JP5390403B2 - 超親水性表面を有する貯蔵可能なインプラントの製造方法 - Google Patents
超親水性表面を有する貯蔵可能なインプラントの製造方法 Download PDFInfo
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- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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Description
120から150mM NaCl
7.5から8.5mM Na2HPO4
2.5から3.5mM KCl
1.0から2.0mM KH2PO4
表面を、コランダムでサンドブラストし、次いで酸浴(HCl/H2SO4)中でエッチングした。表面は、いかなるナノ構造の兆候も示さない滑らかなミクロ構造を示す。
クロモ硫酸は、親水性表面を機能的に生成し、構造的に、SLAミクロ構造の他にも「球形」ナノ構造を生成する。相互接続したナノボールの直径は、約50〜100nmであり、ナノ細孔は、同じ規模の桁数で形成される。
ナノ粒子は、約50nmの直径のものであり、一緒に接続される。10〜100nmの直径の細孔は、球体の間に形成される。
以下に述べる実験では、機械的研磨/電解研磨された、アノード酸化チタンプレート、チタン合金プレートであって、他の酸で予備エッチングされ、多孔質チタン合金でサンドブラストまたはプラズマスプレーされたものであって、クロモ硫酸処理がなされ、またはなされていないものを使用した。同様にステンレス、機械的研磨/電解研磨がなされた鋼であって、クロモ硫酸処理を施したものまたは施していないものを、使用した。
それぞれの使用の前に、材料を、5%HNO3中で2時間、80℃で加熱することによって、清浄化した。水中で新たに行われた洗浄の後、プレートを、乾燥メタノール30mlで洗浄することにより、乾燥した。その後、これらを直接さらに使用し、またはクロモ硫酸で処理した。
クロモ硫酸処理では、チタンプレートを、クロモ硫酸(92%H2SO4、1.35 CrO3)中210〜240℃で衝撃加熱し、その温度で30〜90分間インキュベートし、次いで室温の濃硫酸でクエンチ処理した。その後、金属サンプルを10×50mlの水で洗浄し、2×30分間10%EDTA((pH7)超音波)で処理し、次いで1〜3×30分間、沸騰している10%EDTA(pH7)に入れ、その後、沸騰水で30分間洗浄し、水で濯いだ。その結果、実質的にクロム酸塩を含まない超親水性表面が得られ、即ち、ここでは遊離クロムイオンを表面上に検出することができない。
超親水性チタンプレートにおけるrhBMP−2の固定化
前処理したチタンプレートを、125mM Na−ホウ酸緩衝液、0.066%ドデシル硫酸ナトリウム、pH10.0で洗浄し、平衡化した。50mMトリス、pH8.0、1000mM NaCl、5mM EDTA、33mM 3−[(3−コラミド−プロピル)ジメチルアンモニオ]−プロパンスルホン酸緩衝液(=CPDP緩衝液)中に初期に存在したBMP−2を、125mM Na−ホウ酸緩衝液、0.066%ドデシル硫酸ナトリウム、pH10.0(=NBS緩衝液)に関して透析し、0.2〜0.3mg/mlの濃度で12〜14時間、室温で、チタンプレートを振盪させながらインキュベートした。その後、これらをホウ酸緩衝液で4×洗浄し、次いで水で洗浄した。
超親水性チタンプレートからのrhBMP−2の遊離
図3に示されるように、超親水性チタン表面へのrhBMP−2の吸着、およびその表面からの遊離は、図3に示される、超親水性チタン表面からのrhBMP−2の遊離動態を参照することによってわかるように、清浄化の目的で希釈HNO3のみで処理したチタン表面に比べて著しく改善される。大きな能力差も明らかにされることになる。例示される遊離曲線は、3相指数関数で適合させることができる。対照の場合、実際には2相のみ存在する。遊離を、62日間にわたって測定した。遊離の半値時間、および遊離したrhBMP−2の量を、表3に示す。
Claims (18)
- 超親水性表面を有する貯蔵可能なインプラントを製造するための方法であって、
前記インプラントの表面を水で濡らしたときの動的接触角が0°から10°の間である超親水性表面を有するインプラントを、前記超親水性表面に対して不活性でありかつ前記インプラントをすべての面で閉じ込める中性塩含有水溶液中に入れるステップと、
前記インプラントの前記表面を安定化かつ保護する乾燥層が形成されるように、前記中性塩含有水溶液を蒸発乾固させるステップと、
を含む、
