JP2008539901A - 肺静脈口を画像として再構築する予成形した位置確認カテーテル及びシステム - Google Patents
肺静脈口を画像として再構築する予成形した位置確認カテーテル及びシステム Download PDFInfo
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Abstract
【選択図】図1
Description
本発明は、一般的に、組織を治療するシステムに関し、より具体的には、肺静脈などの血管口やその他の生体構造の開口内および周囲の組織を切除するシステムに関する。
心臓の正常な洞調律は、電気的インパルスを生成する洞房結節(又は「SA結節」)で始まる。このインパルスは、通常、右心房と左心房、及び心房中隔を通って房室結節(又は「AV結節」)へと伝達する。この伝達によって、心房が組織化した態様で収縮し、心房から心室に血液を輸送して、心室に定期的な刺激を提供している。AV結節は、房室束(「HIS」束)への伝達遅延を調節する。この心臓の電気的活性の調節によって、心室拡張期に心房収縮期が生じる。これは心臓の機械的機能を改善する。心臓の生体構造的異物が、心房における電気的インパルスの正常な均一な伝達を妨げると心房細動が起きる。これらの生体構造的異物(「伝導遮断」と呼ばれる)によって、電気的インパルスがこの異物周りを循環しているいくつかの円形ウェーブレットを悪化させることがある。これらのウェーブレットは、「リエントリ回路」とよばれ、左右の心房の正常な均一活性化を妨げる。
本発明の第1の態様によれば、生体構造血管(例えば、肺静脈)の口近傍の組織に医療処置を実行するカテーテルが提供されている。このカテーテルは、近位シャフト部と遠位シャフト部とを具える細長の可撓性カテーテル本体と、遠位シャフト部に担持されたトラッキング要素を具える。近位部分は、血管口内に挿入する大きさの頂部を有する湾曲部を形成するように予成形されており、遠位部分は、血管口内に挿入されたときにこの湾曲部頂部が近傍組織に接触するように構成されている。非限定的な例によれば、この構成により血管口近傍の組織位置を決定することができる。
図1を参照すると、本発明によって構成された例示的な組織切除システム2が示されている。例えば、例えば脈管構造又は消化管を通って、複雑な侵襲的外科処置を行うことなく身体内部領域へのアクセスが得られる場合は、治療及び診断目的のためにルーメン、チャンバ又は体腔内でシステム2を用いることができる。例えば、このシステム2は、心臓内の不整脈の症状の診断及び治療に適用することができる。また、このシステム2は、胃腸管、前立腺、脳、胆嚢、子宮、及びその他の身体の病気の治療に適用される。以下においては、このシステム2は、例として、肺静脈用、特に異所性心房細動を治療するために、肺静脈の口内に基質を生じさせる一又はそれ以上の不整脈を心臓の左心房から電気的に絶縁するためのものとして記載する。
切除/サブマッピングシステム4は、例えば、異常伝導経路といったターゲット組織部位を同定して治療するように構成されている。このため、切除/マッピングサブシステム4は、従来のガイドシース12と、ガイドシース12を通って案内することができる切除/マッピングカテーテル14とを具える。以下で更に詳細に述べるように、切除/マッピングカテーテル14は、患者の脈管構造を通って心臓の左心房内に導入するように構成されており、選択した肺静脈の口内及び/又は周囲の心臓組織を切除してマッピングするのに使用することができる。また、切除/マッピングサブシステム4は、マッピングプロセッサ16及び切除エネルギィ源、特に、高周波発生器18を具える。マッピングプロセッサ16と高周波発生器18は、別々の構成要素として示されているが、代替的にこれらを単一の一体デバイスに組み込んでもよい。
マッピングプロセッサ16は、心臓内での電気信号、特に肺静脈口近傍の電気信号を検出して処理し、記録するように構成されている。外科医は、これらの電気信号に基づいて、切除するべき肺静脈口近傍の特定のターゲット組織を同定して、肺静脈口内の基質の原因となる不整脈を切除処置によって確実に電気的に絶縁することができる。このようなマッピング技術は本技術分野でよく知られており、従って、簡潔にするために、更なる詳細については述べない。
高周波発生器18は、マッピングプロセッサによって認識された標的組織部位を切除するように制御された方法で切除/マッピングカテーテル14に切除エネルギィを送出するように構成されている。代替として、例えば、マイクロ波発生器、超音波発生器、冷凍切除器、及びレーザ又はその他の光パルス発生器などの、高周波発生器18以外のその他の型の切除源を用いることができる。心臓内の組織の切除は当業者には公知であり、従って、簡単にするために、高周波発生器18についての更なる詳細は記載しない。高周波発生器に関する更なる詳細は米国特許第5,383,874号に記載されている。
切除/マッピングカテーテル14は、ガイドシース12を通って標的位置に進めることができる。シース12は、切除/マッピングカテーテル14の動作中の摩擦を低減するために滑らかであり、従来のやり方でガイドワイヤの上を進めることができる。代替として、操縦可能なシースを設けても良い。材料に関しては、シース12の近位部分は、Pebax(登録商標)材料及びステンレススチールブレイズ複合材料が好ましく、遠位部分は、操縦の目的のために、網状でないPebax(登録商標)などのより可撓性のある材料であることが好ましい。また、シース12は、切除/マッピングカテーテル14よりも硬質である。切除/マッピングカテーテル14をシース12内に導入する場合に、バスケットカテーテルと組み合わせて用いられるものなどのシース導入器(図示せず)を用いることができる。ガイドシース12は、バリウム等のX線不透過性化合物を含んでおり、X線透視画像又は超音波画像等を用いてガイドシース12を見られることが好ましい。代替として、X線透視マーカ(図示せず)をガイドシース12の遠位端に配置するようにしてもよい。
