JP5726536B2 - 多孔質生体適合性ポリマー材料および方法 - Google Patents
多孔質生体適合性ポリマー材料および方法 Download PDFInfo
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- JP5726536B2 JP5726536B2 JP2010545025A JP2010545025A JP5726536B2 JP 5726536 B2 JP5726536 B2 JP 5726536B2 JP 2010545025 A JP2010545025 A JP 2010545025A JP 2010545025 A JP2010545025 A JP 2010545025A JP 5726536 B2 JP5726536 B2 JP 5726536B2
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Description
本発明の構造および方法は、多孔質ポリマー材料および多孔質ポリマー材料および構造を作製する方法に関する。構造の例としては、脊髄固定用のスペーサ、頭蓋顎顔面(craniomaxillofacial:CMF)構造、骨の置換のための他の材料および構造が含まれるがこれらに限定されない。
本出願は、2008年2月1日に出願された米国仮特許出願第61/025,426号の利益を主張し、この出願の内容は、本明細書中にその全体を参考として援用される。
自己強化ポリフェニレン、ポリフェニルスルホン、ポリスルホン、PET、ポリエチレン、ポリウレタン、または他の生体適合性ポリマーを含むがこれらに限定されない。
多孔質PEEKの方法
1つのプロセス実施形態は多孔質椎間腔を作り出す。このプロセス実施形態はポリマーを粒子の形態で用いることを含む。粒子サイズは0.25〜1.0mmの範囲内である。この範囲は限定することを意図するものではなく、他の粒子サイズを用いることもできる。粒子は90%のポリマー10%のβ−TCPの割合でβ−TCPと混合される。β−TCPの粒子サイズは0.01〜0.lmmの範囲内である。粒子は容器の中に入れられ、完全に混合される。この混合は標準的な実験室用ボルテックスシェイカを用いて実施することができる。振盪することによって、小さめのβ−TCP粒子が少なくとも部分的にポリマー粒子の表面を覆うことが可能になる。メッシュサイズがβ−TCP粒子サイズよりは大きいがポリマー粒子サイズよりは小さい篩を用いて過剰なβ−TCP粒子を除去する。得られた粉末の混合物は、β−TCPで被覆されたポリマー粒子を含む。β−TCPを用いる目的は、ポリマー粒子が融点超で加熱されたとき、自由に流動するのを阻止することである。β−TCPが存在することによって、ポリマーの融解点で、またはそれを超えると粒子が数珠繋ぎになり、流動が阻止される。このことは、間隙空間を保持しながらポリマー粒子間の強力な結合を可能にする。冷却されると、最終材料はβ−TCP被覆を有する相互に繋がった多孔質ポリマーになる。得られた材料は、骨がイングロースするために相互に繋がった多孔質構造と、より望ましい骨伝導が得られるようにカルシウムが豊富な表面を生成するβ−TCP被覆とを有する。
多孔質PEEK構造の1つの実施形態は、図3、11、および12A〜12Bに示すように、全面的に多孔質PEEKで作製された椎間体癒合(interverbral body fusion)用のプロテーゼである。プロテーゼは、端板の被覆を最適化するために、外側の形状を多様に形成することを前提とすることができる。上面および下面は、椎間腔内でのデバイスの初期安定性を高めるために、型で成型された錐体状のまたは一方向性の歯または隆起を備えてもよい。いくつかの実施形態では、その1つが図3のスペーサ30のようになっているが、固い骨のスルーグロース(through growth)を可能にする1つまたは複数の軸方向の穴32が画定されている。1つの実施形態では、スペーサ30の側面34内に水平方向の窓がさらに設けられ、放射線写真または他の好適な技術による癒合の評価を向上させる。図3には一体式の多孔質構造の例として、ほぼ円筒形の形状が示されているが、固体円柱、足場の形状、特別に適合する複合的な成型形状など、他の一体式の多孔質の形状も本発明の範囲内である。
