JP3688380B2

JP3688380B2 - Bone prosthesis fixture

Info

Publication number: JP3688380B2
Application number: JP04539596A
Authority: JP
Inventors: 道一西尾; 一樹出口
Original assignee: NGK Spark Plug Co Ltd
Current assignee: Niterra Co Ltd
Priority date: 1996-02-06
Filing date: 1996-02-06
Publication date: 2005-08-24
Anticipated expiration: 2016-02-06
Also published as: JPH09206310A

Description

【０００１】
【発明の属する技術分野】
本発明は、頭蓋顎顔面骨（以下、単に頭蓋骨ともいう）の一部が骨腫瘍等に冒されている場合など、その一部（自家骨）を切断、除去した後の骨欠損部の補填（手術）に使用され、内外両面に貫通する適数の貫通孔を有してなる骨補填材を、周囲の自家骨に固定するために使用される骨補填材用固定具（以下、単に固定具ともいう）に関する。
【０００２】
【従来の技術】
脳神経外科手術等で頭蓋骨を開頭し、その手術後に切り取った骨片（自家骨）を被せ、周囲の自家骨（生体骨）と固定する場合には、生体骨同志の固定のため、外側からプレートを跨がせるようにあてがってタッピングスクリュー（セルフタッピング式のスクリュー）によるねじ込み固定やハーケンといわれる抜け止め用突起付き釘などの打ち込みなどにより、かなりしっかりと固定できる。また、骨腫瘍等により、頭蓋骨の一部を切断、除去した後の骨欠損部を骨補填材で補填する場合でも、骨補填材がプラスチック製のものである場合には、その加工が容易なために、上記したのと同様にして固定できる。
【０００３】
ところで、このような骨補填材は、セラミック製のものがその生体適合性や生体骨との結合性などにおいてとくに優れており、好ましい材質とされている。しかし、セラミック製の骨補填材は、その性質上、ドリルによる孔開け程度の加工はできるが、それ自体にねじを立てることが困難なため、上記のようにして固定することはできず、次のようにして固定されていた。
【０００４】
すなわち、セラミック製の骨補填材で骨欠損部を補填する手術をする場合には、その骨欠損部と同様の形状、大きさのセラミック製の骨補填材をつくり、図１５に示したように、その骨補填材Ｃの外周縁にドリルでもって適数個（骨補填材の大きさなどにもよるが外周縁に沿って１０か所ぐらい）の貫通孔Ｋａを斜めに開ける。そして、この貫通孔Ｋａに対応するように患者本人の頭蓋骨（自家骨）Ｚの骨欠損部の内周縁にも同様の貫通孔Ｋｂを斜めに開け、骨補填材Ｃをその骨欠損部に置換してその互いの貫通孔Ｋａ，Ｋｂにナイロン糸Ｎを通すことで縫合して縛り付けるようにして固定されていた。なお、骨の面に直角な貫通孔とせず傾斜孔としているのは、自家骨の孔開け時や縫合過程で硬膜等を傷付けないようにするためである。
【０００５】
【発明が解決しようとする課題】
ところで、このような手術においては、手術時間の短縮を図ることと、その術後における回復をできるだけ早めることが要求される。しかし、ナイロン糸による縫合による固定では、自家骨Ｚに多数の傾斜孔Ｋｂを開ける必要のあることや、縫合の手間が大きいなどにより手術時間が多くかかり、その短縮を図ることは容易でないといった問題があった。とりわけ、自家骨に孔を開けるに際しては斜めに開ける必要があることからしても、その加工が難しくしたがって慎重に行う必要があるために、孔開けだけにもかなり多くの時間がかかっていた。
【０００６】
また、術後の回復を早めるためには、補填部位周辺の新生骨（骨組織）と骨補填材との結合を早期に図る必要があり、このためには、骨補填材Ｃが自家骨（生体骨）Ｚに堅固で安定して固定されないといけない。しかし、ナイロン糸による縫合による固定では、満足のいく十分な固定強度は得られないため、術後の回復に長期間を要する原因となっていた。また、場合によっては、生体骨との固定が不十分なことに起因すると推察される骨組織の結合不良による偽関節の発生の原因ともなる。
【０００７】
本発明は、このような問題点に鑑み、頭蓋顎顔面骨の骨欠損部位に、セラミック製の骨補填材を補填する場合でも比較的短時間の手術で強固に固定できる骨補填材用固定具を提供することをその目的とする。
【０００８】
【課題を解決するための手段】
上記の目的を達成するため、本発明に係る第１の手段は、頭蓋顎顔面骨の骨欠損部の補填に使用され、内外両面に貫通する適数の貫通孔を有してなる骨補填材を自家骨に固定するために使用される骨補填材用固定具であって、
その骨補填材用固定具は、塑性変形により曲げ加工可能に形成された板材からなる一対の固定片を含んで形成され、
該一対の固定片は、
前記骨補填材をその内側から挟み付ける内側挟み付け部及び自家骨の表面に取付けるための取付け部を有してなる内側固定片と、
前記骨補填材をその外側から挟み付ける外側挟み付け部及び自家骨の表面に取付けるための取付け部を有してなる外側固定片とからなり、
前記内側固定片の内側挟み付け部には、前記骨補填材の内側からその貫通孔に嵌入可能であるとともに所定高さをもつ凸部が形成され、またその凸部の先端面にはねじ孔が形成されており、
そして、前記外側固定片の外側挟み付け部には、前記ねじ孔にねじ込む結合用ねじを挿入可能の結合孔が形成されており、
前記内側固定片の内側挟み付け部における前記凸部を前記骨補填材の内側から前記貫通孔に嵌入するとともに前記外側固定片の外側挟み付け部における前記結合孔を前記骨補填材の外側から前記凸部のねじ孔に合わせて前記結合用ねじを該結合孔に挿入して前記ねじ孔にねじ込むことによって、前記内側挟み付け部と前記外側挟み付け部とで前記骨補填材を挟み付けかつ両固定片が結合されるように形成されており、
さらに、前記内側固定片及び外側固定片の前記各取付け部にはその各固定片を自家骨の表面に取り付けるための取付け用ねじ等を挿入し得る取付け孔を各々適数有してなることを特徴とする。
【０００９】
この手段を用いた手術は例えば次のようにして進められる。まず、骨欠損部に適合するように調整され、内外両面の適所に貫通する適数の貫通孔を有してなる骨補填材を用意する。なお、一般には、４か所程度で、固定するのが好ましく、したがって、この貫通孔は、好ましくは等角度（距離）間隔で４か所程度設けておき、その各箇所において本発明に係る骨補填材用固定具で骨補填材を固定する。
【００１０】
例示的には、本発明に係る骨補填材用固定具の内側固定片の凸部を、骨補填材の貫通孔に嵌入し、外側固定片の結合孔をその凸部のねじ孔に合わせて結合用ねじを緩く螺着（仮締め）して、内側挟み付け部と外側挟み付け部で骨補填材を挟むようにしておく。次いで各固定片をその骨補填材の内面と厚み部位（側面）又は外面になじませるように折り曲げ、かつ自家骨（頭蓋骨）の表面の適所に沿いなじむように折り曲げるなどの事前調整をしておく。
【００１１】
