JP3642513B2

JP3642513B2 - Surgical anastomosis device

Info

Publication number: JP3642513B2
Application number: JP2001160107A
Authority: JP
Inventors: 和弘佐々木; 智之助川
Original assignee: Alcare Co Ltd
Current assignee: Alcare Co Ltd
Priority date: 2001-05-29
Filing date: 2001-05-29
Publication date: 2005-04-27
Anticipated expiration: 2021-05-29
Also published as: JP2002345872A

Description

【０００１】
【発明の属する技術分野】
本発明は、生体の表面に形成された開孔に装着し、生体内からの排出物を取り出したり、生体内へ治療目的の液剤を導入するために用いる外科用吻合装置に関する。
【０００２】
【従来の技術】
種々の疾患のため外科手術を行い、腸管、尿管、その他これらに類する管を体表まで導き生体表面に造設した瘻孔、或いは創傷により生体表面に形成された創面といった開孔には、生体内から排出される種々の排泄物、排液を収容し、時には治療、洗浄のため生体内へ液剤を注入するため、いわゆる外科用吻合装置が装着される。人口肛門用装具、人口膀胱用装具はその一例であるが、この外科用吻合装置は生体内から排出される汚物を処理するものであるから、汚物に触れることなく操作を衛生的に行うことができ、使用中汚物が漏れたりすることがないよう信頼性があり、着脱が容易であり、更に生体の表面に直接装着するものであるから肌への感触がよいことが要求される。
【０００３】
これらの要求を満たすため、従来種々の外科用吻合装置が提案されているが、その内比較的上述の要求に近いものとして、生体の開孔の周辺に粘着固定し得るようにした接皮部材と、接皮部材の非接皮側に固定した第１のフランジと、第１のフランジと着脱可能な第２のフランジとを備え、第１のフランジと第２のフランジにそれぞれ相互に嵌合可能なリング状の突起又は溝を有する吻合装置が本出願人により提案されている（実公平7−15542号公報）。この吻合装置は、接皮部材でもって第１のフランジを常時生体の開孔の周囲に固定しておき、第１のフランジと第２のフランジとを突起とそれに対応する溝とにより連結し、開孔から排出された排泄物を第２のフランジに取り付けた袋に収容し、排泄物が溜まったら第２のフランジを第１のフランジから取り外し、袋内の排泄物を除去し洗浄して再使用するか新しい第２のフランジと交換するようにし、場合によっては第２のフランジを袋式からキャップ式に代え得るようにしたものである。
【０００４】
この種の外科用吻合装置においては、使用中排泄物が漏れないようにする上で、突起とそれに対応する溝との連結構造が信頼性に関わる重要な部分であり、この信頼性を高めるため、２つの突起とそれに対応する２つの溝とを備えている。突起とそれに対応する溝とを複数設けることによって、１組の突起と溝との連結構造より漏れに対する信頼性は当然高められるが、突起とそれに対応する溝を２つ設けることによってフランジの外周は大きくなる。また、第１のフランジと第２のフランジとを接合する場合、両フランジに設けた円形リング状の嵌合部を相互に押圧する操作を行うが、その際人体の開孔周囲の肌に直接押圧力が加わらないようにするため、第１のフランジと接皮部材との間に指を挿入して第１のフランジを裏側から十分支えられるようにすることが好ましく、そのためにも第１のフランジの外径は比較的大きくとられている。
【０００５】
この種の外科用吻合装置において、両フランジの嵌合部を嵌め合わせるため位置合わせする場合、生体の開孔は概ね下半身にあり、また第１のフランジ上に第２のフランジの袋が重なるため、嵌合部を直接目視することが難しく、手探りで両嵌合部間の位置合わせをしなければならないことが多く、なかなか位置が定まり難い。この欠点を解決するため、１のフランジの嵌合部の外側にフランジの外周部によってつば部を形成し、つば部が少なくとも一部に嵌合部の最外周縁に達し指が入る大きさの切り込みを有する吻合装置が本出願人により提案されている（実用新案登録第2534783号公報）。この吻合装置によれば、第１のフランジの外周の切り込みに指を添えて持つことにより第１のフランジの嵌合部の位置を明確に知覚することができ、また、第１のフランジのつば部より第１のフランジと接皮部材との間に指を十分差し込むことにより第１のフランジを裏側から指で支持しながら生体の開孔周辺部に圧迫力を加えることなく両フランジの嵌合部を相互に押圧して嵌め合わせることができる。
【０００６】
上述のような従来の外科用吻合装置において、両フランジの嵌合部の位置は正確に認識することはできるものの、一方のフランジの嵌合部に２つの突起がある場合、両嵌合部を噛み合わせることは実際上は必ずしも容易ではない。例えば、一方のフランジの嵌合部に２つの突起がある場合、２つの突起の間に溝がある形状であっても面のように振る舞い、他方のフランジの嵌合部底面が滑って両者は微妙にずれて嵌合ができなくなり、更に２つの突起の形状が完全に同一でなくても大きさが比較的近いと、両嵌合部を位置合わせする際滑って位置が微妙にずれ、突起と溝が１つずれて仮止めのようにその箇所だけ嵌り込んでしまうことがあり、それを外して再び嵌合操作をやり直さなければならないことになる。
【０００７】
排泄物の漏れに対する信頼性の観点からすれば、嵌合部の突起と溝とはそれぞれ２つずつのほうが好ましいことはいうまでもないが、前述のようにフランジが大型となり、装着時違和感があり、また両嵌合部の位置合わせが難しいという問題点がある。その一方で突起が１つの嵌合部の従来の構造では漏れに対する信頼性が今一つ十分ではなく、装着者は排泄物の漏れに対する不安感を払拭することができない。
【０００８】
【発明が解決しようとする課題】
本発明が解決しようとする課題は、嵌合操作を容易且つ迅速に行うことができ、しかも排泄物の漏れに対する信頼性の高い外科用吻合装置を提供することにある。
【０００９】
【課題を解決するための手段】
上述の課題を解決するため、本発明においては、一方の側に１つのリング状の突起を有する第１のフランジと一方の側に１つのリング状の溝付き突起を有する第２のフランジとを備え、
第１のフランジのリング状の突起は、１つの第１のリング状係合部と、１つの第２のリング状係合部と、第１のリング状係合部と第２のリング状係合部との間に位置する１つのリング状スリットとを有し、第１のリング状係合部は、リング状スリットに対し凹又は凸のリング状曲面と、そのリング状曲面に続き、リング状スリットと反対側にリング状段付き係合部分とを有し、第２のリング状係合部の先端より肉厚に形成され、第２のリング状係合部は、リング状スリットと反対側に突出し、リング状スリットに対し凸のリング状曲面と凹のリング状曲面との連続するリング状曲面から形成され、スリット側に変形可能なリング状嵌合部分を有し、
第２のフランジのリング状の溝付き突起は、そのリング状の溝内に第１のフランジのリング状の突起を挿入可能に且つ溝内が第１のフランジのリング状の突起の外面形状に相応するように形成され、リング状の溝は、第１のフランジの第１のリング状係合部のリング状段付き係合部分と係合し得るリング状段付き係合部分と、第１のリング状係合部の凹又は凸のリング状曲面と相応する凸又は凹のリング状曲面と、第１のフランジの第２のリング状係合部のリング状嵌合部分と相応する凹のリング状曲面と凸のリング状曲面との連続するリング状曲面から形成され、第２のリング状係合部のリング状嵌合部分と嵌合し得るリング状嵌合部分とを有し、
第１のフランジのリング状の突起の最先端の幅は、第２のフランジのリング状の溝付き突起の溝の開口部の幅より小さく形成され、
第１のフランジのリング状の突起を第２のフランジのリング状の溝付き突起の溝内に挿入したとき、第１のフランジのリング状の突起の第１のリング状係合部はそのリング状段付き係合部分が第２のフランジのリング状段付き係合部分と係合し、第１のフランジのリング状スリットは狭められ、第１のフランジのリング状の突起の第２のリング状係合部はそのリング状嵌合部分が第２のフランジのリング状嵌合部分に押し付けられて嵌め合いを形成し、
第１のフランジと第２のフランジとは、いずれか一方のフランジのリング状の突起又は溝付き突起と反対側に接皮部、他方のフランジのリング状の溝付き突起又は突起と反対側に袋体を有する。
【００１０】
本発明においては、第１のフランジのリング状の突起に設けられた第１のリング状係合部はその最先端部分からリング状段付き係合部分に至るスリットに対し凹のリング状曲面、凸のリング状曲面、又は凹と凸のリング状曲面を連続して組み合わせたリング状曲面を有し、第２のリング状係合部はその最先端部分からスリットに対し凸のリング状曲面と凹のリング状曲面とを連続して組み合わせたリング状曲面を有し、第２のフランジのリング状の溝付き突起に設けられたリング状の溝は溝の底面からリング状段付き係合部分に至る溝に対し凹のリング状曲面、凸のリング状曲面、又は凹と凸のリング状曲面を連続して組み合わせたリング状曲面と、溝の底面からリング状段付き係合部分と反対側に溝に対し凸のリング状曲面と凹のリング状曲面とを連続して組み合わせたリング状曲面とを有するように構成するのが好ましい。
【００１１】
本発明においては、第１のフランジのリング状の突起に設けられた第１のリング状係合部はその最先端部分からリング状段付き係合部分に至るスリットに対し凹のリング状曲面を有し、第２のリング状係合部はその最先端部分からスリットに対し第１の凸、次いでスリットに対し凹、次いでスリットに対し第２の凸の連続したリング状曲面を有するように形成し、第２のフランジのリング状の溝付き突起に設けられたリング状の溝は溝の底面からリング状段付き係合部分に至る溝に対し凹のリング状曲面と、溝の底面からリング状段付き係合部分と反対側に溝に対し第１の凸、次いで溝に対し凹、次いで溝に対し第２の凸の連続したリング状曲面とを有するのが特に有利である。
【００１２】
また本発明においては、第１のフランジのリング状の突起に設けられた第１及び第２のリング状係合部の最先端部分の半径方向の幅は、第２のフランジの溝の開口端部分の半径方向の幅より小さいことが好ましい。
【００１３】
更に本発明においては、第１のフランジのリング状の突起に設けられたリング状スリットの深さは、第２のリング状係合部のスリットに対し凹のリング状曲面とスリットに対し第２の凸のリング状曲面との移行部に存在する変曲点の位置より浅いことが好ましい。
