JP2017099878A - 外科用ステープラの可撓性の遠位先端 - Google Patents

外科用ステープラの可撓性の遠位先端 Download PDF

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JP2017099878A
JP2017099878A JP2016229819A JP2016229819A JP2017099878A JP 2017099878 A JP2017099878 A JP 2017099878A JP 2016229819 A JP2016229819 A JP 2016229819A JP 2016229819 A JP2016229819 A JP 2016229819A JP 2017099878 A JP2017099878 A JP 2017099878A
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ヘマン ロナルド
Hemmann Ronald
ヘマン ロナルド
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    • 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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Abstract

【課題】外科用ステープラの可撓性の遠位先端を提供する。【解決手段】外科用デバイスのためのツールアセンブリ４００であって、第１の組織接触表面を画定している第１の顎部材４１０と、第２の組織接触表面を画定している第２の顎部材４２０であって、前記第１の顎部材および前記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、前記閉鎖位置において、前記第１の組織接触表面および前記第２の組織接触表面は、互いから離間されており、組織間隙を画定している、第２の顎部材と、前記第１の顎部材の遠位端に固定された圧縮可能材料４３０であって、前記圧縮可能材料は、前記第１の顎部材および前記第２の顎部材が前記閉鎖位置にある場合に、前記第２の顎部材に係合する、圧縮可能材料とを含む、ツールアセンブリ。【選択図】図４

Description

（背景）
（技術分野）
本開示は、外科用デバイスに関し、より特定的には、可変厚さを有する組織を把持しマニピュレートするように機能し得る外科用ステープリングデバイスに関する。
（関連技術の説明）
外科用ステープラは、厚い組織および薄い組織を含む可変厚さの組織に対して外科医によって一般的に利用されている。公知の外科用ステープラは、典型的には、ステープルカートリッジおよびアンビル部材を支持する一対の顎部を含む。顎部は、顎部の遠位端が互いに離間されている開放位置と、顎部が互いに対して並列して整列させられたクランプ位置との間で移動可能である。クランプ位置において、顎部は、縫合される組織を受け取るように寸法決めされた組織間隙を画定するように、互いから離間されている。
公知の外科用ステープラは、開放外科用ステープラおよび内視鏡外科用ステープラを含む。内視鏡外科用ステープラは、外科部位に隣接する位置へと、小さな切開部を通して、または、患者または対象の皮膚における小さな切開部を通して延在するカニューレを通して、挿入される。外科部位にアクセスするための外科医の限定的な能力により、内視鏡外科用ステープラは、典型的には、組織を縫合するように作動されるのに先立って、組織を把持しマニピュレートするために用いられる。
内視鏡ステープラを用いて組織を把持しマニピュレートする能力は、組織間隙のサイズおよびマニピュレートされる組織の厚さによって直接的に制御される。より具体的には、組織の厚さが、組織間隙の高さよりも小さい場合、内視鏡ステープラの顎部は、組織を把持しマニピュレートする能力がより低くあり得る。外科医が薄い組織（例えば、胸部組織）を扱う仕事をする場合、内視鏡外科用ステープラを用いて組織を把持しマニピュレートする能力は、妨げられ得る。このことは、臨床医が内視鏡手技中に外科部位における組織をマニピュレートすることをより困難にし、その結果、外科手技を長引かせ、患者または対象に対する外傷を増大させ得る。
（概要）
従来技術の上述の不利点に対処するために、本開示は、第１の組織接触表面を画定している第１の顎部材と、第２の組織接触表面を画定している第２の顎部材とを含む、外科用デバイスのためのツールアセンブリに関する。第１の顎部材および第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、閉鎖位置において、第１の組織接触表面および第２の組織接触表面は、互いから離間されており、組織間隙を画定する。圧縮可能材料は、第１の顎部材の遠位端に固定されており、第１の顎部材および第２の顎部材が閉鎖位置にある場合に第２の顎部材に係合するように配置されている。
実施形態において、ツールアセンブリは、ツールアセンブリの遠位先端に圧縮可能材料を固定するように配置された接着剤を含み得る。接着剤の材料は、シアノアクリレート（例えば、Ｈｉｇｈ Ｆｌｅｘシアノアクリレート等）および感圧性接着剤（ＰＳＡ）から成る群から選択され得る。
いくつかの実施形態において、ツールアセンブリの第２の顎部は、複数のステープルを支持し得る。
その他の実施形態において、第１の顎部材および第２の顎部材の遠位端は、圧縮可能材料が受け取られる楔状ボリュームを画定し得る。
また他の実施形態において、圧縮可能材料は、対象の組織に接触するように構成された盛り上がった突起を有するテクスチャ加工表面を含み得る。
なおも他の実施形態において、接着剤は、ツールアセンブリの遠位先端に圧縮可能材料を固定するように圧縮可能材料の表面に対する接着を可能にする除去可能バッキング材料とともに構成された感圧性材料を含み得る。
