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  Finite-element study of Rafael's "SafeFlo" Vena Cava Filter  
     
Company Business:
Producer of intravascular devices for simple, safe and minimally invasive medical procedures, such as embolic protection, peripheral vascular interventions, bioinformatics, drug delivery, etc.

Analysis Goals:
:
To assess the structural behavior of the filter during insertion into the delivery catheter and under operational conditions. Specifically, to monitor the strain-stress fields at all points in the structure and locate any strain level that exceeds allowable material limits. To estimate the fatigue factor and life expectancy of the filter, by calculating alternating strain levels resulting from the alternating pressure in the blood vessel.
 
   
 
   
Simulation Details:
Simulation was performed using ABAQUS 6.5, a commercial FE software package capable of simulating highly nonlinear behavior. The 3D geometry of the FE model was defined in Solid Works (CAD system) and read into the ABAQUS/CAE preprocessor. The filter (Figure 1) consists of two functional parts: the Trans-catheter Intravascular Ring Platform [TIRP], or "cage", and the filter element. The parts are connected by fixation rings (also shown in Figure 1), so that no relative motion between parts is possible at the connection points.
All parts and rings are made of Shape Memory Alloy (SMA). The SMA constitutive model available in ABAQUS is able to represent the super-elastic behavior of this material. An example of a typical stress-strain curve, based on material constants obtained from a uniaxial physical experiment, is shown in Figure 2.
Each part of the filter (cage, filter element and fixation ring) was analyzed separately. To test fracture risks due to high strain, the cage and filter element were axially stretched to a nearly straight configuration. At this stretch level, they can fit into the delivery catheter (1.7mm diameter). At the end of that stage the strain level is at its peak.
Due to the high aspect ratio of the structure, the element that best expresses the physical situation is a first-order shear-deformable (Timoshenko) beam element (B31 in ABAQUS). This element is adequate for structures in which one dimension is significantly greater than the other two dimensions, as is clearly the case at hand. It allows for axial, bending and torsional deformation, as well as transverse shear deformation. In addition, B31 is formulated so that its cross section can change as a function of axial deformation in geometrically nonlinear simulation.

Figure 1

Figure 2
Figures 3, 4 and 5 show the resulting deformations at various stages of stretching in the cage and filter element respectively. The original undeformed geometry is shown in green.

In order to calculate the strain field at the fixation rings, a detailed 3D model was built of a ring and the wires it holds. The initial configuration of the model is shown in Figure 6.
Taking into account an overlap between the inner surface of the ring and the outer surfaces of the wires as they are brought together, the final geometry was obtained by solving the interference fit problem. This was achieved in ABAQUS by a special contact solution option, which allows the initial interference to be gradually eliminated over several solution increments. In this configuration the wires were compressed against each other and the initial ring shape was deformed so that no interference existed between the ring's inner surface and the wires' outer surfaces. The resulting strain field at the ring is shown in Figure 7.

In order to calculate the fatigue factor and life of the device, the alternating strain from the pulsating pressure inside the blood vessel needed to be determined. To that end, two analysis steps were defined to obtain the worst-case load conditions that the device can encounter while in operation:

Step 1: Deployed configuration. The cage was pressed between two rigid plates to a distance of a nominal blood-vessel diameter. The strain field at the end of this step was the base state for the fatigue-strain calculation.

Step 2: Obtaining the alternating strain. The plates were moved toward each other to reflect the maximum diameter change of the blood vessel. This step yielded the alternating strain amplitude (change of strain from base state to final state).

Figure 6


Figure 7
The FE model that was used for the cage is described above. In addition, two rigid plates were defined to represent the blood vessel walls. Figures 8 and 9 show side views of the device configuration in the base and final states respectively.
 
     
Results and Benefits
The numerical study was able to show that no material fracture should occur at any stage of device deployment into a blood vessel. Moreover, when the fatigue/life of the device was calculated under operational conditions of alternating blood pressure, the predicted strain value was shown to be within the endurance limit of the material. Thus no fatigue failure was expected; this conclusion was verified in a physical experiment.
Using FEA throughout the filter design and validation process allowed the designer to assess various design alternatives and to obtain a 3D view of product behavior, without the need to perform expensive physical experiments

 
   
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