JP6580604B2 - 組織内でステープルを封止する装置及び方法 - Google Patents
組織内でステープルを封止する装置及び方法 Download PDFInfo
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- JP6580604B2 JP6580604B2 JP2016572469A JP2016572469A JP6580604B2 JP 6580604 B2 JP6580604 B2 JP 6580604B2 JP 2016572469 A JP2016572469 A JP 2016572469A JP 2016572469 A JP2016572469 A JP 2016572469A JP 6580604 B2 JP6580604 B2 JP 6580604B2
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Description
様々な外科用器具が本明細書で開示される補助材と共に使用され得るが、図3に、1つ又は2つ以上の補助材との使用に適した外科用ステープラ10の1つの非限定的な例示的実施形態を示す。器具10は、一般に、ハンドルアセンブリ12と、ハンドルアセンブリ12の遠位端12dから遠位に延在するシャフト14と、シャフト14の遠位端14dにあるエンドエフェクタ50と、を含む。示した実施形態は外科用ステープラであるので、エンドエフェクタ50は、ジョー52、54を有するが、他の種類のエンドエフェクタを、シャフト14、ハンドルアセンブリ12、及びそれらに付随する構成要素と共に使用し得る。外科用ステープラ10は、対向する下部及び上部ジョー52、54を含み、下部ジョー52は、ステープルカートリッジ60を支持するように構成されているステープルチャネル56(図4)を含み、上部ジョー54は、下部ジョー52に対向し、アンビルとして作動してステープルカートリッジ60のステープル70の配備を支援するように構成されている内面58を有する。ジョー52、54は、互いに対して移動してそれらの間に配置された組織又は他の対象物をクランプするように構成されており、発射システムの構成要素は、エンドエフェクタ50の少なくとも一部を通過して、クランプされた組織へとステープルを放出するように構成され得る。様々な実施形態において、ナイフブレード81は発射システムに接続され、ステープリング処置中に組織を切開し得る。対向する下部及び上部ジョー52、54の少なくとも一方は、他方の下部及び上部ジョー52、54に対して移動可能である。対向する下部及び上部ジョー52、54の少なくとも一方は、固定されるか、又は別の方法で移動不能であってよい。いくつかの実施形態において、対向する下部及び上部ジョー52、54の両方が移動可能である。
外科用器具の構成に関わらず、本明細書に記載の実施形態は、器具操作と共に、植え込み可能な材料、例えば、合成及び/又は生体材料、集合的に「補助材」の使用方法を提供し得る。以下で更に詳述するように、本明細書に開示するように、補助材は、様々な方法で下部及び上部ジョー(haw)部材52、54に取り外し可能に結合されて、エンドエフェクタ50の作動時に補助材をジョー部材から分離可能にし得る。より具体的には、補助材は、ジョー部材52、54の間に配置された組織と共に、ステープル70によって捕捉され得る。補助材は、ステープラが患者から除去されたときに、患者の体内に留まり得る。補助材を外科用器具のエンドエフェクタに取り付ける多数の装置及び方法が以下に記載されているが、他には、その全体が参照により本明細書に組み込まれる、米国特許出願公開第2013/0256377号及び同第2013/0153641号に見出すことができる。
上記及び図8に示すように、外科用ステープラから発射されたステープルによって形成された穿刺部は、ステープリングされた組織の種類に応じて、血液、空気、又は他の体液の漏出をもたらすことがある。より具体的には、組織は、ステープル4006がその中に埋め込まれた後で様々な方向4002、4004のいずれかに伸長し得、したがってステープル脚部によって形成された穿刺部4008、4010を伸長させる。場合によっては、導管又は他の体腔のステープリングされた端部が正常に封止されても、ステープル穿刺部からの出血又は他の漏出が存在し得る。
本明細書に記載の方法及び装置の特定の実施形態は、外科用ステープラのアンビル側に配置された、つまり上記のクラウン側の補助部とは反対側のステープル組織上にある1つ、又は2つ以上の補助部セグメントを含む。これらのアンビル側補助部は、クラウン側補助部に加えて使用され得る。クラウン側補助部は、ステープル脚部の周囲での組織変形によって生じる漏出を阻止するように機能し、以下に記載するアンビル側補助部は、ステープル及びステープル線全体によって生じた引っ張りによる組織損傷を阻止し得る。
シーラント材は、外科用ステープラ及びエンドカッターでの処置前又はその後に、補助部セグメントとして適用されるものの代わりとして、外科用ステープルを使用してフィルム又は液体として処置される組織に直接適用され得る。
