JP7337841B2 - 分析物センサ電子装置を作動させるためのシステムおよび方法 - Google Patents
分析物センサ電子装置を作動させるためのシステムおよび方法 Download PDFInfo
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Description
出願データシートで特定されたありとあらゆる優先権主張、またはそれに対するいかなる修正も、米国特許法施行規則1.57の下で参照により本明細書に組み込まれる。本出願は、2018年5月3日に出願された米国仮特許出願第62/666,554号の利益を主張する。前述の出願は、参照によりその全体が本明細書に組み込まれ、本明細書の一部として明示的に作成される。
図1は、例えば、ユーザの血糖値を含む、ユーザの身体に存在する分析物値に関する情報を集取、監視、および/または提供することを伴う本開示の実施形態に関連して使用され得るシステム100を描いている。システム100は、表示デバイス110、120、130、および140、パートナデバイス136、および/またはサーバシステム134に通信可能に結合され得る分析物センサシステム8の態様を描いている。
再び図1を参照すると、上記で述べたように、実施形態では、ホストまたはユーザ内の分析物の測定のために分析物センサシステム8が提供される。概要および例として、分析物センサシステム8は、センサ測定を行い、分析物データを生成し(例えば、連続グルコース監視データの値を計算することにより)、このようなデータをリモートデバイス(例えば、表示デバイス110、120、130、140、パートナデバイス136、および/またはサーバシステム134)に送信する無線通信(例えば、Bluetooth(登録商標)および/または他の無線プロトコル)に従事する、カプセル化されたマイクロコントローラとして実装され得る。
図1を参照して上記で示唆したように、実施形態において、分析物センサ10は、例えば、皮下、経皮(例えば、経皮)、または血管内デバイスなどの連続グルコースセンサを含む。実施形態では、このようなセンサまたはデバイスは、複数の断続的な血液サンプルを分析することができる。分析物センサ10は、例えば、酵素、化学、物理、電気化学、分光光度、偏光、熱量、イオン導入、放射、免疫化学などを含むグルコース測定を含む分析物測定の任意の方法を使用することができる。
上で考察されたように、本開示の実施形態は、特に分析物センサシステム308が事前接続されたシステムである場合、分析物センサシステム308を作動するか、またはより低い電力モードを終了することをそれに行わせるためのタイミングに関する。例えば、このような事前接続されたシステムでは、分析物センサ10は、分析物センサ10がホストに埋め込まれる前に、分析物センサ電子モジュール12に機械的および電気的に結合され得る。分析物センサシステム308がより低い電力モードを終了し得るいくつかの異なる期間があり、各期間は、通常、関連付けられたトレードオフを有する。
上記で言及したように、本開示の実施形態は、例えば、分析物センサ10を使用して埋め込みが検出される場合を含む、ユーザへの分析物センサ10の埋め込みを検出することと、正確かつ電力効率が良い様式でより低い電力状態を作動および/または終了することを分析物センサシステム308に行わせることと、を伴う。例示的な実施形態では、分析物センサ10からの分析物信号は、作動の目的で使用される。例えば、作動検出回路520は、ポテンシオスタットからの1つ以上の信号を使用して、分析物信号を生成し、および/または、例えば、分析物センサ10(または図5を参照すると分析物センサ530であるが、これらのコンポーネントは、いくつかの場合では互換的に呼ばれ得る)を通る電流フローを経時的に検出/測定し得る。このような信号は、pA(電流フロー)、pW(電力)、またはカウント(電圧、電流、電力、および/または時間などのアナログ値から変換されたデジタル値)などの単位で定量化されてもよく、分析物センサシステム308をトリガしてより低い電力状態を終了させる目的でこれらの値を使用することができる。例えば、分析物センサシステム308のウェイクアップまたは作動をトリガするために、電流の単位のベンチマーク閾値が使用され得る。ただし、このようなトリガを所定の電流の単位(例えば、カウント)の閾値に基づかせると、誤ったウェイクアップまたはウェイクアップの見逃しがもたらされ得る。例えば、分析物センサ10がホストに適切に埋め込まれていなくても(例えば、分析物センサ10がパッケージングされている間に、展開前に起こり得る静電放電によって)所定の閾値が満たされている場合、より低い電力状態または保管モードを維持すべき状況で、ウェイクアップまたは動作モードに移行することを分析物センサシステム308に行わせる可能性がある。