【００１４】
また本発明においては、第１のフランジのつば部に滑り止めを設け、さらに第１のフランジの周辺部につまみ部分を設けるのが好ましい。
【００１５】
【発明の実施の形態】
次に本発明の実施の形態を図面に示す実施例について説明する。
【００１６】
図１は本発明の実施例を示し、ａは第１のフランジを設置した接皮部材の正面図、ｂは第２のフランジを設置した袋体の背面図、ｃは図１ａのC−C線に沿う断面図、ｄは図１ｂのD−D線に沿う断面図である。１は接皮部材で例えば正方形状をなし中心部に開口２を備え、接皮側には粘着層３を備えている。４は第１のフランジで、薄肉のリング状部分５でもって接皮部材１の非接皮側表面６上に例えば溶着により固定され、接皮部材１の表面に沿って外方に延びている。第１のフランジ４の接皮部材１と反対側には円形のリング状の突起７が設けられ、このリング状の突起７の外側即ちフランジ４の外周縁にリング状のつば部８が形成され、リング状のつば部８は接皮部材１とほぼ平行に外方へ延び、フランジ４の最外周縁９に達している。第１のフランジ４は更にリング状のつば部８の装着状態において上側にリング状のつば部８を直線状に切り取って形成した切込み１０を備えている。リング状の突起７の詳細は後述する。
【００１７】
２１は第２のフランジで、一方の側即ち接皮部材側に円形のリング状の溝付き突起２２、他方の側に袋体２３を有し、リング状の溝付き突起２２の溝２４中に第１のフランジのリング状の突起７を挿入することにより、突起７と溝２４とが気密に結合されるようになっている。２５は第２のフランジ２１を持ち易くするために付加したつまみ片である。リング状の溝付き突起２２の詳細は後述する。
【００１８】
図２は図１に示す実施例の要部の拡大断面図で、ａは第２のフランジの要部、ｂは第１のフランジの要部、ｃは第１のフランジと第２のフランジとを結合した状態を示し、図１と同等部分には同符号を付してある。第１のフランジ４のリング状の突起７は、第１のリング状係合部１１、第２のリング状係合部１２、両リング状係合部１１、１２間に形成されたリング状スリット１３とを有する。第１のリング状係合部１１は末端部１４にリング状段付き係合部分１５を有し、スリット１３と対向する先端１６からリング状段付き係合部分１５に至るまでスリット１３に対し凹のリング状曲面１７でもって形成されている。第１のリング状係合部１１と対向する第２のリング状係合部１２はスリット１３と対向する先端から、スリット１３に対し第１の凸のリング状曲面１８と、次いでスリット１３に対し凹のリング状曲面１９と、次いでスリット１３に対し第２の凸のリング状曲面１１０とを介して薄肉のリング状部分５に連なるように形成されている。
【００１９】
第２のフランジ２１のリング状の溝付き突起２２の内面は第１のフランジ４のリング状の突起７の外面に相応するように形成されている。溝２４は一方の壁面にリング状段付き係合部分２６を有し、溝２４の底面２７から段付き係合部分２６に至るまで溝２４に対し凹のリング状曲面２８でもって形成され、他方の壁面は、溝２４の底面２７から溝に対し凸の第１のリング状曲面２９と、次いで溝に対し凹のリング状曲面２１０と、次いで溝に対し第２の凸のリング状曲面２１１とを介して溝開口部２１２に至るように形成されている。これらの各リング状曲面は第１のフランジの第２のリング状係合部１２の各リング状曲面１８、１９、１１０とほぼ相応する形状を持っている。
【００２０】
図２ｃに示すように、第１のフランジのリング状の突起７を第２のフランジのリング状の溝付き突起２２の溝２４内に挿入すると、第１のフランジの第１のリング状係合部１１のリング状段付き係合部分１５と第２のフランジの段付き係合部分２６とが係合し、一方、第１のフランジのリング状スリット１３が多少狭められ、第１のフランジの第２のリング状係合部１２の各リング状曲面１８，１９、１１０が第２のフランジの各リング状曲面２９、２１０、２１１とそれぞれ嵌合し、この嵌合曲面が両フランジ間に気密結合を形成し、第１のフランジのリング状突起７のリング状段付き係合部分１５と第２のフランジのリング状溝付き突起２２のリング状段付き係合部分２６との係合作用によってリング状突起７とリング状溝付き突起２２とは外れないように結合される。
【００２１】
図３ａ、ｂは、図２に示す第１のフランジのリング状の突起、第２のフランジのリング状の溝付き突起の好ましい態様を説明するため、各部分を拡大して示す断面図で、図２と同等部分には同符号を付してある。第１のフランジのリング状の突起７の第１のリング状係合部１１の半径方向の最大厚みｐと第２のリング状係合部１２の先端の半径方向の厚みｏはｐ＞ｏの関係にあり、ｐ／ｏの値が1.5以上になるように定めるのが有利である。更に第２のリング状係合部１２の半径方向の最大厚みｑと、ｐ＞ｑ＞ｏの関係になるように定めると有利である。また第１のフランジのリング状段付き係合部分１５のスリット側末端部からリング状スリット１３までの半径方向の厚みｎは、上述のｏとはｎ＞ｏの関係に定めるのが有利である。この厚みの相互関係により、第２のリング状係合部１２の変形が容易になり、第１のリング状係合部はスリット側には変形し難くなり、両フランジ４、２１間の突起の溝に対する挿入が容易となると共に、突起と溝との対向面間に嵌合のための相互押圧力を有利に作用させることができる。なお、第１のフランジの第２のリング状係合部１２のスリットに対し凹のリング状曲面の曲率を適宜変えることでｑ≧ｐとすることもできる。この場合、第２のリング状係合部の半径方向の厚みがやや厚くなる。
【００２２】
両フランジの各リング状段付き係合部分１５、２６の角度は、図示の状態でほぼ水平方向に延びるのが好ましく、それより深いと製造し難く、係合、係合の外しがし難く、浅いと外れ易い。
【００２３】
第１のフランジ４のリング状の突起７のスリット１３の深さｒは、第２のリング状係合部１２の凹のリング状曲面１９とそれに続く凸の第２のリング状曲面１１０との間の変曲点１１２の深さｓより浅いことが有利である。ｒがｓに等しいかｓより大きくなると、係合及び嵌合の程度が小さくなる。スリット１３の幅ｔは第１のフランジのリング状の突起７を第２のフランジのリング状の溝付き突起２２に挿入する際、挿入が可能なようにスリットが縮まる程度の寸法に定めればよく、幅を大きくして、挿入した際第２のリング状係合部による第２のフランジの溝の壁面に対する押圧力が加わらなかったり、装着時に加わる力によって第２のリング状係合部が大きく変形して係合が外れるようであってはならない。このような嵌合状態が維持されるためには、上記のスリット幅ｔと深さｒ以外に、第２のフランジの溝に対するリング状曲面２８の半径方向の幅ｗが、嵌合したときにそのリング状曲面２８に対向する第１のフランジの突起の部分の嵌合しない状態における幅（＝ｐ＋ｕ）より小さいことが必要である。ｗがｐ＋ｕより大きい場合には、第１のフランジの第２係合部１２の先端の変形が起きないため、互いに密着するのに十分な押圧力が生じず、密封性が不充分となる。また、第１のフランジのリング状の突起７の最先端の幅ｕは第２のフランジのリング状の溝付き突起の溝２４の開口部２１２の幅ｖより小さいことが必要である。
【００２４】
次に図４について本発明の外科用吻合装置の操作方法を説明する。なお図示の都合上各フランジの左半分のみを示すが、右半分も同様である。ａに示すように、第１のフランジ４を有する接皮部材１をその開口２が生体の開孔４１と一致するようにして粘着層３でもって生体の皮膚表面４２に貼り付け、第２のフランジ２１を切込み１０（図１参照）を目安にして第１のフランジ４のリング状の突起７に第２のフランジ２１のリング状の溝付き突起２２をほぼ対向させる。次にｂに示すように、第１のフランジ４のリング状の突起７上に第２のフランジ２１のリング状の溝付き突起２２の溝開口部２１２を置くと、第１のフランジのリング状の突起７の先端は、その幅が溝付き突起２２の溝開口部２１２の幅より小さいから、即座に第２のフランジ２１の溝開口部２１２内に嵌り込む。この状態でｃに示すように第１のフランジ４のつば部８の下に指４３を差込んで支え、第２のフランジ２１に上から指４４により押圧力を加えると、先ず第２のフランジ２１の溝のリング状曲面２１１が第１のフランジ４の第２のリング状係合部１２のリング状曲面１８から曲面１９にかけて乗り、一方第２のフランジ２１の段付き係合部分２６より先端に至る部分が第１のフランジ４の第１のリング状係合部１１上に乗り、更に押し込むと、リング状曲面１８はリング状曲面２１１に対しては凹の関係にあるから、ｄに示すように第２のフランジ２１のリング状曲面２１０、２９が順次第１のフランジ４の第２のリング状係合部１２のリング状曲面１８、曲面１９上を滑り落ち、最終段階では図２ｃに示すようにリング状スリット１３が多少閉じられ、リング状段付き係合部分２６はリング状段付き係合部分１５を乗り越えて下側に回り込み係合し合うと共に、第２のリング状係合部１２の反発力によって第２のリング状係合部の曲面１８、１９、１１０と溝のリング状曲面２９、２１０、２１１との間に嵌め合いを形成する。
【００２５】
上述の実施例においては、第１のフランジの第２のリング状係合部が先端からリング状スリットに対し凸、凹、凸の連続したリング状曲面を有し、それに対応するように、第２のフランジのリング状の溝付き突起に設けられたリング状の溝が溝の底面から一方の側において溝に対し凸、凹、凸の連続したリング状曲面を有する構成によれば、２つの凸、凹、凸の長い曲面同士で接触させるものであるから、第１のフランジのリング状の突起と第２のフランジのリング状の溝付き突起とを互いに密着させるに十分な接触面積を確保することができ、十分な密封性と係合性即ち外れ難さを実現することができる。即ち、嵌合面を直線状に形成すれば係合部を溝に挿入することは容易となるが、係合部分に十分な接触面積を得ることができず、密封性、係合性に劣り、接触面積を増加させるため係合部、溝の内面を溝に対し凹に形成すると、係合部を溝に挿入する際係合部の先端が溝の開口部に当り、ここに引っ掛かって滑らかに溝内へ挿入し難くなる。この点、本発明によれば、第１のフランジの第２の係合部の先端部分がスリットに対し凸になっているため先端部分の幅を細く形成することができ、溝内に挿入し易く、挿入された後は前述のようにスムースに溝内に嵌り込む。しかも上述のように嵌合面に大きな接触面積を持たせることができ、密封性、係合性においても優れたものを得ることができ、排泄物、廃液に対して良好にシールを行い、外れに対しても強固である。
【００２６】
