JP7196236B2 - 神経刺激のための両側ジョー構成を備えた医療装置 - Google Patents

神経刺激のための両側ジョー構成を備えた医療装置 Download PDF

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JP7196236B2
JP7196236B2 JP2021089144A JP2021089144A JP7196236B2 JP 7196236 B2 JP7196236 B2 JP 7196236B2 JP 2021089144 A JP2021089144 A JP 2021089144A JP 2021089144 A JP2021089144 A JP 2021089144A JP 7196236 B2 JP7196236 B2 JP 7196236B2
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イェイツ・デビッド・シー
メサーリー・ジェフリー・ディー
マクレイン・キャメロン・ディー
シャイアーズ・ピーター・ケイ
エステラ・フレデリック
ノット・キャメロン・アール
シュテューレン・フォスター・ビー
パパ・クリストファー・エイ
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Description

(関連出願の相互参照)
本出願は、2016年5月3日に出願された米国仮特許出願第62/331,123号、発明の名称「MEDICAL DEVICE WITH A BILATERAL JAW CONFIGURATION FOR NERVE STIMULATION」の米国特許法第119条(e)の下での利益を主張するものであり、この仮特許の全開示は、参照により本明細書に組み込まれる。
(発明の分野)
本開示は概して、組織を把持、切開及び封止するための様々な機構を備えた医療装置に関する。具体的には、本開示は、同一装置内の1つ又は2つ以上のプローブにおいて非治療的エネルギーを使用して神経刺激を行う把持器具を備えた医療装置に関する。
手術中、超音波振動又は電気外科エネルギーなどの、組織を切断及び封止するために使用されるエネルギーが、手術部位内に存在するけれども手術を意図していない特定の身体組織に損傷を与えることがある。例えば、神経は、外科用レベル及び治療レベルで印加されるエネルギーに接触すると、損傷する可能性がある。一方、神経上に、又は神経の近く(例えば、約2mm)に低レベルのエネルギーを印加すると、関連する筋肉の可視振動を起こし、外科医にその存在を警告することができる。この可視表示は、デリケートな神経末端を回避しながら、手術を安全に行うのに十分な情報を外科医に提供することができる。したがって従来、外科医は、例えば、1つの装置を使ってより低い電圧を神経刺激プローブに印加して神経を検出し、別の装置を使って超音波又はより高い電圧の治療的エネルギーを印加することによって組織を把持、封止、及び/又は切断する、というように、複数の装置を利用して手術を行うことができる。治療的エネルギー(例えば、超音波又はより高い電圧の電気外科的エネルギー)を印加し、かつ、神経検出能力(例えば慎重に位置決めされた低電圧神経刺激プローブなど)を備えた、単一の装置の外科用ツールを利用することが好ましい可能性があり、これによってより安全かつより効率的な手術処置が可能になり得る。
これまでにいくつかの装置が製造及び使用されてきたが、本発明者らよりも以前に添付の特許請求の範囲に記載される装置を製造又は使用した者はないものと考えられる。
いくつかの態様において、外科用器具が提供される。
1.一実施例において、外科用器具が提示され、外科用器具は、継手を中心に枢動可能に連結された、第1のジョーハンドル及び第2のジョーハンドルを含み、第1のジョーハンドルは、第1のジョーハンドルの遠位端に第1のジョーを備え、第2のジョーハンドルは、第2のジョーハンドルの遠位端に第2のジョーを備え、第1のジョーハンドル及び第2のジョーハンドルが、継手を中心に閉位置へと枢動回転されると、第1のジョー及び第2のジョーは、それらの間に組織を把持するよう構成されており、第1のジョー及び第2のジョーのうち少なくとも一方が、手術部位で組織を封止又は切断するために、より高いエネルギーレベルで治療的エネルギーを送達するように構成されており、かつ、第1のジョー及び第2のジョーのうち少なくとも一方が、手術部位で神経組織に電気刺激を与えるために、より低いエネルギーレベルで非治療的エネルギーを送達するように構成されている。
2.実施例1の外科用器具の別の一実施例において、治療的エネルギーは超音波エネルギーを含む。
3.実施例1の外科用器具の別の一実施例において、治療的エネルギーは高周波数電気外科用エネルギーを含む。
4.実施例1の外科用器具の別の一実施例において、第1のジョー及び第2のジョーの両方が、非治療的エネルギーを手術部位で組織に送達するように構成されており、第1のジョー及び第2のジョーの両方で送達される非治療的エネルギーは、同じ電位である。
5.実施例1の外科用器具の別の一実施例において、第1のジョー及び第2のジョーのうち少なくとも一方が、当該ジョーの内側部分に絶縁材料を備え、これによって、閉位置において第1のジョーが第2のジョーに、絶縁材料の接触を介して接触する。
6.別の一実施例において、外科用器具が提示され、外科用器具は、ハンドルアセンブリと、ハンドルアセンブリに通信可能に連結され、かつ第1及び第2のジョーを備えるエンドエフェクタとを含み、
ハンドルアセンブリは、第1及び第2のジョーを操作して、開位置及び閉位置を画定するよう構成されており、エンドエフェクタは、手術部位で組織を封止又は切断するために、より高いエネルギーレベルで治療的エネルギーを送達するように構成されており、かつ、手術部位で神経組織に電気刺激を与えるために、より低いエネルギーレベルで非治療的エネルギーを送達するように構成されている。
7.実施例6の外科用器具の別の一実施例において、エンドエフェクタは、手術部位で神経組織を刺激するために非治療的エネルギーを送達するように構成された電気刺激プローブを更に含む。
8.実施例7の外科用器具の別の一実施例において、電気刺激プローブは後退可能であり、かつ、ハンドルアセンブリに向かって近位方向に後退するように、及び、ハンドルアセンブリから離れて遠位方向に延長するように、更に構成されている。
9.実施例7の外科用器具の別の一実施例において、エンドエフェクタは戻りプローブを更に含み、戻りプローブと電気刺激プローブの両方が手術部位で組織に接触すると、電気刺激プローブと戻りプローブとが回路を完成させ、戻りプローブは非治療的エネルギーの電気的戻り経路として働く。
10.実施例7の外科用器具の別の一実施例において、電気刺激プローブは、エンドエフェクタの第1の側面に実質的に近い輪郭になるよう構成され、エンドエフェクタの第1の側面は、第1及び第2のジョーによって画定されるエンドエフェクタの遠位先端の第1の部分を含む。
11.実施例10の外科用器具の別の一実施例において、エンドエフェクタは、第1の側面に対向する、エンドエフェクタの第2の側面に実質的に近い輪郭になるよう構成された戻りプローブを更に含み、エンドエフェクタの第2の側面は、第1及び第2のジョーによって画定されるエンドエフェクタの遠位先端の第2の部分を含み、戻りプローブと電気刺激プローブの両方が手術部位で組織に接触すると、電気刺激プローブと戻りプローブとが回路を完成させる。
12.実施例6の外科用器具の別の一実施例において、エンドエフェクタは、第1又は第2のジョーの遠位端に連結され、かつ、手術部位で神経組織を刺激するために非治療的エネルギーを送達するように構成された、第1の電気的突起プローブを、更に含む。
13.実施例12の外科用器具の別の一実施例において、エンドエフェクタは、第2の電気的突起戻りプローブを更に含み、第2の電気的突起戻りプローブは、第1又は第2のジョーの遠位端に連結され、かつ、第1及び第2のプローブの両方が手術部位で組織に接触すると、第1の電気的突起と共に回路を完成させるように構成されている。
14.実施例6の外科用器具の別の一実施例において、外科用器具は、ハンドルアセンブリの遠位端とエンドエフェクタの近位端とに連結されたシャフトを更に含み、シャフトは、エンドエフェクタをハンドルアセンブリに電気的に連結するように構成されている。
