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研究生:蘇建榮
研究生(外文):Chien-Jung Su
論文名稱:針對不同表面處理之鈦合金骨螺絲作生物親和性的評估
論文名稱(外文):Evaluation of Biocompatibility on Various Surface-Processed Titanium Screws: Animal Model
指導教授:張冠諒張冠諒引用關係
指導教授(外文):Guan-Liang Su
學位類別:碩士
校院名稱:國立成功大學
系所名稱:醫學工程研究所碩博士班
學門:工程學門
學類:綜合工程學類
論文種類:學術論文
論文出版年:2002
畢業學年度:90
語文別:中文
論文頁數:69
中文關鍵詞:生物親和性顯微鏡觀察動物實驗植入物
外文關鍵詞:implantbiocompatibilitymicroscopyanimal experiment
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  本研究目的在於評估不同表面處理之鈦合金骨螺絲的生物親和性。植入物金屬表面除了施予多孔性處理外,亦在金屬表面披覆一層鈣磷酸鹽(calcium phosphate),或是電化學反應的發色處理,使金屬表面產生一層可以防腐蝕之氧化物。評估的方法則採用動物實驗,除了以掃描式電子顯微鏡(SEM)觀察植入物與組織間界面的情形外,亦使用光學顯微鏡(OM)觀察植入物周圍的組織形態。
  結果顯示,除了硫酸發色處理之外,其它處理方式之植入物表面在12週或24週就可以達到骨整合(osseointegration),但鍵結之強度有待進一步作力學測試才可知曉。由SEM和OM觀察證實披覆鈣磷酸鹽之植入物具有骨傳導的能力,磷酸發色處理也可以達到同樣的效果。此外,從植入物表面周圍組織內之鈦元素偵測與組織學觀察比較結果,推論硫酸發色處理可以有效增加鈦合金表面之抗蝕性,但生物活性變差,較不具生物親和性。
  The purpose of this study was to evaluate the biocompatibilities of nine different surface-processed titanium screws. The types of surface processing included porous, calcium phosphate coating, porous + calcium phosphate coating, and coloring treatment of acid liquids. These implants were inserted into the proximal tibia epiphysis of rabbits and were examined after 12 and 24 weeks with optical microscope (OM) and scanning electron microscope (SEM) to observe the histological morphology and bonding condition between the implant and tissue.
  Osseointegration was achieved at 12th and 24th week in all cases except coloring treatment of sulfuric acid. Without mechanical testing, however, interfacial shear strengths were not determined in the study. SEM and OM observations demonstrated calcium phosphate coating implants had the capability of osteoconduction, the same trend was found in coloring treatment of phosphoric acid. In addition to these phenomena, coloring treatment of sulfuric acid could promote resistance of corrosion on the titanium surface but relatively decrease the bioactivity, that is, lower biocompatibility.
總目錄

中文摘要....................................................Ⅰ
英文摘要....................................................Ⅱ
誌謝........................................................Ⅲ
總目錄......................................................Ⅳ
表目錄......................................................Ⅶ
圖目錄......................................................Ⅷ
第一章 緒論................................................1
1-1 生醫材料的簡介.......................................1
1-1-1 生醫材料的定義..................................2
1-1-2 生醫材料必須符合的性質..........................2
1-1-3 生醫材料的分類..................................3
1-2 生醫材料之生物親和性.................................5
1-2-1 生物親和性的相關名詞............................5
1-2-2 生物親和性的分級................................6
1-2-3 評估生物親和性的方法............................7
1-3 骨的性質與植入物界面.................................9
1-3-1 脛骨解剖學......................................9
1-3-2 骨組織學.......................................11
1-3-3 骨骼的生理學及理化特性.........................14
1-3-4 骨的癒合.......................................15
1-3-5 骨與植入物之界面...............................17
1-4 文獻回顧............................................18
1-5 研究動機與目的......................................21
第二章 實驗材料與方法....................................23
2-1 實驗流程圖...........................................23
2-1-1 試件準備流程...................................23
2-1-2 顯微鏡觀察及分析流程...........................24
2-2 實驗材料與植入方法...................................25
2-2-1 植入物的種類...................................25
2-2-2 動物實驗.......................................26
2-2-3 手術方法.......................................27
2-3 試件準備方法.........................................29
2-3-1 試件取樣.......................................29
2-3-2 脫水與包埋.....................................29
2-3-3 切片...........................................31
2-3-4 研磨及拋光.....................................32
2-3-5 乾燥...........................................32
2-4 界面之觀察...........................................33
2-4-1 覆膜...........................................33
2-4-2 掃描式電子顯微鏡觀察...........................34
2-5 組織學觀察與影像處理.................................35
2-5-1 染色...........................................35
2-5-2 光學顯微鏡之觀察...............................36
2-5-3 影像處理方法與骨面積比之計算...................36
第三章 結果................................................38
3-1 試件準備之結果.......................................38
3-2 SEM觀察與EDX分析之結果..............................38
3-3 組織學觀察...........................................46
3-3-1 表面組織形態...................................46
3-3-2 骨傳導的現象...................................49
3-4 影像處理與骨螺絲周圍之骨面積比計算...................50
第四章 討論................................................51
4-1 試件準備之檢討.......................................51
3-1-1 動物實驗.......................................51
3-1-2 切片與研磨.....................................52
4-2生物親和性之探討......................................53
4-2-1 表面多孔性質與骨誘導...........................53
4-2-2 骨整合與骨傳導.................................55
4-2-3 生物活性之探討.................................56
4-3 實驗設計之檢討.......................................58
4-4 造成誤差因素之探討...................................59
第五章 結論與展望.........................................60
5-1 結論.................................................60
5-2 未來展望.............................................61
參考文獻...................................................62

