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Finite Element Simulations of the ID Venous System to Treat Venous Compression Disorders: From Model Validation to Realistic Implant Prediction
Annals of Biomedical Engineering ( IF 3.0 ) Pub Date : 2021-01-04 , DOI: 10.1007/s10439-020-02694-8
Alissa Zaccaria 1 , Francesco Migliavacca 1 , David Contassot 2 , Frederic Heim 3, 4 , Nabil Chakfe 4, 5 , Giancarlo Pennati 1 , Lorenza Petrini 6
Affiliation  

The ID Venous System is an innovative device proposed by ID NEST MEDICAL to treat venous compression disorders that involve bifurcations, such as the May-Thurner syndrome. The system consists of two components, ID Cav and ID Branch, combined through a specific connection that prevents the migration acting locally on the pathological region, thereby preserving the surrounding healthy tissues. Preliminary trials are required to ensure the safety and efficacy of the device, including numerical simulations. In-silico models are intended to corroborate experimental data, providing additional local information not acquirable by other means. The present work outlines the finite element model implementation and illustrates a sequential validation process, involving seven tests of increasing complexity to assess the impact of each numerical uncertainty separately. Following the standard ASME V&V40, the computational results were compared with experimental data in terms of force-displacement curves and deformed configurations, testing the model reliability for the intended context of use (differences < 10%). The deployment in a realistic geometry confirmed the feasibility of the implant procedure, without risk of rupture or plasticity of the components, highlighting the potential of the present technology.



中文翻译:

ID 静脉系统的有限元模拟治疗静脉压迫障碍:从模型验证到现实植入物预测

ID 静脉系统是 ID NEST MEDICAL 提出的一种创新设备,用于治疗涉及分叉的静脉压迫障碍,例如 May-Thurner 综合征。该系统由两个组件组成,ID Cav 和 ID Branch,通过特定连接组合在一起,防止在局部作用于病理区域的迁移,从而保护周围的健康组织。需要进行初步试验以确保设备的安全性和有效性,包括数值模拟。硅片模型旨在证实实验数据,提供其他方式无法获得的额外本地信息。目前的工作概述了有限元模型的实现,并说明了一个连续的验证过程,包括七个越来越复杂的测试,以分别评估每个数值不确定性的影响。遵循标准 ASME V&V40,将计算结果与力-位移曲线和变形配置方面的实验数据进行比较,测试模型在预期使用环境下的可靠性(差异 < 10%)。在现实几何中的部署证实了植入程序的可行性,没有组件破裂或可塑性的风险,突出了本技术的潜力。

更新日期:2021-01-05
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