JP7138740B2 - 振戦を抑制する装置及び方法 - Google Patents
振戦を抑制する装置及び方法 Download PDFInfo
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Description
本出願は、2013年1月21日に出願された米国特許仮出願第61/754,945号、2013年3月15日に出願された米国特許仮出願第61/786,549号、2013年4月25日に出願された米国特許仮出願第61/815,919号、2013年5月10日に出願された米国特許仮出願第61/822,215号、及び2013年7月23日に出願された米国特許仮出願第61/857,248号、の優先権を主張するものであり、これらのそれぞれは参照によってその全内容が本明細書に組み込まれている。
文献の引用
患者の振戦を軽減する方法であって、
第1の末梢神経効果器を、第1の末梢神経に対して相対的な第1の場所に配置するステップと、
前記第1の末梢神経効果器から前記第1の末梢神経に第1の刺激を送達するステップと、
前記患者の神経回路網動態を修正することにより、前記振戦の振幅を低減するステップと、
を含む方法。
〔付記2〕
前記配置するステップは、前記第1の末梢神経効果器を前記患者の皮膚の上に配置するステップを含み、前記第1の刺激は、皮膚表面に印加される電気刺激である、付記1に記載の方法。
〔付記3〕
前記第1の刺激は、振幅が約0.1mAから約10mAであり、周波数が約10Hzから約5000Hzである、付記2に記載の方法。
〔付記4〕
前記配置するステップは、前記第1の末梢神経効果器を前記患者にインプラントするステップを含み、前記第1の刺激は電気刺激である、付記1に記載の方法。
〔付記5〕
前記第1の刺激は、振幅が約3mA未満であり、周波数が約10Hzから約5000Hzである、付記4に記載の方法。
〔付記6〕
測定部により前記患者の手足の動きを感知して、動きデータを生成するステップと、
前記動きデータから振戦情報を決定するステップと、
をさらに含む、付記1に記載の方法。
〔付記7〕
前記送達するステップは、前記振戦情報に基づいて前記第1の刺激を送達するステップを含む、付記6に記載の方法。
〔付記8〕
前記振戦情報は、前記患者の手足の休止位置からの最大偏移を含む、付記7に記載の方法。
〔付記9〕
前記振戦情報は、前記患者の手足の休止位置を含む、付記7に記載の方法。
〔付記10〕
前記振戦情報は、振戦の周波数、位相、及び振幅を含む、付記6に記載の方法。
〔付記11〕
前記第1の刺激を送達する前記ステップは、複数の刺激バーストを送達するステップを含み、前記刺激バースト間には可変時間遅延がある、付記1に記載の方法。
〔付記12〕
第2の末梢神経効果器を、第2の末梢神経に対して相対的な第2の場所に配置するステップと、
前記第2の末梢神経効果器から前記第2の末梢神経に第2の刺激を送達するステップと、
を更に含む、付記1に記載の方法。
〔付記13〕
前記患者の振戦の周期を決定するステップを更に含み、前記第2の刺激を送達する前記ステップは、前記第2の刺激の送達を、前記第1の刺激の送達から、前記振戦の周期の所定の分数又は倍数だけオフセットするステップを含む、付記12に記載の方法。
〔付記14〕
前記患者の脳内の神経回路網の共時性の位相を散逸させるステップを更に含む、付記12に記載の方法。
〔付記15〕
前記第1の場所と前記第2の場所は、隣接する指に位置する、付記12に記載の方法。
〔付記16〕
前記第1の末梢神経と前記第2の末梢神経は、隣接する神経である、付記12に記載の方法。
〔付記17〕
前記第1の末梢神経は正中神経であり、前記第2の末梢神経は尺骨神経又は橈骨神経である、付記12に記載の方法。
〔付記18〕
前記第1の末梢神経と前記第2の末梢神経は、体部位局在的に隣接している、付記12に記載の方法。
〔付記19〕
前記第1の刺激は、振幅が感覚閾値を下回る、付記1に記載の方法。
〔付記20〕
前記第1の刺激は15Hz超である、付記1に記載の方法。
〔付記21〕
前記第1の末梢神経は、前記患者の手足から固有受容情報を運搬する、付記1に記載の方法。
〔付記22〕
前記振戦の振幅を低減することに対する前記第1の刺激の有効性の持続時間を調べるステップと、
前記有効性の持続時間が切れる前に第2の刺激を送達するステップと、
を含む、付記1に記載の方法。
〔付記23〕
前記有効性の持続時間を調べる前記ステップは、所定の期間にわたって行われた複数の刺激印加を分析するステップを含む、付記1に記載の方法。
〔付記24〕
