JP2015532604A - カテーテル、カテーテルシステム、及び組織構造を刺通する方法 - Google Patents
カテーテル、カテーテルシステム、及び組織構造を刺通する方法 Download PDFInfo
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Abstract
Description
本出願は、本出願が依拠し、かつ全文が本出願に引用によって組み込まれている2012年8月9日出願の米国特許仮出願第61/681,552号からの優先権を主張するものである。
図2〜図24を参照すると、受術者の身体内で使用するための経皮カテーテルシステム10を開示している。1つの態様において、経皮カテーテルシステム10は、第1のカテーテル100と第2のカテーテル200を含む。第1のカテーテル100を雄カテーテル100と呼ぶ場合があり、第2のカテーテル200を雌カテーテル200と呼ぶ場合がある。この態様において、第1のカテーテル100及び第2のカテーテル200の各々は、それぞれの長手軸102、202、長手長さ104、204、近位部分106、206、及び遠位部分108、208を有することができる。例示的態様において、第1及び第2のカテーテル100、200の各々は、約20cmから約50cmまでの範囲にわたる長手長さ104、204を有することができる。別の例示的態様において、第1のカテーテル100の長手長さ104と第2のカテーテルの長手長さ204は、ほぼ同じである。互いに対するカテーテル100、200の長さは、多くの態様においてそれ程重要ではないが、カテーテル100、200が対として機能することは重要である。しかし、カテーテル100、200の長さは、カテーテルシステム10を適用する解剖学的構造の重要領域に到達するほど十分に長い組合せ長さを全体的に有するべきである。これらの態様において、第1のカテーテル100と第2のカテーテル200の間の磁気結合の後では、第1のカテーテル100及び第2のカテーテル200の全長は、約40cmから約100cmまでの範囲とすることができると考えられている。
図27〜図34を参照すると、本明細書で受術者の身体内の選択組織領域を焼灼するための焼灼カテーテル20を説明する。例示的態様において、焼灼カテーテル20は、高周波(RF)エネルギ、不可逆電気穿孔(IE)インパルス、及び他の混成電気焼灼技術のうちの1つ又はそれよりも多くを用いて、線形の円周焼灼損傷を生成することができるワイヤ上多電極焼灼カテーテル20である。焼灼カテーテル20は、組織傷害、細胞死をもたらし、一部の事例では細胞機能破壊のみをもたらす高電圧超短直流パルスを組織に印加するように設計される。
J=Ji(Πr2*Iii)/(Πr2*Ii)2−(Πr2*Ii)i)
ここで、Jは、得られる密度であり、Jiは、初期密度であり、(Πr2*Ii)iは、活性化の前の高インピーダンス構造の初期面積であり、(Πr2*Ii)2は、活性化の後の高インピーダンス構造の面積である。
IVC 下大静脈
SVC 上大静脈
Claims (25)
- 受術者の身体内で使用するための経皮カテーテルシステムであって、
長手軸と、長手長さと、近位部分と、遠位部分とを有する第1のカテーテルであって、該第1のカテーテルの該遠位部分が、該第1のカテーテルの遠位端を定め、該第1のカテーテルの該遠位端が、開口部を定め、該第1のカテーテルが、該第1のカテーテルの該長手長さの少なくとも一部分に沿って該遠位端の該開口部から該第1のカテーテルの該近位部分に向けて延びる少なくとも1つの内腔を定め、該第1のカテーテルが、該第1のカテーテルの該遠位端の近くに位置決めされて該第1のカテーテルの該遠位部分と作動的に結合された第1の磁石アセンブリを含む前記第1のカテーテルと、
長手軸と、長手長さと、近位部分と、遠位部分とを有する第2のカテーテルであって、該第2のカテーテルの該遠位部分が、該第2のカテーテルの遠位端を定め、該第2のカテーテルの該遠位端が、開口部を定め、該第2のカテーテルが、該第2のカテーテルの該長手長さの少なくとも一部分に沿って該遠位端の該開口部から該第2のカテーテルの該近位部分に向けて延びる少なくとも1つの内腔を定め、該第2のカテーテルが、該第2のカテーテルの該遠位端の近くに位置決めされて該第2のカテーテルの該遠位部分と作動的に結合された第2の磁石アセンブリを含む前記第2のカテーテルと、