本開示の別の局面において、本開示はまた、外科用デバイスに関し、該外科用デバイスは、ハンドルアセンブリと、ハンドルアセンブリから延在している細長部材と、細長部材の遠位端上に支持されているツールアセンブリとを含む。ツールアセンブリは、第１の組織接触表面を画定している第１の顎部材と、第２の組織接触表面を画定している第２の顎部材とを含む。第１の顎部材および第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、閉鎖位置において、第１の組織接触表面および第２の組織接触表面は、互いから離間されており、組織間隙を画定している。圧縮可能材料は、第１の顎部材の遠位端に固定されており、第１の顎部材および第２の顎部材が閉鎖位置にある場合に、第２の顎部材に係合するように配置されている。
実施形態において、ツールアセンブリは、ツールアセンブリの遠位先端に圧縮可能材料を固定するように配置された接着剤を含み得る。接着剤の材料は、シアノアクリレート（例えば、Ｈｉｇｈ Ｆｌｅｘシアノアクリレート等）および感圧性接着剤（ＰＳＡ）から成る群から選択され得る。
その他の実施形態において、圧縮可能材料は、対象の組織に接触するように構成された盛り上がった突起を有するテクスチャ加工表面を含み得る。
なおも他の実施形態において、接着剤は、ツールアセンブリの遠位先端に圧縮可能材料を固定するように圧縮可能材料の表面に対する接着を可能にする除去可能バッキング材料とともに構成された感圧性材料を含み得る。
本開示の別の局面は、第１の組織接触表面を画定している第１の顎部材と、第２の組織接触表面を画定している第２の顎部材とを含むツールアセンブリを含むキットに関する。第１の顎部材および第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、閉鎖位置において、第１の組織接触表面および第２の組織接触表面は、互いから離間されており、組織間隙を画定している。キットはまた、第１の顎部材の遠位端に固定されるように構成された圧縮可能材料と、圧縮可能材料およびツールアセンブリを支持する無菌パッケージとを含む。
実施形態において、圧縮可能材料は、ツールアセンブリの遠位先端に圧縮可能材料を固定するように配置された接着剤を支持し得る。
なおも他の実施形態において、第１の顎部材および第２の顎部材の遠位端は、圧縮可能材料を受け取る楔状ボリュームを画定し得る。
また別の局面において、本開示は、第１の組織接触表面を画定している第１の顎部材と第２の顎部材とを有するツールアセンブリを含むキットに関しており、第１の顎部材および第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能である。キットは、複数のカートリッジを含み、複数のカートリッジの各々は、第２の顎部材に解放可能に結合され、第２の組織接触表面を画定するように適合されている。圧縮可能材料は、複数のカートリッジのうちの少なくとも１つの遠位端上に支持されている。閉鎖位置において、第１の組織接触表面および第２の組織接触表面は、互いから離間されており、組織間隙を画定しており、圧縮可能材料は、複数のカートリッジのうちの少なくとも１つのカートリッジが第２の顎部材に結合されている場合に、組織間隙を横断して延在するように寸法決めされている。
本明細書は、例えば、以下の項目を提供する。
（項目１）
外科用デバイスのためのツールアセンブリであって、
第１の組織接触表面を画定している第１の顎部材と、
第２の組織接触表面を画定している第２の顎部材であって、上記第１の顎部材および上記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、上記閉鎖位置において、上記第１の組織接触表面および上記第２の組織接触表面は、互いから離間されており、組織間隙を画定している、第２の顎部材と、
上記第１の顎部材の遠位端に固定された圧縮可能材料であって、上記圧縮可能材料は、上記第１の顎部材および上記第２の顎部材が上記閉鎖位置にある場合に、上記第２の顎部材に係合する、圧縮可能材料と
を含む、ツールアセンブリ。
（項目２）
上記圧縮可能材料を上記ツールアセンブリの遠位先端に固定するように配置された接着剤をさらに含む、上記項目に記載のツールアセンブリ。
（項目３）
上記接着剤の材料は、シアノアクリレートおよび感圧性接着剤から成る群から選択される、上記項目のいずれか一項に記載のツールアセンブリ。
（項目４）
上記ツールアセンブリの第２の顎部は、複数のステープルを支持する、上記項目のいずれか一項に記載のツールアセンブリ。
（項目５）
上記第２の顎部材は、遠位端を画定しており、上記第１の顎部材および上記第２の顎部材の上記遠位端は、楔状ボリュームを画定しており、上記圧縮可能材料は、上記楔状ボリューム内に受け取られている、上記項目のいずれか一項に記載のツールアセンブリ。
（項目６）
上記圧縮可能材料は、対象の組織に接触するように構成された盛り上がった突起を有するテクスチャ加工表面を含む、上記項目のいずれか一項に記載のツールアセンブリ。
（項目７）
上記接着剤は、上記ツールアセンブリの上記遠位先端に上記圧縮可能材料を固定するように上記圧縮可能材料の表面に対する接着を可能にする除去可能バッキング材料とともに構成された感圧性材料を含む、上記項目のいずれか一項に記載のツールアセンブリ。
（項目８）
外科用デバイスであって、
ハンドルアセンブリと、
上記ハンドルアセンブリから延在している細長部材と、
上記細長部材の遠位端上に支持されているツールアセンブリであって、上記ツールアセンブリは、
第１の組織接触表面を画定している第１の顎部材と、
第２の組織接触表面を画定している第２の顎部材であって、上記第１の顎部材および上記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、上記閉鎖位置において、上記第１の組織接触表面および上記第２の組織接触表面は、互いから離間されており、組織間隙を画定している、第２の顎部材と、
上記第１の顎部材の遠位端に固定された圧縮可能材料であって、上記圧縮可能材料は、上記第１の顎部材および上記第２の顎部材が上記閉鎖位置にある場合に、上記第２の顎部材に係合する、圧縮可能材料と