15.別の一実施例において、外科用システムが提示され、外科用システムは、ハンドルアセンブリと、ハンドルアセンブリに電気的に連結された発電機と、ハンドルアセンブリに通信可能に連結され、かつ発電機に電気的に連結され、かつ第1及び第2のジョーを備えるエンドエフェクタとを含み、
ハンドルアセンブリは、第1及び第2のジョーを操作して、開位置及び閉位置を画定するよう構成されており、エンドエフェクタは、手術部位で組織を封止又は切断するために、より高いエネルギーレベルで治療的エネルギーを選択的に送達し、かつ、手術部位で神経組織に電気刺激を与えるために、より低いエネルギーレベルで非治療的エネルギーを選択的に送達するように構成されており、発電機は、エンドエフェクタに伝達されるよう、より高いエネルギーレベルで治療的エネルギーを生成し、かつエンドエフェクタに伝達されるよう、より低いエネルギーレベルで非治療的エネルギーを生成するように構成されている。
16.実施例15の外科用システムの別の一実施例において、エンドエフェクタは、手術部位で神経組織を刺激するために非治療的エネルギーを送達するように構成された電気刺激プローブを更に含む。
17.実施例16の外科用システムの別の一実施例において、電気刺激プローブは後退可能であり、かつ、ハンドルアセンブリに向かって近位方向に後退するように、及び、ハンドルアセンブリから離れて遠位方向に延長するように、更に構成されている。
18.実施例16の外科用システムの別の一実施例において、エンドエフェクタは戻りプローブを更に含み、戻りプローブと電気刺激プローブの両方が手術部位で組織に接触すると、電気刺激プローブと戻りプローブとが回路を完成させる。
19.実施例16の外科用システムの別の一実施例において、電気刺激プローブは、エンドエフェクタの第1の側面に実質的に近い輪郭になるよう構成され、エンドエフェクタの第1の側面は、第1及び第2のジョーによって画定されるエンドエフェクタの遠位先端の第1の部分を含む。
20.実施例15の外科用システムの別の一実施例において、エンドエフェクタは、第1の側面に対向する、エンドエフェクタの第2の側面に実質的に近い輪郭になるよう構成された戻りプローブを更に含み、エンドエフェクタの第2の側面は、第1及び第2のジョーによって画定されるエンドエフェクタの遠位先端の第2の部分を含み、戻りプローブと電気刺激プローブの両方が手術部位で組織に接触すると、電気刺激プローブと戻りプローブとが回路を完成させる。
21.実施例18の外科用システムの別の一実施例において、治療的エネルギーは単極であり、かつ、戻りプローブは更に、治療的エネルギーの電気的戻り経路として働く。
上記の「発明の概要」はあくまで例示的なものに過ぎず、いかなる意味においても限定を目的としたものではない。上記に述べた例示的な態様及び特徴に加えて、更なる態様及び特徴が、図面及び以下の詳細な説明を参照することにより明らかになるであろう。
本明細書に記載される態様の新規特徴は、添付の「特許請求の範囲」に具体的に記載される。しかし、これらの態様は、構成及び操作の方法のいずれに関しても、以下の説明文を添付の図面と共に参照することによってより深い理解を得ることができる。
様々な態様による、神経刺激と治療機能の両方を備えて構成可能な医療装置である。 いくつかの態様による、手術部位に治療的エネルギー及び非治療的エネルギーを送達するように構成された外科用器具の代替設計を示す。 いくつかの態様による、外科用器具のジョーに沿って神経刺激プローブを含むための、代替設計を示す。 図3に示す後退可能なプローブの側面図である。 いくつかの態様による、図3及び図4の後退可能なプローブを操作するための、ハンドルアセンブリにある後退機構の部分を示す。 いくつかの態様による、外科用器具のジョーの輪郭に沿って神経刺激プローブを含むための、別の代替設計を示す。 いくつかの態様による、図6の外周プローブ構成の側面図である。 いくつかの態様による、電気的突起プローブ及び戻り突起プローブを備える、ジョーでの神経刺激を含むための、更に別の代替設計を示す。 いくつかの態様による、外科用装置に神経刺激を含めるための更に別の代替設計を示し、これは、ブレードを有効化して治療的エネルギーと非治療的エネルギーの両方を供給することを含む。 いくつかの態様による、手術部位にエネルギーを印加するためのモーター駆動式部品を備えた把持器具を含む外科用システムのブロック図であり、この外科用器具は、発電機に有線接続された刺激源(又は代替的に内部発電機を有する)に連結されている。 いくつかの態様による、静電容量スイッチに基づくボタンを示す。 いくつかの態様による、神経刺激システム1200の一態様を示す。
以下の「発明を実施するための形態」では、本明細書の一部を構成する添付の図面を参照する。図中、一般的に、同様の記号及び参照符合は、内容によりそうでない旨が断られない限り、複数の図を通じて同様の要素を示す。「発明を実施するための形態」、「図面」、及び「特許請求の範囲」に記載される例示的な態様は、限定を目的としたものではない。本明細書に提示される主題の範囲から逸脱することなく、他の態様を使用することが可能であり、他の変更を行うことが可能である。
本技術の特定の実施例の以下の説明文は、その範囲を限定する目的で用いられるべきではない。本技術の他の実施例、特徴、態様、及び利点は、実例として、本技術を実施する上で想到される最良の態様の1つである以下の説明より、当業者には明らかとなるであろう。理解されるように、本明細書に記載された技術は、いずれもその技術から逸脱することなく、その他の異なる、かつ明らかな態様が可能である。したがって、図面と説明は、本質的に例示的であり、限定的ではないとみなすものとする。
本明細書に記載の教示、表現、態様、実施例などのうちのいずれか1つ又は複数を、本明細書に記載の他の教示、表現、態様、実施例などのうちのいずれか1つ又は複数と組み合わせることができる点も更に理解される。したがって、以下に記載されている教示、表現、態様、実施例などは、互いに独立して考慮されるべきではない。本明細書の教示に照らして、本明細書の教示を組み合わせられる種々の好適な方法が、当業者には直ちに明らかとなろう。このような改変及び変変更例は、「特許請求の範囲」内に含まれるものとする。
また、以下の説明において、前、後、内側、外側、上部、下部といった用語は便宜的に用いられる語であると理解するべきであり、限定的な用語として解釈されるべきではない。本明細書で使用される用語は、本明細書に述べられる装置、又はその部分を他の向きに取設されるか又は用いられることが可能である限り、限定的なものではない。図面を参照しながら、様々な態様をより詳細に説明する。本開示の全体を通じて、「近位」なる用語は、外科用器具を操作する使用者(例えば、外科医)により近い構成要素(例えば、シャフト、ハンドルアセンブリなど)の側を述べるために用いられ、「遠位」なる用語は、外科用器具を操作する使用者からより遠い構成要素の側を述べるために用いられる。
本開示の態様は、治療的エネルギー(例えば、超音波エネルギー、及び/又はより高い電圧の電気外科用エネルギー)の印加を介して、組織を把持、封止、及び/又は切断するよう構成され、更に、非治療的エネルギーの印加を介して神経を検出するよう構成された、単一の外科用器具に関して提示される。従来、これらの作用の組み合わせを行うには、少なくとも2つの医療装置が使用され得る。しかしながら、手術部位に密集した複数の装置を有することにより、視認性が低下する可能性があり、これにより、単一の装置で上述の全ての機能を実行することができる場合に比べて、安全性が低下する可能性がある。更に、異なる機能を繰り返し実施するために、手術部位に複数の器具を交互に出入りさせると、外科医の正確さが損なわれる可能性がある。
