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研究生:廖振凱
研究生(外文):Chen-Kai Liao
論文名稱:後方脊椎內固定器測試方法的評估
論文名稱(外文):Evaluation of Testing Method of the Posterior Spinal Fixator
指導教授:鄭誠功鄭誠功引用關係
指導教授(外文):Cheng-Kung Cheng
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:醫學工程研究所
學門:工程學門
學類:生醫工程學類
論文種類:學術論文
論文出版年:2001
畢業學年度:89
語文別:中文
論文頁數:116
中文關鍵詞:脊椎生物力學脊椎內固定器靜態測試疲勞測試
外文關鍵詞:spinebiomechanicsspinal fixatorstatic testfatigue test
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關於背痛(back pain)的問題,嚴重到脊椎不穩定後,往往需要進行脊椎融合手術(spinal fusion)。脊椎融合手術常用到脊椎內固定器(spinal fixator)來幫助椎骨融合。一般內固定器提供以下功能:支撐脊椎、維持脊椎幾何相對位置、避免過大的脊椎變形及減輕或消除疼痛。
目前國內尚無一套完整的標準化測試流程,以致於各種脊椎內固定器設計製造後,各以不同規範的測試方法來進行評估,因此所測試的結果沒有一個相同標準依據,這種結果造成臨床醫療人員無法對現有固定器作客觀的比較。基於此原因,有必要擬定出一套標準化的測試流程來量化國內自行研發或國外進口之各式脊椎內固定器之力學性質,以確保其品質與可信賴度。因此本研究的目的在於建立脊椎內固定器測試標準操作的流程。
本研究以美國材料試驗協會(American Society for Testing and Materials, 簡稱ASTM)所規範的測試流程F1717-96為依據,且修改其不適之處,並加上拉出測試(pullout test)。測試項目包括了以下幾項:軸向壓力測試(axial compression test)、壓力彎曲測試(compression bending test)、張力彎曲測試(tension bending test)、扭轉測試(torsion test)、拉出測試及疲勞測試(fatigue test)。在擬定好測試流程後,按照此流程進行測試。
本研究以美國Metronic Sofamor Danek製CDH (Cortrel Dubbouset Horizon instrumentation)廠牌之脊椎內固定器為測試樣本。以超高分子量聚乙烯(ultra high molecular weight polyethylene, UHMWPE)來模擬脊椎椎體。在靜態測試中,除了扭轉和拉出測試以外,所有破壞皆發生在螺帽(plug)上;拉出測試破壞處在骨螺釘鑽入點的材料上;疲勞測試中,除了50 %壓力彎曲降伏強度時載重週期數達1,000,000次無破壞外,其他二組,75 %和100 %壓力彎曲降伏強度皆使固定器破壞,破壞處為桿件(rod)或螺帽。由本流程中,可知道CDH內固定器在強度上最脆弱之處為螺帽,此處亦為應力集中處。
本研究已針對脊椎內固定器的測試擬定一套標準規範,並對現有脊椎內固定器CDH進行測試,且獲得完整的生物力學性質。此新規範將可提供脊椎內固定器測試的參考,而本研究測試結果也可提供未來測試的比較。

Regarding to the back pain problem, it usually undergoes spinal fusion surgery when the spine results in the occurrence of instability. Spinal fusion is used to help to increase spinal stability by spinal fixators. Spinal fixators can provide following functions including to support spine, maintain correction, prevent progression of deformity, alleviate or eliminate pain.
Nowadays in Taiwan, there are no complete and unique test standards to evaluate different kinds of spinal fixators so that these spinal fixators were tested under different test standards. As the result, clinicians are difficult to compare present spinal fixators with each other under the same test standards. Therefore, it is necessary to make a complete and unique standard to quantify the biomechanical properties of the spinal fixators in Taiwan whatever the spinal fixators were made by compatriots or imported from other countries. The results of tests can be made comparisons with different kinds of spinal fixators and justified the qualities and reliability. The purpose of this study is to establish the test standards of spinal fixators.
The method of this study is based on the standard of “American Society for Testing and Materials, ASTM, F1717-96”. We modified some parts unsuitable and replenished with pullout test. The followings are the test items: axial compression, compression bending, tension bending, torsion, pullout and fatigue test. After establishing the testing standards, we started to test the spinal fixator according to them.
The spinal fixator this study used was CDH (Cortrel Dubbouset Horizon) made by Metronic Sofamor Danek, USA. The ultra high molecular weight polyethylene (UHMWPE) was conducted to imitate spinal vertebra. In the static biomechanical tests, all specimens had fractures in plugs except torsional test and pullout test. There were fractures in the middle part of synthetic bones in pullout test. In fatigue test, there was no damage under the load level of 50 % compressive bending yield load. It then reached 1,000,000 cycles without any destruction. Under the 75 % and 100 % compressive bending yield loads, the rod or plug fractured. In the experiments, the weakest point of CDH was plug that was also the point of stress concentration.
This study has established a complete test standard procedure for spinal fixators. According to the testing standard, this study performed biomechanical testings in CDH and then provided some experimental results for future comparison with other kinds of spinal fixators.

目錄
中文摘要Ⅰ
英文摘要Ⅲ
目錄Ⅴ
圖目錄IX
表目錄XIV
第一章 前言1
1-1 研究背景與現況1
1-2 脊椎解剖構造3
1-2-1 彎曲5
1-2-2 典型的椎骨5
1-2-3 頸椎區域7
1-2-4 胸椎區域8
1-2-5 腰椎區域9
1-2-6 薦椎和尾椎10
1-3 文獻回顧11
1-3-1 脊椎內固定器簡介11
1-3-2 實驗測試材枓14
1-3-2-1 生物體測試14
1-3-2-2 非生物體測試16
1-4 研究動機、目的與假設21
第二章 材料與研究方法22
2-1 材料與場地設備22
2-1-1 材料22
2-1-2 場地設備26
2-2 試件取樣27
2-3 研究方法30
2-3-1 靜態軸向壓力測試30
2-3-2 靜態壓力彎曲測試31
2-3-3 靜態張力彎曲測試33
2-3-4 靜態扭轉測試34
2-3-5 靜態拉出測試36
2-3-6 動態疲勞測試過程37
2-4 資料分析方法40
第三章 結果41
3-1 靜態測試41
3-2 動態疲勞測試58
第四章 討論62
4-1 靜態測試62
4-1-1 壓力彎曲和張力彎曲測試的比較62
4-1-2 靜態測試破壞情形和相對螺帽鎖緊力矩或骨螺釘鑽入扭矩大小之比較63
4-1-3 靜態測試中與相關文獻之比較65
4-1-4 修正後扭轉測試69
4-1-5 拉出測試與其他相關文獻比較74
4-2 動態疲勞測試78
4-2-1 破壞模式探討78
4-2-2 動態疲勞測試破壞情形和相對螺帽鎖緊力矩或骨螺釘鑽入扭矩大小之比較79
4-2-3 疲勞測試中與相關文獻之比較81
4-2-4 本研究所建立的操作規範疲勞測試和ASTM疲勞測試之比較82
4-3 臨床上選用脊椎內固定器方式85
第五章 結論與建議86
參考文獻87
附錄目錄91
附錄一 研究方法專有術語名詞解釋92
附錄二 各種脊椎內固定器研究方法95
附圖100
附錄三 詳細測試確認單108

參考文獻
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