を含む、ツールアセンブリと
を含む、外科用デバイス。
（項目９）
上記圧縮可能材料を上記ツールアセンブリの遠位先端に固定するように配置された接着剤をさらに含む、上記項目に記載の外科用デバイス。
（項目１０）
上記接着剤の材料は、シアノアクリレートおよび感圧性接着剤から成る群から選択される、上記項目のいずれか一項に記載の外科用デバイス。
（項目１１）
上記ツールアセンブリの第２の顎部は、複数のステープルを支持する、上記項目のいずれか一項に記載の外科用デバイス。
（項目１２）
上記外科用デバイスは、外科用ステープラである、上記項目のいずれか一項に記載の外科用デバイス。
（項目１３）
上記第２の顎部材は、遠位端を画定しており、上記第１の顎部材および上記第２の顎部材の上記遠位端は、楔状ボリュームを画定しており、上記圧縮可能材料は、上記楔状ボリューム内に受け取られている、上記項目のいずれか一項に記載の外科用デバイス。
（項目１４）
上記圧縮可能材料は、対象の組織に接触するように構成された盛り上がった突起を有するテクスチャ加工表面を含む、上記項目のいずれか一項に記載の外科用デバイス。
（項目１５）
上記接着剤は、上記ツールアセンブリの上記遠位先端に上記圧縮可能材料を固定するように上記圧縮可能材料の表面に対する接着を可能にする除去可能バッキング材料とともに構成された感圧性材料を含む、上記項目のいずれか一項に記載の外科用デバイス。
（項目１６）
キットであって、
第１の組織接触表面を画定している第１の顎部材と、第２の組織接触表面を画定している第２の顎部材とを含むツールアセンブリであって、上記第１の顎部材および上記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、上記閉鎖位置において、上記第１の組織接触表面および上記第２の組織接触表面は、互いから離間されており、組織間隙を画定している、ツールアセンブリと、
上記第１の顎部材の遠位端に固定されるように構成された圧縮可能材料と、
上記圧縮可能材料および上記ツールアセンブリを支持している無菌パッケージと
を含む、キット。
（項目１７）
上記圧縮可能材料は、上記ツールアセンブリの遠位先端に上記圧縮可能材料を固定するように配置された接着剤を支持している、上記項目に記載のキット。
（項目１８）
上記第２の顎部材は、遠位端を画定しており、上記第１の顎部材および上記第２の顎部材の上記遠位端は、楔状ボリュームを画定しており、上記圧縮可能材料は、上記楔状ボリューム内に受け取られるように構成されている、上記項目のいずれか一項に記載のキット。
（項目１９）
キットであって、
第１の顎部材および第２の顎部材を含むツールアセンブリであって、上記第１の顎部材および上記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、上記第１の顎部材は、第１の組織接触表面を画定している、ツールアセンブリと、
複数のカートリッジであって、上記複数のカートリッジの各々は、上記第２の顎部材に解放可能に結合され、かつ第２の組織接触表面を画定するように適合されている、複数のカートリッジと、
上記複数のカートリッジのうちの少なくとも１つの遠位端上に支持されている圧縮可能材料であって、上記閉鎖位置において、上記第１の組織接触表面および上記第２の組織接触表面は、組織間隙を画定するように互いから離間されており、上記圧縮可能材料は、上記複数のカートリッジのうちの少なくとも１つのカートリッジが上記第２の顎部材に結合されている場合に、上記組織間隙を横断して延在するように寸法決めされている、圧縮可能材料と
を含む、キット。
（摘要）
外科用デバイスのためのツールアセンブリは、第１の組織接触表面を画定している第１の顎部材と、第２の組織接触表面を画定している第２の顎部材とを含む。第１の顎部材および第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、閉鎖位置において、第１の組織接触表面および第２の組織接触表面は、互いから離間されており、組織間隙を画定する。圧縮可能材料は、第１の顎部材の遠位端に固定されている。圧縮可能材料は、第１の顎部材および第２の顎部材が閉鎖位置にある場合に、第２の顎部材に係合する。外科用デバイスは、上記ツールアセンブリを含む。キットは、外科用デバイスのツールアセンブリ上に固定された圧縮可能材料を含む。ツールアセンブリを製造し、圧縮可能材料を固定するための方法が開示される。
本明細書中に組み込まれ本明細書の一部分を構成する添付図面は、本開示の実施形態を図示しており、以下に与えられる実施形態に関する詳細な説明と一緒に本開示の原理を説明する役目を果たしている。
図１は、従来技術に従う手術ツールを含む外科用ステープリングデバイスの例を図示している。
図２は、従来技術に従う図１の外科用ステープリングデバイスの手術ツールを図示している。
図３は、図１および２の手術ツールの組織接触表面の間の相互作用空間の距離である「組織間隙」を図示している。
図４は、本開示の一実施形態に従う、手術ツールの遠位端に可撓性の圧縮可能材料を含む、開放位置における細長シャフトおよび手術ツールを図示している。
図４Ａは、手術ツールの遠位端における圧縮可能材料を図示している図４に示されている印付きエリアの詳細の拡大図である。
図５は、本開示の一実施形態に従う、患者組織の存在を伴わない、閉鎖位置における図４および４Ａの細長シャフトおよび手術ツールを図示しており、圧縮可能材料は、手術ツールの遠位端において顎部材間で圧縮されている。
図６は、本開示の実施形態に従う、圧縮可能材料と手術ツールの遠位端における隣接する顎部との間に配置された組織を伴う、閉鎖位置における図４および４Ａの細長シャフトおよび手術ツールを図示している。 図７は、本開示の一実施形態に従う、図４、４Ａ、５、および６の圧縮可能材料を含むキットを図示している。
図８は、交換ステープルカートリッジアセンブリに事前に固定された図４、４Ａ、５、および６の圧縮可能材料を含むキットを図示している。
（詳細な説明）