図５ａ、ｂ、ｃは、本発明の第１のフランジのリング状突起と第２のフランジのリング状溝付き突起のそれぞれ異なる実施例の断面図である。これらの実施例において、第１のフランジのリング状の突起が第１のリング状係合部、第２のリング状係合部及び両リング状係合部間に形成されたリング状スリット、第１のリング状係合部がリング状段付き係合部分を有すること、第２のフランジがリング状の溝付き突起を有し、その溝がリング状段付き係合部分を有し、第１のフランジのリング状の突起が第２のフランジのリング状の溝付き突起の溝に挿入されるよになっている点は前述の実施例と同様であり、これらの同等部分には同符号を付してある。
【００２７】
図５ａにおいて、第１のリング状係合部１１は、スリット１３と対向する先端１６からリング状段付き係合部分１５に至るまでスリット１３に対し凸のリング状曲面５１で形成され、第２のリング状係合部１２はスリット１３と対向する先端から、スリット１３に対し凹のリング状曲面５２、次いで凸のリング状曲面５３を介して薄肉のリング状部分５に連なるように形成されている。第２のフランジの溝付き突起２２の内面は同様に第１のフランジ４のリング状の突起７の外面に相応するように形成され、溝２４の底面２７から段付き係合部分２６に至るまで溝２４に対し凸のリング状曲面５４で形成され、他方の壁面は溝２４の底面２７から溝に対し凹のリング状曲面５５と、次いで溝に対し凸のリング状曲面５６とを介して溝開口部２１２に至るように形成されている。
【００２８】
図５ｂにおいて、第１のリング状係合部１１は、スリット１３と対向する先端１６からリング状段付き係合部分１５に至るまでスリット１３に対し凹のリング状曲面６１、次いで凸のリング状曲面６２、更に凹のリング状局面６３の連続した３曲面で形成され、第２のリング状係合部１２はスリット１３と対向する先端から、スリット１３に対し凸のリング状曲面６４、次いで凹のリング状曲面６５、更に凸のリング状曲面６６を介して薄肉のリング状部分５に連なるように形成されている。第２のフランジの溝付き突起２２の内面は同様に第１のフランジ４のリング状の突起７の外面に相応するように形成され、溝２４の底面２７から段付き係合部分２６に至るまで溝２４に対し凹のリング状曲面６７、次いで凸のリング状曲面６８、更に凹のリング状曲面６９の連続した３曲面で形成され、他方の壁面は溝２４の底面２７から溝に対し凸のリング状曲面６１０、次いで溝に対し凹のリング状曲面６１１、更に溝に対し凸のリング状局面６１２を介して溝開口部２１２に至るように形成されている。
【００２９】
図５ｃにおいて、第１のリング状係合部は、スリットと対向する先端からリング状段付き係合部分に至るまでスリットに対し凹のリング状曲面７１で形成され、第２のリング状係合部はスリットと対向する先端から、スリットに対し凹のリング状曲面７２、次いで凸のリング状曲面７３、更に凹のリング状曲面７４を介して薄肉のリング状部分５に連なるように形成されている。第２のフランジの溝付き突起２２の内面は同様に第１のフランジ４のリング状の突起７の外面に相応するように形成され、溝２４の底面２７から段付き係合部分２６に至るまで溝２４に対し凹のリング状曲面７５で形成され、他方の壁面は溝２４の底面２７から溝に対し凹のリング状曲面７６、次いで溝に対し凸のリング状曲面７７、更に溝に対し凹のリング状曲面７８を介して溝開口部２１２に至るように形成されている。
【００３０】
図５に示した実施例についても前述の実施例の各部分の大きさについて述べた種々の条件は成立する。これらの形状によれば、第１のフランジのリング状の突起と第２のフランジのリング状の溝付き突起の溝とを互いに密着させるのに十分な接触面積を確保でき、嵌合部分の密封性が向上する。
【００３１】
図６は第１のフランジの異なる実施例の、ａは背面図、ｂはそのＢ-Ｂ線に沿う拡大断面図である。第１図と同等部分には同符号を付してある。第１のフランジ４のつば部８は、その下面に滑り止め８１、その外周縁につまみ部分８２を設けることができる。滑り止め８１は、第１のフランジ４の開口８３を中心に同心円状に形成したリング状凸部として、つば部の下面、即ち接皮側に複数設けることができる。滑り止めの形状としてはこれ以外に、つば部の下面に凹凸を形成するものであれば特に限定されず、点状、筋状等フランジ成形の際に一体化したものとして設けることができる。また、ゴムのようなエラストマーを上記のような適当な形状でつば部の下面に、接着、熱溶着等でも設置可能である。つまみ部分８２は、つば部の外周縁に第２のフランジ２１のつまみ片２５に対応する位置に設けるのが好ましく、こうすることで嵌合の際にフランジの位置合わせが容易になる。また、このつまみ部分はつば部の下面と同様に下面に滑り止め８４を設けることができる。このように、第１のフランジのつば部とつまみ部分の下面に滑り止めを設けることで、フランジの操作時に手が滑り難く、フランジの嵌合、取外しがやり易くなる。なお、図６の実施例では滑り止めを第１のフランジのつば部とつまみ部分の下面のみに設けた例を示したが、これと同様な方法で、滑り止めを第１のフランジのつば部とつまみ部分の上面に設けることもできる。
【００３２】
第１、第２のフランジとしては、エチレン・アクリル酸エチルコポリマー、エチレン・酢酸ビニルコポリマー、エチレン・アクリル酸メチルコポリマー、エチレン・メタクリル酸メチルコポリマー、ポリエチレン、塩化ビニル、エチレン・アクリル酸コポリマー、エチレン・メタクリル酸コポリマー、塩素化ポリエチレン等を用いることができる。特に好適なものとしては、本出願人により提案されたメタロセン触媒を使用して製造したポリオレフィン系プラスチック(特開平10−192318号公報)などを用いることができる。
【００３３】
第１のフランジと接皮部材との結合は、第1のフランジ側から熱溶着する方法、接皮部材の一部を形成するフィルムと第１のフランジとを高周波ウエルダー又は超音波ウエルダーによって溶着し、次いでフィルムを接皮部材に貼付する方法、接着剤による方法などがある。第２のフランジと袋体との結合にも同様に、熱溶着、高周波溶着、超音波溶着、接着剤による接着等を用いることができる。なお、袋体の代りに用途に応じてキャップ、栓などを設けてもよい。
【００３４】
接皮部材には従来外科用吻合装置に使用されてきた種々の素材を用いることができる。即ち、親水性ポリマーと疎水性ポリマーとからなる皮膚保護剤を発泡シート又はフィルム又は不織布に貼り合わせたもの、このように形成した接皮部材の非接皮側の最外周縁に装着状態において周囲の皮膚との間に跨り得るようにリング状の粘着補強テープを設けたもの、発泡シート又はフィルム又は不織布に粘着剤を塗布したものを使用することができる。発泡シート、フィルム、不織布としては、ポリエチレン、エチレン・酢酸ビニルコポリマー、エチレン・アクリル酸エチルコポリマー、エチレン・アクリル酸メチルコポリマー、ポリプロピレン、塩化ビニル、ポリエステル、ナイロン等の材料を単独で、又は組み合わせて使用することができる。
【００３５】
上述の例では第１のフランジは接皮部材に取り付け、第２のフランジは袋体に取り付けたが、その逆に、即ち第１のフランジは袋体に取り付け、第２のフランジは接皮部材に取り付けるようにしてもよい。また上述の例では第１のフランジの第１のリング状係合部は開口に対し外側に、第２のリング状係合部は開口側に位置するものを示したが、その逆も可能である。しかしながら、開口に近い側に嵌合を司る第２のリング状係合部を位置せしめたほうが排泄物の漏れを抑制する機能面から有利である。
【００３６】
【発明の効果】
本発明によれば、以下のような効果を得ることができる。
▲１▼ 第１のフランジの突起をリング状スリットを介して第１のリング状係合部と第２のリング状係合部とに分け、第１のリング状係合部にはリング状段付き係合部分により主として係合機能、第２のリング状係合部にはスリット側への変形による嵌合機能を持たせることにより、両フランジ間の気密結合を可能にし、汚物の漏れ防止を確実にした。
▲２▼ 第１のフランジと第２のフランジとの間に１つのリング状の突起と１つのリング状の溝付き突起とで結合機構を形成することにより、両フランジの突起と溝とを対向させたとき、リング状の突起がリング状の溝内に前後に滑ることなく嵌り込むため、両フランジの位置合わせが極めて容易である。
▲３▼ 両フランジ間に１組のリング状の突起と溝付き突起とを設けるだけであるから、両フランジの外周が大とならず、装着時に違和感を抱くことがない。
▲４▼ 両フランジの外周を従来より小さくできるから、一方のフランジに下側から指を差込んで支えるためのつば部を設けても外周はそれほど大きくならない。
▲５▼ 両フランジの位置合わせ、両フランジの着脱が簡単となり、全般的に操作が容易となる。
【図面の簡単な説明】
【図１】本発明の実施例の、ａは第１のフランジを設置した接皮部材の正面図、ｂは第２のフランジを設置した袋体の背面図、ｃはａのC−C断面図、ｄはｂのD−D断面図である。
【図２】本発明の要部の拡大断面図である。
【図３】本発明の要部の拡大断面図である。
【図４】本発明の操作方法の説明図である。
【図５】ａ、ｂ、ｃはそれぞれ本発明の異なる実施例の要部の拡大断面図である。
【図６】本発明の第１のフランジの異なる実施例の、ａは背面図、ｂはそのＢ-Ｂ線に沿う拡大断面図である。
【符号の説明】
１接皮部材
２開口
３粘着層
４第１のフランジ
５リング状部分
６接皮部材の表面
７リング状の突起
８つば部
９フランジの最外周縁
１０切込み
１１第１のリング状係合部
１２第２のリング状係合部
１３リング状スリット
１４リング状係合部の末端部
１５リング状段付き係合部分
１６リング状係合部の先端
１７リング状曲面
１８リング状曲面
１９リング状曲面
１１０リング状曲面
１１２変曲点
２１第２のフランジ
２２リング状の溝付き突起
２３袋体
２４溝
２５つまみ片
２６リング状段付き係合部分
２７底面
２８リング状曲面
２９リング状曲面
２１０リング状曲面
２１１リング状曲面
２１２溝開口部
５１〜５６リング状曲面
６１〜６１２リング状曲面
７１〜７８リング状曲面
８１滑り止め
８２つまみ部分
８３第１のフランジの開口
８４滑り止め[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a surgical anastomosis device that is attached to an opening formed on the surface of a living body, takes out discharged matter from the living body, and introduces a therapeutic agent into the living body.
[0002]
[Prior art]
