JP2562861B2 - 冷却電極によるラジオ周波数切除用カテーテルおよび方法 - Google Patents
冷却電極によるラジオ周波数切除用カテーテルおよび方法Info
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1402—Probes for open surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00084—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
- A61B2018/00035—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open with return means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00166—Multiple lumina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
- A61B2018/00821—Temperature measured by a thermocouple
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Description
ラジオ周波数(RF)切除用カテーテルおよび方法に関
する。
に提供されてきた。しかし乍ら,そのようなカテーテル
では,十分な大きさの外傷を達成することが難かしいと
いう点で困難に遭遇してきた。外傷の大きさを増加しよ
うとしてカテーテルへのRF電力を増加すると,切除が
行なわれる部位に血液の変質(劣化)を生じた。そのよ
うな血液の変質は,変質生成物を電極面上に沈着せしめ
てインピーダンスを非常に増加する。さらに,増加した
電力レベルが,望ましくない血液の加熱を生じ,それが
凝血を生ずることがあるのが判明した。したがって,こ
れ等の欠点を克服するRF切除用の新しい,改良された
カテーテルの必要性がある。
題は,冷却電極を備えたRF切除用カテーテルおよび大
きな外傷形成を可能にする方法を提供することである。
に小室を有している導電性の電極を備えており,そして
冷却が小室に与えられる上記の特徴のカテーテルおよび
方法を提供することである。
液が,カテーテルが配置される心臓内の小室の血圧に実
質的に等しい圧力に維持される上記の特徴のカテーテル
および方法を提供することである。
テーテル内に導入するため設けられており,そして別の
ポンプがその液をカテーテルから引き出すために設けら
れている上記の特徴のカテーテルおよび方法を提供する
ことである。
シスが,電極に接触した表面を破壊して,電極の下にあ
る種々の深さに形成できるカテーテルおよび方法を提供
することである。
しい実施例が添付図面と関連して詳細に説明されている
以下の説明から明らかとなるであろう。
とも1つの小室を形成している壁を有し,心臓に使用す
る冷却電極によるラジオ周波数切除用カテーテルを具体
化している。このカテーテルは,近位端および遠位端を
有している可撓性の細長い部材により構成されている。
電極は,可撓性の細長い部材の遠位端に取付けられてお
り,かつその中にキャビティを有している。可撓性の細
長い部材を通り,近位端から遠位端に延びていて,ラジ
オ周波数エネルギーをチップ電極に供給する手段が設け
られている。可撓性の細長い部材は,その中に,近位端
から遠位端に延びており,かつ電極に連絡している第1
の穴を備えている。冷却液を穴内に導入する手段が設け
られている。冷却液を穴内に導入する手段は,電極にお
ける穴内の液体の圧力を調整する手段を含むので,その
液体の圧力は,遠位端が配置されている心臓の小室内の
血圧に近似している。
いる冷却電極によるラジオ周波数(RF)切除用カテー
テル11は,近位端13および遠位端14を有している
可撓性の細長い部材12より成っている。中空チップ導
電性電極16が,遠位端14に取付けられており,かつ
内部キャビティ17を備えている。可撓性の細長い部材
12は,ポリウレタンのような適切なプラスチックで形
成されている。使用されるプラスチックは,耐捩れ性
(kink resitant)であることが望ましい。追加の耐捩
れ性を与えるため,適切な材料のブレード21が,その
押出し成形の際に可撓性の細長い部材12内に与えられ
て,細長い部材を強化し,追加の耐捩れ性を与えてもよ
い。ブレード21はナイロンまたはケブラ(kevlar)の
ような適切な材料で形成されることができる。ブレード
21は,図1に示されたように,細長い部材の遠位端に
設けることができる,あるいは,所望により,細長い部
材12の全長に延びることができる。
ルのような適切な材料で形成されることができる,かつ
0.003インチ(約0.076mm)から0.004
インチ(約0.10mm)の肉厚を有することができ
る。細長い部材12は,たとえば大きさ3から7フイン
チ(French)のカテーテルを提供するような適切な大き
さで提供できる。電極16は,全体的に半球状形状を有
し,かつ接着剤(図示せず)のような適切な手段によっ
て細長い部材12の遠位端に固定できる。細長い部材1
2は,第1および第2の比較的大きな液体を通す穴26
および27を備えており,これ等の穴は,近位端13か
ら遠位端14に延びており,かつ中空チップ電極16の
キャビティ17に連絡している。図示のように,穴26
および27は,断面三日月形形状であることができる。
また,細長い部材12の近位端13から遠位端14に延
びている中央の穴28が設けられいてる。三日月形形状
の穴26および27の周りに円周方向に間隔をへだてた
複数の追加の穴29が設けられている。中央の穴28
は,ラジオ周波数エネルギーを電極16に供給する導体
31を保持している。導体31は,また,チップ電極1