ことを特徴とする方法。 - 超親水性表面を有する貯蔵可能なインプラントを製造するための方法であって、
前記インプラントの表面を水で濡らしたときの動的接触角が0°から10°の間である超親水性表面を有するインプラントを、前記超親水性表面に対して不活性でありかつ前記インプラントをすべての面で閉じ込め、0.5モル/lよりも高い全イオン濃度を有する中性塩含有水溶液中に入れるステップと、
前記中性塩含有水溶液中の前記インプラントを、透明なパッケージ内に導入し、前記透明なパッケージを、気密および液密な手法で閉じ込めるステップと、
を含む、
ことを特徴とする方法。 - 前記中性塩含有溶液を、蒸発後に前記インプラントの少なくとも前記超親水性表面を覆う塩層をもたらす量でおよび塩濃度で使用し、層厚が1から500μmである、請求項1に記載の方法。
- 蒸発後に前記インプラントをすべての面で閉じ込める塩層をもたらす、塩含有水溶液を使用する、請求項1または3に記載の方法。
- 前記インプラントを滅菌する追加のステップを含む、請求項1から4のいずれか一項に記載の方法。
- 前記インプラントの滅菌が、イオン化放射線による滅菌を含む、請求項5に記載の方法。
- 請求項1から6のいずれか一項による方法によって製造することができる、貯蔵可能なインプラント。
- インプラントの表面にペプチドを添加するための方法であって、前記ペプチドは、請求項7に記載のインプラントの表面に付着され、ペプチドと前記インプラントの超親水性表面との間の物理吸着または化学吸着相互作用の結果、前記インプラントの超親水性表面に固定化される方法。
- 前記ペプチドが、500ng/cm2よりも高いペプチドの、金属インプラントの酸化物表面への添加を実現するのに十分な濃度で、生理緩衝溶液中で使用される、請求項8に記載の方法。
- 前記ペプチドが、緩衝溶液に対して1μg/mlよりも高い濃度で生理緩衝溶液中で使用される、請求項8または9に記載の方法。
- 請求項8に記載の方法において、
超親水性表面を有する前記インプラントは、純チタン、金属チタン合金、クロム/ニッケル/アルミニウム/バナジウム/コバルト合金、または高品質鋼を含む金属材料、ヒドロキシアパタイト、または酸化アルミニウムを含むセラミック材料、または前記金属材料と前記セラミック材料との組合せから選択され、
前記金属材料はセラミック材料との複合材料の形をとり、
前記ペプチドは、pH4から5の間の酸範囲にあり、またはpH9から11の間の弱アルカリ範囲にある水性緩衝溶液に添加されている、
ことを特徴とする方法。 - 骨成長因子、TGFタンパク質、BMPタンパク質、VEGF、アンギオトロピン、血管成長因子、ユビキチン、抗生物質、またはこれらの混合物を、ペプチドとして使用する、請求項8から11のいずれか一項に記載の方法。
- BMP−2またはBMP−7が前記骨成長因子として使用される、請求項12に記載の方法。
- 請求項8から13のいずれか一項に記載の方法によって製造することができるインプラント。
- インプラントの表面を水で濡らしたときに0から10°の間の動的接触角を有する超親水性表面を備えたインプラントを製造するための方法であって、
前記インプラントを、200℃よりも高い温度で1.40g/cm 3 よりも高い密度の高温クロモ硫酸中に浸漬し、そこに10分から90分までの時間にわたって放置するステップと、
前記インプラントを取り出した直後に、15℃から25℃の温度の濃硫酸に浸漬することによってクエンチ処理するステップ、
前記インプラントの表面を、複数の洗浄処理によって蒸留水を用いて洗浄するステップと、
を含み、
前記インプラントは、金属、金属合金、およびこれらとセラミック材料との組合せの群から選択される、
ことを特徴とする方法。 - 酸化処理の持続時間に対して前記動的接触角をプロットしたときに、前記動的接触角がダイヤグラム中で最小の領域内になるまで、前記インプラントの表面に酸化物層が生成されるよう前記インプラントの表面を前記高温クロモ硫酸中に浸漬する、請求項15に記載の方法。
- 処理された金属の前記インプラントを、当該インプラントにとり異物である金属イオンが当該インプラントの表面上で検出できなくなるまで、キレート剤の水溶液で処理するステップをさらに含む、
請求項15または16に記載の方法。 - 請求項15から17のいずれか一項に記載の方法によって製造することができる、超親水性表面を有するインプラント。
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Application Number | Priority Date | Filing Date | Title |
