JP2004049641A

JP2004049641A - Membrane fixing system

Info

Publication number: JP2004049641A
Application number: JP2002212890A
Authority: JP
Inventors: Yasujiro Uchiyama; 内山　靖二郎
Original assignee: Kawasumi Laboratories Inc
Current assignee: SB Kawasumi Laboratories Inc
Priority date: 2002-07-22
Filing date: 2002-07-22
Publication date: 2004-02-19

Abstract

PROBLEM TO BE SOLVED: To provide a membrane fixing system that can surly fix a membrane to a fixed section and can be decomposed and absorbed safely in human body and can realize safer medical treatment, because the system uses a biodegradable macromolecule as the components of support pins and expansion pipes. SOLUTION: This membrane fixing system (1, 1A, and 1B) is constituted of at least the support pins (2, 2A, and 2B) and expansion pipes (11 and 11B). Each support pin (2, 2A, and 2B) is constituted of a front end section (3) and a column section (5) and has a step section (4) formed between the sections (3) and (5). On the outer periphery of the column section (5), a plurality of projecting parts (6, 6A, and 6B) are formed. Each expansion pipe (11 and 11B) has first and second expanded sections (12 and 14) and is formed to contract in the lengthwise direction of the pipe (11 and 11B) in a state that the outside diameter of the pipe (11 and 11B) when the pipe (11 and 11B) is contracted becomes larger than that of the pipe (11 and 11B) before the pipe (11 and 11B) is contracted. COPYRIGHT: (C)2004,JPO

