JP4011616B2 - 截頭円錐形脊椎融合移植片 - Google Patents
截頭円錐形脊椎融合移植片 Download PDFInfo
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- JP4011616B2 JP4011616B2 JP50115197A JP50115197A JP4011616B2 JP 4011616 B2 JP4011616 B2 JP 4011616B2 JP 50115197 A JP50115197 A JP 50115197A JP 50115197 A JP50115197 A JP 50115197A JP 4011616 B2 JP4011616 B2 JP 4011616B2
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- Prior art keywords
- implant
- spinal fusion
- bone
- graft
- height
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Description
技術分野
本発明は椎骨間の脊椎融合移植片(埋込片)に関し、特に脊椎の2つの隣接した椎骨の解剖学的な前弯状態を回復して維持するように構成された脊椎融合移植に関する。
従来技術
体間脊椎融合とは円板空間(通常椎間板が占めている椎骨間の空間)を通して隣接椎骨をブリッジする方法である。こうした融合を容易にするための種々の移植片がCloward,Brantiganその他の人により提案されている。一般に円筒状移植片は円板空間をまたいで各隣接椎骨の受け孔に嵌入することができる。このような孔はドリルで穿孔することができる。頚堆と腰椎の両者は通常は前弯であり、前方に凸である。このような配列状態は脊椎の適正な機能にとり重要である。一般に脊椎融合による処置が必要なこれらの状態は前弯が失われることと関連している。
従って、解剖学的な前弯の回復を可能にする脊椎融合移植片に対する要求がある。
発明の概要
本発明は脊椎の所望の解剖学的前弯を達成するために、少なくとも部分的に截頭円錐形を有する各種の椎骨間脊椎融合移植片を提供する。好ましい実施例では、本発明の脊椎融合移植片は、少なくともその一部の箇所が、移植片の隣接椎骨に接触する部分に沿って、部分的または完全な截頭円錐形状の外側軌跡(包絡)を有するとともに、挿入端と後端とを有する。本発明の脊椎融合移植片は、上面と下面が截頭円錐形の位置部から構成され、且つ一方または両方の側面が切除されて移植片の縦軸線に平行な平面をなして平坦な壁を構成するように変形出来る。これらの移植片はその挿入端をよりテーパした形に形成することにより、椎骨への挿入を容易にすることが出来る。本発明の脊椎融合移植片はほぼむく及び/又は多孔室及び/又は中空でも良いし、さらに骨の内方成長を促進し及び/又は安定化するために表面粗化部を有しても良い。
本発明の脊椎融合移植片は、融合促進物質を保持しあるいは骨の内方成長部の固定を行うために、その表面から内部へ延びる井戸状の凹所を有することが出来る。これらの凹所又は孔は移植片の内部に延びても良いし、あるいは貫通しても良く、あるいは互いに交差しても、しなくても良い。本発明の脊椎融合移植片は少なくとも一つの孔を通して移植片の表面に連通していても良い少なくとも一つの室を有する。この室は少なくとも一つのアクセス用の開口ないし孔を有し、そこに融合促進物質を充填するようにしても良い。アクセス用の孔は、移植片の安定性を増しあるいは移植片の表面積を増し、及び/又は移植片が容易に挿入出来るように助成するが逆方向の運動には抵抗するように、各種の表面不規則形状を用いることが出来る。本発明の脊椎融合移植片は上記の目的を達成するように全面的又は部分的に上記の目的を達成するために、粗面仕上げ、ぎざぎざ、前向き鋸歯状部、あるいは他の不規則部を有することが出来る。
本発明の脊椎融合移植片は従来技術に比して次の利点を有する。
1.本発明の脊椎融合移植片は少なくとも部分的に截頭円錐形を有するので、その先導縁部から後端へのテーパが融合すべき椎骨部分へ挿入することを容易にし且つ完全に挿入することを可能にする。
2.本発明の移植片の形状は移植片で置換すべき椎間板(椎間板の前端は後端よりも通常高い)に一致する形状を有するので、正常な前弯を可能にする。本発明の移植片は後部よりも前部の方が同様に高い。
3.本発明の移植片は、それを受け入れるように融合の現場で容易に作製出来る受部の幾何学的形状に一致する。
本発明の脊椎融合移植片は、人体への移植に適した任意の物質から製造でき、脊椎融合の目的に利用するに充分な機械的強度を有する、たとえばコバルト・クロム合金、ステンレス鋼、チタン又はその合金、生体吸収性のものを含めた各種プラスチック、各種セラミックス、その他の目的に適合したそれらの組み合わせを使用し得る。さらに、本発明の脊椎融合移植片は、形態を問わず、むくの材料、網状材料及び/又は多孔室材料から製作出来るし、また、直接骨融合過程に参加出来る材料、あるいは骨、形態発生蛋白質、ヒドロキシアパタイト、あるいは骨生成蛋白質等の化学物質で部分的又は全面的に充填され、構成され、処理され、あるいは被覆されて、それらを脊椎融合を模擬する目的に対して生活性を付与し得る。本発明の移植片は部分的に又は全面的に生体吸収性であっても良い。
