JP3857357B2 - 手術機器 - Google Patents
手術機器 Download PDFInfo
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- JP3857357B2 JP3857357B2 JP14777296A JP14777296A JP3857357B2 JP 3857357 B2 JP3857357 B2 JP 3857357B2 JP 14777296 A JP14777296 A JP 14777296A JP 14777296 A JP14777296 A JP 14777296A JP 3857357 B2 JP3857357 B2 JP 3857357B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical 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
- A61B18/1206—Generators therefor
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
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- A—HUMAN NECESSITIES
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- A61B18/12—Surgical 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
- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
- A61B18/1447—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod wherein sliding surfaces cause opening/closing of the end effectors
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- A61B17/115—Staplers for performing anastomosis in a single operation
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- A61B2017/2923—Toothed members, e.g. rack and pinion
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- A61B2017/2926—Details of heads or jaws
- A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
- A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
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- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/032—Automatic limiting or abutting means, e.g. for safety pressure limiting, e.g. hydrostatic
Description
【発明の属する技術分野】
本発明は、外科手術、特に内視鏡手術において焼灼、凝集および/または組織溶接に用いられる電気手術具のためのロック機構及び処置方法に関する。
【0002】
【従来の技術】
組織の切開を要する外科手術においては、その切開箇所において出血を余儀なくされ、出血の制御に関しては、血管の縫合、クリップ止め、ホチキス止め、あるいは電気焼灼や他の組織加熱技術など手術の技術が開発され、それぞれ一定の成功を収めている。そして、組織のつなぎ合わせあるいは溶接、組織の修復および創傷部の閉止技術が進歩したため、以前は不可能であるかあるいはきわめて危険の大きかった手術も行えるようになった。
【0003】
外科用ホチキス装置は、組織の固着、接合および近置のため、ならびに組織の切開時に止血を達成するために使用されている。このホチキス装置には、例えば直線状および円形の切断・ホチキス装置がある。直線状の切断装置は、典型的には平行なステープル(ホチキス針)列と、このステープル列の間を行き来する切断手段用のスロット(長細の溝)を具備する。この型の外科用ホチキス装置は、切断手段が平行なステープル列の間で切断を行う際に、切断をよりうまく行えるように組織を固定し、組織の層をつなぎ合わせ、切断箇所を取り囲む組織層に平行なステープル列を適用することによって止血を与える。ところで、これらのホチキス装置においては、単発型ステープルカートリッジの再射出を防止するためにロック機構が提案されている。
【0004】
電気手術装置は、組織や血管を加熱して凝集や焼灼を生じさせ、より良好な止血を与えるために用いられる。米国特許第5,403,312 号は、組織を挟み付けて、この組織に電気手術エネルギーを送り組織を切断するクランプ・切断装置を開示している。また、この装置に挟み付けられて組織にステープルを適用するより好ましい態様も知られている。超音波、レーザ、熱線、赤外線など他の組織加熱エネルギーを使って組織を切断・凝集させる他の装置も使用されてきた。
【0005】
例えば、止血を与える前に、切断してしまうなど、止血を与えながら切断および/またはホチキス止め機能を発揮する組織加熱装置を用いる際、これらの機能を不適切なまでに連続的に適用することのないよう、止血を与える組織加熱装置を制御する手段を開発することが望ましい。また、組織加熱エネルギーを適用する前にステープルカートリッジが空になったり、組織の処置が完了していないときには、装置の使用を停止させる手段も望まれている。
【0006】
【発明が解決しようとする課題】
そこで、本発明は、装置の適切な連続作動を確保するため、止血を与えながら組織を取扱うロック機構付きの装置及び処置方法を提供することを目的とする。
【0007】
【課題を解決するための手段】