Description

【０００１】
【発明の属する技術分野】
本発明は、膜等を直接接着することが不可能な被接着部（被固定部ともいう）、例えば表面が濡れた被接着部（被固定部）に膜を固定する為の膜固定システムに関する。
【０００２】
【従来技術及び発明が解決しようとする課題】
膜を固定する方法として、ネジ、ピン（釘）、または接着剤等により行う方法がある。
現在、接着剤等により膜等を直接接着することが不可能な被接着部（被固定部）の表面に膜を固定するには、画鋲や釘、ネジ等を打ち込む方法が採用されている。しかしながら、小さな膜に関しては、その留め位置、留め具も小さく制限される為、操作が極めて困難なものになる。特に被接着部（被固定部）が固くて、接着不能な場合、ネジがねじ切れたり釘が途中で折れやすい等操作が困難であった。
【０００３】
現在、骨再生医療用具として、スキャホールド、膜形状のものが使用されている。使用部位によって適正形状は異なるが、膜形状のそれについては、その固定方法が問題となっている。一般的には、骨欠損部を覆った骨再生誘導膜の端部に骨と一緒に微小穴を開け、この部分に骨ピン、骨ネジ、リベット等の固定用具をねじ込むことで、膜を固定している。
しかし、その穴寸法は、径１．０×深さ５〜１０ｍｍと極小である為、ネジ回し、押し込み操作等の手技において困難を極める。また、これらの固定用具は、金属製でも機能するが、骨欠損部の完治と共に再度切開し、除去手術を行う必要がある為、患者への負担も大きいといった問題も抱えている。
これらの理由により、患者への負担も少なく、接着不能な被固定部への簡便な固定用具が望まれていた。
そこで、本発明者は、以上の課題を鋭意検討した結果、次の発明に到達した。
【０００４】
【課題を解決するための手段】
［１］本発明は、少なくとも支柱ピン（２、２Ａ、２Ｂ）と拡張パイプ（１１、１１Ｂ）より構成され、
前記支柱ピン（２、２Ａ、２Ｂ）は、先端部（３）と柱部（５）より構成され、これらの間に段部（４）が形成され、前記柱部（５）の外周に複数の突部（６、６Ａ、６Ｂ）が形成され、
前記拡張パイプ（１１、１１Ｂ）は、第１拡張部（１２）と第２拡張部（１４）を有し、拡張パイプ（１１、１１Ｂ）の長さ方向に収縮しかつ収縮時の外径が収縮前の外径よりも大きくなるように形成されている膜固定システム（１、１Ａ、１Ｂ）を提供する。
［２］本発明は、前記拡張パイプ（１１、１１Ｂ）はその周縁上に少なくとも２つ以上の均等に配設された拡張手段（１３、１５）を有する［１］に記載の膜固定システム（１、１Ａ、１Ｂ）を提供する。
［３］本発明は、前記拡張手段（１３、１５）が、拡張パイプ（１１、１１Ｂ）の長さ方向に形成されたスリットまたは同一形状若しくは不定形状の孔若しくはこれらの組み合わせよりなる［１］ないし［２］に記載の膜固定システム（１、１Ａ、１Ｂ）を提供する。
［４］本発明は、前記拡張パイプ（１１、１１Ｂ）の第１拡張部（１２）と第２拡張部（１４）は、後方から前方に向けてその長さ方向に圧縮する際、第１拡張部（１２）が第２拡張部（１４）より先に拡張できるように形成した［１］ないし［３］に記載の膜固定システム（１、１Ａ、１Ｂ）を提供する。
［５］本発明は、前記突部（６、６Ａ、６Ｂ）は（Ａ）柱部５の外周に複数、不連続、または、連続的に形成された環状の突部６であり、当該突部６はいずれも柱部５の先端部３方向に拡径するようにテーパー状に形成されている突部６である、または（Ｂ）柱部５の外周に複数、規則的にまたは不規則的に形成されたリブ状の突部６Ａである、または（Ｃ）柱部５の外周に螺旋状に形成された突部６Ｂである［１］ないし［４］に記載の膜固定システム（１、１Ａ、１Ｂ）を提供する。
［６］本発明は、前記支柱ピン（２、２Ａ、２Ｂ）、拡張パイプ（１１、１１Ｂ）の一部または全部がプラスチック製または金属製の易変形性物質よりなる［１］ないし［５］に記載の膜固定システム（１、１Ａ、１Ｂ）を提供する。
［７］本発明は、前記支柱ピン（２、２Ａ、２Ｂ）、拡張パイプ（１１、１１Ｂ）の一部または全部が可変形性の生分解性高分子からなる［１］ないし［６］に記載の膜固定システム（１、１Ａ、１Ｂ）を提供する。
［８］本発明は、［１］ないし［７］に記載の支柱ピン（２、２Ａ、２Ｂ）及び拡張パイプ（１１、１１Ｂ）とこれらの拡張用治具（２１、２１Ｂ）より構成され、
前記拡張用治具（２１、２１Ｂ）は筒状に形成され、その先端部は拡張パイプ（１１、１１Ｂ）の後端部に当接できかつ拡張パイプ（１１、１１Ｂ）を支柱ピン（２、２Ａ、２Ｂ）の先端部（３）方向に押圧して圧縮させることができる形状に形成されている膜固定システム（１、１Ａ、１Ｂ）を提供する。
［９］本発明は、［８］に記載の支柱ピン（２Ｂ）及び拡張パイプ（１１Ｂ）とこれらの拡張用治具（２１Ｂ）より構成され、
支柱ピン２Ｂの柱部５の外周には螺旋状の突部６Ｂが形成され、
拡張パイプ１１Ｂの内面には、螺旋状の溝部が形成され、当該拡張パイプ１１Ｂは、半径方向に形成した少なくとも一つ以上の溝部１７により、長さ方向に二ピース以上に分割され、
支柱ピン２Ｂと拡張パイプ１１Ｂはそれぞれに回転により装着可能であり、
拡張パイプ１１Ｂの後端部と拡張用治具２１Ｂの先端部には、互いの接触面が、周縁方向で回転する際にロックすることができるロック部１６、２２を形成した膜固定システム（１Ｂ）を提供する。
