JP2021530309A - 外科用ステープル留め器具の構成要素の湾曲先端部のための永久的取り付け手段 - Google Patents
外科用ステープル留め器具の構成要素の湾曲先端部のための永久的取り付け手段 Download PDFInfo
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Abstract
Description
図1〜図7は、外科的処置を行うために、図1に描写されるような非関節動作状態で、トロカールカニューレを通って患者内の手術部位まで挿入するように寸法決めされている、例示の外科用ステープル留め及び切断器具(10)を示している。単なる例として、患者の腹部内に、患者の2本の肋骨の間に、又は他の部位に、このようなトロカールを挿入してもよい。一部の状況では、器具(10)は、トロカールなしで使用される。例えば、開胸又は他の種類の切開によって、器具(10)を直接挿入してもよい。本発明の例の器具(10)は、シャフト(22)に結合しているハンドル部分(20)を含む。シャフト(22)は、関節動作ジョイント(11)内で遠位方向に終端し、関節動作ジョイント(11)は、エンドエフェクタ(12)と更に連結されている。本明細書では、「近位」及び「遠位」といった用語は、器具(10)のハンドル部分(20)を握っている臨床医を基準として使用されていることを理解されたい。したがって、エンドエフェクタ(12)は、より近位にあるハンドル部分(20)に対して遠位にある。便宜上、また説明を明確にするため、本明細書では「垂直」、「水平」、「上部」及び「下部」といった空間的用語が、図面に対して使用されている点も更に理解されるであろう。しかしながら、外科器具は、多くの向き及び位置で使用されるものであり、これらの用語は、限定的かつ絶対的なものであることを意図するものではない。
いくつかの例では、ユーザーにエンドエフェクタ(12)のより良好な可視化をもたらすことが望まれ得る。特に、エンドエフェクタ(12)が手術部位に挿入される際、ユーザーは、処置中に器具(10)のシャフト(22)を回転させる場合がある。その結果、エンドエフェクタ(12)もまた、回転する。エンドエフェクタ(12)が回転する際、手術部位を目視できることがユーザーにとって望まれ得る。例えば、ユーザーは、組織(90)とエンドエフェクタ(12)との間の境界面又は接触面を見たいと望む場合がある。エンドエフェクタ(12)がハンドル部分(20)に対して長手方向軸(LA)を中心に回転することができるため、ユーザーは、アンビル(18)ではなく、エンドエフェクタの下側ジョー(16)が見えるように、手術部位を見る場合がある。あるいは、ユーザーがエンドエフェクタ(12)を見る際、アンビル(18)がユーザーに見えるように、エンドエフェクタ(12)を回転させることができる。図1の器具(10)において可能であるものを越えて手術部位の視認性をユーザーにもたらすことが望まれ得る。例えば、流体を輸送している血管を切断し、ステープル留めを行ういくつかの外科的処置の場合には、アンビル(18)及び下側ジョー(16)が、切断されるべき血管を完全に覆っていることが目視確認でき、1回の作動で血管を完全に切断かつステープル留めできることが望まれ得る。換言すれば、ユーザーは、血管の一部分のみを切断及びステープル留めすることを回避したいと希望する場合がある。したがって、アンビル(18)及び下側ジョー(16)が血管を完全にクランプできるように、エンドエフェクタ(12)が手術部位内に適切に位置付けられたことがユーザーにわかるような、目視によるモニタリング及び/又はフィードバックの手段が望まれ得る。手術部位をモニタリングする1つの考えられる方法として、下側ジョー(16)及びアンビル(18)の遠位先端に隣接する区域の可視性を改善することが挙げられる。更に、エンドエフェクタ(12)の遠位端の可視化のみならず、アンビル(18)の遠位端が、アンビル(18)が下側ジョー(16)に向かって閉鎖する際にアンビル(18)と下側ジョー(16)との間の空間内に近位方向に組織(例えば、大血管)を付勢するように構成されるように、エンドエフェクタ(12)を構築することが望ましい場合もある。
