JP2017522075A - 薬物送達装置によって収集されたデータを遠隔で処理するためのシステム及び方法 - Google Patents
薬物送達装置によって収集されたデータを遠隔で処理するためのシステム及び方法 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。
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
カニューレが患者内に挿入された、及び/または正しい組織内に挿入された
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
機密保護情報及び/または偽造防止情報
患者の処方/治療体制
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 (81)
- システムであって、
薬物送達装置であって、
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、
前記薬物送達装置の条件または動作状態のうちの少なくとも1つを表すセンサデータを生成するように構成された1つ以上のセンサ、ならびに
前記1つ以上のセンサに結合され、前記センサデータを送信するように構成された第1の通信モジュール、を備える、薬物送達装置と、
外部コンピューティングデバイスであって、
前記第1の通信モジュールから前記センサデータを受信するように構成された第2の通信モジュール、
前記第2の通信モジュールに結合されたプロセッサ、及び
前記プロセッサに結合されたメモリであって、前記プロセッサによって実行されたとき、前記プロセッサに、前記センサデータに基づいて前記薬物送達装置の前記条件または前記動作状態のうちの少なくとも1つを判定させる、非一時的コンピュータ可読命令を保存するメモリを備える、外部コンピューティングデバイスとを備える、システム。 - 前記外部コンピューティングデバイスは、前記プロセッサに結合された表示装置を備える、請求項1に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、(i)前記薬物送達装置の前記条件または前記動作状態のうちの少なくとも1つと、(ii)前記外部コンピューティングデバイスの前記メモリに保存された情報と、に基づいて指示プロンプトまたは情報プロンプトのうちの少なくとも1つを表示するように前記表示装置を制御させる命令を含む、請求項2に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータに基づいて前記薬物送達装置の温度または温度履歴を判定させる命令を含む、請求項1〜3のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記薬物送達装置の前記温度または前記温度履歴を前記外部コンピューティングデバイスの前記メモリに保存された情報と比較させて、前記薬物送達装置の前記温度または前記温度履歴が許容できるかどうかを判定させる命令を含む、請求項4に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータに基づいて前記薬物送達装置が前記患者の皮膚上または皮膚に接して配設されたかどうかを判定させる命令を含む、請求項1〜5のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記薬物送達装置が前記患者の皮膚上または皮膚に接して配設されたという判定に応答して、前記患者の皮膚に対して前記薬物送達装置を正しく配向するように使用者に指示する指示プロンプトを表示するように前記表示装置を制御させる命令を含む、請求項6に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータに基づいて前記薬物送達装置の配向を判定させる命令を含む、請求項1〜7のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、
前記薬物送達装置の前記配向を前記外部コンピューティングデバイスの前記メモリに保存された情報と比較させて、前記患者の皮膚に対する前記薬物送達装置の前記配向が許容できるかどうかを判定させ、
前記薬物送達装置の前記配向が許容できるという判定に応答して、前記薬物送達装置を作動させるよう使用者に指示する指示プロンプトを表示するように前記表示装置を制御させる、命令を含む、請求項8に記載のシステム。 - 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータに基づいて前記薬物送達装置が使用者によって作動されたかどうかを判定させる命令を含む、請求項1〜9のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記薬物送達装置が前記使用者によって作動されたという判定に応答して、前記貯蔵部から前記患者への薬剤の送達の完了を待つように使用者に指示する指示プロンプトを表示するように前記表示装置を制御させる命令を含む、請求項10に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータに基づいて前記貯蔵部から前記患者への薬剤の送達が完了したかどうかを判定させる命令を含む、請求項1〜11のