JP2007029717A - 梨地状表面を有するインプラントおよびその製造方法 - Google Patents
梨地状表面を有するインプラントおよびその製造方法 Download PDFInfo
- Publication number
- JP2007029717A JP2007029717A JP2006172924A JP2006172924A JP2007029717A JP 2007029717 A JP2007029717 A JP 2007029717A JP 2006172924 A JP2006172924 A JP 2006172924A JP 2006172924 A JP2006172924 A JP 2006172924A JP 2007029717 A JP2007029717 A JP 2007029717A
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- Prior art keywords
- acid
- implant
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- etchant
- concentration
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- 239000007943 implant Substances 0.000 title claims description 92
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- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims description 26
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Abstract
【解決手段】ナノメーターおよびマイクロメーターレベルの内径を有する複数の凹みを備えた均一の梨地状表面を有する金属基体を製造するための組成物および方法が提供される。梨地状表面は、ハロゲン化水素酸と、ハロゲン化水素酸とオキシ酸との混合物と、塩素含有化合物と、酸化剤を含むエッチング液に上記基体を曝すことによって形成される。エッチング液は、外界温度で使用可能である。この梨地状表面は、当該梨地状表面上への被膜あるいは細胞の付着性を向上させ、上記表面上の蛋白質の保持性を改善し、骨成長性を向上させるものである。
【選択図】図1
Description
この発明は、整形外科用インプラントに関するものであり、かつ、梨地状表面(textured surface)を有する上記整形外科用インプラントを製造するための方法および組成物に関するものである。
整形外科用インプラントの有効性は、しばしば、当該整形外科用インプラントの不定形表面の存在に依存している。すなわち、上記不定形表面内には、骨が入り込んで成長して、骨と上記インプラントとの間に固有の結合部を創出できるからである。不定形表面を有するインプラントを創出するために、いくつかの手法が使用されている。グリットブラスト法は粗面化法の1つであるが、このグリットブラスト法は、基体の表層上に金属要素(例えば、ビーズ)で傷つけることによって上記表層の微細構成に対して著しい変化を引き起こすことがある。スクラッチ(引掻き)法あるいはバーグラインド(バリ取り研磨)法等の他の機械的な粗面化法も使用されている。これらの方法には、基体に歪みが生じる点、素材を過剰に除去してしまう点、ある特定の表面を粗面化することができないか、あるいは困難である点、および予定とは異なる程度に粗面化してしまう点等の不利益が存在することもある。
この発明は、梨地状表面を有する基体を製造するための方法および組成物を提供するものである。上記梨地状表面は、上記インプラント等の基体の表面を、ハロゲン化水素酸(hydrohalic acid)あるいはハロゲン化水素酸とオキシ酸(oxyacid)(オキソ酸(oxoacid)としても公知)との混合物と、塩素を含有する化合物と、酸化剤を含むエッチング溶液に曝すことによって形成可能である。エッチング溶液には、任意に、リン酸塩を含有する化合物も追加して含めてもよい。上記基体については、ナノメーターおよびマイクロメーターレベルの寸法を有する凹みを形成するために、相対的に短い期間、上記エッチング溶液に曝されることだけは必要である。この梨地状表面は、この表面上に非金属被膜あるいは細胞を付着させる機能を向上させ、上記表面が生物学的流体に接触したときに、上記表面上に蛋白質を保持する機能を改善し、骨成長性を向上させる。上記製造方法および組成物は、コバルトおよびコバルト合金、特にコバルト・クロム合金等の硬質金属上に均一な梨地状表面を形成するのに有用である。
