JP2016540588A - 医療装置 - Google Patents

医療装置 Download PDF

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JP2016540588A
JP2016540588A JP2016539917A JP2016539917A JP2016540588A JP 2016540588 A JP2016540588 A JP 2016540588A JP 2016539917 A JP2016539917 A JP 2016539917A JP 2016539917 A JP2016539917 A JP 2016539917A JP 2016540588 A JP2016540588 A JP 2016540588A
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グリーン・アラン・エドワード
ロバーツ・ポール・クリストファー
タックウェル・マーク・デビッド
ボーナム・ピーター・ラルフ
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Ethicon Endo Surgery LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00137Details of operation mode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00137Details of operation mode
    • A61B2017/00154Details of operation mode pulsed
    • A61B2017/00181Means for setting or varying the pulse energy
    • A61B2017/0019Means for setting or varying the pulse width
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681Aspects not otherwise provided for
    • A61B2017/00734Aspects not otherwise provided for battery operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320071Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with articulating means for working tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320089Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location

Abstract

処置される組織又は血管に超音波エネルギーを送達するために、ハンドルと、ハンドルに連結されたシャフトと、シャフトに連結されたエンドエフェクタと、エンドエフェクタに連結された超音波トランスデューサと、を有する医療装置が説明される。超音波トランスデューサに適用される駆動信号を生成するための駆動回路が提供される。一実施形態では、駆動回路は、超音波トランスデューサに供給される電力を制御する目的で、共振回路と、共振回路を通して送られる駆動信号の周期を変えるコントローラと、を含む。

Description

本発明は、医療装置、特に、排他的にではないが、焼灼及び切除装置の分野に関する。本発明はまた、このような医療装置を駆動するための駆動回路及び方法に関する。
多くの外科手術は、血管又は他の内部組織の切除又は結紮を必要とし、多くの手術は、切除又は結紮を行うための手持ち式焼灼装置を使っての低侵襲的技術を用いて行われている。いくつかの既存の手持ち式焼灼装置は、切除又は結紮される組織に超音波エネルギーを適用するよう、焼灼装置内に超音波トランスデューサを使用する。しかし、超音波トランスデューサを駆動することは、超音波エネルギーを生成するために使用される超音波トランスデューサに関連付けられる固有の不安定性により問題となり得る。
本発明は、そのような超音波切除装置又は超音波焼灼装置の安全で信頼性のある操作が可能となる、代替の回路設計を提供することを目的とする。この回路設計はまた、医療手術に必要な電力及び制御を依然として提供できる一方で、手持ち式焼灼装置に内蔵し得るよう、回路の小型化を好都合に可能にする。
一態様によると、本発明は、医療装置を制御するための入力信号を受信するための入力部と、エンドエフェクタと、エンドエフェクタに連結される超音波トランスデューサと、入力部に連結され、周期的な駆動信号を生成し、超音波トランスデューサに駆動信号を提供するよう操作可能な駆動回路と、を備える医療装置であって、超音波トランスデューサが共振特性を有し、駆動回路が、超音波トランスデューサの共振特性に合わせられている共振回路を備える医療装置を提供する。
一実施形態では、トランスデューサに適用された、検出した負荷電圧と、検出した負荷電流と、に基づいて、駆動信号の周期を変えるための、第1のコントローラが提供されてよい。第1のコントローラは、検出した負荷電圧と検出した負荷電流との間の位相差に基づいて、駆動信号の周期を変えるよう配列されてよい。これは、検出した負荷電圧と検出した負荷電流との間の位相差が、位相要求に対応するよう行われてよい。超音波トランスデューサに適用された電力、電圧、又は電流を変える目的で、位相要求を変えるよう配列されている第2のコントローラがまた提供されてよい。第2のコントローラは、検出した負荷電圧及び/又は検出した負荷電流、若しくは、測定した負荷インピーダンスに基づいて、位相要求を変えてよい。
装置はまた、DC電源から周期的な駆動信号を生成するスイッチング回路を備えてよく、共振回路は、周期的な駆動信号を受信するよう構成されている。
一実施形態では、装置は、反対極性の周期的な駆動パルスを含むデジタル駆動信号を生成するよう配列されている制御回路を備えてよく、駆動信号の第3の高調波成分を最小化するよう、パルスの相対タイミングが選択されている。
好適な実施形態では、回路は、トランスデューサに適用されている駆動信号の高調波成分を減らすよう提供されている。この回路は、i)駆動信号の高調波信号に対する低インピーダンス経路を提供するために、トランスデューサに並列に接続されたスナバ回路と、ii)駆動信号の高調波信号を相殺するよう、高調波補償信号を生成するよう配列されているアクティブフィードバック回路と、のうちの1つ又は複数を備えてよい。
装置は、好ましくは電池により駆動され、駆動信号を生成するための駆動回路に電力を提供するための1つ又は複数の電池を保持するための電池区画を含む。
駆動信号の測定値を受け取り、超音波トランスデューサに送達された電力、電圧、及び/又は電流を制御するよう、駆動信号の周期を変える制御回路もまた提供されてよい。測定値は、駆動信号の周期及び位相と共に変化するサンプリング周波数にて、検出した電圧信号又は電流信号をサンプリングするサンプリング回路から取得されていてよい。制御回路は、駆動信号の周波数が、超音波トランスデューサの共振周波数近辺、好ましくは、超音波トランスデューサの共振周波数の0.1%〜1%以内にて変化するよう、駆動信号の周期を変えるよう構成されてよい。超音波トランスデューサの共振特性は、使用中に超音波トランスデューサに連結される負荷と共に変化してよく、制御回路は、超音波トランスデューサの共振特性における変化を追跡するよう、駆動信号の周期を変えるよう構成されている。
別の態様によると、本発明はまた、装置の動作を制御するための入力を受け取るための入力部と、エンドエフェクタと、エンドエフェクタに連結される超音波トランスデューサと、周期的な駆動信号を生成し、駆動信号を超音波トランスデューサに提供するよう操作可能な駆動回路と、超音波トランスデューサに提供された電力、電圧、及び電流のうちの少なくとも1つを制御するよう、駆動信号の周期を変えるよう操作可能な制御回路と、を備える医療装置を提供する。
制御回路は通常、超音波トランスデューサに適用された、検出した負荷電圧と、検出した負荷電流と、に基づいて、駆動信号の周期を変えるための第1のコントローラを備える。第1のコントローラは、検出した負荷電圧と検出した負荷電流との間の位相差に基づいて、駆動信号の周期を変えるよう配列されてよい。第1のコントローラは、検出した負荷電圧と検出した負荷電流との間の位相差が、位相要求に対応するよう、駆動信号の周期を変えるよう配列されてよい。制御回路は、超音波トランスデューサに適用された電力、電圧、又は電流を変える目的で、位相要求を変えるよう配列されている第2のコントローラを含んでよい。第2のコントローラは、検出した負荷電圧及び/又は検出した負荷電流、若しくは、測定した負荷インピーダンスに基づいて、位相要求を変えてよい。
