JP4125357B2 - 機能的または治療的神経筋刺激を提供するための携帯式アセンブリ、システムおよび方法 - Google Patents
機能的または治療的神経筋刺激を提供するための携帯式アセンブリ、システムおよび方法 Download PDFInfo
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Description
本発明は、神経筋刺激を提供するためのシステムおよび方法に関する。
神経筋刺激は、機能結果および/または治療結果を奏し得る。既存のシステムおよび方法は、神経筋刺激を必要とする個体に顕著な利益をもたらし得るが、多 くの生活の質の問題が依然として残っている。例えば、既存のシステムは、単一の用途のための刺激機能を行う。さらに、これらのコントローラは、今日の標準では、操作および持ち運びには比較的大きくかつ扱いにくい。
本発明により、以下が提供される。
(項目1)
神経筋刺激アセンブリであって、該アセンブリは、
標的とされた神経組織領域または筋組織領域において埋め込むための大きさにされかつそのように構成された少なくとも1つの電極、
該電極に電気的に結合し、かつ外部皮膚表面を貫通して突出している露出領域を備える、経皮的導線、
該外部皮膚表面に装着されるような大きさにされかつそのように構成されたキャリア
刺激パルスを発するように構成された該キャリアを基板上に保持した回路、および
該回路に電気的に結合した該キャリアを該基板上に保持した電極接続要素であって、該電極接続要素は、該電極を該回路に電気的に結合するように、該導線の 露出領域の少なくとも一部分を電気的に係合して、該刺激パルスを該組織領域に経皮的に印加するような大きさにされかつそのように構成されている、電極接続要素、
を備える、神経筋刺激アセンブリ。
(項目2)
項目1に記載のアセンブリであって、該アセンブリは、前記回路に電気的に結合された前記キャリアを基板上に保持した電力入力ベイをさらに備え、該電力入力 ベイは、取り外すことができかつ交換することができる電源を保持するような大きさにされかつそのように構成されている、アセンブリ。
(項目3)
項目2に記載のアセンブリであって、該アセンブリは、プリセットスケジュールに従って、前記電源の取り外しおよび交換を命令する指示をさらに備える、アセンブリ。
(項目4)
前記電源は、バッテリーを含む、項目2に記載のアセンブリ。
(項目5)
前記少なくとも1つの電極は、三頭筋に分布する末梢運動神経において埋め込むための大
きさにされかつそのように構成されている、項目1に記載のアセンブリ。
(項目6)
神経筋刺激アセンブリであって、該アセンブリは、
少なくとも1つの電極、
外部皮膚表面に装着されるような大きさにされかつそのように構成されたキャリア、
該電極に刺激パルスを発するように構成された該キャリアを基板上に保持した回路、
該回路に電気的に結合した該キャリアを基板上に保持した電力入力ベイであって、該電力入力ベイは、取り外すことができかつ交換することができる電源を保持するような大きさにされかつそのように構成されている、電力入力ベイ、
プリセットスケジュールに従って該電源の取り外しおよび交換を命令する指示、および
該プリセットスケジュールに従って該回路を再充電するための電源
を備える、神経筋刺激アセンブリ。
(項目7)
前記電源はバッテリーを含む、項目6に記載のアセンブリ。
(項目8)
前記電極は、標的とされた神経組織領域または筋組織領域において埋め込むための大きさにされかつそのように構成されている、項目6に記載のアセンブリ。
(項目9)
前記電極は、外部皮膚表面に配置するための大きさにされかつそのように構成されている、項目6に記載のアセンブリ。
(項目10)
前記少なくとも1つの電極は、三頭筋に分布する末梢運動神経と関連して配置するための大きさにされかつそのように構成されている、項目6に記載のアセンブリ。
(項目11)
神経筋刺激アセンブリであって、該アセンブリは、
少なくとも1つの電極、
外部皮膚表面に装着されるような大きさにされかつそのように構成された、キャリア、
該電極に刺激パルスを発するように構成された該キャリアを基板上に保持した回路、および