この発明の特定の実施の形態は、この明細書において開示された構造、機能、製造方法、そして、方法および組成物の用途の原理についての総合的な理解を与えるために、記述されることになる。この技術分野における当業者は、この明細書において特に記述される上記方法および組成物が例示的な実施の形態に限定されず、この発明の範囲が特許請求の範囲のみによって規定されることを理解するはずである。1つの例示的な実施の形態に関連して図示され、あるいは記述された特徴は、他の実施の形態の特徴と組み合わせられてもよい。このような修正および変更は、この発明の範囲内に包含されるべきものであると意図されている。
実施例1: 梨地状表面の調製
この実施例は、この発明に係るエッチング液を用いて、複数の凹みを有する梨地状表面の形成方法を示している。すべての化学試薬は、フィッシャー・サイエンティフィック社(Fischer Scientific)から入手した。使用サンプルは、デュピュイ・整形外科社(DePuy Orthopaedics,Inc.)から入手可能なポロコート(POROCOAT:登録商標)コバルト・クロム合金製ビーズで被覆したコバルト・クロム基体であった。各サンプルの一部を、この発明に係るエッチング液に曝した。各エッチング液の同一性を評価することは無論のこと、室温のエッチング液に対する曝露時間は、図1〜図8に詳細に記述されている。
以下、この発明の実施の態様を説明する。
(1)梨地状表面を有する生物医学的インプラントを製造するための方法において、
クロム含有インプラントの少なくとも一部をエッチング液に曝すステップと、
前記インプラントがその曝露部分内に均一に分散された複数の凹みを含むようになるまで、10℃から100℃までの温度のエッチング液で前記インプラントを保温するステップと、
を含む、方法。
(2)実施態様1記載の方法において、
複数の凹みを有する前記梨地状表面は、金属要素を有する表面上に形成される、方法。
(3)実施態様1記載の方法において、
前記エッチング液は、ハロゲン化水素酸と、ハロゲン化水素酸とオキシ酸との混合物とからなる群より選択された酸と、塩素含有化合物と、酸化剤とを含み、前記ハロゲン化水素酸は、1Mから12Mまでの範囲内の濃度を有しており、前記オキシ酸は、0.01Mから14Mまでの範囲内の濃度を有しており、前記塩素含有化合物は、0.01Mから2Mまでの範囲内の濃度を有しており、前記酸化剤は、0.01Mから10Mまでの範囲内の濃度を有しており、前記エッチング液は、生物医学的なクロム含有インプラント上に均一な梨地状表面を形成するのに有用である、方法。
(4)実施態様3記載の方法において、
前記ハロゲン化水素酸は、フッ化水素酸、塩化水素酸、臭化水素酸およびヨウ化水素酸からなる群より選択される、方法。
(5)実施態様3記載の方法において、
前記オキシ酸は、亜リンオキシ酸、硝酸および硫酸からなる群より選択される、方法。
(6)実施態様5記載の方法において、
前記亜リンオキシ酸は、ペルオキソ1リン酸(H3PO5)、2リン酸(H4P2O7)、ペルオキソ2リン酸(H4P2O8)、3リン酸(H5P3O10)、次リン酸(H4P2O6)、ポリリン酸(Hn+2PnO3n+1)、イソ次リン酸(H4P2O6)、シクロトリメタリン酸((HPO3)3)、ホスホン酸(H3PO3)、シクロテトラメタリン酸((HPO3)4)、ジホスホン酸((H4P2)5)、ポリメタリン酸(HPO3)n、ホスフィン酸(H3PO2)、および無水オキシ酸からなる群より選択される、方法。
(7)実施態様3記載の方法において、
前記塩素含有化合物は、塩化ナトリウム、塩化カリウム、塩化カルシウム、塩化アンモニウム、塩化鉄、およびこれらの組み合わせからなる群より選択される、方法。
(8)実施態様3記載の方法において、
前記エッチング液はリン酸塩含有化合物をさらに含み、該リン酸塩含有化合物は、リン酸カリウム、リン酸ナトリウム、およびリン酸2水素ナトリウムからなる群より選択される、方法。
(9)実施態様3記載の方法において、
前記酸化剤は、過酸化水素および過硫酸アンモニウムからなる群より選択される、方法。
(10)実施態様1記載の方法において、
前記梨地状表面は、3分間から60分間までの範囲内のエッチング処理時間に、前記エッチング液に前記インプラントを曝すことによって形成される、方法。
(11)実施態様1記載の方法において、
