JP6808494B2 - 薬物送達システム及び使用方法 - Google Patents
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Description
2014年6月3日出願の米国特許仮出願第62/007,007号の優先権利益が主張され、その全内容は参照により本明細書に明示的に組み込まれる。
温度
衝撃または振動暴露
光暴露
(その薬物と関連した)色及び/または濁度
配向
地理的位置
時間的情報
装置が包装から取り出された
装置が冷蔵(例えば、冷蔵庫)から取り出された
装置/薬物温度は、投与の準備が整った
送達を始動させた
装置が患者に適用された
装置が患者上の正しい位置/配向で適用された
カニューレが患者に挿入された、及び/または正しい組織に挿入された
送達が進行中である
送達が完了した
エラーが起こった
薬物名もしくは識別、濃度、及び/または量
機密保護及び/または偽造防止情報
患者の処方/治療計画
患者の診療現場診断
進捗の自己分析測定
指紋、暗証番号、または他の安全な識別情報
(i)次の特許公開の中に記載されている抗体1A(DSMZ受託番号DSM ACC 2586)、抗体8(DSMZ受託番号DSM ACC 2589)、抗体23(DSMZ受託番号DSM ACC 2588)、及び抗体18を含むがこれらに限定されない、米国特許公開第2006/0040358号(2006年2月23日公開)、同第2005/0008642号(2005年1月13日公開)、同第2004/0228859号(2004年11月18日公開)、
(ii)次の中に記載される抗体2F8、A12、及びIMC−A12を含むがこれらに限定されない、PCT公開第WO06/138729号(2006年12月28日公開)及び同第WO05/016970号(2005年2月24日公開)、及びLu et al.(2004),J.Biol. Chem. 279:2856−2865、
(iii)PCT公開第WO07/012614号(2007年2月1日公開)、同第WO07/000328号(2007年1月4日公開)、同第WO06/013472号(2006年2月9日公開)、同第WO05/058967号(2005年6月30日公開)、及び同第WO03/059951号(2003年7月24日公開)、
(iv)次の特許公開の中に記載される抗体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、及び抗体7H2HMを含むがこれらに限定されない、米国特許公開第2005/0084906号(2005年4月21日公開)、
(v)次のものの中に記載される抗体EM164、再表面形成されたEM164、ヒト化EM164、huEM164 v1.0、huEM164 v1.1、huEM164 v1.2、及びhuEM164 v1.3を含むがこれらに限定されない、米国特許公開第2005/0249728号(2005年11月10日公開)、同第2005/0186203号(2005年8月25日公開)、同第2004/0265307号(2004年12月30日公開)、及び同第2003/0235582号(2003年12月25日公開)、ならびにMaloney et al.(2003),Cancer Res. 63:5073−5083、
(vi)次の中に記載されるATCC受託番号PTA−2792、PTA−2788、PTA−2790、PTA−2791、PTA−2789、PTA−2793、及び抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2、及び4.17.3を有するハイブリドーマによって産生された抗体の各々を含むがこれらに限定されない、抗体CP−751,871などの、米国特許第7,037,498号(2006年5月2日発行)、米国特許公開第2005/0244408号(2005年11月30日公開)及び同第2004/0086503号(2004年5月6日公開)、及びCohen,et al.(2005),Clinical Cancer Res. 11:2063−2073、
(vii)次の特許公開の中に記載される抗体19D12と、ATCCに受託番号PTA−5214で受託されているプラスミド15H12/19D12 HCA(γ4)のポリヌクレオチドによってコードされる重鎖、及びATCCに受託番号PTA−5220で受託されているプラスミド15H12/19D12 LCF(κ)のポリヌクレオチドによってコードされる軽鎖を含む抗体と、を含むがこれらに限定されない、米国特許公開第2005/0136063号(2005年6月23日公開)及び同第2004/0018191号(2004年1月29日公開)、ならびに