Surgery is performed for various diseases, and intestinal tracts, ureters, and other similar tubes are guided to the body surface, fistulas created on the surface of the living body, or wounds such as wounds formed on the surface of the living body by wounds. A so-called surgical anastomosis apparatus is mounted to accommodate various excrements and drainage discharged from the body and sometimes inject the liquid into the living body for treatment and washing. Prosthetic prosthesis and prosthetic bladder appliances are examples of this, but since this surgical anastomosis device treats filth discharged from the living body, the operation can be performed hygienically without touching the filth. It is required to be reliable so that filth does not leak during use, to be easily attached and detached, and to be directly attached to the surface of a living body, so that a good touch to the skin is required.
[0003]
In order to satisfy these requirements, various surgical anastomosis devices have been proposed in the past. Among them, a skin-contacting member that can be adhesively fixed around the opening of a living body as being relatively close to the above-mentioned requirements. And a first flange fixed to the non-skin side of the skin-contacting member, and a second flange detachable from the first flange, and fitted to the first flange and the second flange, respectively. An anastomosis device having a ring-shaped protrusion or groove capable of being proposed by the present applicant (Japanese Utility Model Publication No. 7-15542). In this anastomosis device, the first flange is always fixed around the opening of the living body with a skin member, and the first flange and the second flange are connected by a projection and a groove corresponding to the first flange, The excrement discharged from the opening is accommodated in a bag attached to the second flange, and when the excrement accumulates, the second flange is removed from the first flange, the excrement in the bag is removed, washed, and then reused. It is used or replaced with a new second flange. In some cases, the second flange can be changed from a bag type to a cap type.
[0004]
In this type of surgical anastomosis device, in order to prevent excrement from leaking during use, the connection structure between the protrusion and the corresponding groove is an important part related to reliability. Two protrusions and two corresponding grooves are provided. By providing a plurality of protrusions and corresponding grooves, the reliability of leakage is naturally enhanced by the connection structure of a set of protrusions and grooves, but by providing two protrusions and two corresponding grooves, the outer periphery of the flange can be reduced. growing. Further, when the first flange and the second flange are joined, an operation of pressing the circular ring-shaped fitting portions provided on both flanges is performed, but at that time, directly on the skin around the opening of the human body In order not to apply a pressing force, it is preferable to insert a finger between the first flange and the skin member so that the first flange can be sufficiently supported from the back side. The outer diameter of the flange is relatively large.
[0005]
  In this type of surgical anastomosis device, when positioning is performed to fit the fitting portions of both flanges, the opening of the living body is generally in the lower body, and the bag of the second flange overlaps the first flange. In addition, it is difficult to directly look at the fitting part, and it is often necessary to position the fitting part by hand, and it is difficult to determine the position. In order to solve this disadvantage, a flange portion is formed by the outer peripheral portion of the flange on the outer side of the fitting portion of one flange, and the flange portion reaches at least a part of the outermost peripheral edge of the fitting portion so that a finger enters. An anastomosis device having an incision has been proposed by the present applicant (utility model registration No. 2534783). According to this anastomosis device, the position of the fitting portion of the first flange can be clearly perceived by holding the finger with the notch on the outer periphery of the first flange, and the first flangeFlangeBy inserting a finger between the first flange and the skin member from the collar part, the first flange is supported by the finger from the back side, and both flanges are fitted without applying a compressive force to the periphery of the opening of the living body. The joints can be pressed together to fit together.