前記有効性の持続時間を調べる前記ステップは、前記患者の活動プロファイルを決定するステップを更に含む、付記23に記載の方法。
〔付記25〕
前記有効性の持続時間を調べる前記ステップは、前記振戦のプロファイルを決定するステップを更に含む、付記23に記載の方法。
〔付記26〕
前記活動プロファイルは、カフェイン及びアルコールの消費量に関するデータを含む、付記24に記載の方法。
〔付記27〕
前記第1の末梢神経の上に導電経路エンハンサを配置するステップを更に含む、付記1に記載の方法。
〔付記28〕
前記導電経路エンハンサは導電性タトゥである、付記27に記載の方法。
〔付記29〕
前記導電経路エンハンサは、1つ以上の導電性ストリップを含む、付記27に記載の方法。
〔付記30〕
第1の場所は、手首、前腕、手根管、指、及び上腕からなる群から選択される、付記1に記載の方法。
〔付記31〕
患者の振戦を治療するシステムであって、
決定部と、
末梢神経に電気刺激を送達するように適合された面接触部であって、前記面接触部は、前記決定部と通信する第1の末梢神経効果器を備え、前記第1の末梢神経効果器は少なくとも1つの電極を備える、前記面接触部と、を備え、
前記決定部は、処理部と、命令を記憶するメモリと、を備え、前記命令は、前記処理部によって実行されると、
前記第1の末梢神経効果器から第1の末梢神経に第1の電気刺激を送達することを前記決定部に行わせ、前記電気刺激は、前記患者の神経回路網動態を修正することによって前記患者の手足の振戦を軽減するように、前記制御部によって構成される、
システム。
〔付記32〕
前記第1の電気刺激は、振幅が約10mA未満であり、周波数が約10Hzから約5000Hzである、付記31に記載の方法。
〔付記33〕
前記接触面部は更に、前記決定部と通信する第2の末梢神経効果器を備え、前記第2の末梢神経効果器は少なくとも1つの電極を備え、前記メモリは命令を記憶し、前記命令は、前記処理部によって実行されると、前記第2の末梢神経効果器から前記患者の手足の第2の末梢神経に第2の電気刺激を送達することを前記決定部に更に行わせる、付記31に記載のシステム。
〔付記34〕
前記命令は、前記処理部によって実行されると、前記第1の電気刺激から、前記振戦の周期の所定の分数又は倍数だけ時間オフセットされた前記第2の電気刺激を送達することを前記決定部に行わせる、付記30に記載のシステム。
〔付記35〕
前記第1の末梢神経効果器は第1の指に配置されるように適合され、前記第2の末梢神経効果器は第2の指に配置されるように適合されている、付記30に記載のシステム。
〔付記36〕
前記第1の末梢神経効果器は、直線アレイとして並べられた複数の電極を備える、付記31に記載のシステム。
〔付記37〕
前記複数の電極は、約1mmから約100mmの間隔を置いて配置されている、付記31に記載のシステム。
〔付記38〕
前記第1の末梢神経効果器は、2次元アレイとして並べられた複数の電極を備える、付記31に記載のシステム。
〔付記39〕
前記メモリは命令を記憶し、前記命令は、前記処理部によって実行されると、前記患者の手足上の第1の末梢神経効果器の位置に基づいて前記複数の電極のうちのサブセットを選択することを前記決定部に更に行わせ、前記複数の電極のうちの前記サブセットの前記選択は、前記第1の末梢神経効果器が前記手足上で配置又は再配置されるたびに行われる、付記38に記載のシステム。
〔付記40〕
前記複数の電極は、第1の軸に沿って約1mmから約100mmの間隔を置いて配置され、前記第1の軸に垂直な第2の軸に沿って約1mmから約100mmの間隔を置いて配置される、付記38に記載のシステム。
〔付記41〕
測定部を更に備え、前記メモリは命令を記憶し、前記命令は、前記処理部によって実行されると、
前記測定部を使用して前記患者の手足の動きを測定して動きデータを生成することと、
前記動きデータの分析に基づいて振戦の周波数及び大きさを決定することと、
を前記決定部に更に行わせる、付記31に記載のシステム。
〔付記42〕
前記動きデータの前記分析は、前記動きデータのスペクトル電力の周波数分析を含む、付記41に記載のシステム。
〔付記43〕
前記周波数分析は、約4Hzから約12Hzの間に制限される、付記42に記載のシステム。
〔付記44〕
前記動きデータの前記分析は、所定の時間長の前記動きデータに対して行われる、付記41に記載のシステム。
〔付記45〕
前記決定部は、前記動きデータに基づいて振戦位相情報を決定することと、前記振戦位相情報に基づいて前記第1の電気刺激を送達することと、を行うように更に適合されている、付記41に記載のシステム。
〔付記46〕
