JP4934186B2 - 外科的ステープルデバイスのためのツールアセンブリ - Google Patents

外科的ステープルデバイスのためのツールアセンブリ Download PDF

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JP4934186B2
JP4934186B2 JP2009264421A JP2009264421A JP4934186B2 JP 4934186 B2 JP4934186 B2 JP 4934186B2 JP 2009264421 A JP2009264421 A JP 2009264421A JP 2009264421 A JP2009264421 A JP 2009264421A JP 4934186 B2 JP4934186 B2 JP 4934186B2
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surgical stapling
anvil
stapling device
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dynamic clamping
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シー． レイスネット デービッド
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タイコ ヘルスケア グループ リミテッド パートナーシップ
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105—Wound clamp magazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0686—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying below the tissue during stapling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/07214—Stapler heads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07278—Stapler heads characterised by its sled or its staple holder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/07214—Stapler heads
    • A61B2017/07285—Stapler heads characterised by its cutter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2939—Details of linkages or pivot points
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments

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  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
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Description

本願は、米国仮特許出願番号６０／４１６，０８８（２００２年１１月４日出願）（その全体が本明細書中に参考として援用される）からの優先権を主張する。
（背景）
（１．技術分野）
本開示は、組織を処置するためのツールアセンブリに関する。より具体的には、本開示は、組織を処置するために分節および回転可能な内視鏡的外科ツールアセンブリに関する。
（２．関連技術の背景）
ツールアセンブリの対向するジョー構造の間の組織を把持し、その後、把持した組織を締めるための外科的ステープラーは当該分野で周知である。これらのデバイスは、締められた組織を切開するためのナイフを備え得る。腹腔鏡または内視鏡的な構成を有するこのようなステープラーがまた、当該分野で周知である。これらの内視鏡的外科的ステープラーの例は、米国特許第６，３３０，９６５号、同第６，２５０，５３２号、同第６，２４１，１３９号、同第６，１０９，５００号および同第６，０７９，６０６号に記載され、これらの全ては、その全体が本明細書中に参考として援用される。
代表的に、これらのステープラーは、少なくとも２つの側面に沿って間隔の空いた列に整列される複数のステープルを収容するためのステープルカートリッジと、ステープルがカートリッジから駆動されるにつれて、ステープルのステープル脚を受容し、ステープルを形成するための複数のポケットを備えるアンビルを有するツール部材を備える。このアンビルは、代表的には、カートリッジの近くで旋回可能に支持され、開位置と閉位置との間で旋回可能である。
