JP2001520914A - 部分的に脱鉱化された骨インプラント - Google Patents

部分的に脱鉱化された骨インプラント

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Publication number
JP2001520914A
JP2001520914A JP2000517679A JP2000517679A JP2001520914A JP 2001520914 A JP2001520914 A JP 2001520914A JP 2000517679 A JP2000517679 A JP 2000517679A JP 2000517679 A JP2000517679 A JP 2000517679A JP 2001520914 A JP2001520914 A JP 2001520914A
Authority
JP
Japan
Prior art keywords
implant
bone
segment
demineralized
cut
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2000517679A
Other languages
English (en)
Other versions
JP2001520914A5 (ja
Inventor
ジェイミー グルームス
ケビン シー． カーター
トム サンダー
Original Assignee
ユニバーシティー オブ フロリダ ティシュー バンク インク．
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ユニバーシティー オブ フロリダ ティシュー バンク インク． filed Critical ユニバーシティー オブ フロリダ ティシュー バンク インク．
Publication of JP2001520914A publication Critical patent/JP2001520914A/ja
Publication of JP2001520914A5 publication Critical patent/JP2001520914A5/ja
Pending legal-status Critical Current

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Classifications

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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
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Abstract

(57)【要約】 本発明は、ねじ山、溝、ドライバ・ヘッド、凹部、あるいは対称形状または非対称形状を含むように切削することのできる少なくとも１つの剛性の鉱化骨セグメント（２０１、２０２）と、同様に脱鉱化の前後に任意の所望の形状に切削することのできる可撓性の脱鉱化セグメント（２０３）とを有する新規の単体骨インプラント（２００）を提供する。本発明のインプラント（２００）は、靭帯（３００）、腱（４００）、および関節（８００）の修復または置換を含め、広い整形外科応用可能性を有する。

Description

【発明の詳細な説明】
【０００１】発明の分野 本発明は、靭帯、腱、または副木として移植されるか、あるいは第１の切削さ
れた剛性セグメントおよび第２の可撓性セグメントを有する単体インプラントが
必要とされるその他の応用分野で移植される、部分的に脱鉱化され適切にかたど
られ切削された骨で構成された装置に関する。
【０００２】背景 当技術分野では依然として、生物学的に受け入れられる靭帯置換物または腱置
換物が必要である。当技術分野では、この要件を満たすための様々な努力がなさ
れている。たとえば、米国特許第５０５３０４９号では、所定の形状の可撓性補
綴物と、該補綴物を製造する方法が開示された。この開示によれば、骨を、置き
換えるべき軟骨性身体部分の形状に対応する所望の形状に切削し、該骨を脱鉱化
して可撓性を付与し、なめして抗原性を低減することによって、軟骨性部分に置
き換わる可撓性で生体適合性の非抗原性補綴物が製造された。脱鉱化された骨の
腱置換物または靭帯置換物としての使用に関する開示や示唆はなかった。
【０００３】 米国特許第５０９２８８７号では、損傷した線維性結合組織を置換または補強