前記梨地状表面は、10分間から30分間までの範囲内のエッチング処理時間に、前記エッチング液に前記インプラントを曝すことによって形成される、方法。
(12)実施態様1記載の方法において、
前記梨地状表面は、20℃から25℃までの範囲内の温度で前記エッチング液に前記インプラントを曝すことによって形成される、方法。
(13)実施態様1記載の方法において、
前記梨地状表面を有する前記基体に被膜を加えるステップをさらに含む、方法。
(14)実施態様13記載の方法において、
前記被膜は、セラミック被膜である、方法。
(15)実施態様1〜14のうち、いずれか1項に記載の方法に従って形成された、インプラント。
(16)エッチング液において、
ハロゲン化水素酸と、ハロゲン化水素酸とオキシ酸との混合物とからなる群より選択された酸と、塩素含有化合物と、酸化剤とを含み、
前記ハロゲン化水素酸は、1Mから12Mまでの範囲内の濃度を有しており、前記オキシ酸は、0.01Mから14Mまでの範囲内の濃度を有しており、前記塩素含有化合物は、0.01Mから2Mまでの範囲内の濃度を有しており、前記酸化剤は、0.01Mから10Mまでの範囲内の濃度を有しており、前記エッチング液は、生物医学的なクロム含有インプラント上に均一な梨地状表面を形成するのに有用であり、前記梨地状表面は、200ナノメーターから15マイクロメーターまでの範囲内の内径を有する複数の凹みを有する、エッチング液。
(17)実施態様16記載のエッチング液において、
前記ハロゲン化水素酸は、フッ化水素酸、塩化水素酸、臭化水素酸およびヨウ化水素酸からなる群より選択される、エッチング液。
(18)実施態様16記載のエッチング液において、
前記ハロゲン化水素酸は、塩化水素である、エッチング液。
(19)実施態様16記載のエッチング液において、
前記オキシ酸は、0.01Mから14Mまでの範囲内の濃度を有する、エッチング液。
(20)実施態様16記載のエッチング液において、前記オキシ酸は、亜リンオキシ酸、硝酸および硫酸からなる群より選択される、エッチング液。
(21)実施態様16記載のエッチング液において、
前記オキシ酸は、リン酸である、エッチング液。
(22)実施態様16記載のエッチング液において、
前記亜リンオキシ酸は、ペルオキソ1リン酸(H3PO5)、2リン酸(H4P2O7)、ペルオキソ2リン酸(H4P2O8)、3リン酸(H5P3O10)、次リン酸(H4P2O6)、ポリリン酸(Hn+2PnO3n+1)、イソ次リン酸(H4P2O6)、シクロトリメタリン酸((HPO3)3)、ホスホン酸(H3PO3)、シクロテトラメタリン酸((HPO3)4)、ジホスホン酸((H4P2)5)、ポリメタリン酸(HPO3)n、ホスフィン酸(H3PO2)、および無水オキシ酸からなる群より選択される、エッチング液。
(23)実施態様16記載のエッチング液において、
前記塩素含有化合物は、塩化ナトリウム、塩化カリウム、塩化カルシウム、塩化アンモニウム、塩化鉄、およびこれらの組み合わせからなる群より選択される、エッチング液。
(24)実施態様16記載のエッチング液において、
前記塩素含有化合物は、塩化アンモニウムである、エッチング液。
(25)実施態様16記載のエッチング液において、
0.01Mから0.4Mまでの範囲内の濃度のリン酸塩含有化合物をさらに含む、エッチング液。
(26)実施態様25記載のエッチング液において、
前記リン酸塩含有化合物は、リン酸カリウム、リン酸ナトリウム、およびリン酸2水素ナトリウムからなる群より選択される、エッチング液。
(27)エッチング液において、
1Mから12Mまでの範囲内の濃度の塩酸と、
0.01Mから14Mまでの範囲内の濃度の亜リンオキシ酸と、
0.01Mから2Mまでの範囲内の濃度の塩素含有化合物と、
0.01Mから0.4Mまでの範囲内の濃度のリン酸塩含有化合物と、
0.01Mから10Mまでの範囲内の濃度の酸化剤とを含み、
前記エッチング液は、基体上に、表面被膜あるいは細胞の付着性を促進する均一な梨地状表面を形成し、前記エッチング液は、10℃から100℃までの範囲内の温度で実行されるエッチング条件下で、生物医学的なクロム含有インプラント上に実質的に均一な梨地状表面を形成するのに有用である、エッチング液。
(28)実施態様27記載のエッチング液において、
前記塩素含有化合物は、塩化ナトリウム、塩化カリウム、塩化カルシウム、塩化アンモニウム、塩化鉄、およびこれらの組み合わせからなる群より選択される、エッチング液。
(29)実施態様27記載のエッチング液において、
前記リン酸塩含有化合物は、リン酸カリウム、リン酸ナトリウム、およびリン酸2水素ナトリウムからなる群より選択される、エッチング液。
