JP5847816B2 - エンドエフェクタ内の組織隙間を調節するための機構を有するモーター駆動式外科用締結装置 - Google Patents

エンドエフェクタ内の組織隙間を調節するための機構を有するモーター駆動式外科用締結装置 Download PDF

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JP5847816B2
JP5847816B2 JP2013521892A JP2013521892A JP5847816B2 JP 5847816 B2 JP5847816 B2 JP 5847816B2 JP 2013521892 A JP2013521892 A JP 2013521892A JP 2013521892 A JP2013521892 A JP 2013521892A JP 5847816 B2 JP5847816 B2 JP 5847816B2
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end effector
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anvil
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シェルトン・ザ・フォース・フレデリック・イー
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07207Surgical 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • 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
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/0725Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B17/2909Handles
    • A61B2017/2912Handles transmission of forces to actuating rod or piston
    • A61B2017/2923Toothed members, e.g. rack and pinion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • A61B2017/2927Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320052Guides for cutting instruments

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Description

(関連出願の相互参照)
本非暫定的出願は、2010年1月26日に出願され、Frederick E.Shelton,IVへの「Driven Surgical Stapler Improvement」と題された米国特許出願第12/693,461号の一部継続出願であり、これは2009年2月6日に出願され、Frederick E.Shelton,IVへの「Motor−Driven Surgical Stapler Improvements」と題された米国仮出願61/150,387号の利益を主張するものであり、それぞれの開示全体が、それら対応の全体を参照することにより本明細書に組み込まれるものとする。
内視鏡検査用途に好適な外科用ステープラの一例が米国特許第5,465,895号(その全体が参照によって本明細書に組み込まれる)に記載されている。このような装置は、特殊な閉鎖及び発射動作を行うエンドカッターを含む。モーター駆動式外科用ステープラの別の例が、その全体が参照によって本明細書に組み込まれる、2007年8月2日に公開され、「Motor−Driven Surgical Cutting and Fastening Instrument With User Feedback System」と題された米国特許出願公開第2007/0175958 A1号に開示されている。このような公開文献の引用は、その基礎機能、改善、背景、及び構成要素を詳説するために本明細書で提示されている。最後には、そのシステムに対する更なる改良が開示されている。
米国特許出願公開第2007/0175958 A1号は、一部において以下のように述べている。「[a]この装置を用いる臨床医は、発射の前に組織を所定の位置に置くためにジョー部材を組織上で閉鎖することが可能である。臨床医は、ジョー部材が組織を適切に把持していることを確認した時点で、装置に応じて外科用ステープラを1回の発射ストローク又は複数回の発射ストロークで発射することができる。外科用ステープラの発射は、組織の切断及びステープリングを生じる。この同時的な切断とステープリングにより、それぞれ切断及びステープリングのみを行う別々の手術用器具を用いてそのような動作を逐次的に実施するときに生じ得る煩雑さを回避することができる。」
発射前に組織上で閉鎖できることの具体的な利点の1つは、十分な量の組織が対向するジョーの間に捕捉されていることを含めて、切断のための望ましい箇所が確保されていることを、臨床医が内視鏡を通じて確認できるということである。さもなければ、対向するジョーは、互いに過度に接近して引き寄せられ、特にジョーの遠位端部で挟み、したがって、切断された組織内に閉鎖したステープルを効果的に形成できないことがある。その一方で、締め付けられた過剰量の組織は、結合及び不完全な発射の原因となることもある。
内視鏡ステープラ/カッターは、世代を経るごとに複雑さと機能を増し続けている。この主な理由の1つは、すべて又は大多数の外科医が取り扱うことができる水準へと発射力(FTF)を低減させることが追求されていることである。FTFを低減するための既知の解決策の1つは、C02又は電動モーターを使用することである。これらの装置は、従来の手動式装置と比べて良好に発射するものではなかったが、これは別の理由によるものである。外科医は通常、ほとんどの外科医の力(一般に6.8〜13.6N(15lbs〜30lbs))が及ぶ範囲での上限で、切断/ステープリングサイクルが完了したことを確信できるように、ステープルに付形する際にエンドエフェクタによって体感される力の分布よりも、比例した力の分布を体感する方を好む。また、外科医は通常、ステープルの配置を制御すること、及び、装置のハンドルに感じられる力が強すぎると感じられる場合、あるいは他の臨床上の理由で、いかなるときにも停止できることを維持したいと望む。これらのユーザーフィードバック効果は、現行のモーター駆動式エンドカッターにおいては、適切に実現できるものではない。結果として、単にボタンを押すことで切断/ステープリング動作が作動されるモーター駆動式エンドカッターは、外科医に一般には認められていない。
上述の議論は、本発明の分野にその当時に存在した欠点のいくつかを説明することのみを意図したものであり、特許請求の範囲を否定するものとみなされるべきではない。
本発明の一般的態様によると、ハンドルと細長いシャフトとを有する外科用締結装置が提供される。細長いシャフトは、ハンドルに取り付けられた近位端部を有する。細長いシャフトは、近位端部で旋回され、開位置と閉位置との間で移動可能である一対のジョーを備えるエンドエフェクタに連結される遠位端部を更に有する。複数個の外科用締結具を収容するカートリッジが、エンドエフェクタに取り付けられている。この装置は、外科用締結具を展開するための電動作動装置を更に含む。様々な実施形態では、この作動装置は、電源とモーターとを備える。この装置は、エンドエフェクタが閉位置にある場合、ジョー間の間隔の量を電気で調節するための手段を更に備える。
本発明の別の一般的態様によると、ハンドルを含む外科用締結装置が提供され、ハンドルは操作可能に連結されるエンドエフェクタを有する。様々な実施形態では、エンドエフェクタは、カートリッジを中に支持するよう構成された細長い溝を備える。アンビルが、閉位置へと細長い溝に向かい、開位置へと前記細長い溝から離れる選択的移動のために、細長い溝上に移動可能に支持されている。アンビルは、中に細長いスロットを有する。作動装置部材が、細長い溝内に移動可能に支持され、細長い溝内で非作動の近位位置から作動位置へと選択的に移動可能である。様々な実施形態では、作動装置部材は、細長い溝と滑動可能に係合する下部作動装置部分と細長いスロット中に突出するよう構成された上部作動装置部分とを備える。リテーナ部材が、上部作動装置部分の各外側側部から、アンビル内の細長いスロットをほぼ横断する方向で突出する。アンビルが、それに印加された電流に応答して閉位置のうちの1つにある場合に、アンビルと細長い溝との間の間隔を選択的に調節するための、高さ調節部材が各リテーナ部材上に設けられている。
本発明の別の一般的態様によると、ハンドルを含む外科用締結装置が提供され、ハンドルは操作可能に連結されるエンドエフェクタを有する。様々な実施形態では、エンドエフェクタは、カートリッジを中に支持するよう構成された細長い溝を備える。アンビルが、閉位置へと細長い溝に向かい、開位置へと前記細長い溝から離れる選択的移動のために、細長い溝上に移動可能に支持されている。アンビルは、中に細長いスロットを有する。作動装置部材が細長い溝内に移動可能に支持されており、ハンドル内に支持された第1の電動モーターによってそれに印加される駆動運動に応答して、細長い溝内で非作動の近位位置から作動位置へと選択的に移動可能である。様々な実施形態では、作動装置部材は、細長い溝と滑動可能に係合する下部作動装置部分と、細長いスロット中に突出するよう構成され、下部作動装置部分に対して移動可能である上部作動装置部分とを備える。リテーナ部材が、上部作動装置部分の各外側側部から、アンビル内の細長いスロットをほぼ横断する方向で突出する。第2の電動モーターが、上部作動装置部分を下部作動装置部分に対して選択的に移動させるために、上部及び下部作動装置部分に連結されている。
一般的な一態様において、本発明は、エンドエフェクタの位置、力、及び/又は展開についてユーザーにフィードバックを提供するモーター式外科用切断及び締結器具に関する。この器具はまた、様々な実施形態において、望まれる場合に展開を停止できることを含め、操作者がエンドエフェクタを制御することを可能にしている。この器具は、別々の作動運動を有する2つのトリガー、つまり、閉鎖トリガーと発射トリガーとをハンドル内に有してもよい。器具の操作者が閉鎖トリガーを後退させると、エンドエフェクタ内に配置された組織がエンドエフェクタによってクランプ締めされ得る。次いで、操作者が発射トリガーを後退させると、モーターが、ギア駆動系を介して回転主駆動軸アセンブリに動力を与えることができ、それにより、エンドエフェクタ内の切断器具が、クランプ締めされた組織を切断する。
様々な実施形態において、この器具は、装填力のフィードバック及び制御を有する動力補助システムを備えて、切断操作を完了するために操作者が発揮することが必要となる発射力を低減することができる。そのような実施形態において、発射トリガーは、主駆動軸アセンブリのギア駆動系にギアで結合され得る。そのようにして、操作者は、切断器具に加えられている力に関するフィードバックを体感することができる。つまり、発射トリガーにおける装填力は、切断器具で体感される装填力に関連し得る。また、そのような実施形態において、発射トリガーはギア駆動系にギアで結合されているため、操作者が加える力は、モーターに加えられる力に追加され得る。
様々な実施形態によれば、発射トリガーが適度に(例えば5度)後退すると、規定比で回転させる信号をモーターに送信するオン/オフスイッチが作動されることができ、したがって、駆動軸アセンブリ及びエンドエフェクタの作動が開始される。他の実施形態によれば、比例センサーが使用されてもよい。比例センサーは、操作者が発射トリガーに加えた力に比例する速度で回転させる信号をモーターに送信することができる。そのようにして、発射トリガーの回転位置は、切断器具がエンドエフェクタ内にある場所(例えば、完全に展開しているかあるいは完全に後退している)に概ね比例する。更に、操作者は、ストロークにおけるある時点で発射トリガーの後退を停止させてモーターを停止させ、それによって切断動作を停止させることができる。加えて、エンドエフェクタのストロークの開始(例えば、完全に後退した位置)及び行程の終了(例えば、完全に展開した位置)をそれぞれ検出するために、センサーが使用されてもよい。結果的に、センサーは、モーター、ギア駆動系、及びエンドエフェクタの閉ループ系の範囲外にあるエンドエフェクタ展開を制御するための適応制御システムを提供することができる。
