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Presented by: Radha Krishnan Detroit Engineered Products [email protected] Parameterization & Optimization of balloon expandable stent May14 2012

Parameterization & Optimization of balloon expandable … · Presented by: Radha Krishnan Detroit Engineered Products [email protected] Parameterization & Optimization of balloon

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Presented by:

Radha Krishnan

Detroit Engineered Products

[email protected]

Parameterization & Optimization

of balloon expandable stent

May14 2012

Content

• Introduction to DEP

• BIO Medical Practices at DEP

• Stent case study

• Global Human Body Modeling initiative

• Relationship with Dassault (3DS)

• Paper Presentation

• Conclusions from paper

• Future Vision In Bio medical sciences

• Questions and Answers

3

2

4

1

6

5

7

DETROIT ENGINEERED PRODUCTS

560 Kirts Blvd., Suite 103,

Troy, Michigan - 48084

Ph: (248) 269 7130

www.depusa.com

DEP Introduction

Bio medical practices at DEPTotal Knee Replacement

Femur bone

Cardio vascular devices

Global Human

body model

Human body model

Hip Implants

FE model of stent + crimping tool

Crimping simulation

Unloading crimping tool

Results of crimped stent after spring back

FE model of balloon ( balloon + stent )

(representative model, not actual balloon itself)

Expansion to deployment profile dimension

Deflate / Unload the balloon

Measure recoil and foreshortening

Test data & geometry

FE model generation

Simulation & post-processing

Morpher – FE Model parameterization

Optimization - DOE & RSM

Coronary Stent Optimization – Case Study

Process Followed at DEP

The optimization

process reduced

recoil by 14.37% and

improved flexibility by

6.35% without

compromising on

foreshortening and

induced wall stress

DEP Sponsor at 2011 SIMULIA Regional Users Meeting

Topic presented by DEP during the Users Meet:

Parametric CAE Models, DoE based Multi Disciplinary Optimization

Relationship with Dassault 3DS

MeshWorks Morpher- Isight Integration

Multi-Disciplinary Optimization of Jeep WK 2005 Vehicle

Detroit Ramesh Padmanaban, Radha Krishnan

Detroit Engineered Products, Inc.

Malik Kayupov

Engineous, Inc.

Sachin Gogate, Ganesh Kalpundi, Apurva Kapadia, Durgesh Rege, Manjunath Sharma, Nagesh

Tumu, Tim Wehner, Raghu Yarlagadda , Shekar Yerrapalli DaimlerChrysler Corporation (JEEP)

• Introduction to DEP

• BIO Medical Practices at DEP

– Stent case study

– Global Human Body Modeling initiative

• Relationship with Dassault (3DS)

Paper Presentation

• Conclusions from paper

• Future Vision In Bio medical sciences

• Questions and Answers

3

2

4

1

6

5

7

Introduction

• Vascular stents are deployed in the blocked arteries

to restore the passage of the blood flow. By acting

as a mechanical scaffold, stenting is effective in

preventing and treating coronary occlusion.

• Market expectation of the product is to have better

recoil without compromising flexibility.

• The current stent design activity is aimed at

improving recoil, foreshortening and flexibility.

• CAE design procedures, helps in virtual testing and

simulation of the product in less time and cost.

• FE models were built to simulate realistic stent

deployment and analyzed the flexibility and

optimized for the lesser radial recoil and flexibility.

• The numerical analysis methodology

and sequence was derived by Bio

medical engineers at DEP

• The results from this procedure was

compared to bench test data for

validation

• After validation this procedure was

implemented for analysis and

optimization.

Simulation Method

FE model of stent + crimping tool

Crimping simulation

Unloading crimping tool

Results of crimped stent after spring back

FE model of balloon ( balloon + stent )

(representative model, not actual balloon itself)

Expansion to deployment profile dimension

Deflate / Unload the balloon

Measure recoil and possible foreshortening

Crimping process & Simulation simulation

• Crimping is the procedure by which the stent is

fitted on to the balloon-elastic tube assembly.

• Stent undergoes permanent deformation and gets fit on the balloon.

• This simulation has both loading and unloading phase of the crimping.

MODEL SETUP

STRESS CONTOUR – CRIMPING TO TARGET DIMENSION

MAXIMUM CRIMPING LOAD

Deployment simulation

• The crimped stent is imported into the expansion model along with the results.

• The balloon is expanded to target diameter and then the balloon is deflated.