[0006]
In the conventional surgical anastomosis apparatus as described above, although the position of the fitting portion of both flanges can be accurately recognized, if there are two protrusions in the fitting portion of one flange, Engagement is not always easy in practice. For example, if there are two protrusions in the fitting part of one flange, it behaves like a surface even if there is a groove between the two protrusions, the bottom of the fitting part of the other flange slips and both Even if the shape of the two protrusions is not exactly the same, even if the shapes of the two protrusions are not the same, if the two protrusions are relatively close in size, they will slip when the two fitting parts are aligned, causing the position to shift slightly. If the groove is shifted by one and only that portion is inserted like a temporary fixing, it is necessary to remove the groove and perform the fitting operation again.
[0007]
From the viewpoint of reliability with respect to leakage of excrement, it is needless to say that two protrusions and two grooves are preferable for each fitting portion, but as described above, the flange becomes large and uncomfortable when worn. In addition, there is a problem that it is difficult to align both fitting portions. On the other hand, the conventional structure of the fitting portion having one protrusion is not sufficiently reliable for leakage, and the wearer cannot wipe out the anxiety about leakage of excrement.
[0008]
[Problems to be solved by the invention]
The problem to be solved by the present invention is to provide a surgical anastomosis device that can perform a fitting operation easily and quickly and has high reliability against leakage of excrement.
[0009]
[Means for Solving the Problems]
  In order to solve the above-mentioned problem, in the present invention, on one sideOneA first flange with a ring-shaped protrusion and on one sideOneA second flange having a ring-shaped grooved projection,
  The ring-shaped protrusion of the first flange isOneA first ring-shaped engagement portion;OneLocated between the second ring-shaped engaging portion and the first ring-shaped engaging portion and the second ring-shaped engaging portion.OneA ring-shaped slit, and the first ring-shaped engaging portion is a concave or convex ring-shaped curved surface with respect to the ring-shaped slit,Following that ring-shaped curved surface,It has a ring-shaped stepped engagement portion on the opposite side to the ring-shaped slit, and is formed thicker than the tip of the second ring-shaped engagement portion. The second ring-shaped engagement portion has a ring-shaped slit and Projecting to the opposite side, formed from a continuous ring-shaped curved surface of a convex ring-shaped curved surface and a concave ring-shaped curved surface with respect to the ring-shaped slit, and having a deformable ring-shaped fitting portion on the slit side,
  The ring-shaped grooved protrusion on the second flange allows the ring-shaped protrusion on the first flange to be inserted into the ring-shaped groove.And the inside of the groove corresponds to the outer shape of the ring-shaped protrusion of the first flange.The ring-shaped groove is formed in the ring-shaped stepped engagement portion that can engage with the ring-shaped stepped engagement portion of the first ring-shaped engagement portion of the first flange, and the first ring-shaped groove A concave or convex ring-shaped curved surface of the engaging portionSuitableA convex or concave ring-shaped curved surface, and a ring-shaped fitting portion of the second ring-shaped engagement portion of the first flangeSuitableFormed of a continuous ring-shaped curved surface of a concave ring-shaped curved surface and a convex ring-shaped curved surface, and has a ring-shaped fitting portion that can be fitted to the ring-shaped fitting portion of the second ring-shaped engaging portion. And
  The leading edge width of the ring-shaped protrusion of the first flange is formed smaller than the width of the groove opening of the ring-shaped grooved protrusion of the second flange;
  When the ring-shaped protrusion of the first flange is inserted into the groove of the ring-shaped grooved protrusion of the second flange, the first ring-shaped engaging portion of the ring-shaped protrusion of the first flange is the ring. The stepped engagement portion engages with the ring-shaped stepped engagement portion of the second flange;The ring-shaped slit of the first flange is narrowed,The second ring-shaped engagement portion of the ring-shaped protrusion of the first flange has its ring-shaped fitting portion pressed against the ring-shaped fitting portion of the second flange to form a fit,
  The first flange and the second flange are in contact with the ring-shaped projection or grooved projection of one of the flanges on the side opposite to the ring-shaped projection or projection of the other flange. Has a bag.
[0010]
In the present invention, the first ring-shaped engagement portion provided on the ring-shaped projection of the first flange is a concave ring-shaped curved surface with respect to the slit from the most distal portion to the ring-shaped stepped engagement portion, A convex ring-shaped curved surface, or a ring-shaped curved surface obtained by continuously combining concave and convex ring-shaped curved surfaces, and the second ring-shaped engaging portion The ring-shaped groove provided on the ring-shaped grooved projection of the second flange has a ring-shaped stepped engagement portion from the bottom surface of the groove. A concave ring-shaped curved surface, a convex ring-shaped curved surface, or a ring-shaped curved surface that is a continuous combination of concave and convex ring-shaped curved surfaces, and the opposite side of the groove-shaped stepped engagement portion from the bottom of the groove Convex ring-shaped curved surface and concave ring-shaped Preferably configured to have a ring-shaped curved surface in combination successively a plane.
[0011]
In the present invention, the first ring-shaped engagement portion provided on the ring-shaped protrusion of the first flange has a concave ring-shaped curved surface with respect to the slit extending from the most distal portion to the ring-shaped stepped engagement portion. The second ring-shaped engaging portion is formed so as to have a ring-shaped curved surface having a first convex shape with respect to the slit, then a concave shape with respect to the slit, and then with a second convex shape with respect to the slit. The ring-shaped groove provided on the ring-shaped grooved protrusion of the second flange has a ring-shaped curved surface that is concave with respect to the groove from the groove bottom surface to the ring-shaped stepped engagement portion, and the ring from the groove bottom surface. It is particularly advantageous to have a continuous ring-shaped curved surface on the opposite side of the stepped engagement portion with a first convexity for the groove, then a concave for the groove and then a second convex for the groove.
[0012]
In the present invention, the radial width of the most distal portions of the first and second ring-shaped engaging portions provided on the ring-shaped protrusion of the first flange is the opening end of the groove of the second flange. It is preferably smaller than the radial width of the portion.
[0013]
Furthermore, in the present invention, the depth of the ring-shaped slit provided on the ring-shaped protrusion of the first flange is the second with respect to the concave ring-shaped curved surface and the slit with respect to the slit of the second ring-shaped engaging portion. It is preferable to be shallower than the position of the inflection point existing at the transition portion with the convex ring-shaped curved surface.
[0014]
Further, in the present invention, it is preferable to provide a slip stopper on the flange portion of the first flange and further to provide a knob portion on the peripheral portion of the first flange.
[0015]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to examples shown in the drawings.
[0016]
FIG. 1 shows an embodiment of the present invention, in which a is a front view of a skin-contacting member provided with a first flange, b is a rear view of a bag body provided with a second flange, and c is a C-C of FIG. 1a. Sectional drawing which follows a line, d is sectional drawing which follows the DD line | wire of FIG. 1b. Reference numeral 1 denotes a skin contact member, which has a square shape, for example, and has an opening 2 at the center, and an adhesive layer 3 on the skin side. Reference numeral 4 denotes a first flange, which is fixed on the non-skin-side surface 6 of the skin member 1 by, for example, welding with a thin ring-shaped portion 5 and extends outward along the surface of the skin member 1. . A circular ring-shaped protrusion 7 is provided on the opposite side of the first flange 4 from the skin member 1, and a ring-shaped collar portion 8 is formed outside the ring-shaped protrusion 7, that is, on the outer peripheral edge of the flange 4. The ring-shaped collar portion 8 extends outward substantially parallel to the skin member 1 and reaches the outermost peripheral edge 9 of the flange 4. The first flange 4 further includes an incision 10 formed by cutting the ring-shaped collar portion 8 in a straight line on the upper side in the mounted state of the ring-shaped collar portion 8. Details of the ring-shaped protrusion 7 will be described later.
[0017]
Reference numeral 21 denotes a second flange, which has a circular ring-shaped grooved protrusion 22 on one side, that is, a skin-contacting member side, and a bag body 23 on the other side, in the groove 24 of the ring-shaped grooved protrusion 22. By inserting the ring-shaped protrusion 7 of the first flange, the protrusion 7 and the groove 24 are hermetically coupled. Reference numeral 25 denotes a knob piece added to make it easier to hold the second flange 21. Details of the ring-shaped grooved protrusion 22 will be described later.
