JP6979967B2 - ニューロモジュレーションの改良されたフィードバック制御 - Google Patents
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
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- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/388—Nerve conduction study, e.g. detecting action potential of peripheral nerves
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- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36071—Pain
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36071—Pain
- A61N1/36075—Headache or migraine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
- A61N1/36139—Control systems using physiological parameters with automatic adjustment
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- A—HUMAN NECESSITIES
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36146—Control systems specified by the stimulation parameters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36146—Control systems specified by the stimulation parameters
- A61N1/36182—Direction of the electrical field, e.g. with sleeve around stimulating electrode
- A61N1/36185—Selection of the electrode configuration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37264—Changing the program; Upgrading firmware
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
Description
神経経路上に誘発活動電位を生じさせるために神経経路に神経刺激を印加するステップであって、刺激が少なくとも1つの刺激パラメータによって定義される、ステップと、
刺激によって誘発される神経複合活動電位反応を測定し、測定された誘発反応からフィードバック変数を導出するステップと、
フィードバック変数を用いて少なくとも1つの刺激パラメータ値を制御することにより、フィードバックループを完成するステップと、
フィードバック変数に補償伝達関数を適用することにより、神経経路に対する電極移動によってもたらされるフィードバックループのゲインの変化を適応的に補償するステップであって、補償伝達関数が、(i)刺激の距離依存伝達関数および(ii)(i)とは異なる測定の距離依存伝達関数の両方を補償するように構成される、ステップとを含む方法を提供する。
1つまたは複数の名目刺激電極と1つまたは複数の名目検知電極とを含む複数の電極と、
神経経路に誘発活動電位を生じさせるために、1つまたは複数の刺激電極から神経経路に送達されるように刺激を提供する刺激源と、
1つまたは複数の検知電極において検知される神経複合活動電位信号を記録する測定回路と、
制御装置であって、
少なくとも1つの刺激パラメータによって定義されるように神経刺激の印加を制御し、
測定回路を介して、刺激によって誘発される神経複合活動電位反応を測定し、
測定された誘発反応からフィードバック変数を求め、
フィードバック変数を用いて少なくとも1つの刺激パラメータ値を制御することによりフィードバックループを完成し、
フィードバック変数に補償伝達関数を適用することにより、神経経路に対する電極移動によってもたらされるフィードバックループのゲインの変化を適応的に補償するように構成され、補償伝達関数が、(i)刺激の距離依存伝達関数および(ii)(i)とは異なる測定の距離依存伝達関数の両方を補償するように構成されている、
