JP2017520298A - 制御可能な薬物送達システム及び使用方法 - Google Patents
制御可能な薬物送達システム及び使用方法 Download PDFInfo
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Abstract
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。
(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 (79)
- 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、ならびに制御可能要素を備える、薬物送達装置と、
前記薬物送達装置に結合されたセンサと、
前記センサ及び前記制御可能要素に結合された制御装置であって、
前記センサを使用して、前記薬物送達装置の条件または動作状態を判定し、
前記薬物送達装置の前記条件または動作状態に基づいて、前記制御可能要素を制御するように構成される制御装置とを備える、薬物送達システム。 - 前記制御可能要素は、ロックを含む、請求項1に記載の薬物送達システム。
- 前記薬物送達装置は、前記送達カニューレの前記遠位端に対して可動である針シールドを備え、
前記ロックは、前記ロックが作動すると前記針シールドの動きを防ぐように構成される、請求項2に記載の薬物送達システム。 - 前記薬物送達装置は、前記貯蔵部から薬剤を放出するための、前記貯蔵部を通って可動であるプランジャーを備え、
前記ロックは、前記ロックが作動すると前記プランジャーの動きを防ぐように構成される、請求項2に記載の薬物送達システム。 - 前記薬物送達装置は、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、
前記ロックは、前記ロックが作動すると前記アクチュエータが前記薬物送達装置を始動させることを防ぐように構成される、請求項2に記載の薬物送達システム。 - 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、
前記着脱可能な滅菌バリアの除去から一定期間が経過したかどうかを判定し、
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、かつ前記一定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2〜5のいずれか一項に記載の薬物送達システム。 - 前記センサは、前記貯蔵部内の薬剤の温度を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記貯蔵部内の前記薬剤の前記温度または温度履歴を判定し、
前記貯蔵部内の前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記ロックを作動させるように構成される、請求項2〜5のいずれか一項に記載の薬物送達システム。 - 前記センサは、前記患者の識別を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記患者が権限を与えられた患者であるかどうかを判定し、
前記患者が前記権限を与えられた患者である場合、前記ロックを解除するように構成される、請求項2〜5のいずれか一項に記載の薬物送達システム。 - 前記センサは、指紋センサを含む、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、前記送達カニューレの前記遠位端のための開口部を有するハウジングを備え、
前記センサは、前記ハウジングと対象物との間の接触を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記ハウジングが前記患者に接触しているかどうかを判定し、
前記ハウジングが前記患者に接触している場合、前記ロックを解除するように構成される、請求項2〜5のいずれか一項に記載の薬物送達システム。 - 前記センサは、前記送達カニューレの配向を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記送達カニューレが前記貯蔵部内の薬剤を前記患者に送達するために配向されているかどうかを判定し、
前記送達カニューレが前記貯蔵部内の前記薬剤を前記患者に送達するために配向されている場合、前記ロックを解除するように構成される、請求項2〜5のいずれか一項に記載の薬物送達システム。 - 前記制御装置は、
前記貯蔵部内の薬剤の有効期限を保存し、
現在の日付が前記貯蔵部内の前記薬剤の前記有効期限以降である場合、前記ロックを作動させるように構成される、請求項2〜5のいずれか一項に記載の薬物送達システム。 - 前記制御可能要素は、低エネルギー状態及び高エネルギー状態を有する回路を含む、請求項1に記載の薬物送達システム。
- 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、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えるように構成される、請求項13に記載の薬物送達システム。 - 前記センサは、前記貯蔵部内の薬剤の温度を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記貯蔵部内の前記薬剤の前記温度または温度履歴を判定し、
前記貯蔵部内の前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えるように構成される、請求項13に記載の薬物送達システム。 - 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ための開口部を有するハウジングを備え、
前記センサは、前記ハウジングと対象物との間の接触を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記ハウジングが前記患者に接触しているかどうかを判定し、