そして、この状態のものを骨欠損部にセットし、両固定片の取付け部を自家骨の表面にあてがい、取付け孔（例えば、取付け用ねじのねじ込み位置又はハーケンの打ち込み位置）の位置決めをして自家骨に下孔を穿孔し、その取付け孔から自家骨に取付け用ねじをねじ込むことやハーケンを打ち込むことなどにより各固定片を取付け、固定する。そして、仮締め状態にあった結合用ねじを本締めする。
【００１２】
このように、本発明による固定具の使用に際しては、自家骨に対する機械加工は、取付け用ねじのねじ込みのためやハーケン等の打ち込み用の下孔の穿孔だけであり、骨面に略垂直に開ければよい。また、取付け（固定）は取付け用ねじや結合用ねじのねじ込み、或いはハーケン等の打ち込みによるものである。したがって、ナイロン糸による縫合による場合に比べ、手術時間の短縮が図られるし、骨補填材の自家骨への取付けもねじの締付けやハーケン等の打ち込みによることができるから、その強度の向上も図られる。なお、第２の手段として上記第１の手段において次ぎのようにしてもよい。すなわち、上記第１の手段において、前記一対の固定片は、ともに細長状に形成され、ともに一端寄り部位に前記内側挟み付け部又は外側挟み付け部が形成され、他端寄り部位に前記取付け部が形成されてなるものである。このものは構造が単純であり好ましい。
【００１３】
また、第３の手段として上記第１の手段において次ぎのようにしてもよい。すなわち前記一対の固定片は、ともに少なくとも前記取付け部が一定方向に延びる細長状に形成され、前記内側挟み付け部及び外側挟み付け部が前記細長方向に対して横向きに延びる横向き部を備えており、前記両取付け部が自家骨に取り付けられる際に間隔をおいて略平行に配置可能とされるように、前記凸部及び前記結合孔が各々横向き部側に偏在して形成されているものである。このようにすれば、両固定片の取付け部を略平行にして自家骨に固定できる上、その際でも、その取付け部が重ならず、したがって１つの固定片の厚さ分のみ、皮膚側に出るだけで済むので、術後、ごつごつしないので患者にとっては触感時の違和感もなく、福音となる。
【００１４】
そして、このような効果を得るために第４の手段として、上記第１の手段において次ぎのようにしてもよい。すなわち、前記一対の固定片は、ともに少なくとも前記取付け部が一定方向に延びる細長状に形成され、前記内側挟み付け部が前記細長方向に対して横向きに延びる横向き部を備えており、前記両取付け部が自家骨に取り付けられる際に間隔をおいて略平行に配置可能とされるように、前記凸部が横向き部側に偏在して形成されているものである。また、第５の手段として、上記第１の手段において次ぎのようにしてもよい。すなわち、前記一対の固定片は、ともに少なくとも前記取付け部が一定方向に延びる細長状に形成され、前記外側挟み付け部が前記細長方向に対して横向きに延びる横向き部を備えており、前記両取付け部が自家骨に取り付けられる際に間隔をおいて略平行に配置可能とされるように、前記結合孔が横向き部側に偏在して形成されているものである。
【００１５】
さらに、上記第３又は第５の手段において、前記一対の固定片の両取付け部が自家骨に略平行に取り付けられる際において、該両取付け部の間隔が調節可能に前記結合孔を長孔としておいてもよい。このようにしておけば、両固定片の取付け部を平行に保持しつつもその間隔を調節できるから、自家骨への固定位置の自由度が増すためである。
【００１６】
【発明の実施の形態】
次に本発明に係る骨補填材用固定具を具体化した実施の形態について、図を参照して詳細に説明する。
−第１実施形態例−
図１ないし図４を参照して第１実施形態例について説明する。ただし、図中Ｃは、患者の頭蓋骨（以下、自家骨ともいう）Ｚの骨欠損部（患部）に補填されるアパタイト焼結体等のセラミック製骨補填材であって、骨欠損部に略隙間なくセットされるように、元の自家骨と同様にやや球面状に形成されており、詳しくは図示しないがその適所（例えば、４か所）に内外面に貫通する所定の直径の円形の貫通孔Ｋが形成されている。
【００１７】
図１及び図２は、本例の固定具をなす内側固定片１及び外側固定片２等を示すもので、両固定片１，２は、純チタンからなる帯板状（本例では幅約２．６ｍｍ）の薄板からなり、手術用のプライヤなどで塑性変形により簡易に折り曲げ加工ができるよう形成されている。そして、そのうち内側固定片１は、図１においては、２点鎖線の真っ直ぐな状態から後述するようにして実線で示した形に折り曲げられているところが図示されているが、その一端部（図１右上）寄り部位は、自家骨Ｚの表面に取付けるための取付け部１ａをなしており、略直線状にかつ所定のピッチで、取付け用ねじを挿入し得る取付け孔（本例では内径約１．３ｍｍ）３を本例では３か所備えている。この各取付け孔３は、その上面内周縁が皿もみ状に形成されており、この取付け孔３に取付け用ねじを通して患者の頭蓋骨Ｚにねじ込むことにより固定できるように形成されている。なお、内側固定片１の取付け孔３の両側部には、強度が確保されるように所定の半径（本例では約４ｍｍ）で円弧状に膨出された膨出部４を備えている。
【００１８】
そして、この内側固定片１の反対の端部（先端）寄り部位は、骨補填材Ｃをその内側から挟み付ける内側挟み付け部１ｂをなし、先端側には骨補填材Ｃの貫通孔Ｋの内径より大きく円形に膨出された係合フランジ部５を備えている。そして、この係合フランジ部５の上面の中央には、同フランジ部５の外径（本例では約６ｍｍ）より小さい外径（本例では約３ｍｍ）をもつ円柱状の凸部６が立設されている。そして、その凸部６の上端面７の中央には軸線方向に所定深さをもつねじ孔（本例では、Ｍ１．４）８が形成されている。ただし、その凸部６の外径は、骨補填材Ｃに設けられた貫通孔Ｋよりやや小さめとされ、また、その高さは、骨補填材Ｃの貫通孔Ｋの深さすなわち骨補填材Ｃの厚さよりも小さく設定されている。なお、この凸部６は、その下側端面に円形ボス９が突出形成され、係合フランジ部５の中央に設けられた円形孔に嵌合され、その端面側の境界Ｍをカシメることにより固着されている。
【００１９】
一方、外側固定片２は、内側固定片１と同様に、真っ直ぐな状態をなすとともにその一端部（図１左上）寄り部位が自家骨Ｚの表面に取付けるための取付け部２ａをなし、略直線状にかつ所定のピッチで、取付け用ねじを挿入し得る取付け孔（本例では内径約１．３ｍｍ）１３を本例では３か所備えており、この取付け孔１３に取付け用ねじを通して患者の頭蓋骨Ｚの表面にねじ込むことにより固定できるように形成されている。なお、この取付け孔１３も上面内周縁が皿もみ状に形成され、さらに、それらの両側部には、強度が確保されるように、所定の半径（本例では約４ｍｍ）で円弧状に膨出された膨出部１４を備えている。また、外側固定片２の反対の端部（先端）寄り部位は、骨補填材Ｃをその外側から挟み付ける外側挟み付け部２ｂをなし、その先端側には内側固定片１のねじ孔８にねじ込む結合用ねじ１５を挿入可能の結合孔（本例では内径約１．６ｍｍ）１６が貫設されている。そして、この結合孔１６も上面内周縁が皿もみ状に形成され、その外側部の外径は、骨補填材Ｃの貫通孔Ｋの内径より大きく円形に膨出され、貫通孔Ｋの周縁に係合する係合フランジ部１７をなしている。
【００２０】
