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JP7136591B2 - 最小のデッドスペースを有するツールアセンブリ - Google Patents

最小のデッドスペースを有するツールアセンブリ Download PDF

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JP7136591B2
JP7136591B2 JP2018099654A JP2018099654A JP7136591B2 JP 7136591 B2 JP7136591 B2 JP 7136591B2 JP 2018099654 A JP2018099654 A JP 2018099654A JP 2018099654 A JP2018099654 A JP 2018099654A JP 7136591 B2 JP7136591 B2 JP 7136591B2
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actuation sled
stapling device
surgical stapling
tool assembly
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ニコラス デイビッド
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コヴィディエン リミテッド パートナーシップ
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07207Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/00071Insertion part of the endoscope body
    • A61B1/0008Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087Tools
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00353Surgical instruments, devices or methods for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00681Aspects not otherwise provided for
    • A61B2017/00734Aspects not otherwise provided for battery operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07278Stapler heads characterised by its sled or its staple holder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • A61B2017/2927Details of heads or jaws the angular position of the head being adjustable with respect to the shaft

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
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  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgical Instruments (AREA)

Description

本開示は、外科用ステープル留めデバイスを対象とし、より具体的には、ナイフクランプ部材及び作動スレッドを含むアセンブリを有する関節運動ツールアセンブリを含む、内視鏡外科用ステープル留めデバイスを対象とする。
背景
内視鏡用の外科用ステープル留めデバイスは既知であり、開クランプ位置と近接位置との間で互いに対して可動である一対のジョーを有するツールアセンブリを含む。典型的には、ツールアセンブリの一方のジョーが、複数のステープルを有するステープルカートリッジを支持し、ツールアセンブリの他方のジョーが、アンビルアセンブリを支持する。ツールアセンブリは、外科用ステープル留めデバイスの細長い本体の遠位部に支持される。既知のステープル留めデバイスにおいて、内視鏡外科処置中の患者内の組織へのアクセスを改善するために、ツールアセンブリは、細長い本体の遠位部に支持される。
内視鏡用のリニア外科用ステープル留めデバイスは、ナイフ及び作動スレッドを支持する駆動部材を含む。作動スレッドは、ステープルカートリッジ内の駆動部材の遠位に位置付けられ、駆動部材がステープルカートリッジを通して前進するにつれて、後退位置から前進位置へと駆動部材によって駆動される。作動スレッドは、作動スレッドが前進位置に向かって動くにつれて、ステープルカートリッジからステープルを順次射出するように構成される。ツールアセンブリのジョーはまた、ステープルカートリッジのステープルの位置の近位にある位置のジョーの対によって画定される組織間隙内に組織が位置付けられることを防止する、組織止めも含んでもよい。作動スレッドは、組織の切断に先立って組織内でのステープルの形成を容易にするために、駆動部材のナイフの遠位に位置付けられる。
典型的には、駆動部材は、ツールアセンブリのジョーを開位置から近接位置またはクランプ位置に動かすために、かつツールアセンブリのジョー間に画定される組織間隙のサイズを制限するために、I型梁などのクランプ構造を含む。そのようなデバイスにおいて、駆動部材は、作動スレッドの近位かつ組織止めの近位に位置付けられるため、ツールアセンブリの近位部は、相当量のデッドスペース、すなわち、ステープル留めまたは切断動作の実行に使用不能なツールアセンブリ上のスペースを含む。関節運動するツールアセンブリを有する外科用ステープル留めデバイスにおいて、デッドスペースは、ツールアセンブリの関節運動軸または枢動点から組織止めまで延びる。このデッドスペースは、ツールアセンブリの全長を増加させる。ツールアセンブリの全長の増加は、内視鏡外科処置中の体腔内の領域へのツールアセンブリのアクセスを制限する。
関節運動ツールアセンブリを有する内視鏡外科用ステープル留めデバイスのツールアセンブリのデッドスペースの長さを最小にし、内視鏡外科処置中の患者の体腔内の組織への改善されたアクセスを提供することが望ましいだろう。
本開示の一態様において、外科用ステープル留めデバイスは、細長い本体と、細長い本体の遠位部に支持されたツールアセンブリとを含む。ツールアセンブリは、離間位置と近接位置との間で互いに対して可動であるカートリッジアセンブリ及びアンビルアセンブリを含む。カートリッジアセンブリは、複数のステープルを支持するステープルカートリッジと、ナイフを支持する本体を有するクランプ部材と、第1の部分及び第2の部分を有する作動スレッドとを含む。作動スレッドの第1及び第2の部分の各々は、カム部材を画定する。作動スレッドの第2の部分は、作動スレッドの第1の部分から物理的に分離かつ離間されて、第1の部分と第2の部分との間のチャネルを画定する。外科用ステープル留めデバイスの作動前状態において、クランプ部材のナイフが、作動スレッドの第1及び第2の部分のカム部材の近位端の遠位に位置付けられるように、クランプ部材は、作動スレッドの第1の部分と第2の部分との間に画定されるチャネル内に位置付けられる。外科用ステープル留めデバイスの発射ストロークの少なくとも一部の間、クランプ部材は、ナイフをカム部材の近位に位置付けるために可動である。
実施形態において、作動スレッドの第1及び第2の部分の各々のカム部材は、第1及び第2のカム部材を含む。
いくつかの実施形態において、クランプ部材は、垂直支柱、上部梁、及び下部梁を含み、作動前状態において、垂直支柱は、チャネルの近位部内に位置付けられる。