［１０］本発明は、表面に膜（Ｍ）を当接した被固定部（３１）の小孔（３２）に支柱ピン（２、２Ａ、２Ｂ）を配置し、前記支柱ピン（２、２Ａ、２Ｂ）の柱部（５）の外周に前記拡張パイプ（１１、１１Ｂ）を被冠し、拡張パイプ（１１、１１Ｂ）後端に拡張用治具（２１）先端を当接して、支柱ピン（２、２Ａ、２Ｂ）の先端部（３）方向に押圧して圧縮する際に、前記拡張パイプ（１１、１１Ｂ）は、第１拡張部（１２）が先に拡張して、拡張パイプ（１１）が小孔（３２）に固定され、続いて同方向に押圧して圧縮すると、さらに第２拡張部（１４）が拡張して、当該第１拡張部（１２）と第２拡張部（１４）の間に前記膜Ｍを挟持して固定することができるように形成した［８］ないし［９］に記載の膜固定システム（１、１Ａ、１Ｂ）を提供する。
【０００５】
【発明の実施の形態】
図１は本発明の膜固定システム１の一例を示す概略図で、（Ａ）は支柱ピン２、（Ｂ）は拡張パイプ１１、（Ｃ）は拡張用治具２１の概略図を示す。図２は本発明の膜固定システム１Ａを構成する支柱ピン２Ａの概略図を示す。図３は本発明の膜固定システム１Ｂの一例を示す概略図で、（Ａ）は支柱ピン２Ｂ、（Ｂ）は拡張パイプ１１Ｂ、（Ｃ）は拡張用治具２１Ｂの概略図を示す。
図４は本発明の膜固定システム１を用いて膜Ｍを被固定部３１に固定する方法の一例を示す概略図である。
本発明の膜固定システム１は図１に例示するように少なくとも支柱ピン２と拡張パイプ１１より構成され、さらに必用に応じてこれらの拡張用治具２１より構成される。本発明において膜固定システム１とは、支柱ピン２と拡張パイプ１１より構成されるものを意味し、さらにこれらの拡張用治具２１を含む場合がある。
前記支柱ピン２は、略円錐状の先端部３と柱部５より構成され、これらの間に段部４が形成されている。当該柱部５の外周には複数の環状の突部６が不連続に形成されている。これらの突部６はいずれも柱部５の先端部３方向に向けて拡径するようにテーパー状に形成されている突部６である。
【０００６】
前記拡張パイプ１１は、筒状に形成され、第１拡張部１２と第２拡張部１４を有し、拡張パイプ１１の長さ方向に収縮しかつ収縮時の外径が収縮前の外径よりも大きくなるように形成されている。
このために拡張パイプ１１はその周縁上に少なくとも２つ以上の均等に配設された拡張手段１３、１５を有する。当該拡張手段１３、１５とは、例えば図１（Ｂ）に例示するように拡張パイプ１１の長さ方向へ形成したスリットまたは同一形状（例えば円形または矩形等）若しくは不定形の孔若しくはこれらの組み合わせよりなり、拡張パイプ１１を長さ方向に収縮させる際にその径の拡張（変形ともいう）を助長させることができるものを意味する。
さらに拡張パイプ１１の第１拡張部１２と第２拡張部１４は、後方から前方に向けてその長さ方向に圧縮する際、第１拡張部１２が第２拡張部１４より先に拡張を始めることができるような形状、寸法、材質により形成されている。
例えば、図１（Ｂ）に例示した拡張パイプ１１は、その内面が支柱ピン２の柱部５の突部６に接触して、これに沿って先端部３方向に、その先端が段部４に突き当たるまで、スライドできるように形成されている。さらに変形が２箇所で起こるように第１拡張部１２と第２拡張部１４を拡張パイプ１１の同軸・長さ方向上で、分割して配置し、膜Ｍを第１拡張部１２と第２拡張部１４の間に挟むことができるように形成されている。
なお、第２拡張部１４が第１拡張部１２より先に拡張した場合は、小穴３２内部に拡張パイプ１１が入ることが出来ず、膜が固定できないので好ましくない。
【０００７】
前記拡張用治具２１は筒状に形成され、その先端部は拡張パイプ１１の後端部に当接できかつ拡張パイプ１１を支柱ピン２先端部３方向に押圧して圧縮させることができる形状に形成されている。例えば、図１及び図４に例示するように、拡張用治具２１の先端外径は、拡張パイプ１１の後端外径と実質的に同じに形成され、同内径は支柱ピン２の突部６に接触する程度に形成されている。
以上の構成により本発明の膜固定システム１は、表面に膜Ｍを当接した被固定部３１の小孔３２に支柱ピン２を配置し、前記支柱ピン２の柱部５外周に拡張パイプ１１を被冠し、拡張パイプ１１後端に拡張用治具２１先端を当接して、支柱ピン２の先端部３方向に押圧して圧縮する際に、前記拡張パイプ１１は、第１拡張部１２が先に拡張して、拡張パイプ１１が小孔３２に固定される。
続いて同方向に押圧して圧縮すると、さらに第２拡張部１４が拡張して、当該第１拡張部１２と第２拡張部１４の間に前記膜Ｍを挟持して固定することができる。
【０００８】
前記支柱ピン２、拡張パイプ１１の一部若しくは全部がプラスチック製または金属製の易変形性物質より形成される。さらに好ましくは前記支柱ピン２、拡張パイプ１１の一部若しくは全部が可変形性の生分解性高分子から形成するのが良い。拡張パイプ１１は、易変形性物より構成されていない場合、機械等を使用した複雑な手技を要するので好ましくない。
また本発明では、支柱ピン２、拡張パイプ１１の構成材料として、その一部若しくは全部にポリ乳酸、ポリグリコール酸、ε−カプロラクトン、これらの群より選択される少なくとも一つの物質またはこれらの二種類以上の物質の組み合わせからなる共重合体（三元共重合体も含む）またはこれらにバイオセラミックス粉体（例えばβ−燐酸三カルシウムやハイドロキシアパタイト等）を含有させた柔軟な生分解性高分子を使用するのが好ましい。これらの材料を採用することにより第１拡張部１２と第２拡張部１４等の易変形部を容易に形成でき、尚且つ、治療部が完全に治癒すると体内で安全に分解吸収される。（特にε−カプロラクトンを含有する柔軟な生分解性ポリマーを使用すると前記の効果を得やすいので好ましい。）
