JP6740131B2 - 手術器具を備えたセット、手術システム、及びトレーニング方法 - Google Patents
手術器具を備えたセット、手術システム、及びトレーニング方法 Download PDFInfo
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Description
人間の運動系は、数ある中でも、随意運動の制御によって、手および指等の身体部分を外科医が動かすことにより、体腔の内側の手術器具の移動を制御可能な複雑系である。
上記ツールは、後述の通り組み立てることによって手術器具アセンブリを構成可能な手術器具およびパターン生成部材を備えた最小侵襲手術用の相関セットの形態で提供される。
「遠位方向」という表現は、ベクトルが手術器具の近位端から遠位端を向く方向を意味する。
遠位および近位方向は、手術器具の本体部が直線位置にある場合に決まる。
手術器具の本体部は、直線位置において決まる長手軸を有しており、この長手軸は、遠位および近位方向に平行である。
「手術器具アセンブリ」という用語は、手術器具およびパターン生成部材を備えたアセンブリを意味する。
用語「およそ」は一般的に、測定不確実性の範囲内が含まれるように使用する。本明細書において、範囲として使用する場合の用語「およそ」は、測定不確実性の範囲内が当該範囲に含まれることを意味する場合に採用するものとする。
一実施形態において、外科医が手術野の間接視にて体腔内の外科手術を行う最小侵襲手術で使用する手術器具は、器具を操作するための把持部と、把持部から延びて手術ツールを含む本体部とを備え、本体部は、身体の切開部を介して体腔に挿入されるように構成されている。パターン生成部材は、本体部に固定されており、本体部が体腔に挿入された場合、手術野の領域に光パターンを投射するため、外科医が光パターンの間接視に基づいて手術野の輪郭および器具の位置を推定できるようになっている。
上述の手術器具アセンブリは、最小侵襲手術における外科医のトレーニングおよび実際の外科手術の両方で使用可能である。これにより、トレーニング中の使用の場合は、最小侵襲外科医がライブ手術を行うのに十分熟練するまでのトレーニング時間が短くなる。
パターン生成部材の投射器は、手術ツールの少なくとも任意の非回転移動が投射器の相関移動となるように、手術器具の本体部に対して少なくとも一時的に固定されるように構成されているのが好都合である。
一実施形態においては、手術ツールの単なる回転移動が投射器ひいては投射パターンの相関移動とならないように、投射器またはパターンの形状が構成されている。
一実施形態において、パターン生成部材は、本体部に対して取り外し可能に取り付けられている。そして、外科医は、必要に応じてパターン生成部材を取り外すことができる。また、パターン生成部材は、既存の手術器具に取り付けて、手術器具アセンブリを得ることもできる。
本体を囲むスリーブ材料(ここでは、スリーブ壁と称する)の厚さは、特に切開部およびトレーニングキットのカバーの孔に挿通されるように構成されたスリーブの部分のうちの一方または両方において、手術器具アセンブリが嵩張り過ぎないように考慮された任意の厚さであってもよい。スリーブ壁の厚さは、本体の長さおよび/または本体周りの環状もしくは半環状延長部に沿って変化するものであってもよい。適当なスリーブ壁厚さの例は、およそ2〜5mm等、およそ0.1〜およそ10mmである。
一実施形態において、スリーブは、本体用の第1の細長貫通孔および光ファイバ用の別個の細長孔を備えることにより、搭載時のハンドルおよび投射器に最も近いスリーブの端部から、光ファイバ用の保護カバーを提供するようになっている。スリーブは、たとえば別の部品(たとえば、パターン生成部材のすべての部品)を手術器具(たとえば、手術器具の本体)に固定できるように、たとえばパターン生成部材の他の要素用の付加的な貫通孔およびポケット、あるいは貫通孔またはポケットを備えていてもよい。これによって、パターン生成部材の搭載がさらに簡単となる。
一実施形態において、パターン生成部材のすべての要素は、スリーブにより、手術器具の本体部に対して一時的に固定されている。パターン生成部材の要素には、投射器およびパターン光源と、任意選択としての電源および/または後述のパターン光源制御ユニット等の1つ、もしくは複数の制御要素とを含む。
