JP4898888B2 - 外科手術用ステープリングデバイス - Google Patents
外科手術用ステープリングデバイス Download PDFInfo
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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
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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
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
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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
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B17/1155—Circular staplers comprising a plurality of staples
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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
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00371—Multiple actuation, e.g. pushing of two buttons, or two working tips becoming operational
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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
- A61B2017/07214—Stapler heads
- A61B2017/07257—Stapler heads characterised by its anvil
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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
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2901—Details of shaft
- A61B2017/2905—Details of shaft flexible
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- A—HUMAN NECESSITIES
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/361—Image-producing devices, e.g. surgical cameras
- A61B2090/3616—Magnifying glass
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Description
1.技術分野
本発明の開示事項は、一般に、外科手術用のステープルを人体組織に適用するための外科手術用ステープリングデバイスに関する。詳細には、本発明の開示事項は、中空組織器官の円形吻合実施するのに適する外科手術用ステープリングデバイスに関する。
吻合は、別個の中空組織部分を外科手術で結合することである。一般に、吻合手順は、中空組織の罹患または欠陥部分を除去して、残存端部部分を結合する外科手術に従う。所望の吻合手順に応じて、端部部分は、円形、端部−側部または側部−側部器官の再構築法により結合される。
本発明の開示事項により、外科手術用ステープリングデバイスは、好ましくは円形吻合を行なうために開示する。外科手術用ステープリングデバイスは、ハンドル部分または組立体、本体部分、並びにアンビル組立体およびシェル組立体を備えるヘッド部分を備える。ハンドル部分は、アンビルおよびシェル組立体を接近させるための回転可能な接近ノブと、シェル組立体内に配置されたステープルを取り出すための発射機構を作動させるための発射トリガとを備える。発射トリガは、好ましくは、発射機構を作動させるために設けられた2バーリンケージの1個のリンクを形成する。2バーリンケージは、デバイスを発射するのに要する発射力を減少させるという改善された機械的利益をデバイスに提供する。
(項目1)
外科手術用ステープリングデバイスであって、
発射トリガを含むハンドル組立体と、
該ハンドル組立体から遠位に延在する本体部分と、
アンビル組立体およびシェル組立体を備えるヘッド部分であって、該アンビル組立体が該シェル組立体に対して、離間位置と接近位置との間で移動可能なヘッド部分と、
