JP2023523507A - 外科用ステープルのための、かつ周壁に組織を把持するための***を有する、カートリッジホルダ - Google Patents
外科用ステープルのための、かつ周壁に組織を把持するための***を有する、カートリッジホルダ Download PDFInfo
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- A—HUMAN NECESSITIES
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Abstract
アンビルアセンブリ(24)およびカートリッジアセンブリ(26)を有する、ツールアセンブリ(16)を含む、外科用ステープルデバイス(10)が開示される。カートリッジアセンブリ(26)は、アンビルとカートリッジアセンブリ(24、26)との間にクランプされた組織を把持し、安定化させるために、カートリッジアセンブリ(26)の周壁に沿って形成された***(46)または突起(46)を含む。***(46)は、ステープル形成中に横方向および長手方向の両方で組織が移動することを防止するためのグリッパとして機能する。ステープル形成中に組織を安定化させることにより、ステープル形成の改善を達成することができる。
Description
本開示は、組織をステープルするための外科用器具を対象としており、より具体的には、組織を把持するための構造を含む、組織をステープルするための外科用ステープルデバイスを対象とする。
典型的には、ステープル器具は、一対の対向する顎部材を含み、顎部材の一方が、ステープルカートリッジを支持し、他方の顎部材が、ステープル形成ポケットを有するアンビルを支持する。一部のステープル器具はまた、2つの顎部材間を前進してステープルカートリッジからステープルを同時に排出し、顎部材間にクランプされた組織を切断するナイフ刃部を含むI型鋼を含む。ステープルが組織、特に、厚い組織上に発射されると、組織は2つの顎部材の間で強く圧縮され、顎部材の間から滑ってステープルを変形させる傾向がある。
本開示の一態様は、細長い本体およびツールアセンブリを含む、外科用ステープルデバイスを対象とする。細長い本体は、近位部分および遠位部分を有する。ツールアセンブリは、長手方向軸を画定し、細長い本体の遠位部分上で支持される。ツールアセンブリは、アンビルアセンブリおよびカートリッジアセンブリを含む。アンビルアセンブリは、遠位端部分および組織係合表面を有する。カートリッジアセンブリは、遠位端部分を有し、カートリッジチャネルおよびステープルカートリッジを含む。ステープルカートリッジは、遠位端部分および組織接触表面を有する。カートリッジアセンブリは、アンビルアセンブリに結合されており、そのため、ツールアセンブリは、アンビルおよびカートリッジアセンブリの遠位端部分が互いに離間している開放位置と、アンビルアセンブリおよびステープルカートリッジの組織接触表面が並列に整列されるクランプ位置との間で移動可能である。カートリッジチャネルは、ステープルカートリッジを受容する細長い凹部を画定する、基壁および離間した側壁を含む。離間した側壁の各々は、ステープルカートリッジの組織係合表面の外方に離間されている複数の***を支持する。複数の***の各々は、ステープルカートリッジの組織係合表面の上方でアンビルアセンブリに向かう方向に延在する組織係合部分を含む。
本開示の態様では、複数の***の各々の組織係合部分は、非外傷性形状を有する。
本開示のいくつかの態様では、複数の***の各々の係合部分は、台形形状を有する。
本開示の特定の態様では、複数の***の各々の係合部分は、長方形形状を有する。
本開示の態様では、複数の***の各々の係合部分は、円形形状を有する。
本開示のいくつかの態様では、複数の***の各々の係合部分は、ステープルカートリッジの組織係合表面の上方で、アンビルアセンブリに向かう方向に距離Xで延在しており、Xは、約1.5ミリメートル~約2.5ミリメートルである。
本開示の特定の態様では、Xは、約2ミリメートルである。
本開示の態様では、複数の***の各***は、距離Yだけ、複数の***の隣接する***から離間されており、Yは、約3ミリメートル~約6ミリメートルである。
本開示のいくつかの態様では、Yは、約4.5ミリメートルである。