手術ツールと投射器との間の相関移動は、手術ツールの所与の移動が投射器の所与かつ所定の移動となるようにするのが好都合である。
一実施形態において、パターン光源は、非コヒーレント光源であり、発光ダイオード(LED)等の半導体光源であるのが好ましい。
一実施形態において、パターン光源は、610nm<λ<760nmの範囲の赤色中心波長を有する。
一実施形態において、パターン光源は、570nm<λ<590nmの範囲の黄色中心波長を有する。
一実施形態において、パターン光源は、450nm<λ<500nmの範囲の青色中心波長を有する。
一実施形態において、パターン生成部材は、等しい帯域幅または異なる帯域幅を有する2つ以上のパターン光源を備え、これら2つ以上のパターン光源は、投射器に対して動作可能に接続されているのが好ましい。
一般的には、(1つまたは複数の)パターン光源がオン/オフ切り替え可能であり、任意選択として、パターン光源制御ユニットを用いることにより、波長および強度、あるいは波長または強度を修正可能であるのが望ましい。一実施形態において、パターン光源制御ユニットは、ペダルまたは音声作動式制御ユニット等の非手持ちユニットであるため、外科医は、光パターンを容易に制御可能である。一実施形態において、パターン光源制御ユニットは、外科医が容易に取り扱えるように、手術器具のハンドルに組み込まれている。
一実施形態において、位相光学素子は、周期的な強度分布を有する画像を生成可能である。
一実施形態において、回折光学素子には、レンズの屈折力が光の波長に正比例する単一の回折次数を利用した従来の回折光学レンズ等の「高次回折」レンズを含む。
一実施形態において、投射器は、空間光変調器を備える。空間光変調器は、たとえばコンピュータ変調によって、パターンカバーの透明度を変調することにより、光パターンを変調するように構成されている。一実施形態において、空間光変調器は、パターン光源からの光の強度および位相の変調のうちの一方または両方によって、放出光パターンを変調するように構成されている。
パターン生成部材の投射器は、パターン生成部材が手術器具の本体部に固定され、本体部が直線位置にある場合の近位方向に垂直な最大拡張面積を有し、この最大拡張面積は、最大およそ2cm2、およそ0.01〜およそ1cm2、およそ0.1〜およそ0.5cm2等、最大およそ4cm2であるのが好都合である。
一実施形態において、パターン光源および任意選択としてのバッテリのうちの一方または両方が、手術器具の本体に内蔵または固定されている。パターン光源は、手術器具のハンドルに固定または内蔵され、バッテリは、手術器具の本体に内蔵または固定されているのが好都合であり、たとえば手術ツールよりもハンドルに近い手術器具の近位端の近傍であるのが好ましい。
パターンは、任意所望の形状を有していてもよい。パターンが1つまたは複数の同軸円から成る場合は、手術ツールの任意の非回転移動がパターンの相関変化となるのが好都合である。
一実施形態において、投射器は、手術器具の本体部の長手軸を中心とする円周方向移動を手術器具が専ら行う場合にパターンが実質的に静止状態を維持するように、手術器具の本体部に固定されているか、または固定されるように構成されている。
一実施形態において、搭載状態の(すなわち、手術器具の本体部に固定された)投射器は、手術ツールのすぐ遠位かつ手術器具の本体部の長手軸に垂直な投射表面に投射された場合に、最大およそ60cm、好ましくはおよそ1cm〜およそ25cm等、少なくともおよそ0.5cmのパターン彫刻円の直径として決定されたパターンビームサイズを有するパターンを放出するように構成されている。これにより、手術ツールが組織に接近、あるいは接触している場合であっても、パターンおよびパターンの変形によってユーザを導くことができる。
手術システムは、手術対象部位を照らす照明光源を備えた照明要素と、手術対象部位の画像を取得するカメラ要素と、取得した画像を表示するモニタと、少なくとも1つの手術器具アセンブリとを備える。
手術器具アセンブリは、上述のような組み立て相関セットであるのが好都合である。