該ハンドル組立体上に配置され、球根状の形状を有するインディケータであって、該アンビル組立体およびカートリッジ組立体が接近位置に移動するのに応じて、第1位置から第2位置に移動可能で、前記ヘッド部分が接近位置にあることを執刀医に視覚的に指示するインディケータとを備えるデバイス。
(項目2)
前記インディケータを少なくとも部分的に覆うように配置されたレンズであって、拡大材料から形成されたレンズをさらに備える、項目1に記載の外科手術用ステープリングデバイス。
(項目3)
前記ハンドル組立体内に配置され、前記本体部分を通って少なくとも部分的に延在する接近機構であって、前記アンビル組立体に係合するように構成された遠位端を有し、前記デバイス内で移動可能であり、前記アンビル組立体を前記シェル組立体に対して離間位置と接近位置との間で移動させる接近機構をさらに備える、項目1〜2のいずれか一項に記載の外科手術用ステープリングデバイス。
(項目4)
前記接近機構が、前記接近機構の移動により前記インディケータが移動するように、前記インディケータに動作可能に結合される、項目3に記載の外科手術用ステープリングデバイス。
(項目5)
前記インディケータに動作可能に結合し、前記ハンドル組立体内で移動可能な摺動部材であって、前進位置から後退位置に移動可能であり、前記インディケータを第1位置から第2位置に移動させる摺動部材をさらに備える、項目1〜4のいずれか一項に記載の外科手術用ステープリングデバイス。
(項目6)
前記摺動部材が、付勢部材により前記摺動部材の前進位置に圧迫される、項目5に記載の外科手術用ステープリングデバイス。
(項目7)
前記接近機構が、前記ハンドル組立体内で線形移動可能なスクリュー部材を備え、前記スクリュー部材の上に当接部材が支持され、該当接部材が、該スクリュー部材と共に移動可能で前記摺動部材に係合して、該摺動部材をその前進位置から後退位置に移動させ、前記インディケータをその第1位置から第2位置に移動させる、項目5または6に記載の外科手術用ステープリングデバイス。
(項目8)
前記摺動部材が、内部に形成された長形スロットを含み、前記当接部材が該長形スロット内で移動可能であって、前記スロットの近位端に係合し、該摺動部材をその前進位置から後退位置に移動させる、前記項目5、6または7に記載の外科手術用ステープリングデバイス。
(項目9)
前記インディケータが、前記ハンドル組立体内に枢動可能に支持される、項目1〜8のいずれか一項に記載の外科手術用ステープリングデバイス。
(項目10)
前記インディケータが1対の突出部を備え、前記摺動部材が、上方に折り返されたリップ部分で、突出部の対の間に配置されたリップ部分を備え、該摺動部材の上方に折り返されたリップ部分が突出部の対の一方に係合するように移動可能で、該インディケータをその第1位置から第2位置に移動させ、突出部の対の他方に係合するように移動可能で、該インディケータをその第2位置から第1位置に移動させる、項目5〜9の何れか1項に記載の外科手術用ステープリングデバイス。
(項目11)
前記インディケータが、前記ハンドル組立体内に枢動可能に支持される、項目1〜10のいずれか一項に記載の外科手術用ステープリングデバイス。
(項目12)
前記シェル組立体がステープルの環状アレイを支持する、項目1〜11のいずれか一項に記載の外科手術用ステープリングデバイス。
(項目13)
アンビル組立体であって、
ポストと、ポケットを形成する複数のステープルを備えるアンビルと、第1位置から第2位置に摺動可能にポストの周囲に配置された切断リングとを有するアンビルヘッドと、
該アンビルヘッドのポストから延在するアンビル中心ロッドと、
該アンビルヘッドのポスト上に配置されたリテーナクリップであって、少なくとも1個の弾性アームを有し、非付勢状態で、前記ポストから外側に延在するリテーナクリップとを備え、
第1位置で、前記切断リングが前記弾性アームに少なくとも部分的に係合して、前記弾性アームを前記切断リングの移動経路から離脱するように促進し、第2位置で、前記リテーナの弾性アームが、前記切断リングの移動経路内に突出して、前記切断リングがその第2位置から逆に第1位置に移動するのを防止するアンビル組立体。
(項目14)
前記アンビルヘッドのポストが、内部に形成された横断スロットを備え、前記クリップリテーナが前記横断スロット内に配置される、項目13に記載のアンビル組立体。
(項目15)
第1位置で、前記切断リングが、前記ポストの横断スロット周囲に配置されて前記弾性アームに係合し、前記リテーナクリップの前記弾性アームを前記横断スロット内に圧迫する、項目14に記載のアンビル組立体。
(項目16)
前記リテーナクリップが1対の弾性アームを備える、項目13に記載のアンビル組立体。
(項目17)
前記リテーナクリップが1対の弾性アームを備え、前記切断リングが第2位置にある時に、一方のアームが前記横断スロットの各々の側から延在する、項目15に記載のアンビル組立体。
(項目18)
前記アンビルヘッドが、枢動部材により、前記アンビル中心ロッドに枢動可能に取り付けられる、項目13に記載のアンビル組立体。
(項目19)
前記リテーナクリップが、前記枢動部材を収容して、前記リテーナクリップを前記ポストに固定するための凹部を備える、項目18に記載のアンビル組立体。
(項目20)
