JP2011524199A - Partially reusable surgical stapler - Google Patents
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Abstract
ステープラを組織内に展開するための部分的に再利用可能な外科用ステープラ。ステープラは、遠位端、近位端、及びそれらの間の長手方向軸を有する本体を有する。近位端は、ハンドルを含み、遠位端は、ステープルカートリッジホルダ及び対向するアンビルを含む。ステープラは、ステープルを展開するためのアクチュエータモジュールも有する。アクチュエータモジュールは、アンビルに向かってステープルを連続的に放出するための、少なくとも１つの長手方向に移動可能な部材を含む。アクチュエータモジュールは、本体に、かつそこから容易に除去可能かつ交換可能である。ステープラ本体の構成要素は、異なる外科手術における再利用のために、分解され、再生され、再組立てすることができる。 A partially reusable surgical stapler for deploying a stapler into tissue. The stapler has a body having a distal end, a proximal end, and a longitudinal axis therebetween. The proximal end includes a handle and the distal end includes a staple cartridge holder and an opposing anvil. The stapler also has an actuator module for deploying the staples. The actuator module includes at least one longitudinally movable member for continuously releasing staples toward the anvil. The actuator module is easily removable and replaceable in and out of the body. The stapler body components can be disassembled, regenerated and reassembled for reuse in different surgical procedures.
Description
本発明は、概して、外科用ステープリング装置、より具体的には、その後の外科手術における再利用のために、分解され、部分的に再生され、滅菌することができ、かつ単一の患者の手術中に複数のステープルカートリッジと共に再利用することができる、除去可能なアクチュエータモジュールを備える、外科用ステープラに関する。 The present invention generally relates to a surgical stapling device, more specifically, can be disassembled, partially regenerated, sterilized and reused in a single patient for reuse in subsequent surgery. The present invention relates to a surgical stapler comprising a removable actuator module that can be reused with a plurality of staple cartridges during surgery.
外科用ステープラが導入される以前、外科医は、患者の組織を共に縫い合わせるのに膨大な時間を費やさなければならなかった。これは、最も時間を集約する、外科手術の側面であった。外科用ステープラは、ユーザーが組織を共に縫い合わせるのに費やす時間を短縮させた。そのような外科用ステープラは、以下の発行された米国特許（ＣｈｏｗらのＵＳ第４６３３８６１号、ＣｈｏｗらのＵＳ第４６３３８７４号、及びＳｃｈｕｌｚｅらのＵＳ第５１２９５７０号）に説明されており、これらは、参照によって、本明細書に組み込まれる。 Prior to the introduction of surgical staplers, surgeons had to spend enormous amounts of time stitching together patient tissue. This was the most time intensive aspect of surgery. Surgical staplers have reduced the time spent by users sewing together tissue. Such surgical staplers are described in the following issued US patents (Chow et al. US Pat. No. 4,633,861, Chow et al. US Pat. No. 4,633,874, and Schulze et al. US Pat. No. 5,129,570), which are Which is incorporated herein by reference.
外科用ステープラの１つの懸念は、手術中に使用されるステープラが滅菌であることを保証することである。再利用可能なステープラは、典型的には、使用後に滅菌することが困難である、比較的複雑な機械的装置であった。したがって、かつては外科用ステープラが完全に使い捨てであることが望ましかった。１つ以上の外科用ステープラが外科手術において必要とされ得るため、経済的理由により、再装填可能なステープルカートリッジを備える使い捨て外科用ステープラが開発されてきた。これらの再装填可能なステープルカートリッジは、ステープル及びステープルを排出するための発射モジュールの組み合わせからなっていた。典型的には、切断装置は、発射モジュール内に含まれる。したがって、ステープラが新たなステープルカートリッジで再装填される度に、新たなメス及び発射アセンブリもまた、ステープラ内に挿入される。通常、数々のステープルカートリッジが、患者の単一手術中に使用され、それによって、同一の患者のためにメス及び発射要素が繰り返し交換された。通常、メスは、ステープルカートリッジが空になった後に摩滅するため、メス及び発射アセンブリは、同一の患者内で、更なるステープルカートリッジと共に再利用することができるであろう。患者の単一手術において発射アセンブリを再利用することによって、更なる滅菌工程が不必要であり、手術中に発生した費用を低減することができる。近年、一部分が使い捨て可能であり、かつ一部分がその後の手術において再利用可能であるように、外科用ステープラの部品を再利用可能にする要望も存在している。ステープラの部品を再利用することによって、外科手術に付随する費用が低減され、かつ外科的廃棄物も減少される。 One concern with surgical staplers is to ensure that the stapler used during surgery is sterile. Reusable staplers have typically been relatively complex mechanical devices that are difficult to sterilize after use. Therefore, it was once desirable to have a surgical stapler that is completely disposable. Disposable surgical staplers with reloadable staple cartridges have been developed for economic reasons, as more than one surgical stapler may be required in a surgical procedure. These reloadable staple cartridges consisted of a combination of staples and firing modules for ejecting staples. Typically, the cutting device is included in the firing module. Thus, each time a stapler is reloaded with a new staple cartridge, a new scalpel and firing assembly is also inserted into the stapler. Typically, a number of staple cartridges were used during a single patient operation, whereby the scalpel and firing elements were repeatedly replaced for the same patient. Normally, the scalpel wears out after the staple cartridge is empty, so the scalpel and firing assembly could be reused with additional staple cartridges in the same patient. By reusing the firing assembly in a single patient operation, no further sterilization steps are required and the costs incurred during the operation can be reduced. In recent years, there has also been a desire to make the components of the surgical stapler reusable so that a portion can be disposable and a portion can be reused in subsequent surgery. By reusing the stapler parts, the costs associated with the surgery are reduced and the surgical waste is also reduced.
したがって、外科手術に付随する費用を低減するためには、分解し、かつステープラ部品をその後の使用のために再生することができる、外科用ステープラへの必要性が存在する。具体的には、発射及び切断構成要素が、ステープラと共に使用される材料の量を低減するために、患者の単一手術において複数のステープルカートリッジと共に再利用され得る、外科用ステープラへの必要性が存在する。いくつかのステープラ部品の再生及び再利用を可能にするように、容易に組立てられ、かつ分解することができる外科用ステープラへの必要性も存在する。また、より複雑な切断及びステープリング構成要素が外科手術間で容易に交換されるのを可能にするために、発射モジュールを組み込む、部分的に再利用可能なステープラへの必要性も存在する。更に、再利用可能な部品が、手術間で有効な部品再生を促進するような、簡素な単一部品設計を有する、部分的に再利用可能なステープラへの必要性が存在する。本発明は、これらの目的を達成する、部分的に再利用可能な外科用ステープラを提供する。 Thus, in order to reduce the costs associated with surgery, there is a need for a surgical stapler that can be disassembled and the stapler parts can be regenerated for subsequent use. Specifically, there is a need for a surgical stapler in which the firing and cutting components can be reused with multiple staple cartridges in a single patient operation to reduce the amount of material used with the stapler. Exists. There is also a need for a surgical stapler that can be easily assembled and disassembled to allow the regeneration and reuse of several stapler parts. There is also a need for a partially reusable stapler that incorporates a firing module to allow more complex cutting and stapling components to be easily exchanged between surgical procedures. Furthermore, there is a need for a partially reusable stapler that has a simple single part design such that the reusable part facilitates effective part regeneration between surgeries. The present invention provides a partially reusable surgical stapler that achieves these objectives.
本発明に従う、部分的に再利用可能な外科用ステープラを、ステープルを組織内に展開するために提供する。ステープラは、遠位端、近位端、及びそれらの間の長手方向軸を有する本体を有する。近位端は、ハンドルを備え、遠位端は、ステープルカートリッジホルダ及び対向するアンビルを備える。ステープラは、ステープルを展開するためのアクチュエータモジュールも有する。アクチュエータモジュールは、アンビルに向かってステープルを連続的に放出するための、少なくとも１つの長手方向に移動可能な部材を備える。アクチュエータモジュールは、本体に、かつそこから容易に除去可能かつ交換可能である。 A partially reusable surgical stapler according to the present invention is provided for deploying staples into tissue. The stapler has a body having a distal end, a proximal end, and a longitudinal axis therebetween. The proximal end includes a handle and the distal end includes a staple cartridge holder and an opposing anvil. The stapler also has an actuator module for deploying the staples. The actuator module includes at least one longitudinally movable member for continuously releasing staples toward the anvil. The actuator module is easily removable and replaceable in and out of the body.