を含み、
前記第1の磁石アセンブリは、前記第1のカテーテルの前記長手軸が前記第2のカテーテルの前記長手軸と実質的に軸線方向に位置合わせされるような前記第2の磁石アセンブリとの磁気結合に向けて構成される、
ことを特徴とする経皮カテーテルシステム。 - 前記第1の磁石アセンブリは、前記受術者の前記身体内の組織構造を通した前記第2の磁石アセンブリとの磁気結合に向けて構成されることを特徴とする請求項1に記載の経皮カテーテルシステム。
- 前記第1のカテーテルの前記少なくとも1つの内腔は、1次内腔を含み、
前記第1のカテーテルは、該第1のカテーテルの前記1次内腔内に作動的に位置決めされた針を更に含み、該針は、遠位穿刺面を有し、該針は、該第1のカテーテルの前記長手軸に対する選択的な軸線方向移動に向けて構成される、
ことを特徴とする請求項2に記載の経皮カテーテルシステム。 - 前記第1のカテーテルの前記長手軸が前記第2のカテーテルの前記長手軸と実質的に軸線方向に位置合わせされるような前記第1及び第2の磁石アセンブリ間の磁気結合時に、前記針は、該針の少なくとも一部分が該第1のカテーテルの前記遠位端の前記開口部を抜け出て、かつ該第2のカテーテルの前記遠位端の前記開口部内に受け入れられるような該第1のカテーテルの該長手軸に対する軸線方向移動に向けて構成されることを特徴とする請求項3に記載の経皮カテーテルシステム。
- 前記第1のカテーテルの前記針は、該第1のカテーテルの前記1次内腔内に引き込み可能に固定され、
前記第1のカテーテルの前記針は、送出内腔を定める、
ことを特徴とする請求項4に記載の経皮カテーテルシステム。 - 前記針の前記送出内腔は、ガイドワイヤを受け入れるように構成され、
前記第2のカテーテルの前記遠位端の前記開口部内への前記針の少なくとも一部分の受け入れ時に、該針の前記送出内腔は、前記第1のカテーテルから該第2のカテーテルまでの前記ガイドワイヤの移送を可能にするように構成される、
ことを特徴とする請求項5に記載の経皮カテーテルシステム。 - 前記第1のカテーテルは、該第1のカテーテルの前記1次内腔内に受け入れられて該第1のカテーテルの前記長手軸に対する軸線方向移動に向けて構成されたスタイラスを更に含み、該スタイラスは、該第1のカテーテルの該長手軸に対する該細長部材の移動が該第1のカテーテルの該長手軸に対する前記針の対応する移動を達成するように該第1のカテーテルの該針と作動的に結合されることを特徴とする請求項4に記載の経皮カテーテルシステム。
- 前記第2のカテーテルの前記少なくとも1つの内腔は、1次内腔を含み、
前記第1の磁石アセンブリは、前記第1のカテーテルの前記1次内腔内に位置決めされ、
前記第2の磁石アセンブリは、前記第2のカテーテルの前記1次内腔内に位置決めされる、
ことを特徴とする請求項4に記載の経皮カテーテルシステム。 - 前記第1のカテーテルの前記少なくとも1つの内腔は、該第1のカテーテルの前記遠位端の前記開口部への1つ又はそれよりも多くの流体の送出及び/又は該第1のカテーテルの該遠位端の該開口部への吸引力の印加に向けて構成された補助内腔を更に含むことを特徴とする請求項4に記載の経皮カテーテルシステム。
- 前記第2のカテーテルの前記少なくとも1つの内腔は、1次内腔を含み、
前記第2のカテーテルは、該第2のカテーテルの前記1次内腔内に作動的に位置決めされた針を更に含み、該第2のカテーテルの該針は、該第2のカテーテルの前記長手軸に対する選択的な軸線方向移動に向けて構成される、
ことを特徴とする請求項4に記載の経皮カテーテルシステム。 - 前記第1のカテーテル及び前記第2のカテーテルの少なくとも一方が、可撓性であることを特徴とする請求項1に記載の経皮カテーテルシステム。
- 受術者の身体内の組織構造を刺通する方法であって、