[0018]
2 is an enlarged cross-sectional view of the main part of the embodiment shown in FIG. 1, wherein a is the main part of the second flange, b is the main part of the first flange, and c is the first flange and the second flange. Are shown, and the same parts as those in FIG. The ring-shaped protrusion 7 of the first flange 4 is a ring-shaped slit formed between the first ring-shaped engaging portion 11, the second ring-shaped engaging portion 12, and both the ring-shaped engaging portions 11, 12. 13. The first ring-shaped engagement portion 11 has a ring-shaped stepped engagement portion 15 at the end portion 14 and is recessed with respect to the slit 13 from the tip 16 facing the slit 13 to the ring-shaped stepped engagement portion 15. The ring-shaped curved surface 17 is formed. The second ring-shaped engagement portion 12 that faces the first ring-shaped engagement portion 11 has a first convex ring-shaped curved surface 18 with respect to the slit 13 and then the slit 13 from the tip that faces the slit 13. It is formed so as to continue to the thin ring-shaped portion 5 via the concave ring-shaped curved surface 19 and then the second convex ring-shaped curved surface 110 with respect to the slit 13.
[0019]
The inner surface of the ring-shaped grooved protrusion 22 of the second flange 21 is formed to correspond to the outer surface of the ring-shaped protrusion 7 of the first flange 4. The groove 24 has a ring-shaped stepped engagement portion 26 on one wall surface, and is formed with a ring-shaped curved surface 28 that is concave with respect to the groove 24 from the bottom surface 27 of the groove 24 to the stepped engagement portion 26. The wall surface of the groove 24 includes a first ring-shaped curved surface 29 that is convex from the bottom surface 27 of the groove 24 to the groove, a ring-shaped curved surface 210 that is concave to the groove, and a ring-shaped curved surface 211 that is second convex to the groove. It is formed so as to reach the groove opening 212 via. Each of these ring-shaped curved surfaces has a shape substantially corresponding to each of the ring-shaped curved surfaces 18, 19, 110 of the second ring-shaped engaging portion 12 of the first flange.
[0020]
As shown in FIG. 2c, when the ring-shaped protrusion 7 of the first flange is inserted into the groove 24 of the ring-shaped grooved protrusion 22 of the second flange, the first ring-shaped engagement of the first flange. The ring-shaped stepped engagement portion 15 of the portion 11 and the stepped engagement portion 26 of the second flange are engaged, while the ring-shaped slit 13 of the first flange is somewhat narrowed, The ring-shaped curved surfaces 18, 19, and 110 of the second ring-shaped engaging portion 12 are respectively fitted to the ring-shaped curved surfaces 29, 210, and 211 of the second flange, and the fitting curved surface is airtight between the flanges. By forming an engagement, the engagement action between the ring-shaped stepped engagement portion 15 of the ring-shaped projection 7 of the first flange and the ring-shaped stepped engagement portion 26 of the ring-shaped grooved projection 22 of the second flange Ring-shaped protrusion 7 and ring-shaped grooved protrusion 22 They are coupled so as not to come off.
[0021]
FIGS. 3a and 3b are cross-sectional views showing enlarged portions of the ring-shaped protrusions of the first flange and the ring-shaped grooved protrusions of the second flange shown in FIG. The same parts as those in FIG. 2 are denoted by the same reference numerals. The radial maximum thickness p of the first ring-shaped engaging portion 11 of the ring-shaped protrusion 7 of the first flange and the radial thickness o of the distal end of the second ring-shaped engaging portion 12 are p> o. Therefore, it is advantageous to determine the value of p / o to be 1.5 or more. Furthermore, it is advantageous to determine the relationship so that the maximum thickness q in the radial direction of the second ring-shaped engagement portion 12 is in the relationship of p> q> o. Further, the thickness n in the radial direction from the slit-side end portion of the ring-shaped stepped engagement portion 15 of the first flange to the ring-shaped slit 13 is advantageously determined in a relationship of n> o with the above-described o. . Due to the mutual relationship between the thicknesses, the second ring-shaped engagement portion 12 is easily deformed, and the first ring-shaped engagement portion is not easily deformed toward the slit side, and the protrusion between the flanges 4 and 21 is not deformed. Insertion into the groove is facilitated, and a mutual pressing force for fitting can be advantageously applied between the opposing surfaces of the protrusion and the groove. It is also possible to satisfy q ≧ p by appropriately changing the curvature of the concave ring-shaped curved surface with respect to the slit of the second ring-shaped engaging portion 12 of the first flange. In this case, the radial thickness of the second ring-shaped engaging portion is slightly increased.
[0022]
The angles of the ring-shaped stepped engagement portions 15 and 26 of both flanges preferably extend substantially in the horizontal direction in the state shown in the drawing, and if deeper than that, it is difficult to manufacture, and it is difficult to engage and disengage. It is easy to come off when it is shallow.
[0023]
The depth r of the slit 13 of the ring-shaped protrusion 7 of the first flange 4 is determined between the concave ring-shaped curved surface 19 of the second ring-shaped engaging portion 12 and the convex second ring-shaped curved surface 110 that follows. It is advantageous to be shallower than the depth s of the inflection point 112 in between. When r is equal to or greater than s, the degree of engagement and fitting decreases. If the width t of the slit 13 is set to such a dimension that the slit is contracted so that the insertion can be performed when the ring-shaped protrusion 7 of the first flange is inserted into the ring-shaped grooved protrusion 22 of the second flange. Well, when the width is increased, the second ring-shaped engagement portion is not pressed by the second ring-shaped engagement portion against the wall surface of the groove of the second flange when inserted, or the second ring-shaped engagement portion is It must not be so deformed that it disengages. In order to maintain such a fitting state, in addition to the slit width t and the depth r described above, when the radial width w of the ring-shaped curved surface 28 with respect to the groove of the second flange is fitted, It is necessary that the width of the projection portion of the first flange facing the ring-shaped curved surface 28 is smaller than the width (= p + u) in a non-fitted state. When w is larger than p + u, the tip end of the second engaging portion 12 of the first flange does not deform, so that a sufficient pressing force is not generated to closely contact each other, and the sealing performance is insufficient. Further, the leading edge width u of the ring-shaped protrusion 7 of the first flange needs to be smaller than the width v of the opening 212 of the groove 24 of the ring-shaped grooved protrusion of the second flange.
[0024]
Next, an operation method of the surgical anastomosis apparatus of the present invention will be described with reference to FIG. For the convenience of illustration, only the left half of each flange is shown, but the right half is the same. As shown in a, the skin contact member 1 having the first flange 4 is adhered to the skin surface 42 of the living body with the adhesive layer 3 so that the opening 2 thereof coincides with the opening 41 of the living body, and the second The ring-shaped grooved protrusion 22 of the second flange 21 is substantially opposed to the ring-shaped protrusion 7 of the first flange 4 with the notch 10 (see FIG. 1) as a guide. Next, when the groove opening 212 of the ring-shaped grooved protrusion 22 of the second flange 21 is placed on the ring-shaped protrusion 7 of the first flange 4 as shown in b, the ring shape of the first flange 4 Since the width of the tip of the protrusion 7 is smaller than the width of the groove opening 212 of the grooved protrusion 22, it immediately fits into the groove opening 212 of the second flange 21. In this state, as shown in c, when a finger 43 is inserted and supported under the flange portion 8 of the first flange 4 and a pressing force is applied to the second flange 21 with the finger 44 from above, first the second flange The ring-shaped curved surface 211 of the groove 21 rides from the ring-shaped curved surface 18 to the curved surface 19 of the second ring-shaped engaging portion 12 of the first flange 4, while the tip of the stepped engaging portion 26 of the second flange 21 is on the tip. When the portion extending to the first ring-shaped engaging portion 11 of the first flange 4 rides on the first ring-shaped engaging portion 11 and is further pushed in, the ring-shaped curved surface 18 has a concave relationship with the ring-shaped curved surface 211, so that it is shown in d. Thus, the ring-shaped curved surfaces 210 and 29 of the second flange 21 slide down on the ring-shaped curved surface 18 and the curved surface 19 of the second ring-shaped engaging portion 12 of the first flange 4 sequentially, and in the final stage, FIG. As shown, there are many ring-shaped slits 13 The ring-shaped stepped engagement portion 26 gets over the ring-shaped stepped engagement portion 15 and engages with the second ring-shaped engagement portion 12 by the repulsive force. Fits are formed between the curved surfaces 18, 19, 110 of the ring-shaped engaging portion and the ring-shaped curved surfaces 29, 210, 211 of the groove.