する方法が開示され、この場合、脱鉱化された骨のセグメントで構成された靭帯
が第１の身体部分と第２の身体部分との間に取り付けられた。脱鉱化の前に骨を
切削し、その上に固定端部を作製し、このように切削された骨のセグメントのみ
を脱鉱化して可撓性セグメントを製造したのに対して、切削された取付け端部を
、完全に鉱化した硬性状態にしておき、このような固定端部を受容するように適
合された骨に直接固定できるようにすることの開示や示唆はなかった。背景技術
の議論と骨を脱鉱化する方法とに関する米国特許第５０９２８８７号の開示は、
参照として本明細書に組み入れられる。
【０００４】発明の概要 本発明は、ねじ山、溝、ドライバ・ヘッド、凹部、あるいは対称形状または 非対称形状を含むように切削することのできる少なくとも１つの剛性の鉱化骨セ
グメントと、同様に脱鉱化の前後に任意の所望の形状に切削することのできる可
撓性の脱鉱化セグメントとを有する新規の単体骨インプラントを提供する。
【０００５】好ましい態様の詳細な説明 本発明は、損傷した靭帯、腱、椎間板などに置き換わる生物学的に受け入れら
れる靭帯、腱、副木、またはその他のインプラントを提供する。剛性の切削部分
または切削セグメントと可撓性の脱鉱化部分または脱鉱化セグメントとの両方を
有するインプラントが必要である。本発明の一態様によれば、好ましくは皮質骨
のセグメントが所望の形状に切削され、少なくとも一端が、相補的に切削された
骨にこの端部を直接固定する手段を形成するように切削される。
【０００６】 図１Ａを参照すると、本発明１００のインプラントの第１の態様が示されてい
る。この態様では、インプラントの端部１０１および１０２がねじ山を有するよ
うに切削され、インプラントが取り付けられる骨が、インプラント端部上のねじ
山と相補的な受容側ねじを有するようにねじ立てされる。または、ねじ付き端部
１０１、１０２をセルフタッピングにし、それによって受容側骨のねじ立てを不
要にすることができる。ねじ付きインプラント端部の直径よりもわずかに小さな
直径を有する簡単な穴を、ねじ付きインプラント端部を受容するように、同様な
手段によって掘削または製造することができる。インプラントの内部セグメント
１０３がインプラントの可撓性セグメントを形成するように脱鉱化され、それに
対して、骨の鉱化レベルが完全な鉱化状態から脱鉱化状態に徐々に変化する遷移
ゾーン１０４、１０５が設けられる。本発明のこの態様の好ましいバージョンで
は、インプラント全体を時計回りまたは逆時計回りに回転させたときに、インプ
ラントの両端が、インプラントの可撓性セグメント１０３をよじれさせずに、イ
ンプラントが取り付けられる相補切削骨に同時に挿入されるかあるいは相補切削
骨から抜き取られるように、インプラントの２つの端部１０１、１０２がねじ山
を有するように切削される。図１Ｂには、一方の端部１０１’にねじ山が設けら
れず、固定ブロックなど任意の所望の形状に切削され、それによって、ねじ付き
端部１０２が受容側骨にねじ込まれるのに対して、固定ブロック１０１’が、締
めねじまたは当技術分野で知られている同様な手段によって所定の位置に取り付
けられる代替態様が示されている。図１Ｄに示す他の態様では、インプラント全
体が、その全長または一部にわたってカニューレ挿管１１０を有するように切削
される。このように、インプラントはガイドワイヤまたは同様な誘導手段を介し
て挿入することができる。または、カニューレ挿管１１０は、ねじ付き保持ねじ
を受容することのできる雌ねじでよい。この態様または本発明の任意の他の態様
に関して開示される特徴を本発明の他の態様に適用し、個別に開示される各態様
に関して開示される様々な特徴の様々な組合せを有する態様を生成できることが
認識されると思われる。
【０００７】 図２に示す本発明の他の態様２００では、インプラント２００の一端２０２の
みが、ねじ山または他の切削されたフィーチャを有するように切削されるのに対
して、他端２０１は固定穴２１０または同様なフィーチャを持つように切削する
ことができ、それによって、縫合またはその他の方法で端部を靭帯または腱に固
定することができる。インプラント２０３の可撓性セグメントの場合と同様に、
鉱化状態から脱鉱化状態への遷移ゾーン２０４が設けられる。図２Ｃから図２Ｅ
にそれぞれ、端面図、側面図、および平面図を示す。本発明のこの態様には、任
意選択のカニューレ挿管２２０が示されており、このカニューレ挿管は、インプ
ラントの切削部分２０２を、たとえばガイドワイヤを介してねじ込むことを可能
にし、しかもインプラントの平坦な脱鉱化セグメント２０３に干渉しない。
