JP2011120929A - 輪状吻合を実施するための外科用ステープルデバイス - Google Patents
輪状吻合を実施するための外科用ステープルデバイス Download PDFInfo
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Abstract
【解決手段】外科用ステープルデバイス10であって、ハンドル部分12;該ハンドル部分から遠位に伸延する細長体部分14;アンビルアセンブリ30および複数のステープルを収容するシェルアセンブリ31を備えるヘッド部分16であって、該アンビルアセンブリは細長体部分の間隙部分と細長体部分接近部分との間で該シェルアセンブリに関して移動可能である、ヘッド部分;該アンビルアセンブリに解放可能に係合するアンビル保持具を備える接近機構;および該アンビル保持具によってスライド可能に支持されるトローカルを備える収縮可能トロカールアセンブリであって、該アンビル保持具中に位置付けられるトロカール収縮部分の間で、該アンビル保持具から伸延する前進部分まで移動可能である、収縮可能トロカールアセンブリを備える外科用ステープルデバイス、を提供する。
【選択図】図1
Description
(1.技術分野)
本開示は一般に、身体組織に外科用ステープルを適用するための外科用ステープルデバイスに関する。より詳細には、本開示は、中空組織器官の輪状吻合を実施するための外科用ステープルデバイスに関する。
吻合は、別個の中空器官部分が互いに連絡するためのこれらの部分の外科用連結である。代表的には、吻合手順は、中空組織の疾患部分または欠陥部分が除去され、そして残りの末端部分が連結される手術に続く。所望の吻合手順に依存して、これらの末端部分は、輪状、末端と側面、または側面と側面の器官再構築方法のいずれかによって連結され得る。
本開示によると、輪状吻合を実施するための外科用ステープルデバイスが開示される。この外科用ステープルデバイスは、ハンドル部分、細長本体部分ならびにアンビルアセンブリおよびシェルアセンブリを含むヘッド部分を備える。このハンドル部分は、アンビルアセンブリおよびシェルアセンブリを接近させるための回転可能な接近ノブ、ならびにこのシェルアセンブリ内に配置されたステープルを発射するために発射機構を作動するための発射トリガーを備える。この発射トリガーは、この発射機構を作動するために設けられた二棒リンク機構(two bar linkage)の1つのリンクを形成する。この二棒リンク機構は、デバイスを発射するのに必要な発射力を減少するという改良された機械的利点を有するデバイスを提供する。
(項目1)
外科用ステープルデバイスであって、以下:
ハンドル部分;
該ハンドル部分から遠位に伸延する細長体部分;
アンビルアセンブリおよび複数のステープルを収容するシェルアセンブリを備えるヘッド部分であって、該アンビルアセンブリは細長体部分の間隙部分と細長体部分接近部分との間で該シェルアセンブリに関して移動可能である、ヘッド部分;
該アンビルアセンブリに解放可能に係合するアンビル保持具を備える接近機構;および
該アンビル保持具によってスライド可能に支持されるトローカルを備える収縮可能トロカールアセンブリであって、該アンビル保持具中に位置付けられるトロカール収縮部分の間で、該アンビル保持具から伸延する前進部分まで移動可能である、収縮可能トロカールアセンブリ
を備える、外科用ステープルデバイス。
(項目2)
前記ハンドル部分が、該アンビル保持具に作動可能に接続された接近アクチュエーターを備え、該接近アクチュエーターは、前記細長体部分間隙部分と細長体部分接近部分との間で前記アンビルアセンブリおよびシェルアセンブリを移動するために移動可能である、項目1に記載の外科用ステープルデバイス。
(項目3)
項目2に記載の外科用ステープルデバイスであって、ここで、前記ハンドル部分が発射トリガーを備え、そして前記シェルアセンブリはプッシャーを備え、該発射トリガーは、該プッシャーに作動可能に接続されており、該発射トリガーの発動作用によって、前記シェルアセンブリ中での該プッシャーの移動がもたらされ、該シェルアセンブリからステープルを射出する、外科用ステープルデバイス。
