JP2019103869A - 電極−皮膚インピーダンスを使用する皮膚電極剥離の検出 - Google Patents
電極−皮膚インピーダンスを使用する皮膚電極剥離の検出 Download PDFInfo
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Abstract
Description
本特許出願は、Shai Gozaniによる、係属中の先行の米国特許仮出願番号第61/806,481号(2013年3月29日出願)の「DETECTING ELECTRODE PEELING BY RELATIVE CHANGES IN SKIN−ELECTRODE IMPEDANCE」(代理人整理番号NEURO−64PROV)の利益を主張し、参考として本明細書に組み込まれている。
電極−皮膚インタフェース
ヒドロゲル電極の機能は、経皮的電気神経刺激器(即ち、TENSデバイス)と、刺激される表在感覚神経が存在するユーザの体との間のインタフェースとしての役割を果たす。図5は、TENSデバイスとユーザとの間の電流の流れの略図である。図5は、また、TENSデバイスと生体構造との間のインタフェースの等価回路図350を示す。図5で明らかなように、定電流源310からの刺激電流315は、カソード電極320を介してユーザの皮膚330に流れる。カソード電極320は、導電性下地(例えば、シルバーハッチング)342およびヒドロゲル344で構成される。電極−皮膚インタフェース構成要素320および330(即ち、カソード320および皮膚330)は、インピーダンスを、等価回路350の入力インピーダンスZI352内に含まれる電流の流れに提供する。体に一旦入ると、電流は、等価回路350の生体インピーダンスZB354によって代表される、脂肪組織、筋肉、神経および骨(図示せず)などの、様々な組織要素からさらにインピーダンスを受ける。最後に、電流は、皮膚330とアノード電極332で構成される(アノード電極332も導電性下地342とヒドロゲル344を含む)、別の電極−皮膚インタフェースを通って電流源310に戻る。皮膚330とアノード電極332との間のインタフェースは、等価回路モデル350内の出力インピーダンスZo356によって代表される。アノードとカソード電極(および同様に入力と出力インピーダンス)の名称は単に表記のためであることを理解すべきである。二相刺激パルスがTENS刺激の第2相内で極性を反転すると、電流はインタフェース332を介してユーザの体内に流れ、インタフェース320を介して体外に流れる。
式1は、ZB<<(Zo+ZI)であるため、生体インピーダンスZBを下げることにより簡略化され得る。さらに、Z0とZIは類似した特徴を有するため(例えば、ヒドロゲルの種類、表面積、類似した皮膚の種類に適用等)、次にインピーダンス全体のZは式2に簡略化することが可能であり、ZEは一般的な電極−皮膚インタフェースインピーダンスである。
好ましい実施形態では、モデルを簡略化し、インピーダンスを実質的に測定可能な量に調整するために、電極−皮膚インピーダンスは擬似抵抗を使用して定められる。具体的には、擬似抵抗は、刺激パルスの最後に電圧と電流の比によって与えられる。2相刺激パルスの場合には、第2相に同じ結果が予想されるが、第1相の最後の電圧および電流が使用される。この矩形波分析の手法は、一般的に、電極−皮膚インピーダンスの挙動を説明し研究するために使用される。相の持続時間が電極−皮膚の充電時定数に対して十分に長い場合には、次に擬似抵抗がRp+Rs(図5のパッシブ型電気回路360)に近似する。
「電極剥離」モデル
電極と皮膚の間の接触面積、ヒドロゲルの物理的および生体電気的な特徴、電流密度、および皮膚の状態を含む、いくつかの要因が電極−皮膚インピーダンス(ZE)に影響を与える(Lykken DT.Square−wave analysis of skin impedance. Psychophysiology. Sep 1970;7(2):262−275)(van Boxtel A. Skin resistance during square−wave electrical pulses of 1 to 10 mA. Med Biol Eng Comput. Nov 1977;15(6):679−687)(Keller T, Kuhn A. Electrodes for transcutaneous (surface) electrical stimulation. J Automatic Control, University of Belgrade. 2008;18(2):35−45)。ここで開発された「電極剥離」モデルにおいては、電極−皮膚インピーダンスに影響を与えるすべての要因は、接触面積と電流密度を除いて、TENS治療期間の間は安定している(典型的なTENS治療期間は30から60分の間継続する)として仮定を単純化される。この仮定は厳密ではないが、検出閾値を設定するときに、この理想的なケースからの逸脱は限定され、安全要因を組み込むことにより説明され得る(即ち、「電極剥離」の受入不可能な程度を示す電極−皮膚インピーダンスにおける変化を識別するとき)。