(viii)各々及び全てが、特にIGF−1受容体を標的にする前述の抗体、ペプチボディ、及び関連タンパク質等に関して参照によりその全体が本明細書に組み込まれる次の特許公開の中に記載される抗体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、及びPINT−12A5を含むがこれらに限定されない、米国特許公開第2004/0202655号(2004年10月14日公開)、
Claims (37)
- 薬物送達システムであって、
貯蔵部、ならびに前記貯蔵部と流体連通している近位端及び患者内に受容される遠位端を有する送達カニューレを備える、薬物送達装置と、
前記薬物送達装置に結合される1つ以上のセンサと、
無線送信器と、
前記1つ以上のセンサ及び前記無線送信器に結合される制御装置であって、
前記1つ以上のセンサを使用して、前記薬物送達装置の条件または動作状態を判定し、
前記無線送信器を制御して、前記薬物送達装置の前記条件または前記動作状態を表す1つ以上のレポートを無線で送信するように構成される制御装置と
を備え、
前記貯蔵部は、薬剤を含み、
前記薬剤は、TNF阻害剤、カルシトニン遺伝子関連ペプチド受容体に対する抗体、顆粒球コロニー刺激因子、赤血球生成促進剤、アペリン受容体作動薬、プロタンパク質転換酵素サブチリシン/ケキシン9型(PCSK9)に対する抗体、及びメタロプロテイナーゼの組織阻害剤からなる群から選択される、薬物送達システム。 - 前記薬物送達装置は、前記送達カニューレの前記遠位端の周囲に配設された着脱可能な滅菌バリアを備え、
前記1つ以上のセンサは、前記着脱可能な滅菌バリアの動きを検出するように構成され、
前記制御装置は、
前記1つ以上のセンサを使用して、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去されたかどうかを判定し、
前記無線送信器を制御して、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去された場合、前記着脱可能な滅菌バリアの除去を表すレポートを無線で送信するように構成される、請求項1に記載の薬物送達システム。 - 前記薬物送達装置が、
前記貯蔵部及び前記送達カニューレを格納するハウジングと、
前記ハウジングの遠位端の周囲に配設された、少なくとも1つの回転抑制外部側面を有する、着脱可能な滅菌バリアとを備える、請求項1に記載の薬物送達システム。 - 前記着脱可能な滅菌バリアの少なくとも一部分は、三角形の断面を有する、請求項3に記載の薬物送達システム。
- 前記着脱可能な滅菌バリアは、平坦な遠位端表面を有し、前記少なくとも1つの回転抑制外部側面は、前記平坦な遠位端表面に対して垂直である、請求項3に記載の薬物送達システム。
- 前記着脱可能な滅菌バリアは、被覆部材及び管状部材を含み、前記被覆部材は、前記管状部材の開口端を被覆し、前記管状部材は、前記着脱可能な滅菌バリアを前記ハウジングから除去するときに前記患者によって掴持される複数の外向きに突き出たリブを含む、請求項3に記載の薬物送達システム。
- 前記制御装置及び前記無線送信器は、前記着脱可能な滅菌バリア内に収容される、請求項3に記載の薬物送達ステム。
- 薬物送達システムであって、
貯蔵部、前記貯蔵部と流体連通している第1の端及び患者内に受容される第2の端を有する送達カニューレ、前記患者の皮膚に身体上薬物送達装置を取り付ける接着剤、ならびに着脱可能な滅菌バリアを備える身体上薬物送達装置と、
前記着脱可能な滅菌バリアの動きを検出するように構成された第1のセンサと、
無線送信器と、
前記第1のセンサ及び前記無線送信器に結合された制御装置と
を備え、
前記制御装置は、
前記第1のセンサを使用して、前記着脱可能な滅菌バリアが前記身体上薬物送達装置から除去されたかどうかを判定し、
前記無線送信器を制御して、前記着脱可能な滅菌バリアが前記身体上薬物送達装置から除去された場合、前記着脱可能な滅菌バリアの除去を表すレポートを無線で送信するように構成されている、薬物送達システム。 - 前記薬物送達システムは、
前記薬物送達装置を始動させるように構成されたアクチュエータを備える前記薬物送達装置と、
前記アクチュエータの動きを検出するように構成された第2のセンサと、
前記第2のセンサに結合された前記制御装置と
を備え、
前記制御装置は、
前記第2のセンサを使用して、前記アクチュエータが前記薬物送達装置を始動させるために使用されたかどうかを判定し、
前記無線送信器を制御して、前記アクチュエータが使用された場合、前記薬物送達装置を始動させたことを表すレポートを無線で送信するように構成されている、請求項8に記載の薬物送達システム。 - 前記薬物送達システムは、
近位位置と遠位位置との間で前記送達カニューレの前記第2の端に対して可動である針シールドを備える前記薬物送達装置と、
各々前記針シールドの動きを検出するように構成された第3のセンサ及び第4のセンサと、
