JP4417052B2 - 安定化アレイを有するアブレーションカテーテル及び心房細動の治療方法 - Google Patents
安定化アレイを有するアブレーションカテーテル及び心房細動の治療方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
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- 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
- A61B2017/00039—Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
- A61B2017/00044—Sensing electrocardiography, i.e. ECG
- A61B2017/00048—Spectral analysis
- A61B2017/00053—Mapping
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- 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
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N7/02—Localised ultrasound hyperthermia
Description
(A) 周方向アブレーションカテーテルであって、外壁、近位端部、遠位端部及び少なくとも1つの貫通して延びるルーメンを備えた細長い管状カテーテル本体と、カテーテル本体の遠位端部のところに設けられたアブレーション組立体とを有し、アブレーション組立体は、カテーテル本体の遠位端部に取り付けられた周方向アブレーション要素及び周方向アブレーション要素に対しこれを包囲する関係で設けられていて、半径方向押し潰し位置と半径方向拡張位置との間で調節できる膨らまし可能なバルーンを有し、前記カテーテルは、アブレーション組立体の遠位側でカテーテルに取り付けられた安定化組立体を更に有し、安定化組立体は、心臓の全体として管状の領域又は心臓の近くの内周部周りに位置する複数の箇所に接触できることを特徴とするカテーテル。
(1) 周方向アブレーション要素は、膨らまし可能なバルーン内の固定位置のところでカテーテルに固定された超音波アブレーション要素を有し、超音波アブレーション要素は、これを超音波アブレーションアクチュエータに結合してこれにより作動させたとき、超音波エネルギの実質的に周方向パターンを放出すると共に半径方向拡張位置において膨らまし可能なバルーンが係合する組織の周方向領域の相当多くの部分に焼灼可能に結合するようになっていることを特徴とする実施態様(A)記載のカテーテル。
(2) 周方向アブレーション要素は、超音波変換器から成ることを特徴とする実施態様(A)記載のカテーテル。
(3) 超音波変換器は、実質的に管状であることを特徴とする上記実施形態(2)記載のカテーテル。
(4) 超音波変換器は、支持部材に対しこれを包囲する関係で設けられ、支持部材は、外面を有し、支持部材は、超音波変換器の少なくとも一部と支持部材の外面との間にガス充填隙間を備えた半径方向離隔領域を形成する半径方向離隔距離を置いてカテーテル本体の遠位端部に取り付けられていることを特徴とする上記実施形態(3)記載のカテーテル。
(5) 半径方向離隔領域は、流体が半径方向離隔領域の外部から隙間内へ入るのを実質的に阻止するよう封止されていることを特徴とする上記実施形態(4)記載のカテーテル。
(7) アブレーション組立体は、導電性内面に電気的に結合された遠位端部を備えた第1の電気リード線及び導電性外面に電気的に結合された遠位端部を備える第2の電気リード線を更に有し、第1の電気リード線及び第2の電気リード線はそれぞれ、電流源に結合されるようになった近位端部を有していることを特徴とする上記実施形態(6)記載のカテーテル。
(8) 超音波変換器は、超音波エネルギの連続周方向パターンを放出するようになっていることを特徴とする上記実施形態(2)記載のカテーテル。
(9) 超音波変換器は、音響信号を約5MHz〜約20MHzの周波数で放出するようになっていることを特徴とする上記実施形態(2)記載のカテーテル。
(10) 超音波変換器は、音響信号を1cmラジエータ当たり少なくとも約20ワットの出力レベルで放出するようになっていることを特徴とする上記実施形態(2)記載のカテーテル。
(12) 膨らまし可能なバルーンの拡張時外径は、拡張位置にあるとき、少なくとも約2.0センチメートルであることを特徴とする実施態様(A)記載のカテーテル。