さて、次に上記のように形成された本例の骨補填材用固定具を用いた手術は例えば次のようにして進められる。ただし、骨欠損部に適合するように調整され、内外両面の適所に貫通形成された適数の貫通孔Ｋを有してなる骨補填材Ｃと、この貫通孔Ｋの数と同数の本例に係る固定具、及び所定の取付け用ねじ（タッピングスクリュー）と結合用ねじ１５を所定数用意する。両ねじともに純チタン製のものを用いるのが好ましい。なお、本例の固定具は各貫通孔Ｋにおいて同様に使用される。
【００２１】
まず、図１，２に示したように、内側固定片１の凸部６を同図中２点鎖線で示す骨補填材Ｃの貫通孔Ｋに内側から嵌入する。そして、外側固定片２の結合孔１６を内側固定片１の凸部６のねじ孔８に合わせ、結合用ねじ１５を緩く螺着（仮締め）して両固定片１，２の内側挟み付け部１ｂと外側挟み付け部２ｂが、骨補填材Ｃを挟むようにしておく。そして、一対の固定片１，２について、自家骨Ｚへの取り付け状態及び骨欠損部の状況などに合わせて図１に示したように適度の開脚状態となるようにする。この際、とくに内側固定片１ついては、図１中実線で図示したように（図２中２点鎖線参照）折り曲げ或いはひねりを加えて、骨補填材Ｃと自家骨Ｚになじむようにしておく。すなわち、内側固定片１については、骨補填材Ｃの内面Ｃａと厚み部位（側面）Ｃｂになじむように折り曲げ、そして自家骨Ｚ（頭蓋骨）の表（外）面Ｚｄの適所にもなじむように折り曲げる（図３，４参照）。また外側固定片２については、骨補填材Ｃの外面Ｃｄ及び自家骨Ｚの表面Ｚｄの適所になじむように適量曲げる。これを各貫通孔Ｋの固定片について行っておくが、本例では、一対の固定片１，２を外側から見て平行に近付けると各固定片が重なるので、なるべく重ならないように開脚するのが好ましい。
【００２２】
次いで、この状態のものを、骨欠損部にセットし、取付け孔３，１３の位置に取付け用ねじの下孔を骨面に略垂直に穿孔し、各固定具とも各一対の固定片１，２について、均等かつ平均に、取付け孔３，１３から取付け用ねじ１８を自家骨Ｚの表面にねじ込み固定する（図３参照）。これによって各固定具は、自家骨Ｚに固定される。そして、仮締め状態にあった結合用ねじ１５を本締めする。このようにすると、今度は各両固定片１，２の内側挟み付け部１ｂと外側挟み付け部２ｂによって骨補填材Ｃが強く挟みつけられると共に両固定片１，２が強く結合するから骨補填材Ｃは、適数個の固定具を介して自家骨Ｚにしっかりと固定される。
【００２３】
かくして、新生骨との結合が早く、早期の機能回復が得られることになる。また、ナイロン糸による縫合と異なり手術時間を短くできる。さらに、本例では、係合フランジ部５，１７の外径は、骨補填材Ｃの貫通孔Ｋの内径より大きいことから、貫通孔Ｋの開口部外周縁面の全体を平均に挟み付けることができるので、それらの部位の貫通孔Ｋへの落ち込みも防止される。なお、凸部６の高さは、骨欠損部に補填される骨補填材（人の頭蓋顎顔面骨）の厚さ（３〜８ｍｍ）に応じて、それより小さめで適宜の高さにすればよい。
【００２４】
また本例では、凸部６に設けたねじ孔８は、その奥所（先端）が閉塞されたブラインドナットの形を成しているため、誤ってねじ長さの長い結合用ねじ１５を用いてもその先端で硬膜等を傷つけないように形成されている。また、固定後の横ずれの防止のためには、骨補填材Ｃと骨欠損部との隙間を小さくするのがよいことはいうまでもないが、凸部６と貫通孔Ｋとの隙間も小さいほうがよい。なお、結合用ねじ１５や取付け用ねじ１８の締め付けは、手術の状況次第で、適宜の順序で締め付ければよい。本例では、取付け用ねじを各取付け部の取付け孔に通して自家骨表面にねじ込むことによって各固定片を自家骨に固定した場合を例示したが、この取付け用ねじに代えてハームンを打ち込むことによって固定することもできる。
【００２５】
固定具（固定片）の材質は、チタン又はチタン合金が、生体親和性、高強度、耐腐食性、非毒性、容易な曲げ加工性などより好ましい材料といえるが、本発明においては、これに限定されるものではない。また、本例では、骨補填材Ｃが新生骨との結合性に優れるアパタイトの場合で説明したが、生体適合性や十分な強度を有し、補填材として適する材質であれば適宜の材料のものを用いることができる。すなわち、プラスチックや金属の骨補填材でもまったく同様に適用できるし、生体骨（骨のフラップ）を固定する場合にも適用できる。なお、使用する固定具の数或いは大きさや形状は、頭蓋顎顔面骨の骨欠損部に応じて設定すればよい。
【００２６】
−第２実施形態例−
次に、第２形態例について図５〜７を参照して説明するが、本例のものは、上記した実施形態例１が各固定片１，２の取付け部１ａ，２ａを患部の外側から見て略平行にした際にはそれらが重なるものであったのに対して、これを重ならないように形成した点のみが相違するだけであるので、相違点のみ説明し、同一部位には同一の符号を付し説明を省略する。
【００２７】
すなわち、本例では、一対の固定片２１，２２は、ともにその取付け部をなす部位２１ａ，２２ａが一定方向に延びる細長状に形成されているが、両固定片２１，２２の先端寄り部位（図６左側）の内側挟み付け部２１ｂ及び外側挟み付け部２２ｂが細長（長手）方向に対して横向きに延びる横向き部２３，２４を備えている。そして、両取付け部２１ａ，２２ａが自家骨Ｚに取り付けられる際に、図５，６に示したように所定の間隔をおいて略平行に配置されるように、凸部６は内側挟み付け部２１ｂの横向き部２３側に平面視偏在して形成されている。また、結合孔１６は外側挟み付け部２２ｂの横向き部２４寄り側に、同様に平面視偏在して形成されている。しかして本例でも、両固定片２１，２２を折り曲げるなど、上記したのと同様にして、骨補填材Ｃを自家骨Ｚに固定できるが、その際、両固定片２１，２２の取付け部２１ａ，２２ａは図６に示したように略平行にして固定できる。
【００２８】
すなわち、両固定片２１，２２を略平行な状態として骨補填材Ｃを挟み付けることができることから、その固定が安定する。そして、平行にしても、厚さは固定片の厚さの１枚分であるから、皮膚下の違和感が少ない。なお、前例のように開脚状態でも固定できることはいうまでもない。因みに、この種の固定具（固定片）の板厚は、０．５ｍｍ程度であるが、とくに皮膚の表面に近い箇所を手術する場合に好適である。なお、このことからも理解されるが、本発明における固定片２１，２２はその強度が確保されるかぎり、なるべく薄いものが好ましい。また、上記においては、両固定片２１，２２の先端部の内側挟み付け部と外側挟み付け部ともに横向きに延びる横向き部２３，２４を設けた場合で説明したが、次の２つの例のように、いずれか一方にのみその横向き部を設け、凸部６又は結合孔１６を形成することによっても同様の効果がある。
【００２９】
−第３実施形態例−
図８及び図９は、内側固定片２１の内側挟み付け部２１ｂにのみその細長方向に対して横向きに延びる横向き部２３を設け、凸部６をその横向き部２３側に偏在して形成した形態例である。すなわち本例は、外側固定片２は上記第１実施形態例のそれと同じものであり、また内側固定片２１については、横向き部２３を前記第２実施形態例のものよりも横方向に大きめに延ばした点が異なるだけであるため、各同一部位には各同一の符号を付し、詳細な説明は省略する。
【００３０】
−第４実施形態例−
