JP2009508631A - インプラントの親水化および骨親和化表面の再生方法 - Google Patents
インプラントの親水化および骨親和化表面の再生方法 Download PDFInfo
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- JP2009508631A JP2009508631A JP2008532228A JP2008532228A JP2009508631A JP 2009508631 A JP2009508631 A JP 2009508631A JP 2008532228 A JP2008532228 A JP 2008532228A JP 2008532228 A JP2008532228 A JP 2008532228A JP 2009508631 A JP2009508631 A JP 2009508631A
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Abstract
【課題を解決するための手段】 本発明は、インプラントの表面の疎水性および骨親和性の低下を計測する工程と、インプラントの表面が疎水化および骨親和化の低下を示すとき、経時変化表面を指摘する工程と、疎水化および骨親和化の低下を有する表面を実質的に破壊する工程と、インプラントから疎水化および骨親和化の低下を有する表面を除去し、または、表面の物理化学的性質を変える工程とを含む方法を提供し、さらに、経時変化したインプラントを検査し、前記インプラント上に、親水化および骨親和化した表面を再生するキットを提供する。
【選択図】図1A
Description
図1Bは、酸エッチングしたチタン製表面の親水性の経時減衰を示す図。
図1Cは、機械加工したチタン製表面の親水性の経時減衰を示す図。
図2Aは、サンドブラスト処理後、新たに準備したチタン製表面と、サンドブラスト処理後、経時変化した表面の上における、造骨細胞の細胞増殖を示した図。
図2Bは、酸エッチングした後、新たに準備したチタン製表面と、酸エッチングした後、経時変化した表面の上における、造骨細胞の細胞増殖を示した図。
δ=(ΔE/V)1/2
ここで、δは溶解パラメーター(cal/cm3)1/2で、
ΔEは、蒸発エネルギー(cal/mole)で、
Vは、モル体積(cm3/mole)である。
ある態様において、本発明は、インプラントの経時変化を検査する方法を提供する。前記検査方法は(1)インプラントの親水性/骨親和性表面を計測する工程と、(2)インプラントが疎水化および骨親和化の低下した表面を示すときに経時表面変化を指摘する工程とを含む。
他の態様では、本発明は、インプラントの親水化および骨親和化表面の再生方法を提供する。前記方法は、インプラントを提供し、前記インプラントの表面を物理的工程、化学的工程、物理化学的工程、またはそれらの組み合わせにより処理する過程を含む。前記物理的工程は、サンドブラスト、機械加工、旋盤加工または鑢かけなどでもよい。前記サンドブラストは、限定されないが、酸化チタンや酸化アルミニウムなどの種々の粒子の吹き付けによる。前記化学的工程は、酸や塩基などのエッチング剤を含む溶剤によりインプラントをエッチングする工程と、インプラントを水洗して前記エッチング剤を除去する工程とを含む。前記物理化学的工程は、高エネルギーを持つ光でインプラントを処理して、炭素や炭化水素などの表面の不純物を溶かして除去する方法を含み、この方法は結果的に親水化および骨親和化表面を作り出す。
本発明の医療用インプラントは、現在医療で役立っているインプラントまたは将来導入されるインプラントの何れをも含む。インプラントは、金属製であっても、非金属性であっても良い。ある実施形態では、インプラントは金属製インプラントであっても良い。ある実施形態では、インプラントは非金属性であっても良い。前記非金属性インプラントの例としては、限定されないが、骨セメント製インプラント、メタクリル酸メチルやポリ乳酸などのポリマーを主材料としたインプラント、生体ガラス、セラミック、ジルコニウム製インプラントなどが含まれる。ある実施形態では、前記非金属性インプラントは、燐酸カルシウムやポリマー製インプラントなどを含む。有用なポリマー製インプラントは、何れの生体親和性インプラントであっても良くて、例えば、ポリマーまたはポリマー物質を含む生分解性ポリマーのインプラントなどである。代表的なセラミック製インプラントは、生体ガラスや二酸化ケイ素製のインプラントなどを含む。燐酸カルシウム製インプラントは、ヒドロキシアパタイト、燐酸三カルシウム(TCP)などを含む。代表的なポリマーは、ポリ乳酸とグリコール酸との共重合体(PLGA)、ポリメタクリル酸塩やポリアクリレートなどのポリアクリレート類、ポリ乳酸(PLA)、またはそれらの組み合わせを含む。ある実施形態において、本願で述べたインプラントから、上記物質の何れを除外しても良い。
本発明の医療用インプラントは、哺乳類の被験者に前記医療用インプラントを移植することにより、歯または骨に関する医学的コンディションの徴候を、治療、予防、改良、差し替えまたは低減するために用いても良い。前記哺乳類の被験者は人間および犬、猫、馬、雌牛、雄牛または猿などの家畜動物であっても良い。
チタンの骨伝導能力の経時減衰、チタンの経時検査およびチタン製インプラントの品質管理
チタン製のサンプル