図4A、4Bおよび4Cは、椎間体癒合(intervertebral body fusion)用のインプラント40を図示する。インプラント40は、多孔質端版44に熱結合した固体のPEEKコア42で構築される。このインプラント実施形態40は、骨のイングロースおよび初期安定性の利点を保持しながら、インプラントの軸方向の極限圧縮強度を高めるのに役立つ。
従来の椎間体デバイスの移植の間は、外科医がインプラントを正確に制御し続けることが望ましい。このような制御の1つの重要な部分は、インプラントをしっかりと掴むことによって実現される。掴んで離すステップにとっては、スペーサの導入形状が増大せず、他の点で何ら大幅に変更されないことが望ましい。
図8は、80において椎間板関節形成用の椎間プロテーゼの1つの実施形態を図示し、これは水平方向の挿入スロット86を有し、固体のPEEK84に熱結合した多孔質PEEK端板82を含む。
図9A、9Bおよび9Cは、組み込み式の固定を伴う椎間スペーサ90の1つの実施形態を図示し、固体のPEEKコア94に熱結合し、金属板96に機械的に接続した多孔質PEEK端板92を示す。中央のディストラクタースロット(distractor slot)が挿入を助ける。
図11〜20は、本開示に記載された方法を用いて形成された多孔質ポリマー材料を少なくとも一部含む腰椎スペーサの複数の例示的形態を図示する。複数の例が示されているが、本発明はそれに限定されない。各例においては、説明したようにスペーサの全体が多孔質ポリマー材料で形成される場合もあり、説明したようにスペーサの一部のみが多孔質ポリマー材料で形成される場合もある。本明細書に記載したように、他の材料形態は、多孔質部分に結合した、機械的に繋いだ、または他の仕方で合わされた固体部分を含む。固体部分の例としては、多孔質ポリマー部分に合わされた固体のコア、固体のバンド、固体の膜などを含む。
本開示に記載された実施形態は、所望の最終特性によって、種々の仕上げプロセスを含むことができる。1つの追加の表面処置は、イオン化酸素または他のガスによるプラズマ処理を用いることを含む。選択された実施形態では、このようなプラズマ処理は表面の化学的性質を変化させ、湿潤性を高める。別の表面処置は、インプラントの表面の骨伝導能を高めるためのヒドロキシルアパタイト(Hydroxylapatite:HA)の被覆を含む。別の表面処置は、インプラントの表面の骨伝導能を高めるためのリン酸カルシウム被覆を含む。別の表面処置は、骨のオングロースのために望ましい表面を提供するための窒化チタン被覆を含む。骨のオングロースのために望ましい表面を提供するための他の表面処置は、物理蒸着、化学蒸着などの複数のプロセスのいずれかによって加えられた、チタンもしくは他の生体適合性金属の被覆、または酸化被覆を含む。
さらなる実施形態は、さらに大きくばらばらになったβ−TCP、チタンまたは他の骨伝導性のある粒子を被覆粉末の混合物に組み入れることを含む。これらの大きめの骨伝導性のある粒子は、熱可塑性材料とほぼ同じサイズである。選択された実施形態では、ばらばらになった骨伝導性のある粒子は、β−TCP粉末で既に被覆された多孔質材料の骨伝導特性を高める。骨伝導性のある粒子の供給源は、Synthesが製造するCronOS(商標)を含む。
上で述べたように、多孔質材料の他の使用は脊椎スペーサ以外に、組織のイングロースのための足場用途を含む。上記の実施形態に記載したように多孔質材料は、生理学的な機械的応力下で解剖学的位置に骨のイングロースが所望される複数の用途において、骨空隙充填剤(bone void filler)としてさらに使用可能である。脊椎スペーサ以外の用途の例は、頭蓋の、または頭蓋顔面の欠損の修復に用いるのに好適なインプラントの少なくとも一部を製造することを含む。
本発明のスペーサのいくつかの実施形態の本体またはその部分は、PEEKポリマーまたは他のポリマーで形成される。種々のポリマーの選択肢に加えて、β−TCP以外の被覆粉末の材料が選択可能である。硫酸バリウム(BaSO4)または炭酸ストロンチウム(SrCO3)などの別の粉末は、融解点超で加熱する間、ポリマー上にβ−TCPと同様の効果を有する。