制御装置と、
を含む植込み型デバイスを提供する。
神経経路上に誘発活動電位を生じさせるために神経経路に神経刺激を印加するコンピュータプログラムコード手段であって、刺激が少なくとも1つの刺激パラメータによって定義されるように印加される、コンピュータプログラムコード手段と、
刺激によって誘発される神経複合活動電位反応を測定し、測定された誘発反応からフィードバック変数を導出するコンピュータプログラムコード手段と、
フィードバック変数を用いて少なくとも1つの刺激パラメータ値を制御することにより、フィードバックループを完成するコンピュータプログラムコード手段と、
フィードバック変数に補償伝達関数を適用することにより、神経経路に対する電極移動によってもたらされるフィードバックループのゲインの変化を適応的に補償するコンピュータプログラムコード手段であって、補償伝達関数が、(i)刺激の距離依存伝達関数および(ii)(i)とは異なる測定の距離依存伝達関数の両方を補償するように構成されている、コンピュータプログラムコード手段と、
を含む非一時的コンピュータ可読媒体を提供する。
Ti∝xn
単極点電源刺激の場合、n∈[1,3]である。電極、周囲の組織および神経の他の構成では、nの値はこの範囲外である場合もある。
N∝Ix−n−T0
として変化し、式中、T0は、x=1における最も感受性の高い線維の閾値に対応する正規化閾値である。
Si∝x−m
に従うということが分かり、式中、m=1は線維に近く、m=3は遠方界にある。前者は、x<<Lである場合に予期され、最も近い絞輪の活動電位が記録を支配し、後者は、伝わる活動電位のおよそ三極の性質からもたらされる。
V∝Nx−m (2)
としてECAP振幅を近似することができ、式中、mは記録伝達関数パラメータである。
y=IkV (4)
として最も容易に表され、式中、k=m/nであり、k>0である。
Ii∝xi n
Vi∝xi −m
であることを意味する。したがって、kを推定する1つの単純な方法は、対数Viに対して対数Iiをプロットし、これらのデータ点に線を当てはめることであり、それにより、この線は、−n/m=−kの傾きを有する。こうした式に対する解を近似する他の方法も使用することができる。
V=M(I−T)
T∝xn
M∝x−(m+n)
であることが明らかである。
Claims (17)
- 神経刺激を制御する自動化方法であって、
制御装置によって、神経経路上に誘発活動電位反応を生じさせるために前記神経経路に前記神経刺激を印加するステップであって、前記刺激が少なくとも1つの刺激パラメータによって定義される、ステップと、
前記制御装置によって、前記刺激によって誘発される前記誘発活動電位反応を測定し、前記測定された前記誘発活動電位反応からフィードバック変数を導出するステップと、
前記制御装置によって、前記フィードバック変数を用いて前記少なくとも1つの刺激パラメータの値を制御することにより、フィードバックループを実施するステップと、
前記制御装置によって、前記フィードバック変数に補償伝達関数を適用することにより、前記神経経路に対する電極移動によってもたらされる前記フィードバックループのゲインの変化を適応的に補償するステップであって、前記補償伝達関数が、(i)刺激の距離依存伝達関数および(ii)(i)とは異なる測定の距離依存伝達関数の両方を補償するための関数である、ステップと、
を含む方法。 - 刺激電流(I)と観察されるECAP電圧(V)との単一の測定値対を用いることにより、一定の動員がもたらされ、前記刺激電流(I)は前記刺激パラメータの値を示し、前記ECAP電圧(V)は前記誘発活動電位反応を示す、請求項1に記載の方法。
- 前記補償伝達関数が、動員パラメータnおよび測定パラメータmの両方を反映する単一のパラメータkを含み、m≠nである、請求項1または2に記載の方法。
- 動員された線維の総数NがN∝Ix−n−T0として変化し、前記測定されるECAP電圧の振幅Vが、∝Nx−mとして近似され、k=m/nである、請求項3に記載の方法。
- kが、使用時の刺激および記録構成に対して好適な値をとるように選択される、請求項4に記載の方法。
- 三極刺激が、SCSリードの第1電極から第3電極を用いて送達され、同じリードの第6電極を用いて記録が取られ、kが0.1〜0.7の範囲にあるように選択される、請求項5に記載の方法。
- kが0.22〜0.53の範囲にあるように選択される、請求項6に記載の方法。
- kが約0.37であるように選択される、請求項7に記載の方法。
- kが、動員データを用いて臨床的に求められる、請求項3〜8のいずれか一項に記載の方法。