市販の純チタン(等級2)からなる円盤(直径20mm、厚さ1.5mm)を用いた。前記円盤の表面は、轆轤装置と、距離1cm、圧力3kg/mの下で50μmの酸化アルミニウム粒子による吹き付けと、H2SO4を用いた酸性エッチングとにより新たに準備した。
10μlの蒸留水を、物理的な接触無しで、静かにチタン表面の上に置き、ただちにデジタル写真を撮った。上面から見た水滴の面積として、広がった面積をデジタル分析器(Image Pro Plus, Media Cybernetics, Silver Spring, MD)により計測した。接触角θは、下記式により計算した。
式:θ=2tan−1(2h/d)
ここで、hおよびdは、側面から見た(Ohida, Y. ら, J Master Science 3, 306-312 (1992))水滴の高さおよび直径である。
生後8週間の雄のSDラットの大腿骨から採取された骨髄細胞を、α変性されたイーグルの培地であって、15%の牛胎児血清と、50mg/mlのアスコルビン酸と、10−8Mのデキサメタゾンと、10mMのNa-β-グリセロリン酸エステルと、10000units/mlのペニシリンGナトリウム、10000mg/mlの硫酸ストレプトマイシン、25mg/mlのアムホテリシンBを含む抗生物質作用および抗真菌性を示す溶液とによって補足された培地に配置する。前記細胞は、95%の空気と5%の二酸化炭素からなる加湿された外気の中で培養した。80%の細胞密度に達したら、前記細胞を0.25%のトリプシン-1mM EDTA-4Naを用いて剥離し、機械加工されたチタンまたは酸エッチングされたチタン製の円盤上に、密度5×104cells/cm2で接種する。前記培養用培地は、3日毎に新しいものと取り替えた。
細胞増殖を調べるために、骨芽細胞を、ポリスチレン培養皿の上に置かれたチタン製円盤上で培養した。新たに準備した円盤と、準備をしてから各々異なる期間が経過した複数の円盤とを用いた。細胞は、PBSで2度、静かにすすぎ、300μl、0.25%のトリプシン-1mM EDTA-4Na中の0.1%のコラゲナーゼにより、15分間、37℃で処理した。分離した細胞の数を数えるために血球計算器を用いた。
分散分析(ANOVA)
新たに準備したチタン製の表面と、時間経過した表面との、水和性および細胞増殖の変動性の違いを調べるために、分散分析(ANOVA)を用いた;<0.05を統計的に重要とみなした。
新たなチタン製表面における超親水性と、その経時減衰
機械加工された表面にサンドブラスト処理をしたら、水和性が、疎水性から親水性へ変化した(図1A)。機械加工された表面にサンドブラスト処理後、10μlの水滴が広がった面積は13倍になった。サンドブラスト処理前の水の接触角は69.9度であったが、サンドブラスト処理後は2度まで急激に下がり、超親水性が生成されたことを示した。生成された超親水性領域は、その2週間後に、水滴が広がった面積に関する限り、50%まで減少した。前記接触角は、結果的に、時間経過と共に増加した。
新たに準備したチタン製の表面は、異なる処理をした表面であっても、細胞増殖率が最も高かった。異なる処理をした表面であっても、細胞増殖は、時間経過と共に急激に減少した(P<0.0001)(図2Aおよび2B)。前記増殖は新たに準備した表面と比較すると、4週間経過した表面では約50%まで低減した。
Claims (30)
- インプラントの経時変化表面の検査方法において、
(1)インプラントの表面の疎水性および/または骨親和性の低下を計測する工程と、
(2)インプラントの表面が疎水化および/または骨親和化の低下を示すときに経時変化表面を指摘する工程とを含む検査方法。 - インプラントの表面の接触角が約30度を超えると、前記インプラントの表面が疎水化および/または骨親和化の低下とする、請求項1に記載の検査方法。
- 前記インプラントが金属製インプラントである、請求項1に記載の検査方法。
- 前記インプラントがチタン製インプラントである、請求項1に記載の検査方法。
- 前記金属製インプラントが、チタン、金、プラチナ、タンタル、ニオブ、ニッケル、鉄、クロム、コバルト、ジルコニウム、マグネシウム、アルミニウム、パラジウム、または、それらの合金からなる、請求項3に記載の検査方法。
- 前記インプラントが非金属製インプラントであることを特徴とする、請求項1に記載の検査方法。
- 前記骨親和性は、生体外または生体内検査により分析し、
前記生体外検査は、細胞付着、細胞増殖率、細胞分化率、遺伝子発現率および遺伝子発現量、無機化率、表面への蛋白質付着/吸着、または、それらの組み合わせを評価することにより、細胞反応および細胞挙動を評価することから選択し、
前記生体内検査は、生体組織内におけるインプラント固定源の測定、骨形成の組織形態計測、骨形成のX線検査、または、それらの組み合わせから選択する請求項1に記載の検査方法。 - 前記細胞が、骨芽細胞または骨形成細胞である、請求項7に記載の検査方法。
- インプラントの疎水性を検査できるキットであって、前記インプラントの接触角を計測する装置を含むキット。
- インプラントと同梱されてなる、請求項9に記載のキット。
- 前記インプラントが金属製インプラントまたは非金属製インプラントである、請求項9に記載のキット。
- 前記金属製インプラントが、チタン、金、プラチナ、タンタル、ニオブ、ニッケル、鉄、クロム、コバルト、ジルコニウム、マグネシウム、アルミニウム、パラジウム、または、それらの合金からなる、請求項11に記載のキット。