本明細書に記述される様々な機能を、組織を処置及び/又は破壊する治療目的のために組織に電気エネルギーを印加するための電気外科用装置に組み込むことができ、このような電気外科用装置はまた、外科処置において、ますます広範な用途が見出されている。電気外科用装置は、典型的には、遠位に取り付けられたエンドエフェクタ(例えば、1つ又は2つ以上の電極)を有する器具であるハンドピースを含む。エンドエフェクタは、電流が組織内に導入されるように、組織に対して位置決めすることができる。電気外科用装置は、双極又は単極動作用に構成することができる。双極動作中、電流は、エンドエフェクタの作動電極によって組織に導入され、エンドエフェクタの戻り電極によって組織から戻される。単極動作中、電流は、エンドエフェクタの作動電極により組織に導入され、この電流は、患者の体に別途配置された戻り電極(例えば、手術部位から離れた位置で患者に取り付けられ又は隣接し、かつ、患者に対して容量的に、若しくは導電性接着剤を介して直接、電気的に連結された、接地パッド又は分散電極など)を介して戻される。組織を流れる電流によって生成される熱は、組織内及び/又は組織間の止血封止を形成してもよく、したがって、例えば、血管を封止するために特に有用であってもよい。電気外科用装置のエンドエフェクタはまた、組織に対して可動である切断部材、及び組織を横切するための電極を含んでもよい。
いくつかの態様において、医療装置はエンドエフェクタに2つのジョーを備え、これらは、治療的エネルギーを印加するため、並びに、把持、封止、及び/又は切断処置を行うために使用される。このエンドエフェクタは、シャフトの遠位端に形成されてよく、このシャフトの近位端は、ハンドルアセンブリに通信可能に連結され得る。他の例において、このエンドエフェクタは、鋏のような構成の一対のクランプアームの端部に形成されてもよい。ジョーの一方又は両方は、治療的エネルギーを(例えば超音波振動、又はより高い電圧の電気外科エネルギーの形態で)供給するように構成され得る。いくつかの態様において、ジョーのうちの一方は、ブレードを適用して組織を切断するように構成され得る。また、2つのジョーの一方又は両方は、神経刺激プロービングのための非治療的エネルギーを印加する(例えば、より低い振幅の電気エネルギーを印加する)よう構成されてもよい。いくつかの態様において、非治療的神経刺激エネルギーが印加されている間、治療的エネルギーの印加は使用不可にすることができ、またその逆にすることもできる。いくつかの態様において、この非治療的神経刺激エネルギーは、ジョーの一方又は両方の近傍に配置された1つ又は2つ以上のプローブの使用に印加され得る。
電気外科用装置によって印加される電気エネルギーは、ハンドルアセンブリと通信している発電機によって、器具へと伝達することができる。電気エネルギーは、無線周波数(「RF」)エネルギーの形態であってもよい。RFエネルギーは、200キロヘルツ(kHz)~1メガヘルツ(MHz)の周波数範囲であり得る電気エネルギーの一形態である。印加中、電気外科用装置は、組織を通じて低周波数RFエネルギーを伝送することができ、これはイオン撹拌又は摩擦、すなわち抵抗加熱を生じさせ、これによって組織の温度を上昇させる。罹患組織と周囲組織との間にはっきりとした境界が形成されるため、外科医は、隣接する非標的組織を犠牲にすることなく、高度な正確性及び制御で手術することができる。RFエネルギーの低動作温度は、軟組織を除去、収縮、又は成形しながら、同時に血管を封止するために有用である。RFエネルギーは、主にコラーゲンから構成され、かつ熱に接触した際に収縮する結合組織に対して特に良好に作用する。
図1を参照して、様々な態様による、神経刺激と治療機能の両方を備えて構成可能な医療装置100が示されている。医療装置100は、遠位端に2つのジョー116a及び116bを含み、エンドエフェクタ114を画定している。これらのジョーは両方とも、ジョーアーム162a及び162bにそれぞれ個別に接続されている。ジョーハンドル164a及び164bは、その近位端に、ジョーアーム162a及び162がそれぞれ連結されている。ジョー116a及び116bは、継手168で枢動可能に連結されていてもよく、これによりジョーは、それらの間に組織をクランプ及び/又は把持することができる。いくつかの態様において、ジョー116a及び116bの一方又は両方は、様々な手段(例えば超音波エネルギー、高周波電気外科エネルギー、抵抗発熱体、マイクロ波など)を介して、接触組織に治療的エネルギーを送達するように構成することができる。いくつかの態様において、作動スイッチ、ローラー、又はボタン160は、治療的エネルギーを調節するために、アームの一方の中に含まれ得る。
加えて、医療装置100は、非治療的な神経刺激プロービングエネルギーを、ジョー116a及び160bの一方又は両方に送達するように構成されてもよい。このエネルギーは、低周波数又は低電圧で形成されてよく、これにより、このモードにおいてジョー116a及び116bが組織に接触するとき、いかなる神経又は他の組織をも損傷しないようにすることができる。いくつかの態様において、両方のジョーは、両側神経刺激構成を形成するための非治療的なプロービングエネルギーを送達するよう構成することができる。刺激源170は、例えばエネルギーポート166a及び166bを介して、医療装置100に電気的に連結されてよく、これにより、2つのジョーハンドル164a及び164bを介してプロービングエネルギーを供給することができる。両方のジョーが、同じ電位のエネルギーを受け取ってもよい。次いでこのエネルギーは、矢印150で示されるように、ジョー116a及び116bを介して患者102に印加され得る。この電気刺激経路は、例えば皮下ニードルプローブ、患者接地用クリップワイヤ、又は患者接地用パッドの使用により、完成され得る。よって、この構成において、医療装置100は、ジョー116a及び/又は116bが手術部位の何らかの神経に近づいた場合、これを検出するよう構成することができる。例えば、この神経接触、又は神経にほぼ接触(例えば、約2mm)してエネルギーを印加した場合、神経の可視振動が生じ、これにより外科医に神経の存在を示すことができる。
いくつかの態様において、このタイプの刺激により神経の位置を特定することは、3つの望ましい使用モードの任意のものを介して達成することができる。一例において、神経は、ジョー116a及び116bの先端により、プロービングを介して調べることができる。すなわち、神経又は他の非筋肉組織は、ジョー116a及び/又は116bの先端が触れているか又はその近く(例えば、約1~5mm)にあるとき、収縮又は振動し得る。約0.5mAの刺激出力での試験では、神経は典型的に、導電性部材(ジョー116a及び/又は116bの先端)が神経上にあるとき、又は神経に接触しているとき、又は神経の間近に隣接している(約1mm未満)とき、刺激される。同様に、2mA刺激出力では、神経は典型的に、導電性部材が神経から約2~5mmの位置にある組織に隣接して接触しているとき、刺激される。第2の例は、神経を検出するために組織をクランプすることを含む。ジョー116a又は116bのうちの一方の少なくとも1つの内部クラップ表面が、神経刺激エネルギーを印加するよう構成されている。第3の例は、拡張切開による検出を含む。作動時に非治療的神経刺激エネルギーを印加するように構成された、少なくとも1つの外側表面を使用して、ジョーを広げることにより組織を拡張することで、神経を検出することができる。他の構成において、これらの使用モードのうちの複数のものが、医療装置100に実装されてもよい。
いくつかの態様において、ジョー116a及び116bは、ジョーが閉位置にあるとき、又は組織を把持しているときであっても、電気的に絶縁され得る。絶縁ピンが、ジョー116a及び116bのうち少なくとも一方の内側に配置されてよく、これによってジョーは絶縁ピンでのみ接触するようになる。他の例において、絶縁バンド又は他の非導電性材料が、ジョー116a又は116bの一方又は両方の周りに配置されてよく、これによりジョーが、絶縁バンド又は他の非導電性材料でのみ接触するようになる。このようにして、超音波振動の絶縁のための、又は他の例においては電気的絶縁(双極の電気外科ジョーで利用され得る)のための、十分な物理的空間を割り当てることができる。
