JP6755940B2 - アクティベータの影響を受ける薬剤を有する手術用補助材 - Google Patents
アクティベータ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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- JP6755940B2 JP6755940B2 JP2018511049A JP2018511049A JP6755940B2 JP 6755940 B2 JP6755940 B2 JP 6755940B2 JP 2018511049 A JP2018511049 A JP 2018511049A JP 2018511049 A JP2018511049 A JP 2018511049A JP 6755940 B2 JP6755940 B2 JP 6755940B2
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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、各ステープル空洞は、内部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患者の身体内の組織に運搬されるように構成された、生体適合性かつ生体吸収性の補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能な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、前記患者の前記身体の外部に置かれたアクティベータによって前記患者の前記身体内で活性化されるように構成された活性化物質を含み、前記少なくとも1種の薬剤の前記活性化は、前記補助材料の前記組織への運搬後の前記補助材料のモニタリングを可能にする、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) 前記活性化物質は、磁性粒子、放射線不透過剤、放射性剤、非吸収性剤及び非消化性剤のうちの少なくとも1種を含む、実施態様1に記載のアセンブリ。
(3) 前記アクティベータは、磁石、X線撮像システム、コンピュータ断層撮影(CT)撮像システム及び磁気共鳴画像(MRI)撮像システムのうちの1つを含む、実施態様1に記載のアセンブリ。
(4) 前記活性化物質は、前記アクティベータによって誘発された磁場によって活性化されるように構成されている、実施態様1に記載のアセンブリ。
(5) 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の使用方法であって、
前記カートリッジ本体から前記ステープルを配備して前記補助材料を組織に運搬することと、
前記アクティベータを使用して前記組織に運搬された前記補助材料を活性化することと、を含む、方法。
(7) 前記活性化は、前記補助材料からの前記少なくとも1種の薬剤の放出の増加及び前記補助材料の分解の一方を引き起こす、実施態様5に記載の方法。
(8) 前記アクティベータは、磁石を含み、前記方法は、前記磁石を操作して前記患者の前記身体内の前記少なくとも1種の薬剤を移動させることを更に含む、実施態様5に記載の方法。
(9) 前記アクティベータは、X線撮像システム、コンピュータ断層撮影(CT)撮像システム及び磁気共鳴画像(MRI)撮像システムのうちの1つを含む、実施態様5に記載の方法。
(10) 前記活性化は、手術後に行われる、実施態様5に記載の方法。
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、内部にステープルを設置するように構成されている複数のステープル空洞を、組織に面する表面に有する、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有する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及び前記アンビルの少なくとも一方の前記組織に面する表面上に解放可能に保持され、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患者の身体内の組織に運搬されるように構成された生体適合性かつ生体吸収性の補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能な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、前記患者の前記身体の外部に置かれたアクティベータによって前記患者の前記身体内で活性化されるように構成された活性化物質を含み、前記少なくとも1種の薬剤の前記活性化は、前記補助材料の前記組織への運搬後の前記補助材料のモニタリングを可能にする、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) 前記活性化物質は、磁性粒子、放射線不透過剤、放射性剤、非吸収性剤及び非消化性剤のうちの少なくとも1種を含む、実施態様11に記載のエンドエフェクタ。
(13) 前記アクティベータは、磁石、X線撮像システム、コンピュータ断層撮影(CT)撮像システム及び磁気共鳴画像(MRI)撮像システムのうちの1つを含む、実施態様11に記載のエンドエフェクタ。
(14) 前記活性化物質は、前記アクティベータによって誘発された磁場によって活性化されるように構成されている、実施態様11に記載のエンドエフェクタ。
(15) 実施態様11に記載のエンドエフェクタの使用方法であって、
前記カートリッジ本体から前記ステープルを配備して前記補助材料を組織に運搬することと、
前記アクティベータを使用して前記組織に運搬された前記補助材料を活性化することと、を含む、方法。
(17) 前記活性化は、前記補助材料からの前記少なくとも1種の薬剤の放出の増加及び前記補助材料の分解の一方を引き起こす、実施態様15に記載の方法。
(18) 前記アクティベータは、磁石を含み、前記方法は、前記磁石を操作して前記患者の前記身体内の前記少なくとも1種の薬剤を移動させることを更に含む、実施態様15に記載の方法。
(19) 前記アクティベータは、X線撮像システム、コンピュータ断層撮影(CT)撮像システム及び磁気共鳴画像(MRI)撮像システムのうちの1つを含む、実施態様15に記載の方法。
(20) 前記活性化は、手術後に行われる、実施態様15に記載の方法。
Claims (8)
- 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、各ステープル空洞は、内部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患者の身体内の組織に運搬されるように構成された、生体適合性かつ生体吸収性の補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能な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、前記患者の前記身体の外部に置かれたアクティベータによって前記患者の前記身体内で活性化されるように構成された活性化物質を含み、前記少なくとも1種の薬剤の前記活性化は、前記補助材料の前記組織への運搬後の前記補助材料のモニタリングを可能にする、有効量の少なくとも1種の薬剤と、を備える、アセンブリ。 - 前記活性化物質は、磁性粒子、放射線不透過剤、放射性剤、非吸収性剤及び非消化性剤のうちの少なくとも1種を含む、請求項1に記載のアセンブリ。
- 前記アクティベータは、磁石、X線撮像システム、コンピュータ断層撮影(CT)撮像システム及び磁気共鳴画像(MRI)撮像システムのうちの1つを含む、請求項1に記載のアセンブリ。
- 前記活性化物質は、前記アクティベータによって誘発された磁場によって活性化されるように構成されている、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、内部にステープルを設置するように構成されている複数のステープル空洞を、組織に面する表面に有する、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有する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及び前記アンビルの少なくとも一方の前記組織に面する表面上に解放可能に保持され、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患者の身体内の組織に運搬されるように構成された生体適合性かつ生体吸収性の補助材料と、
前記補助材料内に配置され、前記補助材料から放出可能な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、前記患者の前記身体の外部に置かれたアクティベータによって前記患者の前記身体内で活性化されるように構成された活性化物質を含み、前記少なくとも1種の薬剤の前記活性化は、前記補助材料の前記組織への運搬後の前記補助材料のモニタリングを可能にする、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。 - 前記活性化物質は、磁性粒子、放射線不透過剤、放射性剤、非吸収性剤及び非消化性剤のうちの少なくとも1種を含む、請求項5に記載のエンドエフェクタ。
- 前記アクティベータは、磁石、X線撮像システム、コンピュータ断層撮影(CT)撮像システム及び磁気共鳴画像(MRI)撮像システムのうちの1つを含む、請求項5に記載のエンドエフェクタ。
- 前記活性化物質は、前記アクティベータによって誘発された磁場によって活性化されるように構成されている、請求項5に記載のエンドエフェクタ。
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EP3135320A1 (en) | 2017-03-01 |
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