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記貯蔵部から前記患者への前記薬剤の前記送達が完了したという判定に応答して、前記薬物送達装置を廃棄するよう使用者に指示する指示プロンプトを表示するように前記表示装置を制御させる命令を含む、請求項12に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータに基づいて前記貯蔵部内に残っている薬剤の量を判定させる命令を含む、請求項1〜13のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータ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させる命令を含む、請求項1〜14のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、前記センサデータに基づいて前記送達カニューレの前記遠位端が前記患者内に挿入されているどうかを判定させる命令を含む、請求項1〜15のいずれか一項に記載のシステム。
- 前記非一時的コンピュータ可読命令は、前記プロセッサに、
前記薬物送達装置の前記条件または前記動作状態のうちの少なくとも1つを表すレポートを生成させ、
前記レポートをリモートコンピューティングデバイスに送信するように前記第2の通信モジュールを制御させる、命令を含む、請求項1〜16のいずれか一項に記載のシステム。 - 前記薬物送達装置は制御可能な要素を備え、
前記非一時的コンピュータ可読命令は、前記プロセッサに、
前記制御可能な要素を制御するための命令を生成させ、
前記命令を前記第1の通信モジュールに送信するように前記第2の通信モジュールを制御させる、命令を含む、請求項1〜17のいずれか一項に記載のシステム。 - 前記制御可能な要素は、起動されたとき、(i)前記送達カニューレの前記遠位端の周囲に配設された針シールド、(ii)前記貯蔵部内に配設されたプランジャー、または(iii)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、のうちの少なくとも1つの動きを妨げるように構成されたロックを含む、請求項18に記載のシステム。
- 前記制御可能な要素は、起動されたとき、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19に記載のシステム。
- 前記1つ以上のセンサは、前記貯蔵部内の薬剤の温度を検出するように構成された温度センサを含む、請求項1〜20のいずれか一項に記載のシステム。
- 前記1つ以上のセンサは、圧力センサ、静電容量センサ、抵抗センサ、またはインダクタンスセンサのうちの少なくとも1つを含む皮膚接触センサを含む、請求項1〜21のいずれか一項に記載のシステム。
- 前記皮膚接触センサは、前記送達カニューレの前記遠位端の周囲に配設された針シールド上に装着される、請求項22に記載のシステム。
- 前記1つ以上のセンサは、配向センサを含む、請求項1〜23のいずれか一項に記載のシステム。
- 前記配向センサは、磁力計を含む、請求項24に記載のシステム。
- 前記薬物送達装置は、自動注入装置を含む、請求項1〜25のいずれか一項に記載のシステム。
- 前記外部コンピューティングデバイスは、スマートフォン、スマートウォッチ、スマート装着可能デバイス、パーソナルコンピュータ、ラップトップコンピュータ、スマートテレビ、スマート家電、スマート自動車、ネットワーク化されたコンピュータ、またはタブレットコンピュータのうちの少なくとも1つを含む、請求項1〜26のいずれか一項に記載のシステム。
- 前記第1の通信モジュールは、Bluetooth、Bluetooth低エネルギー、無線自動識別(RFID)、Zigbee、Wi−Fi、または近距離通信(NFC)のうちの少なくとも1つを介して、前記第2の通信モジュールと通信するように構成される、請求項1〜27のいずれか一項に記載のシステム。
- 前記貯蔵部は、薬剤を含む、請求項1〜28のいずれか一項に記載のシステム。
- 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28に記載のシステム。
- システムであって、
薬物送達装置であって、
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、
1つ以上のセンサ、
第1の通信モジュール、
前記1つ以上のセンサ及び前記第1の通信モジュールに結合された第1の制御装置であって、
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のうちの少なくとも1つを判定し、
前記第1の通信モジュールを制御して、前記薬物送達装置の前記条件または前記動作状態のうちの少なくとも1つを表す通信を送信するように構成された、第1の制御装置を備える、薬物送達装置と、
外部コンピューティングデバイスであって、
前記第1の通信モジュールから前記通信を受信するように構成された第2の通信モジュール、
表示装置、
メモリ、ならびに
前記表示装置、前記メモリ、及び前記第2の通信モジュールに結合された第2の制御装置であって、
前記表示装置を制御して、前記第1の通信モジュールからの前記通信に基づいて指示プロンプトまたは情報プロンプトのうちの少なくとも1つを表示するように構成される第2の制御装置を備える、外部コンピューティングデバイスと、を備える、システム。 - 前記第1の制御装置は、