本発明の好ましい態様は、治療エネルギーを組織と組織操作装置に供給する治療用エネルギー供給装置を有する組織処置部を備えた手術装置を提供する。治療用エネルギーは、組織に加熱、切断、凝集、溶接、焼灼などの治療効果を与えるよう組織に処置を施すために用いられる例えば電気手術エネルギー、熱エネルギー、光エネルギー、超音波エネルギーなどのエネルギーである。組織操作装置は、機械的手段あるいは組織に切断、切開、つなぎ合わせ、締め付け、クリップ止め、ホチキス止めなどの機械的効果をもたらす手段を使って組織を治療し、また取扱うために使用される装置である。
【0008】
この好ましい態様における組織治療部は、シャフトに連結される。シャフトは、治療用エネルギーを、組織治療部にある治療用エネルギー供給装置に送る治療用エネルギー導通装置を備える。そのようなエネルギー導通装置は、電気エネルギーを電極あるいはヒータに送るワイヤあるいは導電体と、超音波エネルギーを送る金属製のシャフト、レーザあるいは光エネルギーを送る光ファイバなどを具備する。
【0009】
組織操作作動装置は組織操作装置を作動させ、ロック機構は組織操作作動装置をロック位置から非ロック位置へ、あるいはその逆方向に移動させる。好ましくは、この作動や移動は、組織に治療用エネルギーを供給し始めるかあるいは供給を完了した後に行うのがよい。
【0010】
この好ましい態様においてはさらに、組織治療の状態(例えば溶接や凝集が完了したこと)を知らせるフィードバック信号を送る組織のパラメータを測定し、装置を制御する装置を備える。この組織のパラメータを測定し、装置を制御する装置は、組織治療部に連結され、エネルギー供給装置に供給されるエネルギーを制御したり、組織操作装置を作動させたり、これらの特徴のいずれか一つを発揮もしくは抑止することにより、あるいは装置を連続的に操作したりあるいはユーザに操作させることにより、これを直接または間接に制御する。以下には、本発明の種々の特徴を記載した。
【0011】
本発明の一様相によれば、特に切断路に沿って組織溶接、凝集あるいは焼灼を行うエネルギー供給手段を備えた切断装置が提供される。また、本発明は、凝集、焼灼あるいは溶接が完了した後治療用エネルギーが印加されるまで切断あるいは切断装置の作動を防止するロック機構も提供する。
【0012】
本発明は手術装置以外の装置も企図するものであるが、好ましい態様においては、電気手術エネルギーを用いる。したがって、以下では、本発明は電気手術装置として使用するものとして記載を進める。
【0013】
本発明の種々の態様においては、電気手術エネルギーは、ステープル、クリップ、生体吸収性ファスナなどの一もしくはそれ以上の組織用ファスナとともに、ステープルを組織に打ち込むドライバなどのファスナを適用するアプライヤ(applier) を用いながら適用される。切断・ホチキス止め装置を用いるときは、ロック機構は好ましくは、電気手術エネルギーが印加させるまでステープルの射出を抑え、また一旦ステープルが射出されたらサイドの射出を防止するのがよい。したがって、本発明の一態様に係るロック機構は、高周波エネルギーの印加のない、あるいは適切な止血がない、切断部材やステープルドライバの作動を防止し、また使用済みのステープルカートリッジの再射出を防止する。
【0014】
これら本発明の目的は、電気手術装置が、組織を間に挟むための相対向するインターフェース面と二つの電気的に対極をなす電極、および対応する各極の電圧を具備し、電極の少なくとも一方は、相対向するインターフェース面の一方もしくは両方に設けられる末端作動部を備えた好ましい態様について説明される。好ましくは、二つの電極は、インターフェース面に関して互いに食い違わせる。すなわち、両電極は、相対向するインターフェース面の上で径方向に向かい合うことのないよう互いに食い違わせる。
【0015】
本発明の好ましい態様に係る電気手術装置は、第1のインターフェース面と第2のインターフェース面の間にある圧縮ゾーンで組織を圧縮し、圧縮ゾーンを介して電気エネルギーを印加する。第1のインターフェース面は、バイポーラ型エネルギー源の第1の極に対応する第1の電極と、同じエネルギー源の第2の極に対応する第2の電極を含む。第2の電極は、第1の電極と同じインターフェース面あるいは反対のインターフェース面に設けられる。この特別な態様においては、圧縮ゾーンは、組織を他のインターフェース面に対して圧縮する一または二個のインターフェース面に設けられる圧縮用の突起によって区画される領域である。凝集ゾーンは、第1の電極、第2の電極および、第1の電極と第2の電極を絶縁する絶縁材によって区画される。
【0016】
好ましい態様の一つにおいては、線形切断機械ホチキス装置に類似した直線状切断装置に止血装置が組み込まれる。この態様の場合は、止血装置は、二つの長手電極棒と、切断手段が装置の末端作動部に把持されている組織を切断するためのスロットを具備する。電極棒は好ましくは、焼灼する組織を圧縮するための突起を具備する絶縁材の横方向に隣接しているのがよい。所望により、組織加熱中における機械的な組織の固定と近置のため、一またはそれ以上のステープル列をスロットと電極棒の各側に設ける。装置を扱う際には、組織を二つの顎の間に挟み付ける。電気エネルギーは、焼灼のため、高周波の形で、圧縮された組織に印加される。この場合、装置は、切断部材が通る道筋に隣接して止血線を与える。本発明に関しては、管内円形切断装置など他の切断・ホチキス止め装置も用いることができる。
【0017】
本発明のロックアウト機構は、機械的、電気的および電気機械的ロック部材を備えることができ、コントローラから送られてくる制御信号に応答して作動される。
【0018】
本発明の一態様においては、組織が所望のあるいは所定の程度まで焼灼されたことを、指示器がユーザに伝える。好ましい態様においては、測定した組織インピーダンスに基づいて組織の凝集状態を確認するため、組織インピーダンスのセンサが装置に組み込まれる。組織インピーダンスのセンサは、組織の治療状態に基づいて制御信号を与えるコントローラを具備する。制御信号は、電源装置の制御や、ロック機構の電気的制御、および/またはユーザが感知できる信号を与えるのに使用される。
【0019】
【発明の実施の形態】
本発明の上述の目的は、添付の図面を参照した以下の発明の詳細な説明により、よりよく理解できるであろう。
【0020】