該回路に電気的に結合された該キャリアを基板上に保持した通信ベイであって、該通信ベイは、該回路と外部デバイスとの間のワイヤレス通信を確立するような大きさにされかつそのように構成されている、通信ベイ、
を備える、神経筋刺激アセンブリ。
(項目12)
神経筋刺激アセンブリであって、該アセンブリは、
標的とされた神経組織領域または筋組織領域の刺激のための大きさにされかつそのように構成されている、少なくとも1つの表面取り付け電極、
外部皮膚表面に装着されるような大きさにされかつそのように構成されたキャリア、
刺激パルスを発するように構成された該キャリアを基板上に備えるプログラム可能回路、
該回路に電気的に結合された該キャリアを基板上に保持した電力入力ベイ、ならびに
該回路に電気的に結合した該キャリアを基板上に保持した電極接続要素であって、該電極接続要素は、少なくとも1つの電極を該回路に電気的に結合して、該刺激パルスを該組織領域に印加するような大きさにされかつそのように構成されている、電極接続要素、
を備える、神経筋刺激アセンブリ。
(項目13)
表面取り付けリターン電極をさらに備える、項目12に記載のアセンブリ。
(項目14)
項目12に記載のアセンブリであって、前記プログラム可能回路に電気的に結合された前記キャリアを基板上に保持した通信ベイをさらに備え、該通信ベイは、該回路と外部デバ
イスとの間のワイヤレス通信リンクを確立する様な大きさにされかつそのように構成されている、アセンブリ。
(項目15)
経皮電極用の導入器であって、該導入器は、組織内の望ましい位置に進める間に、組織との接触から経皮電極を保護するような大きさにされかつそのように構成 されている内部管腔を規定する本体を備え、該本体は、該本体を選択したパッチに沿って進めるように選択的に変形することができる材料を含む、遠位組織穿通領域、および遠隔アクチュエーターの操作に応じて該遠位領域の変形を変化させるための該遠位領域に連結した機構、
を備える、導入器。
(項目16)
前記機構は、少なくとも1つのリニアモーターアセンブリを備える、項目15に記載の導入器。
(項目17)
処置についてC5−6四肢麻痺を評価する方法であって、少なくとも1つの電極、外部皮膚表面に装着されるような大きさにされかつそのように構成されている キャリア、および該電極に刺激パルスを発するように構成された該キャリアを基板上に保持した回路を備える神経筋刺激アセンブリを提供する工程、外部皮膚表面に該キャリアを配置して、該電極を三頭筋に分布する末梢運動神経に関連して配置する工程、ならびに該回路を作動させて、個人が、電気刺激に応答する、神 経分布した三頭筋を有するか否かを決定する工程を包含する、方法。
本発明は、プロテーゼによる神経筋刺激または治療的神経筋刺激を提供するための改善されたアセンブリ、システムおよび方法を提供する。
け電極へと、物理的かつ電気的に結合するための電極接続領域を備える。
本発明の種々の局面は、プロテーゼ目的または治療目的のために、機能的神経筋刺激を提供することに関連して記載される。それは、本発明に起因して生じる 特徴および利点が、この目的に十分適しているからである。さらに、本発明の種々の局面が他の目的を達成するためにも同様に適用され得ることが理解されるはずである。
(A.概要)
図1は、神経筋刺激アセンブリ10を示す。図2に示されるように、この神経筋刺激アセンブリ10は、使用時に、外部皮膚表面上に一時的に都合よく装着さ れ得るような大きさにされかつそのように構成される。「一時的」とは、神経筋刺激アセンブリ10の存在が、数時間から1ヶ月または2ヶ月の期間にわたって、不快感なく十分に許容され得ることを意味する;その後、神経筋刺激アセンブリ10は、取り外されかつ廃棄され得る。
その最も基本的な形態(図1および3を参照のこと)において、神経筋刺激アセンブリ10は、パッチまたはキャリア16を備える。このキャリア16は、望 ましくは、例えば、不活性な、形成されるかまたは機械加工されるプラスチック材料または金属材料から作製される、小型の、軽量のハウジングのような大きさにされかつそのように構成される。