前記切断リングが、前記切断リングに固定されたバックアッププレートを備え、該バックアッププレートが、前記切断リングが第1位置にある場合に、アンビルヘッドがアンビル中心ロッドに対して枢動することを防止するように配置された少なくとも1個のタブを有する、項目18に記載のアンビル組立体。
ここに開示する外科手術用ステープリングデバイスの様々な好ましい実施態様について、図面に関して本明細書で開示する。
ここに開示する外科手術用ステープリングデバイスの好ましい実施態様について、図面に関して詳細に説明し、図中、類似の参照符号は、いくつかの図面の各々で同一または対応する要素を指示する。
図3〜図8を参照すると、接近機構は、接近ノブ22、駆動スクリュー32、回転可能スリーブ33、それぞれ第1および第2スクリューの延在部分34および36(図6)、およびアンビルリテーナ38を備える。回転可能スリーブ33は、実質的に円筒状の中空本体部分40と、実質的に円筒状のカラー42とを備え、これらは共に中心ボア33aを画定する。カラー42には、その周囲に環状の溝44が形成され、この溝は、ハンドル部分18aおよび18bの内壁上に形成された内側延在フランジ46を収容する寸法である。溝44とフランジ46との間の係合は、スリーブ33をハンドル18内に軸方向に固定し、しかも固定ハンドル18に関連してスリーブ33の回転を可能にする。回転可能スリーブ33の本体部分40の近位端は、固定ハンドル18の近位端にある開口部18bを通って延在する。正反対に対向する1対の長形リブ48は、本体部分40の外面上に配置されるか、または形成される。接近ノブ22は1対の内側スロット49aを備え、これらのスロットは、スリーブ33のリブ48を収容して、スリーブ33をノブ22に回転可能に固定するように配置され、その結果、ノブ22の回転により、スリーブ33が同時に回転する。
図3〜図6および図9を参照すると、発射機構は、発射トリガ20と、発射リンク72と、長形のプッシャリンク74(図6)とを備える。発射トリガ20は、本体部分76およびトリガカバー80を備える。好ましくはネオプレンまたはゴムから形成されたクッション状把持表面(図示しない)は、トリガカバー80上に設けられる。クッション状把持表面は、滑り止めのクッション状表面を提供して、デバイス10の作動が執刀医にとってさらに快適になるようにする。トリガ20の本体部分76の遠位端は、枢動部材84により、結合部材86に枢動可能に接続される。結合部材86は、プッシャリンク74の近位端に固定され、プッシャリンク74と一体に、またはプッシャリンク74に固締された別個の要素として形成される。発射リンク72は、枢動部材87によりトリガ20の本体部分76に枢動可能に固定された遠位端と、枢動部材79により、固定ハンドル18の固定ハンドル半体部分18aおよび18bとの間に形成された垂直スロット82内に枢動可能に固定された第2端部とを備える。枢動部材79は、スロット82内で垂直に自由に移動する。ばね82a(図9)は、ハンドル18内に支持されて、枢動部材79をスロット82の底部方向に下方に圧迫する。トリガ20の本体部分76は、当接部分89および当接部分91を含む1対の当接部分をさらに備え、これらの当接部分は、以下に詳細に説明するようにトリガロック26の遠位端26a(図4)に係合するように配置され、デバイス10が接近する前にトリガ20が作動するのを防止する。
図10〜図21を参照すると、アンビル組立体30は、アンビルヘッド組立体120と、アンビル中心ロッド組立体152とを含む。アンビルヘッド組立体120は、ポスト122と、アンビルヘッド124と、バックアッププレート126と、切断リング128と、保持クリップ127と、アンビル129とを含む。ポスト122は、アンビルヘッド124内のボアを通して中心に配置される。別法によると、ポスト122は、アンビルヘッド124と一体成形される。アンビル129は、外側環状凹部136内のアンビルヘッド124上に支持され、ステープルを収容して変形させるための複数のポケット140を備える。少なくとも1個のタブ129aは、アンビル129から半径方向外側に延在し、アンビルヘッド124内に形成されたカットアウト124a内に収容される寸法に作られる。タブ129aおよびカットアウト124aは、アンビル129を環状凹部136内でアラインする機能を果たす。バックアッププレート126は中心開口部126bを備え、この開口部は、アンビルヘッド124の内側凹部134内のポスト122周囲であって、ポスト122と環状凹部136との間に配置される。バックアッププレート126は、***したプラットフォーム126aを含む。切断リング128は、プラットフォーム126aと実質的に同じ構成の開口部128aを含む。開口部128aは、切断リング128aをバックアップリング126上に回転可能に固定するために、プラットフォーム126aの周囲に配置される。好ましくは、切断リング128はポリエチレンから形成され、たとえば接着剤を使用してバックアッププレート126に固定して取り付けられる。バックアップリング126は、好ましくは金属から形成し、切断リング128を支持して組織の切断を強化する。別法によると、構造のその他の材料は、プレート126およびリング128を構成するために使用される。切断リング128およびバックアッププレート126は、ポスト122周囲に摺動可能に実装される。バックアッププレート126は、以下で詳細に説明する1対の内側に延在するタブ150を備える。切断リング128はタブ128bを備え、このタブは、アンビルヘッド124内に形成されたカットアウト124b内に収容され、バックアップリング126および切断リング128をアンビルヘッド124内で適切にアラインする。