別の実施形態において、本発明は、近位ハンドル端及び遠位アンビル端を有する、上部ジョー部材を有する部分的に再利用可能な外科用ステープラを提供する。近位のチャネル形状枠及び遠位ステープルカートリッジチャネルを有する下部ジョー部材は、上部ジョーと整合される。アンビルに向かってステープルを連続的に放出するための、少なくとも１つの長手方向に移動可能な部材を有する、アクチュエータモジュールは、下部ジョー枠に、かつそこから容易に除去可能かつ交換可能である。複数のステープルを含むステープルカートリッジは、ステープルカートリッジチャネル内に除去可能に配設される。上部及び下部ジョーを共に接続するためのラッチング部材を、ステープラの長手方向軸に沿った中央位置で提供する。ラッチング部材は、一連の異なる係止状態においてステープラを定置するために、上部及び下部ジョー部材に対して移動可能である。異なる係止状態には、ラッチング部材をジョー部材に接続し、かつ断絶するための組立て状態、及びラッチング部材がジョー部材に係止される閉鎖ラッチ状態が挙げられる。 In another embodiment, the present invention provides a partially reusable surgical stapler having an upper jaw member having a proximal handle end and a distal anvil end. A lower jaw member having a proximal channel shape frame and a distal staple cartridge channel is aligned with the upper jaw. An actuator module having at least one longitudinally movable member for continuously releasing staples toward the anvil is easily removable and replaceable in and out of the lower jaw frame. A staple cartridge including a plurality of staples is removably disposed within the staple cartridge channel. A latching member for connecting the upper and lower jaws together is provided at a central location along the longitudinal axis of the stapler. The latching member is movable relative to the upper and lower jaw members to place the stapler in a series of different locking states. Different locking states include an assembled state for connecting and disconnecting the latching member to the jaw member and a closed latching state where the latching member is locked to the jaw member.
以下、図を通して同じ番号が同じ要素を示す、図面を参照すると、図１〜３は、本発明の第１の例示的外科用ステープラ２０を図示する。ステープラ２０の本体は、上部ジョー部材２２、下部ジョー部材２４、及びラッチング部材３０を備える。図２〜３に示すように、ラッチング部材３０は、上部及び下部ジョー部材２２、２４に対して枢動可能である。ラッチング部材３０は、一連の異なるラッチング状態を介して枢動され、使用のために閉鎖されたステープラを係止するか、又はステープラ内の組織の調節、ステープルカートリッジの交換、又はステープラの分解を可能にする様々な程度に、ステープラを開放することができる。外科手術が完了すると、ラッチング部材３０は、ステープラ２０がステープラの部品の再滅菌及び再利用に備えて分解されるのを可能にするように、完全な開放位置まで枢動することができる。
Referring now to the drawings wherein like numerals indicate like elements throughout the Figures, FIGS. 1-3 illustrate a first exemplary
図４及び５に示すように、上部ジョー２２は、上面壁３６によって接続された一対の対向する側壁３２ａ、３２ｂを有する、単一部品の細長いチャネル形状枠を備える。上面壁３６は、ハンドグリップを形成するように外側表面上に好適に成形され、かつ外科医によるステープラの取り扱い及び操作を促進するための上部ハンドル突出部４０を備える。上部ジョー２２の遠位端は、ステープラのアンビル４４を画定する、一対の内側に延在するフランジ４２を備える。フランジ４２は、アンビル４４の全長に沿って延在する、中央の長手方向スロット４６によって分離される。各々のフランジ４２の内部表面は、均一に離間されたステープル形成ポケット５０の２つの長手方向列で提供される。ステープル形成ポケット５０は、発射中に、Ｕ型ステープルがアンビルフランジに対して放出されるときに、Ｂ形状ステープルの成形を可能にする。アンビル４４は、中空の管状体内器官内へのステープラの挿入を促進するために、最遠位端にテーパー先端を備える。一対の組織停止部５２は、ステープル形成ポケット５０の近位端に隣接するアンビル４４の対向側面上に提供される。組織停止部５２は、組織がアンビル４４を超えてステープラ内に定置されるのを防止するために、ステープル形成ポケット５０の近位端と横方向に整合される。アンビル４４の近位端で組織を阻害することによって、ステープルされていない組織の切り詰め又は切断が防止される。
As shown in FIGS. 4 and 5, the
円筒ピン５４は、組織停止部５２の近位にある上部ジョー２２の対向側面から延在する。ピン５４は、上部及び下部ジョーを共に接続するために、下部ジョー２４上の垂直スロットの内部に適合する。上部ジョー２２は、チャネル側壁３２ａ、３２ｂの近位端付近に一対の湾曲したノッチ６０も備える。図２に示すとおり、ノッチ６０は、下部ジョー２４上の突起部６２と相互作用して、使用中にジョーを容易に整合するための手段を提供する。上部ジョー２２は、好ましくは、例えば、ステンレス鋼等の生物適合性金属の単一部品からなる。材料の単一部品を上部ジョー２２に使用することによって、ステープラの構造的完全性が増加される。あるいは、上部ジョー２２は、例えば、溶接等の周知の接合方法による製造プロセス中に共に接合される、２つ以上の個別の部品として製造することができる。
A
図６に示すように、下部ジョー２４は、底部壁６６によって接続された一対の側壁６４ａ、６４ｂを有する単一部品の細長いＵ型枠を備える。下部ジョー２４の遠位端において、側壁６４ａ、６４ｂは、ステープラ内に単一使用のステープルカートリッジを支持するためのカートリッジチャネル７０を形成するために縮小される。ノッチ７２は、カートリッジチャネル７０の遠位端に隣接する側壁６４ａ、６４ｂ内に提供される。ノッチ７２は、ステープルカートリッジ上の側面の突起部と係合して、カートリッジをチャネル内に把持する。垂直整合スロット５６は、側壁６４ａ、６４ｂの上部縁内のカートリッジチャネル７０の近位に位置する。上述のとおり、上部ジョー２２上のピン５４は、整合スロット５６と相互作用して、ジョー部材を共に整合し、かつ接続する。上部ジョー側壁３２ａと３２ｂとの間の幅は、ピン５４が整合スロット５６内に挿入され、突出物６２がノッチ６０内に挿入されるときに、上部ジョーが下部ジョーに適合するのを可能にするように、下部ジョー側壁６４ａと６４ｂとの間の幅よりもわずかに大きい。圧痕７４は、整合スロット５６の遠位の側壁６４ａ、６４ｂの外側表面内に形成される。以下に更に詳細に説明するとおり、圧痕７４は、アクチュエータモジュールの下部ジョー部材２４への取り付けを促進する。
As shown in FIG. 6, the
開口部７６は、下部ジョー２４に沿った中間位置において底部壁６６を介して形成される。側壁６４ａ、６４ｂは、開口部７６の対向側面上で下方に延在して、遠位に勾配した突起部８０を形成する。突起部８０の遠位端に沿って、側壁６４ａ、６４ｂは、円形端８８を有する直線面のスロット８２を形成するように成形される。円形端８８の直径は、スロット８２の幅よりもわずかに大きい。突起部８０の近位に、側壁６４ａ、６４ｂの外側表面は、ラッチング部材位置決め機能を備える。図６に示すとおり、位置決め機能は、側壁６４ａ、６４ｂの表面内に機械加工される、複数の戻り止め隆起部８４、又は他の表面圧痕を備えることができる。図６は、下部ジョー２４の前面側上の位置決め機能のみを示すが、以下に説明するように、下部ジョーの裏側が、ラッチング部材３０が下部ジョーの両方の側面によって一連のラッチング状態のおいて保持され得るような同一方法で、成形されることを理解されたい。保持機能８６は、側壁６４ａ、６４ｂと底部壁６６との間の接合部における下部ジョー２４の近位端で形成される。保持機能８６は、ステープラ２０の組立て中に、アクチュエータモジュールとのスナップ嵌め接続を促進する、側壁６４ａ、６４ｂの内側方向の拡張を含むことができる。