キャリア16の下面の少なくとも一部分(図1および図3を参照のこと)は、接着領域18を備える。接着領域18の機能は、使用している間に、このキャリ ア16を外部皮膚表面に一時的に固定することである。例えば、不活性な従来の感圧式接着剤が使用され得る。望ましくは、この接着領域は、皮膚刺激または表在性感染(これにより早く外れすぎてしまうことになり得る)を防ぐ、静菌性シーラントを含む。
キャリア16は、電子ポッド20をさらに備え、この電子ポッドは、望ましい電流パターンを発生させ、かつ外部プログラミングシステムまたはコントローラ46とワイヤレスで通信し得る。
図4A/4Bおよび図12A/12Bに示されるように、電子ポッド20はまた、電極接続領域28を備える。電極接続領域28の機能は、経皮電極導線12 の末端を電子ポッド20の回路24に物理的かつ電気的に結合することである(図10に示されるように)。この電極接続領域28は、高度に選択的な刺激パターンが電極14を介して印加され得るように、チャネル(各電極14が、チャネルを含む)に電流パターンを分布させる。4つのチャネル(ポッド20上の番 号付けされた1〜4)が、図4A/4Bおよび図12A/12Bに示される。
とき(図11を参照のこと)、キャリア16は、そのエレクトロニクスポッド20をキャリア16のエレクトロニクスベイ22にスナップばめすることによって、電子ポッド20の上に配置され得る。ポッド20上の電気的接続領域または接触62は、キャリア16上の嵌合接続領域または接触に電気的に結合して、そ のポッド20上の回路24を、キャリア16によって保持される電源42に結合する。
図3に戻って参照すると、このキャリア16は、電力入力ベイ40をさらに備え得る。電力入力ベイ40の1つの機能は、交換可能なかつ(望ましくは)使い 捨ての電池42(例えば、アルカリ電池またはリチウム電池)を取り外し可能に受容することである。この電池42は、電子ポッド20に電力を提供する。望ましい場合(図3を参照のこと)、この電力入力ベイ40は、ヒンジ付きカバー44を備え得る。図12Bはまた、電池を受容する電力入力ベイ40の存在を示 す。あるいは、電池42は、その電池を電力入力ベイ40に固定するためにスナップばめ機構を用いて、ヒンジなしでそのカバーを形成してもよい。
ス46またはコンピューターと通信状態にするために使用され得ることが理解されるべきである(図13Bを参照のこと)。
電極14の構成およびこの電池が埋め込まれる様式は、変動し得る。代表的実施形態は、図14〜16を参照しながら記載される。
される場合)の身体に対する針状体の動きは、アンカー要素48を身体組織に露出することによってこの電極を配置するために使用される。この配置において、その針状体は、一旦電極14が望ましい領域に位置されると、取り外される。
曲トルクが付与され、偏向が引き起こされる。例えば、左側モーター76Lを右側モーター76Rより速く前方向の速度で駆動すると(あるいは左側モーター76Lを駆動すると同時に、右側モーター76Rを逆方向に駆動すると)、図17Cに示されるように、針伸長部74が右に偏向する。対照的に、左側モーター 76Lを右側モーター76Rより遅い速度で駆動すると(または右側モーター76Rを前方向に駆動すると同時に、左側モーター76Lを逆方向に駆動すると)、図17Bに示されるように、針伸長部74が左に偏向する。
取り付ける前に、臨床医は、特定の筋肉領域および/または神経領域を同定し、この領域に、神経筋刺激アセンブリ10を用いて命令した治療が、印加され る。神経筋刺激アセンブリ10を用いることで可能なこの特定の型の治療は、後に記載される。一旦特定の筋肉領域および/または組織量域が同定されると、電子ポッド20(または電子ポッド20と一体化されたキャリア16)が、この領域の上にある皮膚に配置され(図6を参照のこと)、ポッド/キャリアの一方の 半体の底部を感圧式接着剤で適所に固定される。先に述べたように、この接着領域は、望ましくは、皮膚刺激または表在性感染(これにより早く外れすぎてしまうことになり得る)を予防する静菌性シーラントを含む。
着領域18は、キャリア16を皮膚に固定する。電池42が、電力入力ベイ40に配置される。この神経筋刺激アセンブリ10は、使用する準備が整う。
