JP6967558B2 - 電気外科システム - Google Patents
電気外科システム Download PDFInfo
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- JP6967558B2 JP6967558B2 JP2019146021A JP2019146021A JP6967558B2 JP 6967558 B2 JP6967558 B2 JP 6967558B2 JP 2019146021 A JP2019146021 A JP 2019146021A JP 2019146021 A JP2019146021 A JP 2019146021A JP 6967558 B2 JP6967558 B2 JP 6967558B2
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Description
本出願は、現在特許出願中である2008年3月31日出願の「高周波電気エネルギで生物組織を融合するフィードバック制御機構」という名称の米国特許仮出願出願番号第61/040,980号、現在現在特許出願中である2008年3月31日出願の「高周波電気エネルギによる生物組織の融合」という名称の米国特許仮出願出願番号第61/040,994号、現在現在特許出願中である2008年3月31日出願の「無血組織解剖の方法及び装置」という名称の米国特許仮出願出願番号第61/040,957号、現在現在特許出願中である2008年3月31日出願の「腹腔鏡検査バイポーラ電気計測器」という名称の米国特許仮出願出願番号第61/040,828号、現在現在特許出願中である2008年3月31日出願の「生きた組織の融合の装置及び方法」という名称の米国特許仮出願出願番号第61/040、890号、現在現在特許出願中である2008年3月31日出願の「高周波電気エネルギによる生物組織の溶着」という名称の米国特許仮出願出願番号第61/041,045号、現在現在特許出願中である2008年3月31日出願の「高周波電気エネルギで生物組織を融合する電気制御回路」という名称の米国特許仮出願出願番号第61/041,012号、及び現在現在特許出願中である2008年11月18日出願の「電気外科的組織解剖の方法及び装置」という名称の米国特許仮出願出願番号第61/115,756号の恩典を請求するものである。これらの出願の全ては、その全体が引用により本明細書に組み込まれている。
図1Aは、電気外科システム2の概略図を示している。電気外科システム2は、電気外科ユニット(ESU)10及び電気外科ツール40を含むことができる。電気外科ツール40は、電気外科ユニット10に電気的に結合することができる。一部の実施形態では、電気ワイヤ、ワイヤバンドル、又はケーブルのような電子結合器30は、ESU10に電気外科ツール40を電気的に結合することができる。一部の実施形態では、電気外科システム2は、外部ツールコントローラ80を任意的に更に含むことができる。
図3A〜図3Cを参照すると、電気外科ユニット410は、斜視図、正面図、及び後面図に示されている。電気外科ユニット410は、図1Aに関して上述したように一体型ESUとすることができ、かつ発生器及びフィードバック回路を含むことができる。一部の実施形態では、電気外科ユニット410のハウジング又はコンソールは、標準的な手術室カート又は保管棚上に収まるようにサイズ決定及び構成することができる。一部の実施形態では、電気外科ユニット410のハウジング又はコンソールは、他の外科電気機器と積み重ね可能であるように構成することができる。
電気外科ユニット
一般的に、電気外科発生器、電気外科コントローラ、及び1つ又はそれよりも多くの電気外科ツールを含む電気外科ユニットが提供される。コントローラは、ツールがコントローラに取り付けられた発生器内に組み込むか、又はそれに取り付けることができる。
様々な実施形態における電気外科システム及び処理は、手術中に患者に単極又は双極高周波電気エネルギを印加する。このようなシステム及び処理は、特に、空間的に限定されたアクセス及び呼出し及び可視性のために簡単な取り扱いを必要とする腹腔鏡検査で内視鏡手術に適合され、血管を融合して他の生物組織を結合するために、一態様では、組織/血管を切断、切開、及び分離するのに使用される。ある一定の実施形態では、システム及び処理は、(a)組織を乾燥させ、かつ(b)殆どの生物組織内に豊富にあるコラーゲン(タイプI−III)及び他のタンパク質を変性するために機械的に圧迫された組織へのRFエネルギの印加を含む。適切な温度へのコラーゲンの加熱によりコラーゲンが拡張するか、収縮するか、又は変性するので、システムは、血管の永久的な閉塞に向けて手術中の毛細管及び血管の密封を可能にする。以下でより詳細に説明するように、一例として、最大7ミリメートルまでの動脈は、高周波(RF)エネルギ及び機械的圧力により閉塞させ、かつ切開することができる。
一態様では、融合処理の終点の判断は、融合処理中に電圧及び電流の位相シフトをモニタすることによって行われる。インピーダンスとは異なり、位相シフトは、動脈が乾燥して融合が完了する時の方が変化が顕著になり、それゆえに、インピーダンスより影響を受けやすい制御値になる。これは、融合処理の開始に対して図23に示すように、電圧及び電流を異なる融合時間の時間の関数としてモニタする時に見出される。
一実施形態では、ツールキャパシタンス及びツール抵抗の測定及び説明は、一貫した初期組織評価(導電率及び誘電率)に向けて行われ、それによって処理(すなわち、凝固、融合又は溶着)の組織特異的終点が得られる。本発明の別の態様では、ツールキャパシタンス及びツール抵抗の測定及び説明は、一貫した組織フィードバック測定(位相シフト)に向けて行われ、それによって一貫した組織変容結果(すなわち、凝固、融合又は溶着)が保証される。
