JP2018187387A - 拡大可能なバックスパンを備えた外科用ステープル - Google Patents

拡大可能なバックスパンを備えた外科用ステープル Download PDF

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JP2018187387A
JP2018187387A JP2018088001A JP2018088001A JP2018187387A JP 2018187387 A JP2018187387 A JP 2018187387A JP 2018088001 A JP2018088001 A JP 2018088001A JP 2018088001 A JP2018088001 A JP 2018088001A JP 2018187387 A JP2018187387 A JP 2018187387A
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コストシェフスキー スタニスロウ
Kostrzewski Stanislaw
コストシェフスキー スタニスロウ
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    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • 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
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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
    • A61B2017/07235—Stapler heads containing different staples, e.g. staples of different shapes, sizes or materials
    • 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
    • A61B2017/07242—Stapler heads achieving different staple heights during the same shot, e.g. using an anvil anvil having different heights or staples of different sizes
    • 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
    • A61B2017/0725—Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • 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
    • A61B2017/07264—Stapler heads characterised by its anvil characterised by its staple forming cavities, e.g. geometry or material
    • 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

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Abstract

【課題】拡大可能なバックスパンを備えた外科用ステープルを提供する。【解決手段】本体１０を備える外科用ステープル１００であって、本体が、第１の端部１４ａ及び第２の端部１４ｂを有する第１の脚部１４と、第１の端部１６ａ及び第２の端部１６ｂを有する第２の脚部１６と、バックスパン１２と、を含み、バックスパンが、ループ部材１８を有する第１の部分１２ａであって、ループ部材が第１の端部１８ａ及び第２の端部１８ｂを含む、第１の部分と、第１の脚部の第１の端部と、ループ部材の第１の端部との間を延びる第２の部分２０と、第２の脚部の第１の端部と、ループ部材の第２の端部との間を延びる第３の部分２２と、を含み、バックスパンの第２の部分と、バックスパンの第３の部分とが横方向に接触している、外科用ステープル。【選択図】図１

Description

背景
本開示は、外科用ステープル器具で使用するための外科用ステープルに関する。より詳細には、本開示は、厚さが変化する組織を結合するための外科用ステープル器具で使用するための外科用ステープルに関する。
外科用ステープルは、様々な外科工程、例えば、吻合工程において、迅速で効率的な方式で外科用ステープル器具を使用して組織または組織セグメントを結合する組織に適用される。
典型的に、外科用ステープルは、バックスパン及び一対の離間した脚部を含む。脚部は組織を通って外科用ステープル器具のアンビルアセンブリ内へ駆動されて、ステープルを望ましい構成、例えばＢステープルへ変形させて、止血させる。現在の外科用ステープルは、止血させるために所与の厚さの範囲の組織に対して特定の寸法にされ、及び適する。そのため、臨床医は、所与の組織の厚さの範囲に対する適切な寸法を有するステープルを選択して、効果的な止血を確実にしなければならない。組織の厚さが臨床医によって誤認された場合、または組織の厚さが所与のステープルの寸法に対する範囲の外縁に近い場合、効果的ではない止血の可能性が増加する。
したがって、より大きな範囲の組織の厚さに対応して、様々な手術工程を実行するときに、より高い柔軟性を臨床医に提供できる外科用ステープルに対する縫合技術における継続した必要性がある。
本開示は、１つの態様において、第１の脚部と、第２の脚部と、バックスパンと、を有する本体を含む外科用ステープルを提供する。第１及び第２の脚部は、第１の端部及び第２の端部をそれぞれ有する。バックスパンは、第１の部分と、第２の部分と、第３の部分と、を有する。バックスパンの第１の部分は、第１の端部及び第２の端部を有するループ部材を含む。バックスパンの第２の部分は、第１の脚部の第１の端部と、ループ部材の第１の端部との間を延びる。バックスパンの第３の部分は、第２の脚部の第１の端部と、ループ部材の第２の端部との間を延びる。バックスパンの第２の部分及びバックスパンの第３の部分は、実質的に横方向に接触している。
特定の実施形態では、バックスパンの第２の部分は、バックスパンの第３の部分に平行な方向に延びる。
いくつかの実施形態では、バックスパンのループ部材は、バックスパンの第２の部分と、バックスパンの第３の部分との間を横方向に延びる。
特定の実施形態では、バックスパンのループ部材は、バックスパンの第２の部分の第１の端部と、バックスパンの第３の部分の第１の端部との間を延びる軸を画定する。
いくつかの実施形態では、バックスパンの第２の部分は第１の軸を画定し、バックスパンの第３の部分は第２の軸を画定し、第２の部分の第１の軸は、第３の部分の第２の軸から横方向にオフセットされて、第２の部分の第１の軸と、第３の部分の第２の軸との間のオフセット距離を画定する。
特定の実施形態では、バックスパンのループ部材は頂部を含み、バックスパンの第２の部分は第１の中間部分を含み、バックスパンの第３の部分は第２の中間部分を含む。ループ部材の頂部と、バックスパンの第２及び第３の部分の第１及び第２の中間部分とは、第２の部分の第１の軸及び第３の部分の第２の軸に垂直な軸を画定する。
いくつかの実施形態では、第２の部分の第１の軸と、第３の部分の第２の軸との間のオフセット距離は、外科用ステープルの本体の直径に等しい。
特定の実施形態では、外科用ステープルは未形成構成及び形成構成を含む。外科用ステープルの未形成構成において、バックスパンのループ部材の頂部は、バックスパンの第２の部分及び第３の部分の各々から、第１の距離だけ離間している。外科用ステープルの形成構成では、バックスパンのループ部材の頂部は、バックスパンの第２の部分及び第３の部分の各々から、未形成構成の第１の距離よりも少ない第２の距離だけ離間している。