図6を参照すると、シェル組立体31は、シェル182と、プッシャバック186と、円筒状ナイフ188と、ステープルガイド192とを備える。シェル182は、アンビル中心ロッド154(図10)上のスプライン181と嵌合する外側筐体部分194と、溝196aを有する内側ガイド部分196とを備える。外側筐体部分194は、遠位の円筒状セクション200と、中心の円錐状セクション202と、近位の比較的小径の円筒状セクション204とを有する貫通ボア198を画定する。複数の開口部206は、円錐状セクション202内に形成される。開口部206は、デバイスの作動時に、流体および組織の通過が可能な寸法に作られる。1対の正反対に対向する可撓性係合部材207は、シェル182の近位の円筒状セクション204上に形成される。係合部材207は、外側管14aの遠位端上に形成された開口部207a内に収容されて、シェル182を長形本体14aに固定するように配置される。外側管14aの近位端に形成された1対の開口部211は、固定ハンドル18の内壁上に形成された突出部(図示しない)を収容して、管14aをハンドル部分12に容易に取り付けることができる寸法に作られる。
図8および図22〜28を参照すると、カム調節部材400は、セットスクリュー312により、側壁306a内に形成された凹部306b内においてスクリューストップ306の側壁306a上に固定される。カム調節部材400は、貫通ボア404を有する円形ディスク402を備える。貫通ボア404は、ディスク402を貫通して偏心状に形成され、セットスクリュー312を収容する寸法に作られる。ディスク402内には、比較的小さいノッチまたは孔406も形成され、調節ツール(図示しない)の先端を収容する寸法に作られる。凹部306b(図22)は、前部の当接部分の肩状部または表面306cと、後部の当接部分の表面306dとを備え、ディスク402の外側縁部が、前部および後部の当接部分の表面306cおよび306dに当接するようにディスクを収容する寸法に作られる。
図3〜図5および図29を参照すると、インディケータ機構は、球根状インディケータ24と、レンズカバー24aと、摺動部材500とを備える。インディケータ24は、ハンドルセクション18aおよび18bと一体に形成することが好ましい。レンズカバー24aはインディケータ24上に配置し、インディケータ24の容易な視認性を促進するために、拡大材料から形成することが好ましい。摺動部材500は、長形スロット506が内部に形成された本体部分504と、遠位の当接部材、または上方に折り返されたリップ部分508と、近位の延在部分510とを備える。摺動部材500は、ハンドルセクション18aおよび18b間に摺動可能に配置される。近位の延在部分510は、ハンドルセクション18aおよび18bと一体に成形される支持構造(図5)により、固定ハンドル18内に摺動可能に支持される。付勢部材、好ましくはコイルばね512は、支持構造516と、摺動部材500の本体部分504との間の近位の延在部分510の周囲に圧縮して配置され、摺動部材500を遠位に固定ハンドル18内に圧迫する。インディケータ24は、1対の下方に延在する突出部518および520(図32)を備える。摺動部材500の上方に折り返されたリップ部分508は、突出部518および520間に配置され、固定ハンドル18内で移動する時に、突出部518および520に係合するように配置される。デバイス10の非発射位置では、付勢部材512は、摺動部材500を遠位に圧迫し、リップ部分508を突出部518に係合させてインディケータを第1位置に枢動させ、デバイスがまだ接近せず、発射可能状態にないことを執刀医に知らせる。
図3〜図5および図30を参照すると、発射ロックアウト機構はトリガロック26およびロックアウト部材530を備える。トリガロック26は、ハンドルセクション18aおよび18bのボア532(図3)内に、枢動部材534周囲で摺動可能に支持される。枢動部材534は、好ましくはT形であり、ボア532の内壁に摩擦的に係合し、トリガロック26の回転を防止する。別法によると、その他の枢動部材構成が考えられ、たとえば円形、方形などがある。トリガロック26の先端26aは、発射トリガ20の本体部分76上にある当接部分89と91との間に配置され、トリガロック26が係止位置にある時に、トリガ20が作動するのを防止する。トリガロック26は、以下でさらに詳細に説明するように、近位の延在部分26bも備える。
図3、図5、図9および図9Aを参照すると、固定ハンドル18内に設けられた触知式インディケータ機構は、ハンドルセクション18aおよび18b内に画定された垂直スロット582内に摺動可能に配置された当接部材580を備える。当接部材580は突起580aと、ガイドリブ580bとを備える。突起580aは、スロット582の壁部に沿って形成された2個の戻り止めの1個内に収容される寸法に作られる。当接部材580は、突起580aが戻り止め582a内に配置される後退(下方)位置から、突起580aが戻り止め582b内に配置される延在(上方)位置に移動可能である。突起580aと戻り止め582bとの間の係合は、当接部材580をそれぞれ上方位置または下方位置に維持する。