【０００８】 図３に示す本発明の他の態様３００では、インプラントを使用して靭帯と置き
換えることができる。この態様では、可撓性セグメント３０３から末端の鉱化固
定ブロック３０１、３０２までの２つの遷移ゾーン３０４、３０５が設けられる
。固定ブロック３０１および３０２はそれぞれ、固定ねじまたは固定ピンを受容
するように切削された管３０６、３０７を有する。鉱化部分３０２、３０３は、
任意の所望の形態の固定装置として切削することができる。この固定装置は、ね
じ山、または固着ピンもしくは固着ねじを受容する穴、またはスリーブ内で回転
するねじを含むことができる。
【０００９】 図４Ａに示す態様４００では、インプラントが腱を修復または置換するために
使用される。この態様では、インプラント４００の一端４０２のみが骨に固定で
きるように切削され、インプラントの第２の端部４０１は、様々な形状に適合さ
れ、この端部を骨、筋肉、腱、または靭帯に固定できるようにねじ込み可能な穴
４１０などの手段を末端に有する。図４Ｂおよび図４Ｄに示す代替態様では、端
部４０１’は、複数の穴または穿孔４１０’を有するように切削され、したがっ
て、筋肉、靭帯、腱、骨などの受容側の生物学的構造に縫合することができる。
【００１０】 図５には、本発明のインプラント５００を移植する１方法が示されており、こ
の場合、固定ねじ５５３を使用して、インプラント５００をその剛性セグメント
５０１の穴５５２を通して所定の位置にロックする（図５Ａ）か、あるいはイン
プラントをねじ付き凹部を介してインプラントの剛性端部５０３の所定の位置に
ロックする（図５Ｂおよび図５Ｃ）ことによって、本発明のインプラント５００
の態様が骨５５０の切削スロット５５１に保持される。インプラント５０４の他
端は、脱鉱化され、したがって可撓性であり、末端に穴５０２を有するか、ある
いはインプラントの端部を骨、腱、靭帯、または筋肉に取り付けるための他の固
定手段を有する。上記で指摘したように、セクション５０１にねじ山を設けるこ
とができ、端部５０２は、鉱化状態に維持し、締めねじによって保持される固定
ブロックの形状にすることができ、または端部５０２にねじ山を設けることもで
きる。また、インプラント５００にカニューレ挿管を設けることができ、その場
合、凹部５０３はインプラントの全長またはインプラントのある部分にわたって
連続する。
【００１１】 図６は、インプラント６００が大腿輪部材である本発明の態様を示し、この場
合、上端６０１および下端６０４は剛性鉱化状態に維持され、当技術分野で知ら
れている手段（参照として本明細書に組み入れられる国際公開公報第９７／２５
９４５号を参照されたい）によってねじまたは溝を有するように切削することが
できる。インプラント６０３の内部セグメントは、たとえば、隣接する推体の間
に本発明のこの態様における挿入を行う際に可撓性副木を形成するように、軟性
海綿状領域を有するように脱鉱化される。大腿輪には内部管６０１が示されてお
り、この管は、大腿骨または同様な長骨の骨幹を横切るほぼ平面状の平行なクロ
スカットによって得られる大腿輪由来の骨における自然髄内管から得られる。
【００１２】 本発明のインプラントは、第１の鉱化部分または鉱化セグメントおよび第２の
可撓性の脱鉱化部分または脱鉱化セグメントを備える切削され部分的に脱鉱化さ
れた骨を含み、好ましくは１皮質骨片を任意の所望の形状に切削することによっ
て製作される。この骨としては、好ましくは大腿骨、脛骨、腓骨、撓骨、尺骨な
ど強靭な皮質骨が選択される。ドナー・ボーンの供給源としては、自家移植骨、
同種移植骨、または異種移植骨でよく、各場合において、病原性因子または抗原
性因子の受容側骨への導入を防止するために、当技術分野で公知の適切な予防策
がとられる。
【００１３】 インプラント骨ストックを適切に形削りした後、好ましくは、ねじ山、または
相補的に切削された受容側骨にインプラントを直接取り付けることのできる同様
な固定手段を有するように、インプラントのセグメントを切削する。インプラン
トのセグメントを、パラフィルム、ゴムまたはラテックスの被覆、プラスチック
・ラップなど任意の保護装置を用いて適切に保護することによって鉱化状態に維
持する。次いで、当技術分野で知られている方法に従って、インプラントの残り
のセグメントを脱鉱化する。たとえば、図１Ａに示す本発明の態様１００では、
遷移ゾーン１０４、１０５にかかるゴム・ストッパに両端１０１、１０２を挿入
することができ、内部セグメント１０３が、骨のセグメントから鉱物を浸出させ