本発明は、モノポーラ、バイポーラおよびマルチポーラ(どの極からどの極まででも測定できる位相関係をもつ波形のエネルギーを与える二個以上の治療用電極を含む)を含む在来型および内視鏡手術用の種々の電気手術装置に適用できるが、本明細書では内視鏡手術用バイポーラ型直線状切断・ホチキス装置について説明する。
【0021】
直線状切断・ホチキス装置の操作方法は業界でよく知られており、例えば米国特許第4,408,981 号および同第4,633,874 号に記載されている。
【0022】
図1〜17には、インピーダンスフィードバック回路とともに用いられる本発明の一態様に係る切断・ホチキス装置を示す。この内視鏡手術用直線状切断・ホチキス装置10は、管腔が走る鞘30に連結されたハウジング16と、鞘30の遠位端から延びる末端作動部15を備える。末端作動部15は、相対向する顎部材32,34から構成される第1の部材と第2の部材を備える。顎部材32は、顎部材34に対して移動可能に固着される。ハウジング16は、両顎部材32,34を閉止するためのクランプトリガ12と、高周波エネルギー投入用のスイッチ59に連結された高周波スイッチ戻り止めアーム58とスイッチ片67a,67b、および切断部材11をステーション17を適用するためのウェッジ13と組織を通して進める射出トリガ14を有する。顎部材32,34は、非クランプ位置にあるものが図1に示してある。また、電気手術エネルギーの印加前で、かつ切断とホチキス止めを行う前のクランプ位置にあるものが図2に、電気手術エネルギーを印加した後で、かつ切断とホチキス止めを行う前のクランプ位置にあるものが図3に、そして切断とホチキス止めを行った後のクランプ位置にあるものが図4にそれぞれ示してある。
【0023】
顎部材32は、アンビル18、顎部材32の長さ方向に延びるU字形治療用電極39および、治療用電極39の外側を包囲するU字形絶縁材料31を備える。顎部材32は、顎部材34の内面35とほぼ向かい合う内面33を有する。U字形電極39は、顎部材32の内面33上にあってこの長さ方向にほぼ沿いながら延びる第1の極を形成する二つの電気的に連通する電極棒27,28を備える。U字形電極39は、アルミニウムあるいは手術用グレードのステンレススチール等の導体から形成される。U字形絶縁材は、ポリフェニレンオキシドなどのポリマーで形成するのが好ましい。電極棒27,28は、電極39の中央部を通って軸方向に延びるナイフチャネル29によって離隔される。アンビル18の上に位置するステーション端収納用のポケット36は、電極39の各側上にステーション列を形成するよう、電極棒27,28の外側で長さ方向に沿って、また内面33に沿って配置される。電極棒27,28と絶縁材31は、内面33(図16)のアンビル部33aに対して盛り上がった隆起線56を形成する。電極39は、バイポーラ型組織処置あるいは治療システムの第1の極として働く。アンビル18は、導電材料から形成され、バイポーラ型組織処置あるいは治療システムの第2の治療極として働く。アンビル18は処置電極39とは電気的に反対の極をなす。アンビル18は、U字形絶縁材31によって電極39から電気的に絶縁される。
【0024】
顎部材34は、カートリッジチャネル22と、このカートリッジチャネル22に取り外し可能に挿入されるカートリッジ23を備える。カートリッジ23は、ウェッジ13用のトラック25と、カートリッジ23の中心を通って軸方向に延びるナイフチャネル26、トラック25まで延びる一連のドライバ24、および単一の列からなる二つのセットに構成されたステープル17を有する。
【0025】
鞘30は絶縁材から形成され、その管腔を通って延びる導電性の閉止チューブ38を有する。好ましい態様においては、閉止チューブ38は、顎閉止チューブおよび電気的接触片として働く。チャネル保持器27aは、閉止チューブ38の手前端から延び、チャネル37に固定されて、顎34を形成するよう閉止チューブ38の残りの部分から遠方側に延びる。チャネル37は、閉止チューブ38から遠方側に延びるカートリッジチャネル22を含む。
【0026】
本体16は、組織を間に挟んでこれに係合する顎32,34を互いの方向に向けて閉止すべく、閉止チューブを進めるためのクランプトリガ12を備える。クランプトリガ12が回転すると、閉止チューブ38は、顎32のカム面32aの上方で鞘30を通って同軸的に進み、両顎32と34の間に位置する組織に対して、両顎32,34を閉止させる。
【0027】
チャネル保持器37aは、チャネル37内にあるドライブロッド41の同軸的な動きを案内する。ドライブロッド41は、以下に詳述するように、射出トリガ14の回転によって押し進められる。ドライブロッド41は、その遠位端で、ブロック43に連結される。ブロック43は、切断手段11とステープルドライブウェッジ13に連結され、ドライブロッド41は、ブロック43を介して末端作動部15の中に入り込む。ウェッジガイド46は、ウェッジ13をトラック25へ案内するのに用いられる。顎部材32は、チャネル37を介して顎部材34に固着される。
【0028】
ドライブロッド41が切断部材11を押し進めると、切断部材11は、組織の焼灼が済んだときは、両顎32,34に係合した組織を切断するよう、電極棒27と28の間をナイフチャネル26を通って進む。したがって、切断線は、電極棒27,28によって形成された凝集線の中間にできる。ドライブロッド41はブロック43を進めるが、そうするとドライバ24をステープルまで動かすウェッジ13も同時に進んで、ステープルを組織を貫通して射出させ、アンビル18のポケット36まで進める。ステープル17は、切断部材11が組織を切断するとき、切断部材11の各側において長手の単一の列の形で適用される。
【0029】
本体16の遠位端に位置するノブ44は、閉止チューブ38、チャネル保持器37a、チャネル37および末端作動部15を回転させるが、これらは直線間接にノブ44に連結しており、ノブ44は、末端作動部である顎部材32,34を回転させるために使用される。ノブ44は、刻み38aをもつ閉止チューブ38に合わさって係合するペグ(図示せず)を備える。閉止チューブ38は、その手前端において、ハウジング16に嵌る。
【0030】
電気エネルギーは、以下に説明する接続部材や、例えば米国特許第5,403,312 号にあるような他の接続手段を介して、電極39とアンビル18,70に供給される。電源装置70は、ハウジング16にある高周波スイッチ59を介してユーザにより制御される。ワイヤ19c,19dは、スイッチ59から下記の電源装置70内のコントローラまで延びる。