6を固定するのに使用されているので,導体31は,細
長い部材12の遠位端14に固定したままである。
設けられており,その手段は,1991年11月18日
出願の米国同時係属出願第071793,858号(米
国特許第5,238,005号)に記載された形式のも
のである。その出願に記載されているように,その手段
は,穴29内に設けられており,かつ細長い部材12の
中央の穴28の周りに円周方向に間隔をへだてられてい
るステアリングワイヤ33,34および36を含む。ス
テアリングワイヤ33,34および36は,アースリタ
ーン37と一緒に,近位端に延びており,かつ細長い部
材12の近位端に設けられている雄コネクタ39にケー
ブル38を介して接続されている。
ば,細長い部材12の遠位端14の外部上にあって,か
つ中空チップ電極16に比較的近接して設けられた間隔
をへだてたバンドとして形成されている電極41および
42のような追加のラジオ周波数電極を設けることがで
きる。そのような電極41および42は,穴29を通り
近位端に延びており,かつコネクタ41に接続している
導体43および44によって接続されることができる。
1を備えており,その中にチューブ状部材52および他
のチューブ状部材53が延びている。チューブ状部材5
2は,穴27に連絡しており,そしてチューブ状部材5
3は穴28に連絡している。チューブ状部材52および
53は,在来の形式のルアーロック(Luer locks)56
および57を備えている。
17内へ送らせるため,冷却液を穴27に導入する手段
が取付具56に接続されている。キャビティ17内の液
体の圧力が,カテーテルが配置される心臓の小室内の血
圧に近似するように,冷却液をキャビティ17から引き
出す手段が取付具57に固定されている。この手段は,
摂氏5度から10度の範囲の温度を有している冷却した
食塩水62を備えているタンク61より成っている。所
望により,食塩水以外の他の液体も使用できると理解さ
れるべきである。冷却食塩水を取付具56に供給するた
め設けられた手段は,ポンプ66より成っており,この
ポンプ66は,チューブ状部材67によってタンク61
内の冷却食塩水62内に接続されており,そして食塩水
をチューブ状部材68を通り送り出す。このチューブ状
部材68は,圧力計69で計ったとき所定の圧力P1の
冷却食塩水を供給するため,取付具56に接続されてい
る。したがって,ポンプ66が作動したとき,冷却食塩
水が穴27およびキャビティ17に導入される。キャビ
ティ17内の冷却食塩水の圧力を減少し,かつカテーテ
ルが配置される心臓の小室内の血圧に実質的に等しいよ
うにキャビティ17内の圧力を維持するため,冷却液を
穴28を通りキャビティ17から引き出すポンプ71が
設けられいてる。ポンプ71は,チューブ状部材72に
よって,取付具57に接続されており,そして圧力計7
3によって測定される負圧P2を流路28に供給する。
ポンプ71が,キャビティ17から引き出した冷却液を
タンク61に戻すので,冷却液は冷却され,再使用でき
る。
雄コネクタ32を収容するようになっている雌コネクタ
78にケーブル77によって接続されているコントロー
ラ76とに接続するようになっている。ラジオ周波数電
源76は,在来の形式のものであることができる。コン
トローラは,カテーテルの遠位端を操作するのに使用さ
れており,かつ1991年11月18日出願の同時係属
中の出願第07/793,858号(米国特許第5,2
38,005号)に記載された形式のものである装置の
1部分として組み込まれている。
作動および使用,並びにその使用方法を簡単に下記に説
明する。心筋層切除を行なうため,ラジオ周波数エネル
ギーを心臓の小室を形成する壁内に導入したいと望んで
いると仮定しよう。また,従来の方法で,カテーテルが
人間の心臓の小室内に導入されていると仮定しよう。コ
ントローラ76を使用することによって,遠位端14
は,チップ電極16が心筋層に接触するまで移動される
ように,操作される。それから高周波エネルギーが,R
F電源から76から導体31を通りチップ16に供給で
きる。そのようなラジオ周波数エネルギーの送り出し前
に,または同時に,ポンプ69および73が作動される
ので,冷却食塩水が,穴27および電極16のキャビテ
ィ17内に導入されて,ラジオ周波数エネルギーが電極
に加えられている時間中,電極16を冷却する。穴27
内の圧力を比較的低い値に保つために,かつキャビティ
17内の圧力が,カテーテルが配置されている心臓の小
室内の血圧と実質的に同じであるように,ポンプ73が
負圧を生じて,冷却食塩水を通路または穴28を通り引
き出し,そしてそれをタンク61内に排出する。オペレ
ーターはゲージ69および73を観察することによっ
て,キャビティ17内の圧力が,カテーテルチップが配
置されているキャビティの周りの血液だまりの圧力と実
質的に同じであるように,ポンプ66および71を操作
できる。ゲージ69および73上の所望の圧力P1およ
びP2は,カテーテル11を身体の外側においてポンプ
66および71を最初に作動して,小室17内の圧力を
測定し,それから正しい圧力がキャビティ17に存在す
るとき,ゲージ69および73上の圧力を観察すること
によって確認できる。したがって,カテーテル11が,
体内に,そして心臓内に導入されたとき,キャビティ1
7内の所望の圧力は,単にゲージ69および73上の示
度を重複することによって達成できる。
ャビティ17内に設けることができる,そしてその圧力
変換器は,電気的導体を通り延びていて,圧力が適切な
計測器(図示せず)上で読み取ることができるカテーテ
ルの近位端に接続される。
ーテル11の遠位端14が配置されている血圧に,また
は血圧の近くに維持することによって,カテーテル1の
キャビティ17からの食塩水の洩れの最小の傾向があ
る。これは,切除手順が行なわれている時間の間,心臓