るのに十分な強度の酸溶液にさらされる。５％酢酸溶液または１Ｎ塩酸溶液を使
用することができ、インプラントは、内部ゾーン１０３の所望の可撓性レベルに
ついて定期的に検査することができる。内部に鉱物が堆積する膠原マトリックス
のペプチド結合が切断する恐れがあるので、このプロセスでは過度に高い濃度の
強酸は使用されないことに留意されたい。したがって、約０．１Ｎから２ＮのＨ
Ｃｌの濃度を使用することができ、酸にさらす期間は、酸濃度が低くなるにつれ
て長くなり、酸濃度が高くなるにつれて短くなる。同様に、酸にさらす期間は、
使用する酸の強度に応じて異なる。遷移ゾーン１０４、１０５は、保護被覆で覆
われたインプラントのセグメントにおいて、骨中に酸を拡散し、かつ骨外へ鉱物
を拡散させることによって形成される。脱鉱化の程度を変化させることにより、
インプラントが使用される特定の応用分野の必要に応じて最適な強度および可撓
性が付与されるように本発明のインプラントの特性を変更することができる。
【００１４】 このように処理されたインプラントは、インプラントの抗原性を低減するため
に、なめしまたは当技術分野で知られている他の手段によってさらに処理するこ
とができる。たとえば、グルタルアルデヒド処理（当目的のために参照として本
明細書に組み入れられた米国特許第５０５３０４９号を参照されたい）を使用す
ることができる。
【００１５】 図７には、本発明のインプラントの様々な断面形状が示されている。したがっ
て、図７Ａには、円筒状断面が示されている。０．５ｍｍ以下という小さなもの
から１０ｍｍという大きなものまでの様々な直径が望ましく、ある種の応用分野
では、それよりもずっと大きな直径が望ましいことが認識されよう。図７Ｂには
、楕円断面が示されている。図７Ｃには、平坦な断面が示されている。図７Ｄに
は、十字形断面が示されている。当業者には、本発明の開示では、本発明のイン
プラントの可撓性セグメントまたは剛性セグメントについて本質的にいかなる所
望の形状をも製造することができ、そのような変形態様が本開示および特許請求
の範囲の範囲内であることが認識されると思われる。本明細書で示唆される様々
な断面形状を形成する際には、インプラントの剛性端部と可撓性セグメントとの
間で円滑な遷移が行われることが望ましい。これは、可撓性セグメントがテーパ
付けされるように端部を適切に切削し、完全鉱化セグメントから脱鉱化セグメン
トへの段階的な脱鉱化が行われるように脱鉱化プロセスを慎重に制御することに
よって行われる。
【００１６】 さらに、上記の開示から、本発明のインプラントを様々な応用分野向けに適切
に成形できることが理解されると思われる。たとえば、本発明のインプラントは
、必要に応じて手、肱、膝、足、踝、またはその他の解剖学的位置における靭帯
または腱を修復するのに適用することができる。さらに、本発明のインプラント
は、様々な関節の置換に適用することができる。関節置換に関して当技術分野で
知られている方法およびインプラント形状（たとえば、米国特許第４８７１３６
７号、Ｄｅｓ第２８４０９９号、Ｄｅｓ第２７７７８４号、Ｄｅｓ第２７７５０
９号、Ｄｅｓ第３８８６６００号、Ｄｅｓ第３８７５５９４号、Ｄｅｓ第３７７
２７０９号、Ｄｅｓ第５４８４４４３号、Ｄｅｓ第５０９２８９６号、Ｄｅｓ第
５１３３７６１号、Ｄｅｓ第５４０５４００号、Ｄｅｓ第４７５９７６８号を参
照されたい。これらの特許は、関節補綴インプラントに適用できる様々な点の教
示について参照として本明細書に組み入れられる）は、本開示のインプラントに
従って成形することができ、本開示のインプラントで置き換えることができる。
したがって、本発明の一つの態様では、皮質骨片が、米国特許第３８７５５９４
号で開示された（成形シリコンゴムから製造された）荷重分散可撓性ヒンジと同
様な荷重分散可撓性ヒンジを有する外科的に移植可能な補綴関節を形成するよう
に形成される。本発明のこの態様によれば、拡大中央部と、互いに逆方向に突き
出る一対の遠位ステム部および近位ステム部とから成る補綴物が形成される。中
央部の底面（volar aspect）は、中央部が脱鉱化されたときに可撓性ヒンジを形
成するように、幅を横切って延びるくぼみまたは横方向チャネルを有するように
切削される。中央部は、ヒンジとして働くことが意図されるために脱鉱化され、
インプラントの鉱化された末端は、インプラントで置き換える関節に隣接する骨
の髄内空間に各端部を挿入できるように鉱化状態に維持される。鉱化された末端
は、隣接する骨の髄内空間に各端部を挿入したときに、端部が所定の位置に固定