一実施形態において、手術システムは、照明要素およびカメラ要素の両方を含む内視鏡を備える。内視鏡が照明要素(または、照明器具)およびカメラ要素の両方を含む場合、これらの部品は、内視鏡に組み込まれているのが好都合である。一実施形態において、内視鏡は、照明要素用のチャンネルを備えていてもよい。
一実施形態において、カメラ要素は、手術器具アセンブリ用のチャンネルを備えた内視鏡である。
照明器具は、照明が放出される要素である。照明要素は、上述の通り、位相光学素子、空間光変調器、高次回折レンズ、ホログラフィックレンズ、フレネルレンズ、および/またはコンピュータ制御光学素子を備えた投射器等、照明光の投射器であってもよい。
一実施形態において、照明光源は、VCSEL光源およびスーパーコンティニウム光源から選択される。
一般的に、照明光源は、良好な照明を提供するため、相対的に大きな帯域幅を有するのが望ましい。照明光源は、およそ400nm〜およそ900nmの範囲、好ましくはおよそ450nm〜およそ700nmの範囲、好ましくはおよそ500nm〜およそ650nmの範囲の波長を有する可視光を含む帯域幅を有するのが好都合である。後述の通り、照明要素は、狭帯域幅の光で照らされた特定の組織を外科医が観察したい場合に、フィルタ(たとえば、オン/オフフィルタまたは調節可能なフィルタ)を備えていてもよい。
照明光源およびパターン光源は、外科医またはコンピュータが光パターンの反射光を照明の反射光から区別できるように、互いに異なるのが好ましい。パターン光源は、照明光源の帯域幅よりも狭い帯域幅を有するのが好ましい。一実施形態において、パターン光源は、照明光源の帯域幅のおよそ半分以下の帯域幅を有する。一実施形態において、パターン光源は、照明光源の帯域幅の1/10以下の帯域幅を有する。
一実施形態において、マーキング光源は、可視光を含む。
また、本発明は、最小侵襲手術を行うトレーニングに適したトレーニングキットを含む。
このトレーニング方法は、
手術器具アセンブリを用意する工程であり、手術器具アセンブリが、手術器具およびパターン生成部材を備え、手術器具が、遠位端および近位端を有し、その近位端に把持部と、その遠位端に手術ツールと、把持部を手術ツールに接続する本体部とを備え、パターン生成部材が、パターン光源および投射器を備えており、パターン光源が、投射器に対して動作可能に接続されて光パターンを投射し、パターン生成部材の少なくとも投射器が、手術ツールの移動が投射器の相関移動となるように、手術器具の本体部に対して少なくとも一時的に固定された工程と、
複数のトレーニングステップを行う工程であり、各ステップが、遠位端が手術対象部位または人工的な手術部位等のトレーニング表面を指す状態で手術器具を配置することと、トレーニング表面から光パターンが反射されるように、投射器から光パターンを放出することと、手術器具を移動させることと、光パターンの対応する変化を観察することを含む工程とを含む。
別の実施形態において、手術ツール4としては、たとえばハサミまたは上述のような別の手術ツールも可能である。外科医は、把持部2を保持して、このように手術器具アセンブリを制御可能であり、把持部の押圧または操作によって、鉗子を制御可能である。
図8に示すトレーニングキットは、手術システムと、人工的な手術部位73と、当該人工的な手術部位のカバー76とを備える。カバー76は、後面75と、人工的な手術部位73に対向する図示しない反対側の前面とを有する。手術システムは、カバー76の前面に配置されて人工的な手術部位を照らす図示しない照明要素と、同じくカバー76の前面に配置されて人工的な手術部位73の画像を取得する図示しないカメラ要素とを備える。手術システムは、取得した画像を表示するモニタ77と、たとえば図7に示すような少なくとも1つの手術器具アセンブリ71とをさらに備える。モニタ77は、ワイヤ77aを介してカメラ要素に接続されている。カバー76は、手術器具アセンブリ71用の貫通孔75aを備える。貫通孔75aは、手術器具アセンブリ71を弾性的に封止する弾性材料の外周縁75cを含む。カバー76は、手術システムの別の手術器具72用の別の貫通孔75bを備える。貫通孔75bも同様に、手術器具アセンブリ72を弾性的に封止する弾性材料の外周縁75dを含む。
