Designing Reliability into Biomedical Devices: Finite Element Analyses for Bio-Medical Applications Peter R.

Barrett Kenneth Brown Computer Aided Engineering Associates

There is Widespread Interest in Improving the Design Process

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There is Widespread Interest in Designing Reliability

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Design directly influences more than 70% of the product life cycle cost; companies with high product development effectiveness have earnings three times the average earnings; and companies with high product development effectiveness have revenue growth two times the average revenue growth." "40% of product development costs are wasted!"

source: Brenda Reichelderfer of ITT Industries http://www.isixsigma.com/library/content/c020311a.asp

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Example Medical Device Development Cycle

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From start until FDA approval, medical device evolution will typically include:

Conceptual idea development (material selection, manufacturability) Check for patent infringements Develop initial drawings

Preliminary analysis (FEA) Re-design / Optimization

Prototype development and physical testing Pass final design analysis (FEA) and reliability evaluation Pass animal studies Include a delivery system design Meet packaging requirements

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Sample Structural Design Issues (For Stents)

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Maximize stiffness Maximize surface area for drug coating Maximize radiopacity Minimize the delivery size so that it can fit on the smallest possible catheter Maximize flexibility for ease in deployment Meet strength and fatigue requirements

Changing any one of these design variables may adversely affect others

Example: increasing radial stiffness may decrease bending flexibility.

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What Tools Can We Use to Design the Device?

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Maximize stiffness to best support the vessel.

Use Finite Element Analysis Use Finite Element Analysis Material selection

Maximize surface area for drug coating.

Maximize radiopacity for accurate stent deployment.

Minimize the delivery size so that it can fit on the smallest possible catheter.

Design layout Use Finite Element Analysis Use Finite Element Analysis

Maximize flexibility for ease in deployment.

Meet strength and fatigue requirements.

Analysis procedures could potentially be automated via size / shape optimizations

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Application to Medical Devices

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Finite Element Analysis (FEA) is a requirement to achieve Food & Drug Administrations (FDA) approval for many devices that are implanted in the body. FEA is used in the design, verification, and validation of medical devices through the use of thermal, fluid, electromagnetic and structural models. Current analysis models are used to predict:

Ultimate strength and fatigue failure loads. Flexibility Recoil or springback Vessel damage

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Nonlinearities in Analysis
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The structural nonlinearities inherent in medical device design are as follows:

Material nonlinearities
Plasticity Super-elasticity (Nitinol) Hyperelasticity (model of tissue, plastics, rubber materials etc.)

Geometric nonlinearities
Deployment of device Localized large strains

Contact nonlinearities
Part-to-part (self-contact)
Stent Angioplasty balloon

Part to body part

Artificial Hip or Knee Needle

Part to deployment device

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Finite Element Solution Procedure Stent Design

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Solution steps:

The polished laser cut tubing is starting point. Crimp onto balloon. Expansion to insertion diameter. Released to vessel diameter.
Cyclic response for fatigue Radial compression simulation

Contact surfaces are used to simulate radial expansion and compression

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Compression & Deployment Analysis

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Example ANSYS Nitinol Material Input

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Validation of Analysis with Testing

0.3

Base Model Finite Element Results

0.25

Base Case Design Crush Data

0.2

Crush Froce (lb)

0.15

0.1

0.05

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How to Design a Better Device

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Automated Finite Element Analysis

Parametric input Design optimization Validated models Proof of concept Material property development Design confirmation

Rapid prototyping / testing

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FEA Input Parameters

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Geometry:

2-D drawing or 3D CAD model Geometry of test sample for validation Geometry of loading device Stress vs. strain Force vs. deflection for test data Pressure Temperature Acceleration Angular Velocity Cyclic loading for fatigue

Material properties:

Loading conditions:

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Design Simulation - Structural

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Parametric simulations allow variations of the design to be analyzed quickly and effectively in an automated fashion using variable input/output parameters. A single base model is built and analyzed and perturbations about this design can be automatically performed.

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Why Do Parametric Simulations?

