JP2013506535A - 神経精神障害を治療するための頭蓋外植込み型装置、システム、及び方法 - Google Patents
神経精神障害を治療するための頭蓋外植込み型装置、システム、及び方法 Download PDFInfo
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Abstract
【選択図】 図1A
Description
本願は、米国特許法第119条(e)に基づき、以下の出願:2009年10月5日に出願された「Devices and Methods for Treatment of Psychiatric Disorders」と題される米国仮特許出願第61/248,827号;2009年12月23日に出願された「Extracranial Implantable Devices, Systems and Methods for Treatment of Neuropsychiatric Disorders」と題される米国仮特許出願第61/289,829号;2010年2月17日に出願された「Systems, Devices and Methods for Treatment of Neurological Disorders and Conditions」と題される米国仮特許出願第61/305,514号;及び2010年6月14日に出願された「Extracranial Implantable Devices, Systems and Methods for Treatment of Neurological Disorders」と題される米国仮特許出願第61/354,641号に対する優先権の利益を主張し、上記出願の各々は、本明細書に全て記載されたものとして本明細書によって参照により援用される。
図5A〜図5Cは、うつ病を治療するための外部三叉神経刺激の予備試験からの結果を示す。組入れ基準及び除外基準を満たした大うつ病を有する対象者を、UCLAで行われたオープンラベル(非盲検)試験において8週間追跡した。
図6は、眼窩上神経の経皮的刺激に曝露される間に対象者において記録された電流、電荷、電流密度及び電荷密度を要約する。図6は、EMS 7500刺激器、120HZ、150〜250u秒、Tyco superior silver電極1.25”を、眉毛上方の正中線から1インチで使用する対象者において記録された両側性の眼窩上刺激についての代表的なパラメータを示す。データは、Flukeオシロスコープ、50mV/div、抵抗=10.1Ωで記録した。一般に、これらの知見から、パルス幅が増加するほど最大耐容可能電流が低下することが示される。
Claims (20)
- パルス発生器と、
前記パルス発生器と電気的に連通している皮下電極アセンブリであって、前記患者の顔面の第1の領域で皮下に配置するように構成された少なくとも1つの接触子を含む第1の電極を含むアセンブリと、
を含む、神経精神障害の治療用三叉神経刺激システムであって、
前記第1の電極が、三叉神経刺激により神経精神障害を治療するために三叉神経の少なくとも1つの分枝に近接して、それに隣接して、又はそれと接触して植え込まれるように構成され、
前記システムが、患者脳内への最小の電流浸透となるように構成され、
三叉神経の前記少なくとも1つの分枝が、眼神経、眼窩下神経、オトガイ神経、滑車上神経、滑車下神経、頬骨側頭神経、頬骨顔面神経、頬骨眼窩神経、鼻神経、及び耳介側頭神経からなる群から選択される、
システム。 - 前記患者の顔面の第2の領域で皮下に配置するように構成された少なくとも1つの接触子を含む第2の電極をさらに含む、請求項1に記載のシステムであって、前記第2の電極が、三叉神経の少なくとも1つの分枝に近接して、それに隣接して、又はそれと接触して植え込まれるように構成され、三叉神経の前記少なくとも1つの分枝が、眼神経、眼窩下神経、オトガイ神経、滑車上神経、滑車下神経、頬骨側頭神経、頬骨顔面神経、頬骨眼窩神経、鼻神経、及び耳介側頭神経からなる群から選択される、システム。
- 前記第1の電極と前記第2の電極とが、三叉神経の同じ分枝に近接して、それに隣接して、又はそれと接触して植え込むように構成される、請求項2に記載のシステム。
- 前記第1の電極と前記第2の電極とが、三叉神経の異なる分枝に近接して、それに隣接して、又はそれと接触して植え込むように構成される、請求項2に記載のシステム。
- 前記パルス発生器と前記皮下電極アセンブリとを動作可能に接続するワイヤをさらに含む、請求項1に記載のシステム。
- 最大電荷平衡出力電流を約30〜50mA未満に調節するように構成された調節装置をさらに含む、請求項1に記載のシステム。
- 前記神経精神障害が、気分障害、認知障害、行動障害、及び不安障害からなる群から選択される、請求項1に記載のシステム。