腹腔鏡または内視鏡的な外科手順の間に、外科的部位へのアクセスは、小さな切開を介してか、または、患者の小さな入口創傷を通して挿入された狭いカニューラを介して達成される。外科的部位にアクセスするための限定された領域に起因して、多くの内視鏡的ステープラーが、デバイスの内視鏡的身体の部分を回転するか、または、デバイスのツールアセンブリが関節をなすための機構を備える。代表的に、各機構は、外科医によって操作されて、処置される組織に対してツールアセンブリを適切に配向するアクチュエータによって制御される。このような操作は、時間がかかり、外科医により所望されるツールアセンブリの正確な配向を生じないかもしれない。
従って、操作が簡単で、任意の所望の配向においてツールアセンブリを位置付け得るツールアセンブリの配向を調節するための機構を備える、改善された内視鏡的外科的ステープルデバイスに対する必要性が存在する。
（要旨）
本開示に従って、１対のジョーを有するツールアセンブリを備える外科的機器が開示される。このツールアセンブリは、アンビル、および、その中に複数の締め具が支持されているカートリッジアセンブリを備える。このカートリッジアセンブリは、間隔を空けた位置と接近した位置との間でアンビルに関して移動可能である。クランプ部材は、アンビルに関して、カートリッジアセンブリを、間隔を空けた位置から接近した位置まで移動するために、戻った位置から進んだ位置まで移動可能である。動的クランピング部材は、カートリッジアセンブリから複数の締め具を駆出するために、戻った位置から進んだ位置まで、アンビルおよびカートリッジアセンブリに関して移動可能に位置付けられている。可撓性ケーブルから形成される駆動部材は、クランプ部材および動的クランピング部材に作動可能に接続され、その戻った位置と進んだ位置との間でクランプ部材および動的クランピング部材を移動させるために移動可能である。
好ましくは、駆動部材は、外側シースおよび中心ロッドを備える同軸ケーブルを備える。中心ロッドは、軸方向に移動可能であり、外側シースに関して回転可能である。外側シースは、クランプ部材に作動可能に接続され、中心ロッドは、閉鎖部材に作動可能に接続されている。
好ましくは、カラーが、ステープルデバイスの本体部分に旋回可能に固定されている。本体部分は、外科的ステープルデバイスの遠位端または使い捨て可能な充填ユニットの近位端を形成し得る。
好ましくは、ツールアセンブリは、カラー部材に回転可能に取り付けられている。好ましい実施形態において、同軸ケーブルの中心ロッドは、中心ロッドの回転が、閉鎖部材の回転を起こし、ツールアセンブリのカラー部材に関する回転を起こし、ツールアセンブリの独立した回転を容易にするように、動的クランピングデバイスに接続されている。
好ましい実施形態において、動的クランピング部材は、アンビルの表面を係合するように位置付けられた第１のフランジ部分と、カートリッジアセンブリの表面を係合するように位置付けられた第２のフランジ部分を備える。この第１および第２のフランジ部分は、一緒になって、アンビルとカートリッジアセンブリとの間の最大組織ギャップを規定する。
すなわち、本発明は以下を特徴とする。
（項目１） ツールアセンブリであって、以下：
アンビルおよびカートリッジアセンブリであって、該カートリッジアセンブリは、複数の締め具を有し、間隔を空けた位置と接近した位置との間で該アンビルに関して移動可能であり、該カートリッジアセンブリおよび該アンビルは、該接近した位置における組織ギャップを規定する、アンビルおよびカートリッジ；
クランプ部材であって、該カートリッジアセンブリを、該間隔を空けた位置から該接近した位置に、該アンビルに関して移動するために、戻った位置から進んだ位置まで移動可能である、クランプ部材；ならびに
該アンビルおよび該カートリッジアセンブリに関して移動可能に位置付けられた動的クランピング部材であって、該動的クランピング部材は、該カートリッジアセンブリから複数の締め具を駆出するために、戻った位置から進んだ位置まで移動可能である、動的クランピング部材；ならびに
該クランプ部材および該動的クランピング部材に作動可能に接続された駆動部材であって、該駆動部材は、可撓性ケーブルから形成され、かつ、その戻った位置と進んだ位置との間で、該クランプ部材および該動的クランピング部材を移動するために移動可能である、駆動部材
を備える、ツールアセンブリ。
（項目２） 前記駆動部材が、同軸駆動ケーブルを備え、該同軸駆動ケーブルが、外側シースおよび中心ロッドを備える、項目１に記載のツールアセンブリ。
（項目３） 前記中心ロッドが、該中心ロッドに関して移動可能である、請求項２に記載のツールアセンブリ。
（請求項４） 前記中心ロッドが、前記外側シースに関して軸方向に移動可能である、請求項２に記載のツールアセンブリ。
（請求項５） 前記中心ロッドが、前記外側シースに関して回転可能である、項目２に記載のツールアセンブリ。
（項目６） 前記外側シースが、前記クランプ部材に作動可能に接続されている、項目２〜５のいずれか１項に記載のツールアセンブリ。
（項目７） 前記中心ロッドが、前記動的クランピング部材に作動可能に接続されている、項目２〜６のいずれか１項に記載のツールアセンブリ。
（項目８） 前記ツールアセンブリが、本体の部分に旋回可能に固定されている、項目１〜７のいずれか１項に記載のツールアセンブリ。