図１０及び図１１は、外側固定片２２の外側挟み付け部２２ｂにのみその細長方向に対して横向きに延びる横向き部２４を設け、結合孔１６をその横向き部２４側に偏在して形成した形態例である。すなわち本例は、内側固定片１は上記第１実施形態例のそれと同じものであり、また外側固定片２２については、横向き部２４を前記第２実施形態例のものよりも横方向に大きめに延ばした点が異なるだけであるため、各同一部位には各同一の符号を付し、詳細な説明は省略する。
【００３１】
−第５実施形態例−
さて次に、図１２及び図１３を参照して本発明に係る第５実施形態例について説明するが、本例のものは第２実施形態例の改良とでもいうべきものであるので、その点のみ説明し、同一部位には同一の符号を付し説明を省略する。
【００３２】
すなわち、本例のものは、外側固定片３２の外側挟み付け部３２ｂの横向き部２４を前例よりも横方向に大きめに延ばし、結合孔３６を、外側固定片３２の長手方向に略直角な方向に長い長孔（小判孔）としたもので、一対の固定片２１，３２の取付け部２１ａ，３２ａを略平行にした際でも、図中、２点鎖線で示したようにその間隔を調整することができるようにしたものである。したがって、骨欠損部の周囲（自家骨）の状況によって取付け用ねじのねじ込みやハーケンの打ち込みを行うのが不適切な箇所があっても、その調節可能な範囲であればこの一対の固定片２１，３２の取付け部２１ａ，３２ａを平行にして固定することができる。
【００３３】
−第６実施形態例−
図１４は第６実施形態例を示すもので、第５実施形態例が第２実施形態例において結合孔３６を外側固定片３２の長手方向に略直角な方向に長い長孔としたものであるのに対し、本例は、内側固定片１は上記第１実施形態例のそれと同じものであり、また外側固定片３２について、横向き部２４を前記第５実施形態例のものよりも横方向に大きめに延ばした点が異なるだけであるため、各同一部位には各同一の符号を付し、詳細な説明は省略する。
【００３４】
【発明の効果】
以上の説明から明らかなように、本発明に係る骨補填材用固定具の効果は次のようである。ナイロン糸による縫合による固定方法と異なり、自家骨に多数の孔を斜めに開ける必要はなく、取付け用ねじのねじ込みのためやハーケンの打ち込みのための下孔を骨面に垂直に穿孔するだけでよいから、比較的容易にその加工を行うことができる。また、自家骨への骨補填材の固定は、取付け用ねじのねじ込みやハーケンの打ち込みによって行うことができるから、ナイロン糸による縫合による場合に比べ、手術時間の短縮が図られるし、その固定もねじの締付け等によるものであるから、固定強度の向上も図られる。
【００３５】
かくして、本発明によれば、頭蓋顎顔面骨の骨欠損部位に、セラミック製の骨補填材を補填する場合でも、比較的短時間で手術をすることができる。また強固に固定できるから、補填部位周辺の新生骨と骨補填材との結合の早期化を図ることができ、術後の回復を早めることができる。このように、本発明に係る骨補填材用固定具は、この種の手術に極めて有用であり患者にとっても福音となる。
【図面の簡単な説明】
【図１】本発明に係る骨補填材用固定具の第１実施形態例を示す説明用斜視図。
【図２】第１実施形態例の一部破断分解側面図。
【図３】図１の骨補填材用固定具で骨補填材を頭蓋骨の骨欠損部に固定した状態を示す断面図。
【図４】図３の左部分拡大図。
【図５】本発明に係る骨補填材用固定具の第２実施形態例を示す説明用斜視図。
【図６】図５の平面図。
【図７】図６のＤ−Ｄ線拡大断面図。
【図８】本発明に係る骨補填材用固定具の第３実施形態例を示す説明用平面図。
【図９】図８のＤ−Ｄ線拡大断面図。
【図１０】本発明に係る骨補填材用固定具の第４実施形態例を示す説明用平面図。
【図１１】図１０のＤ−Ｄ線拡大断面図。
【図１２】本発明に係る骨補填材用固定具の第５実施形態例を示す説明用平面図。
【図１３】図１２の要部拡大図。
【図１４】本発明に係る骨補填材用固定具の第６実施形態例を示す要部拡大説明用平面図。
【図１５】従来の骨補填材の固定法を説明する部分断面図。
【符号の説明】
１，２１内側固定片
１ａ，２ａ，２１ａ，２２ａ，３２ａ取付け部
１ｂ，２１ｂ内側挟み付け部
２，２２，３２外側固定片
２ｂ，２２ｂ，３２ｂ外側挟み付け部
３，１３取付け孔
６凸部
７凸部の先端面
８ねじ孔
１５結合用ねじ
１６，３６結合孔
１８取付け用ねじ
２３，２４横向き部
Ｃ骨補填材
Ｋ骨補填材の貫通孔
Ｚ頭蓋骨[0001]
BACKGROUND OF THE INVENTION
In the present invention, when a part of a craniofacial bone (hereinafter also simply referred to as a skull) is affected by a bone tumor or the like, the bone defect is compensated after the part (autologous bone) is cut and removed. Bone prosthetic fixing tool (hereinafter simply fixed) used to fix the bone prosthetic material used in (surgery) and having a suitable number of through-holes that penetrate both the inside and outside of the bone. (Also called ingredients).
[0002]
[Prior art]
When the skull is opened by neurosurgery, etc., and the bone piece (autologous bone) cut off after the operation is covered, and fixed to the surrounding autologous bone (living bone), the plate from the outside is used to fix the living bone. It can be fixed fairly firmly by screwing and fixing with a tapping screw (self-tapping screw) or driving in a nail with a retaining protrusion called Harken. In addition, even when a bone defect after a part of the skull has been cut and removed due to a bone tumor or the like is filled with a bone grafting material, if the bone grafting material is made of plastic, the processing is easy. Therefore, it can be fixed in the same manner as described above.