特定の実施形態において、作動スレッドの第1及び第2の部分の各々は、長手方向に延びる部分及び横断部を有する内壁を含む。
実施形態において、作動スレッドの第1及び第2の部分の各々の内壁の長手方向に延びる部分は、クランプ部材の経路内へチャネル内に延びる内側に延びる弾性突出を含み、作動前状態において、クランプ部材は、弾性突出と係合して、弾性突出をチャネル内から付勢するように位置付けられる。
いくつかの実施形態において、発射ストロークは、クランプ部材の遠位面が作動スレッドの第1及び第2の部分の内壁の横断部と係合して、作動スレッドをツールアセンブリ内で遠位に動かすように位置付けられる、第1の前進ステージを含む。
特定の実施形態において、弾性突出がチャネル内へと動くように、発射ストロークは、クランプ部材がチャネル内で近位に動いて、クランプ部材の遠位面を作動スレッドの第1及び第2の部分の弾性突出の近位に位置付ける、後退ステージを含む。
実施形態において、カートリッジアセンブリは、弾性突起を有する支持板を含み、クランプ部材が作動前状態にあるとき、作動スレッドは、弾性突起の上に位置付けられて、弾性突起をチャネル内から付勢し、ステープル留めデバイスが発射ストロークの第1の前進ステージを通して動かされるとき、弾性突起が発射ストロークの後退ステージの間のツールアセンブリ内での作動スレッドの近位方向の運動を防止するように、スレッドは、弾性突起の遠位に位置付けられる。
いくつかの実施形態において、クランプ部材は、作動前状態において弾性突出と係合するように位置付けられる、対向した側方に延びる平面を有する基部を有する。
特定の実施形態において、クランプ部材の基部は、側方に延びる平面の近位部に位置付けられる近位停止部材を含む。
実施形態において、クランプ部材は、ねじ付き穴を画定し、外科用ステープル留めデバイスは、ねじ付き駆動部材を更に含み、ねじ付き駆動部材の回転がクランプ部材の軸方向の運動を引き起こすように、ねじ付き駆動部材は、ねじ付き穴内に受け入れられる。
本開示の別の態様において、外科用ステープル留めデバイスは、細長い本体と、細長い本体の遠位部に支持されたツールアセンブリとを含む。ツールアセンブリは、離間位置と近接位置との間で互いに対して可動であるカートリッジアセンブリ及びアンビルアセンブリを含む。カートリッジアセンブリは、複数のステープルを支持するステープルカートリッジと、ナイフを支持する本体を有するクランプ部材と、第1及び第2の離間したカム部材を有する作動スレッドとを含む。第1及び第2の離間したカム部材は、それらの間にチャネルを画定する。第1及び第2のカム部材の各々は、内部カム部材及び外部カム部材を含む。内部カム部材は、内側に延びる突起を支持する屈曲部を含み、屈曲部は、側方に屈曲して、クランプ部材がチャネル内からチャネルの近位位置へと近位に動くことを可能にする。
実施形態において、内側に延びる突起は、チャネル内に延びて、クランプ部材のチャネル内での運動を妨げる。
いくつかの実施形態において、内側に延びる突起は、細くなった遠位向き表面を有する。
特定の実施形態において、外科用ステープル留めデバイスの作動前状態において、クランプ部材は、作動スレッドのチャネル内に位置付けられ、クランプ部材のナイフは、作動スレッドの第1及び第2のカム部材の近位端の遠位に位置付けられ、外科用ステープル留めデバイスの発射ストロークの少なくとも一部の間、クランプ部材は、ナイフを第1及び第2のカム部材の近位に位置付けるために可動である。
実施形態において、ステープルカートリッジは、長手方向の軸を画定し、中央ナイフスロットは、長手方向の軸に沿って延び、外部及び内部カムスロットは、中央ナイフスロットの各側に位置付けられ、外部及び内部カム部材はそれぞれ、外部及び内部カムスロット内に受け入れられる。
いくつかの実施形態において、外科用デバイスの作動前状態において、内部及び外部カム部材が、中央ナイフスロットから離れるステープルカートリッジの長手方向の軸と整列しない位置への方向に外向きに角度付けされるように、作動スレッドが作動前位置にあるとき、作動スレッドの内部及び外部カム部材は、内部及び外部カムスロットの近位端を越えて延びる。
特定の実施形態において、作動スレッドは、内部カム部材の遠位端を互いに相互接続するクロス部材を含む。
実施形態において、外科用ステープル留めデバイスは、発射ストロークを通して可動であり、発射ストロークは、クランプ部材の遠位面が作動スレッドのクロス部材と係合して、作動スレッドをツールアセンブリ内で遠位に前進させるように位置付けられる、第1の前進ステージを含む。
いくつかの実施形態において、発射ストロークは、クランプ部材がチャネル内から近位に動いて、内部カム部材の屈曲部上の内側に延びる突起と係合して、屈曲部を整列しない位置へと動かし、クランプ部材が作動スレッドのチャネル外に動くことを可能にする、後退ステージを含む。
本願明細書は、例えば、以下の項目も提供する。
(項目1)
外科用ステープル留めデバイスであって、
細長い本体と、
上記細長い本体の遠位部に支持されたツールアセンブリと、を備え、上記ツールアセンブリが、離間位置と近接位置との間で互いに対して可動であるカートリッジアセンブリ及びアンビルアセンブリを含み、上記カートリッジアセンブリが、複数のステープルを支持するステープルカートリッジ、ナイフを支持する本体を有するクランプ部材、ならびに第1の部分及び第2の部分を有する作動スレッドを含み、上記作動スレッドの上記第1及び第2の部分の各々が、カム部材を画定し、上記作動スレッドの上記第2の部分が、上記作動スレッドの上記第1の部分から物理的に分離かつ離間されて、上記第1及び第2の部分の間のチャネルを画定し、上記外科用ステープル留めデバイスの作動前状態において、上記クランプ部材が、上記作動スレッドの上記第1及び第2の部分の間の上記チャネル内に位置付けられ、上記クランプ部材の上記ナイフが、上記作動スレッドの上記第1及び第2の部分の上記カム部材の近位端の遠位に位置付けられ、上記外科用ステープル留めデバイスの発射ストロークの少なくとも一部の間、上記クランプ部材が、上記ナイフを上記カム部材の近位に位置付けるために可動である、上記外科用ステープル留めデバイス。
(項目2)
上記作動スレッドの上記第1及び第2の部分の各々の上記カム部材が、第1及び第2のカム部材を含む、上記項目に記載の外科用ステープル留めデバイス。
(項目3)
上記クランプ部材が、垂直支柱、上部梁、及び下部梁を含み、上記作動前状態において、上記垂直支柱が、上記チャネルの近位部内に位置付けられる、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目4)
上記作動スレッドの上記第1及び第2の部分の各々が、長手方向に延びる部分及び横断部を含む内壁を含む、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目5)
上記作動スレッドの上記第1及び第2の部分の上記内壁の上記長手方向に延びる部分が、上記クランプ部材の経路内へ上記チャネル内に延びる、内側に延びる弾性突出を含み、上記作動前状態において、上記クランプ部材が、上記弾性突出と係合して、上記弾性突出を上記チャネル内から付勢するように位置付けられる、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目6)
上記発射ストロークが、上記クランプ部材の遠位面が上記作動スレッドの上記第1及び第2の部分の上記内壁の上記横断部と係合して、上記作動スレッドを上記ツールアセンブリ内で遠位に動かすように位置付けられる、第1の前進ステージを含む、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目7)
上記弾性突出が上記チャネル内へと動くように、上記発射ストロークが、上記クランプ部材が上記チャネル内で近位に動いて、上記クランプ部材の上記遠位面を上記作動スレッドの上記第1及び第2の部分の上記弾性突出の近位に位置付ける、後退ステージを含む、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目8)
