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研究生：	吳柱龍 Wu, Chu-Lung
論文名稱：	膝下義肢生物力學評估—整合安全限度指標與有限元素分析 Evaluation protocol for trans-tibial sockets – integrating safe margin index and finite element analysis
指導教授：	徐阿田 Hsu, Ar-Tyan 張志涵 Chang, Chih-Han
學位類別：	博士 Doctor
系所名稱：	工學院 - 醫學工程研究所 Institute of Biomedical Engineering
論文出版年：	2006
畢業學年度：	94
語文別：	英文
論文頁數：	74
中文關鍵詞：	膝下義肢、評估指標、疼痛壓力忍受度、安全限度指標、有限元素法
外文關鍵詞：	trans-tibial prosthesis, safe margin index, evaluation index, pain-pressure tolerance, finite element analysis
相關次數：	點閱：171 下載：2
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中文摘要
膝下截肢病人必須要使用膝下義肢才能有獨立自主的日常生活。目前截肢患者穿戴義肢的最大問題仍集中在穿戴的合適性上。一組穿戴合適的膝下義肢能提供患者在行走時良好的穩定性及舒適性，相對的，穿戴不良的義肢容易在殘肢上產生局部疼痛、水泡、膿瘍等，不僅影響患者行走的能力，更嚴重的可能會引起再度截肢。有學者提出殘肢與義肢間的介面應力分佈，與患者穿戴義肢的合適度相關，但由於患者個體間的差異，無法單從介面應力反映出義肢的穿戴是否良好。本研究嘗試以截肢患者個人的疼痛壓力忍受度配合介面應力，提出一個新的指標：安全限度指標係數（safety margin index, SMI），來量化地描述患者穿戴義肢時的合適程度，以提供臨床上在製作義肢時的參考。本研究依照研究目的分成三步驟：首先，量測膝下截肢患者的疼痛忍受度，並探討疼痛壓力忍受度，是否真能反映及代表出個體間的差異，以及安全限度指標與受測者穿戴義肢合適性的相關程度。第二步，建構整套包含SMI的膝下義肢評估及製作流程，並驗證其可行性，最後則對於影響介面應力分佈的因素作參數探討，也提出安全限度指標的另一個應用：可作為不同受測者間比較的基準。另外，安全限度指標也可應用在義肢的設計製造上，擔任導引的指標，並較傳統上單觀察介面應力來的準確。
本研究以自製的手提式壓痕器（indentor）量測7名膝下截肢患者（3名穿戴義肢不適）5個位置上的疼痛壓力忍受度，並以壓力感測器實際測量該位置的介面壓力，求得各區域的SMI數值。結果顯示，SMI在穿戴不適的受測者中，發生疼痛的區域有較低的數值，若穿戴良好的受測者，SMI的數值普遍較高，由此證明SMI的確能反映患者穿戴義肢的合適程度。在義肢製作流程方面的驗證，本研究依據流程，製作一名受測者的全接觸型承套（Total Surface Bearing, TSB socket）。以有限元素分析預先模擬出介面應力分佈，計算各區域的SMI數值後，針對其數值異常區域進行修正，承套依照修正後的數據製作，成功製造出對此患者穿戴合適的承套。最後是參數化分析的方面，本研究以6位受測者的有限元素模型探討4種內襯材料以及5種摩擦係數對介面應力的影響，雖然各參數的影響可歸納出一些趨勢，例如摩擦係數增加會使介面壓力下降而剪應力上升，但並非所有的受測者均有此趨勢出現，故可推測受測者間不同的殘肢幾何外型是影響介面應力另一個重要的因素。另外，承套的局部修型會導致該區域介面應力的改變。應用於臨床上判斷修型的程度，可藉由觀察SMI的改變來達成，將修改有限元素模型的幾何外型，直到所有區域的SMI數值均在安全範圍為止，即可得到一組對此患者穿戴義肢合適的修型參數。

Abstract
Ill-fitness of socket is a major cause leading the discomfort when wearing the transtibial prosthesis. Although the interface stress provides information to justify the socket fitness, it is insufficient to use this index alone for socket evaluation. Integration the pain pressure tolerance with the interface stress seems to be a reasonable biological combination to evaluate the socket fitness on individuals. The purpose of this research was to justify a quantitative index, safety margin index (SMI), which integrated the interface pressure and pain pressure tolerance for socket fitness evaluation. Both experimental measurements and finite element analyses were used to investigate this safe margin index in representing the socket fitness. The study process was divided into three phases: First, the measurements of pain pressure tolerance and socket interface pressure were performed in-vivo to examine the potential ability of SMI in reflecting the socket fitness. The second phase was to joint the pain pressure tolerance information with the finite element analysis to investigate the fitness of Kondylen-Bettung-Münster and total-surface-bearing sockets on a selected amputee and assess the ability of this approach as a evaluation tool for transtibial socket selection. Finally, parametric analyses of liner materials in six total-surface-bearing socket finite element models were executed to demonstrate that the SMI could be a better index than the interface stress value for the guideline in socket design or revision.
To perform the phase one study, seven volunteers were recruited to receive the pain pressure tolerance and interface stresses measurement with pressure sensors. Four of the subjects felt pain when wearing the prosthesis and the pain sites were identical with the region of the lowest SMI values. The SMI values of fitted sockets were all above 0.75. After reshaping the unfitted sockets into fitted socket, the lower SMI raised to the acceptable range (above 0.75). The SMI has the ability to reflect the socket fitness. For phase two study, the selected transtibial volunteer received a new socket manufactured with the modified evaluation protocol proposed in this study. The new socket is fit without the trail-and-error testing procedure which demonstrate the advantage of integrating the SMI and finite element model in evaluation of socket design thus reducing the procedure of socket fitting. For the last phase, six finite element models of total-surface-bearing sockets were established for the parametric analysis of liner material. Three elastic modulus values and five coefficient of friction values were evaluated in the analyses. The results showed that the liner material is not the major factor to influence the distribution of interface stress. The geometry of stump might be a more critical factor to affect the distribution of interface stresses. This demonstrated the importance of reshaping in socket revision and the possible application of SMI in the revision process. The reshape of socket would vary different amounts of interface stress for different regions, due to the fact that the reshaping is just a local change. Regional peak interface stress should be integrated with SMI to reflect the various tolerated ability at different stump region. To conclude, this study using SMI to access the socket fitness and the primary results showed that SMI by providing an absolute reference value is better than interface stress alone. Moreover, by integration with finite element analysis the SMI could be an effective evaluation tool to simplify the process of socket fitting, provided that the finite element model is capable to model the stump/socket biomechanical behavior precise enough.

