JP6588041B2 - ステープル線を補強するための織られた繊維材 - Google Patents
ステープル線を補強するための織られた繊維材 Download PDFInfo
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- JP6588041B2 JP6588041B2 JP2016572504A JP2016572504A JP6588041B2 JP 6588041 B2 JP6588041 B2 JP 6588041B2 JP 2016572504 A JP2016572504 A JP 2016572504A JP 2016572504 A JP2016572504 A JP 2016572504A JP 6588041 B2 JP6588041 B2 JP 6588041B2
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- staple
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- staple cartridge
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- cartridge
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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つ以上の補助材と共に使用するの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、概して、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てもよい。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、ステープル留め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。
本明細書で説明する外科用ステープル留め器具のエンドエフェクタは、エンドエフェクタによって捕捉された組織に作用させる圧縮の量を調節するための1つ又は2つ以上の機構を有してもよい。いくつかの実施形態では、エンドエフェクタは、そこに捕捉された組織に、所望の圧縮プロフィール、例えば、処置組織の出血、引裂け、及び/又は漏出を最小にすることを助けるプロフィールを作成するように構成されてもよい。非限定的な例として、所望の組織圧縮プロフィールは、エンドエフェクタの上下部のジョーの間の間隙の変更、及び/又はエンドエフェクタによって組織に適用されるステープルの向き、寸法、及び/又は形状の変更を用いてもよい。本明細書で説明するように、そのようなエンドエフェクタと共に使用される1つ以上の補助材は、所望の組織圧縮プロフィールを作成することを支援するように、及び/又は所望の組織圧縮プロフィールを作成するために使用される機構に適合するように構成されることができる。
外科用器具の構成に関係なく、本開示は、植え込み可能な材料、例えば、器具動作と関連した合成及び/又は生体材、集合的に「補助材」の使用を提供する。図15Bに示すように、エンドエフェクタ50は、下部と上部のジョー部材52、54の中間に配置された少なくとも1片の補助材30を含んでもよく、該補助材30は、ステープルチャネル56及び/又はアンビル面58のうちの1つに解放可能に保持されてもよい。使用中に、ステープル70が発射されると、補助材30及び患者組織は、ステープル70によって捕捉されることができる。次に、補助材30は、ステープラが患者から取り除かれるとき、外科用ステープラから分離されることができ、そして、患者体内に留置されることができる。外科用器具のエンドエフェクタに1つ又は2つ以上の補助材を取り付けるための例示的な装置及び方法は、参照によってその全体が本明細書に組み込まれる米国特許出願公開第2013/0256377号及び米国特許出願公開第2013/0153641号に見出すことができる。
補助材は、流体漏出を防ぐために、ステープル線の封止のために提供される。組織補助部の1つの利点は、体液又はガスの漏出などの漏出を防止又は最小化する傾向である。組織補助部は、以下の機構、すなわち、ステープル刺穿部位に生じた孔又は引裂けを塞ぐ機構、ステープル刺穿部位周辺の組織の移動を制限して、ステープル孔の寸法の増大を防止する機構及び/又は組織の引裂けを防止する機構、及び、ステープル線の内部に拘束された組織とステープル線に隣接する遊離組織との間に生じる歪み勾配を最小化する機構のうちの1つ又は2つ以上のものによって、この機能を実行してもよい。