本発明はまた、周期的な駆動信号を生成することと、医療装置のエンドエフェクタに連結されている超音波トランスデューサに駆動信号を適用することと、超音波トランスデューサに適用された電力、電流、及び電圧のうちの少なくとも1つを制御するよう、駆動信号の周期を制御することと、を含む、医療装置を操作する方法を提供する。
別の態様によると、本発明は、血管又は組織を焼灼する又は切除する方法を提供し、この方法は、医療装置のエンドエフェクタで血管又は組織を把持することと、エンドエフェクタに連結された超音波トランスデューサに、周期的な駆動信号を適用するよう、駆動回路を使用することと、焼灼又は切除を行うよう、組織に適用された電力、電流、及び電圧のうちの少なくとも1つを制御するよう、駆動信号の周期を制御することと、を含む。
この方法は、焼灼又は切除を行うよう、上述の医療装置を使用してよい。
制御工程は、組織又は血管に適用された超音波信号の電力を制御するよう、駆動信号の周期を変えてよく、方法は、トランスデューサと、組織又は血管と、により生じた、駆動回路上の負荷のインピーダンス測定値を取得することと、取得したインピーダンス測定値に基づいて、組織又は血管に適用される、所望する電力を変えることと、を更に含んでよい。
別の態様によると、本発明は、超音波トランスデューサを有する医療装置にて使用するための電子装置を提供し、この電子装置は、超音波トランスデューサに供給するための周期的な駆動信号を生成するよう操作可能な駆動回路と、超音波トランスデューサに供給された負荷電圧及び/又は負荷電流を検出するための検出回路と、検出回路により検出した負荷電圧及び/又は負荷電流に基づいて、超音波トランスデューサに供給された電力、電圧、及び電流のうちの少なくとも1つを制御するよう、駆動信号の周期を変えるよう操作可能な制御回路と、を備える。
制御回路は、検出した負荷電圧と検出した負荷電流との間の位相差に基づいて、駆動信号の周期を変えるよう配列されてよい。制御回路は、検出した負荷電圧と検出した負荷電流との間の位相差が、位相要求に対応するよう、駆動信号の周期を変えるよう配列されてよい。超音波トランスデューサに適用された電力、電圧、又は電流を変える目的で、位相要求を変えるよう配列されている第2の制御回路が提供されてよい。第2の制御回路は、検出した負荷電圧及び/又は検出した負荷電流に基づいて、位相要求を変えるよう配列されてよい。
一般的に、超音波トランスデューサは共振特性を有し、駆動回路は、超音波トランスデューサの共振特性に合わせられている共振回路と、DC電源から周期的な駆動信号を生成するスイッチング回路を更に備える回路と、を備え、この共振回路は、周期的な駆動信号を受信するよう構成されている。
これら及び本発明の様々な他の特徴並びに態様は、添付の図を参照して説明される以下の実施形態の詳しい説明から明らかとなるであろう。
装置のハンドル部内に搭載された電池及び駆動回路並びに制御回路を有する手持ち式焼灼装置を示す。 本発明の一実施形態にて使用される焼灼装置の主構成部品を示す部品ブロック部概略図である。 図2に示す焼灼装置の主電気構成部品を示すブロック図である。 図3に示す電気構成部品の一部を形成するブリッジ信号発生器により生成された波形の形状を示すタイミング図である。 図2に示すマイクロプロセッサの一部を形成する計算モジュールを概略的に示すブロック図である。 測定した信号の位相が、ブリッジ信号発生器により生成された波形の周期と共に変化する様式を示し、位相のプロットが、焼灼装置により把持された負荷により変化することを示すプロットである。 図5に示すマイクロプロセッサにより行われる処理を示すフローチャートである。 図2に示す回路に加えられ得るスナバ回路の形状を示すブロック図である。 駆動信号の高調波が、マイクロプロセッサ内のフィードバック回路及びコントローラを使用して積極的に相殺され得る様式を示すブロック図である。
医療装置
多くの外科手術は、血管又は他の管状組織を切除又は結紮することを必要とする。低侵襲的手術により、外科医は、患者の身体の小さな切開部を通じて外科手術を行う。制限された空間により、外科医は、横切された血管をクランピング及び/又は結合して、出血を制御するのに苦労する。超音波外科用鉗子を使用することで、外科医は、外科用鉗子のジョー部材の1つ又は双方に連結される1つ又は複数の超音波トランスデューサにより、組織/血管に適用された超音波エネルギーを制御することで、焼灼、凝固/乾燥、及び/又は単に流血を減らし得る。
図1は、本発明の一実施形態による、低侵襲的医療手術のために設計された、超音波外科用医療装置1の形状を示す。図示するように、装置1は、細長いシャフト3を有する内蔵型装置であって、これはシャフト3の近位端に接続されるハンドル5と、シャフト3の遠位端に接続されるエンドエフェクタ7と、を有する。この実施形態では、エンドエフェクタ7は、ハンドル5の制御レバー11及び制御レバー13を操作するユーザにより制御される医療用鉗子9を備える。
外科手術の間、シャフト3は、患者の内側、及び手術部位にアクセスするために、トロカールを通じて挿入される。外科医は鉗子9を、切除又は焼灼される血管の周囲にこの鉗子9が位置するまで、ハンドル5及び制御レバー11並びに制御レバー13を使用して操作する。電気エネルギーが続いて、超音波エネルギーを使用して所望する切除/焼灼を行う目的で、制御された様式にて、ハンドル5内に搭載され、シャフト3内の導波管(図示せず)を介して鉗子9に連結されている超音波トランスデューサ8に適用される。図1に示すように、この実施形態では、ハンドル5はまた、焼灼を行うために必要な電気エネルギーを生成し、制御するための、電池15と、制御電子機器17と、を収容する。このように、装置1は、別個の制御ボックス、及び鉗子9に電気エネルギーを提供するための供給ワイヤを必要としない、という意味において内蔵型である。しかし、そのような別個の制御ボックスは、所望される場合には提供されてよい。
システム回路
図2は、超音波トランスデューサ8に供給される電気エネルギーを生成し、制御するよう、この実施形態にて使用される焼灼/切除装置1の主電気回路を示す概略ブロック図である。以下に更に詳述するように、この実施形態では、回路は、供給される電力量を制御する目的で生成され、超音波トランスデューサ8に適用される電気的駆動波形の周期を制御するよう設計されている。これが達成される様式は、以下の説明から明らかとなろう。
図2に示すように、焼灼/切除装置1はユーザインターフェース21を備え、これを介してユーザには、(エネルギーが超音波トランスデューサ8に適用されていることを示すことなどの)情報が提供され、これを通してユーザは、焼灼/切除装置1の作動を制御する。図示するように、ユーザインターフェース21は、ゲート駆動回路25に出力する制御信号を生成することで焼灼/切除手順を制御する、マイクロプロセッサ23に連結されている。マイクロプロセッサからの制御信号に応じて、ゲート駆動回路25は、ブリッジ信号発生器27に、駆動回路29を介して超音波トランスデューサ8に適用される所望する駆動波形を生成させるゲート制御信号を生成する。電圧検出回路31及び電流検出回路33は、制御の目的でマイクロプロセッサ23にフィードバックされる、超音波トランスデューサ8に適用された電流及び電圧の測定値を生成する。図2はまた、図2に示す電気回路を駆動するための電力を提供する電池15を示す。この実施形態では、電池15は、0Vレール及び14Vレールを供給するよう配列されている。
図3は、この実施形態にて使用されている、ゲート駆動回路25と、ブリッジ信号発生器27と、駆動回路29と、電圧検出回路31と、電流検出回路33と、の構成部品を更に詳細に示す。図3はまた、圧電超音波トランスデューサ8の電気等価回路35と、処置される組織/血管により形成される負荷(R負荷)と、を示す。