（項目９） 前記ツールアセンブリが、カラー部材に作動可能に接続されており、そして、該カラー部材は、前記本体の部分に旋回可能に固定されている、項目８に記載のツールアセンブリ。
（項目１０） 前記ツールアセンブリが、前記カラー部材に回転可能に取り付けられている、項目９に記載のツールアセンブリステープラー。
（項目１１） 前記同軸ケーブルの前記中心ロッドが、前記動的クランピング部材に作動可能に接続されており、その結果、該中心ロッドの回転が、前記ツールアセンブリの回転に影響を及ぼす該動的クランピング部材の回転に影響を及ぼす、項目２〜１０のいずれか１項に記載のツールアセンブリ。
（項目１２） 前記動的クランピング部材が、前記アンビルの表面を係合するように位置付けられた第１のフランジ部分と、前記カートリッジアセンブリの表面を係合するように位置付けられた第２のフランジ部分とを備え、該第１および第２のフランジ部分は、その戻った位置からその進んだ位置までの該動的クランピング部材の移動の間に、最大の組織ギャップを規定するように位置付けられている、項目１〜１１のいずれか１項に記載のツールアセンブリ。
（項目１３） 前記クランプ部材が輪状であり、該クランプ部材が、前記アンビルおよび前記カートリッジアセンブリの近位端付近に位置付けられ、かつ、その進んだ位置にある場合、該クランプ部材は、前記ツールアセンブリの近位端において、最大の組織ギャップを規定する、項目１〜１２のいずれか１項に記載のツールアセンブリ。
（項目１４） 前記中心ロッドが、巻かれた可撓性ケーブルから形成される、項目２に記載のツールアセンブリ。
（項目１５） 前記外側シースが、スチールメッシュ、プラスチック、ニチノールおよびＫｅｖｌａｒからなる群から選択される、項目２に記載のツールアセンブリ。
（項目１６） 前記動的クランピング部材に付随するナイフの刃をさらに備える、項目１に記載のツールアセンブリ。
（項目１７） 前記ナイフの刃が、前記動的クランピング部材上に形成される、項目１４に記載のツールアセンブリ。
（項目１８） 前記ツールアセンブリが駆動カラーを備え、前記外側シースが、該駆動カラーに取り付けられている、項目２〜１７のいずれか１項に記載のツールアセンブリ。
（項目１９） 外科的ステープラーと共に使用するためのツールアセンブリであって、以下：
アンビル；
少なくとも１つのステープルを有するカートリッジアセンブリであって、該カートリッジアセンブリは、間隔を空けた位置と接近した位置との間で該アンビルに関して移動可能である、カートリッジアセンブリ；
該ツールアセンブリの近位端に隣接して位置付けられたクランプ部材であって、該クランプ部材は、該アンビルおよび該カートリッジアセンブリを該接近した位置まで動かすために、戻った位置から進んだ位置まで移動可能である、クランプ部材；ならびに
該ツールアセンブリ内に位置付けられ、かつ、該カートリッジアセンブリからステープルを駆出するために、戻った位置から該ツールアセンブリを通って進んだ位置まで移動可能な、動的クランピング部材であって、該動的クランピング部材は、該アンビルの表面を係合する上側フランジ部分および該カートリッジアセンブリの表面を係合する下側フランジ部分を備え、該上側フランジ部分および下側フランジ部分の少なくとも１つは、該カートリッジアセンブリの長手軸方向軸に対して横方向の軸に沿った弓状断面を有する、動的クランピング部材
を備える、ツールアセンブリ。
（項目２０） 前記動的クランピング部材に付随するナイフの刃をさらに備える、項目１９に記載のツールアセンブリ。
（項目２１） 前記ナイフの刃が、前記動的クランピング部材の中心本体部分上に形成される、項目１９または２０に記載のツールアセンブリ。
（項目２２） 前記カートリッジアセンブリが、少なくとも１つのステープルの各々に付随するそりおよびプッシャーを備え、該ステープルを該カートリッジアセンブリから駆出するために、該そりが、該プッシャーとの係合における閉鎖部材によって駆動されて、該少なくとも１つのステープルとの係合において該プッシャーを駆動する、項目１９〜２１のいずれか１項に記載のツールアセンブリ。
（項目２３） 前記カートリッジアセンブリが、複数のステープルおよびプッシャーを備える、項目２２に記載のツールアセンブリ。
（項目２４） 前記上側フランジおよび前記下側フランジが、実質的に垂直に並んでいる、項目１９〜２３のいずれか１項に記載のツールアセンブリ。
（項目２５） 前記ナイフの刃が、前記上側フランジと前記下側フランジとの間の前記中心本体部分上に配置されている、項目２０〜２４のいずれか１項に記載のツールアセンブリ。
操作が簡単で、任意の所望の配向においてツールアセンブリを位置付け得るツールアセンブリの配向を調節するための機構を備える、改善された内視鏡的外科的ステープルデバイスに対する必要性が存在する。
開示される外科的ステープルデバイスの種々の好ましい実施形態が、図面を参照して本明細書中に開示される。
