JP2016535634A - 外科的ステープリングにおける使用のためのハイブリッド補助材料 - Google Patents
外科的ステープリングにおける使用のためのハイブリッド補助材料 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07292—Reinforcements for staple line, e.g. pledgets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
Abstract
Description
種々の外科用器具が、本明細書に開示される補助材料と共に使用され得るが、図1及び2は、1つ又は2つ以上の補助材料と共に使用するのに好適な外科用ステープラ10の非限定の例示的な一実施形態を例示する。示されるように、器具10は、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から遠位方向に延在するシャフト14と、シャフト14の遠位端14dに着脱可能に連結された取り付け部分16とを含む。例示される実施形態が外科用ステープラであるため、取り付け部分16の遠位端16dは、つかみ具52、54を有するエンドエフェクタ50を含むが、他の種類のエンドエフェクタは、シャフト14、ハンドルアセンブリ12、及びそれらに関連した構成要素と共に使用することができる。示されるように、外科用ステープラは、第1のつかみ具52及び反対側の第2のつかみ具54を含み、第1の下側つかみ具52は、ステープルカートリッジ100を支持するように構成された細長いチャネル56(図4)を含み、第2の上側つかみ具54は、下側つかみ具52に面しており、ステープルカートリッジのステープルを配備する助けとなるアンビルとして動作するように構成された内面58(図3、4、及び6)を有する。つかみ具52、54は、互いに対して移動して、それらの間に配設された組織又は他の物体をクランプするように構成されており、軸方向駆動アセンブリ80(図11)は、エンドエフェクタ50の少なくとも一部分を通過して、ステープルをクランプされた組織中に押し出すように構成されていてもよい。様々な実施形態では、ナイフブレード81が軸方向駆動アセンブリ80と関連付けられ、ステープリング処置中に組織を切断することができる。
外科用器具の構成にかかわらず、本開示は、器具操作と併せて、埋め込み可能な材料、例えば、生体材料及び/又は合成材料、集合的に「補助材料」の使用を提供する。図12及び13に示されるように、エンドエフェクタ50は、第1のつかみ具部材52と第2のつかみ具部材54との中間に位置付けられた少なくとも1片の補助材料200、200’を含むことができ、支持チャネル56及び/又はアンビル部分58のうちの一方に解放可能に保持され得る。例示される実施形態では、解放可能な保持は、保持部材202、202’によって提供され、以下で更に詳細に説明される。少なくとも1つの実施形態では、補助材料200、200’上の表面は、組織が第1のつかみ具部材52と第2のつかみ具部材54との間にクランプされると、組織に接触するように構成されていてもよい。かかる実施形態では、補助材料を使用して、組織にわたって圧縮クランプ力を分散させ、組織から余分な体液を除去し、かつ/又はステープルの取得を向上させることができる。様々な実施形態では、1片又は2片以上の補助材料を、エンドエフェクタ50内に位置付けることができる。少なくとも1つの実施形態では、1片の補助材料200を、ステープルカートリッジ100に取り付けることができ(図12)、1片の補助材料200’を、アンビル部分58に取り付けることができる(図13)。少なくとも1つの他の実施形態では、2片の補助材料200は、支持チャネル56上に位置付けられ得、1片の補助材料200’は、例えば、アンビル部分58上に位置付けられ得る。任意の好適な数の補助材料は、エンドエフェクタ50内に位置し得る。