図3に示すように、ゲート駆動回路25は、2つのFETゲート駆動37、すなわち、FETゲート駆動37−1と、FETゲート駆動37−2と、を含む。マイクロプロセッサ23からの第1の制御信号のセット(CTRL)はFETゲート駆動37−1に供給され、マイクロプロセッサ23からの第2の制御信号のセット(CTRL)はFETゲート駆動37−2に供給される。FETゲート駆動37−1は、2つの駆動信号、すなわち、ブリッジ信号発生器27の2つのFET 41−1及びFET 41−2のそれぞれを駆動するためのものを生成する。マイクロプロセッサ23からの信号に応じて、FETゲート駆動37−1は、下方のFET(41−2)がオフの際に、上方のFET(41−1)をオンにし、その逆も同様の駆動信号を生成する。これにより、ノードAは、14Vレール(FET 41−1がオンに切り替えられた際)と、0Vレール(FET 41−2がオンに切り替えられた際)と、に、交互に接続される。同様に、マイクロプロセッサ23からの信号に応じて、FETゲート駆動37−2は、2つの駆動信号、すなわち、ブリッジ信号発生器27の2つのFET 41−3及びFET 41−4のそれぞれを駆動するためのものを生成する。FETゲート駆動37−2は、下方のFET(41−4)がオフの際に、上方のFET(41−3)をオンにし、その逆もまた同様の駆動信号を生成する。これにより、ノードBは、14Vレール(FET 41−3がオンに切り替えられた際)と、0Vレール(FET 41−4がオンに切り替えられた際)と、に、交互に接続される。したがって、マイクロプロセッサ23により出力される2つの制御信号のセット(CTRL及びCTRL)は、生成され、ノードAとノードBとの間に適用されるデジタル波形を制御する。それぞれの制御信号のセット(CTRL及びCTRL)は、1つは、高側のFETがオンであることを示し、他方は、低側のFETがオンであることを示す、一対の信号線を備える。したがって、マイクロプロセッサ23は、ソフトウェアを通して、又は、専用ハードウェア機能を通してのいずれかにて、高側FET及び低側FETの双方が同時にオンとなる際の好ましくない状況が起こらないことを確かにし得る。実際においてこれは、変動する切り替えの遅れが許容されても、双方のFETが同時にオンとなり得る可能性がないことを確かにするよう、高側FET及び低側FETの双方がオフとなる際にデッドタイムを設けることを必要とする。本実施形態では、約100nsのデッドタイムが使用された。
図3に示すように、ノードA及びノードBは駆動回路29に接続されており、したがって、ブリッジ信号発生器27により生成されたデジタル電圧が、駆動回路29に適用されている。この適用された電圧は、駆動回路29内に電流を流す。ノードAとノードBとの間に印加されている電圧(VAB)のデジタル波形は、基本周波数(f)と、非常に小さい第3の高調波成分(3f)と、を有するよう設計されており、これは、図4に示されている。図示するように、この電圧VABは、第1のパルス39−1と、第2のパルス39−2と、を有する。第1のパルスは、マイクロプロセッサ23からの第1の制御信号のセット(CTRL)に基づいて、FET 41−1及びFET 41−2により生成されている。第2のパルスは、マイクロプロセッサ23からの第2の制御信号のセット(CTRL)に基づいて、FET 41−3及びFET 41−4により生成されている。これらのパルスは、周期Δtにて周期的に生成されている。パルス39は互いに、波形の3rd高調波成分を最小化するよう選択されている時間周期により、周期の始まりから終わりに、間隔があいている。発明者は、圧電超音波トランスデューサ8の安定駆動には、3rd高調波成分の最小化が重要であることを発見した。
図3に示すように、駆動回路29は、コンデンサC 45と、インダクタL 47と、インダクタL 49と、により形成されるコンデンサ−インダクタ−インダクタ共振回路43を含む。マイクロプロセッサ23は、ノードA及びノードBに渡って印加されるデジタル電圧の基本周波数(f=1/Δt)が、共振回路43の共振周波数近辺、この実施形態では約50kHzであるよう、ゲート駆動回路25に対する制御信号を生成するよう配列されている。共振回路43の共振特性の結果として、及び、特に、圧電超音波トランスデューサ35の共振特性と合わせて、ノードA及びノードBに渡って印加されるデジタル電圧は、実質的な正弦波電流を基本周波数(f)にて共振回路43内に流す。これは、駆動電圧(VAB)が最小の3rd高調波成分を有し、より高い高調波成分が、共振回路43により大幅に減衰されるからである。
図3に示すように、インダクタL 49は変圧器51の一次側であり、その二次側はインダクタLsec 53により形成されている。変圧器51は、駆動電圧(V)を、インダクタL 49に渡って、超音波トランスデューサ8に印加される負荷電圧(V;通常は約120ボルト)へアップコンバートする。超音波トランスデューサ8の電気的特性は、鉗子のジョーと、鉗子9により把持される任意の組織又は血管と、のインピーダンスにより変わり、図3は、超音波トランスデューサ8と、鉗子のジョー及び鉗子9により把持された任意の組織又は血管のインピーダンスと、を、インダクタL 57、並列コンデンサCt1 59並びにコンデンサCt2 61、及び抵抗R負荷により、モデル化する。
駆動回路29のインダクタL及びコンデンサCは、超音波トランスデューサ8のインダクタL及びコンデンサCt1のそれに合うLC生成物を有するよう設計されている。直列LCネットワークのLC生成物を合わせることは、ネットワークの共振周波数が維持されることを確かにする。同様に、インダクタの磁気リアクタンス、Lsec、は、共振にて、それが、超音波トランスデューサ8のコンデンサCt2の容量性リアクタンスに合うよう選択されている。例えば、コンデンサCt2が約3.3nFのキャパシタンスを有するようトランスデューサ8が画定されている場合は、インダクタLsecは、約3mHのインダクタンスを有すべきである(約50kHzの共振周波数にて)。このように駆動回路29を設計することは、鉗子9により把持された組織/血管へのエネルギー送達の点において、最適な駆動効率を提供する。効率改善は、Cに流れ、結果として、FETブリッジ27に流れる電流が減少することにより達成される。なぜなら、変圧器磁化電流が、Ct2に流れる電流を相殺するからである加えて、この電流の相殺により、Cに流れる電流がR負荷に流れる電流に比例し、これにより、Cに流れる電流を測定することで負荷電流が決定可能となる。
しかし、処置される組織/血管に電力のすべてを適用することは常に所望されるわけではない。したがって、この実施形態では、血管/組織に供給される超音波エネルギーの量は、駆動周波数(f)が、駆動回路/超音波トランスデューサ8の共振周波数からなくなるよう、ノードA及びノードBに渡って適用されるデジタル波形の周期(Δt)を変えることで制御されている。これは、超音波トランスデューサ8が周波数依存性(無損失)減衰器として作用するために、機能する。駆動信号が超音波トランスデューサ8の共振周波数に近づくほど、超音波トランスデューサ8が組織に送る超音波エネルギーが大きくなる。同様に、駆動信号の周波数が、超音波トランスデューサ8の共振周波数からなくなるにしたがって、超音波トランスデューサ8により組織に送られる超音波エネルギーはますます少なくなる。加えて又はその代りに、パルス39のそれぞれの持続期間は、組織/血管に送達される超音波エネルギーの量を制御するよう変えられてよい。
この実施形態では、マイクロプロセッサ23は、(超音波トランスデューサ8及び鉗子9により把持される組織/血管をモデル化する)回路35に送達される、所望する電力と、電圧検出回路31及び電流検出回路33から取得した負荷電圧(V)及び負荷電流(i)の測定値と、に基づいて、電力送達を制御する。図3に示すように、この実施形態では、電流検出回路33は、インダクタ47(又はインダクタ49)に隣接する更なるインダクタの巻き(単数又は複数)67を配置することと、連結されたインダクタ67から取得した電圧を検出することと、により形成されている。これは、V=Ldi/dtにより、変圧器の一次側に流れる電流に関連し、例えば、インダクタ67のインダクタンスを構成し、インダクタ47とインダクタ67との間の巻き数の比及びインダクタ49とインダクタ53との間の巻き数の比を考慮する積分及びスケーリングにより、負荷電流(i)の適切な測定値に変換され得る電圧を生成する。負荷を通る電流の測定値を取得するこの方法を使用する利点のうちの1つは、この測定値が、変圧器回路の二次側上のLsec及びCt2を通って循環する電流に影響を受けないことである。この循環電流は、負荷(R負荷)を通る電流に比較して非常に大きくなり得るが、組織への超音波エネルギー送達に寄与しないため、これは好適である。図示するように、電流センサ33から取得した信号は、マイクロプロセッサ23に送られる。
図3はまた、電圧検出回路31が、(容量分割回路が代わりに使用され得るが)抵抗分割回路を介して負荷電圧(V)を検出することを示す。電圧検出回路31から取得した、検出した電圧は、マイクロプロセッサ23に送られる。図3には示さないが、電流検出回路33からの出力及び電圧検出回路31からの出力は通常、DCバイアスを提供し、マイクロプロセッサ23への入力に適した値に信号レベルを減らすよう、マイクロプロセッサ23に入力される前に、op−amp回路を通して送られ得る。