吻合とは、接続される組織の各端部にあるステープル線を通る円形切開部を形成することを必要とするプロセスである。ステープル線を切断することにより、引裂かれた、又は部分的に切断されたステープルが生じ得る。ステープル線の角部における組織の角折れは、漏出を有し得るか、破片を収集できるが、完全に角折れを排除することができない場合、漏出を最小限に抑えるように角折れを封止することが望ましい。以下では、角折れ用封止部を含み、円形切開部の配備によって最終的に切開される領域を通る、最少量のステープルを提供する、特定のステープルカートリッジ構成で使用する補助部アセンブリについて説明する。
本明細書に開示される装置は、1回の使用後に廃棄されるように設計され得るか、又は複数回使用されるように設計され得る。しかしながら、いずれの場合も、本装置は、少なくとも1回の使用後に再使用のために再調整することができる。再調整には、装置の分解工程、それに続く洗浄工程又は特定の部品の交換工程、及びその後の再組み立て工程の任意の組み合わせを含むことができる。特に、装置は分解可能であり、装置の任意の数の特定の部品又は部分を、任意の組み合わせで選択的に交換又は取り除くことができる。特定の部分を洗浄及び/又は交換したときに、装置を後の使用のために、再調整施設で、又は外科処置の直前に外科チームによるいずれかによって再組み立てすることができる。当業者であれば、装置の再調整が、分解、洗浄/交換、及び再組み立ての様々な技術を利用できることを理解するであろう。このような技術、及び結果として得られる再調整された装置の使用は、全て本発明の範囲内にある。
(1) 外科用装置であって、
シーラントを受け入れるように構成されている、前記装置の近位端に形成された少なくとも1つのノズルと、
前記少なくとも1つのノズルによって受け入れられた前記シーラントを送達するように構成されている、前記装置の遠位端に形成されたアプリケータと、を備え、
前記アプリケータから送達された前記シーラントが、外科用ステープラに形成された複数の開口部内に堆積され得るように、前記アプリケータが、前記外科用ステープラの第1ジョー及び第2ジョーのうちの少なくとも1つと接続するように構成されている、外科用装置。
(2) 前記アプリケータ内に配置されたシールドを更に備え、前記シールドによって、前記アプリケータによって送達された前記シーラントが、前記外科用ステープラの前記第1ジョー及び前記第2ジョーのうちの少なくとも1つに形成された切開ガイドスロットに入らないようにする、実施態様1に記載の装置。
(3) 過剰なシーラントを除去するために、前記アプリケータの最遠位縁部に形成されたスクィージーを更に備える、実施態様1に記載の装置。
(4) 本体がその近位端に形成された2つのノズルを含み、前記アプリケータは、各ノズルから受け入れたシーラントが前記アプリケータの遠位端から送達される前に混合できるように、前記アプリケータを通って延在する共通の管腔を含む、実施態様1に記載の装置。
(5) 前記2つのノズルが、異なる速度でシーラントを前記共通の管腔に導入するように構成され得る、実施態様4に記載の装置。
(7) 前記少なくとも1つのノズルが、前記容器に形成された封止部を穿刺するように構成されている穿刺先端部を含む、実施態様6に記載の装置。
(8) 前記容器がシリンジである、実施態様6に記載の装置。
(9) 前記アプリケータが、移動不可能かつ交換可能に(replacably)前記ノズルに取り付けられるように構成されている、実施態様1に記載の装置。
(10) シーラントを外科用装置に適用する方法であって、
外科用ステープラのジョー部材に粘着性シーラントを適用することであって、前記ジョー部材が、その内部に形成された複数の開口部を含み、前記複数の開口部が、前記シーラントを受け入れ得る、ことと、
前記複数の開口部内に堆積されたシーラントのみが残るように、前記ジョー部材から過剰な粘着性シーラントを除去することと、を含む、方法。
(12) 過剰な粘着性シーラントを除去することが、前記ジョー部材の長さに沿ってスクィージーを摺動させることを含む、実施態様11に記載の方法。
(13) 前記アプリケータが、前記ジョー部材上での1回のパスでシーラントの適用及び過剰なシーラントの除去の両方を実行できるように、前記アプリケータの最遠位縁部に形成されたスクィージーを備える、実施態様12に記載の方法。
(14) 前記ジョー部材への適用後に前記粘着性シーラントを少なくとも部分的に硬化させることを更に含む、実施態様10に記載の方法。
(15) 前記粘着性シーラントを少なくとも部分的に硬化させることが、化学物質、紫外線、及び熱のいずれかに前記シーラントを曝露することを含む、実施態様14に記載の方法。
外科用ステープラのアンビルに形成された複数のステープル成形開口部内に非圧縮性シーラントを適用することと、
前記アンビルと前記外科用ステープラのカートリッジ本体との間の組織を圧迫することと、
前記外科用ステープラを作動させて、前記カートリッジ本体から前記組織を通して、前記非圧縮性シーラントを含む前記複数のステープル成形開口部内に複数のステープルを送達することと、を含み、
前記非圧縮性シーラントは、前記アンビルと前記カートリッジ本体との間で圧迫された組織が、前記外科用ステープラの作動時に、前記複数のステープル成形開口部に入らないようにする、方法。
(17) 前記非圧縮性シーラントを適用することが、前記アンビルの長さに沿ってアプリケータを摺動させることを含む、実施態様16に記載の方法。
(18) 前記非圧縮性シーラントを適用することが、前記複数のステープル成形開口部内に送達する直前に、多成分シーラントを混合することを含む、実施態様16に記載の方法。