図24および25A〜25Bに関しては、上記のPEEK/β−TCP粉末を型に入れることによって多孔質PEEKスペーサを作り出した。型の中に入れた粉末混合物の量によって最終構造の多孔度が決まった。粒子サイズの範囲によって孔のサイズが決まった。種々の表面積および高さを有する2つのタイプのサンプルを作製して、業界で公知のスペーサと同じ形状のスペーサを形成した。最終サンプルを圧縮強度について試験した。図26は図24のスペーサの圧縮強度と多孔度との関係を示すグラフを図示し、図27は40パーセントの多孔度を有する図25A〜25Bのスペーサの圧縮強度とスペーサの高さとの関係を示すグラフを図示する。
〔実施の態様〕
(1) 多孔質ポリマー材料を形成する方法であって、前記方法が、
ポリマー顆粒および被覆粉末の混合物を形成するステップであって、
被覆粉末粒子が前記ポリマー顆粒より小さく、
前記被覆粉末粒子は前記ポリマー顆粒の融解温度で融解しないステップと、
前記ポリマー顆粒の前記融解温度を超える温度まで前記混合物を加熱するステップと、
前記被覆粉末が前記混合物内に間隙空間を実質的に保存する結果となるように、溶融ポリマーの流動を制御するステップと、
前記混合物を冷却し、被覆された前記ポリマー顆粒の接触点で結合を形成するステップと
を含む方法。
(2) 前記混合物が冷却した後に、形成された孔を通して前記被覆粉末を実質的に除去することをさらに含む、実施態様1に記載の方法。
(3) 前記多孔質ポリマー材料を形成するステップが、前記多孔質複合材料を用いて脊椎固定術用のスペーサを形成することを含む、実施態様1に記載の方法。
(4) ポリマー顆粒および前記被覆粉末の前記混合物を形成するステップが、ポリエーテルエーテルケトン(PEEK)顆粒および被覆粉末の混合物を形成することを含む、実施態様1に記載の方法。
(5) ポリマー顆粒および前記被覆粉末の前記混合物を形成するステップが、ポリエーテルエーテルケトン(PEEK)顆粒およびセラミック被覆粉末の混合物を形成することを含む、実施態様4に記載の方法。
(6) ポリマー顆粒および前記被覆粉末の前記混合物を形成するステップが、ポリエーテルエーテルケトン(PEEK)顆粒と、ベータリン酸三カルシウム(β−TCP)を含む被覆粉末との混合物を形成することを含む、実施態様5に記載の方法。
(7) ポリマー顆粒および前記被覆粉末の前記混合物を形成するステップが、約90重量%のポリエーテルエーテルケトン(PEEK)と、約10重量%のベータ−リン酸三カルシウムとの混合物を形成することを含む、実施態様6に記載の方法。
(8) ポリマー顆粒および前記被覆粉末の前記混合物を形成するステップが、ポリマー顆粒と、硫酸バリウム(BaSO 4 )および炭酸ストロンチウム(SrCO 3 )からなる群から選択される被覆粉末との混合物を形成することを含む、実施態様1に記載の方法。
(9) 前記多孔質ポリマー材料を形成するステップが、前記多孔質ポリマー材料を用いて頭蓋顎顔面(CMF)構造を形成することを含む、実施態様1に記載の方法。
(10) 前記多孔質ポリマー材料の表面を、イオン化酸素を用いてプラズマ処理することをさらに含む、実施態様1に記載の方法。
(11) 前記多孔質ポリマー材料の表面をヒドロキシアパタイトで被覆することをさらに含む、実施態様1に記載の方法。
(12) 前記多孔質ポリマー材料の表面をリン酸カルシウムで被覆することをさらに含む、実施態様1に記載の方法。
(13) 前記多孔質ポリマー材料の表面を窒化チタンで被覆することをさらに含む、実施態様1に記載の方法。
(14) ポリマー顆粒および被覆粉末の混合物を形成するステップが、隣接した組織の対応する機械的特性に前記多孔質複合材料の機械的特性が適合するようにポリマー材料を選択することを含む、実施態様1に記載の方法。
(15) 機械的特性が弾性率を含む実施態様14に記載の方法。
(16) 骨のイングロースを促進するための多孔質構造であって、
接触点で一緒に融解するポリマー顆粒の網状組織と、
前記ポリマー顆粒間の複数の間隙空間と、
前記間隙空間内で前記ポリマー顆粒の表面を実質的に覆う粒子の被覆と
を含む多孔質構造。
(17) 前記構造が脊椎固定術用のスペーサである実施態様16に記載の多孔質構造。
(18) 前記構造が頭蓋顎顔面(CMF)構造である実施態様16に記載の多孔質構造。
(19) 前記構造が足場構造である実施態様16に記載の多孔質構造。
(20) 前記多孔質構造が多孔質/固体の接触面で固体部分に連結する多孔質部分を有する複合構造の一部である、実施態様16に記載の多孔質構造。
(21) 前記多孔質部分が前記固体部分に機械的に固定される、実施態様20に記載の多孔質構造。