カートリッジアセンブリが、弾性突起を有する支持板を含み、上記クランプ部材が上記作動前状態にあるとき、上記作動スレッドが、上記弾性突起の上に位置付けられて、上記弾性突起を上記チャネル内から付勢し、上記ステープル留めデバイスが上記発射ストロークの上記第1の前進ステージを通して動かされるとき、上記弾性突起が上記ステープル留めデバイスの上記後退ステージの間の上記作動スレッドの近位方向の運動を防止するように、上記作動スレッドが、上記弾性突起の遠位に位置付けられる、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目9)
上記クランプ部材が、上記作動前状態において上記弾性突出と係合するように位置付けられる、対向した側方に延びる平面を有する基部を有する、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目10)
上記クランプ部材の上記基部が、上記側方に延びる平面の近位部に位置付けられる近位停止部材を含む、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目11)
クランプ部材が、ねじ付き穴を画定し、上記外科用ステープル留めデバイスが、ねじ付き駆動部材を更に含み、上記ねじ付き駆動部材の回転が上記クランプ部材の軸方向の運動を引き起こすように、上記ねじ付き駆動部材が、上記ねじ付き穴内に受け入れられる、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目12)
外科用ステープル留めデバイスであって、
細長い本体と、
上記細長い本体の遠位部に支持されたツールアセンブリと、を備え、上記ツールアセンブリが、離間位置と近接位置との間で互いに対して可動であるカートリッジアセンブリ及びアンビルアセンブリを含み、上記カートリッジアセンブリが、複数のステープルを支持するステープルカートリッジ、ナイフを支持する本体を有するクランプ部材、ならびに第1及び第2の離間したカム部材を有する作動スレッドを含み、上記第1及び第2の離間したカム部材が、それらの間にチャネルを画定し、上記第1及び第2の離間したカム部材の各々が、内部カム部材及び外部カム部材を含み、上記内部カム部材の各々が、内側に延びる突起を支持する屈曲部を含み、上記屈曲部が、側方に屈曲して、上記クランプ部材が上記チャネル内から上記チャネルの近位位置へと近位に動くことを可能にする、上記外科用ステープル留めデバイス。
(項目13)
上記内側に延びる突起が、上記チャネル内に延びて、上記クランプ部材の上記チャネル内での運動を妨げる、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目14)
上記内側に延びる突起が、細くなった遠位向き表面を有する、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目15)
上記外科用デバイスの作動前状態において、上記クランプ部材が、上記作動スレッドの上記チャネル内に位置付けられ、上記クランプ部材の上記ナイフが、上記作動スレッドの上記第1及び第2のカム部材の近位端の遠位に位置付けられ、上記外科用ステープル留めデバイスの発射ストロークの少なくとも一部の間、上記クランプ部材が、上記ナイフを上記第1及び第2のカム部材の近位に位置付けるために可動である、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目16)
上記ステープルカートリッジが、長手方向の軸を画定し、中央ナイフスロットが、上記長手方向の軸に沿って延び、外部及び内部カムスロットが、上記中央ナイフスロットの各側に位置付けられ、外部及び内部カム部材がそれぞれ、上記外部及び内部カムスロット内に受け入れられる、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目17)
上記外科用ステープル留めデバイスの作動前状態において、上記内部及び外部カム部材が、上記中央ナイフスロットから離れる上記ステープルカートリッジの上記長手方向の軸と整列しない位置への方向に外向きに角度付けされるように、上記作動スレッドの上記内部及び外部カム部材が、上記内部及び外部カムスロットの上記近位端を越えて延びる、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目18)
上記作動スレッドが、上記内部カム部材の遠位端を互いに相互接続するクロス部材を含む、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目19)
上記外科用ステープル留めデバイスが、発射ストロークを通して可動であり、上記発射ストロークが、上記クランプ部材の遠位面が上記作動スレッドの上記クロス部材と係合して、上記作動スレッドを上記ツールアセンブリ内で遠位に前進させるように位置付けられる、第1の前進ステージを含む、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目20)
上記発射ストロークが、上記クランプ部材がチャネル内から近位に動いて、上記内部カム部材の上記屈曲部上の上記内側に延びる突起と係合して、上記屈曲部を上記整列しない位置へと動かし、上記クランプ部材が上記作動スレッドの上記チャネルから出るように動くことを可能にする、後退ステージを含む、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(項目21)
外科用ステープル留めデバイスであって、
離間位置と近接位置との間で互いに対して可動であるカートリッジアセンブリ及びアンビルアセンブリを含むツールアセンブリを備え、上記カートリッジアセンブリが、複数のステープルを支持するステープルカートリッジ、ナイフを支持する本体を有するクランプ部材、ならびに第1の部分及び第2の部分を有する作動スレッドを含み、上記作動スレッドの上記第1及び第2の部分の各々が、カム部材を画定し、上記作動スレッドの上記第2の部分が、上記作動スレッドの上記第1の部分から離間されて、上記第1及び第2の部分の間のチャネルを画定し、上記作動スレッドが、第1のステージにおいて上記クランプ部材によって陥凹される弾性係合部材を有し、上記クランプ部材が、上記第1のステージにおいて上記チャネル内に配設され、上記弾性係合部材が、第2のステージにおいて上記チャネル内に拡張され、上記クランプ部材が、上記第2のステージにおいて上記弾性係合部材の近位に配設される、上記外科用ステープル留めデバイス。
(項目22)
上記作動スレッドの上記第1及び第2の部分が、互いから物理的に分離される、上記項目のいずれかに記載の外科用ステープル留めデバイス。
(摘要)
外科用ステープル留めデバイスは、ハンドルアセンブリと、ハンドルアセンブリから遠位に延びる細長い本体と、ツールアセンブリとを含む。ツールアセンブリは、ステープルカートリッジからステープルを射出するために、ステープルカートリッジを通して可動である作動スレッドと、ツールアセンブリを開位置から近接位置へと動かすために、ツールアセンブリを通して可動であるクランプ部材とを含む。ツールアセンブリの近位部におけるデッドスペースを最小にするために、作動スレッド及びクランプ部材は、外科用ステープル留めデバイスの作動前状態において入れ子の関係で支持される。その後、クランプ部材は、ステープル留めデバイスの発射ストローク中に作動スレッドの近位位置に動かされる。
最小のデッドスペースを有するツールアセンブリを含む本開示の外科用ステープル留めデバイスの様々な実施形態が、図面を参照して本明細書以下に説明される。