マイクロプロセッサ
図5は、この実施形態にて使用されるマイクロプロセッサ23の主構成部品を示すブロック図である。図示するように、マイクロプロセッサ23は、検出回路31及び検出回路33から、検出した電圧信号及び電流信号を受信し、測定電圧及び電流計算モジュール83に送られる、対応するサンプルを取得する、同期I,Qサンプリング回路81を含む。この測定電圧及び電流計算モジュール83は、超音波トランスデューサ8と、鉗子9により把持された組織/血管と、のインピーダンスと、印加されたRMS電圧と、流れる電流と、それらから、超音波トランスデューサ8と、鉗子9により把持された組織/血管と、に現在供給されている電力と、を計算するよう、受け取ったサンプルを使用する。決定された値は続いて、更なる処理のために電力コントローラ85に送られる。測定電圧及び電流計算モジュール83はまた、負荷電圧(V)と負荷電流(i)との間の位相差を計算するよう、受け取ったIサンプル及びQサンプルを処理する。共振にて、この位相差はゼロ近辺であるべきである。測定した位相差はまた、電力コントローラ85に送られ、位相ロックループ(PLL)コントローラ87にも送られる。
電力コントローラ85は、所定のアルゴリズムと、医療装置制御モジュール89から受け取った電力セットポイント値と、にしたがって、PLLコントローラ87に送られるセットポイント位相値(位相要求)を決定するよう、受け取ったインピーダンス値と、送達された電力値と、を使用する。医療装置制御モジュール89はひいては、(例えば、ボタンを押すことによるか、又はハンドル5上の制御レバー11若しくは制御レバー13を起動することによる)ユーザの入力を受け取るユーザ入力モジュール91から受信する信号により制御され、また、ユーザ出力モジュール93を介して、ハンドル5上の出力装置(光、ディスプレイ、スピーカなど)を制御する。PLLコントローラ87は、受け取った位相要求と、最新の測定した位相差を使用し、測定した位相を位相要求に向けて効力があるよう試みるよう、制御信号発生器95に出力される新たな波形周期(Δt)を決定する。制御信号発生器95は、新たな周期Δtに合うよう、波形周期を変える目的で、制御信号CTRL及び制御信号CTRLを変える。当業者に認識されるように、双方のCTRL制御信号は、Δtに対応する周期を伴う周期的なパルスを含むこととなる。この2つの制御信号のパルスの相対タイミングは、ブリッジ信号発生器27により生成された波形の3rd次高調波を最小化するようセットされる。この実施形態では、制御信号CTRLは、この制御信号を増幅し、続いて、この信号をFET 41−1に適用するFETゲート駆動37−1(図2に示す)に出力される。FETゲート駆動37−1はまた、増幅された制御信号を反転させ、続いて、この信号をFET 41−2に適用する。同様に、制御信号CTRLは、この制御信号を増幅し、続いて、この信号をFET 41−3に適用するFETゲート駆動37−2(図2に示す)に出力される。FETゲート駆動37−2はまた、増幅された制御信号を反転させ、続いて、この信号をFET 41−4に適用し、新たな周期(Δt)を伴う、所望する波形を生成する。
I信号& Q信号のサンプリング
負荷電圧及び負荷電流の双方は、それらは、トランスデューサ8と、鉗子9により把持される血管/組織と、により表される負荷のインピーダンスに応じて位相がずれていてもよいが、実質的に正弦波形となる。負荷電流及び負荷電圧は、現在画定されている波形周期(Δt)に対応する、同じ駆動周波数(f)となる。通常、信号のサンプリング時には、サンプリング回路は、サンプリングされている信号の周波数に関して、非同期に作動する。しかし、マイクロプロセッサ23は、スイッチング信号の周波数及び位相を把握しているので、同期サンプリング回路81は、駆動周期中の所定の時点にて、測定した電圧信号/電流信号をサンプリングし得る。この実施形態では、同期サンプリング回路81は、4つのIサンプル及び4つのQサンプルを取得するよう、周期あたり8回、測定した信号をオーバーサンプリングする。オーバーサンプリングは、高調波歪みにより引き起こされる誤差を減少可能にし、したがって、測定した電流値及び電圧値のより正確な決定が可能となる。しかし、オーバーサンプリングは必須ではなく、サンプリング動作の同期特性により、実際に、アンダーサンプリング(周期あたり1回以下のサンプリング)が可能である。同期サンプリング回路81がこれらのサンプルを取得するタイミングは、この実施形態では、制御信号CTRL及び制御信号CTRLにより制御されている。したがって、これら制御信号の周期が変わると、(それらの相対位相は同じままである一方で)同期サンプリング回路81によるサンプリングの周期もまた変わる。このようにして、サンプリング回路81は、駆動波形の周期が変わるにしたがって、サンプルが、駆動波形の周期内の同じ時点にて常に取得されるよう、検出した電圧信号及び電流信号をサンプリングするタイミングを連続して変える。したがって、サンプリング回路81は、固定サンプリングクロックにより画定される固定サンプリング速度にて入力信号を単にサンプリングする従来のサンプリング動作に代わって、「同期」サンプリング動作を行っている。当然のことながら、そのような従来のサンプリング動作が代わりに使用され得る。
測定値
同期サンプリング回路51により取得されたサンプルは、負荷電流及び負荷電圧のわずか1つの「I」サンプルと、わずか1つの「Q」サンプルと、から、測定した信号の大きさ及び位相を決定し得る、測定電圧及び電流計算モジュール83に送られる。しかし、この実施形態では、いくらかの平均化を達成するために、計算モジュール83は、平均「I」値及び平均「Q」値を提供するよう、連続するサンプルを平均化し、続いて、測定した信号の大きさ及び位相を決定するよう、平均I値及び平均Q値を使用する。上述するように、この実施形態では、周期あたりに8つのサンプルが取得され、これらのサンプルは、以下の計算式より、電圧及び電流の双方の同位相(I)コンポーネント及び直角位相(Q)コンポーネントを計算するよう使用される。
Figure 2016540588
及びiはそれぞれ、kth電圧サンプル及びkth電流サンプルを表し、電力(合計)は、高調波成分を含む負荷に送達された合計電力である。計算効率の目的のため、正弦結果及び余弦結果は予備計算され得、早見表に記録され得る。
当然のことながら、実際に測定したIサンプル及びQサンプルを、負荷電圧又は負荷電流のIサンプル及びQサンプルに変換するよう、データのいくらかの予備計算が必要とされてよいことが認識されるべきである。例えば、サンプリングされた値を、負荷電圧(V)及び負荷電流(i)の真のサンプルに変換するよう、サンプル値のスケーリング、積分、又は微分が行われてよい。積分又は微分が必要な場合、これは、正弦波信号を積分すること/微分することは単に、90度の位相変化を伴うだけであるので、Iサンプル及びQサンプルの順序を単に入れ替えるだけで達成し得る。
RMS負荷電圧、RMS負荷電流、及び送達された電力(P送達済)が続いて、以下より決定され得る。
Figure 2016540588
一般的に、(平方根の計算が必要となるであろう)RMS電圧及びRMS電流を計算する必要はなく、その代りに、制御関数の多くは、VRMS 及びIRMS を使用して作用する。送達された電力はまた、上に示すように、個別のサンプルから直接計算され得る。(インピーダンスが純粋に実際のものでない限りは、皮相電力は、送達された電力に等しくないことに注意されたい。)
超音波トランスデューサ8と、鉗子9により把持される血管/組織と、により表される負荷のインピーダンスは、以下より決定され得る。
Figure 2016540588
負荷及びX負荷を計算する代替方法は以下の通り。
Figure 2016540588
負荷電圧と負荷電流との間の位相差は、以下より決定され得る。
Figure 2016540588
計算的に効率の良い、atan2関数への近似は、早見表と、固定小数点演算における補間法と、を用いて、又は、「CORDIC」様アルゴリズムを用いて行われ得る。
制限
任意のシステムと同様に、超音波トランスデューサ8に送達され得る電力、電流、及び電圧に置かれ得る特定の制限がある。これらの制限がこの実施形態において使用され、これらがどのように制御されるかについて以下に説明する。
この実施形態では、駆動回路29は、超音波エネルギーを、以下の要件と共に組織内へ送達するよう設計されている。
1)通常は14V DC電源が供給される
2)約50kHzでの実質的な正弦波出力波形