[0003]
By the way, as such a bone grafting material, a ceramic material is particularly excellent in biocompatibility, binding property to living bone, and the like, and is a preferable material. However, ceramic bone prosthetic materials can be drilled by drilling due to their nature, but it is difficult to set a screw in itself, so it cannot be fixed as described above. It was fixed like that.
[0004]
That is, in the case of performing an operation for filling a bone defect with a ceramic bone grafting material, a ceramic bone grafting material having the same shape and size as the bone defect is produced, as shown in FIG. Then, an appropriate number of through holes Ka (about 10 along the outer periphery depending on the size of the bone replacement material) are obliquely opened by drilling on the outer periphery of the bone repair material C. Then, a corresponding through hole Kb is also obliquely opened on the inner peripheral edge of the bone defect portion of the patient's own skull (autologous bone) Z so as to correspond to the through hole Ka, and the bone filling material C is replaced with the bone defect portion. Then, the nylon thread N was passed through the mutual through holes Ka and Kb so as to be sewn and bound. The reason why the inclined holes are used instead of the through-holes perpendicular to the bone surface is to prevent the dura from being damaged during the drilling of the autologous bone or during the suturing process.
[0005]
[Problems to be solved by the invention]
By the way, in such an operation, it is required to shorten the operation time and to speed up recovery after the operation as much as possible. However, in the fixation by suture with nylon thread, it is necessary to open a large number of inclined holes Kb in the autologous bone Z, and it takes a lot of time for the operation due to a large amount of time and time for sewing, and it is not easy to shorten it. was there. In particular, when a hole is made in an autologous bone, since it is necessary to open it at an angle, it is difficult to process, and thus it is necessary to perform it carefully.
[0006]
In addition, in order to speed up postoperative recovery, it is necessary to aim at an early connection between the new bone (bone tissue) around the region to be repaired and the bone grafting material. (Living bone) must be firmly and stably fixed to Z. However, since fixation with a suture with nylon thread does not provide satisfactory and sufficient fixation strength, it has caused a long period of time for recovery after surgery. In some cases, it may cause a false joint due to poor bone tissue connection, which is presumed to be caused by insufficient fixation with a living bone.
[0007]
In view of such problems, the present invention provides a bone prosthesis fixing device that can be firmly fixed in a relatively short time even when a ceramic bone prosthesis is supplemented to a bone defect site of a craniofacial bone. The purpose is to provide.
[0008]
[Means for Solving the Problems]
In order to achieve the above object, a first means according to the present invention is used for filling a bone defect portion of a craniofacial bone and has a suitable number of through holes penetrating both inside and outside. A bone prosthetic fixture used to fix the bone to the autologous bone,
The bone prosthetic fixing tool is formed to include a pair of fixing pieces made of a plate material that can be bent by plastic deformation,
The pair of fixing pieces is
An inner fixing piece having an inner clamping portion for clamping the bone prosthetic material from its inner side and an attachment portion for attaching to the surface of the autologous bone;
An outer pinching portion for pinching the bone prosthetic material from the outside and an outer fixing piece having an attachment portion for attaching to the surface of the autologous bone,
The inner pinching portion of the inner fixing piece is formed with a convex portion that can be inserted into the through hole from the inside of the bone prosthetic material and has a predetermined height, and a screw hole is formed on the tip surface of the convex portion. Is formed,
And, in the outer sandwiching portion of the outer fixed piece, a coupling hole into which a coupling screw to be screwed into the screw hole can be inserted is formed,
The convex portion in the inner pinching portion of the inner fixing piece is fitted into the through hole from the inside of the bone filling material, and the coupling hole in the outer pinching portion of the outer fixing piece is inserted from the outside of the bone filling material. By inserting the coupling screw into the coupling hole in accordance with the screw hole of the convex portion and screwing it into the screw hole, the bone filling material is sandwiched between the inner clamping portion and the outer clamping portion, and both It is formed so that the fixed piece is joined,
Further, each of the attachment portions of the inner and outer fixing pieces has an appropriate number of attachment holes into which attachment screws for attaching the respective fixing pieces to the surface of the own bone can be inserted. Features.
[0009]
Surgery using this means is performed as follows, for example. First, a bone prosthesis material prepared to have an appropriate number of through-holes that are adjusted so as to be adapted to the bone defect portion and penetrates in appropriate positions on both the inner and outer surfaces is prepared. In general, it is preferable to fix at about four places. Therefore, the through-holes are preferably provided at about four places at equiangular (distance) intervals, and the bone according to the present invention is provided at each place. Fix the bone prosthesis with the fixator.
[0010]
Illustratively, the convex portion of the inner fixing piece of the bone prosthetic fixture according to the present invention is fitted into the through hole of the bone prosthetic material, and the coupling hole of the outer fixing piece is aligned with the screw hole of the convex portion. The coupling screw is loosely screwed (temporarily tightened) so that the bone prosthetic material is sandwiched between the inner clamping portion and the outer clamping portion. Next, make a pre-adjustment such as folding each fixed piece so that it fits the inner surface and thickness part (side surface) or outer surface of the bone grafting material, and bend along the appropriate position on the surface of the own bone (skull). .
[0011]
Then, this state is set in the bone defect portion, the attachment portions of both fixed pieces are applied to the surface of the own bone, and the attachment holes (for example, the screwing position of the mounting screw or the hammering position) are positioned. Each fixing piece is attached and fixed by drilling a pilot hole in the own bone and screwing a mounting screw into the own bone through the attachment hole or driving in a harken. Then, the coupling screw that has been temporarily tightened is finally tightened.
[0012]
As described above, when using the fixture according to the present invention, the machining for the autologous bone is only for screwing a mounting screw or for drilling a pilot hole for driving such as a harken, which can be opened substantially perpendicularly to the bone surface. That's fine. The mounting (fixing) is performed by screwing a mounting screw or a coupling screw or driving a Harken or the like. Therefore, the operation time can be shortened compared to the case of stitching with nylon thread, and the strength of the bone prosthetic material can be improved by attaching the bone prosthetic material to the own bone by tightening screws or driving in with a harken. It is done. The second means may be the following in the first means. That is, in the first means, the pair of fixed pieces are both formed in an elongated shape, and both the inner sandwiched portion or the outer sandwiched portion is formed near the one end, and the mounting portion is disposed near the other end. Is formed. This is preferable because of its simple structure.
[0013]
As the third means, the first means may be as follows. That is, each of the pair of fixed pieces is formed in an elongated shape in which at least the attachment portion extends in a certain direction, and the inner sandwiching portion and the outer sandwiching portion include lateral portions extending laterally with respect to the elongated direction. The convex portion and the coupling hole are each formed to be unevenly distributed on the side of the lateral portion so that the two mounting portions can be arranged substantially in parallel with an interval when attached to the autologous bone. is there. In this way, the fixing portions of the two fixing pieces can be fixed to the autologous bone in a substantially parallel manner, and even in that case, the mounting portions do not overlap. Therefore, only the thickness of one fixing piece is applied to the skin side. Since it only needs to go out, the patient does not get angry after the operation, so there is no sense of incongruity when touching the patient, and the gospel is achieved.