先に全体的に説明し、かつ以下でより詳細に説明するように、様々な手持ち式電気外科ツールは、本明細書で説明する電気外科システムにおいて使用することができる。例えば、電気外科把持器、はさみ、ピンセット、探触子、ニードル、及び本明細書で説明する一態様、一部、又は全てを組み込む他の器具は、電気外科システムにおいて様々な利点を有することができる。様々な実施形態電気外科ツールを以下で説明する。以下で全体的に説明する機能の1つ、一部、又は全ては以下で説明するツールの実施形態のいずれかに含めることができるように考えられている。例えば、以下で説明するツールの各々が上述のようにフィードバック回路との対話のためにメモリを含むことは望ましいとすることができる。しかし、他の実施形態では、以下で説明するツールは、ツールメモリの対話なしで標準双極電源と対話するように構成することができる。しかし、更に、これらの実施形態の特定的な態様は、本出願の範囲の他の電気外科ツールの特定的な態様と組み合わせることができるように考えられている。これらの電気外科ツールの特定的な態様を本明細書で全体的に及び以下でより詳細に様々な実施形態に関して説明する。
図41A〜図41Bを参照すると、手持ち式腹腔鏡検査密封器/分割器又は融合ツール1100の一実施形態が示されている。図示の実施形態では、密封器/分割器は、ハンドルアセンブリ1110、ハンドルアセンブリ1110から延びる細長シャフト1120、及びハンドルアセンブリ1110の反対側の細長シャフト1120上に位置決めされた顎アセンブリ1130を含む。細長シャフト1120は、間に中心縦軸を形成する近位端及び遠位端を有する。図示の実施形態では、ハンドルアセンブリ1110は、ピストル把持方式のハンドルを含む。細長シャフト1120及び顎アセンブリ1130は、一実施形態では、5mmの直径トロカールカニューレ又はアクセスポートを通じて適合するようにサイズ決定及び成形されている。他の実施形態では、細長シャフト及び顎アセンブリは、他の規格又は非標準サイズを有するトロカールカニューレ又はアクセスポートを通じて適合するようにサイズ決定及び構成することができる。図41Aでは、ハンドルアセンブリ1110は、顎が開いている第1の又は初期位置に示されている。
腹腔鏡検査外科的処置では、一般的に結合組織又は脈管組織の切開が必要である。組織タイプ、サイズ、位置、及び特定の組織の条件のようなファクタに依存して、異なるツール及び技術を用いて特定の処置を行うことができる。個々のツールの選択は、機能性と共に、選択したツールでは周囲の組織の損傷が比較的小さいという希望に基づくことができる。一例として、結合組織の切開は、通常機械式切断又は電気外科切断により行われ、一方、脈管組織の切開は、一般的に、ステープラ又はクリップ、次に機械式切断を使用する結紮技術に依存する。その結果として、結合組織及び繊管束組織の両方の切開を含む一般的な腹腔鏡検査処置では、手術部位に至るトロカールアクセスポートを通じて連続して交換される複数のツールが必要である。このツール交換により、外科的処置の経費及び時間が増大する。従って、腹腔鏡検査処置中にツール交換回数を大幅に低減することができる多機能ツールを提供することが望ましい。
従来、生体組織の接続又再接続は、縫合糸、クリップ、又はステープルの使用を伴っている。つい最近では、電気又は熱の使用が、生体組織の接続を完了するか、又は漏れ又は出血のために接続した組織を密封するのに利用されるようになっている。
(実施態様1)第1の顎と、
前記第1の顎に対してピボット回転可能な第2の顎と、
前記第1の顎上に位置決めされた第1の電極,前記第1の顎上に位置決めされた第2の電極,及び,前記第1の顎上に位置決めされた第3の電極,を含む複数の電極と、
を含む電気外科ツールであって、
凝固構成において、前記第1、第2、及び第3の電極の少なくとも1つが、第1の極性を有する電気エネルギ源に電気的に結合され、該複数の電極の少なくとも1つの他のものが、該第1の極性と一般的に反対の第2の極性を有する電気エネルギ源に電気的に結合されるように、かつ切断構成において、該第1、第2、及び第3の電極のうちの1つが、切断電圧を有する電気エネルギ源に電気的に結合され、該複数の電極の少なくとも1つの他のものが、戻り電極であるように構成されるように選択的に構成可能である、ことを特徴とする電気外科ツール。
(実施態様2)前記凝固構成において、前記第1の電極は、前記第1の極性を有する前記電気エネルギ源に電気的に結合され、前記第2の電極は、前記第2の極性を有する前記電気エネルギ源に電気的に結合されることを特徴とする実施態様1に記載の電気外科ツール。
(実施態様3)前記切断構成において、前記第3の電極は、前記切断電圧を有する前記電気エネルギ源に電気的に結合され、前記第1及び第2の電極は、戻り電極であるように構成されることを特徴とする実施態様1に記載の電気外科ツール。
(実施態様4)前記第3の電極は、露出面区域を有し、前記第1及び第2の電極は、露出結合面区域を有し、
前記第3の電極の前記露出面区域は、前記第1及び第2の電極の前記露出結合面区域よりも小さい、ことを特徴とする実施態様3に記載の電気外科ツール。
(実施態様5)前記第1、第2、及び第3の電極を互いから絶縁する1つ又はそれよりも多くの絶縁部材を更に含むことを特徴とする実施態様1に記載の電気外科ツール。