本開示は、開放位置から閉鎖位置またはクランプ位置まで互いに対して移動可能な一対の顎部を有するツールアセンブリを含む内視鏡外科用ステープリングデバイスに関する。クランプ位置において、顎部は、並列して整列させられた状態で配置されており、縫合される組織を受け取るように寸法決めされた組織間隙を画定している。ツールアセンブリの顎部のうちの一方の遠位端は、ツールアセンブリがクランプ位置にある場合に、他方の顎部と係合するように組織間隙を横断して延在するように配置された、低デュロメータ材料または圧縮可能材料（例えば、圧縮可能パッド等）にフィットされている。圧縮可能材料は、組織間隙よりも小さい厚さを有する組織を含む、内視鏡外科手技中の薄い組織の把持を促進する。材料は、組織の把持を促進するために、圧縮可能、可撓性、または変形可能であり得る。
本記載の全体にわたり、用語「近位」は、操作者に最も近いデバイスの部分を参照し、用語「遠位」は、操作者から最も遠いデバイスの部分を参照する。
図１および２は、一般的に用いられる外科用ステープリングデバイスの一例を図示している。ここで図１（本開示の中で用いられる場合、同様の参照番号は、いくつかの図面の各々における同一の要素または対応する要素を識別する）を詳細に参照すると、外科用ステープリングデバイス１００は、ハンドルアセンブリ１１３と、ハンドルアセンブリ１１３から遠位に延在する細長部材１１４と、細長部材１１４の遠位端に解放可能に固定された使い捨てローディングユニット（「ＤＬＵ」）１１６とを含む。ＤＬＵ１１６は、細長部材１１４の延長部を形成している近位本体部分１２９と、一対の顎部１２６および１２８をそれぞれ含む遠位ツールアセンブリ１２７とを含む。一実施形態において、一方の顎部は、カートリッジアセンブリ１２６を含み、他方の顎部は、アンビル部材１２８を含む。ツールアセンブリ１２７は、細長部材１１４の長手方向軸に対して実質的に垂直な軸の周りで本体部分１２９に旋回可能に接続されている。カートリッジアセンブリ１２６は、複数のステープル（図示せず）を収容している。アンビル部材１２８は、カートリッジアセンブリ１２６から離間された開放位置と、カートリッジアセンブリ１２６と並列して整列させられた状態の閉鎖位置またはクランプ位置との間で、カートリッジアセンブリ１２６に対して移動可能である。ツールアセンブリ１２７は、代替的に、カートリッジアセンブリ１２６がアンビル部材１２８に対して移動可能であるように配列され得る。ＤＬＵ１１６は、カートリッジアセンブリ１２６とアンビル部材１２８との間でクランプされる組織にステープルの線形列を適用するように構成されている。さらに、実施形態において、ツールアセンブリ１２７は、直線状構成を有し得、関節運動を提供しない。
ハンドルアセンブリ１１３は、固定ハンドル１１８と、移動可能ハンドル１２０と、バレル部分１１９とを含む。回転制御部材１２２は、ハンドルアセンブリ１１３に対する細長部材１１４の回転を促進するために、バレル部分１１９の前方（遠位）端１１９に回転可能に搭載されている。関節運動レバー１２４もまた、ツールアセンブリ１２７の関節運動を促進するために、回転制御部材１２２に隣接してバレル部分１１９の前方端上に搭載される。デバイス１００を後退位置に戻すために、一対のリトラクタノブ１１５が、バレル部分１１９に沿って移動可能に配置されている。リトラクタノブ１１５は、バレル部分１１９内に画定されたスロット１１７を通して外科用ステープリングデバイスの駆動アセンブリ（図示せず）に接続されており、駆動アセンブリを後退させたりクランプ位置から開放位置へとカートリッジアセンブリ１２６およびアンビル部材１２８を移動させたりするために、バレル部分１１９に沿って移動可能である。Ｍｉｌｌｉｍａｎらに対する米国特許第５，８６５，３６１（以後、「‘３６１特許」と呼ぶ）は、そのようなハンドルアセンブリを記載しており、該米国特許は、その全体が参照により本明細書中に援用される。本開示は、ＤＬＵ上に支持されたツールアセンブリ１２７を図示しているが、本開示のツールアセンブリ１２７が、外科用ステープリングデバイス１００の本体１１４の遠位端上に固定的に支持され得ることが構想され得る。さらに、外科用ステープリングデバイス１００およびツールアセンブリ１２７と同様の態様で機能するツールアセンブリを有する外科用器具は、電動ハンドルを含み得るか、または、ロボット外科システムにおける使用のために構成され得る。
図２は、ステープルカートリッジアセンブリ１２６およびアンビル部材１２８を含むツールアセンブリ１２７の拡大図を図示している。ステープルカートリッジアセンブリ１２６は、組織接触表面２２０を含み、該組織接触表面は、その内部に配置され、ステープルカートリッジアセンブリ１２６の長手方向軸と実質的に整列させられた列に配列されている、複数の保持スロット２２３を有する。保持スロット２２３の各列は、保持スロットの隣接列から長手方向にずれている。実施形態において、ナイフチャネル２３０は、ステープルカートリッジアセンブリ１２６の長手方向軸に沿って配置されており、これは、ナイフ（図示せず）をスライド可能に受け取るように適合されている。例示的な外科用ステープリングデバイスのナイフに関する記載については、‘３６１特許を参照されたい。
当業者は、ステープルカートリッジおよびアンビルに関する同様の設計特徴を有する当該技術分野において公知のその他の外科用ステープリングデバイスが存在することを認識し得る。そのような外科用ステープリングデバイスおよびその使用のための方法に関する別の例は、現在Ｃｏｖｉｄｉｅｎ，ＬＰに譲渡されている米国特許第７，４０７，０７５号に開示されており、その内容の全体は、参照により本明細書中に援用される。