(項目4)
前記収縮可能トロカールアセンブリは、前記トロカールに固定され、かつ前記伸長位置にトロカールを保持するために位置付けられるた係合部材を備える、項目1に記載の外科用ステープルデバイス。
(項目5)
前記係合部材が、前記アンビル保持具の輪状エッジを係合して、前記トロカールを前記伸長位置に保持するためのショルダーを有する少なくとも1つの弾性脚を備える、項目4に記載の外科用ステープルデバイス。
(項目6)
前記トロカールが、該トロカールの長さの少なくとも一部分にそって伸延するスロットを備え、該スロットは、前記係合部材を受けるように配置され、かつ寸法決めされる、項目5に記載の外科用ステープルデバイス。
(項目7)
前記アンビルアセンブリが、穴がその中に形成されるセンターロッドを備え、該穴は、該アンビル保持具を該アンビルアセンブリに結合する間に、該アンビル保持具の中で前記トロカールアセンブリの周りに位置付けられるために寸法決めされ、該トロカールが残基収縮位置まで移動される、項目6に記載の外科用ステープルデバイス。
(項目8)
前記アンビル保持具が、前記アンビルアセンブリのセンターロッドに解放可能に係合する位置付けられる複数の可撓性脚部を備える、項目7に記載の外科用ステープルデバイス。(項目9)
前記アンビル保持具が、前記アンビルアセンブリの前記センターロッドに解放可能に係合する位置付けられる複数の可撓性脚部を備える、項目1に記載の外科用ステープルデバイス。
(項目10)
項目9に記載の外科用ステープルデバイスであって、該デバイスは、前記アンビル保持具の周りにスライド可能に位置付けられるロックアウトチューブを備え、該ロックアウトチューブは、前記アンビルアセンブリおよび前記シェルアセンブリの近接の間で、該アンビル保持具の可撓性脚部の周囲に位置付けられ、細長体部分該アンビル保持具によるアンビルアセンブルからの該アンビルアセンブリの不慮の脱係合を防ぐ、外科用ステープルデバイス。
(項目11)
項目1に記載の外科用ステープルデバイスであって、インジケーターセンブリをさらに備え、該インジケーターセンブリは前記ハンドル部分に支持されたインジケーターを備え、該インジケーターは、前記アンビルと作動可能に結合して、前記アンビルアセンブリが前記アンビル保持具に結合しているか否かを識別する視覚的な指標を提供する、外科用ステープルデバイス。
(項目12)
項目11に記載の外科用ステープルデバイスであって、前記アンビルアセンブリがセンターロッドを備え、該センターロッドは、前記アンビル保持具に対する前記アセンブリの結合の間、前記収縮可能アセンブリと係合するように配置されて、トロカールを前記伸長位置から前記収縮位置へと移動させる、外科用ステープルデバイス。
(項目13)
項目11に記載の外科用ステープルデバイスであって、前記トロカールが前記インジケーターセンブリに作動可能に接続しており、その結果、前記伸長位置と収縮位置との間の該トロカールの移動によって、該インジケーターの移動がもたらされる、外科用ステープルデバイス。
(項目14)
前記細長体部分を通って伸延したワイヤーによって、前記トロカールが前記インジケーターに作動可能に接続している、項目13に記載の外科用ステープルデバイス。
(項目15)
外科用デバイスであって、以下:
ハンドル部分;
該ハンドル部分から遠位に伸延する本体部分;
細長体部分アンビルアセンブリおよびシェルアセンブリを備えるヘッド部分であって、該アンビルアセンブリは細長体部分間隙部分と細長体部分接近部分との間で該シェルアセンブリに対して移動可能である、ヘッド部分;
該アンビルアセンブリに解放可能に係合するように配置されるアンビル保持具を備える接近機構;ならびに
該ハンドル部分によって支持され、そして発射準備位置と発射非準備位置との間で移動可能であるインジケーター部材を備えるインジケーターセンブリであって、該インジケーターは、該アンビルアセンブリと作動可能に結合し、その結果、該インジケーター部材は、アンビルアセンブリが取り付けられない限り、該アンビル保持具に該発射可能位置まで移動しない、
外科用ステープルデバイス。
(項目16)