いくつかの実施形態では、外科用ステープルは、組織と係合すると、未形成構成から形成構成へ変形可能であり、外科用ステープルの形成構成において、バックスパンのループ部材の頂部と、バックスパンの第２の部分及び第３の部分の各々との間の第２の距離は、バックスパンによって係合された組織の厚さが増加するにつれ、減少する。
特定の実施形態では、外科用ステープルの形成構成では、第１の脚部はループ部材の第１の横側に位置付けられ、第２の脚部は、ループ部材の第１の横側とは反対のループ部材の第２の横側に位置付けられる。
本開示は、別の態様において、第１の脚部と、第２の脚部と、バックスパンと、を有する本体を含む外科用ステープルを提供する。第１及び第２の脚部は、第１の端部及び第２の端部をそれぞれ有する。バックスパンは、第１の部分と、第２の部分と、第３の部分と、を有する。バックスパンの第１の部分は、第１の端部及び第２の端部を含むループ部材を有する。バックスパンの第２の部分は、第１の脚部の第１の端部と、ループ部材の第１の端部との間を縦に延びる。バックスパンの第３の部分は、第２の脚部の第１の端部と、ループ部材の第２の端部との間を縦に延びる。バックスパンの第２の部分は、バックスパンの第３の部分の近くに整列して位置付けられる。
いくつかの実施形態では、バックスパンの第２の部分は、バックスパンの第３の部分に平行な方向に延びる。
特定の実施形態では、バックスパンのループ部材は頂部を含み、バックスパンの第２の部分は第１の中間部分を含み、バックスパンの第３の部分は第２の中間部分を含む。第１の脚部及び第２の脚部のうちの少なくとも１つに平行な軸を画定する、ループ部材の頂部、ならびにバックスパンの第２及び第３の部分の第１及び第２の中間部分。
いくつかの実施形態では、外科用ステープルは、未形成構成から形成構成へ変形可能である。外科用ステープルの形成構成では、第１の脚部の第２の端部は、バックスパンのループ部材の第１の横側に位置付けられ、第２の脚部の第２の端部は、バックスパンのループ部材の第１の横側とは反対のバックスパンのループ部材の第２の横側に位置付けられる。
特定の実施形態では、バックスパンの第２の部分及びバックスパンの第３の部分は横方向に接触している。
本開示は、複数の外科用ステープルと、ステープルカートリッジと、複数のプッシャーと、を含む外科用ステープル器具との使用のためのステープルカートリッジアセンブリのさらに別の態様を提供する。複数の外科用ステープルは互いから離間した関係性にあり、各々が第１の脚部と、第２の脚部と、バックスパンと、を含む。第１及び第２の脚部は、第１の端部及び第２の端部をそれぞれ有する。バックスパンは、第１の部分と、第２の部分と、第３の部分と、を有する。バックスパンの第１の部分は、第１の端部及び第２の端部を有するループ部材を含む。バックスパンの第２の部分は、第１の脚部の第１の端部と、ループ部材の第１の端部との間を延びる。バックスパンの第３の部分は、第２の脚部の第１の端部と、ループ部材の第２の端部との間を延びる。ステープルカートリッジは、列で配置され、ステープルカートリッジの縦軸に対して斜めに位置付けられた、複数のステープルポケットを有する。複数のステープルポケットの各々は、複数の外科用ステープルの各々の第１の脚部及び第２の脚部が、他の複数の外科用ステープルの各々の第１の脚部及び第２の脚部に対して縦に整列されるように、複数の外科用ステープルのうちの少なくとも１つを受けるように構成される。複数のプッシャーの各々は、複数のステープルポケットのうちの各１つに関連付けられる。複数のプッシャーの各々は、複数のステープルポケットのうちの各１つから、複数の外科用ステープルのうちの１つを前進させるように構成される。
いくつかの実施形態では、複数のステープルポケットの各々は、外科用ステープルの第１の脚部を受ける形状にされ、及び寸法にされた第１のセグメントと、外科用ステープルの第２の脚部を受ける形状にされ、及び寸法にされた第２のセグメントと、外科用ステープルのバックスパンを受ける形状にされ、及び寸法にされた中間セグメントと、を有する外形を含む。複数のステープルポケットの各々の外形は、ステープルカートリッジの縦軸に対して斜めに位置付けられる。
特定の実施形態では、複数のプッシャーの各々は、複数の外科用ステープルの各々の各バックスパンを解放可能に受けるように構成されたステープルシートを含み、ステープルシートは、複数のプッシャーの各々の縦軸に対して斜めに位置付けられる。複数のプッシャーの各々のステープルシートは、複数の外科用ステープルの各々をステープルカートリッジの複数のステープルポケットの各々と整列させるように適合される。
いくつかの実施形態では、複数のプッシャーの各々のステープルシートは、ステープルシートの第１の部分から突出する第１の壁と、ステープルシートの第２の部分から突出する第２の壁と、を含み、第１の壁及び第２の壁は、ステープルシートの第１の部分と、ステープルシートの第２の部分との間を延びる斜めの通路を画定し、斜めの通路は、プッシャーの縦軸に対して斜めに位置付けられる。
特定の実施形態では、複数のプッシャーの各々のステープルシートの斜めの通路は、複数の外科用ステープルの各々が、複数のプッシャーの各々の縦軸に対して、複数のプッシャーの各々のステープルシート上に斜めに位置付けられるように、複数の外科用ステープルの各々の各バックスパンを解放可能に受けるように適合される。
いくつかの実施形態では、複数の外科用ステープルの各々が複数のプッシャーの各々の各ステープルシート上に位置付けられる場合、各ステープルシートの第１の壁は複数の外科用ステープルの各々の各バックスパンの第２の部分を係合するように構成され、各ステープルシートの第２の壁は複数の外科用ステープルの各々の各バックスパンの第３の部分を係合して、複数の外科用ステープルの各々の各バックスパンを解放可能に受けるように構成される。
例えば、本願は以下の項目を提供する。
（項目１）
本体を備える外科用ステープルであって、
上記本体が、
第１の端部及び第２の端部を有する第１の脚部と、
第１の端部及び第２の端部を有する第２の脚部と、
バックスパンと、を含み、上記バックスパンが、
ループ部材を有する第１の部分であって、上記ループ部材が第１の端部及び第２の端部を含む、第１の部分と、
上記第１の脚部の上記第１の端部と、上記ループ部材の上記第１の端部との間を延びる第２の部分と、
上記第２の脚部の上記第１の端部と、上記ループ部材の上記第２の端部との間を延びる第３の部分と、を含み、上記バックスパンの上記第２の部分と、上記バックスパンの上記第３の部分とが横方向に接触している、外科用ステープル。
（項目２）
上記バックスパンの上記第２の部分が、上記バックスパンの上記第３の部分に平行な方向に延びる、上記項目に記載の外科用ステープル。
（項目３）
上記バックスパンの上記ループ部材が、上記バックスパンの上記第２の部分と、上記バックスパンの上記第３の部分との間を横に延びる、上記項目のいずれか一項に記載の外科用ステープル。
（項目４）
上記バックスパンの上記ループ部材が、上記バックスパンの上記第２の部分の第１の端部と、上記バックスパンの上記第３の部分の第１の端部との間を延びる軸を画定する、上記項目のいずれか一項に記載の外科用ステープル。
（項目５）
上記バックスパンの上記第２の部分が第１の軸を画定し、上記バックスパンの上記第３の部分が第２の軸を画定し、上記第２の部分の上記第１の軸は上記第３の部分の上記第２の軸から横方向にオフセットされて、上記第２の部分の上記第１の軸と上記第３の部分の上記第２の軸との間のオフセット距離を画定する、上記項目のいずれか一項に記載の外科用ステープル。
（項目６）
上記バックスパンの上記ループ部材は頂部を含み、上記バックスパンの上記第２の部分は第１の中間部分を含み、上記バックスパンの上記第３の部分は第２の中間部分を含み、上記ループ部材の上記頂部ならびに上記バックスパンの上記第２及び第３の部分の上記第１及び第２の中間部分が、上記第２の部分の上記第１の軸及び上記第３の部分の上記第２の軸に垂直な軸を画定する、上記項目のいずれか一項に記載の外科用ステープル。
