一种新型可调长度部分听骨替代假体的有限元评估

文献信息

中文摘要

目的： 部分听骨替代假体（PORP）重建是治疗因部分听骨链中断所致传导性听力损失、恢复声音传导的标准耳科手术。现有商用PORP设计存在若干局限，可能影响长期听力结局并增加并发症风险。本研究提出一种新型可调长度PORP，并采用有限元分析（FEA）框架系统评估其生物力学性能和声音传输保真度，从而为临床前可行性评估提供计算证据。
方法： 所提出的假体包含一个可变形的弯曲钛合金连接杆，夹在两个聚醚醚酮（PEEK）耦合部件之间：一个鼓膜侧圆盘和一个镫骨头碗。连接杆具有三个可独立调节的弯曲角度（α、β、γ），可实现术中对准优化。构建了完整人类中耳的FEA模型，并使用镫骨足板频率响应曲线量化基线振动传输特性。随后构建了采用新型可调长度PORP重建的中耳FEA模型，并在2.3-3.5 mm的连续长度设置范围内量化振动传导性能。
结果： 在评估的2.4-3.5 mm长度范围内，该假体表现出一致的镫骨足板速度传输，预测听力损失在100 Hz-10 kHz频率范围内保持在17 dB以下。将假体调整至最小2.3 mm长度时，最大听力损失增加至34 dB，与结构过度压缩一致。
结论： 该有限元分析提供了计算证据，提示所提出的可调长度PORP用于听骨链重建的临床前生物力学可行性。预测结果提示其可能具有可接受的声音传输性能以及假体-骨界面处良好的力学条件。这些发现值得使用物理中耳模型和动物研究进一步进行实验验证，以评估长期安全性和功能结局。

英文摘要

PURPOSE: Partial ossicular replacement prosthesis (PORP) reconstruction is a standard otologic procedure for restoring sound conduction in patients with conductive hearing loss resulting from partial ossicular chain disruption. Current commercial PORP designs exhibit several limitations that may affect long-term hearing outcomes and contribute to complication risks. This study presents a novel adjustable-length PORP and systematically evaluates its biomechanical performance and sound transmission fidelity using a finite element analysis (FEA) framework, thereby providing computational evidence for preclinical feasibility evaluation.
METHODS: The proposed prosthesis incorporates a deformable bent titanium alloy connecting rod sandwiched between two polyetheretherketone (PEEK) coupling components: a tympanic-side circular disc and a stapes-head bowl. The connecting rod incorporates three independently adjustable bend angles (α, β, γ) that enable intraoperative alignment optimization. An FEA model of the intact human middle ear was constructed, and baseline vibratory transmission characteristics were quantified using the stapes footplate frequency response curve. An FEA model of the middle ear reconstructed with the novel adjustable-length PORP was then generated, and vibratory conduction performance was quantified across continuous length settings spanning 2.3-3.5 mm.
RESULTS: Across the evaluated length range of 2.4-3.5 mm, the prosthesis demonstrates consistent stapes footplate velocity transmission, with predicted hearing loss remaining below 17 dB across the 100 Hz-10 kHz frequency range. Adjusting the prosthesis to the minimum 2.3 mm length increased maximum hearing loss to 34 dB, consistent with structural overcompression.
CONCLUSION: This finite element analysis provides computational evidence which suggesting the preclinical biomechanical feasibility of the proposed adjustable-length PORP for ossicular chain reconstruction. The predicted results suggest potentially acceptable sound transmission performance and favorable mechanical conditions at the prosthesis-bone interfaces. These findings warrant further experimental validation using physical middle ear models and animal studies to assess long-term safety and functional outcomes.