図１は、間隔を空けた位置のアンビルおよびカートリッジアセンブリを備える、開示される外科的ステープルデバイスの１つの好ましい実施形態の側面斜視図である。 図１Ａは、図１に示される外科的ステープルデバイスの、アンビルの近位端、回転カラーおよびアダプターの側面斜視図である。 図２は、図１に示される外科的ステープルデバイスの側面図である。 図３は、図２に示される外科的ステープルデバイスの見かけの内側構成要素の平面図である。 図４は、カートリッジアセンブリを通るデバイスの長手軸に沿って取った、図２に示される外科的ステープルデバイスの断面図である。 図５は、近位にツール部材を備える動的クランピング部材を通る横軸に沿って取った、図３に示される外科的ステープルデバイスの断面図である。 図６は、カートリッジアセンブリおよびアンビルを通る、ツールアセンブリの横軸に沿って取った、図３に示される外科的ステープルデバイスの断面図である。 図７は、図１に示される外科的ステープルデバイスの動的クランピング部材の正面斜視図である。 図８は、図１に示される外科的ステープルデバイスのクランプ部材の正面斜視図である。 図９は、図１に示される外科的ステープルデバイスの駆動カラーの正面斜視図である。 図１０は、図１に示される外科的ステープルデバイスのツールアセンブリの側面斜視分解図である。 図１１は、図１０に示されるツールアセンブリの近位端の拡大図である。 図１２は、図１に示される外科的ステープルデバイスの内視鏡の本体部分の側面斜視分解図である。 図１３は、図１に示される外科的ステープルデバイスの側面断面図である。 図１４は、本開示に従う閉鎖部材の別の実施形態である。 図１５は、本開示のカートリッジハウジングの平面図である。 図１６Ａは、本開示のそりおよびプッシャー部材の斜視図である。 図１６Ｂは、本開示のそりおよびプッシャー部材の斜視図である。 図１７Ａは、線１７Ａに沿って取った、図１６Ｂのカートリッジアセンブリの一部の断面端図であり、本開示の１つの実施形態に従うそり、プッシャー部材およびステープルの配列を例示する。 図１７Ｂは、カートリッジアセンブリの一部の断面端図であり、本開示の別の実施形態に従うそり、プッシャー部材およびステープルの配列を例示する。
（好ましい実施形態の詳細な説明）
ここで開示される外科的ステープルデバイスの好ましい実施形態が、図面を参照して詳細に記載され、この図面において、同じ参照番号は、いくつかの図の各々において、同一または対応する要素を示す。
図１〜１３は、一般に１０として示される、開示される外科的ステープルデバイスの１つの好ましい実施形態を例示する。ステープルデバイス１０は、アンビル１４およびカートリッジアセンブリ１６を有するツールアセンブリ１２、内視鏡の本体部分１８、クランプ部材２０および回転カラー２２を備える。ツールアセンブリ１２は、内視鏡の本体部分１８の遠位端において旋回部材２４の周りで旋回可能に支持される。アダプター２６は、本体部分１８の遠位端に固定され、上側および下側の伸長部分２８を備える。アダプター１８ａ（図１２）は、本体の前側８に位置付けられ得、デバイスの内側成分の位置づけを維持する。あるいは、アダプター２６は、内視鏡の本体部分１８と一体となって形成され得る。旋回部材２４は、ツールアセンブリ１２が、内視鏡的部分１８の長手軸に関して約９０°の関節をなし得るように、上側および下側の伸長部分２８と回転カラー２２の近位部分２２ａ（図１Ａ）との間で伸長する。種々の異なる関節型（例えば、球とソケット、可撓性カップリング、汎用関節など）が、よりよい程度の関節を可能にするために提供され得ることが想定される。
カートリッジアセンブリ１６は、複数のステープル（示さず）を収容するカートリッジ１６ａ、カートリッジ１６ａを受容するための間隙を規定するチャネル部分３０、動的クランピング部材３２（図７）およびそり３１を備える。動的クランピング部材３２は、好ましくは、カートリッジ１６ａ内のそり３１の近くに位置付けられる。ナイフの刃３４は、好ましくは、動的クランピング部材３２の本体部分３２ａの中間（好ましくは中央）に位置付けられ、締められた組織を切開する。ナイフの刃３４は、動的クランピング部材に直接機械加工され得るか、または、そこに固定もしくは取り外し可能に固定され得る。あるいは、ナイフの刃３４は、そり上に形成され得るか、または、そりに固定もしくは取り外し可能にもしくは旋回可能に固定され得る。そり３１は、カートリッジ１６ａを通して移動するようにスライド可能に位置付けられ、公知の様式でカートリッジからステープルを駆出する。動的クランピング部材３２は、上側フランジ３６ａおよび下側フランジ３６ｂを備える。図５に示すように、フランジ３６ａは、カートリッジ１６ａ内に形成されたスロットまたは間隙３８内に位置付けられ、フランジ３６ｂは、アンビル１４内に形成された間隙４０内に位置付けられる。あるいは、フランジ３６ａおよび３６ｂは、間隙内にスライド可能に位置付けられる必要はないが、むしろ、アンビル１４上の上側軸受け表面およびカートリッジアセンブリ１６上の下側軸受け表面を係合する必要のみが存在する。図７に例示するように、フランジ３６ａおよび３６ｂは、好ましくは、弓状または半円形であり、ステープラーの作動の間に、歪みを最小限にし、アンビルおよび／またはカートリッジの配列を維持する。動的クランピング部材３２は、それと係合するそりの近位に位置付けられ、カートリッジを通して移動可能である。閉鎖部材３２は、デバイス１０の発射の間に、そり３１に近接するツールアセンブリ１２の領域内に、所望の、好ましくは均質な組織ギャップを提供、修復および／または維持する。動的クランピング部材３２のカートリッジアセンブリ１６を通る移動は、カートリッジアセンブリを通してそりを進める。
