Numerically Simulated Biomechanics ROBERT EBERLEIN THOMAS ZACHARIAS SULZER INNOTEC Sulzer Innotec – formerly corporate research and development – today makes 70% of its sales to customers outside the Corporation (see box on p. 19). This is the reason why Sulzer Innotec is still active in the field of medical technology, although Sulzer had withdrawn from this business with the spin-off of Sulzer Medica in 2001. One example of the activities of Sulzer Innotec are biomechanical calculations which facilitate the development and licensing of orthopedic implants. In the field of medical technology, Sulzer Innotec deals with many different topics, especially in the fields of orthopedics, the cardiovascular system, and the photorealistic visualization of surgical techniques (e. g. with ultrasound and implantable signal generators). The customer projects comprise the provision of both support and advice in the mechan- 18 SULZER TECHNICAL REVIEW 1/2004 ical design of implants and their integration in specially developed and tested calculation models of biological tissue, such as bone, muscle, and ligaments. Numerical simulations play an outstanding role in the solving of these problems. Based on models of the knee and the spine, this article gives an insight into the biomechanical calculation of orthopedic 4113 Simulation of the Knee Flexion Behavior of the materials The most important aim of the implantation of a knee prosthesis is to improve the patient’s quality of life. This is only possible if the implant allows pain-free and nearly physiological movement in the joint. During the development process, the implants are subjected to various tests. On the one hand, stability tests are carried out in order to assure that there is both adequate freedom of movement and no false positioning of the joint resulting from extreme exter- nal loading. On the other hand, by means of in-vitro kinematic tests (knee flexion, gait cycle) it is determined whether or not the artificial joint is suitable and capable of restoring the natural range of movement. In order to accelerate the development of artificial knee joints and to reduce the number of these costly preclinical tests, Sulzer Innotec has developed an idealized and experimentally validated model of the human knee joint based on the finite element method (FEM). This Simulation model The Activities of Sulzer Innotec, the Center for Technology and Innovation Overall behavior 1 A biomechanical analysis in orthopedics leads from the analysis of the behavior of the materials used, through the creation of a simulation model, to the calculation of the behavior of the implant in the body. implants and their interaction with the surrounding biological structures, and into the experimental validation of these calculations (Fig. 1). Both these projects were carried out on behalf of Centerpulse Ltd*. ________________ * After its spin-off in 2001, Sulzer Medica was renamed Centerpulse. On October 2, 2003, Centerpulse was acquired by the American Zimmer Holdings, Inc. Sulzer Innotec offers technological services, worldwide, for the solution of individual customer problems: in contractual research (innovative concepts and methods for future products), in the development of new business concepts, and in the fields of production and quality assurance. These services also include troubleshooting and the further development of existing products. Contractual research is concentrated on: Mechanics, fluid dynamics, materials, and surfaces, as classical industrial fields Medical technology, as specifically applied in the above fields (biomechanics, biofluidics, biocompatible materials, implantable sensory devices, and ultrasound equipment) business fields. Already in 2002, Sulzer Innotec obtained more than two-thirds of its total business from external companies in the fields of energy, transport, chemical industry, and medical technology. Rapid, Flexible, and Interdisciplinary Sulzer Innotec generates an additional value in the rapid application of new technologies in the industrial environment and in this way broadens the possibilities of its customers, as well as of the universities and specialized professional schools. Thanks to its around 140 highly qualified specialists, projects are carried out competently, rapidly, flexibly, and in the strictest confidence. CONTACT Successful Transformation In all fields, Sulzer Innotec is able to call on a great wealth of experience from more than 50 years’ successful industrial research. Since 2001, Sulzer Innotec has been on the way to becoming a self-supporting business area that is making an important contribution to the stability of the core business and to the building-up of new Sulzer Innotec Hans-Walter Schläpfer Postfach 414 8401 Winterthur Switzerland Phone +41 (0)52-262 21 51 Fax +41 (0)52-262 00 15 hans.schlaepfer@sulzer.com www.innotec.ch SULZER TECHNICAL REVIEW 1/2004 19 Hip joint Flexor muscle of the knee Femur Extensor muscle of the knee Patella Collateral ligaments Tibia Ankle joint 2 With this experimental model of a knee joint, Sulzer Innotec validated its finite element model for correctness. 