前記振戦位相情報はピーク振戦偏移を含み、前記決定部は、前記ピーク振戦偏移に対応する時刻に前記第1の電気刺激を送達するように更に適合されている、付記45に記載のシステム。
〔付記47〕
前記メモリは命令を記憶し、前記命令は、前記処理部によって実行されると、前記第1の電気刺激を複数の電気刺激バーストとして送達することを前記決定部に更に行わせ、前記電気刺激バースト間には可変時間遅延がある、付記41に記載のシステム。
〔付記48〕
前記メモリは命令を記憶し、前記命令は、前記処理部によって実行されると、前記決定された振戦の周波数に基づいて前記第1の電気刺激のパラメータを設定することを前記決定部に更に行わせる、付記41に記載のシステム。
〔付記49〕
前記メモリは命令を記憶し、前記命令は、前記処理部によって実行されると、前記決定された振戦の大きさに基づいて前記第1の電気刺激のパラメータを設定することを前記決定部に更に行わせる、付記41に記載のシステム。
〔付記50〕
前記メモリは命令を記憶し、前記命令は、前記処理部によって実行されると、前記決定された振戦の大きさを所定閾値と比較することを前記決定部に更に行わせ、前記第1の電気刺激は、前記決定された振戦の大きさが所定閾値を超えた場合に送達される、付記41に記載のシステム。
〔付記51〕
前記電極は、前記患者の皮膚を貫通して前記第1の電気刺激を送達するように適合されている、付記31に記載のシステム。
〔付記52〕
前記電極は、インプラントされて前記神経に前記電気刺激を送達するように適合されている、付記31に記載のシステム。
〔付記53〕
前記決定部は、前記第1の電気刺激のパラメータを調節する為の入力をユーザから受け入れるように適合されたユーザインタフェースを含む、付記31に記載のシステム。
〔付記54〕
前記メモリは更に、1つ以上の所定の刺激プロトコルのライブラリを記憶する、付記31に記載のシステム。
〔付記55〕
前記面接触部は前記決定部と一体化されている、付記31に記載のシステム。
〔付記56〕
前記面接触部と前記決定部は互いに別々であり、個別のハウジングを有する、付記31に記載のシステム。
〔付記57〕
前記決定部は、前記面接触部に電力を無線で供給するか、前記面接触部と通信するように構成されている、付記56に記載のシステム。
〔付記58〕
前記決定部内に位置する測定部を更に備える、付記56に記載のシステム。
〔付記59〕
前記面接触部内に位置する測定部を更に備える、付記56に記載のシステム。
〔付記60〕
前記決定部は、スマートフォン、タブレット、及びラップトップからなる群から選択されるコンピューティング装置である、付記56に記載のシステム。
〔付記61〕
前記コンピューティング装置と通信するサーバを更に備え、前記サーバは、動きデータを、前記患者に送達された前記電気刺激の履歴とともに前記コンピューティング装置から受信するように構成されている、付記60に記載のシステム。
〔付記62〕
前記サーバは、
前記受信された動きデータと、前記患者に送達された前記電気刺激の前記履歴とを、複数の患者からのデータを記憶しているデータベースに追加するようにプログラムされている、
付記61に記載のシステム。
〔付記63〕
前記サーバは、
前記受信された動きデータ、及び前記患者に送達された前記電気刺激の前記履歴を、前記データベースに記憶されているデータと比較することと、
前記受信された動きデータ、及び前記患者に送達された前記電気刺激の前記履歴を、前記データベースに記憶されているデータと比較した結果に基づいて、修正された電気刺激プロトコルを決定することと、
前記修正された電気刺激プロトコルを前記コンピューティング装置に送信することと、
を行うようにプログラムされている、付記62に記載のシステム。
Claims (21)
- 患者の振戦を治療するためのシステムであって、
経皮ウェアラブル装置であり、
決定部と、
求心性神経経路を調節するように配置されるように構成された少なくとも1つの刺激電極を含む、第1の末梢神経効果器と、を備え、
前記決定部は、
プロセッサと、
前記プロセッサによって実行されたときに前記装置に、前記患者の四肢の振戦を軽減するために前記第1の末梢神経効果器を介して第1求心性神経に電気刺激を与えるステップ、を行わせる命令を格納するメモリと、を備える、
前記ウェアラブル装置と、
前記ウェアラブル装置と通信し、前記ウェアラブル装置からデータを受信するように構成された通信装置であって、前記通信装置は、保存および/またはデータ処理のために前記データをリモートコンピューティングシステムに送信するようにさらに構成されている、前記通信装置と、