が血液を送っているとき,心臓収縮期から心臓拡張期ま
での血圧変化があっても,容易に達成される。これは,
心臓収縮期と心臓拡張期との間の血液範囲が,約2ps
iのような水銀柱60−200mmの範囲として図示さ
れている図3に例示されている。穴27および28内の
冷却液の圧力変化が,カーブ81によって示されてい
る。ポンプ66によって与えられる入口圧力は,図3に
示したようにP1である。圧力は穴内の損失のための穴
27内で降下する。穴28の出口におけるポンプ71に
よって生じた負圧力P2のため,圧力は降下し続ける。
穴の損失を克服するための圧力P1およびP2の適切な
調整によって,チップ電極16のキャビティ17内の圧
力は,それが,チップ16が配置されている小室内のブ
レードの圧力に近似するように調整できる。これは,8
2で示されたようにチップ穴における血圧領域を通り横
切る図3のカーブ81によって表わされている。典型的
な実施例が,長さ150cm,直径0.10インチ(約
2.54mm)の穴を有しているカテーテルによって図
5に示されている。チップにおける冷却液の圧力は,4
0psi(約2.72kg/cm2)の正の入口圧力P
1および負の40psiの負の出口圧力P2を使用して
得られた。
ルにより,5ないし50ワットの電力を用いて,心筋層
に1/2ないし1cmの所望の深さおよび同様の幅の外
傷を達成可能であることが判明した。
なおチップ電極16の温度を測定するのが望ましいかも
知れない。これは熱電対(図示せず)をチップ16に接
近して取付け,リード線を熱電対から細長い部材12内
の追加の穴(図示せず)を通り引き出し,そしてリード
線を近位端に引き出して,それ等を適切な計測器85に
接続して,温度記録をすることにより達成できる。これ
はさらに,切除手順を行なう医師または外科医に対して
冷却が適切であることを保証し,かつ切除手順の際に過
大な温度に達していないのが判る追加の入力を与える。
冷却を高めるために,図4および5の変更したチップ電
極86が提供されている。その図に示したように,適切
な導電性材料で形成できる電極86は,チップ86の円
筒状の壁88から内方に延びており,かつ詳細に図4に
示されたようにチップの遠位端に延びている複数の半径
方向に延びているフィン87を備えている。フィン87
は,チップ86の長手方向の軸線の近くで終わってい
て,フィン87の終端に円筒状の空間89を与えてい
る。したがって,食塩水がチップ16内に導入されるの
と同じ方法で,冷却食塩水がチップ86に入るとき,フ
ィン87の追加の冷却面が,電極86から冷却電極86
に追加の熱電動を生ずるのが判るであろう。チップから
冷却食塩水へのこの増加した熱電動が,冷却食塩水の少
ない流量または達成されつつある切除手順の際に電極へ
の追加のRFエネルギー付加を可能にする。
テルの他の実施例が,図6ないし図8に示されている。
カテーテル91は,近位端13および遠位端14を有し
ている可撓性の細長い部材より成っている。カテーテル
92は,たとえば150cmのような適切な長さであ
り,かつ流路96を備えている。遠位端94は,減少し
た直径の部分92aと,通路96に連絡しているその中
の流路97とを備えている。可撓性の細長い部材92は
また,遠位端94と減少した直径の部分92aとの間に
移行部を形成しているテーパー部分92bを備えてい
る。通路97は,中空チップ導電性電極として役立つ銀
のような適切な導電性材料から形成されたカップ形状の
電極99内に設けられた小室98に連絡している。カッ
プ形状の電極99は,接着剤102のような適切な手段
によって可撓性の細長い部材92の遠位端94に固定さ
れた近位端101を有している。電極99は,複数の間
隔をへだてた穴106を有している半球状の遠位端10
3を備えている。さらに,電極99は,チップ99の軸
線に対して約45度の角度で近位の方に傾斜して延びて
いる図7および8に示したような1対の月形の間隔をへ
だてたスロット107および108を備えている。
手段が設けられており,そしてその手段は,その中に冷
却食塩水を有しており,所望のときに補充できる容器1
11より成っている。冷却食塩水をタンクまたは容器1
11からカテーテル11の通路96に供給する手段が設
けられており,そしてその手段は,ポンプ113に接続
されている入口パイプ112より成っている。ポンプ1
13は,ストップコック114を介して接続されてお
り,そしてストップコック114は,3方向弁を備えて
いて,開閉位置に動かすハンドル116を備えている。
ストップコック114は,可撓性の細長い部材92の近
位端93に固定された取付具118に接続した可撓性パ
イプ117に接続されている。
99に供給する手段が設けられており,そしてその手段
は,コネクタ123に接続した電源コード122を備え
ているラジオ周波数電源121より成っている。コネク
タ123は,取付具118に接続されているコード12
6に接続されている他のコネクタ124に接続されてい
る。コードは,ろう付け128によって電極99に接続
された絶縁線127により,導電される。
カテーテルの作動および使用方法について以下に説明す
る。一方向ポンプ113は,容器111から冷却食塩水
をポンプ移送するのに使用され,そして食塩水を圧力を
かけて通路96,97を通り小室98に供給する。冷却
食塩水は図1に示した実施例におけるように,再循環さ
れるよりもむしろ,冷却液が電極に接触した後,電極9
9から送られてくる冷却液のジェット131によって電
極99から排出される。したがって,チップ99が,心
臓の壁に接触したとき,ジェットがチップ99と心臓の
壁との間の中間面を透過して追加の冷却を生ずることは
判るであろう。冷却食塩水はチップ99の温度によって
わずかに温められるかも知れないが,ジェット131
は,周囲の血液よりもなお冷く,したがって,中間面に
追加の冷却を与えて,チップ99と心臓の壁との間の中
