4.6 Article

A comprehensive simulation framework for predicting the eCLIPs implant crimping into a catheter and its deployment mechanisms

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DOI: 10.1016/j.jmbbm.2023.106227

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Neurovascular device; Cerebral aneurysms; Finite element analysis; Stent crimping and deployment process; Nitinol self -expanding stents

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Tubular flow diverters are important for treating cerebral aneurysms. A new design called VR-eCLIPs has been developed to cover the neck of challenging bifurcation aneurysms. A finite element model has been used to simulate the implantation processes of VR-eCLIPs and assess potential plastic deformation.
Tubular flow diverters (FDs) represent an important subset of the endovascular treatment of cerebral aneurysms (CAs), acting to reduce aneurysm inflow, eventually resulting in aneurysm thrombosis and occlusion. eCLIPs (product of Evasc Neurovascular Enterprises, Vancouver, Canada), an innovative non-tubular implant causes flow diversion by bridging the neck of bifurcation CAs. However, in a small subset of challenging bifurcation aneurysms with fusiform pathology, the currently available eCLIPs models do not provide sufficient neck bridging resulting in a gap created between the device structure and the aneurysm/artery wall. To overcome this challenge, a new design of the eCLIPs (VR-eCLIPs) was developed by varying the rib length to cover such an inflow gap. To optimize the new product development process, and avoiding expensive and time-consuming iterative manufacture of prototype devices, we have developed a new finite element model to simulate the crimping and expansion processes of the VR-eCLIPs implant, and assess the possibility of plastic deformation. Results indicated that neither eCLIPs nor VR-eCLIPs experience plastic deformation during the crimping process. Upon full expansion, the ribs of VR-eCLIPs interact with the aneurysm and artery wall to cover the inflow gap that exists in certain challenging anatomies. This process serves as a basis to expedite design development prior to prototype manufacturing.

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