図2は、いくつかの態様による、手術部位に治療的エネルギー及び非治療的エネルギーを送達するように構成された外科用器具200の代替設計を示す。器具200は、いくつかの態様による、ばね駆動カム閉鎖機構を含むエンドエフェクタ110でジョー116a及び116bを閉じるための、トリガアセンブリ107及び閉鎖システム配置を含み得る。このばね駆動カム閉鎖システムは、対抗するジョー116a、116bのセットを閉じ、いくつかの場合によってはエンドエフェクタ110内で切断エレメントを発射するよう構成されている。トリガアセンブリ107は、外科用器具200のシャフトアセンブリ112に連結されたエンドエフェクタ110に、クランプ及び発射を行わせるように構成されている。外科用器具200は更に、ハンドルアセンブリ104と、シャフトアセンブリ112と、エンドエフェクタ110とを備える。シャフトアセンブリ112は、近位端及び遠位端を備えている。シャフトアセンブリ112の近位端は、ハンドルアセンブリ104の遠位端に連結されている。エンドエフェクタ110は、シャフトアセンブリ112の遠位端に連結されている。ハンドルアセンブリ104は、ピストルグリップ118を備えている。ハンドルアセンブリ104は、左ハンドルハウジングシュラウド106a及び右ハンドルハウジングシュラウド106bを備えている。トリガアセンブリ107は、ピストルグリップ118の方向に作動可能なトリガ109を備えている。回転可能なシャフトノブ120は、ハンドルアセンブリ104に対してシャフトアセンブリ112を回転させるように構成されている。ハンドルアセンブリ104は、エンドエフェクタ110内の1つ又は2つ以上の電極に治療用電気外科エネルギーを供給するように構成されたエネルギーボタン122を更に備えている。シャフトアセンブリ112は、閉鎖/ジョーアクチュエータ、発射/切断部材アクチュエータ、及び外側シースを備えている。いくつかの態様において、外側シースは閉鎖アクチュエータを備える。外側シースは、エンドエフェクタ110と接するように構成された遠位端上に、1つ又は2つ以上の接触電極を備えている。この1つ又は2つ以上の接触電極は、エネルギーボタン122、組織封止モード選択アセンブリ108、及び刺激源170に動作可能に連結されている。
エネルギー源は、治療的な組織の処置、組織の焼灼/封止、及び治療量以下の治療処置及び測定に適したものとすることができる。エネルギーボタン122は、電極へのエネルギーの供給を制御する。この装置200は更に、いくつかの例において、トグルスイッチ又はボタンを介して、例えばボタン122を押圧することにより、エンドエフェクタ110で非治療的エネルギーを印加するよう切り換え、2回目で、神経刺激モードに切り換えるよう構成されている。他の例において、別のボタン又はスイッチの作動(例えばノブ120を所定の方向に回転させること、又は、他のボタン(図示せず)を押すこと)によって、神経刺激エネルギーの作動を可能にしてもよい。刺激源170は、一方又は両方のモードのためのエネルギーを生成するように構成することができる。エネルギー生成波形に関する追加の例示的な詳細は、下記に詳しく記述される。
ユーザは、治療出力又は診断出力を選択でき、あるいは、システムが、その状況に適するように治療出力又は診断出力を選択できることが、理解されよう。
本開示の全体を通じて使用されるように、ボタンとは、機械又はプロセスの一部の側面を制御するためのスイッチ機構のことを指す。ボタンは、通常はプラスチック又は金属などの硬質材料で作製することができる。表面は、簡単に押し込む、又は押せるよう、人の指又は手に適合するように形成又は成形することができる。ボタンは、最も多くの場合、付勢スイッチであってよいが、多くの付勢されていないボタンは、(その物理的性質のため)その押し込まれていない状態に復帰するためにばねを必要とする。ボタンを「押す」という用語には、押すこと、押し込むこと、軽く押すこと、及び叩くことを含み得る。
図11は、本開示のいくつかの態様による、静電容量スイッチに基づくボタンを示す。他の態様において、このボタンは、光学的遮断技術に基づくものであってもよい。図11に戻ると、静電容量タッチスイッチシステム1100が示されている。静電容量タッチスイッチ1100は、プリント回路基板1110の上方に位置する電気絶縁性のカバープレート1106を備えている。導電性パッド1108は、通常、銅又は他の導電性金属で形成される。静電容量タッチスイッチ1100は、指1102がカバープレート1106に触れたときに形成され、指静電容量1104が、指1102と、カバープレート1106の下方に位置する導電性パッド1108との間に生じる。指静電容量1104は、人体を介して接地に連結されている。指1102がカバープレート1106に接触すると、指静電容量1104はパッド静電容量1112と平行になっており、これは、システム内の任意の場所に位置する接地1114に連結されている。この静電容量タッチスイッチシステム1100は、例示的な外科用装置に採用されるボタンがどのように実装され得るかを示す一例である。
図2に戻り、いくつかの態様において、エンドエフェクタ110は、シャフトアセンブリ112の遠位端に連結される。エンドエフェクタ110は、第1のジョー部材116a及び第2のジョー部材116bを備えている。第1のジョー部材116aは、第2のジョー部材116bに枢動可能に連結されている。第1のジョー部材116aは第2のジョー部材116bに対して枢動可能であることで、それらの間に組織を把持することができる。いくつかの態様において、第2のジョー部材116bは固定される。他の態様において、第1のジョー部材116a及び第2のジョー部材116bは枢動可能に移動可能である。エンドエフェクタ110は、少なくとも1つの電極を備える。この電極は電気外科用エネルギーを送達するように構成されている。電極により供給されるエネルギーは、例えば、高周波(RF)エネルギー、治療量以下のRFエネルギー、超音波エネルギー、及び/又は他の適当な形態のエネルギーを含み得る。いくつかの態様において、第1のジョー部材116a及び/又は第2のジョー部材116bによって画定される長手方向のスロット内に切断部材(図示せず)が受容可能となっている。切断部材は、第1のジョー部材116aと第2のジョー部材116bとの間に把持された組織を切断するように構成されている。いくつかの態様において、切断部材は、エネルギー(例えば、RF及び/又は超音波エネルギーなど)を送達するための電極を含む。
図3を参照して、描画300は、いくつかの態様による、ジョー116a及び116bに沿った神経刺激プローブを備えるための代替設計を示す。ここでは、後退可能なプローブ構成が示されている。描画300は、上面視からの医療装置100の一部を示し、ここでは上側ジョー116a及び対応するジョーアーム162aが示されている。描画300のこの構成は、図示のように、ジョー116aの遠位端を越えて延在し得る2つの後退可能なプローブ302及び304を含む。このプローブは、形状記憶材料で製造されていてよく、これによって、プローブは、手術部位の形状に合わせて必要に応じて使用するために、その設計又は形状を若干変更することが可能になる。プローブ302と304の間には隙間306が存在し、これによって、プローブ302及び304の端部が組織に接触すると、電流の戻り経路が完成され得る。この例において、第2のプローブ304は、戻り電極として作用する。他の態様において、単一の電極を提供してもよく、内部又は近くの皮下ニードル又は分散電極が、戻り電極として作用することができる。
図4を参照して、描画400は、描画300に示す後退可能プローブプローブ302及び304の側面図を示す。この構成において、プローブ302及び304は、ジョー116a及び116bの上方に位置する。他の例において、プローブは、ジョーの下側又は側面に位置してもよく、態様はその配置に関して限定されていない。この図から、プローブ302及び304は、図示のように、ジョーアーム162b内へと方向Rに後退し得ることが明らかであり得る。
図5を参照して、描画500は、いくつかの態様による、描画300及び400に示す後退可能プローブを操作するための後退機構の一部を示す。ここで、ジョーハンドル164bの一部分は、後退可能プローブ302及び304(図3参照)を操作するための摺動後退機構のためのスロット502を備える。この例において、ノブ又はスイッチは、プローブ302及び304を後退及び延長させるために、スロット502内で往復摺動するよう構成され得る。他の例において、後退可能プローブは、ホイール後退機構(図示せず)を介して操作することができる。いずれにせよ、ジョーハンドル164bは、エンドエフェクタにおいてプローブに印加される電流のレベルを制御するための電流振幅制御スイッチ504を含み得る。
