塑膠化跨腕關節骨外固定器之快速開發
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2006
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腕關節骨外固定器已廣泛應用於腕部的各類骨折，亦屬於維持復位的方法之一，但是有別於傳統石膏治療易使骨折癒合至不同位置和產生癒合後之僵硬等缺點，腕關節骨外固定器的穩定性和可調性能使病患早日康復且復原良好。腕關節骨外固定器主要分為跨腕型和非跨腕型，跨腕型應用於腕部骨折類型中比較常見的遠端橈骨骨折，市面上大部份為金屬材料的產品，x光下的遮蔽性影響診斷復健的效果，本研究以塑膠化觀點設計跨腕關節骨外固定器，期望改善金屬遮蔽性的缺點，在結構設計上也需達到等同金屬產品一定程度的穩定性，以充分發揮腕關節骨外固定器之功能。本論文先行參考已在臨床上使用的跨腕關節骨外固定器TRAUMA-FIX S-20和國內林晉醫師發明的產品為參考設計組合，並討論其功能性設計，如伸縮臂的調整功能、球接頭的設計目的，可以得到其設計除了可達到牽引整復的效果，也預防手術後所產生的腕部僵硬等後遺症。
本研究自行設計兩組設計組合Design-1和Design-2是以塑膠化為考量，所以幾何尺寸必須有所變更來達到結構補強，同時改良球接頭和骨鉗夾持方式以符合功能性。產品開發導入CAD/CAE/CAM概念，其中CAD以參數化設計，以利尺寸的變更；CAE以電腦模擬結構強度，縮短產品開發時間與減少其製作成本；CAM使用快速原型技術(RP)，以製作的實體樣品來檢查設計上盲點與運動干涉狀況；與傳統產品開發流程相比較則節省許多時間和經費。分析定義主要考慮腕關節骨外固定器的穩定性，因此定義在施力大小下所產生的位移量越少越好，使用CosmosWork分析結果得知，Design-1和Design-2在施力條件下的塑膠材料PC和ABS皆未超過降伏強度，且歸納出影響位移量的結果有材料、施力大小和幾何等因素，再根據先前運動原型的操作整合設計概念，也變更幾何尺寸後產生新一組設計NewDesign，材料上採用強度較高的PC+30%G.F.塑膠材料，此時分析之特定點在30N下位移量為1.3mm，而市面上常使用TRAUMA-FIX S-20金屬材料Al為0.7mm，分析結果顯示此設計組合可有效減少並接近金屬材料所產生的位移量。
由於PC+30%G.F.塑膠材料常用於射出成形，其切削加工性困難，所以驗證實驗改使用80%PC+20%ABS的材料，NC加工製作功能性原型，以驗證產品與CAE分析之一致性，可得其特定點在30N下之位移量分析結果和實驗數據差距少至0.3mm，本設計之產品可達到本研究的目的。
Wrist fixators have already been applied to all kinds of fracture of the wrist joints extensively. They are one of the methods to maintain reconstructive position. The conventional gypsum treating usually coalesces in the incorrect position and has the disadvantage of ankylosis after coalescence. Wrist fixators provide the stability and adjustability and make the patients recover and restore well quicker. Wrist fixators include non-spanning configuration and spanning configuration which is applied to common Distal-Radius-Fracture of all kinds of wrist fractures. The regular apparatus material on the market nowadays is metal. Surgeons can’t be completely benefited from the X-ray photo because of the translucent ability of the fixator’s material. The main objective of this research is to design the plastic spanning wrist fixator. The advantages of the new-designed plastic spanning wrist fixator are not only the functional stability and adjustability, but also X-rays transparence. Moreover, the plastic produce will be easy to be mass production. Referring to current clinical products, which are TRAUMA-FIX S-20 and the wrist fixator invented by Dr. Jinn Lin in Taiwan, they have telescoping shaft for adjustability and ball joints for 3 axis motion, These functions prevent the sequelae of ankylosis after coalescence. In order to accumulate the speed of product development process, the state of the art technologies, which are CAD, CAE, and Rapid Prototyping (RP), have been integrated and used in this research. CAD can aid designer for dimension redefined. CAE can shorten products construction period and reduce the cost by simulate experiment in computer which was taken by material testing using real mode. RP technology can turn designs to physical models and check the kinetic interference and the blind spots of designs. The stability of the plastic wrist fixator has the relation with the displacement results of CAE. The anticipative results on CAE is that the less displacement emerge under the range of force. In this research, Design-1 and Design-2 are new-innovated plastic spanning wrist fixators. According to the suggestions from the CAE results, dimensions have been modified to give enough structural reliability. Design-1 and Design-2, which are plastic material of PC and ABS, haven’t exceeded the yield strength under the range of force by analytic software of CosmosWork. According to the kinetic prototype by RP technology, New Design, which is integrated all of the advantages of previous designs in terms of the mechanism, has been introduced. The material is suggested to use PC+30%G.F plastic for better mechanical properties. The CAE shows the displacement at the dedicate location when the force is 30N is 1.3mm. The displacement of commonly used metal TRAUMA-FIX S-20 is 0.7mm. It shows the similar displacement of the above two and provides good satisfactions of the New Design. However, PC+30%G.F is one of the plastics usually used in injection molding and it is difficult to be used in cutting process. In order to fabricate a benchmark part for function testing, 80%PC+20%ABS was used. The disparity of the dedicate location between the simulation result and experimental data is only 0.3mm in 30N. It shows a good agreement of the New Design.