項目15に記載の外科用ステープルデバイスであって、前記アンビル保持具によって支持される移動可能なセンサーをさらに備え、該センサーは、該アンビル保持具との該アンビルアセンブリの係合および脱係合の間に、該アンビルアセンブリに係合するように位置付けられる、外科用ステープルデバイス。
(項目17)
前記センサーが伸長コネクターによって前記インジケーターセンブリと接続されている、項目16に記載の外科用ステープルデバイス。
(項目18)
項目17に記載の外科用ステープルデバイスであって、前記インジケーターセンブリが、回転可能ディスクを備え、前記伸長コネクターが該回転可能ディスクと前記センサーとの間で接続され、その結果、該センサーの移動によって、該回転可能ディスクの回転がもたらされる、外科用ステープルデバイス。
(項目19)
項目18に記載の外科用ステープルデバイスであって、ここで、前記接近機構がネジ部材を備え、該ネジ部材は、前記アンビル保持具に作動可能に接続し、そして、接続アクチュエーターの回転に応答して、前記ハンドル部分内を軸方向に移動可能である、外科用ステープルデバイス。
(項目20)
項目19に記載の外科用ステープルデバイスであって、ここで、前記旋回可能なディスクは、前記インジケーターで形成されたカムスロットにおいてスライド可能に受け入れられるように配置された突出部を備え、該ディスクは前記ネジとともに移動可能であって、前記アンビルアセンブリと前記シェルアセンブリとの接近の間に、該インジケーターの移動を与え、該デバイスが接近したか否かを識別する指標を提供する、外科用ステープルデバイス。
(項目21)
輪状外科用ステープルデバイスの伸長中空シャフトにおける用途のためのプッシャーリンクであって、該ステープルデバイスは、以下:
伸長プッシャーリンクであって、長手軸、近位端、遠位端、それのそれぞれの近位端および遠位端に隣接する輪状部分、ならびに該輪状部分の間であり、そして該輪状部分に接続する伸長中間部分を有する、伸長プッシャーリンク;
該プッシャーリンクの近位端に近位に位置付けられ、そして、該近位端に接続される、発射アクチュエーター;
該プッシャーリンクの遠位端に作動可能に結合するシェルアセンブリであって、該シェルアセンブリは、複数のステープルを収容し、かつアンビルアセンブリに接続可能な伸長部材を有している、シェルアセンブリ;
該プッシャーリンクを収容するための伸長穴を有する、伸長管シャフト、および
該管シャフト中で、該管シャフトの直径に沿って収容された、一対の伸長した実質的に平坦な伸長部材;
を備え、
ここで、該プッシャーリンクの中間部分の一部分は、該プッシャーリンクの長手軸を横切る垂直切片で見た場合にU字形状の構成を有し、該U字形状の構成は、実質的に平坦な底壁を備え、該底壁は、管シャフトの直径に平行であって、該管シャフトの直径の一方の側に配置され、そして、該管シャフトの直径に隣接し、該底壁の各端は、該直径を横断して、かつ該管シャフトの穴の内面の一部分にそって隣接する直立した側壁を有し、該底壁は該管シャフトの穴の半径の半分よりも小さい厚さを有する、プッシャーリンク。
(項目22)
前記伸長部材は、前記プッシャーリンクの底面壁に隣接する前記管シャフトの直径に沿って配置される、項目21に記載のプッシャーリンク。
本発明により開示される外科用ステープルデバイスの好ましい実施形態は、本明細書中で、図面を参照して詳細に記載され、ここで、同様の参照番号は、いくつかの図面の各々において、同一の要素または対応する要素を示す。
図7〜14を参照して、接近機構は、接近ノブ22、回転可能なスリーブ33(図14)、ネジ32、それぞれ、第一のネジ外延34および第二のネジ外延36(図9)、ならびにアンビル保持具アセンブリ38(図10)を備える。回転可能なスリーブ33は、小さい直径の円筒型中空本体部分40および大きい直径の中空本体部分42を備える。本体部分40および42は、センターボア33aを規定する。本体部分42は、静止ハンドル18の内壁上に形成された内側に伸びる輪状フランジ46を受容するように寸法決めされた、輪状溝44を備える(図7)。溝44とフランジ46との間の係合は、比較的回転可能にしたままで、静止ハンドル18内のスリーブ30を軸方向に固定する。回転可能スリーブ33の中空本体部分40の近位末端は、静止ハンドル18の近位末端に形成される開口部を通って伸び、そして正反対に伸びたリブ48を備える。接近ノブ22は、キャップ22aおよび本体22bを備え、これらは、スリーブ30のリブ48を受容するように構成された正反対に伸びたスロット49aを有するボア49を規定し、その結果、ノブ22の回転は、スリーブ30の同時回転をもたらす。