3 FEM model of an artificial knee joint with collateral ligaments and retained posterior cruciate ligament. model consists of the femur, tibia, patella, ankle, hip joint, and, by means of springs, idealized collateral ligaments (Fig. 2). The knee flexion is controlled by a vertical shifting of the hip joint and stabilizing muscular forces. In the experimental study, the kinematics of the individual components were tracked by means of an optical tracking procedure. Since it takes a matter of several seconds and as the masses involved are comparatively small, a typical knee flexion can be considered as quasi-static. During flexion, the knee joint undergoes major shifts – mainly in relation to the femur –, i.e., the FEM model contains geometric non-linearities. These are correctly taken into account by the Abaqus/Standard FEM program that is used, as are also the major relative shifts in the contact surfaces between femur and tibia, and between femur and patella. According to the validation, the FEM model can be used for various different studies. For example, with this mode, it is possible to study the ligament tensions that are to be set during an operation, or the effect of the retention of a posterior cruciate ligament on the knee kinematics (Fig. 3). Moreover, new implant designs can be incorporated into the model and tested without any problem. This considerably reduces the time required and the costs of the development. Lateral collateral ligament Evaluation of a Mobilityretaining Spinal Implant Posterior cruciate ligament Medial collateral ligament 20 SULZER TECHNICAL REVIEW 1/2004 In order to be able to carry out an evaluation of spinal implants, it is necessary to have a basic understanding of the natural biomechanics of the human spine. This is especially true in the case of the Dynesys™ spinal implant (see STR 1/1999, p. 10) considered here, as it maintains the mobility of the spine, i. e., it stabilizes the vertebrae without stiffening them (Fig. 4). The effect of a Dynesys implant on a degenerated mobile segment (set up by two adjacent vertebrae) of the lumbar spine was compared with the intact kinematics. The conceptional procedure selected for this is divided into three steps. In step 1, all the relevant material parameters and material models, for example for the tissue of the intervertebral discs, were procured. These data formed the basis for subsequent biomechanical modeling of the mobile spinal segment. In step 2, this mobile segment was subjected to various FEM analyses. Specifically investigated was the 4 The Dynesys spinal implant consists of screws, tubular spacers, and an in-lying tie-rod. also allows – besides the simple evaluation of the implant itself – improvements to the implant design. Simplification of Approvals The validated calculation models provide valuable support in the initial development or further development of high-grade implants and prostheses. Besides their use in development and design, the numerical calculations described here also have great potential for simplifying and accelerating CE and FDA approvals and for making this process less costly. They offer the possibility of testing and demonstrating the efficacy and safety of new and further developments in a largely “natural” environment and thus of contributing to increased cost-effectiveness in the health sector. 5 Simulation of two vertebrae together with the Dynesys spinal implant. 6 Calculations show that the Dynesys spinal implant limits the unnaturally high mobility of a spinal segment in flexion to physiological values. Intact segment Degenerated segment Segment stabilized with Dynesys 200 180 Mobility of the segment (%) biomechanical response of the intact mobile segment, but also the effect of an almost completely degenerated intervertebral disc, which has only minimal residual load-bearing capacity. The deformation behavior of a mobile spinal segment is not trivial and can therefore only be simulated exclusively by means of efficient numerical methods such as FEM. Therefore in the present case, as in the previously described knee analysis, the Abaqus/Standard FEM program was used. Finally, in step 3, the effect of the Dynesys implant on the lumbar spine was analyzed. This was done by incorporating the CAD data for the Dynesys spinal implant into the already available calculation model of the mobile segment (Fig. 5). Then, as in step 2, FEM analyses of the mobile segment instrumented with Dynesys were carried out. With the biomechanical FEM analysis, numerous different loadings simulating a real (physiological) loading of the mobile segment in the human body were investigated. One example is flexion (bending forward of the upper part of the body). The resulting rotation of the upper spinal segment compared with the lower is represented for an intact segment, a degenerated segment, and a segment stabilized with a Dynesys implant (Fig. 6). The diagram shows how here the Dynesys implant supports the restoration of the natural kinematics of the particular spinal segment. Naturally, the various components of the implant must first be adjusted to the physiological mobility of two adjacent vertebrae. The biomechanical FEM analysis makes this possible and 160 140 CONTACT 120 Sulzer Innotec Thomas Zacharias Postfach 414 8401 Winterthur Switzerland Phone +41 (0)52-262 42 11 Fax +41 (0)52-262 00 85 thomas.zacharias@sulzer.com 100 80 60 40 20 0 SULZER TECHNICAL REVIEW 1/2004 21