(A.概要)
この神経筋刺激アセンブリ10および/または神経筋刺激システム54は、記載されるように、身体内部の筋肉または神経と、身体の外側の皮膚表面に取り付 けられた刺激発生器または記録機器との間に電気的接続を提供することによって、短期間の治療または診断試験の提供を可能にする。この神経筋刺激アセンブリ10および/または神経筋刺激システム54のプログラム可能コード26は、多くの神経筋刺激機能を行うためにプログラムされ得る。その機能の代表例は、例 示目的で記載される。
神経筋刺激アセンブリ10および/または神経筋刺激システム54を使用するCAMは、心血管耐久性、筋強度、および神経学的協調性を改善するために必要 な刺激を提供する。CAMを介して、この活動補助運動(active−assisted exercise)は、標的四肢の活動、随意運動を補助し、それによって、関節を動かすために必要とされる筋力の量を減らすために使用される技術である。この技術は、非常に低レベルで始まる個体の筋力を増すことにおい て有効であることが判明した。治療上の利益としては、罹患した関節の減少した炎症、運動範囲の改善、疼痛緩和、および機能する可動性の強
化が挙げられる。CAMは、連続的な受動運動(CPM)とは区別され、この受動運動は、四肢の随意運動なしで、ある運動範囲にわたる関節または四肢の運動である。
術後の瘢痕化(例えば、後に棘のようになる)は、大部分の整形外科手順なまたは神経外科手順の悩みである。瘢痕化または癒着は、治癒プロセスの間に通常 は別個の解剖学的構造と一緒に結合する瘢痕組織の繊維状の帯域であり、患者の外科的「失敗」についての共通の最も大きな理由のうちの1つである。才能のある外科医によってすばらしくかつ首尾よく行われる手術は、術後の治癒の間に身体が瘢痕化する傾向に起因して、短時間しかかからない。この神経筋刺激アセン ブリ10および/または神経筋刺激システム54を特定の外科手術創傷領域における筋肉または神経に適用することによって、比較的小さな運動で、組織が治癒している間に、瘢痕化が防止され得る。
特定の永久に埋め込まれる神経調節システムまたは神経刺激システム(例えば、尿失禁、癲癇処置のための迷走神経刺激、疼痛軽減のための脊髄刺激)を施す 前に、この神経筋刺激アセンブリ10および/または神経筋刺激システム54は、末端器官の一時的刺激を介して、処置が現実味のあるいくつかの保証を臨床医および彼らの患者に提供するために適用され得る。このことは、その臨床医が、永久処置の候補でないか、そうでなければ、永久的なシステムの外科的な埋め込 みの努力に値する処置の効果が見出されないかもしれない患者をスクリーニングすることを可能にする。
かを同定する。個体はまた、三頭筋の刺激の間に彼らの肘をさらに伸ばし得ることを実証することによって、彼らの二頭筋が、三頭筋の刺激の力を超えることができなければならない。通常、このことは、個人に彼らの手を口元に持って行くように依頼することによって試験され得る。
神経的欠損を有する個体(例えば、脳卒中から生存した人または多発性硬化症を有する人)は、ある身体機能の制御を失っている可能性がある。脳は、皮質 マップまたは脊髄−根境界を再構成し、補助的に血流(これは神経回復に寄与する)を増加させることによって、「神経可塑性」といわれるプロセスを介して、機能的に回復し得る。神経筋刺激アセンブリ10および/または神経筋刺激システム54を身体の罹患した領域に適用し、脳に悉無的反応 (excitation)および入力を提供することによって、神経可塑効果が発生し得、脳が、失われた機能の制御を再学習および再獲得することができるようになる。
一時的な神経毒(例えば、ボトックス)の使用が、歩行、姿勢の維持および日常活動の改善を補助するために脳性麻痺、頭部損傷、多発性硬化症、および脊髄 損傷が原因の重篤な筋痙攣を処置することにおいて広く行き渡った。ボトックスはまた、視線が交差するかまたは連続的に瞬いてしまう目の状態を処置するために使用され得る。加齢過程を制限することによって、しわをなくすることもまた意味される。この神経筋刺激アセンブリ10および/または神経筋刺激システム 54は、神経および筋肉を一時的に麻痺させる必要なく、痙攣を軽減する代替手段として使用され得る。この神経筋刺激アセンブリ10および/または神経筋刺激システム54はまた、TMJ(顎関節)障害を処置することにおいて