図6を参照して、描画600は、いくつかの態様による、ジョー116a及び116bに沿った神経刺激プローブを備えるための別の代替設計を示す。この例において、プローブ602及び604は、ジョー116aの外周の周りに位置し、エンドエフェクタの輪郭に沿うように形成されている。描画600は、この医療装置の構成の上面図を示す。図3の構成と同様に、プローブ602及び604は隙間によって分離されており、この例においては、隙間内にスペーサ608を含む。よって、スペーサ608は、ジョー116bの遠位端に固定されていてよく、これによって、プローブ602及び604の位置を安定させ、あるいは、移動干渉を防止することができる。組織がプローブ602及び604の両方に接触すると、電流経路は再び閉じてよく、このとき、電流経路は矢印606の方向に進行する。これにより、プローブ604は戻り電極として作用し得る。
図7を参照して、描画700は、いくつかの態様による、描画600の外周プローブ構成の側面図を示す。ここで、プローブ602及び604は、ジョー116bの外周及びジョーハンドル162bの一部に位置するように示されている。描画600及び700の図を組み合わせると、プローブ602及び604がジョー外周の輪郭に沿っていることが明らかであり得る。このように、ジョーを介して治療的エネルギーを供給するよう構成された既存の医療装置は、ジョーの外周に沿って走行する一対の電極又はプローブを含むように、簡単に再利用又は後付けすることができ、これによりシームレスで非侵襲的な神経刺激機能を生み出すことができる。
図8を参照して、描画800は、いくつかの態様による、ジョー116a及び116bでの神経刺激を備えるための更に別の代替設計を示す。ここで、ジョー116bの遠位端の2つの小さい電極突起802及び804は、神経刺激及び位置付けのために使用することができる。突起の一方は刺激プローブとして作用してよく、他方は戻り電極として作用してもよい。プローブ802及び804に達する回路は、ジョーを通ってジョー116bの遠位端まで延在してもよい。プローブ802及び804がジョー116bの外側及び底部に示され配置されているが、これらのプローブは他の構成に配置されてもよい。例えば、プローブ802及び804は、いずれかのジョー116b又は116aの遠位端の前方に面して配置されてもよい。別の例として、プローブ802及び804は、ジョー116aの上面に配置されてもよい。他の例において、2組のプローブが、ジョー116a及び116bのそれぞれに一対ずつ、ジョーの遠位端に配置されてもよい。
図9を参照して、描画900は、いくつかの態様による、クランプ医療装置内に神経刺激を備えるための更に別の代替設計を示す。ここで、ジョー904のうちの一方が、プローブと、クランプ及び/又はブレードとの両方として働き得る。すなわち、ブレード904の1つのモードにおいて、様々な切断又は封止処置を行うために、治療的エネルギーを適用することができる。第2のモードにおいて、神経の位置特定及び/又は刺激を行うために、ブレード904を作動させて、非治療的エネルギーを供給することができる。いくつかの例において、クランピングジョー902は戻り電極として作用することができ、他の例において、皮下ニードル又は分散電極が戻り電極として作用することができる。加えて、図3~図8で述べたように、描画900のこの代替設計は、後退可能プローブ、外周プローブ、又は先端電極構成と組み合わせてもよい。
図10は、いくつかの態様による、手術部位にエネルギーを印加するためのモーター駆動式部品を備えた把持器具100(図1)を含む外科用システム1000のブロック図であり、この外科用器具は、発電機に有線接続された刺激源(又は代替的に内部発電機1005を有する)に連結されている。モーター1030は、エンドエフェクタ110(図2)のジョー116a、116bのいずれか一方又は両方を開閉するために、あるいは、ナイフを発射するために、採用することができる。それにも拘らず、多くの態様において、そのような機能は手動で操作される。外科用システム1000は、把持器具の内部回路の構成部品を示し、更に、代替の把持器具200(図2)の内部回路をも記述し得る。本開示に記載のモーター駆動式外科用器具100は、例えば発電機(又は代替の内部発電機1005)などの有線接続された刺激源170に連結されてよく、この刺激源は、外部手段又は内部手段を介して外科用器具に電力を供給するように構成されている。前述の図では、把持、封止、切断、及びプロービング部品の構造の例について説明してきたが、図10は、いかに治療的エネルギー及び非治療的エネルギーがエンドエフェクタに送達され得るかを示すための部分の例について説明する。特定の例において、モーター駆動式外科用器具100は、外部の有線接続された発電機170又は内部発電機1005に連結されたマイクロコントローラ1010を含むことができる。外部発電機170又は内部発電機1005は、A/C電源に連結されてもよく、あるいは、電池作動してもよく、あるいはそれらの組み合わせであってもよい。モーター駆動式外科用器具100及び/又は発電機要素170、1005に関連付けられた電気及び電子回路素子は、例えば、制御回路基板アセンブリにより支持されてもよい。マイクロコントローラ1010は一般に、メモリ1015と、メモリ1015に動作可能に連結されたマイクロプロセッサ1020(「プロセッサ」)とを含み得る。プロセッサ1020は、モータードライバ1025の回路を制御することができ、これは一般に、モーター1030の位置及び速度を制御するのに利用される。モーター1030は、手術器具のエンドエフェクタにある電極へのエネルギーの伝達を制御するように構成され得る。特定の例では、下記に詳しく述べるように、プロセッサ1020は、モーター1030を停止及び/又は使用不能にするように、モータードライバ1025に信号伝達することができる。特定の例において、プロセッサ1020は、モーターオーバーライドスイッチを含み得る別個のモーターオーバーライド回路を制御することができ、このスイッチは、プロセッサ1020からのオーバーライド信号に応答して、外科用器具の操作中にモーター1030を停止及び/又は使用不能にすることができる。プロセッサという用語は、本明細書で使用するとき、任意の好適なマイクロプロセッサ、マイクロコントローラ、又は、コンピュータの中央処理装置(CPU)の機能を1つの集積回路又は最大で数個の集積回路上に組み込んだ、他の基本コンピューティングデバイスを含むことが理解されるべきである。プロセッサは、デジタルデータを入力として受理し、メモリに記憶された命令に従ってそのデータを処理し、結果を出力として提供する、多目的のプログラマブルデバイスである。これは、内部メモリを有するので、逐次的デジタル論理の一例である。プロセッサは、二進数法で表される数字及び記号で動作する。
いくつかの例において、プロセッサ1020は、Texas Instruments製のARM Cortexの商品名で知られているものなど、任意のシングルコア又はマルチコアプロセッサであってもよい。いくつかの例において、本開示の外科用器具の任意のものが、安全プロセッサを含んでよく、これは例えば、同じくTexas Instrumentsの商標名Hercules ARM Cortex R4として知られる、TMS570及びRM4xなどの2つのマイクロコントローラベースファミリを備える、安全マイクロコントローラプラットフォームなどであり得る。それにもかかわらず、マイクロコントローラ及び安全プロセッサに好適な他の置換品も制限なく用いることができる。一例において、安全プロセッサは、拡張性がある性能、接続性及びメモリの選択肢を提供しながら、高度な集積型安全特性を提供するために、中でも特に、IEC 61508及びISO 26262の安全限界用途向けに特異的に構成されてもよい。
特定の例では、マイクロコントローラ1010は、例えば、Texas Instrumentsから入手可能なLM 4F230H5QRであってもよい。少なくとも一例では、Texas InstrumentsのLM4F230H5QRは、製品データシートから容易に入手可能な他の機構の中でも特に、最大40MHz、256KBの単一サイクルフラッシュメモリ若しくは他の不揮発性メモリのオンチップメモリ1015と、40MHz超の性能を改善するためのプリフェッチバッファと、32KBの単一サイクルシリアルランダムアクセスメモリ(SRAM)と、StellarisWare(登録商標)ソフトウェアを搭載した内部読み取り専用メモリ(ROM)と、2KBの電気的消去可能なプログラマブル読み取り専用メモリ(EEPROM)と、1つ又は2つ以上のパルス幅変調(PWM)モジュールと、1つ又は2つ以上の直交エンコーダ入力(QEI)アナログと、12個のアナログ入力チャネルを備えた、1つ又は2つ以上の12ビットアナログデジタル変換器(ADC)と、を備えたARM Cortex-M4Fプロセッサコアである。モーター駆動式外科用器具100での使用に対して、他のマイクロコントローラが容易に代用され得る。したがって、本開示は、この文脈に限定されるべきではない。