The
図７及び８は、本発明のステープラ２０に使用するための例示的除去可能なステープルカートリッジ９０を示す。カートリッジ９０は、少なくとも２つの横方向に離間した長手方向列内に配列された複数の外科用ステープルを受容するように適合される。カートリッジ９０は、下部ジョーカートリッジチャネル７０の内部に摺動可能に受容されるように構成された、対向側壁９２ａ、９２ｂを備える本体を有する。ステープルカートリッジ９０は、カートリッジの近位端からその遠位端まで延在する中央の細長いスロット９４によって長手方向に分割される。カートリッジ本体によって画定される、複数のステープル開口部９６は、細長い中央スロット９４に沿って配設される。図示の実施形態において、ステープル開口部は、２つの横方向に離間された、互い違いの列内に配列され、列の各々の対は、中央の長手方向スロット９４の対向側面上に配設される。隣接する列内のステープル開口部は、装置が作動するときに、組織のより有効なステープリングを提供するように、互い違いである。図８を参照すると、ステープルカートリッジ９０は、細長い中央スロット９４の対向側面上に位置し、かつ開口部９６の互い違いの列との間に配設された、一対の長手方向スロット１００を備える。各々の長手方向スロット１００は、カートリッジ９０の近位端から遠位端に向かって延在する。複数のステープルドライバ（図示せず）は、ステープルカートリッジ９０内に充填されるステープルを作動させるために、ステープル開口部９６内に摺動可能に実装される。各々のステープルドライバは、ステープルカートリッジ９０内に提供された隣接する列内に位置する２つのステープルを同時に作動させるように設計される。したがって、第１の組のステープルドライバは、中央の長手方向スロット９４の一方の側面上に位置する互い違いの列内のステープルを作動させるために提供され、第２の組のステープルドライバは、中央の長手方向スロットの他方の側面上に位置する一対の隣接する列内のステープルを作動させるために提供される。
7 and 8 show an exemplary removable
ステープルカートリッジ９０の遠位端は、中空の管状体内器官内への下部ジョー部材２４の挿入を促進するための、テーパー先端を備える。テーパー先端の近位の、ステープルカートリッジ９０は、一対の外側に延在する突出部１０２と共に提供される。一対の離間された平行フランジ１０４は、ステープルカートリッジ９０の対向側面から後方に延在する。脚１１０は、ステープルカートリッジの近位端で、フランジ１０４から下方に延在する。各々の脚１１０は、円形の下方に対面するノッチ１１２と共に提供される。カートリッジ９０が下部ジョー２４上で組立てられるとき、突出部１０２は、下部ジョー側壁内のノッチ７２に軽く受容され、脚１１０は、下部ジョー底部壁６６内の開口部７６を介して延在する。以下に説明するとおり、脚ノッチ１１２は、ラッチング部材３０上のピンと係合して、カートリッジを下部ジョーチャネル７０内に把持する。一対のウィング１１４は、カートリッジ９０の近位端で、側壁９２ａ、９２ｂから上方及び下方に延在する。ウィング１１４は、ステープルカートリッジ９０が下部ジョー２４内に手動で挿入され、かつそこから除去されるのを可能にするフィンガーグリップとしての機能を果たす。ウィング１１４を使用することによって、カートリッジ９０は、ジョー開口部７６及びノッチ７２から持ち上げられ、使用後、カートリッジを下部ジョー２４から除去することができる。また、図３に示すとおり、ウィング１１４は、カートリッジチャネル７０の近位端で、下部ジョー側壁６４ａ、６４ｂと係合して、カートリッジを下部ジョー２４内の定位置に係止する。短い拡張部１１６は、カートリッジ９０の背面に形成され、後方に突出する脚１１０の間に位置される。中央のメススロット９４は、スロットの近位端においてその対向側面上の内側に勾配したガイド表面と共に提供することができる、拡張部１１６を介して長手方向に延在する。ロックアウトピン１０６は、一方の端部において拡張部１１６に接続され、かつ接続点に対し枢動可能である。初めに、ステープルカートリッジ９０がステープラ２０内に充填されるとき、ロックアウトピン１０６は、中央のメススロット９４を横切って延在する。
The distal end of
上述のとおり、ステープラ２０は、ステープラの長手方向の長さに沿った中間位置で、上部及び下部ジョー部材を共に接続するための、ラッチング部材３０を備える。好ましくは、ジョー部材２２、２４は、アンビル４４の近位端及びステープルカートリッジ９０に隣接する位置で共に接続される。図９に示す好ましい実施形態において、ラッチング部材３０は、上面壁１３０によって接続された対向する側壁１２４ａ、１２４ｂを有する、単一部品のチャネル形状枠を備える。ラッチング部材３０は、ラッチング部材を下部ジョー２４に枢動可能に接続するための、ラッチピン１２２を更に備える。好ましくは、ラッチング部材は、ステンレス網、又は他の同様の生態適合性金属の単一部品からなる。対向するラッチング部材の側壁１２４ａと１２４ｂとの間の距離は、下部ジョー２４の側壁６４ａ、６４ｂにかかるのに十分である。側壁１２４ａ、１２４ｂは、ラッチングアーム１２０がラッチング位置間で手動で枢動することを可能にするように、フィンガーグリップとしての役割を果たす、外側に延在する、細長いフランジ１３２を備える。ラッチングアーム１２０の外側表面は、ハンドル拡張部１３４を備える。下部ジョー部材２４に接続されたとき、ハンドル拡張部１３４は、外科医のステープラ操作のためのハンドルグリップを形成するように、上部ジョーハンドル拡張部４０と組み合わされる。
As described above, the
ラッチング部材３０の各々の側壁１２４ａ、１２４ｂは、上部ジョーピン５４を係合するために、前方に対面するノッチ１４２と共に提供される、遠位に延在するＣ型フック部材１４０を備える。図９及び１０に示すとおり、フック部材１４０は、フック部材の先端からノッチ１４２内に後方に延在する内部カム表面１４４を備える。ラッチング部材３０が閉鎖動作状態に移動するとき、ノッチ１４２は、上部ジョーピン５４と係合し、ラッチ状態においてラッチング部材を維持するようにオーバーセンターラッチとしての機能を果たす。ノッチ１４２の下で、各々のフック部材１４０は、ラッチング部材の上面壁１３０の端部を越えて遠位に下方に突出する。図１１に示すように、ラッチピン１２２は、ラッチング部材３０の端部にわたり、フック部材１４０の下方に曲がった端部との間に延在する。ラッチピン１２２は、各々の端部に隣接する平坦な表面１５２を有する円筒形状を有する。ラッチピン１２２の直径は、下部ジョースロット８２のための狭い開口部よりも大きい。ラッチング部材３０は、ラッチピン１２２を下部ジョースロット８２内に挿入することによって、下部ジョー２４に脱着可能に接続される。ラッチピン１２２は、平坦な端部１５２がスロットの直線面と平行になるように、ラッチング部材３０を配向することによって、スロット８２内に挿入される。この位置において、ラッチピン１２２は、スロットの幅よりも大きいピンの直径に関わらず、スロット８２内に挿入することができる。平坦な端部１５２がスロット８２の線形面と整合されると、ラッチピン１２２は、図１３に示すとおり、ピンが円形スロット端８８内に休止するまで、図１２に示すとおり、スロット内に挿入される。
Each side wall 124 a, 124 b of the latching
ステープラ２０は、一連の異なるラッチング状態においてラッチング部材を保持するための手段も含む。図９及び１０を参照すると、保持手段は、各々のラッチングアームの側壁１２４ａ、１２４ｂの上面縁から延在するバネアーム１５０を含む。バネアーム１５０は、フック部材１４０の上部輪郭を追従して、遠位に上方に湾曲し、かつ球状自由端を備える。図１３に示すように、ラッチングピン１２２がスロット８２内に組立てられ、ラッチング部材３０が遠位に勾配されると、ステープラ２０は、初期の開放状態にある。ステープラ２０を閉鎖するためには、ラッチング部材３０は、ステープラの近位端に向かって回転され、ラッチング部材を下部ジョー部材２４の本体に接近して引き出す。平坦な端部１５２がスロット８２の側面との整合から外れて回転すると、ピン１２２とスロット８２との間の幅の差異は、ピンがスロット端部８８から滑脱するのを防止する。したがって、ピン１２２は、スロット端部８８内に固定され、ラッチング部材３０を下部ジョー部材２４に係止する。
The
ラッチング部材３０が回転すると、フック部材１４０は、下部ジョー部材２４の側面に沿って引き出される。フック部材１４０が下部ジョーの側壁６４ａ、６４ｂに沿って揺動すると、バネアーム１５０の球状端は、側壁上の戻り止め隆起部８４に接触する。戻り止め隆起部８４との間にバネアーム１５０を移動するためには、バネアームの端部が隆起部上を移動することができるように、ラッチング部材３０に付加的な力が印加し、フック部材１４０に向かうバネアームの屈曲をもたらす。図１４に示すとおり、バネアーム１５０が戻り止め隆起部８４の間に位置付けられると、ラッチング部材３０は、部分的係止状態である。部分的係止状態において、ラッチング部材３０は、下部ジョー２４に取り付けられ、整合スロット５６は、フック部材１４０の先端のすぐ遠位にある。上部ジョーピン５４は、下部ジョースロット５６に自由に挿入するか、又はそこから除去することができ、上部及び下部ジョー部材が分離され、かつ共に再接合されるのを可能にする。