他の実施形態において、発射トリガーは、エンドエフェクタを作動させるために使用されるギア駆動系に直接ギアで結合されなくてもよい。そのような実施形態において、発射トリガーに力を加えてエンドエフェクタにおける切断器具の展開をシミュレートするために、第2のモーターが使用されてもよい。第2のモーターは、主駆動軸アセンブリの漸進的回転に基づいて制御されてもよく、その漸進的回転は、回転エンコーダによって測定され得る。そのような実施形態において、発射トリガーの回転位置は、エンドエフェクタにおける切断器具の位置と関連付けられてもよい。加えて、主モーター(すなわち、主駆動軸に動力を与えるモーター)を制御するために、オン/オフスイッチ又は比例スイッチが使用されてもよい。
様々な実現形態において、エンドエフェクタは、エンドエフェクタの基部にて螺旋形の打込みネジを使用して、切断器具(例えば、ナイフ)を駆動してもよい。また、エンドエフェクタは、切断された組織をステープリングするためのステープル・カートリッジを含んでもよい。他の実施形態によれば、高周波エネルギー及び接着剤を含めて、切断された組織を締結(又は密封)するための他の手段が使用されてもよい。
また、この器具は、機械的な閉鎖システムを含んでもよい。その機械的な閉鎖システムは、細長い溝を含んでもよく、その細長い溝は、エンドエフェクタに配置された組織をクランプ締めするように溝に旋回可能に連結された、アンビルなどのクランプ締め部材を有する。ユーザーは、閉鎖トリガーを後退させることによってエンドエフェクタのクランプ締め作用を作動させることができ、その閉鎖トリガーは、機械的な閉鎖システムを通じて、エンドエフェクタのクランプ締め作用を生じさせる。クランプ締め部材が定位置にロックされると、操作者は別の発射トリガーを後退させることによって切断操作を作動させることができる。これにより、エンドエフェクタによってクランプ締めされた組織を切断するために、切断器具を溝に沿って長手方向に移動させることができる。
様々な実現形態において、この器具は、エンドエフェクタを作動させるための回転主駆動軸アセンブリを含んでもよい。更に、主駆動軸は、関節継手を備えてもよく、それにより、エンドエフェクタは関節をなすことができる。関節継手は、例えば、かさ歯車アセンブリ、自由継手、又は捻り力をエンドエフェクタに伝達することが可能な柔軟捻りケーブルを備えてもよい。
本発明の他の態様は、ハンドルの下方のピストルグリップ部分に閉鎖トリガーをロックするための様々な機構に関する。そのような実施形態では、ギア駆動系及び機械的な閉鎖システムの構成要素を含めて、器具の他の構成要素のために、トリガーのすぐ上及び背後に、ハンドル内に空間が確保される。
本開示は、本明細書において、電池式のギア駆動内蔵型内視鏡ステープリング装置を実現し得る方法を示すものである。
本発明の上記の、並びに他の特徴及び利点、並びにそれらを実現する方法は、本発明の実施形態の以下の説明文を添付の図面と併せて参照することでより明らかとなり、また発明自体のより深い理解が得られるであろう。
本発明の様々な実施形態による外科用切断及び締結器具の斜視図。 本発明の様々な実施形態による外科用切断及び締結器具の斜視図。 本発明の様々な実施形態による器具のエンドエフェクタ及びシャフトの分解組立図。 本発明の様々な実施形態による器具のエンドエフェクタ及びシャフトの分解組立図。 本発明の様々な実施形態による器具のエンドエフェクタ及びシャフトの分解組立図。 本発明の様々な実施形態によるエンドエフェクタの側面図。 本発明の様々な実施形態による器具のハンドルの分解組立図。 本発明の様々な実施形態によるハンドルの部分斜視図。 本発明の様々な実施形態によるハンドルの部分斜視図。 本発明の様々な実施形態によるハンドルの側面図。 本発明の様々な実施形態により用いられ得る比例センサー又はスイッチを示す図。 本発明の様々な実施形態により用いられ得る比例センサー又はスイッチを示す図。 本発明の様々な実施形態による器具において使用される電流制御回路の概略図。 本発明の様々な実施形態による、別のハンドルの側面図。 本発明の様々な実施形態による器具において使用される別の電流制御回路の概略図。 本発明の様々な実施形態による器具において使用される別の電流制御回路の概略図。 本発明の様々な実施形による器具において使用される別の回路の概略図。 本発明の様々な実施形態による器具において使用される別の電流制御回路の概略図。 本発明の様々な実施形態による器具において使用される別の電流制御回路の概略図。 本発明の様々な実施形態による、閉鎖トリガーをロックするための異なる機構を示す図。 本発明の様々な実施形態による、閉鎖トリガーをロックするための異なる機構を示す図。 本発明の様々な実施形態による器具において使用される別の電流制御回路の概略図。 本発明のエンドエフェクタの実施形態の断面図。 本発明のナイフ組立品又は作動装置の実施形態の側面立面図。 本発明の別のナイフ組立品又は作動装置の実施形態の側面立面図。 本発明の別のナイフ組立品又は作動装置の実施形態の側面立面図。 本発明の一実施形態による外科用ステープラの遠位端部の斜視図。 溝からカートリッジが取り外された、本発明の一実施形態による外科用ステープラの遠位端部の斜視図。 ロックアウト指示器を示す図1と同様の、本発明の一実施形態による外科用ステープラの遠位端部の図。 本発明の一実施形態による外科用ステープラの近位端部の斜視図。
本出願の所有者はまた、これと同日付で出願され、それら各々の全体が参照によって本明細書に組み込まれる、以下の米国特許出願を所有している:
「Motor Driven Surgical Fastener Device With Cutting Member Reversing Mechanism」と題された代理人整理番号第END6549USCIP1/100280CIP1号の米国特許出願、及び
「Motor Driven Surgical Fastener Device With Cutting Member Lockout Arrangements」と題された代理人整理番号第END6547USCIP1/100270CIP1号の米国特許出願である。
本明細書に開示される装置並びに方法の構造、機能、製造、及び使用の原理の全体的な理解が与えられるよう、特定の例示的実施形態について以下に説明する。これらの実施形態の1つ以上の例を添付図面に示す。本明細書で詳細に説明され、添付の図面に示される装置及び方法は、非限定的な例示的実施形態であること、並びに、本発明の各種の実施形態の範囲は、特許請求の範囲によってのみ定義されることは、当業者には理解されよう。ある例示的実施形態に関連して例示又は説明される特徴は、他の実施形態の特徴と組み合わせることができる。そのような改変及び変形は、本発明の範囲に含まれるものとする。
本明細書全体を通して、「様々な実施形態」、「いくつかの実施形態」、「一実施形態」、又は「実施形態」、「実装」又は「様々な実装」等の参照は、その実施形態との関連において記述されている特定の特徴、構造、又は特性が、少なくとも1つの実施形態に含まれることを意味する。したがって、本明細書全体を通して複数の場所に出現する「様々な実施形態では」、「いくつかの実施形態では」、「一実施形態では」、又は「実施形態では」、「実装」又は「様々な実装」等のフレーズは、必ずしも全てが同一の実施形態又は実装を指すものではない。更に、特定の特徴、構造、又は特性は、任意の好適な方法で1つ以上の実施形態又は実装に組み合わされてもよい。故に、一実施形態に関して図示又は記載される特定の特徴、構造、又は特性は、1つ以上の他の実施形態の特徴、構造、又は特性と、全体として又は部分的に、制限なしに組み合わせることができる。そのような改変及び変形は、本発明の範囲に含まれるものとする。
「近位」及び「遠位」という用語は、本明細書において、外科用器具のハンドル部分を操作する臨床医を基準にして用いられている。「近位」という用語は、臨床医に最も近い部分を指し、「遠位」という用語は、臨床医から離れた位置にある部分を指す。便宜上、及び明確性のために、「垂直」、「水平」、「上」、「下」などの、空間的用語は、本明細書では、図面に関連して使用し得ることが更に理解されよう。しかしながら、外科用器具は、多くの向き及び位置で使用されるものであり、これらの用語は、限定的及び/又は絶対的であることを意図したものではない。
図1及び図2は、本発明の様々な実施形態による外科用切断及び締結器具10を表わす。この図示された実施形態は内視鏡手術用器具10であり、本明細書に記載される器具10の実施形態は一般的に内視鏡手術用の切断及び締結器具である。しかしながら、本発明の他の実施形態によれば、この器具10は、腹腔鏡(laproscopic)手術用器具などの非内視鏡手術用の切断器具であり得ることに注意されたい。
図1及び図2に示される外科用器具10は、ハンドル6、シャフト8、及び関節運動枢動点14においてシャフト8に旋回可能に連結された関節式エンドエフェクタ12を備えている。関節運動制御部16がハンドル6に隣接して設けられることにより、エンドエフェクタ12を、関節運動枢動点14を中心として回転させることができる。様々な実施形態は、非枢動エンドエフェクタを含んでもよく、したがって関節運動枢動点14又は関節運動制御部16を有さない場合があることが理解される。また、図示された実施形態では、エンドエフェクタ12は組織のクランプ締め、切断、及びステープリングのためのエンドカッターとして機能するように構成されているが、他の実施形態では捕捉器具、カッター、ステープラ、クリップ・アプライヤー、アクセス装置、薬物/遺伝子治療用器具、超音波、無線周波、又はレーザー装置などの、他の種類の外科用装置のエンドエフェクタなどの、異なる種類のエンドエフェクタが使用され得る。
器具10のハンドル6は、エンドエフェクタ12を関節運動させるための閉鎖トリガー18及び発射トリガー20を含むことができる。異なる手術任務を指向するエンドエフェクタを有する器具が、エンドエフェクタ12を操作するための、異なる数若しくは種類のトリガー又は他の適切な制御機器を備え得ることが理解されるであろう。このエンドエフェクタ12は好適には細長いシャフト8によりハンドル6から分離されて示されている。一実施形態において、臨床医又は器具10の操作者は、その全体が参照により本明細書に組み込まれる、Geoffrey C.Hueilらによる「Surgical Instrument Having An Articulating End Effector」と題された米国特許第7,670,334号により詳細に記載されるように、関節運動制御部16を利用することによって、シャフト8に対してエンドエフェクタ12を、関節運動させることができる。
この例において、このエンドエフェクタ12は、とりわけ、ステープル・カートリッジ34をその内部で操作可能に支持するよう構成された細長い溝22及びアンビル24などの旋回可能に並進移動可能なクランプ締め部材を含み、これらは、エンドエフェクタ12にクランプ締めされた組織の効果的なステープリングと切断とを確保するために必要な間隔で保持されている。ハンドル6は、アンビル24がエンドエフェクタ12の細長い溝22に対してクランプ締め又は閉鎖を引き起こし、それによってアンビル24と溝22との間に位置決めされた組織をクランプ締めするため、臨床医がそれに向かって閉鎖トリガー18を旋回可能に引き付けるピストルグリップ26を含む。発射トリガー20は閉鎖トリガー18の外側に設けられている。下記に更に述べるように、閉鎖トリガー18が閉鎖位置(closure position)にロックされると、発射トリガー20はピストルグリップ26の方向にわずかに回転して操作者が片手で操作できるようになる。次いで操作者は、エンドエフェクタ12によりクランプ締めされた組織のステープリング及び切断を引き起こすために、発射トリガー20をピストルグリップ26に向けて旋回可能に引くことができる。他の実施形態では、アンビル24に加えて、例えば対向するジョーなどの、異なった種類のクランプ締め部材を用い得る。
閉鎖トリガー18を最初に作動することができる。臨床医がエンドエフェクタ12の位置決めに満足すると、臨床医は閉鎖トリガー18をピストルグリップ26の近位の完全閉鎖された係止位置に引き戻すことができる。次いで、発射トリガー20が作動され得る。以下でより完全に記載されるように、臨床医が圧力を解放すると、発射トリガー20は開位置に戻る(図1及び図2に示される)。ハンドル6の解除ボタンは押圧された場合にロックされたクロージャトリガー18を解放し得る。解除ボタンは例えば図16に示されるスライド式解除ボタン160及び/又は図17に示されるボタン172のような様々な形態で実装することができる。