（項目７）
上記第２の部分の上記第１の軸と、上記第３の部分の上記第２の軸との間の上記オフセット距離が、上記外科用ステープルの上記本体の直径に等しい、上記項目のいずれか一項に記載の外科用ステープル。
（項目８）
上記外科用ステープルが未形成構成及び形成構成を含み、上記外科用ステープルの上記未形成構成において、上記バックスパンの上記ループ部材の上記頂部が、上記バックスパンの上記第２の部分及び上記第３の部分の各々から第１の距離だけ離間しており、上記外科用ステープルの上記形成構成において、上記バックスパンの上記ループ部材の上記頂部が、上記バックスパンの上記第２の部分及び上記第３の部分の各々から上記未形成構成の上記第１の距離より少ない第２の距離だけ離間している、上記項目のいずれか一項に記載の外科用ステープル。
（項目９）
上記外科用ステープルは、組織と係合すると上記未形成構成から形成構成へ変形可能であり、上記外科用ステープルの上記形成構成において、上記バックスパンの上記ループ部材の上記頂部と、上記バックスパンの上記第２の部分及び上記第３の部分の各々との間の上記第２の距離が、上記バックスパンによって係合された組織の厚さが増加するにつれて減少する、上記項目のいずれか一項に記載の外科用ステープル。
（項目１０）
上記外科用ステープルの上記形成構成において、上記第１の脚部は上記ループ部材の第１の横側に位置付けられ、上記第２の脚部は、上記ループ部材の上記第１の横側とは反対の上記ループ部材の第２の横側に位置付けられる、上記項目のいずれか一項に記載の外科用ステープル。
（項目１１）
本体を備える外科用ステープルであって、上記本体が、
第１の端部及び第２の端部を有する第１の脚部と、
第１の端部及び第２の端部を有する第２の脚部と、
バックスパンと、を含み、上記バックスパンが、
ループ部材を有する第１の部分であって、上記ループ部材が第１の端部及び第２の端部を含む、第１の部分と、
上記第１の脚部の上記第１の端部と、上記ループ部材の上記第１の端部との間を縦に延びる第２の部分と、
上記第２の脚部の上記第１の端部と、上記ループ部材の上記第２の端部との間を縦に延びる第３の部分と、を含み、上記バックスパンの上記第２の部分が、上記バックスパンの上記第３の部分の近くに整列されて位置付けられる、外科用ステープル。
（項目１２）
上記バックスパンの上記第２の部分が、上記バックスパンの上記第３の部分に平行である、上記項目に記載の外科用ステープル。
（項目１３）
上記バックスパンの上記ループ部材は頂部を含み、上記バックスパンの上記第２の部分は第１の中間部分を含み、上記バックスパンの上記第３の部分は第２の中間部分を含み、上記ループ部材の上記頂部ならびに上記バックスパンの上記第２及び第３の部分の上記第１及び第２の中間部分が、上記第１の脚部及び上記第２の脚部のうちの少なくとも１つに平行な軸を画定する、上記項目のいずれか一項に記載の外科用ステープル。
（項目１４）
上記外科用ステープルは、未形成構成から形成構成へ変形可能であり、上記外科用ステープルの上記形成構成において、上記第１の脚部の上記第２の端部は上記バックスパンの上記ループ部材の第１の横側に位置付けられ、上記第２の脚部の上記第２の端部は、上記バックスパンの上記ループ部材の上記第１の横側とは反対の上記バックスパンの上記ループ部材の第２の横側に位置付けられる、上記項目のいずれか一項に記載の外科用ステープル。
（項目１５）
上記バックスパンの上記第２の部分と、上記バックスパンの上記第３の部分とは横方向に接触している、上記項目のいずれか一項に記載の外科用ステープル。
（項目１６）
外科用ステープル器具と使用するためのステープルカートリッジアセンブリであって、上記ステープルカートリッジアセンブリが、
互いから離された関係性で支持される複数の外科用ステープルであって、上記複数の外科用ステープルの各々が、
第１の端部及び第２の端部を有する第１の脚部、
第１の端部及び第２の端部を有する第２の脚部、ならびに
バックスパン、を含み、上記バックスパンが、
ループ部材を有する第１の部分であって、上記ループ部材が第１の端部及び第２の端部を含む、第１の部分、
上記第１の脚部の上記第１の端部と、上記ループ部材の上記第１の端部との間を延びる第２の部分、ならびに
上記第２の脚部の上記第１の端部と、上記ループ部材の上記第２の端部との間を延びる第３の部分、を含む、複数の外科用ステープルと、
列で配置され、上記ステープルカートリッジの縦軸に対して斜めに位置付けられた複数のステープルポケットを有するステープルカートリッジであって、上記複数のステープルポケットの各々が、上記複数の外科用ステープルの各々の上記第１の脚部及び上記第２の脚部が他の上記複数の外科用ステープルの各々の上記第１の脚部及び上記第２の脚部に対して縦に整列されるように、上記複数の外科用ステープルのうちの少なくとも１つを受けるように構成される、ステープルカートリッジと、
複数のプッシャーであって、上記複数のプッシャーの各々が上記複数のステープルポケットのうちの各１つに関連付けられ、上記複数のプッシャーの各々が、上記複数のステープルポケットのうちの各１つから、上記複数の外科用ステープルのうちの１つを前進させるように構成された、複数のプッシャーと、を備える、ステープルカートリッジアセンブリ。
（項目１７）
上記複数のステープルポケットの各々が、上記外科ステープルの上記第１の脚部を受ける形状にされ、及び寸法にされた第１のセグメントと、上記外科ステープルの上記第２の脚部を受ける形状にされ、及び寸法にされた第２のセグメントと、上記外科ステープルの上記バックスパンを受ける形状にされ、及び寸法にされた中間セグメントと、を有する外形を含み、上記複数のステープルポケットの各々の外形が、上記ステープルカートリッジの上記縦軸に対して斜めに位置付けられる、上記項目に記載のステープルカートリッジアセンブリ。
（項目１８）
上記複数のプッシャーの各々が、上記複数の外科用ステープルの各々の各バックスパンを解放可能に受けるように構成されたステープルシートを含み、上記ステープルシートが上記複数のプッシャーの各々の縦軸に対して斜めに位置付けられ、上記複数のプッシャーの各々の上記ステープルシートが、上記複数の外科用ステープルの各々を上記ステープルカートリッジの上記複数のステープルポケットの各々と整列させるように適合された、上記項目のいずれか一項に記載のステープルカートリッジアセンブリ。
（項目１９）
上記複数のプッシャーの各々の上記ステープルシートが、上記ステープルシートの第１の部分から突出する第１の壁と、上記ステープルシートの第２の部分から突出する第２の壁とを含み、上記第１の壁及び上記第２の壁は、上記ステープルシートの上記第１の部分と、上記ステープルシートの上記第２の部分との間を延びる斜めの通路を画定し、上記斜めの通路は、上記プッシャーの上記縦軸に対して斜めに位置付けられる、上記項目のいずれか一項に記載のステープルカートリッジアセンブリ。
（項目２０）
上記複数のプッシャーの各々の上記ステープルシートの上記斜めの通路が、上記複数の外科用ステープルの各々が上記複数のプッシャーの各々の上記ステープルシート上で上記複数のプッシャーの各々の上記縦軸に対して斜めに位置付けられるように、上記複数の外科用ステープルの各々の各バックスパンを解放可能に受けるように適合される、上記項目のいずれか一項に記載のステープルカートリッジアセンブリ。
（項目２１）
上記複数の外科用ステープルの各々が上記複数のプッシャーの各々の各ステープルシート上に位置付けられる場合、各ステープルシートの上記第１の壁は、上記複数の外科用ステープルの各々の上記各バックスパンの上記第２の部分を係合するように構成され、上記各ステープルシートの上記第２の壁は、上記複数の外科用ステープルの各々の上記各バックスパンの上記第３の部分を係合して、上記複数の外科用ステープルの各々の上記各バックスパンを解放可能に受けるように構成される、上記項目のいずれか一項に記載のステープルカートリッジアセンブリ。
