JP2013198782A - 柔軟性手首部を持つ心臓組織アブレーション器具 - Google Patents
柔軟性手首部を持つ心臓組織アブレーション器具 Download PDFInfo
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Abstract
【解決手段】一実施形態において、当該器具は、細長いシャフトと、当該シャフトの作業端にある柔軟性手首部と、当該柔軟性手首部の先端にある視覚スコープレンズとを有する内視鏡である。当該柔軟性手首部は、所望の関節を提供するために、少なくとも1自由度を有する。当該手首部は、シャフトの遠位端にあるハウジング内に位置する駆動機構によって作動および制御される。
【選択図】図31
Description
本出願は、2003年12月2日に出願された第10/726,795号の一部継続であり、該第10/726,795号は、2002年12月6日に出願された仮出願第60/431,636号からの優先権を主張する。本出願は、次の特許および特許出願に関連しており、それらの全開示は、参照により本明細書に援用される:
「Surgical Tool Having Positively Positionable Tendon−Actuated Multi−Disk Wrist Joint」という名称が付けられ、2004年11月16日に発行された米国特許第6,817,974号;
「Platform Link Wrist Mechanism」という名称が付けられ、2004年3月2日に発行された米国特許第6,699,235号;
「Robotic Apparatus」という名称が付けられ、2004年9月7に発行された米国特許第6,786,896号;
「Surgical Robotic Tools, Data Architecture, and Use」という名称が付けられ、2001年12月18日に発行された米国特許第6,331,181号;
「Image Shifting Apparatus and Method for a Telerobotic System」という名称が付けられ、2004年9月28日に発行された米国特許第6,799,065号;
「Stereo Imaging System and Method for Use in Telerobotic System」という名称が付けられ、2004年4月13日に発行された米国特許第6,720,988号;
「Master Having Redundant Degrees of Freedom」という名称が付けられ、2004年3月30日に発行された米国特許第6,714,839号;
「Cooperative Minimally Invasive Telesurgery System」という名称が付けられ、2003年12月9日に発行された米国特許第6,659,939号;
「Camera Referenced Control in a Minimally Invasive Surgical Apparatus」という名称が付けられ、2002年7月23日に発行された米国特許第6,424,885号;
「Surgical Tools for Use in Minimally Invasive Telesurgical Applications」という名称が付けられ、2002年5月28日に発行された米国特許第6,394,998号; および
「Endoscopic Surgical Instrument and Method for Use」という名称が付けられ、1998年9月15日に発行された米国特許第5,808,665号;および
「Devices and Methods for Presenting and
Regulating Auxiliary Information on An Image Display of a Telesurgical System to Assist an Operator in Performing a Surgical Procedure」という名称が付けられ、2003年2月18日に発行された米国特許第6,522,906号。
例えば、本発明は以下の項目を提供する。
(項目1)
作業端と、近位端と、該作業端と該近位端との間のシャフト軸とを有する細長いシャフトと、
遠位端と近位端とを有する柔軟性手首部であって、該手首部の該近位端は該細長いシャフトの該作業端に接続されている、柔軟性手首部と、
