| Objectves: Combining theory calculation with experiment, to design a type of percutaneous device fitting upper leg stump of human body, which can satisfy biomechanical demand of percutaneous site in physiological state. To provide condition for the study of osseointegrated prosthesis, to provide evidence and establish basis for further clinic experiment.Material & Method:â‘ To create finite element models of percutaneous device and jacent soft tissue. Stress distribution of percutaneous device / soft tissue interface and jacent soft tissue of percutaneous devices with different structure was calculated and analysed in physiological state of human body, and texture parameters of percutaneous device were optimized and analysed using FEA technique.â‘¡Percutaneous device with better mechanical characteristics was applied to animal experiment to appraise effects of biological seal.Results:â‘ The maximum stress of traditional cylinder-shaped percutaneous device is situated at the exit whereas the maximum stress of new type of percutaneous device with arch perforated flange is situated at the rim of soft tissue fixation flange. The stress at the exit is obviously reduced, making for getting static mechanical circumstances.â‘¡Optimization of the structure of percutaneous device with arch perforated flange showed: When diameter of stump is 160mm and diameter of flange is 104mm, the net with 20mm pore diameter and 20mm pore interval generate minimum stress at the exit.â‘¢Preliminary animal experiment showed percutaneous device was firmly fixed, free from infection or amotio.Conclusion:â‘ Percutaneous device with arch perforated flange can obviously reduce the stress at the exit as compared with traditional cylinder-shaped design, thus providing good mechanical circumstances for realization of biological seal.â‘¡The design of net with 20mm pore diameter and 20mm pore interval has better mechanical characteristics.â‘¢Preliminary animal experiment showed design rationality of percutaneous device.
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