前記1つ以上のセンサを使用して、前記薬物送達装置の温度または温度履歴を判定し、
前記薬物送達装置の前記温度または前記温度履歴を表す通信を送信するように前記第1の通信モジュールを制御するように構成され、
前記第2の制御装置は、
前記薬物送達装置の前記温度または前記温度履歴を前記外部コンピューティングデバイスの前記メモリに保存された情報と比較して、前記薬物送達装置の前記温度または前記温度履歴が許容できるかどうかを判定し、
前記薬物送達装置が許容できる温度または許容できる温度履歴を有するという判定に応答して、前記表示装置を制御して、前記薬物送達装置を前記患者の皮膚上または皮膚に接して配設するように使用者に指示する指示プロンプトを表示するように構成される、請求項31に記載のシステム。 - 前記第1の制御装置は、
前記1つ以上のセンサを使用して、前記薬物送達装置が患者の皮膚に接触しているかどうかを判定し、
前記薬物送達装置と前記患者の前記皮膚との間の接触を表す通信を送信するように、前記第1の通信モジュールを制御するように構成され、
前記薬物送達装置が前記患者の前記皮膚に接触しているという判定に応答して、前記第2の制御装置は、前記表示装置を制御して、前記患者の前記皮膚に対して前記薬物送達装置を正しく配向するように使用者に指示する指示プロンプトを表示するように構成される、請求項31または32に記載のシステム。 - 前記第1の制御装置は、
前記1つ以上のセンサを使用して、前記薬物送達装置の配向を判定し、
前記薬物送達装置の前記配向を表す通信を送信するように、前記第1の通信モジュールを制御するように構成され、
前記薬物送達装置の前記配向が許容できるという判定に応答して、前記第2の制御装置は、前記表示装置を制御して、前記薬物送達装置を作動させるように使用者に指示する指示プロンプトを表示するように構成される、請求項31〜33のいずれか一項に記載のシステム。 - 前記第1の制御装置は、
前記1つ以上のセンサを使用して、前記使用者が前記薬物送達装置を作動させたかどうかを判定し、
前記薬物送達装置が前記使用者によって作動されたことを示す通信を送信するように、前記第1の通信モジュールを制御するように構成され、
前記薬物送達装置が前記使用者によって作動されたという判定に応答して、前記第2の制御装置は、前記表示装置を制御して、前記貯蔵部から前記患者への薬物の送達の完了を待つように使用者に指示する指示プロンプトを表示するように構成される、請求項31〜34のいずれか一項に記載のシステム。 - 前記第1の制御装置は、
前記1つ以上のセンサを使用して、前記貯蔵部から前記患者への薬物の送達が完了したかどうかを判定し、
前記貯蔵部から前記患者への薬剤の送達の完了を表す通信を送信するように、前記第1の通信モジュールを制御するように構成され、
前記貯蔵部から前記患者への前記薬剤の前記送達が完了したという判定に応答して、前記第2の制御装置は、前記表示装置を制御して、前記薬物送達装置を廃棄するように使用者に指示する指示プロンプトを表示するように構成される、請求項31〜35のいずれか一項に記載のシステム。 - 前記1つ以上のセンサは、前記貯蔵部内の薬剤の温度を検出するように構成された温度センサを備える、請求項31〜36のいずれか一項に記載のシステム。
- 前記1つ以上のセンサは、圧力センサ、静電容量センサ、抵抗センサ、またはインダクタンスセンサのうちの少なくとも1つを含む皮膚接触センサを備える、請求項31〜37のいずれか一項に記載のシステム。
- 前記皮膚接触センサは、前記送達カニューレの前記遠位端の周囲に配設された針シールド上に装着される、請求項8に記載のシステム。
- 前記1つ以上のセンサは、配向センサを含む、請求項31〜39のいずれか一項に記載のシステム。
- 前記配向センサは、磁力計を含む、請求項40に記載のシステム。
- 前記薬物送達装置は、自動注入装置を含む、請求項31〜41のいずれか一項に記載のシステム。
- 前記外部コンピューティングデバイスは、スマートフォン、スマートウォッチ、スマート装着可能デバイス、パーソナルコンピュータ、ラップトップコンピュータ、スマートテレビ、スマート家電、スマート自動車、ネットワーク化されたコンピュータ、またはタブレットコンピュータのうちの少なくとも1つを含む、請求項31〜42のいずれか一項に記載のシステム。
- 前記第1の通信モジュールは、Bluetooth、Bluetooth低エネルギー、無線自動識別(RFID)、Zigbee、Wi−Fi、または近距離通信(NFC)のうちの少なくとも1つを介して、前記第2の通信モジュールと通信するように構成される、請求項31〜43のいずれか一項に記載のシステム。
- 前記貯蔵部は、薬剤を含む、請求項31〜44のいずれか一項に記載のシステム。
- 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45に記載のシステム。
- 薬物送達装置及び外部コンピューティングデバイスを備えるシステムを使用する方法であって、前記薬物送達装置は、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、センサデータを生成するように構成された1つ以上のセンサ、ならびに第1の通信モジュールを備え、前記外部コンピューティングデバイスは、メモリ及び第2の通信モジュールを備え、
