JP2761440B2 - Ｒ−ｆアブレーションを行うための方法及び装置 - Google Patents

Ｒ−ｆアブレーションを行うための方法及び装置

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Publication number
JP2761440B2
JP2761440B2 JP7507576A JP50757695A JP2761440B2 JP 2761440 B2 JP2761440 B2 JP 2761440B2 JP 7507576 A JP7507576 A JP 7507576A JP 50757695 A JP50757695 A JP 50757695A JP 2761440 B2 JP2761440 B2 JP 2761440B2
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Japan
Prior art keywords
catheter system
ablation catheter
ablation
electrode
catheter body
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Expired - Lifetime
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JP7507576A
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JPH09500810A (ja
Inventor
ミューリアー，ピーター・エム・ジェイ
ホーイ，マイケル・エフ
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Medtronic Inc
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Medtronic Inc
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Description

【発明の詳細な説明】 発明の背景 本発明は、心臓手術用の装置の分野に関し、更に詳細
には、心臓組織のＲ−Ｆアブレーショ（ablation、表皮
剥脱）を行うための装置に関する。
本発明は、心臓の心房及び心室が極めて速い拍動を示
す頻拍不整脈の治療に関する。特に、本発明は、心臓組
織内の異所性病巣（ectopic foci）により、又は心臓組
織内の迷走状態経路（aberrant condition pathway）の
存在による頻拍の治療に関する。
異所性病巣又は迷走状態経路を有することが確認さた
心臓組織を破壊することによって頻泊を治療するための
療法が開発された。前記エネルギ又は他の形態のエネル
ギを加えて望ましからぬ心臓組織を破壊することを含む
種々の方法がとられた。心臓組織のアブレーションは、
例として、無線周波数電流、マイクロ波エネルギ、熱、
電気パルス、クライオサーミー（cryothermy）、及びレ
ーザーによって行われた。現在では、非切開心臓（clos
ed heart）に挿入したカテーテルによって実施できるア
ブレーション術に関し、Ｒ−Ｆエネルギを使用したアブ
レーションが恐らく最も広く実施されている。
多くのＲ−Ｆアブレーションカテーテルは、心臓の心
内膜と接触するようになった電極を使用し、場合によっ
ては、米国特許第5,083,565号におけるように、心内膜
に侵入し、心筋に進入するようになっている。一般的に
は、Ｒ−Ｆアブレーションカテーテルは、電極の直ぐ近
くの心臓内膜及び心筋の内層を含む心臓組織の小さな病
変を誘導する上で有効である。しかしながら、医学会
は、頻拍と関連した心臓組織を効果的にアブレーション
処置するのに必要なＲ−Ｆエネルギ（焼灼）の適用数を
少なくするため、大きな病変をつくりだす装置が望まし
いと表明している。
Ｒ−Ｆアブレーションは、電極と接触した組織を、組
織の抵抗に誘導電流を流すことによって加熱する。実際
の加熱の程度は、予期できないところがある。しかしな
がら、温度は、Ｒ−Ｆ信号の持続時間及び振幅が増大す
るに従って高くなる傾向がある。所定の点を越えて組織
を加熱すると、組織の剥離や炭化を引き起こし、結果的
に、Ｒ−Ｆ電極と帰還電極との間のインピーダンスを高
くし、そのため、加熱プロセスが停止し、場合によって
は、炭化した組織に電極がくっついてしまう。この現象
に対する一つの方策は、電極の温度を設定されたパラメ
ータに維持するようにＲ−Ｆ信号を変調するためのフィ
ードバック制御と関連した熱電対をアブレーション電極
内に設けることである。一つのこのようなシステムは、
米国特許第5,122,137号に開示されている。