アンビルおよび／または動的クランピング部材（好ましくは両方）は、１つの物質から形成され、デバイスの把持、デバイスを通る移動、およびデバイスの発射の間に、それぞれのアンビルおよび／または動的クランピング部材のゆがみを最小限にするような厚みもしくはゲージであることが想定される。このような物質としては、外科用グレードのステンレス鋼が挙げられる。好ましくは、アンビルは、固体の１つのピースのユニットとして形成される。あるいは、当該分野で公知なように、アンビルは、アンビル本体と、ステープルを形成する複数のポケットを有するアンビルプレートを備えるパーツのアセンブリから形成され得る。アンビルが、例えば、把持もしくは予備把持の間および／またはステープルの発射の間に上向きに曲がるアンビルの遠位端のような歪みを最小限にするのに、合理的に可能かつ必要な強度であることが望ましい。
図１Ａを参照して、アンビル１４の近位端は、輪状間隙１４ｂを有する円筒状部分１４ａを備える。円筒状部分１４ａは、カラー２２の孔２２ａ内に受容されるような寸法である。少なくとも１つの旋回ピン２３（図１）が、カラー２２を通って間隙１４ｂ内に延び、アンビル１４の近位端を孔２２ａ内に軸方向に固定する。ピン２３は、輪状間隙１４ｂ内に位置付けられるので、アンビル１４は、カラー２２内で回転可能である。他の手段が、アンビル１４をカラー２２に回転可能に取り付けるために提供され得ることが想定される。第２のピン２５（図１）は、以下に説明されるように、カラー２２を通って延び、カラー２２を関節リンク５２の遠位端に固定する。
示されないが、公知の様式で、カートリッジアセンブリ１６のチャネル部分３０の近位端が、アンビル１４の近位端に形成されたか、または、アンビル１４の近位端に取り付けられた旋回部材（例えば、タブまたはピン）を受容するための間隙を備える。アンビル１４の近位端およびカートリッジ１６は、カラー２２内に拘束され、アンビルの旋回部材が、カートリッジアセンブリ１６のチャネル部分３０の間隙から外れることを防止する。あるいは、当該分野で公知の他の機械的配置を使用して、アンビル１４をカートリッジアセンブリ１６に旋回可能に固定し得る。カートリッジアセンブリ１６は、アンビル１４に旋回可能に取り付けられているので、両方が、カラー２２に関して回転可能であることに注意すべきである。
図１および４を参照して、ツールアセンブリ１２が内視鏡の本体部分１８に関して関節をなすための関節機構が提供される。関節機構は、近位の関節リンク５０と遠位の関節リンク５２を備える。近位の関節リンク５０は、内視鏡の本体部分１８の近位端から延びる第１の端部５０ａおよび本体部分１８内に位置付けられた第２の端部５０ｂを有し、第２の関節リンク５２の第１の端部５２ａに旋回可能に接続されている。関節リンク５２の第２の端部５２ｂは、旋回部材２４（すなわち、ツールアセンブリ１２の旋回軸）からずれた点において、ピン２５（図１）によって回転カラー２２に旋回可能に接続されている。関節リンク５２は、内視鏡の本体部分１８に形成されたスロット５４内に拘束される。この拘束に起因して、関節機構は、デバイスの長手軸の片側の弧に渡って、ツールアセンブリ１２が関節をなすことができるのみである。好ましくは、上で同定された旋回接続の各々は、旋回ピンを備える。あるいは、旋回部材は、上記の構成要素と一体に形成され得るか、または、ピンを備えない旋回部材が使用され得る。他の型の関節リンクもまた意図される。
使用に際して、ツールアセンブリ１２の長手軸が、本体部分１８の長手軸と整列され、近位の関節リンク５０が、図４の矢印「Ａ」によって示される方向に引っ込められる場合、リンク５０は、旋回部材２４の周りでのツールアセンブリ１２の、図４の矢印「Ｂ」により示される方向への関節を起こすようにリンク５２を引っ込める。ツールアセンブリ１２は、リンク５０を矢印「Ｃ」により示される方向に進めることによって、関節をなさない位置まで戻され得る。関節機構の動きを制御するための機構は、以下で議論される。
図３〜９を参照して、アンビル１４およびカートリッジアセンブリ１６を近づけ、ステープルを発射し、かつ、ツールアセンブリ１２をカラー２２に関して回転するための駆動機構が提供される。この駆動機構は、中心ロッド６２および外側シース６４を有する同軸ケーブルもしくは駆動部材６０（図３）、駆動カラー６６（図９）、クランプ部材（ここでは、クランプリング２０として示される）ならびに動的クランピング部材３２を備える。中心ロッド６２は、可撓性部材であるか、可撓性部材を備え、この可撓性部材は、カートリッジ１６ａを通して動的クランピング部材３２を押すための適切な圧縮強度を有する。好ましくは、中心ロッド６２は、左巻きまたは右巻きの可撓性ケーブルを備える。あるいは、適切な強度特徴を有する他の物質（例えば、ＮｉｔｉｎｏｌＴＭ）がまた使用され得る。中心ロッド６２の直径は、カートリッジ１６ａ内の利用可能な空間内に位置付けられるために十分小さくなければならない。外側シース６４は、中心ロッド６２の周りに位置付けられ、部分的に、中心ロッド６２が圧縮状態にある間に、中心ロッド６２を安定化かつ中心ロッド６２の座屈を防止するために機能する。好ましくは、外側シース６２はまた、スチールメッシュ、強化プラスチックまたはニッケルチタン合金（例えば、ＮｉｔｉｎｏｌＴＭ）から形成される可撓性ケーブルである。必要な強度要件を有する他の適切な物質（ポリパラ−フェニレンテレフタルアミド物質（例えば、ＤｕＰｏｎｔから市販されているＫｅｖｌａｒＴＭ）が挙げられる）が、外側シースを形成するために使用され得る。