間面における血液の凝固を防止するのを助ける。ジェッ
ト131の他に,電極99を心臓の壁に接触する方に押
す力を生ずる,スロット107および108から近位の
方に向けられた矢印132によって示された追加のジェ
ットがある。換言すると,ジェット132は,ジェット
131に対する反対の力を生じて,電極99を心臓の壁
に接触したままにさせる。
水の一方向の流れに必要であるから,所定のサイズのカ
テーテルに対して遠位端94に延びているより大きな穴
を設けることが可能であることが判るであろう。この増
加した食塩水の流量が,チップ電極99へ送られるラジ
オ周波数パワーを増加可能にし,所望により心臓の壁に
より大きな外傷を作るのを可能にする。血液内への食塩
水の導入は,すでに多くの他の医学的手順において行な
われているので,問題はない。
114は,冷却食塩水をポンプでカテーテル91に送る
ときに,気泡がポンプ113によって送られないのを保
証するため,いかなる空気もカテーテル91から排出す
るのを可能にする。空気がシステムから排出されるや否
や,冷却食塩水が流路96に供給されるように,ハンド
ル116を回すことができる。
数エネルギーを収容できる冷却切除電極を設けることに
よって,心臓以外の切除手順を行なうことが可能であ
る。たとえば,ある腫張を処置するのに利用できる。ま
た,表面と組織の結合を傷つけることなく,表面の下に
ある組織を処置しながら,表面を傷つけずに残すことが
可能である電気焼灼および電気外科に利用できる。した
がって,静脈または動脈壁を通る器官を処置するとき,
壁の裏側を損なうことなく,静脈または動脈壁をなお保
護しながらこれを行なうことが可能である。これは,壁
に対する損傷を防止するため,図4に示したような冷却
チップから流出する食塩水を使用する冷却チップによっ
て容易に達成できる。そのような手順は,特に,胆の
う,泌尿器科および婦人科に適用可能である。
際,穴106およびスロット107と,108内に血液
が入るのを防止するため,カテーテル91が通路96内
に挿入されるとき,食塩水が穴106およびスロット1
07と108から流出するように,冷却食塩水がわずか
に正の圧力を有しているのが望ましい。他の方法では,
RFエネルギーがチップ99に加えられる前に,通路9
6を通り冷却食塩水を加えるべきである。これは,カテ
ーテル内のいかなる血液も,カテーテルが配置されてい
る血液だまり内に押し出すのを保証するのに役立つ。こ
れは,RFエネルギーが加えられて,チップ電極99が
加熱されたとき,小さい穴106またはスロット107
と108内で血液が凝固するのを防止する。
かしくする本発明に組み込まれているカテーテルの他の
実施例が図9ないし図10に示されている。その図に示
されたように,カテーテル136は,流路138を備え
ている可撓性の細長いチューブ状部材137より成って
いる。適切な導電性材料で形成されたチップ電極141
は,接着剤143のような適切な手段によってチューブ
状部材137の遠位端142に接着される。プラスチッ
クのような適切な材料のチューブ状挿入物144は,接
着剤146のような適切な手段によって可撓性の細長い
部材137の内部壁に固定された広がった近位端144
aを備えている。図9から明らかなように,チューブ状
挿入物144は,電極141内にスペースまたは小室1
48を与えるため,チップ電極141の半球状部分の近
くで終わっている遠位端147を備えている。チューブ
状挿入物144は,遠位端147を通り開放しており,
かつ小室148に連絡している流路149をそなかてい
る。流路149はまた,可撓性の細長い部材137内の
流路138に連絡している。1対の直径方向に対向して
いる穴151が可撓性の細長いチューブ状部材137の
遠位端142に設けられている。適切なエラストマー材
料で形成された円筒状の弁スリーブ153の形の弁手段
が,可撓性の細長いチューブ状部材137の遠位端14
2内に設けられたくぼみ154内に配置されている。弁
スリーブ153は,スリーブ153の周りに円周方向に
延びている環状補強リブを備えている。チューブ状挿入
物144の長手方向に延びているスリット157が設け
られており,これは穴151に重なっていて,そしてス
リット157を閉じるため,シールした位置に屈曲可能
に保持されたリーフレット153aおよび153bを形
成するのに役立っている。
136に導入されるとき,食塩水が,チップ141を冷
却する小室148内に矢印157によって示したように
通路149を通過することは判るであろう。その冷却機
能を果たした後,わずかに温められた冷却液は,矢印1
57によって示されたように近位の方に送られ,そして
弁スリーブ153内に設けられたリーフレット153a
および153bを外方に押すことによって穴151およ
びスリット157を通り正の圧力で血液だまり内に排出
される。これは,電極の冷却を続けるため,追加の冷却
食塩水をチップ電極141内に導入可能にする。したが
って,食塩水がカテーテル136に供給されていないと
き,そのような弁スリーブ153が,カテーテル136
を取り囲んでいる血液がカテーテルの内部に入るのを防
止しながら,食塩水の使用を可能にすることは判るであ
ろう。
却食塩水の供給によるような能動的冷却を先行し,そし
てカテーテルがRF切除に使用されている間,カテーテ
ルのチップの受動的冷却に頼ることも可能である。その
ようなカテーテル171が図11および12に示されて
いる,そして前述のプラスチックで形成されていて,か
つそこを通り延びている流路173を備えた可撓性の細
長いチューブ状部材172より成っている。チューブ状
部材172は,銀のような適切な導電性材料で形成され
た円筒状の金属スリーブ176に接続されている。スリ
ーブは,たとえば2ないし5cmのような適切な長さを
有することができる。スリーブ176は,そこを通り延
びている穴177を備えている。スリーブ176の他端