好ましい実施形態では、TENSデバイス100は、定電流刺激器310によって送達される刺激電流315を測定することによって、および、定電流刺激器310のカソード320とアノード332の間の電圧差を測定することによって、TENS刺激の間、継続的に電極−皮膚インピーダンスを監視するための回路および/またはソフトウェアを備える「電極剥離」検出器を備える。刺激器310によって「見られる」全体の等価インピーダンスは、電流で電圧差を割ることにより計算され得る。全インピーダンスは、電極−皮膚インタフェース320および332と関連する(等価回路350の)インピーダンスZIおよびZOによって左右され、接触面積サイズの逆数によって概ね決定される。初期の全インピーダンスはメモリに保存され、「ベースライン」インピーダンスと称される。それぞれ、次のサンプル時刻Tにて測定された全インピーダンスは、ベースラインインピーダンスZt<T=min(Zt<T-1,ZT)をアップデートする。換言すれば、電極−皮膚インピーダンスは通常、電極が皮膚の上にある時間の長さの関数として減少するため、ベースラインインピーダンスは、その治療期間の持続時間の間、測定される最小のインピーダンスに設定されるよう、継続してアップデートされることが好ましい。全インピーダンスZTは、次に、ベースラインインピーダンス値Zt<Tと比較される。もし電極が皮膚から剥離された場合(即ち、電極が意図せずに皮膚から外れた場合)には、電極−皮膚接触面積は減少し、そのため電極−皮膚インピーダンスは増加する。全インピーダンスもまた増加する。したがって、全インピーダンス値がベースラインインピーダンス値の一定の倍数を超過するとき、電極−皮膚接触面積は全接触面積の限界のパーセントより低くなったと推定することができる。経皮的電気刺激は、次に、高い電流および出力密度のために、ユーザに過剰な不快感および/または熱傷を与えないように直ちに停止される(または低減される)。
TENS治療への電極剥離モデルの適用
本発明の有用性は、後述の「電極剥離」検出器を装備したTENSデバイスを使用する実験において証明された。TENSデバイスは100mAまでの強度を有する刺激電流を送達するよう設計されている。二相刺激パルスは230μ秒の持続時間(各相は100μ秒の持続時間で、2つの相の間には30μ秒の間隙がある)および60Hzと100Hzとの間の不規則な周波数を有する。アノードとカソードの電極は、電極配列120が皮膚に正しく配置された場合、少なくとも28cm2の電極−皮膚接触面積を作る。したがって、最大の平均電流密度および出力密度は、それぞれ、0.5mA/cm2および3.6mW/cm2である。最大平均電流密度は、最大強度が100mAかつ最大パルス周波数が100Hzである、二相電流パルスの二乗平均平方根値である。出力密度は、FDA指針案に従って抵抗負荷が500Ωの同じ条件で計算されている(Food and Drug Administration, Draft Guidance for Industry and Staff:Class II Special Controls Guidance Document:Transcutaneous Electrical Nerve Stimulator for Pain Relief April 5, 2010)。TENSデバイスの「電極剥離」検出器は、87.5%を超える電極−皮膚接触面積の減少となる電極剥離の事象を検出するように設計されている(即ち、残存する電極−皮膚接触面積は当初の電極−皮膚接触面積の8分の1未満になったとき)。電極−皮膚接触面積が、当初の電極−皮膚接触面積サイズである28cm2の8分の1になったとき、結果として最大の平均出力密度は28.5mW/cm2であり、実質的に、FDA指針案に記述された熱傷のリスクを増加させると認識される250mW/cm2の閾値未満となる。(Food and Drug Administration, Draft Guidance for Industry and Staff:Class II Special Controls Guidance Document:Transcutaneous Electrical Nerve Stimulator for Pain Relief April 5,2010)。
好ましい実施形態の変形例
本発明の別の実施形態では、その時間インスタンスまで取得されたすべてのインピーダンス値の実行最小インピーダンス値の代わりに、ベースラインインピーダンスは、初期のインピーダンス値である。
Claims (15)
- ユーザにおける経皮的(transcutaneous)電気神経刺激のための装置であって、
少なくとも1つの神経を電気的に刺激するための刺激手段と、
前記刺激手段に接続可能な電極配列であって、前記少なくとも1つの神経の電気刺激のための複数の電極を備え、前記電極は、前記ユーザの皮膚に完全に接触するときに、事前形成された形状、および既知の電極−皮膚接触面積サイズを有する、電極配列と、
前記電極配列を通して、前記電気刺激のインピーダンスを監視するための、前記刺激手段に電気的に接続された監視手段と、
前記電極−皮膚接触面積内の変化を推定するために前記インピーダンスを分析するための分析手段と、を備え、
前記分析手段が、前記監視された電極−皮膚インピーダンス値が著しく変化したと決定するとき、前記刺激手段が前記電気刺激を停止または減少させ、
所与の時刻における前記インピーダンスの変化は、その時刻における前記インピーダンス値とベースラインインピーダンス値との間のインピーダンス比によって定量化され、
前記分析手段は、前記監視した電極−皮膚インピーダンス値が顕著に変化したか否かを判定し、
前記顕著な変化は、前記インピーダンス比がインピーダンス比閾値を超えたときの変化として定義される、