実施形態によれば、本開示の追加の態様は、事前接続された分析物センサシステム308における作動の目的で、(例として、図5を参照して)分析物センサ530以外の2次センサまたは手段を使用することを伴う。様々なイベントが分析物センサシステム308によって検出可能であり得、このようなイベントは分析物センサ530の埋め込みを示す。例は、分析物センサシステム308がアプリケータから分離することと、分析物センサシステム308がパッケージングから分離することと、ホストまたはユーザに対する分析物センサシステム308の近接を検出することと、を含む。これらのイベントまたはフェーズの変化は、以下に記載されるように、複数の様々なセンサタイプを使用して検出され得る。
特定の実施形態では、スイッチ/センサ/機構/手法を用いて、ユーザステップを検出し、それを使用して、分析物センサシステム308の作動を、単独で、または本明細書に記載の他の作動検出手法/手段と組み合わせてトリガすることができる。このようなスイッチ/センサ/機構/手法は、通常、ユーザの介入/アクションに依拠し得る。いくつかの例では、検出スイッチ/素子/センサが、分析物センサシステム308上に配置され、および作動をトリガするか、またはより低い電力状態を終了するために使用され得る。例として、作動検出コンポーネント545の少なくとも一部が、分析物センサシステム308の表面上の取り外し可能なステッカーなどの、分析物センサシステム308の外部にある検出素子/コンポーネントを含み得る。ユーザがステッカーを剥がす/除去することに応答して、分析物センサシステム308は、より低い電力状態を出るようにトリガされ得る。別の例として、検出素子は、分析物センサシステム308の送給に関連付けられたアプリケータ、パッケージング、ボックス、またはトレイの特徴であり得る。ここで、例えば、図6Aおよび図6Bを参照する。いくつかの場合では、検出素子は、分析物センサシステム308の近くのパッケージングに配置されたコンポーネントであり得る。
本明細書に開示された1つ以上の実施形態は、分析物センサ(例えば、図5の分析物センサ530)を流れる電流を示すインピーダンス測定および/または電流カウントを利用して、分析物センサがホストの皮膚内に展開されたとき、したがって、センサ電子回路の少なくとも一部分(例えば、限定ではなく、例として、図5の分析物センサシステム308)が、より低い電力「保管」または「スリープ」モードおよび「ウェイクアップ」を終了して、センサ信号および/またはセンサデータの1つ以上のサンプルを処理することを開始すべきときを、判定し得る。これに加えて、またはこれに代えて、このような分析物センサシステム308のセンサ電子装置がパワード「実行」モードに移行して、分析物センサ530を定期的またはランダムに較正または再較正し、および/または分析物センサ530の感度を監視すると、このような電流カウントおよび/またはインピーダンス測定が、利用され得る。
いくつかの実施形態では、堅牢なウェイクアップ手順のために、および誤ったウェイクアップを回避するために、分析物センサシステム530の埋め込みの多数のインジケータを使用して、分析物センサシステム308がより低い電力状態を終了すべきであることを判定することができる。ただし、分析物センサシステム308の性能特性の損傷または変化を回避するために、分析物センサ530の埋め込み前に作動をトリガする可能性がある湿度イベントに対する堅牢性を維持するために、および電池式デバイスにとって重要であり得る比較的より低い電力の動作を維持するために、一般に注意を払うべきである。
当業者は、本開示を検討すると、本明細書に明示的に記載されていない様々な追加の実施形態が本開示の趣旨および範囲内であることを理解するであろう。
10 電圧バイアス分析物センサ
12 センサ電子モジュール
100 システム
110 表示デバイス
112 タッチスクリーンディスプレイ
120 表示デバイス
122 タッチスクリーンディスプレイ
130 表示デバイス
132 タッチスクリーンディスプレイ
134 サーバシステム
136 パートナデバイス
138 無線アクセスポイント
140 表示デバイス
200 システム
305 通信媒体
308 分析物センサシステム
310 表示デバイス
315 パートナデバイス
326 接着パッチ
334 サーバシステム
338 センサ
360 皮膚上センサアセンブリ
392 第1の上部分
394 第2の下部分
396 開口部
398 開口部
404 回路基板
505 接続インターフェース
510 送受信機
515 記憶装置
520 作動検出回路
525 分析物センサ測定回路
530 分析物センサ
545 作動検出コンポーネント
600 分析物センサ電子モジュール
602 分析物センサ
604 第1の接点
606 第2の接点
608 ばね
612 導電性ジャンパ
614 ハウジング
616 導電性リンク
640 分割コネクタ
642 半円形部分接点
650 分割コネクタ
652 接点
800 回路
802 検出回路
804 基準電圧
806 ドライバ回路
808 分析物センサ
810 分析物測定デバイス