接続又は保持部材を使用して、1片又は2片以上の補助材料を、エンドエフェクタ及び/又はステープルカートリッジの上に少なくとも一時的に固定することができる。これらの保持部材は、種々の形態及び構成、例えば、1つ又は2つ以上の縫合糸、接着材料、ステープル、ブラケット、スナップオン、又は他の連結若しくは嵌合要素などでもたらされ得る。例えば、保持部材は、補助材料の1つ又は2つ以上の側面及び/又は端部に近接して位置付けられることができ、エンドエフェクタがトロカールを通して挿入されるか、又は組織に係合されるときに、補助材料がステープルカートリッジ及び/又はアンビル面から剥離するのを防ぐ助けとなり得る。更に他の実施形態では、保持部材は、補助材料をエンドエフェクタに解放可能に保持するのに好適な接着剤、例えば、シアノアクリレートと共に、又はその形態で使用され得る。少なくとも1つの実施形態では、接着剤を、保持部材が補助材料、ステープルカートリッジ、及び/又はアンビル部分と係合される前に、保持部材に塗布することができる。一般に、発射が完了すると、保持部材(複数可)は、補助材料及び/又はエンドエフェクタから引き離されることができ、それにより、補助材料は、エンドエフェクタが除去されるときに手術部位で留まることができる。保持部材のいくつかの例示的な非限定実施形態は、図12〜15に関して本明細書に記載される。
本明細書に記載されるか、又はさもなければ当業者に既知の圧縮性弾性部材は、種々の補助材料と共に使用され得る。場合によっては、補助材料は、合成材料又は生体材料のいずれかであり得るが、様々な実施形態では、補助材料は、合成材料(複数可)及び生体材料(複数可)を含む(すなわち、それはハイブリッド補助材料である)。得られた組み合わせは、単一ハイブリッド材料中の両方の種類の材料からの有益な特徴を有利に呈し得る。例えば、ハイブリッド補助材料は、生体材料の利益(例えば、手術部位での治癒及び組織増殖の改善)を、合成材料の望ましい機械的特性(例えば、ばね反応性又は弾性)と組み合わせるように設計され得る。様々な実施形態では、合成材料は、生体材料のための構造及び支持を提供する(例えば、繊維生体材料に強度及び/又はせん断耐性を追加する)こともできるが、依然として生体材料が手術部位に接触して、治癒を支持及び/又は促進するのを可能にする。更に、ハイブリッド補助材料は、炎症を低減し、細胞増殖を促進し、かつ/又は別様に治癒を改善する助けとなるように構成されていてもよい。ハイブリッド補助材料は、生体埋め込み可能であり、生体吸収性であり得る。
(1) 外科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、
ステープルを中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カートリッジ本体と、
前記カートリッジ本体上で解放可能に保持され、前記カートリッジ本体中の前記ステープルを配備することによって組織に送達されるように構成されるハイブリッド補助材料であって、前記材料が、生体組織膜、合成基材層、及び少なくとも1つの圧縮性弾性部材を有し、前記少なくとも1つの圧縮性弾性部材は、圧縮力がそれに加えられたときに圧縮し、前記圧縮力が除去されたときに跳ね返り力を提供するように構成されている、ハイブリッド補助材料と、を備える、ステープルカートリッジアセンブリ。
(2) 前記材料が、生体埋め込み可能であり、生体吸収性である、実施態様1に記載のアセンブリ。
(3) 前記弾性部材が、前記生体組織膜と前記合成基材層との間に配設されている、実施態様1に記載のアセンブリ。
(4) 前記弾性部材が、前記生体層及び前記合成層のうちの一方又は両方内に配設されている、実施態様1に記載のアセンブリ。
(5) 前記材料を前記カートリッジ本体に連結するように構成された少なくとも1つの縫合糸保持部材を更に備える、実施態様1に記載のアセンブリ。
(7) 前記少なくとも1つの縫合糸保持部材が、縫合糸を含む、実施態様6に記載のアセンブリ。
(8) 前記膜が、生体マトリックスを含む、実施態様1に記載のアセンブリ。
(9) 前記圧縮性弾性部材が、合成生体吸収性材料を含む、実施態様1に記載のアセンブリ。
(10) 前記合成生体吸収性材料が、ナイロン、ポリプロピレン、ポリジオキサノン、ポリグリセロールセバケート(PGS)、PGA(ポリグリコール酸)、PCL(ポリカプロラクトン)、PLA若しくはPLLA(ポリ乳酸)、PHA(ポリヒドロキシアルカノエート)、PGCL(ポリグレカプロン25)、ポリグラクチン910、ポリグリコネート、PGA/TMC(ポリグリコリド−トリメチレン)、ポリヒドロキシブチレート(PHB)、ポリ(ビニルピロリドン)(PVP)、ポリ(ビニルアルコール)(PVA)、又はそれらの組み合わせを含む、実施態様9に記載のアセンブリ。
(12) 前記材料の長さ寸法及び幅寸法のうちの少なくとも一方にわたって延在する複数の正弦波部材を更に備える、実施態様11に記載のアセンブリ。
(13) 前記圧縮性弾性部材が、前記膜を前記弾性部材に固定するように構成された1つ又は2つ以上の表面特徴部を含む、実施態様9に記載のアセンブリ。