発明の目的
本発明の目的は、椎骨に容易に挿入出来るように、テーパ付き先導端(前端)を有する脊椎融合移植片を提供することである。
本発明の他の目的は、正常な椎間板のテーパに一致して一端から他端に向けて高さが変わるようにテーパしている脊椎融合移植片を提供することにある。
本発明のさらに他の目的は脊椎融合行程中に、2つの隣接椎骨の解剖学的な整列状態と前弯を維持することが出来る脊椎融合移植片を提供することにある。
本発明の他の目的は脊椎内でそれ自体で安定化する脊椎融合移植片を提供することにある。
本発明のさらに他の目的は挿入すると隣接した椎骨が安定化される脊椎融合移植片を提供することにある。
本発明の別の目的は、融合促進物質を収容し、あるいはそれから構成され、あるいはそれで処理されているために、融合過程に関与することができる脊椎融合移植片を提供することにある。
本発明のさらに他の目的は隣接した椎骨を脊椎融合過程において離間して支持することが出来る脊椎融合移植片を提供することである。
本発明のさらに他の目的は、使用時に軟骨様椎骨の厚さを一定に保つことが出来る脊椎融合移植片を提供することにある。
本発明のさらに別の目的は、融着箇所に移植片と相補形状をなす孔を容易に穿孔出来るような形状を有する脊椎融合移植片を提供することである。
本発明の更なる目的は、同一の椎間板空所に他の同一構造の移植片に近接して並べて挿入出来ると共に、上記他の移植片との総合幅が各移植片の幅の総和より小さくした、截頭円錐形の脊椎融合移植片を提供することである。
【図面の簡単な説明】
図1は、截頭円錐体と、骨に係止するための複数の鋸歯状部を含む表面形状と、骨の内方成長を許容する井戸状の凹所及び孔とを備えた本発明の椎骨融合移植片の実施例を示す側面図である。
図1Aは、図1の移植片の表面形状を例示する、図1の線1Aで囲まれた部分の拡大図である。
図2は本発明の移植片の孔及び井戸状の凹所を示すための、図1の線2−2に沿う断面図である。
図3は本発明の移植片の孔及び井戸状の凹所を示すための、図1の線3−3に沿う断面図である。
図3Aは本発明の他の実施例による截頭円錐体と、円筒状の外表面形状を画定する複数の鋸歯状部と、骨の内方成長を許容する凹所及び孔とを備えた本発明の椎骨融合移植片の実施例を示す側面図である。
図4は本発明の椎骨融合移植片の他の実施例の側面図であり、移植片は截頭円錐形の外側軌跡と移植片の縦軸線に平行は平面状側面とを有し、また一定でない半径と高さを有する複数の鋸歯状部を有する。
図5は図4の平面図である。
図6は本発明の他の実施例による椎骨融合移植片の側面図であり、繊維網状の材料から制作され、鎖線で示された同一の他の部分截頭円錐形に接して設けられた部分截頭円錐形の移植片を示す。
図7は図6の線7−7から見た断面図である。
図8は図6の線8で囲まれた部分の移植片の表面形態を示す部分拡大図である。
図9は図6の線8で囲まれた部分の移植片の他の実施例の表面形態を示す部分拡大図である。
図10は図9の線10−10に沿った拡大断面図であり、海面状物質より形成された本発明の移植片の表面構造の他の例を示す。
図11は本発明の他の実施例による椎骨融合移植片の部分破断側面図であり、截頭円錐形の本体と、複数の離間した柱状体より構成される状態を示す図である。
図12は図11の線12−12から見た拡大断面図であり、図11の移植片の表面構造を示す図である。
発明の具体的な説明
図1には本発明の脊椎融合移植片の実施例が示されており、移植片は全体的に数字220で示される。移植片220はほぼ截頭円錐形の本体を有し、脊椎の隣接する椎骨に接触する部分がほぼ截頭円錐形の外側軌跡(包絡)を有する。移植片220は隣接する椎骨に係止するのに適した前向きの複数の鋸歯状部240を有する。各鋸歯状部240は骨係止縁部242と傾斜部244を有する。鋸歯状部240は移植片220の中心線L4から測って半径R4を有し、その半径は挿入端224から後端226に向けて増大する。本体(鋸歯状部を除いた部分)から測った各鋸歯状部240の高さは移植片220の全体で一定である。
鋸歯状部240の傾斜部244が挿入時に傾斜面として作用し、一方反対方向には骨係合縁部242が運動に抵抗するので、移植片220の挿入の方が除去よりも容易である。これらの前向き鋸歯状部240は、椎骨の未除去部分が更なる運動を阻止してしっかり定着するまで移植片220の前進を助ける傾向を有する。移植片220は後端226に凹入下スロット234を有し、そこに移植片220を挿入するための器具を受け入れて係止するようになっている。凹入したスロット234はねじ孔236を有し、移植片220の器具へのねじ結合を可能にする。
好ましい実施例では、鋸歯状部240の骨係止縁部242は移植片220の台部222から測って最も高い部分で0.25〜2.0mmの高さ(根元直径)を有し、好ましくは頚椎で使用する場合には0.4mm、腰椎で使用する場合には1.25mmを有する。
