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

Area of Science:

• Biomedical Engineering
• Neurosurgery
• Medical Devices

Background:

• Tubular flow diverters (FDs) are used for endovascular treatment of cerebral aneurysms (CAs).
• eCLIPs are innovative non-tubular implants for bridging bifurcation CA necks.
• Existing eCLIPs may not adequately bridge complex fusiform bifurcation aneurysms, leaving gaps.

Purpose of the Study:

• To introduce VR-eCLIPs, a novel eCLIPs design with varied rib lengths to address inflow gaps in challenging cerebral aneurysms.
• To develop and utilize a finite element model to simulate VR-eCLIPs crimping and expansion processes.
• To assess the potential for plastic deformation in VR-eCLIPs during deployment.

Main Methods:

• Development of a finite element model to simulate VR-eCLIPs crimping and expansion.
• Simulation of the mechanical behavior of VR-eCLIPs during deployment.
• Analysis of device-wall interaction and gap coverage in simulated challenging anatomies.

Main Results:

• Neither eCLIPs nor VR-eCLIPs exhibited plastic deformation during the simulated crimping process.
• The finite element model confirmed VR-eCLIPs successfully cover inflow gaps in challenging anatomies upon full expansion.
• VR-eCLIPs ribs interact with the aneurysm and artery wall to bridge the inflow gap.

Conclusions:

• VR-eCLIPs offer an improved solution for flow diversion in complex cerebral aneurysms with fusiform pathology.
• Finite element modeling is a valuable tool for optimizing medical device design and development, reducing the need for physical prototypes.
• The VR-eCLIPs design effectively addresses limitations of previous models in specific challenging anatomical cases.