【0031】
ワイヤ19aと19bは、装置の本体16まで延び、それぞれ電極39と18にエネルギーを供給する。ワイヤ19a,19bはそれぞれ、低インピーダンス接触部材20a,20bに接続され、一方この低インピーダンス接触部材20a,20bはそれぞれワイヤ47a,47bに接続する。ワイヤ47a,47bは、各遠位端48a,48bが露出する。ワイヤ47aと47bはそれぞれ、閉止チューブ38と接触リング49bと電気的に接触するよう、チャネル保持器37aの手前端に位置する閉止チューブ38と接触リング49bに向けて偏らされる。
【0032】
ワイヤ19は、導電性の閉止チューブ38に接触する第1のワイヤ47aを介してアンビル18に電流を送る。閉止チューブ38は、閉止チューブ38が両顎32,34を閉止するときに、導電性のアンビル18に接触する。
【0033】
ワイヤ19bは、第2のワイヤ47bを介して電極39に電流を送る。第1のワイヤ47bは、閉止チューブ38を通って電極39まで延びるワイヤ40bに連結する接触リング49bに接触する。
【0034】
閉止チューブ38とリング状接触片49bは、閉止チューブ48、リング状接触片49bおよびワイヤ47a,47bとそれぞれ接触している間は、ノブ44を回転させる。リング状接触片49bは、閉止チューブ38からは電気的に絶縁される。
【0035】
ワイヤ40bは、チャネル保持器37aに嵌り込む封止部材45を通って延びるが、チャネル保持器37aは、閉止チューブ38にはめ付けられる。
【0036】
クランプトリガ12は、ヨーク66の歯66bと噛み合う歯車の歯12aを備える。ヨーク66は、その遠位端で閉止チューブ38に連結する。クランプトリガ12が作動すると、歯車の歯12aは、ヨーク66の歯66bに係合し、ヨーク66を遠方側に進める。閉止チューブ38は、顎32のカム面32aの上方に進むとき、両顎32,34を閉止する。
【0037】
高周波スイッチ59は、治療電極に供給される高周波エネルギーを投入すべく回転する。高周波スイッチ59が回転すると、スイッチ59にある爪の突起59aが戻り止めアーム58の突起58aの下に引っ掛かり、高周波スイッチ59が手動で下の位置に戻される場合以外は、スイッチ59が高周波エネルギーの供給を遮断するのを防止する。高周波エネルギーはまた、電気的に遮断することもできる。
【0038】
スイッチ59は、可動接触片67aと静止接触片67bを備える。可動接触片67aは、スイッチが投入されたときは、静止接触片56bと接触するよう、スイッチ59とともに回転する。信号は、静止接触片67bおよび可動接触片67aとそれぞれ連結しているワイヤ19c、19dを通って電源装置70に送られる。
【0039】
リリースボタン60の棚60aは、ヨーク66の手前端にある階段状の棚66aに隣接するヨークの手前端と整合する。ヨーク66がクランプトリガ12によって押し進められると、棚60aはヨーク66の手前端の背後へ下向きに回転し、リリースボタン60が押されるまで、ヨーク66が後退するのを防止する。したがって、顎32,34は、ユーザがリリースボタン60を押して両顎32,34を開放するまで、閉止位置にとどまる。
【0040】
スイッチ59は、ヨーク66の手前端のちょうど上に載るフィンガー59cを備える。リリースボタン60の棚60aは、フィンガー59cの間にちょうど嵌る。高周波スイッチ59は、スイッチ59のフィンガー59cがヨーク66の手前端の後方へ自由に回転できるようヨーク66が遠方側に押し進められるまで、投入、すなわち前方に回転させることはできない。
【0041】
スイッチ59はまた、射出ラック53の溝53aに係合する下方フック59bを有する。射出ラック53は、射出トリガ14の歯14aが係合する歯車の歯53bを具備する。射出ラック53は、その遠位端で、ピニオン54と噛み合い、ピニオン54はドライブロッド41に係合する。
【0042】
射出トリガ14が引かれると、射出ラック53は遠方側に進み、ドライブロッド41を遠方側に進めるピニオン54を回転させる。すると切断部材11が作動し、ステープル17は末端作動部15が係合する組織に向けて打ち込まれる。
【0043】
しかし、射出ラック53は、高周波スイッチの下方フック59bが射出ラック53の溝53aから外れるまで前進することはできない。これは、高周波スイッチ59が投入された後にのみ生ずる。
【0044】
したがって、本明細書で述べる装置は、両顎32,34が閉止するまで、高周波の印加、ステーションあるいはナイフの作動を防止するロック機構を備える。このロック機構を扱うには、図1〜4と図18に示し、また以下に詳しく述べる適切な手順を踏むことが必要である。
【0045】
本発明はまた、高周波エネルギーが連続的に印加されるように、スイッチ59が手動で解除されるかあるいは高周波エネルギーが例えば電源装置70に送られる電気的なフィードバック制御信号によってスイッチを遮断されるまで、爪付きの高周波スイッチを提供する。
【0046】
閉止トリガ12と射出トリガ14はインターロックされ、ばね57は両トリガ12,14に機械的に連結される。
【0047】
組織が両顎32,34の間に挟み付けられ、高周波エネルギーが印加されると、ハウジング16にある射出トリガ14は、切断部材11を係合した組織を貫通して進め組織を切断すべく作動される。同時に、射出トリガ14が作動されると、ウェッジ13は、トラックを通って押し進められ、ドライバ24をステーション17に向けて変位させる。この結果、ステーション17は組織を貫通して、アンビルのポケット36まで押し出される。
【0048】
本発明の好ましい態様は、所望のあるいは所定の組織に対する効果が得られたらこれを知らせるべく設計されたフィードバックシステムを含む。高周波エネルギーを遮断してもよい十分な焼灼が得られたときにこれを知らせるフィードバックシステムとしては、聴取可能、視覚でとらえ得る、触ることができるあるいはその他のフィードバックシステムを用いることができる。特別な態様においては、フィードバックシステムは、組織の特性、例えば凝集が完了したかを判断するため、システムの一またはそれ以上の電気的なパラメータ、例えば電気エネルギーを印加する組織のインピーダンスなどを測定する。そのようなフィードバックシステムの例は、米国特許出願第08/311,297号(1994年9月23日出願)に記載してある。