(13) 安定化組立体は、カテーテル本体に対し全体として横断方向の全体として円形の主領域を有する管状構造から成ることを特徴とする実施態様(A)記載のカテーテル。
(14) 安定化組立体は、全体として円形の主領域の周りに設けられた複数のリング電極を支持していることを特徴とする上記実施形態(13)記載のカテーテル。
(15) 管状構造は、安定化組立体の全体として円形の主領域を覆って設けられた非導電性カバー及び安定化組立体の全体として円形の主領域内に設けられた形状記憶特性を備えた支持部材を有していることを特徴とする上記実施形態(13)記載のカテーテル。
(17) 遠位領域は、主領域よりも可撓性が高いことを特徴とする上記実施形態(16)記載のカテーテル。
(18) 安定化組立体は、全体として円形の主領域によって支持された複数の電極を有し、電極は、全体として円形の主領域の周囲全体の周りにほぼ等間隔を置いて設けられ、使用中、安定化組立体を心臓の管状領域又は心臓の近くに配置したとき、全体として円形の主領域の外周部が、管状領域の内周部と接触した状態で、電極を用いて管状領域の内周部をマップすることができるようになっていることを特徴とする上記実施形態(13)記載のカテーテル。
(19) 全体として円形の主領域の外径は、約10mm〜約25mmであることを特徴とする上記実施形態(13)記載のカテーテル。
(20) 全体として円形の主領域の外径は、約12mm〜約20mmであることを特徴とする上記実施形態(13)記載のカテーテル。
(22) 全体として円形の主領域に沿って設けられた電極の数は、約8〜約12であることを特徴とする上記実施形態(14)記載のカテーテル。
(23) アブレーション組立体の遠位側で且つ安定化組立体の近位側の位置でカテーテルを偏向させる手段を更に有していることを特徴とする実施態様(A)記載のカテーテル。
(24) 偏向手段は、カテーテル本体のルーメンを貫通して延び、遠位端部が偏向場所のところ又はその近くでしっかりと取り付けられたプラーワイヤと、プラーワイヤをカテーテル本体に対して長手方向に移動させて偏向を生じさせる操作取っ手とから成ることを特徴とする上記実施形態(23)記載のカテーテル。
(25) カテーテルをアブレーション組立体の近位側でカテーテル本体の遠位端部の近くの場所で偏向させる手段を更に有していることを特徴とする実施態様(A)記載のカテーテル。
(27) 全体として円形の主領域は、単一の全体として円曲線から成ることを特徴とする上記実施形態(13)記載のカテーテル。
(28) 安定化組立体は、拡張可能なバスケット形の組立体から成ることを特徴とする実施態様(A)記載のカテーテル。
(B) 患者の心臓の管状領域又は心臓の近くの組織の周方向領域の相当多くの部分を焼灼することにより心房細動を治療する方法であって、実施態様(A)記載のカテーテルを患者の体内に導入する段階を有し、周方向アブレーション要素は、音響エネルギドライバに結合された超音波アブレーション要素を有し、安定化組立体は、管状領域内に位置した状態で管状領域の周囲周りに位置する複数の箇所に接触するようになっており、前記方法は、組織の周方向領域の相当多くの部分と膨らまし可能なバルーンの少なくとも一部を互いに接触させて超音波アブレーション要素が、膨らまし可能なバルーンを通って実質的に周方向のパターンをなす超音波エネルギを組織の周方向領域の相当多くの部分に送るよう位置決めされるようになっている段階と、音響エネルギドライバを作動させて膨らまし可能なバルーンを介して超音波アブレーション要素を組織の周方向領域の相当多くの部分に焼灼可能に結合する段階とを更に有していることを特徴とする方法。
(29) 組織の周方向領域の少なくとも相当多くの部分を接触させる段階は、膨らまし可能なバルーンを拡張させて組織の周方向領域の相当多くの部分に半径方向に係合させる段階から成ることを特徴とする実施態様(B)記載の方法。
(30) 膨らまし可能なバルーンを拡張させる段階は、超音波的に透明なインフレーション流体を膨らまし可能なバルーンの内側領域に導入する段階から成ることを特徴とする上記実施形態(29)記載の方法。
(32) 膨らまし可能なバルーンを拡張させる段階は、膨らまし可能なバルーンの直径を少なくとも約1cmに増大させる段階から成ることを特徴とする上記実施形態(29)記載の方法。
(33) 超音波アブレーション要素を心組織が肺静脈に沿って延びる場所で組織の周方向領域の相当多くの部分に焼灼可能に結合する段階を更に有していることを特徴とする実施態様(B)記載の方法。