[0014]
In order to obtain such an effect, the fourth means may be as follows in the first means. That is, each of the pair of fixed pieces is formed in an elongated shape in which at least the attachment portion extends in a certain direction, and the inner sandwiching portion includes a lateral portion extending laterally with respect to the elongated direction, The convex portions are formed so as to be unevenly distributed on the side of the lateral portion so that the portions can be arranged substantially in parallel at intervals when the portions are attached to the autologous bone. Further, as the fifth means, the following may be performed in the first means. That is, each of the pair of fixed pieces is formed in an elongated shape in which at least the attachment portion extends in a certain direction, and the outer clamping portion includes a lateral portion extending laterally with respect to the elongated direction. The coupling holes are formed to be unevenly distributed on the side of the lateral portion so that the portions can be arranged substantially in parallel with an interval when the portion is attached to the autologous bone.
[0015]
Further, in the third or fifth means, when the attachment portions of the pair of fixing pieces are attached substantially parallel to the own bone, the coupling hole is formed as an elongated hole so that the interval between the attachment portions can be adjusted. It may be left. This is because the distance between the fixing portions can be adjusted while holding the mounting portions of the fixing pieces in parallel, and the degree of freedom of the fixing position to the own bone increases.
[0016]
DETAILED DESCRIPTION OF THE INVENTION
Next, an embodiment in which the bone prosthetic fixture according to the present invention is embodied will be described in detail with reference to the drawings.
-First embodiment-
A first embodiment will be described with reference to FIGS. In the figure, C is a ceramic bone prosthesis material such as apatite sintered body to be compensated for the bone defect part (affected part) of the patient's skull (hereinafter also referred to as autologous bone) Z. It is formed in a slightly spherical shape like the original autologous bone so that it can be set without gaps. Although not shown in detail, a circular shape with a predetermined diameter that penetrates the inner and outer surfaces at appropriate locations (for example, four locations) A through hole K is formed.
[0017]
FIGS. 1 and 2 show an inner fixing piece 1 and an outer fixing piece 2 that constitute the fixture of this example. Both fixing pieces 1 and 2 are strip-like plates made of pure titanium (in this example, about a width of about 1). 2.6 mm) and is formed so that it can be easily bent by plastic deformation with a surgical pliers or the like. In FIG. 1, the inner fixing piece 1 is bent from a straight two-dot chain line into a shape indicated by a solid line as will be described later. The upper right portion is a mounting portion 1a for mounting on the surface of the autologous bone Z, and is a mounting hole into which mounting screws can be inserted substantially linearly at a predetermined pitch (in this example, an inner diameter of about 1. mm). 3 mm) 3 is provided in three places in this example. Each of the attachment holes 3 is formed in a dish-like shape at the inner periphery of the upper surface, and is formed so that it can be fixed by screwing it into the skull Z of the patient through an attachment screw. In addition, the both sides of the mounting hole 3 of the inner fixing piece 1 are provided with bulging portions 4 bulging in an arc shape with a predetermined radius (about 4 mm in this example) so as to ensure strength.
[0018]
The opposite end (tip) portion of the inner fixing piece 1 forms an inner clamping portion 1b that clamps the bone grafting material C from the inner side, and the through hole K of the bone grafting material C is formed on the tip side. An engagement flange portion 5 that is larger than the inner diameter and bulges in a circle is provided. At the center of the upper surface of the engaging flange portion 5, a cylindrical convex portion 6 having an outer diameter (about 3 mm in this example) smaller than the outer diameter (about 6 mm in this example) of the flange portion 5 stands. It is installed. A screw hole (M1.4 in this example) 8 having a predetermined depth in the axial direction is formed at the center of the upper end surface 7 of the convex portion 6. However, the outer diameter of the convex portion 6 is slightly smaller than the through hole K provided in the bone grafting material C, and the height thereof is the depth of the through hole K of the bone grafting material C, that is, the bone grafting material. It is set smaller than the thickness of C. The convex portion 6 has a circular boss 9 projectingly formed on the lower end surface thereof, fitted into a circular hole provided in the center of the engagement flange portion 5, and caulking the boundary M on the end surface side. It is fixed.
[0019]
On the other hand, like the inner fixing piece 1, the outer fixing piece 2 is in a straight state, and a portion closer to one end (upper left in FIG. 1) forms an attachment portion 2a for attaching to the surface of the autologous bone Z, and is substantially straight. In this example, there are provided three mounting holes (in this example, an inner diameter of about 1.3 mm) 13 through which the mounting screws can be inserted. It is formed so that it can be fixed by screwing it into the surface of the skull Z. The mounting hole 13 is also formed in a dish-like shape on the inner peripheral edge of the upper surface, and further, on both sides thereof, it swells in an arc shape with a predetermined radius (about 4 mm in this example) so as to ensure strength. A protruding bulging portion 14 is provided. Further, the portion closer to the end (tip) opposite to the outer fixing piece 2 forms an outer clamping portion 2b that clamps the bone prosthetic material C from the outer side, and a screw hole 8 of the inner fixing piece 1 is formed on the tip side. A coupling hole (in this example, an inner diameter of about 1.6 mm) 16 into which a coupling screw 15 to be screwed can be inserted is provided. The upper peripheral edge of the coupling hole 16 is also formed in a dish shape, and the outer diameter of the outer part is larger than the inner diameter of the through hole K of the bone grafting material C and bulges into a circular shape. An engaging flange portion 17 to be engaged is formed.
[0020]
Now, the operation using the bone prosthesis fixing tool of the present example formed as described above is advanced as follows, for example. However, the bone prosthetic material C having an appropriate number of through-holes K adjusted so as to be adapted to the bone defect portion and formed in appropriate positions on both the inner and outer surfaces, and this example having the same number as the number of the through-holes K. A predetermined number of fixing tools, predetermined mounting screws (tapping screws), and coupling screws 15 are prepared. Both screws are preferably made of pure titanium. In addition, the fixture of this example is similarly used in each through-hole K.
[0021]
First, as shown in FIGS. 1 and 2, the convex portion 6 of the inner fixing piece 1 is fitted into the through hole K of the bone grafting material C indicated by a two-dot chain line in FIG. Then, the coupling hole 16 of the outer fixing piece 2 is aligned with the screw hole 8 of the convex portion 6 of the inner fixing piece 1, and the coupling screw 15 is loosely screwed (temporarily tightened) to clamp the inner sides of the two fixing pieces 1, 2. The part 1b and the outer clamping part 2b are set so as to sandwich the bone prosthetic material C. Then, the pair of fixing pieces 1 and 2 are set in an appropriate open leg state as shown in FIG. 1 according to the attachment state to the autologous bone Z and the condition of the bone defect portion. At this time, especially the inner fixing piece 1 is bent or twisted as shown by a solid line in FIG. 1 (see a two-dot chain line in FIG. 2) so as to become familiar with the bone prosthetic material C and the own bone Z. That is, the inner fixed piece 1 is bent so as to be adapted to the inner surface Ca and the thickness portion (side surface) Cb of the bone prosthetic material C, and is adapted to an appropriate position on the front (outer) surface Zd of the autologous bone Z (skull). Bend (see Figs. 3 and 4). In addition, the outer fixing piece 2 is bent by an appropriate amount so as to fit in an appropriate position on the outer surface Cd of the bone grafting material C and the surface Zd of the own bone Z. This is performed for the fixed pieces of the respective through holes K. In this example, the fixed pieces overlap when the pair of fixed pieces 1 and 2 are brought close to each other when viewed from the outside, so that the legs are opened so as not to overlap as much as possible. Is preferred.