前記ハウジングが前記患者に接触している場合、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えるように構成される、請求項13に記載の薬物送達システム。 - 前記センサは、前記薬物送達装置の外部周囲に配設された保護包装に対する前記薬物送達装置の動きを検出するように構成され、
前記制御装置は、
前記センサを使用して、前記薬物送達装置が前記保護包装から取り出されたかどうかを判定し、
薬物送達装置が前記保護包装から取り出されている場合、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えるように構成される、請求項13に記載の薬物送達システム。 - 前記制御可能要素は、作動すると前記貯蔵部または前記送達カニューレ内の薬剤を加熱するように構成された加熱要素を含む、請求項1に記載の薬物送達システム。
- 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、前記加熱要素を作動させるように構成される、請求項18に記載の薬物送達システム。 - 前記センサは、前記貯蔵部内の薬剤の温度を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記貯蔵部内の前記薬剤の前記温度または温度履歴を判定し、
前記貯蔵部内の前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記加熱要素を作動させるように構成される、請求項18に記載の薬物送達システム。 - 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ための開口部を有するハウジングを備え、
前記センサは、前記ハウジングと対象物との間の接触を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記ハウジングが前記患者に接触しているかどうかを判定し、
前記ハウジングが前記患者に接触している場合、前記加熱要素を作動させるように構成される、請求項18に記載の薬物送達システム。 - 前記薬物送達装置は、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、
前記センサは、前記アクチュエータの動きを検出するように構成され、
前記制御装置は、
前記センサを使用して、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場合、前記加熱要素を作動させるように構成される、請求項18に記載の薬物送達システム。 - 前記加熱要素は、前記貯蔵部または前記送達カニューレに結合された導電性コイルを含む、請求項18〜22のいずれか一項に記載の薬物送達システム。
- 前記制御可能要素は、出力ユニットを含む、請求項1に記載の薬物送達システム。
- 前記センサは、前記貯蔵部内の薬剤の温度を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記貯蔵部内の前記薬剤の前記温度または温度履歴を判定し、
前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記薬物送達装置が前記薬剤を前記患者に送達するために使用されるべきではないことを前記患者に通知するために、前記出力ユニットを制御するように構成される、請求項24に記載の薬物送達システム。 - 前記センサは、前記送達カニューレの配向を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記送達カニューレが前記貯蔵部内の薬剤を前記患者に送達するために配向されているかどうかを判定し、
前記送達カニューレが前記薬剤を前記患者に送達するために配向されている場合、前記薬物送達装置が前記薬剤を前記患者に送達するために使用され得ることを前記患者に通知するために、前記出力ユニットを制御するように構成される、請求項24に記載の薬物送達システム。 - 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ための開口部を有するハウジングを備え、
前記センサは、前記ハウジングと対象物との間の接触を検出するように構成され、
前記制御装置は、
前記センサを使用して、前記ハウジングが前記患者に接触しているかどうかを判定し、
前記ハウジングが前記患者に接触している場合、前記薬物送達装置が前記貯蔵部内の薬剤を前記患者に送達するために使用され得ることを前記患者に通知するために、前記出力ユニットを制御するように構成される、請求項24に記載の薬物送達システム。 - 前記薬物送達装置は、前記貯蔵部から薬剤を放出するための、前記貯蔵部を通って可動であるプランジャーを備え、
前記センサは、前記プランジャーの動きを検出するように構成され、
前記制御装置は、
前記センサを使用して、前記プランジャーが送達行程を完了したかどうかを判定し、
前記プランジャーが前記送達工程を完了した場合、前記貯蔵部から前記患者への前記薬剤の送達の完了を前記患者に通知するために、前記出力ユニットを制御するように構成される、請求項24に記載の薬物送達システム。 - 前記出力ユニットは、表示装置、タッチスクリーン、発光ダイオード、振動器、スピーカー、または警報器のうちの少なくとも1つを含む、請求項24〜28のいずれか一項に記載の薬物送達システム。
- 前記薬物送達装置は、
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1〜29のいずれか一項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、三角形の断面を有する、請求項30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30または31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30〜33のいずれか一項に記載の薬物送達システム。