されるように、ねじ山または歯止め構造を有するように切削される。端部が骨で
構成されているので、インプラントとインプラントの挿入される骨との間の自然
結合プロセスに数週間かかり、したがって、この補綴物は所定の位置に永久的に
固定され、インプラントの端部のいかなる移動も防止される。本発明のこの態様
によるインプラントを使用して、たとえば、中手指節関節、近位指節間関節など
を置き換えることができる。したがって、本発明により、現在関節形成に使用さ
れている金属、ハイドロキシアピタイト、シラスティック、シリコーンなどの弾
性材料の自然代替策が実現され、当技術分野の顕著な進歩が提供される。
【００１７】 図８では、本発明に係る補綴関節のインプラントの概略図が示されており、本
発明の中心的な概念に従って作製できる。インプラント８００は、遷移セグメン
ト８２０の一部を含む脱鉱化された拡大中央部８１０を有する。中央部８１０の
両側には、インプラント８００で置き換えられる関節に隣接する骨の髄内管に挿
入できるように適合された鉱化突起８３０がある。当目的のために参照として本
明細書に組み入れられる米国特許第３８７５５９４号に記載された原理に従って
、ヒンジとして働き関節の湾曲運動を可能にする溝またはチャネル８５０が設け
られる。任意選択で、突起８３０は、髄内空間でのインプラントの保持を強化す
るように設計された外部フィーチャを有することができる。図８に示す態様では
、このフィーチャは、各突起８３０の上面または底面として切削できるか、ある
いは突起の周囲から突き出ることのできる歯状鋸歯形成として示されている。イ
ンプラントの保持を助けることのできる代替外部フィーチャには、保持ピンを挿
入できる穴、溝、リビングなどが含まれる。脱鉱化中央部８１０によって、この
部分を関節として働かせるのに十分な可撓性がインプラント８００に付与され、
それに対して、突起８３０は、永久固定部分を形成するために挿入される骨と結
合する。
【００１８】 本発明の様々な態様について概略的に説明したが、本発明のさらなる例として
以下の実施例を提供する。本明細書で開示され特許請求される発明は、これらの
実施例に示される詳細に限定されないことを認識されたい。
【００１９】実施例１ 本発明のインプラントの切削 実質的に皮質骨から成る骨片を使用して本発明のインプラントを切削するよう
に、開始骨ストックを選択した。大腿骨の粗線または脛骨の前部から得たインプ
ラントをこの目的のために使用したが、他の皮質骨源も使用することができる。
骨のこぎりまたは水冷ダイヤモンド・コア・カッタを用いて所望の骨セグメント
を除去し、所望の外部フィーチャを切削するために旋盤に適合するようにトリミ
ングした。骨をまず、既知の直径および長さに切削した。次いで、端部を雌ねじ
、雄ねじを有するように切削するか、あるいはインプラントの一端を切削し、そ
れに対して、他端をいくつかの穴を有するように掘削した。次いで、脱鉱化すべ
き内部セグメントを円筒形態に維持するか、またはねじ付き端部同士もしくは固
定端部同士の間に平坦な内部セグメントもしくは他の所望の形状を有するように
フライス盤または研削盤で切削した。
【００２０】実施例２ 切削された骨移植片の部分的脱鉱化 １．大形円筒状靭帯修復移植片 切削された大形円筒状靭帯修復移植片の脱鉱化を、約４０ｍＬの０．７５Ｍか
ら１．０Ｍ塩酸溶液を使用して３日間行った。インプラントを、少なくとも1日 に1度、新鮮な溶液にさらした。完全に鉱化された端部から完全に脱鉱化された セグメントへ徐々に遷移させるために、脱鉱化プロセスの所要期間にわたってＨ
Ｃｌ溶液とインプラントとの接触点を変化させた。
【００２１】 ２．小形円筒状靭帯修復移植片 切削された小形円筒状靭帯修復移植片の脱鉱化を、約４０ｍＬの０．７５Ｍか
ら１．０Ｍ塩酸溶液を使用して２日で完了した。インプラントを少なくとも１日
１度新鮮な溶液にさらした。完全に鉱化された端部から完全に脱鉱化されたセグ
メントへ徐々に遷移させるために、脱鉱化プロセスの所要期間にわたってＨＣｌ
溶液とインプラントとの接触点を変化させた。
【００２２】 ３．平坦な靭帯修復移植片または腱修復移植片移植片 移植片の内部セグメントが平坦に切削された切削済み靭帯修復移植片または腱
修復移植片の脱鉱化を、約４０ｍＬの０．７５Ｍから１．０Ｍ塩酸溶液を使用し
て２４時間で完了した。インプラントを少なくとも１日１度新鮮な溶液にさらし
た。完全に鉱化された端部から完全に脱鉱化されたセグメントへ徐々に遷移させ
るために、脱鉱化プロセスの所要期間にわたってＨＣｌ溶液とインプラントとの
接触点を変化させた。
