U.S. flag An official website of the United States government

U.S. Food and Drug Administration

Benchmark Validation Dataset for Laminar Flow in an Anatomical Vascular Model of the Inferior Vena Cava

Catalog of Regulatory Science Tools to Help Assess New Medical Devices 

 

This regulatory science tool presents benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).

 

Technical Description

 Experimental particle image velocimetry (PIV) measurements of the velocity field were acquired in a complex anatomical model of the human IVC at two flow conditions that correspond to resting and exercise flow rates. The flow is laminar under both flow conditions. The provided PIV data serve as a benchmark dataset for validating CFD simulations of laminar flow in a complex anatomical vascular model. 

The full technical description of the experimental methods, including the fluid properties, flow conditions, and PIV measurement locations, is provided in the Materials and Methods section of Gallagher et al. [1]

Intended Purpose

This tool provides a benchmark data set for validating CFD simulations of laminar flow in the human inferior vena cava (IVC). Validating computational modeling and simulation is an important step in demonstrating model credibility. These data are anticipated to be broadly applicable for validating CFD simulations of laminar flow in complex anatomical vascular models.

Testing

All velocity measurements were made using the PIV technique. The accuracy of the PIV measurements was assessed and found acceptable through the following means:

  1. The same PIV setup (camera, laser, and software) was used to perform interlaboratory measurement in the FDA Nozzle and FDA blood pump models [2]. The PIV data for the nozzle and blood pump matched well with other laboratories thereby validating the PIV setup used for the IVC geometry.
  2. As another measure of accuracy, measured velocity profiles for the inlet planes at both flow rates were compared to theoretical Poiseuille flow profiles to confirm fully developed inflow boundary conditions [1].

Limitations

The limitations of this tool include:

  • The IVC geometry is not a patient-specific model but is a realistic anatomical model of the human IVC that is derived from observations of computed tomography (CT) scans of 10 patients.
  • The vascular IVC model is rigid, and it does not include the renal veins.
  • The blood analogue fluid is incompressible and Newtonian.
  • Inflow through the iliac veins is steady.
  • The PIV data are ensemble averaged two-dimensional velocity measurements in two planes (coronal and sagittal) in the infrarenal section of the IVC model from individual experiments conducted at two flow rates corresponding to resting and exercise flow conditions.

See Gallagher et al. [1] for discussion of these limitations.

Supporting Documentation

  1. Gallagher, M. B., Aycock, K. I., Craven, B. A., & Manning, K. B. (2018). Steady Flow in a Patient-Averaged Inferior Vena Cava-Part I: Particle Image Velocimetry Measurements at Rest and Exercise Conditions. Cardiovascular engineering and technology, 9(4), 641–653. https://doi.org/10.1007/s13239-018-00390-2External Link Disclaimer
  2. Malinauskas, R. A., Hariharan, P., Day, S. W., Herbertson, L. H., Buesen, M., Steinseifer, U., Aycock, K. I., Good, B. C., Deutsch, S., Manning, K. B., & Craven, B. A. (2017). FDA Benchmark Medical Device Flow Models for CFD Validation. ASAIO journal (American Society for Artificial Internal Organs : 1992), 63(2), 150–160. https://doi.org/10.1097/MAT.0000000000000499External Link Disclaimer

The computer added design (CAD) model of the anatomical geometry and the PIV velocity data can be downloaded from https://doi.org/10.6084/m9.figshare.7198703.v1.

Contact

For more information