EXPANSION OF BALLOON DEFLATION OF BALLOON

STRESS CONTOUR – EXPANSION

Summary of baseline results

Load case Plastic strain %

Crimped (max. load) 3.31

Crimped 1.1mm (Unloaded) 3.31

Dilated 3.5mm (max. load) 7.7

Dilated (Unloaded) 7.7

• The entire process of crimping and expansion was successfully carried out in ABAQUS Implicit.

• The history stresses due to crimping was carried on to the expansion analysis

Stent crimped on balloon

Stent at full expansion

(balloon inflation)

Intrinsic elastic recoil

(balloon deflation)

Radial recoil 8.35%

Foreshortening 2.5%

Flexibility

• The flexibility of the stent is arrived by

the bending analysis.

• Moment load is applied on the control

nodes, that causes bending of the stent.

Application of bending load

Control node B

(constrained in

2,3,4,6 dof)

Control node A

(constrained in

1,2,3,4,6 dof)

Moment load applied in

Y axis on both sides

with opposite direction

Two point bending model setup Four point bending model setup

Control node B

(constrained in

2,3,4,6 dof)

Control node A

(constrained in

1,2,3,4,6 dof)

Moment load

applied in + Y

axis

Contol node C & D.

Moment load applied

in - Y axis

Flexibility

0

0.02

0.04

0.06

0.08

0.1

0.12

0.14

0.16

Mo

men

t

Deflection (mm)

2 pt bending load

Series1

0

0.02

0.04

0.06

0.08

0.1

0.12

0.14

0.16

0

0.0

015

0.0

03

0.0

0525

0.0

0855

0.0

1368

0.0

213

0.0

327

0.0

498

0.0

7545

0.1

1385

0.1

5

Mo

men

t

Deflection (mm)

4 pt bending load

Series1

Two point bending load case Four point bending load case

Moment deflection curve

DOE based stent optimization

• Optimization objectives:

– Reduce radial recoil by 3%

– Improve flexibility & tractability

• Optimization constraints:

– Foreshortening should not exceed 3%

Design variables

Five design variables are identified for the optimization of stent.

Parameter min max

Slot length 0 1.28

Thickness -0.01 0.01

Width increase -0.005 0

Angle offset -0.015 0.03

Curved Strut width offset -0.01 0.01

Width Thickness

Stent Parameterization

The stent was parameterized with different design variables. The range of every variable varied between

+/- 30%. The aim of the project was to optimize the design for radial recoil and foreshortening.

Slot length

Curved Strut width offset Angle Offset

Stent Parameterization

DOE matrix

The DOE matrix was generated based on Latin Hypercube with 15 points.

Deign no

Design variables

Slot length Thickness Width H bridge height H bridge width

1 0 -0.007142857 -0.003928571 0.03 -0.002857143

2 0.091428571 0.001428571 -0.001785714 0.023571429 0.004285714

3 0.18285714 0.008571429 -0.004285714 0.017142857 -0.005714286

4 0.27428571 -0.002857143 -0.002142857 -0.011785714 -0.008571429

5 0.36571429 -0.005714286 0.000357143 0.026785714 -0.007142857

6 0.45714286 0.01 -0.002857143 0.001071429 0.005714286

7 0.54857143 -0.01 0.000714286 0.004285714 0.001428571

8 0.64 -0.001428571 -0.005 -0.002142857 -0.001428571

9 0.73142857 0.007142857 0 0.013928571 0.002857143

10 0.82285714 0.002857143 -0.001428571 -0.015 0

11 0.91428571 -0.008571429 -0.003571429 -0.005357143 0.007142857

12 1.0057143 0 -0.0025 0.020357143 -0.004285714

13 1.0971429 0.004285714 -0.004642857 0.0075 0.008571429

14 1.1885714 0.005714286 -0.003214286 -0.008571429 -0.01

15 1.28 -0.004285714 -0.001071429 0.010714286 0.01

Optimization Process for Stent design

MORPHER(Unified Control-Blocks

to parameterize

models from different

load cases)

Baseline – crimping

Baseline – recoil

Baseline - flexibility

Flexibility

Design1

Design2

Design3

:

:

Design ‘n’

Recoil

Design1

Design2

Design3

:

:

Design ‘n’

Crimping

Design1

Design2

Design3

:

:

Design ‘n’Optimizer/Prod

uct Integration

I – Sight etc.

