JP2021536299A - 電気手術発生器制御システム - Google Patents
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Abstract
Description
この出願は、これにより全ての目的に対してその全体が引用によって明示的に組み込まれる2018年9月5日出願の同時係属米国仮特許出願第62/727,195号の利益を主張するものである。
60 フィードバックシステム
100 制御システム
501 1次ARMプロセッサ
512 誤差プロセッサ
Claims (70)
- 電気手術RFエネルギを手術部位に供給する電気手術発生器と共に使用されるデジタル閉ループ制御システムであって、
前記手術部位に前記供給されたRFエネルギの電気的性質を同時手術条件として継続的にモニタし、かつそれに関連するデジタルRF信号を発生させるためのフィードバックシステムと、
前記フィードバックシステムからの前記発生されたRF信号に応答して、前記供給されたRFエネルギを複数の調整モードにわたって発生させて外科手順のための最適RF出力をあらゆる手術条件、作動条件、又は手順条件下で提供するRF増幅器を調整かつ制御するように可変利得係数を用いて構成されたマイクロコントローラと、
を含むことを特徴とするデジタル閉ループ制御システム。 - 前記フィードバックシステムは、前記RF出力の電気的性質を少なくとも1つのチャネルを通じて測定して該測定されたデータを前記マイクロコントローラにデジタル送信するように構成されることを特徴とする請求項1に記載のデジタル閉ループ制御システム。
- 前記マイクロコントローラは、前記測定データを受信し、それに関連する電力計算を実行して電圧、電流、及び電力の測定された大きさを取得し、かつ前記複数の調整モードの各々に対する個々の誤差値を計算するように構成されることを特徴とする請求項2に記載のデジタル閉ループ制御システム。
- 前記マイクロコントローラは、前記計算された誤差値に基づいて1つの調整モードを選択するように更に構成され、
前記調整モードは、最もポジティブな誤差値に基づいて選択される、
ことを特徴とする請求項3に記載のデジタル閉ループ制御システム。 - 前記個々の誤差値は、望ましい電圧、電流、及び電力設定値を該電圧、電流、及び電力の前記測定された大きさから減算することによって計算されることを特徴とする請求項3に記載のデジタル閉ループ制御システム。
- 前記マイクロコントローラは、前記複数の調整モードの各々に対する可変利得係数を演算して該計算された誤差値に基づいて1つの可変利得係数を選択するように更に構成され、
前記可変利得は、最もポジティブな誤差値に基づいて選択される、
ことを特徴とする請求項3に記載のデジタル閉ループ制御システム。 - 前記複数の調整モードは、電圧、電流、及び電力調整モードのうちの1つを含むことを特徴とする請求項1に記載のデジタル閉ループ制御システム。
- 前記マイクロプロセッサは、1次完全プログラマブルゲートアレイ(FPGA)及び1次プロセッサを含み、
前記1次プロセッサは、前記複数のRF調整モードの各々に対する望ましいRF出力値又は設定値を確立するように構成される、
ことを特徴とする請求項1に記載のデジタル閉ループ制御システム。 - 前記望ましいRF値又は設定値は、デバイススクリプトによって提供されることを特徴とする請求項8に記載のデジタル閉ループ制御システム。
- 前記複数の調整モードに対する前記可変利得係数は、望ましいRF値又は設定値、測定データの計算された大きさ、計算された組織インピーダンス負荷、及び累積誤差値、又はそのいずれかの組合せを使用して特殊アルゴリズムによって演算されることを特徴とする請求項1に記載のデジタル閉ループ制御システム。
- 前記可変利得係数は、前記電気手術発生器があらゆる変化する手術条件、作動条件、及び手順条件下で決定的に減衰する段階応答を有することを可能にすることを特徴とする請求項1に記載のデジタル閉ループ制御システム。
