JP2013528107A - 薬物送達デバイス - Google Patents
薬物送達デバイス Download PDFInfo
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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
- 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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- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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- A61M5/31545—Setting modes for dosing
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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
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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
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- A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
Abstract
【選択図】図2
Description
(i)米国公開公報第2006/0040358号(2006年2月23日公開)、第2005/0008642号(2005年1月13日公開)、第2004/0228859号(2004年11月18日公開)、そこに記載される、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を含むがこれらに限定されない。
(ii)PCT公開公報WO06/138729(2006年12月28日公開)およびWO05/016970(2005年2月24日公開)、ならびにLu et al.,2004,J Biol.Chem.279:2856−65、そこに記載される抗体2F8、A12、およびIMC−A12を含むがこれらに限定されない。
(iii)PCT公開公報WO07/012614(2007年2月1日公開)、WO07/000328(2007年1月4日公開)、WO06/013472(2006年2月9日公開)、WO05/058967(2005年6月30日公開)、およびWO03/059951(2003年7月24日公開)。
(iv)米国公開公報第2005/0084906号(2005年4月21日公開)、そこに記載される抗体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を含むがこれらに限定されない。
(v)米国公開公報第2005/0249728号(2005年11月10日公開)、第2005/0186203号(2005年8月25日公開)、第2004/0265307号(2004年12月30日公開)、および第2003/0235582号(2003年12月25日公開)、ならびにMaloney et al.,2003,Cancer Res.63:5073−83、そこに記載される抗体EM164、表面再構成EM164、ヒト化EM164、huEM164 v1.0、huEM164 v1.1、huEM164 v1.2、およびhuEM164 v1.3を含むが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)、米国公開公報第2005/0244408号(2005年11月30日公開)、および第2004/0086503号 (2004年5月6日公開)、ならびにCohen,et al.,2005,Clinical Cancer Res.11:2063−73、例えば、抗体CP−751,871、そこに記載されるATCC受託番号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って生成される抗体、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を含むがこれらに限定されない。
(vii)米国公開公報第2005/0136063号(2005年6月23日公開)および第2004/0018191号(2004年1月29日公開)、そこに記載される抗体19D12、ならびにATCC受託番号PTA−5214で寄託されたプラスミド15H12/19D12 HCA(γ4)中のポリヌクレオチドによってコードされる重鎖と、ATCC受託番号PTA−5220で寄託されたプラスミド15H12/19D12 LCF(κ)中のポリヌクレオチドによってコードされる軽鎖とを含む抗体を含むがこれらに限定されない。
(viii)米国公開公報第2004/0202655号(2004年10月14日公開)、そこに記載される抗体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、およびPINT−12A5を含むがこれらに限定されない。これらの記載内容のそれぞれまたは全ては、特に、IGF−1受容体を標的にする上記の抗体、ペプチボディー、および関連タンパク質等に関して、参照によりそれら全体が本明細書に組み込まれる。
Claims (32)
- 薬物送達デバイスであって、
内部空間を画定する内部表面と外部表面とを有する、使い捨てハウジングと、
針が前記内部空間の内側に抜脱される後退状態と、前記針の尖端が前記ハウジングの前記外部表面を越えて突出する展開状態とを有する、針と、