図3〜6は、様々な実施形態による回転駆動エンドエフェクタ12及びシャフト8の実施形態を示す。図3は様々な実施形態によるエンドエフェクタ12の分解組立図である。図示された実施形態に示されるように、エンドエフェクタ12は上述の溝22及びアンビル24に加えて、切断器具32、スレッド(sled)33、溝22に着脱自在に位置するステープル・カートリッジ34、及び螺旋状ネジシャフト36を含み得る。切断器具32は、例えばメスであってよい。少なくとも一実施形態に関して本明細書で使用されるとき、用語「作動装置」とは、ナイフ及び/又はスレッドを指す。アンビル24は、溝22の近位端部に接続された旋回ピン25において旋回可能に開閉することができる。アンビル24は、アンビル24を開閉するために機械的閉鎖システム(下記に詳述する)の特定の構成要素に挿入されるタブ27を近位端部に更に有してもよい。閉鎖トリガー18が作動されると、すなわち器具10のユーザーによって引かれると、アンビル24がクランプ締めした、又は閉じた位置へと旋回ピン25を中心として枢動し得る。エンドエフェクタ12の締めつけが充分である場合、操作者が発射トリガー20を作動させると、下記により詳細に説明するようにナイフ32及びスレッド33が溝22に沿って長手方向に移動してエンドエフェクタ12内に挟まれた組織を切断する。スレッド33が溝22に沿って動くことにより、ステープル・カートリッジ34のステープル(図示せず)が切断された組織を通じて閉じたアンビル24に対して打ちこまれ、アンビル24がステープルを折り曲げて切断組織を締結する。異なる実施形態において、スレッド33はカートリッジ34と一体の構成要素であってもよい。参照により本明細書に組み込まれる、Shelton,IVらへの「Surgical Stapling Instrument Incorporating an E−beam Firing Mechanism」と題された、米国特許第6,978,921号は、そのような2ストロークの切断及び締結器具についてより詳細に記載している。メス32が切断操作後に後退するときにスレッド33が後退しないためにスレッド33はカートリッジ34の一部分であり得る。
図4及び図5は様々な実施形態によるエンドエフェクタ12及びシャフト8の分解組立図であり、図6は同側面図である。例示される実施形態に示されるように、シャフト8は、旋回連結部44によって旋回可能に連結された近位閉鎖管40及び遠位閉鎖管42を含み得る。遠位側閉鎖管42は開口部45を有し、下記に詳述するように開口部45内にアンビル24のタブ27が挿入されることでアンビル24が開閉される。閉鎖管40、42の内部には近位側脊柱管46が配置され得る。近位側脊柱管46の内部には、ベベルギアアセンブリ52を介して第2の(又は近位側)駆動シャフト50と連動した主回転(又は近位側)駆動シャフト48が配置され得る。第2の駆動シャフト50は、螺旋状ネジシャフト36の近位側駆動ギア56と噛み合う駆動ギア54に連結されている。垂直ベベルギア52bは近位側脊柱管46の遠位端部の開口部57内に位置し、開口部57内で旋回し得る。遠位側脊柱管58は、第2の駆動シャフト50及び駆動ギア54、56を収容するために用いられる。主駆動シャフト48、第2の駆動シャフト50、及び関節アセンブリ(例、ベベルギアアセンブリ52a〜c)は本願ではまとめて「主駆動シャフトアセンブリ」と呼ぶ場合がある。
ステープル溝22の遠位端部に配置されたベアリング38が螺旋状駆動ネジ36を受容することにより、螺旋状駆動ネジ36は溝22に対して自由に回転することが可能である。螺旋状ネジシャフト36がナイフ32の螺刻開口部(図示せず)と干渉することにより、シャフト36の回転によってナイフ32がステープル溝22内で遠位方向又は近位方向に(回転方向に応じて)並進運動する。結果的に、発射トリガー20への作動運動の印加の際に主駆動シャフト48が(下記により詳しく説明するように)回転させられると、ベベルギアアセンブリ52a〜cが第2駆動シャフト50を回転させ、これにより、駆動ギア54、56の係合により螺旋状ネジシャフト36が回転し、これによりナイフ駆動部材32が溝22に沿って長手方向に移動してエンドエフェクタ12内でクランプ締めされたいずれかの組織を切断する。スレッド33は例えばプラスチックで形成されてよく、傾斜した遠位面を有し得る。スレッド33が溝22を移動するにしたがって、傾斜した前面がステープル・カートリッジ内のステープルを、クランプ締めされた組織を貫通してアンビル24に対して押し上げる、すなわち駆動することができる。アンビル24がステープルを形成する又は折り曲げることによって、切断された組織をステープリングする。ナイフ32が後退すると、ナイフ32とスレッド33とが分離し、これによりスレッド33は溝22の遠位端部に残される。
図7〜10は、モーター駆動式エンドカッター、及び特にそのハンドルの例示的な実施形態を図示し、これはエンドエフェクタ12における切断器具32の展開及び荷重力に関するユーザーフィードバックを提供する。更に、本実施形態は、装置に電力供給するために発射トリガー20を後退させるうえでユーザーによって与えられる力を利用することができる(いわゆる「パワーアシスト」モード)。この実施形態は、上記の回転駆動エンドエフェクタ12及びシャフト8の実施形態と共に使用され得る。図の実施形態に示されるように、ハンドル6は互いに嵌合してハンドル6の外面を形成する外部下側側面部材59、60及び外部上側側面部材61、62を有する。様々な実施形態では、回転駆動エンドエフェクタは、ハンドルのピストルグリップ部分26の上部に配設され、電源64により電力供給されるモーター65によって作動されてもよい。電源64は、電池又は交流電源を包含し得る。好ましい実施形態では、電源64は、ハンドル6のピストルグリップ部分26内で支持されているリチウムイオン電池を含む。様々な実施形態によると、モーター65は、およそ5000RPMの最大回転数を有するDCブラシ付き駆動モーターであってもよい。モーター65は、第1のベベルギア68及び第2のベベルギア70から構成される90度ベベルギアアセンブリ66を駆動し得る。ベベルギアアセンブリ66は、遊星ギアアセンブリ72を駆動し得る。遊星ギアアセンブリ72は駆動シャフト76に連結されたピニオンギア74を含み得る。ピニオンギア74は、駆動シャフト82を介して螺旋状ギアドラム80を駆動する、係合するリングギア78を駆動し得る。リング84を螺旋状ギアドラム80上に螺着することができる。したがって、モーター65が回転すると、リング84が、挿置されたベベルギアアセンブリ66、遊星ギアアセンブリ72、及びリングギア78によって、螺旋状ギアドラム80に沿って移動される。
ハンドル6は、操作者によってハンドル6のピストルグリップ部分26の方向に発射トリガーが引かれた(又は「閉じられた」)時に発射トリガー20からの作動運動を受容することによってエンドエフェクタ12による切断/ステープリング動作を作動させる、発射トリガー20と連通する走行モータースイッチ110(図10参照)を更に含んでもよい。走行モータースイッチ110は、例えばレオスタット又は可変抵抗器などの比例センサーでよい。発射トリガー20が引かれると、走行モータースイッチ110は、電流が電源64からモーター65に向かって流れることを可能にする。走行モータースイッチ110が可変抵抗器等である場合、モーター65の回転は、発射トリガー20の運動量とほぼ比例し得る。すなわち、操作者がわずかに発射トリガー20を引く、すなわち少しだけ閉じるだけでは、モーター65の回転は比較的低くなる。発射トリガー20が完全に引き込まれる(すなわち完全に閉鎖した位置となる)とモーター65の回転は最大となる。別の言い方をすれば、ユーザーが発射トリガー20を強く引くほどモーター65にかかる電圧が大きくなり、回転速度が大きくなる。
ハンドル6は発射トリガー20の上側部分に隣接して中間ハンドル部材104を有し得る。ハンドル6はまた、中間ハンドル部材104及び発射トリガー20の支柱間に接続されたバイアスバネ112を含み得る。バイアスバネ112は発射トリガー20を完全に開いた位置に付勢する。このように、操作者が発射トリガー20を解放すると、バイアスバネ112は発射トリガー20をその開位置に引き、それによって走行モータースイッチ110を非作動状態にし、それによってモーター65の回転を停止させる。更に、バイアスバネ112により、ユーザーは発射トリガー20を閉じるたびに閉鎖操作に対する抵抗を感じるため、モーター65による回転量に関するフィードバックがユーザーに与えられる。更に、操作者は、発射トリガー20の後退を停止することが可能であり、これによって走行モータースイッチ110を非作動状態にし、モーター65を停止させることが可能である。このようにして、ユーザーはエンドエフェクタ12の展開を停止することが可能であり、これにより操作者に切断/締結操作の制御手段が与えられる。
螺旋状ギアドラム80の遠位端部は、ピニオンギア124と係合するリングギア122を駆動する遠位駆動シャフト120を含む。ピニオンギア124は主駆動シャフトアセンブリの主駆動シャフト48に連結されている。これにより、上記に述べたようにモーター65の回転が主駆動シャフトアセンブリを回転させることでエンドエフェクタ12が作動する。
螺旋状ギアドラム80に螺着されたリング84はスロット付きアーム90のスロット88内に位置する支柱86を有し得る。スロット付きアーム90は、ハンドルの外部側面部材59、60の間に連結される旋回ピン96を受容する開口部92を反対側の端部94に有する。旋回ピン96は、発射トリガー20の開口部100及び中間ハンドル部材104の開口部102にも通される。
加えて、ハンドル6は、逆モータースイッチ(又はストローク終端スイッチ)130及びモーター停止(又はストロークの開始)スイッチ142を含むことができる。様々な実施形態では、逆モータースイッチ130は、螺旋状ギアドラム80の遠位端部に位置するリミットスイッチであってよく、これにより、螺旋状ギアドラム80に螺着されたリング84は、リング84が螺旋状ギアドラム80の遠位端部に達した時に逆モータースイッチ130と接触してこれを始動する。逆モータースイッチ130が作動されると、モーター65に信号を送信して(すなわち、電流が流れることを可能にし)、その回転方向を逆転させ、それによって切断作業後エンドエフェクタ12のナイフ32を引っ込める。
モーター停止スイッチ142は、例えば、常時閉路式リミットスイッチであってよい。異なる実施形態では、モーター停止スイッチ142を螺旋状ギアドラム80の近位端部に配置することにより、リング84が螺旋状ギアドラム80の近位端部に達するとスイッチ142を始動し得る。
器具10の操作者が作動運動を発射トリガー20に印加する場合の操作では、走行モータースイッチ110が、発射トリガー20の展開を検出し、モーター65に信号を送信し(すなわち、電流が流れることを可能にし)、これが、例えば操作者がどれくらいきつく発射トリガー20を後方に引くかに比例する割合で、モーター65の正転を生じる。モーター65の正転により、次に、遊星ギアアセンブリ72の遠位端部におけるリングギア78が回転し、それによって、螺旋状ギアドラム80が回転し、螺旋状ギアドラム80にネジ止めされたリング84が螺旋状ギアドラム80に沿って遠位方向に移動する。螺旋状ギアドラム80の回転により、上記に述べたように主駆動シャフトアセンブリも駆動され、これによりエンドエフェクタ12のナイフ32が展開される。すなわち、ナイフ32及びスレッド33が長手方向に溝22を通じて遠位に移動することによりエンドエフェクタ12にクランプ締めされた組織を切断する。更に、ステープリング型のエンドエフェクタ12が用いられている実施形態では、エンドエフェクタ12のステープリング動作が引き起こされる。
エンドエフェクタ12の切断/ステープリング動作が完了するまでには、螺旋状ギアドラム80上のリング84は螺旋状ギアドラム80の遠位端部に達していると思われ、これにより逆モータースイッチ130が作動され、これがモーター65に信号を送る(すなわち、電流が流れることを可能にする)ことによりモーター65の回転を逆転させる。これによりナイフ32が後退するとともに螺旋状ギアドラム80上のリング84が螺旋状ギアドラム80の近位端部へと戻る。