[0022]
Next, the product in this state is set in the bone defect portion, and a pilot screw is drilled substantially perpendicularly to the bone surface at the position of the attachment holes 3 and 13, and each fixing tool has a pair of fixing pieces 1 and 2. 2, the mounting screws 18 are screwed and fixed to the surface of the own bone Z through the mounting holes 3 and 13 evenly and averagely (see FIG. 3). Thereby, each fixing tool is fixed to the own bone Z. Then, the coupling screw 15 in the temporarily tightened state is finally tightened. In this case, the bone filling material C is strongly clamped by the inner pinching portion 1b and the outer pinching portion 2b of the both fixing pieces 1 and 2 and the both bone fixing pieces 1 and 2 are strongly coupled. The material C is firmly fixed to the autologous bone Z through an appropriate number of fixing tools.
[0023]
Thus, the binding to the new bone is quick and the early functional recovery can be obtained. Also, unlike the suture with nylon thread, the operation time can be shortened. Furthermore, in this example, since the outer diameter of the engagement flange portions 5 and 17 is larger than the inner diameter of the through hole K of the bone grafting material C, the entire outer peripheral surface of the opening of the through hole K is sandwiched on average. Can be prevented from falling into the through-holes K at those sites. In addition, the height of the convex part 6 is smaller than that depending on the thickness (3 to 8 mm) of the bone prosthesis material (human craniofacial bone) to be compensated for the bone defect part. That's fine.
[0024]
Moreover, in this example, since the screw hole 8 provided in the convex part 6 has the shape of a blind nut with its back (tip) closed, the screw 15 for coupling with a long screw length is used by mistake. However, the tip is formed so as not to damage the dura. Needless to say, the gap between the bone prosthetic material C and the bone defect portion is preferably small in order to prevent lateral slip after fixation, but the gap between the convex portion 6 and the through hole K is also small. Better. The coupling screw 15 and the mounting screw 18 may be tightened in an appropriate order depending on the situation of the operation. In this example, the case where each fixing piece is fixed to the own bone by screwing the mounting screw through the mounting hole of each mounting portion and screwing into the own bone is illustrated. However, instead of this mounting screw, a harmon is driven. Can also be fixed.
[0025]
As the material of the fixture (fixed piece), titanium or a titanium alloy can be said to be a more preferable material such as biocompatibility, high strength, corrosion resistance, non-toxicity, easy bending workability, etc. In the present invention, It is not limited. Further, in this example, the case where the bone grafting material C is apatite excellent in binding to new bone has been described. However, any suitable material can be used as long as the material has biocompatibility and sufficient strength and is suitable as a grafting material. Things can be used. That is, the present invention can be applied in the same manner to plastic or metal bone substitutes, and can also be applied to the case of fixing living bones (bone flaps). In addition, what is necessary is just to set the number of the fixing tools to be used, a magnitude | size, or a shape according to the bone defect part of a craniofacial bone.
[0026]
-Second embodiment-
Next, the second embodiment will be described with reference to FIGS. 5 to 7. In the present embodiment, the above-described first embodiment uses the mounting portions 1a and 2a of the fixing pieces 1 and 2 from the outside of the affected part. When viewed almost parallel, they overlap, but only the point where they are formed so as not to overlap is the only difference. The description is omitted.
[0027]
In other words, in this example, the pair of fixed pieces 21 and 22 are formed in an elongated shape in which the portions 21a and 22a forming the attachment portions extend in a certain direction. The inner sandwiching portion 21b and the outer sandwiching portion 22b shown in FIG. 6 (left side) are provided with lateral portions 23 and 24 extending laterally with respect to the elongated (longitudinal) direction. And when both attachment parts 21a and 22a are attached to the autologous bone Z, as shown in FIG.5, 6, the convex part 6 is an inner clamping part so that it may arrange | position substantially parallel at a predetermined space | interval. It is unevenly distributed in plan view on the side portion 23 side of 21b. Similarly, the coupling hole 16 is formed on the side of the outer sandwiching portion 22b closer to the lateral portion 24 so as to be unevenly distributed in plan view. Even in this example, the bone grafting material C can be fixed to the own bone Z in the same manner as described above, such as by bending both the fixing pieces 21 and 22, but at this time, the attachment portion 21a of the both fixing pieces 21 and 22 is fixed. , 22a can be fixed substantially in parallel as shown in FIG.
[0028]
That is, since the bone prosthetic material C can be sandwiched with both the fixing pieces 21 and 22 in a substantially parallel state, the fixation is stable. And even if it is parallel, since the thickness is one sheet of the thickness of the fixed piece, there is little discomfort under the skin. Needless to say, it can be fixed even in the open leg state as in the previous example. Incidentally, the plate thickness of this type of fixture (fixed piece) is about 0.5 mm, which is particularly suitable when operating a portion close to the surface of the skin. As can be understood from this, the fixing pieces 21 and 22 according to the present invention are preferably as thin as possible as long as the strength is secured. Further, in the above description, the case where the laterally extending portions 23 and 24 extending in the lateral direction are provided in both the inner sandwiched portion and the outer sandwiched portion of the distal ends of both the fixing pieces 21 and 22 is described as in the following two examples. In addition, the same effect can be obtained by providing the horizontal portion only on one of them and forming the convex portion 6 or the coupling hole 16.
[0029]
-Third embodiment-
8 and 9, only the inner sandwiching portion 21 b of the inner fixing piece 21 is provided with a lateral portion 23 extending laterally with respect to the elongated direction, and the convex portion 6 is formed so as to be unevenly distributed on the lateral portion 23 side. It is an example. That is, in this example, the outer fixing piece 2 is the same as that of the first embodiment, and the inner fixing piece 21 has a lateral portion 23 larger in the lateral direction than that of the second embodiment. Since only the points that are extended are different, the same portions are denoted by the same reference numerals, and detailed description thereof is omitted.
[0030]
-Fourth embodiment-
10 and 11, the laterally extending portion 24 extending laterally with respect to the elongated direction is provided only on the outer clamping portion 22b of the outer fixed piece 22, and the coupling hole 16 is formed to be unevenly distributed on the laterally facing portion 24 side. It is an example. That is, in this example, the inner fixing piece 1 is the same as that of the first embodiment, and the outer fixing piece 22 has a lateral portion 24 larger in the lateral direction than that of the second embodiment. Since only the points that are extended are different, the same portions are denoted by the same reference numerals, and detailed description thereof is omitted.
[0031]
-Fifth embodiment-
Next, a fifth embodiment according to the present invention will be described with reference to FIGS. 12 and 13, but the present embodiment should be said to be an improvement of the second embodiment. Only the same parts are denoted by the same reference numerals and the description thereof is omitted.
[0032]
That is, in this example, the laterally extending portion 24 of the outer clamping portion 32b of the outer fixed piece 32 is extended in the lateral direction larger than the previous example, and the coupling hole 36 is in a direction substantially perpendicular to the longitudinal direction of the outer fixed piece 32. Even when the mounting portions 21a and 32a of the pair of fixing pieces 21 and 32 are made substantially parallel, the interval is adjusted as shown by a two-dot chain line in the figure. It is something that can be done. Therefore, even if there is a place where it is inappropriate to screw in the mounting screw or to drive in the harken depending on the situation around the bone defect (autologous bone), this pair of fixing pieces 21 is within the adjustable range. , 32 can be fixed in parallel with each other.
