アルカリ熱処理生体活性化チタンおよびチタン合金の整形外科用インプラントの開発

碱性热处理生物活化钛及钛合金骨科植入物的研制

• 批准号: 09358019
• 负责人: NAKAMURA Takashi
• 金额: $ 17.98万
• 依托单位: KYOTO UNIVERSITY
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (A)
• 财政年份: 1997
• 资助国家: 日本
• 起止时间: 1997 至 1999
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-09358019/
• 关键词: Titanium; Bioactive Material; Alkali-Heat-Treatment; Animal Experiment; Push-Out Test; Porous Material; Bone Bonding; チタン合金; アルカリ加熱処理; 多孔性; push out test; プラズマスプレー; バイオマテリアル; 生体活性

The purposes of this study were as follows.1. To confirm that alkali- and heat-treated titanium (AH-Ti) or titanium alloy (AR-TiA) bonds to bone.2. To compare the bone-bonding strength of AH-Ti with that of bioactive ceramics or porous titanium.3. To make screws or implants on the market be bioactive using alkali- and heat-treatment (AH treatment), and to compare their biocompatibility and bioactivity with those of untreated control. To examine chronological changes of their bone-bonding strength.As a result, the following facts were clarified.1. Both AH-Ti and AH-TiA formed bone-like apatite layer on their surface in the simulated body fluid. (Ref.1)2. AH-Ti or AH-TiA bonded to rabbit tibiae chemically. (Ref.2,3,4)3. AH-Ti and untreated Ti cylinders with smooth surface were inserted into canine femora hemi-transcortically, and bone bonding ability of AH-Ti was confirmed. (Ref.5)4. The same experiment as 3 was performed using cylinders with porous surface, and enhancement of bone-bonding strength by AH treatment was demonstrated. (Ref.6)5. When AH-Ti and AH-TiA were preserved in high humidity condition, their ability for apatite formation decreased. Washing the material by distilled water just after the AH treatment was proved to prevent this deterioration. It was demonstrated that bone-bonding strength of AH-Ti was enhanced by this washing treatment. (Paper in preparation)The bone-bonding ability of AH-Ti(A) was demonstrated in many experimental condiotions. This technique is expected to enhance bone-prosthesis bonding strength, and a clinical experiment using AH-treated cementless hip stems is planed to start this year.

本研究的目的如下： 1．确认碱热处理钛(AH-Ti)或钛合金(AR-TiA)与骨的结合。2．比较AH-Ti与生物活性陶瓷或多孔钛的骨结合强度。 3．通过碱处理和热处理（AH处理）使市场上的螺钉或植入物具有生物活性，并与未经处理的对照物比较其生物相容性和生物活性。考察其骨结合强度随时间的变化。结果阐明了以下事实： 1． AH-Ti和AH-TiA在模拟体液中均在其表面形成骨状磷灰石层。 （参考文献1）2。 AH-Ti 或 AH-TiA 通过化学方式与兔胫骨结合。 （参考文献2、3、4）3。将AH-Ti和表面光滑的未经处理的Ti圆柱体半经皮层插入犬股骨，并证实AH-Ti的骨结合能力。 （参考文献 5）4．使用具有多孔表面的圆柱体进行与3相同的实验，并且证明了通过AH处理提高骨结合强度。 （参考文献 6）5．当AH-Ti和AH-TiA在高湿度条件下保存时，它们形成磷灰石的能力下降。事实证明，在 AH 处理后立即用蒸馏水清洗材料可以防止这种恶化。结果表明，通过这种清洗处理，AH-Ti 的骨结合强度得到了增强。 （论文准备中）AH-Ti(A)的骨结合能力在许多实验条件下得到了证明。这项技术有望增强骨假体的粘合强度，并且计划于今年开始使用经 AH 处理的非骨水泥髋关节柄进行临床实验。

项目成果

Nishiguchi. S. et al: "The effect of beat treatment on bone-bonding ability of alkali-treated titanium"Biomaterials. 20. 491-500 (1999)

西口。

中村孝志: "バイオマテリアルと生体-副作用と安全性" 中山書店 編集:佐藤温重(東京医科歯科大学)他, 13 (1998)

中村隆：“生物材料和生物体 - 副作用和安全性”中山书店编辑：Atsushi Sato（东京医科齿科大学）等，13（1998）

H.M.Kim et al.: "Graded surface structure of bioactive titanium prepared by chemical treatment"Journal of Biomedical Materials Research. 45. 100-107 (1999)

H.M.Kim 等：“化学处理制备的生物活性钛的分级表面结构”生物医学材料研究杂志。

S.Nishiguchi, T.Nakamura, et al: "The Effect of Heat Treatment on Bone Bonding Ability of Alkali-treated Titanium" Bioceramics. 10. 561-564 (1997)

S.Nishiguchi、T.Nakamura 等人：“热处理对碱处理钛骨结合能力的影响”生物陶瓷。

Nakamura T. et al: "BIOACTIVE TITANIUM AND ITS ALLOYS"MATERIALS IN CLINICAL APPLICATIONS. 28. 289-300 (1999)

Nakamura T. 等人：“生物活性钛及其合金”材料的临床应用。