該手首部の該遠位端に設置された内視鏡カメラレンズと、
複数のアクチュエータリンクであって、該複数のリンクが該手首部に少なくとも1自由度を提供するように作動可能であるように、該手首部を該細長いシャフトの該近位端に接続する複数のアクチュエータリンクと
を備える、低侵襲関節手術内視鏡。
(項目2)
前記内視鏡に手術器具を解放可能に取り付け可能とするように、前記シャフト軸に沿って連結器をさらに備える、項目1に記載の低侵襲関節手術内視鏡。
(項目3)
前記内視鏡に手術器具ガイドを解放可能に取り付け可能とするように、前記シャフト軸に沿って連結器をさらに備え、手術器具は前記柔軟性手首部に誘導される該手術ガイドに挿入される、項目1に記載の低侵襲関節手術内視鏡。
(項目4)
前記内視鏡に手術器具が解放可能に取り付けられるように、該手術器具が取り外し可能に挿入されたルーメンを前記シャフト軸に沿ってさらに備える、項目1に記載の低侵襲関節手術内視鏡。
(項目5)
前記内視鏡の画像センサが前記シャフトの前記近位端に装着され、ファイバスコープ実装における光ファイバを介して前記内視鏡カメラレンズに連結されている、項目1に記載の低侵襲関節手術内視鏡。
(項目6)
前記内視鏡の画像センサが、実質的にチップオンスティックスコープ実装における前記内視鏡カメラレンズに装着されている、項目1に記載の低侵襲関節手術内視鏡。
(項目7)
前記内視鏡カメラレンズを覆うための透明偏向キャップをさらに備える、項目1に記載の低侵襲関節手術内視鏡。
(項目8)
前記シャフトの前記近位端に連結されたハウジングアセンブリをさらに備え、前記ハウジングアセンブリは、
前記アクチュエータリンクに接続され、該リンクを作動させて前記手首部に所望の関節動作を提供する駆動機構と、
前記画像センサをカメラ制御装置に連結するコネクタと
を含む、項目5に記載の低侵襲関節手術内視鏡。
(項目9)
前記シャフトの前記近位端に連結されたハウジングアセンブリをさらに備え、前記ハウジングアセンブリは、
前記アクチュエータリンクに接続され、該リンクを作動させて前記手首部に所望の関節動作を提供する駆動機構と、
前記画像センサをカメラ制御装置に連結するコネクタと
を含む、項目6に記載の低侵襲関節手術内視鏡。
(項目10)
前記ハウジングアセンブリは、手術ロボットシステムのアームに解放可能に取り付けられ、前記手術ロボットシステムは、前記内視鏡を駆動および制御する、項目8に記載の低侵襲関節手術内視鏡。
(項目11)
前記ハウジングアセンブリは、手術ロボットシステムのアームに解放可能に取り付けられ、前記手術ロボットシステムは、前記内視鏡を駆動および制御する、項目9に記載の低侵襲関節手術内視鏡。
(項目12)
前記アクチュエータリンクは、ケーブルであり、該ケーブルは、エンドエフェクタに接続された遠位部を有し、前記手首部材を介して前記遠位部から前記細長いシャフトの方に向かって、該手首部材をピッチ回転およびヨー回転で屈曲させるように作動可能な近位部まで伸長している、項目10に記載の低侵襲関節手術内視鏡。
(項目13)
前記アクチュエータリンクは、ケーブルであり、該ケーブルは、エンドエフェクタに接続された遠位部を有し、前記手首部材を介して前記遠位部から前記細長いシャフトの方に向かって、前記手首部材をピッチ回転およびヨー回転で屈曲させるように作動可能な近位部まで伸長している、項目11に記載の低侵襲関節手術内視鏡。
(項目14)
前記カメラ制御装置から取得された取得画像は、表示モニタに提供され、補助情報として表示される、項目8に記載の低侵襲関節手術内視鏡。
(項目15)
前記カメラ制御装置から取得された取得画像は、表示モニタに提供され、補助情報として表示される、項目9に記載の低侵襲関節手術内視鏡。
(項目16)
低侵襲関節手術器具であって、
作業端と、近位端と、該作業端と該近位端との間のシャフト軸とを有する細長いシャフトであって、該細長いシャフトは、該器具に内視鏡が解放可能に取り付けられるように、該内視鏡が取り外し可能に挿入されたルーメンを前記シャフト軸に沿って有する、細長いシャフトと、
遠位端および近位端を有する柔軟性手首部であって、該手首部の該近位端は該細長いシャフトの該作業端に接続されている柔軟性手首部と、
該手首部の該遠位端におけるエンドエフェクタと、
複数のアクチュエータリンクであって、該リンクが該手首部に少なくとも1自由度を提供するように作動可能であるように、該手首部を該細長いシャフトの該近位端に接続する複数のアクチュエータリンクと
