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研究生:姚聖恩
研究生(外文):Sheng-En Yao
論文名稱:設計與發展於下肢經皮微創鋼板接骨術之輔助器械
論文名稱(外文):Design and Develop Assisted Instrument for Minimally Invasive Plate Osteosynthesis on Lower Limbs
指導教授:鍾高基鍾高基引用關係
指導教授(外文):Kao-Chi Chung
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:2008
畢業學年度:96
語文別:中文
論文頁數:74
中文關鍵詞:導引輔助器械微創手術
外文關鍵詞:MIPOMIS
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微創手術是日益受到重視的手術觀念,應用於骨科手術可改善傳統開創復位內固定手術 (ORIF) 所引發的感染、癒合不良及延遲癒合等問題。然而礙於有限的視野進行手術,因此以微創手術進行骨折內固定時必需透由X-ray照射來進行手術治療。微創內固定穩定系統 (LISS) 在處理近關節面之骨折內鋼板固定已有相當好的療效;然而LISS只限於該公司產品使用。目前使用於下肢骨折的內固定鋼板種類繁多,且並無相對應導引輔助器械來協助手術進行。因此本研究目的為發展一套鋼板導引輔助系統可適用於下肢骨折之骨板內固定器。

本研究整合臨床在進行 MIPO 對於骨板的導入、骨螺絲定位及導引骨螺絲鎖固的功能性需求,進而發展一套導引輔助系統其包含三裝置:骨板手持導引器、骨板螺絲孔定位裝置及骨螺絲鎖固裝置。係利用 CAD 進行模型建立與初始設計,並利用有限元素進行系統結構穩定性模擬,其次進行機械性質測試,並測試系統定位的適用性,最後以豬腳動物實驗做為系統的驗証評估。

本研究已完成MIPO手術導引輔助系統的雛型設計,包含:骨板手持導引器、骨板螺絲孔定位及骨螺絲鎖固裝置。有限元素模擬分析系統結構結果顯示:各裝置在受力時使的螺絲保護套的中心位移量皆小於容許誤差1.36mm,為骨螺絲可鎖固的容許範圍內。系統機械性質的測試結果顯示:各裝置於受力時的位移量皆小於容許誤差正負3度,表示系統結構的穩定性良好可適於手術操作過程的使用。系統定位適用性測試結果顯示:直板型骨板及交錯型骨板由於定位裝置尺寸過大而造成中心孔位有干涉的現象,只可選其一完成定位,其餘孔位皆可達成定位;彎曲型骨板因定位裝置及骨板的彎曲造型使得定位裝置的無法完成定位,可完成定位的孔位數較少。以交錯型骨板於豬腳上施以動物實驗其結果顯示:骨螺絲皆可順利的鎖固於交錯型骨板上。

未來研究方向建議:(1)定位裝置機構的改善,以增加定位時的穩定度,(2)縮小裝置尺寸或增加用以解決干涉之機構,以提升系統於臨床的應用層面,(3)可收集臨床醫師較常彎曲的使用範圍及骨板類型,用以改良各裝置設計。
Minimally Invasive Surgery ( MIS ) has been developing and implemented in surgical treatment recently. Compared to the traditional open reduction and internal fixation on bone fractures, the MIS can reduce the extensive soft tissue dissection and periosteal injury and improve the infection, delayed union and non-union. However, the disadvantage of MIS is to increase more X-ray exposure. The Less Invasive Stabilization System ( LISS ) developed by Synthes Corporation has been adequately used to treat extra-articular and complex intra-articular proximal tibia fractures with bone plates designed by the Synthes Co.. Although the LISS has been used for Minimally Invasive Plate Osteosynthesis ( MIPO ) with low complication rates and acceptable long-term functional outcomes, there is lack of assisted instrument for various lower limb plates other than those designed by the Synthes. The purpose of this research was to design and develop an assisted instrument system for MIPO on lower limb bone fractures.

The design of the assisted instrument system included a plate holder for guiding plate insertion, a screw guiding device, and a screw insertion guiding device. Solidworks was used for the CAD of the system, and stainless and alumina materials were used for fabricating the prototype system. Finite element analysis (FEA)was used to simulate the system stability. Mechanical testing, which is to simulate surgical conditions, was applied for the system. The performance of system adjustment function was conducted on three types of bone plates. The feasibility of system base on MIPO was verified by using pork leg experiment.