【0049】
そのようなフィードバックシステムを使うと、高周波エネルギーを遮断するため、電気信号が与えられる。そのような電気信号は、ロック機構を電気的に解放するために用いられ、切断部材を作動させ、あるいはステープルを適用させる。高周波が遮断された後は、射出トリガ14を使うことにより、切断部材11を前進させ、ステープル17を射出させることができる。
【0050】
ある態様においては、カートリッジは、ステープルについて、これまでの腹腔鏡手術用ホチキス止め・切断装置で用いられている二重列ではなく、単一列を備えることによってステープルの多重射出能力をもつ。よりよい止血を与えるため、この種のホチキス装置は、これまで互いに平行なステープルの二重列を用いるよう設計されていた。すなわち、ステープルの二重列を納めるために必要なスペースの大きさを考えて、ステープルのスタックを形成するためにはさらにスペースが必要となることから、スタック状のステープルを納めた再射出可能なカートリッジは、好ましいものとはされていなかった。しかし、ステープルを多重射出する態様においては、ステープルの単一列を用いる。ステープルの単一列を用いると、以前はステープルの第2列に占有されていたスペースに、ステープルのスタックを形成することが可能になり、多重射出能力が得られる。しかし、本発明の装置は、所望ならば、二重、三重その他のステープル列を納めることもできる。また、ステープルが必要なく、電気凝集線が必要な止血あるいは組織の溶接硬化を与える態様もある。カートリッジは、本明細書では、ステープル収納機構を意味する。
【0051】
図18は、図1〜17に示した装置の好ましい操作方法である。装置10の両顎32,34は、ボタン60を押すことによって開放される(ブロック501)。カートリッジ22は、使い切った場合は、交換する(ブロック501,502)。ついで、両顎32,34を組織にあてがう(ブロック503)。装置10(両顎32,34)はついで、トリガ12を作動して閉止させる(ブロック504)。装置が完全に閉止されていない場合は、高周波ロックアウト機構はそのままの位置にとどまり、高周波は印加されない(ブロック505)。そして装置は、組織に再配置されるか、またはもう一度閉止される。装置が完全に閉止されている場合は、高周波スイッチ59を投入して高周波を印加する(ブロック506)。高周波スイッチ59を印加すると、切断・ホチキス止めロック機構は解除される(ブロック507)。高周波エネルギーが印加されると、組織の処置が行われ、処置の完了が監視される。そして、組織の処置が完了するとこれを組織処置完了信号がユーザに知らせ、電源装置から出力される高周波エネルギーはこれに対応する電源装置制御信号によって制御される。(ブロック508)。こうして、ユーザは、トリガ14を引くことにより、切断とホチキス止めを行うことができる(ブロック509)。
【0052】
図19〜21は、本発明に係るロック機構のもう一つの態様を示す。ハンドルあるいはハウジング116は、クランプトリガ112と射出トリガ114を備える。クランプトリガ112は、図1〜17に示した閉止チューブと同じような閉止チューブ(図示せず)を、ヨーク116の歯116bとクランプトリガの歯車の歯112aを噛み合わせることによって、押し進めるよう設計される。ヨーク116が遠方側に進むと、閉止チューブは末端作動部の両顎を、図1〜17に示した顎部材と同様な方法で閉止する。
【0053】
高周波スイッチ159は、高周波エネルギーを装置の末端作動部(図示せず)に供給するため、ユーザが操作する。(この態様における装置の末端作動部は、図1〜17のそれと同じである。)高周波スイッチは、例えばハンドル116に取り付けることもできるし、フットスイッチにすることもできる。高周波スイッチ159は、電源装置に、末端作動部にエネルギーを送るよう信号を出す。
【0054】
高周波装置はまた、両顎が閉止、すなわちヨークが遠方側へ進むまで、ハンドル上のスイッチを作動させることができない図1〜17のスイッチと同じような働きをする高周波スイッチを備えることもできる。
【0055】
電源装置は、末端作動部で処置している組織のインピーダンス情報を受け取るように構成される。そのような装置と方法は、本出願人の米国特許出願第08/311,297号(1994年9月23日出願)に記載してある。電源装置が組織インピーダンスのフィードバックを使って凝集完了の条件を検出すると、下記のメカトロ式ロックアウト機構に信号が送られる。
【0056】
この態様におけるメカトロ式ロックアウト機構は、電源装置170からワイヤ181を通じて電気信号を受け取る電磁操作機構(ソレノイド)180を備える。ソレノイド180は、ワイヤ181を通じて送られてくる適当な信号に応答して下降する可動端182を含む引張り式ソレノイドである。ソレノイド180の端182は、ピン184を通じて機械式のレバー183に連結される。レバー183は、爪のついたノブ186に引っ掛かるフック185を備える。ロック位置においては、フック185は、射出ラック153の溝153aに係合する。射出ラック153は、射出トリガ114の歯車の歯114aに係合する歯車の歯153bを具備する。射出ラック153は、末端作動部における切断部材とステープルドライバを、図1〜17について説明した方法とほぼ同じ方法で前進させる役割を果たす。
【0057】
クランプトリガ112を使って両顎が閉じられ、フットスイッチ159を使って高周波エネルギーが投入されると、ソレノイド180がレバー183を引っ張り、フック185を射出ラック153の溝153から離れる方向に回転させるよう、ワイヤ181を使ってソレノイド180へ信号を送らなければならない。こうすると、射出ラック153が解放されて遠方側へ進めるようになる。電源装置170に組み込まれた組織モニタは、インピーダンスフィードバックモニタを使って、凝集が完了したかどうかを確認する。凝集が完了したらすぐに、ワイヤ181からソレノイド180へ制御信号を送り、ソレノイドの端部182をソレノイド180の中へ引き込ませる。こうなると、レバー183がフック185をラック153から離れるように回転させる。レバー183にある爪186は、ハウジングにある爪187に係合し、レバー183をラック153から引き離した状態で保持する。
【0058】