前記第3のセンサに結合された前記制御装置と
を備え、
前記制御装置は、
前記第3のセンサを使用して、前記針シールドが前記送達カニューレの前記第2の端に対して動かされたかどうかを判定し、
前記無線送信器を制御して、前記針シールドが前記送達カニューレの前記第2の端に対して動かされた場合、前記患者内への前記送達カニューレの前記第2の端の挿入を表すレポートを無線で送信し、
前記第4のセンサを使用して、前記針シールドが前記送達カニューレの前記第2の端の周囲に配設されたかどうかを判定し、
前記無線送信器を制御して、前記針シールドが、前記近位位置から前記遠位位置に動かされた後に前記送達カニューレの前記第2の端の周囲に配設された場合、前記貯蔵部から前記患者への薬剤の送達の完了を表すレポートを無線で送信するように構成されている、請求項9に記載の薬物送達システム。 - 前記薬物送達システムは、
近位位置と遠位位置との間で前記送達カニューレの前記第2の端に対して可動である針シールドを備える前記薬物送達装置と、
前記針シールドの動きを検出するように構成された第3のセンサと、
前記第3のセンサに結合された前記制御装置と
を備え、
前記制御装置は、
前記第3のセンサを使用して、前記針シールドが前記送達カニューレの前記第2の端に対して動かされたかどうかを判定し、
前記無線送信器を制御して、前記針シールドが前記送達カニューレの前記第2の端に対して動かされた場合、前記患者内への前記送達カニューレの前記第2の端の挿入を表すレポートを無線で送信するように構成されている、請求項8に記載の薬物送達システム。 - 前記薬物送達システムは、
近位位置と遠位位置との間で前記送達カニューレの前記第2の端に対して可動である針シールドと、
前記針シールドの動きを検出するように構成された第3のセンサと、
前記第3のセンサに結合された前記制御装置と
を備え、
前記制御装置は、
前記第3のセンサを使用して、前記針シールドが前記送達カニューレの前記第2の端の周囲に配設されたかどうかを判定し、
前記無線送信器を制御して、前記針シールドが、前記近位位置から前記遠位位置に動かされた後に前記送達カニューレの前記第2の端の周囲に配設された場合、前記貯蔵部から前記患者への薬剤の送達の完了を表すレポートを無線で送信するように構成されている、請求項8に記載の薬物送達システム。 - 前記薬物送達システムは、
前記送達カニューレの前記第2の端に対して可動である針シールドを備える前記薬物送達装置と、
前記針シールドの動きを検出するように構成された第3のセンサと、
前記第3のセンサに結合された前記制御装置と
を備え、
前記制御装置は、
前記第3のセンサを使用して、前記針シールドが前記送達カニューレの前記第2の端に対して動かされたかどうかを判定し、
前記無線送信器を制御して、前記針シールドが前記送達カニューレの前記第2の端に対して動かされた場合、前記患者内への前記送達カニューレの前記第2の端の挿入を表すレポートを無線で送信するように構成されている、請求項9に記載の薬物送達システム。 - 前記送達カニューレの前記第2の端に対して可動である針シールドを備える前記薬物送達装置と、
前記針シールドの動きを検出するように構成された第3のセンサと、
前記第3のセンサに結合された前記制御装置と
を備え、
前記制御装置は、
前記第3のセンサを使用して、前記針シールドが前記送達カニューレの前記第2の端の周囲に配設されたかどうかを判定し、
前記無線送信器を制御して、前記針シールドが前記送達カニューレの前記第2の端の周囲に配設された場合、前記貯蔵部から前記患者への薬剤の送達の完了を表すレポートを無線で送信するように構成されている、請求項9に記載の薬物送達システム。 - 前記第3のセンサを使用して、前記針シールドが前記送達カニューレの前記第2の端の周囲に配設されたかどうかを判定し、
前記無線送信器を制御して、前記針シールドが、前記近位位置から前記遠位位置に動かされた後に前記送達カニューレの前記第2の端の周囲に配設された場合、前記貯蔵部から前記患者への薬剤の送達の完了を表すレポートを無線で送信するように構成された、前記制御装置と、を備える、請求項11に記載の薬物送達システム。 - 前記第1のセンサ、前記無線送信器、及び前記制御装置は、前記着脱可能な滅菌バリア内に埋め込まれる、請求項8に記載の薬物送達システム。
- 前記制御装置は、前記着脱可能な滅菌バリアが時期尚早に除去されたと判定された場合、前記貯蔵部内に含まれる薬剤の送達を制限するように構成される、請求項8に記載の薬物送達システム。
- 前記制御装置は、前記着脱可能な滅菌バリアが時期尚早に除去されたと判定された場合、前記貯蔵部が交換されたかどうかを判定し、前記貯蔵部が交換されたと判定された場合、送達を許容するように構成される、請求項17に記載の薬物送達システム。