When the latching
ラッチング部材３０を下部ジョー部材２４に接近して引き出しながら、ラッチピン１２２がスロット端８８内で回転し続けると、フック部材の内部カム表面１４４は、整合スロット５６の開口部の上を回転し、スロットを阻害し、スロット内の上部ジョーピン５４を係止する。バネアーム１５０は、戻り止め隆起部８４に沿って移動し、上部隆起部の凹部の外側縁と係合する。図１５に示す、この閉鎖前状態において、ラッチング部材３０並びに上部及び下部ジョー部材２２、２４は、ステープラ２０の本体を形成するために共に接続されるが、上部ジョーピン５４は、スロットの底部と、カム表面１４４との間のスロット５６内に摺動して、ジョー部材間のいくつかの相対的動作を可能にすることができる。ラッチング部材３０は、テープルカートリッジとアンビルとの間の相対的動作を可能にするように、軽くラッチされた位置にジョー部材を保持する。ジョー部材２２、２４の遠位端における相対的動作は、ジョー部材を互いから断絶することなく組織整合を可能にする。
As the
ラッチング部材３０が閉鎖動作状態（図１に図示）まで回転するとき、ラッチング部材は、下部ジョー部材２４を囲繞し、上部ジョー部材２２上のピン５４は、フック部材のノッチ１４２内に格納される。バネアーム１５０は、戻り止め隆起部８４を超えて、下部ジョー部材２４の側面に沿って遠位に上方に前進する。この状態において、上部及び下部ジョー部材は、共に係止され、アンビルとカートリッジ表面との間の組織を圧縮し、ステープラは、組織のステープリング及び切断の準備が整っている。この閉鎖状態において、最低限の離間は、スペーサピン１６０によってアンビルとカートリッジ表面との間で維持され得る。アンビルとカートリッジ表面との間の組織の定置を調節するためには、ラッチング部材３０は、図１６に示すとおり、回転して閉鎖前状態に戻り、ピン５４をフック部材のノッチ１４２から除外することができる。ラッチング部材３０が回転して戻ると、バネアーム１５０は、戻り止め隆起部８４と再係合してラッチング部材を定位置に把持する。閉鎖前状態に戻ることによって、フック部材１４０とピン５２との間の接続が緩み、上部及び下部ジョーを断絶することなく、ピンがスロット５６内に摺動することを可能にする。
When the latching
ステープラ２０を断絶するためには、ラッチング部材３０は、下部ジョー部材２４から離れて回転し、上部ジョーピン５４をフックのノッチ１４２から外に引き出す。ラッチング部材３０は、湾曲したラッチングアーム先端１６２を引張することによって、上部及び下部ジョー部材２２、２４から離れて回転し得る。反回転力がラッチングアーム１２０上で継続すると、バネアーム１５０は、戻り止め隆起部８４を通って移動し、フック部材１４０が下部ジョー側壁６４ａ、６４ｂを通り、かつそこから離れて揺動するのを可能にする。ラッチング部材３０は、ラッチング部材３０が、図１３に示す初期開放位置に戻るまで、およそステープルカートリッジ９０の方向に回転する。ラッチング部材３０が開放状態にあると、ラッチピン１２２上の平坦な端部１５２は、スロット８２の直線面と平行して再度整合され、ラッチピンがスロット８２を介して回収され、ラッチング部材を下部ジョー部材２４から分離するのを可能にする。ラッチング部材３０が脱着されると、ステープラ２０は、３つの個別の単一部品の構成要素、即ち、上部ジョー２２、下部ジョー２４、及びラッチング部材３０に分解することができる。これらの再利用可能な構成要素の単一部品のチャネル形状構造は、使用間に容易であり、かつ徹底的な構成要素の再生及び滅菌を提供する。
To break the
以下、上部ジョー部材２２と下部ジョー部材２４との間に締付けされた組織をステープルし、かつ切断するためのアクチュエータモジュール１７０を示す、図１７及び１８を検討する。アクチュエータモジュール１７０は、アクチュエータモジュール構成要素に支持構造を提供する、Ｕ型長手方向モジュールパン１７２を備える。モジュールパン１７２は、底部壁１７６によって共に接続された一対の側壁１７４を備える（図１９）。モジュールパンの側壁１７４の間の距離は、モジュールパンが下部ジョー２４の近位チャネル内に摺動可能に実装されるのを可能にするように、下部ジョー側壁６４ａと６４ｂとの間の距離未満である。図１９及び２０に示すとおり、モジュールパン１７０の近位端は、側壁１７４の外側表面から突出する、１つ以上の戻り止め隆起部１７８を備える。戻り止め隆起部１７８は、アクチュエータモジュール１７０が下部ジョーチャネル内に近位に摺動するとき、下部ジョー部材２４の内部チャネル上の保持機能８６に係合する。戻り止め隆起部１７８の保持機能８６との相互作用は、アクチュエータモジュールを下部ジョー部材２４内の定位置にスナップ嵌めし、かつ保持する。
In the following, consider FIGS. 17 and 18 showing an
図２１に示すとおり、複数の移動可能なアクチュエータ部材は、上部及び下部ジョー部材２２、２４に対するパン内の長手方向動作のために、モジュールパン１７２内に位置する。アクチュエータ部材は、パン内の相互の長手方向動作のためにモジュールパン１７２内に配設される押出ブロック１８０を備える。押出ブロック１８０は、横方向フランジ１８４によってアクチュエータノブ１８２に取り付けられる。図３に示すとおり、アクチュエータモジュール１７０が下部ジョー２４内に実装されるとき、フランジ１８４は、下部ジョーの側壁６４内に形成された細長いガイドスロット１８６を介して延在する。フランジ１８４は、ノブの手動のアクセスを可能にするように、ジョー部材２２、２４の外側上にノブ１８２を位置付ける。図３において、ノブ１８２は、下部ジョーの側壁６４ｂ内のガイドスロット１８６を通って延在する状態で示す。しかしながら、ガイドスロットは、対向下部ジョー側壁６４ａ内に形成することもでき、その場合では、アクチュエータノブ１８２は、ステープラ２０の対向側面から外に延在するであろう。フランジ１８４は、ノブ１８２がジョー部材２２、２４の外側に沿って手動で移動されると、ガイドスロット１８６を介して延在し、かつそれに沿って移動する。
As shown in FIG. 21, a plurality of movable actuator members are located within the
これから図２１に戻り、アクチュエータモジュール１７０は、一対の長手方向に延在する、平行押出棒１９０も備える。押出棒１９０の近位端は、横方向に離間された押出棒スロット１９２内に固定され（図２２に図示）、押出棒がモジュールパン１７２を介して、押出ブロック１８０と共に長手方向に移動するのを可能にする。押出棒１９０は、押出ブロック１８０から遠位に延在し、かつ図２３に示す、ガイドブロック２００内に形成された長手方向スロット１９４内で摺動可能に受容される。図１８に示すとおり、ガイドブロック２００は、モジュールパン１７２の遠位端で実装される。モジュールパンの側壁１７４の上部縁は、モジュールパン内のガイドブロックを保持するように、ガイドブロック２００の側面縁の上で内側に曲げられる。また、タブ２０２は、パン内のガイドブロックを固定するために、モジュールパンの側壁１７４内の開口部２０４を介してガイドブロック２００の側面から延在する。ガイドブロック２００の遠位端は、モジュールパン１７２の端部を超え、かつステープルカートリッジ９０の後方フランジ１０４の間に延在する。ガイドブロック２００内の横方向スロット１９４は、押出棒１９０を、ステープルカートリッジ９０の細長いステープルドライバスロット１００と整合する。押出棒１９０の遠位端は、ガイドスロット１９４の前方に延在し、かつ図２４に示す、くさび形状の先端２０６と共に提供され、それは、押出棒がカートリッジを介して遠位に移動すると、カートリッジ９０内でステープルドライバを係合するための傾斜したカム表面を画定する。押出棒の先端２０６の長手方向動作は、カミング作用を介して、連続的にステープルドライバを駆動し、カートリッジからステープルを発射させる。
Returning now to FIG. 21, the
図２３に戻り、ガイドブロック２００は、下部ジョーの底部壁６６内の開口部７６を介して下方に延在する、従属中央部分２１０を備える。中央部分２１０は、円形端２１８を有する、遠位に勾配した、直線面のスロット２１２を備える。ステープラ２０が組立てられるとき、ガイドブロックスロット２１２は、ラッチング部材３０がステープラに接続されるとき、ラッチピン１２２が下部ジョー２４及びガイドブロック２００の両方に係合されるのを可能にするように、下部ジョーの側壁６４ａ、６４ｂ内のスロット８２と長手方向に整合される。ラッチピン１２２がスロット８２を介してスロット端８８に挿入されると、ピンもまた、ガイドブロックスロット２１２を通過し、円形端２１８内に格納され、アクチュエータモジュール１７０及び下部ジョー２４を共に係止する。
Returning to FIG. 23, the