3)90Wの電力制限出力
4)1.4Armsの電流制限及び130Vrmsの電圧制限
5)システムが画定した位相制限よりも大きい、測定した位相
電力コントローラ85は、これらの制限を画定するデータを維持し、それらを使用して、最近測定した電力、負荷インピーダンス、及び測定した位相を前提として、位相要求を増やすか、又は減らすかについての決定を制御する。この実施形態では、使用される位相制限は、測定した負荷インピーダンスに依存する。特に、電力コントローラ85は、負荷インピーダンスを位相制限に関連付ける早見表(図示せず)を維持し、この表の値は、測定した負荷インピーダンスが低い(鉗子9のジョーが開いており、組織又は血管を把持していないことを示す)際には、送達された電力が(好ましくはゼロに)減少されるよう、位相を制限する。
位相特性及び位相制御
上述するように、鉗子9に供給される超音波エネルギーの量は、駆動波形(VAB)の周期(Δt)を変えることで制御されている。これは、超音波トランスデューサ8のインピーダンスが、駆動波形の周期(Δt)と共に急速に変わるという事実を用いることで達成される。したがって、駆動波形(VAB)の周期を変えることで、超音波トランスデューサ8を通る電流の大きさが変わり、これは、負荷に送達される超音波エネルギーを制限するよう使用され得る。最大超音波エネルギーの送達は、駆動波形(VAB)の周期が、超音波トランスデューサ8の共振周波数の逆数に対応する際に達成される。更に、駆動回路29の共振周波数は、超音波トランスデューサ8の共振周波数に合うよう設計されているため、この周期での作動中に、測定した位相はおおよそゼロとなる。
しかし、当業者に認識されるように、共振回路43及び超音波トランスデューサ8は、外科手術中にインピーダンスが変化する負荷に連結される。医療装置制御モジュール89は実際にこの変化を使用し、組織又は血管が焼灼され、凝固され/乾燥されているかを判定する。負荷のインピーダンスが変わることは、超音波トランスデューサ8の周波数特性が変わり、したがって、共振回路43を通る電流が変わる。これは、負荷電流と負荷電圧との間の測定した位相差が、負荷インピーダンスの固定値に対する駆動波形(VAB)の周期(周波数)と共に変化する様式を示す位相プロット101である図6に示されている。負荷のインピーダンスが増えるか、又は減るにしたがい、ゼロ度位相点が、周期軸の上又は下(矢印103により表されるように、左及び右)に移動する正味効果と共に位相プロット101の形状が変わる。したがって、PLLコントローラ87は、位相プロット101における変化を追跡するよう、十分速く作動しなければならない。この実施形態では、位相測定値は、位相プロット101におけるほとんどの変化を追跡するのに十分速い、位相測定値更新率が約100μsとなるよう、駆動信号の数サイクル毎に一度更新される。
しかし、PLLコントローラ87が追跡できない、位相プロット101における突然の変化が起こり得る。これは、図6に示すように、位相プロット101は、位相が、減少する周期(Δt)と共に再度上昇し始めるゼロ交差の直後に最低値を有するため、問題を引き起こし得る。この実施形態では、マイクロプロセッサ23は、図6に示す最低値より大きく、このハード制限を超えて位相が常に維持されることを確かにする、測定した位相(位相制限)における制限を維持する。このようにして、マイクロプロセッサ23は、位相が、超音波トランスデューサ8の不安定な作動を生じさせ得る最低点を超えないことを確かにし得る。測定した位相が位相制限に到達すると、電力コントローラ85は続いて位相要求を、PLLコントローラ87が、測定した位相を最低値から離して維持する値にリセットする。例えば、電力コントローラ85は、適用された電力を制御するよう、位相要求の続く変動に対する既知の、安定した応答がある40度に位相要求を変えてよい。このようにして一度リセットされると、電力コントローラ85は続いて、最大電力送達が適用されるゼロ度に向けて位相差を減らす目的で、PLLコントローラ87が続いて波形周期(Δt)を減少し得るよう、位相要求を再度減少し始め得る。当然のことながら、電力コントローラ85が、位相要求信号を、ゼロを超える値にセットすると、PLLコントローラ87は続いて、測定した位相が位相要求に合うまで波形周期を変える。
図7は、マイクロプロセッサ23により、この実施形態にて行われる処理を示すフローチャートである。図示するように、ステップs1におけるプロセスの始まりでは、マイクロプロセッサ23は、電力コントローラ85から初期位相要求をセットし、PLLコントローラ87から出力された初期波形周期をセットすることで、システムが画定する最大波形周期(Δt最大)にて、駆動信号を起動する。ステップs3にて、マイクロプロセッサ23が電力ダウン信号を受信していない場合、処理は、測定電圧及び電流計算モジュール83が、同期サンプリング回路81から電圧サンプル及び電流サンプルを取得するステップs5に進行する。ステップs6では、測定電圧及び電流計算モジュール83は、RMS負荷電圧と、RMS負荷電流と、送達された電力と、負荷インピーダンスと、負荷電圧と負荷電流との間の位相差と、を計算する。測定した値は電力コントローラ85に送られ、測定した位相もまた、PLLコントローラ87に送られる。電力コントローラ85は、ステップs7にて、受け取った位相測定値を、画定された位相制限と比較し、測定した位相が位相制限より大きい場合は、処理は、電力コントローラ85が、受け取った電圧値、電流値、及び電力値を、適用された電圧、電流、及び電力に対して画定された制限と比較するステップs9に進行する。電圧制限及び電流制限は、事前に画定された静的制限である。しかし、上述するように、位相制限は測定した負荷インピーダンスに依存し、電力制限は医療手術に依存し、医療装置制御モジュール89により提供される電力セットポイント(Pセット)により画定される。電力コントローラ85が、ステップs7にて、測定した位相が現在の位相制限未満である(又は等しい)と判定すると、電力コントローラ85は続いて、ステップs10にて、位相要求を、上述するような安定値にリセットし、処理はステップs3に戻る。測定した値のそれぞれが、対応する制限未満の場合は続いて、ステップs11にて、電力コントローラ85は、PLLコントローラ87に送られる位相要求を減らす。処理の開始時にて、波形周期(Δt)は、この実施形態にて使用される回路では、約90度の、負荷電圧と負荷電流との間の位相差に対応すべき、画定された最大値(この実施形態では20.2μsec)にセットされる。したがって、負荷に関わらず、初期波形周期は、図6に示す位相プロット101上のゼロ交差点の左側にあるべきである。位相要求を減らすことで、波形周期(Δt)は、超音波トランスデューサ8の共振周波数に対応する、位相プロット101上のゼロ交差点に近づく。結果として、適用された電流は増加し、より多くの超音波エネルギーが負荷に送達される。処理は続いてステップs3に戻り、上述のプロセスが反復して繰り返される。
したがって、負荷に適用される電流及び電力は、制限のうちの1つに到達するまで増加される。電力コントローラ85が、ステップs9にて、電圧制限、電流制限、又は電力制限に到達したことを判定すると、続いて処理は、電力コントローラ85が、PLLコントローラ87に送られる位相要求を増やし、ここで、波形周期(Δt)がしたがって増加する、ステップs13に進行する。これは、波形周期を、超音波トランスデューサ8の共振周波数から取り除き、負荷に送達される電流及び電力が減少する。処理は続いて、前のように、ステップs3に戻る。
したがって、ゼロ交差点の左側にて開始し、位相プロット101にて、波形周期(Δt)が、ゼロ交差点にゆっくり向かってここからなくなることで、負荷に適用される電流レベル及び電力レベルは、組織/血管が切除/焼灼されるにしたがって、負荷のインピーダンスが変わり、超音波トランスデューサ8の共振特性が変わっても、画定された制限内に制御され得る。
医療装置制御モジュール
上述するように、医療装置制御モジュール89は、切除/焼灼装置1の一般動作を制御する。これは、ユーザ入力モジュール91を介してユーザ入力を受け取る。これらの入力は、鉗子9のジョーが現在、血管又は組織を把持しており、ユーザが切除/焼灼を開始しようとしていることを特定してよい。これに応じて、この実施形態では、医療装置制御モジュール89は、切除/焼灼制御手順を開始する。最初は、医療装置制御モジュール89は、電力コントローラ85に開始信号を送信し、測定電圧及び電流計算モジュール83により決定された負荷インピーダンス測定値を取得する。医療装置制御モジュール89は続いて、負荷が開回路又は短絡でないことを確かめるよう、取得した負荷インピーダンスをチェックする。そうでない場合は、医療装置制御モジュール89は続いて、所望する切除/焼灼を行うよう、電力セットポイントを変え始める。