【００２３】 ４．２つの剛性端部を有する２重平坦靭帯修復移植片 切削された平坦な靭帯修復移植片の脱鉱化を、約４０ｍＬの０．７５Ｍから１
．０Ｍ塩酸溶液を使用して２４時間で完了した。インプラントを少なくとも１日
１度新鮮な溶液にさらした。完全に鉱化された端部から完全に脱鉱化されたセグ
メントへ徐々に遷移させるために、脱鉱化プロセスの所要期間にわたってＨＣｌ
溶液とインプラントとの接触点を変化させた。一方の端部がねじ山を保持し、他
方の端部が固定ブロックである、インプラントの剛性の両端を保護するために、
インプラントのねじ付き端部を酸のメニスカスの上方に維持することによってイ
ンプラントの中央セグメントのみを酸溶液にさらし、インプラントの固定ブロッ
ク端部をボアード・ストッパに挿入した。ボアード・ストッパは、酸容器の底部
でのプラグとしても働き、酸容器には、インプラント保持ストッパを受容するの
に適した穴が掘削されている。
【００２４】 最良の形態を含む、本発明のインプラントの様々な態様を開示し記載した上記
の開示および実施例を鑑みて、本発明の範囲を定義するために特許請求の範囲を
示す。当業者であれば、本明細書に開示される本発明の詳細に対する様々な改変
が特許請求の範囲の範囲内であることを認識すると思われる。
【図面の簡単な説明】
【図１】 剛性の骨セグメントが、各端部にねじ山を有するように切削され
（図１Ａ）、次いで、切削された端部同士の間に可撓性セグメントを形成するよ
うに内部セクションのみが脱鉱化される（図１Ｃ）本発明のインプラントの第１
の態様の図である。図１Ｂは、インプラントの一端が剛性の固定骨ブロックを有
する他の態様を示す。図１Ｄは、本発明のインプラントのカニューレ付き態様の
端面図を示す。
【図２】 剛性の骨セグメントが、一端にねじ山を有し、他端に取付け穴を
有するように切削され（図２Ａ）、次いで、可撓性のセグメントを形成するよう
にインプラントの取付け穴端部が脱鉱化され、それに対して、ねじ付きセグメン
トが剛性部材として保持される（図２Ｂ）本発明のインプラントの第２の態様の
図を示す。インプラントの部分カニューレが端面図（図２Ｃ）、平面図（図２Ｄ
）、および側面図（図２Ｅ）で示されている。
【図３】 剛性の骨セグメントが、インプラントの各端部に固定ブロックを
有するように切削され（図３Ａ）、次いで、切削された固定ブロック端部の間に
可撓性セグメントを形成するように２つの端部の間が脱鉱化される（図３Ｂ）本
発明のインプラントの第３の態様の図を示す。
【図４】 剛性の骨セグメントが、一端に固定ブロックを有し、他端に取付
け穴（図４Ａ）またはいくつかの穴もしくは穿孔（図４Ｂ）を有するように切削
され、次いで、可撓性セグメントを形成するように取付け穴を保持する端部が脱
鉱化され（図４Ｃおよび図４Ｄ）、それに対して、固定ブロックが剛性部材とし
て保持される本発明のインプラントの第４の態様の図を示す。
【図５】 本発明のインプラントを移植する一方法を示す図であって、イン
プラントを剛性セグメントの穴を通して所定の位置にロックする（図５Ａ）か、
またはインプラントをねじ付き凹部を介してインプラントの剛性端部の所定の位
置にロックする（図５Ｂおよび図５Ｃ）ことによって、止めねじを使用して本発
明のインプラントを所定の位置に保持する。
【図６】 インプラントが、リングの上端および下端を剛性鉱化状態に維持
し、ねじ山または溝を有するように切削することができる大腿輪であり、インプ
ラントの内部セグメントが、本発明のこの態様を隣接する推骨の間に挿入する際
に可撓性副木を形成する軟性海綿状層を有するように脱鉱化される、本発明の一
つの態様を示す。
【図７】 本発明のインプラントの脱鉱化セグメントにおける様々な断面図
を示す。
【図８】 本発明に係る補綴関節の一態様を示す図である。
───────────────────────────────────────────────────── フロントページの続き (81)指定国 ＥＰ(ＡＴ，ＢＥ，ＣＨ，ＣＹ， ＤＥ，ＤＫ，ＥＳ，ＦＩ，ＦＲ，ＧＢ，ＧＲ，ＩＥ，Ｉ Ｔ，ＬＵ，ＭＣ，ＮＬ，ＰＴ，ＳＥ)，ＯＡ(ＢＦ，ＢＪ ，ＣＦ，ＣＧ，ＣＩ，ＣＭ，ＧＡ，ＧＮ，ＧＷ，ＭＬ， ＭＲ，ＮＥ，ＳＮ，ＴＤ，ＴＧ)，ＡＰ(ＧＨ，ＧＭ，Ｋ Ｅ，ＬＳ，ＭＷ，ＳＤ，ＳＺ，ＵＧ，ＺＷ)，ＥＡ(ＡＭ ，ＡＺ，ＢＹ，ＫＧ，ＫＺ，ＭＤ，ＲＵ，ＴＪ，ＴＭ) ，ＡＬ，ＡＭ，ＡＴ，ＡＵ，ＡＺ，ＢＡ，ＢＢ，ＢＧ， ＢＲ，ＢＹ，ＣＡ，ＣＨ，ＣＮ，ＣＵ，ＣＺ，ＤＥ，Ｄ Ｋ，ＥＥ，ＥＳ，ＦＩ，ＧＢ，ＧＥ，ＧＨ，ＧＭ，ＨＲ ，ＨＵ，ＩＤ，ＩＬ，ＩＳ，ＪＰ，ＫＥ，ＫＧ，ＫＰ， ＫＲ，ＫＺ，ＬＣ，ＬＫ，ＬＲ，ＬＳ，ＬＴ，ＬＵ，Ｌ Ｖ，ＭＤ，ＭＧ，ＭＫ，ＭＮ，ＭＷ，ＭＸ，ＮＯ，ＮＺ ，ＰＬ，ＰＴ，ＲＯ，ＲＵ，ＳＤ，ＳＥ，ＳＧ，ＳＩ， ＳＫ，ＳＬ，ＴＪ，ＴＭ，ＴＲ，ＴＴ，ＵＡ，ＵＧ，Ｕ Ｓ，ＵＺ，ＶＮ，ＹＵ，ＺＷ (72)発明者 サンダー トム アメリカ合衆国 フロリダ州 アラシュア イノベーション ドライブ １ Ｆターム(参考） 4C081 AB03 AB18 AC03 BA12 BA13 BB07 CD34 DA01 4C097 AA10 AA21 BB01 CC05 DD09 DD15 SC01