[0033]
-Sixth embodiment-
FIG. 14 shows the sixth embodiment. In the fifth embodiment, in the second embodiment, the coupling hole 36 is a long hole that is long in a direction substantially perpendicular to the longitudinal direction of the outer fixing piece 32. On the other hand, in this example, the inner fixing piece 1 is the same as that of the first embodiment, and the lateral fixing portion 24 of the outer fixing piece 32 is set to be more lateral than that of the fifth embodiment. Since only the points that are extended to a larger size are different, the same parts are denoted by the same reference numerals, and detailed description thereof is omitted.
[0034]
【The invention's effect】
As is clear from the above description, the effects of the bone prosthetic fixture according to the present invention are as follows. Unlike the fixing method by stitching with nylon thread, it is not necessary to make a number of holes in the autologous bone at an angle, but only to drill a pilot hole perpendicularly to the bone surface for screwing a mounting screw or driving a harken. Since it is good, it can be processed relatively easily. In addition, since the bone grafting material can be fixed to the autologous bone by screwing in the mounting screw or driving in the harken, the operation time can be shortened compared to the case of suture with nylon thread, and the fixing is also possible. Since it is due to tightening of the screw, etc., the fixing strength can be improved.
[0035]
Thus, according to the present invention, it is possible to perform an operation in a relatively short time even when a bone defect site of a craniofacial bone is supplemented with a ceramic bone grafting material. In addition, since it can be firmly fixed, it is possible to speed up the connection between the new bone around the filling site and the bone filling material, and to speed up post-operative recovery. As described above, the bone prosthesis fixing device according to the present invention is extremely useful for this kind of surgery and is also a gospel for the patient.
[Brief description of the drawings]
FIG. 1 is an explanatory perspective view showing a first embodiment of a bone prosthesis fixing device according to the present invention.
FIG. 2 is a partially broken exploded side view of the first embodiment.
3 is a cross-sectional view showing a state in which the bone grafting material is fixed to the bone defect portion of the skull with the bone grafting material fixing device of FIG. 1. FIG.
4 is an enlarged view of the left part of FIG. 3;
FIG. 5 is an explanatory perspective view showing a second embodiment of the bone grafting fixture according to the present invention.
6 is a plan view of FIG. 5. FIG.
7 is an enlarged sectional view taken along line DD of FIG.
FIG. 8 is an explanatory plan view showing a third embodiment of the bone grafting fixture according to the present invention.
9 is an enlarged sectional view taken along line DD of FIG.
FIG. 10 is an explanatory plan view showing a fourth embodiment of the bone grafting fixture according to the present invention.
11 is an enlarged sectional view taken along line DD of FIG.
FIG. 12 is an explanatory plan view showing a fifth embodiment of the bone grafting fixture according to the present invention.
13 is an enlarged view of a main part of FIG.
FIG. 14 is an enlarged plan view of an essential part showing a sixth embodiment of a bone prosthesis fixing device according to the present invention.
FIG. 15 is a partial cross-sectional view illustrating a conventional method for fixing a bone grafting material.
[Explanation of symbols]
1,21 Inner fixing pieces 1a, 2a, 21a, 22a, 32a Mounting portions 1b, 21b Inner clamping portions 2, 22, 32 Outer fixing pieces 2b, 22b, 32b Outer clamping portions 3, 13 Mounting holes 6 Protruding portion 7 Protruding tip 8 Screw hole 15 Coupling screw 16, 36 Coupling hole 18 Mounting screw 23, 24 Lateral part C Bone prosthesis material K Bone prosthesis through hole Z Skull

Claims

Bone prosthesis fixing tool used to fix bone defect material of craniomaxillofacial bone and used to fix bone repair material with appropriate number of through holes penetrating both inside and outside of the bone. There,
The bone prosthetic fixing tool is formed to include a pair of fixing pieces made of a plate material that can be bent by plastic deformation,
The pair of fixing pieces is
An inner fixing piece having an inner clamping portion for clamping the bone prosthetic material from its inner side and an attachment portion for attaching to the surface of the autologous bone;
An outer pinching portion for pinching the bone prosthetic material from the outside and an outer fixing piece having an attachment portion for attaching to the surface of the autologous bone,
The inner pinching portion of the inner fixing piece is formed with a convex portion that can be inserted into the through hole from the inside of the bone prosthetic material and has a predetermined height, and a screw hole is formed on the tip surface of the convex portion. Is formed,
And, in the outer sandwiching portion of the outer fixed piece, a coupling hole into which a coupling screw to be screwed into the screw hole can be inserted is formed,
The convex portion in the inner pinching portion of the inner fixing piece is fitted into the through hole from the inside of the bone filling material, and the coupling hole in the outer pinching portion of the outer fixing piece is inserted from the outside of the bone filling material. By inserting the coupling screw into the coupling hole in accordance with the screw hole of the convex portion and screwing it into the screw hole, the bone filling material is sandwiched between the inner clamping portion and the outer clamping portion, and both It is formed so that the fixed piece is joined,
Further, each of the mounting portions of the inner fixing piece and the outer fixing piece has an appropriate number of mounting holes into which mounting screws for attaching the fixing pieces to the surface of the own bone can be inserted. A bone fixing material fixture.

Both of the pair of fixing pieces are formed in an elongated shape, and both the inner clamping part or the outer clamping part are formed in a part near one end, and the attachment part is formed in a part near the other end. The bone repair material fixture according to claim 1.

Each of the pair of fixing pieces is formed in an elongated shape in which at least the attachment portion extends in a certain direction, and the inner sandwiching portion and the outer sandwiching portion include a lateral portion extending laterally with respect to the elongated direction, The convex portion and the coupling hole are each formed to be unevenly distributed on the side of the lateral portion so that the two attachment portions can be arranged substantially in parallel with an interval when attached to the autologous bone. The bone prosthetic fixture according to claim 1.

Each of the pair of fixed pieces is formed in an elongated shape in which at least the attachment portion extends in a certain direction, the inner sandwiching portion includes a lateral portion extending laterally with respect to the elongated direction, and the both attachment portions are The bone prosthetic material according to claim 1, wherein the convex portion is formed to be unevenly distributed on the side of the lateral portion so that the convex portion can be arranged substantially in parallel with an interval when attached to the autologous bone. Fixtures.

Each of the pair of fixed pieces is formed in an elongated shape in which at least the attachment portion extends in a certain direction, and the outer sandwiching portion includes a lateral portion extending laterally with respect to the elongated direction, and both the attachment portions are 2. The bone grafting material according to claim 1, wherein the joint hole is formed to be unevenly distributed on the side of the lateral portion so that the joint holes can be arranged substantially in parallel with each other when being attached to the autologous bone. Fixtures.

The coupling hole is a long hole so that the interval between the two attachment portions can be adjusted when both attachment portions of the pair of fixed pieces are attached substantially parallel to the own bone. 5. The bone repair material fixture according to 5.