変更及び代替
医療用焼灼装置が上述されている。当業者に認識されるように、様々な変更が行われ得、それらのいくつかを以下に説明する。他の変更が当業者に明らかである。
上記の実施形態では、ブリッジ信号発生器により生成された駆動電圧は、最小の3rd次高調波成分を有するよう設計されていた。駆動電圧波形のそのような設計を使用することに加えて又はその代りに、3rd高調波を打ち消し、又は減衰し、超音波トランスデューサ8に適用されないよう、スナバ回路が提供されてよい。図8は、そのようなスナビング回路121が、図3に示す回路に加えられてよい方式を示す回路図である。図示するように、スナビング回路121は、トランスデューサ8の端子に渡って直列に接続される、インダクタ−コンデンサ−レジスタの組み合わせを備える。インダクタLスナブの値及びコンデンサCスナブの値は、スナバ回路121が、共振回路43の共振周波数の3rd高調波(3f)にて最小インピーダンスを有するよう選択されている。結果として、スナバ回路121は、駆動信号の3rd次高調波に対する低インピーダンス経路を効果的に提供し、したがって、超音波トランスデューサ8に適用される3rd次高調波を減少する。当業者に認識されるように、スナバ回路121がインダクタ−コンデンサ−レジスタの組み合わせを備えることは必須ではなく、単なるコンデンサ−レジスタの組み合わせを使用して同様のスナビング機能が達成され得る。
加えて又はあるいは、駆動信号内の対応する高調波を相殺するよう、高調波信号を動的に加える有効高調波相殺回路が提供されてよい。そのような有効高調波相殺回路が提供され得る方式が、図9に示されている。図示するように、電圧検出回路31から取得した電圧はマイクロプロセッサ23にフィードバックされ、これは、駆動信号の所望する基本周波数と、前のように、端子A及び端子Bに適用された駆動信号(VAB)の、任意の不要な、より高い周波数高調波(駆動波形が、3rd次高調波を最小化するよう設計されていない場合は、主に3rd高調波)と、を含むこととなる。この実施形態では、駆動信号は、図4に示すより複雑な波形でなく、現在指定されている周期(Δt)を有する、単なる周期的な矩形波信号であってよい。図9に示すように、このフィードバック信号は、コンバイナ133の負入力部に送られ、ここで、フィードバック信号は、フィードバックループの安定性のために、基準信号を遅らせるよう使用される遅延フィルタ131を通して送られた基準信号(VREF)から減じられる。基準信号(VREF)はマイクロプロセッサ23により(例えば、制御信号発生器95により)生成され、一般的にこれは、駆動信号(VAB)に対して現在セットされているものと同じ周期(Δt)及び同じ位相を有する正弦波信号である。コンバイナ133から出力される誤差信号(e)は、増幅器137(好ましくはリニア増幅器)により増幅され、続いて、二次インダクタコイル53に相互に連結されるインダクタコイル139(L)に適用される制御信号を生成し、出力するよう配列されているコントローラ135(PIDコントローラなど)に入力される。したがって、超音波トランスデューサ8に適用される信号は、インダクタ139からの駆動信号と、高調波補償信号と、を含む。したがって、誤差信号(e)をゼロに減らすよう努める制御信号を出力するコントローラ135により、周期(Δt)を有する基本コンポーネントのみが超音波トランスデューサ8に適用されるよう、制御信号の内容が追跡され、駆動信号の高調波成分が実質的に相殺される。
上記の実施形態では、様々な動作周波数、電流、電圧、等が説明された。当業者に認識されるように、正確な電流、電圧、周波数、コンデンサ値、インダクタ値、等はすべて、用途に応じて変更され得、上述の任意の値は、何らかの制限として考慮されるべきでない。しかし、大まかに言えば、上述の回路は、医療装置に駆動信号を提供するよう設計されており、ここで、送達される電力が、少なくとも10W、好ましくは、10Wと200Wとの間となるよう所望され、送達される電圧が、少なくとも20VRMS、好ましくは、30VRMSと120VRMSとの間となるよう所望され、送達される電流は、少なくとも0.5ARMS、好ましくは、1ARMSと2ARMSとの間となるよう設計され、駆動周波数は、少なくとも20kHz、好ましくは、30kHzと80kHzとの間となるよう所望される。
上記の実施形態では、共振回路43は、コンデンサ−インダクタ−インダクタ要素から形成されていた。当業者に認識されるように、様々な直列構成及び並列構成での、複数のコンデンサ及びインダクタを伴う他の共振回路設計、又は、よりシンプルなLC共振回路もまた使用されてよい。また、いくつかの用途では、FETが必要な駆動電圧を送達し得るため、変圧器が駆動電圧を増大させる必要はない。
図1は、電池及び制御電子機器が、医療装置のハンドル内に搭載され得る一方式を示す。当業者に認識されるように、ハンドルの形状因子は、多くの異なる設計を採用してよい。実際に、装置が、電池により電源を得ることは、電源コード類の必要性を排除するために、いくつかの応用では好まれるが、これは必須ではない。
上記の実施形態では、鉗子により把持される血管又は組織の切除/焼灼を行うための例示的な制御アルゴリズムが説明された。当業者に認識されるように、様々な異なる手順が使用されてよく、読み手には、そのような切除/焼灼装置の動作を更に詳しく説明する著述が言及される。
上記の実施形態では、電池により提供されるDC電圧を、所望する周波数での交流信号に変換するよう、4つのFETスイッチが使用された。当業者に認識されるように、4つのスイッチを使用する必要はなく、代わりに、(ハーフブリッジ回路を用いる)2つのスイッチを使用してよい。加えて、FETスイッチが使用されたが、バイポーラトランジスタスイッチなどの他の切替装置を代わりに使用してよい。しかし、上述の周波数レベル及び電流レベルでの作動時の低損失に関する優れた性能により、MOSFETが好適である。
上記の実施形態では、I & Qサンプリング回路81が、検出した電圧信号/電流信号を周期毎に8回サンプリングした。当業者に認識されるように、これは必須ではない。サンプリングの同期特性により、サンプルは、周期毎に一回を超えて、又は、所望する場合は、nth周期毎に一回、取得されてよい。上記の実施形態にて使用されたサンプリングレートは、測定値が、電力コントローラ85と、PLLコントローラ87と、医療装置制御モジュール89と、に利用可能となったレートを最大化するよう選択された。なぜなら、これは、切除プロセス/焼灼プロセス中に適用された電力のよりよい制御を可能にするためである。
上記の実施形態では、14VのDC電源が提供された。他の実施形態では、より低い(又は、より高い)DC電圧電源が提供されてよい。この場合、負荷電圧を所望するレベルに増大するよう、より大きい(又は、より小さい)変圧器巻線比が提供されてよく、又は、より低い作動電圧が使用されてよい。
上記の実施形態では、医療装置は、所望する電力を超音波トランスデューサに送達するよう配列されていた。代替の一実施形態では、装置は、所望する電流レベル又は電圧レベルを超音波トランスデューサに送達するよう配列されてよい。
上記の実施形態では、電池は、医療装置に統合されて示されている。代替の一実施形態では、電池は、外科医のベルトにクリップされるよう、又は、単にメイヨ(Mayo)スタンドに配置されるよう、パッケージ化されてよい。この実施形態では、比較的小型の2つの導体ケーブルが、電池パックを医療装置に接続し得る。
上記の実施形態では、マイクロプロセッサに基づく制御回路が提供された。これは、適切なコンピュータソフトウェアを使用して、上述の制御アクションを行うよう、マイクロプロセッサが容易にプログラムされ得るために好適である。そのようなソフトウェアは、CD−ROM等などの有形キャリア上に提供され得る。あるいは、上述のマイクロプロセッサに基づく回路の代わりに、ハードウェア制御回路が使用され得る。
〔実施の態様〕
(1) 医療装置であって、
前記医療装置を制御するための入力信号を受信するための入力部と、
エンドエフェクタと、
前記エンドエフェクタに連結される超音波トランスデューサと、
前記入力部に連結され、周期的な駆動信号を生成し、前記駆動信号を前記超音波トランスデューサに提供するよう操作可能な駆動回路と、を備え、
前記超音波トランスデューサが共振特性を有し、前記駆動回路が、前記超音波トランスデューサの前記共振特性に合わせられている共振回路を備える、医療装置。
(2) 前記トランスデューサに適用された、検出した負荷電圧及び検出した負荷電流に基づいて、前記駆動信号の前記周期を変えるための第1のコントローラを備える、実施態様1に記載の装置。