Claims (26)

    【特許請求の範囲】
  1. 【請求項１】 第１の鉱化セグメントおよび第２の可撓性脱鉱化セグメント
    を備える部分的に脱鉱化された骨インプラント。
  2. 【請求項２】 鉱化セグメントまたは脱鉱化セグメントが、溝、雄ねじ、雌
    ねじ、ドライバ・ヘッド、凹部、および対称形状または非対称形状から選択され
    た所望のフィーチャを有するように切削される請求項１記載のインプラント。
  3. 【請求項３】 インプラントを骨に固定できるように適合された少なくとも
    １つの切削済み鉱化端部またはセグメントと、該インプラントが第１の身体部分
    と第２の身体部分との間に取り付けられたときに靭帯、腱、または可撓性副木と
    して働くのに十分な可撓性を有する脱鉱化セグメントとを備える請求項２記載の
    インプラント。
  4. 【請求項４】 請求項１記載の部分的に脱鉱化された骨インプラントであっ
    て、鉱化セグメントと脱鉱化セグメントとの間に、鉱化骨から脱鉱化骨へ徐々に
    遷移するゾーンをさらに備える骨インプラント。
  5. 【請求項５】 請求項２記載の部分的に脱鉱化された骨インプラントであっ
    て、インプラントの切削済み鉱化端部を受容するように適合された骨に該インプ
    ラントを固定できるように適合された２つの切削済み鉱化端部を備え、該脱鉱化
    セグメントが、該２つの切削済み鉱化端部の間で延びる骨インプラント。
  6. 【請求項６】 請求項１記載の部分的に脱鉱化された骨インプラントであっ
    て、鉱化セグメントがインプラントの端部を形成し、この端部が、保持ねじ、保
    持ピン、縫合線、またはねじ山を受容する雄ねじ、穴、または雌ねじを有するよ
    うに切削され、該インプラントが、該インプラントの該切削済み鉱化端部または
    該脱鉱化セグメントを受容するように適合された骨に取り付けられる骨インプラ
    ント。
  7. 【請求項７】 請求項４記載の部分的に脱鉱化された骨インプラントであっ
    て、２つの切削済み鉱化端部を備え、該各端部が、ねじ山、セルフタッピングね
    じ山、保持ピンもしくは保持ねじを受容する穴、または保持ねじを受容する雌ね
    じを有するように切削され、該インプラントが取り付けられる骨が該インプラン
    トを受容するように適合される骨インプラント。
  8. 【請求項８】 請求項５記載の部分的に脱鉱化された骨インプラントであっ
    て、該インプラントを時計回りまたは逆時計回りのいずれかに回転させたときに
    、両端が、該インプラントを受容するように適合された骨に同時に挿入されるか
    、またはこの骨から同時に抜き取られるように、該各端部の該ねじ山が画定され
    る骨インプラント。
  9. 【請求項９】 請求項１記載の部分的に脱鉱化された骨インプラントであっ
    て、少なくとも１つの切削済み鉱化端部が、相補的な様式で切削された骨に該イ
    ンプラントを固定できるように適合され、靭帯または腱として働くのに十分な可
    撓性を有する脱鉱化セグメントが、骨、筋肉、腱、または靭帯に該脱鉱化セグメ
    ントを固定できるように適合された脱鉱化セグメントで終わる骨インプラント。
  10. 【請求項１０】 第１の骨と第２の骨との間、骨と筋肉との間、骨と腱との
    間、または骨と靭帯との間に取り付けられる請求項１記載の部分的に脱鉱化され
    た骨インプラント。
  11. 【請求項１１】 ２つの皮質端部と、一つの軟性で可撓性の脱鉱化された骨
    内部領域とを有する、ダウエルまたは大腿輪の形状である請求項１記載のインプ
    ラント。
  12. 【請求項１２】 管が内部に存在する請求項１１記載のインプラント。
  13. 【請求項１３】 隣接する推骨体の間に挿入される請求項１１記載のインプ
    ラント。
  14. 【請求項１４】 インプラント全体にわたって、またはインプラントの一部