前記リモートコンピューティングシステムであって、1つ以上の振戦特性を含む受信データを処理し、集約されたデータに対する学習アルゴリズムの適用に基づいて、追加の電気刺激に対する最適化された刺激パラメータを決定し、前記集約されたデータは、前記受信データおよび他の患者に関連する他のウェアラブル装置から取得されたコミュニティデータを含み、前記最適化された刺激パラメータを前記ウェアラブル装置に送信するように構成された、前記リモートコンピューティングシステムと、を備え、
当該システムは、前記患者内に埋め込むように構成されていない、
システム。 - 前記第1の電気刺激は、少なくとも1000Hzの周波数を有する、
請求項1に記載のシステム。 - 前記ウェアラブル装置は、前記振戦の1つ以上の特性を特定するために前記患者の四肢の動きを測定するように構成された少なくとも1つの生体力学センサをさらに備え、前記振戦の1つ以上の特性は、振戦周波数、振戦周期、および振戦の大きさからなる群から選択され、
前記決定部は、
プロセッサと、
前記プロセッサによって実行されたときに前記装置に、
前記測定部を用いて前記患者の四肢の動きを測定し、動作データを生成するステップと、
前記動作データの解析に基づいて、振戦の周波数、周期、および大きさのうちの1つ以上を決定するステップと、
前記振戦の周波数、周期、および大きさのうちの1つ以上に基づいて、第1の電気刺激の1つ以上のパラメータを設定するステップと、
を行わせる命令を格納するメモリと、を備える、
請求項1に記載のシステム。 - 前記決定部は、振戦を誘発する活動を行うように前記患者に促すおよび/または指示するようにプログラムされている、
請求項3に記載のシステム。 - 前記通信装置は、基地局、スマートフォン、タブレットコンピュータ、ラップトップコンピュータ、およびデスクトップコンピュータからなる群から選択される、
請求項1に記載のシステム。 - 前記ウェアラブル装置から前記通信装置に送信されるデータは、使用状況データおよび/またはパフォーマンスデータである、
請求項1に記載のシステム。 - 前記ウェアラブル装置から前記通信装置に送信されるデータは、行動データ、患者が入力したデータ、フィードバックデータ、または治療の成功データである、
請求項1に記載のシステム。 - 前記決定部は、前記行動データ、前記患者が入力したデータ、前記フィードバックデータ、または前記治療の成功データに基づいて、前記電気刺激の1つ以上のパラメータを調節するようにプログラムされている、
請求項7に記載のシステム。 - 前記決定部は、ディスプレイを備える、
請求項1に記載のシステム。 - 患者の振戦を治療するためのシステムであって、
経皮ウェアラブル装置であり、
決定部と、
前記振戦の1つ以上の特性を特定するために前記患者の四肢の動きを測定するように構成された少なくとも1つの生体力学センサであって、前記振戦の1つ以上の特性は、振戦周波数、振戦周期、および振戦の大きさからなる群から選択される、前記生体力学センサと、
求心性神経経路を調節するように配置されるように構成された少なくとも1つの刺激電極を含む、第1の末梢神経効果器と、を備え、
前記決定部は、
プロセッサと、
前記プロセッサによって実行されたときに前記装置に、
前記患者の四肢の振戦を軽減するために前記第1の末梢神経効果器を介して第1求心性神経に電気刺激を与えるステップと、
振戦を誘発する活動を行うように前記患者に促すおよび/または指示するステップと、
前記誘発された振戦の1つ以上の特徴を特定するために、前記少なくとも1つの生体力学センサで前記患者の四肢の動きを測定するステップと、
を行わせる命令を格納するメモリと、を備える、
前記ウェアラブル装置と、
通信装置であって、
前記ウェアラブル装置と通信し、前記ウェアラブル装置からデータを受信し、
保存および/またはデータ処理のために前記データをクラウドコンピューティングネットワークまたはサーバに送信し、
集約されたデータに対する学習アルゴリズムの適用に基づいて最適化された刺激パラメータを受信し、前記集約されたデータは、前記受信データおよび他の患者に関連する他のウェアラブル装置から取得されたコミュニティデータを含む、
前記通信装置と、を備え、
当該システムは、前記患者内に埋め込むように構成されていない、
システム。 - 前記クラウドコンピューティングネットワークまたはサーバは、前記受信したデータに基づいて前記電気刺激の1つ以上のパラメータを調節するように構成されている、
請求項10に記載のシステム。 - 前記決定部は、前記電気刺激が提供される前と後の両方で、振戦を誘発する活動を行うように前記患者に促すおよび/または指示するように構成されている、