第1のカテーテルの遠位端を前記組織構造の第1の側面の近くに位置決めする段階であって、該第1のカテーテルが、長手軸と、長手長さと、近位部分と、遠位部分とを有し、該第1のカテーテルの該遠位部分が、該第1のカテーテルの該遠位端を定め、該第1のカテーテルの該遠位端が、開口部を定め、該第1のカテーテルが、該第1のカテーテルの該長手長さの少なくとも一部分に沿って該遠位端の該開口部から該第1のカテーテルの該近位部分に向けて延びる少なくとも1つの内腔を定め、該第1のカテーテルが、該第1のカテーテルの該遠位端の近くに位置決めされて該第1のカテーテルの該遠位部分と作動的に結合された第1の磁石アセンブリを含む、前記位置決めする段階と、
第2のカテーテルの遠位端を前記組織構造の第2の側面の近くに位置決めする段階であって、該組織構造の該第2の側面が、該組織構造の前記第1の側面から離間しており、該第2のカテーテルが、長手軸と、長手長さと、近位部分と、遠位部分とを有し、該第2のカテーテルの該遠位部分が、該第2のカテーテルの該遠位端を定め、該第2のカテーテルの該遠位端が、開口部を定め、該第2のカテーテルが、該第2のカテーテルの該長手長さの少なくとも一部分に沿って該遠位端の該開口部から該第2のカテーテルの該近位部分に向けて延びる少なくとも1つの内腔を定め、該第2のカテーテルが、該第2のカテーテルの該遠位端の近くに位置決めされて該第2のカテーテルの該遠位部分と作動的に結合された第2の磁石アセンブリを含む、前記位置決めする段階と、
前記第1のカテーテルの前記長手軸が前記第2のカテーテルの前記長手軸と実質的に軸線方向に位置合わせされるように、前記組織構造を通して前記第1の磁石アセンブリを前記第2の磁石アセンブリに磁気結合させる段階と、
前記第1のカテーテルの前記少なくとも1つの内腔を通して針を該針の少なくとも一部分が該第1のカテーテルの前記遠位端の前記開口部を抜け出て、かつ前記第2のカテーテルの前記遠位端の前記開口部内に受け入れられるように選択的に前進させる段階と、
を含むことを特徴とする方法。 - 前記組織構造は、前記受術者の心臓内の解剖学的翻転部を含むことを特徴とする請求項12に記載の方法。
- 受術者の身体内の選択組織領域を焼灼するための焼灼カテーテルであって、
長手軸と、長手長さと、近位部分と、中心部分と、遠位部分とを有する可撓性細長シャフトと、
前記細長シャフトの前記中心部分内で該細長シャフトの前記長手長さに沿って離間され、該細長シャフトと一体的に形成された複数の電極と、
を含み、
前記可撓性細長シャフトは、該細長シャフトの前記中心部分が前記選択組織領域を少なくとも部分的に取り囲み、かつ該細長シャフトの前記近位及び遠位部分が前記受術者の前記身体の外部に位置決めされるような該受術者の該身体内への選択的位置決めに向けて構成され、
前記細長シャフトの前記中心部分が前記選択組織領域を少なくとも部分的に取り囲むような該細長シャフトの位置決め時に、前記複数の電極の各電極が、該選択組織領域に焼灼エネルギを印加するための選択的で独立した活性化に向けて構成される、
ことを特徴とする焼灼カテーテル。 - 前記可撓性細長シャフトは、ガイドワイヤを受け入れるように構成された1次内腔を定めることを特徴とする請求項14に記載の焼灼カテーテル。
- 少なくとも1つの高インピーダンス構造を更に含み、
前記少なくとも1つの高インピーダンス構造は、前記複数の電極の間に位置決めされ、かつ該複数の電極の一部分によって生成された電流経路を該部分が焼灼エネルギを印加するように活性化された時に変更するように構成される、
ことを特徴とする請求項14に記載の焼灼カテーテル。 - 前記複数の電極のうちの少なくとも2つが、双極方式で機能するように割り当てられることを特徴とする請求項14に記載の焼灼カテーテル。
- 受術者の身体内の選択組織領域を焼灼する方法であって、
前記受術者の前記身体内に焼灼カテーテルの可撓性細長シャフトを該細長シャフトの中心部分が前記選択組織領域を少なくとも部分的に取り囲み、かつ該細長シャフトの近位部分及び遠位部分が該受術者の該身体の外部に位置決めされるように選択的に位置決めする段階であって、該細長シャフトが、長手軸と長手長さを有し、該細長シャフトが、1次内腔を定め、複数の電極が、該細長シャフトの該中心部分内で該細長シャフトの該長手長さに沿って離間され、該複数の電極が、該細長シャフトと一体的に形成される前記選択的に位置決めする段階と、
前記選択組織領域に焼灼エネルギを印加するために前記複数の電極の各電極を選択的に独立して活性化する段階と、