中心ロッド６２は、外側シース６４内でスライド可能に位置付けられ、好ましくは内視鏡の本体部分１８の近位端から延びる第１の近位端６２ａ（図４）および動的クランピン
グ部材３２に取り付けられている第２の端６２ｂを備える。動的クランピング部材３２は、好ましくは、中心ロッド６２の第２の端６２ｂを受容するために、その中に形成される間隙６８（図７）を備える。第２の端６２ｂは、例えば、間隙６８内で、把持、溶接（図４におけるように）、鑞着、ピン付けなどによって、または、間隙６８を利用して、動的クランピング部材３２に固定され得、そしてまた間隙６８の形状に合うように機械加工され得る。
外側シース６４は、好ましくは、細長い本体部分１８の近位端から延びる第１の近位端６４ａと、駆動カラー６６に固定されている第２の遠位端６４ｂを有する。駆動カラー６６（図９）は、好ましくは、外側シース６４を受容し、そこを通る中心ロッド６２の通過のためにチャネルを提供するための中心孔７０を備える。駆動カラー６６の外側表面は、好ましくは、回転可能に固定された関係においてクランプ部材またはリング２０を係合するための係合構造体（例えば、ノッチ７２）を備える。クランプリング２０はまた、駆動カラー６６の係合構造体と嵌合して、駆動カラー６６をクランプリング２０に回転可能に固定し、その結果、これらが、一緒に回転するための係合構造体（例えば、筋または突出部７４）を備える。クランプリング２０の遠位端２０ａは、動的クランピング部材３２のフランジ部分３６ａおよび３６ｂを受容および係合するように構成された１対の切り抜き７６を備える。
使用の際に、中心ロッド６２および外側シース６４は、戻った位置から部分的に進んだ位置まで、一緒に移動可能であり、駆動カラー６６、クランプリング２０および動的クランピング部材３２を第１の進んだ位置まで進める。クランプリング２０は、好ましくは、アンビル１４の近位端とカートリッジアセンブリ１６の周りに位置付けられる。カートリッジアセンブリ１６は、その外側表面上に形成されたカム表面８０（図２）を備える。動的クランピング部材３２は、戻った位置から第１の進んだ位置まで移動し、動的クランピング部材３２のフランジ３６ｂは、カートリッジアセンブリ１６のカム表面８０を係合し、カートリッジアセンブリ１６を開位置から閉位置もしくは把持された位置まで旋回させる。クランプリング２０はまた、第１の進んだ位置からアンビル１４の近位端およびカートリッジアセンブリ１６を取り囲む位置まで遠位に移動させられる。この位置において、クランプリング２０は、アンビル１４の近位端とカートリッジアセンブリ１６との間のギャップが、所定の距離を越えないようにする。
中心ロッド６２および外側シース６４が第１の進んだ位置まで移動し、カートリッジアセンブリ１６を移動させ、従って、アンビル１４を把持された位置まで移動させた後、中心ロッド６２は、第２の進んだ位置まで外側シース６４とは独立して進め得、カートリッジ１６ａを通して、動的クランピング部材３２を移動させて、カートリッジアセンブリからステープルを駆出し、閉鎖部材３２のナイフの刃３４を使用することによって組織を切断し得る。あるいは、閉鎖部材３２のフランジ３６ａおよび３６ｂが、アンビル１４および／またはカートリッジアセンブリ１６上でカム表面を係合して、一方または両方を旋回して、組織の把持を提供し得ることが意図される。図５および６を参照して、チャネル８２が、中心ロッド６２に側方支持を提供するようにカートリッジ１６ａ内に形成され、中心ロッド６２の戻った位置から第２の進んだ位置までの移動の間に、中心ロッド６２が、詰まらないようにしている。
上記のように、アンビル１４は、カラー２２に回転可能に固定されており、中心ロッド６２は、動的クランピング部材３２に固定されており、そして、外側シース６４は、駆動カラー６６に固定されている。同軸上部材６０が回転すると、ツールアセンブリ全体が、カラー２２の中心軸の周りを回転する。より具体的には、動的クランピング部材３２は、アンビル１４およびカートリッジアセンブリ１６内に拘束されているので、中心ロッド６２に適用される任意のトルクは、動的クランピング部材３２を介してツールアセンブリ１２に移される。従って、同軸上部材６０が回転されて、カラー２２の長手軸の周りでツールアセンブリ１２を回転させ得る。
上記のツールアセンブリは、例えば、米国特許第６，３３０，９６５号に開示されるような使い捨ての充填ユニットであり得るか、そのように改変したものであるか、または、これに組み込まれ得、または、任意の公知の外科的ステープルデバイスの遠位端に直接取り付けられ得る。関節部材を起動するため、または接近、把持、発射ならびにツール回転機構のためのハンドルアセンブリは、具体的に本明細書中に開示されていないが、広範種々の異なる作動機構およびハンドル構成（肘金、回転可能かつスライド可能なノブ、旋回可能なレバーもしくはトリガ、ピストルグリップ、インラインハンドル、遠隔操作システムおよびこれらの任意の組み合わせが挙げられる）の使用が想定される。例えば、図１３Ａに示されるように、ハンドルアセンブリは、ピストル型２００（ツールアセンブリ回転ノブ２１０、関節レバー２１２および本体回転ノブ２１４を備える）を備え得る。上記のツールアセンブリの、機械式システムの一部としての使用がまた想定される。
