Journal of Mechanics Engineering and Automation 2 (2012) 251-255

DAVID

PUBLISHING

FEM for Design of Balloon Expandable Stent for Coronary Artery Using Co-Cr Alloy
Chul Woo Park1 and Ho Sung Joe2
1. Industrial Supercompting Department, Korea Institute of Science and Technology Information, Daejeon 305-806, Korea 2. Research Institute of Stent, DIO Co. Ltd, Pusan, Korea

Received: March 07, 2012 / Accepted: March 28, 2012 / Published: April 25, 2012. Abstract: Lately, cardiovascular diseases are becoming a critical issue to human health and patients suffer from such a disease tend to be increasing throughout the world due to the changes in lifestyle. As the remedies to cardiovascular diseases, a coronary artery bypass graft surgery (CABG) and a stent implantation have been widely used. In order to achieve successful results through these treatments, a stent must fulfill the certain conditions with its design and mechanical properties. A stent must have sufficient stiffness to secure the strength of narrowed blood vessel and sufficient fatigue strength against the pulsatory motion of the blood vessel. Also its high flexibility is mandatory not to damage the vessel wall while it is being transferred to the lesion through the blood vessel. A design of stent has considerable influence upon the performance of stent. Thickness, curvature and connection method of strut are main variable factors in stent design. Key words: Stent, finite element method, blood vessel, stainless steel, cobalt chrome alloy.

1. Introduction
Most people in these modern days are exposed to various diseases due to their habit of taking much food with high lipid content, and also due to alcoholic beverages and smoking. Particularly cardiovascular diseases are very fatal, and it is a not only domestic but also worldwide trend that the rate of occurrence is increasing. For the treatment of these diseases, stenting has been widely used along with the CABGs (Coronary artery bypass graft surgery). Stenting, which was first introduced by Dotter in the early 1960s, has been widely used for the semi-permanent treatment of the coronary arterial, gastrointestinal and hepatoiliary diseases [1-3]. Stenting is more convenient than CABGs, with high survival rate after the practice, and with less worry about anesthesia for patients; therefore it may be applied to patients with a potential high risk from surgery. Various
Corresponding author: Chul Woo Park, senior research, Ph.D., research fields: structural analysis, FEM, plastic deformation, process design and die design, cold forging, extrusion. E-mail: p016535@empas.com.

types of stent have been developed for patients according to its uses, while the balloon expandable stent for coronary artery is used to recover normal flow of blood by being implanted into narrowed or blocked artery [4]. Various types of stent have been developed for patients according to its uses, while the balloon expandable stent for coronary artery is used to recover normal flow of blood by being implanted into narrowed or blocked artery [5]. For this, stent must maintain enough strength to assure its inner diameter in the narrowed artery, as well as the fatigue strength to withstand arterial pulses. On the other hand, it must have enough flexibility in order not to damage arterial wall during the transportation to lesion in the body, and also have such a shape that can induce uniform deformation in the radial direction. With regard to such properties, the medical organizations all over the world, such as FDA and CE, require very strict standard to be met. The functionality of stent has been tested through so many experiments and studies by manufacturers all over the world; which, however, cost too much expense and also

252

FEM for Design of Balloon Expandable Stent for Coronary Artery Using Co-Cr Alloy

took too much time and people. Therefore, in this study, the non-linear finite element analysis was carried out to reduce expenses as well as the trial and error for testing the functionality of stent; and also to check the behavior of stent under various conditions of design. Through this the deformation behavior at various expending diameters during balloon expansion was examined; as well as displacement and elastic recovery, longitudinal variation, and the stress and strain distributions, according to the deformation of stent. Also, behaviors of stent according to the shapes and connection conditions of the stent strut and the stent bridge were analyzed.