図2を参照すると、移植片220の断面が示されている。移植片220は移植片220を貫通する孔250と移植片の表面に形成された凹所260を有する。凹所260は孔250に通じていてもいなくてもよい。好ましい実施例では孔250の直径は0.1〜6mm、好ましくは2〜3mmである。孔250と凹所260はほぼ円形であるが、目的に応じて任意の寸法、形状及び配置を有することができる。
図1Aを参照するに、移植片220は骨の成長を促すために椎骨に対して不規則表面を提示する多孔質の外表面238を有する。外表面238はまた融合促進物質を保持することができ、融合過程で骨に係合する増大した表面積を有すると共に、安定性を与える。外表面238及び/又は移植片全体は、融合促進剤物質を保持し、及び/又は骨の内方成長を促し、及び/又は融合過程で骨に係止するような、他の任意の多孔質材料又は粗化表面を有してもよい。移植片220はさらに、ヒドロキシアパタイト化合物、骨生成蛋白質、骨形態形成蛋白質のような生活性融合促進物質で被覆されていてもよい。移植片220はむくのものでも良いし、中空あるいは部分的に中空のものでもよい。
移植片220はむくのものとして記載したが、少なくとも部分的に中空のものにして、骨又は骨融合促進物質を保持できるようにすることができる。このような移植片は移植片の外側の骨が内部室へ向けて成長できるような孔を有することができる。このような構造は、米国特許出願第08/390131(特許第5,593,409),08/074781号(特許第5484437)に記載がある。
図3Aを参照するに、移植片220に代わる他の実施例が移植片220’で示されている。移植片220’は移植片220と同様な構造を有するが、その本体が截頭円錐形を有すると共に、挿入端224’から後端226’まですべての鋸歯状部240’が縦軸線L4から測って一定の半径R3を有する点では違っている。鋸歯状部240’の高さは本体(鋸歯状部を除いた部分)から測って移植片220’の全体にわたり異なった高さを有する。このようにして、鋸歯状部240’は移植片220’のほぼ円筒形の外面形状を画定し、一方本体は截頭円錐形を有する。移植片220’の挿入を容易にするために移植片220’の挿入端224’は小直径のテーパ部223’を有する。
図4〜5を参照すると、移植片220の他の実施例が数字220”で示されている。移植片220”は図1の移植片220と同様な構造を有し、縦軸線L5から測って、挿入端224”から後端226”へ向けて次第に増大する半径R5の鋸歯状部240”を有する。鋸歯状部240”はほぼ円筒形の本体222”から測った高さは移植片220”の全長にわたり一定でない。この実施例では、鋸歯状部の半径R5と高さは挿入端224”から後端226”へ向けて増大している。
図5に示したように、移植片220”は両側部が切除され、直径を挟んで対向する、縦軸線L5に平行な2つの平面を画定する側面270、272を有する。このようにして2個の同一の移植片220”を一方を側面270が他方の側面272が接触するようにして並べることができ、それにより、隣接する椎骨の骨と鋸歯状部240”との接触面積が最大になるようにすることができる。別法として、移植片220”は一方の側部だけが切り取られていてもよい。
図6〜8には、本発明の他の実施例による椎骨融合移植片320aが示されている。移植片320aは鎖線で示した他の同一の移植片320bと並べて配置されている。移植片320aは、金属から製作してもよい糸を一緒に圧縮して、隣接する椎骨と接触する部分に沿う移植片320aの部分にほぼ沿っている部分的な截頭円錐形に成形した、網状材料より構成される本体322を有する。移植片320aは挿入端324と後端326とを有する。移植片320aは全部又は部分的にむくの、及び/又は多孔質の、及び/又は網状の材料から製作することができる。移植片320aは多孔質材料、網状材料、又は粗化した表面を有することができる。移植片320aはむくでも良いし、部分的に中空でも良いし、少なくとも1つの内室を有してもよい。図8に示したように、網状材料は成形され且つ圧縮一体化された多数の糸よりなり、それにより融合促進物質を保持することができ且つ骨の内方成長を可能にする間隙部339が、移植片320aの少なくとも外表面338に存在するようにする。
図9、図10を参照するに、別の形態では、移植片320aは人の海綿骨に類似の海綿状材料350から形成することができる。移植片は間隙部352を有し、そのため外表面338は図9〜10のような形状を有する。移植片320aは全体的又は部分的に海綿状材料から製作して、間隙部352が移植片の外表面338及び/又は内部全体に存在するようにし、それにより骨の内方成長を可能にし、骨癒着促進材料を保持することを可能にしてもよい。
図7を再び参照すると、移植片320aは同様な部分的な截頭円錐形を有するが、移植片320aの中心軸線に対して平行な平面をなす少なくとも一つの側面340を形成するように切除されている。この切除部の側面340は二つの移植片320a,320bを二つの隣接した椎骨の間に並べて密着配置するのに適する(米国特許出願第08/390131号参照)。移植片320aは部分的にねじ部、あるいは実施例で述べたような同様な他の手段とあるいは機能的に同等の他の手段を有することができる。