【０００９】
図２に例示した支柱ピン２Ａは、支柱ピン２の突起部６に代えて、柱部５の外周に複数、規則的または不規則的なリブ状の突部６Ａを形成したものである。
リブ状の突部６Ａとは、図２に例示した形状の他に、板状、矩形状、円柱状等の全ての形態を含む。支柱ピン２Ａは、図１に例示した支柱ピン２と置換して、支柱ピン２と拡張パイプ１１より構成される膜固定システム１Ａ、さらにこれらに拡張用治具２１を加えた膜固定システム１Ａとして、図１に例示した膜固定システム１と実質的に同様に使用することができる。
【００１０】
図３に例示した膜固定システム１Ｂは、支柱ピン２Ｂと拡張パイプ１１Ｂと拡張用治具２１Ｂより構成される。
支柱ピン２Ｂは、図１に例示した支柱ピン２の突起部６に代えて、柱部５の外周に螺旋状の突部６Ｂを形成したものである。
拡張パイプ１１Ｂは、内面に前記螺旋状の突部６Ｂと対向する螺旋状の溝部（図示略）を形成し、さらに半径方向に形成した溝部１７により、長さ方向に二ピースに分割されている。なお溝部１７は少なくとも一つ以上形成し、長さ方向に二ピース以上に分割することができる。溝部１７を（ｎ）箇所形成すれば、長さ方向に（ｎ＋１）ピースに分割することができる。その他は図１に例示した拡張パイプ１１と実質的に同一に形成される。
以上のように、支柱ピン２Ｂと拡張パイプ１１Ｂはそれぞれに回転により装着することができる。
拡張パイプ１１Ｂの後端部と拡張用治具２１Ｂの先端部には、互いの接触面が、周縁方向で回転する際にロックすることができるロック部１６、２２が形成されている。ロック部１６、２２とは、図３に例示するような鍵状（ギア状ともいう）のものに限定されず、相互に接触面をロックすることができる全ての形態を含む。
【００１１】
次に本発明の膜固定システム１の使用方法の一例について図４を参照しながら説明する。
まず、支柱ピン２を表面に膜Ｍを当接した被固定部３１の小穴３２に挿入し、支柱ピン２の段部４に拡張パイプ１１の先端が接触するまで被冠する。なお、支柱ピン２の段部４に拡張パイプ１１が接触するまで被冠し、これを小穴３２にセットしても良い。その後、拡張用治具２１の先端を拡張パイプ１１の後端に当接して拡張パイプ１１を支柱ピン２先端部３方向に押し込むと、まず第１拡張部１２が折れ曲がり、支柱ピン２と垂直な方向に拡張し、支柱ピン２と拡張パイプ１１が小穴３２に固定される。更に拡張パイプ１１を支柱ピン２先端部３方向に押し込み続けると、第２拡張部１４が折れ曲がり、支柱ピン２と垂直な方向に拡張し、２つの拡張部１２、１４の間に膜Ｍが固定される。
【００１２】
次に本発明の膜固定システム１Ｂの使用方法の一例について説明する。
まず、支柱ピン２Ｂを表面に膜Ｍを当接した被固定部３１の小穴３２に挿入し、支柱ピン２Ｂの段部４に拡張パイプ１１Ｂの先端が接触するまで溝部１７両側の第１拡張部１２と第２拡張部１４を同時にねじ回しながら、被冠する。効率良く被冠するには、第１拡張部１２と第２拡張部１４を同時にねじ回すのが良い。
その後、拡張用治具２１Ｂの先端（ロック部２２）を拡張パイプ１１Ｂの後端（ロック部１６）に当接して拡張パイプ１１Ｂが支柱ピン２Ｂ先端部３方向に押し込まれるようにねじ回すと、溝部１７より前方の第１拡張部１２が折れ曲がり、支柱ピン２Ｂと垂直な方向に拡張し、支柱ピン２Ｂと拡張パイプ１１Ｂが小穴３２に固定される。更に拡張パイプ１１Ｂが支柱ピン２Ｂ先端部３方向に押し込まれるように拡張用治具２１Ｂの先端（ロック部２２）を拡張パイプ１１Ｂの後端（ロック部１６）に当接してねじ回し続けると、溝部１７より後方の第２拡張部１４が折れ曲がり、支柱ピン２Ｂと垂直な方向に拡張し、２つの拡張部の間（溝部１７付近）に膜Ｍが固定される。
【００１３】
【実施例】
〈実施例１〉
接着できない表面で、ネジ、くぎ等も通さない硬い壁に、ドリルで小さい穴を開け、そこに本発明による金属製の膜固定システム」を用いて板を固定した。
〈実施例２〉
金属製で、好ましくはチタン製の膜固定システム」を骨再生誘導膜の固定装置として使用した。
〈実施例３〉
ポリ乳酸、ポリグリコール酸、ポリε−カプロラクトンの三元共重合体で引っ張り強度８〜２０ＭＰｓ、ヤング率２〜４０ＭＰｓを示す原料からなる生分解性樹脂を押出・射出・切削により図１のように成形し、これを骨再生誘導膜の固定装置として使用した。
【００１４】
〈比較例１〉
接着できない表面で、ネジ、くぎ等も通さない硬い壁に、板を固定しようとした。
〈比較例２〉
金属製の骨ネジを用いて、骨再生誘導膜を固定した。
【００１５】
【評価方法】
〈実施例１〉の比較対照として、〈比較例１〉を用い、固定能の可否の確認を行った（表−１）。また、〈実施例２〉、〈実施例３〉の比較対照として〈比較例２〉を用い、実際に動物へ骨再生誘導膜を埋込した際の操作の難易性比較を行った（表−２）。また、〈実施例３〉は生分解性高分子である為、その分解状況を経時的な確認を行った（表−３）。
【００１６】
【評価結果】
【表１】