(実施態様6)前記1つ又はそれよりも多くの絶縁部材は、前記第1の電極と前記第3の電極の間で前記第1の顎上に配置された第1の絶縁部材と、該第3の電極と前記第2の電極の間で該第1の顎上に配置された第2の絶縁部材と、を含むことを特徴とする実施態様5に記載の電気外科ツール。
(実施態様7)前記凝固構成において、前記第1の極性を有する前記電気エネルギ源と前記第2の極性を有する前記電気エネルギ源との間の電位差が、約200Vよりも大きくないことを特徴とする実施態様1に記載の電気外科ツール。
(実施態様8)前記切断構成において、切断電圧を有する前記電気エネルギ源と前記戻り電極との間の電位差が、約300Vと約500Vの間であることを特徴とする実施態様1に記載の電気外科ツール。
(実施態様9)前記第2の顎上に位置決めされた第4の電極を更に含むことを特徴とする実施態様1に記載の電気外科ツール。
(実施態様10)前記凝固構成において、前記第1及び第2の電極は、前記第1の極性を有する前記電気エネルギ源に電気的に結合され、前記第4の電極は、前記第2の極性を有する前記電気エネルギ源に電気的に結合されることを特徴とする実施態様9に記載の電気外科ツール。
(実施態様11)前記切断構成において、前記第3の電極は、前記切断電圧を有する前記電気エネルギ源に電気的に結合され、前記第4の電極は、戻り電極として構成されることを特徴とする実施態様9に記載の電気外科ツール。
(実施態様12)前記第2の顎上に位置決めされた第5の電極を更に含むことを特徴とする実施態様9に記載の電気外科ツール。
(実施態様13)前記凝固構成において、前記第1及び第2の電極の一方及び前記第4及び第5の電極の一方が、前記第1の極性を有する前記電気エネルギ源と電気的に結合され、該第1及び第2の電極の他方及び該第4及び第5の電極の他方が、前記第2の極性を有する前記電気エネルギ源に電気的に結合されることを特徴とする実施態様12に記載の電気外科ツール。
(実施態様14)前記切断構成において、前記第3の電極は、前記切断電圧を有する前記電気エネルギ源に電気的に結合され、前記第1の電極、前記第2の電極、前記第4の電極、及び前記第5の電極のうちの少なくとも1つが、戻り電極として構成されることを特徴とする実施態様12に記載の電気外科ツール。
(実施態様15)スイッチの作動によって前記凝固構成と前記切断構成の間で選択的に構成可能であることを特徴とする実施態様1に記載の電気外科ツール。
(実施態様16)開放位置と閉鎖位置の間で前記第1の顎及び前記第2の顎を互いに対してピボット回転させるように作動可能なハンドルアセンブリを更に含み、
前記スイッチは、前記ハンドルアセンブリの移動によって作動される、ことを特徴とする実施態様15の電気外科ツール。
(実施態様17)前記スイッチは、前記顎が前記開放位置にある時に電気外科ツールが前記凝固構成にあり、且つ、該顎が前記閉鎖位置に向けて移動される時に電気外科ツールが前記切断構成にあるように構成されていることを特徴とする実施態様16に記載の電気外科ツール。
第1の顎要素,前記第1の顎要素と互いに対して開放位置と閉鎖位置の間で移動可能である第2の顎要素,及び,前記第1の顎要素及び前記第2の顎要素の少なくとも一方に配置され、凝固構成及び切断構成の一方に選択的に構成可能な複数の電極,を含む、ツールの遠位端に位置決めされた遠位末端部分と、
前記遠位末端部分に接続した遠位端と近位端とを有する細長シャフトと、
ツールの近位端に位置決めされ、かつ前記細長シャフトの前記近位端に接続され、手持部分,及び,前記手持部分にピボット回転可能に結合されたトリガであって、該手持部分に対するトリガの移動が前記第1及び第2の顎要素を互いに対して移動させるように前記遠位末端部分に作動可能に結合されたトリガ,を含むハンドルアセンブリと、
前記複数の電極を前記凝固構成及び前記切断構成の一方に選択的に構成するように前記遠位末端部分に電気的に結合されたスイッチング機構と、を含むことを特徴とするツール。
(実施態様19)前記スイッチング機構は、前記手持部分に対する前記トリガの移動によって、前記トリガの移動が前記複数の電極を前記凝固構成及び前記切断構成の一方に選択的に構成するように作動可能であることを特徴とする実施態様18に記載の電気外科ツール。
(実施態様20)前記スイッチング機構は、前記第1の顎要素及び前記第2の要素が前記開放位置にある時に、前記複数の電極を前記凝固構成に構成することを特徴とする実施態様19に記載である電気外科ツール。
(実施態様21)前記スイッチング機構は、前記第1の顎要素及び前記第2の顎要素が前記開放位置から前記閉鎖位置に向けて移動する時に、前記複数の電極を前記切断構成に構成することを特徴とする実施態様19に記載の電気外科ツール。
(実施態様22)前記スイッチング機構は、
全てが前記手持部分上に位置決めされた第1の電気接点、第2の電気接点、及び第3の電気接点と、
前記トリガ上に位置決めされた第4の電気接点及び第5の電気接点と、
を含む、ことを特徴とする実施態様19に記載の電気外科ツール。
(実施態様23)前記第1の電気接点、第2の電気接点、第3の電気接点、第4の電気接点、及び第5の電気接点は、前記トリガ及び前記手持部分の所定の相対位置で互いに係合及び離脱するように位置決めされることを特徴とする実施態様22に記載の電気外科ツール。
(実施態様24)前記第1の顎要素及び前記第2の顎要素が開放位置にある時に、前記トリガ上の前記第4の電気接点は、前記手持部分上の前記第1の電気接点と係合し、該トリガ上の前記第5の電気接点は、該手持部分上の前記第2の電気接点と係合することを特徴とする実施態様22に記載の電気外科ツール。