図３は、ツールアセンブリ４００の側面図を図示している。例えば図１〜２に関連して上述されたようなもの、および当該技術分野において（少なくとも一部の外科医に対して）公知のその他のもの等の内視鏡外科用ステープリングデバイスの重要な特徴は、臨床医が組織を適切に配置し、縫合される組織にアクセスすることを可能にする、組織を把持しマニピュレートする外科医の能力である。組織を把持するためのこの能力は、「組織間隙」Ｇに直接的に関係しており、該組織間隙は、カートリッジアセンブリ１２６およびアンビル部材１２８がクランプ位置にある場合に、アンビル部材１２８の組織接触表面１２８ａとカートリッジアセンブリ１２６の組織接触表面２２０との間の相互作用空間の距離である。現状の技術は、デバイス構成要素の製造中に「組織間隙」Ｇの公称公差を標的にすることに基づいている。外科医が薄い組織または胸部組織を扱う仕事をする場合、「組織間隙」Ｇの公称公差内の外科用デバイスの製造にも関わらず、組織を把持しマニピュレートする能力は、妨げられ得る。これは、臨床医が外科部位における組織をマニピュレートすることをより困難にし、その結果、外科手技を長引かせ、患者または対象に対する外傷を増大させ得る。追加の器具（例えば、別個の把持器等）が、外科医によって用いられ得るが、これもまた、手技を長引かせ、外傷を増大させ得る。
上述のように、本開示は、上述のような「組織間隙」Ｇの存在によってもたらされる不都合な外科的能力の問題に対する解決策に関する。すなわち、本開示は、例えば外科用ステープリングデバイス等の外科用デバイスのツールアセンブリの遠位先端に配置された圧縮可能材料に関する。圧縮可能材料は、間隙に橋渡しするように、ツールアセンブリの遠位端に（例えば、カートリッジアセンブリ上に）配置される。これは、カートリッジアセンブリの遠位端上に比較的低いデュロメータの材料を取り付けることによって達成され得る。材料は、楔状ボリュームとして構成され得、圧縮可能、可撓性、または変形可能であり得る。
例えば外科用ステープリングデバイス等の外科用デバイスのツールアセンブリの遠位先端に配置された本開示の圧縮可能材料の実施形態が、ここで、詳細に記載される。
図３と併せて図４〜６を参照すると、ＤＬＵ６００が開示されており、該ＤＬＵは、細長シャフト６１０と、細長シャフト６１０の遠位端上に支持されたツールアセンブリ４００とを含む。ツールアセンブリ４００は、ＤＬＵ６００の一部分として図示されているが、ツールアセンブリ４００が、外科用ステープリングデバイスの本体（例えば、本体１１４（図１））の遠位端上に固定的に支持され得ることが構想される。ツールアセンブリ４００は、アンビル部材４１０およびカートリッジアセンブリ４２０を含む一対の顎部を含む。この例において、カートリッジアセンブリ４２０は、アンビル部材４１０に対して旋回可能に移動可能である。
カートリッジアセンブリ４２０は、遠位端４１１を有する角度付き表面４１４を画定するようにアンビル部材４１０の遠位先端４０ｂまで遠位に延びている実質的に平面状の組織接触表面４１２を含む。角度付き表面４１４は、顎部間に組織を誘導するように配置されている。圧縮可能材料４３０の前縁４３６の形状は、材料が自らの上に折り返ることなしに、組織Ｔが材料４３０の上へと、該材料の上方で移動することを可能にする。
カートリッジアセンブリ４２０は、実質的に平面状の組織接触表面４２２および角度付き表面４２４を含む。組織接触表面４２２は、ツールアセンブリ４００の顎部間に組織を誘導するように構成された角度付き表面４２４まで延在している。
図４を参照すると、アンビル部材４１０およびステープルカートリッジ４２０は、アンビル４１０の実質的に平面状の組織接触表面４１０が、顎部間に組織を受け取るように、カートリッジアセンブリ４２０の実質的に平面状の組織接触表面４２２から離間されている、開放位置を画定している。
図５を参照すると、アンビル部材４１０およびステープルカートリッジアセンブリ４２０は、アンビル部材４１０の実質的に平面状の組織接触表面４１２およびカートリッジアセンブリ４２０の実質的に平面状の組織接触表面４２２が、「組織間隙」Ｇを画定するように、互いに密接に近接している、閉鎖位置を画定している。
図５を参照することによって最も良く理解されるように、アンビル部材４１０によって画定されている角度付き表面４１４およびカートリッジアセンブリ４２０によって画定されている角度付き表面４２４は、アンビル部材４１０およびステープルカートリッジアセンブリ４２０が閉鎖位置にある場合に、楔状ボリュームＶを画定する。代替的に、アンビル部材４１０およびカートリッジアセンブリ４２０のその他の構成が構想される。
ハンドルアセンブリ１１３（図１を参照）は、第１の顎部材４２０および第２の顎部材４１０を、それぞれ、組織上にクランプ作用を行うかまたはステープルを発射するかよりも前に、開放位置と閉鎖位置との間で移動させるように構成されている。
図４および４Ａを参照すると、圧縮可能材料４３０は、アンビル部材４１０の遠位端とカートリッジアセンブリ４２０の遠位端との間に支持されている。本開示の実施形態において、圧縮可能材料４３０は、互いに角度をなした関係にある、第１の略平坦なまたは僅かに弓状の表面４３４’と、第２の略平坦な表面４３４’’とを含む、楔状形状を有する。圧縮可能材料４３０の楔状形状は、弓状の外側周囲面４３６を含み、該弓状の外側周囲面は、第１の表面４３４’がおおよそ直角Θで弓状の外側周囲面４３６と交差し、その一方で、第２の表面４３４’’が鋭角Φで弓状の外側周囲面４３６と交差するように、第１の表面４３４’と第２の表面４３４’’との間に延在している。代替的に、その他の構成が、圧縮可能材料４３０に対して構想される。
圧縮可能材料４３０の楔状ボリュームまたは形状は、複数の傾斜または湾曲した表面を含み得る。さらに、第１の表面４３４’の滑らかな手触りとは反対に、圧縮可能材料４３０の楔状ボリュームまたは形状は、患者または対象に対する外傷を低減しながら組織の軽い摩擦把持を提供するように配列された摩擦特徴を含み得る。実施形態において、組織の摩擦把持は、断続的に離間された盛り上がった突起４３５を含むテクスチャ加工表面４３４’によって増強され得る（以下に記載される図５〜８には明示的に示されていないが、当業者は、盛り上がった突起４３５が、図６に示されている患者組織Ｔと相互作用することを認識し得る）。