(3) 前記第1のコントローラが、前記検出した負荷電圧と前記検出した負荷電流との間の位相差に基づいて、前記駆動信号の前記周期を変えるよう配列されている、実施態様2に記載の装置。
(4) 前記検出した負荷電圧と前記検出した負荷電流との間の前記位相差が、位相要求に対応するよう、前記第1のコントローラが、前記駆動信号の前記周期を変えるよう配列されている、実施態様3に記載の装置。
(5) 前記超音波トランスデューサに適用された前記電力、前記電圧、又は前記電流を変える目的で、前記位相要求を変えるよう配列されている第2のコントローラを備える、実施態様4に記載の装置。
(6) 前記第2のコントローラが、前記検出した負荷電圧及び/又は前記検出した負荷電流、若しくは、測定した負荷インピーダンスに基づいて、前記位相要求を変えるよう配列されている、実施態様5に記載の装置。
(7) DC電源から周期的な駆動信号を生成するスイッチング回路を備え、前記共振回路が、前記周期的な駆動信号を受信するよう構成されている、実施態様1〜実施態様6のいずれかに記載の装置。
(8) 反対極性の周期的な駆動パルスを含むデジタル駆動信号を生成するよう配列されている制御回路を備え、前記駆動信号の第3の高調波成分を最小化するよう、前記パルスの相対タイミングが選択されている、実施態様1〜実施態様7のいずれかに記載の装置。
(9) 前記トランスデューサに適用された前記駆動信号の高調波成分を減らすための回路を更に備える、実施態様1〜実施態様8のいずれかに記載の装置。
(10) 前記回路が、i)前記駆動信号の高調波信号に対する低インピーダンス経路を提供するために、前記トランスデューサに並列に接続されたスナバ回路と、ii)前記駆動信号の高調波信号を相殺するよう、高調波補償信号を生成するよう配列されているアクティブフィードバック回路と、のうちの1つ又は複数を備える、実施態様9に記載の装置。
(11) 前記駆動信号を生成するための前記駆動回路に電力を提供するための、1つ又はそれ以上の電池を保持するための電池区画を含む、実施態様1〜実施態様10のいずれかに記載の装置。
(12) 前記駆動信号の測定値を受け取るよう操作可能であり、前記超音波トランスデューサに送達される前記電力、前記電圧、及び/又は前記電流を制御するよう、前記駆動信号の前記周期を変えるよう操作可能な制御回路を備える、実施態様1〜実施態様11のいずれかに記載の装置。
(13) 前記測定値が、前記駆動信号の前記周期及び前記位相と共に変化するサンプリング周波数にて、検出した電圧信号又は電流信号をサンプリングするサンプリング回路から取得されている、実施態様12に記載の装置。
(14) 前記駆動信号の前記周波数が、前記超音波トランスデューサの前記共振周波数近辺、好ましくは、前記超音波トランスデューサの前記共振周波数の0.1%〜1%以内にて変化するよう、前記制御回路が、前記駆動信号の前記周期を変えるよう構成されている、実施態様12又は実施態様13のいずれかに記載の装置。
(15) 前記超音波トランスデューサの前記共振特性が、使用中に前記超音波トランスデューサに連結される負荷と共に変化し、前記制御回路が、前記超音波トランスデューサの前記共振特性における変化を追跡するよう、前記駆動信号の前記周期を変えるよう構成されている、実施態様14に記載の装置。
(16) 医療装置であって、
前記装置の動作を制御するための入力を受け取るための入力部と、
エンドエフェクタと、
前記エンドエフェクタに連結される超音波トランスデューサと、
周期的な駆動信号を生成し、前記駆動信号を前記超音波トランスデューサに提供するよう操作可能な駆動回路と、
前記超音波トランスデューサに提供された前記電力、前記電圧、及び前記電流のうちの少なくとも1つを制御するよう、前記駆動信号の前記周期を変えるよう操作可能な制御回路と、を備える、医療装置。
(17) 前記制御回路が、前記超音波トランスデューサに適用された、検出した負荷電圧及び検出した負荷電流に基づいて、前記駆動信号の前記周期を変えるための第1のコントローラを備える、実施態様16に記載の装置。
(18) 前記第1のコントローラが、前記検出した負荷電圧と前記検出した負荷電流との間の位相差に基づいて、前記駆動信号の前記周期を変えるよう配列されている、実施態様17に記載の装置。
(19) 前記検出した負荷電圧と前記検出した負荷電流との間の前記位相差が、位相要求に対応するよう、前記第1のコントローラが、前記駆動信号の前記周期を変えるよう配列されている、実施態様18に記載の装置。
(20) 前記制御回路が、前記超音波トランスデューサに適用された前記電力、前記電圧、又は前記電流を変える目的で、前記位相要求を変えるよう配列されている第2のコントローラを備える、実施態様19に記載の装置。
(21) 前記第2のコントローラが、前記検出した負荷電圧及び/又は前記検出した負荷電流、若しくは、測定した負荷インピーダンスに基づいて前記位相要求を変えるよう配列されている、実施態様20に記載の装置。
(22) 医療装置を操作する方法であって、
周期的な駆動信号を生成することと、前記医療装置のエンドエフェクタに連結されている超音波トランスデューサに前記駆動信号を適用することと、前記超音波トランスデューサに適用された前記電力、前記電流、及び前記電圧のうちの少なくとも1つを制御するよう、前記駆動信号の前記周期を制御することと、を含む、方法。
(23) 血管又は組織を焼灼又は切除する方法であって、
前記血管又は前記組織を、医療装置のエンドエフェクタを用いて把持することと、
前記エンドエフェクタに連結された超音波トランスデューサに、周期的な駆動信号を適用するよう、駆動回路を使用することと、
前記焼灼又は前記切除を行うよう、前記組織に適用された前記電力、前記電流、及び前記電圧のうちの少なくとも1つを制御するよう、前記駆動信号の前記周期を制御することと、を含む、方法。
(24) 実施態様1〜実施態様21のいずれかに記載の前記医療装置を使用する、実施態様23に記載の方法。
(25) 前記制御工程が、前記組織又は前記血管に適用された前記超音波信号の前記電力を制御するよう、前記駆動信号の前記周期を変え、前記トランスデューサと、前記組織又は前記血管と、により生じた、前記駆動回路上の負荷のインピーダンス測定値を取得することと、前記取得したインピーダンス測定値に基づいて、前記組織又は前記血管に適用される、所望する電力を変えることと、を更に含む、実施態様23又は実施態様24に記載の方法。
(26) 超音波トランスデューサを有する医療装置にて使用するための電子装置であって、
前記超音波トランスデューサに供給するために、周期的な駆動信号を生成するよう操作可能な駆動回路と、
前記超音波トランスデューサに供給された負荷電圧及び/又は負荷電流を検出するための検出回路と、
前記検出回路により検出した前記負荷電圧及び/又は前記負荷電流に基づいて、前記超音波トランスデューサに供給された前記電力、前記電圧、及び前記電流のうちの少なくとも1つを制御するよう、前記駆動信号の前記周期を変えるよう操作可能な制御回路と、を備える、電子装置。
(27) 前記制御回路が、前記検出した負荷電圧と前記検出した負荷電流との間の位相差に基づいて、前記駆動信号の前記周期を変えるよう配列されている、実施態様26に記載の装置。
(28) 前記検出した負荷電圧と前記検出した負荷電流との間の前記位相差が、位相要求に対応するよう、前記制御回路が、前記駆動信号の前記周期を変えるよう配列されている、実施態様27に記載の装置。
(29) 前記超音波トランスデューサに適用された前記電力、前記電圧、又は前記電流を変える目的で、前記位相要求を変えるよう配列されている第2の制御回路を備える、実施態様28に記載の装置。
(30) 前記第2の制御回路が、前記検出した負荷電圧及び/又は前記検出した負荷電流に基づいて、前記位相要求を変えるよう配列されている、実施態様29に記載の装置。
(31) 前記超音波トランスデューサが共振特性を有し、前記駆動回路が、前記超音波トランスデューサの前記共振特性に合わせられている共振回路を備え、DC電源から周期的な駆動信号を生成するスイッチング回路を更に備え、前記共振回路が、前記周期的な駆動信号を受信するよう構成されている、実施態様26〜実施態様30のいずれかに記載の装置。
(32) 実質的に、添付図面を参照して本明細書に上述したとおり、又は、添付図面に示したとおりである、医療装置又は制御回路。
(33) 実質的に、添付図面を参照して本明細書に上述したとおり、又は、添付図面に示したとおりである、医療装置を操作する方法。

Claims (28)

  1. 医療装置であって、
    前記医療装置を制御するための入力信号を受信するための入力部と、
