JP2018530371A - 活性化物質の影響を受ける薬剤を有する手術用補助材 - Google Patents
活性化物質の影響を受ける薬剤を有する手術用補助材 Download PDFInfo
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Abstract
Description
様々な手術用器具が、本明細書で開示された補助材及び/又は薬剤と共に使用され得る。「補助材」は、本明細書において、「補助材料」とも呼ばれる。手術用器具は、手術用ステープラを含み得る。様々な手術用ステープラ、例えば、線状手術用ステープラ及び輪状ステープラが使用され得る。概して、線状ステープラが、長手方向ステープルラインを形成するように構成されることができ、細長いジョーを含むことができる。このジョーは、それに連結され、長手方向ステープル列を収容しているカートリッジを有する。細長いジョーは、ジョー内に保持された組織に沿って、ステープル列間の切断を形成することができるナイフ又は他の切断部材を含み得る。概して、輪状ステープラは、環状ステープルラインを形成するように構成されることができ、輪状ジョーを含むことができる。この輪状ジョーは、環状ステープル列を収容しているカートリッジを有する。輪状ジョーは、ジョー内に保持された組織を通る開口を画定するためのステープル列の内側の切断を形成することができるナイフ又は他の切断部材を含み得る。ステープラは、様々な異なる外科的処置において、例えば、胸部手術又は胃部手術において、様々な組織での様々な異なる外科的処置に使用され得る。
上記されたように、様々な植え込み可能な補助材が、手術用ステープル留め器具と共に使用するのに提供される。補助材は、様々な構成を有することができ、様々な材料から形成されることができる。一般的に、補助材は、1つ以上のフィルム、発泡体、射出成形熱可塑性材料、真空熱成形材料、繊維性構造体、及びそれらのハイブリッドから形成され得る。また、補助材は、1つ以上の生物由来材料及び1つ以上の薬物も含み得る。これらの材料はそれぞれ、以下により詳細に検討される。
記載された技術に基づく補助材は、様々な材料から形成され得る。材料は、異なる目的での様々な実施形態に使用され得る。材料は、組織内方成長を促進するために、組織に提供されるべき所望の治療に従って選択され得る。以下に記載された材料は、任意の所望の組み合わせで、補助材を形成するのに使用され得る。
記載された技術に基づく補助材は、例えば、組織内方成長に対して、所望の様式で所望の効果を提供するために、多くの異なる方法で、少なくとも1種の薬剤と関連付けられ得る。少なくとも1種の薬剤は、施療部位において、所望の治癒プロセスをトリガするために、複数の空間的及び時間的パターンにおいて、補助材から放出されるように構成され得る。薬剤は、補助材内に配置され、補助材に結合し、補助材内に組み込まれ、補助材内に分散され、又は補助材と他の方法で関連付けられ得る。例えば、補助材は、内部に、1種以上の異なる薬剤を放出可能に保持している、1つ以上の領域を有し得る。この領域は、様々なサイズ及び形状の、様々な方法で内部に薬剤を保持する、別個のリザーバであるか、又は、補助材内の他の別個の、若しくは連続した領域であることができる。いくつかの態様では、補助材の特定の構成により、1種の薬剤又は2種以上の異なる薬剤を、内部に放出可能に保持することができる。
外科的処置の実行中に、患者の組織は、様々な様式のいずれかにおいて、傷つく場合がある(例えば、切除、引き裂き、穿刺など)。創傷は、例えば、吻合術において、及び/又は、組織が切断され、手術用装置、例えば、手術用ステープラを使用してファスナ留めされる場合、外科的処置の意図した態様である場合がある。傷ついた組織は、典型的には、全ての患者について一般的に同じ様式で経時的に治癒する。
活性化物質の影響を受ける薬剤を有する様々な例示的な手術用補助材が、本明細書に記載されている。全般的には、補助材は、活性化物質によって活性化されるように構成されている少なくとも1種の薬剤が提供される。補助材は、本明細書で論じるように、補助材を移植することができる患者の組織に運搬することができる。様々な活性化物質を、補助材によって保持された少なくとも1種の薬剤を活性化するように構成することができ、活性化は、様々な作用のうちの任意の1つ以上を引き起こす。例えば、補助材に対してシグナル及び/又は効果のうちの少なくとも1つをもたらすように、少なくとも1種の薬剤を活性化することができる。