Testing & Simulation of Artificial Organs

DauntlessLotus avatar
DauntlessLotus
·
·
Download

Start Quiz

Study Flashcards

60 Questions

Testing & Simulation Medical Device Development Need Design & Prototyping Preclinical Clinical Mechanical strength ______

Functionality

Testing & Simulation Approval Launch Testing – what and how?Thrombogenicity Gas transfer Durability ______

Inflammation

Testing & Simulation Standards & Guidelines ISO: International Organization for ______ − DIN (German Institute for Standardization) participates as member

Standardization

Device-specific standards − Cardiovascular implants - Cardiac valve prostheses – ISO 5840 − Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) – ISO 7199 − ______ - Active implantable medical devices – ISO 14708 ▪ Part 5: Circulatory support devices −…

Implants for surgery

Definition Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application Mandatory tests depend on − Nature of body contact (e.g.

blank

Biological systems are highly complex ➔ Impossible to understand w/o ______

computers

Virtual exploration of many scenarios ➔ Impossible to do ______/in vivo

in vitro

Mechanistic understanding of a system ➔ Therapies, devices etc. Regulatory pipeline medical devices 44 Testing & ______

Simulation

Hemocompatibility tests are challenging but provide lots of information about blood-material ______

interaction

In-vitro tests reduce ______ trials

animal

Testing is highly important for artificial organs and any medical ______

device

The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)

permanent

The interaction of blood components with artificial material is a key aspect of ______

hemocompatibility

Hemolysis leads to the destruction of red blood cells and the release of cell ______ hemoglobin

plasma

The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine

Reduce

Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______

malfunction

The cardiovascular implants and artificial organs standard ISO 5840 is specific to cardiac valve ______

prostheses

The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______

Pressure

Blood pump hemolysis can be assessed using the Normalized Index of Hemolysis (NIH) and the Modified Index of ______

Hemolysis

Biocompatibility testing includes evaluation of cytotoxicity, sensitization, irritation, and material-related ______

pyrogenicity

Biological systems are highly complex ➔ Impossible to understand w/o ______

computers

Virtual exploration of many scenarios ➔ Impossible to do in vitro/in ______

vivo

Mechanistic understanding of a system ➔ Therapies, devices etc. Regulatory pipeline medical devices 44 Testing & ______

Simulation

The interaction of blood components with artificial material is a key aspect of ______

hemocompatibility

Testing is highly important for artificial organs and any medical ______

devices

Modeling, Discretization, and Iterative solutions are used to compute CFD Flow field numerically by ______

testing

Results of CFD Flow field computation are strongly dependent on ______ conditions

boundary

Spatial and temporal resolution, including mesh and timestep, are important for the ______ model

turbulence

Validation and verification are ______ for the development of CFD Flow field computation

warranted

George E.P.Box cleverly said, “All models are wrong, but some are ______”

useful

The interaction of blood components with artificial material is a key aspect of ______

hemocompatibility

Mechanical strength ______

testing

Durability ______

testing

The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)

permanent

Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______

malfunction

CFD stands for Computational ______ Dynamics

Fluid

Turbulence in flow: chaotic changes in pressure/velocity caused by disturbance of the flow field laminar ➔ transitional ➔ turbulent ______ (eddies) on various spatial scales big ➔ smaller ➔ smallest ➔ heat turbulent free jet (CFD Calculation)

vortices

The cardiovascular implants and artificial organs standard ISO 5840 is specific to cardiac valve ______

prostheses

The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine

Reduce

The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)

extended

The interaction of blood components with artificial material is a key aspect of ______

biocompatibility

Results of CFD Flow field computation are strongly dependent on ______ conditions

boundary

The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______

head

Hemolysis leads to the destruction of red blood cells and the release of cell ______ hemoglobin

free

Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______

turbulence

Mesh resolution may affect the entire flow field. Unrealistic velocity distribution. Development of vortices in wake region. Even “simple” numerical setups might be more intriguing than you think. ______ Fine Flow through squeezed tube

Coarse

Mesh strongly influences the results of the simulation. Important step in the verification process. Know what output is of interest for you. Gradient based outputs (shear stresses) need very fine ______

meshes

Recall of CFD theory 1st step: Modeling ✓ 2nd step: Discretization ✓ 3rd step: ______

Solution

Errors/assumptions along the pipeline affect our result. Solution errors: Equations are solved numerically ➔ Are just approximations!!! Mathematical algorithms to solve the system of equations (PDE) Use convergence plots to see if solution algorithm “works” Not ______?

converging

Results of CFD Flow field computation are strongly dependent on ______ conditions. Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______

boundary

Rotational velocity (top), absolute velocity (bottom).Ψ/Φ: Dimensionless numbers pressure/flow 54 Testing & Simulation Example I: CFD based design optimization Homogeneous velocity distribution Stagnation area prone to thrombus formation High velocities at blade outlets Initial and modified design of an RBP and its effect on velocity and ______

shear

Reduction of ______ rates Example I: Parameter based design exploration β1 β2 many variations in β1 and β2 Parameter based design exploration.left: initial design, center: meta-model, right: optimal design

shear

FDA Round Robin initiative – Let’s test CFD/PIV around the world FDA Round Robin Pump curve/pressure head ➔ hydraulic vs.CFD Velocity distribution ➔ PIV vs.CFD Hemolysis ➔ in-vitro blood vs. ______

in vivo

The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine

Reduce

Validation and verification are ______ for the development of CFD Flow field computation

essential

Spatial and temporal resolution, including mesh and timestep, are important for the ______ model

CFD

The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______

pressure

The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)

extended

Results of CFD Flow field computation are strongly dependent on ______ conditions

boundary

Modeling, Discretization, and Iterative solutions are used to compute CFD Flow field numerically by ______

simulation

This quiz covers topics related to the testing and simulation of artificial organs, including general aspects, biocompatibility, hemodynamics, and device-specific parameters. It also addresses simulation testing, medical device development, design and prototyping, preclinical and clinical testing, mechanical strength, functionality, degradation, and shelf life.

Make Your Own Quizzes and Flashcards

Convert your notes into interactive study material.

Get started for free
Use Quizgecko on...
Browser
Browser