中間ハンドル部材104は、図8及び図9に最も分かりやすく示されるように、スロット付きアーム90と係合する後方肩部106を有している。中間ハンドル部材104は更に発射トリガー20と係合する前方運動係止部107を有している。スロット付きアーム90の運動は上記に説明したようにモーター65の回転によって制御される。リング84が螺旋状ギアドラム80の近位端部から遠位端部まで移動するにつれて、スロット付きアーム90が反時計回りに回転すると、中間ハンドル部材104は、自由に反時計回りに回転することができるこれにより、ユーザーが発射トリガー20を引くと発射トリガー20は中間ハンドル部材104の前方運動係止部107と係合して中間ハンドル部材104を反時計回りに回転させる。しかしながら、後方肩部106がスロット付きアーム90と係合するために、中間ハンドル部材104はスロット付きアーム90によって許容される範囲内で反時計回りに回転できるだけである。これにより、何らかの理由によってモーター65の回転が停止した場合、スロット付きアーム90は回転を停止し、スロット付きアーム90のために中間ハンドル部材104が反時計回りに自由に回転できなくなるために、ユーザーは発射トリガー20を更に引くことができなくなる。
図10A及び図10Bは、本発明の様々な実施形態による走行モータースイッチ110として用いられ得る可変スイッチ又はセンサーの2つの状態を示す。走行モータースイッチ110は、フェース部分280、第1電極(A)282、第2電極(B)284、及び例えば、電気活性高分子(EAP)などの、電極282、284の間の圧縮可能誘電材料286を含み得る。走行モータースイッチ110は、発射トリガー20が後退させられた際にフェース部分280がこれと接触するように位置付けられる。結果的に、発射トリガー20が後退すると、図10Bに示されるように誘電体材料286が圧縮されることにより電極282、284が互いに接近する。電極282、284間の距離「b」は、電極282、284間のインピーダンスに直接関係している。すなわち、この距離が大きいほどインピーダンスは高くなり、距離が近いほどインピーダンスは低くなる。これにより、発射トリガー20の後退(図10Bで力「F」として示される)によって誘電体286が圧縮される量は電極282、284間のインピーダンス比例するため、これを用いてモーター65を比例制御することができる。
閉鎖トリガー18を後退させることによってエンドエフェクタ12のアンビル24を閉鎖する(又はクランプ締めする)ための例示的閉鎖システムの構成要素が、更に図7〜10に示されている。図の実施形態では、閉鎖システムは、閉鎖トリガー18及びヨーク250の両方の、位置合わせされた開口部に挿入される旋回ピン251によって閉鎖トリガー18に接続されたヨーク250を含む。旋回ピン252は、これを中心として閉鎖トリガー18が旋回するものであり、閉鎖トリガー18にピン251が挿入された位置からオフセットして閉鎖トリガー18に設けられた別の開口部に挿入されている。したがって、閉鎖トリガー18を後退させることにより、ピン251によってヨーク250が取り付けられる閉鎖トリガー18の上方部分が反時計回りに回転する。ヨーク250の遠位端部はピン254を介して第1の閉鎖ブラケット256に連結されている。第1の閉鎖ブラケット256は第2の閉鎖ブラケット258に連結される。閉鎖ブラケット256、258は、閉鎖ブラケット256、258の長手方向の運動が近位側閉鎖管40(図4を参照)による長手方向の運動を生じるように近位側閉鎖管40の近位端部が内部に配置、保持される開口部を共に形成する。器具10は更に、近位側閉鎖管40の内部に配置される閉鎖ロッド260を有する。閉鎖ロッド260は、図の実施形態の外部下側側面部材59のようなハンドル外部部材の1つの支柱263が内部に配置されることにより閉鎖ロッド260をハンドル6に固定的に連結する窓261を有し得る。これにより、近位側閉鎖管40は閉鎖ロッド260に対して長手方向に動くことが可能となっている。閉鎖ロッド260は、近位スパイン管46内の空洞269に嵌合してキャップ271により空洞269内に保持される遠位カラー267を更に有し得る(図4を参照)。
動作時には、閉鎖トリガー18が後退させられることによりヨーク250が回転すると、閉鎖ブラケット256、258によって近位側閉鎖管40が遠位方向(すなわち器具10のハンドル端部から離れる方向)に動き、これにより遠位閉鎖管42が遠位方向に動くと、アンビル24が旋回ピン25を中心として締め付け位置、すなわち閉位置へと回転する。閉鎖トリガー18がロック位置から解放されると、近位閉鎖管40が近位方向にスライドし、これにより遠位閉鎖管42が近位方向にスライドし、遠位閉鎖管42の窓45にタブ27が挿入されていることによってアンビル24が旋回ピン25を中心として開いた位置、すなわち非締め付け位置へと回転する。これにより、操作者は閉鎖トリガー18を後退させ、かつロックすることによってアンビル24と溝22との間に組織を挟み込み、切断/ステープリング動作後にはロック位置から閉鎖トリガー18を解放することによって組織をクランプから解放することができる。
図11は、本発明の様々な実施形態による器具10の電流制御回路の概略図である。操作者が閉鎖トリガー18をロックした後に最初に発射トリガー20を引くと、走行モータースイッチ110が作動して、それを通して電流が流れる。常時開路式の逆モーターセンサースイッチ130が開いている(つまりエンドエフェクタのストロークの終端に達していない)場合、電流は、単極双投リレー132に流れる。逆モーターセンサースイッチ130が閉じていないので、リレー132の誘導子134は電圧が印加されず、したがって、リレー132は、その電圧が印加されていない状態にある。この回路は更に、カートリッジロックアウトスイッチ136も有している。エンドエフェクタ12にステープル・カートリッジ34が入っている場合、スイッチ136は閉状態にあり、電流が流れる。逆にエンドエフェクタ12にステープル・カートリッジ34が入っていない場合には、スイッチ136は開状態となり、これにより電池64によるモーター65への電力供給が防止される。
ステープル・カートリッジ34が存在する場合にはスイッチ136は閉じられ、これにより単極単投リレー138が励磁される。リレー138が励磁されると、電流が可変抵抗器(走行モーター)スイッチ110を通じ、モーター65へと双極双投リレー140を介してリレー136に流れ、これによりモーター65に電力が供給されてモーター65は順方向に回転する。
エンドエフェクタ12がそのストロークの終端に到達すると、逆モータースイッチ130が起動され、それによって、逆モータースイッチ130を閉じ、リレー134にエネルギー印加する。このことによって、リレー134はそのエネルギー印加された状態を呈し、これにより、電流は、カートリッジロックアウトスイッチ136及び可変抵抗器110を迂回し、その代わりに、電流を、常時閉路式双極双投リレー142、及び戻ってモーター65の双方に、しかし、リレー140によってモーター65がその回転方向を逆転させるような方法で流す。
モーター停止スイッチ142は常時閉路式であるため、電流はリレー134に戻ってモーター停止スイッチ142が開くまでリレー134を閉状態に保つ。ナイフ32が完全に後退すると、モーター停止スイッチ142が作動され、モーター停止スイッチ142を開かせて、モーター65への電力供給が遮断される。
他の実施形態では、比例型スイッチ110よりはむしろ、オン−オフ型センサー又はスイッチが用いられる可能性が高い。こうした実施形態では、モーター65の回転速度は操作者によって加えられる力に比例しない。逆に、モーター65は通常、一定の速度で回転する。しかしながら、発射トリガー20がギア駆動系に連動しているために力に関するフィードバックは依然、操作者に与えられる。
上記で示されたように、確立した順序で一般に実施されなければならないステープラ機能内のいくつかの工程がある。例えば、一旦閉鎖トリガーがクランプ締めされると、発射サイクルが起動され得る。ナイフが完全に展開された後には、今度はシステムの後退が次に続く工程である。ユーザー以外の動力源(すなわち、電池又は空気圧)を含めると、上述されたように、ユーザーによって始動される工程を(したがって装置の複雑さを)システム自体で低減できることにより、これらの工程をシステム自体で達成することが可能となる。
しかしながら、さもなければ「自動的」な作動をユーザーが直感的に遅延させるか、減速させるか又は停止させることが可能であることが望ましい場合がある。例えば、その開示全体が参照によって本明細書に組み込まれる、米国特許出願第11/344,035号、現在は米国特許第7,422,139号で開示された装置のような触覚的フィードバック装置における発射起動を可能にする同一の作動ボタンが、後退中にユーザーがボタンを押圧することによって、自動戻りシステムを遅くするか又は停止させるために用いられ得る。
例えば、図12及び図13は、後退トリガー121が発射トリガー20上に、それとともに移動するように支持されている、本発明の別の実施形態を示している。より具体的には、後退トリガー121は、発射トリガーピン96上に旋回可能に支持され、発射トリガー20内のスロット(図示せず)を通じ突出している。ばね125が、発射トリガー100の結合継手部分123と後退トリガー121の装着部分127との間に取り付けられることで、後退トリガー121を非作動位置へと付勢する。第2の常時閉路式の後退スイッチ131がハンドル内に装着され、発射トリガー20が、完全に作動する位置と完全に非作動の位置との間を移動されると同時に、後退トリガー121の作動部分129が後退スイッチ131を作動させないように、後退スイッチ131は配向されている。しかしながら、後退トリガー121の装着部分127及び作動部分129は、発射トリガー20が後退プロセス中にどこに位置するかに関係なく、後退トリガー121を発射トリガー20に向かって押圧することによって、作動部分129を後退スイッチ131に起動接触させることが可能であるよう構成される。
上述されたように、エンドエフェクタ12がそのストロークの終端に到達するときに、ストローク終端スイッチ130が作動される。図13の例で示されるように、後退スイッチ131は、ストローク終端スイッチ130内で直列で存在する。後退スイッチ131は通常は閉じられているために、リレー134は、両スイッチ130、131が閉じている場合に励磁される。このことが、リレー134にその励磁状態を想定させ、このことが電流にカートリッジロックアウトセンサー136及び可変抵抗器110を迂回させる。電流が双極双投リレー140及びモーター65に流れるが、それはリレー140を介してのモーター65にその回転方向を逆転させる方法で行われる。ストローク開始スイッチ142は閉じているため、電流はリレー134に戻って流れ、スイッチ142が開くまでリレー134を閉状態に保つ。ナイフ32が完全に後退する場合に、ストローク開始スイッチ142が開かれ、これによって、モーター65から電源が遮断される。しかしながら、ユーザーが後退プロセスを減速させたい場合、ユーザーが後退トリガー121を押圧して後退スイッチ131の可変抵抗部分133を作動させてもよい。後退トリガー121が押圧されない場合には、可変抵抗部分133の抵抗は最小である。トリガー121が押圧される場合には、モーター65への電流を低減するために、可変抵抗部分133の抵抗は、後退トリガー121の押圧力に比例して増加する。後退トリガー121を更に押すことで、後退スイッチ131の常時閉路式接点135部分が開き、モーター65への電流の流れを停止するまで、後退プロセスは減速される。様々な実施形態では、一旦ユーザーが後退トリガー121を解放すると、ばね125が後退トリガー121を非作動位置に移動させて、スイッチ131の接触部分135が常時閉路位置へと戻り、これによって、電流が再びモーター65に流れるようにすることで後退プロセスが完了する。
上述の後退スイッチ及び後退トリガー配列の独特かつ新規な特徴はまた、それぞれの全体が参照によって双方ともに本明細書に組み込まれる、米国特許出願公開第2010/007674 A1号並びに米国特許第7,422,139号に開示されている様々な実施形態に関連付けて使用され得る。例えば、図14は、本発明の電流制御回路実施形態の別の実施形態を示す。(i)走行モーター(又は発射)スイッチ110が閉じられる(図14に開状態で示される)場合、(ii)装置安全性が設定されていることを指示している安全スイッチ240が閉じられる(図14に開状態で示される)場合、並びに(iii)器具がロックアウト状態ではないことを指示している常時閉路式ロックアウトスイッチ242が開かれている場合、電流は安全スイッチ240を通じ、ロックアウト指示器244(図14に示されるようなLEDであってよい)を通じて、モーター65に流れる。切断ストロークの終端に到達する場合、ストローク終端又は方向スイッチ130が切り替えられ、モーター65の方向を逆転させる(発射スイッチ110も解除された状態で)。この状態では、電流もまた、LEDなどの逆方向指示器246を通じて流れ、モーター方向が逆転されたことの可視的表示を提供する。
