Analysis and Computational Modeling

ViVitro Labs’ cardiovascular device analysis and computational modeling capabilities are designed to identify worst-case or clinically challenging conditions for cardiovascular and surgical implant. Computational modeling is used to optimize in-vitro testing strategies by predicting potentially unwanted device behaviour and failure modes ahead of any validation studies, thus minimizing device development risks.  Computational modeling plays an important role in providing regulatory rationales and justifications in support of testing strategies.

 

 

Method

ViVitro Labs provides a large array of computational modeling tools, such as Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), Fluid-Structure Interaction (FSI) that can be used to assess the impact of anatomical and physiological boundary conditions on the design of a medical devices.  Determining the worst-case stresses and strains on stent like structure for various physiological loading conditions or identifying design characteristics that could lead to thrombogenic and haemolytic events during a transcatheter valve deployment, can significantly reduce test validation time and cost, and at the same time optimize test samples utilization. The correlation between computational modeling and in-vitro studies is strong: in-vitro experiments can be used to validate or provide input to CFD models, FEA can be used to predict failure modes to apply proper cyclic loads during accelerate fatigue studies.

 

Tools

Structural analysis – FEA

  • Advanced structural analysis capabilities
  • ANSYS Structural software, using Finite Element Method
  • ANSYS Explicit dynamics for drop testing and impact assessments
  • Advanced linear and nonlinear modeling

Computational fluid dynamics – CFD

  • Thermal, fluid dynamics modeling,
  • Multiphase, multi-physics modeling
  • ANSYS – Fluent, CFX
  • Finite volume method

Fluid-Structure Interaction – FSI

  • One way coupling and two-way coupling (implicit iterative).
  • Internal coupling within ANSYS Workbench
  • Requires proper planning to identify most efficient modeling strategy.

ViVitro Labs’ computational modeling studies include

  • 3D Models numerical models
  • Sensitivity analysis
  • Verification of model
  • Parametric studies as appropriate

 

Measured Parameters

Maximum stress and strain for various loading conditions.

Flow field velocity assessment, shear rates, wall shear stresses, and estimation of the washout time/recirculation/separation, stagnation and turbulent.

 

Scope

  • Balloon expandable stent: CrCo, SS, Biores
  • Self-expanding stent: NiTi, SS
  • Coronary stent
  • Peripheral stent: Carotid, renal, ilio-femoral
  • Stent-Graft: AAA, TAA, PE covered, PTFE covered, tissue covered
  • TAVI stent structure
  • TMVR stent structure
  • Vena Cava filters
  • Occluders- LAA closure, PFO closure
  • Oesophageal Stent
  • Any stent like structure

 

Service Levels

Fast Track
Standard Service
Full Service

 

Applicable Standards

ISO 25539-2:2020
ISO 5840-3:2021
FDA-1545

 

Related Tests

Radial Fatigue and Pulsatile Durability
Experimental Flow Field Assessment – Digital Partical Image Velocimetry (DPIV)

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