- 疎水性または非骨親和性を有するインプラントの表面を、親水化または骨親和化表面に再生する方法であって、疎水化または非骨親和化表面を破壊または除去することからなる再生方法。
- 物理的工程または化学的工程により、前記疎水化または非骨親和化表面を実質的に破壊または除去する、請求項13に記載の再生方法。
- 前記物理的工程は、サンドブラスト、機械加工、または、粒子の吹き付けである、請求項14に記載の再生方法。
- 前記化学的工程は、エッチング剤によるエッチングである、請求項14に記載の再生方法。
- 紫外線照射をさらに含む、請求項14に記載の再生方法。
- エッチング用物質が酸または塩基であることを特徴とする、請求項16に記載の再生方法。
- 前記インプラントが金属製インプラントである、請求項13に記載の再生方法。
- 前記インプラントがチタン製インプラントである、請求項13に記載の再生方法。
- 前記金属製インプラントが、チタン、金、プラチナ、タンタル、ニオブ、ニッケル、鉄、クロム、コバルト、ジルコニウム、マグネシウム、アルミニウム、パラジウム、または、それらの合金からなる、請求項19に記載の再生方法。
- 前記インプラントは非金属製インプラントであることを特徴とする、請求項13に記載の再生方法。
- インプラントに親水化表面を再生できるキットであって、前記インプラントの疎水化表面を実質的に破壊または除去できる装置または薬剤からなるキット。
- 前記装置が粗面を有する、請求項23に記載のキット。
- 前記装置はサンドペーパーまたはヤスリである、請求項24に記載のキット。
- エッチング剤を含む、請求項23に記載のキット。
- 前記エッチング剤が酸または塩基である、請求項26に記載のキット。
- インプラントと同梱されてなる、請求項23に記載のキット。
- 前記インプラントが金属製または非金属性である、請求項28に記載のキット。
- 前記金属製インプラントが、チタン、金、プラチナ、タンタル、ニオブ、ニッケル、鉄、クロム、コバルト、ジルコニウム、マグネシウム、アルミニウム、パラジウム、または、それらの合金からなる、請求項29に記載のキット。
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JP2012509750A (ja) * | 2008-11-25 | 2012-04-26 | ザ・リージェンツ・オブ・ザ・ユニバーシティ・オブ・カリフォルニア | 機能性チタンインプラントおよびそれに類する再生可能材料 |
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CA2629600C (en) | 2005-11-14 | 2011-11-01 | Biomet 3I, Inc. | Deposition of discrete nanoparticles on an implant surface |
JP5806466B2 (ja) | 2008-01-28 | 2015-11-10 | バイオメット・3アイ・エルエルシー | 親水性を向上させたインプラント表面 |
WO2011113568A1 (en) * | 2010-03-15 | 2011-09-22 | Nobel Biocare Services Ag | Surface treatment method |
US8641418B2 (en) | 2010-03-29 | 2014-02-04 | Biomet 3I, Llc | Titanium nano-scale etching on an implant surface |
WO2013142118A1 (en) | 2012-03-20 | 2013-09-26 | Biomet 3I, Llc | Surface treatment for an implant surface |
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JP2004187739A (ja) * | 2002-12-06 | 2004-07-08 | Pentax Corp | 骨形成治療デバイス |
JP2005046530A (ja) * | 2003-07-31 | 2005-02-24 | National Institute Of Advanced Industrial & Technology | 多孔質リン酸カルシウム硬化体、その製造方法及びそれを用いた人工骨及び薬剤徐放体 |
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WO2007035217A3 (en) | 2009-05-22 |
WO2007035217A2 (en) | 2007-03-29 |
CA2621970A1 (en) | 2007-03-28 |
EP1941052B1 (en) | 2013-12-18 |
EP1941052A4 (en) | 2011-11-23 |
EP1941052A2 (en) | 2008-07-09 |
AU2006292762A1 (en) | 2007-03-29 |
JP5186376B2 (ja) | 2013-04-17 |
US20080254469A1 (en) | 2008-10-16 |
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