Fig. 1 The commercial product SCM-10 and the analysis model. Table 1 Essential measurements of stent (SCM-10). Stent before expansion 57 1.3843 21.4 102.85 200 180 18.188

2. Analysis Model and Material

The stent used in this study is SCM-10 (DSI, Yangsan-city, Korea), which is shown in Fig. 1 along with its analysis model. The mathematical model for analysis, which was used to examine the deformation behaviors for crimping process and expanding process in artery, is as follows: the thicknesses of strut were 70, 80, 90 and 100 , inner diameter was 1.8 mm, and the length of stent was 18.188 mm. The shape of SCM-10 is a series of arcs with a specific radius of curvature, composed of 10 repeating cells each of which is connected by a bridge. Table 1 shows the essential measurements of the stent. The material used for SCM-10 was ASTM-F90, which is a Cobalt-Chrome alloy that has higher biocompatibility than stainless steel. Its mechanical properties and the relation between stress and strain is shown in Fig. 2. During the crimping and expanding processes, the very small size of the section area of the strut of the stent, compared to the total size of the stent, causes very big displacement which is accompanied by plastic deformation. Therefore, both the large deformation and the non-linearity of material on work hardening must be considered together for analysis. To resolve the problem of the non-linearity, I-DEAS was used for element tearing of the model; and the ABAQUS/Standard program of non-linear analysis

Category Number of cell Cell area (mm2) Metal surface area (mm2) Stent surface area (mm2) Outer diameter of stent (mm) Inner diameter of stent (mm) Length of stent (mm)

Fig. 2 Mechanical properties of the material, and the relation between stress and strain.

code was used for calculation, applying the Newton-Rapson Method with an iteration in sufficiently small increments. The mathematical model was composed of 10 node tetrahedron elements, and the size of the elements was set smaller than 1/2 of the strut thickness so that the curvature of the strut may be sufficiently reflected. The radius of the curvature of crown body and that of crown curve were set as the major variables of the deformation behavior of the mathematical model, to examine the results according to their variation.

FEM for Design of Balloon Expandable Stent for Coronary Artery Using Co-Cr Alloy

253

3. Result of Analysis and Discussion

The stent in real practice is inserted into artery after its diameter has been reduced by crimping process, and then expanded by the balloon that is attached to catheter when it arrives the lesion; but for simplification, the effect caused by the contact between the balloon and the artery upon the deformation of the stent was not considered. During the deformation of the stent, the inner diameter changed to 1.0 mm at the crimping step, and to 3.0 mm at the expanding step; while the stress, the strain, the radial recoil and the foreshortening were examined at each step. 3.1 Stress Distribution and Strain Distribution According to the Strut Thickness Figs. 3-4 show the mechanism of the deformation of strut in crown area. In these figures, we can see the deformation of the curvature area of the crown is the major factor of deformation during the strut expansion. During the deformation of the strut, the stress generated by the expanding force of the balloon is exerted on the strut, thereby increasing the diameter in the radial direction. The stress and strain distributions during this process show different behaviors according to the strut thickness. Figs. 5-6 show the results of maximum stress distribution and maximum strain distribution, according to the strut thickness, at each step of deformation. We can see from the results that the maximum stress increases as the strut thickness increases, due to the increase in the strength of the material, because the increase in the strut thickness causes the increase in the modulus of section for bending moment. It was 97.65 Mpa after crimping and 158.70 Mpa after expanding when the strut thickness was 70 ; when the strut thickness was 100 , it increased to 112.15 MPa (about 15% increase) and 166.20 MPa (about 5% increase), respectively. Figs. 5-6 show the results of maximum stress distribution and maximum strain distribution, according to the strut thickness, at

Fig. 3 Stress distribution upon deformation of stent.

Fig. 4 Strain distribution upon deformation of stent.

Fig. 5 Stress distribution upon deformation according to strut thickness.