本開示のツールアセンブリの一実施形態を含む外科用ステープル留めデバイスの開位置での側面、斜視図である。 図1に示されるツールアセンブリの近接位置での側面、斜視図である。 図2に示されるツールアセンブリの側面、斜視、分解図である。 図3に示される詳細な指示領域の拡大図である。 図3に示される詳細な指示領域の拡大図である。 図5に示されるツールアセンブリの作動スレッドの遠位端からの斜視図である。 図5に示されるツールアセンブリの作動スレッド及びクランプ部材の遠位端からの斜視図である。 図3に示されるツールアセンブリの駆動ねじに支持される、図7に示されるツールアセンブリのクランプ部材及び作動スレッドの斜視図である。 図8の断面線9-9に沿って取った断面図である。 図1の断面線10-10に沿って取った断面図である。 カートリッジチャネルを取り除いた、図3に示されるツールアセンブリのカートリッジアセンブリの斜視、切欠図である。 図11の断面線11A-11Aに沿って取った断面図である。 図2に示されるツールアセンブリのカートリッジアセンブリの近接位置での側面、断面図である。 カートリッジチャネルを取り除き、ツールアセンブリがツールアセンブリの近接位置にある、図3に示されるツールアセンブリのカートリッジアセンブリの平面、斜視図である。 図12の断面線14-14に沿って取った断面図である。 ツールアセンブリが発射ストロークの第1のステージを通して動かされるときの、図12に示されるツールアセンブリの側面、断面図である。 ツールアセンブリが発射ストロークの第2のステージを通して動かされるときの、図15に示されるツールアセンブリの側面、断面図である。 ツールアセンブリの作動スレッド及びクランプ部材を示し、ツールアセンブリの残りの構成要素を破線で示す、図16に示されるツールアセンブリの頂部、斜視図である。 ツールアセンブリが発射ストロークの第3のステージを通して動かされるときの、図16に示されるツールアセンブリの側面、断面図である。 部品を分離した、図1に示される本開示の外科用ステープル留めデバイスの作動スレッド及びクランプ部材の別の実施形態の近位端からの側面、斜視図である。 部品を分離した、図19に示される作動スレッド及びクランプ部材の遠位端からの側面、斜視図である。 ツールアセンブリが非クランプ位置にある、図19に示される作動スレッド及びクランプ部材を含む、図1に示されるツールアセンブリの近位部の側面、断面図である。 図21Aに示されるツールアセンブリのカートリッジアセンブリの頂部、概略図である。 図21Bの断面線21C-21Cに沿って取った断面図である。 非クランプ位置で組み立てた、図19に示される作動スレッド及びクランプ部材の近位端からの側面、斜視図である。 図19に示される作動スレッド及びクランプ部材がクランプ位置にある、図1に示される外科用ステープル留めデバイスのツールアセンブリの側面、断面図である。 図22Aに示されるツールアセンブリの頂部、概略図である。 クランプ位置で組み立てた、図19に示される作動スレッド及びクランプ部材の遠位端からの側面、斜視図である。 ツールアセンブリが発射ストロークの第1のステージを通して動かされるときの、図22Bに示されるツールアセンブリの頂部、概略図である。 ツールアセンブリが発射ストロークの第2のステージを通して動かされるときの、図22Bに示されるツールアセンブリの頂部、概略図である。 ツールアセンブリが発射ストロークの第2のステージを通して動かされるときの、図24に示されるツールアセンブリの頂部、概略図である。 図25Aに示されるツールアセンブリの作動スレッド及びクランプ部材の側面、斜視図である。 ツールアセンブリが発射ストロークの第3のステージを通して動かされるときの、図25Aに示されるツールアセンブリの頂部、概略図である。
ここで、本開示の外科用ステープル留めデバイスが、図面を参照して詳細に説明され、同様の参照番号は、いくつかの図の各々において、同一または対応する要素を示す。この説明において、「近位」という用語は一般に、臨床医により近いデバイスの部分を指すために使用される一方で、「遠位」という用語は一般に、臨床医からより遠いデバイスの部分を指すために使用される。加えて、「内視鏡」という用語は一般に、内視鏡、腹腔鏡、関節鏡、及び/または小径切開部またはカニューレを通して行われる任意の他の処置を指すために使用される。更に、「臨床医」という用語は一般に、医師、看護師、及びサポート要員を含む医療関係者を指すために使用される。
本開示の外科用ステープル留めデバイスは、ハンドルアセンブリと、ハンドルアセンブリから遠位に延びる細長い本体と、細長い本体の遠位部に支持されるツールアセンブリとを含む。実施形態において、ツールアセンブリは、関節運動のために細長い本体の遠位部に取り付けられ、複数のステープル及びプッシャーを支持するステープルカートリッジと、ステープルカートリッジからステープルを射出するためにステープルカートリッジを通して可動である作動スレッドと、駆動またはクランプ部材とを含む。クランプ部材は、ツールアセンブリを開位置から近接位置へと動かすために、かつステープルカートリッジを通して作動スレッドを前進させて、ステープルカートリッジから複数のステープルを射出し、組織を切断するために、ツールアセンブリを通して可動である。ツールアセンブリの近位部におけるデッドスペースの長さを最小にするために、ツールアセンブリが非クランプ位置または開位置にあるとき、作動スレッド及びクランプ部材は、ステープルカートリッジ内で入れ子の関係で支持される。
図1は、ハンドルアセンブリ12と、細長い本体14と、本開示のツールアセンブリ100の一例示的実施形態とを含む、外科用ステープル留めデバイス10を図示する。本明細書では詳細には説明しないものの、ツールアセンブリ100は、ツールアセンブリ100を支持し、当該技術分野において既知であるように、細長い本体14から取り外し可能であるシャフト部16aを含む、リロードアセンブリ16の一部を形成してもよい。あるいは、ツールアセンブリ100は、細長い本体14の遠位部にしっかりと固定されてもよい。ツールアセンブリ100は、取り外し可能かつ交換可能なステープルカートリッジアセンブリを有しても、有さなくてもよい。
ハンドルアセンブリ12は、ハンドグリップ18、複数の作動装置ボタン20、及び回転ノブ22を含む。回転ノブ22は、当該技術分野において既知であるように、細長い本体14及びリロード100が、ハンドルアセンブリ12に対して細長い本体14の長手方向の軸のまわりで回転するのを容易にする。作動装置ボタン20は、近接、発射、及び切断を含むステープル留めデバイス10の様々な機能の動作を制御する。ステープル留めデバイス10は、その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9,055,943号(「’943特許」)に説明されるものなどの電動ステープル留めデバイスとして図示される。しかしながら、本開示のツールアセンブリ100はまた、その全体が参照によって同様に本明細書に組み込まれる米国特許第7,891,534号に説明されるものなどの手動外科用ステープル留めデバイスとの使用にも好適であることが想定される。ステープル留めデバイス10は、ロボット手術システムとの使用のために構成されてもよく、ハンドルアセンブリを有してもよいこともまた想定される。
図2~4を参照すると、ツールアセンブリ100は、アンビル102及びカートリッジアセンブリ104を含む。カートリッジアセンブリ104は、複数のステープル108及びプッシャー110(図3)を支持するステープルカートリッジ106と、底面112aを画定するカートリッジチャネル112と、ステープルカートリッジ支持板114と、駆動ねじ116と、クランプ部材118と、作動スレッド120とを含む。支持板114は、以下に更に詳細に説明される作動スレッド120の停止面を画定する弾性突起、例えば、弾性ランス114a(図4)を含む。あるいは、他の突起構成が想定される。ステープルカートリッジ106は、中央ナイフスロット140(図3)を画定し、スナップフィット接続によって支持板114内に取り付けられる。支持板114及びステープルカートリッジ106は、ともに組み立てられ、同様にスナップフィット接続によってカートリッジチャネル112に取り付けられる。あるいは、これらの構成要素をともに固定するための他の技術が使用されてもよい。