(34) 超音波アブレーション要素を心組織が肺静脈の口に沿って延びる場所で組織の周方向領域の相当多くの部分に焼灼可能に結合する段階を更に有していることを特徴とする実施態様(B)記載の方法。
(35) 超音波アブレーション要素を、心房壁に沿い且つ肺静脈の口を包囲する場所で組織の周方向領域の相当多くの部分に焼灼可能に結合する段階を更に有していることを特徴とする実施態様(B)記載の方法。
(36) 超音波アブレーション要素を作動させて超音波エネルギの実質的に周方向パターンを約5MHz〜約20MHzの周波数で放出する段階を更に有していることを特徴とする実施態様(B)記載の方法。
(37) 組織の周方向領域全体は、超音波アブレーション要素に焼灼可能に結合されていることを特徴とする実施態様(B)記載の方法。
14 アブレーション組立体
16 操作取っ手
17 安定化組立体
20,21,22,23 ルーメン
26 バルーン
27 マーカバンド
28 変換器
29 金属チューブ
30 内側支持部材
40 同軸ケーブル
50 主領域
52 近位ネック領域
54 遠位ネック領域
88 安定化組立体の近位領域
89 安定化組立体の主領域
90 安定化組立体の遠位領域
92,93 プラーワイヤ
96 リング電極
98 電気リード線又はリードワイヤ
104 コイルばね
Claims (18)
- 周方向アブレーションカテーテルであって、
外壁、近位端部、遠位端部及び少なくとも1つの貫通して延びるルーメンを備えた細長い管状カテーテル本体と、
カテーテル本体の遠位端部のところに設けられたアブレーション組立体であって、カテーテル本体の遠位端部に取り付けられた周方向アブレーション要素と、周方向アブレーション要素に対しこれを包囲する関係で設けられていて、半径方向押し潰し位置と半径方向拡張位置との間で調節できる膨らまし可能なバルーンとを有する、アブレーション組立体と、
アブレーション組立体の遠位側でカテーテルに取り付けられた安定化組立体であって、カテーテル本体に対し全体として横断方向の全体として円形の主領域を有する管状構造と、全体として円形の主領域によって支持された複数の電極とを有する、安定化組立体とを備え、
膨らまし可能なバルーンは、半径方向拡張位置にあるとき、心臓の又は心臓近くの管状領域の内周部に係合するように構成されており、
安定化組立体は、膨らまし可能なバルーンが半径方向拡張位置にあるとき、全体として円形の主領域が心臓の又は心臓近くの管状領域の内周部と接触するように構成されている、カテーテル。 - 周方向アブレーション要素は、膨らまし可能なバルーン内の固定位置でカテーテルに固定された超音波アブレーション要素を有し、超音波アブレーション要素は、これを超音波アブレーションアクチュエータに結合してこれにより作動させたとき、実質的に周方向パターンの超音波エネルギーを放出すると共に半径方向拡張位置において膨らまし可能なバルーンが係合する組織の周方向領域の相当多くの部分に焼灼可能に結合するように構成されている請求項1記載のカテーテル。
- 周方向アブレーション要素は、超音波変換器を備える請求項1記載のカテーテル。
- 超音波変換器は、実質的に管状である請求項3記載のカテーテル。
- 超音波変換器は、支持部材に対しこれを包囲する関係で設けられ、支持部材は、外面を有し、支持部材は、超音波変換器の少なくとも一部と支持部材の外面との間にガス充填隙間を備えた半径方向離隔領域を形成する半径方向離隔距離を置いてカテーテル本体の遠位端部に取り付けられている請求項4記載のカテーテル。
- 半径方向離隔領域は、流体が半径方向離隔領域の外部から隙間内へ入るのを実質的に阻止するよう封止されている請求項5記載のカテーテル。
- 実質的に管状の超音波変換器は、圧電セラミック材料を備え、導電性内面及び導電性外面を有している請求項4記載のカテーテル。
- アブレーション組立体は、導電性内面に電気的に結合された遠位端部を備えた第1の電気リード線及び導電性外面に電気的に結合された遠位端部を備える第2の電気リード線を更に有し、第1の電気リード線及び第2の電気リード線はそれぞれ、電流源に結合するように構成された近位端部を有している請求項7記載のカテーテル。
- 超音波変換器は、連続周方向パターンの超音波エネルギーを放出するように構成されている請求項3記載のカテーテル。
- 電極は、リング電極である請求項1記載のカテーテル。
- 管状構造は、安定化組立体の全体として円形の主領域を覆って設けられた非導電性カバーと、安定化組立体の全体として円形の主領域内に設けられた形状記憶特性を備えた支持部材とを有している請求項1記載のカテーテル。