発明の概要 本発明は、Ｒ−Ｆアブレーションの一貫性及び効力を
改善することに関し、Ｒ−Ｆアブレーションによって誘
導された病変の全体としての大きさ及び程度を大きくす
ることに関する。これらの目的は、アブレーションを行
う場所の心筋にねじ込まれるようになった螺旋状電極を
使用したアブレーションカテーテルによって行われた。
螺旋状電極は、心内膜に挿入するための比較的真っ直ぐ
な即ち針状の電極と比べて大きな表面を提供し、更に、
Ｒ−Ｆ信号の適用中にカテーテルの位置を安定させるの
に役立つ。更に、螺旋状電極を除去した後、本質的に出
血が起こらない。そのため遺伝地図作製（mapping）を
行うため及びアブレーションを行うために多くの位置に
安全に配置することができる。
本発明の好ましい実施例における本発明の特徴は、リ
ンゲル液のような、毒性のない、不整脈を引き起こさな
い、導電性の溶液を、Ｒ−Ｆエネルギの適用前及び適用
中に電極の領域に入れることである。螺旋状電極は、そ
の好ましい実施例では、中空であり、導電性の溶液は、
電極に設けられた一つ又はそれ以上の開口部を通して患
部に適用される。Ｒ−Ｆ信号の適用前に注入された導電
性の溶液は、電極の近くの血液を移動させると考えられ
ている。リンゲル液の導電性は、例えば、血液（約３倍
乃至４倍）や心筋（約７倍）よりも遥かに大きく、誘導
電流の誘導に対する全体として抵抗は、電流の有効適用
領域を広い領域に亘って拡げることによって、病変の大
きさを拡張するのを助けるものと考えられる。焼灼中に
導電性溶液を適用することによって、組織の過熱を回避
し、Ｒ−Ｆ信号を長期間に亘って、通常は火傷や炭化を
生じる点を越えて適用できる。これらの要因は、両方と
も、Ｒ−Ｆエネルギを特定の位置に適用することによっ
てつくりだされた病変の全体としての大きさを増大する
のに寄与するものと考えられる。
図面の簡単な説明 第１図は、本発明による改良されたＲ−Ｆアブレーシ
ョン法を実行するようになったカテーテルの平面図であ
る。
第２図は、第１図に示すカテーテルの先端の断面図で
ある。
第３図、第４図、及び第５図は、第１図及び第２図に
示すカテーテルの螺旋状電極の変形例を示す部分断面側
面図である。
第６図は、Ｒ−Ｆエネルギの螺旋状電極への適用前及
び適用中に導電性溶液を投与するための関連した装置の
概略図である。
好ましい実施例の詳細な説明 第１図は、本発明に従ってＲ−Ｆアブレーションを行
うように特別に設計されたカテーテルの平面図である。
カテーテルは、絶縁外シース12を持つ細長いカテーテル
本体10を含む。シースは、ポリウレタン、テフロン、又
は他の生体親和性プラスチックでつくられているのがよ
い。螺旋状中空電極14がカテーテルの先端に配置されて
おり、この電極は、カテーテルの長さに亘って延びる内
部チューブ30の先端に連結されている。カテーテルの基
端には継手16が配置されており、この継手にはルエルロ
ック18が連結されている。ルエルロック（luer lock）1
8は、内部チューブ30の基端に連結されている。カテー
テルがルエルロック（luer lock）22に対して回転でき
るように旋回取り付け対20がルエルロック18に取り付け
られている。ルエルロック22は、リンゲル液のような導
電性の流体の供給源に連結されるようになっており、電
極14が心臓組織にねじ込まれた状態で、カテーテル及び
電極14を通してリンゲル液を供給することができる。電
極14に接続された電気コネクタ24が継手16から出てお
り、Ｒ−Ｆエネルギを心臓組織に加えるのに電極14を使
用できる。更に、電極14は、心臓内の電気曲線図の計測
や心臓の歩調取り即ちペーシングに適した低エネルギの
パルスを加えることによって心臓組織のペーシングを行
うといった他の関連した機能についても使用できる。使
用に当たっては、所望のアブレーション位置までカテー
テルを前進させる。この位置は、好ましくは、Ｒ−Ｆア
ブレーション術で現在使用されている心臓遺伝地図作製
と同様の方法で心臓遺伝地図作製を行うことによって予
め確認してある。カテーテルは、例えばバッジャー等に
賦与された米酷特許第5,030,204号に開示された操舵可
能な即ち案内可能なカテーテルに次々に入れることによ
って、又は例えばイスナーに賦与された米国特許第5,10
4,393号の固定形体案内カテーテルによって所望の位置
まで案内できる。これらの特徴について触れたことによ
り、両特許に開示されている内容は本明細書中に組み入
れたものとする。変形例では、1993年３月18日に発行さ
れたPCT特許出願第WO93/04724号に開示されているよう
な変形自在のスタイレットによって、又はギャンベール
等に賦与された米国特許第5,060,660号に開示されてい
るような変形自在の案内ワイヤによって、カテーテルを
心臓内の所望の場所まで前進させることができる。これ