(実施態様25)前記第1の顎要素及び前記第2の顎要素が前記開放位置と前記閉鎖位置の間にある時に、前記トリガ上の前記第4の電気接点は、前記手持部分上の前記第2の電気接点と係合し、該トリガ上の前記第5の電気接点は、該手持部分上の前記第3の電気接点と係合することを特徴とする実施態様22に記載の電気外科ツール。
(実施態様26)前記スイッチング機構は、前記手持部分上に配置された複数の接触ストリップと、前記トリガ上に装着された複数の接触ピンと、を含むことを特徴とする実施態様19に記載の電気外科ツール。
(実施態様27)前記複数のピンは、2本のピンを含むことを特徴とする実施態様26に記載の電気外科ツール。
(実施態様28)前記複数の接触ストリップは、2つの同心接触ストリップを含むことを特徴とする実施態様26に記載の電気外科ツール。
(実施態様29)前記スイッチング機構は、単極電気スイッチ及び二極電気スイッチを含むことを特徴とする実施態様18に記載の電気外科ツール。
(実施態様30)前記スイッチング機構は、第1の二極電気スイッチ及び第2の二極電気スイッチを含むことを特徴とする実施態様18に記載の電気外科ツール。
(実施態様31)前記スイッチング機構は、第3の二極電気スイッチを更に含むことを特徴とする実施態様30に記載の電気外科ツール。
(実施態様32)前記スイッチング機構は、多電極スイッチング電源を含むことを特徴とする実施態様18に記載の電気外科ツール。
凝固構成及び切断構成の一方に構成可能な複数の電極を含む電気外科ツールを切開される組織に隣接して位置決めする段階と、
前記組織で止血を達成するために前記凝固構成において前記電気外科ツールに電気エネルギを印加する段階と、
前記電気外科ツールを前記切断構成にスイッチングする段階と、
前記切断構成において前記電気外科ツールに電気エネルギを印加する段階と、
を含むことを特徴とする方法。
(実施態様34)前記凝固構成において前記電気外科ツールに電気エネルギを印加する前に、切開される前記組織を評価する段階と、
前記凝固構成において前記電気外科ツールに電気エネルギを印加中に、前記組織の特性を測定する段階と、
を更に含むことを特徴とする実施態様33に記載の方法。
(実施態様35)切開される前記組織を評価する段階は、前記凝固構成において前記電極によって測定信号を切開される該組織を通して印加する段階を含むことを特徴とする実施態様34に記載の方法。
(実施態様36)前記測定信号は、前記組織の導電率及び誘電率を評価することを特徴とする実施態様35に記載の方法。
(実施態様37)前記凝固構成において前記電気外科ツールに電気エネルギを印加中に、前記組織の特性を測定する段階は、印加電圧と該組織に生じた電流の間の位相シフトを測定する段階を含むことを特徴とする実施態様34に記載の方法。
(実施態様38)前記電気外科ツールを切断構成にスイッチングする段階は、多電極スイッチング電源の継電器列内の継電器を選択的にスイッチングする段階を含むことを特徴とする実施態様34に記載の方法。
(実施態様39)前記電気外科ツールは、トリガを有するハンドルアセンブリと、該トリガの移動が開放位置と閉鎖位置の間で顎アセンブリを移動させるように該ハンドルアセンブリの該トリガに作動的に結合された顎アセンブリとを含み、
前記複数の電極は、前記顎アセンブリ上に位置決めされ、
スイッチング機構が、前記ハンドルアセンブリに電気的に結合され、
前記電気外科ツールを前記切断構成にスイッチングする段階は、前記スイッチング機構を作動させるために前記トリガを所定の方向に移動させる段階を含む、
ことを特徴とする実施態様33に記載の方法。
(実施態様40)前記電気外科ツールを前記切断構成にスイッチングする段階は、前記トリガを移動して前記顎アセンブリを前記開放位置から前記閉鎖位置まで移動する段階を含むことを特徴とする実施態様39に記載の方法。
(実施態様41)前記凝固構成において前記電気外科ツールに電気エネルギを印加する段階は、前記複数の電極の1つに第1の極性を有する電気エネルギを供給し、該複数の電極の別のものに該第1の極性と一般的に反対の第2の極性を有する電気エネルギを供給する段階を含むことを特徴とする実施態様33に記載の方法。
(実施態様42)前記凝固構成において前記電気外科ツールに電気エネルギを印加する段階は、前記第1の極性を有する前記電気エネルギ源と前記第2の極性を有する前記電気エネルギ源の間の約200Vよりも大きくない電位差を維持する段階を含むことを特徴とする実施態様41に記載の方法。
(実施態様43)前記切断構成において前記電気外科ツールに電気エネルギを印加する段階は、前記複数の電極の1つに電気エネルギを供給し、該複数の電極の別のものを戻り電極として構成する段階を含むことを特徴とする実施態様33に記載の方法。
(実施態様44)前記切断構成において前記電気外科ツールに電気エネルギを印加する段階は、前記電気エネルギと前記戻り電極の間の約300Vと約500Vの間の電位差を維持する段階を含むことを特徴とする実施態様43に記載の方法。
中心縦軸をその間に形成する近位端及び遠位端を有し、前記ハンドルから遠位側に延びる細長シャフトと、
前記細長シャフトの前記遠位端上に位置決めされた顎アセンブリであって、内面と,外面と,該内面上に配置された少なくとも1つの電極とを有する第1の顎、及び、内面と,外面と,該内面上に配置された少なくとも1つの電極とを有する第2の顎、を含み、前記第1の顎の前記内面が前記第2の顎の前記内面から離間した開放構成から、該第1の顎の該内面が該第2の顎の該内面に近い閉鎖構成まで前記作動ハンドルの移動によって作動可能である、前記顎アセンブリと、
前記ハンドルアセンブリを前記顎アセンブリに結合する力調節機構であって、前記閉鎖構成において、該顎アセンブリが前記第1の顎と前記第2の顎の間に所定の最小力と所定の最大力の間の把持力を送出するように構成された、前記力調節機構と、