Table of Contents
ABSTRACT…………………………………………………………………………………I
中文摘要………………………………………………………………………………III
TABLE OF CONTENTS……………………………………………………………………V
LIST OF TABLES………………………………………………………………………VIII
LIST OF FIGURES………………………………………………………………………IX
CHAPTER 1.  GENERAL INTRODUCTION…………………………………………………1
1	BACKGROUND OF THE AMPUTATION AND PROSTHESIS………………………1
2	PAPER REVIEWS……………………….………………………………………3
3	MOTIVATIONS…………………………………………………………………7
4	OBJECTIVES……………………………………………………………………9
CHAPTER 2. SAFETY MARGIN INDEX (SMI): INTEGRATING PAIN PRESSURE TOLERANCE AND INTERFACE STRESS…………………………………………………………………………11
1 INTRODUCTION…………………………………………………………………………11
2 MATERIALS AND METHODS……………………………………………………………13
2.1 Subject Selection………………………………………………………………13
2.2 PPT Measurements…………………………………………………………………14
2.3 Interface Stress Measurements…………………………………………………15
2.4 Definition of the Safety Margin Index………………………………………17
3 RESULTS…………………………………………………………………………………18
3.1 Pain pressure tolerance…………………………………………………………18
3.2 Interface stresses………………………………………………………………18
3.3 Safety margin index………………………………………………………………21
4 DISCUSSION……………………………………………………………………………23
4.1 Pain Pressure Tolerance (PPT)…………………………………………………23
4.2 Interface Stresses and Loading Effect………………………………………24
4.3 Safety Margin Index………………………………………………………………25
5 SUMMARY…………………………………………………………………………………29
CHAPTER 3.  AN MODIFIED EVALUATION PROTOCOL: INCLUDING THE SAFETY MARGIN INDEX (SMI) AND FINITE ELEMENT ANALYSIS……………………………………………………30
1 INTRODUCTION……………………………………………………………………………30
2 MATERIALS AND METHODS………………………………………………………………34
2.1 Geometry and Materials of the FE Mesh Model………………………………34
2.2 Loading and Boundary Conditions of the FE Simulations…………………38
2.3 Indentor Test for Soft-tissue Materials and Pain pressure Threshold and Tolerance……………………………………………………………………………………39
2.4 X-ray Measurement of the Sliding of KBM Socket……………………………39
2.5 Interface Pressure Measurement with Force Sensors for Both Sockets…39
3 RESULTS……………………………………………………………………………………41
4 DISCUSSION…………………………………………………………………………………45
4.1 Mechanical Index for Evaluation……………………………………………………45
4.2 Loading Effect…………………………………………………………………………48
5 SUMMARY………………………………………………………………………………………49
CAPTER 4.  PARAMETRIC ANALYSIS OF MATERIAL PROPERTIES OF LINER……………………………………………………………………………………………50
1 INTRODUCTION………………………………………………………………………………50
2 MATERIALS AND METHODS…………………………………………………………………52
2.1 Establishing the FE Mesh Models…………………………………………………52
2.2 Loading and Boundary Conditions of the FE Simulations……………………52
2.3 Material properties of FE models………………………………………………53
2.4 Validation of FE models……………………………………………………………54
3 RESULTS……………………………………………………………………………………55
3.1 Validation of FE models……………………………………………………………55
3.2 Interface stresses under different liners……………………………………55
3.3 Interface stresses under varies COF……………………………………………59
4 DISCUSSION…………………………………………………………………………………61
5 SUMMARY……………………………………………………………………………………67
CAPTER 5. CONCLUSIONS AND FUTURE WORKS………………………………………………68
1 CONCLUSIONS………………………………………………………………………………68
2 LIMITATION AND FUTURE WORKS…………………………………………………………70
2.1 SMI index and processing of evaluation protocol……………………………70
2.2 FE models………………………………………………………………………………70
REFERENCES………………………………………………………………………………………72

                                    

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校內：2007-05-10公開
校外：2007-05-10公開

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