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For reducing the adjacent segment degeneration of the lumbar spine, the interspinous process device as a kind of flexible non-fusion device was designed to overcome the deficiencies associated with rigid fusion devices. However, it was not clear how the interspinous process device influenced the human spine system, especially the lumbar spine under a vibration environment. This study was designed to evaluate the effect of StenoFix under the vibration condition and also to optimize the structure of the device to obtain better biomechanical performance. A finite element model of the intact lumbar spine was developed and validated. The surgical finite element model was constructed by implanting the interspinous process device StenoFix. Using topology optimization, a new device StenoFix-new was redesigned. The results showed that the interspinous process device decreased vibration amplitudes of annulus stress and intradiscal pressure under vibration at the surgical level. The redesigned StenoFix-new with the smaller stiffness exhibited a better dynamic flexibility performance than StenoFix. In addition, the range of motions of StenoFix-new was closer to the intact model than StenoFix at the surgical level. These results might encourage the designers to give more consideration to the dynamic characteristics of the human spine on the premise of ensuring the safety and strength of implanted devices.

Topology optimization and dynamic characteristic evaluation of W-shaped interspinous process device