図14に示されるように、回路はまた、手動戻りスイッチ248を備えることができる。切断器具32が部分的に発射されただけの場合に、操作者は、このスイッチを手動で作動させてもよい。手動戻りスイッチ248を入れることで、モーター65を逆回転させ、切断器具32を元の位置又は定位置に戻すことができる。ユーザーが後退プロセスを減速又は停止させたい場合に、ユーザーは後退トリガー121を押圧することで後退スイッチ131の可変抵抗部分133を作動させる。トリガー121が押圧されると、抵抗が一部で押圧力を増加させ、モーター65への電流の流れを低減させる。後退トリガー121を更に押すことで、後退スイッチ131の常時閉路式接点135部分が開き、モーター65への電流の流れを停止するまで、後退プロセスは減速される。様々な実施形態では、一旦ユーザーが後退トリガー121を解放すると、ばね125が後退トリガー121を非作動位置に移動させて、スイッチ131の接触部分135が常時閉路位置へと戻り、これによって、電流が再びモーター65に流れるようにすることで後退プロセスが完了する。
電動式手術用器具に関する更なる構成が、その全体が参照として本明細書に組み込まれる、「Motor−Driven Surgical Cutting Instrument」と題された、公開された米国特許出願公開第2010/007647 A1号に開示されている。例えば、図15は、本発明の様々な実施形態による、別の電流制御回路の概略図である。様々な実施形態では、モーター制御回路は、例えば、プロセッサ、メモリ、マイクロコントローラ、時間回路等、などの1つ以上の集積回路(IC)を有する。他の実施形態では、モーター制御回路は、いずれのICを備えなくてもよい。ICを含有する手術用器具を滅菌することは困難、複雑、かつ高価であることが多いために、このような非IC電流制御回路は、好都合であり得る。
閉鎖トリガー18をロックした後に、操作者が最初に作動運動を発射トリガー20に加える場合、走行モータースイッチ110が作動され(又は閉じられ)、電流がそれを通して流れることが可能となる。常時開路式逆モーターセンサースイッチ130が開いている(つまりエンドエフェクタのストローク終端に達していない)場合、電流は、単極双投リレー132に流れる。逆モーターセンサースイッチ130が閉じていない場合、リレー132のコイル134には電圧が印加されず、したがって、リレー132は、その電圧が印加されていない状態にある。
図15に示されるように、回路はまた、リレー132と直列に接続されている並列化エレメントと並列に接続されている抵抗性エレメント144及びスイッチ146を有する。抵抗性エレメント144及びスイッチ146はまた、電源64にも接続されている。スイッチ146は、切断器具位置センサー150に応答する制御回路148によって制御され得る。様々な実施形態によると、切断器具32が、(i)そのストロークの開始に非常に近い場合、及び(ii)そのストロークの終端に非常に近い場合に、制御回路148は、スイッチ146を開くことができる。例えば、切断器具位置センサー150によって決定されるとおり、切断器具32が(i)そのストロークの開始点から0.25mm(0.001インチ)にある場合、及び(ii)そのストロークの終端から0.025mm(0.001インチ)にある場合、制御回路はスイッチを開くことができる。スイッチ146が開くことで、電流が抵抗性エレメント144を通じて流れ、次いでリレー132、リレー138、走行モーターセンサースイッチ110を通じ、モーター65まで流れる。抵抗性エレメント144を通じ流れる電流は、モーター65に供給される電流の大きさを減らし、これによってモーター65により供給される電力を低減する。したがって、切断器具32が、(i)そのストロークの開始に非常に近い場合、又は(ii)そのストロークの終端に非常に近い場合に、モーター65から供給される電力が低減される。逆に、一旦切断器具32がストロークの開始点又は終端点から十分に遠くに移動すると、制御回路148がスイッチ146を閉じて、これによって抵抗性エレメント144をショートさせ、これによってモーター65への電流を増加させ、したがって、モーターによって供給される電力を増加させる。
様々な実施形態によると、電流制御回路は、電源が断たれるときに、モーター65の電気的操作が開始されるようにリレー132からの電流がそこを通過する、インターロック回路137を集合的に形成しているロックアウトセンサースイッチ136a〜dを更に含む。それぞれのロックアウトセンサースイッチ136a〜dは、それぞれの対応する状態の有無に応答して、開かれた(すなわち、非導電性)スイッチ状態又は閉じられた(すなわち、導電性)スイッチ状態を維持するよう構成され得る。器具10が発射される場合に対応する状態のいずれかが存在するならば、不十分な切断及びステープリング動作及び/又は器具10への損傷をもたらし得る。ロックアウトセンサースイッチ136a〜dが応答する状態としては、例えば(a)溝22内にステープル・カートリッジ34がない状態、(b)消耗した(すなわち、先に発射された)ステープル・カートリッジ34が溝22内に存在する状態、及び(c)溝22に対してアンビル24が開かれた(ないしは別の方法で不十分に閉じられた)位置にある状態、を挙げることができる。構成部材の摩耗などのロックアウトセンサースイッチ136a〜dが応答し得る他の状態は、器具10によって生じる発射操作の積算回数に基づいて推定され得る。結果的に、様々な実施形態では、これら状態のいずれかが存在する場合、対応するロックアウトセンサースイッチ136a〜dがスイッチ開状態を維持し、したがって、モーター65の操作を開始するために必要とされる電流の通過を防止する。様々な実施形態では、全ての状態が修復された後にのみ、ロックアウトセンサー136a〜dによる電流の通過が可能となる。上述の状態は、単に例として提示されたものであり、器具10の操作に悪影響を及ぼす他の状態に応答するための追加的ロックアウトセンサーが提供されてもよいことを理解されたい。1つ以上の上述の状態が存在しないか又は無関係であるような実施形態については、ロックアウトセンサースイッチの数が、表示されているものより少ない場合もあることも同様に理解されたい。
図15に示されるように、ロックアウトセンサースイッチ136aが常時開路式スイッチ構成を用いて実装され得ることで、ステープル・カートリッジ34が溝22によるその適切な受け取りに対応する位置にある場合、スイッチ閉状態が維持される。ステープル・カートリッジ34が溝22内に装着されていないか、又は不適切に装着される(すなわち、誤って配置される)場合、ロックアウトセンサースイッチ136aは、スイッチ開状態を維持する。ロックアウトセンサースイッチ136bが常時開路式スイッチ構成を用いて実装され得ることで、消耗されていないステープル・カートリッジ34(すなわち、非発射位置のスレッド33を有するステープル・カートリッジ34)が溝22内に存在する場合のみ、スイッチ閉状態が維持される。溝22内の消耗したステープル・カートリッジ34の存在が、ロックアウトセンサースイッチ136bにスイッチ開状態を維持させる。ロックアウトセンサースイッチ136cが、常時開路式スイッチ構成を用いて実装され得ることで、アンビル24が溝22に対して閉位置にある場合に、スイッチ閉状態が維持される。ロックアウトセンサースイッチ136cは、遅延特性により制御され得、ここにおいてスイッチ閉状態は、アンビル24が所定の時間閉位置にあった後だけ、維持される。
ロックアウトセンサースイッチ136dが、常時閉路式スイッチ構成を用いて実装され得ることで、器具10によって生じる発射の積算回数が所定の回数未満である場合だけ、スイッチ閉状態が維持される。ロックアウトセンサースイッチ136dは、器具10により実行される発射操作の積算回数の計数表示を維持し、所定の回数に対して計数を比較し、かつこの比較に基づいて、ロックアウトセンサースイッチ136dのスイッチ状態を制御するよう構成された計数器139に連通し得る。図15に別個に示されているが、一般的な装置を形成するために、計数器139は、ロックアウトセンサースイッチ136dと一体化されてもよい。好ましくは、計数器139は電子素子として実装され、この電子素子は、それにもたらされた別個の電気信号の移行に基づいて維持された計数を増加するための入力を有する。機械的な入力(例えば、発射トリガー20の後退)に基づいて計数を維持するために構成される機械的な計数器が代わりに用いられてもよいことを理解されたい。電子素子として実装される場合、それぞれの発射操作について1回切り替わる電気回路内に存在する任意の別個の信号が、計数器139入力に使用され得る。図15に示されるように、例えば、ストローク終端センサー130の作動からもたらされる別個の電気信号が使用されてもよい。計数器139は、維持された計数が計数器139内に保存された所定の回数未満である場合にスイッチ閉状態が維持されるように、ロックアウトセンサースイッチ136dのスイッチ状態を制御し得る。維持された計数が所定の回数と等しい場合に、計数器139は、ロックアウトセンサースイッチ136dをスイッチ開状態に維持させて、これによって、そこを通る電流の通過を防止する。計数器139によって保存される所定の回数は、要求に応じて選択的に調節され得ることを理解されたい。様々な実施形態によると、計数器304は、LCDディスプレイなどの外部のディスプレイ(図示せず)と連通し得、これは器具10と一体となって、維持された計数又は所定の回数と維持された計数との差のいずれかをユーザーに示すためのものである。
様々な実施形態によると、インターロック回路137は、ロックアウトセンサースイッチ136a〜dの少なくとも1つの状態を表示するための、器具10のユーザーが視認できる1つ以上の指示器を備えてもよい。このような指示器に関するより詳細な説明は、その全体が参照として本明細書に組み込まれる、「Electric Lockout and Surgical Instrument Including Same」と題された公開された米国特許出願公開第2007/0175956号で確認され得る。本願はまた、ロックアウトセンサースイッチ136a〜dに関する装着配置及び構成の例を包含する。
図示した実施形態では、ロックアウトセンサースイッチ136a〜dが集合的にスイッチ閉状態を維持する場合、単極単投リレー138が励磁される。リレー138が励磁されると、電流がリレー138を通じ、走行モータースイッチセンサー110を通じ、かつ双極双投リレー140を介してモーター65に流れ、これによりモーター65に電力が供給されてモーター65は順方向に回転する。様々な実施形態によると、一旦励磁されると、リレー132が励磁されるまで、リレー138の出力がリレー138を励磁された状態で維持するために、たとえ1つ以上のインターロックセンサースイッチ136a〜dがスイッチ開状態を継続的に維持しようと、インターロック回路137は、一旦始動したモーター165の動作を防止するよう機能しない。しかしながら、他の実施形態では、一旦始動したモーター165の動作を持続するために、1つ以上のロックアウトセンサースイッチ136a〜dがスイッチ閉状態を維持せねばならぬように、インターロック回路137とリレー138を連結することが必要であるか、さもなくば望ましい場合がある。
順方向でのモーターの回転は、リングを遠位に移動させるので、これによって、様々な実施形態では、停止モーターセンサースイッチ142を非作動状態にする。スイッチ142は通常は閉じられているために、スイッチ142に接続されたソレノイド141が励磁され得る。ソレノイド141は、従来のプッシュタイプのソレノイドであり得、励磁されると、プランジャ(図示せず)を軸方向に伸ばす。プランジャの伸張は、閉鎖トリガー18を後退した位置に保持するよう動作することが可能であり、故に、発射操作が進行すると同時に(すなわち、スイッチ142が起動されていない間に)アンビル24が開くことを防止する。ソレノイド141の遮断の際に、プランジャが後退されることで、閉鎖トリガー18の手動での解放が可能である。
