JP2023510201A - 組織及び最大電流識別を用いる電気手術システム - Google Patents
組織及び最大電流識別を用いる電気手術システム Download PDFInfo
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Abstract
Description
この出願は、本明細書にその全体が引用によって組み込まれている2019年12月31日出願の「組織及び最大電流識別を用いる電気手術システム(Electrosurgical System with Tissue and Maximum Current Identification)」という名称の米国仮特許出願第62/955,758号に対する優先権及びその利益を主張するものである。
図1から図3は、電気手術システムの例示的実施形態の構成要素を例示している。特に、電気手術システムは、電気手術発電機10(図1に示す)と、取り外し可能に接続可能な電気手術器具20(図2及び図3に示す)とを含む。これらの構成要素の各々に関する詳細に関して下記でより詳細に提供する。
上述の節では、電気手術システムによって実施される密封プロセスに関する異なる段階を説明した。特に、RFピーク出力条件の識別は、電気手術システムが、組織に供給されているRFエネルギを管理することを可能にするための重要な段階である。上述のように、RFピーク出力条件は、乾燥が始まる温度まで組織を加熱するのに使用される初期電圧ランプに対応する。以下の実施形態は、密封プロセスを受けている組織に関連付けられた特徴(例えば、タイプ、厚み、条件)をより的確に識別してRFピーク出力条件を識別することに伴って起こり得る問題に対処するために電気手術システムと共に組み込む又は他に含めることができる追加の特徴に関するものである。このようにして、電気手術システムは、密封プロセスを受けている組織にどれだけ多くの量のRFエネルギが供給されるかをより的確に及び/又はより効率的に計算し、その後に、従って、発生RFエネルギを実時間で修正するように構成することができる。
密封プロセスを管理するのに、組織のタイプ(並びに組織の現在の状態)の識別が電気手術システムに対して有用である場合がある。密封されている組織の厚み又は組織が過去に密封された(例えば、重複密封される)か否かの識別に基づいて、適正量のRFエネルギが供給されるようにRFエネルギ出力を修正することができる。例えば、厚めの組織は、乾燥が始まるように加熱するのに又は組織から必要量の流体/水分を除去するのにより多くのエネルギを必要とする可能性があるので、電気手術システムは、厚めの組織に対してより多くのRFエネルギを供給することができる。それとは対照的に、過去に密封された又は薄めの側にある組織を加熱するか又はこれらの組織から流体/水分を除去するには少ないエネルギしか必要とされない場合があるので、これらの組織には少ないRFエネルギを供給することができる。
測定最大電流値を使用することにより、電気手術システムは、様々な異なる閾値を計算することができる。測定最大電流値に基づくこれらの閾値は、電気手術システムが密封プロセスを受けている組織に関する異なる条件に対応するように使用することができる。実施することができる1つの閾値は、組織が密封プロセスを過去に受けた(例えば、重複密封)か否かを識別するのに使用することができる。
最大電流測定を用いて、電気手術システムは、密封プロセスで使用されるRFエネルギを管理するのに使用することができる組織に関する情報を決定することができる。一実施形態では、電気手術システムは、最大電流測定に関する情報に基づいて密封されている組織の厚みを計算することができる。図(図11Aを参照されたい)は、類似の直径の異なる組織タイプの(例えば、静脈と動脈との)間の厚み比較を例示している。一般的に、最大電流は、組織厚に反比例する。しかし、これは、密封プロセスを受けている組織の面積及び導電率が異なる密封されているサンプルにわたって一定/同じであると仮定する。電気手術器具の場合に、負荷の長さは、電気手術器具の顎内に捕捉された組織の厚みである。更に、最大電流と組織のタイプ及び/又は厚みとの間の関係を図11Bに見ることができ、この図は、引き込まれている電流の量に関して異なる厚みを有する同じ面積に対する大動脈を静脈と比較する。動脈は、一般的に平滑筋によって補強された厚い壁を有する。従って、動脈は、一般的に静脈よりも厚いものとして特徴付けられる。
組織厚∝1/最大電流
