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 utilizes a large array of computational modeling tools, such as Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), Fluid-Structure Interaction (FSI), to assess the impact of anatomical and physiological boundary conditions on the design ofa medical device. 

Determining worst-case stresses and strains on stent like structures 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, while optimizing test sample 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

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

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
  • 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

Standard Service
Full Service

 

Applicable Standards

ISO 25539-2:2020 : Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

ISO 5840-1:2021: Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

FDA-1545: FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff

 

Related Tests

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

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