作動部材部分がそのストロークの最遠位端部に到達するときに、逆モータースイッチ130が起動され、これによって、スイッチ130を閉じ、リレー132を励磁する。これによりリレー132は励磁状態(図11には示されていない)となり、電流はインターロック回路137及び走行モーターセンサースイッチ110を迂回し、代わりに通常は閉状態にある双極双投リレー140及びモーター65の双方に流れるが、この場合はリレー140を介してモーター65の回転方向を逆転させるように流れる。停止モーターセンサースイッチ142は通常は閉じているため、電流はリレー132に戻ってスイッチ142が開くまでリレー132を励磁状態に保つ。ナイフ32が完全に後退すると、停止モーターセンサースイッチ142が起動され、スイッチ142を開かせることによって、モーター65の電力を遮断し、かつソレノイド141を遮断する。
図15に示される実施形態では、後退トリガー121(図15には示されていない)と連携する、常時閉路式後退スイッチ137が使用される。後退スイッチ137が起動される場合、これが開き、モーター65に向かう電流の流れを停止させる。別の実施形態(図15A)では、常時閉路式後退スイッチ137が、後退トリガー121と連携する可変抵抗器137’に置き換えられ得る。このような実施形態では、後退トリガー121が押されない場合は、可変抵抗器の抵抗が最小となり、最大の電流をモーター65に流すことを可能にする。押される場合には、抵抗が押す力に比例して増加し、モーターへの電流を減少させる。このような可変抵抗器はまた上述のような(図15B参照)後退スイッチ131と置き換えられ得る。
動力付きエンドカッターに対する偶発的な作動の防止:装置の機能がユーザーの力によって制限されないようにする動力付きシステムを導入すると、発射サイクルが偶発的に始動されることが、より一般的な問題となる。ユーザーは器具が既に発射を開始していることに気付かないので、作動制御部に「ぶつかり」、器具を発射させ、それによってカートリッジのロックアウトを外すか、あるいは組織上でカートリッジを「詰まらせる」ことも、更に容易となる。様々なロックアウト装置が、その開示全体が参照によって本明細書に組み込まれる、Swayzeらへの「Electronic Lockouts and Surgical Instrument Including Same」と題された、米国特許第7,644,848号に開示されている。この問題を排除するために、第2のロック解除作動スイッチ又はボタンを使用して、発射機構をロック解除することもできる。これは、動力鋸産業並びに軍隊において偶発的な作動を防止するために使用される2重スイッチシステムとほぼ同じものである。第2のスイッチは、発射トリガーのロックを解除するか、あるいは単純に制御部の電源に給電することができる。
上記に述べたように、2ストロークモーター駆動式器具の使用に際しては操作者はまず、閉鎖トリガー18を引き戻してロックする。図16及び図17は、閉鎖トリガー18をハンドル6のピストルグリップ部分26に対してロックする方法の一実施形態を示したものである。図の実施形態では、ピストルグリップ部分26はトーションバネ152によって旋回点151を中心として反時計回りに回転するように付勢されたフック150を有している。更に、閉鎖トリガー18は閉鎖バー154を有している。操作者が閉鎖トリガー18を引くと、閉鎖バー154がフック150の傾斜部分156と係合することにより、閉鎖バー154が傾斜部分156を完全に超えてフック150の陥凹切り欠き部158内に入り込んで閉鎖トリガー18が定位置にロックされるまでフック150が上向き(又は図16及び図17の時計回り)に回転する。操作者はピストルグリップ部分26の後ろ側又は反対側のスライド解除ボタン160を押し下げることによって閉鎖トリガー18を解放することができる。スライド解除ボタン160を押し下げることにより、フック150が時計回りに回転して閉鎖バー154が陥凹切り欠き部158から解放される。解放可能に閉鎖トリガー18をロックするための他の装置は、参照により本明細書に組み込まれる、米国特許第7,422,139号に開示されている。
図16及び図17に示され得るように、様々な実施形態では、閉鎖ロックスイッチ151がフック150内に装着され得ることで、フック150が定位置にラッチ留めされる場合だけ、スイッチ151が始動される。しかしながら、閉鎖トリガー18が定位置にロックされる場合に、閉鎖ロックスイッチ151は、閉鎖トリガー18による起動用にピストルグリップ部分26内に装着され得る。更に別の実施形態では、閉鎖ロックスイッチ151がエンドエフェクタに装着されることで、アンビル又は他の移動可能な部分が「閉じた」位置にある場合にだけ、閉鎖ロックスイッチが起動される。閉鎖ロックスイッチ151の特定の場所に関係なく、様々な実施形態では、閉鎖ロックスイッチは常時開路式スイッチであり、これは閉鎖トリガー18のロック又は別の方法でエンドエフェクタを「閉じた」位置に操作する際に閉じられる。
図18は、閉鎖ロックスイッチ151の使用を図示する、本発明の様々な実施形態による器具10の電気回路の概略図である。この図でわかるように、閉鎖ロックスイッチ151が閉じられなければ、たとえカートリッジが存在していても、電流が電池64からモーター65に向かって流れることが可能にならない。したがって、モーター65は、エンドエフェクタが閉状態にあることも反映するものである閉鎖トリガーがロックされた閉位置にある状態でなければ、モーター65は作動されることはできない。
様々な実施形態は、電流が電池64から他の回路構成部材に、最終的にはモーター65に流れることが可能となる前に、外科医によって起動されねばならない始動スイッチ153を更に含んでよい。始動スイッチ153は、常時開状態であり、ハンドル6上の便利な場所に位置していてよい。図1を参照されたい。したがって、これら実施形態では、たとえエンドエフェクタがカートリッジを収容し、かつ閉鎖トリガー18が閉位置にロックされていても、始動スイッチ153が外科医によって閉じられるまで電流がモーター65に流れることが可能とならない。別の実施形態では、始動スイッチ153は、スイッチ153が作動位置に移動されない限り、発射トリガー20がピストルグリップ部分に向かって物理的に回転されることを防止する機械的スイッチを備えてもよい。
動力付きエンドカッターのための能動的調節可能なステープル高さ:組織の厚さ及び種類に合わせて調節可能なステープル高さが、長年にわたって追求されてきた。ごく最近では、それぞれの開示全体がそれら対応の全体を参照することにより本明細書に組み込まれる、2005年9月21に出願され、現在では米国特許第7,407,078号である米国特許出願第11/231,456号、並びに2006年9月29日に出願され、現在では米国特許第7,467,740号である、米国特許出願第11/540,735号が、器具の隙間を装置内のより厚い組織によって誘起される負荷で拡張させることが可能なたわみ継手部材又は支持部材を概ね伴う。この「受動的な」可変のステープル高さにより、より大きなステープルの形状を生じさせる組織の厚さが許容される。
電源を器具の中に導入することで、電気を使用して、動的な結合要素の中の内部要素の高さを変化させることが可能となり、それにより、外科医又は器具を所望の高さに設定することで、ステープルの高さが「能動的に」変化する。この内部要素は、形状記憶材料であってもよく、電気によってその温度が変化し、したがって、事前に設定された形状により、その物理的高さを変化させることが可能となる。別の実用的な方法は、電場の導入により高さと幅を変化させる電気活性高分子(EAP)を含めることである。更に、第3の実施形態は、従来の線形電気ステッパー要素を利用することであり、その線形電気ステッパー要素は、高さを調節する連結梁の中に、小さな調節可能なネジ要素をラチェット係合させ得るものである。
より具体的に、また図19及び図20を参照すると、本発明の様々な実施形態のエンドエフェクタ12が、アンビル24が閉じられた又はクランプ締めされた位置の状態での断面図で示されている。これからわかるように、切断器具又はナイフ32は、螺旋状ネジシャフト36に螺合するよう構成されるネジ付きスリーブ又はナット部分37’を有する下部作動装置部分37を有する。更に、フィン39がナット部分37のそれぞれの外側側部から横方向に突出し、溝22の対応のスライド部分23に対面する。図19からもわかるように、ナイフ32は、アンビル24内の長手方向のT形状スロット43の内部で受け取るようサイズ設定された上部作動装置部分41を有する。図19で見られるように、一対の上部保持ピン41’が、ナイフ32の上部作動装置部分41のそれぞれの側面から横方向に突出している。それぞれの上部保持ピン41’は、アンビル24内に設けられているT形状スロット43の対応の部分に向かって延びるよう構成されている。したがって、ナイフ32がエンドエフェクタ12を通して遠位方向に駆動されると同時に、フィン39及び保持ピン41’がアンビル24とカートリッジ34との間の空隙の量を所定の空隙の最大量に制限するよう働く。
本発明の様々な実施形態は、溝22内に設置されたアンビル24とカートリッジ34との間の空隙の量を調節するための手段を提供している。例えば、いくつかの実施形態では、それぞれのフィン39が、溝22のそれぞれのスライド部分23内に装着されている対応の電気接点47とすり接触するためのスレッド接点45を支持する。電気接点47は、ナイフ32が溝22内で駆動されると同時に、スレッド接点45がそれに対応の電気接点47と常に接触しているように、溝22の内部で細長く延在している。電気接点47は電源又は電池64に接続され、モーター65が電力供給されナイフ32を遠位方向に駆動させる場合に、そこから電流を受容するよう構成される。更にある実施形態では、図19に示されるように、電気的に応答する高さ調節部材49がそれぞれの保持ピン41’に装着されている。高さ調節部材49は、スレッド接点45に電気的に結合され、そこから電流を受容する。様々な実施形態では、高さ調節部材49は、通電されると、事前設定された形状により、その物理的高さを変化させる形状記憶材料を備えてもよい。したがって、受容される電流の量に依存して、高さ調節部材49は膨張し得、アンビル24をカートリッジ34に向かって押し込むことによって、それらの間の空隙の量を低減する。このような材料の量は、受容される電流の量に比例しており、既知である。制御回路(図示せず)が、膨張の量、故にアンビル24とカートリッジ34との間の空隙の量を制御するために使用されてもよい。他の実施形態では、高さ調節材料は、ピン41のポケット内に保持されるか又は別の方法でそれに取り付けられる電気活性高分子(EAP)を含む。
図21は、図19に示された実施形態と同様である別の実施形態を図示する。しかしながら、この実施形態では、高さ調節部材49はアンビル24内に装着されており、それに直接的に取り付けられた導電体を通じて電源からの電流を受容する。したがって、この実施形態では、上述されたような接点43及び45は必要ない。
図22は、保持ピン41’が、ナイフ組立品32’の下部300に対して垂直方向「VD」で選択的に移動可能である別個の上部作動装置部分302に装着されていることを除けば、上述のナイフ組立品32に実質的に同一である代替的なナイフ組立品32’を図示する。第2のモーター304が下部300に装着されてもよく、上部保持部分302のナット部分308に螺合する主ネジ306を有してよい。上部保持部分は、下部300の対応する形状のスロット312内に滑動可能に貫通する「T」形状の舌状部分310を有することで、上部保持部分302が下部保持部分300に対して垂直に移動することを可能にする一方で、下部保持部分300に対する上部保持部分302の回転を防止する。したがって、上部保持部分302と下部保持部分300との間の距離は、第2のモーター304に電力供給することで調節され得る。結果的に、外科医がアンビル24とカートリッジ34との間の空隙の量を減らしたい場合は、第2のモーター304が電力供給され、それが上部保持部分302を下部保持部分300に向かって引くよう第1の方向で回転する。しかしながら、外科医がアンビル24とカートリッジ34との間の空隙の量を増加させることを望む場合には、第2のモーター304が反対方向に回転される。
