4に記載の薬物送達装置。
- 前記電動コイルに流れる電流の形状を経時的に監視することによって前記棒の速度を監視する、請求項5から請求項7のいずれか1項に記載の薬物送達装置。
- 接点を含む電気回路を更に備え、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧がほとんどまたは全く発生していない場合において前記電動コイルに印加される電流によって前記棒を移動させるのに十分な磁場が生じた場合、前記棒は前記接点と係合して前記電気回路を閉じる、請求項4から請求項8のいずれか1項に記載の薬物送達装置。
- 前記圧力センサは、前記蛇腹または前記隔壁に取り付けられたケーブルと、電動モーターであって、前記電動モーターが励磁されたときに前記ケーブルを引き、巻いて前記蛇腹または前記隔壁を伸長するための前記電動モーターとを更に備える、請求項3に記載の薬物送達装置。
- 前記励磁されたモーターは、前記ケーブルを引き、巻いて前記蛇腹または前記隔壁を伸長するためのトルクを発生させ、前記ケーブルを引き、巻いて前記蛇腹または前記隔壁を伸長するために必要なトルクの量により、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧が発生しているかどうかを判定し、前記電動モーターによって発生されたトルクの量は、前記電動モーターに流れる電流の量に比例する、請求項10に記載の薬物送達装置。
- 前記電動モーターに所定閾値を超える電流が流れて前記ケーブルを引き、巻いた場合、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧が発生しており、それにより前記薬物送達装置が前記粘着剤層によって前記身体組織に適切に取り付けられていることを示す、請求項11に記載の薬物送達装置。
- 前記電動モーターに所定閾値未満の電流が流れて前記ケーブルを引き、巻いた場合、露出された前記身体組織と前記蛇腹または前記隔壁との間に負圧がほとんどまたは全く発生しておらず、それにより前記薬物送達装置が前記粘着剤層によって前記身体組織に不適切に取り付けられていることを示す、請求項11または請求項12に記載の薬物送達装置。
- 正圧の供給源を更に備え、前記少なくとも1つの圧力連通経路または開口は、投与量の送達が完了したことを示すために注射終了時に前記粘着剤層全体に前記正圧を分配するように更に作動する、請求項1から請求項13のいずれか1項に記載の薬物送達装置。
- 投与量の送達が完了したことを示すために注射終了時に前記薬物送達装置と前記身体組織の間に正圧を印加する正圧の供給源を更に備える、請求項1から請求項13のいずれか1項に記載の薬物送達装置。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201562117420P | 2015-02-17 | 2015-02-17 | |
US62/117,420 | 2015-02-17 | ||
JP2017542094A JP6484345B2 (ja) | 2015-02-17 | 2016-02-17 | 固定及び/または戻りが真空によって支援された薬物送達装置 |
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AU (2) | AU2016220141B2 (ja) |
CA (2) | CA2976935C (ja) |
ES (1) | ES2748750T3 (ja) |
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CN113950341B (zh) | 2019-05-20 | 2024-03-19 | 优诺医疗有限公司 | 可旋转的输注装置及其方法 |
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