は,プラスチックのような適切な絶縁材料で形成された
他のチューブ状部材179に接続されている。チューブ
状部材179は,大きな中央の穴181と,穴181の
周りに円周方向に間隔をへだてている複数の追加穴18
1ないし187とを備えている。穴182,184およ
び185は,その中を通り延びており,チューブ状部材
179の遠位端に接続されている要素191,192お
よび193を有している。これ等の要素191,192
おひ193は,負の膨張係数を有しているニチノールの
ような材料で形成されている。アース戻り導体194が
穴183内に設けられている。導体196は,穴186
内に設けられていて,そして導電性材料で形成された半
球状のチップ電極197に接続されており,かつ接着剤
(図示せず)のような適切な手段によってチューブ状部
材179の遠位端に固定されている。
71の遠位端内に設けられており,そして,たとえば水
または食塩水のような熱吸収流体で含浸させた木綿繊維
のような適切な繊維状材料より成っている。この熱伝導
性材料201は,チューブ状部材172の遠位端から通
路177を通り金属スリーブ176に延びており,そし
て金属スリーブ176に密着している。この材料201
はまた,チューブ状部材179内に設けられた穴181
を通り,そしてチップ電極197の内部に延びている。
図11から明らかなように,穴182ないし186内の
前述の種々の導体および要素が,受動的熱伝導材料20
1を通り,接着剤206を通過し,それから通路173
を通ってカテーテルの近位端に延びており,そこでそれ
等の導体および要素は,前述の形式の適切な制御装置に
接続されている。
ル171の使用では,電極197へのラジオ周波数エネ
ルギーの付加が電極197を加熱して受動的熱伝導手段
201内の液体を加熱せしめ,対流によって受動的熱伝
導手段201の方に移動せしめる。これはさらに,冷却
液を循環せしめて,その場所を冷却する。加熱された液
体は,芯のような熱伝導性材料201を通り流れ,そし
て金属スリーブ176に接触し,そして金属スリーブ1
76は,スリーブ176を通過する液体に熱を伝えるこ
とによって冷却せしめられる。冷却液はそれから前述の
ように対流を続けるためチップに戻される。
3に示したような構成を使用することができる。金属の
半径方向に延びている伝導フィン211は,スリーブ1
76の外面にろう付けされるか,あるいはスリーブ17
6と一体に形成される。フィン211を設けることによ
って,追加の熱分散表面積が与えられ,これが,スリー
ブ176およびフィン211の周りを循環する血液への
熱分散能力を増加する。
に関連して前述したカテーテルの機能は,図14を参照
することによってより明確に理解できる。図14は,グ
ラフの縦の軸に示されたような摂氏の温度に対する切除
手順の際に生じた外傷の深さmmを横の軸に沿って示し
ているグラフである。グラフ上の「0」は,組織に接続
している電極チップ面と同等である。図14に示したよ
うに,グラフの右の方に行くにしたがって,組織内の深
さが増加する。組織内に送られるラジオ周波数エネルギ
ーの3つの異なるパワーレベルに対する3つのカーブ
A,BおよびCがグラフに示されている。グラフ上の温
度は100℃で始まっている。100℃はそれが温度の
上部限界と考えられるので,示された,あるいは,約9
0℃で血液は電極上で沸騰し,凝固し始め,そのインピ
ンーダンスを大幅に増加し,外傷を作るその能力を構成
するので,100℃よりもわずかに低い。したがって,
電極またはチップの温度を,出来れば,90℃以下に保
つのが望ましい。50℃のとき,ライン216がグラフ
に示されている,というのは,これは,この温度以下で
心筋層並びに結合性の組織のネクローシスが止む温度で
あるからである。
1,A2およびA3に分割されている。破線部分A2
は,冷却が電極に加えられていないときの指数カーブA
3の連続を表わしている。したがって,カーブAによっ
て表わされた5ワットの電力レベルから,カーブの開始
を示した80℃のチップ温度から温度は,組織からの距
離が増加するにつれて指数関数的に減少することが判
る。図示のように,カーブA3は,深さ5mmにおいて
ライン216によって表わされた50℃のネクローシス
境界線に交差する。生じた外傷は,距離a1によって表
わされたように約5mmの深さを有している。さらにそ
れ以上の切除は,この電力レベルのとき停止する。カー
ブAによって表わされた電力レベルを供給されるチップ
電極が前述の方法で,能動的に冷却されれば,チップ電
極温度は,たとえば,距離0mmのスキンインターフェ
ースのチップにおけるカーブA1によって表わさたよう
な35℃の低いレベルまて下降する。この温度はネクロ
ーシス温度以下であるから,カーブA2がたとえば表面
から3mmの深さのような,50℃のネクローシスライ
ンに交差する点の距離d2まで,切除は起り始めない。
ネクローシスは,距離d3によって表わされたような3
mmないし5mmの深さで起る。そのような冷却切除手
順は,ネクローシスが接触面およびそのすぐ下にある組
織を破壊することなく接触面の下で起るのを可能にする
ので,非常に有利である。これは,たとえば心臓の裏面
を破壊することなく,心臓内に不整脈を生ずる部位周囲
を破壊するため,ある組織を切除するのが望ましい心臓
の適用に特に望ましい。
熱を生ずる10ワットのラジオ周波数の高電力レベルの
とき,電極チップを冷却したときおよび冷却しないと
き,どのようになるかを表わしている。カーブBの部分
B2は,セグメントB3の指数カーブの連続を表わして
いる。見て判るように,チップスキンインターフェース
における温度は,100℃に接近しており,これは,電
極上の血液を沸騰し,血液を凝固し,そのインピーダン
スを高くし,そして外傷を生ずる能力を構成するので,
非常に問題がある。チップ電極に対する能動的冷却を設