いくつかの処置では、組織に沿って、又は組織を通して切断することが必要であり得、その場合、1つよりも多い切断順序が、処理を完了するために必要であり、換言すれば、連続経路に沿って連続的に切断する。このような処置では、この連続的な切断技術は、「マーチング(marching)」として定義され得る。マーチングを伴う処置では、器具(10)は、手術部位に配置され、切断及びステープル留めするように作動され、次いで、新しいカートリッジ(37)を装着するために手術部位から除去され、次いで、以前の切断及びステープル留めサイクルが行われた同一経路に沿った次の切断及びステープル留めのために手術部位に再び配置され得る。このプロセスは、切断及びステープル留め処置が完了するまで繰り返される。図4A、図4B及び図7からわかるように、エンドエフェクタ(12)の遠位端構成は、アンビル(18)の遠位端とカートリッジ(37)の遠位端との間に間隙を提供する。この間隙は、各マーチング工程の開始時に、エンドエフェクタ(12)の遠位端を進入させる組織の非外傷性空間を提供することによって、マーチングを容易にし得る。
外科用器具が、上述したものと同じ又は類似の偏向可能な先端部を組み込む場合、偏向可能な先端部は、外科用器具のエンドエフェクタの遠位端に取り付けられた構造体であり得る。場合によっては、この取り付けは、偏向可能な先端部とエンドエフェクタとの間に永久的な取り付けを作り出すように構成されてもよいが、他の例では、この取り付けは、永久的な取り付けを必要としないように選択されてもよい。取り付けの性質にかかわらず、偏向可能な先端部は、器具の使用中にエンドエフェクタで固定されたままであるようにエンドエフェクタに取り付けられる。
図12〜図14は、エンドエフェクタのジョー(418)の拡大部分の図を示し、これは、上述のように器具(10、310)と共に使用するために、かつ/又はロボット使用のために構成されている。ジョー(418)は、エンドエフェクタを形成する際に、上述のようなジョー(16)又はジョー(216)などの別のジョーとは反対側に配置可能である。ジョー(418)及び/又はエンドエフェクタの他の対向するジョーは、開放位置と閉鎖位置との間で互いに対して移動するように動作可能である。このようにして、エンドエフェクタは、ジョー間に組織を受容し、続いて組織を解放、クランプ、切断、及び/又はステープル留めするように動作可能である。本明細書の教示を考慮すると、ジョー(418)は、様々なエンドエフェクタと共に使用されてもよく、そのうちの少なくともいくつかは、本明細書に記載されるか、又は参照により組み込まれることが、当業者に明らかになるであろう。
上記のセクションは、締結具又は鋲などの保持特徴部を使用して偏向可能な配置先端部をエンドエフェクタのジョーに取り付ける方法を説明し図示しているが、偏向可能な配置先端部をエンドエフェクタのジョーに取り付ける他の方法は、エンドエフェクタのジョーの一部上に配置先端部をオーバーモールドすることを含む。以下のジョーの説明では、変形可能又は偏向可能な配置先端部の改善されたオーバーモールド取り付けを提供し、分離及び縁部剥離を防止するために、表面処理及び/又は表面特徴部がジョーに加えられる。
以下の実施例は、本明細書の教示を組み合わせるか又は適用することができる、様々な非網羅的な方式に関する。以下の実施例は、本出願における又は本出願の後の出願におけるどの時点でも提示され得る、いずれの特許請求の範囲の適用範囲をも限定することを目的としたものではない、と理解すべきである。一切の棄権を意図するものではない。以下の実施例は、単なる例示の目的で与えられるものに過ぎない。本明細書の様々な教示は、多くの他の方式で構成及び適用され得ると考えられる。また、いくつかの変形形態では、以下の実施例において言及される特定の特徴を省略してよいことも、考えられる。したがって、本発明者ら又は本発明者らの利益の継承者により、後日、そうである旨が明示的に示されない限り、以下に言及される態様又は特徴のいずれも重要なものとしてみなされるべきではない。以下に言及される特徴以外の更なる特徴を含むいかなる特許請求の範囲も本出願において、又は本出願に関連する後の出願において示される場合、それらの更なる特徴は、特許性に関連するいかなる理由によっても追加されたものとして仮定されるべきではない。
本明細書に記載の教示、表現要素、実施形態、実施例などのうちのいずれか1つ又は2つ以上を、本明細書に記載の他の教示、表現要素、実施形態、実施例などのうちのいずれか1つ又は2つ以上と組み合わせることができる点が理解されるべきである。したがって、上記の教示、表現要素、実施形態、実施例などは、互いに対して独立して考慮されるべきではない。本明細書における教示を鑑みると、本明細書の教示を組み合わせることができる種々の好適な方法が、当業者には直ちに明らかとなろう。このような修正形態及び変形形態は、特許請求の範囲の範囲内に含まれるものとする。