図11は、本発明の移植片の他の実施例の部分的に切除された側面図である。移植片420は隣接した椎骨に接触する部分に沿った截頭円錐形の本体を有し、また挿入端424と後端426を有する。移植片420は融合に参加しあるいは骨の成長を促進することができる骨保持部材を有することができる外表面438を有する。好ましい実施例では、表面438は多数の離間配置された柱状体440を有し、それらの間に粉砕した骨又は人工骨による内方成長促進物質を保持することができる不完全井戸状の多数の凹所442を有する。移植片420は表面438に適当な融合促進物質を充填または被覆することにより移植可能なように調製できる。
図12を参照すると、移植片420の表面438の拡大図が示されている。好ましい実施例では、柱状体440は頭部444が残りの部分よりも大きい直径を有し、それらの間の各凹所442は柱状体440とは逆の形状を有する。この凹所442と柱状体440の構成によると、骨物質の表面438への保持作用が大きくなり、さらに骨の内方成長により生成される骨融合塊への係止力が向上する。骨の内方成長は凹所442の底446へ向けて成長するにつれて幅が広くなるので、骨の内方成長は入口448から出ていくことは出来ず、凹所に閉じ込められる。移植片420の表面438は利用可能な表面積を増大するが、さらに粗化、フロック処理、又は他の表面を非平滑にする方法により、この表面積をさらに増すことが出来る。
好ましい実施例では、柱状体440は約0.1〜2mmの範囲の最大直径を有し、約0.1〜2mmの高さを有し、約0.1〜2mm互いに離間しているので、凹所442は約0.1〜2mmの幅を有することになる。柱状体の寸法、形状、及び分布は同一の移植片内で異なっても良い。
以上により本発明を好ましい実施例に関連して説明したが、本発明の範囲内で他の変形例が可能なことは明らかであろう。
Claims (9)
- 人の脊椎の隣接した椎骨の間の外科的に補正された高さの円板空間に横から挿入される無ねじ脊椎融合移植片において、
前記移植片は、縦軸線と、挿入端と、後端と、両端間に延長する長手部と、前記隣接した椎骨の一方の椎骨へ向いた上部と、前記隣接した椎骨の他方へ向いた下部とを有する本体であって、前記長手部を横断する前記上部及び下部の間の前記長手部に沿った高さが一定であり、さらに前記隣接した椎骨相互の方向へ骨の成長を許容するための互いに連通した少なくとも2つの開孔を有している本体;
並びに前記上部及び下部の少なくとも一部から延びていて、脊椎に移植された際に前記隣接した椎骨に前記移植片を係止させる無ねじ骨係止手段であって、前記長手部に沿った高さが一定の部分で、前記本体の長手部に沿って前記挿入端側から他方の前記後端側へ向けて増加する高さを有する骨係止手段、を有する人体適合性の材料から製作されている脊椎融合移植片。 - 前記骨係止手段は、前記隣接した椎骨に係止するため及び前記移植片を所定位置に保持するための複数の表面粗化部である請求項1の脊椎融合移植片。
- 前記表面粗化部は少なくとも1つのぎざぎざ、複数個の柱状体、又は複数個の鋸歯状部である請求項2の脊椎融合移植片。
- 前記骨係止手段は前記移植片の前記円板状空間への挿入を容易にするためのテーパ部を挿入端に有する請求項1〜3のいずれかの脊椎融合移植片。
- 前記本体は内室を有する請求項1〜4のいずれかの脊椎融合移植片。
- 前記本体は前記移植片の縦軸線に平行な平面を形成する少なくとも1つの截頭平面を有する請求項1〜5のいずれかの脊椎融合移植片。
- 前記移植片は少なくとも部分的に生体吸収性である請求項1〜6のいずれかの脊椎融合移植片。
- さらに融合促進物質を表面に組み合わせた請求項1〜7のいずれかの脊椎融合移植片。
- 融合促進物質は少なくとも骨、骨形成タンパク質、ヒドロキシアパタイト、ヒドロキシアパタイト化合物、骨生成蛋白質及び骨形態形成蛋白質より選択される請求項8の脊椎融合移植片。
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US08/484,928 | 1995-06-07 | ||
US08/484,928 US6923810B1 (en) | 1988-06-13 | 1995-06-07 | Frusto-conical interbody spinal fusion implants |
PCT/US1996/008613 WO1996040019A1 (en) | 1995-06-07 | 1996-06-06 | Frusto-conical interbody spinal fusion implants |
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JP50115197A Expired - Lifetime JP4011616B2 (ja) | 1995-06-07 | 1996-06-06 | 截頭円錐形脊椎融合移植片 |