    にカニューレが挿入される請求項１記載のインプラント。
  15. 【請求項１５】 脱鉱化された骨で製作された縦長の人工靭帯または人工腱
    を第１の身体部分と第２の身体部分との間に取り付けることを含み、該人工靭帯
    が、修復すべき領域の構成に整合するような形状にされるのに十分な可撓性を有
    するようにコンプライアンス弾性と高長手方向強度との両方を有する、該第１の
    身体部分と該第２の身体部分との間の領域内の損傷した線維性結合組織を置換ま
    たは補強するための改良された方法であって、部分的な脱鉱化の前に骨の少なく
    とも一端を切削し、脱鉱化されていない少なくとも１つの固定端部を作製し、こ
    のように切削された骨のセグメントを脱鉱化して可撓性セグメントを作製するこ
    とを含む方法。
  16. 【請求項１６】 人工靭帯または人工腱が、２つの切削済み鉱化端部と中間
    可撓性脱鉱化セグメントとを備える請求項１５記載の方法。
  17. 【請求項１７】 損傷した靭帯または腱を置換または補強する方法であって
    、切削された部分的に脱鉱化された骨インプラントを、第１の骨と第２の骨との
    間、骨と第２の骨上の靭帯との間、または骨と筋肉の腱セグメントとの間に取り
    付けることを含む方法。
  18. 【請求項１８】 腱インプラントまたは靭帯インプラントを製造する方法で
    あって、実質的に皮質の骨のセグメントを任意の所望の形状に切削する段階、骨
    に直接固定される少なくとも１つの端部を切削する段階、および脱鉱化セグメン
    トが腱置換物または靭帯置換物として働くのに十分な可撓性および弾性を得るよ
    うに該実質的に皮質の骨のセグメントを部分的に脱鉱化する段階を含む方法。
  19. 【請求項１９】 請求項１８記載の方法によって製造されたインプラント。
  20. 【請求項２０】 可撓性脱鉱化中央部および２つの鉱化突起を備える請求項
    １記載のインプラント。
  21. 【請求項２１】 鉱化突起が、鋸歯形縁部、ねじ山、およびリビングから選
    択される外部フィーチャを有する請求項２０記載のインプラント。
  22. 【請求項２２】 拡大中央部の脱鉱化骨からなる荷重分散可撓性ヒンジと、
    本質的に鉱化骨からなる互いに逆方向に突き出る一対の遠位ステム部および近位
    ステム部とを有する皮質骨を備える補綴関節インプラント。
  23. 【請求項２３】 中央部の底面（volar aspect）が、幅を横切るくぼみまた
    は横方向チャネルを有するように切削される請求項２２記載の補綴関節。
  24. 【請求項２４】 互いに逆方向に突き出る遠位ステム部および近位ステム部
    が、インプラントで置き換えられる関節に隣接する骨の髄内空間に挿入される請
    求項２３記載の補綴関節。
  25. 【請求項２５】 隣接する骨の髄内空間に各端部が挿入されたときに、端部
    が所定の位置に固定されるように、鉱化された末端が、保持ピンもしくは一連の
    保持ピン、鋸歯型縁部、または歯止め構造を受容する雄ねじ、雌ねじ、穴、また
    は一連の穴を有するように切削される請求項２４記載の補綴関節。
  26. 【請求項２６】 中手指節関節、近位指節間関節などの関節を、部分的に脱
    鉱化された骨を備えるインプラントで置き換えることを含む関節形成方法。
JP2000517679A 1997-10-27 1998-10-13 部分的に脱鉱化された骨インプラント Pending JP2001520914A (ja)

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US08/958,364 1997-10-27
US08/958,364 US6090998A (en) 1997-10-27 1997-10-27 Segmentally demineralized bone implant
PCT/US1998/021530 WO1999021515A1 (en) 1997-10-27 1998-10-13 Segmentally demineralized bone implant
US09/778,046 US20010020188A1 (en) 1997-10-27 2001-02-05 Selective uptake of materials by bone implants

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