- 安定化組立体は、全体として円形の主領域の遠位側に設けられた全体として真っ直ぐな遠位領域を更に有している請求項1記載のカテーテル。
- 遠位領域は、主領域よりも可撓性が高い請求項12記載のカテーテル。
- 電極は、全体として円形の主領域の周囲全体の周りにほぼ等間隔を置いて設けられ、使用中、アブレーション組立体を心臓の又は心臓近くの管状領域に配置したとき、全体として円形の主領域の外周部が、管状領域の内周部と接触した状態で、電極は管状領域の内周部をマップするために使用可能である請求項1記載のカテーテル。
- アブレーション組立体の遠位側で且つ安定化組立体の近位側の位置でカテーテルを偏向させる手段を更に有している請求項1記載のカテーテル。
- 偏向手段は、カテーテル本体のルーメンを貫通して延び、遠位端部が偏向位置又はその近くでしっかりと取り付けられたプラーワイヤと、プラーワイヤをカテーテル本体に対して長手方向に移動させて偏向を生じさせる操作取っ手とを備えた請求項15記載のカテーテル。
- カテーテルをアブレーション組立体の近位側でカテーテル本体の遠位端部の近くの位置で偏向させる手段を更に有している請求項1記載のカテーテル。
- 偏向手段は、カテーテル本体のルーメンを貫通して延び、遠位端部が偏向位置又はその近くでしっかりと取り付けられたプラーワイヤと、プラーワイヤをカテーテル本体に対して長手方向に移動させて偏向を生じさせる操作取っ手とを備えた請求項17記載のカテーテル。
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-
2002
- 2002-07-23 US US10/201,052 patent/US6866662B2/en not_active Expired - Lifetime
-
2003
- 2003-07-18 IL IL157015A patent/IL157015A/en active IP Right Grant
- 2003-07-21 DE DE60303570T patent/DE60303570T2/de not_active Expired - Lifetime
- 2003-07-21 EP EP03254566A patent/EP1384445B1/en not_active Expired - Lifetime
- 2003-07-22 JP JP2003277728A patent/JP4417052B2/ja not_active Expired - Lifetime
- 2003-07-23 CA CA2435866A patent/CA2435866C/en not_active Expired - Fee Related
-
2004
- 2004-12-29 US US11/024,537 patent/US7410486B2/en not_active Expired - Lifetime
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011155424A1 (ja) | 2010-06-08 | 2011-12-15 | 東レ株式会社 | 電位測定用カテーテル |
US9131897B2 (en) | 2010-06-08 | 2015-09-15 | Toray Industries, Inc. | Catheter for measuring electric potential |
Also Published As
Publication number | Publication date |
---|---|
DE60303570D1 (de) | 2006-04-20 |
IL157015A (en) | 2009-12-24 |
DE60303570T2 (de) | 2006-09-07 |
US7410486B2 (en) | 2008-08-12 |
IL157015A0 (en) | 2004-02-08 |
US20050113822A1 (en) | 2005-05-26 |
CA2435866A1 (en) | 2004-01-23 |
CA2435866C (en) | 2012-05-08 |
EP1384445B1 (en) | 2006-02-15 |
US6866662B2 (en) | 2005-03-15 |
JP2004130096A (ja) | 2004-04-30 |
EP1384445A1 (en) | 2004-01-28 |
US20040019349A1 (en) | 2004-01-29 |
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