再び図10を参照して、外科用システム1000は、例えば、有線接続された刺激源170を含み得る。特定の例において、有線接続された刺激源170は、外部発電機に連結された貫通電線などの外部手段を介して、電力を供給するように構成されてもよい。いくつかの例において、外科用システム1000は更に、又は代替的に、内部発電機1005を含んでもよい。内部発電機1005は、例えば電池電力又は他の貯蔵された静電容量源などの内部的手段を介して、電力を供給するように構成することができる。内部発電機1005及び有線接続された発電機170の更なる説明が、下記に記述される。
特定の例において、モーター駆動式外科用器具100は、ファームウェア、ソフトウェア、ハードウェア又はこれらの任意の組み合わせとして実装される1つ又は2つ以上の埋め込みアプリケーションを含んでもよい。特定の例において、モーター駆動式外科用器具100は、例えば、ソフトウェア、プログラム、データ、ドライバ、及び/又はアプリケーションプログラムインターフェース(API)などの様々な実行可能モジュールを備え得る。特定の例において、手術器具100は更に、例えばエンドエフェクタに印加されているエネルギーレベルを示すための、1つ又は2つ以上のディスプレイ又は他のグラフィックインジケータ1035を含んでもよい。
いくつかの態様において、戻り電極は、治療的出力及び神経刺激出力の両方のための電気的戻り経路として作用するように、二重目的であってもよい。このように、単一の戻り電極は双極エネルギー送達の必要を回避することができるため、治療用エネルギーの送達は単極電気外科手術の形態であってもよい。この構成は、図1~図10を含め、神経刺激エネルギー経路のための戻り電極を示す例の任意のもので可能であり得る。
図12は、本開示のいくつかの態様による、神経刺激システム1200の一態様を示す。神経刺激システム1200は、複数の経路を伴う、双極、超音波、又は双極と超音波の組み合わせ器具で、神経を刺激するための技法を提供する。神経刺激システム1200は、図1~図11に記載のように、同じ医療装置において、低エネルギー刺激が高エネルギー治療用適用とどのように組み合わされ得るかの一例を表すことができる。典型的には、神経刺激電極セットは、一対の近接離間した電極、あるいは、戻りパッド又は戻りニードルを伴うプローブ電極のいずれかである。組織は、最初に記述された対の間に配置されて刺激を受けるか、あるいは、戻りパッド又はニードルが適切な位置に配置されてから、標的組織が他方の電極で探査される。一態様において、この神経刺激システム1200は2つの別々の回路A及びBを含み、これらは、同じ波形によって駆動される(好ましくは二相波源だが、単純な直流[DC]レベルであってもよい)。回路A及びBは両方とも、パッド又はニードル内に共通の戻り回路を有するが、A及びBは、互いに対して位相が異なるよう構成される。双極器具の場合には、A及びBの節は、RFブロッキング回路(ローパスフィルタ)を介して処置電極に連結されており、これによって、治療用RFは、刺激回路、又は、刺激回路のニードル又はパッド戻り回路を通って、戻っては来ないようになっている。このようにして、組織は、A及びB回路を通って、Aから戻り回路、又はBから戻り回路へと、処置電極の間で刺激され得る。
特に図12に示すように、神経刺激システム1200は、RF発電機回路1202及び神経刺激回路1204を含む。RF発電機回路1202は、増幅器1208に連結されたRF源1206を含む。増幅器1208の出力は、絶縁トランス1210を介して、第1及び第2のブロッキングコンデンサ1212、1214に連結されている。第1のブロッキングコンデンサ1212は第1の電極1216に連結され、第2のブロッキングコンデンサ1214は第2の電極1220に連結されている。図に示すように、処置される組織1220は、第1の電極1216と第2の電極1218との間に配置される。パッド又はニードルのような導電性要素1222は、組織1220に連結され、かつ、神経刺激回路1204の共通の戻り1238に連結される。
ここで神経刺激回路1204に注目し、図12に示すように、神経刺激回路1024は、2つの別個の回路(第1の刺激増幅器1226及び第2の刺激増幅器1228)に連結された、二相波源1224を含む。図に示すように、第1及び第2の刺激増幅器1226、1228は、好ましくは二相波源1224により生成された同じ波形により駆動されているが、これらは例えば、単純なDC電源によって駆動することもできる。第1及び第2の刺激増幅器1226、1228の両方が、組織1220に連結された共通の戻り1238を有し、これらは、パッド又はニードルに連結され得る。しかしながら、第1及び第2の刺激増幅器1226、1228は、互いに対して異なる位相になるように構成される。双極機器の場合において、第1及び第2の刺激増幅器1226、1228の節は、対応するRFブロッキング回路(例えば、ローパスフィルタ)を介して処置電極1216、1218に連結されており、この第1のブロッキング回路は、第1のコンデンサ1230及び第1のインダクタ1234を含み、第2のブロッキング回路は、第2のコンデンサ1232及び第2のインダクタ1236を含み、これによって、治療用RFは、刺激回路1204や、刺激回路1204の共通の戻り1238に連結されているニードル若しくはパッド1222を通って戻って来ることはない。このようにして、組織1220は、第1及び第2の増幅回路1226、1228を通って、第1の増幅回路1226から戻りへ、又は第2の増幅回路1228から戻りへと、処置電極1216、1218の間で刺激されることができる。したがって、第1の極及び第2の極は、共通の戻り1238を備えた第1及び第2の増幅回路1226及び1228を含む、別個の信号発生回路を有する。刺激の経路は、第1の増幅回路1226を通って、あるいは第2の増幅回路1228を通って、戻り1238へと至ってよく、並びに、共通の戻り1238により、第1の増幅回路1226から第2の増幅回路1228へと至ってもよい。
RF及び超音波の組み合わせ器具は、全て同じ機器/発電機で、RFエネルギー、超音波エネルギーを送達するよう構成することができ、更に、神経を刺激することができる。利点としては、外科医にとっての単純さ、器具交換の必要性の低減、神経刺激機能を器具のジョー内に組み込むことにより、完全な把持力を組織に印加する前に、神経に関して組織を評価することができ(これにより、それらの神経又は構造に対する損傷を回避する)、更に、器具の把持内にあり得る神経を破壊するエネルギーを印加する前に、又は、RF及び/又は超音波治療的エネルギーの熱効果で処置する前に、神経に関して組織を評価することができることが挙げられるが、これらに限定されない。
他の態様において、治療的エネルギー処置は、他のエネルギー源のうち、レーザー、マイクロ波を含み得る。
他の態様において、神経刺激信号は、装置のハンドル内の別の回路を介して、あるいは、発電機からの特別な出力波形を備えて、発電機内で生成され得る。
更に、他の態様において、神経刺激信号は、ジョーが完全に閉じる前に自動的に処置電極の間に印加することができ、これによって外科医は、刺激の効果があればそれを観察し、望ましくない神経損傷を潜在的に回避することができる。一態様において、この機能を遮断するためにコントローラを採用することができる。別の態様において、IEC 60601-2-10(これは、そのような刺激器具のためのインジケータを示している)に示されるように、神経刺激回路が「オン」(例えば、通電、活性化など)であることを示すインジケータを器具上に配置することができる。
他の態様において、組織検出回路が提案され、これは、組織が刺激電極若しくは処置電極、又は超音波ブレード、又は組織パッドに接触しているときに、神経刺激信号を「オン」(例えば、通電、活性化など)にする。
本開示の神経刺激機能のエネルギープロファイルは、治療機能のエネルギープロファイルとは異なる。よって、本開示の態様は、治療的エネルギー生成に加え、神経刺激エネルギーをどのように生成し得るかについての説明を含む。