254

FEM for Design of Balloon Expandable Stent for Coronary Artery Using Co-Cr Alloy

Fig. 6 Strain distribution upon deformation according to strut thickness.

each step of deformation. We can see from the results that the maximum stress increases as the strut thickness increases, due to the increase in the strength of the material, because the increase in the strut thickness causes the increase in the modulus of section for bending moment. It was 97.65 Mpa after crimping and 158.70 Mpa after expanding when the strut thickness was 70 ; when the strut thickness was 100 , it increased to 112.15 MPa (about 15% increase) and 166.20 MPa (about 5% increase), respectively. 3.2 Stress Distribution and Strain Distribution According to the Radius of the Curvature of Crown Fig. 7 shows the change in the inner angle of the strut upon the expansion of the stent. The more the stent expands, the more the inner angle of the strut increases, thereby causing the increase in the maximum stress. As the stent expands, as shown in Fig. 5, stress is focused on the curvature area of the crown, resulting in the deformation; and this deformation is the major cause of the deformation for the bending of the strut. Therefore, the increase in the radius of the curvature of crown makes big deformation possible by less force, due to the decrease in the deformation resistance against bending. It was also proved that a breaking of crown may occur during an excessive expansion beyond appropriate expanding diameter, because of the excessive increase in the bending angle of the strut. Figs. 8-9 show the maximum stress and maximum strain at each step, according to the radius of the curvature of crown. We can see here that maximum

Fig. 7 Variation of strut angle and the maximum stress upon the expansion of stent.

Fig. 8 Maximum stress according to the radius of the curvature of crown.

Fig. 9 Maximum strain according to the radius of the curvature of crown.

stress and maximum strain decrease as the curvature of crown increases. This is because, as stated above, the deformation resistance decreases as the radius of the

FEM for Design of Balloon Expandable Stent for Coronary Artery Using Co-Cr Alloy

255

curvature of crown increases, which confirmed that big deformation is possible with less expanding force. 3.3 Radial Recoil and Foreshortening Fig. 10 shows the deformation states in the radial direction at each step, while Fig. 11 shows the longitudinal variation at the expanding step. The mathematical formula for quantitative calculation is shown in Eqs. (1)-(2), respectively.

4. Conclusions
In this study, the elements that have important effects on the deformation behaviors of the stent for coronary artery were examined, such as the strut thickness, the stress, the strain, the radial recoil and the foreshortening, according to the radius of the curvature of crown. The following conclusions were obtained: (1) The high strength of material due to the increase in the strut thickness causes the increase in maximum stress, the maximum strain and the radical recoil; while causing the decrease in the foreshortening. (2) The increase in the radius of the curvature of crown reduces the resistance against warp, which causes the decrease in maximum stress, the maximum strain and the radial recoil; while causing the increase in the foreshortening. Therefore, both the strength of strut and the elastic recovery after expansion must be considered for ideal design of stent to assure its inner diameter in artery; while, the two elements have opposite effects and must be balanced.

Fig. 10 Radial recoil of SCM-10.

References
[1] T. Asakura, T. Karino, Flow patterns and spatial distribution of atherosclerotic lesions in human coronary artery, Circulation Res 66 (1990) 1045-1066. C.M. Gibson, L. Diaz, K. Kandarpa, et al., Relation of vessel wall shear stress to atherosclerotic progression in human coronary arteries, Arterioscler Thromb 13 (1993) 310-315. M. Sato, N. Ohshima, Effect of wall shear rate on thrombogenesis in micro-vessels of the rat mesentery, Circulation Res 66 (1990) 941-945. J.A. Ormiston, S.R. Dixon, M.W. Webster, P.N. Ruygrok, J.T. Stewart, I. Minchington, et al., Stent longitudinal flexibility a comparison of 13 stent designs before and after balloon expansion, Catheter Cardiovasc Interv. 50 (2000) 120-124. L.B. Tan, D.C. Webb, K. Kormi, S.T. Al-Hassani, A method for investigating the mechanical properties of intracoronary stents using finite element numerical simulation, International Journal Cardiol. 78 (2001) 51-67.

[2]

[3]

[4]

[5]

Fig. 11 Foreshortening of SCM-10.