を備える、低侵襲関節手術器具。
(項目17)
前記シャフトの前記近位端に連結されたハウジングアセンブリをさらに備え、該ハウジングアセンブリは、
前記アクチュエータリンクに接続され、該リンクを作動させて前記手首部に所望の関節動作を提供する駆動機構と、
前記内視鏡をカメラ制御装置に連結するコネクタと、
を含む、項目16に記載の低侵襲関節手術器具。
(項目18)
前記ハウジングアセンブリは手術ロボットシステムのアームに解放可能に取り付けられ、該手術ロボットシステムは、前記器具および前記内視鏡を駆動および制御する、
項目17に記載の低侵襲関節手術器具。
(項目19)
前記カメラ制御装置から取得された取得画像は、表示モニタに提供され、補助情報として表示される、項目17に記載の低侵襲関節手術器具。
図1は、手術道具用の、遠位エンドエフェクタ12と近位ツールシャフトまたは主管14との間に接続された手首部10を示す。図示されているエンドエフェクタ12は、図2で最もよく見えるように、遠位クレビス18に装着されたグリップ16を含む。遠位クレビス18は、ハイポチューブ26の付近に接続する複数のワイヤまたはケーブル24の遠位圧着端子22を格納するサイドアクセススロット20を含み、プラットフォームまたはガイド30およびツールシャフト14の内側を通って伸長している。ガイド30は、ハイポチューブ26およびワイヤアセンブリを正しい位置に置くものであり、器具のツールシャフト14に取り付けられている。ガイド30は、ツールシャフト14が回転して移動される際に、手首部10の転動の開始も行う。サイドアクセススロット20は、クリンプ22を都合よく所定の位置に押し付けさせる。当然ながら、その他の実施形態においては、レーザー溶接等、ワイヤ24を遠位クレビス18に取り付けるその他の手法を用いてよい。
図4は、管42を含む手首部40を示し、管42は、外周の周囲に分布する穴またはルーメン43を有し、アクチュエータケーブルまたはワイヤ44を受け、アクチュエータケーブルまたはワイヤ44は、ニチノールででき得る。管42は、ケーブル44を牽引することにより、ピッチおよびヨーにおいて屈曲できるように柔軟である。手首部40は、好ましくは、(図4Bの代替の実施形態に示すような)剛性遠位末端ディスク41、または、可撓管42にケーブル力を均等に分布させるために、可撓管42よりも実質的に堅いその他の補強材を含む。管42の中空は、グリップケーブル等のエンドエフェクタケーブル用の余地を提供する。一般に、少なくとも4つのルーメンがある。インナースプリング47を設けてもよい。
図8および9は、手首部80を示し、該手首部80は、複数の柔軟な軸方向摺動部材82を有し、該軸方向摺動部材82は、管状手首部80を形成するように、軸方向の舌部および溝接続84によって互いに接続または係合されている。各摺動部材82は、管80の長手方向断片を形成する。軸方向接続84は、手首部の長手方向中心線に対する各部材の横位置を維持しながら、摺動部材82が互いに対して軸方向に摺動するのを可能にする。各摺動部材82は、アクチュエータケーブルを受けるための穴またはルーメン86を含み、該アクチュエータケーブルは、手首部80の遠位端付近で終端処理される。図9は、摺動部材82の摺動運動によって容易になるような、ケーブル90のケーブル牽引力を受けている手首部80の屈曲を図示している。ケーブル90はツールシャフト92を通って伸長し、アクチュエーション用のジンバルプレート94等、作動機構の付近に接続されている。摺動部材82は、手首部80の屈曲中に、摺動部材82に対する曲率半径の差異に起因する量の違いによって屈曲する。あるいは、軸方向摺動部材を有する手首部の実施形態は、統合ケーブルおよび摺動部材を有してよく、例えば、それによって摺動部材がケーブルの周囲に(例えば、押出成形によって)統合摺動要素として一体的に形成されるか、または、それによって作動機構が摺動部材の近位端と連結し、当該摺動部材は手首部の遠位端に直接的に力を伝える。
図10および11は、管状手首部100を形成するように外周の周囲に配列された複数の軸スプリング102によって形成された手首部100を示す。スプリング102は、同じ方向に、または、むしろ逆方向に巻かれた、コイルスプリングである。ケーブル104は、図11でより明らかに分かるように、隣接するスプリング102の各対の重複領域を通って伸長する。手首部がケーブル張力を受けて完全に圧縮されている場合、重複により、手首部100の密着高さは個々のスプリング102の密着高さの2倍となるであろう。スプリング102は、一般に、ケーブルが緩まないように、また手首部の安定性を増大させるために、圧縮状態で事前搭載されている。