（摘要）
外科用ステープルは、第１の脚部と、第２の脚部と、バックスパンとを有する本体を含む。第１及び第２の脚部は、第１の端部及び第２の端部をそれぞれ有する。バックスパンは、第１の部分と、第２の部分と、第３の部分とを有する。バックスパンの第１の部分は、第１の端部と第２の端部とを有するループ部材を含む。バックスパンの第２の部分は、第１の脚部の第１の端部と、ループ部材の第１の端部との間を延びる。バックスパンの第３の部分は、第２の脚部の第１の端部と、ループ部材の第２の端部との間を延びる。バックスパンの第２の部分及びバックスパンの第３の部分は横方向に接触している。
本開示される拡大可能なバックスパンステープル及びステープルを支持するためのカートリッジの様々な実施形態が、図面を参照して本明細書で開示される。
未形成構成における外科用ステープルを例証する、本開示される外科用ステープルの例示の実施形態の斜視図である。 図１の外科用ステープルの正面図である。 図１の外科用ステープルの上面図である。 第１の厚さを有する組織を係合する形成構成における図１の外科用ステープルの正面図である。 より大きな第２の厚さを有する組織を係合する形成構成における図１の外科用ステープルの正面図である。 さらに大きな第３の厚さを有する組織を係合する形成構成における図１の外科用ステープルの正面図である。 締付解除位置における外科用ステープル器具のツールアセンブリを備えた、図１の外科用ステープルを支持するカートリッジを含む外科用ステープル器具の斜視図である。 締付解除位置における装填部のツールアセンブリを備えた図５の外科用ステープル器具の装填部の斜視図である。 締付位置における図６のツールアセンブリの斜視図である。 図６の装填部のステープルカートリッジアセンブリの分解図である。 図８のステープルカートリッジアセンブリのステープルカートリッジの上面図である。 図９において１０として線引きされた詳細の示される範囲の拡大図である。 図８において１１として線引きされた詳細の示される範囲の拡大図である。 図８のステープルカートリッジアセンブリのプッシャーの側部斜視図である。 図１の複数の外科用ステープルがプッシャーに配置された図１２のプッシャーの側部斜視図である。 図１２のプッシャーの上面図である。 第１の厚さを有する組織が装填部のツールアセンブリ内に締め付けられている、図７の切断線「１５−１５」に沿った断面図である。 第２の厚さを有する組織が装填部のツールアセンブリ内に締め付けられている、図７の切断線「１６−１６」に沿った断面図である。
次に本開示される外科用ステープルの実施形態が、同じ参照符号が同様の、または同一の要素を表す図面を参照して詳細に説明される。図面において、及び以下の説明において、当技術における伝統及び慣習であるように、「近位」という用語は、その部分または適当な使用中にユーザに最も近い器具の端部を指すことが理解されるべきであり、一方で、「遠位」という用語は、その部分または適当な使用中にユーザに最も遠い器具の端部を指すことが理解されるべきである。
最初に図１〜３を参照すると、本開示の例示の実施形態が、外科用ステープル１００として一般的に示される。外科用ステープル１００は、バックスパン１２と、第１の脚部１４と、第２の脚部１６と、を有する本体１０を含む。外科用ステープル１００は、図１〜３に示されるように未形成構成を有し、第１の脚部１４及び第２の脚部１６は、互いに対して平行であり、または実質的に平行であり、互いから距離を空けられている。代替的に、未形成構成では、第１及び第２の脚部１４、１６は、互いに対して、わずかに分かれる、または集まることなどができる。
第１及び第２の脚部１４、１６の各々は、第１の端部１４ａ、１６ａのそれぞれと、第２の端部１４ｂ、１６ｂのそれぞれと、を含む。第１及び第２の脚部１４、１６の第２の端部１４ｂ、１６ｂの各々は、組織を貫通する先端１４ｃ、１６ｃを含む。１つの実施形態では、外科用ステープル１００の各第１及び第２の脚部１４、１６の組織を貫通する先端１４ｃ、１６ｃの各々は、斜めの、または先細りの端部を備えて形成されて、第１及び第２の脚部１４、１６の組織「Ｔ」（図４Ａ〜４Ｃを参照）への貫通を容易にすることができる。代替的に、外科用ステープル１００の各第１及び第２の脚部１４、１６の組織を貫通する先端１４ｃ、１６ｃは、先細りである必要はなく、異なる方向に先細りであることができ、または円錐または平面を画定することができる。
図１〜３を続けて参照すると、バックスパン１２はループ部材１８を有する第１の部分１２ａと、実質的に直線状であり、第１の脚部１４の第１の端部１４ａと、ループ部材１８の第１の端部１８ａとの間を延びる第２の部分２０と、実質的直線状であり、第２の脚部１６の第１の端部１６ａと、ループ部材１８の第２の端部１８ｂとの間を延びる第３の部分２２と、を含む。バックスパン１２のループ部材１８は、バックスパン１２の第２及び第３の部分２０、２２間を延びる弧状部分２４を含む。外科用ステープル１００の未形成構成では、図１に例証されるように、バックスパン１２の第２の部分２０は、バックスパン１２の第３の部分２２に実質的に平行であってもよく、バックスパン１２の第３の部分２２に横方向に接触していてもよく、または近くに整列されてもよい。
実施形態では、ループ部材１８の弧状部分２４は、バックスパン１２の第２の部分２０と第３の部分２２との間を横に延びる。外科用ステープル１００の未形成構成では、バックスパン１２の第２の部分２０は、軸「Ｘ１−Ｘ１」を画定し、バックスパン１２の第３の部分２２は軸「Ｘ２−Ｘ２」を画定する。第２の部分２０の軸「Ｘ１−Ｘ１」及び第３の部分２２の軸「Ｘ２−Ｘ２」は、互いからオフセット距離「ＯＤ」だけ横方向にオフセットされてもよい。第２の部分２０の軸「Ｘ１−Ｘ１」と、第３の部分２２の軸「Ｘ２−Ｘ２」との間のオフセット距離「ＯＤ」は、第２の部分２０及び第３の部分２２が互いに対して近くに位置付けられる、または互いと接触するように、外科用ステープル１００の本体１０の直径「ＢＤ」と実質的に等しくあり得ることが想定される。
ループ部材１８の弧状部分２４は、バックスパン１２の第２の部分２０の第１の端部２０ａと、バックスパン１２の第３の端部２２の第１の端部２２ａとの間を延びる軸「Ｘ３−Ｘ３」を画定する。実施形態では、ループ部材１８ならびに第２及び第３の部分２０、２２は、円形または楕円形の構成を有してもよい囲まれた開口２６を画定してもよい。バックスパン１２のループ部材１８の弧状部分２４は、特定の必要性、外科工程、または組織の厚さの範囲（下記で説明されるような）に適合する曲率の任意の望ましい半径を有して形成されることができることが想定される。バックスパン１２によって画定される開口２６は、円形または楕円形である必要がなく、むしろ、例えば、Ｕ形状、台形、長方形などの他の構成を有してもよいことも想定される。バックスパンは、丸、直線などの他の形状を有することができ、部材１８は直線である、角度が付けられている、または湾曲していることができる。さらに、実施形態では、バックスパン１２は１つ以上のループ部材１８を含んでもよい。
外科用ステープル１００の本体１０は、本体１０の長さにわたる円形の断面を有することができる。代替的に、外科用ステープル１００の本体１０が、長方形、楕円形、四角形、三角形、台形などを含む様々な異なる断面形状を有してもよいことが想定される。外科用ステープル１００のバックスパン１２及び外科用ステープル１００の第１及び第２の脚部１４、１６は、異なる断面形状を有してもよいことも想定される。例えば、１つの実施形態では、外科用ステープル１００のバックスパン１２は、長方形の断面形状を有することができ、外科用ステープル１００の第１及び第２の脚部１４、１６は、楕円形の断面形状を有することができる。
外科用ステープル１００は、例えば、チタン、ステンレス鋼、または様々な異なる生体適合性のポリマーなどの形成可能な材料から作られてもよい。この方式では、未形成構成で外科用ステープル１００は、組織上に導入され、次に組織上に変形され、または留められて、外科用ステープル１００を組織に固定してもよい。外科用ステープル１００は、当業者に知られた非分解性の任意の生体適合性材料から作られてもよいことが想定される。