- 前記マイクロプロセッサは、前記複数の調整モードの各々の間の前記電気手術発生器のシームレスな移行を可能にするプレロード関数を用いて更に構成されることを特徴とする請求項1に記載のデジタル閉ループ制御システム。
- 前記プレロード関数は、前記電気手術発生器がそこに移行している次の調整モードに対する前記可変利得係数を計算し、かつこの値を累積誤差値の中にプレロードするように構成されることを特徴とする請求項12に記載のデジタル閉ループ制御システム。
- 前記マイクロコントローラは、前記RF増幅器のBuck及びH−ブリッジ回路のRF出力を決定するための可変積分制御システムを提供するように構成されることを特徴とする請求項1に記載のデジタル閉ループ制御システム。
- 前記マイクロコントローラは、望ましいRF値又は設定値と計算された組織インピーダンス負荷とを使用して前記RF増幅器の前記Buck回路に対する負荷サイクル値を駆動するように構成されることを特徴とする請求項14に記載のデジタル閉ループ制御システム。
- 前記マイクロコントローラは、前記選択されたモードの前記計算された誤差値を積分して前記可変利得係数によって乗算することによって発生された積分信号を使用して前記RF増幅器の前記H−ブリッジ回路に対する負荷サイクル値を駆動するように構成されることを特徴とする請求項14に記載のデジタル閉ループ制御システム。
- 前記フィードバックシステムは、フロントエンド回路を通じてアナログRF出力を測定し、アナログ/デジタル変換器(ADC)を通じて該測定データをデジタル化し、完全プログラマブルゲートアレイ(FPGA)を通じて該測定データの実数及び虚数成分を駆動し、かつ該測定データの該実数及び虚数成分を前記マイクロコントローラにデジタル送信するように構成されることを特徴とする請求項1に記載のデジタル閉ループ制御システム。
- 電気手術器具を通して手術部位まで電気手術RFエネルギを供給する電気手術発生器を動的に制御する方法であって、
複数のRF調整モードに対する望ましいRF設定値又はターゲット値を取り出し、かつ該望ましいRF設定値でRFエネルギを発生させる段階と、
フィードバックシステムからの少なくとも1つのチャネルを通じてRF出力の電気特性を測定し、かつその実数及び虚数成分をマイクロコントローラに通信する段階と、
測定データの前記実数及び虚数成分を受信し、かつ電力計算を実行して前記複数のRF調整モードの各々に対する測定データ及び組織インピーダンス負荷の大きさを取得する段階と、
前記望ましいRF設定値をそれらのそれぞれの計算された大きさから減算することによって前記複数のRF調整モードの各々に対する誤差信号を発生させ、かつ該計算された誤差値に基づいて1つの調整モードを選択する段階と、
特殊アルゴリズムを使用して前記複数の調整モードの各々に対する可変利得係数を計算し、かつ計算された誤差値に基づいて1つの可変利得を選択する段階と、
前記電気手術発生器のRF増幅器のBuck及びH−ブリッジ回路に対する出力制御信号を決定する段階と、
前記出力制御信号に応答して前記電気手術発生器のRF出力の量を制御して該発生器の望ましい出力値を維持する段階と、
を含むことを特徴とする方法。 - 出力制御信号を決定する前記段階は、
前記望ましいRF設定値及び計算された組織インピーダンス負荷を使用して前記発生器の出力電圧を予想する段階と、
前記予想出力電圧を使用して前記RF増幅器の前記Buck回路に対するカウントを設定する段階と、
更に含む、
ことを特徴とする請求項18に記載の方法。 - 前記決定する段階は、
前記選択された誤差信号を積分することによって積分信号を発生させ、かつ該発生された積分信号を前記選択された可変利得係数によって乗算する段階と、
前記RF増幅器の前記H−ブリッジ回路に対するカウントを設定する段階と、
を更に含む、
ことを特徴とする請求項19に記載の方法。 - 前記RF増幅器のBuck回路に対する前記出力制御信号は、前記発生器の前記望ましい出力値の近傍に粗く到達するのに使用されることを特徴とする請求項18に記載の方法。
- 前記RF増幅器の前記H−ブリッジ回路に対する前記出力制御信号は、前記発生器の前記望ましい出力値に対してRF出力の前記量を微調整するのに使用されることを特徴とする請求項18に記載の方法。