アンビルアセンブリのみのために、好ましくはまた、閉鎖部材およびクランピングリングのために、より重いゲージの物質を利用することにより、組織の長さに沿って増強された把持圧力を提供し、今度は、組織を通してステープルが形成される場所の近くにあるアンビルと、その場所の上にあるカートリッジ表面との間のより均質な組織ギャップを提供する。さらに、組織を予備把持する（すなわち、ステープルの変形の前に組織を把持する）ためのクランピングリングの使用は、遠位方向に、そして、半径方向外側にいくらかの組織流体を追いやり、その変形の間にステープルの水力による取り外しが起こる可能性を減少させる傾向にある。ツール部材に沿って移動するにつれて把持する、閉鎖部材などの使用は、組織からおよび／もしくは組織内での流体流れ、ならびに／または、アンビルの遠位端の引き戻りを補うことを補助し、それによって、アンビルとカートリッジアセンブリとの間の所望の組織ギャップを維持する。
図１４に示すような別の好ましい実施形態において、閉鎖部材１３２は、間隔の空いた、中間部分１３２ａに取り付けられた、上側フランジ１３６ａおよび下側フランジ１３６ｂを備える。以前の実施形態においてのように、閉鎖部材１３２は、好ましくは、部分的にカートリッジアセンブリ１１６のカートリッジ１１８の内部にあるそり１４０の近位に位置付けられる。ナイフの刃１３４は、好ましくは、締められた組織を切開するために、閉鎖部材１３２の中間部分１３２ａ上に位置付けられる。ナイフの刃１３４は、中間部分１３２ａのセクション上に直接機械加工され得るか、または、中間部分１３２ａに固定もしくは取り外し可能に取り付けられ得る。あるいは、ナイフの刃１３４は、そり１４０の一部として形成され得るか、または、そり１４０に固定もしくは取り外し可能に固定され得る。上側フランジ１３６ａおよび下側フランジ１３６ｂは、ほぼ弓状の構造であり、実質的に同一の湾曲を有する。あるいは、上側フランジ１３６ａおよび下側フランジ１３６ｂの湾曲は、異なっていて、より大きいか、またはより少ない構造支持を提供してもよい。各フランジ１３６ａ、１３６ｂは、さらに、内側表面１３５ａ、１３５ｂおよび外側表面１３７ａ、１３７ｂを備える。好ましくは、閉鎖部材１３２は、内側表面１３５ａ、１３５ｂが互いに向き合うように構築される。上側フランジ１３６ａおよび下側フランジ１３６ｂは、アンビルとカートリッジ表面との間の最大の組織ギャップを規定するように機能する。
１つの好ましい実施形態において、カートリッジアセンブリ１１６は、カートリッジハウジング１１８の長手軸に沿って整列した複数の保持スロット１２２を備える。図１５に示されるように、保持スロット１２２は、第１のグループ１２４および第２のグループ１２６を形成するように整列される。好ましくは、各グループ１２４、１２６は、列のうちの少なくとも１つが、残りの列から長手軸方向にずれるように構成される、３列の保持スロット１２２を備える。内側列の各保持スロット１２２が、外側列の対応する保持スロット１２２と実質的に長手軸に整列しており、保持スロット１２２の中間列が、内側列および外側列から長手軸方向にずれるように、保持スロット１２２の少なくとも２列が、カートリッジアセンブリ１１８の各グループ１２４、１２６に配置されることがさらに好ましい。従って、保持スロット１２２の内側列および外側列は、カートリッジハウジング１１８の最も近位の位置から最も遠位の位置まで長手軸方向に整列している。好ましくは、内側列および外側列の保持スロット１２２は、最も近位および最も遠位の保持スロットを規定する。記載されるような保持スロット１２２の有利な位置づけは、組織の締めを改善し、出血を最小限にする。
図１６Ａ〜１７Ｂを参照して、そり１４０およびプッシャー部材１５０のさらなる実施形態が例示される。プッシャー部材１５０は、ベース部分１５２を備える。図１６Ａにおいて、そり１４０は、カートリッジハウジング１１８内を長手軸方向に進み、プッシャー部材１５０のベース１５２を係合し始める。そり１４０が、さらに長手軸方向に進むにつれて（図１６Ｂ）、プッシャー部材１５０のベース１５２は、そり１４０の直立したカムウェッジ１４４を係合する。そり１４０の長手軸方向の動きは、カムウェッジ１４４に沿って、それによって、プッシャー部材１５０まで長手軸方向の推進力を移動させる。好ましくは、プッシャー部材１５０は、そりの長手軸方向の移動に対して固定した関係にあり、カートリッジアセンブリ１１８の長手軸に対して実質的に直交して移動し、それによって、保持スロット１２２を通してステープル１６０を移動させるために、ステープル１６０のバックスパン１６２に推進力を移動させる。図１７Ａに示すように、１つの好ましい実施形態において、そり１４０のカムウェッジ１４４は、プッシャー部材１２２内の間隙１５４を係合する。間隙１５４は、カムウェッジ１４４をスライド係合するために構成および適合されている。一旦カムウェッジ１４４が間隙１５４を係合すると、そり１４０のさらなる長手軸方向の移動が、プッシャー部材１５０を長手軸に対して実質的に垂直な整列に維持するように働く。このように構成され、一旦そり１４０によって係合されると、プッシャー部材１５０は、保持スロット１２２を通って移動する際に、長手軸に対して実質的に直交するその関係性を維持する。あるいは、プッシャー部材１５０ａは、図１７Ｂに示すような、そり１４０ａのカムウェッジ１４４ａの間の空間１４６ａと共存するように構成され得る。以前の実施形態においてのように、プッシャー部材１５０ａのベース１５２ａは、そり１４０ａの空間１４６ａとのスライド係合のために構成および適合される。なおさらに、プッシャー部材１５０ａはそり１４０ａのカムウェッジ１４４ａを係合するので、プッシャー部材１５０ａは、保持スロット１２２を通って移動する際に、長手軸に対して実質的に直交するその関係性を維持する。