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DE102007007865A DE102007007865A1 (de) | 2007-02-14 | 2007-02-14 | Verfahren zur Herstellung von lagerfähigen Implantaten mit einer ultrahydrophilen Oberfläche |
DE102007007865.1 | 2007-02-14 | ||
PCT/EP2008/051764 WO2008098976A2 (de) | 2007-02-14 | 2008-02-13 | Verfahren zur herstellung von lagerfähigen implantaten mit einer ultrahydrophilen oberfläche |
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JP2010517729A JP2010517729A (ja) | 2010-05-27 |
JP5390403B2 true JP5390403B2 (ja) | 2014-01-15 |
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JP2009549828A Active JP5390403B2 (ja) | 2007-02-14 | 2008-02-13 | 超親水性表面を有する貯蔵可能なインプラントの製造方法 |
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EP (4) | EP4151245A1 (ja) |
JP (1) | JP5390403B2 (ja) |
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AT (1) | ATE503506T1 (ja) |
AU (1) | AU2008214613B2 (ja) |
CA (1) | CA2678378C (ja) |
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ES (2) | ES2929432T3 (ja) |
HK (1) | HK1136788A1 (ja) |
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CA2678378C (en) | 2015-11-24 |
US20160136336A1 (en) | 2016-05-19 |
DE102007007865A1 (de) | 2008-08-21 |
JP2010517729A (ja) | 2010-05-27 |
EP3590549B1 (de) | 2022-09-07 |
US9242029B2 (en) | 2016-01-26 |
DE502008003007D1 (de) | 2011-05-12 |
ES2361895T3 (es) | 2011-06-24 |
WO2008098976A2 (de) | 2008-08-21 |
AU2008214613B2 (en) | 2011-09-01 |
HK1136788A1 (en) | 2010-07-09 |
ATE503506T1 (de) | 2011-04-15 |
US20170258969A1 (en) | 2017-09-14 |
CA2678378A1 (en) | 2008-08-21 |
EP2121058A2 (de) | 2009-11-25 |
WO2008098976A3 (de) | 2009-07-23 |
ES2929432T3 (es) | 2022-11-29 |
EP4151245A1 (de) | 2023-03-22 |
EP2121058B1 (de) | 2011-03-30 |
KR20090117807A (ko) | 2009-11-12 |
EP3590549A1 (de) | 2020-01-08 |
US20100168854A1 (en) | 2010-07-01 |
US10369257B2 (en) | 2019-08-06 |
AU2008214613A1 (en) | 2008-08-21 |
US10376613B2 (en) | 2019-08-13 |
EP2428232A3 (de) | 2014-06-25 |
EP2428232A2 (de) | 2012-03-14 |
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