シグナル及び/又は効果は、補助材が手術用ステープルと共に適用される組織の治癒を促進してもよい。手術用ステープルが患者の体内で使用される場合、例えば、ステープリング、患者の手術後の動き、病的な組織、ステープルの破損、及び/又はその他の要因により引き起こされる予期せぬ組織裂傷(tissue tearing)に起因して、ステープルが患者の組織を効果的に封止しないという危険性が存在する。封止が完全に有効ではなく、漏口が発生する場合、例えば、流体及び/又はその他の物質が、組織内及び/又は組織によって画定された内腔内から漏出する場合、患者は、不快感及び/又はその他の悪影響を経験する場合があり、かつ/あるいは更なる外科的介入なしに、完全に防止されない場合には、組織の治癒が遅れる場合がある。シグナル及び/又は効果は、例えば、漏口を検出するための無効な封止の検出を可能にし、それによって、医療専門家が必要に応じて漏口に対処することを可能にする。シグナル及び/又は効果は、従来、漏口を手術後に検出及び/又は確認する方法である、漏口を検出及び/又は検査するための外科的介入なしで提供され得る。外科的介入を必要としないことにより、手術よりも安上がりであることができ、かつ/又は漏口を検出及び/若しくは確認する外科的介入よりも患者の感情的及び/若しくは肉体的ストレスを軽減させることができる。
(1) 手術用ステープラと共に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、
複数のステープル空洞を有するカートリッジ本体であって、それぞれのステープル空洞は、前記ステープル空洞内に配置された手術用ステープルを有する、カートリッジ本体と、
前記カートリッジ本体に解放可能に連結され、かつ前記カートリッジ本体内の前記ステープルを配備することによって組織に運搬されるように構成された、生体適合性補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能である有効量の少なくとも1種の薬剤であって、前記少なくとも1種の薬剤は、前記補助材料、前記カートリッジ本体、及び前記ステープルのうちのいずれとも関連付けられていない活性化物質により活性化されることが可能であり、前記少なくとも1種の薬剤が活性化すると、活性化された薬剤が前記補助材料に対してシグナル及び効果のうちの少なくとも1つをもたらす、有効量の少なくとも1種の薬剤と、を備える、アセンブリ。
(2) 前記補助材料は、前記カートリッジ本体の組織に接触する表面に解放可能に保持されている、実施態様1に記載のアセンブリ。
(3) 前記補助材料は、前記ステープルのそれぞれの表面に配置されている、実施態様1に記載のアセンブリ。
(4) 前記シグナルは、色の変化を含む、実施態様1に記載のアセンブリ。
(5) 前記効果は、発泡を含む、実施態様1に記載のアセンブリ。
(7) 前記少なくとも1種の薬剤のそれぞれは、所定の方法で、組織内方成長に対する所望の効果を提供するのに有効であり、前記少なくとも1種の薬剤の前記活性化は、前記所望の効果を停止させる、実施態様1に記載のアセンブリ。
(8) 前記組織は、体内腔を含み、前記少なくとも1種の薬剤は、前記活性化物質の存在下で反応して、前記体内腔を通過する物質の放射線濃度を変化させるように構成された反応性ポリマーを含む、実施態様1に記載のアセンブリ。
(9) 実施態様1に記載のステープルカートリッジアセンブリを使用する方法であって、
前記ステープルを前記カートリッジ本体から配備して、前記補助材料を患者の組織の外部表面に運搬することであって、前記組織は、前記患者の結腸及び前記患者の肺の内腔のうちの1つを含み、前記補助材料は、前記結腸の外部表面又は前記肺の前記内腔の外部表面に運搬される、ことを含む、方法。
(10) 実施態様1に記載のステープルカートリッジアセンブリを使用する方法であって、
前記ステープルを前記カートリッジ本体から配備して、前記補助材料を患者の組織に運搬することと、
前記ステープルの前記配備とは別に、前記活性化物質を前記患者に投与することと、を含む、方法。
着脱可能に取り付けられたカートリッジ本体を有する第1のジョーであって、前記カートリッジ本体は、組織に面する表面に、ステープルを内部に設置するように構成された複数のステープル空洞を有する、第1のジョーと、
組織に面する表面に形成された複数のステープル成形空洞を含むアンビルを有する第2のジョーであって、前記第1のジョー及び前記第2のジョーのうちの少なくとも一方は、他方に対して移動可能である、第2のジョーと、