本開示の特定の態様では、複数の***は、第1のグループおよび第2のグループを含むカートリッジチャネルに沿って離間された***のグループに形成され、***の各グループは、複数の***のうちの少なくとも2つの***を含む。
本開示の態様では、***のグループの各々における複数の***の各***は、***のそれぞれのグループ内の隣接する***から距離Yだけ離間されており、Yは、約3ミリメートル~約6ミリメートルである。
本開示のいくつかの態様では、Xは、約2ミリメートルである。
本開示の態様では、外科用ステープルデバイスは、細長い本体の近位部分に結合されているハンドルアセンブリを含む。
本開示の他の態様は、長手方向軸を画定するツールアセンブリを対象とする。ツールアセンブリは、アンビルアセンブリおよびカートリッジアセンブリを含む。アンビルアセンブリは、遠位端部分および組織係合表面を有する。カートリッジアセンブリは、遠位端部分を有し、カートリッジチャネルおよびステープルカートリッジを含む。ステープルカートリッジは、遠位端部分および組織接触表面を有する。カートリッジアセンブリは、アンビルアセンブリに結合されており、そのため、ツールアセンブリは、アンビルおよびカートリッジアセンブリの遠位端部分が互いに離間している開放位置と、アンビルおよびステープルカートリッジの組織接触表面が並列に整列されるクランプ位置との間で移動可能である。カートリッジチャネルは、ステープルカートリッジを受容する細長い凹部を画定する、基壁および離間した側壁を含む。離間した側壁の各々は、ステープルカートリッジの組織係合表面の外方に離間されている複数の***を支持する。複数の***の各々は、ステープルカートリッジの組織係合表面の上方でアンビルアセンブリに向かう方向に延在する組織係合部分を含む。
本開示のいくつかの態様では、複数の***の各々の係合部分は、台形形状を有する。
本開示の特定の態様では、複数の***の各々の係合部分は、長方形形状を有する。
本開示の態様では、複数の***の各々の係合部分は、円形形状を有する。
本開示のいくつかの態様では、複数の***の各々の係合部分は、ステープルカートリッジの組織係合表面の上方で、アンビルアセンブリに向かう方向に距離Xで延在しており、Xは、約1.5ミリメートル~約2.5ミリメートルである。
本開示の特定の態様では、Xは、約2ミリメートルである。
本開示の態様では、複数の***の各***は、距離Yだけ、複数の***の隣接する***から離間されており、Yは、約3ミリメートル~約6ミリメートルである。
本開示のいくつかの態様では、Yは、約4.5ミリメートルである。
本開示の特定の態様では、複数の***は、第1のグループおよび第2のグループを含むカートリッジチャネルに沿って離間された***のグループに形成され、***の各グループは、複数の***のうちの少なくとも2つの***を含む。
本開示の態様では、***のグループの各々における複数の***の各***は、***のそれぞれのグループ内の隣接する***から距離Yだけ離間されており、Yは、約3ミリメートル~約6ミリメートルである。
本開示のいくつかの態様では、Xは、約2ミリメートルである。
本開示の態様では、外科用ステープルデバイスは、細長い本体の近位部分に結合されているハンドルアセンブリを含む。
本開示の他の態様は、長手方向軸を画定するツールアセンブリを対象とする。ツールアセンブリは、アンビルアセンブリおよびカートリッジアセンブリを含む。アンビルアセンブリは、遠位端部分および組織係合表面を有する。カートリッジアセンブリは、遠位端部分を有し、カートリッジチャネルおよびステープルカートリッジを含む。ステープルカートリッジは、遠位端部分および組織接触表面を有する。カートリッジアセンブリは、アンビルアセンブリに結合されており、そのため、ツールアセンブリは、アンビルおよびカートリッジアセンブリの遠位端部分が互いに離間している開放位置と、アンビルおよびステープルカートリッジの組織接触表面が並列に整列されるクランプ位置との間で移動可能である。カートリッジチャネルは、ステープルカートリッジを受容する細長い凹部を画定する、基壁および離間した側壁を含む。離間した側壁の各々は、ステープルカートリッジの組織係合表面の外方に離間されている複数の***を支持する。複数の***の各々は、ステープルカートリッジの組織係合表面の上方でアンビルアセンブリに向かう方向に延在する組織係合部分を含む。