図3を参照すると、ステープルカートリッジ106は、複数の列の側方に離間されたステープル保持スロット124aを画定する組織接触面124を含む。保持スロット124aは、組織接触面124内の孔として構成される。各保持スロット124aは、ステープル108のうちの一方、及びプッシャー110のそれぞれ1つのうちの少なくとも一部を受け入れる。ステープルカートリッジ106はまた、複数の長手方向のカムスロット106aも画定する(図11A)。長手方向のカムスロット106aは、ステープルプッシャー110(図11)を収容し、作動スレッド120の通過を容易にするために組織接触面124の反対の端部に開口している。
アンビル102は、枢動部材122のまわりでカートリッジアセンブリ104に枢動可能に連結される。枢動部材122は、アンビル102の近位部内に画定される開口部125(図3)、及びカートリッジアセンブリ106の近位部内に画定される開口部127を通して延びる。アンビル102は、ツールアセンブリ100を開位置(図1)と近接位置(図2)との間で移行させるために、カートリッジアセンブリ106に対して枢動可能である。アンビル102は、当該技術分野において既知であるように、複数のステープル変形陥凹(図示せず)を画定する組織接触面102a(図10)を含む。アンビル102はまた、チャネル129(図10)も画定し、傾斜当接面128(図10)及び組織止め130を含む。傾斜当接面128は、チャネル129の近位端に隣接して位置付けられ、クランプ部材118によって係合されて、開位置から近接位置へのツールアセンブリ100の運動を容易にする。実施形態において、組織止め130は、アンビル102の組織接触面102aのそれぞれ反対側に位置付けられる、一対の下方に延びる翼部130aを含む。翼部130aの各々は、ツールアセンブリ100が開位置にあるとき、ステープルカートリッジ106の組織接触面124の下方に延びる遠位組織係合面130bを有する。組織止め130の遠位係合面130bは、組織が、アンビルと、ツールアセンブリ100のカートリッジアセンブリ102、104との間をステープル保持スロット124aを越えて近位に通過するのを防止する。
図5~9をまた参照すると、クランプ部材118は、遠位面142aを有する基部142と、垂直支柱144と、上部梁146と、下部梁148とを含む。垂直支柱144は、基部142に固定された第1の端部と、上部梁146に固定された第2の端部とを有する。いくつかの実施形態において、基部142は、実質的に円柱状であり、駆動ねじ116(図3)を回転可能に受け入れるねじ付き穴150を画定する。実施形態において、基部142は、対向した長手方向に延びる平面164と、以下に更に詳細に論じられる近位停止部材166とを含む。いくつかの実施形態において、駆動ねじ116(図9)は、ねじ山を持ち、クランプ部材118のねじ付き穴150内に受け入れられて、駆動ねじ116の回転運動をクランプ部材118の長手方向の運動に変換する。
垂直支柱144は、上部梁146と下部梁148との間に位置付けられるナイフ152を画定する遠位面を含む。クランプ部材118の後退位置からクランプ位置への運動が、ツールアセンブリ100を開位置(図10)から近接位置(図12)へと移行させるように、上部梁146は、アンビルアセンブリ102の傾斜当接面128(図10)と係合するように位置付けられる。上部梁146はまた、アンビルアセンブリ102内に画定されるチャネル129(図10)を通して平行移動するように位置付けられ、下部梁148は、カートリッジチャネル112の底面112a(図10)に沿って平行移動して、ステープル留めデバイス10の発射中、アンビル102及びカートリッジアセンブリ104の外向きの歪みを防止するように位置付けられる。上部梁146及び下部梁148は、ツールアセンブリ100の発射中、アンビルアセンブリ102の組織接触面102aとステープルカートリッジ106の組織接触面124との間に最大組織間隙「X」(図12)を可能にするように寸法決めされている。
作動スレッド120は、第1の対の離間したカム部材170aを含む第1の部分120aと、第2の対の離間したカム部材170bを含む第2の部分120bとを含む。作動スレッド120の第1の部分120a及び第2の部分120bは、示されるように別個の構成要素であってもよい。あるいは、作動スレッド120の第1及び第2の部分は、それらの近位端及び/または遠位端で互いに接合されてもよい。離間したカム部材170a、170bの各対は、ステープルカートリッジ106によって画定されるそれぞれの長手方向カムスロット106a(図11A)を通して平行移動して、プッシャー110(図3)と相互作用し、当該技術分野において既知であるように、ステープルカートリッジ106からステープル108を射出するように位置付けられる。実施形態において、離間したカム部材170a、170bの対の各々は、作動スレッド120がステープルカートリッジ106を通して平行移動して、ステープルカートリッジ106のステープル保持スロット124a内のプッシャー110を持ち上げ、ステープルカートリッジ106のステープル保持スロット124aからステープル108を射出するとき、プッシャー110(図3)と順次係合する、2つの離間したカム面174、176を含む。カム面174、176の角度は、ステープル保持スロット124aを通したプッシャー108の運動をより良好に制御し、より良好なステープル形成を提供するために、カム面174、176の長さに沿って変化してもよい。例えば、カム面174、176は、遠位部180及び近位部182を有してもよく、近位部182は、遠位部180よりも急勾配である。
図5~11Aをまた参照すると、作動スレッド120の第1の部分120a及び第2の部分120bの各々は、内側に延びる弾性突出185(図6)を有する長手方向に延びる部分184a及び横断部184bを有する内壁184を含む。作動スレッド120の第1の部分120a及び第2の部分120bがステープルカートリッジ106内に位置付けられるとき、クランプ部材118がチャネル188内で後退位置から前進位置へと可動であるように、第1の部分120a及び第2の部分120bは、クランプ部材118の基部142を受け入れるように位置付けられるチャネル188を画定する。傾いていない状態において、弾性突出185は、チャネル188内へ内側に延びる。作動スレッド120の第1の部分120a及び第2の部分120bの横断部184bは、チャネル188の遠位端を画定し、クランプ部材118がチャネル188内で前進位置に動かされるとき、クランプ部材118の遠位面142a(図5)と係合するように位置付けられる。作動スレッド118及びクランプ部材120は、作動スレッド120の第1の部分120a及び第2の部分120bがナイフ152を含むクランプ部材120と並んで配設される、アセンブリを形成する。
クランプ部材118の基部142が作動スレッド120の第1の部分120aと第2の部分120bとの間に位置付けられるとき(図8)、基部142の平面164(図5)は、弾性突出185を作動スレッド120の第1の部分120a及び第2の部分120bの内壁184のそれぞれ1つと整列するように傾かせ、保持するように、作動スレッド120の弾性突出185と整列する。弾性部185がチャネル188から内側に傾けられるとき、クランプ部材118は、チャネル188を通して自由に動き、作動スレッド120の第1の部分120a及び第2の部分120bの内壁184の横断部184bと係合する。以下に論じられるように、クランプ部材118が作動スレッド120に対してチャネル188内で動かされて、平面164が弾性突出184aの近位に位置付けられるとき、弾性突出185は、クランプ部材118の遠位面142a(図5)と整列する位置へと、作動スレッド120の第1の部分120aと第2の部分120bとの間に画定されるチャネル188内に跳ねる。したがって、弾性突出185を越えるクランプ部材118の遠位運動が防止される。