従って、電気手術システムは、密封されている組織の厚みに適合させるために、RFエネルギが電気手術発電機によって発生されている量及び方式を修正することができる。
組織厚∝水蒸発時間
組織厚∝水蒸発時間/最大電流
更に、図11Dは、水蒸発時間と最大電流の比の間の区別/分離が2つの異なる組織厚に対応することをデータがどのように示すかを示している。
異なる組織に関してRF出力ピーク条件(例えば、最大電流)が発生する時点を予想及び/又は識別するのは困難である場合がある。上述のように、電気手術システムは、密封されている組織に関するRF出力ピーク条件の識別を流体/水蒸発が少なくとも始まったことのインジケータとして使用することができる。更に、RF出力ピーク条件が検出されると、電気手術システムは、大量のRFエネルギの過剰露出によって引き起こされる組織への損傷を最小にするか又は防止するために組織へのRFエネルギの量及び/又は送出を修正するように構成することができる。
上述のように、組織内の流体/水分の蒸発は、最大値までの電流増加とその後の測定電流の降下(例えば、下方に予め決められた閾値に至るまでの)とを検出した時に電気手術システムによって認識することができる。しかし、組織の流体/水分が蒸発し始めたという決定は、電気手術器具によって把持された組織が電場、圧縮、及び/又は温度に関して均一な状態(例えば、タイプ、厚み)を有する単一回路であるという仮定に基づいている。従って、複数の異なるタイプの組織が同じ電気手術器具を用いて全て同時に密封される状況は、異なる組織の流体/水分が全て蒸発し始めた時点を適切に識別することでは問題を課す場合がある(例えば、静脈と動脈の両方の一部分が電気手術器具の中に把持されている状況)。最初の測定最大電流に頼ることは、流体/水分の蒸発を適切に開始するのに必要な温度に組織の一部分しか達しないという結果をもたらす場合がある。蒸発を開始するのに必要とされる適正温度まで組織全体が加熱されない場合に、その後の流体/水分の除去が効率的に実施されない可能性がある。その結果、組織の密封時間が延びる場合があり、又は得られる密封に一貫性がない又はそれが弱い場合がある。
組織に電圧が印加されると、組織内のイオン及び流体/水分が加熱されるので、組織の導電率は増大する。組織の温度が十分に増大した時に、組織内の流体/水分の蒸発が始まる。組織から発せられる蒸気、並びに組織からの流体/水分の損失は、組織の導電率を低減する。従って、水蒸発が始まると、電流は増加を停止し、代わりに減少し始める。これは、電気手術システムによって識別することができる組織に対してある時点で測定された「ピーク」又は最大電流に対応する。
組織は、組成及び幾何学形状で変化を有する場合があるので、電気手術システムによって使用される閾値は、密封されている組織の特性に基づいて異なる場合がある。更に、ノイズ(密封プロセスの開始点でより可能性が高いような)及び振幅(例えば、200mAで不変のノイズは、信号が3Aである場合と比較して5Aである場合により良好なSN比を有する)は経時変化する可能性がある。大量の電流を引き込む組織片では、図15Aに示すようなより高い閾値(最大電流の90%又は95%のような)が最も有効である。高い電流引き込みに起因して、ノイズは、信号のより小さいパーセントである。更に、導電率は、導体の長さ(すなわち、組織の厚み)と反比例するので、高電流引き込みの性質は、組織が薄めである可能性を高くする。従って、薄い組織は、水蒸発点に早めに到達し、それによってより短い応答時間(より小さい降下による)をより重要にする。それとは対照的に、それ程電流を引き込まない組織(すなわち、厚めの組織)では、図15Bに示すようなより低い閾値(最大電流の70%又は85%のような)をより有効とすることができる。
緩やかな電圧ランプは、電気手術システムが、流体/水蒸発が始まる時に組織の導電率が立ち下がることに起因して電場強度を徐々に増大させて組織での電力出力を維持するのに使用することができる。電気手術システムによる電場の維持は、流体/水蒸発が制御式速度で続くことを保証するためのものである。一般的に、所与の電圧に対する電場は、組織の厚みに反比例する。従って、一実施形態では、厚めの組織に対してより高い電圧が供給され、それに対して薄めの組織がより低い電圧量のみを必要とすることができるように電気手術システムが電圧を修正することを望ましいとすることができる。