【表２】

【表３】

以上より、本発明の膜固定システムの有効性が確認できた。また、その構成材料が、生分解性高分子であれば、より安全で機能的であることも確認できた。
【００１７】
【発明の作用効果】
以上のように、本発明の膜固定システム１、１Ａ、１Ｂは、被固定部３１の小穴３２及び膜Ｍが極微小であっても、支柱ピン２、２Ａ、２Ｂの段部４を利用し、拡張パイプ１１、１１Ｂを拡張用治具２１、２１Ｂで押し込むだけで被固定部３１に膜Ｍを確実に固定することができる。支柱ピン２、２Ａ、２Ｂと拡張パイプ１１、１１Ｂの構成材料に生分解性高分子を使用することにより、体内で安全に分解吸収されるので、より安全な治療を実施することができる。
【図面の簡単な説明】
【図１】本発明の膜固定システム１の一例を示す概略図。（Ａ）は支柱ピン２、（Ｂ）は拡張パイプ１１、（Ｃ）は拡張用治具２１の概略図。
【図２】本発明の膜固定システム１Ａを構成する支柱ピン２Ａの概略図。
【図３】本発明の膜固定システム１Ｂの一例を示す概略図。（Ａ）は支柱ピン２Ｂ、（Ｂ）は拡張パイプ１１Ｂ、（Ｃ）は拡張用治具２１Ｂの概略図。
【図４】本発明の膜固定システム１を用いて膜Ｍを被固定部３１に固定する方法の一例を示す概略図。
【符号の説明】
１、１Ａ、１Ｂ　　膜固定システム
２、２Ａ、２Ｂ　　支柱ピン
３　　先端部
４　　段部
５　　柱部
６　　突部
１１、１１Ｂ　　拡張パイプ
１２　　第１拡張部
１３　　スリット
１４　　第２拡張部
１５　　スリット
１６　　ロック部
１７　　溝部
２１、２１Ｂ　　拡張用治具
２２　　ロック部
Ｍ　　膜
３１　　被固定部
３２　　小穴[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a film fixing system for fixing a film to a portion to be bonded (also referred to as a fixed portion) to which a film or the like cannot be directly bonded, for example, a bonded portion (fixed portion) having a wet surface. .
[0002]
2. Prior Art and Problems to be Solved by the Invention
As a method of fixing the film, there is a method of using a screw, a pin (a nail), an adhesive, or the like.
At present, in order to fix a film on the surface of a portion to be bonded (fixed portion) where it is impossible to directly bond the film or the like with an adhesive or the like, a method of driving a thumbtack, a nail, a screw, or the like is employed. However, with respect to a small membrane, its fastening position and fasteners are also limited to a small size, which makes the operation extremely difficult. In particular, when the part to be bonded (the part to be fixed) is hard and cannot be bonded, the operation is difficult, such as a screw being cut off or a nail being easily broken in the middle.
[0003]
At present, scaffolds and membrane-shaped devices are used as bone regeneration medical devices. Although the appropriate shape differs depending on the use site, the fixing method of the film shape is problematic. Generally, a small hole is made with the bone at the end of the bone regeneration-inducing membrane that covers the bone defect, and a fixing tool such as a bone pin, bone screw, or rivet is screwed into this part to fix the membrane. are doing.
However, since the hole size is as small as 1.0 mm in diameter and 5 to 10 mm in depth, it is extremely difficult in procedures such as screwing and pushing operation. In addition, although these fixing devices function even if they are made of metal, they also have a problem that the burden on the patient is large because it is necessary to re-open and remove the bone when the bone defect is completely cured.
For these reasons, there has been a demand for a simple fixing tool that is less burdensome on a patient and that can be easily fixed to a fixed portion that cannot be adhered.
The inventor of the present invention has intensively studied the above problems, and has reached the following invention.
[0004]
[Means for Solving the Problems]
[1] The present invention comprises at least a support pin (2, 2A, 2B) and an expansion pipe (11, 11B),
Each of the support pins (2, 2A, 2B) includes a tip (3) and a column (5), and a step (4) is formed therebetween. Projections (6, 6A, 6B) are formed,
The expansion pipe (11, 11B) has a first expansion part (12) and a second expansion part (14), contracts in the length direction of the expansion pipe (11, 11B), and has an outer diameter when contracted. A membrane fixation system (1, 1A, 1B) is provided that is configured to be larger than the outer diameter before shrinkage.
[2] The present invention provides the membrane fixing system according to [1], wherein the expansion pipe (11, 11B) has at least two or more expansion means (13, 15) evenly arranged on the periphery thereof. 1, 1A, 1B).
[3] In the present invention, the expanding means (13, 15) is formed of a slit formed in the length direction of the expanding pipe (11, 11B), a hole of the same shape or an irregular shape, or a combination thereof. Or a membrane immobilization system (1, 1A, 1B) according to [2].
[4] The present invention is characterized in that the first expansion part (12) and the second expansion part (14) of the expansion pipe (11, 11B) are compressed when the first expansion part (12) and the second expansion part (14) are compressed in the length direction from the rear to the front. There is provided a membrane fixing system (1, 1A, 1B) according to [1] to [3], wherein the extension part (12) is formed so as to be able to expand before the second extension part (14).
[5] In the present invention, the protrusions (6, 6A, 6B) are (A) a plurality of, discontinuously, or continuously formed annular protrusions 6 formed on the outer periphery of the column portion 5; Each of the portions 6 is a protrusion 6 formed in a tapered shape so as to expand in the direction of the tip 3 of the column portion 5, or (B) a plurality, regularly or irregularly on the outer periphery of the column portion 5. The membrane fixing system (1) according to any one of [1] to [4], which is a rib-shaped protrusion 6A formed in a random manner or (C) a protrusion 6B formed in a spiral shape on the outer periphery of the column 5. , 1A, 1B).
[6] In the present invention, a part or all of the support pins (2, 2A, 2B) and the expansion pipes (11, 11B) are made of a plastic or metal easily deformable substance [1] to [5]. 3. The membrane fixing system (1, 1A, 1B) according to (1).
[7] The present invention provides the invention according to [1] to [6], wherein a part or all of the support pins (2, 2A, 2B) and the expansion pipes (11, 11B) are made of a deformable biodegradable polymer. There is provided a membrane fixation system (1, 1A, 1B) as described.
[8] The present invention includes the support pins (2, 2A, 2B) and expansion pipes (11, 11B) according to [1] to [7], and expansion jigs (21, 21B) thereof.
The expansion jig (21, 21B) is formed in a cylindrical shape, and its tip can abut on the rear end of the expansion pipe (11, 11B) and connects the expansion pipe (11, 11B) to the support pin (2, 21B). 2A, 2B) is provided with a membrane fixing system (1, 1A, 1B) formed in a shape that can be pressed and compressed in the direction of a tip (3).
[9] The present invention includes the support pin (2B) and the expansion pipe (11B) according to [8] and an expansion jig (21B),
A helical protrusion 6B is formed on the outer periphery of the pillar 5 of the support pin 2B,
A spiral groove is formed on the inner surface of the expansion pipe 11B, and the expansion pipe 11B is divided into two or more pieces in a length direction by at least one or more grooves 17 formed in a radial direction.
The support pin 2B and the expansion pipe 11B can be attached to each by rotation,
At the rear end of the expansion pipe 11B and the front end of the expansion jig 21B, a membrane fixing system (1B) having lock portions 16 and 22 formed so that contact surfaces thereof can be locked when rotating in the peripheral direction. )I will provide a.
[10] In the present invention, a support pin (2, 2A, 2B) is arranged in a small hole (32) of a fixed portion (31) having a surface in contact with a membrane (M), and the support pin (2, 2A) is provided. The extension pipe (11, 11B) is covered on the outer periphery of the pillar portion (5) of (2B), and the tip of the extension jig (21) is brought into contact with the rear end of the extension pipe (11, 11B), to thereby provide a support pin. When the expansion pipes (11, 11B) are pressed and compressed in the direction of the distal end portion (3) of (2, 2A, 2B), the first expansion section (12) expands first, and the expansion pipe (11, 11B) expands. 11) is fixed to the small hole (32) and subsequently pressed and compressed in the same direction, the second expanded portion (14) further expands, and the first expanded portion (12) and the second expanded portion (12) are further expanded. 14) The membrane fixing system (1, 1A) according to [8] or [9], which is formed so that the membrane M can be sandwiched and fixed between the two. 1B) provides.
[0005]
BEST MODE FOR CARRYING OUT THE INVENTION
FIG. 1 is a schematic view showing an example of a membrane fixing system 1 of the present invention. FIG. 1A is a schematic view of a support pin 2, FIG. 1B is a schematic view of an expansion pipe 11, and FIG. 1C is a schematic view of an expansion jig 21. FIG. 2 is a schematic view of a support pin 2A constituting a membrane fixing system 1A of the present invention. FIGS. 3A and 3B are schematic diagrams showing an example of the membrane fixing system 1B of the present invention. FIG. 3A is a schematic diagram of a support pin 2B, FIG. 3B is a schematic diagram of an expansion pipe 11B, and FIG. 3C is a schematic diagram of an expansion jig 21B.