本明細書中に開示された実施形態に対して、種々の改変がなされ得ることが理解される。例えば、ツールアセンブリは、もっぱらステープルデバイスとして記載されているが、ステープル以外の締め具（２つのパーツからなる締め具を含む）に適用するために使用され得る。従って、上記明細書は、限定としてではなく、単なる好ましい実施形態の例示として解釈されるべきである。当業者は、本明細書に添付される特許請求の範囲の範囲および精神内で、他の改変を想定する。
１０ ステープルデバイス
１４ アンビル
１６ カートリッジアセンブリ
１２ ツールアセンブリ
１８ 内視鏡の本体部分
２０ クランプ部材
２２ 回転カラー
２４ 旋回部材
２６ アダプター

Claims (12)

  1. ツールアセンブリを備える外科的ステープルデバイスであって、
    該ツールアセンブリは、以下：
    アンビルと；
    複数の外科的締め具を有するカートリッジアセンブリと；
    動的クランピング部材であって、該動的クランピング部材は、該アンビルに係合する上側フランジと、該カートリッジアセンブリに係合する下側フランジとを備え、該アンビルおよび該カートリッジアセンブリは、開位置と把持された位置との間で互いに関して旋回可能である、動的クランピング部材と；
    該カートリッジアセンブリから該締め具を駆出するために、該カートリッジアセンブリを通して移動するようにスライド可能に配置されたそりであって、該動的クランピング部材が、それと係合し、かつカートリッジアセンブリを通して移動可能である該そりの近位に配置され、該動的クランピング部材は、該デバイスの発射の間に、該そりに近接する該ツールアセンブリの領域内に所望の組織ギャップを提供する、そりと；
    該アンビルの近位端および該カートリッジアセンブリの近位端間の該ギャップが所定の距離を越えることを防止するために、戻った位置から該アンビルの近位の部分およびカートリッジアセンブリを取り囲む進んだ位置まで移動可能であるクランプリングと；
    該クランプリングおよび該動的クランピング部材を進めるための駆動機構であって、該クランプリングは、該動的クランピング部材が締め具を該カートリッジから駆出する間に、該アンビルの近位端および該カートリッジアセンブリの近位端の周囲に配置されたままである、駆動機構と；
    を有し、
    該駆動機構が、該動的クランピング部材に接続された可撓性部材を備え、かつ該カートリッジアセンブリを通して該動的クランピング部材を遠位に進めるために遠位に移動可能であり、該クランプリングに接続されたシースをさらに備え、該可撓性部材が該シースに独立して進められ得る、外科的ステープルデバイス。
  2. 前記動的クランピング部材が、組織を切開するためのナイフの刃を備える、請求項１に記載の外科的ステープルデバイス。
  3. 前記動的クランピング部材が、前記可撓性部材の遠位端を受け入れる間隙を備える、請求項１に記載の外科的ステープルデバイス。
  4. 前記可撓性部材の遠位端が、前記間隙に一致する形状である、請求項３に記載の外科的ステープルデバイス。
  5. 前記カートリッジアセンブリがカム表面を有し、前記下側フランジが該カム表面と係合し、カートリッジアセンブリを間隔のあいた位置から近接する位置まで旋回させる、請求項１に記載の外科的ステープルデバイス。
  6. 前記ツールアセンブリが、旋回軸の周りに相関的な結合のために取付けられている、請求項１に記載の外科的ステープルデバイス。
  7. さらに、前記旋回軸に旋回部材を有する、請求項６に記載の外科的ステープルデバイス。
  8. さらに、前記旋回部材からずれた位置において前記ツールアセンブルに取付けられた関節リンクを有する、請求項７に記載の外科的ステープルデバイス。
  9. さらに、カラーを有し、前記旋回部材が該カラーに接続されている、請求項８に記載の外科的ステープルデバイス。
  10. 前記アンビルおよびカートリッジアセンブリが、前記カラーに関連して回転可能である、請求項９に記載の外科的ステープルデバイス。
  11. さらに、内視鏡の本体部分を有し、前記ツールアセンブリが該内視鏡の本体部分の遠位端に支持されている、請求項１に記載の外科的ステープルデバイス。
  12. さらに、前記ツールアセンブリを駆動するためのハンドルアセンブリを有する、請求項１に記載の外科的ステープルデバイス。
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