請求項10に記載のシステム。 - 前記決定部は、前記電気刺激が提供される前と後の両方で、前記誘発された振戦を特徴付けるために、前記生体力学センサを用いて前記患者の四肢の動きを測定するように構成されている、
請求項12に記載のシステム。 - 前記クラウドコンピューティングネットワークまたはサーバは、前記電気刺激が提供される前と後の両方で、前記誘発された振戦の特徴に基づいて、治療効果の測定値を決定するように構成される、
請求項13に記載のシステム。 - 患者の振戦を治療するためのシステムであって、
経皮ウェアラブル装置であり、
決定部と、
前記振戦の1つ以上の特性を特定するために前記患者の四肢の動きを測定するように構成された少なくとも1つの生体力学センサであって、前記振戦の1つ以上の特性は、振戦周波数、振戦周期、および振戦の大きさからなる群から選択される、前記生体力学センサと、
求心性神経経路を調節するように配置されるように構成された少なくとも1つの刺激電極を含む、第1の末梢神経効果器と、を備え、
前記決定部は、
プロセッサと、
前記プロセッサによって実行されたときに前記装置に、
前記患者の四肢の振戦を軽減するために前記第1の末梢神経効果器を介して第1求心性神経に電気刺激を与えるステップと、
振戦を誘発する活動を行うように前記患者に促すおよび/または指示するステップと、
前記誘発された振戦の1つ以上の特徴を特定するために、前記生体力学センサで前記患者の四肢の動きを測定するステップと、
を行わせる命令を格納するメモリと、を備える、
前記ウェアラブル装置を備え、
前記電気刺激の1つ以上の刺激パラメータは、集約されたデータに対する学習アルゴリズムの適用に基づいて最適化され、前記集約されたデータは、前記患者から測定された前記1つ以上の特徴および他の患者に関連する他のウェアラブル装置から取得されたコミュニティデータを含み、
当該システムは、前記患者内に埋め込むように構成されていない、
システム。 - 前記決定部は、前記電気刺激が提供される前と後の両方で、振戦を誘発する活動を行うように前記患者に促すおよび/または指示するように構成されている、
請求項15に記載のシステム。 - 前記決定部は、前記電気刺激が提供される前と後の両方で、前記誘発された振戦を特徴付けるために、前記生体力学センサを用いて前記患者の四肢の動きを測定するように構成されている、
請求項16に記載のシステム。 - 前記決定部は、前記電気刺激が提供される前と後の両方で、前記誘発された振戦の特徴に基づいて、治療効果の測定値を決定するように構成される、
請求項17に記載のシステム。 - 患者の振戦を治療するためのシステムであって、
経皮ウェアラブル装置であり、
決定部と、
前記振戦の1つ以上の特性を特定するために前記患者の四肢の動きを測定するように構成された少なくとも1つの生体力学センサであって、前記振戦の1つ以上の特性は、振戦周波数、振戦周期、および振戦の大きさからなる群から選択される、前記生体力学センサと、
求心性神経経路を調節するように配置されるように構成された少なくとも1つの刺激電極を含む、第1の末梢神経効果器と、を備え、
前記決定部は、
プロセッサと、
前記プロセッサによって実行されたときに前記装置に、
第1の求心性神経に電気刺激を与える前に、前記振戦の1つ以上の特徴を特定するために、前記少なくとも1つの生体力学センサを用いて前記患者の四肢の動きを測定し、
前記患者の四肢の振戦を軽減するために、前記第1の末梢神経効果器を介して前記第1の求心性神経に前記電気刺激を与えるステップと、
前記第1の求心性神経に電気刺激を与えた後に、前記振戦の1つ以上の特徴を特定するために、前記少なくとも1つの生体力学センサを用いて前記患者の四肢の動きを測定するステップと、
を行わせる命令を格納するメモリと、を備える、
前記ウェアラブル装置を備え、
前記電気刺激の1つ以上の刺激パラメータは、集約されたデータに対する学習アルゴリズムの適用に基づいて最適化され、前記集約されたデータは、前記患者から測定された前記1つ以上の特徴および他の患者に関連する他のウェアラブル装置から取得されたコミュニティデータを含み、
当該システムは、前記患者内に埋め込むように構成されていない、
システム。 - 前記決定部は、4~12Hzの範囲の周波数の動きデータを抽出するように構成されている、
請求項19に記載のシステム。 - 前記集約されたデータは、前記振戦の振幅、前記振戦の周波数、前記振戦の一時的存在のうちの少なくとも1つを含む、
請求項1、10、15、または19のいずれか一項に記載のシステム。
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