(1) 装置であって、
(a)本体と、
(b)前記本体から延在するシャフトであって、第1の長手方向軸線を画定する、シャフトと、
(c)前記シャフトに連通するエンドエフェクタであって、前記エンドエフェクタは、組織を圧縮し、ステープル留めし、かつ切断するように動作可能であり、前記エンドエフェクタは、
(i)第1のジョーと、
(ii)前記第1のジョーに対向する第2のジョーであって、前記ジョーのうちの少なくとも1つが、開放位置と閉鎖位置との間で他方のジョーに対して移動可能である、第2のジョーと、
(iii)弾性的に変形可能な配置先端部であって、前記第1のジョーから遠位に延在する、配置先端部と、
(iv)前記配置先端部を前記第1のジョーと固定するように構成された保持特徴部であって、前記保持特徴部が装着されたときに、前記配置先端部の外れを防止するように更に構成されている、保持特徴部と、を含む、エンドエフェクタと、を備える、装置。
(2) 前記保持特徴部が、前記配置先端部の近位部分を前記第1のジョーと接続する、実施態様1に記載の装置。
(3) 前記保持特徴部が、締結具を含む、実施態様1に記載の装置。
(4) 前記配置先端部の前記近位部分が接続部材を含み、前記接続部材が、前記締結具を受容するように構成された開口部を含む、実施態様3に記載の装置。
(5) 前記第1のジョーが、前記配置先端部の前記接続部材に対して相補的な形状を有する空隙空間を含む、実施態様4に記載の装置。
(7) 前記延長部材が、第1の横方向突出翼及び第2の横方向突出翼を含み、前記接続部材の前記開口部内に前記締結具を挿入することにより、前記延長部材の前記第1の突出翼及び前記第2の突出翼が、前記配置先端部によって画定される第2の長手方向軸線から外向きに偏向する、実施態様6に記載の装置。
(8) 前記第1の突出翼及び前記第2の突出翼の偏向が、前記第1の突出翼及び前記第2の突出翼と前記第1のジョーとの間の接触圧を増大させる、実施態様7に記載の装置。
(9) 前記第1のジョーが、前記第2のジョーに面する下表面を含み、前記保持特徴部は、前記第1のジョーの前記下表面と反対側の前記第1のジョーの上表面から装着されるように構成されている、実施態様1に記載の装置。
(10) 前記第1のジョーが、基部と、前記基部に選択的に取り付けるように構成されたキャップと、を含む、実施態様9に記載の装置。
(12) 前記保持特徴部が、把持特徴部を含む、実施態様1に記載の装置。
(13) 前記把持特徴部が、前記第2のジョーに向かって延在する、実施態様12に記載の装置。
(14) 前記第1のジョーが、アンビルを含む、実施態様1に記載の装置。
(15) 前記保持特徴部が、前記第1のジョー内に実質的に隠されている、実施態様1に記載の装置。
(a)本体と、
(b)前記本体から延在するシャフトであって、第1の長手方向軸線を画定する、シャフトと、
(c)前記シャフトに連通するエンドエフェクタであって、前記エンドエフェクタは、組織を圧縮し、ステープル留めし、かつ切断するように動作可能であり、前記エンドエフェクタは、
(i)弾性的に変形可能な配置先端部と、
(ii)第1のジョーであって、前記第1のジョーは、前記第1のジョーの遠位端に表面特徴部を含み、前記表面特徴部は、前記配置先端部が前記第1のジョーから遠位方向に延在するように前記配置先端部を前記第1のジョーとオーバーモールド取り付けをするように構成されており、前記第1のジョーの前記表面特徴部は、オーバーモールドされた前記配置先端部の分離を防止するように更に構成されている、第1のジョーと、
(ii)前記第1のジョーに対向する第2のジョーであって、前記ジョーのうちの少なくとも1つは、開放位置と閉鎖位置との間で他方のジョーに対して移動可能である、第2のジョーと、を含む、エンドエフェクタと、を備える、装置。
(17) 前記第1のジョーの前記表面特徴部が、前記オーバーモールドされた配置先端部によって少なくとも実質的に囲まれている、実施態様16に記載の装置。
(18) 前記表面特徴部が、前記オーバーモールドされた配置先端部の縁部剥離を防止するように更に構成されている、実施態様16に記載の装置。
(19) 前記表面特徴部が、
(A)前記第1のジョーに対して長手方向に延在する第1の部分であって、内部を通って延在する孔を含む、第1の部分と、
(B)前記第1の部分に接続された第2の部分であって、前記第2の部分は、前記第1の部分に対して直交して延在し、前記第2の部分は複数のノッチを含む、第2の部分と、を備える、実施態様16に記載の装置。