図7〜9を参照して、発射機構は、発射トリガー20、発射リンク72および伸長プッシャーリンク74を備える。発射トリガー20は、本体部分76およびトリガーカバー80を備える。好ましくはネオプレンまたはゴムによって形成されたクッション性グリップ表面82が、トリガーカバー80上に提供される。クッション性グリップ表面19は、滑らないクッション性表面を提供して、デバイス10の作動を、外科医にとってより快適なものにする。トリガー20の本体部分76は、旋回部材84によって、プッシャーリンク74の近位末端に固定された連結部材86に旋回可能に接続される。連結部材86は、プッシャーリンク74と一体形成され得るか、またはプッシャーリンク74に固定された別個の要素として形成され得る。発射リンク72は、旋回部材87によってトリガー20の本体部分76に旋回可能に固定された第一末端、および旋回部材79によって、静止ハンドル18の静止ハンドルの半分区画18aおよび18bとの間に形成された垂直スロット82内に旋回可能に固定された第二末端を有する。旋回部材79は、スロット82内を垂直に移動するように、フリーである。バネ82aは、ハンドル18内に支持されて、スロット82の底に向けて下側へ、旋回部材79を推進する。本体部分76は、アバットメント89およびアバットメント91を含む1対のアバットメントをさらに備え、これらは、デバイス10が接近する前およびデバイス10が発射した後に、トリガー20の作動を防止するために、以下により詳細に記載される様式で、トリガーロック26の遠位末端に係合するように位置づけられる。突出部93はまた、発射トリガー20の本体部分76上に形成され、そして以下に記載されるように、外科用ステープルデバイス10の発射ロックアウト機構のトリガーロック戻し機構を起動するように構成される。
図15〜16Aを参照して、アンビルアセンブリ30は、アンビルヘッドアセンブリ120およびアンビルセンターロッドアセンブリ152を備える。アンビルヘッドアセンブリ120は、ポスト122、アンビルヘッド124、バックアッププレート126、切断リング128およびアンビル129を備える。アンビルヘッド124は、内側管状レセス134および外側管状レセス136を備える。ポスト122は、アンビルヘッド124の内側管状レセス134内の中心に配置される。アンビル129は、管状レセス136内のアンビルヘッド124上に支持され、そしてステープルを受容しそして変形させるための複数のポケット140を備える。バックアッププレート126は、中心開口126bを備え、この中心開口は、ポスト122と管状レセス136との間に規定されるレセス134内のポスト122の周りに配置される。バックアップリング126は、高くなったプラットフォーム126aを備える。切断環128は、プラットフォーム126aと実質的に同じ構成を有する開口128aを備える。開口128aは、プラットフォームの周りに配置されて、バックアップリング126上に切断環128aを回転可能に固定する。好ましくは、切断環128は、ポリエチレンから形成され、そして例えば、接着剤を使用してバックアッププレート126に固定的に固定される。バックアップ環126は、好ましくは、金属から形成される。あるいは、構築のための他の材料は、プレート126および環128を構築するために使用され得る。切断環126およびバックアッププレート148は、ポスト122の周りにスライド可能に取り付けられる。バックアッププレート126は、一対の内向きに伸長するタブ150を備え、これは、以下にさらに詳細に記載される。
