Predicting Buckling for Medical Device-Catheter Interaction during Implant

Yong Zhao Medtronic, Inc., Mail Stop B252 7000 Central Avenue, NE Minneapolis, MN 55432, USA Tel: (763) 514-8368 Web-site: www.medtronic.com E-mail: yong.zhao@medtronic.com

Abstract
Buckling is one of the major concerns for medical device-catheter interaction when implanting intracardiac devices through a delivery catheter. The devices typically consist of high strength alloy reinforcements / conductors and polymeric tubing. These devices having small diameters are slender, and often highly flexible. The catheter of high strength polymer is much stiffer than the devices. To predict the device buckling using finite element analysis (FEA) modeling is challenged by the 3-D deformable rigid contact interaction with larger frictional sliding, and the computation efforts due to the large number of elements. This paper presents the FEA modeling results that were verified with experimental tests. ABAQUS/Standard is feasible to handle this problem.

Background
A pacemaker lead and its connector must be compatible with the delivery catheter (Figure 1) during implant. There is a concern that the lead, which is a long slender complicated structure, may buckle when pushed through the catheter when a large clearance exists between the lead and catheter. In order to address trade offs between physician handling presences and the final function of the lead after implantation, FEA modeling parametric buckling analyses were performed to study the lead-catheter interaction during implant.

Methods
In the FEA model the lead was placed freely inside the catheter with its tip close to the catheter bend and its end to be pushed along the catheter centerline with displacement control. 3-D models were developed to predict the lead buckling behavior comparing physical tests. A large number of 2-D models were developed that could much more efficiently generate the buckling curves in terms of generic design parameters to cover other lead and catheter products.

2002 ABAQUS Users Conference

The material mechanical behavior for the lead composite structure was assumed as linear. The three dimensional elements C3D8R (8-node linear brick reduced integration with hourglass control) and R3D4 (4-node bilinear quadrilateral rigid), and the two dimensional elements B21H (2-node linear beam with hybrid formulation) were used in the FEA models. The maximum element size of 0.02 (longitudinal) x 0.098 (hoop) x 0.007 (radius), yielding an aspect ratio of 2.86, was defined for the C3D8R element mesh for an acceptable mesh density quality. The parametric nonlinear problems with large frictional sliding contact effects were solved with ABAQUS/Standard Version 5.8. The coefficients of friction between the catheter and lead were tested in dry and wet conditions, which were used as input for the FEA models.

Results and Discussions

Local buckling was observed in both the FEA modeling and physical tests. The buckling strength curves (pushing displacement vs. force as shown in Figure 2) were expressed with lead stiffness, lead-catheter clearance, and coefficient of friction. The curves can be used for generic design optimization purposes. The FEA results match the empirical experiences in product development and practice in the field, but also can predict quantitatively the lead-catheter interaction differences from the different design parameters. The FEA results were validated with physical experimental tests. Both the 3-D and 2-D FEA models indicate that local buckling is the major mechanical mechanism with lateral constrain from the frictional lead-catheter contact support. The critical buckling force (CBF) can be explained with the following formulation:

Pc k(2EI / L2)
Where, k---constant for end boundary conditions E---Youngs modulus of the slender structure I---Moment of inertia of the slender structure L---Effective length of the slender structure EI---stiffness of the slender structure The lateral constrain from the frictional lead-catheter contact support primarily changes the effective length L, and the CBF is proportional to the stiffness. The lateral constrains primarily depends on the lead-catheter clearance and the coefficient of friction (or material types, surface smoothness, and working environmental condition).

2002 ABAQUS Users Conference

Figure 1. A Pacing Lead Is Implanted through a Delivery Catheter

Figure 2. A Critical Buckling Force Predicted by the FEA Modeling

2002 ABAQUS Users Conference