JP2017529176A - 患者入力に応答する知覚以下変調 - Google Patents
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- A—HUMAN NECESSITIES
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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Abstract
Description
本出願は、2014年9月23日出願の米国仮特許出願第62/054,116号の「35 U.S.C.§119(e)」の下での優先権の利益を主張し、引用によってその全体を本明細書に組込む。
脊髄の領域内の神経組織は、異なる特性を有する。例えば、後柱(DC)線維(主に有髄軸索)は軸線方向に延び、後角(DH)線維(例えば、ニューロン細胞終端、ニューロン細胞体、樹状突起、及び軸索)は多方向に配向されている。典型的に配置される硬膜外脊髄刺激(SCS)リードから後角(DH)線維までの距離は、かかる硬膜外脊髄刺激(SCS)リードから後柱(DC)線維までの距離と異なる。更に、後角(DH)線維と後柱線維は、電気変調に対して異なる応答(例えば、活性化関数)を有する。後柱(DC)線維及び後柱(DC)ニューロンの変調(すなわち、脱分極又は過分極)の強度は、脊柱の長手方向後柱軸線に沿う電圧の2次空間微分(∂2V/∂x2)に比例するいわゆる「活性化関数」によって表される。この理由は、部分的には、後柱(DC)内の大きい有髄軸索が主に脊柱の長手方向に沿って整列しているからである。一方、後角(DH)線維及び後角ニューロン内に活動電位を発生させる可能性は、脊柱に沿う電圧の1次空間微分(∂V/∂x)に比例する活性化関数によって表され、これは、電場として既知である。かくして、後角(DH)活性化関数は、線維軸線に沿う電圧の1次微分に比例し、後柱(DC)活性化関数は、線維軸線に沿う電圧の2次微分に比例する。従って、電場中心からの距離は、後柱活性化関数(∂2V/∂x2)に及ぼす影響より小さい影響しか後角(DH)活性化関数(∂V/∂x)に及ぼさない。後柱(DC)に沿う神経変調リードによって発生させた電場の長手方向勾配を最小にすることによって、後角(DH)内のニューロン要素(例えば、ニューロン、樹状突起、軸索、細胞体、及びニューロン細胞終端)は、後柱(DC)ニューロン細胞要素よりも優先的に刺激され、それにより、感覚異常の感覚を生成することのなしに、疼痛緩和の形態で治療を行うことができる。この技術は、後角(DH)線維と後柱(DC)線維が電気変調に対して異なる応答(活性化関数)を有するという自然現象に少なくとも部分的に依存する。
知覚以下変調は、変調を送出するのに使用するための電極を選択して絞り込むための幾つかの課題をもたらすことがある。例えば、在来の脊髄刺激(SCS)は、後柱(DC)を変調させ且つ感覚異常を生じさせるために、ターゲットが定められた小さい刺激を単に提供することを試みる。在来の脊髄刺激(SCS)のための変調は、疼痛領域にわたって感覚異常のマップを形成するように調節されることがある。しかしながら、患者は、知覚以下変調のための変調エネルギの送出を知覚しない。
知覚以下変調は、患者が変調エネルギの送出を知覚しないので、変調治療を較正することについて幾つかの課題がある可能性がある。較正は、2015年9月23日に出願された特許文献1に解説されているもの等のセンサを含むのがよい。センサの例は、定量的感覚検査(QST)、脳波図(EEG)、脳皮質電図(ECoG)、拡散光撮像、機能的磁気共鳴映像法(fMRI)、軸索内の局所電場電位(LFPs)、及び軸索内の誘起複合活動電位(eCAPs)を含む。
Claims (15)
- システムであって、
後角組織、後根組織、又は後柱組織のうちの少なくとも1つを含む神経組織を変調させる際の使用のために作動的に位置決めされるように構成された少なくとも1つのリード上の複数の電極と、
埋込み可能なデバイスと、を有し、
前記埋込み可能なデバイスは、知覚以下変調を神経組織に送出する変調場を発生させるために、前記複数の電極の少なくとも幾つかを使用するように構成された神経変調デバイスを含み、知覚以下変調は、患者知覚閾値よりも低い強度を有し、患者知覚閾値は、それよりも低い変調場の発生を患者が感知しない境界であり、
前記埋込み可能なデバイスは、更に、コントローラを含み、前記コントローラは、変調場を発生させ且つ患者入力に応答して前記変調場を自動的に調節するように前記神経変調デバイスを制御するように構成される、システム。 - 更に、前記埋込み可能なデバイスと通信するように構成された外部デバイスを有し、
前記外部デバイスは、患者入力を受信するためのユーザインタフェースと、患者入力に応答するように構成されたコントローラと、を含み、