図9を参照して、シェルアセンブリ31は、シェル182、プッシャーバック186、円筒形ナイフ188、およびステープルガイド192を備える。シェル182は、外側ハウジング部分194および内側ガイド部分196を備える。外側ハウジング部分194は、遠位円筒形セクション200、中心円錐セクション202および近位小直径円筒形セクション204を有するスルーボア198を規定する。複数の開口206が、円錐セクション202に形成される。開口206は、このデバイスの操作の間、流体および組織の通過を可能にするような寸法である。一対の直径方向で対向する可撓性係合部材207は、シェル182の近位円筒形セクション204上に形成される。係合部材207は、細長本体14の遠位端上に形成される開口209に受容されるように位置づけられて、シェル182を細長本体14に固定する。一対の開口211は、外側チューブ14aの近位端内に形成される。開口211は、固定ハンドル18の内壁に形成される突出部(図示せず)を受容するような寸法であり、ハンドル部分12へのチューブ14aの装着を容易にする。
図11〜13を参照して、カム調節部材400は、側壁306aに形成されるレセス306b内で、ネジストップ306の側壁306a上に固定ネジ312によって固定される。カム調節部材400は、スルーボア404を有する円形ディスク402を備える。スルーボア404は、スルーディスク402を通って偏心的に形成され、そして固定ネジ312を受容するような寸法である。より小さなノッチまたはホール406もまた、ディスク402に形成される。ノッチ406は、調節ツール(図示せず)の先端を受容するような寸法である。レセス306b(図11A)は、前ショルダーおよび後ろショルダーまたはアバット表面306cおよび306dをそれぞれ備え、そしてディスク402の外側縁部が前ショルダーおよび後ろショルダー306cおよび306dに接するように、ディスク402を受容する寸法である。
図9および10を参照して、ステープルデバイス10は、アンビル保持具38内にスライド可能に配置される、収縮可能トロカールアセンブリを備える。この収縮可能トロカールアセンブリは、トロカールアセンブリ240および係合部材242を備える。係合部材242は、示されるように、バネクリップの形態であり得る。あるいは、他の係合部材(例えば、バネ装填突出など)が想定される。トロカールアセンブリ240は、トロカール本体240aおよびトロカール先端240bを備える。トロカール本体240aは、トロカール本体240aを通って、その長さの一部に沿って伸長するスロット244を有する。スロット244は、係合部材242を受容するような寸法である。トロカール先端240bは、例えば、ネジ山を使用して、トロカール本体240aに固定される。あるいは、他の締め付け技術を使用して、トロカール先端240bをトロカール本体240aに固定し得る。トロカール先端240aが丸いかまたは鈍く示されるが、他の先端構成が想定される。トロカール先端240bは、トロカールが組織をアンビル保持具38の上で傾けるために組織を通して押される場合、変形する(すなわち、真っ直ぐになる)一対の弾性レッグ240cを備える。レッグ240cを提供することによって、組織は、使用の間、アンビル保持具38上に捕捉される可能性が少ない。
図9および図10に再び戻って、円筒形ロックアウトチューブ270が、アンビル保持具38の外面の周りにスライド可能に位置づけられ、そしてシェル182の内側ガイド部分196およびプッシャーバック186の中心ボア208を通って伸長するように位置づけられる。ロックアウトチューブ270の近位端は、管状フランジ272を備える。円筒形フィッティング273は、プッシャーバック186のボア208の近位端においてロックアウトチューブ270の近位端の周りに固定される。付勢部材187は、フランジ272と係合し、そしてロックアウトチューブ270を、フランジ272がフィッティング273と係合する位置へと遠位に押しやる(図20D)。付勢部材187は、好ましくは、ロックアウトチューブ270のフランジ272とプッシャーリンク74内に形成されるアバットメントとの間で圧縮して位置づけられるねじれバネ(torsion spring)である。