- 前記調整モードは、最もポジティブな誤差値に基づいて選択されることを特徴とする請求項18に記載の方法。
- 前記可変利得係数は、最もポジティブな誤差値に基づいて選択されることを特徴とする請求項18に記載の方法。
- 前記複数の調整モードの各々に対する前記可変利得係数は、望ましいRF値又は設定値、測定データの計算された大きさ、計算された組織インピーダンス負荷、及び積分された誤差信号、又はそのいずれかの組合せを使用して計算されることを特徴とする請求項18に記載の方法。
- 前記発生器が前記複数の調整モードの各々の間でスイッチングする時にRF出力の滑らかな移行を保証するために前記発生された積分信号にプレロード関数を印加する段階を更に含むことを特徴とする請求項20に記載の方法。
- 前記プレロード関数は、前記RF増幅器の前記Buck及びH−ブリッジ回路に対する前記カウントと前記計算された組織インピーダンス負荷とを使用して計算されることを特徴とする請求項26に記載の方法。
- 前記複数のRF調整モードは、電圧、電流、及び電力調整モードのうちの1つを含むことを特徴とする請求項18に記載の方法。
- 前記望ましいRF設定値又はターゲット値は、前記電気手術器具又はそのデバイスキーのメモリの中に格納されたデバイススクリプトによって提供されることを特徴とする請求項18に記載の方法。
- 外科手順を実行するための電気手術システムであって、
プロセッサと1次完全プログラマブルゲートアレイ(FPGA)とを含むマイクロコントローラを含み、RFエネルギを手術部位に供給するようになった電気手術発生器であって、該1次FPGAが、
前記発生器のRF増幅器に望ましいRF設定値でRFエネルギを発生させ、
前記発生器のフィードバックシステムから測定データの実数及び虚数成分を受信すること、及び電力計算を実行して複数のRF調整モードに対する測定データ及び組織インピーダンス負荷の大きさを取得することを引き起こし、
前記複数のRF調整モードの各々に対する誤差信号を発生させること、及び最もポジティブな誤差値に基づいて1つの調整モードを選択することを引き起こし、
特殊アルゴリズムを使用して前記複数の調整モードの各々に対する可変利得係数を演算すること、及び前記発生された誤差信号に基づいて1つの可変利得係数を選択することを引き起こし、
前記選択された誤差信号を積分することによって積分信号を発生させること、及び該発生された積分信号を前記選択された可変利得係数によって乗算することを引き起こし、
前記望ましいRF設定値及び計算された組織インピーダンス負荷を使用して前記発生器の出力電圧を予想することを引き起こし、かつ
前記予想された出力電圧及び前記発生された積分信号をそれぞれ使用して前記RF増幅器のBuck及びH−ブリッジ回路に対する負荷サイクルを駆動することを引き起こす、
ように構成される前記電気手術発生器と、
前記電気手術発生器に接続された電気手術器具であって、前記手術部位で組織に電気手術RFエネルギを印加するようになった少なくとも1つの能動電極を有する前記電気手術器具と、
を含むことを特徴とする電気手術システム。 - 前記複数の調整モードの各々に対する前記可変利得係数は、望ましいRF値又は設定値、測定データの計算された大きさ、計算された組織インピーダンス負荷、及び発生された積分信号、又はそのいずれかの組合せを使用して計算されることを特徴とする請求項30に記載の電気手術システム。
- 前記誤差信号は、誤差計算器と前記RF調整モードを選択するための誤差セレクタとを含む誤差プロセッサによって発生されることを特徴とする請求項30に記載の電気手術システム。
- 前記電力計算及び組織インピーダンス負荷計算が、個別の負荷計算器を有するVCW(電圧、電流、電力)モジュールを使用して実行されることを特徴とする請求項30に記載の電気手術システム。
- 前記複数の調整モードは、電圧、電流、及び電力調整モードのうちの1つを含むことを特徴とする請求項30に記載の電気手術システム。