を含むことを特徴とする電気外科ツール。
(実施態様46)前記力調節機構は、
前記作動ハンドルを前記固定ハンドルに結合し、該固定ハンドルに対して縦方向に摺動可能に位置決めされた第1のピボット点と、
前記作動ハンドルを前記固定ハンドルに結合し、該固定ハンドルに対して摺動可能な第2のピボット点と、
所定の前負荷を用いて前記第2のピボット点を付勢するアクチュエータバネと、
を含む、ことを特徴とする実施態様45に記載の電気外科ツール。
(実施態様47)前記力調節機構は、作動部材と、前記細長シャフトに対して縦方向に移動可能であり、かつ前記ハンドルアセンブリを前記顎アセンブリに結合する作動ロッドとを更に含むことを特徴とする実施態様46に記載の電気外科ツール。
(実施態様48)前記ハンドルアセンブリは、前記第2のピボット点の作動経路を定める少なくとも1つのガイドを含むことを特徴とする実施態様46に記載の電気外科ツール。
(実施態様49)前記力調節機構は、前記顎アセンブリが、前記第1及び第2の顎の間に3kg/cm2と39kg/cm2の間の圧力を生じる把持力を送出するように構成されることを特徴とする実施態様45に記載の電気外科ツール。
(実施態様50)前記力調節機構は、前記顎アセンブリが、前記顎の間に約23kg/cm2の平均圧力を生じる把持力を送出するように構成されることを特徴とする実施態様49に記載の電気外科ツール。
(実施態様51)前記顎アセンブリは、近位端及び遠位端を有し、前記顎間の前記圧力は、該顎アセンブリの該近位端で第1の圧力、及び該顎アセンブリの該遠位端で該第1の圧力よりも小さい第2の圧力を有し、
前記第1の圧力及び前記第2の圧力の両方が、3kg/cm2と39kg/cm2の間である、ことを特徴とする実施態様49に記載の電気外科ツール。
(実施態様52)前記顎アセンブリは、前記第1の顎及び前記第2の顎の一方に位置決めされて近位位置から遠位位置まで前進可能である切断ブレードを更に含むことを特徴とする実施態様45に記載の電気外科ツール。
(実施態様53)前記ハンドルアセンブリは、前記固定ハンドルに対して移動可能なトリガを更に含み、該トリガは、該トリガの移動が前記近位位置と前記遠位位置の間で前記切断ブレードを移動するように該切断ブレードに結合されることを特徴とする実施態様52に記載の電気外科ツール。
(実施態様54)前記第1の顎は、近位端及び遠位端を有し、
前記第2の顎は、近位端及び遠位端を有し、
前記第2の顎の前記遠位端は、前記顎アセンブリが前記閉鎖構成にある時に前記第1の顎の前記遠位端よりも更に遠位側に延びる、
ことを特徴とする実施態様45に記載の電気外科ツール。
(実施態様55)前記第2の顎の前記遠位端の外面上に位置決めされた切断電極を更に含むことを特徴とする実施態様54に記載の電気外科ツール。
(実施態様56)前記顎アセンブリを前記ハンドルアセンブリに接続する回転カプリングを更に含むことを特徴とする実施態様45に記載の電気外科ツール。
(実施態様57)前記回転カプリングは、前記ハンドルアセンブリに対する前記中心縦軸周りの前記顎アセンブリの無限の回転を可能にするように構成されることを特徴とする実施態様56に記載の電気外科ツール。
前記ハンドルから遠位側に延び、中心縦軸をその間に形成する近位端及び遠位端を有する細長シャフトと、
前記細長シャフトの前記遠位端上に位置決めされた顎アセンブリであって、内面と,外面と,近位端及び遠位端と,該内面上に配置された少なくとも1つの電極と,を有する第1の顎、内面と,外面と,近位端及び遠位端と,該内面上に配置された少なくとも1つの電極と,を有する第2の顎、及び、前記第1の顎の前記内面に沿って、前記近位端に隣接する後退位置と該近位端と前記遠位端の間の前進位置との間に形成された切断経路に沿って前進可能なブレード、を含む前記顎アセンブリと、
を備え、
前記顎アセンブリは、前記作動ハンドルの移動によって開放構成から閉鎖構成まで作動可能であり、
前記第1の顎上の前記少なくとも1つの電極及び前記第2の顎上の前記少なくとも1つの電極が、前記ブレードの前記切断経路を取り囲む密封区域を形成する、
ことを特徴とする電気外科ツール。
(実施態様59)前記第1の顎の前記内面上に配置された前記少なくとも1つの電極は、前記第1の顎に沿って前記近位端から前記遠位端に向けて縦方向に延びる2つのほぼ平行な脚部と、該2つのほぼ平行な脚部の間に延びて該第1の顎の該遠位端に隣接して位置決めされた湾曲コネクタ部分と、を有する略U字形の電極を含み、
前記第2の顎の前記内面上に配置された前記少なくとも1つの電極は、前記第2の顎に沿って前記近位端から前記遠位端に向けて縦方向に延びる2つのほぼ平行な脚部と、該2つのほぼ平行な脚部の間に延びて該第2の顎の該遠位端に隣接して位置決めされた湾曲コネクタ部分と、を有する略U字形の電極を含む、
ことを特徴とする実施態様58に記載の電気外科ツール。
(実施態様60)前記第1の顎の前記内面上に配置された前記少なくとも1つの電極は、前記第1の顎に沿って前記近位端から前記遠位端に向けて縦方向に延びる2つのほぼ平行な脚部と、該2つのほぼ平行な脚部の間に延びて該第1の顎の該遠位端に隣接して位置決めされた湾曲コネクタ部分と、を各々有する2つの略U字形の電極を含み、
前記第2の顎の前記内面上に配置された前記少なくとも1つの電極は、前記第2の顎に沿って前記近位端から前記遠位端に向けて縦方向に延びる2つのほぼ平行な脚部と、該2つのほぼ平行な脚部の間に延びて該第2の顎の該遠位端に隣接して位置決めされた湾曲コネクタ部分と、を各々有する2つの略U字形の電極を含む、
ことを特徴とする実施態様58に記載の電気外科ツール。