(20) 偏向可能な配置先端部を外科用器具のエンドエフェクタに取り付ける方法であって、前記エンドエフェクタは、遠位端に表面特徴部を有する第1のジョーと、前記第1のジョーに対向する第2のジョーと、を含み、前記ジョーのうちの少なくとも1つは、開放位置と閉鎖位置との間で他方のジョーに対して移動可能であり、前記方法は、
(a)前記第1のジョーを潤滑することと、
(b)前記配置先端部をオーバーモールド取り付けするために前記第1のジョーの前記表面特徴部を準備することであって、前記表面特徴部を準備することが、前記表面特徴部をエッチングして前記表面特徴部から潤滑剤を除去すること、潤滑剤が前記表面特徴部に接触することを防止するために前記第1のジョーを潤滑する前に前記表面特徴部をマスキングすること、及びこれらの組み合わせのうちの選択した1つを含む、ことと、
(c)前記配置先端部を前記第1のジョーの前記遠位端にオーバーモールドすることであって、前記配置先端部が、前記第1のジョーの前記表面特徴部と接触し、かつ実質的に囲んでいる、ことと、を含む、方法。
Claims (20)
- 装置であって、
(a)本体と、
(b)前記本体から延在するシャフトであって、第1の長手方向軸線を画定する、シャフトと、
(c)前記シャフトに連通するエンドエフェクタであって、前記エンドエフェクタは、組織を圧縮し、ステープル留めし、かつ切断するように動作可能であり、前記エンドエフェクタは、
(i)第1のジョーと、
(ii)前記第1のジョーに対向する第2のジョーであって、前記ジョーのうちの少なくとも1つが、開放位置と閉鎖位置との間で他方のジョーに対して移動可能である、第2のジョーと、
(iii)弾性的に変形可能な配置先端部であって、前記第1のジョーから遠位に延在する、配置先端部と、
(iv)前記配置先端部を前記第1のジョーと固定するように構成された保持特徴部であって、前記保持特徴部が装着されたときに、前記配置先端部の外れを防止するように更に構成されている、保持特徴部と、を含む、エンドエフェクタと、を備える、装置。 - 前記保持特徴部が、前記配置先端部の近位部分を前記第1のジョーと接続する、請求項1に記載の装置。
- 前記保持特徴部が、締結具を含む、請求項1に記載の装置。
- 前記配置先端部の前記近位部分が接続部材を含み、前記接続部材が、前記締結具を受容するように構成された開口部を含む、請求項3に記載の装置。
- 前記第1のジョーが、前記配置先端部の前記接続部材に対して相補的な形状を有する空隙空間を含む、請求項4に記載の装置。
- 前記接続部材が延長部材を更に含み、前記接続部材の前記開口部が、前記延長部材の少なくとも一部分を通って延在する、請求項4に記載の装置。
- 前記延長部材が、第1の横方向突出翼及び第2の横方向突出翼を含み、前記接続部材の前記開口部内に前記締結具を挿入することにより、前記延長部材の前記第1の突出翼及び前記第2の突出翼が、前記配置先端部によって画定される第2の長手方向軸線から外向きに偏向する、請求項6に記載の装置。
- 前記第1の突出翼及び前記第2の突出翼の偏向が、前記第1の突出翼及び前記第2の突出翼と前記第1のジョーとの間の接触圧を増大させる、請求項7に記載の装置。
- 前記第1のジョーが、前記第2のジョーに面する下表面を含み、前記保持特徴部は、前記第1のジョーの前記下表面と反対側の前記第1のジョーの上表面から装着されるように構成されている、請求項1に記載の装置。
- 前記第1のジョーが、基部と、前記基部に選択的に取り付けるように構成されたキャップと、を含む、請求項9に記載の装置。
- 前記第1のジョーが、前記第2のジョーに面する下表面を含み、前記保持特徴部は、前記第1のジョーの前記下表面から装着されるように構成されている、請求項1に記載の装置。
- 前記保持特徴部が、把持特徴部を含む、請求項1に記載の装置。
- 前記把持特徴部が、前記第2のジョーに向かって延在する、請求項12に記載の装置。
- 前記第1のジョーが、アンビルを含む、請求項1に記載の装置。
- 前記保持特徴部が、前記第1のジョー内に実質的に隠されている、請求項1に記載の装置。
- 装置であって、
(a)本体と、
(b)前記本体から延在するシャフトであって、第1の長手方向軸線を画定する、シャフトと、
(c)前記シャフトに連通するエンドエフェクタであって、前記エンドエフェクタは、組織を圧縮し、ステープル留めし、かつ切断するように動作可能であり、前記エンドエフェクタは、
(i)弾性的に変形可能な配置先端部と、
