JP6431624B2 - 歩行型の長時間装着用心電図記録および失神センサモニタ - Google Patents
歩行型の長時間装着用心電図記録および失神センサモニタ Download PDFInfo
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Description
Claims (20)
- 歩行型の長時間装着用心電図記録および失神センサモニタレコーダであって、
使い捨ての長時間装着用電極パッチ上の非導電性レセプタクル内に取り外し可能に固定されるように適合された密閉ハウジングと、
密閉ハウジング内に含まれる電子回路であって、
ファームウェアにて指定されたマイクロプログラム可能な制御下で実行するように動作可能な、外部給電低電力マイクロコントローラと、
前記マイクロコントローラに電気的にインタフェースされ、前記使い捨ての長時間装着用電極パッチ上に設けられた心電図記録電極を介して心電図記録信号を感知するように動作可能な、心電図記録フロントエンド回路であって、前記心電図記録電極の各々は、活動電位伝播を捕捉するために胸骨の正中線に沿って軸方向に位置決めされるように適合され、前記心電図記録フロントエンド回路はさらに、前記感知された心電図記録信号を処理して、前記処理された信号のサンプルを格納するよう動作可能であり、前記処理は、
前記心電図記録フロントエンド回路に含まれるユニティゲインアンプを介して前記心電図記録信号の電流を増幅することと、
前記電流の前記増幅後、前記心電図記録信号にローパスフィルタを適用しつつ、オペアンプを介して前記心電図記録信号の電圧を増幅することと
を含み、
電源ノイズおよびシステムノイズを受信して、前記電源ノイズおよび前記システムノイズを含む駆動参照を患者に注入するよう構成された一対の抵抗を含むサブ回路を含む、心電図記録フロントエンド回路と、
前記マイクロコントローラと電気的にインタフェースされ、失神事象を感知するように動作可能な失神センサと、
前記マイクロコントローラと電気的にインタフェースされ、前記処理された心電図記録信号のサンプルおよび前記失神事象を格納するように動作可能な、外部給電フラッシュメモリと
を含む電子回路と
を備える、歩行型の長時間装着用心電図記録および失神センサモニタレコーダ
を備える心電図記録および失神監視システム。 - 前記失神センサは、アクティグラフィデータを感知し、前記感知されたアクティグラフィデータにアクティグラフィフィルタリング基準を適用し、前記アクティグラフィフィル
タリング基準適用に基づいて前記失神事象を示す前記アクティグラフィデータの部分を識別し、前記データの前記部分に基づいて前記失神事象を検出し、前記検出された失神事象を前記マイクロコントローラに提供する、アクティグラフィベース失神センサアセンブリを含み、前記マイクロコントローラは前記失神事象を前記メモリに格納する、請求項1に記載のシステム。 - 前記失神事象は、転倒事象および姿勢変化事象のうちの少なくとも1つを含み、前記失神センサはさらに患者介在触覚フィードバック失神ボタンを含む、請求項2に記載のシステム。
- 前記アクティグラフィフィルタリング基準が、前記密閉ハウジングの加速または減速の閾値を含む、請求項2に記載のシステム。
- 前記アクティグラフィベース失神センサアセンブリに含まれる、3軸加速度計
をさらに備える、請求項2に記載のシステム。 - データ通信ネットワークを介してセントラルアクセス可能であり、メモリに格納されたプログラムコードを実行するように構成されたプロセッサを含む、サーバコンピュータシステムであって、
前記電子回路の前記フラッシュメモリから前記心電図記録信号の前記サンプルおよび前記失神事象データを検索し、
前記感知された失神事象の1つと実質的に同時に感知されたそれらの前記心電図記録信号のサンプルを識別し、
前記失神事象データの前記サンプルおよび前記識別された心電図記録信号を出力するように構成されたサーバコンピュータシステム
をさらに備える、請求項1に記載のシステム。 - 前記サーバコンピュータシステムが、
前記心電図記録信号に基づいて異常心電図記録ベースラインが失神事象に関連するか否かを検出し、