を含むことを特徴とする方法。 - 受術者の身体内の選択組織領域を焼灼するための焼灼カテーテルシステムであって、
長手軸と、長手長さと、近位部分と、中心部分と、遠位部分とを有し、1次内腔を定める可撓性細長シャフト、及び
前記細長シャフトの前記中心部分内で該細長シャフトの前記長手長さに沿って離間され、該細長シャフトと一体的に形成された複数の電極、
を含み、
前記可撓性細長シャフトが、該細長シャフトの前記中心部分が前記選択組織領域を少なくとも部分的に取り囲み、かつ該細長シャフトの前記近位及び遠位部分が前記受術者の前記身体の外部に位置決めされるような該受術者の該身体内への選択的位置決めに向けて構成され、
前記細長シャフトの前記中心部分が前記選択組織領域を少なくとも部分的に取り囲むような該細長シャフトの位置決め時に、前記複数の電極の各電極が、該選択組織領域に焼灼エネルギを印加するための選択的で独立した活性化に向けて構成される、
焼灼カテーテルと、
1つ又はそれよりも多くの信号発生器であって、該1つ又はそれよりも多くの信号発生器の各発生器が、1つ又はそれよりも多くの電気信号を選択的に発生させるように構成された前記1つ又はそれよりも多くの信号発生器と、
前記1つ又はそれよりも多くの信号発生器と前記複数の電極とに電気結合された経路指定コンソールであって、該経路指定コンソールが、該1つ又はそれよりも多くの信号発生器からの前記1つ又はそれよりも多くの電気信号を受け入れるように構成され、該経路指定コンソールが、該1つ又はそれよりも多くの電気信号の送出によって該複数の電極を選択的に活性化するように更に構成される前記経路指定コンソールと、
を含むことを特徴とする焼灼カテーテルシステム。 - 前記複数の電極の各電極が、1つ又はそれよりも多くの電気信号を選択的に記録するように更に構成されることを特徴とする請求項19に記載の焼灼カテーテルシステム。
- 前記1つ又はそれよりも多くの信号発生器によって発生される前記1つ又はそれよりも多くの電気信号の各電気信号が、インパルス強度、持続時間、負荷サイクル、及びタイミングを含み、
前記1つ又はそれよりも多くの信号発生器の各それぞれの信号発生器が、それが発生させる前記1つ又はそれよりも多くの電気信号の前記インパルス強度、前記持続時間、前記負荷サイクル、及び前記タイミングのうちの少なくとも1つを選択的に変化させるように構成される、
ことを特徴とする請求項20に記載の焼灼カテーテルシステム。 - 前記経路指定コンソールは、前記複数の電極によって記録された前記1つ又はそれよりも多くの電気信号をモニタするように構成され、
前記1つ又はそれよりも多くの信号発生器による前記1つ又はそれよりも多くの電気信号の前記インパルス強度、前記持続時間、前記負荷サイクル、及び前記タイミングの前記選択的な変化は、前記複数の電極によって記録された該1つ又はそれよりも多くの電気信号に基づくものである、
ことを特徴とする請求項21に記載の焼灼カテーテルシステム。 - 受術者の身体内の選択組織領域を焼灼する方法であって、
前記受術者の前記身体内に焼灼カテーテルの可撓性細長シャフトを該細長シャフトの中心部分が前記選択組織領域を少なくとも部分的に取り囲み、かつ該細長シャフトの近位部分及び遠位部分が該受術者の該身体の外部に位置決めされるように選択的に位置決めする段階であって、該細長シャフトが、長手軸と長手長さを有し、該細長シャフトが、1次内腔を定め、複数の電極が、該細長シャフトの該中心部分内で該細長シャフトの該長手長さに沿って離間され、該複数の電極が、該細長シャフトと一体的に形成される、前記選択的に位置決めする段階と、
1つ又はそれよりも多くの電気信号を選択的に発生させる段階と、
経路指定コンソールを通じて、1つ又はそれよりも多くの信号発生器からの前記1つ又はそれよりも多くの電気信号を受け入れる段階と、
前記経路指定コンソールを通じて、前記複数の電極の各電極が前記選択組織領域に焼灼エネルギを印加するために選択的に独立して活性化されるように該複数の電極に前記1つ又はそれよりも多くの電気信号を送出する段階と、