ステープルが射出された後は、両顎を閉止位置から解放し、装置を組織から引き離すため、リリースボタン160を押さなければならない。リリースボタン160は、これを押したときレバー183にある棚162に係合するフィンガー161を備える。フィンガー162は、棚162に上向きの力を与えるが、こうするとレバー183は爪187から解放され、射出ラック153の溝153aをレバー183のフック185と再度係合させる。
【0059】
図22には、図19〜21に示した装置を操作する方法を示す。装置110の両顎は、リリースボタン160を押すことによって開放される(ブロック600)。カートリッジは、使い終わったら交換する(ブロック601,602)。ついで、装置の両顎を組織にあてがい(ブロック603)、トリガ112によって閉止する(ブロック604)。そして、ユーザが両顎が組織に適切にあてがわれていると判断したら(ブロック605)、フットスイッチ159を投入して高周波エネルギーを印加する。組織は、組織モニタフィードバック装置(例えば米国特許出願第08/311,297号に記載した装置)を使って、処理が完了したかどうかを監視される(ブロック606,607)。そして、処理が完了したときは、組織処理完了信号が送られる。さらに、組織処理が完了したときは、高周波エネルギーも遮断され(ブロック609)、ソレノイド180も切断・ホチキス止めロックアウト機構を解除すべく作動される(ブロック610)。この後、切断・ホチキス止め機構が作動される(ブロック610)。
【0060】
以上、電気手術用止血装置と内視鏡手術用切断・ホチキス止め装置を含む本発明の特定の態様に関連して、種々の変形例も説明してきた。当然のことながら、本発明は、止血が求められる多くの用途に適用することができる。また、ここで説明したロック機構は、装置で組織を切断・ホチキス止めする前に組織処置エネルギーを使用するような多くの装置に使用することができる。組織の切断、ホチキス止めあるいは他の組織の機械的な操作の前に、超音波エネルギー、熱エネルギー、レーザエネルギー、赤外線エネルギー等、種々の止血エネルギーが使用される。また、応答性の電気−機械フィードバック信号を与えるため、種々の組織モニタ用パラメータあるいは手段が用いられる。例えば、電気インピーダンス、機械インピーダンス、温度あるいは光の吸収もしくは反射などがフィードバック信号を生成するためのフィードバック用パラメータとして用いられる。したがって、特許請求の範囲に謳った本発明の範囲内で、種々の変更・変形例を生み出すことができることは、当業者ならば理解できるであろう。
【0061】
本発明の具体的な実施態様は以下の通りである。
(I)手術装置であって、
組織に治療用エネルギーを供給する治療用エネルギー供給装置と組織取扱い装置を備える組織処置部と、
前記組織処置部に連結されるシャフトであって、前記治療用エネルギー供給装置に操作可能に連結され、組織に治療用エネルギーを供給するため前記治療用エネルギー供給装置とともに作動される治療エネルギー導通装置を備えるシャフトと、
ロック位置と非ロック位置を有し、前記シャフトを通って延びながら前記組織取扱い装置に操作可能に連結される組織取扱い作動装置と、
組織に治療用エネルギーを供給するため前記治療用エネルギー供給装置と治療用エネルギー導通装置が作動された後、前記組織取扱い作動装置を前記ロック位置から非ロック位置まで移動させるため、前記組織取扱い装置に連結されるロック機構を備える装置。
1)前記治療用エネルギー供給装置によって処置を施されている組織の処置状態を表すフィードバック信号を与えるよう構成され、前記装置の組織処置部と連結する、組織パラメータ測定・機器制御装置をさらに備える、実施態様(I)記載の手術装置。
2)前記組織パラメータ測定・機器制御装置に連結された状態指示器であって、組織の処置状態を指示するユーザが感知可能な信号を与えるように配された状態指示器をさらに備える、上記実施態様1)記載の手術装置。
3)前記組織の処置状態は完了した凝集状態である、上記実施態様2)記載の手術装置。
4)前記ロック機構は、前記組織パラメータ測定・機器制御装置に操作可能に連結され、前記フィードバック信号を受け取って、このフィードバック信号が組織状態が適当との指示した場合は、このフィードバック信号に応答して前記組織操作作動装置を前記ロック位置から非ロック位置へ移動させる電気機械式装置を備える、上記実施態様1)記載の手術装置。
5)前記組織の処置状態は所望の程度まで完了した凝集状態である、上記実施態様4)記載の手術装置。
【0062】
6)前記組織操作装置は、組織切断装置を備える、実施態様(I)記載の手術装置。
7)前記組織操作装置は、組織にファスナを適用する装置をさらに備える、上記実施態様6)記載の手術装置。
8)前記組織にファスナを適用する装置は、組織ステープル装置である、上記実施態様7)記載の手術装置。
9)前記治療用エネルギー供給装置は、前記電気手術系電極における電極の少なくとも一個を備え、前記治療用エネルギー供給装置は、前記少なくとも一個の電極に電気手術エネルギーを供給するための電気手術エネルギー導通手段を具備する、実施態様(I)記載の手術装置。
10)前記組織パラメータ測定・機器制御装置は、組織の電気インピーダンスを測定する装置である、上記実施態様1)記載の手術装置。
【0063】
(II)電気手術装置であって、
遠方端を有するシャフトと、
前記シャフトの遠方端に位置し、電気手術用のエネルギーを受け取る終端効果器であって、
それぞれ第1および第2の相対向する組織接触面を有する第1および第2の部材であって、前記二つの組織接触面は、組織を間に置く開放・離隔位置から、組織に係合する閉止位置まで互いに移動可能であり、これら組織接触面の一方の少なくとも一部は導電性で電気手術用エネルギーを受け取るべく配置される第1および第2の部材ならびに、
前記終端効果器に係合した組織を切断すべく移動する切断部材を備える終端効果器と、
前記切断部材に操作可能に連結される作動装置であって、前記シャフトを通って前記切断部材まで延び、組織を切断するよう前記切断部材を作動させるべく配置される作動装置と、
前記作動装置に操作可能に連結されるロック機構であって、前記切断部材の作動を防止 するため前記作動装置に係合する第1の位置と、前記切断部材を作動させるため前記作動装置を解除する第2の位置を有するロック機構を具備する電気手術装置。
11)前記ロック機構は電気機械式の装置を具備する、実施態様(II)記載の手術装置。