前記針が前記後退状態と前記展開状態との間を移動するように前記針に連結される、注入器と、
前記内部空間内に配置される容器であって、ある容量の薬物を受容し、かつ前記針と流体連通するように構成される、容器と、
前記注入器と前記容器とに連結される制御器であって、前記制御器は、前記針が前記後退状態から前記展開状態に一度だけ移動するように前記注入器を作動させ、かつ事前選択された時間が経過した後に、前記容量の薬物を単回ボーラスとして患者に送達するように前記容器を作動させるように構成され、前記制御器は、前記内部空間内に配置され、かつ前記内部空間内に配置される前に構成される、制御器と、を備え、
前記送達デバイスは、装着可能な使い捨ての単回使用である、前記薬物送達デバイス。 - 前記容器内に配置されるある容量の赤血球生成促進剤をさらに含む、請求項1に記載の送達デバイス。
- 前記容器内に配置されるある容量の顆粒球コロニー刺激因子をさらに含む、請求項1に記載の送達デバイス。
- 前記容器内に配置されるある容量のTNF阻害薬をさらに含む、請求項1に記載の送達デバイス。
- 前記容器内に配置されるある容量のペグ化顆粒球コロニー刺激因子をさらに含む、請求項1に記載の送達デバイス。
- 前記容器内に配置されるある容量のインターロイキン受容体特異抗体をさらに含む、請求項1に記載の送達デバイス。
- 前記容器内に配置されるある容量のIGF受容体特異抗体をさらに含む、請求項1に記載の送達デバイス。
- 前記容器内に配置されるある容量のTGF特異抗体をさらに含む、請求項1に記載の送達デバイス。
- 前記制御器は、前記事前選択された時間が経過したことを判定する、請求項1から請求項8のうちのいずれか1つに記載の送達デバイス。
- 前記制御器は、入力デバイスの作動後少なくとも24時間が経過したことを判定する、請求項9に記載の送達デバイス。
- 前記制御器は、30分未満の間に前記容量の薬物を単回ボーラスとして前記患者に送達するように、前記容器を作動させるように構成される、請求項1から請求項10のうちのいずれか1つに記載の送達デバイス。
- 前記制御器は、6秒未満の間に前記容量の薬物を単回ボーラスとして前記患者に送達するように、前記容器を作動させるように構成される、請求項11に記載の送達デバイス。
- 前記制御器は、前記針が前記展開状態から前記後退状態に一度だけ移動するように、前記注入器を作動させるように構成される、請求項1から請求項12のうちのいずれか1つに記載の送達デバイス。
- 前記制御器に連結される入力デバイスを備え、前記制御器は、前記入力デバイスの作動に応答して前記制御器の動作を開始する、請求項1から請求項13のうちのいずれか1つに記載の送達デバイス。
- 前記制御器は、前記注入器を作動させ、かつ前記容器を作動させるようにプログラムされるマイクロプロセッサを備える、請求項1から請求項14のうちのいずれか1つに記載の送達デバイス。
- ポンプをさらに備え、前記制御器は、前記容量の薬物が前記容器から前記針に移動するように、ポンプを作動させる、請求項1から請求項15のうちのいずれか1つに記載の送達デバイス。
- 前記ポンプと前記針との間に配置されるピンチ弁をさらに備え、前記制御器は、前記ポンプを作動させる前に、前記ピンチ弁を開放する、請求項16に記載の送達デバイス。
- 前記内部空間は、密閉空間である、請求項1から請求項17のうちのいずれか1つに記載の送達デバイス。
- 単回適用時に前記ハウジングを皮膚に解放可能に固定するように適合される接着剤をさらに備え、前記接着剤は、前記外部表面の一部上に配置され、かつ患者の皮膚への前記ハウジングの適用前に着脱可能の使い捨てシートで覆われる、請求項1から請求項18のうちのいずれか1つに記載の送達デバイス。
- 前記容器と流体連通している注入口を備え、前記注入口は、前記ハウジングの前記外部表面上に配置される入口を有する、請求項1から請求項19のうちのいずれか1つに記載の送達デバイス。
- 注射器と併せて、請求項1から請求項20のうちのいずれか1つに記載の送達デバイスを備える、キット。
- 装着可能な使い捨ての単回使用薬物送達デバイスの操作方法であって、
内部空間内に含まれる制御器に従って、一度だけ注射部位を画定するように、前記送達デバイスのハウジング内に画定される前記内部空間から前記患者に針の尖端を自動的に注射することと、
前記内部空間内に含まれる前記制御器に従って、事前選択された時間が経過した後に、ある容量の薬物を単回ボーラスとして前記注射部位を通して患者に送達するように、容器を自動的に作動させることと、
を含む、前記方法。 - 前記薬物は、赤血球生成促進剤を含む、請求項22に記載の方法。
- 前記薬物は、顆粒球コロニー刺激因子を含む、請求項22に記載の方法。
- 前記薬物は、TNF阻害薬を含む、請求項22に記載の方法。
- 前記薬物は、ペグ化顆粒球コロニー刺激因子を含む、請求項22に記載の方法。
- 前記薬物は、インターロイキン受容体特異抗体を含む、請求項22に記載の方法。
- 前記薬物は、IGF受容体特異抗体を含む、請求項22に記載の方法。
- 前記薬物は、TGF特異抗体を含む、請求項22に記載の方法。
- 前記内部空間内に含まれる前記制御器に従って、前記事前選択された時間が経過したことを自動的に判定することをさらに含み、前記制御器は、前記制御器が前記内部空間内に配置される前に、前記事前選択された時間を判定するように構成される、請求項22から29のうちのいずれか1つに記載の方法。
- 前記事前選択された時間は、少なくとも24時間である、請求項30に記載の方法。
- 前記内部空間内に含まれる前記制御器の構成に従って、前記針の前記尖端を前記内部空間内に一度だけ自動的に後退させることを含む、請求項22から31のうちのいずれか1つに記載の方法。
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