けることによって,カーブB1が発生される,これは,
d4によって表わされたような2mmの深さからネクロ
ーシスを生じせしめ,そしてカーブB3がd5によって
表わされたように50℃のネクローシスライン216に
交差する約8mmの深さにまで及ぶことを示している。
したがって,電極のチップ上に血液の凝固を生ずる望ま
しくない高温度に達することなく,高電力レベルを使用
してより深いかつ大きい外傷を与えることが可能である
ことが判るであろう。図示のように,表面が破壊される
必要がないように,表面の下の外傷の形成を開始するこ
とが可能であり,したがって本発明による処置から,患
者による早期発見を容易にする。
1,C2およびC3によって表わされている40ワット
のような,さらに高い電力レベルを表わしている。指数
カーブC3の連続である破線ライン部分C2は,電極ス
キンインターフェースの温度がはるかに100℃を超え
ており,そして本発明により提供される能動的冷却を除
いては,使用できないことを示している。能動的冷却に
より,スキン電極インターフェースの温度は80℃に近
づき,そして徐々に増加し,95℃に接近し,それから
指数関数的に,距離d6によって表わされたスキンの表
面から15mmの距離でネクローシスライン216に交
差するまで下降することが判る。スタートの温度が50
℃のネクローシスライン216の上方にあるという事実
から見て,ネクローシスは,スキンの表面から15mm
の深さまで起り,大きな,かつ深い外傷を与える。
た,図16ないし図18に示された等温線図によって強
められる,これ等の図は,高温度が,電極スキンインタ
ーフェースからの距離である深さにのみ達する冷却電極
に対して示されている。
有限要素(finite element)分析プログラムANSYS
を用いてコンピュータシュミレーションから得られたグ
ラフである。これ等のグラフは,カテーテル11の可撓
性の細長い部材12の遠位端のチップの電極16におい
て,かつ異なる状態に対して電極・組織干渉からの組織
内の異なる深さにおいて達成される温度を示している。
図15は,10ワットの電力が冷却せずに電極16に加
えられる状態を表わしている。図16は,5℃で電極に
送られる食塩水の1分間当り20ccsの形の冷却のと
きの電極に加えられる同じ10ワットの電力に対するグ
ラフである。図17は,冷却せずに40ワットの電力が
電極16に加えられる状態に対するグラフであり,これ
に反して,図18は,1分間20ccs,5℃の温度の
食塩水によって冷却が電極に加えられるとき,同じ40
ワットの電力が電極に加えられる状態に対するグラフで
ある。図16ないし18に示したグラフまたは線図は,
電極16の可撓性の細長い部材12の遠位端の長手方向
の軸線から半径方向に離れて延びている温度断面または
輪郭の1/2のを表わしている。
電極チップ16は,人間の心臓の心筋層に接触するよう
に,組織に接触していると仮定されている。心筋層は,
231として識別されており,心臓内の血液は232と
して識別されている。図15ないし18のグラフから明
らかなように,等温カーブはアルファベット文字によっ
て識別されている。図15に示した等温カーブは,冷却
しない電極16に対する下記の温度を摂氏度で表わして
いる。 A=37.811°摂氏 B=39.433°摂氏 C=41.056°摂氏 D=42.678°摂氏 E=44.300°摂氏 F=45.923°摂氏 G=47.545°摂氏 H=49.167°摂氏 I=50.789°摂氏 J=52.412°摂氏 K=54.034°摂氏 L=55.656°摂氏 M=57.279°摂氏 N=58.901°摂氏 O=60.523°摂氏 P=62.145°摂氏 R=65.390°摂氏 約50℃の温度を表わしている上記に識別したカーブH
は,永久的ネクローシスがたとえば心筋層のような組織
に起る温度である。換言すると,非可逆損傷がこの温度
より高い温度で起る。その温度以下では,浮腫は一時的
であり,典型的には,逆に戻る。カーブI,J,K,L
ないしRによって表わされた温度は,ネクローシスが起
る50°以上の温度を表わしている。したがって,達し
た温度のため,チップ16から図15のカーブHによっ
て表わされた距離または深さまでネクローシスを起こす
ことがある。
極16の冷却を利用することによって,等温カーブは下
記の温度を有している。 A=19.518°摂氏 B=21.425°摂氏 C=23.333°摂氏 D=25.240°摂氏 E=27.148°摂氏 F=29.055°摂氏 G=30.963°摂氏 H=32.870°摂氏 I=34.778°摂氏 J=36.685°摂氏 K=38.593°摂氏 L=40.500°摂氏 M=42.408°摂氏 N=44.315°摂氏 O=47.228°摂氏 P=48.130°摂氏 R=51.495°摂氏 等温カーブから,50℃の等温カーブが電極から間隔を
へだてられ,温度のみが,等温カーブRの近くで49な
いし50℃を超え初めているのが判るであろう。したが
って,チップと直接隣接する心筋層部分が,安全に保た
れるのが判るであろう。換言すると,ネクローシスは心
筋層の第1の部分に現われない,つまり冷却チップのた
め,たとえばカーブPおよびRによって示されたよう
に,心筋層表面の下の1または2mmのようなある距離
まてネクローシスは起きない。したがって,切除チップ
の冷却が心筋層表面を保護するのに役立つことは判るで
あろう。同時に,冷却チップは,心筋層内への電力の供
給を制御する血液の凝固を防止するのに役立つ。
記の温度を有している。 A=40.160°摂氏 B=46.479°摂氏 C=52.798°摂氏 D=59.117°摂氏 E=65.436°摂氏 F=71.756°摂氏 G=78.075°摂氏 H=84.394°摂氏 I=90.713°摂氏 J=97.032°摂氏 K=103.352°摂氏 L=109.671°摂氏 M=1115.990°摂氏 N=122.309°摂氏 O=128.629°摂氏 P=134.943°摂氏 R=147.586°摂氏 この図では,血液が電極面上で凝固する実質的に100