カメラ要素は、たとえばモニタ77と一体化されたコンピュータに接続されており、コンピュータは、手術器具アセンブリ71の手術ツール64の動きを監視するようにプログラムされているのが好都合である。
Claims (27)
- 手術器具およびパターン生成部材を備えた最小侵襲手術を行うための相関セットであり、前記手術器具が、遠位端および近位端を有し、その近位端に把持部と、その遠位端に外科的処置を実行することに適合された手術処置ツールと、前記把持部を前記手術処置ツールに接続する本体部とを備え、前記パターン生成部材が、パターン光源および投射器を備えた、相関セットであって、前記パターン光源が、前記投射器に対して動作可能に接続されて光パターンを投射し、前記パターン生成部材の少なくとも前記投射器が、前記手術処置ツールの所与の移動が前記投射器の相関する所与の移動となり、これに応じて、遠位配置された表面上に見られる投射パターンが変化するように、前記手術器具の前記本体部に対して少なくとも一時的に固定されるように構成され、
前記パターン光源が、複数の発光領域を備え、前記複数の発光領域の内の第1の複数の発光領域は、第1の列に沿って配置され、前記複数の発光領域の内の第2の複数の発光領域は、第2の列に沿って配置され、前記第1の列および前記手術処置ツール間の前記本体部の軸が延在方向における距離は、前記第2の列および前記手術処置ツール間の前記本体部の軸が延在方向における距離よりも大きく、前記第2の複数の発光領域からの光パターンは、前記第1の複数の発光領域からの光パターンよりも、前記本体部の軸に対して、小さな角度で投射される、相関セット。 - 前記パターン生成部材が、前記手術器具から取り外し可能であり、前記パターン生成部材の少なくとも前記投射器が、クリックロック、スリーブロック、スクリューロック、ターンロック、ウェッジロック、またはこれらの組み合わせにより、前記手術器具に対して一時的に固定されるように構成された、請求項1に記載の相関セット。
- 前記パターン生成部材の少なくとも前記投射器が、前記手術器具に対して完全に固定されている、請求項1に記載の相関セット。
- 前記把持部が、ロボットに接続されたアクチュエータによって制御されるように構成されている、請求項1〜3のいずれか一項に記載の相関セット。
- 前記手術器具の前記本体部が、前記把持部と前記手術処置ツールとの間に剛性の相互接続を提供する、請求項1〜4のいずれか一項に記載の相関セット。
- 前記手術器具の前記本体部が、柔軟性を有する、請求項1〜4のいずれか一項に記載の相関セット。
- 前記手術処置ツールが、手術対象部位の前記外科的処置を行うように構成されている、請求項1〜6のいずれか一項に記載の相関セット。
- 前記パターン光源が、コヒーレント光源である、請求項1〜7のいずれか一項に記載の相関セット。
- 前記手術器具が侵襲動作を行うように構成されている、請求項1〜8のいずれか一項に記載の相関セット。
- 前記パターン光源が、およそ400nm〜およそ900nmの範囲の波長を有する可視光を含む帯域幅を有する、請求項1〜9のいずれか一項に記載の相関セット。
- 前記パターン光源が、非可視光を含む帯域幅を有する、請求項1〜10のいずれか一項に記載の相関セット。
- 前記パターン光源が、最大およそ50nmの帯域幅を有する、請求項1〜11のいずれか一項に記載の相関セット。
- 前記パターン生成部材の前記投射器が、位相光学素子、空間光変調器、高次回折レンズ、ホログラフィックレンズ、フレネルレンズ、コンピュータ制御光学素子、ミラー、フィルタ、スプリッタ、およびレンズの少なくとも1つを備えた、請求項1〜12のいずれか一項に記載の相関セット。
- 前記パターン生成部材の前記投射器が、前記手術器具の前記本体部に対して少なくとも一時的に固定されるとともに、前記手術処置ツールの移動が相関変化となるパターンを放出するように構成された、請求項1〜13のいずれか一項に記載の相関セット。
- 前記パターン生成部材の前記投射器が、前記手術器具の前記本体部に対して少なくとも一時的に固定されるとともに、前記手術処置ツールの任意の非回転移動が相関変化となるパターンを放出するように構成された、請求項1〜14のいずれか一項に記載の相関セット。