次に、外科手術用ステープリングデバイス10の動作について、図31〜図61に関して詳細に説明する。
Claims (2)
- 外科手術用ステープリングデバイス内の使用のためのアンビル組立体であって、
ポストと、複数のステープル形成ポケットを備えるアンビルと、該ポストの周囲に摺動可能に搭載され第1位置から第2位置に移動可能である切断リングであって該第1位置は該デバイスが発射される前の位置であり該第2位置は該デバイスが既に発射されている位置である切断リングとを有するアンビルヘッドと、
該アンビルヘッドのポストから延在するアンビル中心ロッドと、
該アンビルヘッドのポスト上に配置されたリテーナクリップであって、少なくとも1個の弾性アームを有し、非付勢状態で、該ポストから外側に延在するリテーナクリップとを備え、
該第1位置で、該切断リングが該弾性アームに少なくとも部分的に係合して、該弾性アームを該切断リングの移動経路から離脱するように促進し、該第2位置で、該リテーナクリップの弾性アームが、該切断リングの移動経路内に突出して、該切断リングが該第2位置から逆に該第1位置に移動するのを防止するアンビル組立体。 - 請求項1に記載のアンビル組立体であって、前記アンビルヘッドのポストが、内部に形成された横断スロットを備え、前記リテーナクリップが該横断スロット内に配置され、該リテーナクリップが1対の弾性アームを備え、前記切断リングが前記第2位置にあるときに、一方のアームが該横断スロットの各々の側から延在し、前記第1位置で、該切断リングが、該ポストの横断スロット周囲に配置されて該弾性アームに係合し、該リテーナクリップの該弾性アームを該横断スロット内に圧迫し、
ここで、前記アンビルヘッドが、枢動部材により、前記アンビル中心ロッドに枢動可能に取り付けられ、該リテーナクリップが、該枢動部材を収容して、該リテーナクリップを前記ポストに固定するための凹部を備え、前記切断リングが、該切断リングに固定されたバックアッププレートを備え、該バックアッププレートが、少なくとも1個のタブを備え、該少なくとも1個のタブが、該切断リングが第1位置にある場合に、該アンビルヘッドが該アンビル中心ロッドに対して枢動することを防止するように該アンビル中心ロッドの上面と係合する、アンビル組立体。
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- 2003-10-06 ES ES08171932T patent/ES2385522T3/es not_active Expired - Lifetime
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US7546940B2 (en) | 2009-06-16 |
ES2324407T3 (es) | 2009-08-06 |
AU2008258161B2 (en) | 2010-12-16 |
WO2004032766A2 (en) | 2004-04-22 |
WO2004032766A3 (en) | 2004-07-01 |
ES2385522T3 (es) | 2012-07-26 |
EP2055246B1 (en) | 2012-04-18 |
JP2006501950A (ja) | 2006-01-19 |
CA2754689A1 (en) | 2004-04-22 |
AU2008258161B8 (en) | 2011-01-20 |
US20060097025A1 (en) | 2006-05-11 |
EP1545338B1 (en) | 2009-04-15 |
CA2754689C (en) | 2014-12-16 |
JP2010042285A (ja) | 2010-02-25 |
US8348122B2 (en) | 2013-01-08 |
AU2008258161A1 (en) | 2009-01-08 |
JP2012024608A (ja) | 2012-02-09 |
JP4422027B2 (ja) | 2010-02-24 |
US20080054045A1 (en) | 2008-03-06 |
CA2501049C (en) | 2012-01-03 |
AU2003279147A1 (en) | 2004-05-04 |
DE60327227D1 (de) | 2009-05-28 |
EP1545338A2 (en) | 2005-06-29 |
US20130072955A1 (en) | 2013-03-21 |
EP2055246A1 (en) | 2009-05-06 |
CA2501049A1 (en) | 2004-04-22 |
US7303106B2 (en) | 2007-12-04 |
US20070075117A1 (en) | 2007-04-05 |
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