FIG. 4 is a schematic view showing an example of a method for fixing the film M to the fixed portion 31 using the film fixing system 1 of the present invention.
As shown in FIG. 1, the membrane fixing system 1 of the present invention includes at least a support pin 2 and an expansion pipe 11, and further includes an expansion jig 21 as necessary. In the present invention, the membrane fixing system 1 means a system composed of the support pin 2 and the expansion pipe 11, and may further include these expansion jigs 21.
The support pin 2 includes a substantially conical tip 3 and a column 5, and a step 4 is formed therebetween. A plurality of annular protrusions 6 are formed discontinuously on the outer periphery of the column 5. Each of these protrusions 6 is a protrusion 6 that is formed in a tapered shape so as to increase in diameter in the direction of the tip 3 of the column 5.
[0006]
The expansion pipe 11 is formed in a tubular shape, has a first expansion part 12 and a second expansion part 14, and contracts in the length direction of the expansion pipe 11 and the outer diameter at the time of contraction is larger than the outer diameter before contraction. Is also formed to be large.
For this purpose, the expansion pipe 11 has at least two or more equally arranged expansion means 13, 15 on its periphery. The expansion means 13 and 15 are, for example, slits formed in the length direction of the expansion pipe 11 as shown in FIG. 1B, or holes having the same shape (for example, circular or rectangular) or irregular shapes, or a combination thereof. This means that the expansion pipe 11 can promote expansion of its diameter (also called deformation) when the expansion pipe 11 is contracted in the length direction.
Further, when the first expansion part 12 and the second expansion part 14 of the expansion pipe 11 are compressed in the length direction from the rear to the front, the first expansion part 12 starts expanding before the second expansion part 14. It is formed of a shape, size and material that can be used.
For example, the expansion pipe 11 illustrated in FIG. 1B has an inner surface that comes into contact with the protrusion 6 of the column 5 of the support pin 2, and moves in the direction of the tip 3 along the same. It is formed so that it can slide until it abuts. Further, the first extension portion 12 and the second extension portion 14 are divided and arranged on the coaxial lengthwise direction of the extension pipe 11 so that the deformation occurs at two places, and the membrane M is connected to the first extension portion 12 and the second extension portion 12. It is formed so as to be sandwiched between the extension portions 14.
If the second expansion portion 14 expands before the first expansion portion 12, the expansion pipe 11 cannot enter the small hole 32, and the film cannot be fixed, which is not preferable.
[0007]
The expansion jig 21 is formed in a cylindrical shape, and the distal end thereof can be brought into contact with the rear end of the expansion pipe 11 and the expansion pipe 11 can be pressed and compressed in the direction of the tip 3 of the support pin 2. Is formed. For example, as illustrated in FIGS. 1 and 4, the outer diameter of the distal end of the expansion jig 21 is formed to be substantially the same as the outer diameter of the rear end of the expansion pipe 11, and the inner diameter is the protrusion of the support pin 2. 6 is formed to such an extent as to come into contact.
According to the above configuration, the membrane fixing system 1 of the present invention arranges the support pin 2 in the small hole 32 of the fixed part 31 having the surface in contact with the membrane M, and extends the expansion pipe 11 around the column 5 of the support pin 2. When the tip of the expansion jig 21 is brought into contact with the rear end of the expansion pipe 11 and pressed toward the front end 3 of the support pin 2 to be compressed, the expansion pipe 11 Is expanded first, and the expansion pipe 11 is fixed to the small hole 32.
Subsequently, when pressed and compressed in the same direction, the second expanded portion 14 is further expanded, and the film M can be sandwiched and fixed between the first expanded portion 12 and the second expanded portion 14.
[0008]
Part or all of the support pin 2 and the expansion pipe 11 are formed of a plastic or metal easily deformable substance. More preferably, part or all of the support pin 2 and the expansion pipe 11 are made of a deformable biodegradable polymer. When the expansion pipe 11 is not made of an easily deformable material, it is not preferable because a complicated procedure using a machine or the like is required.
Further, in the present invention, as a constituent material of the support pin 2 and the expansion pipe 11, at least one of polylactic acid, polyglycolic acid, ε-caprolactone, at least one substance selected from the group or two or more of them is used. Copolymers (including terpolymers) consisting of combinations of the above substances or flexible biodegradable polymers containing bioceramics powders (eg, β-tricalcium phosphate, hydroxyapatite, etc.) It is preferred to use. By employing these materials, easily deformable portions such as the first expansion portion 12 and the second expansion portion 14 can be easily formed, and when the treatment portion is completely cured, it is safely decomposed and absorbed in the body. (Especially, it is preferable to use a flexible biodegradable polymer containing ε-caprolactone because the above-mentioned effects are easily obtained.)
[0009]
The pillar pin 2A illustrated in FIG. 2 has a plurality of regular or irregular rib-shaped projections 6A formed on the outer periphery of the pillar 5 instead of the projection 6 of the pillar pin 2.
The rib-shaped protrusion 6A includes not only the shape illustrated in FIG. 2 but also all forms such as a plate shape, a rectangular shape, and a columnar shape. The strut pin 2A is replaced with the strut pin 2 illustrated in FIG. 1 to form a membrane fixing system 1A composed of the strut pin 2 and the expansion pipe 11, and a membrane fixing system 1A in which an expansion jig 21 is added thereto. , Can be used in substantially the same manner as the membrane fixation system 1 illustrated in FIG.
[0010]
The membrane fixing system 1B illustrated in FIG. 3 includes a support pin 2B, an expansion pipe 11B, and an expansion jig 21B.
The support pin 2B is formed by forming a spiral protrusion 6B on the outer periphery of the pillar 5 instead of the protrusion 6 of the support pin 2 illustrated in FIG.
The expansion pipe 11B has a spiral groove (not shown) facing the spiral protrusion 6B on the inner surface, and is further divided into two pieces in the length direction by a groove 17 formed in the radial direction. . At least one groove 17 can be formed and divided into two or more pieces in the length direction. If the groove 17 is formed at (n) places, it can be divided into (n + 1) pieces in the length direction. Others are formed substantially the same as the expansion pipe 11 illustrated in FIG.
As described above, the support pin 2B and the expansion pipe 11B can be mounted on each of them by rotation.
Lock portions 16 and 22 are formed at the rear end of the expansion pipe 11B and the front end of the expansion jig 21B so that their contact surfaces can be locked when rotating in the peripheral direction. The lock portions 16 and 22 are not limited to those having a key shape (also referred to as a gear shape) as illustrated in FIG. 3 and include all forms that can mutually lock the contact surfaces.
[0011]
Next, an example of a method of using the membrane fixing system 1 of the present invention will be described with reference to FIG.
First, the support pin 2 is inserted into the small hole 32 of the fixed portion 31 having the surface in contact with the film M, and is covered until the tip of the expansion pipe 11 contacts the step portion 4 of the support pin 2. The extension pipe 11 may be covered until the expansion pipe 11 comes into contact with the step portion 4 of the support pin 2, and may be set in the small hole 32. Thereafter, when the distal end of the expansion jig 21 is brought into contact with the rear end of the expansion pipe 11 and the expansion pipe 11 is pushed in the direction of the tip 3 of the support pin 2, the first expansion portion 12 first bends and is perpendicular to the support pin 2. The support pin 2 and the expansion pipe 11 are fixed to the small holes 32. Further, when the expansion pipe 11 is continuously pushed in the direction of the tip 3 of the support pin 2, the second expansion portion 14 bends and expands in the direction perpendicular to the support pin 2, and the film M is fixed between the two