(22) 前記複合構造は、多孔質部分が2つの面で前記固体部分を中間に挟んで該固体部分に結合されるサンドイッチ構造を含む、実施態様20に記載の多孔質構造。
(23) 前記複合構造の設置を容易にするために、前記固体部分の一部として形成された保持部材をさらに含む、実施態様22に記載の多孔質構造。
(24) 骨のイングロースを促進するための多孔質構造であって、
接触点で一緒に融解するポリマー顆粒の網状組織と、
前記顆粒上の微多孔質の表面構造と、
前記ポリマー顆粒間の複数の間隙空間と
を含む多孔質構造。
(25) 前記微多孔質の表面構造の孔のサイズが実質的に0.1〜100μmの範囲内である、実施態様24に記載の多孔質構造。
(26) 前記微多孔質の表面構造の孔のサイズが実質的に1および50μmの範囲内である、実施態様24に記載の多孔質構造。
(27) 前記構造が脊椎固定術用のスペーサである、実施態様24に記載の多孔質構造。
(28) 前記構造が頭蓋顎顔面(CMF)構造である、実施態様24に記載の多孔質構造。
(29) 前記構造が足場構造である、実施態様24に記載の多孔質構造。
(30) 前記多孔質構造が多孔質/固体の接触面で固体部分に連結する多孔質部分を有する複合構造の一部である、実施態様24に記載の多孔質構造。
(31) 前記多孔質部分が前記固体部分に機械的に固定される、実施態様30に記載の多孔質構造。
(32) 前記複合構造は、多孔質部分が2つの面で前記固体部分を中間に挟んで該固体部分に結合されるサンドイッチ構造を含む、実施態様30に記載の多孔質構造。
(33) 前記複合構造の設置を容易にするために、前記固体部分の一部として形成された保持部材をさらに含む、実施態様32に記載の多孔質構造。
Claims (31)
- 多孔質ポリマー材料を形成する方法であって、前記方法が、
ポリマー顆粒および被覆粉末の混合物を形成することであって、
前記ポリマー顆粒は、PEEK、カーボン強化PEEK、PEKK、PAEK、PEK PEKK、およびPEKEKKからなる群より選択されるポリエーテルケトンを含み、
前記被覆粉末は、カルシウム粉末、骨粉、ヒドロキシアパタイト、およびリン酸カルシウムからなる群から選択され、
被覆粉末粒子が前記ポリマー顆粒より小さく、
前記被覆粉末粒子は前記ポリマー顆粒の融解温度で融解しないことと、
前記ポリマー顆粒の前記融解温度を超える温度まで前記混合物を加熱することと、
前記被覆粉末が前記混合物内に間隙空間を実質的に保存する結果として、溶融ポリマーの流動を制御することと、
前記混合物を冷却し、被覆された前記ポリマー顆粒の接触点で結合を形成することと
を含む方法。 - 前記混合物が冷却した後に、形成された孔を通して前記被覆粉末を実質的に除去することをさらに含む、請求項1に記載の方法。
- 前記多孔質ポリマー材料を形成することが、前記多孔質複合材料を用いて脊椎固定術用のスペーサを形成することを含む、請求項1に記載の方法。
- ポリマー顆粒および前記被覆粉末の前記混合物を形成することが、ポリエーテルエーテルケトン(PEEK)顆粒および前記被覆粉末の混合物を形成することを含む、請求項1に記載の方法。
- ポリマー顆粒および前記被覆粉末の前記混合物を形成することが、ポリエーテルエーテルケトン(PEEK)顆粒およびヒドロキシアパタイトおよびリン酸カルシウムから選択される被覆粉末の混合物を形成することを含む、請求項4に記載の方法。
- ポリマー顆粒および前記被覆粉末の前記混合物を形成することが、ポリエーテルエーテルケトン(PEEK)顆粒と、ベータリン酸三カルシウム(β−TCP)を含む被覆粉末との混合物を形成することを含む、請求項5に記載の方法。
- ポリマー顆粒および前記被覆粉末の前記混合物を形成することが、90重量%のポリエーテルエーテルケトン(PEEK)と、10重量%のベータ−リン酸三カルシウムとの混合物を形成することを含む、請求項6に記載の方法。
- 前記多孔質ポリマー材料を形成することが、前記多孔質ポリマー材料を用いて頭蓋顎顔面(CMF)構造を形成することを含む、請求項1に記載の方法。
- 前記多孔質ポリマー材料の表面を、イオン化酸素を用いてプラズマ処理することをさらに含む、請求項1に記載の方法。
- 前記多孔質ポリマー材料の表面をヒドロキシアパタイトで被覆することをさらに含む、請求項1に記載の方法。
- 前記多孔質ポリマー材料の表面をリン酸カルシウムで被覆することをさらに含む、請求項1に記載の方法。