- 前記パルス発生器が、周波数約20〜300ヘルツ、パルス持続時間約50〜500マイクロ秒、約25mA/cm2以下の出力電流密度、及び大脳皮質において約10マイクロクーロン/cm2以下の出力電荷密度で電気信号を印加するように構成される、請求項1に記載のシステム。
- 神経精神障害を治療するための三叉神経刺激用の皮下電極アセンブリであって、前記アセンブリが、前記患者の顔面の第1の領域で皮下に配置するように構成された少なくとも1つの接触子を含む第1の電極を含み、
前記第1の電極が、三叉神経刺激により神経精神障害を治療するために三叉神経の少なくとも1つの分枝に近接して、それに隣接して、又はそれと接触して植え込まれるように構成され、
前記アセンブリが、患者脳内への最小の電流浸透となるように構成され、
三叉神経の前記少なくとも1つの分枝が、眼神経、眼窩下神経、オトガイ神経、滑車上神経、滑車下神経、頬骨側頭神経、頬骨顔面神経、頬骨眼窩神経、鼻神経、及び耳介側頭神経からなる群から選択される、
アセンブリ。 - 前記患者の顔面の第2の領域で皮下に配置するように構成された少なくとも1つの接触子を含む第2の電極をさらに含み、前記第2の電極が、三叉神経の少なくとも1つの分枝に近接して、それに隣接して、又はそれと接触して植え込まれるように構成され、三叉神経の前記少なくとも1つの分枝が、眼神経、眼窩下神経、オトガイ神経、滑車上神経、滑車下神経、頬骨側頭神経、頬骨顔面神経、頬骨眼窩神経、鼻神経、及び耳介側頭神経からなる群から選択される、請求項9に記載のアセンブリ。
- 前記第1の電極と前記第2の電極とが、三叉神経の同じ分枝に近接して、それに隣接して、又はそれと接触して植え込むように構成される、請求項10に記載のアセンブリ。
- 前記第1の電極と前記第2の電極とが、三叉神経の異なる分枝に近接して、それに隣接して、又はそれと接触して植え込むように構成される、請求項10に記載のアセンブリ。
- 前記神経精神障害が、気分障害、認知障害、行動障害、及び不安障害からなる群から選択される、請求項9に記載のアセンブリ。
- 三叉神経刺激による神経精神障害の治療方法であって、
患者に電極アセンブリを植え込む工程であって、
前記皮下電極アセンブリが、前記患者の顔面の第1の領域で皮下に配置するように構成された少なくとも1つの接触子を含む第1の電極を含み、
前記第1の電極が、三叉神経刺激により神経精神障害を治療するために三叉神経の少なくとも1つの分枝に近接して、それに隣接して、又はそれと接触して植え込まれるように構成され、
前記アセンブリが、患者脳内への最小の電流浸透となるように構成され、
三叉神経の前記少なくとも1つの分枝が、眼神経、眼窩下神経、オトガイ神経、滑車上神経、滑車下神経、頬骨側頭神経、頬骨顔面神経、頬骨眼窩神経、鼻神経、及び耳介側頭神経からなる群から選択される、工程と、
神経精神障害を治療するための特定の動作パラメータで前記電極アセンブリに電気信号を印加する工程と、
を含む方法。 - 前記患者の顔面の第2の領域で皮下に配置するように構成された少なくとも1つの接触子を含む第2の電極を含むアセンブリをさらに含み、前記第2の電極が、三叉神経の少なくとも1つの分枝に近接して、それに隣接して、又はそれと接触して植え込まれるように構成され、三叉神経の前記少なくとも1つの分枝が、眼神経、眼窩下神経、オトガイ神経、滑車上神経、滑車下神経、頬骨側頭神経、頬骨顔面神経、頬骨眼窩神経、鼻神経、及び耳介側頭神経からなる群から選択される、請求項14に記載の方法。
- 電気信号を印加する前記工程が、周波数約20〜300ヘルツ、0.1〜3ミリアンペア(mA)の電流、及び500マイクロ秒以下のパルス持続時間で電気信号を印加することを含む、請求項14に記載の方法。
- 電気信号を印加する前記工程が、周波数約20〜300ヘルツ、パルス持続時間約50〜500マイクロ秒、約25mA/cm2以下の出力電流密度、及び大脳皮質において約10マイクロクーロン/cm2以下の電荷密度で電気信号を印加することを含む、請求項14に記載の方法。
- 前記神経精神障害が、気分障害、認知障害、行動障害、及び不安障害からなる群から選択される、請求項14に記載の方法。
- 神経精神障害の治療用三叉神経刺激キットであって、
請求項1に記載の皮下電極アセンブリと、
神経精神障害を治療するための患者における前記電極アセンブリの植込みについての説明書と
を含むキット。 - パルス発生器と、
神経精神障害を治療するための前記電極アセンブリへの電気信号の印加についての説明書と
をさらに含む、請求項19に記載のキット。
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JP2019205900A (ja) * | 2013-04-15 | 2019-12-05 | ジーエスケイ コンシューマー ヘルスケア エス.エイ. | ユーザの睡眠覚醒状態を自動的に検出する、経皮的電気神経刺激装置 |
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