- 前記1次FPGAは、前記複数のRF調整モード内の前記発生器のシームレスな移行を可能にするプレロード関数を用いて前記積分信号がプレロードされることを引き起こすように更に構成されることを特徴とする請求項30に記載の電気手術システム。
- 前記プレロード関数は、前記RF増幅器の前記Buck及びH−ブリッジ回路に対する前記負荷サイクルと前記計算された組織インピーダンス負荷とを使用して計算されることを特徴とする請求項35に記載の電気手術システム。
- 前記フィードバックシステムは、アナログ入力、デジタル処理、及びデジタル出力から構成されることを特徴とする請求項30に記載の電気手術システム。
- 前記発生器の前記フィードバックシステムは、該フィードバックシステムの少なくとも主チャネルにわたって前記手術部位に供給されたRFエネルギの電気的性質を測定し、アナログ/デジタル変換器(ADC)を使用して該測定値をデジタル化し、かつ完全プログラマブルゲートアレイ(FPGA)を使用して該測定データの実数及び虚数成分を駆動するように構成されることを特徴とする請求項30に記載の電気手術システム。
- 前記フィードバックシステムは、前記測定データの前記実数及び虚数成分を前記マイクロコントローラにデジタル送信するように更に構成されることを特徴とする請求項38に記載の電気手術システム。
- 前記フィードバックシステムは、少なくとも1つの冗長チャネルを含み、
前記冗長チャネルからの前記測定データは、前記主チャネルのものと常に比較されて該主チャネルが予め決められたパラメータ及び/又は公差内で作動していることを保証する、
ことを特徴とする請求項38に記載の電気手術システム。 - 前記フィードバックシステムの前記FPGAは、実数及び虚数サンプルを取得するために離散電圧及び電流測定サンプルに対してI/Q復調を実行するように構成され、
電圧及び電流測定値に対する前記実数及び虚数値のDC成分が、離散フーリエ変換を使用して取得される、
ことを特徴とする請求項38に記載の電気手術システム。 - 前記プロセッサは、前記複数の調整モードの各々に対する望ましいRF出力値又は設定値を確立するように構成されることを特徴とする請求項30に記載の電気手術システム。
- 前記プロセッサは、前記接続された電気手術器具又はそれに対するデバイスキーのメモリの中に格納されたデバイススクリプトから前記望ましいRF出力値又は設定値を取り出すように構成されることを特徴とする請求項42に記載の電気手術システム。
- RFエネルギを供給するためのRF増幅器と、
供給されたRFエネルギの電気的性質を継続的にモニタしてそれに関連するデジタルRF信号を発生するようになったフィードバックシステムと、
あらゆる手術条件、作動条件、及び手順条件の下で複数のRF調整モード及び複数のRF分解能設定値にわたって前記供給されたRFエネルギを動的に制御することを可能にする可変利得係数及びプレロード関数を計算するようにプログラムされた1次マイクロコントローラと、
を含むことを特徴とする電気手術発生器。 - 前記1次マイクロコントローラは、前記発生器の前記RF出力を前記複数のRF調整モード及びRF分解能設定値の各々に対する望ましいRF設定値に調整するように構成されることを特徴とする請求項44に記載の電気手術発生器。
- 前記複数のRF調整モードは、電圧、電流、及び電力調整モードのうちの1つを含み、
前記複数のRF分解能設定値は、低、中、及び高電圧設定値のうちの1つを含む、
ことを特徴とする請求項44に記載の電気手術発生器。 - 前記1次マイクロコントローラは、前記複数のRF調整モード及び前記複数のRF分解能設定値の各々に対する前記望ましいRF設定値を確立するように構成されたプロセッサを含むことを特徴とする請求項45に記載の電気手術発生器。
- 前記望ましいRF設定値は、デバイススクリプトによって提供され、
前記プロセッサは、前記接続された電気手術器具又はそれに対するデバイスキーのメモリの中に格納された前記デバイススクリプトから前記望ましいRF設定値を取り出すように更に構成される、