いくつかの場合では、様々な態様は製造物品として実装されてもよい。製造物品は、1つ又は2つ以上の態様の様々な動作を行うための論理、命令、及び/又はデータを格納するように構成されたコンピュータ可読記憶媒体を含んでもよい。様々な態様において、例えば、製造物品は、汎用プロセッサ又は特定用途向けプロセッサによって実行するのに好適なコンピュータプログラム命令を含む磁気ディスク、光学ディスク、フラッシュメモリ、又はファームウェアを含んでもよい。しかしながら、態様は、この文脈に限定されない。
本明細書に開示する態様に関連して記載される様々な機能的要素、論理ブロック、モジュール、及び回路素子の機能は、処理装置によって実行されるソフトウェア、制御モジュール、論理、及び/又は論理モジュールなど、コンピュータ実行可能命令の一般的文脈で実施され得る。一般に、ソフトウェア、制御モジュール、論理、及び/又は論理モジュールは、特定の動作を行うように構成された任意のソフトウェア要素を含む。ソフトウェア、制御モジュール、論理、及び/又は論理モジュールは、特定の作業を行うか又は特定の抽象データ型を実現する、ルーチン、プログラム、オブジェクト、コンポーネント、データ構造などを含むことができる。ソフトウェア、制御モジュール、論理、並びに/又は論理モジュール及び技術の実装例は、何らかの形態のコンピュータ可読媒体に格納され、かつ/又はそれを介して伝達されてもよい。これに関して、コンピュータ可読媒体は、情報を格納しコンピューティング装置がアクセスできるように使用可能な、任意の入手可能な媒体であることができる。いくつかの態様はまた、通信ネットワークを通して連結された1つ又は2つ以上の遠隔処理装置によって動作が行われる、分散コンピューティング環境で実施されてもよい。分散コンピューティング環境では、ソフトウェア、制御モジュール、論理、及び/又は論理モジュールは、メモリ記憶装置を含むローカル及び遠隔両方のコンピュータ記憶媒体に配置されてよい。
加えて、本明細書で説明した態様は例示的な実施を示すものであり、また、機能要素、論理ブロック、モジュール、及び回路素子は、説明した態様と調和する様々な他の方式で実装され得ることが理解されよう。更に、かかる機能要素、論理ブロック、モジュール、及び回路素子によって実施される動作は、所与の実装例に対して結合及び/又は分離されてもよく、より多い又はより少ない数の要素又はモジュールによって行われることができる。本開示を読むことによって当業者には明白となるように、本明細書に記載し例示される個々の態様はそれぞれ、本開示の範囲から逸脱することなく、他のいくつかの態様のいずれかの特徴から容易に分離されるか、又はそれらの特徴と組み合わされ得る、別個の構成要素及び特徴を有する。説明したいずれの方法も、説明した事象の順序で、又は論理的に可能な他の任意の順序で実施することができる。
特段の具体的な規定がない限り、「処理する(processing)」、「算定する(computing)」、「計算する(calculating)」、「判断する(determining)」などの用語は、レジスタ及び/又はメモリ内の物理量(例えば、電子)として表されるデータを、メモリ、レジスタ、又はその他のかかる情報記憶、送信、若しくは表示装置内の物理量として同様に表される他のデータへと操作及び/又は変換する、汎用プロセッサ、DSP、ASIC、FPGA、又はその他のプログラマブル論理装置、個別のゲート若しくはトランジスタ論理、個別ハードウェア要素、又は本明細書に記載した機能を実施するように設計されたそれらの任意の組み合わせなど、コンピュータ若しくはコンピューティングシステム、又は類似の電子コンピューティング装置の動作及び/又はプロセスを指すものであると理解されてよい。
特筆すべきこととして、いくつかの態様は、「連結された」及び「接続された」という表現を、それらの派生語と共に用いて説明され得る。これらの用語は、互いに同義語であることは意図されない。例えば、いくつかの態様は、2つ又はそれ以上の要素が互いに直接、物理的又は電気的接触をなすことを示すために、「接続された」及び/又は「連結された」という用語を用いて説明され得る。しかしながら、「連結された」という用語はまた、2つ又はそれ以上の要素が互いに直接接触はしないが、依然として互いに協働又は相互作用することを意味することがある。例えばソフトウェア要素に関しては、「連結された」という用語は、インターフェース、メッセージインターフェース、及びアプリケーションプログラムインターフェース、交換メッセージなどを指し得る。
本明細書に開示される装置は、1回の使用後に廃棄されるように設計することができ、又は複数回使用されるように設計することができる。しかしながら、いずれの場合も、装置は、少なくとも1回の使用後に再使用のために再調整することができる。再調整には、装置の分解工程、それに続く特定の部品の洗浄工程又は交換工程、及びその後の再組立工程の任意の組み合わせを含むことができる。特に、装置は分解することができ、装置の任意の数の特定の部品又は部分を、任意の組み合わせで選択的に交換するか又は取り外すことができる。特定の部分を洗浄及び/又は交換した後、装置を後の使用のために、再調整施設で、又は外科処置の直前に外科チームによって再組み立てることができる。当業者であれば、装置の再調整が、分解、洗浄/交換、及び再組立のための様々な技術を利用できることを理解するであろう。このような技術の使用、及び結果として得られる再調整された装置は、全て本発明の範囲内にある。
様々な態様について本明細書で述べたが、これらの態様に対する多くの改変例、変形例、代替例、変更例及び同等物を実施することが可能であり、また、当業者には想到されるであろう。また、材料が特定の構成要素に関して開示されているが、他の材料が使用されてもよい。したがって、上記の説明文及び添付の「特許請求の範囲」は、全てのそのような改変例及び変形例を、開示された態様の範囲に含まれるものとして網羅することを目的としたものである点を理解されたい。以下の「特許請求の範囲」は、全てのそのような改変例及び変形例を網羅することを目的としたものである。
〔実施の態様〕
(1) 外科用器具であって、
継手を中心に枢動可能に連結された、第1のジョーハンドル及び第2のジョーハンドルを含み、
該第1のジョーハンドルは、該第1のジョーハンドルの遠位端に第1のジョーを備え、
該第2のジョーハンドルは、該第2のジョーハンドルの遠位端に第2のジョーを備え、
該第1のジョーハンドル及び該第2のジョーハンドルが、該継手を中心に閉位置へと枢動回転されると、該第1のジョー及び該第2のジョーは、それらの間に組織を把持するよう構成されており、
該第1のジョー及び該第2のジョーのうち少なくとも一方が、手術部位で組織を封止又は切断するために、より高いエネルギーレベルで治療的エネルギーを送達するように構成されており、かつ、
該第1のジョー及び該第2のジョーのうち少なくとも一方が、該手術部位で神経組織に電気刺激を与えるために、より低いエネルギーレベルで非治療的エネルギーを送達するように構成されている、外科用器具。
(2) 前記治療的エネルギーが超音波エネルギーを含む、実施態様1に記載の外科用器具。
(3) 前記治療的エネルギーが高周波数電気外科用エネルギーを含む、実施態様1に記載の外科用器具。
(4) 前記第1のジョー及び第2のジョーの両方が、前記非治療的エネルギーを前記手術部位で前記組織に送達するように構成されており、該第1のジョー及び第2のジョーの両方で送達される該非治療的エネルギーは、同じ電位である、実施態様1に記載の外科用器具。
(5) 前記第1のジョー及び第2のジョーのうち少なくとも一方が、該ジョーの内側部分に絶縁材料を備え、これによって、前記閉位置において該第1のジョーが該第2のジョーに、該絶縁材料の接触を介して接触する、実施態様1に記載の外科用器具。
(6) 外科用器具であって、
ハンドルアセンブリと、
該ハンドルアセンブリに通信可能に連結され、かつ第1及び第2のジョーを備えるエンドエフェクタとを含み、
該ハンドルアセンブリは、該第1及び第2のジョーを操作して、開位置及び閉位置を画定するよう構成されており、
該エンドエフェクタは、
手術部位で組織を封止又は切断するために、より高いエネルギーレベルで治療的エネルギーを送達するように構成されており、かつ、
該手術部位で神経組織に電気刺激を与えるために、より低いエネルギーレベルで非治療的エネルギーを送達するように構成されている、外科用器具。