実施形態において、圧縮可能材料４３０は、例えばオーバーモールド成形、化学ボンディング、または接着剤等により、カートリッジアセンブリ４３０の角度付き表面４２４上に固定的に配置される。別様に、圧縮可能材料が、アンビル部材４１０に留められることも構想される。図４Ａに図示されている実施形態において、圧縮可能材料は、第２の略平坦表面４３４’’が角度付き表面４２４と相互作用し、それと直接的に接触するように、カートリッジアセンブリ４２０に留められている。代替的に、化学ボンディングの場合、接着剤層４３８は、角度付き表面４２４と第２の略平坦表面４３４’’との間に適用され得る。ここで、第２の表面４３４’’は、破線の引き出し線を介して、図４Ａにおいて破線として示されている。そのような接着剤は、圧縮可能材料４３０の第２の表面４３４’’に対して接着する接着剤４３８の第１の表面４３８’においてテープまたは液体または半固体として提供され得、感圧性接着剤（ＰＳＡ）またはシアノアクリレート（例えば、Ｈｉｇｈ Ｆｌｅｘシアノアクリレート）を含み得る。ここで、接着剤層４３８の第２の表面４３８’’は、角度付き表面４２４に接着している。接着剤層４３８がＰＳＡの形態である場合、ＰＳＡは、第１の表面４３８’および第２の表面４３８’’の一方または両方上に、バッキング材料４３８ａ（例えば、紙）（図７を参照）を含み得る。バッキング材料４３８ａは、接着剤層４３８の第１の表面４３８’が第２の表面４３４’’に適用され、その一方で接着剤層４３８の第２の表面４３８’’が角度付き表面４２４に適用されることを可能にするように、除去され得る。
圧縮可能材料４３０は、熱可塑性ゴム（ＴＰＶ）（例えば、ＳａｎｔｏｐｒｅｎｅＴＭ熱可塑性加硫物（米国テキサス州スプリングのＥｘｘｏｎＭｏｂｉｌ Ｃｈｅｍｉｃａｌ Ｃｏ．によって製造されているＴＰＶ））、ポリ塩化ビニル（ＰＣＶ）発泡体、あるいは、その他の材料（可撓性、圧縮可能および／または変形可能であるといった所望の特性を有しているか、または、低いデュロメータ特性（例えば、約４０〜約５５Ａの間のデュロメータ示度値）を有している）等の材料から作製され得る。
一実施形態において、図４Ａに示されているように、圧縮可能材料４３０の第１の表面４３４’は、圧縮可能材料が留められている顎部の組織接触表面（例えば、ステープルカートリッジ４２０の組織接触表面４２２）によって画定された平面を横断して、他方の顎部（例えば、アンビル部材４１０）に密接に近接した位置まで、または、それと係合するように、延在している。このことは、組織が組織間隙Ｇよりも薄い厚さを有している場合に、ツールアセンブリがクランプ位置まで移動させられたときに、圧縮可能材料４３０が、対向する顎部に対して組織を圧縮することを可能にする。図４および４Ａにおけるツールアセンブリ４００は、圧縮可能材料４３０を含んでいることのみによって図１〜３における一般的なツールアセンブリ１２７とは異なっていることが理解される。図５は、患者組織の存在を伴わずに、閉鎖位置またはクランプ位置におけるツールアセンブリ４００を図示しており、アンビル部材４１０の組織接触表面４１２は、既に図示し上述したように、間隙Ｇを形成するように、組織接触表面４２２に密接に近接している。これにより、圧縮可能材料４３０は、アンビル部材４１０およびステープルカートリッジアセンブリ４２０が閉鎖位置にある場合に、ツールアセンブリ４００の遠位端において楔形ボリュームＶ内に受け取られるように構成されている。ここで、圧縮可能材料４３０は、アンビル部材４１０の角度付き表面４１４とカートリッジアセンブリ４２０の角度付き表面４２４との間で圧縮される。圧縮可能材料は、外科用ステープリングデバイスの把持機能を向上させるために、既存の組織間隙Ｇよりも短い距離だけ、対向する顎部に近い位置へと延在するように寸法決めされることのみを必要としているということに留意されたい。したがって、圧縮可能材料４３０は、ツールアセンブリ４００の顎部が閉鎖位置にある場合に、圧縮状態にあることを必要としない。さらに、図４〜６、８に示されているように、楔形状の圧縮可能材料４３０は、カートリッジアセンブリ４２０の組織接触表面４２２上に延在すべきではない。
図６は、患者組織Ｔの存在を伴う、閉鎖位置におけるツールアセンブリ４００を図示しており、アンビル部材４１０の組織接触表面４１２は、間隙Ｇを形成するように、組織接触表面４２２に密接に近接している。患者組織Ｔは、２つの組織接触表面４１２および４２２の間に、および、アンビル部材４１０の角度付き表面４１４と圧縮可能材料４３０の第１の表面４３４’との間に、遠位に延在しており、そして、弓状外側周囲面４３６の上で、および、角度付き表面４２４の遠位端４２１を越えて、さらに遠位に突出している。ここでは、患者組織Ｔが存在しているので、圧縮可能材料４３０は、依然として楔状ボリュームＶ内に受け取られており、患者組織Ｔもまた、楔状ボリュームＶ内に存在している。
外科医が種々の組織Ｔを把持しマニピュレートするために顎部４１０および４２０を閉鎖すると、圧縮可能材料４３０は、異なる組織厚さに適応し得る。組織に対してクランプ作用を行う場合、圧縮可能材料が留められるツールアセンブリ４００の顎部（例えば、ツールアセンブリ４２０）は、組織Ｔに接触し、外向きに撓んで、適切な組織圧縮を可能にし得る。デバイスの切断ナイフが、ナイフチャネル２３０内を遠位へと移動してツールアセンブリ４００の長さを下る場合（図３を参照）、圧縮可能材料４３０は、圧縮を継続し、最小の力で外向きに撓み得る。
圧縮可能材料４３０のこのデュロメータは、圧縮可能材料４３０が、良好なステープル形成を伴う組織の切断および密閉といった主要なデバイス機能に僅かな影響しか有しないか全く影響を有しないようなものである。圧縮可能材料４３０の前縁４３６の形状は、材料が自らの上に折り返ることなしに、組織Ｔが材料４３０の上へと、該材料上で移動することを可能にする。
楔形状の圧縮可能材料４３０は、製造業者によって、ステープルカートリッジ、アンビル、または何らかのその他の構成要素に取り付けられ得るか、あるいは、楔形状の圧縮可能材料は、別々に提供され得る。