図12は、複数の波形スプリング断片または構成要素122を有する波形スプリング120の形態の手首部を示し、該複数の波形スプリング断片または構成要素122は、束ねられまたは巻かれて管状の波形スプリング手首部120を形成する。一実施形態において、波形スプリングは、疑似螺旋形態のフラットワイヤの連続する片から形成され且つ巻かれたものであり、波形は1つのサイクルの高点が次のサイクルの低点と接触するように、サイクルごとに多様である。そのようなスプリングは、例えばSmalley Spring Companyから、市販されている。アクチュエータケーブルを受けるために、波形スプリング手首部120には穴が形成される。あるいは、複数の別々のディスク様波形スプリング断片が、アクチュエータケーブル上で(ケーブルによって留保されて、または、互いに固着されて)一続きのビード形態になっていてもよい。
図14は、手首部140のいくつかの断片またはディスク142を示す。内側スプリング144はディスク142の内部空間内に設けられ、一方、複数のケーブルまたはワイヤ145はピッチおよびヨーで手首部140を屈曲させるために使用される。ディスク142は、インナースプリング144に螺着または連結され、当該スプリングは、エンドエフェクタ用のケーブルを牽引するためのルーメンとして作用する。インナースプリング144は軸方向剛性を提供するため、牽引ケーブルを通してエンドエフェクタに加えられる力は、手首部140を歪曲させない。代替の実施形態において、この機能を実現するために、スプリング144の代わりに積み重ねた固体スペーサを使用してもよい。ディスク142はそれぞれ、隣接するディスクの曲線内側結合面148と結合する曲線外側結合面146を含む。図15は、ディスク142間に関連する相対的回転を持つ手首部140の屈曲を図示している。ディスク142は、例えばプラスチックまたはセラミックでできていてよい。球状結合面146、148の間の摩擦は、手首部140の動作を妨げるほど強くないことが好ましい。この潜在的な問題を緩和するための1つの手法は、いくらかの圧縮荷重に耐え得る適切な内側スプリング144を選択し、手首部140を屈曲させるためのケーブル145の作動中に、ディスク142への過重な圧縮荷重を防止することである。内側スプリング144は、シリコンゴム等でできていてよい。さらなるシリコン部材150でアクチュエータケーブルを囲んでもよい。代替の実施形態において、別々のディスク142を一続きの螺旋帯と置換してもよい。
図18は、エラストマー部材184によって隔てられた複数のディスク182を有する手首部180を示す。エラストマー部材184は、環状部材であってもよいし、ディスク182の外周の周囲に分布する複数のブロックを含んでもよい。図14の手首部140と同様に、内側スプリング186はディスク182およびエラストマー部材184の内部空間内に設けられ、一方、複数のケーブルまたはワイヤ188はピッチおよびヨーで手首部180を屈曲させるために使用される。ディスク182は、インナースプリング184に螺着または連結され、当該スプリングは、エンドエフェクタ用のケーブルを牽引するためのルーメンとして作用する。インナースプリング184は軸方向剛性を提供するため、牽引ケーブルを通してエンドエフェクタに加えられる力は、手首部180を歪曲させない。この手首部180の構成は、手首部140よりもヒトの脊椎に類似している。エラストマー部材184は、ピッチおよびヨーでの手首部180の屈曲を可能にするために弾性的に変形する。エラストマー部材184を使用することにより、ディスク182間の結合面および関連する摩擦力の必要性がなくなる。
図19は、複数のディスク192を含む手首部190を示し、該複数のディスク192は、手首部190のピッチおよびヨーでの屈曲を容易にするために、直行方向に向けられた交互の梁またはリブ194、196によって支持される。手首部190は、隣接するディスク192間に略直行のリブ194、196の層を交互に残すように、隣接するディスク192間の切り欠きを除去することによって、管から形成され得る。ディスク192は、アクチュエータケーブルを通すための穴198を有する。ディスク192およびリブ194、196は、鋼鉄、アルミニウム、ニチノール、またはプラスチック等の様々な材料でできていてよい。図20に図示するような手首部200の代替の実施形態において、ディスク202は、ケーブルを受けるための穴の代わりにスロット204を含む。そのような管は、ケーブルを通過させるための穴を持つ管よりも、押し出すことが容易である。ケーブルを支持するために、スプリング206をディスク202上で巻く。