図１８及び２１に示すとおり、アクチュエータモジュール１７０は、押出棒１９０との間に位置付けられたメス支持棒２１４を更に備える。メス支持棒２１４及び押出棒１９０は、好ましくは、金属板構成要素として製造される。メス支持棒２１４の近位端は、ノブ１８２を発射することによる動作のために、メス支持棒を押出ブロックに接続するために、押出ブロック１８０の中央スロット２１６（図２２）内に固定される。押出ブロック１８０の遠位の、メス支持棒２１４は、メス支持棒をステープルカートリッジの細長い中央スロット９４と整合するように、ガイドブロック２００内に形成された中央スロット２２０（図２３に図示）内に摺動可能に受容される。図２５に示すとおり、面取りされた刃先を有する傾斜したメスブレード２２２は、メス支持棒２１４の前面端に位置付けられる。メスブレード２２２の面取りされた刃先は、ジョー部材２２、２４に対する角度に配向され、かつガイドブロック２００の中央の長手方向スロット２２０内で摺動可能に受容される。メスブレード２２２の近位端の、メス支持棒２１４は、カートリッジ係止ノッチ２２８と、係止カットアウト部分２２４とを備え、それらは、以下に説明する安全なロックアウト機構の一部である。メス支持棒２１４の近位端は、参照番号２２６で示す、オフセット部分を備える。メスオフセット２２６は、近位端付近のメス支持棒２１４の一部分を切除して、支持棒上に２つの隆起した点２３０、２３２を生成することによって形成される。
As shown in FIGS. 18 and 21, the
図２６及び２７に示すとおり、保護キャップ２３４は、ガイドブロック２００の遠位端を被覆する。キャップ２３４の中央部分２３６は、メスブレード２２２及び押出棒１９０のくさび状先端２０６を囲繞する。内側に配向されたリップ２４０は、キャップの底部縁に沿って延在する。組立て中、下方の圧力は、下部ジョーチャネル内の定位置にアクチュエータモジュールの遠位端をスナップ嵌めするように、保護キャップ２３４に印加される。キャップ２３４が下方に押圧されると、キャップリップ２４０は、下部ジョー２４の外側表面上の圧痕７４内にスナップ嵌めされる。
As shown in FIGS. 26 and 27, the
図１９に示すリーフバネ２５０は、ガイドブロック２００の真下のモジュールパンの底部壁１７６内に統合される。バネ２５０は、使用されたカートリッジの再発射を防止するために、発射後、メス支持棒のカットアウト２２４をガイドブロック２００に対して持ち上げることによって、安全なロックアウト機能を提供する。第２のバネ２５２は、パンの近位端付近のモジュールパンの底部壁１７６内に統合される。この第２のバネ２５２は、運搬中のアクチュエータノブ１８２の前方動作を防止し、かつアクチュエータノブが、発射後、モジュールパン内の最近位位置に戻るときに、聴覚的かつ触覚的フィードバックを提供するように、押出ブロック１８０上のノッチと相互作用する、戻り止めバネである。図２８及び２９は、戻り止めバネ２５２の操作をより詳細に図示する。図２８において、バネ２５２は、押出ブロックの不測の遠位動作を防止するために、押出ブロック１８０上のノッチ２５４と係合された状態で示す。図２９は、アクチュエータノブ１８２上への意図的な遠位に配向された力の印加によって、ノッチ２５４から係脱された戻り止めバネ２５２を示す。押出棒１９０及びメス支持棒２１４は、アクチュエータノブ１８２に十分な力を印加して、バネ２５２のノッチ２５４に対する力を克服することによって遠位に前進する。バネ２５２がノッチ２５４から係脱された後、押出棒ブロック１８０は、モジュールパン１７２を介して第１の前進押出棒１９０まで遠位に摺動することができ、次いで、メス支持棒２１４をガイドブロック２００からステープルカートリッジ９０内に前進させる。
The
図２８に示す、初期発射位置において、押出ブロック１８０の下方に配向された縁は、オフセット部分２２６の近位端点２３２でメス支持棒２１４と接触している。アクチュエータノブ１８２は、ガイドスロット１８６内の完全な近位位置まで後退し、それによって、押出棒１９０及びメスブレード２２２を、ガイドブロック２００のスロット１９４及び２２０内に定置する。遠位の押圧力がアクチュエータノブ１８２に印加されるとき、バネ２５２は、ノッチ２５４から係脱し、押出ブロック１８０がモジュールパン１７２内で長手方向に前進することを可能にする。押出ブロック１８０が移動すると、ブロックは、押出棒１９０を遠位に前進させ、棒の傾斜した先端のカートリッジドライバスロット１００内への前進がもたらされる。押出ブロック１８０の初期動作中に、ブロックの遠位縁は、図２９に示すとおり、メス支持棒のオフセット２２６を介して移動し、それによってそれ自体では支持棒と接触しない。したがって、メス支持棒２１４は、押出棒１９０及びブロック１８０の初期遠位動作中に、不動のままである。
In the initial firing position shown in FIG. 28, the downwardly oriented edge of the
押出ブロック１８０がメスオフセット部分２２６を介して前進すると、ブロックの遠位縁は、メス支持棒２１４の遠位端点２３０と接触する。この押出ブロック１８０とメス支持棒２１４との接触は、ノブ１８２が前進すると、押出ブロック及び押出棒１９０に沿って、メス支持棒が遠位に前進し始める。メス支持棒２１４が遠位に移動すると、メスブレード２２２は、中央スロット２２０によって誘導され、後方カートリッジ拡張部１１６は、ステープルカートリッジ９０の中央長手方向スロット９４及びアンビル４４の中央長手方向スロット４６内に誘導される。メスブレード２２２がカートリッジ拡張部１１６を介して前進すると、ブレードは、ロックアウトピン１０６を前進支持棒の通路から外に偏向する。メスブレード２２２及び押出棒先端２０６は、開口部９６及び切断組織を介してステープルを駆動するステープルカートリッジ９０を介して同時に前進する。メスブレード２２２は、メスブレードがステープル列との間の組織を前進させ、かつ切断する前に、ステープルがアンビルとカートリッジとの間に掴まれている組織内に形成されるように、押出棒１９０のわずか後ろのステープルカートリッジ９０内に前進する。
As the push block 180 advances through the knife offset
メス及び押出棒が、ノブ１８２によって完全に前進（又は、所望の前方位置まで前進）した後、押出ブロック１８０は、アクチュエータノブをジョーガイドスロット１８６を介して近位に引き戻すことによって、モジュールパン１７２内に後退する。最初に、押出ブロック１８０が近位に引き出されると、押出棒１９０は、近位に引き出される一方、メス支持棒２１４は、支持棒内のオフセット部分２２６により、遠位の不動位置に留まる。遠位の押出ブロック縁が後退して近位のメス棒オフセット点２３２と接触すると、メス支持棒２１４は、押出ブロック及び棒と共に近位に後退し始める。メス支持棒２１４がガイドブロック２００内に後退すると、支持棒は、メス係止カットアウト２２４がガイドブロックの中央柱２５６（図２３）を捕らえるまで、リーフバネ２５０によって持ち上げられ、ガイドブロックと接触する。メスカットアウト２２４がガイドブロック柱２５６に係合すると、メス支持棒２１４は、押出ブロック１８０に関連する更なる動作から阻止される。好ましくは、メス支持棒２１４は、押出ブロック１８０及び押出棒１９０が完全な近位位置に到達すると、係止カットアウト部分２２４に係合する。
After the knife and pusher bar are fully advanced (or advanced to the desired forward position) by the
図２８に示すとおり、アクチュエータノブ１８２が完全に後退した後、ラッチング部材３０は、上述のとおり、ジョー部材２２、２４に対して枢動して、上部及び下部ジョーを分離する。ジョー部材が分離されると、ステープルカートリッジ９０は、除去され、かつ新たなカートリッジで交換することができる。使用されたカートリッジは、カートリッジウィング１１４を引き上げて、カートリッジ脚１１０を下部ジョー開口部７６から除外することによって、除去することができる。ステープルカートリッジの近位端が下部ジョー開口部７６から外に持ち上げられると、カートリッジ脚のノッチ１１２（図７）は、ラッチピン１２２との係合から外れて引き出される。ステープルカートリッジ９０の近位端が除外された後、カートリッジはカートリッジチャネル７０から外に遠位に摺動し、かつ破棄することができる。
As shown in FIG. 28, after the
新たなカートリッジ９０は、カートリッジのフランジ遠位端を、下部ジョーカートリッジチャネル７０の遠位端に対して押圧し、かつジョー開口部７６を介してウィング１１４を下部脚１１０まで下に押圧することによって、下部ジョー２４内に充填することができる。カートリッジ脚１１０は、脚ノッチ１１２がラッチピン１２２上にスナップ嵌めされるまで、下部ジョー開口部７６を介して押圧される。ステープルカートリッジ９０の近位端が下に押圧されると、カートリッジ上のロックアウトピン１０６は、リーフバネ２５０の抵抗力に対して、係止ノッチ２２８でメス支持棒２１４を押圧する。ロックアウトピン１０６の力は、メス支持棒のカットアウト２２４を下に、かつガイドブロック中央柱２５６と接触しないで押圧する。メス支持棒２１４が下に押圧されると、支持棒は、支持棒がスロットを遠位に通過し、新たなカートリッジ内に入ることが可能にするように、ガイドブロック中央スロット２２０と整合される。したがって、安全なロックアウト機能は、新たなステープルカートリッジの充填中にリセットされる。新たなカートリッジが充填されると、ステープラは、上部ジョー２２を下部ジョー２４に上に定置し、かつ上部ジョーピン５４を下部ジョー整合スロット５６内に再挿入することによって、再組立てすることができる。ラッチングフック部材１４０は、ピン５４がノッチ１４２内に格納されるまで、スロット５６の開口部の上で枢動し戻される。ピン５４がフック部材ノッチ１４２内に係止され、ラッチング部材３０が下部ジョー２４に対する位置内で枢動すると、ステープラは、閉鎖され、新たなカートリッジからステープルを発射する準備が整う。