図７は、ツールアセンブリ４００’の遠位先端４０ｂにおいて楔状ボリュームＶ内に受け取られるように構成された圧縮可能材料４３０と、その内部に圧縮可能材料４３０を含んでいる無菌パッケージ４４０とを含むキット４０５を図示している。一実施形態において、無菌パッケージ４４０は、上述したように、接着剤ボンディング材料４３８のチューブの形態で、破線で示された接着剤４５０をさらに含み得る。代替的に、接着剤４５０は、やはり破線によって表された（テープディスペンサに組み込まれ得る）テープの形態であり得る。キット４０５は、圧縮可能材料４３０が、例えば、図４Ａに関して上述されたように接着剤層４３８を介して、またはテープにより、または除去可能バッキング材料４３８ａを有する感圧性接着剤４３８により、化学ボンディングによってツールアセンブリ４００’内に挿入されるような場合に特に利用され得る。このようにして、圧縮可能材料４３０は、既存の外科用器具６００に容易に後付けされ得、キット４０５を介して別個に提供され得る。圧縮可能材料４３０は、新規または既存に関わらず、適切な場所（例えば、製造工場を含む）において、または、外科医による使用のための病院またはその他の医療設備といった施設において、外科用器具６００にフィットされ得る。
特定の実施形態において、キット４０５は、テープの形態であり得る接着剤４５０と一緒に、１つよりも多くの楔形状の圧縮可能部材４３０を含み得る。
図８を参照すると、代替的な実施形態において、キット４０５’は、当該技術分野において公知のように、ツールアセンブリの顎部から除去可能な１つ以上の交換可能カートリッジアセンブリ４２０を無菌パッケージ４４０’内に含み得、カートリッジアセンブリ４２０のうちの少なくとも１つは、カートリッジアセンブリ４２０の端部に固定されている圧縮可能材料４３０を含む。この場合、圧縮可能材料４３０は、カートリッジアセンブリ４２０に事前に固定されているので、接着剤４５０は、もし存在する場合には、改善努力のみを必要とされる。
当業者は、上述の記載から、本開示は、外科用デバイスと共に用いるためのツールアセンブリ４００に対して図３〜７を参照している一実施形態において、第１の組織接触表面４２２を画定している第１の顎部材４２０および第２の組織接触表面４１２を画定している第２の顎部材４１０を含むツールアセンブリ４００に関していることを認識し得る。第１の顎部材４２０および第２の顎部材４１０は、開放位置と閉鎖位置との間で互いに対して移動可能であり、閉鎖位置において、第１の組織接触表面４２２および第２の組織接触表面４１２は、それぞれ、互いから離間されており、組織間隙Ｇを画定している。外科用デバイス６００は、第１の顎部材４２０の遠位端４２１に固定された圧縮可能材料４３０を含み、圧縮可能材料４３０は、第１の顎部材４２０および第２の顎部材４１０が、それぞれ、閉鎖位置にある場合に、第２の顎部材４１０に係合する。
第２の顎部材４１０は、遠位端４１１を画定しており、第１の顎部材および第２の顎部材の遠位端４２１、４１１は、それぞれ、楔状ボリュームＶを画定しており、圧縮可能材料４３０は、楔状ボリュームＶ内に受け取られている。代替的に、その他の顎部構成が構想される。
本開示はまた、一実施形態においては、上述したように、圧縮可能材料４３０をさらに含むツールアセンブリ４００に関している。
なおもさらに、本開示は、一実施形態において、ツールアセンブリ４００の顎部材４２０の遠位端４２１に固定されるように構成された圧縮可能材料４３０を設置するためのキット４０５に関している。キット４０５は、その内部に圧縮可能材料４３０を含む無菌パッケージ４０５を含む。キット４０５は、接着剤ボンディング材料４３８のチューブ４５０をさらに含み得る。
代替的に、図８に示されているように、キット４０５’は、複数の交換可能カートリッジアセンブリを含み得、カートリッジアセンブリ４２０のうちの少なくとも１つは、圧縮可能材料４３０を含む。より具体的には、キット４０５’は、ツールアセンブリの顎部材のうちの一方に解放可能に結合されるように適合された複数のカートリッジアセンブリ４２０を含み得る。カートリッジアセンブリのうちの少なくとも１つは、必要な場合、臨床医がツールアセンブリを用いて組織をマニピュレートすることを可能にするために、圧縮可能材料４３０を含む。キット４０５’はまた、カートリッジアセンブリ４２０およびツールアセンブリを支持する無菌パッケージ４４０’を含む。
本開示はさらに、なおも別の実施形態においては、外科用デバイスのためのツールアセンブリ４００を製造するための方法に関しており、該方法は、外科用デバイス６００のためのツールアセンブリ４００を提供することと、第１の顎部材４２０の遠位端４２１に対して圧縮可能材料４３０を固定することとを含み、該圧縮可能材料４３０は、第１の顎部材および第２の顎部材が閉鎖位置にある場合に、第２の顎部材４１０に密接に近接するか、またはそれと係合するように配置されている。
圧縮可能材料４３０の固定は、ツールアセンブリ４００の楔状ボリュームＶ内に受け取られる圧縮可能材料を含み得る。
本開示のいくつかの実施形態が図面に示されてきたが、本開示が当該技術分野の許容し得る範囲の広さであることおよび本明細書が同様に読まれることが意図されていることから、本開示がそれらの図面に限定されることは意図されてはいない。したがって、上記記載は、限定として考えられるべきではなく、特定の実施形態の例にすぎないと考えられるべきである。当業者は、添付の請求項の範囲および趣旨内のその他の改変を構想し得る。
上記開示は、明確化または理解を目的として、図示および実施例によっていくぶん詳細に記載されてきたが、特定の変更および改変が添付の請求項の範囲内で行われ得ることは明らかであり得る。

Claims (19)

  1. 外科用デバイスのためのツールアセンブリであって、
    第１の組織接触表面を画定している第１の顎部材と、
    第２の組織接触表面を画定している第２の顎部材であって、前記第１の顎部材および前記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、前記閉鎖位置において、前記第１の組織接触表面および前記第２の組織接触表面は、互いから離間されており、組織間隙を画定している、第２の顎部材と、