前記薬物送達装置を用いてセンサデータを収集することと、
前記第1の通信モジュールを用いて前記薬物送達装置から前記センサデータを送信することと、
前記第2の通信モジュールを用いて前記外部コンピューティングデバイスで前記薬物送達装置から前記センサデータを受信することと、
前記外部コンピューティングデバイスを用いて、前記センサデータに基づいて前記薬物送達装置の条件または動作状態のうちの少なくとも1つを判定することと、を含む、方法。 - (i)前記薬物装置の前記条件または前記動作状態のうちの少なくとも1つ、及び(ii)前記外部コンピューティングデバイスの前記メモリに保存された情報に従って、指示プロンプトまたは情報プロンプトのうちの少なくとも1つを表示することを含む、請求項47に記載の方法。
- 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記外部コンピューティングデバイスを用いて、前記センサデータに基づいて前記薬物送達装置の温度または温度履歴を判定することを含む、請求項47または48に記載の方法。
- 前記薬物送達装置の前記温度または前記温度履歴を前記外部コンピューティングデバイスの前記メモリ内に保存されている情報と比較して、前記薬物送達装置の前記温度または前記温度履歴が許容できるかどうかを判定することと、
前記薬物送達装置が許容できる温度または許容できる温度履歴を有するという判定に応答して、前記患者の皮膚上または皮膚に接して前記薬物送達装置を配設するように使用者に指示する指示プロンプトを表示することと、を含む、請求項49に記載の方法。 - 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記外部コンピューティングデバイスを用いて、前記センサデータに基づいて前記薬物送達装置が患者の皮膚上または皮膚に接して配設されたかどうかを判定することを含む、請求項47〜50のいずれか一項に記載の方法。
- 前記薬物送達装置が前記患者の皮膚上または皮膚に接して配設されたという判定に応答して、前記患者の皮膚に対して前記薬物送達装置を正しく配向するように使用者に指示する指示プロンプトを表示するように、前記表示装置を制御することを含む、請求項51に記載の方法。
- 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記外部コンピューティングデバイスを用いて、前記センサデータに基づいて前記薬物送達装置の配向を判定することを含む、請求項47〜52のいずれか一項に記載の方法。
- 前記薬物送達装置の前記配向を前記外部コンピューティングデバイスの前記メモリに保存されている情報と比較して、患者の皮膚に対する前記薬物送達装置の前記配向が許容できるかどうかを判定することと、
前記薬物送達装置の前記配向が許容できるという判定に応答して、前記薬物送達装置を作動させるように使用者に指示する指示プロンプトを表示することと、を含む、請求項53に記載の方法。 - 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記外部コンピューティングデバイスを用いて、前記センサデータに基づいて前記薬物送達装置が使用者によって作動されたかどうかを判定することを含む、請求項47〜54のいずれか一項に記載の方法。
- 前記薬物送達装置が前記使用者によって作動されたという判定に応答して、前記貯蔵部から前記患者への薬物の送達の完了を待つように使用者に指示する指示プロンプトを表示することを含む、請求項55に記載の方法。
- 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記外部コンピューティングデバイスを用いて、前記センサデータに基づいて前記貯蔵部から患者への薬剤の送達が完了したかどうかを判定することを含む、請求項47〜56のいずれか一項に記載の方法。
- 前記貯蔵部から前記患者への前記薬剤の前記送達が完了したという判定に応答して、前記薬物送達装置を廃棄するように使用者に指示する指示プロンプトを表示することを含む、請求項57に記載の方法。
- 前記外部コンピューティングデバイスを用いて、前記薬物送達装置の前記条件または前記動作状態のうちの少なくとも1つを表すレポートを生成することと、
前記レポートをリモートコンピューティングデバイスに送信するように、前記第2の通信モジュールを制御することと、を含む、請求項47〜57のいずれか一項に記載の方法。 - 前記薬物送達装置は、自動注入装置を含む、請求項47〜59のいずれか一項に記載のシステム。
- 前記外部コンピューティングデバイスは、スマートフォン、スマートウォッチ、スマート装着可能デバイス、パーソナルコンピュータ、ラップトップコンピュータ、スマートテレビ、スマート家電、スマート自動車、ネットワーク化されたコンピュータ、またはタブレットコンピュータのうちの少なくとも1つを含む、請求項47〜60のいずれか一項に記載のシステム。
- 前記第1の通信モジュールは、Bluetooth、Bluetooth低エネルギー、無線自動識別(RFID)、Zigbee、Wi−Fi、または近距離通信(NFC)のうちの少なくとも1つを介して、前記第2の通信モジュールと通信するように構成される、請求項47〜61のいずれか一項に記載のシステム。
- 前記貯蔵部は、薬剤を含む、請求項47〜62のいずれか一項に記載のシステム。