Wrist fixators have already been applied to all kinds of fracture of the wrist joints extensively. They are one of the methods to maintain reconstructive position. The conventional gypsum treating usually coalesces in the incorrect position and has the disadvantage of ankylosis after coalescence. Wrist fixators provide the stability and adjustability and make the patients recover and restore well quicker. Wrist fixators include non-spanning configuration and spanning configuration which is applied to common Distal-Radius-Fracture of all kinds of wrist fractures. The regular apparatus material on the market nowadays is metal. Surgeons can’t be completely benefited from the X-ray photo because of the translucent ability of the fixator’s material. The main objective of this research is to design the plastic spanning wrist fixator. The advantages of the new-designed plastic spanning wrist fixator are not only the functional stability and adjustability, but also X-rays transparence. Moreover, the plastic produce will be easy to be mass production. Referring to current clinical products, which are TRAUMA-FIX S-20 and the wrist fixator invented by Dr. Jinn Lin in Taiwan, they have telescoping shaft for adjustability and ball joints for 3 axis motion, These functions prevent the sequelae of ankylosis after coalescence. In order to accumulate the speed of product development process, the state of the art technologies, which are CAD, CAE, and Rapid Prototyping (RP), have been integrated and used in this research. CAD can aid designer for dimension redefined. CAE can shorten products construction period and reduce the cost by simulate experiment in computer which was taken by material testing using real mode. RP technology can turn designs to physical models and check the kinetic interference and the blind spots of designs. The stability of the plastic wrist fixator has the relation with the displacement results of CAE. The anticipative results on CAE is that the less displacement emerge under the range of force. In this research, Design-1 and Design-2 are new-innovated plastic spanning wrist fixators. According to the suggestions from the CAE results, dimensions have been modified to give enough structural reliability. Design-1 and Design-2, which are plastic material of PC and ABS, haven’t exceeded the yield strength under the range of force by analytic software of CosmosWork. According to the kinetic prototype by RP technology, New Design, which is integrated all of the advantages of previous designs in terms of the mechanism, has been introduced. The material is suggested to use PC+30%G.F plastic for better mechanical properties. The CAE shows the displacement at the dedicate location when the force is 30N is 1.3mm. The displacement of commonly used metal TRAUMA-FIX S-20 is 0.7mm. It shows the similar displacement of the above two and provides good satisfactions of the New Design. However, PC+30%G.F is one of the plastics usually used in injection molding and it is difficult to be used in cutting process. In order to fabricate a benchmark part for function testing, 80%PC+20%ABS was used. The disparity of the dedicate location between the simulation result and experimental data is only 0.3mm in 30N. It shows a good agreement of the New Design.
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Keywords
腕關節骨外固定器, 產品開發, 快速原型, CAD/CAE, wrist fixators, product development, rapid prototype(RP), CAD/CAE