DOE

Design Variables

& Limits

Input-Output

matrix

Objectives

Constraints

Structural

Solver

Structural

Solver

Structural

Solver

Optimized design

Input / Output matrix

Input Output

Deign no

Design variablesRadialRecoil

%

Stiffness2pt flexNmm2

Stiffness4pt flexNmm2

Foreshortening

%Slot length Thickness Width

H bridgeheight

H bridge width

Baseline 0 0 0 0 0 8.35 2.035 22.69 2.5

1 0 -0.007143 -0.003929 0.03 -0.0028571 7.75 3.14 31.42 0.89

2 0.0914286 0.0014286 -0.001786 0.0235714 0.00428571 7.82 2.012 21.46 0.921

3 0.1828571 0.0085714 -0.004286 0.0171429 -0.0057143 8.1 2.294 22.23 0.96

4 0.2742857 -0.002857 -0.002143 -0.0117857 -0.0085714 7.08 3.271 29.54 0.68

5 0.3657143 -0.005714 0.0003571 0.0267857 -0.0071429 7.08 2.603 23.3 1.12

6 0.4571429 0.01 -0.002857 0.0010714 0.00571429 8.22 1.876 17.59 0.911

7 0.5485714 -0.01 0.0007143 0.0042857 0.00142857 7.25 3.191 27.27 0.85

8 0.64 -0.001429 -0.005 -0.0021429 -0.0014286 8.01 3.905 32.53 0.64

9 0.7314286 0.0071429 0 0.0139286 0.00285714 7.21 1.965 18.31 0.824

10 0.8228571 0.0028571 -0.001429 -0.015 0 0.87 2.289 19.33 0.87

11 0.9142857 -0.008571 -0.003571 -0.0053571 0.00714286 8.11 3.258 27.65 0.965

12 1.0057143 0 -0.0025 0.0203571 -0.0042857 6.66 2.558 20.53 1.0

13 1.0971429 0.0042857 -0.004643 0.0075 0.00857143 7.34 2.893 22.59 0.88

14 1.1885714 0.0057143 -0.003214 -0.0085714 -0.01 7.06 2.671 20.67 0.729

15 1.28 -0.004286 -0.001071 0.0107143 0.01 7.99 2.509 19.03 1.15

Response surface

Optimized Design

• From the input output table it is observed that the design 12 has the

minimum radial recoil with improved flexibility.

• The simulation results from the DOE approach reflects the effect of every

design variable.

• From the input output table the optimized design can be arrived by creating

a meta model (RSM). The meta model after validation was taken up for

optimization.

• The designs has reduction in radial recoil and foreshortening without

compromising flexibility.

Hbridge_height -0.015

Hbridge_width -0.01

Slot_length 1.28

Thickness -0.01

Width -0.001223655

Optimized design variable values

Conclusion & Future work

• The DOE based optimization technique is effective in finding the optimum

design of the stent with improved radial recoil and flexibility.

• The response surface method will be followed to find the global optimum

design.

• The study was conducted in 3 weeks time. The model building and the

baseline runs were completed in 1 week. Parameterization and DOE

generation were completed in 2 weeks.

• Study of blood vessel stress due to stenting is another parameter that is in

process, which will also be incorporated in the MDO approach in future.

Hyper elastic material model will be used for modeling the blood vessel.

• Cardio vascular devices :

– The benchmarked numerical analyses scheme coupled with optimizer (Isight)

and MeshWorks as a way forward for optimizing stent characteristics

– Stent rolling tool in MeshWorks drastically cuts down the time to build stent 3D

models from 2D line data.

– Design process for NiTinol (SMA) stent.

– Investigation into drug eluting stents.

• Human Body Modeling :

– MeshWorks process based on scaling and morphing successfully extended to

build non standard and standard percentile human body models.

– Our own hex mesher to build human body models.

– Continue engagement with 3DS team at Rhode Islands on the human body

model

• Implants :

– Patient specific implant initiative

Future Vision In Bio medical sciences

Build a Stent 3D FE model from 2D Line data in MeshWorks

2D line data of stent

Stent Rolling Tool in MeshWorks

Creation of 3D Hexahedral Mesh of the stent in

MeshWorks

3D Hexahedral Mesh Quality Improvement in

MeshWorks

Performance Evaluation

Demonstration of Morpher Role in HBM (Illustrated on a dummy due to confidentiality)

Before Morphing lower limbs After Morphing lower limbs

323 mm

98 mm

404 m

m163 mm 150 mm

Base point selected for

Morphing

363 m

m

291 mm

88 mm

Q and A

Thank you.