図22は、コイルスプリング222を含む手首部220の一部を示し、該手首部220の一部は、スプリング222の長さに沿って分布する複数の薄いディスク224を持つ。図22の手首部分には、図23および24に図示するように、互いに直行するタブ226によって正しい位置に置かれた224Aおよび224Bを含む2つのディスク224のみ見える。スプリング222は、ディスク224をそこに挿入するために設けられた間隙を除き、密着高さでコイル状になる。スプリング222は、ディスク224のインナーエッジおよびタブ226付近のディスク224に接続される。ディスク224は、エッチングによって形成でき、アクチュエータケーブルを受けるための穴228を含むものである。タブ226は、ピッチおよびヨーでの手首部220の屈曲中に、ある点でスプリング222を屈曲できるようにするための支点として作用する。ディスク224は、いくつかの実施形態においては比較的堅くてよいが、その他の実施形態においては、手首部220の屈曲中に屈曲してスプリング要素として作用するのに十分なほど柔軟であってよい。コイルスプリング222およびディスク224の周囲には、誘電性絶縁体としてシリコン外被を設けてよい。また、スプリング222およびディスク224アセンブリは、例えば、図25および図26の外片またはアーマー片250から形成された表面構造によって保護することができる。各アーマー片250は、外側結合面252および内側結合面254を含む。1つのアーマー片250の外側結合面252は、隣接するアーマー片250の内側結合面254と結合する。アーマー片250は、スプリング222の長さに沿って積み重ねられ、手首部220の屈曲から回転する際に接触を維持する。
柔軟性手首部の精度は、加えられた負荷に対する様々な材料の剛性によって決まる。すなわち、使用される材料が硬いほど、および/または手首部の長さが短いほど、および/または手首部が有する直径が大きいほど、ある手術の力を受けて手首部に対して生み出される横偏向は少なくなる。牽引ケーブルが有するコンプライアンスがわずかである場合、手首部の端部の角度は正確に決定され得るが、ケーブルでは対抗できない力を受けて遊走または横偏向が起こり得る。例えば、手首部が直線であり、そのような力が及ぼされた場合、手首部はS字型偏向を呈し得る。これに対抗するための1つの手法は、十分な剛性の適切な材料および手首部に関して適切なジオメトリを用いることである。もう1つの手法は、米国特許出願第10/187,248号に記載されているように、牽引ケーブルの半数を手首部の長さに沿って途中で終端させ、残りのケーブルに関しては半分牽引させることである。S字型偏向に対する抵抗を大きくすれば、モーメントに耐える能力の費用がかかることになる。S字型偏向を回避するためのさらに別の手法は、手首部の外側に編組カバーを設けることである。
上記では、手首部用のアーマーまたはカバーをいくつか開示している。図28および29は、手首カバーのさらなる例を示す。図28において、手首カバー280は、プラスチックまたはセラミック等の非導電材料のフラットスパイラルによって形成されている。手首部が屈曲されると、スパイラルカバー280の異なるコイルが、互いの上を摺動する。図29は、スパイラルの隣接する層間での重複を確実にするために、屈曲された、または渦巻いた縁292を含む手首カバー290を示す。手首部にねじり剛性を提供するために、手首カバー300は、手首部の軸に対して平行に向けられた隆線または溝302を含み得る。隆線302は、1つのスパイラル層から隣のスパイラル層へのスプラインとして作用し、手首部用のねじり安定化装置を構成する。ステントのように構成されたニチノールレーザーカバーについてさらに考察する。
