利用微米製程與表面加工技術生產特定形貌之聚醚醚酮磨耗顆粒及其臨床前試驗之應用

Applying microfabricated surface texture to generate poly-ether-ether-ketone (PEEK) wear particles with controlled size and shape and pre-clinical testing application

郭建緯(Chien-Wei Kuo)

指導教授 ： 方旭偉

國立臺北科技大學/工程學院/化學工程研究所/碩士(2010年)

摘要

人工椎間盤-超高分子量聚乙烯 (UHMWPE) 元件所產生的磨耗顆粒，經證實會如同人工關節一樣在人體內引發免疫反應，產生骨溶解的現象，最終造成人工椎間盤鬆脫、手術失敗。目前解決方法除了針對材料與元件進行改良外，就是換上於人工椎間盤應用上較UHMWPE磨耗性質佳的聚醚醚酮 (PEEK)，以期能改善磨耗顆粒的產生與降低磨耗顆粒引發骨溶解現象的可能。
本研究利用半導體中的微米製程（microfabrication）技術，於矽晶圓上製作不同尺寸之切割裝置（cutting device）的微米加工表面（surface texture），再藉此加工表面對 PEEK 棒材進行加速磨耗試驗，觀察水、生物潤滑液-胎牛血清（feral bovine serum, FBS）與不同濃度甘油（glycerine）溶液和與其他磨耗參數下對磨耗行為的差異，藉此探討並找出控制特定PEEK磨耗顆粒大小形狀的參數，同時，建立PEEK 磨耗顆粒之分離程序與內毒素檢測流程。
由實驗結果得知，利用胎牛血清建立有效分離 PEEK 磨耗顆粒之分離程序。磨耗試驗部份，在49 N荷重等參數下，配合100 %甘油潤滑液可量產細小顆粒狀與纖維狀之PEEK磨耗顆粒，與臨床分析之UHMWPE磨耗顆粒相似；而在50 % 與75 %甘油潤滑液可量產細小之圓珠狀與顆粒狀等特定形貌大小之 PEEK 磨耗顆粒；最後，經由內毒素檢測，完成臨床試驗應用前之平台建立。未來期望能利用此建立平台進一步探討 PEEK 與 UHMWPE 之磨耗顆粒相關生物實驗差異。

關鍵字

磨耗顆粒 ； 微米加工表面 ； 聚醚醚酮

並列摘要

The wear debris of Ultra High Molecular Weight Polyethyelene (UHMWPE) generated in joint organization can induce osteolysis and eventually caused prosthesis failure. In order to understand the possible of the Poly-Ether-Ether-Ketone (PEEK) material substitutes for UHMWPE.We are looking for the methods to control the wear particles of PEEK induced bioactivies by surface texturing techniques、lubricating and other experiment parameter improvements.
In this study, we applied micro-fabricated surface texture to rub against the PEEK to accelerate the wear rate of PEEK, we discussed the effects of wear behavior under water、biological lubrication such as bovine serum (FBS) amd glycerine of different concentration. The outcome shows that thinner and fibril-like wear particles were found in different lubricants. Simultaneously, the procedure that can separate the PEEK wear particles effectively from the organization be established. Finally,in order to the pre-clinical testing demand in the future, establish the flow purifies the PEEK wear particles.
Results from the study demonstrated that we have succeed to establish a separate procedure of the wear particles of PEEK by using Fetal Bovine Serum (FBS) lubricant. Then, we can produce the wear particles of PEEK with specifial size and appearance matchs literature, coordinate parameters with 50~100% glycerine、49N loadings and so on. Finally, By the test of endotoxin, we complete the flow of purification of the wear particles of PEEK. In the future, we hope we can apply this percedure to further research into both's the related biological response about the wear particles of PEEK and UHMWPE.

並列關鍵字

Wear particles ； Micron surface texture ； Poly-ether-ether-ketone (PEEK)

參考文獻

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