前記カートリッジ本体内の前記ステープルを配備することによって組織に運搬されるように構成された生体適合性補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能である有効量の少なくとも1種の薬剤であって、前記少なくとも1種の薬剤は、前記補助材料、前記カートリッジ本体、及び前記ステープルのうちのいずれとも関連付けられていない活性化物質により活性化されることが可能であり、前記少なくとも1種の薬剤が活性化すると、活性化された薬剤が前記補助材料に対してシグナル及び効果のうちの少なくとも1つをもたらす、有効量の少なくとも1種の薬剤と、
を備える、エンドエフェクタ。
(12) 前記補助材料は、前記カートリッジ本体及び前記アンビルの前記組織に面する表面のうちの少なくとも一方に解放可能に保持されている、実施態様11に記載のエンドエフェクタ。
(13) 前記補助材料は、前記ステープルのそれぞれの表面に配置されている、実施態様11に記載のエンドエフェクタ。
(14) 前記シグナルは、色の変化を含む、実施態様11に記載のエンドエフェクタ。
(15) 前記効果は、発泡を含む、実施態様11に記載のエンドエフェクタ。
(17) 前記少なくとも1種の薬剤のそれぞれは、所定の方法で、組織内方成長に対する所望の効果を提供するのに有効であり、前記少なくとも1種の薬剤の前記活性化は、前記所望の効果を停止させる、実施態様11に記載のエンドエフェクタ。
(18) 前記組織は、体内腔を含み、前記少なくとも1種の薬剤は、前記活性化物質の存在下で反応して、前記体内腔を通過する物質の放射線濃度を変化させるように構成された反応性ポリマーを含む、実施態様11に記載のエンドエフェクタ。
(19) 実施態様11に記載のステープルカートリッジアセンブリを使用する方法であって、
前記ステープルを前記カートリッジ本体から配備して、前記補助材料を患者の組織の外部表面に運搬することであって、前記組織は、前記患者の結腸及び前記患者の肺の内腔のうちの1つを含み、前記補助材料は、前記結腸の外部表面又は前記肺の前記内腔の外部表面に運搬される、ことを含む、方法。
(20) 実施態様11に記載のステープルカートリッジアセンブリを使用する方法であって、
前記ステープルを前記カートリッジ本体から配備して、前記補助材料を患者の組織に運搬することと、
前記ステープルの前記配備とは別に、前記活性化物質を前記患者に投与することと、を含む、方法。
体内腔に隣接する患者の体内の標的位置に手術用ステープラを位置付けることであって、前記ステープラは、遠位端に前記エンドエフェクタを有する、ことと、
前記ステープラを前記標的位置に位置付けた状態で、前記ステープラを作動させて、前記ステープルを前記カートリッジ本体から前記組織内に配備し、これによって、前記補助材料を前記組織に運搬することと、を含む、方法。
Claims (16)
- 手術用ステープラと共に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、
複数のステープル空洞を有するカートリッジ本体であって、それぞれのステープル空洞は、前記ステープル空洞内に配置された手術用ステープルを有する、カートリッジ本体と、
前記カートリッジ本体に解放可能に連結され、かつ前記カートリッジ本体内の前記ステープルを配備することによって組織に運搬されるように構成された、生体適合性補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能である有効量の少なくとも1種の薬剤であって、前記少なくとも1種の薬剤は、前記補助材料、前記カートリッジ本体、及び前記ステープルのうちのいずれとも関連付けられていない活性化物質により活性化されることが可能であり、前記少なくとも1種の薬剤が活性化すると、活性化された薬剤が前記補助材料に対してシグナル及び効果のうちの少なくとも1つをもたらす、有効量の少なくとも1種の薬剤と、を備える、アセンブリ。 - 前記補助材料は、前記カートリッジ本体の組織に接触する表面に解放可能に保持されている、請求項1に記載のアセンブリ。
- 前記補助材料は、前記ステープルのそれぞれの表面に配置されている、請求項1に記載のアセンブリ。
- 前記シグナルは、色の変化を含む、請求項1に記載のアセンブリ。
- 前記効果は、発泡を含む、請求項1に記載のアセンブリ。
- 前記効果は、前記補助材料の構造の変化を含む、請求項1に記載のアセンブリ。