次に図４Ａ〜４Ｃを参照すると、いくつかの実施形態では、外科用ステープル１００の第１及び第２の脚部１４、１６は、外科用ステープル器具１０００のアンビルアセンブリ１４００（図５を参照）に対して、実質的にＢ形状のステープル構成へと変形される。外科用ステープル１００の第１及び第２の脚部１４、１６はバックスパン１２の第２及び第３の部分２０、２２それぞれから延び、第２の部分２０の軸「Ｘ１−Ｘ１」及び第３の部分２２の軸「Ｘ２−Ｘ２」は互いから、外科用ステープル１００の本体１０の直径「ＢＤ」と実質的に等しいオフセット距離「ＯＤ」だけ横方向にオフセットされるため、外科用ステープル１００の形成構成では、外科用ステープル１００の第１の脚部１４はループ部材１８の弧状部分２４の第１の横側２４ａに位置付けられ、第２の脚部１６はループ部材１８の弧状部分２４の第２の、反対の横側２４ｂに位置付けられる（図３、４Ａ及び４Ｂを参照）ことが想定される。
形成構成では、バックスパン１２のループ部材１８の弧状部分２４は、バックスパン１２の第２及び第３の部分２０、２２に対して変形するように構成され、バックスパン１２のループ部材１８の第１及び第２の横部分２０、２２は実質的に直線のままである。詳しくは、外科用ステープル１００のバックスパン１２の変形は、留められる組織「Ｔ」の厚さ、例えば、「Ｔ１」、「Ｔ２」、「Ｔ３」などに依存する。最初に、外科用ステープル１００の未形成構成では、バックスパン１２のループ部材１８は、図２に例証されるように、ループ部材１８の弧状部分２４の頂部２４ｃと、バックスパン１２の第２及び第３の部分２０、２２との間の圧縮されていない距離「Ｄ１」を含む。いくつかの実施形態では、弧状部分２４の頂部２４ｃ、ならびにバックスパン１２の第２の部分２０の中間部分「Ｍ１」（図１を参照）及びバックスパン１２の第３の部分２２の中間部分「Ｍ２」（図１を参照）が、外科用ステープル１００の第１及び第２の脚部１４、１６のうちの少なくとも１つに実質的に平行な、及び／またはバックスパン１２の第２の部分２０の軸「Ｘ１−Ｘ１」及びバックスパン１２の第３の部分２２の軸「Ｘ２−Ｘ２」に実質的に垂直な軸「Ｘ４−Ｘ４」を画定することが想定される。図４Ａ〜４Ｃに例証されるように、組織「Ｔ」と係合すると、バックスパン１２のループ部材１８は、バックスパン１２のループ部材１８が、ループ部材１８の弧状部分２４の頂部２４ｃと、バックスパン１２の第２及び第３の部分２０、２２との間の圧縮距離「Ｄ２」を画定するように、組織「Ｔ」と外科用ステープル器具１０００のアンビルアセンブリ１４００（図５を参照）との間で圧縮される。ステープル１００が変形して、ループ部材１８が第１及び第２の脚部１４とループ部材１８との間に位置付けられた組織「Ｔ」と接触すると、距離「Ｄ２」は、組織「Ｔ」の厚さに直接関係する量だけ減少する。より詳細には、組織の厚さが増加すると、ステープル１００の第１及び第２の脚部１４、１６とループ部材１８との間に位置付けられた組織「Ｔ」によってループ部材１８に加わる力は、ステープル１００が変形するにつれて増加し、ループ部材１８の変形の量を増加させる。
図４Ａは、第１の厚さ「Ｔ１」を有する比較的薄い組織「Ｔ」においてステープル１００が形成される、ステープル１００を例証する。ステープル１００は、厚さ「Ｔ１」を有する比較的薄い組織「Ｔ」の周りで変形すると、組織「Ｔ」は第１及び第２の脚部１４、１６と、ステープル１００のループ部材１８との間で圧縮される。ステープル１００の第１及び第２の脚部１４、１６が、外科用ステープル器具１０００のアンビルアセンブリ１４００に対するＢ構成へ変形されると（図５）、第１及び第２の脚部１４、１６は、バックスパン１２のループ部材１８に向かって、及びバックスパン１２のループ部材１８に対して、組織「Ｔ」を押す。アンビルアセンブリ１４００は、カートリッジアセンブリ１３００から固定された距離に配置されるため、ステープル器具が熱せれると（下記で詳細に説明されるように）、すべての組織「Ｔ」は、第１及び第２の脚部１４、１６と、バックスパン１２のループ部材１８との間に嵌らなければならない。したがって、組織「Ｔ」が比較的薄い場合、第１及び第２の脚部１４、１６が変形し、ループ部材１８への変形がほとんど、または全く起こらないため、組織はあらゆる実質的な力をループ部材１８上に加えない。したがって、ループ部材１８の弧状部分２４の頂部２４ｃと、外科用ステープル１００の第２及び第３の部分２０、２２との間の距離「Ｄ２」は、実質的に変化しない、またはわずかに減少するだけである。組織「Ｔ」が適度な厚さ「Ｔ２」を有する図４Ｂを参照すると、組織「Ｔ」は第１及び第２の脚部１４、１６と、バックスパン１２のループ部材１８との間にさらに空間を必要とする。したがって、第１及び第２の脚部１４、１６がアンビルアセンブリ１４００に対して変形され、組織「Ｔ」がバックスパン１２のループ部材１８に向かって押されると、より大きな力がループ部材１８に加えられて、バックスパン１２のループ部材１８のより大きな量の変形をもたらす。したがって、ループ部材１８の弧状部分２４の頂部２４ｃと、外科用ステープル１００のバックスパン１２の第２及び第３の部分２０、２２との間の距離「Ｄ２」が適度な量だけ減少する。同様に、図４Ｃに示されるように組織「Ｔ」が大きな厚さ「Ｔ３」を有する場合、ステープル１００が変形されると、組織「Ｔ」は、第１及び第２の脚部１４、１６と、バックスパン１２のループ部材１８との間のより大きな空間を必要とする。したがって、第１及び第２の脚部１４、１６がアンビルアセンブリ１４００に対して変形され、組織「Ｔ」がバックスパン１２のループ部材１８に向けて押されると、より大きな力がループ部材１８に加えられて、バックスパン１２のループ部材１８のより大きな量の変形をもたらして、ループ部材１８の弧状部分２４の頂部２４ｃと、外科用ステープル１００のバックスパン１２の第２及び第３の部分２０、２２との間の距離「Ｄ２」をさらに減少させる。
図４Ａ〜４Ｃに例証されるように、バックスパン１２のループ部材１８の弧状部分２４は、組織「Ｔ」の厚さが増加するにつれ、漸進的に、より直線状になることが想定される。組織「Ｔ」の相対的な厚さに従って変形する外科用ステープル１００のバックスパン１２の能力は、効果的な止血を提供しながら、より広い範囲の厚さを有する組織での本開示されるステープルの使用を容易にする。
本開示される外科用ステープル１００を組織「Ｔ」に配置するために、図５に例証されるような、外科用ステープル器具１０００の形状の外科用器具が提供される。外科用ステープル器具１０００は、近似される、及び同様に熱せされ、ならびに他の知られた外科用ステープル器具、例えば、内容全体が参照によって本明細書に組み込まれる米国特許第５，８６５，３６１号に開示された外科用ステープル器具に従う。
図５に例証されるように、外科用ステープル器具１０００は一般的に、可動ハンドル１００３ａ及び固定ハンドル１００３ｂを備えたハンドルアセンブリ１００２と、ハンドルアセンブリ１００２から離れて延びる細長のシャフト１００４と、細長のシャフト１００４の遠位部に連結された装填部１００８と、を含む。本明細書で開示される実施形態のいずれにおいても、ハンドルアセンブリは、１つ以上のモータを含むことができ、または１つ以上のモータに取り付けられることができ、もしくは、外科用ロボットシステムと協働するように構成されることができる。
図６〜８を参照すると、外科用ステープル器具１０００の装填部１００８は、複数の外科用ステープル１００を収容するステープルカートリッジアセンブリ１３００を有するツールアセンブリ１２００（図８を参照）と、ツールアセンブリ１２００が、ステープルカートリッジアセンブリ１３００がアンビルアセンブリ１４００から離間している開構成（図６を参照）と、ステープルカートリッジアセンブリ１３００及びアンビルアセンブリ１４００が近似される締付構成（図７を参照）との間を移動できるように、ステープルカートリッジアセンブリ１３００に対して移動可能に固定されたアンビルアセンブリ１４００と、を含む。代替的に、カートリッジアセンブリ１３００は、アンビルアセンブリ１４００に対して移動可能に支持されることができる。