℃以上の比較的高い温度に達することが判るであろう。
49℃の等温カーブは図17に示されていなが,それは
等温カーブBとCとの間にある。したがって電極チップ
における血液の凝固を除き,ネクローシスはカーブCと
Dの間のカーブによって表わされた深さまで起るに違い
ない。これは単に理論上のことである,というのは,そ
のような高温度のときには,血液の凝固がチップ上に起
り,チップから心筋層の組織への電力の転移を非常に妨
げるからである。
下記の温度を有している。 A=32.980°摂氏 B=38.589°摂氏 C=44.197°摂氏 D=49.806°摂氏 E=55.415°摂氏 F=61.024°摂氏 G=66.633°摂氏 H=72.242°摂氏 I=77.851°摂氏 J=83.460°摂氏 K=89.069°摂氏 L=94.678°摂氏 M=100.386°摂氏 N=105.895°摂氏 O=111.504°摂氏 P=117.113°摂氏 R=128.331°摂氏 これ等のカーブから,カーブDがネクローシスを止める
領域を表わしている等温カーブであることが判るであろ
う。図18の等温カーブから,電極表面における温度が
100°以下であり,したがって血液の凝固が起るのを
制御されることが判るであろう。したがって,今まで冷
却なしでは達成不可能であった冷却切除電極を利用する
比較的深い,かつ広い外傷を達成することが可能であ
る。切除チップ電極に対する冷却を使用せずに,チップ
電極に供給できる電力量が大幅に減少される,というの
は,さもなくば,チップ電極温度が非常に急激に上昇
し,チップ上に血液の凝固を生じ,それが電極から電極
に接触する組織への電力の転移を妨げるか,または少く
とも制御するからである。
多くの予期しない結果を有していることは判るであろ
う。冷却電極の使用が,ネクローシスを電極によって接
触される表面の十分下に作るのを可能にする。これは心
内膜下の不整脈惹起性の病巣によって作り出される不整
脈を処置するのに特に望ましい。したがって,皮膚表面
を損傷または切り開かずに,皮膚表面の下にある腫脹細
胞を処置可能にする組織表面の数ミリメーターの下であ
る外傷を達成可能にする。これは,傷口における可能性
のある感染を防止する大きな助けとなる。それはまた,
患者に対して,作り出されたネクローシスの周りの速や
かな癒合(ゆごう)を促進する。したがって,本発明に
よって,心筋層の真中に非常に小さい外傷,たとえば直
径2および3mmの外傷を設けることが可能である。適
切な電力の付加および適切な電極からの熱除去によっ
て,表面を電極によって損傷することなく,組織内の任
意の所望の深さに外傷を達成することが可能である。
たけれども,また,たとえば電気外科のような他の適用
も有していると理解すべきである。また,たとえば,胸
部癌および前立腺癌のような皮膚の下にある腫脹を処置
するのにも使用できる。
ジオ周波数切除に特に適しているカテーテルおよび切除
が血液変質を生ずることなく行なわれる部位の近くの血
液の不当な加熱を生ずることなく心臓の心筋層の切除を
可能にするその使用方法が提供されることは判るであろ
う。これは,チップにおける血圧に実質的に等しいカテ
ーテルのチップにおける圧力に維持されている食塩水の
使用によって達成できる。
よるラジオ周波数切除に使用するカテーテルの側部立面
図であり,そして冷却液をカテーテルのチップに送り,
かつそれから引き出すポンプシステムに概略的に接続さ
れているカテーテルを示している。
である。
血圧範囲のゼロまたはその近くであることを示している
グラフである。
であり,本発明に組み込まれている冷却チップの他の実
施例を示している。
である。
よるラジオ周波数切除に使用するカテーテルの他の実施
例の側部立面図であり,冷却液をカテーテルのチップに
供給するポンプシステムに概略的に接続されたカテーテ
ルを示している。
部部分立面図である。
たチップを示している側部立面図である。
に組み込まれたカテーテルの他の実施例の横断面の側部
立面図である。
端部立面図である。
ルギーを引き出す受動的芯を利用している本発明に組み
込まれているカテーテルの他の実施例である。
た横断面図である。
テーテルの遠位端の横断面図である。
度を示しているグラフである。
いる等温カーブと,切除の際の組織への影響を示してい
るグラフを示している。
いる等温カーブと,切除の際の組織への影響を示してい
るグラフを示している。
いる等温カーブと,切除の際の組織への影響を示してい
るグラフを示している。
いる等温カーブと,切除の際の組織への影響を示してい
るグラフを示している。
Claims (11)
- 【請求項1】 表面を有している組織に使用する冷却電
極によるラジオ周波数切除用カテーテルにおいて, 近位端および遠位端を有し、血管中を配送するのに適し
た寸法形状を有する細長い部材と,細長い部材の遠位端
に固定されていて,その中に小室を有しており,かつ組
織に接触するようになっている金属導電性電極と,細長
い部材を通り近位端から遠位端に延びていて,ラジオ周
波数エネルギーを電極に供給する導体手段と,前記細長
い部材は,遠位端に穴を有しており,かつ小室に連絡し
ており,前記小室に配置され,かつラジオ周波数エネル
ギーの付加によって電極内に生じた熱を分散するため電
極に接触する冷却手段と,電極に接触する組織の温度を
測定する手段と,冷却手段を使用せずに形成されるより
もより深いかつ広い外傷が組織内に形成できるようにす
るため、測定した温度に応答して,組織の表面温度が9
0℃を超えないように,電極に供給されるラジオ周波数
エネルギーの量を制御する手段とを有していることを特
徴とするカテーテル。 - 【請求項2】 前記冷却手段が,対流を生ずる受動的冷