装置。 - 前記ベースラインインピーダンス値は、初期インピーダンスである、請求項1記載の装置。
- 前記インピーダンスの前記監視が、前記少なくとも1つの神経を刺激するために使用されるものと同様の電気刺激にて実施される、請求項1に記載の装置。
- 前記インピーダンスの前記監視が、前記少なくとも1つの神経を刺激するために使用されるものと異なる電気刺激にて実施される、請求項1に記載の装置。
- 前記インピーダンスを監視するために使用される前記電気刺激が、前記ユーザの電気触覚閾値(electrotactile sensation threshold)より低い強度を有する、請求項4に記載の装置。
- 前記インピーダンスが、前記電気刺激における特定の時刻で、
[(アノード−カソードの電圧差)/(前記監視手段の前記電気刺激の刺激電流)]
として定められる、請求項1に記載の装置。 - 前記電極−皮膚インピーダンス値の履歴が前記監視手段によって保存される、請求項1に記載の装置。
- 前記ベースラインインピーダンス値が、その時間インスタンスまでに取得されたすべてのインピーダンス値の実行最小インピーダンス値である、請求項7に記載の装置。
- 前記インピーダンス比閾値が、前記電極の、前記事前形成された形状および既知の電極−皮膚接触領域のサイズに依存する、請求項1に記載の装置。
- 前記少なくとも1つの神経を刺激するために使用される前記電気刺激の状態にかかわらず、前記インピーダンスを監視するための手段のために使用される前記電気刺激が、継続的に起動している、請求項4に記載の装置。
- 前記インピーダンスが、
(Zt=T)/(Zt=0)=[1+[alfa](delta-1)]/2 (式7)
を用いて、
アノード−カソード電圧差曲線に適合すること
により導かれ、
Zt=T が、時刻t=Tにおけるインピーダンス値であり、
Zt=0 が、初期インピーダンス値であり、
alfa が、以下の比であり、
[接触面積の減少後の接触サイズ]/[ユーザの皮膚との完全な接触時の既知の電極−皮膚接触領域サイズ]
delta が、アノード−カソード電圧差曲線の適合のために使用される現在の強度の効果を表す因子である、請求項1に記載の装置。 - Cpと並列に接続された抵抗Rpであって、両者が、抵抗Rsと直列に接続される等価回路を用いてインピーダンスが、シミュレートされ、
Rpが、角質層の抵抗に関連し、
Cpが、角質層のキャパシタンスに関連し、
Rsが、角質層を含む種々の皮膚構造の抵抗である、
請求項11に記載の装置。 - ユーザにおける経皮的電気神経刺激のための装置であって、
複数の電極を備える電極配列であって、前記複数の電極は、前記複数の電極がユーザの皮膚に完全に接触するときに、予め形成された形状と既知の電極−皮膚接触面積を有する、電極配列と、
前記ユーザの少なくとも1つの神経を刺激するように、前記ユーザの前記皮膚に電気刺激を提供するための前記電極配列に接続可能な刺激手段と、
電極−皮膚インピーダンス値を監視するための、前記電極配列に電気的に接続可能な監視手段と、
前記監視手段が、前記電極−皮膚インピーダンス値が所定の値だけ変更されたと決定するときに、前記ユーザの前記皮膚に提供されるべき前記電気刺激を制御するための制御手段と、を備え、
前記刺激手段は、ユーザからのマニュアル操作にしたがって前記電気刺激を加えることにより、第1治療期間を開始し、
前記第1治療期間が完了した後、前記刺激手段は、あらかじめ設定されたタイマ機能が起動することによって、第2治療期間を自動的に開始し、
前記第1治療期間を完了するとき、前記制御手段は前記インピーダンス値をベースラインインピーダンスとして記憶部に格納し、
前記第2治療期間を開始するとき、前記刺激手段は、前記格納したインピーダンス値を前記ベースラインインピーダンスの初期値として用いる、
装置。 - 前記監視手段が、刺激が与えられる間のインピーダンスを監視する、請求項1に記載の装置。
- 前記監視手段が、前記刺激手段が、少なくとも1つの神経を電気的に刺激した後のインピーダンスを監視する、請求項1に記載の装置。
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EP2978488A1 (en) | 2016-02-03 |
JP2016515428A (ja) | 2016-05-30 |
US20190269909A1 (en) | 2019-09-05 |
CN105377359A (zh) | 2016-03-02 |
EP2978488A4 (en) | 2017-06-21 |
CN105377359B (zh) | 2019-02-01 |
EP2978488B1 (en) | 2021-04-14 |
US10159835B2 (en) | 2018-12-25 |
US20140296934A1 (en) | 2014-10-02 |
ES2879286T3 (es) | 2021-11-22 |
US9474898B2 (en) | 2016-10-25 |
US11191443B2 (en) | 2021-12-07 |
US20170036015A1 (en) | 2017-02-09 |
JP7017676B2 (ja) | 2022-02-09 |
WO2014161000A1 (en) | 2014-10-02 |
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