812 スイッチ素子
814 スイッチ素子
816 スイッチ素子
818 基準電圧
820 基準端子
822 入力端子
824 第1の端子
826 第2の端子
828 第1の端子
830 第2の端子
832 抵抗素子
834 容量性素子
836 出力
840 信号(例えば、電圧、電流など)
842 時間
844 パルス
845 期間
846 パルス
848 基準電圧
900 プロット
906 トリガ
908 トリガ
910 領域
912 プロット
914 時間領域
916 時間領域
918 サンプリング期間
1000 方法
1100 コンピューティングモジュール
1110 プロセッサ
1115 メインメモリ
1120 情報記憶デバイス
1125 リム-バブル記憶媒体
1130 媒体ドライブ
1135 記憶ユニットインターフェース
1140 固定またはリムーバブル記憶ユニット
1140 リムーバブル記憶ユニット
1150 通信インターフェース
1200 状態図
1202 開始ブロック
1206 遅延状態
1208 第1のサンプリング状態
1220 遅延状態
1220 第2のサンプリング状態
1220 パルスカウント状態
1224 第4の遅延状態
7100 アプリケータ
7101 外側ハウジング
7102 内側ハウジング
7104 作動素子
7106 開口部
7130 遠位表面
7130 底部開口の遠位表面
7194 バリア層
Claims (11)
- 分析物センサシステムの作動を制御するための回路であって、
検出回路の入力端子における信号が条件を満たしているかどうかを示すように適合され、かつ前記信号が前記条件を満たしていることを前記検出回路が示す場合、より低い電力状態を終了するように前記分析物センサシステムをトリガするようにさらに適合されている検出回路と、
前記検出回路の前記入力端子と分析物センサの第1の端子との間の結合を制御するように適合された第1のスイッチ素子であって、前記分析物センサが、ホスト内の分析物レベルに関連する情報を集取するように適合されている、第1のスイッチ素子と、
前記分析物センサの前記第1の端子とポテンシオスタットの第1の端子との間の結合を制御するように適合された第2のスイッチ素子であって、前記ポテンシオスタットは、前記分析物センサに電圧バイアスを印加し、前記分析物センサに前記ホスト内の分析物レベルに関連する前記情報を集取させるように適合されている、第2のスイッチ素子と、
を含み、
前記検出回路の前記入力端子が、前記分析物センサの第2の端子に、および前記ポテンシオスタットの第2の端子に結合されており、
前記回路が、第1の時点で、前記分析物センサの前記第1の端子を前記ポテンシオスタットの前記第1の端子に前記第2のスイッチ素子を結合させ、かつ前記検出回路の前記入力端子を前記分析物センサの前記第1の端子から前記第1のスイッチ素子を分離させることと、第2の時点で、前記分析物センサの前記第1の端子を前記ポテンシオスタットの前記第1の端子から前記第2のスイッチ素子を分離させ、かつ前記検出回路の前記入力端子を前記分析物センサの前記第1の端子に前記第1のスイッチ素子を結合させることによって前記分析物センサシステムを作動させるための追加の検出可能なイベントを生成するように適合されている、回路。 - 前記検出回路の前記入力端子と第2の基準電圧との間に結合された容量性素子をさらに含む、請求項1に記載の回路。
- 前記第1のスイッチ素子が、前記検出回路の前記入力端子を、抵抗素子を介して前記分析物センサの前記第1の端子に結合するように適合されている、請求項1に記載の回路。
- 前記検出回路の前記入力端子を前記第2の基準電圧に結合するように適合された第3のスイッチ素子をさらに含む、請求項2に記載の回路。
- 前記第3のスイッチ素子が、前記検出回路の前記入力端子を前記第2の基準電圧に結合すると、前記容量性素子が放電する、請求項4に記載の回路。
- 前記第3のスイッチ素子の端子が、前記検出回路の前記入力端子を前記第2の基準電圧に周期的に前記第3のスイッチ素子を結合させるクロックに結合されている、請求項5に記載の回路。
- 前記第1のスイッチ素子が、共通信号によって駆動され、前記第2のスイッチ素子が、前記共通信号の反転バージョンによって駆動される、請求項1に記載の回路。
- 前記第1のスイッチ素子と前記第2のスイッチ素子とが、共通信号によって駆動され、反対の極性を有する、請求項1に記載の回路。
- 前記分析物センサが前記ホストに埋め込まれると、前記検出回路の前記入力端子における電圧が、前記分析物センサの前記第1の端子と前記分析物センサの前記第2の端子との間の電流を示す、請求項1に記載の回路。
- 前記検出回路の基準端子が、第1の基準電圧に結合されており、前記検出回路が、比較器を含む、請求項1に記載の回路。
- 前記第2の基準電圧が、グランドである、請求項2に記載の回路。
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