切除/マッピングカテーテル14は、一体化した可撓性カテーテル本体20と、遠位側に取り付けた複数の操作要素、特に、組織切除要素22及びマッピング要素24と、近位側に取り付けたハンドル26とを具える。カテーテル本体20は、近位部材28と、遠位部材30を具え、これらは、好ましくは、オーバーラッピング熱接合でインターフェイス32において互いに接着されている、あるいは、「突き合わせ接合」と呼ばれるスリーブで端部と端部を接着接合されている。代替として、一体化カテーテル本体20は、後に一体化する別々の近位部材28と遠位部材30とを有しておらず、代わりに、一体的なボディデザイン(unibody design)を有するようにしてもよい。
図1に戻って参照すると、位置確認サブシステム6は、複数のトラッキング要素56と、複数の基準要素58と、基準要素58とトラッキング要素56に接続されたコントローラ/プロセッサ60とを具える。図1の切除/マッピングサブシステム4に示すように、トラッキング要素56(この場合は、近位要素56(1)、中間要素56(2)、及び遠位要素56(3))は、マッピング/切除カテーテル14の遠位部材30に担持されている。重大なことは、図2及び3に示すように、近位トラッキング要素56(1)が近位部分42の近位端に配置され、中間要素56(2)が中間部分42の近位端に配置され、遠位部分56(3)が遠位部分44の近位端に配置されることである。
図1を更に参照すると、グラフィックユーザインターフェイス8は、画像プロセッサ62と、ユーザ入力デバイス64と、出力デバイス66(特に、モニタ)とを具える。画像プロセッサ62は、図16に示すように、コンピュータ処理画像表示Sの形で、内部生体構造表面(この場合、選択した肺静脈口Oを含む心臓の左心房内の心内膜表面)の画像を生成するように構成されている。この画像は次いで、モニタ66上の3−Dディスプレイウィンドウ72に表示される。3次元画像プロセッサ62は、マッピング/切除カテーテル14が、肺静脈口を含む左心房のキャビティ内を動き回るときに、位置確認サブシステム6から、地球座標系内でのトラッキング要素56の位置を取得し、この表面画像S(特に、生体構造外郭)をカテーテル14の遠位チップの位置に変形することによって、この画像生成を行う。これは、トラッキング要素56の取得した位置と、カテーテル14の既知のジオメトリから推定される。
Claims (8)
- 生体構造血管口近傍の組織に医療処置を実行するカテーテルにおいて:
近位シャフト部と、血管口内に挿入する大きさの頂部を有する曲線を形成するように予成形した近位部分と、前記曲線頂部を血管口に挿入するときに前記近傍組織に接触するように構成された遠位部分とを有する遠位シャフト部とを具える細長可撓性カテーテル本体と;
前記遠位シャフト部によって担持される少なくとも一のトラッキング要素と;
を具えることを特徴とするカテーテル。 - 請求項1に記載のカテーテルにおいて、前記遠位部分が、前記曲線頂部を血管口内に挿入するときに、前記血管口と非放射状関係に配置されるように構成されていることを特徴とするカテーテル。
- 請求項1に記載のカテーテルにおいて、前記遠位シャフト部が、前記曲線と反対方向に屈曲するもう一つの曲線を形成するように予成形された中間部分を更に具えることを特徴とするカテーテル。
- 請求項3に記載のカテーテルにおいて、前記曲線が単純曲線であり、前記もう一つの曲線が、前記単純曲線と反対方向に、面外の方向に屈曲する複合曲線であることを特徴とするカテーテル。
- 請求項4に記載のカテーテルにおいて、前記少なくとも1つのトラッキング要素が少なくとも3つのトラッキング要素を具え、第1のトラッキング要素が前記近位部分に担持されており、第2のトラッキング要素が前記中間部分によって担持されており、第3のトラッキング要素が前記遠位部分によって担持されていることを特徴とするカテーテル。
- 生体構造血管口近傍の組織に医療処置を実行するカテーテルシステムにおいて:
請求項1に記載のカテーテルと;
少なくとも1つのトラッキング要素の座標系内の位置を決定するように構成されたカテーテルナビゲーションサブシステムと;
を具えることを特徴とするカテーテルシステム。 - 請求項6に記載のカテーテルシステムにおいて、前記カテーテルナビゲーションサブシステムが、前記決定した少なくとも1つのトラッキング要素の位置に基づいて、前記血管口を画像に再構築するように構成した画像ナビゲーションサブシステムであることを特徴とするカテーテルシステム。
- 請求項6に記載のカテーテルシステムにおいて、前記カテーテルが前記遠位部分に担持されている治療又は診断要素を具え、前記カテーテルナビゲーションサブシステムが、前記決定した少なくとも1つのトラッキング要素の位置に基づいて前記診断又は治療要素の位置を決定するように構成されているカテーテルシステム。
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JP2018509981A (ja) * | 2015-05-11 | 2018-04-12 | セント・ジュード・メディカル,カーディオロジー・ディヴィジョン,インコーポレイテッド | 高密度マッピングおよびアブレーションカテーテル |
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US20140018797A1 (en) | 2014-01-16 |
US9320564B2 (en) | 2016-04-26 |
US8784414B2 (en) | 2014-07-22 |
WO2006121916A1 (en) | 2006-11-16 |
CA2607935C (en) | 2014-07-08 |
US8535303B2 (en) | 2013-09-17 |
WO2006121883A1 (en) | 2006-11-16 |
CA2607935A1 (en) | 2006-11-16 |
US20060253116A1 (en) | 2006-11-09 |
EP1876985B1 (en) | 2016-08-31 |
JP5188389B2 (ja) | 2013-04-24 |
US20060253115A1 (en) | 2006-11-09 |
EP1876985A1 (en) | 2008-01-16 |
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