(14) 前記1つ又は2つ以上の表面特徴部が、ボール形状エンドキャップ、シェルフ、かかり、及びそれらの組み合わせからなる群から選択されている、実施態様13に記載のアセンブリ。
(15) 前記圧縮性弾性部材が、球形、卵形、半球形、ドーム、ジャック様(jack-like)、又は3次元放射状の形態のうちの1つ又は2つ以上を含む、実施態様9に記載のアセンブリ。
生体組織膜と、
合成基材層と、
少なくとも1つの圧縮性弾性部材であって、前記少なくとも1つの圧縮性弾性部材は、圧縮力がそれに加えられたときに圧縮し、前記圧縮力が除去されたときに跳ね返り力を提供するように構成されている、少なくとも1つの圧縮性弾性部材と、を含み、
前記材料は、外科用ステープラカートリッジ本体からステープルが配備された時に組織に送達されるために、前記カートリッジ本体に解放可能に取り付けられるように構成されている、ハイブリッド補助材料。
(17) 前記弾性部材が、前記生体組織膜と前記合成基材層との間に配設されている、実施態様16に記載のハイブリッド補助材料。
(18) 前記弾性部材が、前記生体層及び合成層のうちの一方又は両方内に配設されている、実施態様16に記載のハイブリッド補助材料。
(19) 生体組織をステープリングするための方法であって、
手術部位で組織を外科用ステープラカートリッジ本体と係合させることであって、前記カートリッジ本体が、その上に解放可能に保持されたハイブリッド補助材料を有し、前記材料が、生体組織膜、合成基材層、及び少なくとも1つの圧縮性弾性部材を含み、前記少なくとも1つの圧縮性弾性部材は、圧縮力がそれに加えられたときに圧縮し、前記圧縮力が除去されたときに跳ね返り力を提供するように構成される、係合させることと、
前記カートリッジ本体から前記生体組織中にステープルを押し出すように前記外科用ステープラを作動させることであって、前記ステープルが、前記材料を前記手術部位で維持するように前記材料を通って延在する、作動させることと、を含む、方法。
Claims (18)
- 外科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、
ステープルを中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カートリッジ本体と、
前記カートリッジ本体上で解放可能に保持され、前記カートリッジ本体中の前記ステープルを配備することによって組織に送達されるように構成されるハイブリッド補助材料であって、前記材料が、生体組織膜、合成基材層、及び少なくとも1つの圧縮性弾性部材を有し、前記少なくとも1つの圧縮性弾性部材は、圧縮力がそれに加えられたときに圧縮し、前記圧縮力が除去されたときに跳ね返り力を提供するように構成されている、ハイブリッド補助材料と、を備える、ステープルカートリッジアセンブリ。 - 前記材料が、生体埋め込み可能であり、生体吸収性である、請求項1に記載のアセンブリ。
- 前記弾性部材が、前記生体組織膜と前記合成基材層との間に配設されている、請求項1に記載のアセンブリ。
- 前記弾性部材が、前記生体層及び前記合成層のうちの一方又は両方内に配設されている、請求項1に記載のアセンブリ。
- 前記材料を前記カートリッジ本体に連結するように構成された少なくとも1つの縫合糸保持部材を更に備える、請求項1に記載のアセンブリ。
- 前記少なくとも1つの縫合糸保持部材が、前記カートリッジ本体の外縁部、並びに前記生体組織膜及び前記合成基材層のうちの少なくとも一方の外縁部に結合されている、請求項5に記載のアセンブリ。
- 前記少なくとも1つの縫合糸保持部材が、縫合糸を含む、請求項6に記載のアセンブリ。
- 前記膜が、生体マトリックスを含む、請求項1に記載のアセンブリ。
- 前記圧縮性弾性部材が、合成生体吸収性材料を含む、請求項1に記載のアセンブリ。
- 前記合成生体吸収性材料が、ナイロン、ポリプロピレン、ポリジオキサノン、ポリグリセロールセバケート(PGS)、PGA(ポリグリコール酸)、PCL(ポリカプロラクトン)、PLA若しくはPLLA(ポリ乳酸)、PHA(ポリヒドロキシアルカノエート)、PGCL(ポリグレカプロン25)、ポリグラクチン910、ポリグリコネート、PGA/TMC(ポリグリコリド−トリメチレン)、ポリヒドロキシブチレート(PHB)、ポリ(ビニルピロリドン)(PVP)、ポリ(ビニルアルコール)(PVA)、又はそれらの組み合わせを含む、請求項9に記載のアセンブリ。
- 前記圧縮性弾性部材が、前記材料の少なくとも1つの寸法にわたって正弦波パターンで延在する少なくとも1つの部材を含む、請求項9に記載のアセンブリ。