(実施態様61)前記第1の顎上の前記2つの略U字形の電極は、少なくとも1つの橋部材によって接続され、前記第2の顎上の前記2つの略U字形の電極は、少なくとも1つの橋部材によって接続されることを特徴とする実施態様60に記載の電気外科ツール。
(実施態様62)前記第1の顎及び前記第2の顎は、前記細長シャフトの前記中心縦軸に対して湾曲していることを特徴とする実施態様58に記載の電気外科ツール。
(実施態様63)前記第1の顎の前記内面上に配置された前記少なくとも1つの電極は、前記第1の顎に沿って前記近位端から前記遠位端に向けて曲線的に延びる2つのほぼ平行な円弧セグメント脚部と、該2つのほぼ平行な脚部の間に延びて該第1の顎の該遠位端に隣接して位置決めされた湾曲コネクタ部分と、を有する略U字形の電極を含み、
前記第2の顎の前記内面上に配置された前記少なくとも1つの電極は、前記第2の顎に沿って前記近位端から前記遠位端に向けて曲線的に延びる2つのほぼ平行な円弧セグメント脚部と、該2つのほぼ平行な脚部の間に延びて該第2の顎の該遠位端に隣接して位置決めされた湾曲コネクタ部分と、を有する略U字形の電極を含む、
ことを特徴とする実施態様62に記載の電気外科ツール。
(実施態様64)前記作動ハンドルは、作動機構によって前記顎アセンブリに結合されており、
前記作動機構は、
前記作動ハンドルに結合された近位端と前記第1の顎及び前記第2の顎の少なくとも一方に結合された遠位端とを有する摺動可能な作動チューブと、
前記摺動可能な作動チューブを取り囲むカバーチューブと、
前記カバーチューブを取り囲み、前記細長シャフトの外面を形成する外側チューブと、 を含むことを特徴とする実施態様58に記載の電気外科ツール。
(実施態様65)前記ハンドルは、前記後退位置と前記前進位置の間で前記ブレードを選択的に前進させるように該ブレードに結合されたトリガを更に含むことを特徴とする実施態様64に記載の電気外科ツール。
(実施態様66)前記作動機構は、前記摺動可能な作動チューブ内に位置決めされて前記トリガを前記ブレードに結合するブレード前進部材を更に含むことを特徴とする実施態様65に記載の電気外科ツール。
(実施態様67)前記ブレード前進部材は、ブレード前進シャフトを含むことを特徴とする実施態様66に記載の電気外科ツール。
(実施態様68)前記ブレード前進シャフトは、嵌合インタフェースによって接続された近位区画及び遠位区画を含むことを特徴とする実施態様67に記載の電気外科ツール。
(実施態様69)前記ブレード前進シャフトは、ポリマー材料から成ることを特徴とする実施態様68に記載の電気外科ツール。
中心縦軸をその間に形成する近位端及び遠位端を有し、前記ハンドルアセンブリから遠位側に延びる細長シャフトと、
前記細長シャフトの前記遠位端上に位置決めされた顎アセンブリであって、内面と,外面と,近位端及び遠位端と,該内面上に配置された少なくとも1つの融合電極と,を有する第1の顎、及び、内面と,外面と,近位端及び遠位端と,該内面上に配置された少なくとも1つの融合電極と,該外面上に配置された切断電極と,を有する第2の顎、を含む前記顎アセンブリと、を含むことを特徴とする電気外科ツール。
(実施態様71)前記第1の顎及び前記第2の顎のうちの一方の前記遠位端は、該第1の顎及び該第2の顎のうちの他方の前記遠位端よりも前記中心縦軸に対して更に遠位側に延びていることを特徴とする実施態様70に記載の電気外科ツール。
(実施態様72)前記第2の顎の前記遠位端は、前記第1の顎の前記遠位端よりも前記中心縦軸に対して更に遠位側に延びていることを特徴とする実施態様71に記載の電気外科ツール。
電気外科発生器と、
ツールデータ格納するメモリモジュールを含む電気外科ツールと、
を含み、
前記電気外科発生器は、前記メモリモジュールから前記ツールデータを受け取って、該ツールデータに基づいて前記電気外科ツールに電気外科信号プロフィールを適用するように構成される、ことを特徴とするシステム。
(実施態様74)前記電気外科ツールは、凝固状態及び切断状態において作動するように構成可能な少なくとも2つの電極を含み、
前記ツールデータは、電極構成データを含む、ことを特徴とする実施態様73に記載のシステム。
(実施態様75)前記ツールデータは、暗号化されたフォーマットで格納されることを特徴とする実施態様73に記載のシステム。
(実施態様76)前記ツールデータは、ツール使用データを含むことを特徴とする実施態様73に記載のシステム。
(実施態様77)前記電気外科発生器は、前記メモリモジュールから前記ツールデータを受け取るように構成された分析モジュールを含むことを特徴とする実施態様73に記載のシステム。
(実施態様78)前記分析モジュールは、前記電気外科ツールからの作動データをモニタするように構成されることを特徴とする実施態様77に記載のシステム。
(実施態様79)前記作動データは、患者の人体組織の複素インピーダンスを含むことを特徴とする実施態様78に記載のシステム。
(実施態様80)前記作動データは、電圧と電流の間の位相角を含むことを特徴とする実施態様78に記載のシステム。
(実施態様81)前記電気外科発生器は、所定の位相角終点データを含み、
前記分析モジュールは、モニタされた位相角を所定の位相角終点データと比較するように構成される、ことを特徴とする実施態様80に記載のシステム。
電源と、
前記電源に電気的に結合され、高周波信号を発生するように構成された信号発生モジュールと、
ツールデータを格納した電気外科ツールとインタフェースで接続するように構成され、該電気外科ツール上に格納された該ツールデータを受け取って前記信号発生モジュールからの前記高周波信号を該ツールに供給するように構成された第1のツールポートと、