図8~11Aを参照すると、外科用ステープル留めデバイス10が作動前状態にあるとき、クランプ部材118及び作動スレッド120は入れ子の構成にある。この入れ子の構成において、クランプ部材118の基部部材142の遠位面142aが、作動スレッド120の第1の部分120a及び第2の部分120bの内壁184の横断部184bから距離「Y」(図9)だけ近位に位置付けられるように、クランプ部材118は、チャネル188内の作動スレッド120の第1の部分120aと第2の部分120bとの間に位置付けられる(図6)。この位置において、突起部185が作動スレッド120のチャネル188外に付勢されるように、基部部材142(図6A)の平面164(図5)は、作動スレッド120の内壁184の弾性突出185と整列する。加えて、ランス114aを作動スレッド120の第1の部分120aと第2の部分120bとの間に画定されるチャネル188外に付勢するように、作動スレッド120は、カートリッジアセンブリ104の支持板114のランス114a(図10)の上に位置付けられる。
駆動ねじ116は、クランプ部材118のねじ付き穴150を通して延び、かつベアリングに支持され、外科用ステープル留めデバイス10の細長い本体114(図1)内に支持される駆動部材(図示せず)に連結される、近位部「P」(図10)を含む。米国特許第8,512,359号は、駆動ねじ及び駆動部材を含む外科用ステープル留めデバイスを開示し、その全体が参照によって本明細書に組み込まれる。
図12~14を参照すると、駆動ねじ116がハンドルアセンブリ12(図1)及び細長い本体14(図1)を介して作動されて、外科用ステープル留めデバイス10のクランプストロークを通してクランプ部材118を前進させるとき、クランプ部材118は、後退位置からクランプ位置に動く。クランプ部材118がクランプ位置に向かって動くにつれて、クランプ部材118は、作動スレッド120とは独立して、作動スレッド120の第1の部分120aと第2の部分120bとの間に画定されるチャネル188を通して、駆動ねじ116に沿って遠位に動く。クランプ部材118がツールアセンブリ100の近位部内で遠位に動くにつれて、図12で矢印「A」によって指示される方向の、クランプ位置へのクランプ部材118の連続した遠位運動が、アンビルアセンブリ102を図12で矢印「B」によって指示される方向に枢動して、ツールアセンブリ100を開位置(図10)から近接位置に付勢するように、クランプ部材118の上部梁146は、アンビルアセンブリ102の傾斜当接面128(図12)と係合する。アンビルアセンブリ102は静止していてもよく、カートリッジアセンブリ104はアンビルアセンブリ102に対して開位置から近接位置に枢動してもよいことが想定される。
クランプ部材118がクランプ位置にあるとき、クランプ部材118の基部142の遠位面142a(図12)は、作動スレッド120の第1の部分120a及び第2の部分120bの内壁184の横断部184bに隣接して位置付けられる。この位置において、弾性突出184aが作動スレッド120のチャネル188から外向きに位置付けられるように、基部部材142(図11A)の平面164は、依然として作動スレッド120の内壁184の弾性突出185と整列している。加えて、ツールアセンブリ100は、アンビルアセンブリ102の組織接触面102aと並置した整列に位置付けられるカートリッジアセンブリ106の組織接触面124と近接位置にあることで、最大組織間隙「X」(図12)を画定する。ツールアセンブリ100内で動いていない作動スレッド120は、カートリッジアセンブリ104の支持板114のランス114aの上に位置付けられたままである。
ツールアセンブリ100からステープル108(図3)を射出するために、駆動部材116は、ハンドルアセンブリ12を介して再び作動され、細長い本体14(図1)は、発射ストロークを通してクランプ部材118を動かす。発射ストローク中、クランプ部材118及び作動スレッド120は、図15に示される第1の前進ステージを通して、図16及び17に示される後退ステージを通して、ならびに図18に示される第2の前進ステージを通して動かされる。これらのステージの各々を、以下に説明する。
図15を参照すると、発射ストロークの第1の前進ステージ中、駆動ねじ116はまず、矢印「C」によって指示される方向へと、クランプ部材118をクランプ位置から遠位に前進させる。上記に論じられるように、クランプ位置において、クランプ部材118の基部142の遠位面142aは、作動スレッド120の第1の部分120a及び第2の部分120bの内壁184の横断部184bに隣接して位置付けられる。したがって、クランプ部材118がツールアセンブリ100内でクランプ位置から遠位に動くとき、クランプ部材118の遠位面142aは、作動スレッド120の横断部184bと係合して、作動スレッド120をカートリッジ106内で遠位に前進させる。作動スレッド120がランス114aを通過して前進するとき、ランス114aは、作動スレッド120の経路内へ上方に撓み、発射ストロークの第1の前進ステージが終了する。
図16及び17を参照すると、発射ストロークの後退ステージ中、駆動ねじ116は、発射ストロークの第1のステージの駆動ねじ116の回転方向とは反対の方向に回転して、クランプ部材118を矢印「D」によって指示される方向にツールアセンブリ100内へと後退させる。作動スレッド120のチャネル118内に位置付けられるランス114aは、作動スレッド120の近位端と係合して、作動スレッド120がクランプ部材118とともに近位方向に動くのを防止する。したがって、クランプ部材118は、ツールアセンブリ100内の作動スレッド118とは独立して、近位に動く。クランプ部材118が近位に動くにつれて、クランプ部材118の遠位面142aが、作動スレッド120の弾性突出185を通過することで、弾性突出185は、作動スレッド120のチャネル188内に外向きに跳ねて、弾性突出184を越えるチャネル188を通したクランプ部材118の遠位運動を防止する。クランプ部材118を更に作動スレッド120の近位に動かし、保持することによって、ツールアセンブリ100が、作動スレッド120のカム面174、176をナイフ152の遠位に位置付けるように再構成されることで、ツールアセンブリ100が組織を切断する前に組織をステープル留めする。
図18を参照すると、発射ストロークの後退ステージの後、クランプ部材118の基部142の遠位面142aは、作動スレッド120の弾性突出185の近位に位置付けられる。発射ストロークの第2の前進ステージ中、駆動ねじ116は、矢印「E」によって指示される方向へと、クランプ部材118をツールアセンブリ100を通して遠位に前進させるように回転する。クランプ部材118の基部142の遠位面142aは、作動スレッド120の弾性突出185のわずかに近位に位置付けられるため、クランプ部材118の遠位運動は、クランプ部材118の遠位面142aを動かし、弾性突出185と係合させて、作動スレッド120をツールアセンブリ100内で遠位に動かす。作動スレッド120及びクランプ部材118がツールアセンブリ100を通して前進するにつれて、作動スレッド120の第1の部分120a及び第2の部分120bの離間したカム部材170a、170bの対は、プッシャー110(図3)と順次係合して、ステープル保持スロット124a(図17)からステープル108を順次駆動する。
発射ストロークの第2の前進ステージの後、ツールアセンブリは、手術部位から退けられてもよく、駆動ねじ116は、クランプ部材118をその発射前状態に後退させるように回転されてもよい。クランプ部材118が発射前状態に戻ると、ツールアセンブリは開位置に戻る。
図19及び20は、図1に示される外科用ステープル留めデバイスとともに使用することができる、本開示のクランプ部材218及び作動スレッド220の代替的な一実施形態を図示する。クランプ部材218は、基部242と、垂直支柱244と、上部梁246と、下部梁248とを含む。垂直支柱244は、基部242に固定された第1の端部と、上部梁246に固定された第2の端部とを有する。実施形態において、基部242は、駆動ねじ116(図3)を回転可能に受け入れるねじ付き穴250を画定する。ツールアセンブリ100に関して上記に論じられるように、駆動ねじ116は、ねじ山を持ち、クランプ部材218のねじ付き穴250内で回転可能であることで、駆動ねじ116の回転運動をツールアセンブリ200内でクランプ部材218の長手方向の運動に変換する(図21A)。