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Parametric simulations can be used to:

Reduce design cycle

Cost savings Man power Time to market Prototyping

Design verification of existing or new designs Design optimization to design a better device. Sensitivity studies on product performance Quality assurance
Set manufacturing tolerances Meet six sigma requirements Satisfy ISO 9001:2000 regulations

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CAD Parametric Model Development

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Example Input Parameters

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Automated Finite Element simulation scripts

Parametric modeling
Strut diameters, radii, widths Number of repeating segments Tubing thickness

Geometry generation
Scripted based on parameters
2D base revolved to 3D

Material property input

Elastic moduli Non-linear material modeling Material testing and validation

Loading and boundary conditions

Displacements Couples Pressures Inertial loads

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Example Output Parameters

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Parametric results data can also be extracted

Displacements Reaction forces Radial stiffness Bending flexibility Stresses

Single max. value Average values

Strains
Extent of permanent deformation Elastic springback

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Optimizing the Design Procedure

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Once a parametric model exists, the design can be optimized using automated techniques.
Initial Design Parametric Model & Loading Solution Parametric Results Analysis File Optimize the Design Explore the Design Domain

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Example Analysis Goal

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The goal of the analysis is to determine the configurations of the eyeglass frame that can tolerate being stepped on and still be capable of recovery meeting stiffness design requirements.

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Setting up the Analysis Environment

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Meshing, material properties, boundary conditions, and solution controls are defined in a solution tool that is linked directly to the CAD system Toggling between the design and analysis tools is possible at any time

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Initial Solution to Debug Model

Prior to the sensitivity study, an initial solution is generated by solving in the simulation environment. This is not a required step, but it is always recommended, particularly for debugging the nonlinear solution.

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Postprocessing of Hystersis Nitinol Super Elastic Material

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Setting up the Sensitivity Study Environment

Once the initial solution is resolved, input and output variables for the sensitivity study are defined in the simulation environment. Input and output variables are defined by checking the box to the left of the parameter. In this case we specify the defining geometric parameters as the input variables

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Results from the Sensitivity Study Environment

The output variables for this study are the Von Mises stress and the deformation in the load direction. The stress can be used to simulate the elastic response, while the displacement is used to measure stiffness

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DOE Method Analyses

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Optimization; Design for Six Sigma

Output; Histograms; Probability Tables

Input Distributions

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DOE Solution

Sensitivity of Max. Von Mises stress vs. frame thickness and frame bottom radius are illustrated in the figure As expected the larger the bottom radius & thinner frame produces the lowest stress values Specific data is extracted from the Response Tabs

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Conclusions
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Sensitivity results (example on right) provide valuable data for the design engineer to quickly determine the most relevant design parameters Optimization routines can be used to develop more robust designs Probabilistic evaluations can be used to quantify tolerances required to meet quality control

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Inferior Vena Cava Filter Example Fluid Structure Interaction

Inferior Vena Cava (IVC) Filters prevents the passage of large lifethreatening emboli to the lungs. Treatment is an alternative to anticoagulant therapy Analyses provide:

Understanding of the filter-vesselflow interaction Opportunity for design iterations to modify flow field, limit filter deformations reduce filter stresses, etc.

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Structure Geometry and Mesh

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Structural Geometry from CAD Model (Pro/E, Unigraphics, Design Modeler, etc.) Computational mesh generated in Ansys Mapped mesh using extrusion and sweep meshing techniques Boundary Conditions created in ANSYS GUI.

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Structural Boundary Conditions

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Similar to structural analysis modeling Symmetric model with symmetry BCs Vessel supported on Ends to prevent rigid body motion Fluid structure interaction defined with surface loading Total time and time step setup matches CFX input Forces passed from CFX to ANSYS Displacements passed from ANSYS to CFX
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Fluid Geometry and Mesh

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Flow domain generated by ANSYS Design Modeler Computational mesh generated by ANSYS CFXMesh 4 filter legs attached to vessel walls 12 legs unattached 150 K elements symmetry of model
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Filter CFD analysis

Solid surfaces act as interface between fluid and solid domains CFD solution provides unsteady pressure loads on solid surfaces Solid deformations constitute new boundary for CFD Two-way interactions, fully coupled iterative solutions at each time level
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Inlet pressure pulse

Pressure = 100mmHG Duration = 1.0 s Analysis ends at 1.5 s

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CFD Analysis Results

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Blood flow model

Density as a function of unsteady pressure pulse, weakly compressible Non-Newtonian fluid

Moving mesh capability to accommodate deformed solid boundaries

Filter face and legs Vessel wall

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Flow animations

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Structural Analysis Results - Deformations

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