%最大閾値を用いて初期電圧ランプを停止するのと同様に、タイムスタンプを密封するためのRFエネルギの印加も、電気手術システムが対応する%最大閾値を使用することによって停止することができる。電気手術システムが、RFエネルギの印加を早めに停止しなければならないことを決定することができる条件が存在する場合がある(例えば、密封するのに追加の時間又は熱を必要としない薄い組織又は過去に密封された組織のようなある一定の組織に関して)。電気手術システムは、十分に乾燥した時にRFエネルギの印加を停止することができる時点(組織水平化に関連付けられた測定電流によって示される)を検出することができる。
少量の組織が電気手術器具の先端で密封される時に、小さい面積が非常に低い電流引き込み(例えば、低い最大測定電流)をもたらす場合がある。そのような密封サイクルの終了時に、電流は、電気手術システムが測定値を断線に対応するものと間違えるほど十分に低く立ち下がる場合がある。測定最大電流に対して適正な%最大閾値を使用することにより、電気手術システムがこの特定の低電流シナリオを識別するためのより低い断線条件閾値を利用可能にすることを可能にする。ピーク電流が低い場合に(先端シールの場合のような)、電気手術システムは、この条件を認識し、これらのより小さい組織咬合が断線シナリオに対応する不要な警報条件をトリガすることなく成功裏に密封することを可能にするように適応させることができる。
図16は、RFシャットオフに向けて動的閾値を使用する電気手術システムのグラフ表現である。最大電流値に対する静的%値を用いて初期電圧ランプ及びRFエネルギを停止する(上述のように)のと同様に、RFエネルギは、電気手術システムが最大電流値に関して行った実時間計算に基づく動的シャットオフ曲線を用いて停止することができる。測定電流が動的閾値の1つを満足したこと又は交差したことを電気手術システムが検出した場合に、これを電気手術システムが用いて、密封プロセスを完了されること及びRFエネルギの停止が実施されることを示すことができる。
静的抵抗器では、回路のインピーダンスは、この抵抗器に印加されているRFエネルギの関数として変化しない。更に、このインピーダンスは、回路を流れている電力の量の関数として変化しない。組織のインピーダンスは可変であるので、これらの特徴のいずれも組織には当て嵌まらない。RFエネルギが組織に印加される時に、組織のインピーダンスは、組織が加熱されることで増大するイオン導電率と共に最初に降下する。その後に、流体/水蒸発が始まる時に組織のインピーダンスの増大が続く。インピーダンスの増大は、組織に関して発生している乾燥(例えば、組織の組成をほぼ生理食塩水からほぼ可塑性物に変化させる)と組織での蒸気の存在(高いインピーダンスを有する)の両方に起因する。組織が電気手術システムによって密封されている時に、一般的に、殆どの組織でインピーダンス関連の傾向が存在し、数秒(例えば、2.5秒)にわたって存続する。
・密封されている組織を把持し、かつ把持されている組織を融合する又は密封するために把持されている組織のある領域にRFエネルギを伝達するように構成された電気手術器具と、電気手術器具に接続され、組織を密封するのに使用されるRFエネルギを電気手術器具に提供する電気手術発電機とを備え、電気手術発電機が、RFエネルギが把持されている組織に伝達されているのに応答して組織に関する電流を測定するように構成されたセンサと、RFエネルギを発生させて電気手術器具に伝達し、コントローラから受け入れる命令に基づいてRFエネルギを修正するRF増幅器と、センサから測定電流を受信し、予め決められた期間中に、把持されている組織内の流体の蒸発の開始点に対応する時間に関する最大電流値を測定電流から識別し、把持されている組織の融合又は密封に関する異なる条件又は状態を特徴付ける閾値を最大電流値に基づいて発生させ、センサからその後の電流測定値を受信し、その後の電流測定値が閾値のうちの少なくとも1つを交差されたことを検出し、かつ発生されているRFエネルギを閾値のうちの少なくとも1つが交差されたことに基づいて修正するようにRF増幅器に命令するコントローラとを備える組織を融合する又は密封するための電気手術システム。
