JP7133453B2 - 神経精神障害を治療するための装置、システム及び方法 - Google Patents
神経精神障害を治療するための装置、システム及び方法 Download PDFInfo
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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。
少なくとも1つの電極を、三叉神経の分枝の少なくとも1つの皮膚分布上にある皮膚表面と接触するように、患者に皮膚的に取り付ける工程と;少なくとも1つの電極によって患者の三叉神経の少なくとも1つに調整可能な電気信号を印加する工程とを含む方法。
図6A~図6C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7は、眼窩上神経の皮膚刺激に曝露中の対象者における記録された電流、電荷、電流密度及び電荷密度を要約する。図7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。
1.患者の顔面の第1の領域に配置するように構成された第1の接触子対と;患者の顔面の第2の領域に配置するように構成された第2の接触子対と;第1の接触子対と第2の接触子対とを接続する絶縁接続領域とを含む、神経精神障害を治療するための三叉神経刺激用皮膚電極アセンブリであって、第1の接触子対及び第2の接触子対が、三叉神経の少なくとも1つの分枝の皮膚分布上にある患者の顔面の一部分と接触するように、且つ頭蓋の表面下への電流浸透を最小限として又は全くなしで前記神経の前記分枝を刺激するように構成される、皮膚電極アセンブリ。
2.三叉神経の少なくとも1つの分枝が、表在性の眼分枝、眼窩下分枝、及びオトガイ分枝からなる群から選択される、請求項1に記載の皮膚電極アセンブリ。
3.三叉神経の少なくとも1つの分枝が眼窩上神経である、請求項1に記載の皮膚電極アセンブリ。
4.三叉神経の少なくとも1つの分枝が耳介側頭神経である、請求項1に記載の皮膚電極アセンブリ。
5.三叉神経の少なくとも1つの分枝が頬骨顔面神経である、請求項1に記載の皮膚電極アセンブリ。
6.電極アセンブリを患者の前額に固定するように構成された保持要素をさらに含む、請求項1に記載の皮膚電極アセンブリ。
7.神経精神障害がうつ病である、請求項1に記載の電極アセンブリ。
8.神経刺激器と;患者の顔面の第1の領域に配置するように構成された第1の接触子対と、患者の顔面の第2の領域に配置するように構成された第2の接触子対と、第1の接触子対と第2の接触子対とを接続する絶縁接続領域とを含む皮膚電極アセンブリと;を含む神経精神障害又は病態の治療用三叉神経刺激システムであって、第1の接触子対及び第2の接触子対が、三叉神経の少なくとも1つの分枝の皮膚分布上にある患者の顔面の一部分と接触するように構成される、システム。
9.神経刺激器と皮膚電極アセンブリとを動作可能に接続するケーブル及びリードワイヤをさらに含む、請求項8に記載のシステム。
10.電流出力を調節して頭蓋骨の表面下への電流浸透を最小限にするように、又は回避するように構成された調節装置をさらに含む、請求項8に記載のシステム。
11.三叉神経の少なくとも1つの分枝が、表在性の眼分枝、眼窩下分枝、及びオトガイ分枝からなる群から選択される、請求項8に記載のシステム。
12.電極アセンブリを患者の前額に固定するように構成された保持要素をさらに含む、請求項8に記載のシステム。
13.三叉神経の少なくとも1つの分枝が眼窩上神経である、請求項8に記載のシステム。
14.三叉神経の少なくとも1つの分枝が耳介側頭神経である、請求項8に記載のシステム。
15.三叉神経の少なくとも1つの分枝が頬骨顔面神経である、請求項8に記載のシステム。
16.神経精神障害又は病態の治療用三叉神経刺激キットであって、請求項1に記載の皮膚電極アセンブリと;神経精神障害を治療するための患者に対する電極アセンブリの配置についての説明書とを含むキット。
17.神経刺激器と;神経精神障害を治療するための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16に記載のキット。
18.三叉神経刺激による神経精神障害の治療方法であって、電極アセンブリを患者に取り付ける工程であって、電極アセンブリが、患者の顔面の第1の領域に配置するように構成された第1の接触子対と、患者の顔面の第2の領域に配置するように構成された第2の接触子対と、第1の接触子対と第2の接触子対とを接続する絶縁接続領域とを含み、第1の接触子対及び第2の接触子対が、三叉神経の少なくとも1つの分枝の皮膚分布上にある患者の顔面の一部分と接触するように構成される、工程と;頭蓋骨下への電流浸透を最小限として神経精神障害を治療する特定の動作パラメータで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。
19.電気信号を印加する工程が、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ことを含む、請求項18に記載の方法。
20.電極アセンブリが、眼窩上神経を覆う皮膚表面と接触するように患者に取り付けられる、請求項18に記載の方法。
21.電極アセンブリが、耳介側頭神経を覆う皮膚表面と接触するように患者に取り付けられる、請求項18に記載の方法。
22.電極アセンブリが、頬骨顔面神経を覆う皮膚表面と接触するように患者に取り付けられる、請求項18に記載の方法。
23.神経精神障害がうつ病である、請求項18に記載の方法。
Claims (1)
- 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膚電極アセンブリであって、
絶縁性領域と、
前記絶縁性領域の一方の側に取り付けられており、且つ患者の前額の一方の側にある眼神経上の皮膚に配置するように構成された第1の接触子対と、
前記絶縁性領域の他方の側に取り付けられており、且つ前記患者の前額の他方の側にある残りの眼神経上の皮膚に配置するように構成された第2の接触子対と、
を含む皮膚電極アセンブリと
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の接触子対と前記第2の接触子対とが、前記患者の前額の一方の側にある眼神経上と前記患者の前額の他方の側にある残りの眼神経との間の間隔に相当する距離で、固定された状態で分離されており、
前記第1の接触子対の各々の高さが前記第1の接触子対の各々の長さより小さくなるような細長の形を、前記第1の接触子対の各々が含み、
前記第2の接触子対の各々の高さが前記第2の接触子対の各々の長さより小さくなるような細長の形を、前記第2の接触子対の各々が含み、
前記患者の前額の一方の側にある眼神経が、前記患者の前額の一方の側にある眼窩上神経、滑車上神経、又はその両方を含み、
前記患者の前額の他方の側にある残りの眼神経が、前記患者の前額の他方の側にある残りの眼窩上神経、残りの滑車上神経、又はその両方を含み、
前記第1の接触子対の中点と前記第2の接触子対の中点が、前記患者の前額の一方の側にある眼神経と前記患者の前額の他方の側にある眼神経との間の予測される間隔で、固定された状態で分離されており、
前記パルス発生器が、電流0.05mA~5mAを前記皮膚電極アセンブリに印加するよう構成されており、
前記パルス発生器と前記皮膚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み、
最大電荷平衡出力電流を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み、
前記パルス発生器が、周波数20~300ヘルツ、パルス持続時間50~125マイクロ秒、25mA/cm2以下の出力電流密度及び前記患者の大脳皮質において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ており、
前記神経精神障害が心的外傷後ストレス障害である、システム。
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JP2008246040A (ja) | 2007-03-30 | 2008-10-16 | Shinshu Univ | 三叉神経固有知覚枝刺激装置 |
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