前記異常ベースラインが少なくとも1つの失神事象の検出に関連するか否かに基づいて、前記失神事象が心臓ベースの失神タイプおよび非心臓ベースの失神タイプのうちの1つを示すことを決定するようにさらに構成された、請求項6に記載のシステム。 - 前記モニタレコーダおよび前記使い捨てパッチの少なくとも1つに位置付けされ、SpO2、血圧、温度、グルコースレベル、エアフローおよび容積圧力の1つ以上を含む生理学的データを収集するよう構成された少なくとも1つの追加センサをさらに備え、前記サーバコンピュータシステムは、
前記SpO2、前記血圧、前記温度、前記グルコースレベル、前記エアフローおよび前記容積圧力を含む群から選択される生理学的サンプルの少なくとも1つを検索し、
失神事象の時間と実質的に同時に感知されたそれらの生理学的サンプルを識別し、
前記失神事象および識別された前記生理学的サンプルを出力するようにさらに構成される、
請求項6に記載のシステム。 - 前記処理は、
前記電流の前記増幅の前に前記心電図記録信号の高周波ノイズを低減することと、
前記電圧の前記増幅の前に前記増幅された電流で前記心電図記録信号にハイパスフィルタを適用することと、
前記増幅された電圧で前記心電図記録信号にアンチエイリアシングローパスフィルタを
適用することと
をさらに備え、
前記調節が、ローパスフィルタを適用することを含む、請求項1に記載のシステム。 - 前記心電図記録信号を心臓活動波面振幅のデジタル表現に変換するように動作可能なアナログ/デジタル変換器と、
前記ファームウェアに含まれる少なくとも1つのローパスフィルタと、
前記ファームウェアに含まれる少なくとも1つのハイパスフィルタと
をさらに備え、
前記心臓活動波面振幅は、前記デジタル表現への変換に続いて、少なくとも1つのローパスフィルタおよび少なくとも1つのハイパスフィルタを通過する、請求項1に記載のシステム。 - 前記マイクロコントローラは、
前記ファームウェアに含まれる圧縮アルゴリズム
をさらに備え、
前記心臓活動波面振幅は、前記電子回路の前記フラッシュメモリに格納される前に、前記圧縮アルゴリズムを用いて圧縮されたデジタル表現に圧縮される、
請求項10に記載のシステム。 - 低振幅心臓活動電位伝播を捕捉するために最適化された、歩行型の長時間装着用心電図記録および失神センサモニタであって、
使い捨ての長時間装着用電極パッチであって、
狭い長手方向中央セクションを有する伸長可能材料の細長いストリップと、各端部上の、クリンプレリーフとして設けられた接着剤ドレッシングで少なくとも部分的にコーティングされたコンタクト面とから形成され、前記細長いストリップは前記端部においてよりも前記長手方向中央セクションにおいてより狭い、可撓性バッキングと、
前記細長いストリップの各端部の前記コンタクト面上に導電的に露出された一対の心電図記録電極と、
前記細長いストリップの外向きに面した端部に接着され、複数の電気パッドを含む非導電性レセプタクルと、
ストレインレリーフとして前記細長いストリップの各端部に取り付けられ、前記一対の心電図記録電極および一対の前記電気パッドに電気的に結合された一対の回路トレースを含む可撓性回路と、
異なる一対の前記パッドに電気的にインタフェースされたバッテリと
を備える使い捨ての長時間装着用電極パッチと、
使い捨ての長時間装着用電極パッチ上の非導電性レセプタクルに取り外し可能に固定されるように適合された密閉ハウジングと、
前記密閉ハウジング内に含まれる電子回路であって、
前記異なる一対の前記電気パッドを介して前記バッテリから電力を引き出すよう動作可能で、ファームウェアにて指定されたマイクロプログラム可能な制御下で実行するように動作可能な、低電力マイクロコントローラと、
前記マイクロコントローラに電気的にインタフェースされ、前記使い捨ての長時間装着用電極パッチ上に設けられた心電図記録電極を介して心電図記録信号を感知するように動作可能な心電図記録フロントエンド回路であって、前記心電図記録電極の各々は活動電位伝播を捕捉するために胸骨の正中線に沿って軸方向に位置決めされるように適合され、電源ノイズおよびシステムノイズを受信して、前記電源ノイズおよび前記システムノイズを含む駆動参照を患者に注入するよう構成された一対の抵抗を含むサブ回路を含む、心電図記録フロントエンド回路と、