- 前記パターン生成部材の前記投射器が、遠位方向に垂直な表面に投射された場合に複数の傾斜線を含むパターンを放出するように構成された、請求項1〜15のいずれか一項に記載の相関セット。
- 前記パターンが格子状の線を含む、請求項16に記載の相関セット。
- 前記パターン生成部材が、前記パターン光源をオン/オフするための制御ユニットを備える、請求項1〜17のいずれか一項に記載の相関セット。
- 請求項1〜18のいずれか一項に記載の相関セットを少なくとも1つと、照明光源を有する照明要素と、カメラ要素と、モニタとを備える手術システム。
- 前記照明光源及び前記照明要素の少なくとも1つが、波長可変光学フィルタを備える、請求項19に記載の手術システム。
- 前記モニタは、前記カメラ要素が取得した画像を解析するコンピュータをさらに備える、請求項19または20に記載の手術システム。
- 前記カメラ要素が、内視鏡である、請求項19〜21のいずれか一項に記載の手術システム。
- 前記カメラ要素が、前記手術器具の前記手術処置ツールの動きを監視するようにプログラムされたコンピュータにデータ接続されている、請求項19〜22のいずれか一項に記載の手術システム。
- 前記カメラ要素が、前記モニタに対して動作可能に接続された、請求項19〜23のいずれか一項に記載の手術システム。
- 前記照明光源および前記パターン光源が互いに異なる、請求項19〜24のいずれか一項に記載の手術システム。
- 前記パターン光源が、前記照明光源の帯域幅よりも強度が高い波長を帯域幅に含む、請求項19〜25のいずれか一項に記載の手術システム。
- 前記パターン光源が、前記照明光源の帯域幅に含まれない波長を帯域幅に含む、請求項19〜25のいずれか一項に記載の手術システム。
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2015
- 2015-02-20 CN CN201580009012.3A patent/CN106028930B/zh active Active
- 2015-02-20 WO PCT/DK2015/050035 patent/WO2015124159A1/en active Application Filing
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- 2015-02-20 EP EP15751532.1A patent/EP2976015B1/en active Active
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JP2020114439A (ja) | 2020-07-30 |
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WO2015124159A1 (en) | 2015-08-27 |
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EP2976015B1 (en) | 2017-06-07 |
JP6922024B2 (ja) | 2021-08-18 |
DK3228254T3 (da) | 2020-03-23 |
US11033182B2 (en) | 2021-06-15 |
CA2935506A1 (en) | 2015-08-27 |
CN106028930A (zh) | 2016-10-12 |
CN106028930B (zh) | 2021-10-22 |
AU2015221258A1 (en) | 2016-07-14 |
US20170055819A1 (en) | 2017-03-02 |
EP3228254A1 (en) | 2017-10-11 |
EP2976015A4 (en) | 2016-03-09 |
US12075981B2 (en) | 2024-09-03 |
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