(ii)第1のジョーであって、前記第1のジョーは、前記第1のジョーの遠位端に表面特徴部を含み、前記表面特徴部は、前記配置先端部が前記第1のジョーから遠位方向に延在するように前記配置先端部を前記第1のジョーとオーバーモールド取り付けをするように構成されており、前記第1のジョーの前記表面特徴部は、オーバーモールドされた前記配置先端部の分離を防止するように更に構成されている、第1のジョーと、
(ii)前記第1のジョーに対向する第2のジョーであって、前記ジョーのうちの少なくとも1つは、開放位置と閉鎖位置との間で他方のジョーに対して移動可能である、第2のジョーと、を含む、エンドエフェクタと、を備える、装置。 - 前記第1のジョーの前記表面特徴部が、前記オーバーモールドされた配置先端部によって少なくとも実質的に囲まれている、請求項16に記載の装置。
- 前記表面特徴部が、前記オーバーモールドされた配置先端部の縁部剥離を防止するように更に構成されている、請求項16に記載の装置。
- 前記表面特徴部が、
(A)前記第1のジョーに対して長手方向に延在する第1の部分であって、内部を通って延在する孔を含む、第1の部分と、
(B)前記第1の部分に接続された第2の部分であって、前記第2の部分は、前記第1の部分に対して直交して延在し、前記第2の部分は複数のノッチを含む、第2の部分と、を備える、請求項16に記載の装置。 - 偏向可能な配置先端部を外科用器具のエンドエフェクタに取り付ける方法であって、前記エンドエフェクタは、遠位端に表面特徴部を有する第1のジョーと、前記第1のジョーに対向する第2のジョーと、を含み、前記ジョーのうちの少なくとも1つは、開放位置と閉鎖位置との間で他方のジョーに対して移動可能であり、前記方法は、
(a)前記第1のジョーを潤滑することと、
(b)前記配置先端部をオーバーモールド取り付けするために前記第1のジョーの前記表面特徴部を準備することであって、前記表面特徴部を準備することが、前記表面特徴部をエッチングして前記表面特徴部から潤滑剤を除去すること、潤滑剤が前記表面特徴部に接触することを防止するために前記第1のジョーを潤滑する前に前記表面特徴部をマスキングすること、及びこれらの組み合わせのうちの選択した1つを含む、ことと、
(c)前記配置先端部を前記第1のジョーの前記遠位端にオーバーモールドすることであって、前記配置先端部が、前記第1のジョーの前記表面特徴部と接触し、かつ実質的に囲んでいる、ことと、を含む、方法。
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2018
- 2018-07-16 US US16/035,872 patent/US10973515B2/en active Active
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2019
- 2019-07-15 EP EP19186243.2A patent/EP3597119A3/en not_active Withdrawn
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- 2019-07-16 BR BR112021000740-7A patent/BR112021000740A2/pt not_active Application Discontinuation
- 2019-07-16 JP JP2021502595A patent/JP7366992B2/ja active Active
- 2019-07-16 CN CN201980048037.2A patent/CN112423679A/zh active Pending
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CN112423679A (zh) | 2021-02-26 |
WO2020016759A1 (en) | 2020-01-23 |
US10973515B2 (en) | 2021-04-13 |
BR112021000740A2 (pt) | 2021-04-13 |
EP3597119A2 (en) | 2020-01-22 |
US20200015815A1 (en) | 2020-01-16 |
JP7366992B2 (ja) | 2023-10-23 |
EP3597119A3 (en) | 2020-02-26 |
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