12)少なくとも一個の電極によって処置を施されている組織の処置状態を表すフィードバック信号を与えるよう構成され、前記装置の末端作動部と連結する、組織パラメータの測定と組織の制御を行う装置をさらに備える、実施態様(II)記載の電気手術装置。
13)前記組織パラメータ測定・機器制御装置に連結された状態指示器であって、組織の処置状態を指示するユーザが感知可能な信号を与えるように配された、状態指示器をさらに備える、上記実施態様12)記載の電気手術装置。
14)前記組織の処置状態は完了した凝集状態である、上記実施態様13)記載の電気手術装置。
15)前記ロック機構は、前記組織パラメータ測定・機器制御装置に操作可能に連結され、前記フィードバック信号を受け取って、このフィードバック信号が組織状態が適当との指示をした場合は、このフィードバック信号に応答して前記ロック機構を前記第1の位置から第2の位置へ移動させる電気機械式装置を備える、上記実施態様12)記載の電気手術装置。
(III)組織に手術によって処置を施す方法であって、
組織に治療用エネルギーを供給する治療用エネルギー供給装置と組織取扱い装置を備える組織処置部と、
前記組織処置部に連結されるシャフトであって、前記治療用エネルギー供給装置に操作可能に連結され、組織に治療用エネルギーを供給するため前記治療用エネルギー供給装置とともに作動される治療エネルギー導通装置を備えるシャフトと、
ロック位置と非ロック位置を有し、前記シャフトを通って延びながら前記組織取扱い装置に操作可能に連結される組織取扱い作動装置と、
組織に治療用エネルギーを供給するため前記治療用エネルギー供給装置と治療用エネルギー導通装置が作動された後、前記組織取扱い作動装置を前記ロック位置から非ロック位置まで移動させるため、前記組織取扱い装置に連結されるロック機構を備える手術装置を提供する工程と、
組織を前記組織処置部に係合させる工程と、
前記組織に処置を施すため治療エネルギーを印加する工程と、
組織の処置が完了したことを決定する工程と、
前記ロック機構を前記ロック位置から非ロック位置まで移動させる工程と、
前記組織を組織取扱い装置によって取扱う工程を含む方法。
(IV)組織に手術によって処置を施す方法であって、
組織に治療用エネルギーを供給する治療用エネルギー供給装置と組織取扱い装置を備える組織処置部と、
前記組織処置部に連結されるシャフトであって、前記治療用エネルギー供給装置に操作可能に連結され、組織に治療用エネルギーを供給するため前記治療用エネルギー供給装置とともに作動される治療エネルギー導通装置を備えるシャフトと、
ロック位置と非ロック位置を有し、前記シャフトを通って延びながら前記組織取扱い装置に操作可能に連結される組織取扱い作動装置と、
組織に治療用エネルギーを供給するため前記治療用エネルギー供給装置と治療用エネルギー導通装置が作動された後、前記組織取扱い作動装置を前記ロック位置から非ロック位置まで移動させるため、前記組織取扱い装置に連結されるロック機構を備える手術装置を提供する工程と、
組織を前記組織処置部に係合させる工程と、
前記組織に処置を施すため治療エネルギーを印加し、前記ロック機構を前記ロック位置から非ロック位置まで移動させる工程と、
組織の処置が完了したことを決定する工程と、
前記組織を組織取扱い装置によって取扱う工程を含む方法。
(V)組織に手術によって処置を施す方法であって、
遠方端を有するシャフトと、
前記シャフトの遠方端に位置し、電気手術用のエネルギーを受け取る終端効果器であって、
それぞれ第1および第2の相対向する組織接触面を有する第1および第2の部材であって、前記二つの組織接触面は、組織を間に置く開放・離隔位置から、組織に係合する閉止位置まで互いに移動可能であり、これら組織接触面の一方の少なくとも一部は導電性で電気手術用エネルギーを受け取るべく配置される第1および第2の部材ならびに、
前記終端効果器に係合した組織を切断すべく移動する切断部材を備える終端効果器と、
前記切断部材に操作可能に連結される作動装置であって、前記シャフトを通って前記切断部材まで延び、組織を切断するよう前記切断部材を作動させるべく配置される作動装置と、
前記作動装置に操作可能に連結されるロック機構であって、前記切断部材の作動を防止するため前記作動装置に係合する第1の位置と、前記切断部材を作動させるため前記作動装置を解除する第2の位置を有するロック機構を具備する電気手術装置を提供する工程と、
組織を組織接触面の間に挟み付ける工程と、
前記組織に処置を施すため治療エネルギーを印加する工程と、
組織の処置が完了したことを決定する工程と、
前記ロック機構を前記ロック位置から非ロック位置まで移動させる工程と、
前記組織を前記切断装置によって切断する工程を含む方法。
16)電気手術エネルギーが印加される組織の電気インピーダンスを測定する工程と、この組織を切断する前に、前記装置のユーザに組織が所望の程度まで凝集した時期を指示する工程をさらに含む、実施態様(V)記載の方法。
【0064】
【発明の効果】
以上のように、本発明によれば、装置の適切な連続作動を確保するため、止血を与えながら組織を取扱う、ロック機構付きの装置及び処置方法を提供することができる。
【図面の簡単な説明】
【図1】 本発明の一態様に係る内視鏡電気手術装置の斜視図。
【図2】 図1の装置が切断あるいはホチキス止めに用いられる前に、閉止・クランプ位置にあるときの側面図。
【図3】 図1の装置が、組織にRFエネルギーを適用する状態にあるときの側面図。
【図4】 図1の装置が、組織にRFエネルギーを適用して、組織をホチキス止めし切断した後の状態にあるときの側面図。
【図5】 図1に示した装置の手前側ハンドル部分の拡散分解図。
【図6】 図1に示した装置の中間部分と遠方側部分の拡散分解図。
【図7】 図1に示した装置の手前側ハンドル部分が第1の開放位置にあるときの状態を、左側ハンドルカバーとワイヤを取り外した状態で示す側面図。
【図8】 本発明で使用されるワイヤとコネクタの配置を示す左側ハンドル部分の内側を見た図。
【図9】 図1に示した装置の中間部分の軸方向断面図。
【図10】 図1に示した装置の中間部分手前端における各部材のワイヤとの接触の模様を示す図。
【図11】 (a)は図1に示した装置の中間部分手前端の拡大断面図、(b)は図11(a)の11b−11b方向断面図。
【図12】 各接触部位に接触したワイヤの斜視図。