前記マイクロコントローラと電気的にインタフェースされ、失神事象を感知するように動作可能な失神センサであって、前記失神センサは、アクティグラフィデータを感知し、前記感知されたアクティグラフィデータにアクティグラフィフィルタリング基準を適
用し、前記アクティグラフィフィルタリング基準適用に基づいて前記失神事象を示す前記アクティグラフィデータの部分を識別し、前記データの前記部分に基づいて前記失神事象を検出し、前記検出された失神事象を前記マイクロコントローラに提供する、アクティグラフィベース失神センサを含み、前記マイクロコントローラは前記失神事象を前記メモリに格納する、失神センサと
前記マイクロコントローラと電気的にインタフェースされ、前記心電図記録信号のサンプルおよび前記失神事象を格納するように動作可能であって、前記メモリはさらに前記異なる一対の前記電気パッドを介して前記バッテリから電力を引き出すよう動作可能である、フラッシュメモリと
を備える電子回路と、
を備える、歩行型の長時間装着用心電図記録および失神センサモニタ
を備える、低振幅心臓活動電位伝播を捕捉するために最適化された心電図記録および失神監視システム。 - 前記失神センサは、患者介在触覚フィードバック失神ボタンをさらに備える、請求項12に記載のシステム。
- 前記失神事象は、転倒事象および姿勢変化事象のうちの少なくとも1つを含む、請求項12に記載のシステム。
- 前記アクティグラフィフィルタリング基準が、前記密閉ハウジングの加速または減速の閾値を含む、請求項12に記載のシステム。
- データ通信ネットワークを介してセントラルアクセス可能であり、メモリに格納されたプログラムコードを実行するように構成されたプロセッサを含む、サーバコンピュータシステムであって、前記サーバが、
前記電子回路の前記フラッシュメモリから前記心電図記録信号の前記サンプルおよび前記失神事象データを検索し、
前記失神事象の1つと実質的に同時に感知されたそれらの前記心電図記録信号のサンプルを識別し、
前記失神事象データの前記サンプルおよび前記識別された心電図記録信号を出力するように構成された、サーバコンピュータシステム
をさらに備える、請求項12に記載のシステム。 - 前記サーバコンピュータシステムが、
前記心電図記録信号に基づいて異常心電図記録ベースラインが失神事象に関連するか否かを検出し、
前記異常ベースラインが少なくとも1つの失神事象の検出に関連するか否かに基づいて、前記失神事象が心臓ベースの失神タイプおよび非心臓ベースの失神タイプのうちの1つを示すことを決定するようにさらに構成された、請求項16に記載のシステム。 - 前記心電図記録フロントエンド回路はさらに、
前記感知された心電図記録信号の高周波ノイズを低減し、
前記高周波ノイズを低減した前記感知された心電図記録信号の電流を増幅し、
前記増幅された電流で前記感知された心電図記録信号にハイパスフィルタを適用し、
前記フィルタリングされた心電図記録信号にローパスフィルタを適用しつつ、前記フィルタリングされた心電図記録信号の電圧を増幅し、
前記増幅された電圧で前記心電図記録信号にアンチエイリアシングローパスフィルタを適用する
よう動作可能である、請求項12に記載のシステム。 - 前記心電図記録信号を心臓活動波面振幅のデジタル表現に変換するように動作可能なアナログ/デジタル変換器と、
前記ファームウェアに含まれる少なくとも1つのローパスフィルタと、
前記ファームウェアに含まれる少なくとも1つのハイパスフィルタと
をさらに備え、
前記心臓活動波面振幅は、前記デジタル表現への変換に続いて、少なくとも1つのローパスフィルタおよび少なくとも1つのハイパスフィルタを通過する、請求項12に記載のシステム。 - 前記マイクロコントローラは、
前記ファームウェアに含まれる圧縮アルゴリズム
をさらに備え、
前記心臓活動波面振幅は、前記電子回路の前記フラッシュメモリに格納される前に、前記圧縮アルゴリズムを用いて圧縮されたデジタル表現に圧縮される、
請求項19に記載のシステム。
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