次に図８を参照すると、ステープルカートリッジアセンブリ１３００は、細長の支持通路１３１２を有するキャリア１３１０を含む。細長の支持通路１３１２は、ステープルカートリッジ１３１４を受ける寸法にされ、ステープルカートリッジ１３１４を受ける構成にされる。ステープルカートリッジアセンブリ１３００は、ツールアセンブリ１２００のステープルカートリッジアセンブリ１３００とアンビルアセンブリ１４００（図１５及び１６を参照）との間に位置付けられた組織「Ｔ」に一定の圧縮力を加え、維持するように構成された、及び寸法にされた一対の細長の、または弾性の部材１３１６ａ、１３１６ｂを含む。実施形態では、一対の細長の、または弾性の部材１３１６ａ、１３１６ｂは、ステープルカートリッジ１３１４と、キャリア１３１０上に形成された一対の肩部１３１８ａ、１３１８ｂそれぞれとの間に位置付けられた、２つの実質的に平行で、細長の部材として構成されてもよい。一対の弾性部材１３１６ａ、１３１６ｂは、キャリア１３１０の一対の肩部１３１８ａ、１３１８ｂに取り付けられてもよく、または配置されてもよく、代替の実施形態では、キャリア１３１０の一対の肩部１３１８ａ、１３１８ｂに固定して、または解放可能に取り付けられてもよい。一対の弾性部材１３１６ａ、１３１６ｂは、カートリッジアセンブリ１３００とアンビルアセンブリ１４００との間で異なる厚さの組織を圧縮して対応するように構成される。一対の弾性部材１３１６ａ、１３１６ｂの例の構造及び動作のさらに詳細な説明については、内容全体が参照によって本明細書に組み込まれる米国特許第８，１５２，０４１号を参照されたい。
ステープルカートリッジアセンブリ１３００のステープルカートリッジ１３１４は、列で並べられた複数のステープルポケット１３２０を含む。複数のステープルポケット１３２０は、下記で詳細が述べられるように、複数の外科用ステープル１００及び複数のプッシャー１３２２を受けるための寸法にされる。ステープルカートリッジアセンブリ１３００は、キャリア１３１０の細長の支持通路１３１２内に移動可能に支持された作動スレッド１３２４を含む。動作中、作動スレッド１３２４は、複数のプッシャー１３２２が複数のステープルポケット１３２０内で変位されて、複数の外科用ステープル１００を複数のステープルポケット１３２０からアンビルアセンブリ１４００に向けて排出するように、キャリア１３１０の細長の支持通路１３１２に沿って前進して、複数のプッシャー１３２２を順に接触させるように構成される。
図１〜４Ｃを参照して上記で詳細が述べられたように、バックスパン１２の第２の部分２０の軸「Ｘ１−Ｘ１」及びバックスパン１２の第３の部分２２の軸「Ｘ２−Ｘ２」は、互いからオフセット距離「ＯＤ」だけ横方向にオフセットされる。外科用ステープル１００のバックスパン１２の横方向のオフセット配向に対して補償し、複数の外科用ステープル１００の各々の第１及び第２の脚部１４、１６が、外科用ステープル１００の対応する列における他の複数の外科用ステープル１００に対して縦に整列されることを確実にするために、ステープルカートリッジ１３１４の複数のステープルポケット１３２０及び複数のプッシャー１３２２の複数のステープルシート１３２６は、下記で詳細が述べられるような寸法にされ、及び形状にされる。
詳細には、図９〜１１を参照すると、ステープルカートリッジ１３１４の複数のステープルポケット１３２０の各々は、図３における外科用ステープル１００の上面図において示されるような外科用ステープル１００の配向に対応する外形「Ｃ」を含む。ステープルカートリッジ１３１４のステープルポケット１３２０の外形「Ｃ」は、外科用ステープル１００の第１の脚部１４を受ける形状にされ、及び寸法にされた第１の部分「Ｃ１」と、外科用ステープル１００の第２の脚部１６を受ける形状にされ、及び寸法にされた第２の部分「Ｃ２」と、外科用ステープル１００のバックスパン１２を受ける形状にされ、及び寸法にされた、第１の部分「Ｃ１」と第２の部分「Ｃ２」との間に位置付けられた中間部分「Ｃ３」と、を含む。ステープルカートリッジ１３１４の複数のステープルポケット１３２０は、複数の外科用ステープル１００の各々の第１及び第２の脚部１４、１６が、外科用ステープル１００の対応する列における他の複数の外科用ステープル１００に対して縦方向に整列されるように、ステープルカートリッジ１３１４の縦軸「Ａ−Ａ」に対して斜めに位置付けられる。
図１２〜１４を参照すると、複数のプッシャー１３２２の複数のステープルシート１３２６の各々は、外科用ステープル１００のバックスパン１２を解放可能に受けるために適合される。図１４に例証されるように、プッシャー１３２２のステープルシート１３２６は、プッシャー１３２２の縦軸「Ｂ−Ｂ」に対して斜めに位置付けられる。図１０、１５、及び１６に例証されるように、プッシャー１３２２のステープルシート１３２６の斜めの構成は、外科用ステープル１００がステープルポケット１３２０を通してアンビルアセンブリ１４００へ向けて排出されると、外科用ステープル１００を、ステープルカートリッジ１３１４の斜めに位置付けられたステープルポケット１３２０と整列させるように適合されることが想定される。詳細には、プッシャー１３２２のステープルシート１３２６は、ステープルシート１３２６の第１の部分１３２６ｂから、ステープルカートリッジ１３１４のステープルポケット１３２０へ向けて突出する第１の壁１３２６ａと、ステープルシート１３２６の第２の部分１３２６ｄから、ステープルカートリッジ１３１４のステープルポケット１３２０へ向けて突出する第２の壁１３２６ｃと、を含む。プッシャー１３２２のステープルシート１３２６の第１及び第２の壁１３２６ａ、１３２６ｃは、プッシャー１３２２のステープルシート１３２６の第１及び第２の部分１３２６ｂ、１３２６ｄ間を延びる斜めの通路１３２８を画定する。ステープルシート１３２６の斜めの通路１３２８は、プッシャー１３２２の縦軸「Ｂ−Ｂ」に対して斜めに位置付けられる。
外科用ステープル１００がプッシャー１３２２のステープルシート１３２６上に置かれる場合、ステープルシート１３２６の第１の壁１３２６ａは、バックスパン１２の第２の部分２０を係合するように構成され、ステープルシート１３２６の第２の壁１３２６ｂは、バックスパン１２の第３の部分２２を係合して、外科用ステープル１００のバックスパン１２を解放可能に受けるように構成される。図１３及び１４に例証されるように、ステープルシート１３２６の斜めの通路１３２８はプッシャー１３２２の縦軸「Ｂ−Ｂ」に対して斜めに位置付けられるため、外科用ステープル１００がプッシャー１３２２のステープルシート１３２６上に置かれる場合、外科用ステープル１００はプッシャー１３２２の縦軸「Ｂ−Ｂ」に対して斜めに位置付けられることが想定される。
図８、９、１５及び１６を次に参照すると、実施形態では、複数のステープルポケット１３２０は、ステープルカートリッジアセンブリ１３００のステープルカートリッジ１３１４を貫通するナイフスロット１３３０の横側に列で並べられる。ナイフスロット１３３０は、ナイフ１３３２、またはステープルカートリッジアセンブリ１３００とアンビルアセンブリ１４００との間に配置された組織「Ｔ」（図４Ａ〜４Ｃを参照）を切断する他のこのような切断要素の移動に対応するように構成される。実施形態では、図８に例証されるように、ナイフスロット１３３０は、ステープルカートリッジアセンブリ１３００のステープルカートリッジ３１４の中央線「ＣＬ」に沿って伸びてもよい。代替的に、ナイフスロット１３３０は、ステープルカートリッジアセンブリ１３００のステープルカートリッジ１３１４の中央線「ＣＬ」から横方向にオフセットされてもよい。