らの特許について触れたことにより、両特許に開示され
ている内容は本明細書中に組み入れたものとする。中空
電極14は、所望の位置に配置されると、カテーテル本体
を回転させることによって心臓組織にねじ込まれる。カ
テーテル本体内のトルクケーブルは、カテーテルの基端
から中空電極14までトルクを1:1で伝達する。
所望の位置まで前進したとき、ルエルロック22をリン
ゲル液加圧供給源に連結する。適当な供給源を第６図と
関連して以下に詳細に論じる。しかしながら、本発明の
目的について、リンゲル液を大気圧で毎分1cc送出でき
るリンゲル液供給源が適当であることがわかっている。
リンゲル液の送出は、アブレーションが行われるべき組
織に電極14をねじ込む前、又はねじ込むときに開始しな
ければならない。動物実験では、本発明者は、Ｒ−Ｆエ
ネルギを送り出す前にリンゲル液を二分間に亘って送出
すると、大きいが制御された規則的な病変をつくりだす
のを補助するということがわかった。
電極を配置し、リンゲル液を所望の期間に亘って投与
した後、電気コネクタ24を、商業的に利用可能な種類
の、電気凝固組織の切断に使用されるＲ−Ｆ電気外科電
源に接続する。本発明者は、ブレンドトーム（Blendtom
e）の商標の電気外科発電機第755型、凝固設定番号第７
番、切断設定番号第１番を使用した。これらの設定で
は、大きな制御された病変をつくりだすのに、Ｒ−Ｆエ
ネルギを、長期間、例えば一分間位に亘って使用でき
る。しかしながら、期間をこれよりも長くしてもよいし
短くしてもよく、二十秒以下の期間をカウンタに表示で
き、このような短いＲ−Ｆ適用時間では、リンゲル液の
冷却効果により、実際には、病変の効果的な大きさが小
さくなるということがわかっているためである。
Ｒ−Ｆアブレーションを行った後、電極を心臓ペース
メーカーに接続でき、ペーシング閾値を計測する試みに
おいて、心臓ペーシングエネルギを病変場所に送ること
ができる。ペーシング閾値は、種々のエネルギレベルの
ペーシングパルスを送出することによって、例えばパル
スの振幅又は幅を変化させて心臓組織を脱分極するのに
有効な最小エネルギレベルを決定することによって計測
できる。本発明者は、病変が比較的同構造であると仮定
すると、ペーシング閾値が大きければ大きい程、病変の
大きさが大きいと考えているる。このように、病変の全
体としての大きさを概算するのに電極14を使用できる。
更に、電極は、頻拍が持続するかどうか及び頻拍と関連
した迷走状態又は異所性活性（ectopic activity）に電
極近傍の組織が関与しているかどうかを決定するのを助
けるカップルドEKG監視装置（coupled EKG monitoring
equipment）であるのがよい。
電極14の螺旋形体は、アブレーション電極と関連して
特に有利であると考えられる。電極が、血流の外で、心
臓組織内にねじ込まれ、この組織内に完全に配置される
ため、Ｒ−Ｆエネルギは、組織自体に限定される。心内
膜と接触するだけであるため、加えられたエネルギの大
部分が電極の場所に隣接した心臓内の血液中に散逸する
従来のＲ−Ｆアブレーション電極とは異なる。更に、血
流に加わえられたＲ−Ｆエネルギは、電極近くの血液を
凝結させ、電極が凝血により開路する（clots breaking
loose of electrode）危険が大きくなる。
更に、螺旋状の電極は、上文中で引用したパリンスの
特許で提案された針状電極と比べて表面積がかなり大き
く、また、Ｒ−Ｆエネルギを加えているときにカテーテ
ルを確実に固定するのに役立つ。更に、真っ直ぐな中空
電極を使用した場合には、電極が、液圧によってその挿
入場所から後方に抜けてしまうが、電極が螺旋錠である
ため、電極を通して加えられた導電性の溶液によって、
電極が、液圧によってその挿入場所から後方に引き抜け
ることがない。更に、螺旋状電極が構成する細長い行路
は、導電性の流体が針に沿って漏れ、心臓組織の外に出
る可能性を小さくする。
第２図は、第１図に示すカテーテルの端部の断面図で
ある。この図では、螺旋状電極14は内腔26を有し、この
内腔がチューブ30の内腔と連通しているということがわ
かる。チューブ30は、カテーテルの基端まで延びてお
り、上文中に論じたような、ルエルロック18と完全に連
通している。チューブ30は、ポリイミド製チューブ又は
ステンレス鋼製チューブでできているのがよい。本発明
では、ステンレス鋼製チューブは、電極14を電気コネク
タ24に接続し、カテーテルの全体としての導電性を高め
る追加の導体として役立つ。ポリイミド製チューブを使
用すると、カテーテルの全体としての導電性が小さくな
るが、可撓性が幾分高くなり、場合によっては有利であ
る。カテーテルを脈管系を通して電極場所まで通過させ
るとき、可能であれば、リンゲル液の一定の流れをチュ
ーブを通して電極14に加えることが推奨される。この場