有用であり得る。この障害は、顎の領域における疼痛および関連する筋肉の痙攣、ならびに通常の会話の動き、顔の表情、食べること、噛むこと、および飲み込むことを行う能力における制限によって現れる。
身体のあらゆる領域における局所的な疼痛は、神経筋刺激アセンブリ10および/または神経筋刺激システム54を、実行される領域に直接適用することに よって、このアセンブリおよび/またはシステムで処置され得る。この神経筋刺激アセンブリ10および/または神経筋刺激システム54は、疼痛シグナルが脳に達しないように妨害または遮断することによって作用する。
術後の体力および筋機能の回復は、神経筋刺激アセンブリ10および/または神経筋刺激システム54を用いて促進され得る。このアセンブリ10および/ま たはシステム54は、単独でかまたは能動的な運動のプログラムとともに、筋肉刺激の一時的レジメンを提供して、術後の筋肉の活動状態(tone)、機能および調子を回復することにおいて個体を補助するために、適切な筋肉領域と関連づけて術後に指示され、取り付けられ得る。
この神経筋刺激アセンブリ10および/または神経筋刺激システム54は、脚の筋肉を刺激することによって抗血栓症治療を提供し得、このことは、静脈によ る戻りを増し、可視における血液の滞留と関連した血餅を予防する。慣用的な術後治療は、現在は、床についている間に患者が彼らのふくらはぎに装着している空気式圧迫帯(pneumatic
compression cuff)を使用することである。その圧迫帯は、ふくらはぎの筋肉を周期的にかつ機械的に圧迫し、それにより、静脈の流れを刺 激する。患者は、これを嫌うが、現在では病院の全ての外科用ベッドに、取り付けられたこのユニットがある。この同じ効果が、神経筋刺激アセンブリ10を取り付けることによって再現され得る。予防は、手術の間に始められる場合に最も効果的であり、同じだけ、そうでない場合は、大部分、手術の間に血餅が形成さ れる。従って、手術の開始時に、神経筋刺激アセンブリ10を取り付け、神経筋刺激システム54の使用を開始することが望ましい。
周期的な筋肉収縮は、骨粗鬆症を予防し、(おそらくは)改善するに十分、骨に負荷を与える。このような処置の有効性は、頻度依存性であることが公知であ る。この神経筋刺激アセンブリ10および/または神経筋刺激システム54は、骨粗鬆症を予防/改善するために適切な頻度で筋肉を刺激するようにプログラムされ得る。
麻痺性の疾患または損傷に起因して失われた運動の回復が達成され得る。この神経筋刺激アセンブリ10および/または神経筋刺激システム54は、外部コン トロール源(例えば、歩行をモニタリングするヒールスイッチ)を介してリアルタイムでワイヤレスで制御され得る。この外部コントロール源は、プリセット期間の間に活性にするために、神経筋刺激システムを誘発し、個人の下肢または上肢における機能的な運動を可能にし、それにより、以前は機能していなかった麻 痺した四肢を回復させる。
ヒトの解剖学的構造の筋肉特性は高められ得、その全体的な筋肉輪郭は、筋肉の特定の群を神経筋刺激することによって変化され得る。例は、腹部領域の刺激 であり、筋力が増し、筋肉の調子および輪郭が改善される。この神経筋刺激アセンブリ10および/または神経筋刺激システム54は、体格を変化させ、活発な運動の影響を補助するために、適切
な頻度で筋肉を刺激するようにプログラムされ得る。
Claims (12)
- 神経筋刺激アセンブリであって、該アセンブリは、
標的とされた神経領域または筋領域またはその付近の外部皮膚表面に移植されるような大きさにされかつそのように構成された少なくとも1個の電極、
経皮的導線であって、該電極に電気的に結合され、そして外部皮膚領域を通って突出する露出領域を備える、経皮的導線、
該外部皮膚領域に装着されるような大きさにされかつそのように構成されたキャリアであって、該キャリアは、
(a)刺激パルスを発するように構成された回路、