前記外部デバイスのコントローラは、患者開始制御信号を前記埋込み可能なデバイスに送るための通信を自動的に開始させ、
前記埋込み可能なデバイスのコントローラは、前記変調場を発生させ、前記患者開始制御信号に応答して前記変調場を自動的に調節するように構成される、請求項1に記載のシステム。 - 前記患者入力は、投与調節を含み、前記埋込み可能なデバイスのコントローラは、前記患者開始制御信号に応答して、知覚以下変調の投与を自動的に調節するように構成される、請求項2に記載のシステム。
- 前記システムは、前記患者開始制御信号に応答して投与の自動調節を制限するように構成される、請求項3に記載のシステム。
- 更に、知覚以下変調の治療の有効性を評価するフィードバック部を有し、前記コントローラは、フィードバック入力で受信したフィードバックを使用して、知覚以下変調を自己較正する自己較正ルーチンを自動的に開始させるように構成される、請求項2〜4のいずれか1項に記載のシステム。
- 前記コントローラによって開始される自己較正ルーチンは、
刺激電極のアレイ内の活性電極のための知覚異常感覚のレベルを提供する変調強度のレベルを決定することと、
決定された変調強度のレベルを用いて、異常感覚を知覚するための閾値よりも低いレベルで前記活性電極を介して送出される知覚以下変調を正規化する段階と、を含む請求項5に記載のシステム。 - 前記外部デバイスのユーザインタフェースは、前記ユーザインタフェースを用いて患者により提供される疼痛緩和の指示を含む前記フィードバックを提供するように構成される、請求項5又は6に記載のシステム。
- 前記フィードバック部は、センサを含む、請求項5〜7のいずれか1項に記載のシステム。
- 前記センサは、局所電場電位(LFP)センサを含む、請求項8に記載のシステム。
- 前記センサは、加速度計を含む、請求項8又は9に記載のシステム。
- 前記患者入力は、患者活動入力を含み、前記コントローラは、患者活動入力を用いて評価された患者の健康状態の質が示されたときに較正ルーチンを自動的に作動させるように構成される、請求項1〜10のいずれか1項に記載のシステム。
- 患者の健康状態の質は、患者活動の検出された変化を用いて評価される、請求項11に記載のシステム。
- 前記コントローラは、検出された患者活動に特有の較正データを発生させるための較正ルーチンを実施し、発生させた前記検出された患者活動に特有の較正データを用いて変調プログラムを調節するように構成される、請求項1〜12のいずれか1項に記載のシステム。
- 前記患者入力は、患者姿勢入力を含み、前記コントローラは、患者姿勢入力を用いて評価された患者の健康状態の質が示されたときに較正ルーチンを自動的に作動させるように構成される、請求項1〜13のいずれか1項に記載のシステム。
- 前記コントローラは、検出された患者姿勢に特有の較正データを発生させるための較正ルーチンを実施し、発生させた前記検出された患者姿勢に特有の較正データを用いて変調プログラムを調節するように構成される、請求項1〜14のいずれか1項に記載のシステム。
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US201462054116P | 2014-09-23 | 2014-09-23 | |
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PCT/US2015/051378 WO2016048976A1 (en) | 2014-09-23 | 2015-09-22 | Sub-perception modulation responsive to patient input |
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JP2019088939A (ja) | 2019-06-13 |
US20160082262A1 (en) | 2016-03-24 |
CN106714900A (zh) | 2017-05-24 |
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AU2015321493A1 (en) | 2017-05-11 |
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US9993646B2 (en) | 2018-06-12 |
US20180256897A1 (en) | 2018-09-13 |
EP3197541A1 (en) | 2017-08-02 |
EP3197541B1 (en) | 2020-11-04 |
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