を含むことを特徴とする発生器。
(実施態様83)ツールデータを格納した第2の電気外科ツールとインタフェースで接続するように構成され、該第2の電気外科ツール上に格納された該ツールデータを受け取って前記信号発生モジュールからの前記高周波信号を該第2のツールに供給するように構成された第2のツールポートを更に含むことを特徴とする実施態様82の電気外科発生器。
(実施態様84)前記発生器を双極電気外科ツールに結合するように構成された双極ツールポートを更に含むことを特徴とする実施態様83に記載の電気外科発生器。
(実施態様85)前記発生器を直流デバイスに結合するように構成された電力ポートを更に含むことを特徴とする実施態様84に記載の電気外科発生器。
(実施態様86)前記発生器を双極電気外科ツールに結合するように構成された双極ツールポートを更に含むことを特徴とする実施態様82に記載の電気外科発生器。
(実施態様87)前記発生器を直流デバイスに結合するように構成された電力ポートを更に含むことを特徴とする実施態様82に記載の電気外科発生器。
(実施態様88)前記信号発生モジュールは、前記高周波信号の電圧と電流の間の位相角をモニタし、かつ該モニタされた位相角に基づいて電気外科処置終点を判断するように構成されることを特徴とする実施態様82の電気外科発生器。
(実施態様89)前記第1のツールポートに電気的に結合されたアクチュエータポートを更に含むことを特徴とする実施態様82に記載の電気外科発生器。
(実施態様90)前記アクチュエータポートは、足ペダルコントローラポートを含むことを特徴とする実施態様89の電気外科発生器。
(実施態様91)前記第1のツールポートと前記第2のツールポートとに電気的に結合されたアクチュエータポートを更に含むことを特徴とする実施態様83に記載の電気外科発生器。
(実施態様92)前記アクチュエータポートは、足ペダルコントローラポートを含むことを特徴とする実施態様91の電気外科発生器。
オン位置とオフ位置の間で移動可能であり、該オン位置にある時に第1の電気外科アクションを作動させるための第1のアクチュエータと、
オン位置とオフ位置の間で移動可能であり、該オン位置にある時に第2の電気外科アクションを作動させるための第2のアクチュエータと、
コントローラが第1の電気外科ツールに作動的に結合されるように構成された第1の状態,及び,コントローラが第2の電気外科ツールに作動的に結合されるように構成された第2の状態,を有するツールセレクタと、を含むことを特徴とするコントローラ。
(実施態様94)前記第1のアクチュエータは、凝固作動を起動するための凝固スイッチを含むことを特徴とする実施態様93に記載のコントローラ。
(実施態様95)前記凝固スイッチは、足ペダルを含むことを特徴とする実施態様94に記載のコントローラ。
(実施態様96)前記第2のアクチュエータは、切断作動を起動するための切断スイッチを含むことを特徴とする実施態様93に記載のコントローラ。
(実施態様97)前記切断スイッチは、切断足ペダルを含むことを特徴とする実施態様96に記載のコントローラ。
(実施態様98)前記ツールセレクタは、トグルスイッチを含むことを特徴とする実施態様93に記載のコントローラ。
電気外科デバイスの少なくとも1つの電極を通じて患者の組織に印加され、かつ該電気外科デバイスによる該組織の治療の前に該組織に印加された第1の測定信号の位相角を測定する段階と、
前記第1の測定信号の前記位相角を使用してターゲット位相角を判断する段階と、
前記組織の変容を引き起こすことができる該組織への治療信号の送出に続いて、該組織に印加された第2の測定信号の位相角を測定する段階と、
前記第2の測定信号の前記位相角が前記ターゲット位相角に到達した時に、前記組織への前記治療信号の送出を中止する段階と、を含むことを特徴とする方法。
(実施態様100)前記治療信号及び前記第2の測定信号は、時間交互方式で前記組織に交互に印加されることを特徴とする実施態様100に記載の方法。
(実施態様101)前記治療信号及び前記第2の測定信号は、実質的に同時に前記組織に印加されることを特徴とする実施態様100に記載の方法。
(実施態様102)前記組織の変容は、組織融合を含むことを特徴とする実施態様100に記載の方法。
(実施態様103)前記組織の変容は、凝固を含むことを特徴とする実施態様100に記載の方法。
電気外科デバイスの少なくとも1つの電極を通じて患者の組織に印加され、かつ該電気外科デバイスによる該組織の変容の前に該組織に印加された測定信号を使用して患者の組織の誘電率及び導電率を判断する段階と、
前記組織の前記誘電率及び前記導電率に基づいて閾値位相角を判断する段階と、
前記組織に印加された信号の位相角を測定する段階と、
前記信号の前記位相角が前記閾値位相角に到達した時に、前記組織への治療信号の送出を中止する段階と、を含むことを特徴とする方法。
電気外科デバイスの少なくとも1つの電極を通じて患者の組織に印加され、かつ該電気外科デバイスによる該組織の変容の前に所定の周波数で該組織に印加された測定信号の位相角を測定する段階と、
前記位相角測定値及び前記所定の周波数を使用して、前記組織の相対誘電率と導電率との積を判断する段階と、
前記組織の前記相対誘電率と導電率との前記積に基づいて該組織を特徴付ける段階と、 を含むことを特徴とする方法。
(実施態様106)前記特徴付けに少なくとも部分的に基づいて、前記組織の変容を引き起こすことができる該組織への治療信号の送出を制御する段階を更に含むことを特徴とする実施態様105に記載の方法。
(実施態様107)前記特徴付ける段階は、治療終点を判断する段階を含むことを特徴とする実施態様105に記載の方法。