expansion portions

12 and 14. Is done.
[0012]
Next, an example of a method of using the membrane fixing system 1B of the present invention will be described.
First, the support pin 2B is inserted into the small hole 32 of the fixed portion 31 having the surface in contact with the film M, and the first expansion portions on both sides of the groove 17 until the tip of the expansion pipe 11B contacts the step portion 4 of the support pin 2B. 12 and the second expanded portion 14 are put on while being simultaneously screwed. To cover the head efficiently, it is preferable to simultaneously screw the first extension part 12 and the second extension part 14.
Thereafter, when the distal end (lock portion 22) of the expansion jig 21B is brought into contact with the rear end (lock portion 16) of the expansion pipe 11B and the expansion pipe 11B is screwed so as to be pushed in the direction of the distal end portion 3 of the support pin 2B, The first expansion portion 12 in front of the groove portion 17 is bent and expands in a direction perpendicular to the support pin 2B, and the support pin 2B and the expansion pipe 11B are fixed to the small holes 32. Further, when the distal end (lock portion 22) of the expansion jig 21B abuts on the rear end (lock portion 16) of the expansion pipe 11B so that the expansion pipe 11B is pushed in the direction of the end portion 3 of the support pin 2B, the screw is continuously screwed. The second expanded portion 14 behind the groove 17 is bent and expanded in a direction perpendicular to the support pin 2B, and the film M is fixed between the two expanded portions (near the groove 17).
[0013]
【Example】
<Example 1>
A small hole was drilled in a hard wall through which screws, nails, and the like could not pass, on a surface that could not be bonded, and a plate was fixed there using the metal membrane fixing system according to the present invention.
<Example 2>
A metal, preferably titanium membrane fixation system "was used as the fixation device for the bone regeneration-inducing membrane.
<Example 3>
As shown in FIG. 1, a biodegradable resin made of a raw material having a tensile strength of 8 to 20 MPs and a Young's modulus of 2 to 40 MPs, which is a terpolymer of polylactic acid, polyglycolic acid and polyε-caprolactone, is extruded, injected and cut as shown in FIG. It was molded and used as a device for fixing a bone regeneration-inducing membrane.
[0014]
<Comparative Example 1>
An attempt was made to fix the board to a hard wall that could not be glued and did not allow screws, nails, etc. to pass through.
<Comparative Example 2>
The bone regeneration-inducing membrane was fixed using a metal bone screw.
[0015]
【Evaluation method】
As a control for <Example 1>, <Comparative Example 1> was used to confirm whether or not immobilization ability was possible (Table 1). In addition, using <Comparative Example 2> as a comparative control of <Example 2> and <Example 3>, the difficulty of the operation when the bone regeneration-inducing membrane was actually implanted in an animal was compared (Table 1). 2). Also, since <Example 3> is a biodegradable polymer, its degradation status was confirmed over time (Table 3).
[0016]
【Evaluation results】
[Table 1]

[Table 2]

[Table 3]

