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研究生: 林合宣
Ho-shiuan Lin
論文名稱: 連續式毛囊真皮乳頭細胞植入器之改良
The Improvement of Continuous Implanter for Dermal Papilla Cells
指導教授: 鄭逸琳
Yih-Lin Cheng
口試委員: 陳志強
Chih-chiang Chen
王勵群
Li-Chun Wang
學位類別: 碩士
Master
系所名稱: 工程學院 - 機械工程系
Department of Mechanical Engineering
論文出版年: 2010
畢業學年度: 98
語文別: 中文
論文頁數: 109
中文關鍵詞: QFDDFAFMEA植入器真皮乳頭細胞
外文關鍵詞: QFD, DFA, FMEA, Implanter, Dermal Papilla Cells
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  • 現今普遍治療雄性禿(androgenetic alopecia)的方法有口服柔沛(finasteride)、外用生髮水(minoxidil)與植髮(hair transplantation),但這些方法的成效都各有其所無法突破的地方。近年經學者研究發現,於毛囊中萃取出之毛囊真皮乳頭細胞(dermal papilla cells)在體外大量增生後,再將其植入禿髮處,即可誘導毛囊新生。但現階段的植入方式為採用手術或注射器等方式置入細胞團,須耗費大量時間在細胞團製備及裝填的步驟上。為了縮短前置作業時間、加快植入效率及固定植入深度,具有細胞儲存能力之連續式細胞團植入器確有其開發的必要性。
    本研究以先前研究之第一代連續式細胞植入器為基礎,藉由QFD、DFA與FMEA工具系統化地改良設計出第二代連續式細胞植入器,其同樣以將半固體狀的真皮乳頭細胞團放入「彈匣」中或直接於「彈匣」中進行培養,再利用器械的自動進給機制推送植入體透過針具進行植入的概念為設計初衷。第二代連續式細胞植入器之各零組件於3D繪圖軟體中繪製完成後,即以SDM製程與快速原型技術製作出原型零件,再將零件與針具結合組裝,隨後進行多項實驗比較其與先前研究的差異;並利用染色洋菜膠作為模擬植入體植入豬皮,切片後以放大鏡觀察其植入效果與植入深度並進行評估。測試結果發現第二代連續式細胞植入器具有相對舒適的操作方式,且其植入效果和速度都大幅的領先第一代連續式細胞植入器。


    The general treatments of androgenetic alopecia include finasteride, minoxidil, and hair transplantation. Each of them has certain issues to break through. The recent study found that implanting the dermal papilla cells, which was extracted from the hair follicles and proliferated in vitro, in the bald areas can induce new hair follicles. However, the existing approaches to implant the cell aggregates are by surgery or syringe, requiring a lot of time on preparation and loading the cells. In order to shorten the preparation time, speed up the efficiency and control the implanted depth, development of a continous implanter which has cell storage capability is needed.
    The concept of the continuous implanter is to place semi-solid dermal papilla cells or cultivate them directly in a cartridge, and an auto-feed mechanism is utilized to push the cells into the derma through a needle. In this research, QFD, DFA, and FMEA tools were adopted to systematically analyze the first generation continuous cell implanter developed in the previous study. Based on the analysis results, the second generation implanter was designed to improve its performance and reduce its assembly time and failure risk. All the components were designed in a 3D CAD software and fabricated their prototypes by SDM process or commercial rapid prototyping technique. After assembly of the components and the needles, several tests were conducted to compare with the first generation of continuous cell implanter. Moreover, dyed agar was used to simulate the cell aggregates implanting into porcine derma. The implanted biopsy samples were observed by a microscope. The results revealed that the second generation continuous cell implanter can operate easier and more comfortable. The effectiveness and speed of implanting are improved significantly.

    摘要 I Abstract II 誌謝 III 目錄 IV 圖目錄 V 表目錄 XII 第一章 緒論 1 1.1研究背景 1 1.2研究動機 2 1.3研究目的與方法2 1.4論文架構 4 第二章 文獻探討 5 2.1雄性基因禿髮之病理機轉 5 2.1.1毛髮週期動力學 6 2.1.2毛囊微小化 7 2.1.3發炎 8 2.2雄性禿的治療 8 2.3植髮技術 11 2.4毛髮移植之綜合性比較 13 2.5植髮器械及植入工具介紹 15 2.5.1Choi植髮器 15 2.5.2毛髮移植筆 17 2.5.3轉盤式植髮器 18 2.5.4KNU植髮器 20 2.5.5顯微毛囊植髮器 21 2.5.6科維創植髮系統 22 2.5.7第一代連續式細胞植入器 24 2.5.8其他植入工具 25 2.6毛囊複製技術 27 2.6.1ICX-TRC毛髮再生療法 29 2.6.2真皮乳頭細胞之微組織培養 29 2.6.3皮膚結構 30 2.7快速原型技術 31 2.7.1PolyJetTM技術 32 2.7.2形狀沉積製造 34 2.8DFM相關工具介紹 36 2.8.1品質機能部署 36 2.8.2易組裝性設計 37 2.8.3失效模式與效應分析 38 第三章 第一代連續式細胞植入器之分析 40 3.1連續式細胞植入器之QFD分析40 3.2第一代連續式細胞植入器之DFA分析 43 3.3分析結果與討論 48 第四章 第二代連續式細胞植入器之設計與原型製作 51 4.1植入機制的選擇與針具之製作 51 4.2植入器設計、繪製與模擬 53 4.2.1進給機構設計 53 4.2.2CAD模型繪製與模擬 56 4.3DFA、FMEA分析 61 4.3.1第二代植入器之DFA分析 61 4.3.2第二代植入器之FMEA分析63 4.3.3分析結果與相關改良 67 4.4原型製作69 4.4.1進給螺桿之製作 70 4.4.2SDM製程零件分層規劃與製作 71 4.5原型零件組裝與基本功能測試 87 4.5.1原型零件組裝87 4.5.2基本功能測試89 4.6氣動模組設計 90 4.6.1周邊組件選用與連結套筒設計 90 4.6.2氣動模組參數設定 92 4.7植入器商品化成本估算 93 第五章 植入器之測試與比較 96 5.1性能測試 96 5.1.1模擬植入 96 5.1.2針組與彈匣更換 97 5.1.3操作與控制 98 5.2植入效果 99 5.2.1模擬植入體之製備 100 5.2.2測試方法 101 5.2.3測試結果 103 5.2.4綜合比較 105 第六章 結論與未來研究方向 107 6.1結論 107 6.2未來工作與展望 108 參考文獻110 附錄一 Assembly Time Chart 117 附錄二 FMEA失效風險指數對照表 120 附錄三 不同針頭斜角之傷口深度豬皮切片 121 附錄四 不同推出桿長度植入測試豬皮切片 123 附錄五 手動與氣動植入測試豬皮切片 129 附錄六 注射針頭表 133

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