- 前記制御装置または前記センサのうちの少なくとも1つは、前記着脱可能な滅菌バリア内に収容される、請求項30〜33のいずれか一項に記載の薬物送達ステム。
- 前記貯蔵部は、薬剤を含む、請求項1〜34のいずれか一項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35に記載の薬物送達システム。
- 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、ならびに制御可能要素を備える、薬物送達装置と、
前記患者の識別、前記薬物送達装置の識別、または前記貯蔵部内に保持される薬剤の識別のうちの少なくとも1つを表す識別情報を保存するように構成されたメモリと、
前記メモリ及び前記制御可能要素に結合された制御装置であって、前記識別情報に基づいて前記制御可能要素を制御するように構成される制御装置とを備える、薬物送達システム。 - 前記制御可能要素は、ロックを含む、請求項37に記載の薬物送達システム。
- 前記薬物送達装置は、前記送達カニューレの前記遠位端に対して可動である針シールドを備え、
前記ロックは、前記ロックが作動すると前記針シールドの動きを防ぐように構成される、請求項38に記載の薬物送達システム。 - 前記薬物送達装置は、前記貯蔵部から薬剤を放出するための、前記貯蔵部を通って可動であるプランジャーを備え、
前記ロックは、前記ロックが作動すると前記プランジャーの動きを防ぐように構成される、請求項38に記載の薬物送達システム。 - 前記薬物送達装置は、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、
前記ロックは、前記ロックが作動すると前記薬物送達装置を始動させることから前記アクチュエータに構成される、請求項38に記載の薬物送達システム。 - 前記識別情報は、前記貯蔵部内に保持される前記薬剤の有効期限を示し、
前記制御装置は、現在の日付が前記貯蔵部内の前記薬剤の前記有効期限以降である場合、前記ロックを作動させるように構成される、請求項38〜41のいずれか一項に記載の薬物送達システム。 - 前記薬物送達装置は、入力ユニットを備え、
前記識別情報は、パスワードを含み、
前記制御装置は、前記入力ユニットを介して入力されたパスワードが、前記識別情報に含まれている前記パスワードと一致する場合、前記ロックを解除するように構成される、請求項38〜41のいずれか一項に記載の薬物送達システム。 - 前記制御可能要素は、表示装置を含み、
前記制御装置は、前記識別情報を表示させるために前記表示装置を制御するように構成される、請求項37に記載の薬物送達システム。 - 前記識別情報は、前記貯蔵部内に保持される前記薬剤の有効期限を含む、請求項44に記載の薬物送達システム。
- 前記識別情報は、薬物名、薬物濃度、投与量情報、前記薬物送達装置の通し番号、前記貯蔵部内に保持される前記薬剤の通し番号、薬物送達装置の種類、前記貯蔵部内に保持される前記薬剤の種類、前記薬物送達装置の製造日、権限を与えられた患者の名前、パスワード、生体情報、人口統計データ情報、または患者サブグループ情報のうちの少なくとも1つを含む、請求項37〜45のいずれか一項に記載の薬物送達システム。
- 前記薬物送達装置は、
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37〜46のいずれか一項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、三角形の断面を有する、請求項47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47または48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47〜49のいずれか一項に記載の薬物送達システム。
- 前記制御装置または前記メモリのうちの少なくとも1つは、前記着脱可能な滅菌バリア内に収容される、請求項47〜50のいずれか一項に記載の薬物送達ステム。
- 前記貯蔵部は、前記薬剤を含む、請求項37〜51のいずれか一項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52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、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着脱可能な滅菌バリア、ならびに制御可能要素を備える、薬物送達装置と一緒に使用するための方法であって、
1つ以上のセンサを用いて、前記薬物送達装置の条件または動作状態を判定することと、
前記薬物送達装置の前記条件または動作状態に基づいて、前記制御可能要素を制御することと、を含む、方法。 - 前記制御可能要素は、ロックを含む、請求項54に記載の方法。
- 前記1つ以上のセンサを用いて、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、
前記着脱可能な滅菌バリアの除去から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遠位端から除去され、かつ前記一定期間が経過した場合、前記ロックを作動させることと、を含む、請求項55に記載の方法。 - 前記1つ以上のセンサを用いて、前記貯蔵部内の薬剤の温度を判定することと、
前記貯蔵部内の前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記ロックを作動させることと、を含む、請求項55または56に記載の方法。 - 前記1つ以上のセンサを用いて、前記患者が権限を与えられた患者であるかどうかを判定することと、