別の実施形態では、不織布繊維材は、補助材の全て又は一部分を形成することができる。織布補助材と同様に、繊維補助材の機械的特性は、補助物の形状、使用される繊維の種類、及び繊維の密度によって影響を受け得る。
別の実施形態では、補助材は、別の構成、例えば、メッシュによって囲まれた織布又は不織布補助材を有してもよい。例えば、図23は、繊維3201から形成されたメッシュ3200を示し、これは補助材3100を囲むことができる。メッシュ3200は、様々な構成を有してもよく、示すように、はちの巣構造のような繰返しパターンで配列された複数の繊維3201を含んでもよい。上記の不織布材料の構成に加えて、メッシュの寸法及びメッシュの種類を変更することにより、上記のように不織布材料の機械的特性を修正することができる。メッシュは、前述の芯層に類似している芯層の周りに配置されることができる。例えば、メッシュは、フリース芯層、又はメルトブロー繊維からつくられた層を囲むことができる。メッシュを使用して、補助材3100を使用のための所望の状態に拘束してもよい。更に、メッシュを使用して、ステープル留め装置への取り付けを容易にしてもよい。
補助材の繊維は、治療物質、すなわち、治癒及び/又は感染と闘うか又は感染を防止することを支援し得、そして、補助材の植え込みの際に効果的に放出され得る治療物質によって被覆されてもよい。例えば、図21Aは、アンビル3054の組織対向面3058に装着された補助材3013を示し、この補助材は、図21Bに示すように、治療物質3011で被覆された繊維3010を含む。別の実施形態(図示せず)では、織布補助材の繊維は、治療物質によって被覆されてもよい。当業者であれば、治療物質で被覆された繊維の数/割合が様々であってもよいことを理解するであろう。別の実施形態(図示せず)では、補助材のうちのわずかな割合の繊維だけ、例えば、繊維の約5〜50容積%の範囲の繊維だけが、被覆される。
カートリッジ組立体上の補助材は、全体にわたって様々な特性を有してもよく、又は、補助材の特定の領域が、補助物が連結されるエンドエフェクタの一部分に対応するように修正されてもよい。例えば、補助材がナイフを有する外科用ステープラ、例えば、外科用ステープラ10、100、及び200において使用される場合、補助物の特性は、ナイフが補助材を切り開くことになる領域において修正されてもよい。そのような修正は、可撓性支持層を薄くすること、より少ない材料を使用すること、この領域の芯層だけが補助物の別の層よりも緩く織られた層を有すること、又は、レーザーによって過剰材料を除去すること、を含む。別の実施形態では、ナイフがより容易に補助材に貫入して補助材を切り開くことができるように、フェルト化が補助物の指定領域に適用されてもよい。別の実施形態では、補助物の特性は、織り構造をより剛性又は可撓性にするために、それぞれ、織り構造に繊維を加える又は織り構造から繊維を除去することによって修正されてもよい。剛性が増加した区画は、ステープル留め装置への取り付けに役立ち得る。更に、可撓性が増加した区画は、組織相互作用の最適化を促進する助けになり得る。
本明細書で説明した補助材は、外科用ステープル留め装置、例えば、外科用ステープラ10、100、200、オープンリニア切断ステープラを使用して、組織に配備されてもよい。使用する際、組織は、手術部位において、外科用ステープラのカートリッジ組立体とアンビルとの間に係合されることができ、この場合、カートリッジ組立体及びアンビルのうちの少なくとも1つは、補助材をその上に解放可能に保持している。外科用ステープラは、ステープルをカートリッジ組立体から、補助材を通して、組織の中へと放出するように作動させることができる。補助材は、ステープル留めによる衝撃及び損傷を低減し、かつステープル線に沿って歪みを一様に分散させるのに役立つことができ、また、変化する組織厚さを補償し、組織の薄い又は病変した領域にステープルを固定させることができる。補助材の異なる領域は、補助材が組織にステープル留めされると、異なる機能を発揮することができる。
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、及び再組み立てのため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であって、
ステープルを中に据付けるように構成された複数のステープルキャビティ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保持され、前記カートリッジ本体の中の前記ステープルの配備によって組織に送達されるように構成された生体適合性の圧縮可能な補助材であって、前記材は、圧縮力の作用の際に圧縮し、前記圧縮力の除去の際に拡張するように構成された圧縮可能な弾性芯層、及び、前記圧縮可能な弾性芯層の少なくとも第1の表面に連結された少なくとも1つの可撓性支持層を有する、補助材と、