図21Aもまた参照すると、クランプ部材218の垂直支柱244は、上部梁246と下部梁248との間に位置付けられるナイフ252を画定する遠位面を含む。クランプ部材218の後退位置(図21A)からクランプ位置(図22A)への運動が、ツールアセンブリ200を開位置から近接位置へと動かすように、上部梁246は、ツールアセンブリ200のアンビルアセンブリ202の当接面228と係合するように位置付けられる。ツールアセンブリ100に関して上記に論じられるように、クランプ部材218の上部梁246は、アンビルアセンブリ202内に画定されるチャネル229(図21A)を通して平行移動するように位置付けられ、下部梁248は、カートリッジアセンブリ204のカートリッジチャネル212の底面212a(図21A)に沿って平行移動して、ツールアセンブリ200が近接位置にあるとき、アンビルアセンブリ202の組織接触面202aと、ツールアセンブリ200のステープルカートリッジ206の組織接触面224との間に最大組織間隙「X」(図22A)を画定するように位置付けられる。クランプ部材218の基部242はまた、以下に更に詳細に説明されるように、作動スレッド220と係合し、それを前進させるように位置付けられる遠位面242a(図19)も含む。
作動スレッド220は、作動スレッド120に関して上述される離間したカム部材170a、170bと実質的に類似したカム部材270a、270b(図20)を含み、ここでは更に詳細には説明しない。カム部材270a、270bは離間され、開近位端と、クロス部材288によって囲まれる遠位端とを有するチャネル271を画定する。カム部材270a、270bの各々は、カム面174及び176に関して上述のカム面を有する、第1の外部カム部材274及び第2の内部カム部材276を含み、ここでは更に詳細には説明しない。外部及び内部カム部材274、276は、側方に屈曲性かつ弾性である。内部カム部材276は、細くなった遠位面を有する内側に延びる突起277aを有する屈曲部277(図20)を含む。
図21A~21Cをまた参照すると、ステープルカートリッジ206は、長手方向の軸を画定し、中央ナイフスロット240は、長手方向の軸に沿って延び、外部カムスロット206a及び内部カムスロット206bは、中央ナイフスロット240の各側上に位置付けられる。外部カムスロット206aは、作動スレッド220の外部カム部材274を受け入れ、内部カムスロット206bは、作動スレッド220の内部カム部材276を受け入れる。作動スレッド220の外部及び内部カム部材274及び276はそれぞれ、側方に弾性であり、傾いていない状態において、中央ナイフスロット240から離れるステープルカートリッジの長手方向の軸と整列しない位置への方向に外向きに角度付けされる近位端を有する(「整列しない位置付け」)。外部カムスロット206a及び内部カムスロット206bは、ステープルカートリッジ206の近位端の遠位に位置付けられる近位端206c(図21B)を画定する。以下に更に詳細に説明されるように、作動スレッド220が完全な後退位置にあるとき、内部カム部材276及び外部カム部材274が整列しない位置付けにあるように、内部カム部材276及び外部カム部材274は、内部カムスロット206b及び外部カムスロット206aの近位端206cを越えて近位に位置付けられる(図21B)。作動スレッド220がステープルカートリッジ206内で完全な後退位置から前進するとき、内部カム部材276及び外部カム部材274は、内部カムスロット206b及び外部カムスロット206a内へと動き、カム部材276、274がステープルカートリッジ206の長手方向の軸と整列した位置(図23)へと、カムスロット206a、206bを画定する壁によって内側に傾けられる。
内部カム部材276及び外部カム部材274の整列しない位置において、作動スレッド220の屈曲部277上の突起277aは、クランプ部材218の基部242が作動スレッド220の屈曲部277の突起277a間をチャネル271へと通過することを可能にする距離だけ、互いから離間される。内部及び外部カム部材274の整列した位置において、作動スレッド220の屈曲部277上の突起277aは、クランプ部材218がチャネル271を通して近位に通過することを防止する距離だけ、互いから離間される。
図21Aを簡単に参照すると、ツールアセンブリ200は、支持板114(図3)に類似した支持板214を含み、作動スレッド220の停止面を画定する弾性突起、例えば、弾性ランス214a(同様に図4を参照されたい)を含む。作動スレッド218がその後退位置にあるとき、ランス214aを作動スレッド220の経路外に付勢するように、スレッド218は、ランス214aの上に位置付けられる。作動スレッド220の近位端がランス214aを通過して遠位に動くと、ランス214aは、作動スレッド220がその後退位置に戻る近位方向の運動を防止する位置へと上方に跳ねる。
図21A~Dを参照すると、ツールアセンブリ200の作動前、クランプ部材218及び作動スレッド220は、クランプ前位置にある。クランプ前位置において、クランプ部材218及び作動スレッド220は、それらの後退位置で入れ子の関係にあり(図21D)、クランプ部材218は、作動スレッド220の屈曲部277上の突起277a間で作動スレッド220のチャネル271の近位部に位置する。この位置において、ランス214aを作動スレッド220のチャネル271外に付勢するように、作動スレッド220は、ランス214aの上に位置付けられる。クランプ前位置において、内部カム部材276及び外部カム部材274の長さの実質的に全てが、内部カムスロット206b及び外部カムスロット206aの近位端206c(図21B)の近位に位置付けられる。
図22A~22Cを参照すると、駆動ねじ116(図3)がハンドルアセンブリ12(図1)を介して作動されて、クランプストロークを通してクランプ部材218を前進させるとき、クランプ部材218は、作動スレッド220とは独立して、図22Aで矢印「F」によって指示される方向へと、その後退位置(図21B)からクランプ位置(図22B)にツールアセンブリ200(図22A)内で遠位に動く。クランプ部材218が作動スレッド220のチャネル271を通してクランプ位置に向かって動くにつれて、クランプ部材218の上部梁246は、アンビルアセンブリ202の当接面228(図22A)と係合して、アンビルアセンブリ202を図22Aで矢印「G」によって指示される方向へと、近接位置に枢動する。作動スレッド220はツールアセンブリ内で軸方向に固定された位置のままであるため、作動スレッド220は、ランス214aの上に位置付けられたままであり、内部カム部材276及び外部カム部材274は、内部カムスロット206b及び外部カムスロット206aの近位端206cの近位に位置する整列しない位置のままである。クランプ部材218のクランプ位置において、クランプ部材218は、作動スレッド220のクロス部材288に隣接して位置付けられる。
ツールアセンブリ200からステープルを射出するために、駆動部材116(図3)は、ハンドルアセンブリ12(図1)を介して再び作動されて、発射ストロークを通してクランプ部材218を動かす。発射ストローク中、クランプ部材218及び作動スレッド220は、図23に示される第1の前進ステージを通して、図24~25Bに示される後退ステージを通して、及び図26に示される第2の前進ステージを通して動かされる。これらのステージの各々を、以下に説明する。
図23を参照すると、発射ストロークの第1の前進ステージ中、駆動ねじ116(図3)は、クランプ部材218を矢印Hによって指示される方向に前進させる。クランプ部材218がツールアセンブリ200を通して遠位に動くにつれて、内部カム部材276及び外部カム部材274がそれぞれ、内部カムスロット206b及び外部カムスロット206a内に部分的に前進することで、内部カム部材276及び外部カム部材274は、ステープルカートリッジ206の長手方向の軸と整列した位置に動く。発射ストロークの第1の前進ステージの後、内部カム部材276の屈曲部277は、外部カムスロット206aの近位端206cの近位に位置付けられたままである。
