Laboratory of Biological Structure Mechanics (LaBS), Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano, Milan, Italy.
Laboratory of Biological Structure Mechanics (LaBS), Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano, Milan, Italy.
J Biomech. 2021 Sep 20;126:110631. doi: 10.1016/j.jbiomech.2021.110631. Epub 2021 Jul 12.
Intra-arterial thrombectomy is a minimally invasive procedure in which an obstructing thrombus (clot) is removed using a minimally-invasive device: a stent-retriever. The stent-retriever is first deployed, and then the thrombus is removed during stent-retriever retraction. This procedure can be simulated using a detailed computational model. However, to be useful for an in silico trial in a clinical setting, model credibility should be demonstrated. The aim of this work is to apply a credibility process for the validation phases to the thrombectomy procedure in order to deem it credible for use in an in silico trial. Validation evidence is proposed for the identified context of use and then used to build credibility to the numerical model. Applicability of the proposed model is justified and assessed using a rigorous step-by-step method based on the ASME V&V40 protocol.
动脉内血栓切除术是一种微创介入手术,使用微创器械(支架取栓器)清除阻塞的血栓。首先部署支架取栓器,然后在支架取栓器缩回过程中清除血栓。可以使用详细的计算模型来模拟该过程。然而,为了在临床环境下的计算机模拟试验中有用,模型的可信度需要得到证明。这项工作的目的是将可信度过程应用于血栓切除术过程的验证阶段,以使其在计算机模拟试验中具有可信度。为所确定的使用场景提出了验证证据,然后用于为数值模型建立可信度。使用基于 ASME V&V40 协议的严格逐步方法,证明并评估了所提出模型的适用性。