を備える、ステープルカートリッジ。
(2) 前記可撓性支持層は、前記圧縮可能な弾性芯層の前記第1の表面及び反対側の第2の表面に連結されている、実施態様1に記載のステープルカートリッジ。
(3) 前記可撓性支持層は、インターロック織りによって前記圧縮可能な弾性芯の表面に連結されている、実施態様1に記載のステープルカートリッジ。
(4) 前記可撓性支持層は、前記圧縮可能な弾性芯層の表面に接着されている、実施態様1に記載のステープルカートリッジ。
(5) 前記可撓性支持層は、X及びY次元にインターロックされた織り繊維から構成されている、実施態様1に記載のステープルカートリッジ。
(7) 前記可撓性支持層の前記繊維は、約8−0〜4−0の範囲の寸法を有する縫合糸フィラメントから構成されている、実施態様1に記載のステープルカートリッジ。
(8) 前記可撓性支持層は、フィルムを備える、実施態様1に記載のステープルカートリッジ。
(9) 前記弾性芯は、非インターロック織り繊維から構成されている、実施態様1に記載のステープルカートリッジ。
(10) 前記弾性芯層の織り密度は、前記可撓性支持層の織り密度よりも密度が低い、実施態様1に記載のステープルカートリッジ。
(12) 前記弾性芯層は、約0〜0−0の範囲の寸法を有する織り繊維から形成されている、実施態様1に記載のステープルカートリッジ。
(13) 前記補助材は、特定領域において選択的に剛性化されている、実施態様1に記載のステープルカートリッジ。
(14) 前記補助材は、フリースから構成されており、前記フリースは、前記圧縮可能な弾性芯層に第1の密度、及び前記可撓性支持層に第2の異なる密度を有する、実施態様1に記載のステープルカートリッジ。
(15) 外科用器具のためのエンドエフェクタであって、
カートリッジ本体が取外し可能に取り付けられている第1のジョーであって、前記カートリッジ本体は、ステープルを中に据付けるように構成された複数のステープルキャビティを有する、第1のジョーと、
複数のステープル成形開口部が中に形成されたアンビルを有する第2のジョーであって、前記第1及び第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、
組織補強材であって、(i)圧縮力の作用の際に圧縮し、前記圧縮力の除去の際に拡張するように構成された圧縮可能な弾性領域、及び(ii)前記圧縮可能な弾性芯の少なくとも1つの表面に連結された可撓性支持層、を備える、組織補強材と、を備え、
前記組織補強材は、ステープルを前記カートリッジ本体から前記圧縮可能な弾性領域を通して配備する際に組織に送達されるよう前記カートリッジ本体及び前記アンビルの組織接触面のうちの少なくとも1つに解放可能に保持されている、エンドエフェクタ。
手術部位において外科用ステープラのカートリッジ組立体とアンビルとの間に組織を係合することであって、前記カートリッジ組立体及び前記アンビルのうちの少なくとも1つは、そこに解放可能に保持された組織補強材を有し、前記組織補強材は、圧縮力の作用の際に圧縮し、前記圧縮力の除去の際に拡張するように構成された圧縮可能な弾性芯、及び、前記圧縮可能な弾性芯の1つの表面に連結された可撓性支持層を備える、ことと、
前記外科用ステープラを作動させて、ステープルを前記カートリッジ組立体から前記圧縮可能な弾性領域を通して前記組織の中に放出し、前記組織補強材を前記手術部位において維持することと、
を含む、方法。
Claims (15)
- 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であって、
ステープルを中に据付けるように構成された複数のステープルキャビティ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保持され、前記カートリッジ本体の中の前記ステープルの配備によって組織に送達されるように構成された生体適合性の圧縮可能な補助材であって、前記補助材は、圧縮力が適用されると圧縮し、前記圧縮力が除去されると拡張するように構成された圧縮可能な弾性芯層、及び、前記圧縮可能な弾性芯層の少なくとも第1の表面に連結された少なくとも1つの可撓性支持層を有する、補助材と、
を備え、前記弾性芯層は、織り繊維を有するか、または不織布材料から構成されている、ステープルカートリッジ。 - 前記可撓性支持層は、前記圧縮可能な弾性芯層の前記第1の表面及び反対側の第2の表面に連結されている、請求項1に記載のステープルカートリッジ。
- 前記可撓性支持層は、インターロック織りによって前記圧縮可能な弾性芯の表面に連結されている、請求項1に記載のステープルカートリッジ。
- 前記可撓性支持層は、前記圧縮可能な弾性芯層の表面に接着されている、請求項1に記載のステープルカートリッジ。