From the above, the effectiveness of the membrane fixing system of the present invention was confirmed. It was also confirmed that if the constituent material was a biodegradable polymer, it was safer and more functional.
[0017]
Operation and Effect of the Invention
As described above, the membrane fixing systems 1, 1A, and 1B of the present invention use the step portions 4 of the support pins 2, 2A, and 2B even if the small holes 32 of the fixed portion 31 and the membrane M are extremely small. By simply pushing the

expansion pipes

11 and 11B with the expansion jigs 21 and 21B, the film M can be securely fixed to the fixed portion 31. By using a biodegradable polymer as a constituent material of the support pins 2, 2A, 2B and the

expansion pipes

11, 11B, the biodegradable polymer can be safely decomposed and absorbed in the body, so that a safer treatment can be performed.
[Brief description of the drawings]
FIG. 1 is a schematic view showing an example of a membrane fixing system 1 of the present invention. (A) is a schematic view of a support pin 2, (B) is an expansion pipe 11, and (C) is a schematic view of an expansion jig 21.
FIG. 2 is a schematic view of a support pin 2A constituting the membrane fixing system 1A of the present invention.
FIG. 3 is a schematic view showing an example of a membrane fixing system 1B of the present invention. (A) is a schematic view of a support pin 2B, (B) is an expansion pipe 11B, and (C) is a schematic view of an expansion jig 21B.
FIG. 4 is a schematic diagram showing an example of a method for fixing a film M to a fixed portion 31 using the film fixing system 1 of the present invention.
[Explanation of symbols]
1, 1A, 1B

Membrane fixing system

2, 2A, 2B Support pin 3 Tip 4 Step 5 Column 6

Projection

11, 11B Expansion pipe 12 First expansion 13 Slit 14 Second expansion 15 Slit 16 Lock 17

Grooves

21 and 21B Extension jig 22 Lock portion M Film 31 Fixed portion 32 Small hole

Claims

It is composed of at least support pins (2, 2A, 2B) and expansion pipes (11, 11B),
Each of the support pins (2, 2A, 2B) includes a tip (3) and a column (5), and a step (4) is formed between them. Projections (6, 6A, 6B) are formed,
The expansion pipe (11, 11B) has a first expansion part (12) and a second expansion part (14), contracts in the length direction of the expansion pipe (11, 11B), and has an outer diameter when contracted. A membrane fixation system (1, 1A, 1B) characterized in that it is formed to be larger than the outer diameter before shrinkage.

2. The membrane fixing system (1, 1) according to claim 1, characterized in that the expansion pipe (11, 11B) has at least two or more equally arranged expansion means (13, 15) on its periphery. 1A, 1B).

The said expansion means (13, 15) consists of a slit formed in the longitudinal direction of the expansion pipe (11, 11B), a hole of the same shape or an irregular shape, or a combination thereof. The membrane fixation system (1, 1A, 1B) according to 1.

When the first expansion part (12) and the second expansion part (14) of the expansion pipe (11, 11B) are compressed in the length direction from the rear to the front, the first expansion part (12) is in the first position. 4. The membrane fixation system (1, 1A, 1B) according to claim 1, characterized in that it is formed so that it can be expanded before the two expansion parts (14).

The protrusions (6, 6A, 6B) are (A) a plurality of, discontinuous, or continuous annular protrusions 6 formed on the outer periphery of the column portion 5, and each of the protrusions 6 is a column portion. 5 is a protrusion 6 which is formed in a tapered shape so as to expand in the direction of the tip 3 or (B) a plurality of ribs formed regularly or irregularly on the outer periphery of the column 5 5. The membrane fixing system according to claim 1, wherein (C) is a protrusion 6 B spirally formed on an outer periphery of the column 5. 6. 1B).

6. The membrane fixing system according to claim 1, wherein a part or all of the support pins (2, 2A, 2B) and the expansion pipes (11, 11B) are made of a plastic or metal easily deformable substance. 1A, 1B).

7. The membrane fixing device according to claim 1, wherein a part or all of the support pins (2, 2 A, 2 B) and the expansion pipes (11, 11 B) are made of a deformable biodegradable polymer. System (1, 1A, 1B).

The support pin (2, 2A, 2B) and the expansion pipe (11, 11B) according to claim 1 to 7, and these expansion jigs (21, 21B) are constituted,
The expansion jig (21, 21B) is formed in a cylindrical shape, and its tip can abut on the rear end of the expansion pipe (11, 11B) and connects the expansion pipe (11, 11B) to the support pin (2, 21B). A membrane fixing system (1, 1A, 1B) characterized in that it is formed in a shape that can be pressed and compressed in the direction of a tip portion (3) of 2A, 2B).

It comprises a support pin (2B) and an expansion pipe (11B) according to claim 8 and a jig (21B) for expanding them.
A helical projection 6B is formed on the outer periphery of the column 5 of the support pin 2B,
A spiral groove is formed on the inner surface of the expansion pipe 11B, and the expansion pipe 11B is divided into two or more pieces in the length direction by at least one or more grooves 17 formed in the radial direction.
The support pin 2B and the expansion pipe 11B can be attached to each by rotation,
The rear end of the expansion pipe 11B and the front end of the expansion jig 21B are provided with locking portions 16 and 22 that can lock each other when they rotate in the peripheral direction. Membrane fixing system (1B).

The support pins (2, 2A, 2B) are arranged in the small holes (32) of the fixed portion (31) having the membrane (M) in contact with the surface thereof, and the support pins (2, 2A, 2B) have the column portions (2, 2A, 2B). The extension pipe (11, 11B) is covered on the outer periphery of 5), and the tip of the extension jig (21) is brought into contact with the rear end of the extension pipe (11, 11B), and the support pin (2, 2A, 2B) When the expansion pipe (11, 11B) is compressed by pressing in the direction of the tip (3), the first expansion part (12) expands first, and the expansion pipe (11) ), And subsequently pressed and compressed in the same direction, the second expanded portion (14) expands further, and the film extends between the first expanded portion (12) and the second expanded portion (14). The membrane fixing system according to claim 8, wherein the membrane fixing system is formed so as to be able to clamp and fix M. 10. A, 1B).