発射ストロークの第1の前進ステージ中、クランプ部材218がツールアセンブリ200内で遠位に動くにつれて、クランプ部材218の遠位面242aは、作動スレッド220のクロス部材288と係合して、矢印「I」によって指示される方向への作動スレッド220の対応する遠位運動を引き起こす。作動スレッド220がツールアセンブリ220内で遠位に動くにつれて、作動スレッド220が、ランス214a(図22A)から退くように動くことで、ランス214aは、作動スレッド220の近位端の近位位置へと上方に跳ねる。
図24~25Bを参照すると、発射ストロークの後退ステージ中、駆動ねじ116(図3)は、図24で矢印「J」によって指示される方向にツールアセンブリ100内でクランプ部材218を後退させるように反対方向に回転される。クランプ部材118が、作動スレッド218とは独立して、作動スレッド220のチャネル271内で近位に動くように、ランス214aは、作動スレッド220の近位方向の運動を防止する。クランプ部材218がツールアセンブリ200内で近位に動くにつれて、クランプ部材218の基部部材242の近位端は、作動スレッド220の内部カム部材276の屈曲部277上の内側に延びる突起277aの細くなった遠位面と係合する。上記に論じられるように、発射ストロークの第1の前進ステージの後、内部カム部材276の屈曲部277は、内部カムスロット206bの近位に位置付けられる。したがって、クランプ部材218の基部部材242が、屈曲部277の突起277aの細くなった遠位面と係合するとき、内部カム部材276の屈曲部277は、図24で矢印「K」によって指示される方向へと外向きに撓んで、クランプ部材218が作動スレッド220のチャネル271内から作動スレッド220の近位位置へと近位に動くことを可能にする(図25A~B)。ステープル留めデバイス10の発射中、組織を切断する前にステープル留めが生じるように、この運動は、クランプ部材218が作動スレッド220の近位に動いて、ナイフ252を内部カム部材276及び外部カム部材274の近位に位置付けることを可能にする。
図26を参照すると、発射ストロークの第2の前進ステージ中、駆動ねじ116(図3)は、矢印「L」によって指示される方向へと、クランプ部材218をツールアセンブリ200を通して遠位に前進させるように回転する(図22A)。クランプ部材218の遠位面242aは、突起277aの近位にある作動スレッド220の近位側に隣接して位置付けられるため、クランプ部材218の遠位運動は、ツールアセンブリ200内での作動スレッド220の遠位運動をもたらす。作動スレッド220及びクランプ部材218がツールアセンブリ200を通して前進するにつれて、作動スレッド220の内部カム部材276及び外部カム部材274は、プッシャー110(図3)と順次係合して、ステープル保持スロット124aから、カートリッジアセンブリとアンビルアセンブリとの間にクランプされた組織内へと、ステープル108を順次駆動する。
当業者であれば、本明細書に具体的に説明され、添付の図面に図示されるデバイス及び方法が、非限定的な例示的実施形態であることを理解するだろう。1つの例示的実施形態に関連して図示または説明される要素及び特徴は、本開示の範囲から逸脱することなく、別の例示的実施形態の要素及び特徴と組み合わせられ得ることが想定される。同様に、当業者であれば、上述の実施形態に基づいて、本開示の更なる特徴及び利点を理解するであろう。したがって、本開示は、添付の特許請求の範囲によって示される以外は、具体的に示され、説明されているものによって限定されるものではない。

Claims (11)

  1. 外科用ステープル留めデバイスであって、
    細長い本体と、
    前記細長い本体の遠位部に支持されたツールアセンブリと、を備え、前記ツールアセンブリが、離間位置と近接位置との間で互いに対して可動であるカートリッジアセンブリ及びアンビルアセンブリを含み、前記カートリッジアセンブリが、複数のステープルを支持するステープルカートリッジ、ナイフを支持する本体を有するクランプ部材、ならびに第1の部分及び第2の部分を有する作動スレッドを含み、前記作動スレッドの前記第1及び第2の部分の各々が、カム部材を画定し、前記作動スレッドの前記第2の部分が、前記作動スレッドの前記第1の部分から物理的に分離かつ離間されて、前記第1及び第2の部分の間のチャネルを画定し、前記外科用ステープル留めデバイスの作動前状態において、前記クランプ部材が、前記作動スレッドの前記第1及び第2の部分の間の前記チャネル内に位置付けられ、前記クランプ部材の前記ナイフが、前記作動スレッドの前記第1及び第2の部分の前記カム部材の近位端の遠位に位置付けられ、前記外科用ステープル留めデバイスの発射ストロークの少なくとも一部の間、前記クランプ部材が、前記ナイフを前記カム部材の近位に位置付けるために可動であり、前記作動スレッドの前記第1及び第2の部分の各々が、長手方向に延びる部分及び横断部を含む内壁を含む、外科用ステープル留めデバイス。
  2. 前記作動スレッドの前記第1及び第2の部分の各々の前記カム部材が、第1及び第2のカム部材を含む、請求項1に記載の外科用ステープル留めデバイス。
  3. 前記クランプ部材が、垂直支柱、上部梁、及び下部梁を含み、前記作動前状態において、前記垂直支柱が、前記チャネルの近位部内に位置付けられる、請求項2に記載の外科用ステープル留めデバイス。
  4. 前記作動スレッドの前記第1及び第2の部分の前記内壁の前記長手方向に延びる部分が、前記クランプ部材の経路内へ前記チャネル内に延びる、内側に延びる弾性突出を含み、前記作動前状態において、前記クランプ部材が、前記弾性突出と係合して、前記弾性突出を前記チャネル内から付勢するように位置付けられる、請求項に記載の外科用ステープル留めデバイス。
  5. 前記発射ストロークが、前記クランプ部材の遠位面が前記作動スレッドの前記第1及び第2の部分の前記内壁の前記横断部と係合して、前記作動スレッドを前記ツールアセンブリ内で遠位に動かすように位置付けられる、第1の前進ステージを含む、請求項に記載の外科用ステープル留めデバイス。
  6. 前記弾性突出が前記チャネル内へと動くように、前記発射ストロークが、前記クランプ部材が前記チャネル内で近位に動いて、前記クランプ部材の前記遠位面を前記作動スレッドの前記第1及び第2の部分の前記弾性突出の近位に位置付ける、後退ステージを含む、請求項に記載の外科用ステープル留めデバイス。
  7. カートリッジアセンブリが、弾性突起を有する支持板を含み、前記クランプ部材が前記作動前状態にあるとき、前記作動スレッドが、前記弾性突起の上に位置付けられて、前記弾性突起を前記チャネル内から付勢し、前記ステープル留めデバイスが前記発射ストロークの前記第1の前進ステージを通して動かされるとき、前記弾性突起が前記ステープル留めデバイスの前記後退ステージの間の前記作動スレッドの近位方向の運動を防止するように、前記作動スレッドが、前記弾性突起の遠位に位置付けられる、請求項に記載の外科用ステープル留めデバイス。
  8. 前記クランプ部材が、前記作動前状態において前記弾性突出と係合するように位置付けられる、対向した側方に延びる平面を有する基部を有する、請求項に記載の外科用ステープル留めデバイス。
  9. 前記クランプ部材の前記基部が、前記側方に延びる平面の近位部に位置付けられる近位停止部材を含む、請求項に記載の外科用ステープル留めデバイス。
  10. クランプ部材が、ねじ付き穴を画定し、前記外科用ステープル留めデバイスが、ねじ付き駆動部材を更に含み、前記ねじ付き駆動部材の回転が前記クランプ部材の軸方向の運動を引き起こすように、前記ねじ付き駆動部材が、前記ねじ付き穴内に受け入れられる、請求項1に記載の外科用ステープル留めデバイス。
  11. 前記作動スレッドの前記第1及び第2の部分が、互いから物理的に分離される、請求項1に記載の外科用ステープル留めデバイス。
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