却手段の形である請求項1に記載のカテーテル。 - 【請求項3】 前記電極が,導電性材料で形成されてお
り,電極に固定された複数の外方に延びているフィンを
備えている請求項2に記載のカテーテル。 - 【請求項4】 前記冷却手段が,冷却液が小室内に供給
される能動的冷却手段の形である請求項1に記載のカテ
ーテル。 - 【請求項5】 電極によって保持されており,小室内に
延びており,かつ冷却液に接触する内方に延びているフ
ィンと一緒である請求項4に記載のカテーテル。 - 【請求項6】 前記電極が,その中にオリフィスを有し
ている丸いチップを有しているチップ電極であり,その
オリフィスを通り冷却液を小室から送ることができる請
求項1に記載のカテーテル。 - 【請求項7】 前記チップ電極が,長手方向に延びてい
る軸線を有し,そして前記チップ電極が,チップ電極の
軸線から離れて延びる方向に近位の方に傾斜した追加の
オリフィスを備えており,そのオリフィスを通り,電極
を表面に係合する方に押す力を生ずるジェットを生ずる
ように,冷却液が漏出できる請求項6に記載のカテーテ
ル。 - 【請求項8】 電極の近位のチューブ状部材によっ支持
持された弁手段と,チューブ状部材および電極内の小室
に設けられ、冷却液を小室内に排出せしめ,それからチ
ャンバーからの近位の方に送り,そして弁手段を通り排
出せしめる手段とを含み,前記弁手段が,血液のような
液体がカテーテル内に入るのを防止するのに役立ってい
る請求項4に記載のカテーテル。 - 【請求項9】 前記細長い部材が,冷却液を第1に挙げ
た穴を通り供給し,そして冷却液を追加の穴から引き出
す手段と一緒に,電極内の小室内に延びている追加の穴
を備えている請求項1に記載のカテーテル。 - 【請求項10】 ラジオ周波数エネルギーを電極に供給
する導体手段は、5ワットより大きいが50ワットより
小さい電力のラジオ周波数エネルギーを供給する能力を
有する請求項1に記載のカテーテル。 - 【請求項11】 前記能動的冷却手段は5℃から10℃
の範囲の温度を有する冷却液を供給する能力を有する請
求項4に記載のカテーテル。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/983732 | 1992-12-01 | ||
US07/983,732 US5348554A (en) | 1992-12-01 | 1992-12-01 | Catheter for RF ablation with cooled electrode |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH06254103A JPH06254103A (ja) | 1994-09-13 |
JP2562861B2 true JP2562861B2 (ja) | 1996-12-11 |
Family
ID=25530075
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP5301999A Expired - Lifetime JP2562861B2 (ja) | 1992-12-01 | 1993-12-01 | 冷却電極によるラジオ周波数切除用カテーテルおよび方法 |
Country Status (7)
Country | Link |
---|---|
US (4) | US5348554A (ja) |
EP (1) | EP0608609B1 (ja) |
JP (1) | JP2562861B2 (ja) |
AT (1) | ATE206032T1 (ja) |
AU (1) | AU673015B2 (ja) |
CA (1) | CA2110309A1 (ja) |
DE (1) | DE69330821T2 (ja) |
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Cited By (3)
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WO2012086313A1 (ja) * | 2010-12-24 | 2012-06-28 | 日本ライフライン株式会社 | 電極カテーテル |
JP2012135338A (ja) * | 2010-12-24 | 2012-07-19 | Japan Lifeline Co Ltd | 電極カテーテル |
CN102364319A (zh) * | 2011-09-30 | 2012-02-29 | 珠海和佳医疗设备股份有限公司 | 一种双中空冷极射频针质量的检验装置及方法 |
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EP0608609A2 (en) | 1994-08-03 |
AU673015B2 (en) | 1996-10-24 |
US5348554A (en) | 1994-09-20 |
EP0608609A3 (en) | 1995-05-24 |
US5697927A (en) | 1997-12-16 |
DE69330821T2 (de) | 2002-05-16 |
US5658278A (en) | 1997-08-19 |
CA2110309A1 (en) | 1994-06-02 |
EP0608609B1 (en) | 2001-09-26 |
DE69330821D1 (de) | 2001-10-31 |
ATE206032T1 (de) | 2001-10-15 |
US5423811A (en) | 1995-06-13 |
AU5201993A (en) | 1994-06-16 |
JPH06254103A (ja) | 1994-09-13 |
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