前記患者が前記権限を与えられた患者である場合、前記ロックを解除することと、を含む、請求項55〜57のいずれか一項に記載の方法。 - 前記1つ以上のセンサを用いて、前記薬物送達装置のハウジング接点が前記患者に接触しているかどうかを判定することと、
前記ハウジングが前記患者に接触している場合、前記ロックを解除することと、を含む、請求項55〜58のいずれか一項に記載の方法。 - 前記1つ以上のセンサを用いて、前記送達カニューレが前記貯蔵部内の薬剤を前記患者に送達するために配向されているかどうかを判定することと、
前記送達カニューレが前記貯蔵部内の前記薬剤を前記患者に送達するために配向されている場合、前記ロックを解除することと、を含む、請求項55〜59のいずれか一項に記載の方法。 - 前記薬物送達装置に搭載されたメモリ内に有効期限を保存することと、
現在の日付が前記貯蔵部内の前記薬剤の前記有効期限以降である場合、前記ロックを作動させることと、を含む、請求項55〜60のいずれか一項に記載の方法。 - 前記制御可能要素は、低エネルギー状態及び高エネルギー状態を有する回路を含む、請求項54に記載の方法。
- 前記1つ以上のセンサを用いて、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、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えることと、を含む、請求項62のいずれか一項に記載の方法。 - 前記1つ以上のセンサを用いて、前記貯蔵部内の薬剤の温度または温度履歴を判定することと、
前記貯蔵部内の前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えることと、を含む、請求項62または63に記載の方法。 - 前記1つ以上のセンサを用いて、前記薬物送達装置のハウジングが前記患者に接触しているかどうかを判定することと、
前記ハウジングが前記患者に接触している場合、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えることと、を含む、請求項62〜64のいずれか一項に記載の方法。 - 前記1つ以上のセンサを用いて、前記薬物送達装置が保護包装から取り出されたかどうかを判定することと、
薬物送達装置が前記保護包装から取り出された場合、前記回路を前記低エネルギー状態から前記高エネルギー状態に切り替えることと、を含む、請求項62〜65のいずれか一項に記載の方法。 - 前記制御可能要素は、作動すると前記貯蔵部または前記送達カニューレ内の薬剤を加熱するように構成された加熱要素を含む、請求項54に記載の方法。
- 前記1つ以上のセンサを用いて、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、前記加熱要素を作動させることと、を含む、請求項67のいずれか一項に記載の方法。 - 前記1つ以上のセンサを用いて、前記貯蔵部内の薬剤の温度または温度履歴を判定することと、
前記貯蔵部内の前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記加熱要素を作動させることと、を含む、請求項67または68に記載の方法。 - 前記1つ以上のセンサを用いて、前記薬物送達装置のハウジングが前記患者に接触しているかどうかを判定することと、
前記ハウジングが前記患者に接触している場合、前記加熱要素を作動させることと、を含む、請求項67〜69のいずれか一項に記載の方法。 - 前記1つ以上のセンサを用いて、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することと、
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場合、前記加熱要素を作動させることと、を含む、請求項67〜70のいずれか一項に記載の方法。 - 前記制御可能要素は、出力ユニットを含む、請求項54に記載の方法。
- 前記1つ以上のセンサを用いて、前記貯蔵部内の薬剤の温度または温度履歴を判定することと、
前記薬剤の前記温度または温度履歴が標的温度より高いか、またはそれ未満である場合、前記出力ユニットを用いて、前記薬物送達装置が前記薬剤を前記患者に送達するために使用されるべきではないことを前記患者に通知することと、を含む、請求項72に記載の方法。 - 前記1つ以上のセンサを用いて、送達カニューレが前記貯蔵部内の薬剤を前記患者に送達するために配向されているかどうかを判定することと、
前記送達カニューレが前記薬剤を前記患者に送達するために配向されている場合、前記出力ユニットを用いて、前記薬物送達装置が前記薬剤を前記患者に送達するために使用され得ることを前記患者に通知することと、を含む、請求項72または73に記載の方法。 - 前記1つ以上のセンサを用いて、前記薬物送達装置のハウジングが前記患者に接触しているかどうかを判定することと、
前記ハウジングが前記患者に接触している場合、前記出力ユニットを用いて、前記薬物送達装置が前記貯蔵部内の薬剤を前記患者に送達するために使用され得ることを前記患者に通知することと、を含む、請求項72〜74のいずれか一項に記載の方法。 - 前記1つ以上のセンサを用いて、プランジャーが送達工程を完了したかどうかを判定することと、
前記プランジャーが前記送達工程を完了した場合、前記出力ユニットを用いて、前記貯蔵部から前記患者への前記薬剤の送達の完了を前記患者に通知することと、を含む、請求項72〜75のいずれか一項に記載の方法。 - 前記出力ユニットは、表示装置、タッチスクリーン、発光ダイオード、振動器、スピーカー、または警報器のうちの少なくとも1つを含む、請求項72〜76のいずれか一項に記載の方法。
- 前記貯蔵部は、薬剤を含む、請求項54〜77のいずれか一項に記載の方法。
- 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78に記載の方法。
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