[0025]
  In the above-described embodiment, the second ring-shaped engaging portion of the first flange has a continuous ring-shaped curved surface that is convex, concave, and convex from the tip to the ring-shaped slit, The ring-shaped groove provided on the ring-shaped grooved protrusion of the flange 2 is a continuous ring-shaped curve that is convex, concave and convex with respect to the groove on one side from the bottom surface of the grooveFaceSince the two convex, concave, and convex long curved surfaces are brought into contact with each other, the ring-shaped protrusion of the first flange and the ring-shaped grooved protrusion of the second flange are brought into close contact with each other. A sufficient contact area can be ensured, and sufficient sealing performance and engagement, that is, difficulty of disengagement can be realized. That is, if the mating surface is formed in a straight line, it becomes easy to insert the engaging portion into the groove, but a sufficient contact area cannot be obtained at the engaging portion, and the sealing property and the engaging property are poor. If the inner surface of the engaging portion and the groove are formed to be concave with respect to the groove in order to increase the contact area, the tip of the engaging portion hits the opening of the groove when the engaging portion is inserted into the groove, and is caught and smoothed. It becomes difficult to insert into the groove. In this respect, according to the present invention, since the tip end portion of the second engaging portion of the first flange is convex with respect to the slit, the width of the tip portion can be narrowed and inserted into the groove. Easily fits into the groove after insertion as described above. Moreover, as described above, a large contact area can be provided on the fitting surface, and an excellent sealing property and engagement property can be obtained. Is also strong.
[0026]
FIGS. 5a, b and c are cross-sectional views of different embodiments of the ring-shaped protrusions of the first flange and the ring-shaped grooved protrusions of the second flange of the present invention. In these embodiments, the ring-shaped protrusion of the first flange has a ring-shaped slit formed between the first ring-shaped engaging portion, the second ring-shaped engaging portion, and both ring-shaped engaging portions, The first ring-shaped engagement portion has a ring-shaped stepped engagement portion, the second flange has a ring-shaped grooved projection, the groove has a ring-shaped stepped engagement portion, The ring-shaped projections of the flange of the second flange are inserted into the grooves of the ring-shaped grooved projections of the second flange, as in the previous embodiment. It is attached.
[0027]
In FIG. 5 a, the first ring-shaped engagement portion 11 is formed with a ring-shaped curved surface 51 that is convex with respect to the slit 13 from the tip 16 facing the slit 13 to the ring-shaped stepped engagement portion 15. The ring-shaped engaging portion 12 is formed so as to continue from the tip facing the slit 13 to the thin ring-shaped portion 5 through a concave ring-shaped curved surface 52 and then a convex ring-shaped curved surface 53 with respect to the slit 13. Yes. Similarly, the inner surface of the grooved protrusion 22 of the second flange is formed so as to correspond to the outer surface of the ring-shaped protrusion 7 of the first flange 4, from the bottom surface 27 of the groove 24 to the stepped engagement portion 26. The groove 24 is formed with a ring-shaped curved surface 54 that is convex with respect to the groove 24, and the other wall surface is formed through a ring-shaped curved surface 55 that is concave with respect to the groove from the bottom surface 27 of the groove 24 and then a ring-shaped curved surface 56 that is convex with respect to the groove. It is formed so as to reach the opening 212.
[0028]
In FIG. 5 b, the first ring-shaped engaging portion 11 has a ring-shaped curved surface 61 that is concave with respect to the slit 13 from the tip 16 facing the slit 13 to the ring-shaped stepped engaging portion 15, and then a convex ring-shaped The second ring-shaped engagement portion 12 is formed from a tip facing the slit 13 and has a convex ring-shaped curved surface 64 with respect to the slit 13 and then a concave shape. The ring-shaped curved surface 65 and the convex ring-shaped curved surface 66 are connected to the thin ring-shaped portion 5. Similarly, the inner surface of the grooved protrusion 22 of the second flange is formed so as to correspond to the outer surface of the ring-shaped protrusion 7 of the first flange 4, from the bottom surface 27 of the groove 24 to the stepped engagement portion 26. A concave ring-shaped curved surface 67 is formed with respect to the groove 24, then a convex ring-shaped curved surface 68, and further a concave ring-shaped curved surface 69, and the other wall surface is convex from the bottom surface 27 of the groove 24 to the groove. It is formed so as to reach the groove opening 212 through a ring-shaped curved surface 610, a ring-shaped curved surface 611 that is concave with respect to the groove, and a ring-shaped curved surface 612 that is convex with respect to the groove.
[0029]
In FIG. 5c, the first ring-shaped engaging portion is formed with a ring-shaped curved surface 71 that is concave with respect to the slit from the tip facing the slit to the ring-shaped stepped engaging portion, and the second ring-shaped engaging portion. The portion is formed so as to continue from the tip facing the slit to the thin ring-shaped portion 5 via a concave ring-shaped curved surface 72, then a convex ring-shaped curved surface 73, and a concave ring-shaped curved surface 74 with respect to the slit. Yes. Similarly, the inner surface of the grooved protrusion 22 of the second flange is formed so as to correspond to the outer surface of the ring-shaped protrusion 7 of the first flange 4, from the bottom surface 27 of the groove 24 to the stepped engagement portion 26. It is formed with a ring-shaped curved surface 75 that is concave with respect to the groove 24, and the other wall surface is a ring-shaped curved surface 76 that is concave with respect to the groove from the bottom surface 27 of the groove 24, and then a ring-shaped curved surface 77 that is convex with respect to the groove. It is formed so as to reach the groove opening 212 through the ring-shaped curved surface 78.
[0030]
Also for the embodiment shown in FIG. 5, various conditions described regarding the size of each part of the above-described embodiment are satisfied. According to these shapes, it is possible to secure a sufficient contact area for bringing the ring-shaped protrusion of the first flange and the groove of the ring-shaped grooved protrusion of the second flange into close contact with each other. Improves.
[0031]
FIG. 6 is a rear view of a different embodiment of the first flange, and b is an enlarged sectional view taken along line BB. The same parts as those in FIG. 1 are denoted by the same reference numerals. The flange portion 8 of the first flange 4 can be provided with a non-slip 81 on its lower surface and a knob portion 82 on its outer periphery. A plurality of anti-slip 81 can be provided on the lower surface of the collar portion, that is, on the skin side, as a ring-shaped convex portion formed concentrically around the opening 83 of the first flange 4. In addition to this, the shape of the non-slip is not particularly limited as long as it forms irregularities on the lower surface of the collar portion, and can be provided as an integral part in the case of flange formation such as a dot shape or a streak shape. Further, an elastomer such as rubber can be installed on the lower surface of the collar portion in an appropriate shape as described above by adhesion, heat welding, or the like. The knob portion 82 is preferably provided at a position corresponding to the knob piece 25 of the second flange 21 on the outer peripheral edge of the collar portion, which facilitates the positioning of the flange during fitting. Further, this knob portion can be provided with a non-slip 84 on the lower surface in the same manner as the lower surface of the collar portion. Thus, by providing a slip stopper on the flange portion of the first flange and the lower surface of the knob portion, it is difficult for the hand to slip when the flange is operated, and the flange can be easily fitted and removed. In the embodiment of FIG. 6, an example in which the slip stopper is provided only on the flange portion of the first flange and the lower surface of the knob portion is shown, but the slip stopper is provided in the same manner as this. It can also be provided on the upper surface of the knob portion.
[0032]
The first and second flanges include ethylene / ethyl acrylate copolymer, ethylene / vinyl acetate copolymer, ethylene / methyl acrylate copolymer, ethylene / methyl methacrylate copolymer, polyethylene, vinyl chloride, ethylene / acrylic acid copolymer, ethylene / acrylic acid copolymer, A methacrylic acid copolymer, chlorinated polyethylene, etc. can be used. Particularly preferred is a polyolefin plastic produced by using the metallocene catalyst proposed by the present applicant (Japanese Patent Laid-Open No. 10-192318).
[0033]
The first flange and the skin member are joined by a method of heat welding from the first flange side, a film forming a part of the skin member and the first flange are welded by a high frequency welder or an ultrasonic welder. Then, there are a method of sticking the film to the skin contact member, a method using an adhesive, and the like. Similarly, heat welding, high frequency welding, ultrasonic welding, bonding with an adhesive, or the like can be used for bonding the second flange and the bag. In addition, you may provide a cap, a stopper, etc. according to a use instead of a bag.
[0034]
Various materials that have been used in conventional surgical anastomosis devices can be used for the skin contact member. That is, a skin protective agent composed of a hydrophilic polymer and a hydrophobic polymer is bonded to a foam sheet, film or non-woven fabric. What provided the ring-shaped adhesion reinforcement tape so that it may straddle between the skin of this, and what apply | coated the adhesive to the foam sheet or film, or the nonwoven fabric can be used. For foam sheets, films, and non-woven fabrics, materials such as polyethylene, ethylene / vinyl acetate copolymer, ethylene / ethyl acrylate copolymer, ethylene / methyl acrylate copolymer, polypropylene, vinyl chloride, polyester, and nylon are used alone or in combination. can do.