【図13】 ワイヤの各接触部位に対する押圧の元となるわずかな偏りを示す図11(a)の端面図。
【図14】 閉止・クランプ位置にある図1に示した装置の遠方側端面の軸方向断面図。
【図15】 図13に示した遠方側部分の拡大部分断面図。
【図16】 図14の16−16線断面図。
【図17】 図14の17−17線断面図。
【図18】 図1に示した装置を使用する際の流れ図。
【図19】 他の態様に係るロック機構のロック位置におけるハンドル部材の側面図。
【図20】 図19のハンドル部材の、ロック機構が非ロック位置にあるときの側面図。
【図21】 図19と図20に示したハンドル部材の、ロック機構が射出後リセット状態にあるときの側面図。
【図22】 図19〜21に示したロック機構の好ましい使用態様を示す流れ図。
Claims (2)
- 電気手術装置において、
遠位端を有するシャフト(30)と、
前記シャフトの遠位端に配置され、電気手術用のエネルギーを受け取るのに適合された、末端作動部(15)であって、
相対向する第1および第2の組織接触面(32,34)を含む第1および第2の部材であって、前記両組織接触面が、これら両組織接触面間で組織を位置決めするための開放・離隔位置から、前記組織に係合するための閉止位置へ互いに移動可能であり、前記両組織接触面の一方の少なくとも一部が導電性であり、かつ、電気手術用エネルギーを受け取るように構成された、第1および第2の部材、および、
前記末端作動部によって係合された組織を切断するために移動可能である切断部材、
を備える、末端作動部と、
前記切断部材(11)に作動可能に接続され、前記シャフトを通って前記切断部材まで延在し、前記切断部材を作動させて組織を切断するように構成された、作動装置(14)と、
前記作動装置に作用可能に連結されたロック機構であって、前記切断部材の作動を防止するために前記ロック機構が前記作動装置に係合できる第1の位置、および、前記切断部材の作動を許容するために前記ロック機構が前記作動装置を解放できる第2の位置を有する、ロック機構と、
を具備し、
前記ロック機構は電気機械装置(180,182,183)を備える、
電気手術装置。 - 請求項1に記載の電気手術装置において、
前記末端作動部によって処置を施されている組織の処置状態を示すフィードバック信号を提供するように構成された組織パラメータ測定・機器制御装置であって、前記末端作動部に連結された組織パラメータ測定・機器制御装置をさらに具備する、電気手術装置。
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JPH08336544A JPH08336544A (ja) | 1996-12-24 |
JP3857357B2 true JP3857357B2 (ja) | 2006-12-13 |
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JP14777296A Expired - Lifetime JP3857357B2 (ja) | 1995-05-08 | 1996-05-08 | 手術機器 |
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US (2) | US5807393A (ja) |
EP (1) | EP0741996B1 (ja) |
JP (1) | JP3857357B2 (ja) |
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1995
- 1995-05-08 US US08/437,262 patent/US5807393A/en not_active Expired - Lifetime
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1996
- 1996-05-06 CA CA002175870A patent/CA2175870C/en not_active Expired - Lifetime
- 1996-05-07 DE DE69631613T patent/DE69631613T2/de not_active Expired - Lifetime
- 1996-05-07 ES ES96303149T patent/ES2216038T3/es not_active Expired - Lifetime
- 1996-05-07 EP EP96303149A patent/EP0741996B1/en not_active Expired - Lifetime
- 1996-05-07 AU AU52135/96A patent/AU722398B2/en not_active Expired
- 1996-05-08 JP JP14777296A patent/JP3857357B2/ja not_active Expired - Lifetime
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1997
- 1997-03-05 US US08/810,896 patent/US6024741A/en not_active Expired - Lifetime
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AU5213596A (en) | 1996-11-21 |
EP0741996A3 (en) | 1997-04-23 |
EP0741996B1 (en) | 2004-02-25 |
ES2216038T3 (es) | 2004-10-16 |
US5807393A (en) | 1998-09-15 |
JPH08336544A (ja) | 1996-12-24 |
CA2175870A1 (en) | 1996-11-09 |
DE69631613T2 (de) | 2004-12-16 |
US6024741A (en) | 2000-02-15 |
DE69631613D1 (de) | 2004-04-01 |
EP0741996A2 (en) | 1996-11-13 |
CA2175870C (en) | 2007-01-02 |
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