- 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63に記載のシステム。
- 薬物送達装置及び外部コンピューティングシステムを備えるシステムを使用する方法であって、前記薬物送達装置は、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、前記外部コンピューティングデバイスは、メモリを備え、 前記薬物送達装置の条件または動作状態のうちの少なくとも1つを判定することと、
前記薬物送達装置から前記条件または前記動作状態のうちの少なくとも1つを表す通信を送信することと、
前記外部コンピューティングデバイスで前記薬物送達装置から前記通信を受信することと、
前記外部コンピューティングデバイスの前記メモリに保存された情報に従って、前記薬物送達装置から受信された前記通信を処理することと、を含む、方法。 - (i)前記薬物送達装置から受信された前記通信、及び(ii)前記外部コンピューティングデバイスの前記メモリに保存された前記情報に従って、指示プロンプトまたは情報プロンプトのうちの少なくとも1つを表示することを含む、請求項65に記載の方法。
- 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記薬物送達装置を用いて、前記センサデータに基づいて前記薬物送達装置の温度または温度履歴を判定することを含む、請求項65または66に記載の方法。
- 前記薬物送達装置の前記温度または前記温度履歴を前記外部コンピューティングデバイスの前記メモリ内に保存されている前記情報と比較して、前記薬物送達装置の前記温度または前記温度履歴が許容できるかどうかを判定することと、
前記薬物送達装置が許容できる温度または許容できる温度履歴を有するという判定に応答して、前記患者の皮膚上または皮膚に接して前記薬物送達装置を配設するように使用者に指示する指示プロンプトを表示することと、を含む、請求項67に記載の方法。 - 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記薬物送達装置を用いて、前記センサデータに基づいて前記薬物送達装置が患者の皮膚上または皮膚に接して配設されたかどうかを判定することを含む、請求項65〜68のいずれか一項に記載の方法。
- 前記薬物送達装置が前記患者の皮膚上または皮膚に接して配設されたという判定に応答して、前記患者の皮膚に対して前記薬物送達装置を正しく配向するように使用者に指示する指示プロンプトを表示することを含む、請求項69に記載の方法。
- 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記薬物送達装置を用いて、前記センサデータに基づいて前記薬物送達装置の配向を判定することを含む、請求項65〜70のいずれか一項に記載の方法。
- 前記薬物送達装置の前記配向を前記外部コンピューティングデバイスの前記メモリに保存されている前記情報と比較して、患者の皮膚に対する前記薬物送達装置の前記配向が許容できるかどうかを判定することと、
前記薬物送達装置の前記配向が許容できるという判定に応答して、前記薬物送達装置を作動させるように使用者に指示する指示プロンプトを表示することと、を含む、請求項71に記載の方法。 - 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記薬物送達装置を用いて、前記センサデータに基づいて前記薬物送達装置が使用者によって作動されたかどうかを判定することを含む、請求項65〜72のいずれか一項に記載の方法。
- 前記薬物送達装置が前記使用者によって作動されたという判定に応答して、前記貯蔵部から前記患者への薬物の送達の完了を待つように使用者に指示する指示プロンプトを表示することを含む、請求項73に記載の方法。
- 前記薬物送達装置の前記条件または前記動作状態のうちの前記少なくとも1つの前記判定は、前記薬物送達装置を用いて、前記センサデータに基づいて前記貯蔵部から患者への薬剤の送達が完了したかどうかを判定することを含む、請求項65〜74のいずれか一項に記載の方法。
- 前記貯蔵部から前記患者への前記薬剤の前記送達が完了したという判定に応答して、前記薬物送達装置を廃棄するように使用者に指示する指示プロンプトを表示することを含む、請求項75に記載の方法。
- 前記薬物送達装置は、自動注入装置を含む、請求項65〜76のいずれか一項に記載の方法。
- 前記外部コンピューティングデバイスは、スマートフォン、スマートウォッチ、またはタブレットコンピュータのうちの少なくとも1つを含む、請求項65〜77のいずれか一項に記載の方法。
- 前記第1の通信モジュールは、Bluetooth、Bluetooth低エネルギー、無線自動識別(RFID)、Zigbee、Wi−Fi、または近距離通信(NFC)のうちの少なくとも1つを介して、前記第2の通信モジュールと通信するように構成される、請求項65〜78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65〜79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16に記載の方法。
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