    前記第１の顎部材の遠位端に固定された圧縮可能材料であって、前記圧縮可能材料は、前記第１の顎部材および前記第２の顎部材が前記閉鎖位置にある場合に、前記第２の顎部材に係合する、圧縮可能材料と
    を含む、ツールアセンブリ。
  2. 前記圧縮可能材料を前記ツールアセンブリの遠位先端に固定するように配置された接着剤をさらに含む、請求項１に記載のツールアセンブリ。
  3. 前記接着剤の材料は、シアノアクリレートおよび感圧性接着剤から成る群から選択される、請求項２に記載のツールアセンブリ。
  4. 前記ツールアセンブリの第２の顎部は、複数のステープルを支持する、請求項１に記載のツールアセンブリ。
  5. 前記第２の顎部材は、遠位端を画定しており、前記第１の顎部材および前記第２の顎部材の前記遠位端は、楔状ボリュームを画定しており、前記圧縮可能材料は、前記楔状ボリューム内に受け取られている、請求項１に記載のツールアセンブリ。
  6. 前記圧縮可能材料は、対象の組織に接触するように構成された盛り上がった突起を有するテクスチャ加工表面を含む、請求項１に記載のツールアセンブリ。
  7. 前記接着剤は、前記ツールアセンブリの前記遠位先端に前記圧縮可能材料を固定するように前記圧縮可能材料の表面に対する接着を可能にする除去可能バッキング材料とともに構成された感圧性材料を含む、請求項２に記載のツールアセンブリ。
  8. 外科用デバイスであって、
    ハンドルアセンブリと、
    前記ハンドルアセンブリから延在している細長部材と、
    前記細長部材の遠位端上に支持されているツールアセンブリであって、前記ツールアセンブリは、
    第１の組織接触表面を画定している第１の顎部材と、
    第２の組織接触表面を画定している第２の顎部材であって、前記第１の顎部材および前記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、前記閉鎖位置において、前記第１の組織接触表面および前記第２の組織接触表面は、互いから離間されており、組織間隙を画定している、第２の顎部材と、
    前記第１の顎部材の遠位端に固定された圧縮可能材料であって、前記圧縮可能材料は、前記第１の顎部材および前記第２の顎部材が前記閉鎖位置にある場合に、前記第２の顎部材に係合する、圧縮可能材料と
    を含む、ツールアセンブリと
    を含む、外科用デバイス。
  9. 前記圧縮可能材料を前記ツールアセンブリの遠位先端に固定するように配置された接着剤をさらに含む、請求項８に記載の外科用デバイス。
  10. 前記接着剤の材料は、シアノアクリレートおよび感圧性接着剤から成る群から選択される、請求項９に記載の外科用デバイス。
  11. 前記ツールアセンブリの第２の顎部は、複数のステープルを支持する、請求項８に記載の外科用デバイス。
  12. 前記外科用デバイスは、外科用ステープラである、請求項８に記載の外科用デバイス。
  13. 前記第２の顎部材は、遠位端を画定しており、前記第１の顎部材および前記第２の顎部材の前記遠位端は、楔状ボリュームを画定しており、前記圧縮可能材料は、前記楔状ボリューム内に受け取られている、請求項８に記載の外科用デバイス。
  14. 前記圧縮可能材料は、対象の組織に接触するように構成された盛り上がった突起を有するテクスチャ加工表面を含む、請求項８に記載の外科用デバイス。
  15. 前記接着剤は、前記ツールアセンブリの前記遠位先端に前記圧縮可能材料を固定するように前記圧縮可能材料の表面に対する接着を可能にする除去可能バッキング材料とともに構成された感圧性材料を含む、請求項９に記載の外科用デバイス。
  16. キットであって、
    第１の組織接触表面を画定している第１の顎部材と、第２の組織接触表面を画定している第２の顎部材とを含むツールアセンブリであって、前記第１の顎部材および前記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、前記閉鎖位置において、前記第１の組織接触表面および前記第２の組織接触表面は、互いから離間されており、組織間隙を画定している、ツールアセンブリと、
    前記第１の顎部材の遠位端に固定されるように構成された圧縮可能材料と、
    前記圧縮可能材料および前記ツールアセンブリを支持している無菌パッケージと
    を含む、キット。
  17. 前記圧縮可能材料は、前記ツールアセンブリの遠位先端に前記圧縮可能材料を固定するように配置された接着剤を支持している、請求項１６に記載のキット。
  18. 前記第２の顎部材は、遠位端を画定しており、前記第１の顎部材および前記第２の顎部材の前記遠位端は、楔状ボリュームを画定しており、前記圧縮可能材料は、前記楔状ボリューム内に受け取られるように構成されている、請求項１６に記載のキット。
  19. キットであって、
    第１の顎部材および第２の顎部材を含むツールアセンブリであって、前記第１の顎部材および前記第２の顎部材は、開放位置と閉鎖位置との間で互いに対して移動可能であり、前記第１の顎部材は、第１の組織接触表面を画定している、ツールアセンブリと、
    複数のカートリッジであって、前記複数のカートリッジの各々は、前記第２の顎部材に解放可能に結合され、かつ第２の組織接触表面を画定するように適合されている、複数のカートリッジと、
    前記複数のカートリッジのうちの少なくとも１つの遠位端上に支持されている圧縮可能材料であって、前記閉鎖位置において、前記第１の組織接触表面および前記第２の組織接触表面は、組織間隙を画定するように互いから離間されており、前記圧縮可能材料は、前記複数のカートリッジのうちの少なくとも１つのカートリッジが前記第２の顎部材に結合されている場合に、前記組織間隙を横断して延在するように寸法決めされている、圧縮可能材料と
    を含む、キット。
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US10835242B2 (en) 2020-11-17
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