The
上述の再利用可能な上部及び下部ジョー、並びにラッチング部材構成要素を、非滅菌パッケージ内でユーザーに提供する。ステープラ２０の組立て前に、構成要素は、ｐＨ中性酵素洗浄剤で洗浄され、次いで、構成要素を滅菌するために加圧蒸気滅菌される。この調節手順は、構成成分の各々のその後の再利用の前にも行われる。アクチュエータモジュール１７０は、その複数の可動構成要素により、モジュールの複雑な洗浄を除去するように、患者への単一使用のために設計される。アクチュエータモジュールは、滅菌場所で開封される、滅菌の使い捨てパッケージでユーザーに提供される。ステープルカートリッジ９０もまた、滅菌場所で開封される、滅菌の使い捨てパッケージとして送達される。
The reusable upper and lower jaws and latching member components described above are provided to the user in a non-sterile package. Prior to assembly of the
ステープラ２０を組立てるためには、アクチュエータモジュール１７０を、そのパッケージから除去され、かつ近位端を、まず下部ジョー部材２４の近位チャネル内に挿入する。アクチュエータモジュール１７０は、近位の戻り止め隆起部１７８が下部ジョー保持機能８６に係合するときに、定置にスナップ嵌めする。次いで、アクチュエータモジュールの遠位端を、下部ジョー２４のチャネル形状枠内に下方に回転する。下部ジョーチャネル内のアクチュエータモジュール１７０を用いて、保護キャップ２３４を、下方に押圧し、キャップリップ２４０を下部ジョー側壁６４ａ、６４ｂ上の圧痕７４内にスナップ嵌めする。保護キャップ２３４を下に押圧することによって、下部ジョー開口部７６を介してガイドブロック中央部分２１２が押圧され、ガイドブロックスロット２１２を下部ジョースロット８２と整合し、かつアクチュエータモジュールを下部ジョー部材２４内の定位置に係止する。アクチュエータモジュール１７０が下部ジョー部材２４内に充填されると、ラッチング部材３０は、上述のとおり、ラッチピン１２２をスロット８２及び２１２内に挿入することによって、下部ジョーに取り付けられる。ラッチング部材３０は、下部ジョー部材２４対して、図１４に示す部分的係止位置まで回転する。この位置において、ラッチング部材３０は、下部ジョー部材２４に取り付けられるが、上部ジョー２２は、下部ジョーから分離可能である。保護キャップ２３４は、図に示すキャップ上の矢印で示すとおり、キャップを遠位方向に移動させることによって、アクチュエータモジュール１７０から除去される。
To assemble the
次に、新たなステープルカートリッジ９０を、上述の方法で、下部ジョーカートリッジチャネル７０内に挿入する。ステープルカートリッジが充填された後、上部ジョー部材２２を、整合スロット５６内に挿入されたピン５４を用いて、下部ジョー部材２４の上に定置する。ラッチング部材３０は、上部及び下部ジョー部材２２、２４に対して枢動し、フック部材カム表面１４４が、ピン５４がスロットから係脱するのを防止するために、整合スロット５６まで開口部の上に延在する、閉鎖前位置（図１５に示す）にステープラを定置する。切断される組織は、アンビル４４とステープルカートリッジ９０との間に定置され、所望位置に調節される。組織停止部５２は、組織がステープラ内の遥か後ろに位置付けられるのを防止する。組織が適切に位置されると、ステープラは、ラッチング部材３０を回転させて、爪部材２４と接触させ、フック部材１４０をスロット５６の上に定置し、かつ係止ピン５４をフック部材ノッチ１４２の内部に定置することによって、発射に向けて閉鎖される。この状態において、組織は、デバイス内で締付られる。更なる組織調整が必要とされる場合、ステープラは、図１６に示すとおり、閉鎖前状態に戻すことができ、そこで、上部及び下部ジョー部材の遠位端は、互いに対してわずかに移動し、組織の再配置を調整することができる。組織がジョー部材との間に適切に締付けられ、ラッチング部材３０が閉鎖動作位置に枢動されると、ステープラは、ノブが停止するまで、ガイドスロット１８６を介してアクチュエータノブ１８２を前方に押圧することによって、発射することができる。ノブが前進すると、締付けられた組織は、ステープルされ、切断される。アクチュエータノブ１８２がその遠位停止部に到達した後、ノブは、ガイドスロット１８６を介して近位に引き戻される。ノブ通路の遠位端で、戻り止めバネ２５２とプッシュブロックノッチ２５４との相互作用は、ノブが完全に後退したという触覚的かつ聴覚的フィードバックを提供し、アクチュエータ構成要素がステープルカートリッジ９０からモジュールパン１７２内に回収され戻されたことをシグナル伝達する。
Next, a
更なるステープリング及び切断工程が手術を完了するのに望ましい場合、ラッチング部材３０は、上部ジョー２２が除去され、使用済みステープルカートリッジが破棄され、かつ新たなステープルカートリッジと交換されるように、枢動して部分的係止状態に戻る。新たなカートリッジが定位置に置かれた後、ラッチング部材３０は、組織が、新たなカートリッジを使用して、再度、位置付けられ、締付けられ、ステープルされるのを可能にするために、枢動して閉鎖前及び閉鎖状態に戻ることができる。すべての必要な組織が切断されると、ラッチング部材３０は、部材を回転して開放状態（図１３に示す）に戻し、かつラッチピン１２２をスロット８２及び２１２から外に摺動させることによって、除去される。次いで、アクチュエータモジュール１７０及びステープルカートリッジ９０は、下部ジョー部材２４から除去され、破棄することができる。残りの構成要素（上部ジョー、下部ジョー、及びラッチング部材）は、再利用に向けて個別の構成成分として洗浄し、かつ滅菌することができる。
If additional stapling and cutting steps are desired to complete the surgery, the latching
本発明において、アクチュエータモジュール１７０は、ステープルカートリッジ９０とは個別の構成成分であり、アクチュエータモジュールを交換せずに、使用済みステープルカートリッジが患者の単一手術中に交換されるのを可能にする。したがって、アクチュエータモジュールは、異なるステープルカートリッジを使用して、同一の患者に複数回使用し得る。単一部品のモジュールパン１７２を、アクチュエータモジュール構成要素の支持構造として使用することによって、アクチュエータモジュールを下部ジョーチャネル内に容易に組立て、かつそこから分解することが可能になる。再利用可能なステープラ構成要素は、部品の再生及び再利用の繰り返しを促進するような簡素な単一部品設計を有する。ラッチング部材の脱着可能な設計は、ステープラの再利用可能な構成要素の容易な分解及び再組立てを促進する。更に、ステープラが組立てられると、ラッチング及び下部ジョー部材の保持及び係止機能は、手術中の不測の分解を予防する。
In the present invention, the
本発明の好ましい実施形態の前述の説明は、例示及び説明の目的で提示してきたものである。これまでの記述は、包括的であることも、開示されたそのままの形態に本発明を限定することも意図しない。以上の教示を考慮すれば、明らかな修正及び変形が可能である。実施形態は、本発明の原理及びその実際的な用途の最良の例示を提供し、それによって当業者が本発明を様々な実施形態で、また企図される特定の用途に適するように様々な修正を行って利用できるように、選択され説明された。本発明の範囲が本明細書に添付される請求項によって画定されることを意図する。 The foregoing description of the preferred embodiment of the present invention has been presented for purposes of illustration and description. The above description is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, modifications and variations are possible in view of the above teachings. The embodiments provide the best illustration of the principles of the invention and its practical application so that those skilled in the art can make various modifications to suit the invention in various embodiments and for the particular application contemplated. Selected and explained to be available. It is intended that the scope of the invention be defined by the claims appended hereto.