図１５及び１６を参照すると、アンビルアセンブリ１４００は、ナイフ１３３２の移動に対応するように構成されたアンビルアセンブリ１４００の組織に面する面１４０４上の対応するナイフスロット１４０２を含む。実施形態では、ナイフ１３３２は、ナイフ１３３２の上部１３３２ａがアンビルアセンブリ１４００のナイフスロット１４０２内で移動可能に配置され、ナイフ１３３２の底部１３３２ｂがステープルカートリッジアセンブリ１３００のステープルカートリッジ１３１４のナイフスロット１３３０内で移動可能に配置される、Ｉ形梁構成を含む。本明細書で開示されるいずれの実施形態でも、ナイフは他の形状を有することができ、もしくはスレッドの部分であることができる、またはスレッドに取り付けられることができる。
図１５及び１６を続けて参照すると、ナイフ１３３２は、高さ「Ｈ」を含む。ステープルカートリッジアセンブリ１３００及びアンビルアセンブリ１４００が近似され、ナイフ１３３２が各ナイフスロット１３３０、１４０２を取って並進させられる場合、ナイフ１３３２の高さ「Ｈ」は、ステープルカートリッジアセンブリ１３００と、アンビルアセンブリ１４００との間に配置された組織「Ｔ」（図４Ａ〜４Ｃを参照）の厚さに関わらず、かつ、ステープルカートリッジ１３１４の位置付けに関わらず、アンビルアセンブリ１４００と、複数のプッシャー１３２２の複数のステープルシート１３２６の各々との間の一定の距離「Ｄ３」を提供する。ナイフ１３３２が各ナイフスロット１３３０、１４０２を通って並進させられる場合、ナイフ１３３２の高さ「Ｈ」は、最大の組織間隔も提供する。
図５〜１６を次に参照すると、動作において、外科用ステープル器具１０００は、開構成で（図６を参照）、組織「Ｔ」がステープルカートリッジアセンブリ１３００とアンビルアセンブリ１４００との間に配置され、ツールアセンブリ１２００から離間されるように操作される。次にステープルカートリッジアセンブリ１３００及びアンビルアセンブリ１４００は、ハンドルアセンブリ１００２の可動ハンドル１００３Ａを作動することによって近似され、圧縮力が組織「Ｔ」に加えられるように、ステープルカートリッジアセンブリ１３００とアンビルアセンブリ１４００との間に配置された組織「Ｔ」を締め付ける。
組織「Ｔ」がステープルカートリッジアセンブリ１３００とアンビルアセンブリ１４００との間に固定して締め付けられた状態で、次に、可動ハンドル１００３Ａを作動することによって外科用ステープル器具１０００が熱せられて、複数の外科用ステープル１００が排出される。外科用ステープル器具１０００を熱すると、作動スレッド１３２４（図８）は、キャリア１３１０の細長の支持通路１３１２に沿って前進して、複数のプッシャー１３２２が複数のステープルポケット１３２０内で変位されて複数の外科用ステープル１００を複数のステープルポケット１３２０からアンビルアセンブリ１４００に向けて排出するように、複数のプッシャー１３２２に順に接触する。
複数の外科用ステープル１００は、ステープルカートリッジ１３１４の複数のステープルポケット１３２０を通り過ぎて（図８を参照）、組織「Ｔ」を通る。組織「Ｔ」を通り過ぎた後、複数の外科用ステープル１００はアンビルアセンブリ１４００の組織に面する面１４０４を係合して、実質的にＢステープル構成（図４Ａ〜４Ｃを参照）へと変形される。組織「Ｔ」内で形成されると、複数の外科用ステープル１００は組織「Ｔ」への圧縮力を維持して、止血させる。
外科用ステープル１００を順に熱することは、作動スレッド１３２４がステープルカートリッジ１３１４の遠位端まで前進されるまで継続し、その時、ステープルカートリッジ１３１４に収容されたすべての複数の外科用ステープル１００が排出される。次にナイフ１３３２がツールアセンブリ１２００を通って並進されて、ステープルされた組織「Ｔ」の列間の切開を形成する。
本明細書で開示されるいずれの実施形態でも、ツールアセンブリは、ハンドルアセンブリの細長の部分に組み込まれることができる。ステープルカートリッジは、交換可能な装填部もしくはツールアセンブリまたは組み込まれたツールアセンブリを備えた器具における、除去可能な、及び交換可能なアセンブリであることができる。
本明細書で説明される外科用ステープルは、バックスパンが変形されることが意図されない構成において利用されることができる。特定の実施形態では、バックスパンは、変形可能なバックスパン、または変形可能ではないバックスパンで、材料または物体を収容するように構成されることができる。その材料または物体は、止血剤または封止剤などの医療用の有用な材料、化学療法剤などの医薬品、及び小線源治療粒子またはシードなどの放射性医薬品でさえも含むことができる。このような材料または物体は、ループ部材によって形成された開口に配置されることができる、またはループ部材に配置されたメッシュの、織られた、編まれた、不織の材料、または縫合に組み込まれることができる。
本明細書で開示された実施形態に様々な修正がされてもよいことが理解されるであろう。例えば、上記で説明されたステープルは、チタン、プラスチック、吸収性材料などを含む様々な任意の外科用の許容可能な材料から形成されてもよい。したがって、上記の説明は、限定として解釈されるべきではなく、単に好ましい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及び趣旨内での他の修正を想定するであろう。

Claims (21)

  1. 本体を備える外科用ステープルであって、
    前記本体が、
    第１の端部及び第２の端部を有する第１の脚部と、
    第１の端部及び第２の端部を有する第２の脚部と、
    バックスパンと、を含み、前記バックスパンが、
    ループ部材を有する第１の部分であって、前記ループ部材が第１の端部及び第２の端部を含む、第１の部分と、
    前記第１の脚部の前記第１の端部と、前記ループ部材の前記第１の端部との間を延びる第２の部分と、
    前記第２の脚部の前記第１の端部と、前記ループ部材の前記第２の端部との間を延びる第３の部分と、を含み、前記バックスパンの前記第２の部分と、前記バックスパンの前記第３の部分とが横方向に接触している、外科用ステープル。
  2. 前記バックスパンの前記第２の部分が、前記バックスパンの前記第３の部分に平行な方向に延びる、請求項１に記載の外科用ステープル。
  3. 前記バックスパンの前記ループ部材が、前記バックスパンの前記第２の部分と、前記バックスパンの前記第３の部分との間を横に延びる、請求項１に記載の外科用ステープル。
  4. 前記バックスパンの前記ループ部材が、前記バックスパンの前記第２の部分の第１の端部と、前記バックスパンの前記第３の部分の第１の端部との間を延びる軸を画定する、請求項３に記載の外科用ステープル。
  5. 前記バックスパンの前記第２の部分が第１の軸を画定し、前記バックスパンの前記第３の部分が第２の軸を画定し、前記第２の部分の前記第１の軸は前記第３の部分の前記第２の軸から横方向にオフセットされて、前記第２の部分の前記第１の軸と前記第３の部分の前記第２の軸との間のオフセット距離を画定する、請求項１に記載の外科用ステープル。
  6. 前記バックスパンの前記ループ部材は頂部を含み、前記バックスパンの前記第２の部分は第１の中間部分を含み、前記バックスパンの前記第３の部分は第２の中間部分を含み、前記ループ部材の前記頂部ならびに前記バックスパンの前記第２及び第３の部分の前記第１及び第２の中間部分が、前記第２の部分の前記第１の軸及び前記第３の部分の前記第２の軸に垂直な軸を画定する、請求項３に記載の外科用ステープル。
  7. 前記第２の部分の前記第１の軸と、前記第３の部分の前記第２の軸との間の前記オフセット距離が、前記外科用ステープルの前記本体の直径に等しい、請求項５に記載の外科用ステープル。
  8. 前記外科用ステープルが未形成構成及び形成構成を含み、前記外科用ステープルの前記未形成構成において、前記バックスパンの前記ループ部材の前記頂部が、前記バックスパンの前記第２の部分及び前記第３の部分の各々から第１の距離だけ離間しており、前記外科用ステープルの前記形成構成において、前記バックスパンの前記ループ部材の前記頂部が、前記バックスパンの前記第２の部分及び前記第３の部分の各々から前記未形成構成の前記第１の距離より少ない第２の距離だけ離間している、請求項６に記載の外科用ステープル。