ここで、図31を参照して、図31は、本発明によるロボット低侵襲手術において使用される内視鏡310の実施形態を図示する。内視鏡310は、細長いシャフト14’を含む。柔軟性手首部10’は、シャフト14’の作業端に位置している。ハウジング53’は、手術器具310を、シャフト14’の反対端に位置するロボットのアーム(図示せず)と解放可能に連結させるものである。内視鏡カメラレンズは、柔軟性手首部10’の遠位端において実装される。ルーメン(図示せず)は、柔軟性手首部10’の遠位端をハウジング53’と接続するシャフト14’の長さに沿って走っている。「ファイバスコープ」実施形態において、シャフト14’の長さに沿ってルーメンの内側を走り、実質的に柔軟性手首部10’の遠位端で終わる光ファイバを接続することにより、電荷結合素子(Charge Coupled Device;CCD)等の内視鏡310の画像センサをハウジング53’の内側に装着してよい。続いてCCDは、ハウジング53’の端部に位置するコネクタ312を介してカメラ制御装置と連結される。代替の「チップオンスティック」実施形態において、ハウジング53’の端部においてコネクタ312に連結されたカメラ制御装置とのハードワイヤまたはワイヤレス電気接続によって、内視鏡310の画像センサを柔軟性手首部10’の遠位端に装着してよい。画像センサは、2次元であってもよいし、3次元であってもよい。
上記の関節内視鏡の延長として、アブレーションカテーテルの所望の心臓組織への配置をさらに支援するために、カテーテルを関節内視鏡と解放可能に連結してよい。図32は、一連の解放可能なクリップ320によって内視鏡310と解放可能に連結されたカテーテル321を図示している。その他の種類の解放可能な連結器(機械的な、またはそうでないもの)を使用してもよく、これは十分に本発明の範囲内である。図32に示すように、クリップ320は、CTA処置において所望の手術目的地に到達するために、構造体(例えば、肺血管等)の周囲で駆動、操縦、および関節動作する際、アブレーションデバイス/カテーテル321が内視鏡310に続くように、アブレーションデバイス/カテーテル321を内視鏡310に解放可能に取り付けることができるようにする。関節内視鏡310および取り付けられたアブレーションデバイス/カテーテル321が目的地へ到達すると、カテーテル321は例えばロボットのアームに接続された別の器具によって適所に保持/保存され、一方、内視鏡310はアブレーション/カテーテル321から解放され、除去される。その際、操縦中に内視鏡310によって撮影された見え難い場所および/または到達し難い場所の画像を、ガイダンス目的で利用することができる。また、内視鏡の関節により、到達し難い心臓組織におけるアブレーションデバイス/カテーテル321の配置はさらに容易になる。
さらに別の実施形態において、関節内視鏡を有する代わりに、所望の関節を持つ器具を提供するためにエンドエフェクタが柔軟性手首部に取り付けられる。この関節器具については、例えば図1〜2に関連して上述した。しかしながら、当該関節器具は、外部内視鏡を挿入し柔軟性手首部の先端に向けて誘導することができる器具のシャフトに沿って走るルーメン(例えば、空腔、作業チャネル等)をさらに含む。この実施形態は、上述したような、解放可能に取り付けられたアブレーションカテーテル/デバイスを持つ、または、解放可能に取り付けられたカテーテルガイドを持つ関節内視鏡と、実質的に同じ機能を実現するものである。違いは、アブレーションカテーテル/デバイスが、組み込み型ルーメンへの挿入によって当該アブレーションデバイスに解放可能に取り付けられた内視鏡で駆動および操縦するために使用されることである。組み込み型ルーメンが付いている場合、解放可能な連結器(例えば、クリップ)は排除される。
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WO2023032070A1 (ja) * | 2021-09-01 | 2023-03-09 | リバーフィールド株式会社 | 処置具ユニット |
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JP2008531222A (ja) | 2008-08-14 |
WO2006094242A1 (en) | 2006-09-08 |
JP2012000487A (ja) | 2012-01-05 |
US20050182298A1 (en) | 2005-08-18 |
EP1853193A1 (en) | 2007-11-14 |
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