- 前記可撓性支持層は、X及びY次元にインターロックされた織り繊維から構成されている、請求項1に記載のステープルカートリッジ。
- 前記可撓性支持層の繊維は、生体適合性の吸収性縫合糸材料から構成されており、前記縫合糸材料は、ポリジオキサノン、ポリグリセロールセバケート、ポリグリコール酸、ポリカプロラクトン、ポリ乳酸、ポリヒドロキシアルカノエート、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、ポリグリコリド−トリメチレンカーボネート、ポリヒドロキシ酪酸、ポリ(ビニルピロリドン)、ポリ(ビニルアルコール)、吸収性ポリウレタン、再生セルロース、及び酸化再生セルロース繊維からなる群から選択される、請求項1に記載のステープルカートリッジ。
- 前記可撓性支持層の繊維は、約8−0〜4−0の範囲の寸法を有する縫合糸フィラメントから構成されている、請求項1に記載のステープルカートリッジ。
- 前記可撓性支持層は、フィルムを備える、請求項1に記載のステープルカートリッジ。
- 前記弾性芯層は、非インターロック織り繊維から構成されている、請求項1に記載のステープルカートリッジ。
- 前記弾性芯層の織り密度は、前記可撓性支持層の織り密度よりも密度が低い、請求項1に記載のステープルカートリッジ。
- 前記弾性芯層は、約10−0〜2−0の範囲の寸法を有する織り繊維から形成されている、請求項1に記載のステープルカートリッジ。
- 前記補助材は、特定領域において選択的に剛性化されている、請求項1に記載のステープルカートリッジ。
- 前記補助材は、フリースから構成されており、前記フリースは、前記圧縮可能な弾性芯層に第1の密度、及び前記可撓性支持層に第2の異なる密度を有する、請求項1に記載のステープルカートリッジ。
- 前記弾性芯層の織り繊維は、前記織り繊維が圧縮の方向で前記圧縮の方向に垂直な第2の方向よりも緩くなるように向けられている、請求項1に記載のステープルカートリッジ。
- 外科用器具のためのエンドエフェクタであって、
カートリッジ本体が取外し可能に取り付けられている第1のジョーであって、前記カートリッジ本体は、ステープルを中に据付けるように構成された複数のステープルキャビティを有する、第1のジョーと、
複数のステープル成形開口部が中に形成されたアンビルを有する第2のジョーであって、前記第1及び第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、
組織補強材であって、(i)圧縮力を適用すると圧縮し、前記圧縮力を除去すると拡張するように構成された圧縮可能な弾性領域、及び(ii)前記圧縮可能な弾性領域の少なくとも1つの表面に連結された可撓性支持層、を備える、組織補強材と、を備え、
前記圧縮可能な弾性領域は、織り繊維を有するか、または不織布材料から構成されており、
前記組織補強材は、前記ステープルを前記カートリッジ本体から前記圧縮可能な弾性領域を通して配備する際に組織に送達されるよう前記カートリッジ本体及び前記アンビルの組織接触面のうちの少なくとも1つに解放可能に保持されている、エンドエフェクタ。
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US14/300,804 US9848871B2 (en) | 2014-06-10 | 2014-06-10 | Woven and fibrous materials for reinforcing a staple line |
PCT/US2015/030933 WO2015191229A1 (en) | 2014-06-10 | 2015-05-15 | Woven and fibrous materials for reinforcing a staple line |
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BR112016028854A2 (pt) | 2017-08-22 |
PL2954855T3 (pl) | 2019-09-30 |
CN106572855B (zh) | 2019-10-25 |
US9848871B2 (en) | 2017-12-26 |
WO2015191229A1 (en) | 2015-12-17 |
US20150351754A1 (en) | 2015-12-10 |
EP2954855B1 (en) | 2019-04-17 |
EP2954855A1 (en) | 2015-12-16 |
JP2017521135A (ja) | 2017-08-03 |
CN106572855A (zh) | 2017-04-19 |
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