(実施態様108)前記特徴付ける段階は、組織タイプを判断する段階を含むことを特徴とする実施態様105に記載の方法。
顎部材の少なくとも1つが電極を含む電気外科デバイスの少なくとも2つの顎部材の間に位置決めされた患者の組織に印加され、該電極を通じて該組織に送出されて該電気外科デバイスによる該組織の変容に対して印加される測定信号を発生する段階と、
前記測定信号を使用して、前記少なくとも2つの顎部材の間に位置決めされた前記組織の寸法とは実質的に独立して判断される治療終点条件を判断する段階と、
前記治療終点条件に到達した時に前記組織の変容を引き起こすことができる該組織への治療信号の送出を停止する段階と、を含むことを特徴とする方法。
測定信号と共に治療エネルギを発生して出力するように構成された電気外科発生器と、 治療エネルギ及び測定信号の前記出力を指示するように構成された電気外科制御ユニットと、
前記電気外科発生器及び前記電気外科制御ユニットの一方に取外し可能に接続され、かつ組織に接触して該組織に前記治療エネルギ及び前記測定信号を印加するように配置された電気外科ツールと、
を含み、
前記電気外科制御ユニットは、前記測定信号の前記印加を通じて前記組織の誘電率及び導電率を測定する、ことを特徴とするシステム。
(実施態様111)前記電気外科制御ユニットは、前記治療エネルギの前記印加の前に前記測定信号を印加することを特徴とする実施態様110に記載のシステム。
(実施態様112)前記電気外科制御ユニットは、前記組織の前記測定された誘電率及び導電率に基づいて前記治療エネルギの前記印加を中断させる終点を判断することを特徴とする実施態様110に記載のシステム。
(実施態様113)前記終点は、前記治療エネルギの位相パラメータであることを特徴とする実施態様112に記載のシステム。
(実施態様114)前記終点は、前記治療エネルギの前記位相パラメータの導関数を更に含むことを特徴とする実施態様113に記載のシステム。
(実施態様115)前記終点は、前記治療エネルギの印加電圧及び電流の間の位相差であることを特徴とする実施態様112に記載のシステム。
(実施態様116)前記終点は、前記位相差の導関数を更に含むことを特徴とする実施態様115に記載のシステム。
(実施態様117)前記終点は、前記電気外科ツールのインピーダンスに応じることを特徴とする実施態様115に記載のシステム。
(実施態様118)前記終点の位相差は、前記電気外科ツールの前記インピーダンスが増加すると減少することを特徴とする実施態様117に記載のシステム。
(実施態様119)前記終点の位相差は、前記電気外科ツールの前記インピーダンスが減少すると増加することを特徴とする実施態様117に記載のシステム。
(実施態様120)前記終点は、前記電気外科ツールのキャパシタンスに応じることを特徴とする実施態様115に記載のシステム。
(実施態様121)前記終点の位相差は、前記電気外科ツールの前記キャパシタンスが増加すると減少することを特徴とする実施態様120に記載のシステム。
(実施態様122)前記終点の位相差は、前記電気外科ツールの前記キャパシタンスが減少すると増加することを特徴とする実施態様120に記載のシステム。
10 電気外科ユニット(ESU)
30 電子結合器
40 電気外科ツール
80 外部ツールコントローラ
Claims (5)
- 患者への治療エネルギの印加のための及び双極電気外科手術での使用に適した電気外科システムであって、
測定信号と共に治療エネルギを発生して出力するように構成された電気外科発生器と、
治療エネルギ及び前記測定信号の出力を指示するように構成され、所定周波数350kHzの前記測定信号の印加を通じて組織の誘電率ε及び導電率ρを測定し、前記測定信号の電圧と電流の間の位相シフトをモニターするように構成された電気外科制御ユニットと、
前記電気外科発生器及び前記電気外科制御ユニットの一方に取外し可能に接続され、ブレードと少なくとも1つの電極を有する複数の顎とを有し、組織を前記顎により把持及び圧迫し、各顎の前記少なくとも1つの電極を通して前記組織に前記治療エネルギ及び前記測定信号を印加し、前記複数の顎の間の組織を前記ブレードにより切断するように構成された電気外科ツールと、
を含み、
前記電気外科制御ユニットは、位相シフト終点を決定するように構成され、前記位相シフト終点は、測定された前記組織の誘電率と測定された前記組織の導電率との積の関数で表され、前記関数は、φ終了=38+27[1−exp(-0.00091ρε)]であり、前記電気外科制御ユニットは、モニターされた前記位相シフトが決定された前記位相シフト終点を超えたとき、前記組織の融合を示すものとして、前記電気外科発生器に前記治療エネルギの出力を中断させるように構成されている、システム。 - 前記電気外科制御ユニットは、前記治療エネルギの印加の前に前記測定信号を印加するように構成されている、請求項1に記載のシステム。
- 前記電気外科制御ユニットは、各顎の前記少なくとも1つの電極を介して組織に印加された前記測定信号の位相角をモニターするように構成されている、請求項1又は2に記載のシステム。
- 前記電気外科制御ユニットは、前記治療エネルギの電圧及び周波数と異なる電圧及び周波数の前記測定信号を印加するように構成されている、請求項1又は3に記載のシステム。
- 前記電気外科制御ユニットは、前記治療エネルギの出力を定期的に中断し、前記治療エネルギの出力が中断されている間に前記測定信号の出力を指示するように構成されている、請求項1,3及び4のいずれか1項に記載のシステム。
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