附錄一......................................................67
附錄二......................................................68
附錄三......................................................68
附錄四......................................................69

表目錄
表1-1 生醫材料的分類與應用...................................3
表1-2 根據骨組織親和性將硬組織取代物材料分類.................6
表1-3 生物親和性體外試驗之優缺點.............................7
表1-4 骨癒合的三個階段......................................16
表2-1 不同表面處理方式之骨螺絲的編號........................25
表2-2 植入位置與兔隻編號....................................26
表2-3 脫水及包埋過程........................................30

圖目錄
圖1-1 生醫陶瓷依活性分類的原則............................... 4
圖1-2 生物親和性分級與生醫材料性質比較....................... 6
圖1-3 兔隻脛骨解剖圖........................................ 10
圖1-4 骨組織的細部構造...................................... 12
圖1-5 植入物與骨界面骨癒合過程.............................. 15
圖1-6 力學測試裝置簡圖...................................... 19
圖1-7 剪力強度曲線圖........................................ 19
圖2-1 試件準備流程圖........................................ 23
圖2-2 觀察及分析流程圖...................................... 24
圖2-3 骨螺絲外貌及規格...................................... 25
圖2-4 手術進行時之骨螺絲植入兔隻脛骨位置圖.................. 28
圖2-5 手術後拍攝X光片,植入位置圖........ ............. ..... 28
圖2-6 低溫光重合樹脂包埋機........................... .......30
圖2-7 慢速切割機與切片前後之試件............................ 31
圖2-8 自然乾燥時水分子不斷脫離液面表面張力的作用............ 32
圖2-9 真空鍍碳設備及其內部構造.............................. 33
圖2-10 SEM(HITACHI S-2500)附加美國 Kevex公司之EDX......... 34
圖2-11 染色後效果,新生骨-紫色,骨髓-藍色................... 35
圖 2-12 新生骨在骨髓區之面積比計算程式視窗介面..... ......... 37
圖3-1 多孔處理與未多孔處理之骨螺絲表面...................... 39
圖3-2 多孔處理在鈦合金表面之情形............................ 39
圖3-3 Calcium Phosphate Coating 12週之界面情形..............41
圖3-4 Calcium Phosphate Coating 24週之界面情形..............41
圖3-5 (a) CPC(C) 24週骨傳導之情形...........................42
   (b) CPC(B) 12週新生骨斷裂之情形.......................42
圖3-6 Porous+ Calcium Phosphate Coating 12週之界面情形....... 43
圖3-7 Porous+ Calcium Phosphate Coating 24週之界面情形....... 43
圖3-8 (a) CPC(A) 12週表面粗糙情形.......................... 45
   (b) 針對鈦合金表面附近作EDX點分析.....................45
圖3-9 (a) CPC(A) 12週表面粗糙情形.......................... 45
   (b) 針對鈦合金表面附近作EDX點分析.................... 45
圖3-10 (a) 磷酸發色 12週表面粗糙情形........................ 45
(b) 針對鈦合金表面附近作EDX點分析................... 45
圖3-11 組織學觀察圖......................................... 47
圖3-12 組織學觀察圖......................................... 47
圖3-13 組織學觀察圖......................................... 47
圖3-14 組織學觀察圖......................................... 47
圖3-15 組織學觀察圖......................................... 48
圖3-16 組織學觀察圖......................................... 48
圖3-17 組織學觀察圖......................................... 48
圖3-18 組織學觀察圖......................................... 49
圖3-19 組織學觀察圖......................................... 49
圖3-20 不同表面處理方式之骨髓區新骨面積比................... 50
圖4-1 (a) SEM觀察到之不連續斷面............................. 52
   (b) OM無法在斷面上聚焦................................ 52
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