JP2005296242A Expired - Fee Related JP4005613B2 (ja) | 1995-06-07 | 2005-10-11 | 無ねじ脊椎融合移植片 |
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JP2005296242A Expired - Fee Related JP4005613B2 (ja) | 1995-06-07 | 2005-10-11 | 無ねじ脊椎融合移植片 |
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EP (2) | EP0836457B1 (ja) |
JP (2) | JP4011616B2 (ja) |
KR (1) | KR19990022610A (ja) |
CN (1) | CN1149059C (ja) |
AT (2) | ATE274889T1 (ja) |
AU (1) | AU6036096A (ja) |
CA (1) | CA2224249C (ja) |
DE (3) | DE69633287T2 (ja) |
ES (1) | ES2293113T3 (ja) |
WO (1) | WO1996040019A1 (ja) |
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1995
- 1995-06-07 US US08/484,928 patent/US6923810B1/en not_active Expired - Lifetime
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- 1996-06-06 EP EP96917996A patent/EP0836457B1/en not_active Expired - Lifetime
- 1996-06-06 DE DE69633287T patent/DE69633287T2/de not_active Expired - Lifetime
- 1996-06-06 KR KR1019970709091A patent/KR19990022610A/ko not_active Application Discontinuation
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Also Published As
Publication number | Publication date |
---|---|
EP1442732B1 (en) | 2007-09-26 |
US7942933B2 (en) | 2011-05-17 |
JPH11506656A (ja) | 1999-06-15 |
KR19990022610A (ko) | 1999-03-25 |
CA2224249C (en) | 2007-11-27 |
DE69633287T2 (de) | 2005-01-13 |
JP4005613B2 (ja) | 2007-11-07 |
DE69637271T2 (de) | 2008-01-24 |
DE29623360U1 (de) | 1998-03-19 |
US20050165399A1 (en) | 2005-07-28 |
US6923810B1 (en) | 2005-08-02 |
EP0836457B1 (en) | 2004-09-01 |
CA2224249A1 (en) | 1996-12-19 |
US8409292B2 (en) | 2013-04-02 |
US20110224795A1 (en) | 2011-09-15 |
CN1190881A (zh) | 1998-08-19 |
JP2006061708A (ja) | 2006-03-09 |
AU6036096A (en) | 1996-12-30 |
ES2293113T3 (es) | 2008-03-16 |
DE69637271D1 (de) | 2007-11-08 |
US7691148B2 (en) | 2010-04-06 |
WO1996040019A1 (en) | 1996-12-19 |
US20050165489A1 (en) | 2005-07-28 |
ATE274889T1 (de) | 2004-09-15 |
ATE373999T1 (de) | 2007-10-15 |
EP0836457A4 (en) | 1999-09-15 |
EP1442732A1 (en) | 2004-08-04 |
CN1149059C (zh) | 2004-05-12 |
US20100217394A1 (en) | 2010-08-26 |
EP0836457A1 (en) | 1998-04-22 |
DE69633287D1 (de) | 2004-10-07 |
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