[0035]
In the above example, the first flange is attached to the skin member, and the second flange is attached to the bag body. Conversely, the first flange is attached to the bag body, and the second flange is the skin member. You may make it attach to. In the above example, the first ring-shaped engagement portion of the first flange is located outside the opening, and the second ring-shaped engagement portion is located on the opening side, but the reverse is also possible. is there. However, it is more advantageous in terms of the function of suppressing the excrement leakage to position the second ring-shaped engaging portion that controls fitting on the side close to the opening.
[0036]
【The invention's effect】
According to the present invention, the following effects can be obtained.
(1) The projection of the first flange is divided into a first ring-shaped engaging portion and a second ring-shaped engaging portion through a ring-shaped slit, and the first ring-shaped engaging portion has a ring-shaped step. Engagement function is mainly provided by the attached engagement part, and the second ring-shaped engagement part is provided with a fitting function by deformation to the slit side, thereby enabling airtight coupling between both flanges and preventing leakage of dirt. Secured.
(2) By forming a coupling mechanism with one ring-shaped protrusion and one ring-shaped grooved protrusion between the first flange and the second flange, the protrusions on both flanges face each other. When this is done, the ring-shaped protrusion fits into the ring-shaped groove without sliding back and forth, so that the positioning of both flanges is extremely easy.
(3) Since only a pair of ring-shaped projections and grooved projections are provided between both flanges, the outer circumference of both flanges does not become large, and there is no sense of incongruity during mounting.
(4) Since the outer peripheries of both flanges can be made smaller than before, even if a flange is provided on one flange to support by inserting a finger from below, the outer perimeter is not so large.
(5) Positioning of both flanges and attachment / detachment of both flanges are easy, and operation is generally easy.
[Brief description of the drawings]
BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a front view of a skin-contacting member provided with a first flange, b is a rear view of a bag body provided with a second flange, and FIG. Drawing d is a DD sectional view of b.
FIG. 2 is an enlarged cross-sectional view of a main part of the present invention.
FIG. 3 is an enlarged cross-sectional view of a main part of the present invention.
FIG. 4 is an explanatory diagram of an operation method of the present invention.
FIGS. 5a, 5b and 5c are enlarged sectional views of essential parts of different embodiments of the present invention.
FIG. 6 is a rear view of a different embodiment of the first flange of the present invention, and b is an enlarged cross-sectional view taken along the line BB.
[Explanation of symbols]
1 Skin contact material
2 opening
3 Adhesive layer
4 First flange
5 Ring-shaped part
6 Surface of skin contact member
7 Ring-shaped protrusion
8 collar
9 Outermost edge of flange
10 notches
11 1st ring-shaped engaging part
12 2nd ring-shaped engaging part
13 Ring-shaped slit
14 End of the ring-shaped engaging part
15 Ring-shaped stepped engagement part
16 Tip of ring-shaped engaging part
17 Ring-shaped curved surface
18 Ring-shaped curved surface
19 Ring-shaped curved surface
110 Ring-shaped curved surface
112 Inflection point
21 Second flange
22 Ring-shaped grooved protrusion
23 bags
24 groove
25 Knob
26 Ring-shaped stepped engagement part
27 Bottom
28 Ring-shaped curved surface
29 Ring-shaped curved surface
210 Ring-shaped curved surface
211 Ring-shaped curved surface
212 Groove opening
51-56 Ring-shaped curved surface
61-612 Ring-shaped curved surface
71-78 Ring-shaped curved surface
81 Non-slip
82 Knob part
83 Opening of the first flange
84 Non-slip

Claims

A first flange having one ring-shaped protrusion on one side and a second flange having one ring-shaped grooved protrusion on one side;
The ring-shaped protrusion of the first flange includes one first ring-shaped engagement portion, one second ring-shaped engagement portion, the first ring-shaped engagement portion, and the second ring-shaped engagement. A ring-shaped slit positioned between the ring-shaped slit, the first ring-shaped engaging portion is a concave or convex ring-shaped curved surface with respect to the ring-shaped slit, and the ring-shaped curved surface; A ring-shaped stepped engagement portion on the opposite side of the slit and formed thicker than the tip of the second ring-shaped engagement portion. The second ring-shaped engagement portion is opposite to the ring-shaped slit. Projecting to the side, formed from a continuous ring-shaped curved surface of a convex ring-shaped curved surface and a concave ring-shaped curved surface with respect to the ring-shaped slit, and having a deformable ring-shaped fitting portion on the slit side,
The ring-shaped grooved protrusion of the second flange allows the ring-shaped protrusion of the first flange to be inserted into the ring-shaped groove , and the groove has the outer surface shape of the ring-shaped protrusion of the first flange. The ring-shaped groove is formed correspondingly , and the ring-shaped groove has a ring-shaped stepped engagement portion that can engage with the ring-shaped stepped engagement portion of the first ring-shaped engagement portion of the first flange, and the first A concave or convex ring-shaped curved surface corresponding to the concave or convex ring-shaped curved surface of the ring-shaped engaging portion, and a concave corresponding to the ring-shaped fitting portion of the second ring-shaped engaging portion of the first flange. A ring-shaped curved surface formed of a continuous ring-shaped curved surface and a convex ring-shaped curved surface, and having a ring-shaped fitting portion that can be fitted to the ring-shaped fitting portion of the second ring-shaped engaging portion;
The leading edge width of the ring-shaped protrusion of the first flange is formed smaller than the width of the groove opening of the ring-shaped grooved protrusion of the second flange;
When the ring-shaped protrusion of the first flange is inserted into the groove of the ring-shaped grooved protrusion of the second flange, the first ring-shaped engaging portion of the ring-shaped protrusion of the first flange is the ring. The ring-shaped stepped engagement portion engages the ring-shaped stepped engagement portion of the second flange, the ring-shaped slit of the first flange is narrowed, and the second ring of the ring-shaped protrusion of the first flange The ring-shaped engaging part is pressed against the ring-shaped fitting part of the second flange to form a fit,
The first flange and the second flange are in contact with the ring-shaped projection or grooved projection of one of the flanges on the side opposite to the ring-shaped projection or projection of the other flange. A surgical anastomosis device having a bag.

The first ring-shaped engaging portion provided on the ring-shaped protrusion of the first flange has a concave ring-shaped curved surface and a convex ring-shaped curved surface with respect to the slit from the most distal portion to the ring-shaped stepped engaging portion. Or a ring-shaped curved surface obtained by continuously combining concave and convex ring-shaped curved surfaces, and the second ring-shaped engaging portion has a convex ring-shaped curved surface and a concave ring-shaped curved surface with respect to the slit from the most advanced portion. The ring-shaped groove provided on the ring-shaped grooved projection of the second flange is in contrast to the groove extending from the groove bottom surface to the ring-shaped stepped engagement portion. Convex ring-shaped curved surface, convex ring-shaped curved surface, or ring-shaped curved surface that is a combination of concave and convex ring-shaped curved surfaces, and convex from the bottom of the groove to the opposite side of the ring-shaped stepped engagement portion A ring-shaped curved surface and a concave ring-shaped curved surface Having a combined ring curved surgical anastomosis device of claim 1, wherein.

The first ring-shaped engagement portion provided on the ring-shaped protrusion of the first flange has a concave ring-shaped curved surface with respect to the slit extending from the most distal portion to the ring-shaped stepped engagement portion, The ring-shaped engagement portion of the second flange has a continuous ring-shaped curved surface having a first convexity with respect to the slit, then a concave with respect to the slit, and then with a second convexity with respect to the slit. The ring-shaped groove provided on the groove-shaped projection is concave with respect to the groove extending from the groove bottom surface to the ring-shaped stepped engagement portion, and opposite the ring-shaped stepped engagement portion from the groove bottom surface. 3. The surgical anastomosis device according to claim 1, further comprising a ring-shaped curved surface having a first convexity with respect to the groove, a concave with respect to the groove, and a second convex with respect to the groove.

The radial width of the foremost portion of the first and second ring-shaped engaging portions provided on the ring-shaped protrusion of the first flange is the radial width of the open end portion of the groove of the second flange. The surgical anastomosis device according to any one of claims 1 to 3, wherein the surgical anastomosis device is smaller.

The depth of the ring-shaped slit provided on the ring-shaped protrusion of the first flange is a ring-shaped curved surface that is concave with respect to the slit of the second ring-shaped engaging portion and a ring-shaped curved surface that is second convex with respect to the slit. The surgical anastomosis device according to any one of claims 1 to 4, wherein the surgical anastomosis device is shallower than the position of the inflection point existing at the transition portion.

The surgical anastomosis device according to any one of claims 1 to 5, wherein a slip stopper is provided on a flange portion of the first flange.

The surgical anastomosis device according to any one of claims 1 to 6, wherein a knob portion is provided on a peripheral portion of the first flange.