本開示の他の特徴は、以下の説明から理解されるであろう。
開示された外科用ステープルデバイスの様々な態様は、本明細書において図面を参照しながら以下に説明される。
ここで、本開示の外科用ステープルデバイスについて、図面を参照しながら詳細に説明し、図面では、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。しかしながら、本明細書に説明される本開示の態様は、単に本開示の例示であり、様々な形態で具体化され得ることを理解されたい。周知の機能または構成は、不必要に詳細に本開示を曖昧にすることを回避するために、詳細には説明されない。したがって、本明細書で開示された特定の構造的および機能的な詳細は、限定として解釈されるべきではなく、単に特許請求の範囲の基礎として、かつ本開示を実質的に任意の適切な詳細構造に様々に用いることを当業者に教示するための代表的な基礎として解釈されるべきである。
本明細書では、「近位」という用語は一般に、臨床医に近い方のデバイスの当該部分を指すために使用されるのに対し、「遠位」という用語は、一般に、臨床医から遠い方のデバイスの当該部分を指すために使用される。さらに、「内視鏡」という用語は、一般に、小径の切開またはカニューレを通して行われる、内視鏡、腹腔鏡、関節鏡、および/または任意の他の処置を指すために使用される。さらに、「臨床医」という用語は、一般に、医師、看護師、および支援要員を含む医療従事者を指すために使用される。
組織をクランプおよびステープルするために開放位置からクランプ位置まで相対的に移動可能であるアンビルアセンブリおよびカートリッジアセンブリを有するツールアセンブリを含む、外科用器具が開示される。ツールアセンブリは、アンビルとカートリッジとの間にクランプされた組織を把持して安定化させるために、ツールアセンブリの周壁に沿って形成された***または突起を含む。本開示の態様では、***は、カートリッジアセンブリの周壁に沿って形成され、ステープル形成中に横方向および長手方向の両方で組織が移動することを防止するためのグリッパとして機能する。ステープル形成中に組織を安定化させることにより、ステープル形成の改善を達成することができる。
図1は、一般に、ステープルデバイス10として示される本開示の態様を含む外科用ステープルデバイスの斜視図である。ステープルデバイス10は、ハンドルアセンブリ12、細長い本体14、およびツールアセンブリ16を含む。細長い本体14は、長手方向軸「X」を画定し、ハンドルアセンブリ12上で支持される近位部分14aと、ツールアセンブリ16を支持する遠位部分14bとを含む。本開示のいくつかの態様では、ツールアセンブリ16は、ステープルデバイス10の細長い本体14の遠位部分14bに解放可能に結合されるように適合されている近位本体部分18aを含むリロードアセンブリ18の一部を形成する。リロードアセンブリ18の近位本体部分18aは、ツールアセンブリ16を支持する遠位部分を含む。本開示の代替の態様では、ツールアセンブリ16は、細長い本体14の遠位部分に固定的に固設されている。
ステープルデバイス10のハンドルアセンブリ12は、静止ハンドル20a、作動ボタン22、および回転ノブ23を画定する本体20を含む。作動ボタン22を押して、ツールアセンブリ16を作動させる、例えば、ツールアセンブリ16を接近させること、ツールアセンブリ16を関節運動させること、ステープルを発射させることなどを行うことができる。回転ノブ23は、ハンドルアセンブリ12の本体20上に回転可能に支持されており、ステープルデバイス10の細長い本体14を支持し、そのため、回転ノブ23の回転は、細長い本体14およびツールアセンブリ16がハンドルアセンブリ12に対する回転を引き起こす。本開示の態様では、電池(図示せず)は、ハンドルアセンブリ12に電力供給するために静止ハンドル20a内で支持されている。ステープルデバイス10は、電力供給される必要はないが、米国特許第5,865,361号(「‘361特許」)に説明されるような手動ハンドルアセンブリもまた含むことができることが想定される。
