Abstract:
This patent describes a system and method for the virtual prototyping and testing of medical devices, particularly intracorporeal devices such as cardiovascular stents and endovascular grafts. The invention aims to accelerate the development process and enhance device safety by enabling early and rapid evaluation of designs through computational simulation, thus reducing the need for expensive and time-consuming physical prototyping and clinical trials. The system is composed of four main modules: a geometry generator, a mesh generator, a stress/strain/deformation analyzer, and a visualization tool. The process begins with the geometry generator, which creates a geometric model of a patient's anatomy from 3D volumetric data (e.g., CT or MRI scans). The mesh generator then receives this anatomical model along with a geometric model of the candidate medical device and generates a combined finite element model (FEM), or mesh. This FEM is passed to the stress/strain/deformation analyzer, which uses nonlinear analysis to simulate the biomechanical interaction between the device and the anatomy under specified physiological loads and with defined material models. The analyzer predicts the resulting stresses, strains, and deformations on the device, allowing for the assessment of performance, durability, and potential failure modes. This virtual testing framework can be used to optimize designs, simulate long-term fatigue under cyclic loading (like a heartbeat), and serve as a pre-procedural planning tool for physicians.