- 前記動員データが、患者の知覚閾値、不快閾値、ある部位または身体部分の適用範囲、患者の刺激の知覚の定性的特徴、患者の最適な快適さの知覚、電気生理学的基準、筋反応/痙攣の発現および神経活動の基準のうちの1つまたは複数を含む、請求項9に記載の方法。
- 患者が一続きの姿勢をとるステップと、
前記制御装置によって、各姿勢で、要求される動員データが達成されるまで前記刺激の強度を調整するステップと、
前記制御装置によって、異なる姿勢における一定の動員データからkを推定するステップと
をさらに含む、請求項9または10に記載の方法。 - kが、記録電極を用いて、複数の姿勢で末梢刺激に対する神経反応を測定して、各姿勢におけるViデータを取得し、刺激電極を用いて、各姿勢においてそれぞれのViをもたらす電流レベルIiに調整された刺激を送達し、一定の動員の(Ii,Vi)対の組を用いてkを導出することにより、臨床的に求められる、請求項3〜11のいずれか一項に記載の方法。
- kが、前記患者をある範囲の姿勢iに配置し、各姿勢において前記刺激強度をスイープし、成長曲線を記録して、各それぞれの姿勢に対する前記成長曲線を線形に当てはめて、それぞれの閾値Tiおよび成長の傾きMiを求め、対数TiMiに対して対数Tiを比較してkを導出することによって臨床的に求められる、請求項3〜12のいずれか一項に記載の方法。
- 入来するECAPの測定値(V)に、そのECAPを発生させるために使用された前記刺激電流(I)の累乗したもの(Ik)が掛け合わされ、設定値に対して誤差信号が生成され、次の刺激強度を決定するコントローラに提供される、請求項3〜13のいずれか一項に記載の方法。
- 神経刺激を制御可能に印加する植込み型デバイスであって、
1つまたは複数の名目刺激電極と1つまたは複数の名目検知電極とを含む複数の電極と、
神経経路に誘発活動電位反応を生じさせるために、前記1つまたは複数の刺激電極から前記神経経路に送達されるように刺激を提供する刺激源と、
前記1つまたは複数の検知電極において検知される前記誘発活動電位反応の信号を記録する測定回路と、
制御装置であって、
少なくとも1つの刺激パラメータによって定義されるように神経刺激の印加を制御し、
前記測定回路を介して、前記刺激によって誘発される前記誘発活動電位反応を測定し、
前記測定された誘発活動電位反応からフィードバック変数を求め、
前記フィードバック変数を用いて前記少なくとも1つの刺激パラメータの値を制御することによりフィードバックループを実施し、
前記フィードバック変数に補償伝達関数を適用することにより、前記神経経路に対する電極移動によってもたらされる前記フィードバックループのゲインの変化を適応的に補償するように構成され、前記補償伝達関数が、(i)刺激の距離依存伝達関数および(ii)(i)とは異なる測定の距離依存伝達関数の両方を補償するための関数である、
制御装置と、
を含む植込み型デバイス。 - 前記制御装置が、ECAPの測定値(V)にそれぞれのECAPを発生させるために使用された前記刺激電流(I)の累乗したもの(Ik)を掛け合わせることにより適応的に補償するように構成され、設定値に対して誤差信号を生成し、前記誤差信号をその後の刺激強度を決定するコントローラに提供するようにさらに構成されており、前記刺激電流(I)は前記刺激パラメータの値を示し、前記ECAPの測定値(V)は前記誘発活動電位反応を示す、請求項15に記載の植込み型デバイス。
- 神経刺激を制御可能に印加するための非一時的コンピュータ可読媒体であって、1つまたは複数のプロセッサによって実行される以下の命令、すなわち、
神経経路上に誘発活動電位反応を生じさせるために前記神経経路に前記神経刺激を印加するコンピュータプログラムコード手段であって、前記刺激が少なくとも1つの刺激パラメータによって定義されるように印加される、コンピュータプログラムコード手段と、
前記刺激によって誘発される前記誘発活動電位反応を測定し、前記測定された誘発活動電位反応からフィードバック変数を導出するコンピュータプログラムコード手段と、
前記フィードバック変数を用いて前記少なくとも1つの刺激パラメータの値を制御することにより、フィードバックループを実施するコンピュータプログラムコード手段と、
前記フィードバック変数に補償伝達関数を適用することにより、前記神経経路に対する電極移動によってもたらされる前記フィードバックループのゲインの変化を適応的に補償するコンピュータプログラムコード手段であって、前記補償伝達関数が、(i)刺激の距離依存伝達関数および(ii)(i)とは異なる測定の距離依存伝達関数の両方を補償するための関数である、コンピュータプログラムコード手段と、
を含む非一時的コンピュータ可読媒体。
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