ツールアセンブリ16は、ともに結合されているアンビルアセンブリ24およびカートリッジアセンブリ26を含み、そのため、ツールアセンブリ16は、開放位置(図1)とクランプ位置(図6)との間で移動することができる。アンビルアセンブリ24は、組織係合表面24a(図7)を含む。カートリッジアセンブリ26は、ステープルカートリッジ28およびカートリッジチャネル30を含む。ステープルカートリッジ28は、組織係合表面48を含む。開放位置では、アンビルアセンブリ24の遠位端部分は、ステープルカートリッジ28の遠位端部分から離間され、アンビルアセンブリ24とカートリッジアセンブリ26との間の組織の通過を容易にする。クランプ位置では、アンビルアセンブリ24の組織係合表面24aは、ステープルカートリッジ28の組織係合表面48と並列に整列されている。カートリッジチャネル30は、ステープルカートリッジ28を受容および収容する細長い凹部32(図4)を画定する。本開示の態様では、ステープルデバイス10の再利用を容易にするために、ステープルカートリッジ28は、カートリッジチャネル30から取り外して交換することができる。代替的に、ステープルカートリッジ28は、カートリッジチャネル30内に固定的に保持することができ、ステープルデバイス10の再利用を容易にするためにリロードアセンブリ18を交換することができる。
図2~5は、ステープルデバイス10のカートリッジチャネル30を示している。カートリッジチャネル30は、細長い凹部32を画定する、基壁40および離間した側壁42を含む。離間した側壁42の各々は、ツールアセンブリ16の長手方向軸に平行な軸に沿って延在し、ステープルカートリッジ28を支持する上部肩部44を含む。カートリッジチャネル30の側壁42はまた、側壁42の長さに沿って離間されている***または突起46を支持する。***40の各々は、ステープルカートリッジ28の組織接触表面48の上方に延在し、その半径方向外方に位置付けられる。本開示の態様では、***46は、組織への損傷を最小限に抑えるための非外傷性構成を含む上部または組織係合部分50を含む。係合部分50は、台形形状50(図3)、長方形形状50bおよび50c(図3Aおよび3B)、ならびに円形形状50dを含む様々な形状を有し得る。代替的に、他の形状が想定される。
***46は、組織に損傷を生じさせることなく組織を適切に把持するための高さおよび間隔を有する。本開示の態様では、***46は、ステープルカートリッジ28の組織接触表面48から約1.5ミリメートル~約2.5ミリメートルの高さを有し、本開示のいくつかの態様では、約2ミリメートルの高さを有する。本開示のいくつかの態様では、***40は、側壁42に沿って約3ミリメートル~約6ミリメートルまで互いに離間され、本開示のいくつかの態様では、互いに約4.5ミリメートル離間されている。他の間隔が想定される。本開示の特定の態様では、***46は、カートリッジチャネル30の側壁42に沿って位置付けられた***46のグループを含み、***46の各グループの各***46は、上で説明されるように、それぞれのグループの他の***46から離間されており、そのグループは他のグループからより大きな距離だけ離間している。例えば、カートリッジチャネル30は、***の2つ以上のグループ、例えば、近位グループ60a、中間グループ60b、および遠位グループ60cを含む、***の3つのグループを含み得る(図4)。
図6および7は、クランプ位置にあるツールアセンブリ16を示しており、組織「T」が、アンビルアセンブリ24の組織接触表面24aとカートリッジアセンブリ26のステープルカートリッジ28の組織接触表面48との間にクランプされている。クランプ位置では、係合部分の***46は、アンビルアセンブリ24およびステープルカートリッジ28の組織接触表面24aおよび28の外方に離間され、組織「T」と係合している。クランプ位置では、***46の係合部分50は、アンビルアセンブリ24から外方に離間されており、ツールアセンブリ16のいかなる部分にも対向していない。したがって、組織は、ツールアセンブリ16の対向する表面の間で圧縮されない。これにより、組織「T」への損傷が最小限に抑えられる。組織「T」と***46との係合は、ツールアセンブリ16内の組織「T」を安定化させ、ステープル形成中の横方向および長手方向の両方で組織の動きを制限して、ステープルデバイス10の発射中のステープル形成を改善する。