  9. 前記外科用ステープルは、組織と係合すると前記未形成構成から形成構成へ変形可能であり、前記外科用ステープルの前記形成構成において、前記バックスパンの前記ループ部材の前記頂部と、前記バックスパンの前記第２の部分及び前記第３の部分の各々との間の前記第２の距離が、前記バックスパンによって係合された組織の厚さが増加するにつれて減少する、請求項８に記載の外科用ステープル。
  10. 前記外科用ステープルの前記形成構成において、前記第１の脚部は前記ループ部材の第１の横側に位置付けられ、前記第２の脚部は、前記ループ部材の前記第１の横側とは反対の前記ループ部材の第２の横側に位置付けられる、請求項８に記載の外科用ステープル。
  11. 本体を備える外科用ステープルであって、前記本体が、
    第１の端部及び第２の端部を有する第１の脚部と、
    第１の端部及び第２の端部を有する第２の脚部と、
    バックスパンと、を含み、前記バックスパンが、
    ループ部材を有する第１の部分であって、前記ループ部材が第１の端部及び第２の端部を含む、第１の部分と、
    前記第１の脚部の前記第１の端部と、前記ループ部材の前記第１の端部との間を縦に延びる第２の部分と、
    前記第２の脚部の前記第１の端部と、前記ループ部材の前記第２の端部との間を縦に延びる第３の部分と、を含み、前記バックスパンの前記第２の部分が、前記バックスパンの前記第３の部分の近くに整列されて位置付けられる、外科用ステープル。
  12. 前記バックスパンの前記第２の部分が、前記バックスパンの前記第３の部分に平行である、請求項１１に記載の外科用ステープル。
  13. 前記バックスパンの前記ループ部材は頂部を含み、前記バックスパンの前記第２の部分は第１の中間部分を含み、前記バックスパンの前記第３の部分は第２の中間部分を含み、前記ループ部材の前記頂部ならびに前記バックスパンの前記第２及び第３の部分の前記第１及び第２の中間部分が、前記第１の脚部及び前記第２の脚部のうちの少なくとも１つに平行な軸を画定する、請求項１２に記載の外科用ステープル。
  14. 前記外科用ステープルは、未形成構成から形成構成へ変形可能であり、前記外科用ステープルの前記形成構成において、前記第１の脚部の前記第２の端部は前記バックスパンの前記ループ部材の第１の横側に位置付けられ、前記第２の脚部の前記第２の端部は、前記バックスパンの前記ループ部材の前記第１の横側とは反対の前記バックスパンの前記ループ部材の第２の横側に位置付けられる、請求項１３に記載の外科用ステープル。
  15. 前記バックスパンの前記第２の部分と、前記バックスパンの前記第３の部分とは横方向に接触している、請求項１１に記載の外科用ステープル。
  16. 外科用ステープル器具と使用するためのステープルカートリッジアセンブリであって、前記ステープルカートリッジアセンブリが、
    互いから離された関係性で支持される複数の外科用ステープルであって、前記複数の外科用ステープルの各々が、
    第１の端部及び第２の端部を有する第１の脚部、
    第１の端部及び第２の端部を有する第２の脚部、ならびに
    バックスパン、を含み、前記バックスパンが、
    ループ部材を有する第１の部分であって、前記ループ部材が第１の端部及び第２の端部を含む、第１の部分、
    前記第１の脚部の前記第１の端部と、前記ループ部材の前記第１の端部との間を延びる第２の部分、ならびに
    前記第２の脚部の前記第１の端部と、前記ループ部材の前記第２の端部との間を延びる第３の部分、を含む、複数の外科用ステープルと、
    列で配置され、前記ステープルカートリッジの縦軸に対して斜めに位置付けられた複数のステープルポケットを有するステープルカートリッジであって、前記複数のステープルポケットの各々が、前記複数の外科用ステープルの各々の前記第１の脚部及び前記第２の脚部が他の前記複数の外科用ステープルの各々の前記第１の脚部及び前記第２の脚部に対して縦に整列されるように、前記複数の外科用ステープルのうちの少なくとも１つを受けるように構成される、ステープルカートリッジと、
    複数のプッシャーであって、前記複数のプッシャーの各々が前記複数のステープルポケットのうちの各１つに関連付けられ、前記複数のプッシャーの各々が、前記複数のステープルポケットのうちの各１つから、前記複数の外科用ステープルのうちの１つを前進させるように構成された、複数のプッシャーと、を備える、ステープルカートリッジアセンブリ。
  17. 前記複数のステープルポケットの各々が、前記外科ステープルの前記第１の脚部を受ける形状にされ、及び寸法にされた第１のセグメントと、前記外科ステープルの前記第２の脚部を受ける形状にされ、及び寸法にされた第２のセグメントと、前記外科ステープルの前記バックスパンを受ける形状にされ、及び寸法にされた中間セグメントと、を有する外形を含み、前記複数のステープルポケットの各々の外形が、前記ステープルカートリッジの前記縦軸に対して斜めに位置付けられる、請求項１６に記載のステープルカートリッジアセンブリ。
  18. 前記複数のプッシャーの各々が、前記複数の外科用ステープルの各々の各バックスパンを解放可能に受けるように構成されたステープルシートを含み、前記ステープルシートが前記複数のプッシャーの各々の縦軸に対して斜めに位置付けられ、前記複数のプッシャーの各々の前記ステープルシートが、前記複数の外科用ステープルの各々を前記ステープルカートリッジの前記複数のステープルポケットの各々と整列させるように適合された、請求項１６に記載のステープルカートリッジアセンブリ。
  19. 前記複数のプッシャーの各々の前記ステープルシートが、前記ステープルシートの第１の部分から突出する第１の壁と、前記ステープルシートの第２の部分から突出する第２の壁とを含み、前記第１の壁及び前記第２の壁は、前記ステープルシートの前記第１の部分と、前記ステープルシートの前記第２の部分との間を延びる斜めの通路を画定し、前記斜めの通路は、前記プッシャーの前記縦軸に対して斜めに位置付けられる、請求項１８に記載のステープルカートリッジアセンブリ。
  20. 前記複数のプッシャーの各々の前記ステープルシートの前記斜めの通路が、前記複数の外科用ステープルの各々が前記複数のプッシャーの各々の前記ステープルシート上で前記複数のプッシャーの各々の前記縦軸に対して斜めに位置付けられるように、前記複数の外科用ステープルの各々の各バックスパンを解放可能に受けるように適合される、請求項１９に記載のステープルカートリッジアセンブリ。
  21. 前記複数の外科用ステープルの各々が前記複数のプッシャーの各々の各ステープルシート上に位置付けられる場合、各ステープルシートの前記第１の壁は、前記複数の外科用ステープルの各々の前記各バックスパンの前記第２の部分を係合するように構成され、前記各ステープルシートの前記第２の壁は、前記複数の外科用ステープルの各々の前記各バックスパンの前記第３の部分を係合して、前記複数の外科用ステープルの各々の前記各バックスパンを解放可能に受けるように構成される、請求項１９に記載のステープルカートリッジアセンブリ。
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US10524784B2 (en) 2020-01-07
US20220257243A1 (en) 2022-08-18
EP4070737A1 (en) 2022-10-12
US20200129175A1 (en) 2020-04-30
EP3406202B1 (en) 2022-06-29
US20180317907A1 (en) 2018-11-08
CA3022047A1 (en) 2019-05-09

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