〔実施の態様〕
（１） ステープルを組織内に展開するための外科用ステープラであって、
ａ．遠位端、近位端、及びそれらの間の長手方向軸を有する本体であって、前記近位端は、ハンドルを備え、前記遠位端は、ステープルカートリッジチャネル及び対向アンビルを備える、本体と、
ｂ．ステープルを展開するためのアクチュエータモジュールであって、前記アクチュエータモジュールは、前記アンビルに向かってステープルを連続的に放出するための、少なくとも１つの長手方向に移動可能な部材を含み、前記本体に対して、かつそこから、容易に除去可能かつ交換可能である、アクチュエータモジュールと、
を含む、ステープラ。
（２） 複数のステープルを含むステープルカートリッジを更に含み、前記ステープルカートリッジは、前記ステープルカートリッジチャネル内に配設される、実施態様１に記載の外科用ステープラ。
（３） 前記ステープラ本体が、各々、単一部品として形成される上部ジョー部材及び下部ジョー部材を備え、前記上部ジョー部材は、一対の固定ピンを有し、前記下部ジョー部材は、一対の整合スロットを備え、前記上部ジョーピンは、前記ジョー部材を整合するために、前記下部ジョースロット内に挿入される、実施態様２に記載の外科用ステープラ。
（４） 前記ステープラが、前記ステープラの前記長手方向軸に沿った中間位置で、前記上部及び下部ジョー部材を共に接続するためのラッチング部材を更に含み、前記ラッチング部材は、前記上部及び下部ジョー部材に対して移動可能である、実施態様３に記載の外科用ステープラ。
（５） 前記ラッチング部材が、前記ステープラを一連の異なる係止状態に定置するために、前記上部及び下部ジョー部材に対して移動可能である、実施態様４に記載の外科用ステープラ。
（６） 前記ラッチング部材が、閉鎖係止状態において前記ステープラに接続し、かつ開放係止状態において前記ステープラから断絶することができる、単一部品の構成要素として形成される、実施態様５に記載の外科用ステープラ。
（７） 前記ラッチング部材が、ラッチピンを更に備え、前記ラッチピンは、前記ラッチング部材を前記ステープラに接続し、かつ断絶するために、前記ステープラ本体上のスロット内に挿入可能であり、かつそこから除去可能である、実施態様６に記載の外科用ステープラ。
（８） 前記ステープラが、前記上部及び下部ジョー部材に対して、前記異なる係止状態において前記ラッチング部材を保持するために、前記ステープラ本体上に保持手段を更に備える、実施態様７に記載の外科用ステープラ。
（９） 前記ラッチング部材が、単一部品の構成要素であり、前記上部ジョー部材、前記下部ジョー部材、及び前記ラッチング部材は、異なる患者の手術における再利用のために、前記ステープラから分解可能であり、かつ個々に再生することができる、実施態様６に記載の外科用ステープラ。
（１０） 前記保持手段が、閉鎖前係止状態において前記ラッチング部材を把持することができ、前記閉鎖前係止状態では、前記上部ジョーピンが前記下部ジョースロットから係脱するのを防止するが、前記ステープルカートリッジは、前記アンビルに対して移動することができる、実施態様８に記載の外科用ステープラ。
Embodiment
(1) A surgical stapler for deploying staples in tissue,
a. A body having a distal end, a proximal end, and a longitudinal axis therebetween, the proximal end comprising a handle, and the distal end comprising a staple cartridge channel and an opposing anvil; and ,
b. An actuator module for deploying staples, the actuator module including at least one longitudinally movable member for continuously releasing staples toward the anvil, with respect to the body And from there an actuator module that is easily removable and replaceable;
Including stapler.
(2) The surgical stapler according to embodiment 1, further comprising a staple cartridge including a plurality of staples, wherein the staple cartridge is disposed in the staple cartridge channel.
(3) The stapler body includes an upper jaw member and a lower jaw member each formed as a single component, the upper jaw member has a pair of fixing pins, and the lower jaw member is a pair of alignments. The surgical stapler according to embodiment 2, comprising a slot, wherein the upper jaw pin is inserted into the lower jaw slot to align the jaw members.
(4) The stapler further includes a latching member for connecting the upper and lower jaw members together at an intermediate position along the longitudinal axis of the stapler, and the latching member includes the upper and lower jaw members. The surgical stapler according to embodiment 3, wherein the surgical stapler is movable with respect to.
5. The surgical stapler according to
6. The latching member of claim 5, wherein the latching member is formed as a single-piece component that can be connected to the stapler in the closed locked state and can be disconnected from the stapler in the open locked state. Surgical stapler.
(7) The latching member further comprises a latch pin, the latch pin being insertable into and removed from the slot on the stapler body to connect and disconnect the latching member to the stapler. Embodiment 7. The surgical stapler according to embodiment 6, which is possible.
(8) The surgery according to embodiment 7, wherein the stapler further comprises holding means on the stapler body to hold the latching member in the different locked states with respect to the upper and lower jaw members. Stapler.
(9) The latching member is a single piece component, and the upper jaw member, the lower jaw member, and the latching member are separable from the stapler for reuse in different patient procedures. Embodiment 7. The surgical stapler of embodiment 6, wherein the surgical stapler is and can be individually regenerated.
(10) The holding means can grip the latching member in the locked state before closing, and in the locked state before closing, the upper jaw pin is prevented from being disengaged from the lower jaw slot. The surgical stapler according to embodiment 8, wherein the staple cartridge is movable relative to the anvil.