ことを特徴とする請求項45に記載の電気手術発生器。 - 前記フィードバックシステムは、少なくとも1つのチャネルを通じて前記RF出力の電気的性質を測定し、かつ該測定データを前記1次マイクロコントローラにデジタル送信するようにプログラムされることを特徴とする請求項44に記載の電気手術発生器。
- 前記1次マイクロコントローラは、前記フィードバックシステムからの前記発生されたRF信号に応答して、前記測定データを受信し、それに関連する電力計算を実行して電圧、電流、及び電力の測定された大きさを取得し、かつ前記複数のRF調整モード及びRF分解能設定値の各々に対する個々の誤差値を計算するようにプログラムされることを特徴とする請求項44に記載の電気手術発生器。
- 前記個々の誤差値は、電圧、電流、及び電力に対する前記望ましいRF設定値を該電圧、電流、及び電力の前記測定された大きさから減算することによって計算され、
前記1次マイクロコントローラは、前記計算された誤差値に基づいて1つのRF調整モードを選択するように更にプログラムされる、
ことを特徴とする請求項50に記載の電気手術発生器。 - 前記可変利得係数は、特殊アルゴリズムを使用して前記複数のRF調整モードの各々に対して演算され、
前記1次マイクロコントローラは、計算された誤差値に基づいて1つの可変利得係数を選択するように更にプログラムされる、
ことを特徴とする請求項44に記載の電気手術発生器。 - 前記1次マイクロコントローラは、前記RF増幅器のBuck及びH−ブリッジ回路に対する出力制御信号を決定し、それによって該出力制御信号に応答してあらゆる手術条件、作動条件、及び手順条件の下で外科手順に対する最適RF出力を提供するように更にプログラムされることを特徴とする請求項44に記載の電気手術発生器。
- 前記RF増幅器の前記Buck回路に対する前記出力制御信号は、前記望ましいRF設定値及び計算されたインピーダンス負荷を使用して前記発生器のRF出力を予想することにより、かつその負荷サイクルを該RF増幅器の該Buck回路に対して駆動することによって決定されることを特徴とする請求項53に記載の電気手術発生器。
- 前記RF増幅器の前記H−ブリッジ回路に対する前記出力制御信号は、選択された個々の誤差値の積分信号を発生させて該発生された積分信号を選択された可変利得係数によって乗算することにより、かつその負荷サイクルを該RF増幅器の該H−ブリッジ回路に対して駆動することによって決定されることを特徴とする請求項53に記載の電気手術発生器。
- 前記1次マイクロコントローラは、プレロード関数を計算して該プレロード関数値を用いて前記発生された積分信号をプレロードするように更にプログラムされることを特徴とする請求項55に記載の電気手術発生器。
- 前記プレロード関数は、前記RF増幅器の前記Buck及びH−ブリッジに対して取得された前記負荷サイクルを使用して計算されることを特徴とする請求項56に記載の電気手術発生器。
- 外科手順を実行する前の電気手術発生器に接続された電気手術器具のインピーダンス評価の方法であって、
前記接続された電気手術器具の起動時に低電圧モード又は受動モードを開始する段階と、
前記低電圧モードによって定められた値に制限されたRF出力を発生させる段階と、
前記RF出力の電気特性を測定して該測定データを前記電気手術発生器のマイクロコントローラにデジタル送信する段階と、
前記受信した測定データに基づいて前記RF出力の他の電気特性を計算し、かつ該計算結果を前記マイクロコントローラ内の1次プロセッサに送信する段階と、
前記計算結果が前記接続された電気手術器具のデバイススクリプトによって設定されたある一定の判断基準を満足したか否かを決定する段階と、
を含むことを特徴とする方法。 - 前記接続された電気手術器具又はそのデバイスキーのメモリの中に格納された前記デバイススクリプトを取り出す段階を更に含み、
前記取り出す段階は、前記マイクロコントローラの前記1次プロセッサによって実行される、
ことを特徴とする請求項58に記載の方法。 - 前記計算結果が前記1次プロセッサによって受信された状態で、前記デバイススクリプトによって定められた事前設定範囲に対して該計算結果を比較する段階を更に含むことを特徴とする請求項58に記載の方法。