    エンドエフェクタと、
    前記エンドエフェクタに連結される超音波トランスデューサと、
    前記入力部に連結され、周期的な駆動信号を生成し、前記駆動信号を前記超音波トランスデューサに提供するよう操作可能な駆動回路と、を備え、
    前記超音波トランスデューサが共振特性を有し、前記駆動回路が、前記超音波トランスデューサの前記共振特性に合わせられている共振回路を備える、医療装置。
  2. 前記トランスデューサに適用された、検出した負荷電圧及び検出した負荷電流に基づいて、前記駆動信号の前記周期を変えるための第1のコントローラを備える、請求項1に記載の装置。
  3. 前記第1のコントローラが、前記検出した負荷電圧と前記検出した負荷電流との間の位相差に基づいて、前記駆動信号の前記周期を変えるよう配列されている、請求項2に記載の装置。
  4. 前記検出した負荷電圧と前記検出した負荷電流との間の前記位相差が、位相要求に対応するよう、前記第1のコントローラが、前記駆動信号の前記周期を変えるよう配列されている、請求項3に記載の装置。
  5. 前記超音波トランスデューサに適用された前記電力、前記電圧、又は前記電流を変える目的で、前記位相要求を変えるよう配列されている第2のコントローラを備える、請求項4に記載の装置。
  6. 前記第2のコントローラが、前記検出した負荷電圧及び/又は前記検出した負荷電流、若しくは、測定した負荷インピーダンスに基づいて、前記位相要求を変えるよう配列されている、請求項5に記載の装置。
  7. DC電源から周期的な駆動信号を生成するスイッチング回路を備え、前記共振回路が、前記周期的な駆動信号を受信するよう構成されている、請求項1〜請求項6のいずれか一項に記載の装置。
  8. 反対極性の周期的な駆動パルスを含むデジタル駆動信号を生成するよう配列されている制御回路を備え、前記駆動信号の第3の高調波成分を最小化するよう、前記パルスの相対タイミングが選択されている、請求項1〜請求項7のいずれか一項に記載の装置。
  9. 前記トランスデューサに適用された前記駆動信号の高調波成分を減らすための回路を更に備える、請求項1〜請求項8のいずれか一項に記載の装置。
  10. 前記回路が、i)前記駆動信号の高調波信号に対する低インピーダンス経路を提供するために、前記トランスデューサに並列に接続されたスナバ回路と、ii)前記駆動信号の高調波信号を相殺するよう、高調波補償信号を生成するよう配列されているアクティブフィードバック回路と、のうちの1つ又は複数を備える、請求項9に記載の装置。
  11. 前記駆動信号を生成するための前記駆動回路に電力を提供するための、1つ又はそれ以上の電池を保持するための電池区画を含む、請求項1〜請求項10のいずれか一項に記載の装置。
  12. 前記駆動信号の測定値を受け取るよう操作可能であり、前記超音波トランスデューサに送達される前記電力、前記電圧、及び/又は前記電流を制御するよう、前記駆動信号の前記周期を変えるよう操作可能な制御回路を備える、請求項1〜請求項11のいずれか一項に記載の装置。
  13. 前記測定値が、前記駆動信号の前記周期及び前記位相と共に変化するサンプリング周波数にて、検出した電圧信号又は電流信号をサンプリングするサンプリング回路から取得されている、請求項12に記載の装置。
  14. 前記駆動信号の前記周波数が、前記超音波トランスデューサの前記共振周波数近辺、好ましくは、前記超音波トランスデューサの前記共振周波数の0.1%〜1%以内にて変化するよう、前記制御回路が、前記駆動信号の前記周期を変えるよう構成されている、請求項12又は請求項13のいずれか一項に記載の装置。
  15. 前記超音波トランスデューサの前記共振特性が、使用中に前記超音波トランスデューサに連結される負荷と共に変化し、前記制御回路が、前記超音波トランスデューサの前記共振特性における変化を追跡するよう、前記駆動信号の前記周期を変えるよう構成されている、請求項14に記載の装置。
  16. 医療装置であって、
    前記装置の動作を制御するための入力を受け取るための入力部と、
    エンドエフェクタと、
    前記エンドエフェクタに連結される超音波トランスデューサと、
    周期的な駆動信号を生成し、前記駆動信号を前記超音波トランスデューサに提供するよう操作可能な駆動回路と、
    前記超音波トランスデューサに提供された前記電力、前記電圧、及び前記電流のうちの少なくとも1つを制御するよう、前記駆動信号の前記周期を変えるよう操作可能な制御回路と、を備える、医療装置。
  17. 前記制御回路が、前記超音波トランスデューサに適用された、検出した負荷電圧及び検出した負荷電流に基づいて、前記駆動信号の前記周期を変えるための第1のコントローラを備える、請求項16に記載の装置。
  18. 前記第1のコントローラが、前記検出した負荷電圧と前記検出した負荷電流との間の位相差に基づいて、前記駆動信号の前記周期を変えるよう配列されている、請求項17に記載の装置。
  19. 前記検出した負荷電圧と前記検出した負荷電流との間の前記位相差が、位相要求に対応するよう、前記第1のコントローラが、前記駆動信号の前記周期を変えるよう配列されている、請求項18に記載の装置。
  20. 前記制御回路が、前記超音波トランスデューサに適用された前記電力、前記電圧、又は前記電流を変える目的で、前記位相要求を変えるよう配列されている第2のコントローラを備える、請求項19に記載の装置。
  21. 前記第2のコントローラが、前記検出した負荷電圧及び/又は前記検出した負荷電流、若しくは、測定した負荷インピーダンスに基づいて前記位相要求を変えるよう配列されている、請求項20に記載の装置。
  22. 医療装置を操作する方法であって、
    周期的な駆動信号を生成することと、前記医療装置のエンドエフェクタに連結されている超音波トランスデューサに前記駆動信号を適用することと、前記超音波トランスデューサに適用された前記電力、前記電流、及び前記電圧のうちの少なくとも1つを制御するよう、前記駆動信号の前記周期を制御することと、を含む、方法。
  23. 超音波トランスデューサを有する医療装置にて使用するための電子装置であって、
    前記超音波トランスデューサに供給するために、周期的な駆動信号を生成するよう操作可能な駆動回路と、
    前記超音波トランスデューサに供給された負荷電圧及び/又は負荷電流を検出するための検出回路と、
    前記検出回路により検出した前記負荷電圧及び/又は前記負荷電流に基づいて、前記超音波トランスデューサに供給された前記電力、前記電圧、及び前記電流のうちの少なくとも1つを制御するよう、前記駆動信号の前記周期を変えるよう操作可能な制御回路と、を備える、電子装置。
  24. 前記制御回路が、前記検出した負荷電圧と前記検出した負荷電流との間の位相差に基づいて、前記駆動信号の前記周期を変えるよう配列されている、請求項23に記載の装置。
  25. 前記検出した負荷電圧と前記検出した負荷電流との間の前記位相差が、位相要求に対応するよう、前記制御回路が、前記駆動信号の前記周期を変えるよう配列されている、請求項24に記載の装置。
  26. 前記超音波トランスデューサに適用された前記電力、前記電圧、又は前記電流を変える目的で、前記位相要求を変えるよう配列されている第2の制御回路を備える、請求項25に記載の装置。
  27. 前記第2の制御回路が、前記検出した負荷電圧及び/又は前記検出した負荷電流に基づいて、前記位相要求を変えるよう配列されている、請求項26に記載の装置。
  28. 前記超音波トランスデューサが共振特性を有し、前記駆動回路が、前記超音波トランスデューサの前記共振特性に合わせられている共振回路を備え、DC電源から周期的な駆動信号を生成するスイッチング回路を更に備え、前記共振回路が、前記周期的な駆動信号を受信するよう構成されている、請求項23〜請求項27のいずれか一項に記載の装置。
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EP3970642A1 (en) 2022-03-23
EP3082625B1 (en) 2021-10-20
CN105979890B (zh) 2019-08-23
US20160317178A1 (en) 2016-11-03
BR112016013983B1 (pt) 2022-03-22
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GB201322211D0 (en) 2014-01-29
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