(7) 前記エンドエフェクタが、前記手術部位で前記神経組織を刺激するために前記非治療的エネルギーを送達するように構成された電気刺激プローブを更に含む、実施態様6に記載の外科用器具。
(8) 前記電気刺激プローブは後退可能であり、かつ、前記ハンドルアセンブリに向かって近位方向に後退するように、及び、該ハンドルアセンブリから離れて遠位方向に延長するように、更に構成されている、実施態様7に記載の外科用器具。
(9) 前記エンドエフェクタは戻りプローブを更に含み、該戻りプローブと前記電気刺激プローブの両方が前記手術部位で組織に接触すると、該電気刺激プローブと該戻りプローブとが回路を完成させ、該戻りプローブは前記非治療的エネルギーの電気的戻り経路(electrical return)として働く、実施態様7に記載の外科用器具。
(10) 前記電気刺激プローブは、前記エンドエフェクタの第1の側面に実質的に近い輪郭になるよう構成され、該エンドエフェクタの該第1の側面は、前記第1及び第2のジョーによって画定される該エンドエフェクタの遠位先端の第1の部分を含む、実施態様7に記載の外科用器具。
(11) 前記エンドエフェクタは、前記第1の側面に対向する、該エンドエフェクタの第2の側面に実質的に近い輪郭になるよう構成された戻りプローブを更に含み、該エンドエフェクタの該第2の側面は、前記第1及び第2のジョーによって画定される該エンドエフェクタの前記遠位先端の第2の部分を含み、該戻りプローブと前記電気刺激プローブの両方が前記手術部位で組織に接触すると、該電気刺激プローブと該戻りプローブとが回路を完成させる、実施態様10に記載の外科用器具。
(12) 前記エンドエフェクタは、前記第1又は第2のジョーの遠位端に連結され、かつ、前記手術部位で前記神経組織を刺激するために前記非治療的エネルギーを送達するように構成された、第1の電気的突起プローブを、更に含む、実施態様6に記載の外科用器具。
(13) 前記エンドエフェクタは、第2の電気的突起戻りプローブを更に含み、該第2の電気的突起戻りプローブは、前記第1又は第2のジョーの前記遠位端に連結され、かつ、前記第1及び第2のプローブの両方が前記手術部位で組織に接触すると、前記第1の電気的突起と共に回路を完成させるように構成されている、実施態様12に記載の外科用器具。
(14) 前記ハンドルアセンブリの遠位端と前記エンドエフェクタの近位端とに連結されたシャフトを更に含み、該シャフトは、該エンドエフェクタを該ハンドルアセンブリに電気的に連結するように構成されている、実施態様6に記載の外科用器具。
(15) 外科用システムであって、
ハンドルアセンブリと、
該ハンドルアセンブリに電気的に連結された発電機と、
該ハンドルアセンブリに通信可能に連結され、かつ該発電機に電気的に連結され、かつ第1及び第2のジョーを備えるエンドエフェクタとを含み、
該ハンドルアセンブリは、該第1及び第2のジョーを操作して、開位置及び閉位置を画定するよう構成されており、
該エンドエフェクタは、
手術部位で組織を封止又は切断するために、より高いエネルギーレベルで治療的エネルギーを選択的に送達し、かつ、
該手術部位で神経組織に電気刺激を与えるために、より低いエネルギーレベルで非治療的エネルギーを選択的に送達するように構成されており、
該発電機は、
該エンドエフェクタに伝達されるよう、該より高いエネルギーレベルで治療的エネルギーを生成し、かつ
該エンドエフェクタに伝達されるよう、該より低いエネルギーレベルで非治療的エネルギーを生成するように構成されている、外科用システム。
(16) 前記エンドエフェクタが、前記手術部位で前記神経組織を刺激するために前記非治療的エネルギーを送達するように構成された電気刺激プローブを更に含む、実施態様15に記載の外科用システム。
(17) 前記電気刺激プローブは後退可能であり、かつ、前記ハンドルアセンブリに向かって近位方向に後退するように、及び、該ハンドルアセンブリから離れて遠位方向に延長するように、更に構成されている、実施態様16に記載の外科用システム。
(18) 前記エンドエフェクタは戻りプローブを更に含み、該戻りプローブと前記電気刺激プローブの両方が前記手術部位で組織に接触すると、該電気刺激プローブと該戻りプローブとが回路を完成させ、該戻りプローブは前記非治療的エネルギーの電気的戻り経路として働く、実施態様16に記載の外科用システム。
(19) 前記電気刺激プローブは、前記エンドエフェクタの第1の側面に実質的に近い輪郭になるよう構成され、該エンドエフェクタの該第1の側面は、前記第1及び第2のジョーによって画定される該エンドエフェクタの遠位先端の第1の部分を含む、実施態様16に記載の外科用システム。
(20) 前記エンドエフェクタは、前記第1の側面に対向する、該エンドエフェクタの第2の側面に実質的に近い輪郭になるよう構成された戻りプローブを更に含み、該エンドエフェクタの該第2の側面は、前記第1及び第2のジョーによって画定される該エンドエフェクタの前記遠位先端の第2の部分を含み、該戻りプローブと前記電気刺激プローブの両方が前記手術部位で組織に接触すると、該電気刺激プローブと該戻りプローブとが回路を完成させる、実施態様15に記載の外科用システム。
(21) 前記治療的エネルギーは単極であり、かつ、前記戻りプローブは更に、前記治療的エネルギーの電気的戻り経路として働く、実施態様18に記載の外科用システム。

Claims (2)

  1. 外科用器具であって、
    ハンドルアセンブリと、
    該ハンドルアセンブリに通信可能に連結され、かつ第1及び第2のジョーを備えるエンドエフェクタとを含み、
    該ハンドルアセンブリは、該第1及び第2のジョーを操作して、開位置及び閉位置を画定するよう構成されており、
    該エンドエフェクタは、
    手術部位で、神経組織ではなく血管組織を封止又は切断するために、より高いエネルギーレベルで治療的エネルギーを送達するように構成されており、かつ、
    該手術部位で神経組織に電気刺激を与えるために、より低いエネルギーレベルで非治療的エネルギーを送達するように構成されており、
    前記エンドエフェクタが、前記手術部位で前記神経組織を刺激するために前記非治療的エネルギーを送達するように構成されており、前記第1及び第2のジョーと接触していない電気刺激プローブを更に含
    前記エンドエフェクタは戻りプローブを更に含み、該戻りプローブと該電気刺激プローブの両方が前記手術部位で前記神経組織に接触すると、該電気刺激プローブと該戻りプローブとが回路を完成させ、該戻りプローブは前記非治療的エネルギーの電気的戻り経路として働き、
    該電気刺激プローブおよび該戻りプローブの内の一方は、該第1及び第2のジョーの内の一方における一方の側面である第1の外周面に接触せず、該第1の外周面の輪郭に沿って配置されており、該電気刺激プローブおよび該戻りプローブの内の他方は、該第1及び第2のジョーの内の該一方における他方の側面である第2の外周面に接触せず、該第2の外周面の輪郭に沿って配置されており、前記戻りプローブおよび前記電気刺激プローブは、隙間によって分離されており、該隙間内にスペーサが配置されている、外科用器具。
  2. 前記電気刺激プローブは後退可能であり、かつ、前記ハンドルアセンブリに向かって近位方向に後退するように、及び、該ハンドルアセンブリから離れて遠位方向に延長するように、更に構成されている、請求項1に記載の外科用器具。
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US20200078085A1 (en) 2020-03-12
US20240216042A1 (en) 2024-07-04
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US11864820B2 (en) 2024-01-09
US20170319265A1 (en) 2017-11-09
WO2017192377A1 (en) 2017-11-09
JP2019521724A (ja) 2019-08-08
JP2021130030A (ja) 2021-09-09
EP3451949B1 (en) 2022-07-06
CN109414274B (zh) 2021-10-26
US10456193B2 (en) 2019-10-29
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