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Additive manufacturing and biomechanical validation of a patient‐specific diabetic insole
Authors:Ayfer Peker  Levent Aydin  Serdar Kucuk  Guralp Ozkoc  Berrin Cetinarslan  Zeynep Canturk  Alev Selek
Abstract:Centers for Disease Control and Prevention (CDC) has reported that lower extremity amputation (LEA) rate of per 1000 diabetic patients is 18.4 because of the complications that first appeared in the foot. A second amputation is also required for 9% to 17% of these patients within the same year although LEA may be preventable. Most of the diabetic foot conditions may be prevented and treated by a therapeutic footwear or a medical device such as an insole or an orthotic shoe. Traditional insole manufacturing is a laborious work that requires specific skills. Moreover, traditional approaches contain harmful material particles that may cause respiratory failure. Unfortunately, manufactured insoles may not be suitable for any mass‐produced footwear in all cases. Therefore, patient requires to get insole‐specific footwear. In this study, a diabetic insole was manufactured by means of a fused deposition modeling‐(FDM) based system and a thermoplastic polymer. Biomechanical functionality was determined according to the applied polymer analysis on each produced sample and foam material. Subsequently, finite element analysis (FEA) was performed to target insole geometry to ensure the quality of the final medical product. Additive and traditional manufactured insoles are compared according to the cost and function. As a result, fabrication of an insole, based on the FDM method, was improved down to 8 h and 9 m. The weight of an insole prototype was 74.74 g, and the material cost was $3.44 while total cost of the traditional foam casting was determined as $35.37 and weight of the insole was 72.6 g for this study. Consequently, benefits of the applied method are evaluated.
Keywords:additive manufacturing  biomechanical functionality  diabetes  finite element analysis  insole  patient‐specific
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