Nitinol FEA

Finite Element Analysis for the Design of Nitinol Medical Devices
By Nuno Rebelo and Michael Perry Hibbitt, Karlsson & Sorensen (West), Inc.
Introduction
Medical technology continues to advance rapidly as physicians and engineers move closer to and understand better each others needs. Nowhere is this in better evidence in the development of advanced medical implants. Traditionally, new products were developed by prototyping and evaluation, however this process is very time consuming and often does not fully reveal the potential failures. Finite element modeling and analysis can greatly reduce testing and time to market by allowing the designer to computer test his product in advance of any prototypes. Algorithms have been developed by HKS, Inc., and are used in its ABAQUS finite element modeling software allowing for accurate predictive finite element analysis of nickel-titanium alloys (Nitinol). Nitinol alloys have extremely complex but highly attractive mechanical behavior for medical applications not only for its mechanical properties but also for its bio-compatibility. Since its discovery and first fabrication Nitinol alloys have come to be used in a myriad of unique ways. The super elastic and shape memory properties of the alloy along with its bio-com patibility give the material a wide range of potential applications in the medical field. However, the many benefits of the material come at a cost and the complexity of its properties make it difficult to process. Trial and error techniques have been commonly employed in the past, however it is very time consuming and in today's market place time is among the most valuable commodities. This brief article will discuss how Finite Element Analysis (FEA) can be employed to hasten time to market of NiTi products but greatly reducing the number of design iterations required.
many other potential reasons related to such important issues as the effort required for deployment of the part, stresses induced in parts, durability, etc. Each of these is also com monly associated with the execution of such simulations. Simulation and modeling allows the prediction of behavior before any physical building occurs. This allows the designer to examine ny number of "what if" scenarios in optimizing the design. Simulation can lso provide detailed insight into the mechanical behavior of the design, which may not be discoverable through normal testing and experimentation. Simulation cannot be done without physical properties and some sim plifying assumptions are inevitably made. Thus simulation is a complement and amplifier to testing, rather than a substitute.
Abstract Finite element modeling and analysis can greatly reduce testing and time to market by allowing the designer to computer test his product in advance of any prototypes. Algorithms have been developed by HKS, Inc., and are used in its ABAQUS finite element modeling software allowing for accurate predictive finite element analysis of nickel-titanium alloys (Nitinol). Nitinol alloys have extremely complex but highly attractive mechanical behavior for medical applications not only for its mechanical properties but also for its bio-compatibility. Since its discovery and first fabrication Nitinol alloys have come to be used in a myriad of unique ways.
Finite Element Analysis Basics

Finite Element Analysis (FEA) is particularly well suited to dealing with complex problems, which in reality are normally a composite of continuous fields fields of displacements, strains, stresses, temperatures, state variables, etc.) The problem can thus be solved by using an approximate, discrete element based solution. In actual practice, the continuum is subdivided into small pieces or elements. (see Figure 1) Each element is in itself continuous, however it also assumes a given distribution pattern of the fields, based on values at a selected number of control points or nodes. For example, in a conventional displacement element, one starts with displacements at nodes. The element then automatically defines a continuous displacement field based strictly on the value of each node. This displacement field thus defines a strain field, by taking the appropriate derivatives. Then by applying a material behavior constitutive law, the stresses can be calculated based on the calculated strains. These stresses can then be integrated over the elements to provide the nodal forces. The nodal force contributions from all the elements sharing a common node are then added together. These nodal forces must be in equilibrium with any external load applied to the body or with the actions of other bodies. If displacements are known, then reaction forces are calculated as a result. Likewise if applied forces are known, then resulting displacements
The Role of FEA

Finite element analysis is emerging as one of the most important tools available to material sensitive product developers. [1] The technique has unique capabilities and can be a very costeffective tool if properly used. There are a num ber of very good reasons why one might want to do simulations of the mechanical behavior of medical devices or components. For example, ascertaining the functionality of the devices is certainly a first requirement, however, there are
can be calculated. Thus the method transforms the unknowns from fields into finite vectors of nodal variables. Provided certain mathematical requirements are satisfied, the finer the mesh, (i.e. the smaller the element sizes) the closer the approximate solution is to the exact solution.
Figure 3 Subtle effects associated with the manufacturing process such as the outward distension of the round tips of the stent are discoverable using proper model design techniques. Figure 1 Finite element models are created by breaking the design in to numerous discrete parts or elements. Thus, the purpose of FEA is to expose and solve, to the extent possible, design flaws before a product is produced. This includes the capability to perform fatigue studies on materials. It does not normally preclude the manufacture of prototypes but it should greatly reduce the number of prototype iterations required and in the best case will reduce the number of prototypes to one. In fact in areas of high confidence of the materials and the model model set-up, it is possible that prototyping can be skipped altogether. Processes that can be modeled include mandrel expansion, forming and annealing. It is very important that forming and annealing tools also be co-modeled as three-dimensional structures to assure proper boundary loading conditions. Process effects and tooling can cause subtle changes in the finished part. (see Figure 3) Finite element modeling will highlight any design or process problems well in advance. If one fails to perform complete modeling of all elements, there is a real possibility that the effects caused by the tools and process will go undetected until the device is fabricated, resulting in otherwise avoidable delays in production and costs associated with such time loss.
Conclusion
Finite element analysis is a method well suited to the needs of the medical product designer. The method allows the designer to quickly access his or her design and to iterate the design on a computer before a single piece of metal is ever touched. The finite element modeling method's capability to quickly and accurately solve complex material problems such as are often presented by Nitinol alloys, makes the method an ideal candidate for such situations. Combined with competent error analysis techniques and in the hands of a knowledgeable finite element modeler, enabled by advanced software such as ABAQUS, finite element analysis should prove itself to be and indispensable part of future minimally invasive medical device design and development.
Figure 2 Contour strain maps make strain locations easily visible though the use of color.
References: Stent Example

Stents are cylindrical metal mesh tubes made of materials such as Nitinol and inserted into blood vessels to counter act the effects associated with vascular diseases, such as narrowing of blood vessels do to plaque build up. Because of their critical function it is vital that design be thoroughly validated by methods such as FEA. One of the important capabilities made possible by competent use of FEA, is the ability to accurately model the processing of Nitinol. [2] There are a very limited number of companies possessing this skill. When the skill is possessed, manufacturing processes can be modeled along with the part. 1. Haridas, B. and Haynes, C. "Predictive Analysis at the Forefront of Medical Product Development," Med. Devc and Diag Indsty, Oct 1999: 112-119 2. Perry, MD and Chang, RT, "Finite Element Analysis of NiTi Alloy Stent Deployment," The Second International Conference on Shape Memory and Superelastic Technologies. Pacific Grove: MIAS, 1997: 601-606. Note: This article is and abridged version of an article originally published in Minimally Invasive Therapy & Allied Technologies. For a full text version please contact the authors.
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Finite Element Analysis for the Design of Nitinol Medical Devices

Finite Element Analysis Basics

The Role of FEA

References: Stent Example

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