図7、8、および11〜13を参照して、インジケーターアセンブリは、固定ハンドル18内に取り付けられ、そしてその上に形成される係合部材501および印(indicia)(「図示せず)を有するインジケータープレート500を備える。印は、好ましくは、着色ドットの形態であり、これは、デバイス10が発射準備状態であるか否かを同定する。例えば、緑色ドットは、発射準備位置を示し得、そして赤色ドットは、発射準備位置にないことを示し得る。あるいは、他の形態の印が使用され得、これには、グラフィック印、書かれた印または数字の印が挙げられる。インジケータープレート500は、固定ハンドル18内にスライド可能に配置され、その結果、その印は、インジケーター開口24を通して見ることができる。付勢部材502、好ましくは、コイルバネは、一端において固定ハンドル18の内壁に固定され、そして他端において、インジケータープレート500に固定される。付勢部材502は、張力下で配置されて、インジケータープレート500を、固定ハンドル18内のその最も前の位置に押しやる。
図8、図14、図17および図18を参照して、トリガーロック26(図1および8)、安全ブラケット520、ロックアウトスリーブ522および圧縮部材523を備える、発射ロックアウトアセンブリが提供される。安全ブラケット520は、前カラー部分524、細長スロット528を有する本体部分526および後ろC型部分530を備える。前カラー部分524は、回転可能スリーブ30の本体部分42の前に隣接して、ネジ32の近位端の周りに配置される。圧縮部材523は、複数のフィン532を備え、これらのフィンは、管状チャネル534を部分的に規定する。C型部分530は、圧縮部材523の管状チャネル534内に配置される。付勢部材536(好ましくは、コイルバネ)は、圧縮部材523の後ろの固定ハンドル18に配置されて、圧縮部材523および安全ブラケット520を、固定ハンドル18内で前に押しやる。
図8、8A、8B、および11を参照すると、触覚インジケーター580は、ステーショナリーハンドル18内に位置付けられ、そして収縮位置と伸長位置との間の垂直方向スロット582内に移動可能である。触覚インジケーター580は、隆起部580aを備え、この隆起部580aは、スロット582に形成された2つの凹部582aおよび582bの1つの中に受容されるように構成される。伸長位置において、触覚インジケーター580は、チルトアンビルアセンブリを傾けるのに十分な細長体部分離れた位置(position of unapproximation)で、ネジストップ306上に形成されたウィング584を係合するように位置付けられる。デバイス10を発射する前に、触覚インジケーター580は、凹部582a内に位置付けられた隆起部580aと共に収縮位置にある。デバイス10が発射される場合、発射リンク72上に形成されたアバットメント表面588(図8)は、インジケーター580を係合して、インジケーター580を伸長位置に動かし、その結果、隆起部580aは、凹部582a内に位置付けられる。デバイス10が、アンビルヘッドを旋回させるのに十分な距離に離れている場合、ネジストップ306のウィング584は、インジケーター580を係合して、このような離れた地点に到達したという、可聴指標および/または触覚指標を提供する。その後、外科医は、患者からこのデバイスを取り出し得る。アンビル保持具からアンビルアセンブリを取り出すために、これが患者から取り出された後、外科医は、伸長位置から収縮位置に触覚インジケーター580を進めるのに十分な力を接近ノブ22にさらに提供することにとり、このデバイスをさらに接近させない必要がある。
フランジリンク672の末端694に向かってセイフティーリンク692を偏らせる。発射リンクの本体部分692aは、弱い部分699を備える。弱い部分699の目的は、以下に詳細に記載される。
外科用ステープルデバイス610を使用して、円形吻合を実施する。代表的に、円形吻合は、結腸または腸管のような疾患した脈管の一部を除去するための手順の間に必要とされる。このような手順の間、疾患した脈管の一部が除去され、そして残りの脈管セクションの末端部分が、外科用ステープルデバイスを使用して共に結合される。
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