・上述した電気手術システムの特徴の一部は、○組織内の水分/流体の蒸発が始まる時点に対応する最大電流ピークを識別すること、○予め決められた期間内で2又は3以上の電流ピークが検出される時に真の最大電流値を識別すること、○この最大電流値に基づいて組織厚を識別し、それに基づいてRFエネルギを修正すること、○最大電流値が検出されるまでに要する時間に基づいて組織厚を識別し、それに基づいてRFエネルギを修正すること、○把持されている組織が過去に密封された(すなわち、二重/重複密封組織)であるか否かを識別し、組織が過去に密封されているという決定に基づいてRFエネルギを修正すること、○組織の密封又は融合の状態をモニタするための静的及び/又は動的な閾値を最大電流値に基づいて発生させること、○発生させた静的及び/又は動的な閾値を用いて、組織に印加されているRFエネルギを管理することを備える。
72 急な電圧ランプを確立する段階
75 緩やかな電圧ランプ段階
77 電圧を調節する段階
79 RF停止段階
Claims (20)
- 組織を融合する又は密封するための電気手術システムであって、
密封されている組織を把持し、かつ
把持されている前記組織を融合する又は密封するように構成されたRFエネルギを把持されている該組織の区域に伝達する、
ように構成された電気手術器具と、
前記電気手術器具に接続され、前記組織を密封するのに使用される前記RFエネルギを該電気手術器具に供給する電気手術発電機と、
を備え、
前記電気手術発電機は、
前記電気手術器具によって把持されている前記組織に関連付けられた電流を測定するように構成された複数のセンサであって、測定されている該電流が、該電気手術器具によって該組織に伝達されている前記RFエネルギに応答するものである前記複数のセンサと、
コントローラによって命令されるような量のRFエネルギを発生し、かつ
発生された前記RFエネルギを前記電気手術器具に伝達する、
ように構成されたRF増幅器と、
予め決められた期間にわたって前記測定された電流を前記複数のセンサから受信し、
最大電流値と、該最大電流値が前記予め決められた期間にわたって前記測定された電流からいつ発生したかとを識別し、
把持されている前記組織を融合する又は密封するのにどれだけ多くの量のRFエネルギが必要であるかを各々が指示する該組織に関連付けられた異なる条件又は状態を特徴付けるのに使用される複数の閾値を前記最大電流値に基づいて発生し、
前記複数のセンサからその後の電流測定値を受信し、かつ
融合又は密封を受けている前記組織の前記条件又は状態に対応して発生されている前記RFエネルギを前記その後の電流測定値が前記複数の閾値のうちの1又は2以上と交差することに基づいて修正するように前記RF増幅器に命令する、
ように構成されたコントローラと、
を備える、
ことを特徴とする電気手術システム。 - 発生される前記複数の閾値は、前記電気手術器具によって把持されている前記組織のタイプ、容積、又は厚み、使用されている電気手術器具のタイプ、又は実行されている手術手順のうちの1又は2以上に基づいていることを特徴とする請求項1に記載の電気手術システム。
- 前記RFエネルギの修正が、前記RF増幅器によって発生されている該RFエネルギの電圧、電流、又は電力のうちの1又は2以上を調整することを備えることを特徴とする請求項1に記載の電気手術システム。
- 前記電気手術発電機に関連付けられた情報を表示するように構成されたディスプレイを更に備えることを特徴とする請求項1に記載の電気手術システム。
- 前記ディスプレイは、現在のRFエネルギ出力と該現在のRFエネルギ出力に関連付けられた1又は2以上のパラメータとを含む前記電気手術発電機のステータスを表示するように構成されることを特徴とする請求項4に記載の電気手術システム。
- 前記ディスプレイは、前記電気手術発電機に接続された前記電気手術器具のステータスを表示するように構成されることを特徴とする請求項4に記載の電気手術器具。
- 前記電気手術発電機の1又は2以上の作動を制御するユーザ入力を受信するように構成されたユーザインタフェースを更に備えることを特徴とする請求項1に記載の電気手術器具。
- ユーザにステータス情報を表示し、聴覚、触覚、又は視覚インジケータのうちの1又は2以上を備えるインジケータを更に備えることを特徴とする請求項1に記載の電気手術器具。
- 組織を融合する又は密封するための電気手術システムであって、
密封されている組織を把持し、かつ
把持されている前記組織を融合する又は密封するように構成されたRFエネルギを把持されている該組織の区域に伝達する、
ように構成された電気手術器具と、
前記電気手術器具に接続されて該電気手術器具にRFエネルギを供給するように構成された電気手術発電機であって、
把持されている前記組織に関連付けられた少なくとも1つの特性を予め決められた期間にわたって測定するように構成された少なくとも1つのセンサ、