本発明の様々な実施形態は、エンドエフェクタ照明方法及び動力付きエンドカッターを使用する場合の手術部位を照明するための方法を包含する。現在、エンドエフェクタがその展開位置に又はその近くにあるとき、隣接する構造物によって投じられる影が存在するだけでなく、エンドエフェクタが完全に別の構造物の背後に隠れることもあるため、外科医が治療部位を視覚化することは時に困難である。図23は、アンビル404、カートリッジ本体406、及び溝408を有する本発明の様々な実施形態の手術用ステープラ400の遠位端部402を一般的な形式で図示する。この図から分かるように、組織401を照明するために、更なる光源410がカートリッジ本体406の端部に配置され得る。この光源410は、器具のハンドル内に支持された電池から電力供給されるか、又は、他の実施形態では、交流電流によって電力供給され得る、電池半導体(LEDなどの)、従来の白熱若しくはフィラメント電球、エレクトロルミネセント又はレーザーが挙げられるが、これに限定されない、電気エネルギーを光に変換する実用的手段の任意の組み合わせであり得る。このような装置は、外科医が処置部位を直接的に照らすことを可能にするのみならず、これは構造物の背面照明が脈管構造などの内部構成要素を見ること、並びに他に関心のある領域を指し示す伝統的なスコープを通してレーザーポインターの使用を容易にすることを可能にする。
様々な実施形態では、1つ以上の接点420がカートリッジ本体406の背面上に設けられており、これは溝408内の接点422に係合するよう構成されている。図24を参照されたい。これにより、外科医は、ハンドル430に配置されたスイッチを通じて接点の組に電圧を加えることによって、必要に応じて光源410に電圧を加えることが可能となる。説明する強度は主要な装置の作動速度を制御し得るので、このスイッチは、可変の強度を有し得る。円形の手術用ステープラに取り付けられたアンビルの端部を照明するための他の照明装置は、その開示全体が参照により本明細書に組み込まれる、2010年4月22日に公開された、「Surgical Stapling Instrument With Apparatus For Providing Anvil Position Feedback」と題された、米国特許出願公開第2010/0096435 A1号に開示されている。
その開示全体が参照により本明細書に組み込まれる、2007年8月2日に公開された、「Surgical Instrument Having a Feedback System」と題された米国特許出願公開第2007/0175949 A1号は、その公開の図45〜47において、とりわけエンドエフェクタのこの位置フィードバック、ロックアウト状態、発射の回数などを示すことが可能な出力ディスプレイを更に開示している。このことは、装置の状態の識別、特に装置を起動させることなく装置のロックアウト状態を識別することであるユーザーにとってより困難な問題の1つを最小化すると思われる。ユーザーに役立つ更なるフィードバックは、カートリッジが装填されるときの、そのカートリッジの状態に関する即時フィードバックである。上記の用途と同様に、その即時フィードバックはハンドル430上のロックアウト指示にまとめられ得る。指示器432(LED、電球、LCD、音声発生器(sonic enunciator)、振動器など)が単独で、カートリッジロックアウト手段又は機構の状態に関連付けられることができ、それにより、この情報が外科医に提供される。LEDはハンドル430上に設置されてもよい。図26を参照されたい。別法として、カートリッジの「発射準備」が整っているか否かについての即時情報を外科医及びローダーに提供する指示器434が、遠位端部402の近くに設置され得る。図25を参照されたい。これは、機械的ロックアウトに直接関連付けられるスイッチ又は接点の組を用いて達成され得る。このスイッチ又は接点は、指示器が適切な情報を提供するように回路を完成させる。この完成した接点の組は、スレッド(米国特許出願公開第2007/0175958号における部品33)内の導電性要素を通じたものでもよく、これらの2つの接点は、溝(部品22)の近位の位置にあってもよい。ロックアウト状態を検出するための別の方法は、器具の状態を間接的に用いるものである(例1:カートリッジが装填されており、発射の試行がないことは、ロックアウトが係合していないことを示す。例2:器具が発射しており、新たなカートリッジが取り付けられていないことは、ロックアウトが係合していることを示す、など)。別の実施形態では、LED又は視覚的指示の合図をカートリッジ自体に置くこととなる。カートリッジが所定の位置へとスナップ嵌めされると、カートリッジに電力を供給する接点が生じる。カートリッジが発射した場合、機械的ロックアウトがナイフの前進を停止させるだけでなく、カートリッジ回路がカートリッジ上のLEDを照らして、カートリッジがロックアウトしていることを顕微鏡モニター上で外科医に通知する。このことは、カートリッジ自体の中に小型の電池又は他の電荷蓄積部を置いて、主装置への電力接続の必要性を排除することによって、更に拡張され得る。また、カートリッジ回路は、装置が閉鎖される度にロックアウト光を照らして、使用済みのカートリッジが装置内にあることをユーザーに通知するように設定され得る。
動力付き関節動作及びカートリッジの色に関するフィードバックの指示:取り付けられたカートリッジのタイプ(色)及び関節の角度を指示することは、外科医に有用であると考えられる。関節角度の指示は、LEDの弧光などにおける数値的又は図形的な方式を含めて、いくつかの方式で指示され得る。この指示の位置は、便利な配置においてはハンドル上であってもよく、あるいはエンドエフェクタに対してわずかに近位側の装置のシャフト上であってもよい。エンドエフェクタのフィードバックは、受動的であっても能動的であってもよい。能動的である場合、更なるLEDが照らされて角度が示される。受動的である場合、照らされた半円を単に示してもよく、それにより、外科医は、エンドエフェクタがどの程度に関節角度をなしているかを直感的に知ることができる。本発明者らが外科手技を更に調査するにつれて、外科医の目は、器具のハンドルではなく手術部位に向けられる必要があることが更に明らかとなっている。また本発明者らは、装置からの完全な状態フィードバックを外科医が必要としていることを理解するようになった。関節角度は、関節接合の一部として照明され得る。ライト、LEDなどで種々の角度を示すか、あるいは小さなLCDで角度を示す。これにより、外科医は、直線から外れた角度に対するフィードバックを有することが可能となり、その結果、外科医は、取外し及び再挿入の後に、この角度に容易に戻ることができる。別の問題は、何色のカートリッジが装置内にあるかという「明白な」指示である。これは、エンドエフェクタ又はカートリッジのいずれかの上にある、色分けされたライトの配列によって達成され得る。また、どのカートリッジがジョー内にあるのかについての混乱が最小限となるように、この情報は、「冗長な」ディスプレイに表示するために再びハンドルに伝送され得る。別の改良点として、カートリッジの近位デッキに連結された小型の板バネ接点を挙げることができ、この板バネ接点は、最小限の組織圧力がジョー内に達成されたか否かを示すものである。デッキ上の不十分な組織の圧力が存在する場合には点灯しないので、この最小圧力は、少なくとも、厚い組織用のカートリッジが薄い組織の用途に使用されているか否かを示す。
非無菌電池パック(おそらく、プログラム可能なロジックが顧客の重要な要求となる場合、電池パックと一体の電子機器を有する)を導入するための方法が、おそらくは必要とされている。別々に滅菌された再利用可能な装置内に非無菌電池パックを挿入することに関し、整形外科用ドリルの業界には既に特許が存在している。この技術革新は、非無菌電池パックを挿入する際に使い捨ての装置無菌パッケージを利用して器具の無菌性を保護することによって、その構想を改善することを意図したものである。更なる改善点は、「ハッチ」ドアを含めたことであり、そのハッチドアは、器具の中に設計されたものであり、パックが挿入された後、装置が最終的な無菌パッケージから取り出される前に閉鎖可能である。このハッチは次いで、無菌の手術野を汚染し得る非無菌電池を「収容する」。その方法は、パッケージの更なる層を含めることであり、このパッケージの層は、追加層を破裂させ電池を通して、あるいは、完全に挿入されたときに、露出する電池のピン先端によって破裂されるように、電池の電極の組を押し進めて、電池を押し通すことができる穴あき領域を有する。これに代わる方法は、ガン(gun)の内部端子(電池保護用の空洞の奥深くにある)で無菌バリアを破裂させ、その内部端子を電池パック内のピンホールに着座させることである。ハッチは次いで、システムを封止する無菌パックによって閉鎖され得る。ガンは次いで、任意の無菌装置がそうであるように、無菌野に手渡され得る。
位置ロケータの実施形態/直線エンコーダ及びモーターパラメータの負荷制御:米国特許第6,646,307号及び同第6,716,223号には、回転及びそれに関連するトルクを測定してモーターパラメータを制御し、エンドエフェクタの形状及び負荷の同定に基づいてこれらのパラメータの最適化する機構が開示されている。米国特許出願公開第2007/0175958号には、図8〜13の全長にネジ山の付いた一次シャフトの使用により、このタイプの直線運動制御を使用してトリガー位置を制御する方法が示されている。同じタイプの方法が、電子式の直線制御方法に用いられ得る。エンドエフェクタは、少なくとも1つのバネ付勢プランジャを押し下げることによって、長さとタイプを機械的に識別することができ、それによって、モーターを稼働させることができるハンドルのタイプ及び長さを識別することができる。モーターの回転は、回転運動から直線的なラック又はケーブル運動へと変換されることができ、次いでこの運動は、制御スライドの所望の直線運動に変化をもたらすように、モーターの電圧、電流、及び速度を調節するために使用され得る。制御スライドは次いで、ナイフ駆動運動に直接結合され得る。この制御スライドは、プランジャ識別子が後退前の最大の「到達」直線変位として記す、離散的又は連続的な「停止」位置を有することができる。
モジュールへの直線駆動装置の再搭載の確認:手術用器具のある有用な特徴は、どのエンドエフェクタが器具に取り付けられているかを確認できることである。動力付きの手術用ステープラの場合、複数の異なるタイプのエンドエフェクタが取り付けられ得る。加えて、あるタイプのエンドエフェクタが、選択的に利用又は有効化される少なくとも1つの機能及び/又は特徴を有することがある。どのエンドエフェクタが取り付けられているかを識別するための手段が開示される。以下で述べるエンドエフェクタの「タイプ」は、機械的、空気圧的、又は油圧的に結合されたエンドエフェクタに限定されないことに留意されたい。その器具は、このエンドエフェクタを検出した結果として、種々の動作を行い、操作パラメータを調節し、利用可能な機能などを示すことができる。
エンドエフェクタは、器具に取り付けられたときになされる電気接続を有する。器具はエンドエフェクタと通信し、複数のタイプの信号のうちの少なくとも1つを読み取る。スイッチ位置又は接点位置は、どのタイプのエンドエフェクタが存在するかを示す。受動素子がインピーダンスに関して測定され、その結果により、どのタイプのエンドエフェクタが存在するかが示される。
エンドエフェクタは、器具への無線周波数リンクを有し、データは、エンドエフェクタと器具との間で少なくとも1つの方向に転送される。
エンドエフェクタは、器具との音響リンクを有し、データは、エンドエフェクタと器具との間で少なくとも1つの方向に転送される。
エンドエフェクタは、器具への光学リンクを有し、データは、エンドエフェクタと器具との間で少なくとも1つの方向に転送される。
エンドエフェクタは、そのエンドエフェクタを識別する器具の中の各要素(スイッチ又は接点など)を連動させる機械的リンクを有し、それにより、データは、エンドエフェクタと器具との間で少なくとも1つの方向に転送される。
いくつかの実施形態の記載により本発明が説明され、説明的実施形態がかなり詳細に記載されているが、出願人には添付された請求範囲をかかる詳細によっていかなる方法によっても制限する意図はない。当業者には更なる効果及び改変が直ちに明らかとなり得る。
例えば、上述の実施形態は内視鏡を使用する外科用切断及びステープラ器具10について利点を有したが、同様の実施形態が、他の臨床的処置で用いられてもよい。概して、内視鏡的処置は腹腔鏡的処置よりもより一般的である。したがって、本発明は内視鏡的手術及び装置との関連において議論される。しかしながら、本願における「内視鏡」などの用語の使用は、本発明を内視鏡チューブ(すなわちトロカール)との組み合わせにおいてのみ使用される外科用器具に限定するものとして解釈されてはならない。むしろ本発明は、腹腔鏡手術及び開放手術などを含むがこれらに限定されない、小さな切開創にアクセスが限定されるあらゆる手術に用途を見出し得るものと考えられる。