(30)実施態様27記載のエッチング液において、
前記酸化剤は、過酸化水素および過硫酸アンモニウムからなる群より選択される、エッチング液。
Claims (15)
- 梨地状表面を有する生物医学的インプラントを製造するための方法において、
クロム含有インプラントの少なくとも一部をエッチング液に曝すステップと、
前記インプラントがその曝露部分内に均一に分散された複数の凹みを含むようになるまで、10℃から100℃までの温度のエッチング液で前記インプラントを保温するステップと、
を含む、方法。 - 請求項1記載の方法において、
複数の凹みを有する前記梨地状表面は、金属要素を有する表面上に形成される、方法。 - 請求項1記載の方法において、
前記エッチング液は、ハロゲン化水素酸と、ハロゲン化水素酸とオキシ酸との混合物とからなる群より選択された酸と、塩素含有化合物と、酸化剤とを含み、前記ハロゲン化水素酸は、1Mから12Mまでの範囲内の濃度を有しており、前記オキシ酸は、0.01Mから14Mまでの範囲内の濃度を有しており、前記塩素含有化合物は、0.01Mから2Mまでの範囲内の濃度を有しており、前記酸化剤は、0.01Mから10Mまでの範囲内の濃度を有しており、前記エッチング液は、生物医学的なクロム含有インプラント上に均一な梨地状表面を形成するのに有用である、方法。 - 請求項3記載の方法において、
前記ハロゲン化水素酸は、フッ化水素酸、塩化水素酸、臭化水素酸およびヨウ化水素酸からなる群より選択される、方法。 - 請求項3記載の方法において、
前記オキシ酸は、亜リンオキシ酸、硝酸および硫酸からなる群より選択される、方法。 - 請求項5記載の方法において、
前記亜リンオキシ酸は、ペルオキソ1リン酸(H3PO5)、2リン酸(H4P2O7)、ペルオキソ2リン酸(H4P2O8)、3リン酸(H5P3O10)、次リン酸(H4P2O6)、ポリリン酸(Hn+2PnO3n+1)、イソ次リン酸(H4P2O6)、シクロトリメタリン酸((HPO3)3)、ホスホン酸(H3PO3)、シクロテトラメタリン酸((HPO3)4)、ジホスホン酸((H4P2)5)、ポリメタリン酸(HPO3)n、ホスフィン酸(H3PO2)、および無水オキシ酸からなる群より選択される、方法。 - 請求項3記載の方法において、
前記塩素含有化合物は、塩化ナトリウム、塩化カリウム、塩化カルシウム、塩化アンモニウム、塩化鉄、およびこれらの組み合わせからなる群より選択される、方法。 - 請求項3記載の方法において、
前記エッチング液はリン酸塩含有化合物をさらに含み、該リン酸塩含有化合物は、リン酸カリウム、リン酸ナトリウム、およびリン酸2水素ナトリウムからなる群より選択される、方法。 - 請求項3記載の方法において、
前記酸化剤は、過酸化水素および過硫酸アンモニウムからなる群より選択される、方法。 - 請求項1記載の方法において、
前記梨地状表面は、3分間から60分間までの範囲内のエッチング処理時間に、前記エッチング液に前記インプラントを曝すことによって形成される、方法。 - 請求項1記載の方法において、
前記梨地状表面は、10分間から30分間までの範囲内のエッチング処理時間に、前記エッチング液に前記インプラントを曝すことによって形成される、方法。 - 請求項1記載の方法において、
前記梨地状表面は、20℃から25℃までの範囲内の温度で前記エッチング液に前記インプラントを曝すことによって形成される、方法。 - 請求項1記載の方法において、
前記梨地状表面を有する前記基体に被膜を加えるステップをさらに含む、方法。 - 請求項13記載の方法において、
前記被膜は、セラミック被膜である、方法。 - 請求項1〜14のうち、いずれか1項に記載の方法に従って形成されたインプラント。
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Also Published As
Publication number | Publication date |
---|---|
US20060289388A1 (en) | 2006-12-28 |
AU2006202717A1 (en) | 2007-01-18 |
JP5026003B2 (ja) | 2012-09-12 |
US7368065B2 (en) | 2008-05-06 |
AU2006202717B2 (en) | 2011-03-10 |
EP1736182B1 (en) | 2014-06-18 |
EP1736182A1 (en) | 2006-12-27 |
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