前記電気手術器具に対する量のRFエネルギを発生する構成されたRF増幅器、及び
前記少なくとも1つのセンサによって測定された前記少なくとも1つの特性に基づいて複数の閾値を計算し、
前記少なくとも1つのセンサからのその後の測定値によって少なくとも1つの閾値が交差されたと決定し、かつ
発生されている前記RFエネルギを前記少なくとも1つの閾値が交差されていることに応答して修正するように前記RF増幅器に命令する、
ように構成されたコントローラ、
を備える前記電気手術発電機と、
を備えることを特徴とする電気手術システム。 - 前記少なくとも1つのセンサによって測定されている前記少なくとも1つの特性は、把持されている前記組織に対して現在発生されている前記RFエネルギに関連付けられた電流又は電圧を測定すること、該RFエネルギの電力測定値を計算すること、又は前記電気手術発電機から該組織を把持している前記電気手術器具への該RFエネルギの供給中にRF出力電圧とRF出力電流の間の位相角又は差を計算することを含むことを特徴とする請求項9に記載の電気手術システム。
- 前記複数の閾値は、融合又は密封を受けている前記組織の異なる状態に対応することを特徴とする請求項9に記載の電気手術システム。
- 前記異なる状態のうちの1つが、前記組織が乾燥点に到達した時を含むことを特徴とする請求項11に記載の電気手術システム。
- 前記異なる状態のうちの1つが、前記組織が以前に密封されたものである又は反復シールであると決定することを含むことを特徴とする請求項11に記載の電気手術システム。
- 前記コントローラは、前記閾値のうちの少なくとも1つが交差されたか否かを決定すること及び前記電気手術器具に対して発生されている前記RFエネルギを修正するように前記RF増幅器に命令することの間に予め決められた期間にわたって遅延を実施することを特徴とする請求項9に記載の電気手術システム。
- 前記コントローラは、更に、前記複数の閾値のうちの1つが交差されることになるか否かを予想するために異なる予め決められた期間にわたって前記少なくとも1つのセンサから取得したパラメータの測定値の変化を計算することを特徴とする請求項9に記載の電気手術システム。
- 前記RF増幅器は、初期期間にわたってランプ方式でRFエネルギを最初に発生し、
前記少なくとも1つのセンサは、RF出力ピークに対応する前記初期期間中の最大値又はピークに関して前記少なくとも1つの特性をモニタする、
ことを特徴とする請求項9に記載の電気手術システム。 - 前記ランプ方式は、融合又は密封されている組織のタイプに基づいていることを特徴とする請求項16に記載の電気手術システム。
- 前記RFエネルギを最初に発生するための前記ランプ方式は、500msの予め定められた期間にわたる35Vの初期の予め決められた値から45Vの最大値までに対応することを特徴とする請求項17に記載の電気手術システム。
- 十分な量の組織が前記電気手術器具によって把持されたか否かを更に検出することを特徴とし、
前記検出は、
前記組織に伝達されている低電圧測定信号を前記電気手術器具に対して前記電気手術発電機で発生し、
前記伝達された低電圧測定信号に関連付けられた把持されている前記組織のインピーダンスを前記電気手術器具で測定し、かつ
前記測定されたインピーダンスが作動範囲であるか否かを決定する、
ことによって実行される、
ことを特徴とする請求項9に記載の電気手術システム。 - エネルギ発生を管理する方法を実施するためにプロセッサによって実行可能なプログラムをその上に具現化したメモリモジュールを有する電気手術発電機であって、
前記方法は、
電気手術器具によって把持されている組織に関するセンサデータを予め決められた期間にわたって受信する段階と、
電気手術発電機によって発生されているエネルギの量を前記受信したセンサデータに基づいて修正するように構成された1又は2以上の閾値条件を発生する段階と、
その後のセンサデータを受信する段階と、
前記その後に受信したセンサデータが前記1又は2以上の閾値条件のうちの少なくとも1つを満足すると決定する段階と、
電気手術発電機によって発生されている前記エネルギの量を満足された前記1又は2以上の閾値条件に基づいて修正する段階と、
を備える、
ことを特徴とする電気手術発電機。
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2020
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