- 前記制御装置は、前記着脱可能な滅菌バリアが適切に除去されたと判定されない限り、前記貯蔵部内に含まれる薬剤の送達を制限するように構成される、請求項8に記載の薬物送達システム。
- 前記制御装置は、前記第1のセンサを使用して、前記着脱可能な滅菌バリアが前記送達カニューレの前記第2の端から除去されたかどうかを判定し、かつ一定期間が経過したかどうかを判定し、前記無線送信器を制御して、前記着脱可能な滅菌バリアが前記送達カニューレの前記第2の端から除去され、かつ前記期間が経過した場合、レポートを送信するように構成される、請求項8に記載の薬物送達システム。
- 前記薬物送達装置はロックを備え、前記制御装置は前記ロックに結合され、前記制御装置は、前記着脱可能な滅菌バリアが前記送達カニューレの前記第2の端から除去され、かつ前記期間が経過した場合、前記ロックを作動させるように構成される、請求項20に記載の薬物送達システム。
- 前記貯蔵部は、薬剤を含む、請求項8に記載の薬物送達システム。
- 前記薬剤は、TNF阻害剤、カルシトニン遺伝子関連ペプチド受容体に対する抗体、顆粒球コロニー刺激因子、赤血球生成促進剤、アペリン受容体作動薬、プロタンパク質転換酵素サブチリシン/ケキシン9型(PCSK9)に対する抗体、及びメタロプロテイナーゼの組織阻害剤からなる群から選択される、請求項22に記載の薬物送達システム。
- 貯蔵部、前記貯蔵部と流体連通している第1の端及び患者内に受容される第2の端を有する送達カニューレ、前記患者の皮膚に身体上薬物送達装置を取り付ける接着剤、ならびに着脱可能な滅菌バリアを備える、身体上薬物送達装置の作動方法であって、前記薬物送達装置は、コンピューティングデバイスと通信するように構成されており、
前記コンピューティングデバイスによって、前記着脱可能な滅菌バリアが前記身体上薬物送達装置から除去されたかどうかを判定することと、
前記着脱可能な滅菌バリアが前記身体上薬物送達装置から除去された場合、前記コンピューティングデバイスによって、前記着脱可能な滅菌バリアの前記除去を表すレポートを送信することと、を含む、作動方法。 - 前記コンピューティングデバイスは、第1のコンピューティングデバイスと、第2のコンピューティングデバイスとを備え、前記方法は、前記第1のコンピューティングデバイスが、前記着脱可能な滅菌バリアの前記除去を表す前記レポートを受信することと、
前記第1のコンピューティングデバイスが、前記第2のコンピューティングデバイスに前記レポートを送信することと、をさらに含む、請求項24に記載の作動方法。 - 前記着脱可能な滅菌バリアが除去されたと判定される場合、前記コンピューティングデバイスによって、前記貯蔵部内に含まれる薬剤の送達を制限することをさらに含む、請求項24に記載の作動方法。
- 前記着脱可能な滅菌バリアが除去されたと判定された場合、前記コンピューティングデバイスによって、前記貯蔵部が交換されたかどうかを判定することと、
前記貯蔵部が交換されたと判定された場合、前記コンピューティングデバイスによって、前記貯蔵部内に含まれる薬剤の送達を許容することと、をさらに含む、請求項24に記載の作動方法。 - 前記着脱可能な滅菌バリアが除去されたと判定されるまで、前記コンピューティングデバイスによって、前記貯蔵部内に含まれる薬剤の送達を制限することをさらに含む、請求項24に記載の作動方法。
- 前記コンピューティングデバイスによって、前記着脱可能な滅菌バリアの除去後に一定期間が経過したかどうかを判定することと、
前記着脱可能な滅菌バリアが前記送達カニューレの前記第2の端から除去され、かつ前記一定期間が経過した場合、前記コンピューティングデバイスによって、レポートを送信することをさらに含む、請求項24に記載の作動方法。 - 前記着脱可能な滅菌バリアが前記送達カニューレの前記第2の端から除去され、かつ前記期間が経過した場合、前記コンピューティングデバイスによって、前記薬物送達装置をロックすることをさらに含む、請求項29に記載の作動方法。
- 前記貯蔵部は、薬剤を含む、請求項24に記載の作動方法。
- 前記薬剤は、TNF阻害剤、カルシトニン遺伝子関連ペプチド受容体に対する抗体、顆粒球コロニー刺激因子、赤血球生成促進剤、アペリン受容体作動薬、プロタンパク質転換酵素サブチリシン/ケキシン9型(PCSK9)に対する抗体、及びメタロプロテイナーゼの組織阻害剤からなる群から選択される、請求項31に記載の作動方法。
- 薬物送達装置を含む薬物送達システムであって、
前記薬物送達装置は、
貯蔵部と、
前記貯蔵部と流体連通している近位端及び患者内に受容される遠位端を有する送達カニューレと、
前記貯蔵部及び前記送達カニューレを格納するハウジングと、
前記ハウジングの遠位端に配設された着脱可能な滅菌バリアとを備え、
