JP2021511111A - スマートバイアルアダプタおよび方法 - Google Patents
スマートバイアルアダプタおよび方法 Download PDFInfo
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- JP2021511111A JP2021511111A JP2020538612A JP2020538612A JP2021511111A JP 2021511111 A JP2021511111 A JP 2021511111A JP 2020538612 A JP2020538612 A JP 2020538612A JP 2020538612 A JP2020538612 A JP 2020538612A JP 2021511111 A JP2021511111 A JP 2021511111A
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 8
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Abstract
Description
本出願は、2018年1月12日に出願された米国仮出願第62/616,688号、ならびに共に2018年7月31日出願された米国非仮出願第16/051,177号および第16/051,249号の優先権を主張し、その全体が参照によって本明細書に組み込まれる。
Claims (20)
- 第1および第2の端部を有するハウジングであって、前記第1の端部は、開口しおよびバイアルに取り付け可能であり、前記第2の端部は、突き通し可能なセプタムによって密封される流体口を有する、ハウジングと、
ハウジングに固定されおよび前記流体口と連通するバイアルアクセスカニューレであって、前記バイアルアクセスカニューレは、前記ハウジングに取り付けられるバイアルの前記セプタムを突き通すための前記ハウジングの前記開口する第1の端部内部に位置決めされる、バイアルアクセスカニューレと、
前記ハウジング内に含まれるまたは前記ハウジングに取り付けられたバイアルから引かれる薬物に関して少なくとも1つの投与量捕捉、状態監視または情報報告機能を実行するための前記ハウジング内部に含まれる電気部品と、
を含むことを特徴とするバイアルアダプタ。 - 前記投与量捕捉、状態監視または情報報告機能は、前記バイアルから引かれる前記薬物の量を測定すること、前記薬物が前記バイアルから引かれた時間を測定すること、前記バイアルの温度を監視すること、前記バイアルの動きを測定すること、視覚表示を生成すること、可聴表示を生成すること、および外部デバイスに情報を無線で通信することからなる群から選択されることを特徴とする請求項1に記載のバイアルアダプタ。
- 前記ハウジング内部に含まれる前記電気部品は、流量センサ、熱センサ、加速度計、マイクロコントローラ、視覚指示器、可聴指示器、およびBluetooth(登録商標)モジュールのうちの1つまたは複数を含むことを特徴とする請求項1に記載のバイアルアダプタ。
- 前記ハウジング内部に含まれる前記電気部品は、前記バイアルアクセスカニューレ内部の流量を検知するための前記バイアルアクセスカニューレの内部ルーメンに隣接して位置決めされる流量センサを含むことを特徴とする請求項1に記載のバイアルアダプタ。
- 前記流量センサは、熱飛行時間(TTOF)流量センサを含むことを特徴とする請求項4に記載のバイアルアダプタ。
- 前記ハウジングは、前記流体口と前記バイアルアクセスカニューレとの間に内部流体チャンバを含み、前記内部チャンバは、前記セプタムによって密封され、および前記バイアルアクセスカニューレの内部ルーメンと連通することを特徴とする請求項1に記載のバイアルアダプタ。
- 前記電気部品は、前記内部流体チャンバに隣接する前記ハウジングの内部キャビティ内に受け入れられることを特徴とする請求項6に記載のバイアルアダプタ。
- 前記内部キャビティは、前記内部流体チャンバを少なくとも部分的に取り囲むことを特徴とする請求項7に記載のバイアルアダプタ。
- 前記ハウジングおよび前記内部流体チャンバは、各々、概して円筒状であり、および前記内部キャビティは、概して環状であることを特徴とする請求項8に記載のバイアルアダプタ。
- 前記セプタムは、シリンジ針によって突き通し可能である中実セプタムを含むことを特徴とする請求項1に記載のバイアルアダプタ。
- 前記セプタムは、鈍端カニューレまたはルアー先端によって突き通し可能である事前スリットセプタムを含むことを特徴とする請求項1に記載のバイアルアダプタ。
- バイアル内に含まれる薬物を保管しおよび使用するための方法であって、
前記薬物が前記バイアル内に含まれている間またはアダプタを通して前記バイアルから引き抜かれている間に、前記薬物に関して、少なくとも1つの投与量捕捉、状態監視または情報報告機能を実行することができる前記アダプタを、前記バイアルに取り付ける工程と、
前記バイアルアダプタに、前記薬物が前記バイアル内に含まれている間または前記アダプタを通して前記バイアルから引き抜かれている間に、前記薬物に関して、前記少なくとも1つの投与量捕捉、状態監視または情報報告機能を実行させる工程と、
を含むことを特徴とする方法。 - 前記投与量捕捉、状態監視または情報報告機能は、前記バイアルから引かれる前記薬物の量を測定すること、前記薬物が前記バイアルから引かれた時間を測定すること、前記バイアルの温度を監視すること、前記バイアルの動きを測定すること、視覚表示を生成すること、可聴表示を生成すること、および外部デバイスに情報を無線で通信すること、からなる群から選択されることを特徴とする請求項12に記載の方法。
- 前記バイアルアダプタは、流量センサを含み、および前記機能は、前記流量センサを使用して前記バイアルから引き抜かれる薬物の量を測定することによって実行される投与量捕捉機能を含むことを特徴とする請求項12に記載の方法。
- 前記バイアルアダプタは、Bluetooth(登録商標)モジュールを含み、および前記機能は、前記Bluetooth(登録商標)モジュールを使用して外部デバイスに情報を無線で通信することによって実行される情報報告機能を含むことを特徴とする請求項12に記載の方法。
- 前記情報は、投与量、投与時間、バイアル温度、およびバイアルの動きからなる群から選択されることを特徴とする請求項15に記載の方法。
- 前記外部デバイスは、コンピュータ、スマートフォン、または前記情報を処理しおよびユーザー出力を提供するためのソフトウエアアプリケーションを含むモバイルデバイスを含むことを特徴とする請求項15に記載の方法。
- 前記ユーザー出力は、以下の、(a)所定の期間の間に前記バイアルから引き抜かれる投与量の数、(b)所定の期間の間に前記バイアルから引き抜かれる複数の投与量の各々に関する前記投与量、(c)同時に測定される生理学上のデータと組み合わされる投与イベント、および(d)投与ヒストリーに基づいて推定されるまたは見積られる生理学上のデータ、のうちの1つまたは複数の視覚またはグラフ表示を含むことを特徴とする請求項17に記載の方法。
- 前記薬物は、インスリンを含み、および前記生理学上のデータは、グルコースレベルまたはA1cレベルを含むことを特徴とする請求項18に記載の方法。
- バイアル内に含まれる薬物を保管しおよび使用するための方法であって、
前記バイアルに、請求項1に記載のアダプタを取り付ける工程と、
前記バイアルアダプタに、前記薬物が前記バイアル内に含まれている間または前記アダプタを通して前記バイアルから引き抜かれている間に、前記薬物に関して、前記少なくとも1つの投与量捕捉、状態監視または情報報告機能を実行させる工程と、
を含むことを特徴とする方法。
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