本開示は、***46がツールアセンブリ16のカートリッジチャネル30上に形成されるとして説明しているが、***46は、アンビルアセンブリ24の組織接触表面24aの外方にあるアンビルアセンブリ24上に形成され得ることが想定される。***46は、カートリッジチャネル30、ステープルカートリッジ28、またはアンビルアセンブリ24と一体的に形成され得ることもまた想定される。***46は、カートリッジチャネル30、ステープルカートリッジ28、またはアンビルアセンブリ24のうちの1つとは別個に形成され、それらに固設され得ることもまた想定される。
当業者であれば、本明細書において具体的に説明され、添付の図面に図示される装置および方法が、本開示の非限定的な例示的な態様であることを理解するであろう。1つの例示的な実施形態に関連して図示または説明された要素および特徴を、本開示の範囲から逸脱することなく、別の実施形態の要素および特徴と組み合わされ得ることが想定される。同様に、当業者であれば、本開示の上で説明される開示の態様に基づく本開示の更なる特徴およ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指示される場合を除いて、具体的に図示および説明されたものによって限定されるべきではない。
Claims (20)
- 外科用ステープルデバイスであって、
近位部分および遠位部分を有する細長い本体と、
細長い本体の遠位部分で支持され、かつ長手方向軸を画定する、ツールアセンブリと、を備え、前記ツールアセンブリが、アンビルアセンブリおよびカートリッジアセンブリを含み、前記アンビルアセンブリが、遠位端部分および組織係合表面を有し、前記カートリッジアセンブリが、遠位端部分を有し、カートリッジチャネルおよびステープルカートリッジを含み、前記ステープルカートリッジが、遠位端部分および組織接触表面を有し、前記カートリッジアセンブリが、前記アンビルアセンブリと結合されており、そのため、前記ツールアセンブリが、前記アンビルおよびカートリッジアセンブリの前記遠位端部分が互いに離間する開放位置と、前記アンビルアセンブリおよび前記ステープルカートリッジの前記組織接触表面が並列に配置されるクランプ位置との間で移動可能であり、
前記カートリッジチャネルが、細長い凹部を画定する、基壁および離間した側壁を含み、前記細長い凹部が、前記ステープルカートリッジを受容し、前記離間した側壁の各々が、複数の***を支持し、前記複数の***の各々が、前記ステープルカートリッジの前記組織係合表面の外方に離間され、前記ステープルカートリッジの前記組織係合表面の上方で前記アンビルアセンブリに向かう方向に延在する組織係合部分を含む、外科用ステープルデバイス。 - 前記複数の***の各々の前記組織係合部分が、非外傷性形状を有する、請求項1に記載の外科用ステープルデバイス。
- 前記複数の***の各々の前記係合部分が、台形形状を有する、請求項2に記載の外科用ステープルデバイス。
- 前記複数の***の各々の前記係合部分が、長方形形状を有する、請求項2に記載の外科用ステープルデバイス。
- 前記複数の***の各々の前記係合部分が、円形形状を有する、請求項2に記載の外科用ステープルデバイス。
- 前記複数の***の各々の前記係合部分が、前記ステープルカートリッジの前記組織係合表面の上方で前記アンビルアセンブリに向かう方向に距離Xで延在し、Xが、約1.5ミリメートル~約2.5ミリメートルである、請求項1に記載の外科用ステープルデバイス。
- Xが、約2ミリメートルである、請求項6に記載の外科用ステープルデバイス。
- 前記複数の***の各***が、前記複数の***の隣接する***から距離Yだけ離間しており、Yが、約3ミリメートル~約6ミリメートルである、請求項1に記載の外科用ステープルデバイス。
- Yが、約4.5ミリメートルである、請求項1に記載の外科用ステープルデバイス。
- 前記複数の***が、第1のグループおよび第2のグループを含む、前記カートリッジチャネルに沿って離間された***のグループに形成され、***の各グループが、前記複数の***のうちの少なくとも2つの***を含む、請求項1に記載の外科用ステープルデバイス。