(19) 前記アンビルから過剰なシーラントを除去することを更に含む、実施態様16に記載の方法。
(20) 前記アンビルへの適用後に前記非圧縮性シーラントを少なくとも部分的に硬化させることを更に含む、実施態様16に記載の方法。
Claims (16)
- 外科用装置であって、
シーラントを受け入れるように構成されている、前記装置の近位端に形成された少なくとも1つのノズルと、
前記少なくとも1つのノズルによって受け入れられた前記シーラントを送達するように構成されている、前記装置の遠位端に形成されたアプリケータと、を備え、
前記アプリケータから送達された前記シーラントが、外科用ステープラに形成された複数の開口部内に堆積され得るように、前記アプリケータが、前記外科用ステープラの第1ジョー及び第2ジョーのうちの少なくとも1つと接続するように構成されており、
前記外科用装置が、前記アプリケータ内に配置されたシールドを更に備え、前記シールドによって、前記アプリケータによって送達された前記シーラントが、前記外科用ステープラの前記第1ジョー及び前記第2ジョーのうちの少なくとも1つに形成された切開ガイドスロットに入らないようにする、外科用装置。 - 過剰な前記シーラントを除去するために、前記アプリケータの最遠位縁部に形成されたスクィージーを更に備える、請求項1に記載の装置。
- 前記少なくとも1つのノズルが、前記装置の近位端に形成された2つのノズルを含み、前記アプリケータは、各前記ノズルから受け入れたシーラントが前記アプリケータの遠位端から送達される前に混合できるように、前記アプリケータを通って延在する共通の管腔を含む、請求項1に記載の装置。
- 前記2つのノズルが、異なる速度で前記シーラントを前記共通の管腔に導入するように構成され得る、請求項3に記載の装置。
- 前記少なくとも1つのノズルに結合された、前記シーラントの容器を更に備える、請求項1に記載の装置。
- 前記少なくとも1つのノズルが、前記容器に形成された封止部を穿刺するように構成されている穿刺先端部を含む、請求項5に記載の装置。
- 前記容器がシリンジである、請求項5に記載の装置。
- 前記アプリケータが、移動不可能かつ交換可能に前記ノズルに取り付けられるように構成されている、請求項1に記載の装置。
- シーラントを外科用装置に適用する方法であって、
外科用ステープラのジョー部材に粘着性シーラントを適用することであって、前記ジョー部材が、その内部に形成された複数の開口部を含み、前記複数の開口部が、前記シーラントを受け入れ得る、ことと、
前記複数の開口部内に堆積されたシーラントのみが残るように、前記ジョー部材から過剰な粘着性シーラントを除去することと、を含む、方法。 - 前記ジョー部材に前記粘着性シーラントを適用することは、アプリケータを通って前記シーラントが導入されるときに、前記ジョー部材の長さに沿って前記アプリケータを摺動させることを含む、請求項9に記載の方法。
- 前記過剰な粘着性シーラントを除去することが、前記ジョー部材の長さに沿ってスクィージーを摺動させることを含む、請求項10に記載の方法。
- 前記アプリケータが、前記ジョー部材上での1回のパスで前記粘着性シーラントの適用及び前記過剰な粘着性シーラントの除去の両方を実行できるように、前記アプリケータの最遠位縁部に形成されたスクィージーを備える、請求項11に記載の方法。
- 前記ジョー部材への適用後に前記粘着性シーラントを少なくとも部分的に硬化させることを更に含む、請求項9に記載の方法。
- 前記粘着性シーラントを少なくとも部分的に硬化させることが、化学物質、紫外線、及び熱のいずれかに前記シーラントを曝露することを含む、請求項13に記載の方法。
- 前記粘着性シーラントが、非圧縮性シーラントであり、
前記ジョー部材が、前記外科用ステープラのカートリッジ本体との間に組織を圧迫するためのアンビルを含み、
前記非圧縮性シーラントは、前記アンビルと前記カートリッジ本体との間で圧迫された組織が、前記外科用ステープラの作動時に、前記複数の開口部に入らないようにするものである、請求項9〜14のいずれか1項に記載の方法。 - 前記非圧縮性シーラントを適用することが、前記複数の開口部内に送達する直前に、多成分シーラントを混合することを含む、請求項15に記載の方法。
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US14/300,817 US9913646B2 (en) | 2014-06-10 | 2014-06-10 | Devices for sealing staples in tissue |
US14/300,815 US9924946B2 (en) | 2014-06-10 | 2014-06-10 | Devices and methods for sealing staples in tissue |
US14/300,811 US9936954B2 (en) | 2014-06-10 | 2014-06-10 | Devices and methods for sealing staples in tissue |
US14/300,807 US10390828B2 (en) | 2014-06-10 | 2014-06-10 | Devices and methods for sealing staples in tissue |
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