- 前記多孔質ポリマー材料の表面を窒化チタンで被覆することをさらに含む、請求項1に記載の方法。
- ポリマー顆粒および被覆粉末の混合物を形成することが、隣接した組織の対応する機械的特性に前記多孔質複合材料の機械的特性が適合するようにポリマー材料を選択することを含む、請求項1に記載の方法。
- 機械的特性が弾性率を含む請求項13に記載の方法。
- 骨のイングロースを促進するための多孔質構造であって、
接触点で一緒に結合するポリマー顆粒の網状組織であって、前記ポリマー顆粒は、PEEK、カーボン強化PEEK、PEKK、PAEK、PEK PEKK、およびPEKEKKからなる群より選択されるポリエーテルケトンを含む、網状組織と、
前記顆粒上の微多孔質の表面構造であって、前記微多孔質の表面構造の孔のサイズが実質的に1μmおよび50μmの間の範囲内である、表面構造と、
前記ポリマー顆粒間の複数の間隙空間と
を含む多孔質構造。 - 前記間隙空間内で前記ポリマー顆粒の表面を実質的に覆う粒子の被覆をさらに含む、請求項15に記載の多孔質構造。
- 前記構造が脊椎固定術用のスペーサである、請求項15に記載の多孔質構造。
- 前記構造が頭蓋顎顔面(CMF)構造である、請求項15に記載の多孔質構造。
- 前記構造が足場構造である、請求項15に記載の多孔質構造。
- 前記多孔質構造は、多孔質部分が多孔質/固体の接触面で固体部分に連結する複合構造の一部である、請求項15に記載の多孔質構造。
- 前記多孔質部分が前記固体部分に機械的に固定される、請求項20に記載の多孔質構造。
- 前記複合構造は、多孔質部分が2つの面で前記固体部分を中間に挟んで該固体部分に結合されるサンドイッチ構造を含む、請求項20に記載の多孔質構造。
- 前記複合構造の設置を容易にするために、前記固体部分の一部として形成された保持部材をさらに含む、請求項22に記載の多孔質構造。
- 前記複数の間隙空間の中に注入された生物活性物質をさらに含む、請求項15または16に記載の多孔質構造。
- 前記多孔質構造が患者に植え込まれると前記生物活性物質の制御された放出が可能になるように構成された被覆をさらに含む、請求項24に記載の多孔質構造。
- 前記間隙空間は、5μm〜5000μmの平均孔サイズを有する、請求項15または16に記載の多孔質構造。
- 前記間隙空間は、100μm〜500μmの平均孔サイズを有する、請求項26に記載の多孔質構造。
- 前記ポリマー顆粒の網状組織に組み込まれた放射線不透過性材料をさらに含み、
前記放射線不透過性材料は、選択的な放射線不透過領域を提供するように構成されている、請求項15または16に記載の多孔質構造。 - 前記放射線不透過性材料は、前記多孔質構造を機械的に強化するように構成されている、請求項28に記載の多孔質構造。
- 前記ポリマー顆粒は、ポリエーテルエーテルケトンを含む、請求項15または16に記載の多孔質構造。
- 前記固体部分は、ポリエーテルエーテルケトンを含む、請求項20に記載の多孔質構造。
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US20160184483A1 (en) | 2016-06-30 |
US8530560B2 (en) | 2013-09-10 |
CA2711403A1 (en) | 2009-08-13 |
AU2009210750A1 (en) | 2009-08-13 |
KR101618887B1 (ko) | 2016-05-09 |
CA2711403C (en) | 2016-08-09 |
BRPI0906750B8 (pt) | 2021-07-27 |
BRPI0906750A2 (pt) | 2015-07-07 |
WO2009099559A2 (en) | 2009-08-13 |
EP2238192A2 (en) | 2010-10-13 |
JP2011511128A (ja) | 2011-04-07 |
US20140207237A1 (en) | 2014-07-24 |
US20200139014A1 (en) | 2020-05-07 |
WO2009099559A3 (en) | 2010-03-25 |
EP2238192B1 (en) | 2017-03-01 |
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