- 前記計算結果が前記ある一定の判断基準を満足しなかった場合にデバイスエラーを発生させる段階を更に含み、
前記ある一定の判断基準は、前記デバイススクリプトによって設定された最大及び/又は最小値を含む、
ことを特徴とする請求項58に記載の方法。 - 前記計算結果が前記ある一定の判断基準を満足した場合に前記外科手順を実行するための完全なデバイススクリプトを開始する段階を更に含み、
前記ある一定の判断基準は、前記デバイススクリプトによって設定された最大及び/又は最小値を含む、
ことを特徴とする請求項58に記載の方法。 - 前記デバイスエラーが最初に発生された場合に前記電気手術デバイスを再起動する又は再接続する段階を更に含むことを特徴とする請求項61に記載の方法。
- 前記比較する段階及び決定する段階は、前記マイクロコントローラの前記1次プロセッサによって実行されることを特徴とする請求項60に記載の方法。
- 前記1次プロセッサは、高度縮小命令セットマシン(ARM)プロセッサを含むことを特徴とする請求項58に記載の方法。
- 前記計算する段階は、前記マイクロコントローラの1次FPGA(フィールドプログラマブルゲートアレイ)によって実行されることを特徴とする請求項58に記載の方法。
- 前記RF出力の電気特性を測定する前記段階は、前記電気手術発生器からのフィードバックシステムの少なくとも1つのチャネルにわたって実行されることを特徴とする請求項58に記載の方法。
- 前記低電圧モード又は受動モードの前記RF出力は、5−500オーム抵抗の範囲にわたって指定電圧範囲(≦10V)及び指定電流範囲(≦10mA)に制限されることを特徴とする請求項58に記載の方法。
- RFエネルギを供給するためのRF増幅器と、
前記供給されたRFエネルギを複数のRF調整モードからの少なくとも1つの調整モードと複数のRF分解能設定値とにわたって動的に制御するように構成されたマイクロコントローラと、
を含むことを特徴とする電気手術発生器。 - RFエネルギを供給するためのRF増幅器と、
前記供給されたRFエネルギを動的に制御するために可変利得係数及びプレロード関数のうちの少なくとも一方を決定するように構成されたマイクロコントローラと、
を含むことを特徴とする電気手術発生器。
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- 2019-09-05 CA CA3111558A patent/CA3111558A1/en active Pending
- 2019-09-05 JP JP2021512216A patent/JP2021536299A/ja active Pending
- 2019-09-05 WO PCT/US2019/049807 patent/WO2020051369A1/en unknown
- 2019-09-05 EP EP19773593.9A patent/EP3846717A1/en active Pending
- 2019-09-05 KR KR1020217010048A patent/KR20210055073A/ko active Search and Examination
- 2019-09-05 AU AU2019335013A patent/AU2019335013A1/en active Pending
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US11864812B2 (en) | 2024-01-09 |
KR20210055073A (ko) | 2021-05-14 |
WO2020051369A1 (en) | 2020-03-12 |
CA3111558A1 (en) | 2020-03-12 |
US20200069358A1 (en) | 2020-03-05 |
AU2019335013A1 (en) | 2021-03-25 |
EP3846717A1 (en) | 2021-07-14 |
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