（１１） 前記保持手段が、部分的に係止された状態にある前記ラッチング部材を把持することができ、前記部分的に係止された状態では、前記ラッチング部材が前記下部ジョー部材に接続されるが、前記上部ジョーピンは、前記上部及び下部ジョー部材が分離するのを可能にするために、前記下部ジョースロットから係脱することができる、実施態様８に記載の外科用ステープラ。
（１２） 前記ラッチング部材が、前記下部ジョー部材の対向する側壁に対して移動可能なフックラッチ部材を更に備え、前記フックラッチ部材は、閉鎖係止状態にある前記上部ジョーピンを係合して、動作位置において前記上部及び下部ジョー部材を共に固定する、実施態様８に記載の外科用ステープラ。
（１３） 前記アクチュエータモジュールが、前記モジュールの実装及び前記ステープラ本体からの除去を促進するための構造を更に備える、実施態様７に記載の外科用ステープラ。
（１４） 前記アクチュエータモジュール構造が、前記少なくとも１つの長手方向に移動可能な部材を把持する、チャネル形状のパンを備え、前記パンは、前記長手方向に移動可能な部材が前記パンと前記ステープルカートリッジとの間を移動するのを可能にするように、前記下部ジョー部材のチャネル形状枠内に挿入可能であり、かつそこから除去可能である、実施態様１３に記載の外科用ステープラ。
（１５） 前記アクチュエータモジュールが、前記長手方向のステープラの軸に沿った前記ステープラ本体開口部と整合した開口部を更に備え、前記ラッチピンは、前記ピンが、前記ステープラ本体内の前記アクチュエータモジュールを把持するように前記ステープラ本体に接続されるときに、前記アクチュエータモジュール開口部内に挿入可能であり、かつそこから除去可能である、実施態様１４に記載の外科用ステープラ。
（１６） 前記アクチュエータモジュールに対してステープルカートリッジを前記ステープラ本体に接続し、かつ断絶するための構造を更に備え、複数のステープルカートリッジが、前記ステープラ本体内の単一のアクチュエータモジュールと共に使用され得る、実施態様１５に記載の外科用ステープラ。
（１７） 前記長手方向に移動可能な部材が、切断部材及び一対のステープル作動棒を備え、前記アクチュエータモジュールは、前記切断部材及びステープル作動棒を、前記アクチュエータモジュールと前記ステープルカートリッジとの間の往復運動のためにステープルカートリッジと整合するための誘導手段を更に含む、実施態様１６に記載の外科用ステープラ。
（１８） ステープルを組織内に展開するための外科用ステープラであって、
ａ．ハンドルを備える近位端と、アンビルを備える遠位端とを有する上部ジョー部材と、
ｂ．近位のチャネル形状枠と、ステープルカートリッジチャネルを備える遠位端とを有する下部ジョー部材と、
ｃ．ステープルを展開するためのアクチュエータモジュールであって、前記アンビルに向かってステープルを連続的に放出するための少なくとも１つの長手方向に移動可能な部材を含み、前記下部ジョーチャネルに対して、かつそこから容易に除去可能かつ交換可能である、アクチュエータモジュールと、
ｄ．前記ステープルカートリッジチャネル内に配設された複数のステープルを含むステープルカートリッジと、
ｅ．前記ステープラの長手方向軸に沿った中間位置で前記上部及び下部ジョー部材を共に接続するためのラッチング部材であって、一連の異なる係止状態において前記ステープラを定置するために、前記上部及び下部ジョー部材に対して移動可能である、ラッチング部材と、
を備える、ステープラ。
（１９） 前記上部ジョー部材、前記下部ジョー部材、及び前記ラッチング部材が、異なる組織ステープリング手術において再利用するために、前記ステープラから分解され、個々に再生され、かつその後に再組立てされることができる単一部品の構成要素である、実施態様１８に記載の外科用ステープラ。
（２０） 前記ラッチング部材を前記異なる係止状態のうちの１つ以上において前記下部ジョー部材に把持するための前記ラッチング部材上の保持手段を更に備える、実施態様１８に記載の外科用ステープラ。
(11) The holding means can grip the latching member in a partially locked state, and in the partially locked state, the latching member is connected to the lower jaw member. 9. The surgical stapler according to embodiment 8, wherein the upper jaw pin can be disengaged from the lower jaw slot to allow the upper and lower jaw members to separate.
(12) The latching member further includes a hook latch member movable with respect to the opposing side wall of the lower jaw member, and the hook latch member engages the upper jaw pin in a closed locking state, The surgical stapler according to embodiment 8, wherein the upper and lower jaw members are secured together in an operating position.
(13) The surgical stapler according to embodiment 7, wherein the actuator module further comprises a structure for facilitating mounting and removal of the module from the stapler body.
(14) The actuator module structure includes a channel-shaped pan that grips the at least one longitudinally movable member, and the pan has the longitudinally movable member as the pan and the staple cartridge. The surgical stapler according to embodiment 13, wherein the surgical stapler is insertable into and removable from a channel-shaped frame of the lower jaw member so as to allow movement there between.
(15) The actuator module further includes an opening aligned with the stapler body opening along the longitudinal axis of the stapler, the latch pin holding the actuator module in the stapler body. Embodiment 15. The surgical stapler of embodiment 14, wherein the surgical stapler is insertable into and removable from the actuator module opening when connected to the stapler body.
(16) The apparatus further comprises a structure for connecting and disconnecting a staple cartridge to the stapler body with respect to the actuator module, and a plurality of staple cartridges can be used with a single actuator module in the stapler body. The surgical stapler according to embodiment 15.
(17) The longitudinally movable member includes a cutting member and a pair of staple actuating bars, and the actuator module reciprocates the cutting member and the staple actuating bar between the actuator module and the staple cartridge. The surgical stapler according to embodiment 16, further comprising guide means for aligning with the staple cartridge for movement.
(18) A surgical stapler for deploying staples in tissue,
a. An upper jaw member having a proximal end with a handle and a distal end with an anvil;
b. A lower jaw member having a proximal channel-shaped frame and a distal end comprising a staple cartridge channel;
c. An actuator module for deploying staples, comprising at least one longitudinally movable member for continuously releasing staples toward the anvil, with respect to and from the lower jaw channel An actuator module that is easily removable and replaceable;
d. A staple cartridge comprising a plurality of staples disposed within the staple cartridge channel;
e. A latching member for connecting the upper and lower jaw members together at an intermediate position along the longitudinal axis of the stapler, the upper and lower jaws for placing the stapler in a series of different locking states A latching member movable relative to the member;
A stapler.
(19) The upper jaw member, the lower jaw member, and the latching member are disassembled from the stapler, individually regenerated, and then reassembled for reuse in different tissue stapling procedures.
The surgical stapler according to claim 18, further comprising holding means on the latching member for gripping the latching member to the lower jaw member in one or more of the different locking states.
（２１） 前記ラッチング部材は、前記上部及び下部ジョー部材に対し、組立てのための初期開放状態にあり、使用中に前記ラッチング部材が前記上部及び下部ジョー部材から係脱するのを防止するために前記ステープラの動作前に、前記ジョー部材に対して閉鎖係止状態に移動する、実施態様１８に記載の外科用ステープラ。
(21) The latching member is in an initial open state for assembly with respect to the upper and lower jaw members, and prevents the latching member from being detached from the upper and lower jaw members during use.
Claims (10)
ａ．遠位端、近位端、及びそれらの間の長手方向軸を有する本体であって、前記近位端は、ハンドルを備え、前記遠位端は、ステープルカートリッジチャネル及び対向アンビルを備える、本体と、
ｂ．ステープルを展開するためのアクチュエータモジュールであって、前記アクチュエータモジュールは、前記アンビルに向かってステープルを連続的に放出するための、少なくとも１つの長手方向に移動可能な部材を含み、前記本体に対して、かつそこから、容易に除去可能かつ交換可能である、アクチュエータモジュールと、
を含む、ステープラ。 A surgical stapler for deploying staples into tissue,
a. A body having a distal end, a proximal end, and a longitudinal axis therebetween, the proximal end comprising a handle, and the distal end comprising a staple cartridge channel and an opposing anvil; and ,
b. An actuator module for deploying staples, the actuator module including at least one longitudinally movable member for continuously releasing staples toward the anvil, with respect to the body And from there an actuator module that is easily removable and replaceable;
Including stapler.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12/137,571 | 2008-06-12 | ||
| US12/137,571 US20090308907A1 (en) | 2008-06-12 | 2008-06-12 | Partially reusable surgical stapler |
| PCT/US2009/047009 WO2009152307A1 (en) | 2008-06-12 | 2009-06-11 | A partially reusable surgical stapler |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2011524199A true JP2011524199A (en) | 2011-09-01 |
| JP5512663B2 JP5512663B2 (en) | 2014-06-04 |
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ID=44693540
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011513683A Active JP5512663B2 (en) | 2008-06-12 | 2009-06-11 | Partially reusable surgical stapler |
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| Country | Link |
|---|---|
| JP (1) | JP5512663B2 (en) |
| BR (1) | BRPI0915375B8 (en) |
| RU (1) | RU2500360C2 (en) |
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| Publication number | Publication date |
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| RU2011100173A (en) | 2012-07-20 |
| JP5512663B2 (en) | 2014-06-04 |
| BRPI0915375A2 (en) | 2015-11-03 |
| BRPI0915375B1 (en) | 2019-09-10 |
| BRPI0915375B8 (en) | 2021-06-22 |
| RU2500360C2 (en) | 2013-12-10 |
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