を含むことを特徴とする方法。 - 前記1つ又はそれよりも多くの信号発生器を通じて、前記複数の電極によって記録された前記1つ又はそれよりも多くの電気信号に基づいて、該1つ又はそれよりも多くの信号発生器によって発生された該1つ又はそれよりも多くの電気信号のインパルス強度、持続時間、負荷サイクル、及びタイミングのうちの少なくとも1つを選択的に変化させる段階を更に含むことを特徴とする請求項23に記載の方法。
- 受術者の身体の選択組織領域を焼灼するのに使用するための焼灼システムであって、
a.前記選択組織領域の周りの配置に向けて構成されたガイドワイヤと、
b.i.長手軸と、長手長さと、近位部分と、遠位部分とを有する第1のカテーテルであって、該第1のカテーテルの該遠位部分が、該第1のカテーテルの遠位端を定め、該第1のカテーテルの該遠位端が、開口部を定め、該第1のカテーテルが、該第1のカテーテルの該長手長さの少なくとも一部分に沿って該遠位端の該開口部から該第1のカテーテルの該近位部分に向けて延びる少なくとも1つの内腔を定め、該少なくとも1つの内腔が、前記ガイドワイヤと、該第1のカテーテルの該遠位端の近くに位置決めされ、かつ該第1のカテーテルの該遠位部分と作動的に結合された第1の磁石アセンブリと、該少なくとも1つの内腔内に作動的に位置決めされた針とを受け入れるように構成され、該針が、遠位穿刺面を有し、かつ該第1のカテーテルの該長手軸に対する選択的な軸線方向移動に向けて構成される前記第1のカテーテル、及び
ii.長手軸と、長手長さと、近位部分と、遠位部分とを有する第2のカテーテルであって、該第2のカテーテルの該遠位部分が、該第2のカテーテルの遠位端を定め、該第2のカテーテルの該遠位端が、開口部を定め、該第2のカテーテルが、該第2のカテーテルの該長手長さの少なくとも一部分に沿って該遠位端の該開口部から該第2のカテーテルの該近位部分に向けて延びる少なくとも1つの内腔を定め、該少なくとも1つの内腔が、前記ガイドワイヤと、該第2のカテーテルの該遠位端の近くに位置決めされ、かつ該第2のカテーテルの該遠位部分と作動的に結合された第2の磁石アセンブリとを受け入れるように構成され、前記針の前記遠位穿刺面が、組織構造を穿刺して該第2のカテーテルの該遠位端の該開口部内に受け入れられるように、前記第1の磁石アセンブリが、前記第1のカテーテルの前記長手軸が該第2のカテーテルの該長手軸と実質的に軸線方向に位置合わせされ、かつ該第1のカテーテルから該第2のカテーテルまでの該ガイドワイヤの移送を可能にすることができるような前記受術者の前記身体内の該組織構造を通じた該第2の磁石アセンブリとの磁気結合に向けて構成され、該第1及び第2のカテーテルが、磁気的に脱結合して該ガイドワイヤを前記選択組織領域の周りの所定位置に残すように構成される前記第2のカテーテル、
を含む経皮カテーテルシステムと、
c.前記選択組織領域を焼灼するための焼灼カテーテルであって
i.長手軸と、長手長さと、近位部分と、中心部分と、遠位部分とを有する可撓性細長シャフトであって、該可撓性細長シャフトが、前記焼灼カテーテルを前記選択組織領域の周りに配置するための前記ガイドワイヤを受け入れるように構成された1次内腔を定める前記可撓性細長シャフト、及び
ii.前記細長シャフトの前記中心部分内で該細長シャフトの前記長手長さに沿って離間され、該細長シャフトと一体的に形成された複数の電極であって、該可撓性細長シャフトが、該細長シャフトの該中心部分が前記選択組織領域を少なくとも部分的に取り囲み、かつ該細長シャフトの前記近位及び遠位部分が前記受術者の前記身体の外部に位置決めされるような該受術者の該身体内への選択的位置決めに向けて構成され、該細長シャフトの該中心部分が該選択組織領域を少なくとも部分的に取り囲むような該細長シャフトの位置決め時に、該複数の電極の各電極が、該選択組織領域に焼灼エネルギを印加するための選択的で独立した活性化に向けて構成される前記複数の電極、
を含む前記焼灼カテーテルと、
を含むことを特徴とする焼灼システム。
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JP2018089431A (ja) | 2018-06-14 |
EP2882336A4 (en) | 2016-08-10 |
EP2882336B1 (en) | 2019-06-26 |
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