- 前記材料の長さ寸法及び幅寸法のうちの少なくとも一方にわたって延在する複数の正弦波部材を更に備える、請求項11に記載のアセンブリ。
- 前記圧縮性弾性部材が、前記膜を前記弾性部材に固定するように構成された1つ又は2つ以上の表面特徴部を含む、請求項9に記載のアセンブリ。
- 前記1つ又は2つ以上の表面特徴部が、ボール形状エンドキャップ、シェルフ、かかり、及びそれらの組み合わせからなる群から選択されている、請求項13に記載のアセンブリ。
- 前記圧縮性弾性部材が、球形、卵形、半球形、ドーム、ジャック様、又は3次元放射状の形態のうちの1つ又は2つ以上を含む、請求項9に記載のアセンブリ。
- ハイブリッド補助材料であって、
生体組織膜と、
合成基材層と、
少なくとも1つの圧縮性弾性部材であって、前記少なくとも1つの圧縮性弾性部材は、圧縮力がそれに加えられたときに圧縮し、前記圧縮力が除去されたときに跳ね返り力を提供するように構成されている、少なくとも1つの圧縮性弾性部材と、を含み、
前記材料は、外科用ステープラカートリッジ本体からステープルが配備された時に組織に送達されるために、前記カートリッジ本体に解放可能に取り付けられるように構成されている、ハイブリッド補助材料。 - 前記弾性部材が、前記生体組織膜と前記合成基材層との間に配設されている、請求項16に記載のハイブリッド補助材料。
- 前記弾性部材が、前記生体層及び合成層のうちの一方又は両方内に配設されている、請求項16に記載のハイブリッド補助材料。
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US14/074,902 US9936950B2 (en) | 2013-11-08 | 2013-11-08 | Hybrid adjunct materials for use in surgical stapling |
US14/074,902 | 2013-11-08 | ||
PCT/US2014/062511 WO2015069487A1 (en) | 2013-11-08 | 2014-10-28 | Hybrid adjunct materials for use in surgical stapling |
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JP6422968B2 JP6422968B2 (ja) | 2018-11-14 |
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JP2016528115A Active JP6422968B2 (ja) | 2013-11-08 | 2014-10-28 | 外科的ステープリングにおける使用のためのハイブリッド補助材料 |
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US (1) | US9936950B2 (ja) |
EP (1) | EP2870925B1 (ja) |
JP (1) | JP6422968B2 (ja) |
CN (1) | CN105939675B (ja) |
BR (1) | BR112016010236B1 (ja) |
MX (1) | MX2016005986A (ja) |
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WO2015069487A1 (en) | 2015-05-14 |
MX2016005986A (es) | 2016-12-09 |
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RU2676524C2 (ru) | 2018-12-29 |
CN105939675A (zh) | 2016-09-14 |
US9936950B2 (en) | 2018-04-10 |
JP6422968B2 (ja) | 2018-11-14 |
EP2870925A1 (en) | 2015-05-13 |
RU2016122455A (ru) | 2017-12-13 |
BR112016010236B1 (pt) | 2022-03-15 |
CN105939675B (zh) | 2019-03-15 |
RU2016122455A3 (ja) | 2018-06-21 |
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