参照によって全体又は一部が本明細書に組み込まれるとされる任意の特許、公開又は情報は、組み込まれる資料が、この文書に記載されている既存の定義、記述、又は他の開示資料と矛盾しない程度にのみ、本明細書に組み込まれる。したがって、本明細書に明確に示した開示内容は、本明細書に援用されるいかなる矛盾する文献にも優先するものとする。
以上、本発明を例示的な構成を有するものとして説明したが、本発明は本開示の趣旨及び範囲内で更に改変することができる。したがって、本出願はその一般的原理を利用した本発明のあらゆる変形、使用又は適応を網羅するものとする。更に、本出願は、本発明が関連する技術分野における公知の、又は従来の実施に含まれる本開示からの発展形を網羅するものとする。
〔実施の態様〕
(1) 外科用締結装置であって、
a.ハンドルと、前記ハンドルに取り付けられた近位端部及びそれから延びる遠位端部を有する細長いシャフトと、近位端部で旋回され、開位置と閉位置との間で移動可能である一対のジョーを備えるエンドエフェクタと、複数個の外科用締結具を収容し、前記エンドエフェクタに取り付けられているカートリッジと、
b.前記外科用締結具を展開するための電動作動装置であって、電源及びモーターを備える、電動作動装置と、
c.前記エンドエフェクタが前記閉位置にある場合、前記ジョー間の間隔の量を電気で調節するための手段と、を備える、外科用締結装置。
(2) 前記エンドエフェクタが、
前記カートリッジを中に操作可能に支持するよう構成された細長い溝と、
前記細長い溝に旋回可能に連結され、前記開位置と前記閉位置との間で選択的に旋回可能であるアンビルと、を備える、実施態様1に記載の外科用締結装置。
(3) 前記作動装置が、前記モーターから受容された作動動作に応答して前記エンドエフェクタ内で移動可能である作動装置部分を備え、前記作動装置部分が、前記細長い溝に滑動可能に係合する下部作動装置部分と、前記アンビルに滑動可能に係合するよう構成された一対のリテーナ部材を有する上部部分とを有する、実施態様2に記載の外科用締結装置。
(4) 前記電気で調節するための手段が、前記保持部材のそれぞれに高さ調節部材を備え、前記高さ調節部材のそれぞれが、前記保持部材と前記アンビルの対応の部分との間に配置され、かつ前記電源と電気的連通状態にあり、前記高さ調節部材のそれぞれが、前記電源からの電流に応答して増加する厚さを有する、実施態様3に記載の外科用締結装置。
(5) 前記電気で調節するための手段が、前記上部作動装置部分上の前記保持部材のそれぞれに対応する、前記アンビル上の高さ調節部材を備え、前記高さ調節部材のそれぞれが、前記対応する保持部材と前記アンビルとの間に配置され、かつ前記電源と電気的連通状態にあり、前記高さ調節部材のそれぞれが、前記電源からの電流に応答して増加する厚さを有する、実施態様3に記載の外科用締結装置。
(6) 前記細長い溝内にあり、前記電源と電気的連通する少なくとも1つの電気接点と、
前記下部作動装置上の少なくとも1つのすり接点(slide contact)と、を更に備え、前記少なくとも1つのすり接点が、前記細長い溝内の前記少なくとも1つの電気接点の対応する1つと電気滑り接触し、前記高さ調節部材と電気的連通状態にあり、そこに前記電流を伝送する、実施態様4に記載の外科用締結装置。
(7) 前記上部作動装置部分が、前記下部作動装置部分に対して移動可能である、実施態様3に記載の外科用締結装置。
(8) 前記電気で調節する手段が、前記上部作動装置部分を前記下部作動装置部分に対して電気で移動させるための手段を備える、実施態様7に記載の外科用締結装置。
(9) 前記電気で移動させるための手段が、前記上部及び下部作動装置部分に連結され、前記電源と電気的連通状態にある第2の電動モーターを備える、実施態様8に記載の外科用締結装置。
(10) 前記細長い溝内にあり、前記電源と電気的連通する少なくとも1つの電気接点と、
前記下部作動装置上の少なくとも1つのすり接点と、を更に備え、前記少なくとも1つのすり接点が、前記細長い溝内の前記少なくとも1つの電気接点の対応する1つと電気滑り接触し、前記第2の電動モーターと電気的連通状態にある、実施態様9に記載の外科用締結装置。
(11) 前記高さ調節部材が、電気活性高分子材料を備える、実施態様4に記載の外科用締結装置。
(12) 外科用締結装置であって、
ハンドルと、
前記ハンドルに操作可能に連結されたエンドエフェクタと、を備え、前記エンドエフェクタが、
中にカートリッジを支持するよう構成された細長い溝と、
閉位置へと前記細長い溝に向かい、開位置へと前記細長い溝から離れる選択的移動のために前記細長い溝上に移動可能に支持され、中に細長いスロットを有するアンビルと、
前記細長い溝内に移動可能に支持され、前記細長い溝内で非作動の近位位置から作動位置へと選択的に移動可能である作動装置部材とを備え、前記作動装置部材が、
前記細長い溝と滑動可能に係合する下部作動装置部分と、
前記細長いスロット中に突出するよう構成された上部作動装置部分と、
前記上部作動装置部分の各外側側部から、前記アンビル内の前記細長いスロットをほぼ横断する方向で突出しているリテーナ部材と、
前記アンビルが、それに印加された電流に応答して、前記閉位置のうちの1つにある場合に、前記アンビルと前記細長い溝との間の間隔を選択的に調節するための、前記リテーナ部材のそれぞれの上にある高さ調節部材と、を備える、外科用締結装置。
(13) 前記細長い溝内にあり、前記電源と電気的連通する少なくとも1つの電気接点と、
前記下部作動装置部分上の少なくとも1つのすり接点と、を更に備え、前記少なくとも1つのすり接点が、前記細長い溝内の前記少なくとも1つの電気接点の対応する1つと電気滑り接触し、前記第2の電動モーターと電気的連通状態にある、実施態様12に記載の外科用締結装置。
(14) 前記高さ調節部材が、前記リテーナ部材と直面する関係性を持つために、前記細長いスロットの各外側側部に隣接して前記アンビル上にある、実施態様12に記載の外科用締結装置。
(15) 前記細長い溝内にあり、前記電源と電気的連通する少なくとも1つの電気接点と、
前記下部作動装置部分上の少なくとも1つのすり接点と、を更に備え、前記少なくとも1つのすり接点が、前記細長い溝内の前記少なくとも1つの電気接点の対応する1つと電気滑り接触し、前記第2の電動モーターと電気的連通状態にある、実施態様14に記載の外科用締結装置。
(16) 前記高さ調節部材が、電気活性高分子材料を備える、実施態様12に記載の外科用締結装置。
(17) 前記高さ調節部材が、電気活性高分子材料を備える、実施態様14に記載の外科用締結装置。
(18) 外科用締結装置であって、
ハンドルと、
前記ハンドルに操作可能に連結されたエンドエフェクタと、を備え、前記エンドエフェクタが、
中にカートリッジを支持するよう構成された細長い溝と、
閉位置へと前記細長い溝に向かい、開位置へと前記細長い溝から離れる選択的移動のために前記細長い溝上に移動可能に支持され、中に細長いスロットを有するアンビルと、
前記溝内に移動可能に支持され、前記ハンドル内に支持された第1の電動モーターによって作動装置部材に印加される駆動運動に応答して、前記細長い溝内で非作動の近位位置から作動位置へと選択的に移動可能である作動装置部材とを備え、前記作動装置部材が、
前記細長い溝と滑動可能に係合する下部作動装置部分と、
前記細長いスロット中に突出するよう構成され、前記下部作動装置部分に対して移動可能である上部作動装置部分と、
前記上部作動装置部分の各外側側部から、前記アンビル内の前記細長いスロットをほぼ横断する方向で突出しているリテーナ部材と、
前記上部作動装置部分を前記下部作動装置部分に対して選択的に移動させるために、前記上部及び下部作動装置部分に連結された第2の電動モーターと、を備える、外科用締結装置。
(19) 前記細長い溝内にあり、前記電源と電気的連通する少なくとも1つの電気接点と、
前記下部作動装置上の少なくとも1つのすり接点と、を更に備え、前記少なくとも1つのすり接点が、前記細長い溝内の前記少なくとも1つの電気接点の対応する1つと電気滑り接触し、前記第2の電動モーターと電気的連通状態にある、実施態様18に記載の外科用締結装置。

Claims (7)

  1. 外科用締結装置であって、
    a.ハンドルと、前記ハンドルに取り付けられた近位端部及びそれから延びる遠位端部を有する細長いシャフトと、近位端部で旋回され、開位置と閉位置との間で移動可能である一対のジョーを備えるエンドエフェクタと、複数個の外科用締結具を収容し、前記エンドエフェクタに取り付けられているカートリッジと、
    b.前記外科用締結具を展開するための電動作動装置であって、電源及びモーターを備える、電動作動装置と、
    c.前記エンドエフェクタが前記閉位置にある場合、前記ジョー間の間隔の量を電気で調節するための手段と、を備え、
    前記エンドエフェクタが、
    前記カートリッジを中に操作可能に支持するよう構成された細長い溝と、
    前記細長い溝に旋回可能に連結され、前記開位置と前記閉位置との間で選択的に旋回可能であるアンビルと、を備え、
    前記作動装置が、前記モーターから受容された作動動作に応答して前記エンドエフェクタ内で移動可能である作動装置部分を備え、前記作動装置部分が、前記細長い溝に滑動可能に係合する下部作動装置部分と、前記アンビルに滑動可能に係合するよう構成された一対の保持部材を有する上部部分とを有し、
    前記電気で調節するための手段が、前記保持部材のそれぞれに高さ調節部材を備え、前記高さ調節部材のそれぞれが、前記保持部材と前記アンビルの対応の部分との間に配置され、かつ前記電源と電気的連通状態にあり、前記高さ調節部材のそれぞれが、前記電源からの電流に応答して増加する厚さを有する、外科用締結装置。
  2. 外科用締結装置であって、
    a.ハンドルと、前記ハンドルに取り付けられた近位端部及びそれから延びる遠位端部を有する細長いシャフトと、近位端部で旋回され、開位置と閉位置との間で移動可能である一対のジョーを備えるエンドエフェクタと、複数個の外科用締結具を収容し、前記エンドエフェクタに取り付けられているカートリッジと、
    b.前記外科用締結具を展開するための電動作動装置であって、電源及びモーターを備える、電動作動装置と、
    c.前記エンドエフェクタが前記閉位置にある場合、前記ジョー間の間隔の量を電気で調節するための手段と、を備え、
    前記エンドエフェクタが、
    前記カートリッジを中に操作可能に支持するよう構成された細長い溝と、
    前記細長い溝に旋回可能に連結され、前記開位置と前記閉位置との間で選択的に旋回可能であるアンビルと、を備え、
    前記作動装置が、前記モーターから受容された作動動作に応答して前記エンドエフェクタ内で移動可能である作動装置部分を備え、前記作動装置部分が、前記細長い溝に滑動可能に係合する下部作動装置部分と、前記アンビルに滑動可能に係合するよう構成された一対の保持部材を有する上部部分とを有し、
    前記電気で調節するための手段が、前記上部作動装置部分上の前記保持部材のそれぞれに対応する、前記アンビル上の高さ調節部材を備え、前記高さ調節部材のそれぞれが、前記対応する保持部材と前記アンビルとの間に配置され、かつ前記電源と電気的連通状態にあり、前記高さ調節部材のそれぞれが、前記電源からの電流に応答して増加する厚さを有する、外科用締結装置。
  3. 前記細長い溝内にあり、前記電源と電気的連通する少なくとも1つの電気接点と、
    前記下部作動装置上の少なくとも1つのすり接点と、を更に備え、前記少なくとも1つのすり接点が、前記細長い溝内の前記少なくとも1つの電気接点の対応する1つと電気滑り接触し、前記高さ調節部材と電気的連通状態にあり、そこに前記電流を伝送する、請求項に記載の外科用締結装置。
  4. 前記上部作動装置部分が、前記下部作動装置部分に対して移動可能である、請求項1または2に記載の外科用締結装置。
  5. 前記電気で調節する手段が、前記上部作動装置部分を前記下部作動装置部分に対して電気で移動させるための手段を備える、請求項に記載の外科用締結装置。
  6. 前記電気で移動させるための手段が、前記上部及び下部作動装置部分に連結され、前記電源と電気的連通状態にある第2の電動モーターを備える、請求項に記載の外科用締結装置。
  7. 前記細長い溝内にあり、前記電源と電気的連通する少なくとも1つの電気接点と、
    前記下部作動装置上の少なくとも1つのすり接点と、を更に備え、前記少なくとも1つのすり接点が、前記細長い溝内の前記少なくとも1つの電気接点の対応する1つと電気滑り接触し、前記第2の電動モーターと電気的連通状態にある、請求項に記載の外科用締結装置。
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