- 前記少なくとも1種の薬剤のそれぞれは、所定の方法で、組織内方成長に対する所望の効果を提供するのに有効であり、前記少なくとも1種の薬剤の前記活性化は、前記所望の効果を停止させる、請求項1に記載のアセンブリ。
- 前記組織は、体内腔を含み、前記少なくとも1種の薬剤は、前記活性化物質の存在下で反応して、前記体内腔を通過する物質の放射線濃度を変化させるように構成された反応性ポリマーを含む、請求項1に記載のアセンブリ。
- 手術用器具用のエンドエフェクタであって、
着脱可能に取り付けられたカートリッジ本体を有する第1のジョーであって、前記カートリッジ本体は、組織に面する表面に、ステープルを内部に設置するように構成された複数のステープル空洞を有する、第1のジョーと、
組織に面する表面に形成された複数のステープル成形空洞を含むアンビルを有する第2のジョーであって、前記第1のジョー及び前記第2のジョーのうちの少なくとも一方は、他方に対して移動可能である、第2のジョーと、
前記カートリッジ本体内の前記ステープルを配備することによって組織に運搬されるように構成された生体適合性補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能である有効量の少なくとも1種の薬剤であって、前記少なくとも1種の薬剤は、前記補助材料、前記カートリッジ本体、及び前記ステープルのうちのいずれとも関連付けられていない活性化物質により活性化されることが可能であり、前記少なくとも1種の薬剤が活性化すると、活性化された薬剤が前記補助材料に対してシグナル及び効果のうちの少なくとも1つをもたらす、有効量の少なくとも1種の薬剤と、
を備える、エンドエフェクタ。 - 前記補助材料は、前記カートリッジ本体及び前記アンビルの前記組織に面する表面のうちの少なくとも一方に解放可能に保持されている、請求項9に記載のエンドエフェクタ。
- 前記補助材料は、前記ステープルのそれぞれの表面に配置されている、請求項9に記載のエンドエフェクタ。
- 前記シグナルは、色の変化を含む、請求項9に記載のエンドエフェクタ。
- 前記効果は、発泡を含む、請求項9に記載のエンドエフェクタ。
- 前記効果は、前記補助材料の構造の変化を含む、請求項9に記載のエンドエフェクタ。
- 前記少なくとも1種の薬剤のそれぞれは、所定の方法で、組織内方成長に対する所望の効果を提供するのに有効であり、前記少なくとも1種の薬剤の前記活性化は、前記所望の効果を停止させる、請求項9に記載のエンドエフェクタ。
- 前記組織は、体内腔を含み、前記少なくとも1種の薬剤は、前記活性化物質の存在下で反応して、前記体内腔を通過する物質の放射線濃度を変化させるように構成された反応性ポリマーを含む、請求項9に記載のエンドエフェクタ。
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2015
- 2015-08-31 US US14/840,431 patent/US10349938B2/en active Active
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- 2016-08-24 CN CN201680063808.1A patent/CN108348641B/zh active Active
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- 2016-08-24 JP JP2018511015A patent/JP6843839B2/ja active Active
- 2016-08-24 WO PCT/US2016/048369 patent/WO2017040144A1/en active Application Filing
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WO2017040144A1 (en) | 2017-03-09 |
BR112018003845A2 (pt) | 2018-09-25 |
US20170055992A1 (en) | 2017-03-02 |
EP3135306A1 (en) | 2017-03-01 |
CN108348641B (zh) | 2021-01-08 |
US10349938B2 (en) | 2019-07-16 |
JP6843839B2 (ja) | 2021-03-17 |
CN108348641A (zh) | 2018-07-31 |
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