合、リンゲル液の流れは、チューブ30の内腔の開存性の
維持を助け、心筋内に前進させるときに電極の出口ポー
トが塞がらないようにする。
チューブ30は、逆方向に巻いた二つのコイル32及び34
によって取り囲まれており、トルクケーブルを構成す
る。本発明者が使用した特定の装置の場合には、ミネソ
タ州チャカスのレーク・リージョン製造社が製造したト
ルクケーブルを使用し、このトルクケーブルは、米国特
許第5,165,421号に記載されている。同特許について触
れたことにより、その特許に開示されている内容は本明
細書中に組み入れたものとする。コイル32及び34は、導
体としても役立つ。図示のように、チューブ30は、金属
コイル32及び34と螺旋状電極14との間にある。しかしな
がら、ポリイミド製チューブを使用した場合には、コイ
ル32及び34は、単なる導体として役立ち、かくして、溶
接、ハンダ付け、又は機械的相互連結によって電極14に
電気的に接続される。絶縁スリーブ12は、カテーテルに
滑らかな外側を提供するのに役立ち、更に、金属コイル
32及び34をカテーテルの長さに沿って絶縁するのに役立
つ。
第３図、第４図、及び第５図は、第２図に示す螺旋状
電極の変形例を示す。第２図の電極は、中空チューブか
らなり、単一の出口レポートがその先端に配置されてい
る。第３図に示す電極36は、螺旋状電極の長さに沿って
リンゲル液を出すことができる追加の出口ポート38、4
0、及び42が設けられていることを除き、電極14と同じ
である。ポートは、レーザーを使用して穿孔されている
のがよく、電極36の周囲に亘って及び電極36の長さに沿
って任意の所望の方法で間隔を隔てられているのがよ
い。リンゲル液を均等に分配し且つ分散するため、ポー
トは、好ましくは、電極の全周に亘って間隔が隔てられ
ているのが望ましいと考えられている。
第４図に示す電極44は、電極14と対応する螺旋状電極
の第２の変形例であり、電極の基端部分を覆う絶縁スリ
ーブ46が加えられている。スリーブ46は、Ｒ−Ｆエネル
ギが電極の先端部分だけで適用されるようにする。随意
であるが、図３に示すポート38、40、及び42と対応する
追加の出口ポートを電極44と関連して使用してもよい。
これらの追加の出口ポートは、電極44の露呈された絶縁
されていない部分に限定されるか或いは電極44の全長に
亘って設けられている。
第５図に示す電極48は、全体に電極14と対応する第３
の変形例である。しかしながら、この例では、電極48の
先端に熱電対50が設けられている。熱電対の導線52及び
54は、電極48の内腔を通って後方に延びており、これら
の導線は、上文中で引用したレノックス等の特許に記載
されているように、電極に加えられる電力のフィードバ
ック制御で使用するため、電極先端の温度を監視するの
に使用される。熱電対の導線52及び54の一方だけが絶縁
され、他方は、電極48の内部に接続される。第５図の電
極を使用するためには、電極48に接続されていない熱電
対の導線に接続できるようにするため、追加の電気コネ
クタを第５図に示す実施例に加えなければならない。変
形例では、熱電対の両導線を絶縁する。この場合には、
熱電対の一本の導線に各々接続された二つの追加の電気
コネクタを装置の基端に設ける必要がある。熱電対50が
電極48の内腔の先端開口部を効果的に塞ぎ、そのため、
リンゲル液が側ポート56、58、及び60からしか分配され
ないということに着目されたい。
第６図は、第１図に示すカテーテルと関連して使用で
きるリンゲル液加圧供給源を示す。ブロック・メディカ
ル社が商業的に製造し、「ホンムポンプ」の商標で販売
しているリザーバ100が設けられている。リザーバには
リンゲル液が入っており、リンゲル液を一気圧の圧力で
フィルタ104を介して流れ制御装置102に提供する。流れ
制御装置102は、例えば、流れを毎分20滴又は1ccに制限
する。流れ制御装置102は、第２流れ制御要素104に連結
されている。第２流れ制御要素104は、本発明者が使用
する実験装置において、流量を追加に調節できるように
する。流れ制御要素104は、第１図に示すルエルロック2
2に連結されており、これは、電極14（第１図参照）と
流体連通しており、リンゲル液を電極に送出することが
できる。Ｒ−Ｆ電気エネルギを提供するための電気外科
発電機200が、機能を示すブロックの形体で示してあ
る。この発電機は、電気コネクタ24及び接地プレート電
極202（等縮尺でない）に接続されている。この他の全
ての要素は、第１図に示したものと対応する。
上掲の実施例は、カテーテルを前進させ所望の位置に
位置決めするための第２要素（例えば、案内カテーテル
又は案内ワイヤ）を必要とするが、上文中に開示した基
本的な装置を、臨床研究で現在用いられているＲ−Ｆア
ブレーションカテーテルと同様の、それ自体が操舵可能