This research has completed a prototype of assisted instrument system, consisting of plate holder, screw guiding device, and screw insertion guiding device, for MIPO on lower limb bone fractures. The results from FEA indicate that the center displacement of sleeve on the screw guiding device is smaller than 1.36mm, which is within tolerance range. The results from mechanical testing show that the system deformation leads to ± 3。 changes, which is within tolerance angle. The findings indicate that the prototype system is stable and is feasible for the MIPO. The results of performance testing indicate that the system is unable to lock the screw on the central hole of the straight , broad and bending plates. The broad plate was used to pork leg experiment, the screw was successfully locked on bone plate.

The future work are suggested to: (1) improve the mechanical stability of screw guiding device and increase stability of system; (2) reduce the size of screw guiding device; and (3) improve the mechanism of system for other types of bone plate.
中文摘要…………….……………………………………………...……......Ⅰ
Abstract…………………………………………………....………...……….Ⅱ
誌謝...................................................................................................................Ⅲ
目錄……………………………………………………………………..........Ⅳ
表目錄…………………………………………………………………....…..Ⅵ
圖目錄…………………………………………………………………....…..Ⅶ

第一章 緒論 1
1.1 股骨與脛骨功能性解剖構造及骨頭生理機制 2
1.1.1 股骨功能性解剖構造 2
1.1.2 骨骼的構造與重塑機制 4
1.2 股骨與脛骨骨折 7
1.2.1 股骨與脛骨骨折之流行病學 7
1.2.2長骨骨折的分類 7
1.2.3 骨折的修復機制 9
1.3 骨折手術治療與固定器 10
1.3.1骨折手術 10
1.3.2 固定器及其輔助器械 11
1.4 文獻回顧 18
1.5 研究動機與目的 20
第二章 材料與方法 22
2.1 下肢經皮微創鋼板接骨術手術導引輔助器械系統功能性考量 23
2.2 導引輔助器械系統設計 24
2.3 有限元素分析導引輔助器械系統 36
2.4 導引輔助系統功能測試 41
第三章 結果與討論 47
3.1 導引輔助器械系統雛形 47
3.2 有限元素模擬導引輔助器械系統之力學分析結果 50
3.3 系統初步測試及動物實驗結果 56
3.3.1系統測試結果 56
3.3.2動物實驗 65
第四章 結論與未來展望 69
4.1 結論 69
4.2 未來展望 69
參考文獻 71
附錄 73
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[3]Robert W. Bucholz, James D. Heckman, Charles Court-Brown” Rockwood and Green’s Fractures in adults”, sixth edititon, Lippincoot Williams & Wilkins, 2006.

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[5]Texhammar R., Colton C., “AO/ASIF Instruments and implants: a technical manual”, second edition, Springer-Verlag, 1994.

[6]侯勝茂、林晉,「鎖定式骨髓內釘之基礎科學與臨床應用」,合記圖書出版社,2004

[7]Hans K. Uhthoff, Philippe Poitras, David S. Backman, “Internal plate fixation of fractures: short history and recent developments”, J Orthopaedic science, 2006(11), 118-126

[8]楊榮森譯,「基本骨科學與創傷學」,合記圖書出版社,2001

[9]Less Invasive Stabilization System (LISS) Distal Femur Technique Guide, Synthes

[10]Heitemeyer U, Kemper F, Hierholzer G, et al. “Severely comminuted femoral shaft fractures: treatment by bridging-plate osteosynthesis”Arch Orthop Trauma Surg. 1987; 106:327-330.

[11]Krettek Christian, “Foreword: concepts of minimally invasive plate osteosynthesis”, injury, vol. 28, suppl. No1., pp. S-A1-S-A2, 1997

[12]Collinge C, Sanders R, DiPasquale T, “Treatment of complex tibial periarticular fractures using percutaneous techniques”,Clin Orthop 2000; 375;69-77.

[13]Redfern D.J., Syed S.U., Davies S.J.M., “Fractures of the distal tibia: minimally invasive plate osteosynthesis”, Injury, Int. J. Care Injured (2004) 35, 615-620

[14]Hasenboehler E., Rikli D., Babst R., “Locking compression plate with minimally invasive plate osteosynthesis in diaphyseal and distal tibial fracture: A retrospective study of patients”, Injury, Int. J. Care Injured (2007) 38, 365-370

[15]Frigg R., Appenzeller A., Christensen R., Frenk A., Gilbert S., Schavan R., “The development of the distal femur Less Invasive Stabilization System (LISS)”, Injury, Int. J. Care Injured (2001) 32, S-C-24-31

[16]Christian Boldin, Florian Fankhauser, Herwig Peter Hofer, Rudoif Szyszkowitz, “Three-year results of proximal tibia fractures treated with the LISS”, Clinical Orthopedics and Related Research Number 445, pp. 222-229, (2006)

[17]李玉龍編著,「人體工學概論」,六合出版社,1998
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