(b)該回路を保持するような大きさにされかつそのように構成されており、処置の経過の間取り外し可能かつ交換可能である、電子ポッド、および
(c)該回路に電気的に結合された電極接続要素であって、該導線の露出領域の少なくとも一部を電気的に係合し、該回路への電極を電気的に結合して、該刺激パルスを該組織領域に経皮的に印加するような大きさにされかつそのように構成されている、電極接続要素、
を備える、キャリア、
を備える、神経筋刺激アセンブリ。 - 前記電子ポッドが、電源を保持するような大きさにされかつそのように構成されている、請求項1に記載のアセンブリ。
- 前記電子ポッドが、取り外し可能かつ交換可能であり得る電源を保持するような大きさにされかつそのように構成されている、請求項1に記載のアセンブリ。
- プリセットスケジュールに従って、前記電源の取り外しおよび交換を命令する指示をさらに備える、請求項3に記載のアセンブリ。
- 前記電源は、バッテリーを含む、請求項2または3に記載のアセンブリ。
- 前記キャリアを基板上に保持した回路が、前記刺激パルスの発生を制御するプログラム可能コードを備える、請求項1に記載のアセンブリ。
- 前記プログラム可能コードが、ユーザーによってプログラム可能である、請求項6に記載のアセンブリ。
- 前記電子ポッドが、電源を保持するような大きさにされかつそのように構成されている、請求項7に記載のアセンブリ。
- 前記電子ポッドが、取り外し可能かつ交換可能であり得る電源を保持するような大きさにされかつそのように構成されている、請求項7に記載のアセンブリ。
- プリセットスケジュールに従って、前記電源の取り外しおよび交換を命令する指示をさらに備える、請求項9に記載のアセンブリ。
- 前記電源は、バッテリーを含む、請求項8または9に記載のアセンブリ。
- 前記キャリアが、(d)該キャリアを前記外部皮膚表面に接着させ、そして該外部皮膚表面からの該キャリアの取り外しを可能にするような大きさにされかつそのように構成された領域をさらに備える、請求項1に記載のアセンブリ。
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JP2006553270A Withdrawn JP2007531562A (ja) | 2004-02-12 | 2005-02-11 | 機能的または治療的神経筋刺激を提供するための携帯式アセンブリ、システムおよび方法 |
JP2007146323A Active JP4125357B2 (ja) | 2004-02-12 | 2007-05-31 | 機能的または治療的神経筋刺激を提供するための携帯式アセンブリ、システムおよび方法 |
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JP2007268293A (ja) | 2007-10-18 |
AU2005214041A1 (en) | 2005-09-01 |
EP1720606A4 (en) | 2009-12-30 |
US20080154335A1 (en) | 2008-06-26 |
WO2005079295A2 (en) | 2005-09-01 |
CA2554676A1 (en) | 2005-09-01 |
EP1720606A2 (en) | 2006-11-15 |
HK1098715A1 (en) | 2007-07-27 |
AU2005214041B2 (en) | 2011-08-25 |
US7376467B2 (en) | 2008-05-20 |
JP2007531562A (ja) | 2007-11-08 |
CA2554676C (en) | 2015-06-02 |
WO2005079295A3 (en) | 2006-04-27 |
ATE520440T1 (de) | 2011-09-15 |
ES2395128T3 (es) | 2013-02-08 |
US20050182457A1 (en) | 2005-08-18 |
EP1720606B1 (en) | 2011-08-17 |
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