であり即ち変形可能なカテーテルに組み込むこともでき
ると考えられている。同様に、商業的実施例において、
リンゲル液の流れを制御するための別の機構（例えば、
精密なポンプ）を使用できると考えられている。同様
に、本発明者はリンゲル液を使用したが、これとは異な
る流体を使用してもよい。このように、上文中に論じた
実施例は、限定的でなく例示の実施例であると考えられ
るべきである。
───────────────────────────────────────────────────── フロントページの続き (58)調査した分野(Int.Cl.6，ＤＢ名) A61B 17/39

Claims (9)

    (57)【特許請求の範囲】
  1. 【請求項１】基端部分と、先端部分と、長手方向の内腔
    とを有する、細長いカテーテル本体と、 前記カテーテル本体の先端部分に取り付けられ、かつ、
    前記カテーテル本体の前記内腔に連結された内腔を有す
    る、身体組織に所望位置において侵入するための中空針
    と、 導電性流体を前記カテーテル本体の前記内腔に送出する
    ため、前記カテーテル本体の内腔に連結された、導線性
    流体供給源と、 Ｒ−Ｆエネルギを前記所望位置に送出するため、前記カ
    テーテル本体の前記先端部分に取り付けられた、導電性
    の電極表面と、 前記電極表面に接続されたＲ−Ｆ電気エネルギ源とを有
    し、 前記中空針は導電性を有し、前記電極表面は前記中空針
    の表面からなり、前記中空針は螺旋状の針からなること
    を特徴とする、アブレーションカテーテルシステム。
  2. 【請求項２】請求項１に記載のアブレーションカテーテ
    ルシステムにおいて、前記流体送出手段はリンゲル液を
    送出するための手段を有する、前記アブレーションカテ
    ーテルシステム。
  3. 【請求項３】請求項２に記載のアブレーションカテーテ
    ルシステムにおいて、前記導線性流体を送出するための
    手段は、前記導電性流体を収容するリザーバと、流体の
    流れを制御するための手段とを有する、前記アブレーシ
    ョンカテーテルシステム。
  4. 【請求項４】請求項１に記載のアブレーションカテーテ
    ルシステムにおいて、前記カテーテル本体は、前記カテ
    ーテル本体に沿って長手方向に延在するトルク伝達ケー
    ブルを有する、前記アブレーションカテーテルシステ
    ム。
  5. 【請求項５】請求項１に記載のアブレーションカテーテ
    ルシステムにおいて、前記カテーテル本体は、前記カテ
    ーテル本体に沿って長手方向に延在するトルク伝達ケー
    ブルを有し、前記ケーブルは前記中空針と前記Ｒ−Ｆエ
    ネルギ源とに接続されている、前記アブレーションカテ
    ーテルシステム。
  6. 【請求項６】請求項１に記載のアブレーションカテーテ
    ルシステムにおいて、前記カテーテル本体は前記カテー
    テル本体に沿って長手方向に延在する導電性チューブを
    有し、前記チューブは前記中空針と前記Ｒ−Ｆエネルギ
    源とに接続されている、前記アブレーションカテーテル
    システム。
  7. 【請求項７】請求項１に記載のアブレーションカテーテ
    ルシステムにおいて、前記カテーテル本体は、前記カテ
    ーテル本体に沿って延在するプラスチックチューブを有
    し、前記チューブは前記中空針と前記送出手段とに連結
    されている、前記アブレーションカテーテルシステム。
  8. 【請求項８】請求項１に記載のアブレーションカテーテ
    ルシステムにおいて、前記アブレーションカテーテルシ
    ステムは、更に、電気信号を検出するための電気信号検
    出手段を有し、前記電気信号検出手段は前記電極表面に
    連結されている、前記アブレーションカテーテルシステ
    ム。
  9. 【請求項９】請求項１又は８に記載のアブレーションカ
    テーテルシステムにおいて、前記アブレーションカテー
    テルシステムは、更に、刺激パルスを送出するための刺
    激パルス送出手段を有し、前記刺激パルス送出手段は前
    記電極表面に接続されている、前記アブレーションカテ
    ーテルシステム。
JP7507576A 1993-08-27 1994-07-25 Ｒ−ｆアブレーションを行うための方法及び装置 Expired - Lifetime JP2761440B2 (ja)

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US08/113,441 1993-08-27

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