前記着脱可能な滅菌バリアは、少なくとも1つの回転抑制外部側面を有する管状部材と、前記着脱可能な滅菌バリアを前記ハウジングから除去するときに前記患者によって掴持される複数の外向きに突き出たリブと、
を含み、
前記薬物送達システムはさらに、
前記薬物送達装置に結合された1つ以上のセンサと
無線送信器と、
前記1つ以上のセンサおよび前記無線送信器に結合された制御装置と
を備え、
前記制御装置は、
前記1つ以上のセンサを使用して、前記薬物送達装置の条件または動作状態を判定し、
前記無線送信器を制御して、前記薬物送達装置の前記条件または前記動作状態を表す1つ以上のレポートを無線で送信するように構成されている、薬物送達システム。 - 薬物送達システムであって、
貯蔵部、前記貯蔵部と流体連通している近位端及び患者内に受容される遠位端を有する送達カニューレ、ならびに前記送達カニューレの前記遠位端の周囲に配設された着脱可能な滅菌バリアを備える薬物送達装置と、
前記着脱可能な滅菌バリアの動きを検出するように構成された第1のセンサと、
無線送信器と、
前記第1のセンサおよび前記無線送信器に結合された制御装置と
を備え、
前記制御装置は、
前記第1のセンサを使用して、前記着脱可能な滅菌バリアが送達カニューレの遠位端から除去されたかどうかを判定し、
前記無線送信器を制御して、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去された場合、前記着脱可能な滅菌バリアの除去を表すレポートを無線で送信し、
前記着脱可能な滅菌バリアが時期尚早に除去されたと判定された場合、前記貯蔵部内に含まれる薬剤の送達を制限するように構成されている、薬物送達システム。 - 薬物送達システムであって、
貯蔵部、前記貯蔵部と流体連通している近位端及び患者内に受容される遠位端を有する送達カニューレ、ならびに前記送達カニューレの前記遠位端の周囲に配設された着脱可能な滅菌バリアを備える薬物送達装置と、
前記着脱可能な滅菌バリアの動きを検出するように構成された第1のセンサと、
無線送信器と、
前記第1のセンサおよび前記無線送信器に結合された制御装置と
を備え、
前記制御装置は、
前記第1のセンサを使用して、前記着脱可能な滅菌バリアが送達カニューレの遠位端から除去されたかどうかを判定し、
前記無線送信器を制御して、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去された場合、前記着脱可能な滅菌バリアの除去を表すレポートを無線で送信し、
前記着脱可能な滅菌バリアが適切に除去されたと判定されない限り、前記貯蔵部内に含まれる薬剤の送達を制限するように構成されている、薬物送達システム。 - 薬物送達システムであって、
貯蔵部、前記貯蔵部と流体連通している近位端及び患者内に受容される遠位端を有する送達カニューレ、ならびに前記送達カニューレの前記遠位端の周囲に配設された着脱可能な滅菌バリアを備える薬物送達装置と、
前記着脱可能な滅菌バリアの動きを検出するように構成された第1のセンサと、
無線送信器と、
前記第1のセンサおよび前記無線送信器に結合された制御装置と
を備え、
前記制御装置は、
前記第1のセンサを使用して、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去されたかどうかを判定し、
無線送信器を制御して、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去された場合、前記着脱可能な滅菌バリアの除去を表すレポートを無線で送信するように構成されており、
前記第1のセンサ、前記無線送信器、および前記制御装置は、前記着脱可能な滅菌バリアに含まれている、薬物送達システム。 - 貯蔵部、前記貯蔵部と流体連通している近位端及び患者内に受容される遠位端を有する送達カニューレ、ならびに前記送達カニューレの前記遠位端の周囲に配設された着脱可能な滅菌バリアを備える、薬物送達装置の作動方法であって、前記薬物送達装置は、コンピューティングデバイスと通信するように構成されており、
前記コンピューティングデバイスによって、前記着脱可能な滅菌バリアに含まれる制御装置を用いて、前記着脱可能な滅菌バリアに含まれるセンサからの信号出力に基づいて、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去されたかどうかを判定することと、
前記コンピューティングデバイスによって、前記着脱可能な滅菌バリアに含まれる無線送信器を用いて、前記着脱可能な滅菌バリアが前記送達カニューレの前記遠位端から除去された場合、前記着脱可能な滅菌バリアの前記除去を表すレポートを送信することと、を含む作動方法。
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