- 前記***のグループの各々における前記複数の***の各***が、前記***のそれぞれのグループの隣接する***から距離Yだけ離間され、Yが、約3ミリメートル~約6ミリメートルである、請求項10に記載の外科用ステープルデバイス。
- Xが、約2ミリメートルである、請求項11に記載の外科用ステープルデバイス。
- ハンドルアセンブリをさらに含み、前記ハンドルアセンブリにが、前記細長い本体の前記近位部分が結合されている、請求項1に記載の外科用ステープルデバイス。
- ツールアセンブリであって、
遠位端部分および組織係合表面を有するアンビルアセンブリと、
遠位端部分を有し、カートリッジチャネルおよびステープルカートリッジを含むカートリッジアセンブリと、を備え、前記ステープルカートリッジが、遠位端部分および組織接触表面を有し、前記カートリッジアセンブリが、前記アンビルアセンブリに結合されており、そのため、前記ツールアセンブリが、前記アンビルおよびカートリッジアセンブリの前記遠位端部分が互いに離間する開放位置と、前記アンビルアセンブリおよび前記ステープルカートリッジの前記組織接触表面が並列に配置されるクランプ位置との間で移動可能であり、前記カートリッジチャネルが、細長い凹部を画定する、基壁および離間した側壁を含み、前記細長い凹部が、前記ステープルカートリッジを受容し、前記カートリッジチャネルの前記離間した側壁の各々が、複数の***を支持し、前記複数の***の各々が、前記ステープルカートリッジの前記組織係合表面の外方に離間され、前記ステープルカートリッジの前記組織係合表面の上方で前記アンビルアセンブリに向かう方向に延在する組織係合部分を含む、ツールアセンブリ。 - 前記複数の***の各々の前記組織係合部分が、非外傷性形状を有する、請求項14に記載のツールアセンブリ。
- 前記非外傷性形状が、台形形状、長方形形状、および円形形状から選択される、請求項14に記載のツールアセンブリ。
- 前記複数の***の各々の前記係合部分が、前記ステープルカートリッジの前記組織係合表面の上方で前記アンビルアセンブリに向かう方向に距離Xで延在し、Xが、約1.5ミリメートル~約2.5ミリメートルである、請求項14に記載のツールアセンブリ。
- 前記複数の***の各***が、前記複数の***の隣接する***から距離Yだけ離間しており、Yが、約3ミリメートル~約6ミリメートルである、請求項14に記載のツールアセンブリ。
- 前記複数の***が、第1のグループおよび第2のグループを含む、前記カートリッジチャネルに沿って離間された***のグループに形成され、***の各グループが、前記複数の***のうちの少なくとも2つの***を含む、請求項14に記載のツールアセンブリ。
- 前記***のグループの各々における前記複数の***の各***が、前記***のそれぞれのグループの隣接する***から距離Yだけ離間され、Yが、約3ミリメートル~約6ミリメートルである、請求項19に記載のツールアセンブリ。
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- 2020-02-14 JP JP2022548890A patent/JP2023523507A/ja active Pending
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- 2020-02-14 US US17/799,306 patent/US11890014B2/en active Active
- 2020-02-14 CN CN202080096519.8A patent/CN115135251A/zh active Pending
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CN115135251A (zh) | 2022-09-30 |
EP4103070A4 (en) | 2023-11-08 |
EP4103070A1 (en) | 2022-12-21 |
US20230076091A1 (en) | 2023-03-09 |
WO2021159483A1 (en) | 2021-08-19 |
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